Designing for Humans in Autonomous Systems: Military Applications

DTIC Science & Technology

2014-01-01

attentional control, and gaming experience are important determinants of how well humans interact with agents supervising multiple assets . 6 4...mission performance, operator workload, trust, SA, and, most important , how they affected human safety. The initial experiments were conducted in a...that humans can also play an important role by being able to identify these objects (perception by proxy). Therefore, human involvement is useful

42 CFR 3.408 - Factors considered in determining the amount of a civil money penalty.

Code of Federal Regulations, 2011 CFR

2011-10-01

... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT... respondent had financial difficulties that affected its ability to comply; (2) Whether the imposition of a civil money penalty would jeopardize the ability of the respondent to continue to provide health care or...

Human factors in modern traffic systems.

PubMed

Noy, Y I

1997-10-01

Traffic systems are undergoing enormous change with the advent of Intelligent Transport Systems (ITS). Although productivity and quality of mobility are emerging interests, safety remains the predominant preoccupation of ITS human factors. It should be evident that while intelligent technologies may have the potential to improve traffic safety, they also have the potential to adversely affect it. Ultimately, the effect on safety depends on the specific technologies that are invoked and the manner in which they are incorporated within the vehicle as well as within the larger road transportation system. Current automotive developments can be characterized as technology-centred solutions rather than user-centred solutions. Greater effort must be directed at understanding and accommodating the human element in the road transportation system in order that future transportation objectives can be achieved. There is a need to expand the scope of traditional human factors to include macro-level effects as well as to place greater emphasis on understanding human interactions with other elements of the system. There is also increasing recognition of the urgent need for systematic procedures and criteria for testing the safety of ITS prior to large-scale market penetration.

9 CFR 311.22 - Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema.

Code of Federal Regulations, 2012 CFR

2012-01-01

... folliculorum, or erythema may be passed for human food after detaching and condemning the affected skin, if the... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema. 311.22 Section 311.22 Animals and Animal Products FOOD SAFETY...

9 CFR 311.22 - Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema.

Code of Federal Regulations, 2011 CFR

2011-01-01

... folliculorum, or erythema may be passed for human food after detaching and condemning the affected skin, if the... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema. 311.22 Section 311.22 Animals and Animal Products FOOD SAFETY...

9 CFR 311.22 - Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema.

Code of Federal Regulations, 2014 CFR

2014-01-01

... folliculorum, or erythema may be passed for human food after detaching and condemning the affected skin, if the... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema. 311.22 Section 311.22 Animals and Animal Products FOOD SAFETY...

9 CFR 311.22 - Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema.

Code of Federal Regulations, 2013 CFR

2013-01-01

... folliculorum, or erythema may be passed for human food after detaching and condemning the affected skin, if the... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or erythema. 311.22 Section 311.22 Animals and Animal Products FOOD SAFETY...

9 CFR 314.11 - Handling of certain condemned products for purposes other than human food.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Handling of certain condemned products for purposes other than human food. 314.11 Section 314.11 Animals and Animal Products FOOD SAFETY AND... other than human food. Condemned carcasses of animals affected with one or more of the following...

Developing Healthy Companies through Human Resources Management. WBGH Worksite Wellness Series.

ERIC Educational Resources Information Center

Rosen, Robert; Freedman, Carol

Four areas--health benefits, occupational safety and health, prevention and wellness, and human resource development--have contributed significantly to enhancing worker health. The "healthy corporation" is both a goal and a comprehensive attitude about organizational life and about the factors the affect organizational health and, ultimately,…

Chemotherapy safety in clinical veterinary oncology.

PubMed

Klahn, Shawna

2014-09-01

Exposure to chemotherapy is a health hazard for all personnel in facilities that store, prepare, or administer antineoplastic agents. Contamination levels have been measured as much as 15 times higher in the veterinary medicine sector than in human facilities. Recent publications in human and veterinary medicine indicate that exposure extends beyond the clinic walls to affect the patient's home and family. This article provides an update on the advances in chemotherapy safety, the current issues, and the impact on cancer management in veterinary medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

The Role of Interpersonal Relations in Healthcare Team Communication and Patient Safety: A Proposed Model of Interpersonal Process in Teamwork.

PubMed

Lee, Charlotte Tsz-Sum; Doran, Diane Marie

2017-06-01

Patient safety is compromised by medical errors and adverse events related to miscommunications among healthcare providers. Communication among healthcare providers is affected by human factors, such as interpersonal relations. Yet, discussions of interpersonal relations and communication are lacking in healthcare team literature. This paper proposes a theoretical framework that explains how interpersonal relations among healthcare team members affect communication and team performance, such as patient safety. We synthesized studies from health and social science disciplines to construct a theoretical framework that explicates the links among these constructs. From our synthesis, we identified two relevant theories: framework on interpersonal processes based on social relation model and the theory of relational coordination. The former involves three steps: perception, evaluation, and feedback; and the latter captures relational communicative behavior. We propose that manifestations of provider relations are embedded in the third step of the framework on interpersonal processes: feedback. Thus, varying team-member relationships lead to varying collaborative behavior, which affects patient-safety outcomes via a change in team communication. The proposed framework offers new perspectives for understanding how workplace relations affect healthcare team performance. The framework can be used by nurses, administrators, and educators to improve patient safety, team communication, or to resolve conflicts.

Safety of street: The role of street design

NASA Astrophysics Data System (ADS)

Rashid, Suhaila Abdul; Wahab, Mohammad Hussaini; Rani, Wan Nurul Mardiah Wan Mohd.; Ismail, Syuhaida

2017-10-01

Living in the cities poses many challenges for the vulnerable group of user especially women where they are exposed to many issues related to safety. With the changing of lifestyle and demands, women are expected to play multiple roles in the society and working is one of the tasks. When women are expected to be working as men do, they are no longer occupied at one place. Women nowadays travel on a daily basis and being in the streets is one of the important activities. With the influx of diverse group of people into the country, our streets are dominated by different types of people from different background. Due to these factors, there are possibilities of challenges and threats for users especially women. Therefore, city spaces especially the street become an important public realm for women. The design of the street should be able to make women feel safe as these are the public space where they spend time getting to and from work. The way women perceived their environment might be different from men especially when they fear of crime. Perception of safety will affect the quality of life where fear is an important psychological factor in human life. Living in fear will restrict human's freedom. Therefore, this study aimed to explore women's perception of safety in the streets of Kuala Lumpur. The study adopted a mixed-method approach of qualitative and quantitative in order to understand the safety perception among women that will later establish the relationship between built environment and human psychology. 120 respondents were selected randomly around Jalan Benteng, Jalan Tun Perak, Jalan Melaka and Jalan Melayu. Questionnaire survey forms were distributed and structured observation was conducted at interval period at these streets to examined and assess women's behavior. Finding shows that fear does affect women's perception and physical design of the streets are important in affecting their behavior.

No Effect of Ambient Odor on the Affective Appraisal of a Desktop Virtual Environment with Signs of Disorder

PubMed Central

Toet, Alexander; van Schaik, Martin; Theunissen, Nicolet C. M.

2013-01-01

Background Desktop virtual environments (VEs) are increasingly deployed to study the effects of environmental qualities and interventions on human behavior and safety related concerns in built environments. For these applications it is essential that users appraise the affective qualities of the VE similar to those of its real world counterpart. Previous studies have shown that factors like simulated lighting, sound and dynamic elements all contribute to the affective appraisal of a desktop VE. Since ambient odor is known to affect the affective appraisal of real environments, and has been shown to increase the sense of presence in immersive VEs, it may also be an effective tool to tune the affective appraisal of desktop VEs. This study investigated if exposure to ambient odor can modulate the affective appraisal of a desktop VE with signs of public disorder. Method Participants explored a desktop VE representing a suburban neighborhood with signs of public disorder (neglect, vandalism and crime), while being exposed to either room air or subliminal levels of unpleasant (tar) or pleasant (cut grass) ambient odor. Whenever they encountered signs of disorder they reported their safety related concerns and associated affective feelings. Results Signs of crime in the desktop VE were associated with negative affective feelings and concerns for personal safety and personal property. However, there was no significant difference between reported safety related concerns and affective connotations in the control (no-odor) and in each of the two ambient odor conditions. Conclusion Ambient odor did not affect safety related concerns and affective connotations associated with signs of disorder in the desktop VE. Thus, semantic congruency between ambient odor and a desktop VE may not be sufficient to influence its affective appraisal, and a more realistic simulation in which simulated objects appear to emit scents may be required to achieve this goal. PMID:24250810

No effect of ambient odor on the affective appraisal of a desktop virtual environment with signs of disorder.

PubMed

Toet, Alexander; van Schaik, Martin; Theunissen, Nicolet C M

2013-01-01

Desktop virtual environments (VEs) are increasingly deployed to study the effects of environmental qualities and interventions on human behavior and safety related concerns in built environments. For these applications it is essential that users appraise the affective qualities of the VE similar to those of its real world counterpart. Previous studies have shown that factors like simulated lighting, sound and dynamic elements all contribute to the affective appraisal of a desktop VE. Since ambient odor is known to affect the affective appraisal of real environments, and has been shown to increase the sense of presence in immersive VEs, it may also be an effective tool to tune the affective appraisal of desktop VEs. This study investigated if exposure to ambient odor can modulate the affective appraisal of a desktop VE with signs of public disorder. Participants explored a desktop VE representing a suburban neighborhood with signs of public disorder (neglect, vandalism and crime), while being exposed to either room air or subliminal levels of unpleasant (tar) or pleasant (cut grass) ambient odor. Whenever they encountered signs of disorder they reported their safety related concerns and associated affective feelings. Signs of crime in the desktop VE were associated with negative affective feelings and concerns for personal safety and personal property. However, there was no significant difference between reported safety related concerns and affective connotations in the control (no-odor) and in each of the two ambient odor conditions. Ambient odor did not affect safety related concerns and affective connotations associated with signs of disorder in the desktop VE. Thus, semantic congruency between ambient odor and a desktop VE may not be sufficient to influence its affective appraisal, and a more realistic simulation in which simulated objects appear to emit scents may be required to achieve this goal.

Thematic Analysis of Women's Perspectives on the Meaning of Safety During Hospital-Based Birth.

PubMed

Lyndon, Audrey; Malana, Jennifer; Hedli, Laura C; Sherman, Jules; Lee, Henry C

2018-05-01

To explore women's birth experiences to develop an understanding of their perspectives on patient safety during hospital-based birth. Qualitative description using thematic analysis of interview data. Seventeen women ages 29 to 47 years. Women participated in individual or small group interviews about their birth experiences, the physical environment, interactions with clinicians, and what safety meant to them in the context of birth. An interdisciplinary group of five investigators from nursing, medicine, product design, and journalism analyzed transcripts thematically to examine how women experienced feeling safe or unsafe and identify opportunities for improvements in care. Participants experienced feelings of safety on a continuum. These feelings were affected by confidence in providers, the environment and organizational factors, interpersonal interactions, and actions people took during risk moments of rapid or confusing change. Well-organized teams and sensitive interpersonal interactions that demonstrated human connection supported feelings of safety, whereas some routine aspects of care threatened feelings of safety. Physical and emotional safety are inextricably embedded in the patient experience, yet this connection may be overlooked in some inpatient birth settings. Clinicians should be mindful of how the birth environment and their behaviors in it can affect a woman's feelings of safety during birth. Human connection is especially important during risk moments, which represent a liminal space at the intersection of physical and emotional safety. At least one team member should focus on the provision of emotional support during rapidly changing situations to mitigate the potential for negative experiences that can result in emotional harm. Copyright © 2018 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

49 CFR 520.2 - Policy.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 6 2012-10-01 2012-10-01 false Policy. 520.2 Section 520.2 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT... affect the quality of the human environment. ...

49 CFR 520.2 - Policy.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 6 2014-10-01 2014-10-01 false Policy. 520.2 Section 520.2 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT... affect the quality of the human environment. ...

49 CFR 520.2 - Policy.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 6 2011-10-01 2011-10-01 false Policy. 520.2 Section 520.2 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT... affect the quality of the human environment. ...

49 CFR 520.2 - Policy.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 6 2013-10-01 2013-10-01 false Policy. 520.2 Section 520.2 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT... affect the quality of the human environment. ...

49 CFR 520.2 - Policy.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Policy. 520.2 Section 520.2 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT... affect the quality of the human environment. ...

Direct Human Contact with Siloxanes (Silicones) – Safety or Risk Part 1. Characteristics of Siloxanes (Silicones)

PubMed Central

Mojsiewicz-Pieńkowska, Krystyna; Jamrógiewicz, Marzena; Szymkowska, Katarzyna; Krenczkowska, Dominika

2016-01-01

Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exclusively obtained by synthesis. Their chemical structure determines a range of physicochemical properties which were recognized as unique. Due to the susceptibility to chemical modifications, ability to create short, long or complex polymer particles, siloxanes found an application in many areas of human life. Siloxanes differ in particle size, molecular weight, shape and chemical groups. As a result, this determines the different physico-chemical properties, that directly affect the safety or the risk of their use. The areas that can be a source of danger to human health will be commented in this paper. PMID:27303296

Safe traffic : Vision Zero on the move

DOT National Transportation Integrated Search

2006-03-01

Vision Zero is composed of several basic : elements, each of which affects safety in : road traffic. These concerns ethics, human : capability and tolerance, responsibility, : scientific facts and a realisation that the : different components in the ...

Current and Future Technologies for Microbiological Decontamination of Cereal Grains.

PubMed

Los, Agata; Ziuzina, Dana; Bourke, Paula

2018-06-01

Cereal grains are the most important staple foods for mankind worldwide. The constantly increasing annual production and yield is matched by demand for cereals, which is expected to increase drastically along with the global population growth. A critical food safety and quality issue is to minimize the microbiological contamination of grains as it affects cereals both quantitatively and qualitatively. Microorganisms present in cereals can affect the safety, quality, and functional properties of grains. Some molds have the potential to produce harmful mycotoxins and pose a serious health risk for consumers. Therefore, it is essential to reduce cereal grain contamination to the minimum to ensure safety both for human and animal consumption. Current production of cereals relies heavily on pesticides input, however, numerous harmful effects on human health and on the environment highlight the need for more sustainable pest management and agricultural methods. This review evaluates microbiological risks, as well as currently used and potential technologies for microbiological decontamination of cereal grains. © 2018 Institute of Food Technologists®.

National plan to enhance aviation safety through human factors improvements

NASA Technical Reports Server (NTRS)

Foushee, Clay

1990-01-01

The purpose of this section of the plan is to establish a development and implementation strategy plan for improving safety and efficiency in the Air Traffic Control (ATC) system. These improvements will be achieved through the proper applications of human factors considerations to the present and future systems. The program will have four basic goals: (1) prepare for the future system through proper hiring and training; (2) develop a controller work station team concept (managing human errors); (3) understand and address the human factors implications of negative system results; and (4) define the proper division of responsibilities and interactions between the human and the machine in ATC systems. This plan addresses six program elements which together address the overall purpose. The six program elements are: (1) determine principles of human-centered automation that will enhance aviation safety and the efficiency of the air traffic controller; (2) provide new and/or enhanced methods and techniques to measure, assess, and improve human performance in the ATC environment; (3) determine system needs and methods for information transfer between and within controller teams and between controller teams and the cockpit; (4) determine how new controller work station technology can optimally be applied and integrated to enhance safety and efficiency; (5) assess training needs and develop improved techniques and strategies for selection, training, and evaluation of controllers; and (6) develop standards, methods, and procedures for the certification and validation of human engineering in the design, testing, and implementation of any hardware or software system element which affects information flow to or from the human.

75 FR 754 - Safety Zone and Regulated Navigation Area, Chicago Sanitary and Ship Canal, Romeoville, IL

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-06

... barriers would affect a human body if immersed in the water. The NEDU final report concluded that the possible effects to a human body if immersed in the water include paralysis of body muscles, inability to... body of your document so that we can contact you if we have questions regarding your submission. To...

Understanding the relationship between safety investment and safety performance of construction projects through agent-based modeling.

PubMed

Lu, Miaojia; Cheung, Clara Man; Li, Heng; Hsu, Shu-Chien

2016-09-01

The construction industry in Hong Kong increased its safety investment by 300% in the past two decades; however, its accident rate has plateaued to around 50% for one decade. Against this backdrop, researchers have found inconclusive results on the causal relationship between safety investment and safety performance. Using agent-based modeling, this study takes an unconventional bottom-up approach to study safety performance on a construction site as an outcome of a complex system defined by interactions among a worksite, individual construction workers, and different safety investments. Instead of focusing on finding the absolute relationship between safety investment and safety performance, this study contributes to providing a practical framework to investigate how different safety investments interacting with different parameters such as human and environmental factors could affect safety performance. As a result, we could identify cost-effective safety investments under different construction scenarios for delivering optimal safety performance. Copyright © 2016 Elsevier Ltd. All rights reserved.

Olfaction

PubMed Central

Pinto1, Jayant M.

2011-01-01

Olfaction represents an ancient, evolutionarily critical physiologic system. In humans, chemosensation mediates safety, nutrition, sensation of pleasure, and general well-being. Factors that affect human olfaction included structural aspects of the nasal cavity that can modulate airflow and therefore odorant access to the olfactory cleft, and inflammatory disease, which can affect both airflow as well as olfactory nerve function. After signals are generated, olfactory information is processed and coded in the olfactory bulb and disseminated to several areas in the brain. The discovery of olfactory receptors by Axel and Buck sparked greater understanding of the molecular basis of olfaction. However, the precise mechanisms used by this system are still under great scrutiny due to the complexity of understanding how an enormous number of chemically diverse odorant molecules are coded into signals understood by the brain. Additionally, it has been challenging to dissect olfactory sensation due to the multiple areas of areas of the brain that receive and modulate this information. Consequently, our knowledge of olfactory dysfunction in humans remains primitive. Aging represents the major cause of loss of smell, although a number of clinical and environmental factors are thought to affect chemosensory function. Treatment options focus on reducing sinonasal inflammation when present, ruling out other treatable causes, and counseling patients on safety measures. PMID:21364221

Los Angeles congestion reduction demonstration (Metro ExpressLanes) program. National evaluation : safety data test plan.

DOT National Transportation Integrated Search

1999-07-01

This document presents human factors guidelines for designers, owners operators, and planners involved in the development and operation of traffic management centers. Dimensions of the work environment affecting operator and system performance are ad...

Soils and public health: the vital nexus

USDA-ARS?s Scientific Manuscript database

Soils sustain life. They affect human health via quantity, quality, and safety of available food and water, and via direct exposure of individuals to soils. Throughout the history of civilization, soil-health relationships have inspired spiritual movements, philosophical systems, cultural exchanges,...

The safety of treatment options available for gout.

PubMed

Schlesinger, Naomi

2017-04-01

Gout is the most common inflammatory arthritis in humans. Gout treatment includes rapid initiation of anti-inflammatory medications for acute attacks and chronically treating with urate lowering drugs as well as chronic anti-inflammatory prophylaxis. Areas covered: This review aims to provide an overview and discussion of the safety concerns of current treatment options available for gout. Expert opinion: Gout is a curable disease with appropriate treatment. The advent of new therapies provides encouraging opportunities to improve gout management. However, clinicians should be aware of some of the safety concerns of medications used to treat acute and chronic gout. When prescribing medications for gout one has to be mindful of the presence of comorbidities commonly affecting gout patients that may affect drug safety and efficacy, especially in the elderly and in patients treated with multiple drugs. The benefits of gout drugs, usually, outweigh their safety concerns. Studies are needed in gout patients with chronic kidney disease and/or cardiovascular disease, so that escalation of dosing /combination of anti-inflammatory drugs needed to suppress gouty inflammation as well as escalation of dosing/combination of urate lowering drugs needed to achieve target serum urate level will lead to better understanding of gout treatment safety issues.

Nurse-Technology Interactions and Patient Safety.

PubMed

Ruppel, Halley; Funk, Marjorie

2018-06-01

Nurses are the end-users of most technology in intensive care units, and the ways in which they interact with technology affect quality of care and patient safety. Nurses' interactions include the processes of ensuring proper input of data into the technology as well as extracting and interpreting the output (clinical data, technical data, alarms). Current challenges in nurse-technology interactions for physiologic monitoring include issues regarding alarm management, workflow interruptions, and monitor surveillance. Patient safety concepts, like high reliability organizations and human factors, can advance efforts to enhance nurse-technology interactions. Copyright © 2018 Elsevier Inc. All rights reserved.

75 FR 36288 - Amended Safety Zone and Regulated Navigation Area, Chicago Sanitary and Ship Canal, Romeoville, IL

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-25

... current from the barriers would affect a human body if immersed in the water. The NEDU final report concluded that the possible effects to a human body if immersed in the water include paralysis of body... address, an e-mail address, or a telephone number in the body of your document so that we can contact you...

75 FR 75145 - Regulated Navigation Area, Chicago Sanitary and Ship Canal, Romeoville, IL; Safety Zone, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-02

... current from the barriers would affect a human body if immersed in the water. The NEDU final report concluded that the possible effects to a human body if immersed in the water include paralysis of body..., an e-mail address, or a telephone number in the body of your document so that we can contact you if...

Animal vehicle crash mitigation using advanced technology phase I : review, design, and implementation.

DOT National Transportation Integrated Search

2006-08-01

Animal-vehicle collisions affect human safety, property and wildlife. The number of these types of collisions has increased : substantially over the last decades. This report describes the results of a project that explored the prospects for a relati...

Climate Change Impact Assessment for Surface Transportation in the Pacific Northwest and Alaska

DOT National Transportation Integrated Search

2012-01-01

The states in the Pacific Northwest and Alaska region share interconnected transportation networks for people, goods, and services that support the : regional economy, mobility, and human safety. Regional weather has and will continue to affect the p...

Microbiological Safety of Animal Wastes Processed by Physical Heat Treatment: An Alternative To Eliminate Human Pathogens in Biological Soil Amendments as Recommended by the Food Safety Modernization Act.

PubMed

Chen, Zhao; Jiang, Xiuping

2017-03-01

Animal wastes have high nutritional value as biological soil amendments of animal origin for plant cultivation in sustainable agriculture; however, they can be sources of some human pathogens. Although composting is an effective way to reduce pathogen levels in animal wastes, pathogens may still survive under certain conditions and persist in the composted products, which potentially could lead to fresh produce contamination. According to the U.S. Food and Drug Administration Food Safety Modernization Act, alternative treatments are recommended for reducing or eliminating human pathogens in raw animal manure. Physical heat treatments can be considered an effective method to inactivate pathogens in animal wastes. However, microbial inactivation in animal wastes can be affected by many factors, such as composition of animal wastes, type and physiological stage of the tested microorganism, and heat source. Following some current processing guidelines for physical heat treatments may not be adequate for completely eliminating pathogens from animal wastes. Therefore, this article primarily reviews the microbiological safety and economic value of physically heat-treated animal wastes as biological soil amendments.

Fire safety applications for spacecraft

NASA Technical Reports Server (NTRS)

Friedman, Robert; Olson, Sandra L.

1989-01-01

Fire safety for spacecraft is reviewed by first describing current practices, many of which are adapted directly from aircraft. Then, current analyses and experimental knowledge in low-gravity combustion, with implications for fire safety are discussed. In orbiting spacecraft, the detection and suppression of flames are strongly affected by the large reduction in buoyant flows under low gravity. Generally, combustion intensity is reduced in low gravity. There are some notable exceptions, however, one example being the strong enhancement of flames by low-velocity ventilation flows in space. Finally, the future requirements in fire safety, particularly the needs of long-duration space stations in fire prevention, detection, extinguishment, and atmospheric control are examined. The goal of spacecraft fire-safety investigations is the establishment of trade-offs that promote maximum safety without hampering the useful human and scientific activities in space.

DISPELLING MYTHS AND MISCONCEPTIONS TO IMPLEMENT A SAFETY CULTURE

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

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

2003-02-27

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

Climate Change and Food Security: Health Impacts in Developed Countries

PubMed Central

Hooper, Lee; Abdelhamid, Asmaa; Bentham, Graham; Boxall, Alistair B.A.; Draper, Alizon; Fairweather-Tait, Susan; Hulme, Mike; Hunter, Paul R.; Nichols, Gordon; Waldron, Keith W.

2012-01-01

Background: Anthropogenic climate change will affect global food production, with uncertain consequences for human health in developed countries. Objectives: We investigated the potential impact of climate change on food security (nutrition and food safety) and the implications for human health in developed countries. Methods: Expert input and structured literature searches were conducted and synthesized to produce overall assessments of the likely impacts of climate change on global food production and recommendations for future research and policy changes. Results: Increasing food prices may lower the nutritional quality of dietary intakes, exacerbate obesity, and amplify health inequalities. Altered conditions for food production may result in emerging pathogens, new crop and livestock species, and altered use of pesticides and veterinary medicines, and affect the main transfer mechanisms through which contaminants move from the environment into food. All these have implications for food safety and the nutritional content of food. Climate change mitigation may increase consumption of foods whose production reduces greenhouse gas emissions. Impacts may include reduced red meat consumption (with positive effects on saturated fat, but negative impacts on zinc and iron intake) and reduced winter fruit and vegetable consumption. Developed countries have complex structures in place that may be used to adapt to the food safety consequences of climate change, although their effectiveness will vary between countries, and the ability to respond to nutritional challenges is less certain. Conclusions: Climate change will have notable impacts upon nutrition and food safety in developed countries, but further research is necessary to accurately quantify these impacts. Uncertainty about future impacts, coupled with evidence that climate change may lead to more variable food quality, emphasizes the need to maintain and strengthen existing structures and policies to regulate food production, monitor food quality and safety, and respond to nutritional and safety issues that arise. PMID:23124134

Climate change and food security: health impacts in developed countries.

PubMed

Lake, Iain R; Hooper, Lee; Abdelhamid, Asmaa; Bentham, Graham; Boxall, Alistair B A; Draper, Alizon; Fairweather-Tait, Susan; Hulme, Mike; Hunter, Paul R; Nichols, Gordon; Waldron, Keith W

2012-11-01

Anthropogenic climate change will affect global food production, with uncertain consequences for human health in developed countries. We investigated the potential impact of climate change on food security (nutrition and food safety) and the implications for human health in developed countries. Expert input and structured literature searches were conducted and synthesized to produce overall assessments of the likely impacts of climate change on global food production and recommendations for future research and policy changes. Increasing food prices may lower the nutritional quality of dietary intakes, exacerbate obesity, and amplify health inequalities. Altered conditions for food production may result in emerging pathogens, new crop and livestock species, and altered use of pesticides and veterinary medicines, and affect the main transfer mechanisms through which contaminants move from the environment into food. All these have implications for food safety and the nutritional content of food. Climate change mitigation may increase consumption of foods whose production reduces greenhouse gas emissions. Impacts may include reduced red meat consumption (with positive effects on saturated fat, but negative impacts on zinc and iron intake) and reduced winter fruit and vegetable consumption. Developed countries have complex structures in place that may be used to adapt to the food safety consequences of climate change, although their effectiveness will vary between countries, and the ability to respond to nutritional challenges is less certain. Climate change will have notable impacts upon nutrition and food safety in developed countries, but further research is necessary to accurately quantify these impacts. Uncertainty about future impacts, coupled with evidence that climate change may lead to more variable food quality, emphasizes the need to maintain and strengthen existing structures and policies to regulate food production, monitor food quality and safety, and respond to nutritional and safety issues that arise.

77 FR 33724 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-07

... and OMB Number: Assessing Human Response to Military Impulse Noise; OMB Control Number 0710-TBD. Type... community annoyance and complaints, related to impulsive noise from military installations. The [[Page 33725... the need for training operations at military installations with public safety and welfare. Affected...

FACTORS AFFECTING DISINFECTION AND STABILIZATION OF SEWAGE SLUDGE

EPA Science Inventory

Effective disinfection and stabilization of sewage sludge prior to land application is essential to not only protect human health, but also to convince the public of its benefits and safety. A basic understanding of the key factors involved in producing a stable biosolid product ...

Suspected botulism in dairy cows and its implications for the safety of human food.

PubMed

Cobb, S P; Hogg, R A; Challoner, D J; Brett, M M; Livesey, C T; Sharpe, R T; Jones, T O

2002-01-05

A large outbreak of suspected botulism occurred on a dairy farm. The affected animals were listless and showed signs ranging from hindlimb unsteadiness to lateral recumbency, although the most common presentation was sternal recumbency with an apparent hindlimb weakness when stimulated to rise. Postmortem examinations revealed no conclusive gross pathology or histopathology. The affected cattle were found to have neutrophilia and hyperglycaemia with no other consistent haematological or biochemical abnormalities. The combination of clinical signs, disease epidemiology and the ruling out of other differential diagnoses strongly supported a diagnosis of unconfirmed botulism; however, the source of toxin was not demonstrated. Botulism is a severe disease in human beings and there are uncertainties about the pharmacokinetics and pharmacodynamics of Clostridium botulinum toxins. In such circumstances, a precautionary approach to food safety is essential. Restrictions were placed on the movement of livestock and sale of milk from the farm premises until 14 days after the onset of the last clinical case.

Safety and side effects of cannabidiol, a Cannabis sativa constituent.

PubMed

Bergamaschi, Mateus Machado; Queiroz, Regina Helena Costa; Zuardi, Antonio Waldo; Crippa, José Alexandre S

2011-09-01

Cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, has multiple pharmacological actions, including anxiolytic, antipsychotic, antiemetic and anti-inflammatory properties. However, little is known about its safety and side effect profile in animals and humans. This review describes in vivo and in vitro reports of CBD administration across a wide range of concentrations, based on reports retrieved from Web of Science, Scielo and Medline. The keywords searched were "cannabinoids", "cannabidiol" and "side effects". Several studies suggest that CBD is non-toxic in non-transformed cells and does not induce changes on food intake, does not induce catalepsy, does not affect physiological parameters (heart rate, blood pressure and body temperature), does not affect gastrointestinal transit and does not alter psychomotor or psychological functions. Also, chronic use and high doses up to 1,500 mg/day of CBD are reportedly well tolerated in humans. Conversely, some studies reported that this cannabinoid can induce some side effects, including inhibition of hepatic drug metabolism, alterations of in vitro cell viability, decreased fertilization capacity, and decreased activities of p-glycoprotein and other drug transporters. Based on recent advances in cannabinoid administration in humans, controlled CBD may be safe in humans and animals. However, further studies are needed to clarify these reported in vitro and in vivo side effects.

Workforce Characteristics, Perceptions, Stress, and Satisfaction among Staff in Green House and Other Nursing Homes.

PubMed

Brown, Patrick B; Hudak, Sandra L; Horn, Susan D; Cohen, Lauren W; Reed, David Allen; Zimmerman, Sheryl

2016-02-01

To compare workforce characteristics and staff perceptions of safety, satisfaction, and stress between Green House (GH) and comparison nursing homes (CNHs). Primary data on staff perceptions of safety, stress, and satisfaction from 13 GHs and 8 comparison NHs in 11 states; secondary data from human resources records on workforce characteristics, turnover, and staffing from 01/01/2011-06/30/2012. Observational study. Workforce data were from human resources offices; staff perceptions were from surveys. Few significant differences were found between GH and CNHs. Exceptions were GH direct caregivers were older, provided twice the normalized hours per week budgeted per resident than CNAs in CNHs or Legacy NHs, and trended toward lower turnover. GH environment may promote staff longevity and does not negatively affect worker's stress, safety perceptions, or satisfaction. Larger studies are needed to confirm findings. © Health Research and Educational Trust.

Neurotoxins at home and in the workplace. Hearings before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, House of Representatives, Ninety-Ninth Congress, First Session, October 8, 9, 1985

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

Not Available

1986-01-01

Experts in neurology and toxicology, disabled workers, health and safety agencies, and labor unions were among those represented at two days of hearings on the impact of chemicals on human health and safety. The witnesses described how neurotoxins, which occur in everyday household and workplace situations, affect the human body and how it would be possible to test for these effects before exposure. Representatives of the Occupational Safety and Health Administration (OSHA) described the communication standard for letting workers know about potential hazards. At issue was whether OSHA has done as much as it should to see that employers whomore » produce or use hazardous chemicals are providing adequate information to workers and consumers. An appendix with additional material submitted for the record follows the testimony of 13 witnesses.« less

Human health and safety risks management in underground coal mines using fuzzy TOPSIS.

PubMed

Mahdevari, Satar; Shahriar, Kourosh; Esfahanipour, Akbar

2014-08-01

The scrutiny of health and safety of personnel working in underground coal mines is heightened because of fatalities and disasters that occur every year worldwide. A methodology based on fuzzy TOPSIS was proposed to assess the risks associated with human health in order to manage control measures and support decision-making, which could provide the right balance between different concerns, such as safety and costs. For this purpose, information collected from three hazardous coal mines namely Hashouni, Hojedk and Babnizu located at the Kerman coal deposit, Iran, were used to manage the risks affecting the health and safety of their miners. Altogether 86 hazards were identified and classified under eight categories: geomechanical, geochemical, electrical, mechanical, chemical, environmental, personal, and social, cultural and managerial risks. Overcoming the uncertainty of qualitative data, the ranking process is accomplished by fuzzy TOPSIS. After running the model, twelve groups with different risks were obtained. Located in the first group, the most important risks with the highest negative effects are: materials falling, catastrophic failure, instability of coalface and immediate roof, firedamp explosion, gas emission, misfire, stopping of ventilation system, wagon separation at inclines, asphyxiation, inadequate training and poor site management system. According to the results, the proposed methodology can be a reliable technique for management of the minatory hazards and coping with uncertainties affecting the health and safety of miners when performance ratings are imprecise. The proposed model can be primarily designed to identify potential hazards and help in taking appropriate measures to minimize or remove the risks before accidents can occur. Copyright © 2014 Elsevier B.V. All rights reserved.

Stability of Cortisol and Cortisone in Human Breast Milk During Holder Pasteurization.

PubMed

van der Voorn, Bibian; de Waard, Marita; Dijkstra, Lisette R; Heijboer, Annemieke C; Rotteveel, Joost; van Goudoever, Johannes B; Finken, Martijn J J

2017-12-01

Human donor milk is the feeding of choice for preterm infants, when own mother's milk is not available. Holder pasteurization is necessary to secure the safety of donor milk, although it can affect milk quality by reduction of nutritional and bioactive components. Recently, research has focused on the potential role of breast milk glucocorticoids for infant development. At this moment, it is unknown whether pasteurization affects milk glucocorticoid levels. Therefore, we assessed whether Holder pasteurization, the most frequently used method nowadays, reduces breast milk cortisol and cortisone levels, using breast milk samples from 30 women who delivered at term. We found tight correlations between pre- and postpasteurization levels of cortisol (R = 0.99) and cortisone (R = 0.98), and good agreement in Passing and Bablok regression analysis. In conclusion, cortisol and cortisone in human term breast milk are not significantly affected by Holder pasteurization.

Human factors evaluation of remote afterloading brachytherapy: Human error and critical tasks in remote afterloading brachytherapy and approaches for improved system performance. Volume 1

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

Callan, J.R.; Kelly, R.T.; Quinn, M.L.

1995-05-01

Remote Afterloading Brachytherapy (RAB) is a medical process used in the treatment of cancer. RAB uses a computer-controlled device to remotely insert and remove radioactive sources close to a target (or tumor) in the body. Some RAB problems affecting the radiation dose to the patient have been reported and attributed to human error. To determine the root cause of human error in the RAB system, a human factors team visited 23 RAB treatment sites in the US The team observed RAB treatment planning and delivery, interviewed RAB personnel, and performed walk-throughs, during which staff demonstrated the procedures and practices usedmore » in performing RAB tasks. Factors leading to human error in the RAB system were identified. The impact of those factors on the performance of RAB was then evaluated and prioritized in terms of safety significance. Finally, the project identified and evaluated alternative approaches for resolving the safety significant problems related to human error.« less

Impact of a Food Safety Campaign on Streptococcus suis Infection in Humans in Thailand.

PubMed

Takeuchi, Dan; Kerdsin, Anusak; Akeda, Yukihiro; Chiranairadul, Piphat; Loetthong, Phacharaphan; Tanburawong, Nutchada; Areeratana, Prasanee; Puangmali, Panarat; Khamisara, Kasean; Pinyo, Wirasinee; Anukul, Rapeepun; Samerchea, Sutit; Lekhalula, Punpong; Nakayama, Tatsuya; Yamamoto, Kouji; Hirose, Masayo; Hamada, Shigeyuki; Dejsirilert, Surang; Oishi, Kazunori

2017-06-01

Abstract Streptococcus suis is an important zoonotic pathogen in swine and humans that causes sepsis and meningitis. Our previous study in Thailand showed that the prevalence of S. suis infection in humans, especially in northern areas of Thailand, and the transmission of the pathogen occurred mainly through the consumption of traditional raw pork products. Considering the high incidence proportion and mortality rate of the disease as an important public health problem, we implemented a food safety campaign in the Phayao Province in northern Thailand in 2011. We evaluated the effects of a food safety campaign by comparing the sociodemographic, clinical, and bacteriological characteristics of cases before and after the campaign. The follow-up study showed a marked decrease of the incidence proportion in the first 2 years, indicating the effectiveness of the campaign. In the third year, however, the incidence proportion slightly increased again, indicating the existence of deep-rooted cultural behaviors and the necessity of continuous public health intervention. Furthermore, epidemiological analysis of the cases made it possible to estimate the infectivity of the pathogen via the oral route of infection. In the present study, we showed the effectiveness of the food safety campaign for controlling the S. suis infection, and we present a role model public health intervention for prevalent areas affected by S. suis infection in humans.

Impact of a Food Safety Campaign on Streptococcus suis Infection in Humans in Thailand

PubMed Central

Takeuchi, Dan; Kerdsin, Anusak; Akeda, Yukihiro; Chiranairadul, Piphat; Loetthong, Phacharaphan; Tanburawong, Nutchada; Areeratana, Prasanee; Puangmali, Panarat; Khamisara, Kasean; Pinyo, Wirasinee; Anukul, Rapeepun; Samerchea, Sutit; Lekhalula, Punpong; Nakayama, Tatsuya; Yamamoto, Kouji; Hirose, Masayo; Hamada, Shigeyuki; Dejsirilert, Surang; Oishi, Kazunori

2017-01-01

Streptococcus suis is an important zoonotic pathogen in swine and humans that causes sepsis and meningitis. Our previous study in Thailand showed that the prevalence of S. suis infection in humans, especially in northern areas of Thailand, and the transmission of the pathogen occurred mainly through the consumption of traditional raw pork products. Considering the high incidence proportion and mortality rate of the disease as an important public health problem, we implemented a food safety campaign in the Phayao Province in northern Thailand in 2011. We evaluated the effects of a food safety campaign by comparing the sociodemographic, clinical, and bacteriological characteristics of cases before and after the campaign. The follow-up study showed a marked decrease of the incidence proportion in the first 2 years, indicating the effectiveness of the campaign. In the third year, however, the incidence proportion slightly increased again, indicating the existence of deep-rooted cultural behaviors and the necessity of continuous public health intervention. Furthermore, epidemiological analysis of the cases made it possible to estimate the infectivity of the pathogen via the oral route of infection. In the present study, we showed the effectiveness of the food safety campaign for controlling the S. suis infection, and we present a role model public health intervention for prevalent areas affected by S. suis infection in humans. PMID:28719258

NASA technical advances in aircraft occupant safety. [clear air turbulence detectors, fire resistant materials, and crashworthiness

NASA Technical Reports Server (NTRS)

Enders, J. H.

1978-01-01

NASA's aviation safety technology program examines specific safety problems associated with atmospheric hazards, crash-fire survival, control of aircraft on runways, human factors, terminal area operations hazards, and accident factors simulation. While aircraft occupants are ultimately affected by any of these hazards, their well-being is immediately impacted by three specific events: unexpected turbulence encounters, fire and its effects, and crash impact. NASA research in the application of laser technology to the problem of clear air turbulence detection, the development of fire resistant materials for aircraft construction, and to the improvement of seats and restraint systems to reduce crash injuries are reviewed.

Safety profile and long-term engraftment of human CD31+ blood progenitors in bone tissue engineering.

PubMed

Zigdon-Giladi, Hadar; Elimelech, Rina; Michaeli-Geller, Gal; Rudich, Utai; Machtei, Eli E

2017-07-01

Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering. hEPCs were isolated from peripheral blood, cultured and characterized. β tricalcium phosphate scaffold (βTCP, control) or 10 6 hEPCs loaded onto βTCP were transplanted in a nude rat calvaria model. New bone formation and blood vessel density were analyzed using histomorphometry and micro-computed tomography (CT). Safety of hEPCs using karyotype analysis, tumorigenecity and biodistribution to target organs was evaluated. On the cellular level, hEPCs retained their karyotype during cell expansion (seven passages). Five months following local hEPC transplantation, on the tissue and organ level, no inflammatory reaction or dysplastic change was evident at the transplanted site or in distant organs. Direct engraftment was evident as CD31 human antigens were detected lining vessel walls in the transplanted site. In distant organs human antigens were absent, negating biodistribution. Bone area fraction and bone height were doubled by hEPC transplantation without affecting mineral density and bone architecture. Additionally, local transplantation of hEPCs increased blood vessel density by nine-fold. Local transplantation of hEPCs showed a positive safety profile. Furthermore, enhanced angiogenesis and osteogenesis without mineral density change was found. These results bring us one step closer to first-in-human trials using hEPCs for bone regeneration. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

The impact of nursing work environments on patient safety outcomes: the mediating role of burnout/engagement.

PubMed

Spence Laschinger, Heather K; Leiter, Michael P

2006-05-01

To test a theoretical model of professional nurse work environments linking conditions for professional nursing practice to burnout and, subsequently, patient safety outcomes. The 2004 Institute of Medicine report raised serious concerns about the impact of hospital restructuring on nursing work environments and patient safety outcomes. Few studies have used a theoretical framework to study the nature of the relationships between nursing work environments and patient safety outcomes. Hospital-based nurses in Canada (N = 8,597) completed measures of worklife (Practice Environment Scale of the Nursing Work Index), burnout (Maslach Burnout Inventory-Human Service Scale), and their report of frequency of adverse patient events. Structural equation modeling analysis supported an extension of Leiter and Laschinger's Nursing Worklife Model. Nursing leadership played a fundamental role in the quality of worklife regarding policy involvement, staffing levels, support for a nursing model of care (vs medical), and nurse/physician relationships. Staffing adequacy directly affected emotional exhaustion, and use of a nursing model of care had a direct effect on nurses' personal accomplishment. Both directly affected patient safety outcomes. The results suggest that patient safety outcomes are related to the quality of the nursing practice work environment and nursing leadership's role in changing the work environment to decrease nurse burnout.

21 CFR 610.15 - Constituent materials.

Code of Federal Regulations, 2012 CFR

2012-04-01

... evidence that it does not affect adversely the safety or potency of the product. The amount of aluminum in... culture produced vaccines. Extraneous protein known to be capable of producing allergenic effects in human subjects shall not be added to a final virus medium of cell culture produced vaccines intended for...

21 CFR 610.15 - Constituent materials.

Code of Federal Regulations, 2013 CFR

2013-04-01

... evidence that it does not affect adversely the safety or potency of the product. The amount of aluminum in... culture produced vaccines. Extraneous protein known to be capable of producing allergenic effects in human subjects shall not be added to a final virus medium of cell culture produced vaccines intended for...

21 CFR 610.15 - Constituent materials.

Code of Federal Regulations, 2014 CFR

2014-04-01

... evidence that it does not affect adversely the safety or potency of the product. The amount of aluminum in... culture produced vaccines. Extraneous protein known to be capable of producing allergenic effects in human subjects shall not be added to a final virus medium of cell culture produced vaccines intended for...

40 CFR 300.135 - Response operations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... exposure; the potential impact on human health, welfare, and safety and the environment; whether the discharge or release poses a substantial threat to the public health or welfare of the United States as discussed in § 300.322; the potential impact on natural resources and property which may be affected...

40 CFR 300.135 - Response operations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... exposure; the potential impact on human health, welfare, and safety and the environment; whether the discharge or release poses a substantial threat to the public health or welfare of the United States as discussed in § 300.322; the potential impact on natural resources and property which may be affected...

Why Population Matters, 1996.

ERIC Educational Resources Information Center

Population Action International, Washington, DC.

Population growth around the world affects Americans through its impact on economy, environment, safety, and health, and the condition of the world children will inherit. The cumulative evidence is strong that current rates of population growth pose significant and interacting risks to human well-being and are a legitimate concern for Americans.…

GSD Update: Strategies for understanding and controlling species invasions

Treesearch

Deborah M. Finch

2013-01-01

Invasive species are significant environmental and economic threats to our Nation's and the world's ecosystems and natural resources. They impact wildlife habitat, endanger native species, threaten ecosystem services, damage lakes and rivers, reduce recreational opportunities, affect production of wood products, jeopardize human health and safety and reduce...

Impacts of soil and water pollution on food safety and health risks in China.

PubMed

Lu, Yonglong; Song, Shuai; Wang, Ruoshi; Liu, Zhaoyang; Meng, Jing; Sweetman, Andrew J; Jenkins, Alan; Ferrier, Robert C; Li, Hong; Luo, Wei; Wang, Tieyu

2015-04-01

Environmental pollution and food safety are two of the most important issues of our time. Soil and water pollution, in particular, have historically impacted on food safety which represents an important threat to human health. Nowhere has that situation been more complex and challenging than in China, where a combination of pollution and an increasing food safety risk have affected a large part of the population. Water scarcity, pesticide over-application, and chemical pollutants are considered to be the most important factors impacting on food safety in China. Inadequate quantity and quality of surface water resources in China have led to the long-term use of waste-water irrigation to fulfill the water requirements for agricultural production. In some regions this has caused serious agricultural land and food pollution, especially for heavy metals. It is important, therefore, that issues threatening food safety such as combined pesticide residues and heavy metal pollution are addressed to reduce risks to human health. The increasing negative effects on food safety from water and soil pollution have put more people at risk of carcinogenic diseases, potentially contributing to 'cancer villages' which appear to correlate strongly with the main food producing areas. Currently in China, food safety policies are not integrated with soil and water pollution management policies. Here, a comprehensive map of both soil and water pollution threats to food safety in China is presented and integrated policies addressing soil and water pollution for achieving food safety are suggested to provide a holistic approach. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

PubMed

2008-02-01

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

What can be learned in the snake antivenom field from the developments in human plasma derived products?

PubMed

Burnouf, Thierry

2018-05-01

Human plasma-derived medicinal products and snake antivenom immunoglobulins are unique and complex therapeutic protein products. Human plasma products are obtained by fractionating large pools of plasma collected from blood plasma donors. They comprise a wide range of protein products, including polyvalent and hyperimmune immunoglobulins, coagulation factors, albumin, and various protease inhibitors that are transfused to patients affected by congenital or acquired protein deficiencies, immunological disorders, or metabolic diseases. Snake antivenoms are manufactured from pools of plasma collected from animals, typically horses, which have been immunized against snake venoms. Transfusing antivenoms is the cornerstone therapy to treat patients affected by snakebite envenoming. Over the last thirty years, much technical and regulatory evolution has been implemented to ensure that this class of biologicals meets modern quality requirements. The purpose of this review is to compare the main developments that took place in plasma production, protein fractionation, pathogen safety, quality control, preclinical and clinical studies, and regulations of these products. We also analyze whether both fields have been influencing and cross-fertilizing each other technically and in regulatory aspects to reach modern safety and efficacy standards at global levels, and how experience in the human plasma fractionation industry can further impact the manufacture of snake antivenom and that of other animal-derived antisera. Copyright © 2018 Elsevier Ltd. All rights reserved.

A lipid transfer protein increases the glutathione content and enhances Arabidopsis resistance to a trichothecene mycotoxin

USDA-ARS?s Scientific Manuscript database

Fusarium head blight (FHB) or scab is one of the most important plant diseases worldwide, affecting wheat, barley and other small grains. Trichothecene mycotoxins such as deoxynivalenol (DON) accumulate in the grain, presenting a food safety risk and health hazard to humans and animals. Despite cons...

Prebiotics in food animals, a potential to reduce foodborne pathogens and disease

USDA-ARS?s Scientific Manuscript database

Animals can be seriously impacted by bacterial pathogens that affect their growth efficiency and overall health, as well as food safety of animal-derived products. Some pathogenic bacteria, such as Salmonella, can be a shared problem for both human and animal health and can be found in many animal ...

Prebiotics in food animals: A potential to reduce foodborne pathogens and disease

USDA-ARS?s Scientific Manuscript database

Animals can be seriously impacted by bacterial pathogens that affect their growth efficiency and overall health, as well as food safety of animal-derived products. Some pathogenic bacteria, such as Salmonella, can be a shared problem for both human and animal health and can be found in many animal ...

Tetracycline can induce the expression of invasion factors in multidrug-resistant Salmonella during early-log phase

USDA-ARS?s Scientific Manuscript database

The prevalence of multidrug-resistant (MDR) Salmonella continues to be an important health and safety concern in both humans and animals worldwide. Because the response of drug resistant bacteria exposed to antibiotics can affect a variety of cellular processes, such as motility, attachment, and in...

21 CFR 12.87 - Purpose; oral and written testimony; burden of proof.

Code of Federal Regulations, 2010 CFR

2010-04-01

... proof. 12.87 Section 12.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... in promptly settling controversial matters affecting the public health and welfare. (b) Accordingly... safety of a food or color additive, or a definition and standard of identity for a food; or the issues...

30 CFR 551.6 - Obligations and rights under a permit or a Notice.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., coastal, or human environment; (3) Cause harm or damage to any mineral resource (in areas leased or not... environmental hazards which imminently threaten life and property; or (3) Adversely affect the environment... of the area for navigation and safety purposes. (d) Any persons conducting shallow test drilling or...

30 CFR 551.6 - Obligations and rights under a permit or a Notice.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., coastal, or human environment; (3) Cause harm or damage to any mineral resource (in areas leased or not... environmental hazards which imminently threaten life and property; or (3) Adversely affect the environment... of the area for navigation and safety purposes. (d) Any persons conducting shallow test drilling or...

30 CFR 551.6 - Obligations and rights under a permit or a Notice.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., coastal, or human environment; (3) Cause harm or damage to any mineral resource (in areas leased or not... environmental hazards which imminently threaten life and property; or (3) Adversely affect the environment... of the area for navigation and safety purposes. (d) Any persons conducting shallow test drilling or...

Effects of national culture on human failures in container shipping: the moderating role of Confucian dynamism.

PubMed

Lu, Chin-Shan; Lai, Kee-hung; Lun, Y H Venus; Cheng, T C E

2012-11-01

Recent reports on work safety in container shipping operations highlight high frequencies of human failures. In this study, we empirically examine the effects of seafarers' perceptions of national culture on the occurrence of human failures affecting work safety in shipping operations. We develop a model adopting Hofstede's national culture construct, which comprises five dimensions, namely power distance, collectivism/individualism, uncertainty avoidance, masculinity/femininity, and Confucian dynamism. We then formulate research hypotheses from theory and test the hypotheses using survey data collected from 608 seafarers who work on global container carriers. Using a point scale for evaluating seafarers' perception of the five national culture dimensions, we find that Filipino seafarers score highest on collectivism, whereas Chinese and Taiwanese seafarers score highest on Confucian dynamism, followed by collectivism, masculinity, power distance, and uncertainty avoidance. The results also indicate that Taiwanese seafarers have a propensity for uncertainty avoidance and masculinity, whereas Filipino seafarers lean more towards power distance, masculinity, and collectivism, which are consistent with the findings of Hofstede and Bond (1988). The results suggest that there will be fewer human failures in container shipping operations when power distance is low, and collectivism and uncertainty avoidance are high. Specifically, this study finds that Confucian dynamism plays an important moderating role as it affects the strength of associations between some national culture dimensions and human failures. Finally, we discuss our findings' contribution to the development of national culture theory and their managerial implications for reducing the occurrence of human failures in shipping operations. Copyright © 2012 Elsevier Ltd. All rights reserved.

Subjective perception of safety in healthy individuals working with 7 T MRI scanners: a retrospective multicenter survey.

PubMed

Fatahi, Mahsa; Demenescu, Liliana Ramona; Speck, Oliver

2016-06-01

To retrospectively assess perception of safety of healthy individuals working with human 7 Tesla (T) magnetic resonance imaging (MRI) scanners. A total of 66 healthy individuals with a mean age of 31 ± 7 years participated in this retrospective multicentre survey study. Nonparametric correlation analysis was conducted to evaluate the relation between self-reported perception of safety and prevalence of sensory effects while working with 7 T MRI scanners for an average 47 months. The results indicated that 98.5 % of the study participants had a neutral or positive feeling about safety aspects at 7 T MRI scanners. 45.5 % reported that they feel very safe and none of the participants stated that they feel moderately or very unsafe while working with 7 T MRI scanners. Perception of safety was not affected by the number of hours per week spent in the vicinity of the 7 T MRI scanner or the duration of experience with 7 T MRI. More than 50 % of individuals experienced vertigo and metallic taste while working with 7 T MRI scanners. However, participants' perceptions of safety were not affected by the prevalence of MR-related symptoms. The overall data indicated an average perception of a moderately safe work environment. To our knowledge, this study delineates the first attempt to assess the subjective safety perception among 7 T MRI workers and suggests further investigations are indicated.

Fifty years of driving safety research.

PubMed

Lee, John D

2008-06-01

This brief review covers the 50 years of driving-related research published in Human Factors, its contribution to driving safety, and emerging challenges. Many factors affect driving safety, making it difficult to assess the impact of specific factors such as driver age, cell phone distractions, or collision warnings. The author considers the research themes associated with the approximately 270 articles on driving published in Human Factors in the past 50 years. To a large extent, current and past research has explored similar themes and concepts. Many articles published in the first 25 years focused on issues such as driver impairment, individual differences, and perceptual limits. Articles published in the past 25 years address similar issues but also point toward vehicle technology that can exacerbate or mitigate the negative effect of these issues. Conceptual and computational models have played an important role in this research. Improved crash-worthiness has contributed to substantial improvements in driving safety over the past 50 years, but future improvements will depend on enhancing driver performance and perhaps, more important, improving driver behavior. Developing models to guide this research will become more challenging as new technology enters the vehicle and shifts the focus from driver performance to driver behavior. Over the past 50 years, Human Factors has accumulated a large base of driving-related research that remains relevant for many of today's design and policy concerns.

Significance of Waterway Navigation Positioning Systems On Ship's Manoeuvring Safety

NASA Astrophysics Data System (ADS)

Galor, W.

The main goal of navigation is to lead the ship to the point of destination safety and efficiently. Various factors may affect ship realisating this process. The ship movement on waterway are mainly limited by water area dimensions (surface and depth). These limitations cause the requirement to realise the proper of ship movement trajectory. In case when this re requirement cant't fulfil then marine accident may happend. This fact is unwanted event caused losses of human health and life, damage or loss of cargo and ship, pollution of natural environment, damage of port structures or blocking the port of its ports and lost of salvage operation. These losses in same cases can be catas- trophical especially while e.i. crude oil spilling could be place. To realise of safety navigation process is needed to embrace the ship's movement trajectory by waterways area. The ship's trajectory is described by manoeuvring lane as a surface of water area which is require to realise of safety ship movement. Many conditions affect to ship manoeuvring line. The main are following: positioning accuracy, ship's manoeuvring features and phenomena's of shore and ship's bulk common affecting. The accuracy of positioning system is most important. This system depends on coast navigation mark- ing which can range many kinds of technical realisation. Mainly used systems based on lights (line), radionavigation (local system or GPS, DGPS), or radars. If accuracy of positiong is higer, then safety of navigation is growing. This article presents these problems exemplifying with approaching channel to ports situated on West Pomera- nian water region.

Worldwide Emerging Environmental Issues Affecting the U.S. Military. July 2006 - December 2006

DTIC Science & Technology

2006-12-01

and Biological Safety Eleventh Chemical Weapons Convention Better International Controls Needed to Prevent Bioterrorism Human Biomonitoring for...Environmental Cooperation to Increase Enforcement of Environmental Regulations and Public Participation Sixth Review Conference of the Biological Weapons ...scanning reports.] [September 2006. Military Implications, Sources] Chemical and Biological Safey Eleventh Chemical Weapons Convention The 11th

Pursuing the Human Side of Driving. A Senior Grade Level Driver Education Refresher Course Curriculum.

ERIC Educational Resources Information Center

Bradley, David L.; Sorte, Bruce M.

Designed for high school seniors, this supplemental traffic safety program serves as a catalyst for discussion and learning in the area of affective education and safe and responsible driving. The guide is comprised of seven instructional units: (1) Orientation; (2) Communication Skills; (3) Skillful Decision Maker and Why; (4) Recognizing…

A Review of Recent Advances in Perioperative Patient Safety.

PubMed

Fowler, Alexander J

2013-01-01

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

Space Medicine

NASA Technical Reports Server (NTRS)

Pool, Sam L.

2000-01-01

The National Academy of Sciences Committee on Space Biology and Medicine points out that space medicine is unique among space sciences, because in addition to addressing questions of fundamental scientific interest, it must address clinical or human health and safety issues as well. Efforts to identify how microgravity affects human physiology began in earnest by the United States in 1960 with the establishment of the National Aeronautics and Space Administration (NASA's) Life Sciences program. Before the first human space missions, prediction about the physiological effects of microgravity in space ranged from extremely severe to none at all. The understanding that has developed from our experiences in space to date allows us to be guardedly optimistic about the ultimate accommodations of humans to space flight. Only by our travels into the microgravity environment of space have we begun to unravel the mysteries associated with gravity's role in shaping human physiology. Space medicine is still at its very earliest stages. Development of this field has been slow for several reasons, including the limited number of space flights, the small number of research subjects, and the competition within the life sciences community and other disciplines for flight opportunities. The physiological changes incurred during space flight may have a dramatic effect on the course of an injury or illness. These physiological changes present an exciting challenge for the field of space medicine: how to best preserve human health and safety while simultaneously deciphering the effects of microgravity on human performance. As the United States considers the future of humans in long-term space travel, it is essential that the many mysteries as to how microgravity affects human systems be addressed with vigor. Based on the current state of our knowledge, the justification is excellent indeed compelling- for NASA to develop a sophisticated capability in space medicine. Teams of physicians and scientists should be actively engaged in fundamental and applied research designed to ensure that it is safe for humans to routinely and repeatedly stay and work in the microgravity environment of space.

Children affected by HIV/AIDS: SAFE, a model for promoting their security, health, and development.

PubMed

Betancourt, Theresa S; Fawzi, Mary K S; Bruderlein, Claude; Desmond, Chris; Kim, Jim Y

2010-05-01

A human security framework posits that individuals are the focus of strategies that protect the safety and integrity of people by proactively promoting children's well being, placing particular emphasis on prevention efforts and health promotion. This article applies this framework to a rights-based approach in order to examine the health and human rights of children affected by HIV/AIDS. The SAFE model describes sources of insecurity faced by children across four fundamental dimensions of child well-being and the survival strategies that children and families may employ in response. The SAFE model includes: Safety/protection; Access to health care and basic physiological needs; Family/connection to others; and Education/livelihoods. We argue that it is critical to examine the situation of children through an integrated lens that effectively looks at human security and children's rights through a holistic approach to treatment and care rather than artificially limiting our scope of work to survival-oriented interventions for children affected by HIV/AIDS. Interventions targeted narrowly at children, in isolation of their social and communal environment as outlined in the SAFE model, may in fact undermine protective resources in operation in families and communities and present additional threats to children's basic security. An integrated approach to the basic security and care of children has implications for the prospects of millions of children directly infected or indirectly affected by HIV/AIDS around the world. The survival strategies that young people and their families engage in must be recognized as a roadmap for improving their protection and promoting healthy development. Although applied to children affected by HIV/AIDS in the present analysis, the SAFE model has implications for guiding the care and protection of children and families facing adversity due to an array of circumstances from armed conflict and displacement to situations of extreme poverty.

Immunogenicity of glycans on biotherapeutic drugs produced in plant expression systems—The taliglucerase alfa story

PubMed Central

Rup, Bonita; Alon, Sari; Amit-Cohen, Bat-Chen; Brill Almon, Einat; Chertkoff, Raul; Rudd, Pauline M.

2017-01-01

Plants are a promising alternative for the production of biotherapeutics. Manufacturing in-planta adds plant specific glycans. To understand immunogenic potential of these glycans, we developed a validated method to detect plant specific glycan antibodies in human serum. Using this assay, low prevalence of pre-existing anti-plant glycan antibodies was found in healthy humans (13.5%) and in glucocerebrosidase-deficient Gaucher disease (GD) patients (5%). A low incidence (9% in naïve patient and none in treatment experienced patients) of induced anti-plant glycan antibodies was observed in GD patients after up to 30 months replacement therapy treatment with taliglucerase alfa, a version of human glucocerebrosidase produced in plant cells. Detailed evaluation of clinical safety and efficacy endpoints indicated that anti-plant glycan antibodies did not affect the safety or efficacy of taliglucerase alfa in patients. This study shows the benefit of using large scale human trials to evaluate the immunogenicity risk of plant derived glycans, and indicates no apparent risk related to anti-plant glycan antibodies. PMID:29088235

Immunogenicity of glycans on biotherapeutic drugs produced in plant expression systems-The taliglucerase alfa story.

PubMed

Rup, Bonita; Alon, Sari; Amit-Cohen, Bat-Chen; Brill Almon, Einat; Chertkoff, Raul; Tekoah, Yoram; Rudd, Pauline M

2017-01-01

Plants are a promising alternative for the production of biotherapeutics. Manufacturing in-planta adds plant specific glycans. To understand immunogenic potential of these glycans, we developed a validated method to detect plant specific glycan antibodies in human serum. Using this assay, low prevalence of pre-existing anti-plant glycan antibodies was found in healthy humans (13.5%) and in glucocerebrosidase-deficient Gaucher disease (GD) patients (5%). A low incidence (9% in naïve patient and none in treatment experienced patients) of induced anti-plant glycan antibodies was observed in GD patients after up to 30 months replacement therapy treatment with taliglucerase alfa, a version of human glucocerebrosidase produced in plant cells. Detailed evaluation of clinical safety and efficacy endpoints indicated that anti-plant glycan antibodies did not affect the safety or efficacy of taliglucerase alfa in patients. This study shows the benefit of using large scale human trials to evaluate the immunogenicity risk of plant derived glycans, and indicates no apparent risk related to anti-plant glycan antibodies.

A multilevel examination of affective job insecurity climate on safety outcomes.

PubMed

Jiang, Lixin; Probst, Tahira M

2016-07-01

Previous research has established a causal link between individual perceptions of job insecurity and safety outcomes. However, whether job insecurity climate is associated with safety outcomes has not been studied. The purpose of the current study was to explore the main and cross-level interaction effects of affective job insecurity climate on safety outcomes, including behavioral safety compliance, reporting attitudes, workplace injuries, experienced safety events, unreported safety events, and accident underreporting, beyond individual affective job insecurity. With 171 employees nested in 40 workgroups, multilevel analyses revealed that the negative impacts of individual affective job insecurity on safety outcomes are exacerbated when they occur in a climate of high affective job insecurity. These results are interpreted in light of safety management efforts and suggest that efforts to create a secure climate within one's workgroup may reap safety-related benefits. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Preclinical safety evaluation of human platelets treated with antimicrobial peptides in severe combined immunodeficient mice.

PubMed

Bosch-Marcé, Marta; Mohan, Ketha V K; Gelderman, Monique P; Ryan, Patricia L; Russek-Cohen, Estelle; Atreya, Chintamani D

2014-03-01

Bacterial sepsis is a complication attributed to room temperature (RT)-stored platelets (PLTs) in transfusion medicine. Antimicrobial peptides (AMPs) are emerging as new therapeutic agents against microbes. We had previously demonstrated bactericidal activity of select synthetic AMPs against six types of bacteria in stored PLTs. In this report, we tested these AMPs for their potential antibody response and interference with the recovery and survival of human PLTs in an animal model. Two separate studies were conducted to evaluate the safety of the synthetic AMPs. 1) Two AMPs (PD3 and PD4), derived from thrombin-induced human PLT microbicidal protein, and four repeats of arginine-tryptophan (RW), containing two to five repeats (RW2-RW5), were tested in rabbits for potential antibody response. 2) RT-stored human PLTs treated for 2 hours with each of the six AMPs individually or with phosphate-buffered saline (PBS) alone were infused into severe combined immunodeficient (SCID) mice to evaluate their in vivo recovery and survival by flow cytometry. Except for PD3, which showed a weak immune response, all other peptides did not induce any detectable antibodies in rabbits. Furthermore, all six AMPs tested did not significantly affect the in vivo recovery and survival of human PLTs in SCID mice compared to PBS alone-treated PLTs. Preclinical evaluation studies reported here demonstrate that the selected AMPs used in the study did not adversely affect the human PLT recovery and survival in the SCID mouse model, suggesting further study of AMPs toward addressing the bacterial contamination of PLTs. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

The NASA Ames Fatigue Countermeasures Program: The Next Generation

NASA Technical Reports Server (NTRS)

Rosekind, Mark R.; Neri, David F.; Miller, Donna L.; Gregory, Kevin B.; Webbon, Lissa L.; Oyung, Ray L.

1997-01-01

Twenty-four hour, global aviation operations pose unique challenges to humans. Physiological requirements related to sleep, the internal circadian clock, and human fatigue are critical factors that are known to affect safety, performance, and productivity. Understanding the human operators' physiological capabilities, and limitations, will be important to address these issues as global demand for aviation activities continues to increase. In 1980, in response to a Congressional request, the National Aeronautics and Space Administration (NASA) Ames Research Center initiated a Fatigue/Jet Lag Program to examine the role of fatigue in flight operations. Originally established by Dr. John K. Lauber and Dr. Charles E. Billings, the Program was designed to address three objectives: (1) determine the extent of fatigue, sleep loss, and circadian disruption in flight operations; (2) determine how fatigue affected flight crew performance; and (3) develop strategies to maximize performance and alertness during flight operations.

Aptamer-based technology for food analysis.

PubMed

Liu, Xiaofei; Zhang, Xuewu

2015-01-01

Aptamers are short and functional single-stranded oligonucleotide sequences selected from systematic evolution of ligands by exponential enrichment (SELEX) process, which have the capacity to recognize various classes of target molecules with high affinity and specificity. Various analytical aptamers acquired by SELEX are widely used in many research fields, such as medicine, biology, and chemistry. However, the application of this innovative and emerging technology to food safety is just in infant stage. Food safety plays a very important role in our daily lives because varieties of poisonous and harmful substances in food affect human health. Aptamer technique is promising, which can overcome many disadvantages of existing detection methods in food safety, such as long detection time, low sensitivity, difficult, and expensive antibody preparation. This review provides an overview of various aptamer screening technologies and summarizes the recent applications of aptamers in food safety, and future prospects are also discussed.

Human Milk Processing: A Systematic Review of Innovative Techniques to Ensure the Safety and Quality of Donor Milk.

PubMed

Peila, Chiara; Emmerik, Nikki E; Giribaldi, Marzia; Stahl, Bernd; Ruitenberg, Joost E; van Elburg, Ruurd M; Moro, Guido E; Bertino, Enrico; Coscia, Alessandra; Cavallarin, Laura

2017-03-01

Pasteurization, performed at 62.5°C for 30 minutes (holder pasteurization), is currently recommended in all international human milk banks guidelines, but it affects some human milk bioactive and nutritive components. The present systematic review is aimed at critically reviewing evidence on the suitability of human milk processing techniques other than holder pasteurization, both thermal and nonthermal, to ensure microbiological safety, and on the effects of these techniques on biologically active donor milk components. A systematic review of English and non-English articles using Medline, PubMed, Embase, SCOPUS, and CAB Abstracts, with no restriction in publication date was performed. Search terms included: human, breast, donor, or banked milk, breastmilk, breast fed, breastfed, breastfeed; HTST, Flash, High Pressure, UV, ultrasonic or nonthermal; process, pasteuris, pasteuriz. Only primary research articles published in peer-reviewed journals were included, providing or not a comparison with holder pasteurized human milk, provided that the pasteurization technique was clearly described, and not intended for domestic use. Additional studies were identified by searching bibliographies of relevant articles. Twenty-six studies were identified as being relevant. Two examined both High Pressure Processing and High-Temperature-Short-Time pasteurization; 10 only examined High Pressure Processing; 10 only examined High-Temperature-Short-Time; 2 articles examined ultraviolet irradiation; 2 articles examined (thermo-)ultrasonic processing. The results indicate that data about safety for microbiological control are still scarce for most of the novel technologies, and that consensus on processing conditions is necessary for nonthermal technologies, before any conclusions on the qualitative and nutritional advantages of these techniques can be drawn.

Comparative study of hop-containing products on human cytochrome p450-mediated metabolism.

PubMed

Foster, Brian C; Kearns, Nikia; Arnason, John T; Saleem, Ammar; Ogrodowczyk, Carolina; Desjardins, Suzanne

2009-06-10

Thirty-five national and international brands of beer were examined for their potential to affect human cytochrome P450 (CYP)-mediated metabolism. They represented the two main categories of beer, ales and lagers, and included a number of specialty products including bitter (porter, stout), coffee, ice, wheat, Pilsner, and hemp seed. Aliquots were examined for nonvolatile soluble solids, effect on CYP metabolism and P-glycoprotein (Pgp) transport, and major alpha- and beta-hop acids. Wide variance was detected in contents of alcohol, nonvolatile suspended solids, and hop acids and in the potential to affect CYP-mediated metabolism and Pgp-mediated efflux transport. Many of the products affected CYP2C9-mediated metabolism, and only two (NRP 306 and 307) markedly affected CYP3A4; hence, some products have the capacity to affect drug safety. CYP3A4, CYP3A5, CYP3A7, and CYP19 (aromatase) inhibition to the log concentration of beta-acid content was significant with r(2) > 0.37, suggesting that these components can account for some of the variation in inhibition of CYP metabolism.

Human factors paradigm and customer care perceptions.

PubMed

Clarke, Colin; Eales-Reynolds, Lesley-Jane

2015-01-01

The purpose of this paper is to examine if customer care (CC) can be directly linked to patient safety through a human factors (HF) framework. Data from an online questionnaire, completed by a convenience healthcare worker sample (n=373), was interrogated using thematic analysis within Vincent et al.'s (1998) HF theoretical framework. This proposes seven areas affecting patient safety: institutional context, organisation and management, work environment, team factors, individual, task and patient. Analysis identified responses addressing all framework areas. Responses (597) principally focused on work environment 40.7 per cent (n=243), organisation and management 28.8 per cent (n=172). Nevertheless, reference to other framework areas were clearly visible within the data: teams 10.2 per cent (n=61), individual 6.7 per cent (n=40), patients 6.0 per cent (n=36), tasks 4.2 per cent (n=24) and institution 3.5 per cent (n=21). Findings demonstrate congruence between CC perceptions and patient safety within a HF framework. The questionnaire requested participants to identify barriers to rather than CC enablers. Although this was at a single site complex organisation, it was similar to those throughout the NHS and other international health systems. CC can be viewed as consonant with patient safety rather than the potentially dangerous consumerisation stance, which could ultimately compromise patient safety. This work provides an original perspective on the link between CC and patient safety and has the potential to re-focus healthcare perceptions.

Revisiting the safety of aspartame.

PubMed

Choudhary, Arbind Kumar; Pretorius, Etheresia

2017-09-01

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

[Study on the safety of blue light leak of LED].

PubMed

Shen, Chong-Yu; Xu, Zheng; Zhao, Su-Ling; Huang, Qing-Yu

2014-02-01

In this paper, the blue light properties of LED illumination devices have been investigated. Against the status quo of China's LED lighting, we measured the spectrum component of LED lamps and analyzed the photobiological safety under the current domestic and international standards GB/T 20145-2006/CIE S009/E: 2002 and IEC62471: 2006 standards as well as CTL-0744_2009-laser resolution, which provides the reference to the manufacture of LED lighting lamps as well as related safety standards and laws. If the radiance intensity of blue light in LED is lower than 100 W x m(-2) x Sr(-1), there is no harm to human eyes. LEDs will not cause harm to human eyes under normal use, but we should pay attention to the protection of special populations (children), and make sure that they avoid looking at a light source for a long time. The research has found that the blue-rich lamps can affect the human rule of work and rest, and therefore, the LED lamps with color temperature below 4 000 K and color rendering index of 80 are suitable for indoor use. At the same time, the lamps with different parameters should be selected according to the different distances.

The affect heuristic in occupational safety.

PubMed

Savadori, Lucia; Caovilla, Jessica; Zaniboni, Sara; Fraccaroli, Franco

2015-07-08

The affect heuristic is a rule of thumb according to which, in the process of making a judgment or decision, people use affect as a cue. If a stimulus elicits positive affect then risks associated to that stimulus are viewed as low and benefits as high; conversely, if the stimulus elicits negative affect, then risks are perceived as high and benefits as low. The basic tenet of this study is that affect heuristic guides worker's judgment and decision making in a risk situation. The more the worker likes her/his organization the less she/he will perceive the risks as high. A sample of 115 employers and 65 employees working in small family agricultural businesses completed a questionnaire measuring perceived safety costs, psychological safety climate, affective commitment and safety compliance. A multi-sample structural analysis supported the thesis that safety compliance can be explained through an affect-based heuristic reasoning, but only for employers. Positive affective commitment towards their family business reduced employers' compliance with safety procedures by increasing the perceived cost of implementing them.

In vitro assessment of the effects of vedolizumab binding on peripheral blood lymphocytes

PubMed Central

Wyant, Tim; Yang, Lili; Fedyk, Eric

2013-01-01

Vedolizumab (VDZ) is a humanized monoclonal antibody in development for the treatment of inflammatory bowel disease. VDZ binds to the α4β7 integrin complex and inhibits its binding to mucosal addressin cell adhesion molecule-1 (MAdCAM-1), thus preventing lymphocyte extravasation to gut mucosal tissues. To understand whether VDZ has additional effects that may affect its overall safety as a therapeutic molecule, we examined other potential actions of VDZ. In vitro assays with human peripheral blood lymphocytes demonstrated that VDZ fails to elicit cytotoxicity, lymphocyte activation, and cytokine production from memory T lymphocytes and does not interfere with the suppressive ability of regulatory T cells. Furthermore, we demonstrated that VDZ induces internalization of α4β7 and that the integrin is rapidly re-expressed and fully functional after VDZ withdrawal. These studies provide insight into the mechanisms underlying the observed safety profile of VDZ in clinical trials. PMID:24492340

People-Technology-Ecosystem Integration: A Framework to Ensure Regional Interoperability for Safety, Sustainability, and Resilience of Interdependent Energy, Water, and Seafood Sources in the (Persian) Gulf.

PubMed

Meshkati, Najmedin; Tabibzadeh, Maryam; Farshid, Ali; Rahimi, Mansour; Alhanaee, Ghena

2016-02-01

The aim of this study is to identify the interdependencies of human and organizational subsystems of multiple complex, safety-sensitive technological systems and their interoperability in the context of sustainability and resilience of an ecosystem. Recent technological disasters with severe environmental impact are attributed to human factors and safety culture causes. One of the most populous and environmentally sensitive regions in the world, the (Persian) Gulf, is on the confluence of an exponentially growing number of two industries--nuclear power and seawater desalination plants--that is changing its land- and seascape. Building upon Rasmussen's model, a macrosystem integrative framework, based on the broader context of human factors, is developed, which can be considered in this context as a "meta-ergonomics" paradigm, for the analysis of interactions, design of interoperability, and integration of decisions of major actors whose actions can affect safety and sustainability of the focused industries during routine and nonroutine (emergency) operations. Based on the emerging realities in the Gulf region, it is concluded that without such systematic approach toward addressing the interdependencies of water and energy sources, sustainability will be only a short-lived dream and prosperity will be a disappearing mirage for millions of people in the region. This multilayered framework for the integration of people, technology, and ecosystem--which has been applied to the (Persian) Gulf--offers a viable and vital approach to the design and operation of large-scale complex systems wherever the nexus of water, energy, and food sources are concerned, such as the Black Sea. © 2016, Human Factors and Ergonomics Society.

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).

MIT January Operational Internship Experience 2011

NASA Technical Reports Server (NTRS)

DeLatte, Danielle; Furhmann, Adam; Habib, Manal; Joujon-Roche, Cecily; Opara, Nnaemeka; Pasterski, Sabrina Gonzalez; Powell, Christina; Wimmer, Andrew

2011-01-01

This slide presentation reviews the 2011 January Operational Internship experience (JOIE) program which allows students to study operational aspects of spaceflight, how design affects operations and systems engineering in practice for 3 weeks. Topics include: (1) Systems Engineering (2) NASA Organization (3) Workforce Core Values (4) Human Factors (5) Safety (6) Lean Engineering (7) NASA Now (8) Press, Media, and Outreach and (9) Future of Spaceflight.

Midwives and human rights: dream or reality?

PubMed

Thompson, Joyce E

2002-09-01

Midwives as predominantly women caring for other women are subject to the same human rights violations and abuse that affect all the women of the world. They need to know and recognise these human rights violations before being able to take action that will reduce or eliminate such harmful practices. In this article, I address gender-based violations of the basic human rights of particular concern to women during their childbearing years, such as personal safety, respect for human dignity, fair and equitable access to health services, along with autonomous decision-making based on complete and unbiased information. The ethical and legal foundations of human rights are discussed in relation to viewing women as fully human, fully persons. Guidance for midwives taken from key documents of the International Confederation of Midwives are offered as midwives work together with women to end gender-based violations of one's human rights.

2009 Human Factors and Roadway Safety Workshop : Teen Driver Safety [SD .WMV (720x480/29fps/177.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: Teen Driver Safety : Keynote Speaker Dan McGehee, director, Human Factors & Vehicle Safety Res...

Perceptual load in different regions of the visual scene and its relevance for driving.

PubMed

Marciano, Hadas; Yeshurun, Yaffa

2015-06-01

The aim of this study was to better understand the role played by perceptual load, at both central and peripheral regions of the visual scene, in driving safety. Attention is a crucial factor in driving safety, and previous laboratory studies suggest that perceptual load is an important factor determining the efficiency of attentional selectivity. Yet, the effects of perceptual load on driving were never studied systematically. Using a driving simulator, we orthogonally manipulated the load levels at the road (central load) and its sides (peripheral load), while occasionally introducing critical events at one of these regions. Perceptual load affected driving performance at both regions of the visual scene. Critically, the effect was different for central versus peripheral load: Whereas load levels on the road mainly affected driving speed, load levels on its sides mainly affected the ability to detect critical events initiating from the roadsides. Moreover, higher levels of peripheral load impaired performance but mainly with low levels of central load, replicating findings with simple letter stimuli. Perceptual load has a considerable effect on driving, but the nature of this effect depends on the region of the visual scene at which the load is introduced. Given the observed importance of perceptual load, authors of future studies of driving safety should take it into account. Specifically, these findings suggest that our understanding of factors that may be relevant for driving safety would benefit from studying these factors under different levels of load at different regions of the visual scene. © 2014, Human Factors and Ergonomics Society.

Effects of an Advanced Reactor’s Design, Use of Automation, and Mission on Human Operators

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

Jeffrey C. Joe; Johanna H. Oxstrand

The roles, functions, and tasks of the human operator in existing light water nuclear power plants (NPPs) are based on sound nuclear and human factors engineering (HFE) principles, are well defined by the plant’s conduct of operations, and have been validated by years of operating experience. However, advanced NPPs whose engineering designs differ from existing light-water reactors (LWRs) will impose changes on the roles, functions, and tasks of the human operators. The plans to increase the use of automation, reduce staffing levels, and add to the mission of these advanced NPPs will also affect the operator’s roles, functions, and tasks.more » We assert that these factors, which do not appear to have received a lot of attention by the design engineers of advanced NPPs relative to the attention given to conceptual design of these reactors, can have significant risk implications for the operators and overall plant safety if not mitigated appropriately. This paper presents a high-level analysis of a specific advanced NPP and how its engineered design, its plan to use greater levels of automation, and its expanded mission have risk significant implications on operator performance and overall plant safety.« less

Effect of temperature and sunlight on the stability of human adenoviruses and MS2 as fecal contaminants on fresh produce surfaces.

PubMed

Carratalà, Anna; Rodriguez-Manzano, Jesús; Hundesa, Ayalkibet; Rusiñol, Marta; Fresno, Sandra; Cook, Nigel; Girones, Rosina

2013-06-17

Determining the stability, or persistence in an infectious state, of foodborne viral pathogens attached to surfaces of soft fruits and salad vegetables is essential to underpin risk assessment studies in food safety. Here, we evaluate the effect of temperature and sunlight on the stability of infectious human adenoviruses type 2 and MS2 bacteriophages on lettuce and strawberry surfaces as representative fresh products. Human adenoviruses have been selected because of their double role as viral pathogens and viral indicators of human fecal contamination. Stability assays were performed with artificially contaminated fresh samples kept in the dark or under sunlight exposure at 4 and 30°C over 24h. The results indicate that temperature is the major factor affecting HAdV stability in fresh produce surfaces, effecting decay between 3 and 4 log after 24h at 30°C. The inactivation times to achieve a reduction between 1 and 4-log are calculated for each experimental condition. This work provides useful information to be considered for improving food safety regarding the transmission of foodborne viruses through supply chains. Copyright © 2013 Elsevier B.V. All rights reserved.

Effects of human fatigue on speech signals

NASA Astrophysics Data System (ADS)

Stamoulis, Catherine

2004-05-01

Cognitive performance may be significantly affected by fatigue. In the case of critical personnel, such as pilots, monitoring human fatigue is essential to ensure safety and success of a given operation. One of the modalities that may be used for this purpose is speech, which is sensitive to respiratory changes and increased muscle tension of vocal cords, induced by fatigue. Age, gender, vocal tract length, physical and emotional state may significantly alter speech intensity, duration, rhythm, and spectral characteristics. In addition to changes in speech rhythm, fatigue may also affect the quality of speech, such as articulation. In a noisy environment, detecting fatigue-related changes in speech signals, particularly subtle changes at the onset of fatigue, may be difficult. Therefore, in a performance-monitoring system, speech parameters which are significantly affected by fatigue need to be identified and extracted from input signals. For this purpose, a series of experiments was performed under slowly varying cognitive load conditions and at different times of the day. The results of the data analysis are presented here.

Domestic Violence Counseling in Rural Northern China: Gender, Social Harmony, and Human Rights.

PubMed

Xie, Lijia; Eyre, Stephen L; Barker, Judith

2018-03-01

Domestic violence (DV) affects over a third of Chinese women in a relationship. Focusing on ethnographic data from six staff members and six DV survivors at a rural, state-affiliated women's center in China in 2010, this article relies on Henrietta Moore's notion of the poststructuralist gendered subject to examine how the staff draw on discourses about gender and social harmony in persuading women to stay in their marriages, rather than on human rights discourses that emphasize survivor safety. It shows that DV survivors are frequently sent back to dangerous homes where their health is placed at risk.

Understanding the Complexities of Food Safety Using a "One Health" Approach.

PubMed

Kniel, Kalmia E; Kumar, Deepak; Thakur, Siddhartha

2018-02-01

The philosophy of One Health is growing in concept and clarity. The interdependence of human, animal, and environmental health is the basis for the concept of One Health. One Health is a comprehensive approach to ensure the health of people, animals, and the environment through collaborative efforts. Preharvest food safety issues align with the grand concept of One Health. Imagine any food production system, and immediately, parallel images from One Health emerge: for example, transmission of zoonotic diseases, antibiotic residues, or resistance genes in the environment; environmental and animal host reservoirs of disease; challenges with rearing animals and growing fresh produce on the same farm; application and transport of manure or diseased animals. During a recent celebration of #OneHealthDay, information was shared around the globe concerning scientists dedicated to One Health research systems. An ever-growing trade and global commerce system mixed with our incessant desire for food products during the whole year makes it all the more important to take a global view through the One Health lens to solve these growing challenges. The recent explosion of Zika virus around the globe renewed the need for assessing transmissible diseases through the eyes of One Health. It is not good enough to know how a disease affects the human population without a thorough understanding of the environment and vector reservoirs. If 60 to 75% of infectious diseases affecting humans are of animal origin, the need for better One Health research strategies and overdue solutions is imperative.

Soy and Health Update: Evaluation of the Clinical and Epidemiologic Literature

PubMed Central

Messina, Mark

2016-01-01

Soyfoods have long been recognized as sources of high-quality protein and healthful fat, but over the past 25 years these foods have been rigorously investigated for their role in chronic disease prevention and treatment. There is evidence, for example, that they reduce risk of coronary heart disease and breast and prostate cancer. In addition, soy alleviates hot flashes and may favorably affect renal function, alleviate depressive symptoms and improve skin health. Much of the focus on soyfoods is because they are uniquely-rich sources of isoflavones. Isoflavones are classified as both phytoestrogens and selective estrogen receptor modulators. Despite the many proposed benefits, the presence of isoflavones has led to concerns that soy may exert untoward effects in some individuals. However, these concerns are based primarily on animal studies, whereas the human research supports the safety and benefits of soyfoods. In support of safety is the recent conclusion of the European Food Safety Authority that isoflavones do not adversely affect the breast, thyroid or uterus of postmenopausal women. This review covers each of the major research areas involving soy focusing primarily on the clinical and epidemiologic research. Background information on Asian soy intake, isoflavones, and nutrient content is also provided. PMID:27886135

Operator performance-enhancing technologies to improve safety. A US DOT safety initiative for meeting the human-centered systems challenge.

DOT National Transportation Integrated Search

1999-11-01

The program implements DOT Human Factors Coordinating Committee (HFCC) recommendations for a coordinated Departmental Human Factors Research Program to advance the human-centered systems approach for enhancing transportation safety. Human error is a ...

The effect of Cree traditional medicinal teas on the activity of human cytochrome P450-mediated metabolism.

PubMed

Tam, Teresa W; Liu, Rui; Saleem, Ammar; Arnason, John T; Krantis, Anthony; Haddad, Pierre S; Foster, Brian C

2014-08-08

Rhododendron groenlandicum (Bog Labrador tea), Rhododendron tomentosum (Marsh Labrador tea) and Juniperus communis (Juniper) are used in medicinal teas by Canadian aboriginal cultures alone and in combination with conventional drug products. The safety of this combination had not been previously examined and this study was initiated to examine the potential of medicinal teas to inhibit the major human drug metabolizing enzyme, cytochrome P450 3A4 (CYP3A4). The decoctions of Rhododendron groenlandicum and Rhododendron tomentosum leaves and Juniperus communis berries were examined in a microtiter fluorometric assay to examine their potential to inhibit CYP-mediated metabolism. The decoctions showed progressive inhibition towards CYP3A4 the longer the leaves or berries were brewed. R. Rhododendron groenlandicum and Juniperus communis may have the potential to inhibit CYP3A4-mediated metabolism. The findings of this study with these traditional medicines are significant in that they provide mechanistic support that these products have the potential to affect the safety and efficacy of other health and medicinal products. As this study only examined CYP3A4, it is possible that these medicinals contain substances that could also affect other metabolic enzymes. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Sentinels of safety: service dogs ensure safety and enhance freedom and well-being for families with autistic children.

PubMed

Burrows, Kristen E; Adams, Cindy L; Spiers, Jude

2008-12-01

Children with autism might display unpredictable and volatile behavior that places them in considerable physical danger and creates stress for the family. Families of autistic children often have limited freedom and experience difficulty with everyday activities. In this qualitative ethology study, we examined the effect of integrating service dogs into ten families with an autistic child. Data included participant observation, video recordings of family-parent-dog interaction, and semistructured interviews with the parents. The themes were (a) the dog as a sentinel of safety, (b) gaining freedom through enhanced safety, facilitating public outings and family activities, and (c) improving social recognition and status, in which the presence of the dog promoted awareness of autism and affected social interaction. The triadic relationship between parent, autistic child, and service dog constantly evolves. This research provides valuable information for parents interested in having a service dog for their autistic child, and has implications for long-term human-animal companionship for children with special needs and their caregivers.

An Integrated Human/Murine Transcriptome and Pathway Approach To Identify Prenatal Treatments For Down Syndrome.

PubMed

Guedj, Faycal; Pennings, Jeroen LA; Massingham, Lauren J; Wick, Heather C; Siegel, Ashley E; Tantravahi, Umadevi; Bianchi, Diana W

2016-09-02

Anatomical and functional brain abnormalities begin during fetal life in Down syndrome (DS). We hypothesize that novel prenatal treatments can be identified by targeting signaling pathways that are consistently perturbed in cell types/tissues obtained from human fetuses with DS and mouse embryos. We analyzed transcriptome data from fetuses with trisomy 21, age and sex-matched euploid controls, and embryonic day 15.5 forebrains from Ts1Cje, Ts65Dn, and Dp16 mice. The new datasets were compared to other publicly available datasets from humans with DS. We used the human Connectivity Map (CMap) database and created a murine adaptation to identify FDA-approved drugs that can rescue affected pathways. USP16 and TTC3 were dysregulated in all affected human cells and two mouse models. DS-associated pathway abnormalities were either the result of gene dosage specific effects or the consequence of a global cell stress response with activation of compensatory mechanisms. CMap analyses identified 56 molecules with high predictive scores to rescue abnormal gene expression in both species. Our novel integrated human/murine systems biology approach identified commonly dysregulated genes and pathways. This can help to prioritize therapeutic molecules on which to further test safety and efficacy. Additional studies in human cells are ongoing prior to pre-clinical prenatal treatment in mice.

Neuroprotective, neurotherapeutic, and neurometabolic effects of carbon monoxide.

PubMed

Mahan, Vicki L

2012-12-27

Studies in animal models show that the primary mechanism by which heme-oxygenases impart beneficial effects is due to the gaseous molecule carbon monoxide (CO). Produced in humans mainly by the catabolism of heme by heme-oxygenase, CO is a neurotransmitter important for multiple neurologic functions and affects several intracellular pathways as a regulatory molecule. Exogenous administration of inhaled CO or carbon monoxide releasing molecules (CORM's) impart similar neurophysiological responses as the endogenous gas. Its' involvement in important neuronal functions suggests that regulation of CO synthesis and biochemical properties may be clinically relevant to neuroprotection and the key may be a change in metabolic substrate from glucose to lactate. Currently, the drug is under development as a therapeutic agent and safety studies in humans evaluating the safety and tolerability of inhaled doses of CO show no clinically important abnormalities, effects, or changes over time in laboratory safety variables. As an important therapeutic option, inhaled CO has entered clinical trials and its clinical role as a neuroprotective and neurotherapeutic agent has been suggested. In this article, we review the neuroprotective effects of endogenous CO and discuss exogenous CO as a neuroprotective and neurotherapeutic agent.

Building a Formal Model of a Human-Interactive System: Insights into the Integration of Formal Methods and Human Factors Engineering

NASA Technical Reports Server (NTRS)

Bolton, Matthew L.; Bass, Ellen J.

2009-01-01

Both the human factors engineering (HFE) and formal methods communities are concerned with finding and eliminating problems with safety-critical systems. This work discusses a modeling effort that leveraged methods from both fields to use model checking with HFE practices to perform formal verification of a human-interactive system. Despite the use of a seemingly simple target system, a patient controlled analgesia pump, the initial model proved to be difficult for the model checker to verify in a reasonable amount of time. This resulted in a number of model revisions that affected the HFE architectural, representativeness, and understandability goals of the effort. If formal methods are to meet the needs of the HFE community, additional modeling tools and technological developments are necessary.

50 CFR 600.355 - National Standard 10-Safety of Life at Sea.

Code of Federal Regulations, 2011 CFR

2011-10-01

... measures shall, to the extent practicable, promote the safety of human life at sea. (b) General. (1... considered the same as “safety of human life at sea. The safety of a vessel and the people aboard is... their development to ensure they recognize any impact on the safety of human life at sea and minimize or...

Need for a gender-sensitive human security framework: results of a quantitative study of human security and sexual violence in Djohong District, Cameroon

PubMed Central

2014-01-01

Background Human security shifts traditional concepts of security from interstate conflict and the absence of war to the security of the individual. Broad definitions of human security include livelihoods and food security, health, psychosocial well-being, enjoyment of civil and political rights and freedom from oppression, and personal safety, in addition to absence of conflict. Methods In March 2010, we undertook a population-based health and livelihood study of female refugees from conflict-affected Central African Republic living in Djohong District, Cameroon and their female counterparts within the Cameroonian host community. Embedded within the survey instrument were indicators of human security derived from the Leaning-Arie model that defined three domains of psychosocial stability suggesting individuals and communities are most stable when their core attachments to home, community and the future are intact. Results While the female refugee human security outcomes describe a population successfully assimilated and thriving in their new environments based on these three domains, the ability of human security indicators to predict the presence or absence of lifetime and six-month sexual violence was inadequate. Using receiver operating characteristic (ROC) analysis, the study demonstrates that common human security indicators do not uncover either lifetime or recent prevalence of sexual violence. Conclusions These data suggest that current gender-blind approaches of describing human security are missing serious threats to the safety of one half of the population and that efforts to develop robust human security indicators should include those that specifically measure violence against women. PMID:24829613

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.

Individual differences and their impact on the safety and the efficiency of human-wheelchair systems.

PubMed

Jipp, Meike

2012-12-01

The extent to which individual differences in fine motor abilities affect indoor safety and efficiency of human-wheelchair systems was examined. To reduce the currently large number of indoor wheelchair accidents, assistance systems with a high level of automation were developed. It was proposed to adapt the wheelchair's level of automation to the user's ability to steer the device to avoid drawbacks of highly automated wheelchairs. The state of the art, however, lacks an empirical identification of those abilities. A study with 23 participants is described. The participants drove through various sections of a course with a powered wheelchair. Repeatedly measured criteria were safety (numbers of collisions) and efficiency (times required for reaching goals). As covariates, the participants' fine motor abilities were assessed. A random coefficient modeling approach was conducted to analyze the data,which were available on two levels as course sections were nested within participants.The participants' aiming, precision, and armhand speed contributed significantly to both criteria: Participants with lower fine motor abilities had more collisions and required more time for reaching goals. Adapting the wheelchair's level of automation to these fine motor abilities can improve indoor safety and efficiency. In addition, the results highlight the need to further examine the impact of individual differences on the design of automation features for powered wheelchairs as well as other applications of automation. The results facilitate the improvement of current wheelchair technology.

Technical Reference Suite Addressing Challenges of Providing Assurance for Fault Management Architectural Design

NASA Technical Reports Server (NTRS)

Fitz, Rhonda; Whitman, Gerek

2016-01-01

Research into complexities of software systems Fault Management (FM) and how architectural design decisions affect safety, preservation of assets, and maintenance of desired system functionality has coalesced into a technical reference (TR) suite that advances the provision of safety and mission assurance. The NASA Independent Verification and Validation (IVV) Program, with Software Assurance Research Program support, extracted FM architectures across the IVV portfolio to evaluate robustness, assess visibility for validation and test, and define software assurance methods applied to the architectures and designs. This investigation spanned IVV projects with seven different primary developers, a wide range of sizes and complexities, and encompassed Deep Space Robotic, Human Spaceflight, and Earth Orbiter mission FM architectures. The initiative continues with an expansion of the TR suite to include Launch Vehicles, adding the benefit of investigating differences intrinsic to model-based FM architectures and insight into complexities of FM within an Agile software development environment, in order to improve awareness of how nontraditional processes affect FM architectural design and system health management.

Defining health information technology-related errors: new developments since to err is human.

PubMed

Sittig, Dean F; Singh, Hardeep

2011-07-25

Despite the promise of health information technology (HIT), recent literature has revealed possible safety hazards associated with its use. The Office of the National Coordinator for HIT recently sponsored an Institute of Medicine committee to synthesize evidence and experience from the field on how HIT affects patient safety. To lay the groundwork for defining, measuring, and analyzing HIT-related safety hazards, we propose that HIT-related error occurs anytime HIT is unavailable for use, malfunctions during use, is used incorrectly by someone, or when HIT interacts with another system component incorrectly, resulting in data being lost or incorrectly entered, displayed, or transmitted. These errors, or the decisions that result from them, significantly increase the risk of adverse events and patient harm. We describe how a sociotechnical approach can be used to understand the complex origins of HIT errors, which may have roots in rapidly evolving technological, professional, organizational, and policy initiatives.

A Qualitative Study on Organizational Factors Affecting Occupational Accidents

PubMed Central

ESKANDARI, Davood; JAFARI, Mohammad Javad; MEHRABI, Yadollah; KIAN, Mostafa Pouya; CHARKHAND, Hossein; MIRGHOTBI, Mostafa

2017-01-01

Background: Technical, human, operational and organizational factors have been influencing the sequence of occupational accidents. Among them, organizational factors play a major role in causing occupational accidents. The aim of this research was to understand the Iranian safety experts’ experiences and perception of organizational factors. Methods: This qualitative study was conducted in 2015 by using the content analysis technique. Data were collected through semi-structured interviews with 17 safety experts working in Iranian universities and industries and analyzed with a conventional qualitative content analysis method using the MAXQDA software. Results: Eleven organizational factors’ sub-themes were identified: management commitment, management participation, employee involvement, communication, blame culture, education and training, job satisfaction, interpersonal relationship, supervision, continuous improvement, and reward system. The participants considered these factors as effective on occupational accidents. Conclusion: The mentioned 11 organizational factors are probably involved in occupational accidents in Iran. Naturally, improving organizational factors can increase the safety performance and reduce occupational accidents. PMID:28435824

A Qualitative Study on Organizational Factors Affecting Occupational Accidents.

PubMed

Eskandari, Davood; Jafari, Mohammad Javad; Mehrabi, Yadollah; Kian, Mostafa Pouya; Charkhand, Hossein; Mirghotbi, Mostafa

2017-03-01

Technical, human, operational and organizational factors have been influencing the sequence of occupational accidents. Among them, organizational factors play a major role in causing occupational accidents. The aim of this research was to understand the Iranian safety experts' experiences and perception of organizational factors. This qualitative study was conducted in 2015 by using the content analysis technique. Data were collected through semi-structured interviews with 17 safety experts working in Iranian universities and industries and analyzed with a conventional qualitative content analysis method using the MAXQDA software. Eleven organizational factors' sub-themes were identified: management commitment, management participation, employee involvement, communication, blame culture, education and training, job satisfaction, interpersonal relationship, supervision, continuous improvement, and reward system. The participants considered these factors as effective on occupational accidents. The mentioned 11 organizational factors are probably involved in occupational accidents in Iran. Naturally, improving organizational factors can increase the safety performance and reduce occupational accidents.

From cognition to the system: developing a multilevel taxonomy of patient safety in general practice.

PubMed

Kostopoulou, O

The paper describes the process of developing a taxonomy of patient safety in general practice. The methodologies employed included fieldwork, task analysis and confidential reporting of patient-safety events in five West Midlands practices. Reported events were traced back to their root causes and contributing factors. The resulting taxonomy is based on a theoretical model of human cognition, includes multiple levels of classification to reflect the chain of causation and considers affective and physiological influences on performance. Events are classified at three levels. At level one, the information-processing model of cognition is used to classify errors. At level two, immediate causes are identified, internal and external to the individual. At level three, more remote causal factors are classified as either 'work organization' or 'technical' with subcategories. The properties of the taxonomy (validity, reliability, comprehensiveness) as well as its usability and acceptability remain to be tested with potential users.

Rage against the machine? Google's self-driving cars versus human drivers.

PubMed

Teoh, Eric R; Kidd, David G

2017-12-01

Automated driving represents both challenges and opportunities in highway safety. Google has been developing self-driving cars and testing them under employee supervision on public roads since 2009. These vehicles have been involved in several crashes, and it is of interest how this testing program compares to human drivers in terms of safety. Google car crashes were coded by type and severity based on narratives released by Google. Crash rates per million vehicle miles traveled (VMT) were computed for crashes deemed severe enough to be reportable to police. These were compared with police-reported crash rates for human drivers. Crash types also were compared. Google cars had a much lower rate of police-reportable crashes per million VMT than human drivers in Mountain View, Calif., during 2009-2015 (2.19 vs 6.06), but the difference was not statistically significant. The most common type of collision involving Google cars was when they got rear-ended by another (human-driven) vehicle. Google cars shared responsibility for only one crash. These results suggest Google self-driving cars, while a test program, are safer than conventional human-driven passenger vehicles; however, currently there is insufficient information to fully examine the extent to which disengagements affected these results. Results suggest that highly-automated vehicles can perform more safely than human drivers in certain conditions, but will continue to be involved in crashes with conventionally-driven vehicles. Copyright © 2017. Published by Elsevier Ltd.

Safety Profile of TiO2-Based Photocatalytic Nanofabrics for Indoor Formaldehyde Degradation

PubMed Central

Cui, Guixin; Xin, Yan; Jiang, Xin; Dong, Mengqi; Li, Junling; Wang, Peng; Zhai, Shumei; Dong, Yongchun; Jia, Jianbo; Yan, Bing

2015-01-01

Anatase TiO2 nanoparticles (TNPs) are synthesized using the sol-gel method and loaded onto the surface of polyester-cotton (65/35) fabrics. The nanofabrics degrade formaldehyde at an efficiency of 77% in eight hours with visible light irradiation or 97% with UV light. The loaded TNPs display very little release from nanofabrics (~0.0%) during a standard fastness to rubbing test. Assuming TNPs may fall off nanofabrics during their life cycles, we also examine the possible toxicity of TNPs to human cells. We found that up to a concentration of 220 μg/mL, they do not affect viability of human acute monocytic leukemia cell line THP-1 macrophages and human liver and kidney cells. PMID:26610470

76 FR 35130 - Pipeline Safety: Control Room Management/Human Factors

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts...: Control Room Management/Human Factors AGENCY: Pipeline and Hazardous Materials Safety Administration... safety standards, risk assessments, and safety policies for natural gas pipelines and for hazardous...

A model of Occupational Safety and Health Management System (OSHMS) for promoting and controlling health and safety in textile industry.

PubMed

Manimaran, S; Rajalakshmi, R; Bhagyalakshmi, K

2015-01-01

The development of Occupational Safety and Health Management System in textile industry will rejuvenate the workers and energize the economy as a whole. In India, especially in Tamil Nadu, approximately 1371 textile business is running with the help of 38,461 workers under Ginning, Spinning, Weaving, Garment and Dyeing sectors. Textile industry of contributes to the growth of Indian economy but it fails to foster education and health as key components of human development and help new democracies. The present work attempts to measure and develop OSHMS which reduce the hazards and risk involved in textile industry. Among all other industries textile industry is affected by enormous hazards and risk because of negligence by management and Government. It is evident that managements are not abiding by law when an accident has occurred. Managements are easily deceiving workers and least bothered about the Quality of Work Life (QWL). A detailed analysis of factors promoting safety and health to the workers has been done by performing confirmatory factor analysis, evaluating Risk Priority Number and the framework of OHMS has been conceptualized using Structural Equation Model. The data have been collected using questionnaire and interview method. The study finds occupation health for worker in Textile industry is affected not only by safety measure but also by technology and management. The work shows that difficulty in identifying the cause and effect of hazards, the influence of management in controlling and promoting OSHMS under various dimensions. One startling fact is existence of very low and insignificance correlation between health factors and outcome.

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

PubMed

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

2016-09-19

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

Pregnant woman and road safety: experimental crash test with post mortem human subject.

PubMed

Delotte, Jerome; Behr, Michel; Thollon, Lionel; Arnoux, Pierre-Jean; Baque, Patrick; Bongain, Andre; Brunet, Christian

2008-05-01

Trauma affect between 3 and 7% of all pregnancies in industrialized countries, and the leading cause of these traumas is car crashes. The difficulty to appreciate physiologic and anatomic changes occurring during pregnancy explain that majority of studies were not based on anatomical data. We present a protocol to create a realistic anatomical model of pregnant woman using a post mortem human subject (PMHS). We inserted a physical model of the gravid uterus into the pelvis of a PMHS. 3D acceleration sensors were placed on the subject to measure the acceleration on different body segments. We simulated three frontal impact situations at 20 km/h between two average European cars. Two main kinematics events were identified as possible causes of injuries: lap belt loading and backrest impact. Cadaver experiments provide one interesting complementary approach to study injury mechanisms related to road accidents involving pregnant women. This anatomical accuracy makes it possible to progress in the field of safety devices.

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

PubMed

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Human factors and ergonomics as a patient safety practice

PubMed Central

Carayon, Pascale; Xie, Anping; Kianfar, Sarah

2014-01-01

Background Human factors and ergonomics (HFE) approaches to patient safety have addressed five different domains: usability of technology; human error and its role in patient safety; the role of healthcare worker performance in patient safety; system resilience; and HFE systems approaches to patient safety. Methods A review of various HFE approaches to patient safety and studies on HFE interventions was conducted. Results This paper describes specific examples of HFE-based interventions for patient safety. Studies show that HFE can be used in a variety of domains. Conclusions HFE is a core element of patient safety improvement. Therefore, every effort should be made to support HFE applications in patient safety. PMID:23813211

Protection of non-human primates against rabies with an adenovirus recombinant vaccine

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

Xiang, Z.Q.; Greenberg, L.; Ertl, H.C., E-mail: ertl@wistar.upenn.edu

Rabies remains a major neglected global zoonosis. New vaccine strategies are needed for human rabies prophylaxis. A single intramuscular immunization with a moderate dose of an experimental chimpanzee adenovirus (Ad) vector serotype SAd-V24, also termed AdC68, expressing the rabies virus glycoprotein, resulted in sustained titers of rabies virus neutralizing antibodies and protection against a lethal rabies virus challenge infection in a non-human primate model. Taken together, these data demonstrate the safety, immunogenicity, and efficacy of the recombinant Ad-rabies vector for further consideration in human clinical trials. - Highlights: • Pre-exposure vaccination with vaccine based on a chimpanzee derived adenovirus protectsmore » against rabies. • Protection is sustained. • Protection is achieved with single low-dose of vaccine given intramuscularly. • Protection is not affected by pre-existing antibodies to common human serotypes of adenovirus.« less

Nanotechnology and health safety--toxicity and risk assessments of nanostructured materials on human health.

PubMed

Singh, Surya; Nalwa, Hari Singh

2007-09-01

The field of nanotechnology has recently emerged as the most commercially viable technology of this century because of its wide-ranging applications in our daily lives. Man-made nanostructured materials such as fullerenes, nanoparticles, nanopowders, nanotubes, nanowires, nanorods, nanofibers, quantum dots, dendrimers, nanoclusters, nanocrystals, and nanocomposites are globally produced in large quantities due to their wide potential applications, e.g., in skincare and consumer products, healthcare, electronics, photonics, biotechnology, engineering products, pharmaceuticals, drug delivery, and agriculture. Human exposure to these nanostructured materials is inevitable, as they can enter the body through the lungs or other organs via food, drink, and medicine and affect different organs and tissues such as the brain, liver, kidney, heart, colon, spleen, bone, blood, etc., and may cause cytotoxic effects, e.g., deformation and inhibition of cell growth leading to various diseases in humans and animals. Since a very wide variety of nanostructured materials exits, their interactions with biological systems and toxicity largely depend upon their properties, such as size, concentration, solubility, chemical and biological properties, and stability. The toxicity of nanostructured materials could be reduced by chemical approaches such by surface treatment, functionalization, and composite formation. This review summarizes the sources of various nanostructured materials and their human exposure, biocompatibility in relation to potential toxicological effects, risk assessment, and safety evaluation on human and animal health as well as on the environment.

Distinct Responses of Stem Cells to Telomere Uncapping-A Potential Strategy to Improve the Safety of Cell Therapy.

PubMed

Liu, Chang Ching; Ma, Dong Liang; Yan, Ting-Dong; Fan, XiuBo; Poon, Zhiyong; Poon, Lai-Fong; Goh, Su-Ann; Rozen, Steve G; Hwang, William Ying Khee; Tergaonkar, Vinay; Tan, Patrick; Ghosh, Sujoy; Virshup, David M; Goh, Eyleen L K; Li, Shang

2016-10-01

In most human somatic cells, the lack of telomerase activity results in progressive telomere shortening during each cell division. Eventually, DNA damage responses triggered by critically short telomeres induce an irreversible cell cycle arrest termed replicative senescence. However, the cellular responses of human pluripotent stem cells to telomere uncapping remain unknown. We generated telomerase knockout human embryonic stem (ES) cells through gene targeting. Telomerase inactivation in ES cells results in progressive telomere shortening. Telomere DNA damage in ES cells and neural progenitor cells induces rapid apoptosis when telomeres are uncapped, in contrast to fibroblast cells that enter a state of replicative senescence. Significantly, telomerase inactivation limits the proliferation capacity of human ES cells without affecting their pluripotency. By targeting telomerase activity, we can functionally separate the two unique properties of human pluripotent stem cells, namely unlimited self-renewal and pluripotency. We show that the potential of ES cells to form teratomas in vivo is dictated by their telomere length. By controlling telomere length of ES cells through telomerase inactivation, we can inhibit teratoma formation and potentially improve the safety of cell therapies involving terminally differentiated cells as well as specific progenitor cells that do not require sustained cellular proliferation in vivo, and thus sustained telomerase activity. Stem Cells 2016;34:2471-2484. © 2016 AlphaMed Press.

Future challenges to microbial food safety.

PubMed

Havelaar, Arie H; Brul, Stanley; de Jong, Aarieke; de Jonge, Rob; Zwietering, Marcel H; Ter Kuile, Benno H

2010-05-30

Despite significant efforts by all parties involved, there is still a considerable burden of foodborne illness, in which micro-organisms play a prominent role. Microbes can enter the food chain at different steps, are highly versatile and can adapt to the environment allowing survival, growth and production of toxic compounds. This sets them apart from chemical agents and thus their study from food toxicology. We summarize the discussions of a conference organized by the Dutch Food and Consumer Products Safety Authority and the European Food Safety Authority. The goal of the conference was to discuss new challenges to food safety that are caused by micro-organisms as well as strategies and methodologies to counter these. Management of food safety is based on generally accepted principles of Hazard Analysis Critical Control Points and of Good Manufacturing Practices. However, a more pro-active, science-based approach is required, starting with the ability to predict where problems might arise by applying the risk analysis framework. Developments that may influence food safety in the future occur on different scales (from global to molecular) and in different time frames (from decades to less than a minute). This necessitates development of new risk assessment approaches, taking the impact of different drivers of change into account. We provide an overview of drivers that may affect food safety and their potential impact on foodborne pathogens and human disease risks. We conclude that many drivers may result in increased food safety risks, requiring active governmental policy setting and anticipation by food industries whereas other drivers may decrease food safety risks. Monitoring of contamination in the food chain, combined with surveillance of human illness and epidemiological investigations of outbreaks and sporadic cases continue to be important sources of information. New approaches in human illness surveillance include the use of molecular markers for improved outbreak detection and source attribution, sero-epidemiology and disease burden estimation. Current developments in molecular techniques make it possible to rapidly assemble information on the genome of various isolates of microbial species of concern. Such information can be used to develop new tracking and tracing methods, and to investigate the behavior of micro-organisms under environmentally relevant stress conditions. These novel tools and insight need to be applied to objectives for food safety strategies, as well as to models that predict microbial behavior. In addition, the increasing complexity of the global food systems necessitates improved communication between all parties involved: scientists, risk assessors and risk managers, as well as consumers. Copyright 2009 Elsevier B.V. All rights reserved.

29 CFR 1960.19 - Other Federal agency standards affecting occupational safety and health.

Code of Federal Regulations, 2014 CFR

2014-07-01

... safety and health. 1960.19 Section 1960.19 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Standards § 1960.19 Other Federal agency standards affecting occupational safety and health. (a) Where employees of different agencies...

29 CFR 1960.19 - Other Federal agency standards affecting occupational safety and health.

Code of Federal Regulations, 2013 CFR

2013-07-01

... safety and health. 1960.19 Section 1960.19 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Standards § 1960.19 Other Federal agency standards affecting occupational safety and health. (a) Where employees of different agencies...

29 CFR 1960.19 - Other Federal agency standards affecting occupational safety and health.

Code of Federal Regulations, 2012 CFR

2012-07-01

... safety and health. 1960.19 Section 1960.19 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Standards § 1960.19 Other Federal agency standards affecting occupational safety and health. (a) Where employees of different agencies...

From Bench to Bedside: Utility of the Rabbit Elastase Aneurysm Model in Pre-Clinical Studies of Intracranial Aneurysm Treatment

PubMed Central

Brinjikji, Waleed; Ding, Yong H; Kallmes, David F; Kadirvel, Ramanathan

2016-01-01

Summary Pre-clinical studies are important in helping practitioners and device developers improve techniques and tools for endovascular treatment of intracranial aneurysms. Thus, an understanding of the major animal models used in such studies is important. The New Zealand rabbit elastase induced arterial aneurysm of the common carotid artery is one of the most commonly used models in testing the safety and efficacy of new endovascular devices. In this review we discuss 1) various techniques used to create the aneurysm, 2) complications of aneurysm creation, 3) natural history of the arterial aneurysm, 4) histopathologic and hemodynamic features of the aneurysm 5) devices tested using this model and 6) weaknesses of the model. We demonstrate how pre-clinical studies using this model are applied in treatment of intracranial aneurysms in humans. The model has a similar hemodynamic, morphological and histologic characteristics to human aneurysms and demonstrates similar healing responses to coiling as human aneurysms. Despite these strengths however, the model does have many weaknesses including the fact that the model does not emulate the complex inflammatory processes affecting growing and ruptured aneurysms. Furthermore the model’s extracranial location affects its ability to be used in preclinical safety assessments of new devices. We conclude that the rabbit elastase model has characteristics that make it a simple and effective model for preclinical studies on the endovascular treatment of intracranial aneurysms however further work is needed to develop aneurysm models that simulate the histopathologic and morphologic characteristics of growing and ruptured aneurysms. PMID:25904642

An Evaluation of the Effects of Human Factors and Ergonomics on Health Care and Patient Safety Practices: A Systematic Review

PubMed Central

Zhang, Longhao; Zhao, Pujing; Chen, Ying; Zhang, Mingming

2015-01-01

Background From the viewpoint of human factors and ergonomics (HFE), errors often occur because of the mismatch between the system, technique and characteristics of the human body. HFE is a scientific discipline concerned with understanding interactions between human behavior, system design and safety. Objective To evaluate the effectiveness of HFE interventions in improving health care workers’ outcomes and patient safety and to assess the quality of the available evidence. Methods We searched databases, including MEDLINE, EMBASE, BIOSIS Previews and the CBM (Chinese BioMedical Literature Database), for articles published from 1996 to Mar.2015. The quality assessment tool was based on the risk of bias criteria developed by the Cochrane Effective Practice and Organization of Care (EPOC) Group. The interventions of the included studies were categorized into four relevant domains, as defined by the International Ergonomics Association. Results For this descriptive study, we identified 8, 949 studies based on our initial search. Finally, 28 studies with 3,227 participants were included. Among the 28 included studies, 20 studies were controlled studies, two of which were randomized controlled trials. The other eight studies were before/after surveys, without controls. Most of the studies were of moderate or low quality. Five broad categories of outcomes were identified in this study: 1) medical errors or patient safety, 2) health care workers’ quality of working life (e.g. reduced fatigue, discomfort, workload, pain and injury), 3) user performance (e.g., efficiency or accuracy), 4) health care workers’ attitudes towards the interventions(e.g., satisfaction and preference), and 5) economic evaluations. Conclusion The results showed that the interventions positively affected the outcomes of health care workers. Few studies considered the financial merits of these interventions. Most of the included studies were of moderate quality. This review highlights the need for scientific and standardized guidelines regarding how HFE should be implemented in health care. PMID:26067774

Evaluation of the antimicrobial efficacy and skin safety of a novel color additive in combination with chlorine disinfectants.

PubMed

Tyan, Kevin; Kang, Jason; Jin, Katherine; Kyle, Aaron M

2018-05-23

A novel color additive colorizes chlorine disinfectants blue to improve visibility and enhance spray surface coverage, and it fades to colorless to indicate elapsed contact time. We investigated its interactions with 3 chlorine disinfectants to determine if the additive would adversely affect the disinfectants' antimicrobial efficacy or skin safety. We tested 0.5% sodium hypochlorite, 0.2% calcium hypochlorite, and 0.5% sodium dichloroisocyanurate (NaDCC) alone versus with color additive. An independent laboratory tested efficacy against Staphylococcus aureus, Pseudomonas aeruginosa, Vibrio cholerae, and human coronavirus 229E. An independent laboratory also tested direct skin irritation. Chlorine disinfectants with and without color additive achieved equal levels of efficacy against the tested pathogens. Against S. aureus, 0.5% sodium hypochlorite with and without color additive met Environmental Protection Agency criteria for disinfection success. Against human coronavirus 229E, 0.5% sodium hypochlorite alone failed disinfection success criteria, whereas 0.5% sodium hypochlorite with color additive achieved full viral inactivation (≥4.50 log 10 reduction). Against V. cholerae, 0.2% calcium hypochlorite alone and with color additive achieved 5.99 log 10 and >6.03 log 10 reductions, respectively. Against S. aureus and P. aeruginosa, 0.5% NaDCC with and without color additive achieved >4.9 log 10 and >3.54 log 10 reductions, respectively. All 3 chlorine disinfectants with color additive tested as negligible skin irritants. This color additive can be combined with chlorine disinfectants without adversely affecting antimicrobial efficacy or skin safety. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Probabilistic analysis on the failure of reactivity control for the PWR

NASA Astrophysics Data System (ADS)

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

2018-02-01

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

Safety climate in university and college laboratories: impact of organizational and individual factors.

PubMed

Wu, Tsung-Chih; Liu, Chi-Wei; Lu, Mu-Chen

2007-01-01

Universities and colleges serve to be institutions of education excellence; however, problems in the areas of occupational safety may undermine such goals. Occupational safety must be the concern of every employee in the organization, regardless of job position. Safety climate surveys have been suggested as important tools for measuring the effectiveness and improvement direction of safety programs. Thus, this study aims to investigate the influence of organizational and individual factors on safety climate in university and college laboratories. Employees at 100 universities and colleges in Taiwan were mailed a self-administered questionnaire survey; the response rate was 78%. Multivariate analysis of variance revealed that organizational category of ownership, the presence of a safety manager and safety committee, gender, age, title, accident experience, and safety training significantly affected the climate. Among them, accident experience and safety training affected the climate with practical significance. The authors recommend that managers should address important factors affecting safety issues and then create a positive climate by enforcing continuous improvements.

Promoting safety voice with safety-specific transformational leadership: the mediating role of two dimensions of trust.

PubMed

Conchie, Stacey M; Taylor, Paul J; Donald, Ian J

2012-01-01

Although safety-specific transformational leadership is known to encourage employee safety voice behaviors, less is known about what makes this style of leadership effective. We tested a model that links safety-specific transformational leadership to safety voice through various dimensions of trust. Data from 150 supervisor-employee dyads from the United Kingdom oil industry supported our predictions that the effects of safety-specific transformational leadership are sequentially mediated by affect-based trust beliefs and disclosure trust intentions. Moreover, we found that reliance trust intentions moderated the effect of disclosure: employees' disclosure intentions mediated the effects of affect-based trust on safety voice behaviors only when employees' intention to rely on their leader was moderate to high. These findings suggest that leaders seeking to encourage safety voice behaviors should go beyond "good reason" arguments and develop affective bonds with their employees.

How does enhancing cognition affect human values? How does this translate into social responsibility?

PubMed

Cabrera, Laura Y

2015-01-01

The past decade has seen a rise in the use of different technologies aimed at enhancing cognition of normal healthy individuals. While values have been acknowledged to be an important aspect of cognitive enhancement practices, the discussion has predominantly focused on just a few values, such as safety, peer pressure, and authenticity. How are values, in a broader sense, affected by enhancing cognitive abilities? Is this dependent on the type of technology or intervention used to attain the enhancement, or does the cognitive domain targeted play a bigger role in how values are affected? Values are not only likely to be affected by cognitive enhancement practices; they also play a crucial role in defining the type of interventions that are likely to be undertaken. This paper explores the way values affect and are affected by enhancing cognitive abilities. Furthermore, it argues that knowledge of the interplay between values and cognitive enhancement makes a strong case for social responsibility around cognitive enhancement practices.

2009 Human Factors and Roadway Safety Workshop : Overviews of Safety Initiatives in Iowa [SD .WMV (720x480/29fps/80.2 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: Overview of Safety Initiatives in Iowa : Tom Welch, Iowa DOT Highway Division Safety Engineer,...

Immunogenicity of therapeutics: a matter of efficacy and safety.

PubMed

Nechansky, Andreas; Kircheis, Ralf

2010-11-01

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

Identifying and assessing human activity impacts on groundwater quality through hydrogeochemical anomalies and NO3-, NH4+, and COD contamination: a case study of the Liujiang River Basin, Hebei Province, P.R. China.

PubMed

Peng, Cong; He, Jiang-Tao; Wang, Man-Li; Zhang, Zhen-Guo; Wang, Lei

2018-02-01

In the face of rapid economic development and increasing human activity, the deterioration of groundwater quality has seriously affected the safety of the groundwater supply in eastern China. Identifying and assessing the impact of human activities is key to finding solutions to this problem. This study is an effort to scientifically and systematically identify and assess the influence of human activities on groundwater based on irregularities in hydrochemical properties and water contamination, which are considered to directly result from anthropogenic activity. The combination of the hydrochemical anomaly identification (HAI) and the contaminant identification (CI) was proposed to identify the influence of human activities on groundwater quality. And the degree of abnormality was quantified by the background threshold value. The principal component analysis (PCA) and land use map were used to verify the reliability of the identification result. The final result show that the strong influence areas mainly distributed in the south of the basin and the affected indicators contained the major elements and NO 3 - , NH 4 + , COD. Impacts from anthropogenic activities can be divided into two types: mine drainage that disrupts natural water-rock interaction processes, agricultural cultivation, and sewage emissions that contribute to nitrate pollution.

2009 Human Factors and Roadway Safety Workshop : Opening Session [SD .WMV (720x480/29fps/546.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: 2009 Human Factors and Roadway Safety Workshop Opening Session : Sandra Larson, director, Iowa...

A Framework to Guide the Assessment of Human-Machine Systems.

PubMed

Stowers, Kimberly; Oglesby, James; Sonesh, Shirley; Leyva, Kevin; Iwig, Chelsea; Salas, Eduardo

2017-03-01

We have developed a framework for guiding measurement in human-machine systems. The assessment of safety and performance in human-machine systems often relies on direct measurement, such as tracking reaction time and accidents. However, safety and performance emerge from the combination of several variables. The assessment of precursors to safety and performance are thus an important part of predicting and improving outcomes in human-machine systems. As part of an in-depth literature analysis involving peer-reviewed, empirical articles, we located and classified variables important to human-machine systems, giving a snapshot of the state of science on human-machine system safety and performance. Using this information, we created a framework of safety and performance in human-machine systems. This framework details several inputs and processes that collectively influence safety and performance. Inputs are divided according to human, machine, and environmental inputs. Processes are divided into attitudes, behaviors, and cognitive variables. Each class of inputs influences the processes and, subsequently, outcomes that emerge in human-machine systems. This framework offers a useful starting point for understanding the current state of the science and measuring many of the complex variables relating to safety and performance in human-machine systems. This framework can be applied to the design, development, and implementation of automated machines in spaceflight, military, and health care settings. We present a hypothetical example in our write-up of how it can be used to aid in project success.

Human factors and systems engineering approach to patient safety for radiotherapy.

PubMed

Rivera, A Joy; Karsh, Ben-Tzion

2008-01-01

The traditional approach to solving patient safety problems in healthcare is to blame the last person to touch the patient. But since the publication of To Err is Human, the call has been instead to use human factors and systems engineering methods and principles to solve patient safety problems. However, an understanding of the human factors and systems engineering is lacking, and confusion remains about what it means to apply their principles. This paper provides a primer on them and their applications to patient safety.

Teaching patient safety and human factors in undergraduate nursing curricula in England: a pilot survey.

PubMed

Robson, Wayne; Clark, Debbie; Pinnock, David; White, Nick; Baxendale, Bryn

Patient safety is a key priority for all healthcare systems, and there is growing recognition for the need to educate tomorrow's nurses about the role of human factors in reducing avoidable harm to patients. A pilot survey was sent to 20 schools of nursing in England to explore the teaching of patient safety and human factors. All 13 schools that responded (65% response rate) stated that patient safety was covered in their curricula and was allocated more than 4 hours; all the classes included human factors. Only two respondents indicated their teaching to be multi-professional. Awareness of the World Health Organization's multiprofessional patient safety curriculum guide was poor. Faculties also seemed unaware that the Institute for Healthcare Improvement provides free online patient safety modules for students and that there is a global network of student patient safety chapters.

The Role of Affect in Cross-Cultural Competence

DTIC Science & Technology

2012-04-26

4.56 2.58 .70 .89 Food Affect (pre) 1.00 5.00 3.10 .70 .91 Food Affect (post) 1.00 5.00 3.22 1.00 .95 Food Safety (pre) 1.57 5.00 3.35 .82 Food ...controlled for  Looked at affect in terms of food affect and food safety Hypotheses and Results (cont.) • Hypothesis 2a*: Disgust sensitivity will be...05 • Food Safety , r(96)=-.13, n.s. • Disgust Sensitivity, r(96)=-.16, n.s. • Contamination, r(96)=-.24, p<.05 • Core Disgust, r(96)=-.20, p=.05

The effects of organizational commitment and structural empowerment on patient safety culture.

PubMed

Horwitz, Sujin K; Horwitz, Irwin B

2017-03-20

Purpose The purpose of this paper is to investigate the relationship between patient safety culture and two attitudinal constructs: affective organizational commitment and structural empowerment. In doing so, the main and interaction effects of the two constructs on the perception of patient safety culture were assessed using a cohort of physicians. Design/methodology/approach Affective commitment was measured with the Organizational Commitment Questionnaire, whereas structural empowerment was assessed with the Conditions of Work Effectiveness Questionnaire-II. The abbreviated versions of these surveys were administered to a cohort of 71 post-doctoral medical residents. For the data analysis, hierarchical regression analyses were performed for the main and interaction effects of affective commitment and structural empowerment on the perception of patient safety culture. Findings A total of 63 surveys were analyzed. The results revealed that both affective commitment and structural empowerment were positively related to patient safety culture. A potential interaction effect of the two attitudinal constructs on patient safety culture was tested but no such effect was detected. Research limitations/implications This study suggests that there are potential benefits of promoting affective commitment and structural empowerment for patient safety culture in health care organizations. By identifying the positive associations between the two constructs and patient safety culture, this study provides additional empirical support for Kanter's theoretical tenet that structural and organizational support together helps to shape the perceptions of patient safety culture. Originality/value Despite the wide recognition of employee empowerment and commitment in organizational research, there has still been a paucity of empirical studies specifically assessing their effects on patient safety culture in health care organizations. To the authors' knowledge, this study is the first empirical study to examine the relationship between structural empowerment as proposed by Kanter and the culture of patient safety using physicians.

Electronic distractions of the respiratory therapist and their impact on patient safety.

PubMed

Papadakos, Peter J

2014-08-01

Over the last decade, data from the lay press, government agencies, and the business world have identified ever-growing problems with electronic distraction and changes in human relationships in this electronically interconnected planet. As health professionals, we are well aware of the epidemic growth of injuries and deaths related to texting and driving. It should not surprise us that this distracted behavior has affected all levels of health-care providers and has impacted patient care. This advent of “distracted doctoring” was first coined by the Pulitzer Prize-winning correspondent Matt Richtel in a landmark article in the New York Times, “As doctors use more devices, potential for distraction grows.” This article was a flashpoint for professional organizations to reflect on this change in behavior and how it will impact patient safety and how we relate to patients. The explosion in technology (both personnel and hospital-based), coupled with a rapid social shift, creates an environment that constantly tempts health-care workers to surf the internet, check social media outlets, or respond to e-mails. Studies and commentaries in the medical literature only support how this is a growing problem in patient safety and may both increase medical errors and affects costs and the way we relate to patients and fellow staff. The Emergency Care Research Institute (ECRI) released its annual list of technology hazards for 2013, and three ring true for United States caregivers: distractions from smartphones and mobile devices, alarm hazards, and patient/data mismatches in electronic medical records and other health IT systems, all being in the top 10. How do we begin to address these new technological threats to our patients? First and foremost, we accept that this problem exists. We begin by educating our students and staff that this electronic explosion affects our behavior through addiction and the environment within our hospital through the use of electronic medical records, alarms, and alerts that may impact vigilance and affect our focus. These educational and policy changes should, at their core, address human-to-technology interfacing and teach electronic etiquette. How we approach patients should always have at its core the ancient adage “know thyself”; in other words, always practice self-examination in our daily interactions with technology.

Safety coaches in radiology: decreasing human error and minimizing patient harm.

PubMed

Dickerson, Julie M; Koch, Bernadette L; Adams, Janet M; Goodfriend, Martha A; Donnelly, Lane F

2010-09-01

Successful programs to improve patient safety require a component aimed at improving safety culture and environment, resulting in a reduced number of human errors that could lead to patient harm. Safety coaching provides peer accountability. It involves observing for safety behaviors and use of error prevention techniques and provides immediate feedback. For more than a decade, behavior-based safety coaching has been a successful strategy for reducing error within the context of occupational safety in industry. We describe the use of safety coaches in radiology. Safety coaches are an important component of our comprehensive patient safety program.

Agent Based Modeling of Collaboration and Work Practices Onboard the International Space Station

NASA Technical Reports Server (NTRS)

Acquisti, Alessandro; Sierhuis, Maarten; Clancey, William J.; Bradshaw, Jeffrey M.; Shaffo, Mike (Technical Monitor)

2002-01-01

The International Space Station is one the most complex projects ever, with numerous interdependent constraints affecting productivity and crew safety. This requires planning years before crew expeditions, and the use of sophisticated scheduling tools. Human work practices, however, are difficult to study and represent within traditional planning tools. We present an agent-based model and simulation of the activities and work practices of astronauts onboard the ISS based on an agent-oriented approach. The model represents 'a day in the life' of the ISS crew and is developed in Brahms, an agent-oriented, activity-based language used to model knowledge in situated action and learning in human activities.

Lessons for HIV from Tuskegee.

PubMed

Stebbing, Justin; Bower, Mark

2004-09-01

We are fortunate to live in an era in which research allows significant progress in the therapy of the major diseases that affect us. However, evaluating their efficacy and safety is expensive, laborious and involves the study of human subjects in an appropriate manner. The principles of such trials have a heterogeneous basis encompassing the principles of utilitarianism, distributive justice, the protection of individual rights and the investigators' commitment to patients. The Tuskegee study of untreated syphilis is the longest non-therapeutic experiment on human beings in medical history. It continues to cast its shadow on the relationship between black Americans and the broader biomedical community. Parallels and the relationship with the HIV pandemic are discussed.

Safety of novel projects, the battle against Murphy's law.

PubMed

Schmidt, R

2001-01-01

With great pleasure and respect I have accepted the offer to speak in this congress. Medicine was a dream for me sometime ago and my second choice for studies. I remained with my first choice engineering and I am still happy with it; but I never forgot my love and enthusiasm for medicine. My career brought me in contact with many countries and technologies, but the development towards safety management became a dominant trend. At CERN I am a Group Leader in Matters of Safety for the Compact Muon Solenoid (CMS) experiment. In the last few years my attention has been increasingly focused on human and institutional safety aspects, besides the technical ones. My paper deals with three major topics: Safety management at CERN-CMS Murphy's law and the growing importance of institutional and human factors in safety Future outlook for safety and conclusions. In the conclusions the commonalities between different technologies become more evident as the importance of the human nature and man's role and enticement to actively and intelligently contribute to safety are presented. Based on experience and references an appeal is launched to pay more attention to the human factor in safety and recognize the rules and regularities of human behaviour in order to better combat Murphy's law.

2009 Human Factors and Roadway Safety Workshop : National Perspectives on Safety [SD .WMV (720x480/29fps/227.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: National Perspectives on Safety : Essie Wagner, program analyst, National Highway Traffic Safe...

75 FR 44967 - National Institute for Occupational Safety and Health

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone 877-222...

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

PubMed

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

2018-01-01

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

[Role of some psycho-physiological factors on driving safety].

PubMed

Bergomi, M; Vivoli, G; Rovesti, S; Bussetti, P; Ferrari, A; Vivoli, R

2010-01-01

Within a research project on the role played by human factors on road accidents, the aim of the present study is to evaluate, in young adults, the relationships between driver behaviour and personality factors as well as to assess the neuroendocrine correlates of psychological and behavioural factors investigated. Another aim is to estimate in what measure the performance levels are affected by demographic, psychological and chronobiological variables. It has been found a positive relation between highway code violations, extroversion trait of personality and Sensation Seeking scores, so confirming that this component of personality can affect risky behaviour. Furthermore the subjects more oriented to morningness chronotype were found to be prone to adopt safe driving behaviour. Regarding the relations of the neuroendocrine parameters and driving behaviour a positive correlation was observed between dopamine levels and frequency of driving violations while a negative relationship was found between adrenaline levels and frequency of driving errors. In conclusion the identification of psycho-physiological variables related to driving risky behaviour might be a useful instrument to design traffic safety programs tailored to high risk subjects.

Modeling Techniques for Shipboard Manning: A Review and Plan for Development

DTIC Science & Technology

1993-02-01

manning levels. Once manning models have been created, experiments can be conducted to show how changes in the manning structure might affect ship safety...these predictions, users of the manning models can evaluate how changes in crew configurations, manning levels, and voyage profiles affect ship safety...mitigate emergency situations would provide crucial information on how changes in manning structure would affect overall ship safety. Like emergency

Priming effect of dengue and yellow fever vaccination on the immunogenicity, infectivity, and safety of a tetravalent dengue vaccine in humans.

PubMed

Qiao, Ming; Shaw, David; Forrat, Remi; Wartel-Tram, Anh; Lang, Jean

2011-10-01

A dengue vaccine effective against all four serotypes is urgently needed. However, safety and immunogenicity could be affected by prior exposure to flaviviruses. This open, controlled, phase IIa study was conducted in 35 healthy adults who had received monovalent, live attenuated Vero cell-derived dengue vaccine against dengue virus 1 (VDV1) or 2 (VDV2) or yellow fever (YF) vaccine 1 year before or who were flavivirus-naïve. All participants received one subcutaneous injection of tetravalent dengue vaccine (TDV) and were followed for 180 days. Previous vaccination did not increase reactogenicity, laboratory abnormalities, or incidence of vaccine viremia, but it did increase the neutralizing antibody response to dengue virus that persisted at day 180. There was no increase in YF antibodies in participants previously immunized with YF vaccine. Prior exposure to YF or monovalent dengue vaccines had no adverse effects on the safety or incidence of viremia associated with this TDV, but it increased immunogenicity.

Epidemiology, Diagnosis, Treatment, and Control of Trichinellosis

PubMed Central

Gottstein, Bruno; Pozio, Edoardo; Nöckler, Karsten

2009-01-01

Summary: Throughout much of the world, Trichinella spp. are found to be the causative agents of human trichinellosis, a disease that not only is a public health hazard by affecting human patients but also represents an economic problem in porcine animal production and food safety. Due to the predominantly zoonotic importance of infection, the main efforts in many countries have focused on the control of Trichinella or the elimination of Trichinella from the food chain. The most important source of human infection worldwide is the domestic pig, but, e.g., in Europe, meats of horses and wild boars have played a significant role during outbreaks within the past 3 decades. Infection of humans occurs with the ingestion of Trichinella larvae that are encysted in muscle tissue of domestic or wild animal meat. Early clinical diagnosis of trichinellosis is rather difficult because pathognomonic signs or symptoms are lacking. Subsequent chronic forms of the disease are not easy to diagnose, irrespective of parameters including clinical findings, laboratory findings (nonspecific laboratory parameters such as eosinophilia, muscle enzymes, and serology), and epidemiological investigations. New regulations laying down rules for official controls for Trichinella in meat in order to improve food safety for consumers have recently been released in Europe. The evidence that the disease can be monitored and to some extent controlled with a rigorous reporting and testing system in place should be motivation to expand appropriate programs worldwide. PMID:19136437

A human factors framework and study of the effect of nursing workload on patient safety and employee quality of working life

PubMed Central

Holden, Richard J.; Scanlon, Matthew C.; Patel, Neal R.; Kaushal, Rainu; Escoto, Kamisha Hamilton; Brown, Roger L.; Alper, Samuel J.; Arnold, Judi M.; Shalaby, Theresa M.; Murkowski, Kathleen; Karsh, Ben-Tzion

2010-01-01

Backgrounds Nursing workload is increasingly thought to contribute to both nurses’ quality of working life and quality/safety of care. Prior studies lack a coherent model for conceptualizing and measuring the effects of workload in health care. In contrast, we conceptualized a human factors model for workload specifying workload at three distinct levels of analysis and having multiple nurse and patient outcomes. Methods To test this model, we analyzed results from a cross-sectional survey of a volunteer sample of nurses in six units of two academic tertiary care pediatric hospitals. Results Workload measures were generally correlated with outcomes of interest. A multivariate structural model revealed that: the unit-level measure of staffing adequacy was significantly related to job dissatisfaction (path loading = .31) and burnout (path loading = .45); the task-level measure of mental workload related to interruptions, divided attention, and being rushed was associated with burnout (path loading = .25) and medication error likelihood (path loading = 1.04). Job-level workload was not uniquely and significantly associated with any outcomes. Discussion The human factors engineering model of nursing workload was supported by data from two pediatric hospitals. The findings provided a novel insight into specific ways that different types of workload could affect nurse and patient outcomes. These findings suggest further research and yield a number of human factors design suggestions. PMID:21228071

A human factors framework and study of the effect of nursing workload on patient safety and employee quality of working life.

PubMed

Holden, Richard J; Scanlon, Matthew C; Patel, Neal R; Kaushal, Rainu; Escoto, Kamisha Hamilton; Brown, Roger L; Alper, Samuel J; Arnold, Judi M; Shalaby, Theresa M; Murkowski, Kathleen; Karsh, Ben-Tzion

2011-01-01

Nursing workload is increasingly thought to contribute to both nurses' quality of working life and quality/safety of care. Prior studies lack a coherent model for conceptualising and measuring the effects of workload in healthcare. In contrast, we conceptualised a human factors model for workload specifying workload at three distinct levels of analysis and having multiple nurse and patient outcomes. To test this model, we analysed results from a cross-sectional survey of a volunteer sample of nurses in six units of two academic tertiary care paediatric hospitals. Workload measures were generally correlated with outcomes of interest. A multivariate structural model revealed that: the unit-level measure of staffing adequacy was significantly related to job dissatisfaction (path loading=0.31) and burnout (path loading=0.45); the task-level measure of mental workload related to interruptions, divided attention, and being rushed was associated with burnout (path loading=0.25) and medication error likelihood (path loading=1.04). Job-level workload was not uniquely and significantly associated with any outcomes. The human factors engineering model of nursing workload was supported by data from two paediatric hospitals. The findings provided a novel insight into specific ways that different types of workload could affect nurse and patient outcomes. These findings suggest further research and yield a number of human factors design suggestions.

Carcinogens and cancers in freshwater fishes

USGS Publications Warehouse

Black, John J.; Baumann, Paul C.

1991-01-01

Epizootics of neoplasms in freshwater fish species are considered in relation to circumstantial and experimental evidence that suggest that some epizootics of neoplasia of hepatocellular, cholangiocellular, epidermal, and oral epithelial origin may be causally related to contaminant exposure. Although there is concern for the safety of consuming fish affected with neoplasms, this concern may be misdirected as direct transmission of cancer by ingesting cancerous tissue would seem unlikely. Of greater concern is the matter of toxic and cancer-causin chemicals present in edible fish that exhibit neoplasia as a symptom of past exposure via residence in a polluted waterway. There is ample evidence to suggest that contaminant chemicals ingested via contaminated Great Lakes fish may already be affecting both human and ecosystem health, but these effects are subtle and may require new approaches to the study of the affected systems.

Improving Safety through Human Factors Engineering.

PubMed

Siewert, Bettina; Hochman, Mary G

2015-10-01

Human factors engineering (HFE) focuses on the design and analysis of interactive systems that involve people, technical equipment, and work environment. HFE is informed by knowledge of human characteristics. It complements existing patient safety efforts by specifically taking into consideration that, as humans, frontline staff will inevitably make mistakes. Therefore, the systems with which they interact should be designed for the anticipation and mitigation of human errors. The goal of HFE is to optimize the interaction of humans with their work environment and technical equipment to maximize safety and efficiency. Special safeguards include usability testing, standardization of processes, and use of checklists and forcing functions. However, the effectiveness of the safety program and resiliency of the organization depend on timely reporting of all safety events independent of patient harm, including perceived potential risks, bad outcomes that occur even when proper protocols have been followed, and episodes of "improvisation" when formal guidelines are found not to exist. Therefore, an institution must adopt a robust culture of safety, where the focus is shifted from blaming individuals for errors to preventing future errors, and where barriers to speaking up-including barriers introduced by steep authority gradients-are minimized. This requires creation of formal guidelines to address safety concerns, establishment of unified teams with open communication and shared responsibility for patient safety, and education of managers and senior physicians to perceive the reporting of safety concerns as a benefit rather than a threat. © RSNA, 2015.

Manufacturing of dental pulp cell-based products from human third molars: current strategies and future investigations

PubMed Central

Ducret, Maxime; Fabre, Hugo; Degoul, Olivier; Atzeni, Gianluigi; McGuckin, Colin; Forraz, Nico; Alliot-Licht, Brigitte; Mallein-Gerin, Frédéric; Perrier-Groult, Emeline; Farges, Jean-Christophe

2015-01-01

In recent years, mesenchymal cell-based products have been developed to improve surgical therapies aimed at repairing human tissues. In this context, the tooth has recently emerged as a valuable source of stem/progenitor cells for regenerating orofacial tissues, with easy access to pulp tissue and high differentiation potential of dental pulp mesenchymal cells. International guidelines now recommend the use of standardized procedures for cell isolation, storage and expansion in culture to ensure optimal reproducibility, efficacy and safety when cells are used for clinical application. However, most dental pulp cell-based medicinal products manufacturing procedures may not be fully satisfactory since they could alter the cells biological properties and the quality of derived products. Cell isolation, enrichment and cryopreservation procedures combined to long-term expansion in culture media containing xeno- and allogeneic components are known to affect cell phenotype, viability, proliferation and differentiation capacities. This article focuses on current manufacturing strategies of dental pulp cell-based medicinal products and proposes a new protocol to improve efficiency, reproducibility and safety of these strategies. PMID:26300779

Space station crew safety alternatives study. Volume 3: Safety impact of human factors

NASA Technical Reports Server (NTRS)

Rockoff, L. A.; Raasch, R. F.; Peercy, R. L., Jr.

1985-01-01

The first 15 years of accumulated space station concepts for Initial Operational Capability (IOC) during the early 1990's was considered. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris. Of particular interest here is volume three (of five volumes) pertaining to the safety impact of human factors.

76 FR 68192 - Meeting of the Advisory Committee on Blood Safety and Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and.... Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety... Health, on a broad range of issues involving the safety and availability of blood and blood products. The...

Human health risks from heavy metals in fish of Buriganga river, Bangladesh.

PubMed

Kawser Ahmed, Md; Baki, Mohammad Abdul; Kundu, Goutam Kumar; Saiful Islam, Md; Monirul Islam, Md; Muzammel Hossain, Md

2016-01-01

Heavy metals are known to cause deleterious effects on human health through food chain. Human health risks were evaluated from consumption of heavy metal contaminated fish from Buriganga River in Bangladesh. Whole body of five fish species ( Puntius ticto, Puntius sophore, Puntius chola, Labeo rohita and Glossogobius giuris ) were analyzed which contained various concentrations of Cd, As, Pb, Cr, Ni, Zn, Se, Cu, Mo, Mn, Sb, Ba, V and Ag. Concentrations of Mn, Zn, Se and Pb in all fish species were above the Food Safety Guideline (FSG) by WHO/FAO. Assessment of noncarcinogenic health hazard by target hazard quotient (THQ) indicated no concern from consumption of these fish except for Mn. However, all metals together may affect human health as revealed by hazard index (HI). The target cancer risk (TR) values suggested carcinogenic risk from Ni and As. Taken together it can be concluded that there is potential human health risk in consuming fish from river Buriganga.

Safety assessment methodology in management of spent sealed sources.

PubMed

Mahmoud, Narmine Salah

2005-02-14

Environmental hazards can be caused from radioactive waste after their disposal. It was therefore important that safety assessment methodologies be developed and established to study and estimate the possible hazards, and institute certain safety methodologies that lead and prevent the evolution of these hazards. Spent sealed sources are specific type of radioactive waste. According to IAEA definition, spent sealed sources are unused sources because of activity decay, damage, misuse, loss, or theft. Accidental exposure of humans from spent sealed sources can occur at the moment they become spent and before their disposal. Because of that reason, safety assessment methodologies were tailored to suit the management of spent sealed sources. To provide understanding and confidence of this study, validation analysis was undertaken by considering the scenario of an accident that occurred in Egypt, June 2000 (the Meet-Halfa accident from an iridium-192 source). The text of this work includes consideration related to the safety assessment approaches of spent sealed sources which constitutes assessment context, processes leading an active source to be spent, accident scenarios, mathematical models for dose calculations, and radiological consequences and regulatory criteria. The text also includes a validation study, which was carried out by evaluating a theoretical scenario compared to the real scenario of Meet-Halfa accident depending on the clinical assessment of affected individuals.

Human Stem Cell Derived Cardiomyocytes: An Alternative ...

EPA Pesticide Factsheets

Chemical spills and associated deaths in the US has increased 2.6-fold and 16-fold from 1983 to 2012, respectfully. In addition, the number of chemicals to which humans are exposed to in the environment has increased almost 10-fold from 2001 to 2013 within the US. Internationally, a WHO report on the global composite impact of chemicals on health reported that 16% of the total burden of cardiovascular disease was attributed to environmental chemical exposure with 2.5 million deaths per year. Clearly, the cardiovascular system, at all its various developmental and life stages, represents a critical target organ system that can be adversely affected by existing and emerging chemicals (e.g., engineered nanomaterials) in a variety of environmental media. The ability to assess chemical cardiac risk and safety is critically needed but extremely challenging due to the number and categories of chemicals in commerce, as indicated. This presentation\\session will evaluate the use of adult human stem cell derived cardiomyocytes, and existing platforms, as an alternative model to evaluate environmental chemical cardiac toxicity as well as provide key information for the development of predictive adverse outcomes pathways associated with environmental chemical exposures. (This abstract does not represent EPA policy) Rapid and translatable chemical safety screening models for cardiotoxicity current status for informing regulatory decisions, a workshop sponsored by the Society

Research of Influence of Noise Pollution on the Value of the Threshold Current Tangible

NASA Astrophysics Data System (ADS)

Khanzhina, Olga; Sidorov, Alexander; Zykina, Ekaterina

2017-12-01

Stable safety while working on electrical installations can be achieved by following the rules of the electrical safety. Today maximum permissible levels of touch voltage and electric current flow through any part of a person’s body are established by Russian Federation GOST system 12.1.038-82. Unfortunately, recommended by International Electrotechnical Commission (IEC) maximum allowable amount of electric current and voltage level do not take into account interaction between said electric current and other physical factors; noise, in particular. The influence of sound frequency and its pressure level on body resistance has been proven earlier in thesis by V.V. Katz. Studies of the noise effects on the value of the threshold current tangible have been renewed in laboratories of Life Safety Department in South Ural State University. To obtain reliable results, testing facility that includes anechoic chamber, sources of simulated voltages and noise and a set of recording instruments was designed and built. As a rule, noise influence on electrotechnical personnel varies depending on noise level or/and the duration of its impact. According to modern theories, indirect noise influence on various organs and systems through central nervous system has to be considered. Differential evaluation of noise pollution and its correlation with emerged effects can be obtained with the usage of the dose approach. First of all, there were conducted studies, in which frequency of the applied voltage (f) was to 50 Hz. Voltages and currents that caused sensations before and during 97 dB noise affections were measured. Obtained dependence led to questioning previous researches results of the necessity of reducing the amperage of tripping protection devices. At the same time electrical resistance changes of human body were being studied. According to those researches, no functional dependence between fluctuations in the magnitude of the resistance of human body to electric current flow and constant noise affection were found. Taking into account that contradiction, additional studies of primary electrical safety criteria for cases when exposed to high frequency noise pollution were conducted.

Relational approach in managing construction project safety: a social capital perspective.

PubMed

Koh, Tas Yong; Rowlinson, Steve

2012-09-01

Existing initiatives in the management of construction project safety are largely based on normative compliance and error prevention, a risk management approach. Although advantageous, these approaches are not wholly successful in further lowering accident rates. A major limitation lies with the approaches' lack of emphasis on the social and team processes inherent in construction project settings. We advance the enquiry by invoking the concept of social capital and project organisational processes, and their impacts on project safety performance. Because social capital is a primordial concept and affects project participants' interactions, its impact on project safety performance is hypothesised to be indirect, i.e. the impact of social capital on safety performance is mediated by organisational processes in adaptation and cooperation. A questionnaire survey was conducted within Hong Kong construction industry to test the hypotheses. 376 usable responses were received and used for analyses. The results reveal that, while the structural dimension is not significant, the mediational thesis is generally supported with the cognitive and relational dimensions affecting project participants' adaptation and cooperation, and the latter two processes affect safety performance. However, the cognitive dimension also directly affects safety performance. The implications of these results for project safety management are discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Reprogramming Methods Do Not Affect Gene Expression Profile of Human Induced Pluripotent Stem Cells.

PubMed

Trevisan, Marta; Desole, Giovanna; Costanzi, Giulia; Lavezzo, Enrico; Palù, Giorgio; Barzon, Luisa

2017-01-20

Induced pluripotent stem cells (iPSCs) are pluripotent cells derived from adult somatic cells. After the pioneering work by Yamanaka, who first generated iPSCs by retroviral transduction of four reprogramming factors, several alternative methods to obtain iPSCs have been developed in order to increase the yield and safety of the process. However, the question remains open on whether the different reprogramming methods can influence the pluripotency features of the derived lines. In this study, three different strategies, based on retroviral vectors, episomal vectors, and Sendai virus vectors, were applied to derive iPSCs from human fibroblasts. The reprogramming efficiency of the methods based on episomal and Sendai virus vectors was higher than that of the retroviral vector-based approach. All human iPSC clones derived with the different methods showed the typical features of pluripotent stem cells, including the expression of alkaline phosphatase and stemness maker genes, and could give rise to the three germ layer derivatives upon embryoid bodies assay. Microarray analysis confirmed the presence of typical stem cell gene expression profiles in all iPSC clones and did not identify any significant difference among reprogramming methods. In conclusion, the use of different reprogramming methods is equivalent and does not affect gene expression profile of the derived human iPSCs.

Investigation of clinical pharmacokinetic variability of an opioid antagonist through physiologically based absorption modeling.

PubMed

Ding, Xuan; He, Minxia; Kulkarni, Rajesh; Patel, Nita; Zhang, Xiaoyu

2013-08-01

Identifying the source of inter- and/or intrasubject variability in pharmacokinetics (PK) provides fundamental information in understanding the pharmacokinetics-pharmacodynamics relationship of a drug and project its efficacy and safety in clinical populations. This identification process can be challenging given that a large number of potential causes could lead to PK variability. Here we present an integrated approach of physiologically based absorption modeling to investigate the root cause of unexpectedly high PK variability of a Phase I clinical trial drug. LY2196044 exhibited high intersubject variability in the absorption phase of plasma concentration-time profiles in humans. This could not be explained by in vitro measurements of drug properties and excellent bioavailability with low variability observed in preclinical species. GastroPlus™ modeling suggested that the compound's optimal solubility and permeability characteristics would enable rapid and complete absorption in preclinical species and in humans. However, simulations of human plasma concentration-time profiles indicated that despite sufficient solubility and rapid dissolution of LY2196044 in humans, permeability and/or transit in the gastrointestinal (GI) tract may have been negatively affected. It was concluded that clinical PK variability was potentially due to the drug's antagonism on opioid receptors that affected its transit and absorption in the GI tract. Copyright © 2013 Wiley Periodicals, Inc.

30 CFR 56.19107 - Precautions for work in compartment affected by hoisting operation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Precautions for work in compartment affected by hoisting operation. 56.19107 Section 56.19107 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND...

30 CFR 57.19107 - Precautions for work in compartment affected by hoisting operation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Precautions for work in compartment affected by hoisting operation. 57.19107 Section 57.19107 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL...

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

MEMS sensor technologies for human centred applications in healthcare, physical activities, safety and environmental sensing: a review on research activities in Italy.

PubMed

Ciuti, Gastone; Ricotti, Leonardo; Menciassi, Arianna; Dario, Paolo

2015-03-17

Over the past few decades the increased level of public awareness concerning healthcare, physical activities, safety and environmental sensing has created an emerging need for smart sensor technologies and monitoring devices able to sense, classify, and provide feedbacks to users' health status and physical activities, as well as to evaluate environmental and safety conditions in a pervasive, accurate and reliable fashion. Monitoring and precisely quantifying users' physical activity with inertial measurement unit-based devices, for instance, has also proven to be important in health management of patients affected by chronic diseases, e.g., Parkinson's disease, many of which are becoming highly prevalent in Italy and in the Western world. This review paper will focus on MEMS sensor technologies developed in Italy in the last three years describing research achievements for healthcare and physical activity, safety and environmental sensing, in addition to smart systems integration. Innovative and smart integrated solutions for sensing devices, pursued and implemented in Italian research centres, will be highlighted, together with specific applications of such technologies. Finally, the paper will depict the future perspective of sensor technologies and corresponding exploitation opportunities, again with a specific focus on Italy.

When fear forms memories: threat of shock and brain potentials during encoding and recognition.

PubMed

Weymar, Mathias; Bradley, Margaret M; Hamm, Alfons O; Lang, Peter J

2013-03-01

The anticipation of highly aversive events is associated with measurable defensive activation, and both animal and human research suggests that stress-inducing contexts can facilitate memory. Here, we investigated whether encoding stimuli in the context of anticipating an aversive shock affects recognition memory. Event-related potentials (ERPs) were measured during a recognition test for words that were encoded in a font color that signaled threat or safety. At encoding, cues signaling threat of shock, compared to safety, prompted enhanced P2 and P3 components. Correct recognition of words encoded in the context of threat, compared to safety, was associated with an enhanced old-new ERP difference (500-700 msec; centro-parietal), and this difference was most reliable for emotional words. Moreover, larger old-new ERP differences when recognizing emotional words encoded in a threatening context were associated with better recognition, compared to words encoded in safety. Taken together, the data indicate enhanced memory for stimuli encoded in a context in which an aversive event is merely anticipated, which could assist in understanding effects of anxiety and stress on memory processes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Safety assessment for hair-spray resins: risk assessment based on rodent inhalation studies.

PubMed

Carthew, Philip; Griffiths, Heather; Keech, Stephen; Hartop, Peter

2002-04-01

The methods involved in the safety assessment of resins used in hair-spray products have received little peer review, or debate in the published literature, despite their widespread use, in both hairdressing salons and the home. The safety assessment for these resins currently involves determining the type of lung pathology that can be caused in animal inhalation exposure studies, and establishing the no-observable-effect level (NOEL) for these pathologies. The likely human consumer exposure is determined by techniques that model the simulated exposure under "in use" conditions. From these values it is then possible to derive the likely safety factors for human exposure. An important part of this process would be to recognize the intrinsic differences between rodents and humans in terms of the respiratory doses that each species experiences during inhalation exposures, for the purpose of the safety assessment. Interspecies scaling factors become necessary when comparing the exposure doses experienced by rats, compared to humans, because of basic differences between species in lung clearance rates and the alveolar area in the lungs. The rodent inhalation data and modeled human exposure to Resin 6965, a resin polymer that is based on vinyl acetate, has been used to calculate the safety factor for human consumer exposure to this resin, under a range of "in use" exposure conditions. The use of this safety assessment process clearly demonstrates that Resin 6965 is acceptable for human consumer exposure under the conditions considered in this risk assessment.

75 FR 5536 - Pipeline Safety: Control Room Management/Human Factors, Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-03

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts...: Control Room Management/Human Factors, Correction AGENCY: Pipeline and Hazardous Materials Safety... following correcting amendments: PART 192--TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM...

Leader-member exchange and safety citizenship behavior: The mediating role of coworker trust.

PubMed

Jiang, Li; Li, Feng; Li, YongJuan; Li, Rui

2017-01-01

To achieve high safety levels, mere compliance with safety regulations is not sufficient; employees must be proactive and demonstrate safety citizenship behaviors. Trust is considered as a mechanism for facilitating the effects of a leader on employee citizenship behaviors. Increasingly research has focused on the role of trust in a safety context; however, the role of coworker trust has been overlooked. The mediating role of coworker trust in the relationship between the leader-member exchange and safety citizenship behavior is the focus of this field study. Front-line employees from an air traffic control center and an airline maintenance department completed surveys measuring leader-member exchange, co-worker trust, and safety citizenship behavior. Structural Equation Modeling revealed affective and cognitive trust in coworkers is influenced by leader-member exchange. A trust-based mediation model where cognitive trust and affective trust mediate the relationship between the leader-member exchange and safety citizenship behavior emerged. Results of this study add to our understanding of the relationship between leader-member exchange and safety behavior. The effect of co-worker trust and the extent to which employees participate in workplace safety practice were identified as critical factors. The findings show that managers need to focus on developing cognitive and affective coworker trust to improve safety citizenship behaviors.

A path analysis model for explaining unsafe behavior in workplaces: the effect of perceived work pressure.

PubMed

Ghasemi, Fakhradin; Kalatpour, Omid; Moghimbeigi, Abbas; Mohhamadfam, Iraj

2018-06-01

Unsafe behavior is closely related to occupational accidents. Work pressure is one the main factors affecting employees' behavior. The aim of the present study was to provide a path analysis model for explaining how work pressure affects safety behavior. Using a self-administered questionnaire, six variables supposed to affect safety employees' behavior were measured. The path analysis model was constructed based on several hypotheses. The goodness of fit of the model was assessed using both absolute and comparative fit indices. Work pressure was determined not to influence safety behavior directly. However, it negatively influenced other variables. Group attitude and personal attitude toward safety were the main factors mediating the effect of work pressure on safety behavior. Among the variables investigated in the present study, group attitude, personal attitude and work pressure had the strongest effects on safety behavior. Managers should consider that in order to improve employees' safety behavior, work pressure should be reduced to a reasonable level, and concurrently a supportive environment, which ensures a positive group attitude toward safety, should be provided. Replication of the study is recommended.

Statistical Detection of Atypical Aircraft Flights

NASA Technical Reports Server (NTRS)

Statler, Irving; Chidester, Thomas; Shafto, Michael; Ferryman, Thomas; Amidan, Brett; Whitney, Paul; White, Amanda; Willse, Alan; Cooley, Scott; Jay, Joseph;

Patient safety - the role of human factors and systems engineering.

PubMed

Carayon, Pascale; Wood, Kenneth E

2010-01-01

Patient safety is a global challenge that requires knowledge and skills in multiple areas, including human factors and systems engineering. In this chapter, numerous conceptual approaches and methods for analyzing, preventing and mitigating medical errors are described. Given the complexity of healthcare work systems and processes, we emphasize the need for increasing partnerships between the health sciences and human factors and systems engineering to improve patient safety. Those partnerships will be able to develop and implement the system redesigns that are necessary to improve healthcare work systems and processes for patient safety.

Genetic variation in serotonin transporter function affects human fear expression indexed by fear-potentiated startle.

PubMed

Klumpers, Floris; Heitland, Ivo; Oosting, Ronald S; Kenemans, J Leon; Baas, Johanna M P

2012-02-01

The serotonin transporter (SERT) plays a crucial role in anxiety. Accordingly, variance in SERT functioning appears to constitute an important pathway to individual differences in anxiety. The current study tested the hypothesis that genetic variation in SERT function is associated with variability in the basic reflex physiology of defense. Healthy subjects (N=82) were presented with clearly instructed cues of shock threat and safety to induce robust anxiety reactions. Subjects carrying at least one short allele for the 5-HTTLPR polymorphism showed stronger fear-potentiated startle compared to long allele homozygotes. However, short allele carriers showed no deficit in the downregulation of fear after the offset of threat. These results suggest that natural variation in SERT function affects the magnitude of defensive reactions while not affecting the capacity for fear regulation. Copyright © 2011 Elsevier B.V. All rights reserved.

Missing focus on Human Factors – organizational and cognitive ergonomics – in the safety management for the petroleum industry

PubMed Central

Johnsen, Stig O; Kilskar, Stine Skaufel; Fossum, Knut Robert

2017-01-01

More attention has recently been given to Human Factors in petroleum accident investigations. The Human Factors areas examined in this article are organizational, cognitive and physical ergonomics. A key question to be explored is as follows: To what degree are the petroleum industry and safety authorities in Norway focusing on these Human Factors areas from the design phase? To investigate this, we conducted an innovative exploratory study of the development of four control centres in Norwegian oil and gas industry in collaboration between users, management and Human Factors experts. We also performed a literature survey and discussion with the professional Human Factors network in Norway. We investigated the Human Factors focus, reasons for not considering Human Factors and consequences of missing Human Factors in safety management. The results revealed an immature focus and organization of Human Factors. Expertise on organizational ergonomics and cognitive ergonomics are missing from companies and safety authorities and are poorly prioritized during the development. The easy observable part of Human Factors (i.e. physical ergonomics) is often in focus. Poor focus on Human Factors in the design process creates demanding conditions for human operators and impact safety and resilience. There is lack of non-technical skills such as communication and decision-making. New technical equipment such as Closed Circuit Television is implemented without appropriate use of Human Factors standards. Human Factors expertise should be involved as early as possible in the responsible organizations. Verification and validation of Human Factors should be improved and performed from the start, by certified Human Factors experts in collaboration with the workforce. The authorities should check-back that the regulatory framework of Human Factors is communicated, understood and followed. PMID:29278242

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

NASA Astrophysics Data System (ADS)

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

2018-01-01

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

Stress-oriented driver assistance system for electric vehicles.

PubMed

Athanasiou, Georgia; Tsotoulidis, Savvas; Mitronikas, Epaminondas; Lymberopoulos, Dimitrios

2014-01-01

Stress is physiological and physical reaction that appears in highly demanding situations and affects human's perception and reaction capability. Occurrence of stress events within highly dynamic road environment could lead to life-threatening situation. With the perspective of safety and comfort driving provision to anxious drivers, in this paper a stress-oriented Driver Assistance System (DAS) is proposed. The DAS deployed on Electric Vehicle. This novel DAS customizes driving command signal in respect to road context, when stress is detected. The effectiveness of this novel DAS is verified by simulation in MATLAB/SIMULINK environment.

Human Factors and Safety Considerations of Night Vision Systems Flight Using Thermal Imaging Systems

DTIC Science & Technology

1990-04-01

s4 tank with engine, drive playa that are twit very daIrk in the kcast brightest wheel-, and eXhSAus at temprrAtures between M5 anid Warea IvPKlly...be presented to the pilot on a miniature (1- sources, when viewed through the combiner, degra- inch diameter) cathodec ray tube (CRT) in the de the...performance. Also. flme Ccas Affect the display’s performance as well. The see-through chrsctcrisics of the display permit de Unlike sytcms using the

Noise As A Risk Factor In The Preparation Of Useful Mineral Substances

NASA Astrophysics Data System (ADS)

Irimia, Alin; Sorin, Simion; Pupăzan, Daniel; Călămar, Angela

2015-07-01

Noise from industrial activities is a major problem because of its noxious and its presence in all technological activities. The coal preparation activity from industry, in the presence of risks of exposure to noise, is affecting the health and safety of workers. Occupational hearing loss and deafness caused by exposure to noise at work are the most encountered illnesses occurring in the European Union. This paper examines the main sources of noise in coal preparation technological process and their effects on the human factor.

Inhibition of Fear by Learned Safety Signals: minisymposium review

PubMed Central

Fernando, Anushka B. P.; Kazama, Andy M.; Jovanovic, Tanja; Ostroff, Linnaea E.; Sangha, Susan

2012-01-01

Safety signals are learned cues that predict the non-occurrence of an aversive event. As such, safety signals are potent inhibitors of fear and stress responses. Investigations of safety signal learning have increased over the last few years due in part to the finding that traumatized persons are unable to utilize safety cues to inhibit fear, making it a clinically relevant phenotype. The goal of this review is to present recent advances relating to the neural and behavioral mechanisms of safety learning and expression in rodents, non-human primates and humans. PMID:23055481

The "highs and lows" of the human brain on dopaminergics: Evidence from neuropharmacology.

PubMed

Martins, Daniel; Mehta, Mitul A; Prata, Diana

2017-09-01

Rewards are appetitive events that elicit approach. Ground-breaking findings from neurophysiological experiments in animals, alongside neuropharmacology and neuroimaging research in human samples have identified dopamine as the main neurochemical messenger of global reward processing in the brain. However, dopamine's contribution to the different components of reward processing remains to be precisely defined. To facilitate the informed design and interpretation of reward studies in humans, we have systematically reviewed all existing human pharmacological studies investigating how drug manipulation of the dopamine system affects reward-related behaviour and its neural correlates. Pharmacological experiments in humans face methodological challenges in terms of the: 1) specificity and safety of the available drugs for administration in humans, 2) uncertainties about pre- or post-synaptic modes of action, and 3) possible interactions with inter-individual neuropsychological or genotypic variables. In order to circumvent some of these limitations, future research should rely on the combination of different levels of observation, in integrative pharmaco-genetics-neurobehavioral approaches, to more completely characterize dopamine's role in both general and modality-specific processing of reward. Copyright © 2017 Elsevier Ltd. All rights reserved.

16 CFR 1207.11 - References.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY...,” U.S. Dept. of Commerce, pp. 181-185, 192. (b) “Human Engineering Guide for Equipment Designers... St., Berkeley, California 94720. (c) “Human Engineering Guide to Equipment Design,” Van Cott and Kin...

16 CFR 1207.11 - References.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY...,” U.S. Dept. of Commerce, pp. 181-185, 192. (b) “Human Engineering Guide for Equipment Designers... St., Berkeley, California 94720. (c) “Human Engineering Guide to Equipment Design,” Van Cott and Kin...

16 CFR § 1207.11 - References.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY...,” U.S. Dept. of Commerce, pp. 181-185, 192. (b) “Human Engineering Guide for Equipment Designers... St., Berkeley, California 94720. (c) “Human Engineering Guide to Equipment Design,” Van Cott and Kin...

16 CFR 1207.11 - References.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY...,” U.S. Dept. of Commerce, pp. 181-185, 192. (b) “Human Engineering Guide for Equipment Designers... St., Berkeley, California 94720. (c) “Human Engineering Guide to Equipment Design,” Van Cott and Kin...

21 CFR 172.809 - Curdlan.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition... examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100...

Establishing a culture for patient safety - the role of education.

PubMed

Milligan, Frank J

2007-02-01

This paper argues that the process of making significant moves towards a patient safety culture requires changes in healthcare education. Improvements in patient safety are a shared international priority as too many errors and other forms of unnecessary harm are currently occurring in the process of caring for and treating patients. A description of the patient safety agenda is given followed by a brief analysis of human factors theory and its use in other safety critical industries, most notably aviation. The all too common problem of drug administration errors is used to illustrate the relevance of human factors theory to healthcare education with specific mention made of the Human Factors Analysis and Classification System (HFACS).

Considerations for the design of safe and effective consumer health IT applications in the home.

PubMed

Zayas-Cabán, Teresa; Dixon, Brian E

2010-10-01

Consumer health IT applications have the potential to improve quality, safety and efficiency of consumers' interactions with the healthcare system. Yet little attention has been paid to human factors and ergonomics in the design of consumer health IT, potentially limiting the ability of health IT to achieve these goals. This paper presents the results of an analysis of human factors and ergonomics issues encountered by five projects during the design and implementation of home-based consumer health IT applications. Agency for Healthcare Research and Quality-funded consumer health IT research projects, where patients used the IT applications in their homes, were reviewed. Project documents and discussions with project teams were analysed to identify human factors and ergonomic issues considered or addressed by project teams. The analysis focused on system design and design processes used as well as training, implementation and use of the IT intervention. A broad range of consumer health IT applications and diverse set of human factors and ergonomics issues were identified. The design and implementation processes used resulted in poor fit with some patients' healthcare tasks and the home environment and, in some cases, resulted in lack of use. Clinician interaction with patients and the information provided through health IT applications appeared to positively influence adoption and use. Consumer health IT application design would benefit from the use of human factors and ergonomics design and evaluation methods. Considering the context in which home-based consumer health IT applications are used will likely affect the ability of these applications to positively impact the quality, safety and efficiency of patient care.

Preclinical Pharmacokinetics and First-in-Human Pharmacokinetics, Safety, and Tolerability of Velpatasvir, a Pangenotypic Hepatitis C Virus NS5A Inhibitor, in Healthy Subjects

PubMed Central

German, Polina; Kearney, Brian P.; Yang, Cheng Yong; Brainard, Diana; Link, John; McNally, John; Han, LingLing; Ling, John; Mathias, Anita

2017-01-01

ABSTRACT Preclinical characterization of velpatasvir (VEL; GS-5816), an inhibitor of the hepatitis C virus (HCV) NS5A protein, demonstrated that it has favorable in vitro and in vivo properties, including potent antiviral activity against hepatitis C virus genotype 1 to 6 replicons, good metabolic stability, low systemic clearance, and adequate bioavailability and physicochemical properties, to warrant clinical evaluation. The phase 1 (first-in-human) study evaluated the safety, tolerability, and pharmacokinetics of VEL in healthy human subjects following administration of single and multiple (n = 7) once-daily ascending doses and of VEL in the presence and absence of food. Following administration of single and multiple doses, VEL was safe and well tolerated when administered at up to 450 mg and when administered with food. The pharmacokinetic behavior of VEL observed in humans was generally in agreement with that seen during preclinical characterization. Following administration of multiple doses, VEL trough concentrations were significantly greater than the protein-adjusted half-maximal (50%) effective concentration of VEL against HCV genotype 1 to 6 replicons at all evaluated doses greater than 5 mg. The pharmacokinetics of VEL were not significantly affected by administration with food. Collectively, the results of this study support the further clinical investigation of VEL administered once daily as part of a regimen with other pangenotypic direct-acting antivirals for the treatment of HCV infection. PMID:28193657

Antibiotic-resistant bacteria: prevalence in food and inactivation by food-compatible compounds and plant extracts.

PubMed

Friedman, Mendel

2015-04-22

Foodborne antibiotic-resistant pathogenic bacteria such as Campylobacter jejuni, Bacillus cereus, Clostridium perfringens, Escherichia coli, Salmonella enterica, Staphylococcus aureus, Vibrio cholerae, and Vibrio parahemolyticus can adversely affect animal and human health, but a better understanding of the factors involved in their pathogenesis is needed. To help meet this need, this overview surveys and interprets much of our current knowledge of antibiotic (multidrug)-resistant bacteria in the food chain and the implications for microbial food safety and animal and human health. Topics covered include the origin and prevalence of resistant bacteria in the food chain (dairy, meat, poultry, seafood, and herbal products, produce, and eggs), their inactivation by different classes of compounds and plant extracts and by the use of chlorine and physicochemical methods (heat, UV light, pulsed electric fields, and high pressure), the synergistic antimicrobial effects of combinations of natural antimicrobials with medicinal antibiotics, and mechanisms of antimicrobial activities and resistant effects. Possible areas for future research are suggested. Plant-derived and other safe natural antimicrobial compounds have the potential to control the prevalence of both susceptible and resistant pathogens in various environments. The collated information and suggested research will hopefully contribute to a better understanding of approaches that could be used to minimize the presence of resistant pathogens in animal feed and human food, thus reducing adverse effects, improving microbial food safety, and helping to prevent or treat animal and human infections.

Hazardous properties and toxicological update of mercury: From fish food to human health safety perspective.

PubMed

Okpala, Charles Odilichukwu R; Sardo, Giacomo; Vitale, Sergio; Bono, Gioacchino; Arukwe, Augustine

2017-04-10

The mercury (Hg) poisoning of Minamata Bay of Japan widely activated a global attention to Hg toxicity and its potential consequences to the aquatic ecosystem and human health. This has resulted to an increased need for a dynamic assembly, contextualization, and quantification of both the current state-of-the-art and approaches for understanding the cause-and-effect relationships of Hg exposure. Thus, the objective of this present review is to provide both hazardous toxic properties and toxicological update of Hg, focusing on how it ultimately affects the aquatic biota to potentially produce human health effects. Primarily, we discussed processes that relate to Hg exposure, including immunological aspects and risk assessment, vulnerability, toxicokinetics, and toxicodynamics, using edible fish, swordfish (Xiphias gladius), as a model. In addition, we summarized available information about Hg concentration limits set by different governmental agencies, as recognized by national and international standardization authorities.

Recent Advances towards the Clinical Application of Stem Cells for Retinal Regeneration

PubMed Central

Becker, Silke; Jayaram, Hari; Limb, G. Astrid

2012-01-01

Retinal degenerative diseases constitute a major cause of irreversible blindness in the world. Stem cell-based therapies offer hope for these patients at risk of or suffering from blindness due to the deterioration of the neural retina. Various sources of stem cells are currently being investigated, ranging from human embryonic stem cells to adult-derived induced pluripotent stem cells as well as human Müller stem cells, with the first clinical trials to investigate the safety and tolerability of human embryonic stem cell-derived retinal pigment epithelium cells having recently commenced. This review aims to summarize the latest advances in the development of stem cell strategies for the replacement of retinal neurons and their supportive cells, the retinal pigment epithelium (RPE) affected by retinal degenerative conditions. Particular emphasis will be given to the advances in stem cell transplantation and the challenges associated with their translation into clinical practice. PMID:24710533

Nonclinical Safety Assessment of Anti-Factor D: Key Strategies and Challenges for the Nonclinical Development of Intravitreal Biologics.

PubMed

Bantseev, Vladimir; Erickson, Rebecca; Leipold, Douglas; Amaya, Caroline; Miller, Paul E; Booler, Helen; Thackaberry, Evan A

The nonclinical toxicology program described here was designed to characterize the safety profile of anti-factor D (AFD; FCFD4514S, lampalizumab) to support intravitreal (ITV) administration in patients with geographic atrophy (GA). The toxicity of AFD was assessed in a single-dose and 6-month repeat-dose study in monkeys at doses up to 10 mg/eye. Toxicity was assessed by clinical ophthalmic examinations, intraocular pressure measurements, ocular photography, electroretinography, fluorescein angiography, optical coherence tomography, and anatomic pathology. Systemic exposure to AFD generally increased with the increase in dose level. The increases in mean maximal concentration and area under the curve values were roughly dose proportional. No accumulation of AFD was observed following 10 doses, and drug exposures were not affected by anti-drug antibodies. AFD was locally and systemically well tolerated in monkeys following ITV doses of up to 10 mg/eye. Ocular effects associated with AFD were limited to transient, reversible, dose-related, aqueous cell responses and injection-related, mild, vitreal cell responses. In the 6-month repeat-dose study, 2 monkeys had a nonspecific immune response to AFD that resulted in severe ocular inflammation, attributed to administration of a heterologous (humanized) protein. The comprehensive toxicology program in monkeys described here was designed to evaluate the safety profile of AFD and to support multiple ITV injections in the clinic. Administration of a heterologous (humanized) protein presents a challenge, and immunogenicity in nonclinical species is not predictive of immunogenicity in humans. Taken together, the results of the nonclinical program described here support the use of AFD in patients with GA.

Addressing the human factors issues associated with control room modifications

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

O`Hara, J.; Stubler, W.; Kramer, J.

1998-03-01

Advanced human-system interface (HSI) technology is being integrated into existing nuclear plants as part of plant modifications and upgrades. The result of this trend is that hybrid HSIs are created, i.e., HSIs containing a mixture of conventional (analog) and advanced (digital) technology. The purpose of the present research is to define the potential effects of hybrid HSIs on personnel performance and plant safety and to develop human factors guidance for safety reviews of them where necessary. In support of this objective, human factors issues associated with hybrid HSIs were identified. The issues were evaluated for their potential significance to plantmore » safety, i.e., their human performance concerns have the potential to compromise plant safety. The issues were then prioritized and a subset was selected for design review guidance development.« less

Understanding safety and production risks in rail engineering planning and protection.

PubMed

Wilson, John R; Ryan, Brendan; Schock, Alex; Ferreira, Pedro; Smith, Stuart; Pitsopoulos, Julia

2009-07-01

Much of the published human factors work on risk is to do with safety and within this is concerned with prediction and analysis of human error and with human reliability assessment. Less has been published on human factors contributions to understanding and managing project, business, engineering and other forms of risk and still less jointly assessing risk to do with broad issues of 'safety' and broad issues of 'production' or 'performance'. This paper contains a general commentary on human factors and assessment of risk of various kinds, in the context of the aims of ergonomics and concerns about being too risk averse. The paper then describes a specific project, in rail engineering, where the notion of a human factors case has been employed to analyse engineering functions and related human factors issues. A human factors issues register for potential system disturbances has been developed, prior to a human factors risk assessment, which jointly covers safety and production (engineering delivery) concerns. The paper concludes with a commentary on the potential relevance of a resilience engineering perspective to understanding rail engineering systems risk. Design, planning and management of complex systems will increasingly have to address the issue of making trade-offs between safety and production, and ergonomics should be central to this. The paper addresses the relevant issues and does so in an under-published domain - rail systems engineering work.

Patient Safety: The Role of Human Factors and Systems Engineering

PubMed Central

Carayon, Pascale; Wood, Kenneth E.

2011-01-01

Patient safety is a global challenge that requires knowledge and skills in multiple areas, including human factors and systems engineering. In this chapter, numerous conceptual approaches and methods for analyzing, preventing and mitigating medical errors are described. Given the complexity of healthcare work systems and processes, we emphasize the need for increasing partnerships between the health sciences and human factors and systems engineering to improve patient safety. Those partnerships will be able to develop and implement the system redesigns that are necessary to improve healthcare work systems and processes for patient safety. PMID:20543237

How a Stressed Local Public System Copes With People in Psychiatric Crisis

PubMed Central

Wells, Rebecca; La, Elizabeth Holdsworth; Morrissey, Joseph; Hall, Marissa; Lich, Kristen Hassmiller; Blouin, Rachel

2012-01-01

In order to bolster the public mental health safety net, we must first understand how these systems function on a day-to-day basis. This study explored how individual attributes and organizational interdependencies within one predominantly urban US county affected responses to individuals’ needs during psychiatric crises. We interviewed clinicians and managers within the crisis response network about people at immediate risk of psychiatric hospitalization, what had happened to them during their crises, and factors affecting services provided (N = 94 individuals and 9 agencies). Social network diagrams depicted patterns of referrals between agencies. Iterative coding of interview transcripts was used to contextualize the social network findings. Often, agencies saw crises through to resolution. However, providers also limited the types of people they served, leaving many people in crisis in limbo. This study illustrates how attributes of individuals with mental illness, service providers and their interactions, and state and federal policies intersect to shape the trajectories of individuals during psychiatric crises. Understanding both the structures of current local systems and their contexts may support continued evolution toward a more humane and robust safety net for some of our society’s most vulnerable members. PMID:23065371

The effect of volatility on percutaneous absorption.

PubMed

Rouse, Nicole C; Maibach, Howard I

2016-01-01

Topically applied chemicals may volatilize, or evaporate, from skin leaving behind a chemical residue with new percutaneous absorptive capabilities. Understanding volatilization of topical medications, such as sunscreens, fragrances, insect repellants, cosmetics and other commonly applied topicals may have implications for their safety and efficacy. A systematic review of English language articles from 1979 to 2014 was performed using key search terms. Articles were evaluated to assess the relationship between volatility and percutaneous absorption. A total of 12 articles were selected and reviewed. Key findings were that absorption is enhanced when coupled with a volatile substance, occlusion prevents evaporation and increases absorption, high ventilation increases volatilization and reduces absorption, and pH of skin has an affect on a chemical's volatility. The articles also brought to light that different methods may have an affect on volatility: different body regions; in vivo vs. in vitro; human vs. Data suggest that volatility is crucial for determining safety and efficacy of cutaneous exposures and therapies. Few articles have been documented reporting evaporation in the context of percutaneous absorption, and of those published, great variability exists in methods. Further investigation of volatility is needed to properly evaluate its role in percutaneous absorption.

Reference Maps of Human ES and iPS Cell Variation Enable High-Throughput Characterization of Pluripotent Cell Lines

PubMed Central

Bock, Christoph; Kiskinis, Evangelos; Verstappen, Griet; Gu, Hongcang; Boulting, Gabriella; Smith, Zachary D.; Ziller, Michael; Croft, Gist F.; Amoroso, Mackenzie W.; Oakley, Derek H.; Gnirke, Andreas; Eggan, Kevin; Meissner, Alexander

2011-01-01

SUMMARY The developmental potential of human pluripotent stem cells suggests that they can produce disease-relevant cell types for biomedical research. However, substantial variation has been reported among pluripotent cell lines, which could affect their utility and clinical safety. Such cell-line-specific differences must be better understood before one can confidently use embryonic stem (ES) or induced pluripotent stem (iPS) cells in translational research. Toward this goal we have established genome-wide reference maps of DNA methylation and gene expression for 20 previously derived human ES lines and 12 human iPS cell lines, and we have measured the in vitro differentiation propensity of these cell lines. This resource enabled us to assess the epigenetic and transcriptional similarity of ES and iPS cells and to predict the differentiation efficiency of individual cell lines. The combination of assays yields a scorecard for quick and comprehensive characterization of pluripotent cell lines. PMID:21295703

Department of Pesticide Regulation Databases

Science.gov Websites

; Safety Report an Illness | Food Safety | Risk Assessment & Mitigation | Human Health | Physicians Endangered Species Enforcement Food Safety Forms Human Health Laws Licensing Mill Assessment Permitting Pest Statewide search: Search Search Search this site: Search Search DPR California Home Programs Health &

California Department of Pesticide Regulation Home Page

Science.gov Websites

; Safety Report an Illness | Food Safety | Risk Assessment & Mitigation | Human Health | Physicians Endangered Species Enforcement Food Safety Forms Human Health Laws Licensing Mill Assessment Permitting Pest Statewide search: Search Search Search this site: Search Search DPR California Home Programs Health &

Health and safety and the Human Rights Act 1998.

PubMed

Tearle, P

2001-03-01

The Human Rights Act 1998 came into effect on 2 October 2000. The list of human rights now embodied in United Kingdom law reflects the ideas and values of our changing and developing society. As a dynamic document the act has parallels with the ideals found in health and safety law. This article looks at the act and considers its implications for employers with regard to existing health and safety law.

The Impact of Market Orientation on Patient Safety Climate Among Hospital Nurses.

PubMed

Weng, Rhay-Hung; Chen, Jung-Chien; Pong, Li-Jung; Chen, Li-Mei; Lin, Tzu-Chi

2016-03-01

Improving market orientation and patient safety have become the key concerns of nursing management. For nurses, establishing a patient safety climate is the key to enhancing nursing quality. This study explores how market orientation affects the climate of patient safety among hospital nurses. We proposed adopting a cross-sectional research design and using questionnaires to collect responses from nurses working in two Taiwanese hospitals. Three-hundred and forty-three valid samples were obtained. Multiple regression and path analyses were conducted to test the study. Market orientation was defined as the combination of customer orientation, competitor orientation, and interfunctional coordination. Customer orientation directly affects the climate of patient safety. Although the findings only supported Hypothesis 1, competitor orientation and interfunctional coordination positively affected the patient safety climate through the mediating effects of hospital support for staff. Health care managers could encourage nurses to adopt customer-oriented perspectives to enhance their nursing care. In addition, to enhance competitor orientation, interfunctional coordination, and the patient safety climate, hospital managers could strengthen their support for staff members. © The Author(s) 2014.

Does the concept of safety culture help or hinder systems thinking in safety?

PubMed

Reiman, Teemu; Rollenhagen, Carl

2014-07-01

The concept of safety culture has become established in safety management applications in all major safety-critical domains. The idea that safety culture somehow represents a "systemic view" on safety is seldom explicitly spoken out, but nevertheless seem to linger behind many safety culture discourses. However, in this paper we argue that the "new" contribution to safety management from safety culture never really became integrated with classical engineering principles and concepts. This integration would have been necessary for the development of a more genuine systems-oriented view on safety; e.g. a conception of safety in which human, technological, organisational and cultural factors are understood as mutually interacting elements. Without of this integration, researchers and the users of the various tools and methods associated with safety culture have sometimes fostered a belief that "safety culture" in fact represents such a systemic view about safety. This belief is, however, not backed up by theoretical or empirical evidence. It is true that safety culture, at least in some sense, represents a holistic term-a totality of factors that include human, organisational and technological aspects. However, the departure for such safety culture models is still human and organisational factors rather than technology (or safety) itself. The aim of this paper is to critically review the various uses of the concept of safety culture as representing a systemic view on safety. The article will take a look at the concepts of culture and safety culture based on previous studies, and outlines in more detail the theoretical challenges in safety culture as a systems concept. The paper also presents recommendations on how to make safety culture more systemic. Copyright © 2013 Elsevier Ltd. All rights reserved.

Safety and the Human Factor.

ERIC Educational Resources Information Center

Smith, Ann

1982-01-01

Discusses four elements of safety programs: (1) safety training; (2) safety inspections; (3) accident investigations; and (4) protective safety equipment. Also discusses safety considerations in water/wastewater treatment facilities focusing on falls, drowning hazards, trickling filters, confined space entry, collection/distribution system safety,…

Persecutory delusions: a cognitive perspective on understanding and treatment.

PubMed

Freeman, Daniel

2016-07-01

A spectrum of severity of paranoia (unfounded thoughts that others are deliberately intending to cause harm) exists within the general population. This is unsurprising: deciding whether to trust or mistrust is a vital aspect of human cognition, but accurate judgment of others' intentions is challenging. The severest form of paranoia is persecutory delusions, when the ideas are held with strong conviction. This paper presents a distillation of a cognitive approach that is being translated into treatment for this major psychiatric problem. Persecutory delusions are viewed as threat beliefs, developed in the context of genetic and environmental risk, and maintained by several psychological processes including excessive worry, low self-confidence, intolerance of anxious affect and other internal anomalous experiences, reasoning biases, and the use of safety-seeking strategies. The clinical implication is that safety has to be relearned, by entering feared situations after reduction of the influence of the maintenance factors. An exciting area of development will be a clinical intervention science of how best to enhance learning of safety to counteract paranoia. Copyright © 2016 Elsevier Ltd. All rights reserved.

Simulation of Range Safety for the NASA Space Shuttle

NASA Technical Reports Server (NTRS)

Rabelo, Luis; Sepulveda, Jose; Compton, Jeppie; Turner, Robert

2005-01-01

This paper describes a simulation environment that seamlessly combines a number of safety and environmental models for the launch phase of a NASA Space Shuttle mission. The components of this simulation environment represent the different systems that must interact in order to determine the Expectation of casualties (E(sub c)) resulting from the toxic effects of the gas dispersion that occurs after a disaster affecting a Space Shuttle within 120 seconds of lift-off. The utilization of the Space Shuttle reliability models, trajectory models, weather dissemination systems, population models, amount and type of toxicants, gas dispersion models, human response functions to toxicants, and a geographical information system are all integrated to create this environment. This simulation environment can help safety managers estimate the population at risk in order to plan evacuation, make sheltering decisions, determine the resources required to provide aid and comfort, and mitigate damages in case of a disaster. This simulation environment may also be modified and used for the landing phase of a space vehicle but will not be discussed in this paper.

Safety of Sculptra: a review of clinical trial data.

PubMed

Engelhard, Peter; Humble, Gail; Mest, Douglas

2005-12-01

The development of facial lipoatrophy as a result of highly active antiretroviral therapy (HAART) used to treat patients with human immunodeficiency virus (HIV) has adversely affected patient quality of life and compliance with therapy. Thanks to modern pharmacotherapies, HIV can now be viewed as a chronic disease; however, this welcome change has exacerbated the effect of facial lipoatrophy since HIV-infected patients can now expect to live longer and healthier lives but remain subject to public scrutiny of their ongoing disease state. Sculptra (Dermik Laboratories, Berwyn, PA, USA) has recently been introduced in the USA for correction of the appearance of facial lipoatrophy. The device affords long-lasting restoration while still being non-permanent, thus providing an extended but adjustable cosmetic effect. The safety profile of this product has been observed in four investigator-initiated clinical trials of more than 250 HIV patients and in numerous investigator reports, with no serious adverse events or infections deemed associated with the product. Maintenance of the excellent safety profile for this injectable device requires adherence to a novel technique and appreciation of its unique attributes.

Human performance cognitive-behavioral modeling: a benefit for occupational safety.

PubMed

Gore, Brian F

2002-01-01

Human Performance Modeling (HPM) is a computer-aided job analysis software methodology used to generate predictions of complex human-automation integration and system flow patterns with the goal of improving operator and system safety. The use of HPM tools has recently been increasing due to reductions in computational cost, augmentations in the tools' fidelity, and usefulness in the generated output. An examination of an Air Man-machine Integration Design and Analysis System (Air MIDAS) model evaluating complex human-automation integration currently underway at NASA Ames Research Center will highlight the importance to occupational safety of considering both cognitive and physical aspects of performance when researching human error.

Human performance cognitive-behavioral modeling: a benefit for occupational safety

NASA Technical Reports Server (NTRS)

Gore, Brian F.

2002-01-01

Human Performance Modeling (HPM) is a computer-aided job analysis software methodology used to generate predictions of complex human-automation integration and system flow patterns with the goal of improving operator and system safety. The use of HPM tools has recently been increasing due to reductions in computational cost, augmentations in the tools' fidelity, and usefulness in the generated output. An examination of an Air Man-machine Integration Design and Analysis System (Air MIDAS) model evaluating complex human-automation integration currently underway at NASA Ames Research Center will highlight the importance to occupational safety of considering both cognitive and physical aspects of performance when researching human error.

Fall Protection Characteristics of Safety Belts and Human Impact Tolerance.

PubMed

Hino, Yasumichi; Ohdo, Katsutoshi; Takahashi, Hiroki

2014-08-23

Many fatal accidents due to falls from heights have occurred at construction sites not only in Japan but also in other countries. This study aims to determine the fall prevention performance of two types of safety belts: a body belt 1) , which has been used for more than 40 yr in the Japanese construction industry as a general type of safety equipment for fall accident prevention, and a full harness 2, 3) , which has been used in many other countries. To determine human tolerance for impact trauma, this study discusses features of safety belts with reference 4-9) to relevant studies in the medical science, automobile crash safety, and aircrew safety. For this purpose, simple drop tests were carried out in a virtual workplace to measure impact load, head acceleration, and posture in the experiments, the Hybrid-III pedestrian model 10) was used as a human dummy. Hybrid-III is typically employed in official automobile crash tests (New Car Assessment Program: NCAP) and is currently recognized as a model that faithfully reproduces dynamic responses. Experimental results shows that safety performance strongly depends on both the variety of safety belts used and the shock absorbers attached onto lanyards. These findings indicate that fall prevention equipment, such as safety belts, lanyards, and shock absorbers, must be improved to reduce impact injuries to the human head and body during falls.

Fall protection characteristics of safety belts and human impact tolerance.

PubMed

Hino, Yasumichi; Ohdo, Katsutoshi; Takahashi, Hiroki

2014-01-01

Many fatal accidents due to falls from heights have occurred at construction sites not only in Japan but also in other countries. This study aims to determine the fall prevention performance of two types of safety belts: a body belt, which has been used for more than 40 yr in the Japanese construction industry as a general type of safety equipment for fall accident prevention, and a full harness, which has been used in many other countries. To determine human tolerance for impact trauma, this study discusses features of safety belts with reference to relevant studies in the medical science, automobile crash safety, and aircrew safety. For this purpose, simple drop tests were carried out in a virtual workplace to measure impact load, head acceleration, and posture in the experiments, the Hybrid-III pedestrian model was used as a human dummy. Hybrid-III is typically employed in official automobile crash tests (New Car Assessment Program: NCAP) and is currently recognized as a model that faithfully reproduces dynamic responses. Experimental results shows that safety performance strongly depends on both the variety of safety belts used and the shock absorbers attached onto lanyards. These findings indicate that fall prevention equipment, such as safety belts, lanyards, and shock absorbers, must be improved to reduce impact injuries to the human head and body during falls.

Fall Protection Characteristics of Safety Belts and Human Impact Tolerance

PubMed Central

HINO, Yasumichi; OHDO, Katsutoshi; TAKAHASHI, Hiroki

2014-01-01

Abstract: Many fatal accidents due to falls from heights have occurred at construction sites not only in Japan but also in other countries. This study aims to determine the fall prevention performance of two types of safety belts: a body belt1), which has been used for more than 40 yr in the Japanese construction industry as a general type of safety equipment for fall accident prevention, and a full harness2, 3), which has been used in many other countries. To determine human tolerance for impact trauma, this study discusses features of safety belts with reference4,5,6,7,8,9) to relevant studies in the medical science, automobile crash safety, and aircrew safety. For this purpose, simple drop tests were carried out in a virtual workplace to measure impact load, head acceleration, and posture in the experiments, the Hybrid-III pedestrian model10) was used as a human dummy. Hybrid-III is typically employed in official automobile crash tests (New Car Assessment Program: NCAP) and is currently recognized as a model that faithfully reproduces dynamic responses. Experimental results shows that safety performance strongly depends on both the variety of safety belts used and the shock absorbers attached onto lanyards. These findings indicate that fall prevention equipment, such as safety belts, lanyards, and shock absorbers, must be improved to reduce impact injuries to the human head and body during falls. PMID:25345426

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

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

Beyerle, Andrea, E-mail: andrea.beyerle@cslbehring.com; Nolte, Marc W.; Solomon, Cristina

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii)more » the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated, with no adverse events. • Overall, human fibrinogen concentrate demonstrated a good safety profile. • This data adds to the safety information available to date on this hemostatic agent.« less

Applying human factors and ergonomics to the misuse of nonsterile clinical gloves in acute care.

PubMed

Wilson, Jennie; Bak, Aggie; Loveday, Heather P

2017-07-01

Health care workers (HCWs) are recommended to wear nonsterile clinical gloves (NSCG) for direct contact with blood and body fluids. However, there is evidence of extensive inappropriate NSCG use. A mixed-methods study comprising observation of NSCG use in 2 acute hospitals and semistructured HCW interviews. Qualitative data were categorized using thematic analysis. Findings were mapped to the Systems Engineering Initiative for Patient Safety model and used to develop a strategy for improving NSCG use. Two hundred seventy-eight procedures performed in 178 episodes of care involved the use of NSCG. NSCG were inappropriate for 59% of procedures (165 out of 278). Risk of cross-contamination occurred in 49% (87 out of 178) episodes. Twenty-six HCWs were interviewed; emotion and socialization were key factors influencing decisions to use NSCG. Data from observation and thematic analysis were mapped to 6 interacting components of the Systems Engineering Initiative for Patient Safety work system. Interventions targeting each component informed quality improvement strategies CONCLUSIONS: Despite intense promotion of hand hygiene as the key measure to protect patients from health care-associated infection, NSCG dominate routine clinical practice and potential cross-contamination occurs in 50% of care episodes. Such practice is associated with significant environmental and financial costs and adversely affects patient safety. The application of human factors and ergonomics to the complex drivers of inappropriate NSCG behavior may be more effective than conventional approaches of education and policy in achieving the goal of preventing health care-associated infection and improving patient safety. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Capturing Safety Requirements to Enable Effective Task Allocation Between Humans and Automaton in Increasingly Autonomous Systems

NASA Technical Reports Server (NTRS)

Neogi, Natasha A.

2016-01-01

There is a current drive towards enabling the deployment of increasingly autonomous systems in the National Airspace System (NAS). However, shifting the traditional roles and responsibilities between humans and automation for safety critical tasks must be managed carefully, otherwise the current emergent safety properties of the NAS may be disrupted. In this paper, a verification activity to assess the emergent safety properties of a clearly defined, safety critical, operational scenario that possesses tasks that can be fluidly allocated between human and automated agents is conducted. Task allocation role sets were proposed for a human-automation team performing a contingency maneuver in a reduced crew context. A safety critical contingency procedure (engine out on takeoff) was modeled in the Soar cognitive architecture, then translated into the Hybrid Input Output formalism. Verification activities were then performed to determine whether or not the safety properties held over the increasingly autonomous system. The verification activities lead to the development of several key insights regarding the implicit assumptions on agent capability. It subsequently illustrated the usefulness of task annotations associated with specialized requirements (e.g., communication, timing etc.), and demonstrated the feasibility of this approach.

Brucellosis vaccines based on the open reading frames from genomic island 3 of Brucella abortus.

PubMed

Gómez, Leonardo; Alvarez, Francisco; Betancur, Daniel; Oñate, Angel

2018-05-17

Brucella abortus is the etiological agent of brucellosis, a zoonotic disease affecting cattle and humans. This disease has been partially controlled in cattle by immunization with live attenuated B. abortus S19 and RB51 strains. However, use of these vaccine strains has been associated with safety issues in animals and humans. New vaccines have since emerged in the prevention of brucellosis, particularly DNA vaccines, which have shown effectiveness and a good safety profile. Their protection efficacy in mice is associated with the induction of Th1 type and cytotoxic T cell mediated immune response against structural antigens and virulence factors expressed during B. abortus infection. Some antigenic candidate for vaccine design against brucellosis (mainly DNA vaccines) have been obtained from genomic island 3 (GI-3) of B. abortus, which encodes several open reading frames (ORFs) involved in the intracellular survival and virulence of this pathogen. The immunogenicity and protection conferred by these DNA vaccines in a murine model is reviewed in this article, suggesting that some of them could be safe and effective vaccine candidates against to prevent B. abortus infection. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effect of animal products and extracts on wound healing promotion in topical applications: a review.

PubMed

Napavichayanun, Supamas; Aramwit, Pornanong

2017-06-01

Wound healing is a natural process of body reaction to repair itself after injury. Nonetheless, many internal and external factors such as aging, comorbidity, stress, smoking, alcohol drinking, infections, malnutrition, or wound environment significantly affect the quality and speed of wound healing. The unsuitable conditions may delay wound healing process and cause chronic wound or scar formation. Therefore, many researches have attempted to search for agents that can accelerate wound healing with safety and biocompatibility to human body. Widely studied wound healing agents are those derived from either natural sources including plants and animals or chemical synthesis. The natural products seem to be safer and more biocompatible to human tissue. This review paper demonstrated various kinds of the animal-derived products including chitosan, collagen, honey, anabolic steroids, silk sericin, peptides, and proteoglycan in term of mechanisms of action, advantages, and disadvantages when applied as wound healing accelerator. The benefits of these animal-derived products are wound healing promotion, anti-inflammatory, antimicrobial activity, moisturizing effect, biocompatibility, and safety. However, the drawbacks such as allergy, low stability, batch-to-batch variability, and high extraction and purification costs could not be avoided in some products.

Environmental Assessment for Construction of Multiple Roadway Improvement Projects MacDill AFB, Florida

DTIC Science & Technology

2011-01-01

flooded) is within tidal areas and occurs mainly on mangrove areas . These soils are subject to Affected Environment Environmental Assessment for...requires that Federal agencies identify and assess environmental health and safety risks that might disproportionately affect children. The Proposed...Action would not pose any adverse or disproportionate environmental health or safety risks to children living near the base. Safety precautions

Cypermethrin induced toxicities in fish and adverse health outcomes: Its prevention and control measure adaptation.

PubMed

Ullah, Sana; Zuberi, Amina; Alagawany, Mahmoud; Farag, Mayada Ragab; Dadar, Maryam; Karthik, Kumaragurubaran; Tiwari, Ruchi; Dhama, Kuldeep; Iqbal, Hafiz M N

2018-01-15

Pesticides are being widely employed in the modern agriculture, though in different quantities, across the globe. Although it is useful for crops yield enhancement, however, there are the serious environment, health and safety related concerns for aquatic and terrestrial living biomes that include humans, animals, and plants. Various in practice and emerging pesticides adversely affect the survival, development and biological systems stability. Several research efforts have been made to highlight the bio-safety and toxicological features of toxicants through risk assessment studies using different animal models, e.g., different fish species. Among several pesticides, cypermethrin is extensively used in agriculture and households, and the reported concentrations of this pesticide in different water bodies including rivers and streams, soil and even in rainwater are threatening. Consequently, cypermethrin is considered for risk assessment studies to know about its deep and different level of toxicological effects subject to its dose, exposure time and route. The cypermethrin existence/persistence in the environment is posing a severe threat to humans as well as another non-target terrestrial and aquatic organism. Herein, the toxic effects of pesticides, with special reference to cypermethrin, on fish, the mode of toxicity, concerns regarding public health and harmful impacts on human beings are comprehensively reviewed. The information is also given on their appropriate control and prevention strategies. Copyright © 2017 Elsevier Ltd. All rights reserved.

RiskSOAP: Introducing and applying a methodology of risk self-awareness in road tunnel safety.

PubMed

Chatzimichailidou, Maria Mikela; Dokas, Ioannis M

2016-05-01

Complex socio-technical systems, such as road tunnels, can be designed and developed with more or less elements that can either positively or negatively affect the capability of their agents to recognise imminent threats or vulnerabilities that possibly lead to accidents. This capability is called risk Situation Awareness (SA) provision. Having as a motive the introduction of better tools for designing and developing systems that are self-aware of their vulnerabilities and react to prevent accidents and losses, this paper introduces the Risk Situation Awareness Provision (RiskSOAP) methodology to the field of road tunnel safety, as a means to measure this capability in this kind of systems. The main objective is to test the soundness and the applicability of RiskSOAP to infrastructure, which is advanced in terms of technology, human integration, and minimum number of safety requirements imposed by international bodies. RiskSOAP is applied to a specific road tunnel in Greece and the accompanying indicator is calculated twice, once for the tunnel design as defined by updated European safety standards and once for the 'as-is' tunnel composition, which complies with the necessary safety requirements, but calls for enhancing safety according to what EU and PIARC further suggest. The derived values indicate the extent to which each tunnel version is capable of comprehending its threats and vulnerabilities based on its elements. The former tunnel version seems to be more enhanced both in terms of it risk awareness capability and safety as well. Another interesting finding is that despite the advanced tunnel safety specifications, there is still room for enriching the safe design and maintenance of the road tunnel. Copyright © 2016 Elsevier Ltd. All rights reserved.

Road weather management best practices : version 3.0.

DOT National Transportation Integrated Search

2013-01-01

The impacts of weather on the nations road system greatly affect safety, mobility, and productivity. Weather affects roadway safety through increased crash risk, as well as exposure to weather-related hazards. On average 7,130 fatalities and 629,0...

Understanding Risk Tolerance and Building an Effective Safety Culture

NASA Technical Reports Server (NTRS)

Loyd, David

2018-01-01

Estimates range from 65-90 percent of catastrophic mishaps are due to human error. NASA's human factors-related mishaps causes are estimated at approximately 75 percent. As much as we'd like to error-proof our work environment, even the most automated and complex technical endeavors require human interaction... and are vulnerable to human frailty. Industry and government are focusing not only on human factors integration into hazardous work environments, but also looking for practical approaches to cultivating a strong Safety Culture that diminishes risk. Industry and government organizations have recognized the value of monitoring leading indicators to identify potential risk vulnerabilities. NASA has adapted this approach to assess risk controls associated with hazardous, critical, and complex facilities. NASA's facility risk assessments integrate commercial loss control, OSHA (Occupational Safety and Health Administration) Process Safety, API (American Petroleum Institute) Performance Indicator Standard, and NASA Operational Readiness Inspection concepts to identify risk control vulnerabilities.

Healthcare professionals' views of smart glasses in intensive care: A qualitative study.

PubMed

Romare, Charlotte; Hass, Ursula; Skär, Lisa

2018-04-01

The aim of this study was to describe healthcare professionals' views of smart glasses before their implementation in an intensive care unit, both regarding quality of use of the glasses and to identify possible intensive care situations where the glasses could be used to increase patient safety. Data were generated through focus group interviews and analysed using thematic content analysis. The findings describe participants' views of smart glasses divided into three categories; Smart glasses to facilitate work at intensive care unit; Quality of use and Utilisation. Participants assumed smart glasses to cause both effect and affect in intensive care. Participants' concern for patients arose recurrently and through their concern intention to work to promote patient safety. Smart glasses are suggested as a complement to existing monitoring and routines and cannot replace human presence in intensive care. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Effect of dissolved oxygen level of water on ultrasonic power measured using calorimetry

NASA Astrophysics Data System (ADS)

Uchida, Takeyoshi; Yoshioka, Masahiro; Horiuchi, Ryuzo

2018-07-01

Ultrasonic therapeutic equipment, which exposes the human body to high-power ultrasound, is used in clinical practice to treat cancer. However, the safety of high-power ultrasound has been questioned because the equipment affects not only cancer cells but also normal cells. To evaluate the safety of ultrasound, it is necessary to accurately measure the ultrasonic power of the equipment. This is because ultrasonic power is a key quantity related to the thermal hazard of ultrasound. However, precise techniques for measuring ultrasonic power in excess of 15 W are yet to be established. We have been studying calorimetry as a precise measurement technique. In this study, we investigated the effect of the dissolved oxygen (DO) level of water on ultrasonic power by calorimetry. The results show that the measured ultrasonic power differed significantly between water samples of different DO levels. This difference in ultrasonic power arose from acoustic cavitation.

Metrological Support in Technosphere Safety

NASA Astrophysics Data System (ADS)

Akhobadze, G. N.

2017-11-01

The principle of metrological support in technosphere safety is considered. It is based on the practical metrology. The theoretical aspects of accuracy and errors of the measuring instruments intended for diagnostics and control of the technosphere under the influence of factors harmful to human beings are presented. The necessity to choose measuring devices with high metrological characteristics according to the accuracy class and contact of sensitive elements with a medium under control is shown. The types of additional errors in measuring instruments that arise when they are affected by environmental influences are described. A specific example of the analyzers application to control industrial emissions and measure the oil and particulate matter in wastewater is shown; it allows assessing advantages and disadvantages of analyzers. Besides, the recommendations regarding the missing metrological characteristics of the instruments in use are provided. The technosphere continuous monitoring taking into account the metrological principles is expected to efficiently forecast the technosphere development and make appropriate decisions.

Assessing driver's mental representation of Adaptive Cruise Control (ACC) and its possible effects on behavioural adaptations.

PubMed

Piccinini, Giulio Francesco; Simões, Anabela; Rodrigues, Carlos Manuel; Leitão, Miguel

2012-01-01

The introduction of Adaptive Cruise Control (ACC) could be very helpful for making the longitudinal driving task more comfortable for the drivers and, as a consequence, it could have a global beneficial effect on road safety. However, before or during the usage of the device, due to several reasons, drivers might generate in their mind incomplete or flawed mental representations about the fundamental operation principles of ACC; hence, the resulting usage of the device might be improper, negatively affecting the human-machine interaction and cooperation and, in some cases, leading to negative behavioural adaptations to the system that might neutralise the desirable positive effects on road safety. Within this context, this paper will introduce the methodology which has been developed in order to analyse in detail the topic and foresee, in the future, adequate actions for the recovery of inaccurate mental representations of the system.

Catastrophic sinkhole formation in Kansas: A case study

USGS Publications Warehouse

Lambrecht, J.L.; Miller, R.D.

2006-01-01

Sinkholes represent a hazard to property and human safety in a wide variety of geologic settings across the globe. In most cases, the subsidence rate of a sinkhole represents the most significant potential impact and risk to public safety. Since 1979, the Kansas Geological Survey has studied numerous sinkholes using high-resolution seismic reflection in an attempt to better understand the mechanisms that control their formation. Most sinkholes in central Kansas form as a result of dissolution of the Permian Hutchinson salt (Figure 1). The fluid source and associated pathway responsible for leaching these bedded evaporites have been natural, anthropogenic, and a combination of both. Sinkholes have been a part of the landscape in the North American midcontinent long before modern oil, gas, and mineral exploration, but clearly the activities of man have played a significant role in both increasing the number of sinkholes and affecting their subsidence rates.

Agricultural Safety. FMO: Fundamentals of Machine Operation. Second Edition.

ERIC Educational Resources Information Center

John Deere Co., Moline, IL.

This manual is intended to provide students with basic information on the safe operation of farm machinery. The following topics are covered in the individual chapters: safe farm machinery operation (the importance of safety, the role of communication in safety, and types of farm accidents); human factors (human limitations and capabilities;…

75 FR 74733 - National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS... days aggregating at least 250 work days, occurring either solely under this employment or in...

75 FR 74733 - National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS... aggregating at least 250 work days, occurring either solely under this employment, or in combination with work...

75 FR 51816 - National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS... number of work days aggregating at least 250 work days, occurring either solely under this employment or...

75 FR 65018 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... aggregating at least 250 work days, occurring either solely under this employment, or in combination with work...

75 FR 32783 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... aggregating at least 250 work days, occurring either solely under this employment or in combination with work...

75 FR 65018 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... work days aggregating at least 250 work days, occurring either solely under this employment or in...

75 FR 65018 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... number of work days aggregating at least 250 work days, occurring either solely under this employment or...

75 FR 57024 - National Institute for Occupational Safety and Health; Designation of a Class of Employees for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY... number of work days aggregating at least 250 work days, occurring either solely under this employment or...

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2013 CFR

2013-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2011 CFR

2011-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2010 CFR

2010-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

21 CFR 170.20 - General principles for evaluating the safety of food additives.

Code of Federal Regulations, 2012 CFR

2012-04-01

... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching a...

Human Systems Integration in Expeditionary Medical Treatment Facilities

DTIC Science & Technology

2010-04-01

mental models and situation awareness Human Factors Engineering, Personnel, and Safety / Occupational Health The following issue is associated with...domains are human factors engineering, manpower, personnel, training, safety and occupational health , survivability, habitability, and environment...certain responsibilities to less-qualified personnel. Human error is a particularly sensitive topic across all sectors of health care, but the time

Investigating industrial investigation: examining the impact of a priori knowledge and tunnel vision education.

PubMed

Maclean, Carla L; Brimacombe, C A Elizabeth; Lindsay, D Stephen

2013-12-01

The current study addressed tunnel vision in industrial incident investigation by experimentally testing how a priori information and a human bias (generated via the fundamental attribution error or correspondence bias) affected participants' investigative behavior as well as the effectiveness of a debiasing intervention. Undergraduates and professional investigators engaged in a simulated industrial investigation exercise. We found that participants' judgments were biased by knowledge about the safety history of either a worker or piece of equipment and that a human bias was evident in participants' decision making. However, bias was successfully reduced with "tunnel vision education." Professional investigators demonstrated a greater sophistication in their investigative decision making compared to undergraduates. The similarities and differences between these two populations are discussed. (c) 2013 APA, all rights reserved

The Introduction of "Safety Science" into an Undergraduate Nursing Programme at a Large University in the United Kingdom.

PubMed

White, Nick; Clark, Deborah; Lewis, Robin; Robson, Wayne

2016-04-13

Implementing safety science {a term adopted by the authors which incorporates both patient safety and human factors (Sherwood, G. (2011). Integrating quality and safety science in nursing education and practice. Journal of Research in Nursing, 16(3), 226-240. doi: 10.1177/1744987111400960)} into healthcare programmes is a major challenge facing healthcare educators worldwide (National Advisory Group on the Safety of Patients in England, 2013; World Health Organisation, 2009). Patient safety concerns relating to human factors have been well-documented over the years, and the root cause(s) of as many as 65-80 % of these events are linked to human error (Dunn et al., 2007; Reason, 2005). This paper will describe how safety science education was embedded into a pre-registration nursing programme at a large UK university. The authors argue that the processes described in this paper, may be successfully applied to other pre-registration healthcare programmes in addition to nursing.

Vaxchora: A Single-Dose Oral Cholera Vaccine.

PubMed

Cabrera, Adriana; Lepage, Jayne E; Sullivan, Karyn M; Seed, Sheila M

2017-07-01

To review trials evaluating the efficacy and safety of Vaxchora, a reformulated, single-dose, oral, lyophilized Vibrio cholerae CVD 103-HgR vaccine for the prevention of travel-related cholera caused by V cholerae serogroup O1. A literature search was conducted using MEDLINE (1946 to January week 3, 2017) and EMBASE (1996 to 2017 week 3). Keywords included oral cholera vaccine, single-dose, Vaxchora, and CVD 103-HgR. Limits included human, clinical trials published in English since 2010. ClinicalTrials.gov was used as a source for unpublished data. Additional data sources were obtained through bibliographic review of selected articles. Studies that addressed the safety and efficacy of Vaxchora, the reformulated, single-dose oral CVD 103-HgR cholera vaccine, were selected for analysis. Approval of Vaxchora, was based on efficacy of the vaccine in human trials demonstrating 90.3% protection among those challenged with V cholerae 10 days after vaccination and in immunogenicity studies with 90% systemic vibriocidal antibody conversion at 6 months after a single-dose of vaccine. Tolerability was acceptable, with the most common adverse effects reported to be fatigue, headache, and abdominal pain. Vaxchora is the only FDA-approved, single-dose oral vaccine for the prevention of cholera caused by V cholerae serogroup O1 in adult travelers from the United States going to cholera-affected areas. Safety and efficacy has not been established in children, immunocompromised persons, and pregnant or breastfeeding women or those living in cholera-endemic areas.

Design of the environment of care for safety of patients and personnel: does form follow function or vice versa in the intensive care unit?

PubMed

Bartley, Judene; Streifel, Andrew J

2010-08-01

We review the context of the environment of care in the intensive care unit setting in relation to patient safety and quality, specifically addressing healthcare-associated infection issues and solutions involving interdisciplinary teams. Issues addressed include current and future architectural design and layout trends, construction trends affecting intensive care units, and prevention of construction-associated healthcare-associated infections related to airborne and waterborne risks and design solutions. Specific elements include single-occupancy, acuity-scalable intensive care unit rooms; environmental aspects of hand hygiene, such as water risks, sink design/location, human waste management, surface selection (floor covering, countertops, furniture, and equipment) and cleaning, antimicrobial-treated or similar materials, ultraviolet germicidal irradiation, specialized rooms (airborne infection isolation and protective environments), and water system design and strategies for safe use of potable water and mitigation of water intrusion. Effective design and operational use of the intensive care unit environment of care must engage critical care personnel from initial planning and design through occupancy of the new/renovated intensive care unit as part of the infection control risk assessment team. The interdisciplinary infection control risk assessment team can address key environment of care design features to enhance the safety of intensive care unit patients, personnel, and visitors. This perspective will ensure the environment of care supports human factors and behavioral aspects of the interaction between the environment of care and its occupants.

The safety of bone allografts used in dentistry: a review.

PubMed

Holtzclaw, Dan; Toscano, Nicholas; Eisenlohr, Lisa; Callan, Don

2008-09-01

Recent media reports concerning "stolen body parts" have shaken the public's trust in the safety of and the use of ethical practices involving human allografts. The authors provide a comprehensive review of the safety aspects of human bone allografts. The authors reviewed U.S. government regulations, industry standards, independent industry association guidelines, company guidelines and scientific articles related to the use of human bone allografts in the practice of dentistry published in the English language. The use of human bone allografts in the practice of dentistry involves the steps of procurement, processing, use and tracking. Rigorous donor screening and aseptic proprietary processing programs have rendered the use of human bone allografts safe and effective as a treatment option. When purchasing human bone allografts for the practice of dentistry, one should choose products accredited by the American Association of Tissue Banks for meeting uniformly high safety and quality control measures. Knowledge of human bone allograft procurement, processing, use and tracking procedures may allow dental clinicians to better educate their patients and address concerns about this valuable treatment option.

MEMS Sensor Technologies for Human Centred Applications in Healthcare, Physical Activities, Safety and Environmental Sensing: A Review on Research Activities in Italy

PubMed Central

Ciuti, Gastone; Ricotti, Leonardo; Menciassi, Arianna; Dario, Paolo

2015-01-01

Over the past few decades the increased level of public awareness concerning healthcare, physical activities, safety and environmental sensing has created an emerging need for smart sensor technologies and monitoring devices able to sense, classify, and provide feedbacks to users’ health status and physical activities, as well as to evaluate environmental and safety conditions in a pervasive, accurate and reliable fashion. Monitoring and precisely quantifying users’ physical activity with inertial measurement unit-based devices, for instance, has also proven to be important in health management of patients affected by chronic diseases, e.g., Parkinson’s disease, many of which are becoming highly prevalent in Italy and in the Western world. This review paper will focus on MEMS sensor technologies developed in Italy in the last three years describing research achievements for healthcare and physical activity, safety and environmental sensing, in addition to smart systems integration. Innovative and smart integrated solutions for sensing devices, pursued and implemented in Italian research centres, will be highlighted, together with specific applications of such technologies. Finally, the paper will depict the future perspective of sensor technologies and corresponding exploitation opportunities, again with a specific focus on Italy. PMID:25808763

Are Technology Interruptions Impacting Your Bottom Line? An Innovative Proposal for Change.

PubMed

Ledbetter, Tamera; Shultz, Sarah; Beckham, Roxanne

2017-10-01

Nursing interruptions are a costly and dangerous variable in acute care hospitals. Malfunctioning technology equipment interrupts nursing care and prevents full utilization of computer safety systems to prevent patient care errors. This paper identifies an innovative approach to nursing interruptions related to computer and computer cart malfunctions. The impact on human resources is defined and outcome measures were proposed. A multifaceted proposal, based on a literature review, aimed at reducing nursing interruptions is presented. This proposal is expected to increase patient safety, as well as patient and nurse satisfaction. Acute care hospitals utilizing electronic medical records and bar-coded medication administration technology. Nurses, information technology staff, nursing informatics staff, and all leadership teams affected by technology problems and their proposed solutions. Literature from multiple fields was reviewed to evaluate research related to computer/computer cart failures, and the approaches used to resolve these issues. Outcome measured strategic goals related to patient safety, and nurse and patient satisfaction. Specific help desk metrics will demonstrate the effect of interventions. This paper addresses a gap in the literature and proposes practical and innovative solutions. A comprehensive computer and computer cart repair program is essential for patient safety, financial stewardship, and utilization of resources. © 2015 Wiley Periodicals, Inc.

Investigation and identification of factors affecting migrating peasant workers' usage of safety footwear in the Chinese construction industry.

PubMed

Suo, Qinghui; Zhang, Daming

2017-09-01

A sample of 300 migrating peasant workers from 15 Chinese building construction sites completed a demographic questionnaire to investigate the usage of safety footwear. The survey form was constructed based on the theory of planned behaviour, and a total of 12 questions focusing on the workers' past experience, attitudes, subjective norms and perceived behavioural control were included in the survey. It was found that 92% of the participants did not wear safety footwear while working on construction sites, although more than 91% of them believed that safety footwear would protect the foot from injury; none of the participants had been provided free safety footwear by their employer. Regression analysis shows that employers' attitude is the most important factor affecting their usage of safety footwear, 'providing free safety footwear' and 'comfortability of the safety footwear' ranking second and third respectively.

Modeling the factors affecting unsafe behavior in the construction industry from safety supervisors' perspective.

PubMed

Khosravi, Yahya; Asilian-Mahabadi, Hassan; Hajizadeh, Ebrahim; Hassanzadeh-Rangi, Narmin; Bastani, Hamid; Khavanin, Ali; Mortazavi, Seyed Bagher

2014-01-01

There can be little doubt that the construction is the most hazardous industry in the worldwide. This study was designed to modeling the factors affecting unsafe behavior from the perspective of safety supervisors. The qualitative research was conducted to extract a conceptual model. A structural model was then developed based on a questionnaire survey (n=266) by two stage Structural Equation Model (SEM) approach. An excellent confirmed 12-factors structure explained about 62% of variances unsafe behavior in the construction industry. A good fit structural model indicated that safety climate factors were positively correlated with safety individual factors (P<0.001) and workplace safety condition (P<0.001). The workplace safety condition was found to play a strong mediating role in linking the safety climate and construction workers' engagement in safe or unsafe behavior. In order to improve construction safety performance, more focus on the workplace condition is required.

Ocean Engineering Studies Compiled 1991. Volume 7. Acrylic Windows- Diverse Design Features and Types of Service

DTIC Science & Technology

1991-01-01

acrylic plastic windows in chambers for human occupancy, the design stress should not exceed 800 psi (i.e., conversion factor of 20). 3. installed...pressure vessels for human occupancy Is 10 yr based on the conserva- tive assumption that in that length of time even stressed acrylic in a tropioal...the Safety Standard for Pressure Ves- sels for Human Oc-upancy (ASME PVHO-1 Safety Standard). Since that time, this ASME Safety Standard has

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

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 needed to design, test, and verify the safety and reliability of modern complex technological systems. The effects of primary cosmic ray particles and secondary particle showers produced by nuclear reactions with the atmosphere, 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. Finally, 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). In this paper we review the discovery of cosmic ray effects on the performance and reliability of microelectronic systems as well as human health and the development of the engineering and health science tools used to evaluate and mitigate cosmic ray effects in ground-based atmospheric flight, and space flight environments. Ground test methods applied to microelectronic components and systems are used in combinations with radiation transport and reaction codes to predict the performance of microelectronic systems in their operating environments. Similar radiation transport codes are used to evaluate possible human health effects of cosmic ray exposure, however, the health effects are based on worst-case analysis and extrapolation of a very limited human exposure data base combined with some limited experimental animal data. Finally, the limitations on human space operations beyond low-Earth orbit imposed by long term exposure to galactic cosmic rays are discussed.

LD-aminopterin in the canine homologue of human atopic dermatitis: a randomized, controlled trial reveals dosing factors affecting optimal therapy.

PubMed

Zebala, John A; Mundell, Alan; Messinger, Linda; Griffin, Craig E; Schuler, Aaron D; Kahn, Stuart J

2014-01-01

Options are limited for patients with atopic dermatitis (AD) who do not respond to topical treatments. Antifolate therapy with systemic methotrexate improves the disease, but is associated with adverse effects. The investigational antifolate LD-aminopterin may offer improved safety. It is not known how antifolate dose and dosing frequency affect efficacy in AD, but a primary mechanism is thought to involve the antifolate-mediated accumulation of 5-aminoimidazole-4-carboxamide ribonucleotide (AICAR). However, recent in vitro studies indicate that AICAR increases then decreases as a function of antifolate concentration. To address this issue and understand how dosing affects antifolate efficacy in AD, we examined the efficacy and safety of different oral doses and schedules of LD-aminopterin in the canine model of AD. This was a multi-center, double-blind trial involving 75 subjects with canine AD randomized to receive up to 12 weeks of placebo, once-weekly (0.007, 0.014, 0.021 mg/kg) or twice-weekly (0.007 mg/kg) LD-aminopterin. The primary efficacy outcome was the Global Score (GS), a composite of validated measures of disease severity and itch. GS improved in all once-weekly cohorts, with 0.014 mg/kg being optimal and significant (43%, P<0.01). The majority of improvement was seen by 8 weeks. In contrast, GS in the twice-weekly cohort was similar to placebo and worse than all once-weekly cohorts. Adverse events were similar across all treated cohorts and placebo. Once-weekly LD-aminopterin was safe and efficacious in canine AD. Twice-weekly dosing negated efficacy despite having the same daily and weekly dose as effective once-weekly regimens. Optimal dosing in this homologue of human AD correlated with the concentration-selective accumulation of AICAR in vitro, consistent with AICAR mediating LD-aminopterin efficacy in AD.

LD-Aminopterin in the Canine Homologue of Human Atopic Dermatitis: A Randomized, Controlled Trial Reveals Dosing Factors Affecting Optimal Therapy

PubMed Central

Zebala, John A.; Mundell, Alan; Messinger, Linda; Griffin, Craig E.; Schuler, Aaron D.; Kahn, Stuart J.

2014-01-01

Background Options are limited for patients with atopic dermatitis (AD) who do not respond to topical treatments. Antifolate therapy with systemic methotrexate improves the disease, but is associated with adverse effects. The investigational antifolate LD-aminopterin may offer improved safety. It is not known how antifolate dose and dosing frequency affect efficacy in AD, but a primary mechanism is thought to involve the antifolate-mediated accumulation of 5-aminoimidazole-4-carboxamide ribonucleotide (AICAR). However, recent in vitro studies indicate that AICAR increases then decreases as a function of antifolate concentration. To address this issue and understand how dosing affects antifolate efficacy in AD, we examined the efficacy and safety of different oral doses and schedules of LD-aminopterin in the canine model of AD. Methods and Findings This was a multi-center, double-blind trial involving 75 subjects with canine AD randomized to receive up to 12 weeks of placebo, once-weekly (0.007, 0.014, 0.021 mg/kg) or twice-weekly (0.007 mg/kg) LD-aminopterin. The primary efficacy outcome was the Global Score (GS), a composite of validated measures of disease severity and itch. GS improved in all once-weekly cohorts, with 0.014 mg/kg being optimal and significant (43%, P<0.01). The majority of improvement was seen by 8 weeks. In contrast, GS in the twice-weekly cohort was similar to placebo and worse than all once-weekly cohorts. Adverse events were similar across all treated cohorts and placebo. Conclusions Once-weekly LD-aminopterin was safe and efficacious in canine AD. Twice-weekly dosing negated efficacy despite having the same daily and weekly dose as effective once-weekly regimens. Optimal dosing in this homologue of human AD correlated with the concentration-selective accumulation of AICAR in vitro, consistent with AICAR mediating LD-aminopterin efficacy in AD. PMID:25255447

78 FR 52848 - Occupational Safety and Health Standards for Aircraft Cabin Crewmembers

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-27

... [Docket No.: FAA-2012-0953] Occupational Safety and Health Standards for Aircraft Cabin Crewmembers AGENCY... regulation of some occupational safety and health conditions affecting cabin crewmembers on aircraft by the Occupational Safety and Health Administration. This policy statement will enhance occupational safety and...

Microwaves from GSM mobile telephones affect 53BP1 and gamma-H2AX foci in human lymphocytes from hypersensitive and healthy persons.

PubMed

Markovà, Eva; Hillert, Lena; Malmgren, Lars; Persson, Bertil R R; Belyaev, Igor Y

2005-09-01

The data on biologic effects of nonthermal microwaves (MWs) from mobile telephones are diverse, and these effects are presently ignored by safety standards of the International Commission for Non-Ionizing Radiation Protection (ICNIRP). In the present study, we investigated effects of MWs of Global System for Mobile Communication (GSM) at different carrier frequencies on human lymphocytes from healthy persons and from persons reporting hypersensitivity to electromagnetic fields (EMFs). We measured the changes in chromatin conformation, which are indicative of stress response and genotoxic effects, by the method of anomalous viscosity time dependence, and we analyzed tumor suppressor p53-binding protein 1 (53BP1) and phosphorylated histone H2AX (gamma-H2AX), which have been shown to colocalize in distinct foci with DNA double-strand breaks (DSBs), using immunofluorescence confocal laser microscopy. We found that MWs from GSM mobile telephones affect chromatin conformation and 53BP1/gamma-H2AX foci similar to heat shock. For the first time, we report here that effects of MWs from mobile telephones on human lymphocytes are dependent on carrier frequency. On average, the same response was observed in lymphocytes from hypersensitive and healthy subjects.

Microwaves from GSM Mobile Telephones Affect 53BP1 and γ-H2AX Foci in Human Lymphocytes from Hypersensitive and Healthy Persons

PubMed Central

Markovà, Eva; Hillert, Lena; Malmgren, Lars; Persson, Bertil R. R.; Belyaev, Igor Y.

2005-01-01

The data on biologic effects of nonthermal microwaves (MWs) from mobile telephones are diverse, and these effects are presently ignored by safety standards of the International Commission for Non-Ionizing Radiation Protection (ICNIRP). In the present study, we investigated effects of MWs of Global System for Mobile Communication (GSM) at different carrier frequencies on human lymphocytes from healthy persons and from persons reporting hypersensitivity to electromagnetic fields (EMFs). We measured the changes in chromatin conformation, which are indicative of stress response and genotoxic effects, by the method of anomalous viscosity time dependence, and we analyzed tumor suppressor p53-binding protein 1 (53BP1) and phosphorylated histone H2AX (γ-H2AX), which have been shown to colocalize in distinct foci with DNA double-strand breaks (DSBs), using immunofluorescence confocal laser microscopy. We found that MWs from GSM mobile telephones affect chromatin conformation and 53BP1/γ-H2AX foci similar to heat shock. For the first time, we report here that effects of MWs from mobile telephones on human lymphocytes are dependent on carrier frequency. On average, the same response was observed in lymphocytes from hypersensitive and healthy subjects. PMID:16140623

The Design of Transportation Equipment in Terms of Human Capabilities. The Role of Engineering Psychology in Transport Safety.

ERIC Educational Resources Information Center

McFarland, Ross A.

Human factors engineering is considered with regard to the design of safety factors for aviation and highway transportation equipment. Current trends and problem areas are identified for jet air transportation and for highway transportation. Suggested solutions to transportation safety problems are developed by applying the techniques of human…

76 FR 62409 - National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health...: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS..., from January 1, 1961 through June 30, 1970, for a number of work days aggregating at least 250 work...

The integration of Human Factors (HF) in the SAR process training course text

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

Ryan, T.G.

1995-03-01

This text provides the technical basis for a two-day course on human factors (HF), as applied to the Safety Analysis Report (SAR) process. The overall objective of this text and course is to: provide the participant with a working knowledge of human factors-related requirements, suggestions for doing a human safety analysis applying a graded approach, and an ability to demonstrate using the results of the human safety analysis, that human factors elements as defined by DOE (human factors engineering, procedures, training, oversight, staffing, qualifications), can support wherever necessary, nuclear safety commitments in the SAR. More specifically, the objectives of themore » text and course are: (1) To provide the SAR preparer with general guidelines for doing HE within the context of a graded approach for the SAR; (2) To sensitize DOE facility managers and staff, safety analysts and SAR preparers, independent reviewers, and DOE reviewers and regulators, to DOE Order 5480.23 requirements for HE in the SAR; (3) To provide managers, analysts, reviewers and regulators with a working knowledge of HE concepts and techniques within the context of a graded approach for the SAR, and (4) To provide SAR managers and DOE reviewers and regulators with general guidelines for monitoring and coordinating the work of preparers of HE inputs throughout the SAR process, and for making decisions regarding the safety relevance of HE inputs to the SAR. As a ready reference for implementing the human factors requirements of DOE Order 5480.22 and DOE Standard 3009-94, this course text and accompanying two-day course are intended for all persons who are involved in the SAR.« less

The influence of environmental conditions on safety management in hospitals: a qualitative study.

PubMed

Alingh, Carien W; van Wijngaarden, Jeroen D H; Huijsman, Robbert; Paauwe, Jaap

2018-05-02

Hospitals are confronted with increasing safety demands from a diverse set of stakeholders, including governmental organisations, professional associations, health insurance companies, patient associations and the media. However, little is known about the effects of these institutional and competitive pressures on hospital safety management. Previous research has shown that organisations generally shape their safety management approach along the lines of control- or commitment-based management. Using a heuristic framework, based on the contextually-based human resource theory, we analysed how environmental pressures affect the safety management approach used by hospitals. A qualitative study was conducted into hospital care in the Netherlands. Five hospitals were selected for participation, based on organisational characteristics as well as variation in their reputation for patient safety. We interviewed hospital managers and staff with a central role in safety management. A total of 43 semi-structured interviews were conducted with 48 respondents. The heuristic framework was used as an initial model for analysing the data, though new codes emerged from the data as well. In order to ensure safe care delivery, institutional and competitive stakeholders often impose detailed safety requirements, strong forces for compliance and growing demands for accountability. As a consequence, hospitals experience a decrease in the room to manoeuvre. Hence, organisations increasingly choose a control-based management approach to make sure that safety demands are met. In contrast, in case of more abstract safety demands and an organisational culture which favours patient safety, hospitals generally experience more leeway. This often results in a stronger focus on commitment-based management. Institutional and competitive conditions as well as strategic choices that hospitals make have resulted in various combinations of control- and commitment-based safety management. A balanced approach is required. A strong focus on control-based management generates extrinsic motivation in employees but may, at the same time, undermine or even diminish intrinsic motivation to work on patient safety. Emphasising commitment-based management may, in contrast, strengthen intrinsic motivation but increases the risk of priorities being set elsewhere. Currently, external pressures frequently lead to the adoption of control-based management. A balanced approach requires a shift towards more trust-based safety demands.

Blame the Patient, Blame the Doctor or Blame the System? A Meta-Synthesis of Qualitative Studies of Patient Safety in Primary Care

PubMed Central

Daker-White, Gavin; Hays, Rebecca; McSharry, Jennifer; Giles, Sally; Cheraghi-Sohi, Sudeh; Rhodes, Penny; Sanders, Caroline

2015-01-01

Objective Studies of patient safety in health care have traditionally focused on hospital medicine. However, recent years have seen more research located in primary care settings which have different features compared to secondary care. This study set out to synthesize published qualitative research concerning patient safety in primary care in order to build a conceptual model. Method Meta-ethnography, an interpretive synthesis method whereby third order interpretations are produced that best describe the groups of findings contained in the reports of primary studies. Results Forty-eight studies were included as 5 discrete subsets where the findings were translated into one another: patients’ perspectives of safety, staff perspectives of safety, medication safety, systems or organisational issues and the primary/secondary care interface. The studies were focused predominantly on issues seen to either improve or compromise patient safety. These issues related to the characteristics or behaviour of patients, staff or clinical systems and interactions between staff, patients and staff, or people and systems. Electronic health records, protocols and guidelines could be seen to both degrade and improve patient safety in different circumstances. A conceptual reading of the studies pointed to patient safety as a subjective feeling or judgement grounded in moral views and with potentially hidden psychological consequences affecting care processes and relationships. The main threats to safety appeared to derive from ‘grand’ systems issues, for example involving service accessibility, resources or working hours which may not be amenable to effective intervention by individual practices or health workers, especially in the context of a public health system. Conclusion Overall, the findings underline the human elements in patient safety primary health care. The key to patient safety lies in effective face-to-face communication between patients and health care staff or between the different staff involved in the care of an individual patient. Electronic systems can compromise safety when they override the opportunities for face-to-face communication. The circumstances under which guidelines or protocols are seen to either compromise or improve patient safety needs further investigation. PMID:26244494

Addressing fear of crime in public space: gender differences in reaction to safety measures in train transit.

PubMed

Yavuz, Nilay; Welch, Eric W

2010-01-01

Research has identified several factors that affect fear of crime in public space. However, the extent to which gender moderates the effectiveness of fear-reducing measures has received little attention. Using data from the Chicago Transit Authority Customer Satisfaction Survey of 2003, this study aims to understand whether train transit security practices and service attributes affect men and women differently. Findings indicate that, while the presence of video cameras has a lower effect on women's feelings of safety compared with men, frequent and on-time service matters more to male passengers. Additionally, experience with safety-related problems affects women significantly more than men. Conclusions discuss the implications of the study for theory and gender-specific policies to improve perceptions of transit safety.

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

Human factors in airport surface incidents : an analysis of pilot reports submitted to the Aviation Safety Reporting System (ASRS)

DOT National Transportation Integrated Search

2006-12-01

The purpose of this study was to examine human factors involved in airport surface incidents as reported by pilots. Reports submitted to the : Aviation Safety Reporting System (ASRS) are a good source of information regarding the human performance is...

Making safety an integral part of 5S in healthcare.

PubMed

Ikuma, Laura H; Nahmens, Isabelina

2014-01-01

Healthcare faces major challenges with provider safety and rising costs, and many organizations are using Lean to instigate change. One Lean tool, 5S, is becoming popular for improving efficiency of physical work environments, and it can also improve safety. This paper demonstrates that safety is an integral part of 5S by examining five specific 5S events in acute care facilities. We provide two arguments for how safety is linked to 5S:1. Safety is affected by 5S events, regardless of whether safety is a specific goal and 2. Safety can and should permeate all five S's as part of a comprehensive plan for system improvement. Reports of 5S events from five departments in one health system were used to evaluate how changes made at each step of the 5S impacted safety. Safety was affected positively in each step of the 5S through initial safety goals and side effects of other changes. The case studies show that 5S can be a mechanism for improving safety. Practitioners may reap additional safety benefits by incorporating safety into 5S events through a safety analysis before the 5S, safety goals and considerations during the 5S, and follow-up safety analysis.

Species-specific effects of neuregulin-1β (cimaglermin alfa) on glucose handling in animal models and humans with heart failure.

PubMed

Huang, Zhihong; Sawyer, Douglas B; Troy, Erika L; McEwen, Corissa; Cleator, John H; Murphy, Abigail; Caggiano, Anthony O; Eisen, Andrew; Parry, Tom J

2017-10-01

Neuregulin-1β is a member of the neuregulin family of growth factors and is critically important for normal development and functioning of the heart and brain. A recombinant version of neuregulin-1β, cimaglermin alfa (also known as glial growth factor 2 or GGF2) is being investigated as a possible therapy for heart failure. Previous studies suggest that neuregulin-1β stimulation of skeletal muscle increases glucose uptake and, specifically, sufficient doses of cimaglermin alfa acutely produce hypoglycemia in pigs. Since acute hypoglycemia could be a safety concern, blood glucose changes in the above pig study were further investigated. In addition, basal glucose and glucose disposal were investigated in mice. Finally, as part of standard clinical chemistry profiling in a single ascending-dose human safety study, blood glucose levels were evaluated in patients with heart failure after cimaglermin alfa treatment. A single intravenous injection of cimaglermin alfa at doses of 0.8mg/kg and 2.6mg/kg in mice resulted in a transient reduction of blood glucose concentrations of approximately 20% and 34%, respectively, at 2h after the treatment compared to pre-treatment levels. Similar results were observed in diabetic mice. Treatment with cimaglermin alfa also increased blood glucose disposal following oral challenge in mice. However, no significant alterations in blood glucose concentrations were found in human heart failure patients at 0.5 and 2h after treatment with cimaglermin alfa over an equivalent human dose range, based on body surface area. Taken together, these data indicate strong species differences in blood glucose handling after cimaglermin alfa treatment, and particularly do not indicate that this phenomenon should affect human subjects. Copyright © 2017 Elsevier Inc. All rights reserved.

Polar bear attacks on humans: Implications of a changing climate

USGS Publications Warehouse

Wilder, James; Vongraven, Dag; Atwood, Todd C.; Hansen, Bob; Jessen, Amalie; Kochnev, Anatoly A.; York, Geoff; Vallender, Rachel; Hedman, Daryll; Gibbons, Melissa

2017-01-01

Understanding causes of polar bear (Ursus maritimus) attacks on humans is critical to ensuring both human safety and polar bear conservation. Although considerable attention has been focused on understanding black (U. americanus) and grizzly (U. arctos) bear conflicts with humans, there have been few attempts to systematically collect, analyze, and interpret available information on human-polar bear conflicts across their range. To help fill this knowledge gap, a database was developed (Polar Bear-Human Information Management System [PBHIMS]) to facilitate the range-wide collection and analysis of human-polar bear conflict data. We populated the PBHIMS with data collected throughout the polar bear range, analyzed polar bear attacks on people, and found that reported attacks have been extremely rare. From 1870–2014, we documented 73 attacks by wild polar bears, distributed among the 5 polar bear Range States (Canada, Greenland, Norway, Russia, and United States), which resulted in 20 human fatalities and 63 human injuries. We found that nutritionally stressed adult male polar bears were the most likely to pose threats to human safety. Attacks by adult females were rare, and most were attributed to defense of cubs. We judged that bears acted as a predator in most attacks, and that nearly all attacks involved ≤2 people. Increased concern for both human and bear safety is warranted in light of predictions of increased numbers of nutritionally stressed bears spending longer amounts of time on land near people because of the loss of their sea ice habitat. Improved conflict investigation is needed to collect accurate and relevant data and communicate accurate bear safety messages and mitigation strategies to the public. With better information, people can take proactive measures in polar bear habitat to ensure their safety and prevent conflicts with polar bears. This work represents an important first step towards improving our understanding of factors influencing human-polar bear conflicts. Continued collection and analysis of range-wide data on interactions and conflicts will help increase human safety and ensure the conservation of polar bears for future generations.

Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

PubMed Central

Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C.; Urbano, Manuela; Ribeiro, Helena M.

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids. PMID:24294598

Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

PubMed

Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

Phytotoxins: environmental micropollutants of concern?

PubMed

Bucheli, Thomas D

2014-11-18

Natural toxins such as mycotoxins or phytotoxins (bioactive compounds from fungi and plants, respectively) have been widely studied in food and feed, where they are stated to out-compete synthetic chemicals in their overall human and animal toxicological risk. A similar perception and awareness is yet largely missing for environmental safety. This article attempts to raise concern in this regard, by providing (circumstantial) evidence that phytotoxins in particular can be emitted into the environment, where they may contribute to the complex mixture of organic micropollutants. Exposures can be orders-of-magnitude higher in anthropogenically managed/affected (agro-)ecosystems than in the pristine environment.

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

Jacques V Hugo

This book chapter describes the considerations for the selection of advanced human–system interfaces (HSIs) for the new generation of nuclear power plants. The chapter discusses the technologies that will be needed to support highly automated nuclear power plants, while minimising demands for numbers of operational staff, reducing human error and improving plant efficiency and safety. Special attention is paid to the selection and deployment of advanced technologies in nuclear power plants (NPPs). The chapter closes with an examination of how technologies are likely to develop over the next 10–15 years and how this will affect design choices for the nuclearmore » industry.« less

Integrated Safety Assessment of 2′-O-Methoxyethyl Chimeric Antisense Oligonucleotides in NonHuman Primates and Healthy Human Volunteers

PubMed Central

Crooke, Stanley T; Baker, Brenda F; Kwoh, T Jesse; Cheng, Wei; Schulz, Dan J; Xia, Shuting; Salgado, Nelson; Bui, Huynh-Hoa; Hart, Christopher E; Burel, Sebastien A; Younis, Husam S; Geary, Richard S; Henry, Scott P; Bhanot, Sanjay

2016-01-01

The common chemical and biological properties of antisense oligonucleotides provide the opportunity to identify and characterize chemical class effects across species. The chemical class that has proven to be the most versatile and best characterized is the 2′-O-methoxyethyl chimeric antisense oligonucleotides. In this report we present an integrated safety assessment of data obtained from controlled dose-ranging studies in nonhuman primates (macaques) and healthy human volunteers for 12 unique 2′-O-methoxyethyl chimeric antisense oligonucleotides. Safety was assessed by the incidence of safety signals in standardized laboratory tests for kidney and liver function, hematology, and complement activation; as well as by the mean test results as a function of dose level over time. At high doses a number of toxicities were observed in nonhuman primates. However, no class safety effects were identified in healthy human volunteers from this integrated data analysis. Effects on complement in nonhuman primates were not observed in humans. Nonhuman primates predicted safe doses in humans, but over predicted risk of complement activation and effects on platelets. Although limited to a single chemical class, comparisons from this analysis are considered valid and accurate based on the carefully controlled setting for the specified study populations and within the total exposures studied. PMID:27357629

Characterization of human-induced pluripotent stem cell-derived cardiomyocytes: bioenergetics and utilization in safety screening.

PubMed

Rana, Payal; Anson, Blake; Engle, Sandra; Will, Yvonne

2012-11-01

Cardiotoxicity remains the number one reason for drug withdrawal from the market, and Food and Drug Administration issued black box warnings, thus demonstrating the need for more predictive preclinical safety screening, especially early in the drug discovery process when much chemical substrate is available. Whereas human-ether-a-go-go related gene screening has become routine to mitigate proarrhythmic risk, the development of in vitro assays predicting additional on- and off-target biochemical toxicities will benefit from cellular models exhibiting true cardiomyocyte characteristics such as native tissue-like mitochondrial activity. Human stem cell-derived tissue cells may provide such a model. This hypothesis was tested using a combination of flux analysis, gene and protein expression, and toxicity-profiling techniques to characterize mitochondrial function in induced pluripotent stem cell (iPSC) derived human cardiomyocytes in the presence of differing carbon sources over extended periods in cell culture. Functional analyses demonstrate that iPSC-derived cardiomyocytes are (1) capable of utilizing anaerobic or aerobic respiration depending upon the available carbon substrate and (2) bioenergetically closest to adult heart tissue cells when cultured in galactose or galactose supplemented with fatty acids. We utilized this model to test a variety of kinase inhibitors with known clinical cardiac liabilities for their potential toxicity toward these cells. We found that the kinase inhibitors showed a dose-dependent toxicity to iPSC cardiomyocytes grown in galactose and that oxygen consumption rates were significantly more affected than adenosine triphosphate production. Sorafenib was found to have the most effect, followed by sunitinib, dasatinib, imatinib, lapatinib, and nioltinib.

Human Milk Management Redesign: Improving Quality and Safety and Reducing Neonatal Intensive Care Unit Nurse Stress.

PubMed

Settle, Margaret Doyle; Coakley, Amanda Bulette; Annese, Christine Donahue

2017-02-01

Human milk provides superior nutritional value for infants in the neonatal intensive care unit and is the enteral feeding of choice. Our hospital used the system engineering initiative for patient safety model to evaluate the human milk management system in our neonatal intensive care unit. Nurses described the previous process in a negative way, fraught with opportunities for error, increased stress for nurses, and the need to be away from the bedside and their patients. The redesigned process improved the quality and safety of human milk management and created time for the nurses to spend with their patients.

Children and Youth Camp Safety Act, 1978. Hearing Before the Subcommittee on Child and Human Development of the Committee on Human Resources, United States Senate, 95th Congress, 2nd Session on S. 258--To Provide for the Development and Implementation of Programs for Children and Youth Camp Safety (March 21, 1978).

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. Senate Committee on Human Resources.

The product of some 10 years of work directed toward federal legislation addressing and defining youth camp safety, the Youth Camp Safety Act (S. 258), as presented in these hearings, calls for the federal government to assume a role in the development of state health and safety standards for children attending youth camps in any state in the…

Power Goals for NASA's Exploration Program

NASA Technical Reports Server (NTRS)

Jeevarajan, Judith A.

2009-01-01

Exciting Future Programs ahead for NASA. Power is needed for all Exploration vehicles and for the missions. For long term missions as in Lunar and Mars programs, safe, high energy/ultra high energy batteries are required. Safety is top priority for human-rated missions. Two-fault tolerance to catastrophic failures is required for human-rated safety To meet power safety goals -inherent cell safety may be required; it can lessen complexity of external protective electronics and prevents dependency on hardware that may also have limitations. Inherent cell safety will eliminate the need to carry out screening of all cells (X-rays, vibration, etc.)

Human Papillomavirus (HPV)

MedlinePlus

... Healthy Living Healthy Living Healthy Living Nutrition Fitness Sports Oral Health Emotional Wellness Growing Healthy Sleep Safety & Prevention Safety & Prevention Safety and Prevention Immunizations ...

NASA human factors programmatic overview

NASA Technical Reports Server (NTRS)

Connors, Mary M.

1992-01-01

Human factors addresses humans in their active and interactive capacities, i.e., in the mental and physical activities that they perform and in the contributions they make to achieving the goals of the mission. The overall goal of space human factors in NASA is to support the safety, productivity, and reliability of both the on-board crew and the ground support staff. Safety and reliability are fundamental requirements that human factors shares with other disciplines, while productivity represents the defining contribution of the human factors discipline.

A human factors engineering paradigm for patient safety: designing to support the performance of the healthcare professional

PubMed Central

Karsh, B‐T; Holden, R J; Alper, S J; Or, C K L

2006-01-01

The goal of improving patient safety has led to a number of paradigms for directing improvement efforts. The main paradigms to date have focused on reducing injuries, reducing errors, or improving evidence based practice. In this paper a human factors engineering paradigm is proposed that focuses on designing systems to improve the performance of healthcare professionals and to reduce hazards. Both goals are necessary, but neither is sufficient to improve safety. We suggest that the road to patient and employee safety runs through the healthcare professional who delivers care. To that end, several arguments are provided to show that designing healthcare delivery systems to support healthcare professional performance and hazard reduction should yield significant patient safety benefits. The concepts of human performance and hazard reduction are explained. PMID:17142611

77 FR 40622 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH..., oxygen supply partnership, safety culture, occupational health and safety management systems, preventing...

Applying lessons learned to enhance human performance and reduce human error for ISS operations

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

Nelson, W.R.

1999-01-01

A major component of reliability, safety, and mission success for space missions is ensuring that the humans involved (flight crew, ground crew, mission control, etc.) perform their tasks and functions as required. This includes compliance with training and procedures during normal conditions, and successful compensation when malfunctions or unexpected conditions occur. A very significant issue that affects human performance in space flight is human error. Human errors can invalidate carefully designed equipment and procedures. If certain errors combine with equipment failures or design flaws, mission failure or loss of life can occur. The control of human error during operation ofmore » the International Space Station (ISS) will be critical to the overall success of the program. As experience from Mir operations has shown, human performance plays a vital role in the success or failure of long duration space missions. The Department of Energy{close_quote}s Idaho National Engineering and Environmental Laboratory (INEEL) is developing a systematic approach to enhance human performance and reduce human errors for ISS operations. This approach is based on the systematic identification and evaluation of lessons learned from past space missions such as Mir to enhance the design and operation of ISS. This paper will describe previous INEEL research on human error sponsored by NASA and how it can be applied to enhance human reliability for ISS. {copyright} {ital 1999 American Institute of Physics.}« less

Applying lessons learned to enhance human performance and reduce human error for ISS operations

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

Nelson, W.R.

1998-09-01

A major component of reliability, safety, and mission success for space missions is ensuring that the humans involved (flight crew, ground crew, mission control, etc.) perform their tasks and functions as required. This includes compliance with training and procedures during normal conditions, and successful compensation when malfunctions or unexpected conditions occur. A very significant issue that affects human performance in space flight is human error. Human errors can invalidate carefully designed equipment and procedures. If certain errors combine with equipment failures or design flaws, mission failure or loss of life can occur. The control of human error during operation ofmore » the International Space Station (ISS) will be critical to the overall success of the program. As experience from Mir operations has shown, human performance plays a vital role in the success or failure of long duration space missions. The Department of Energy`s Idaho National Engineering and Environmental Laboratory (INEEL) is developed a systematic approach to enhance human performance and reduce human errors for ISS operations. This approach is based on the systematic identification and evaluation of lessons learned from past space missions such as Mir to enhance the design and operation of ISS. This paper describes previous INEEL research on human error sponsored by NASA and how it can be applied to enhance human reliability for ISS.« less

A Real-time Evaluation of Human-based Approaches to Safety Testing: What We Can Do Now (TDS)

EPA Science Inventory

Despite ever-increasing efforts in early safety assessment in all industries, there are still many chemicals that prove toxic in humans. While greater use of human in vitro test methods may serve to reduce this problem, the formal validation process applied to such tests represen...

76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability AGENCY: Department of Health and Human Services, Office of the Secretary, Office of the Assistant.... Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Blood...

78 FR 66006 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability AGENCY: Department of Health and Human Services, Office of the Secretary, Office... Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory...

Food Safety

Science.gov Websites

veggies? Federal Pesticide Regulation Pesticides and Human Health Regulating Organic Food Production fruit and veggies? Federal Pesticide Regulation Pesticides and Human Health Regulating Organic Food ; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

10 CFR 35.315 - Safety precautions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Required § 35.315 Safety precautions. (a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall— (1) Quarter the patient or the human research subject either in— (i) A... released under § 35.75; (2) Visibly post the patient's or the human research subject's room with a...

75 FR 69912 - Pipeline Safety: Control Room Management/Human Factors

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-16

... 192 and 195 [Docket ID PHMSA-2007-27954] RIN 2137-AE64 Pipeline Safety: Control Room Management/Human... rulemaking; Extension of comment period. SUMMARY: On September 17, 2010, PHMSA published a Control Room... Control Room Management/Human Factors rule at 49 CFR 192.631 and 195.446. The NPRM proposes to expedite...

76 FR 45582 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

... and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human... concerning the safety and effectiveness of marketed and investigational human drug products for use in... and evaluates available data concerning the safety and effectiveness of marketed and investigational...

Human Spaceflight Safety Hearing

NASA Image and Video Library

2009-12-02

U.S. Rep. Pete Olson, R-Texas, speaks during a hearing before the House Subcommitte on Space and Aeronautics regarding Safety of Human Spaceflight on Capitol Hill, Wednesday, Dec. 2, 2009, in Washington. Photo Credit: (NASA/Bill Ingalls)

Human Spaceflight Safety Hearing

NASA Image and Video Library

2009-12-02

Dr. Joseph R. Fragola, Vice President, Valador, Inc., testifies during a hearing before the House Subcommitte on Space and Aeronautics regarding Safety of Human Spaceflight on Capitol Hill, Wednesday, Dec. 2, 2009, in Washington. Photo Credit: (NASA/Bill Ingalls)

75 FR 34365 - Safety Zone, Alligator River, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... interest, since immediate action is needed to ensure the safety of human life and property from the hazards... do not individually or cumulatively have a significant effect on the human environment. This rule is...

The science of human factors: separating fact from fiction

PubMed Central

Russ, Alissa L; Fairbanks, Rollin J; Karsh, Ben-Tzion; Militello, Laura G; Saleem, Jason J; Wears, Robert L

2013-01-01

Background Interest in human factors has increased across healthcare communities and institutions as the value of human centred design in healthcare becomes increasingly clear. However, as human factors is becoming more prominent, there is growing evidence of confusion about human factors science, both anecdotally and in scientific literature. Some of the misconceptions about human factors may inadvertently create missed opportunities for healthcare improvement. Methods The objective of this article is to describe the scientific discipline of human factors and provide common ground for partnerships between healthcare and human factors communities. Results The primary goal of human factors science is to promote efficiency, safety and effectiveness by improving the design of technologies, processes and work systems. As described in this article, human factors also provides insight on when training is likely (or unlikely) to be effective for improving patient safety. Finally, we outline human factors specialty areas that may be particularly relevant for improving healthcare delivery and provide examples to demonstrate their value. Conclusions The human factors concepts presented in this article may foster interdisciplinary collaborations to yield new, sustainable solutions for healthcare quality and patient safety. PMID:23592760

30 CFR 77.1007 - Drilling; general.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL MINES Ground... each shift by a competent person. Equipment defects affecting safety shall be reported. (b) Equipment...

Leader communication approaches and patient safety: An integrated model.

PubMed

Mattson, Malin; Hellgren, Johnny; Göransson, Sara

2015-06-01

Leader communication is known to influence a number of employee behaviors. When it comes to the relationship between leader communication and safety, the evidence is more scarce and ambiguous. The aim of the present study is to investigate whether and in what way leader communication relates to safety outcomes. The study examines two leader communication approaches: leader safety priority communication and feedback to subordinates. These approaches were assumed to affect safety outcomes via different employee behaviors. Questionnaire data, collected from 221 employees at two hospital wards, were analyzed using structural equation modeling. The two examined communication approaches were both positively related to safety outcomes, although leader safety priority communication was mediated by employee compliance and feedback communication by organizational citizenship behaviors. The findings suggest that leader communication plays a vital role in improving organizational and patient safety and that different communication approaches seem to positively affect different but equally essential employee safety behaviors. The results highlights the necessity for leaders to engage in one-way communication of safety values as well as in more relational feedback communication with their subordinates in order to enhance patient safety. Copyright © 2015 Elsevier Ltd. and National Safety Council. Published by Elsevier Ltd. All rights reserved.

Human factors in safety and business management.

PubMed

Vogt, Joachim; Leonhardt, Jorg; Koper, Birgit; Pennig, Stefan

2010-02-01

Human factors in safety is concerned with all those factors that influence people and their behaviour in safety-critical situations. In aviation these are, for example, environmental factors in the cockpit, organisational factors such as shift work, human characteristics such as ability and motivation of staff. Careful consideration of human factors is necessary to improve health and safety at work by optimising the interaction of humans with their technical and social (team, supervisor) work environment. This provides considerable benefits for business by increasing efficiency and by preventing incidents/accidents. The aim of this paper is to suggest management tools for this purpose. Management tools such as balanced scorecards (BSC) are widespread instruments and also well known in aviation organisations. Only a few aviation organisations utilise management tools for human factors although they are the most important conditions in the safety management systems of aviation organisations. One reason for this is that human factors are difficult to measure and therefore also difficult to manage. Studies in other domains, such as workplace health promotion, indicate that BSC-based tools are useful for human factor management. Their mission is to develop a set of indicators that are sensitive to organisational performance and help identify driving forces as well as bottlenecks. Another tool presented in this paper is the Human Resources Performance Model (HPM). HPM facilitates the integrative assessment of human factors programmes on the basis of a systematic performance analysis of the whole system. Cause-effect relationships between system elements are defined in process models in a first step and validated empirically in a second step. Thus, a specific representation of the performance processes is developed, which ranges from individual behaviour to system performance. HPM is more analytic than BSC-based tools because HPM also asks why a certain factor is facilitating or obstructing success. A significant need for research and development is seen here because human factors are of increasing importance for organisational success. This paper suggests integrating human factors in safety management of aviation businesses - a top-ranking partner of technology and finance - and managing it with professional tools. The tools HPM and BSC were identified as potentially useful for this purpose. They were successfully applied in case studies briefly presented in this paper. In terms of specific safety-steering tools in the aviation industry, further elaboration and empirical study is crucial. Statement of Relevance: The importance of human factors is recognised by operators at the sharp end of aviation, where flights are conducted or coordinated. At the blunt end, measurement tools are needed to manage operational resources.

Human Factors Science: Brief History and Applications to Healthcare.

PubMed

Parker, Sarah Henrickson

2015-12-01

This section will define the science of human factors, its origins, its impact on safety in other domains, and its impact and potential for impact on patient safety. Copyright © 2015 Mosby, Inc. All rights reserved.

The role of ferric carboxymaltose in the treatment of iron deficiency anemia in patients with gastrointestinal disease.

PubMed

Koduru, Pramoda; Abraham, Bincy P

2016-01-01

Iron deficiency anemia (IDA) is the most common form of nutritional anemia worldwide. Iron plays a pivotal role in vital functioning of almost every organ system. IDA affects both physical and psychological functioning of humans. Oral iron is considered as first-line therapy for the treatment of IDA due to low cost, good safety profile and ease of administration. However, the absorption of oral iron is affected by several factors and incidence of gastrointestinal side effects can lead to lack of adherence to therapy as well as poor efficacy. This has led to the emergence of intravenous iron therapy which is clearly superior to oral iron with higher increment of hemoglobin levels and rapid replenishment of iron stores. Ferric carboxymaltose (FCM) is a novel non-dextran intravenous iron form which has been approved for use in patients with iron deficiency who have had inadequate response to oral iron therapy, intolerance to oral iron, or nondialysis-dependent chronic kidney disease. The safety and efficacy of using FCM for the treatment of IDA has been demonstrated in several clinical trials. One dose can provide a large amount of iron and has a very short infusion time. It should be considered as first-line therapy in patients with active inflammation like inflammatory bowel disease when gastrointestinal absorption of oral iron may be compromised. It should also be given to patients who have inadequate response to oral iron therapy. It has been shown to be noninferior to other intravenous iron formulations with a good safety profile and produced fewer anaphylactic reactions.

49 CFR 236.911 - Exclusions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... system technology. However, a subsystem or component of an office system must comply with the requirements of this subpart if it performs safety-critical functions within, or affects the safety performance... this subpart if they result in a degradation of safety or a material increase in safety-critical...

49 CFR 236.911 - Exclusions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... system technology. However, a subsystem or component of an office system must comply with the requirements of this subpart if it performs safety-critical functions within, or affects the safety performance... this subpart if they result in a degradation of safety or a material increase in safety-critical...

49 CFR 236.911 - Exclusions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... system technology. However, a subsystem or component of an office system must comply with the requirements of this subpart if it performs safety-critical functions within, or affects the safety performance... this subpart if they result in a degradation of safety or a material increase in safety-critical...

49 CFR 236.911 - Exclusions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... system technology. However, a subsystem or component of an office system must comply with the requirements of this subpart if it performs safety-critical functions within, or affects the safety performance... this subpart if they result in a degradation of safety or a material increase in safety-critical...

49 CFR 236.911 - Exclusions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... system technology. However, a subsystem or component of an office system must comply with the requirements of this subpart if it performs safety-critical functions within, or affects the safety performance... this subpart if they result in a degradation of safety or a material increase in safety-critical...

Examining psychosocial and physical hazards in the Ghanaian mining industry and their implications for employees' safety experience.

PubMed

Amponsah-Tawiah, Kwesi; Jain, Aditya; Leka, Stavroula; Hollis, David; Cox, Tom

2013-06-01

In addition to hazardous conditions that are prevalent in mines, there are various physical and psychosocial risk factors that can affect mine workers' safety and health. Without due diligence to mine safety, these risk factors can affect workers' safety experience, in terms of near misses, disabling injuries and accidents experienced or witnessed by workers. This study sets out to examine the effects of physical and psychosocial risk factors on workers' safety experience in a sample of Ghanaian miners. 307 participants from five mining companies responded to a cross sectional survey examining physical and psychosocial hazards and their implications for employees' safety experience. Zero-inflated Poisson regression models indicated that mining conditions, equipment, ambient conditions, support and security, and work demands and control are significant predictors of near misses, disabling injuries, and accidents experienced or witnessed by workers. The type of mine had important implications for workers' safety experience. Copyright © 2013 Elsevier Ltd and National Safety Council. All rights reserved.

Numerical human models for accident research and safety - potentials and limitations.

PubMed

Praxl, Norbert; Adamec, Jiri; Muggenthaler, Holger; von Merten, Katja

2008-01-01

The method of numerical simulation is frequently used in the area of automotive safety. Recently, numerical models of the human body have been developed for the numerical simulation of occupants. Different approaches in modelling the human body have been used: the finite-element and the multibody technique. Numerical human models representing the two modelling approaches are introduced and the potentials and limitations of these models are discussed.

Achilles Tendonitis

MedlinePlus

... almost impossible. Achilles tendonitis is a very common running injury. But it can also affect basketball players, dancers, ... Proximal Biceps Tendonitis Safety Tips: Basketball Safety Tips: Running Repetitive Stress Injuries Sports and Exercise Safety Dealing With Sports Injuries ...

High levels of hydrogen peroxide in overnight tooth-whitening formulas: effects on enamel and pulp.

PubMed

Pugh, George; Zaidel, Lynette; Lin, Nora; Stranick, Michael; Bagley, Daniel

2005-01-01

Limited data are available to assess the safety of high levels of hydrogen peroxide in overnight tooth-whitening formulas. The purpose of this study was to assess the effects of hydrogen peroxide on enamel microhardness, pulp penetration, and enamel morphology. Colgate Platinum Professional Overnight Whitening System (Colgate Oral Pharmaceuticals, Inc., Canton, MA, USA) (10% carbamide peroxide, equivalent to 3.5% hydrogen peroxide) was compared with two prototype formulations containing either 7.0% or 12.0% hydrogen peroxide. In the pulp chamber studies, human extracted teeth were exposed to 3.5%, 7.0%, or 12.0% hydrogen peroxide for 30 minutes, 4 hours, or 7 hours. Microhardness, electron spectroscopy for chemical analysis, and atomic force microscopy evaluations were made from enamel blocks cut from human extracted molars. The enamel blocks were evaluated following 14 7-hour treatments (98 h total). At 7 hours' post-treatment, hydrogen peroxide penetrated the pulp chamber at 23.12 +/- 10.09, 24.58 +/- 6.90, and 26.39 +/- 5.43 microg for 3.5%, 7.0%, and 12.0% hydrogen peroxide, respectively. With regard to enamel morphology, pulp penetration, microhardness, and elemental composition, no statistically significant differences were observed between treatment groups following 98 hours of treatment. Hydrogen peroxide does not adversely affect enamel morphology or microhardness. The levels recovered in pulp indicate that hydrogen peroxide is not expected to inhibit pulpal enzymes. Overnight tray products containing levels of hydrogen peroxide of 3.5%, 7.0%, and 12.0% are not expected to adversely affect the enamel or pulpal enzymes. Additional safety studies are needed to assess the potential for tooth sensitivity and gingival irritation.

Characterization of wood plastic composites made from landfill-derived plastic and sawdust: Volatile compounds and olfactometric analysis

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

Félix, Juliana S., E-mail: jfelix@unizar.es; Domeño, Celia, E-mail: cdomeno@unizar.es; Nerín, Cristina, E-mail: cnerin@unizar.es

Graphical abstract: This work details the characterization of VOCs of WPC, produced from residual materials which would have landfills as current destination, and evaluates their odor profile. Highlights: ► More than 140 volatile compounds were identified in raw materials and WPC products. ► Markers were related to the thermal degradation, sawdust or coupling agents. ► WPC prototype showed a characteristic odor profile of burnt, sweet and wax-like. ► Aldehydes, carboxylic acids, ketones and phenols were odor descriptors of WPC. - Abstract: Application of wood plastic composites (WPCs) obtained from recycled materials initially intended for landfill is usually limited by theirmore » composition, mainly focused on release of volatile organic compounds (VOCs) which could affect quality or human safety. The study of the VOCs released by a material is a requirement for new composite materials. Characterization and quantification of VOCs of several WPC produced with low density polyethylene (LDPE) and polyethylene/ethylene vinyl acetate (PE/EVA) films and sawdust were carried out, in each stage of production, by solid phase microextraction in headspace mode (HS-SPME) and gas chromatography–mass spectrometry (GC–MS). An odor profile was also obtained by HS-SPME and GC–MS coupled with olfactometry analysis. More than 140 compounds were observed in the raw materials and WPC samples. Some quantified compounds were considered WPC markers such as furfural, 2-methoxyphenol, N-methylphthalimide and 2,4-di-tert-butylphenol. Hexanoic acid, acetic acid, 2-methoxyphenol, acetylfuran, diacetyl, and aldehydes were the most important odorants. None of the VOCs were found to affect human safety for use of the WPC.« less

75 FR 3471 - International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0470... Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability AGENCY: Food and... the availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human...

77 FR 47662 - Proposed Supplementary Rules for Public Lands Within the Lower Lake Creek Special Recreation...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-09

... certain recreational activities on certain public lands to protect natural resources and human health and... resources and the environment and provide for human health and safety. Therefore, the BLM has determined... resources and the environment and human health and safety. Therefore, the BLM is not required to prepare a...

Dental metal-induced innate reactivity in keratinocytes.

PubMed

Mortazavi, S M J; Mortazavi, Ghazal; Paknahad, Maryam

2016-06-01

In their paper that is published in Toxicology in Vitro, Rachmawati et al. have recently claimed that in spite of the growing concern about the safety of amalgam, negative reports about the health effects of dental amalgam are still scarce or controversial. Substantial evidence indicates that mercury release from dental amalgam fillings may adversely affect human health. Over the past years, we have shown that exposure to electromagnetic fields (EMFs) can increase the release of mercury from dental amalgam fillings. It is worth mentioning that the results of investigations on the microleakage of amalgam fillings following MRI have confirmed our results. Furthermore, exposure to X-rays as a part of the electromagnetic spectrum has also been linked to increased mercury release from dental amalgam fillings. Considering the explosive rise in human exposure to electromagnetic fields, the role of human exposure to EMF as a key factor in increasing the release of mercury from dental amalgam restorations cannot be simply ignored. Copyright © 2016 Elsevier B.V. All rights reserved.

SARSCEST (human factors)

NASA Technical Reports Server (NTRS)

Parsons, H. Mcilvaine

1988-01-01

People interact with the processes and products of contemporary technology. Individuals are affected by these in various ways and individuals shape them. Such interactions come under the label 'human factors'. To expand the understanding of those to whom the term is relatively unfamiliar, its domain includes both an applied science and applications of knowledge. It means both research and development, with implications of research both for basic science and for development. It encompasses not only design and testing but also training and personnel requirements, even though some unwisely try to split these apart both by name and institutionally. The territory includes more than performance at work, though concentration on that aspect, epitomized in the derivation of the term ergonomics, has overshadowed human factors interest in interactions between technology and the home, health, safety, consumers, children and later life, the handicapped, sports and recreation education, and travel. Two aspects of technology considered most significant for work performance, systems and automation, and several approaches to these, are discussed.

The novel JNK inhibitor AS602801 inhibits cancer stem cells in vitro and in vivo.

PubMed

Okada, Masashi; Kuramoto, Kenta; Takeda, Hiroyuki; Watarai, Hikaru; Sakaki, Hirotsugu; Seino, Shizuka; Seino, Manabu; Suzuki, Shuhei; Kitanaka, Chifumi

2016-05-10

A phase 2 clinical trial investigating the efficacy and safety of AS602801, a newly developed JNK inhibitor, in the treatment of inflammatory endometriosis is complete. We are now examining whether AS602801 acts against human cancer cells in vitro and in vivo. In vitro, AS602801 exhibited cytotoxicity against both serum-cultured non-stem cancer cells and cancer stem cells derived from human pancreatic cancer, non-small cell lung cancer, ovarian cancer and glioblastoma at concentrations that did not decrease the viability of normal human fibroblasts. AS602801 also inhibited the self-renewal and tumor-initiating capacity of cancer stem cells surviving AS602801 treatment. Cancer stem cells in established xenograft tumors were reduced by systemic administration of AS602801 at a dose and schedule that did not adversely affect the health of the tumor-bearing mice. These findings suggest AS602801 is a promising anti-cancer stem cell agent, and further investigation of the utility of AS602801 in the treatment of cancer seems warranted.

Effects of biochar on reducing the abundance of oxytetracycline, antibiotic resistance genes, and human pathogenic bacteria in soil and lettuce.

PubMed

Duan, Manli; Li, Haichao; Gu, Jie; Tuo, Xiaxia; Sun, Wei; Qian, Xun; Wang, Xiaojuan

2017-05-01

Antibiotics and antibiotic resistance genes (ARGs) in soil can affect human health via the food chain. Biochar is a soil amendment but its impacts on ARGs and the microbial communities associated with soil and vegetables are unclear. Therefore, we established three lettuce pot culture experiments, i.e., O300: 300 mg/kg oxytetracycline (OTC), BO300: 300 mg/kg OTC + 2% biochar, and a control without OTC or biochar. We found that under BO300, the relative abundances of ARGs were reduced by 51.8%, 43.4%, and 44.1% in lettuce leaves, roots, and soil, respectively, compared with O300. intI1 was highly abundant in soil and lettuce, and it co-occurred with some ARGs (tetW, ermF, and sul1). Redundancy analysis and network analysis indicated that the bacterial community succession was the main mechanism that affected the variations in ARGs and intI1. The reduction of Firmicutes due to the biochar treatment of soil and lettuce was the main factor responsible for the removal of tetracycline resistance genes in leaves. Biochar application led to the disappearance of human pathogenic bacteria (HPB), which was significantly correlated with the abundances of ermF and ermX. In summary, biochar is an effective farmland amendment for reducing the abundances of antibiotics, ARGs, and HPB in order to ensure the safety of vegetables and protect human health. Copyright © 2017 Elsevier Ltd. All rights reserved.

Designing visual displays and system models for safe reactor operations based on the user`s perspective of the system

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

Brown-VanHoozer, S.A.

Most designers are not schooled in the area of human-interaction psychology and therefore tend to rely on the traditional ergonomic aspects of human factors when designing complex human-interactive workstations related to reactor operations. They do not take into account the differences in user information processing behavior and how these behaviors may affect individual and team performance when accessing visual displays or utilizing system models in process and control room areas. Unfortunately, by ignoring the importance of the integration of the user interface at the information process level, the result can be sub-optimization and inherently error- and failure-prone systems. Therefore, tomore » minimize or eliminate failures in human-interactive systems, it is essential that the designers understand how each user`s processing characteristics affects how the user gathers information, and how the user communicates the information to the designer and other users. A different type of approach in achieving this understanding is Neuro Linguistic Programming (NLP). The material presented in this paper is based on two studies involving the design of visual displays, NLP, and the user`s perspective model of a reactor system. The studies involve the methodology known as NLP, and its use in expanding design choices from the user`s ``model of the world,`` in the areas of virtual reality, workstation design, team structure, decision and learning style patterns, safety operations, pattern recognition, and much, much more.« less

Poly-(amidoamine) dendrimers with a precisely core positioned sulforhodamine B molecule for comparative biological tracing and profiling.

PubMed

Wu, Lin-Ping; Ficker, Mario; Mejlsøe, Søren L; Hall, Arnaldur; Paolucci, Valentina; Christensen, Jørn B; Trohopoulos, Panagiotis N; Moghimi, Seyed M

2017-01-28

We report on a simple robust procedure for synthesis of generation-4 poly-(amidoamine) (PAMAM) dendrimers with a precisely core positioned single sulforhodamine B molecule. The labelled dendrimers exhibited high fluorescent quantum yields where the absorbance and fluorescence spectrum of the fluorophore was not affected by pH and temperature. Since the stoichiometry of the fluorophore to the dendrimer is 1:1, we were able to directly compare uptake kinetics, the mode of uptake, trafficking and safety of dendrimers of different end-terminal functionality (carboxylated vs. pyrrolidonated) by two phenotypically different human endothelial cell types (the human brain capillary endothelial cell line hCMEC/D3 and human umbilical vein endothelial cells), and without interference of the fluorophore in uptake processes. The results demonstrate comparable uptake kinetics and a predominantly clathrin-mediated endocytotic mechanism, irrespective of dendrimer end-terminal functionality, where the majority of dendrimers are directed to the endo-lysosomal compartments in both cell types. A minor fraction of dendrimers, however, localize to endoplasmic reticulum and the Golgi apparatus, presumably through the recycling endosomes. In contrast to amino-terminated PAMAM dendrimers, we confirm safety of carboxylic acid- and pyrrolidone-terminated PAMAM dendrimers through determination of cell membrane integrity and comprehensive respiratory profiling (measurements of mitochondrial oxidative phosphorylation and determination of its coupling efficiency). Our dendrimer core-labelling approach could provide a new conceptual basis for improved understanding of dendrimer performance within biological settings. Copyright © 2016 Elsevier B.V. All rights reserved.

IGIV: contents, properties, and methods of industrial production--evolving closer to a more physiologic product.

PubMed

Martin, Turf D

2006-04-01

Is the process the product? Immune globulin intravenous (IGIV) is not manufactured, but is purified (fractionated) from human plasma. Machines can only damage what Mother Nature makes; they cannot improve it. Therefore, fractionators of biologic molecules must strive to ensure what is taken from a human body is exactly the same when it is returned to the human body for optimal tolerability and safety. The processes of purification have the potential to adversely affect the product. Four primary purification processes exist for commercial IGIV. The Cohn-Oncley process is 1940s technology, which has been modified through the decades, but the basic process remains unchanged. The Kistler-Nitschmann process was developed in the 1950s by the Central Laboratory of the Swiss Red Cross (ZLB, today known as ZLB-Behring, a subsidiary of CSL Limited). Various attempts have been made to utilize chromatography as the sole separation technology without much success. Most recently, Bayer HealthCare (Talecris Biotherapeutics acquired the contributed assets of the worldwide plasma business of Bayer Biological Products and became operational April 1, 2005; all plasma-based products, including Gamunex, Prolastin, the hyperimmune line (Fraction II), Plasbumin (Bayer Albumin), Koate DVI, and Thrombate III were included) introduced a new product into the United States and Canada that utilizes caprylate and chromatography for high purity, better yields, and integration of safety and efficacy. This is the first new IGIV purification technology in over 20 years.

A safety study of oral tangeretin and xanthohumol administration to laboratory mice.

PubMed

Vanhoecke, Barbara W; Delporte, Femke; Van Braeckel, Eva; Heyerick, Arne; Depypere, Herman T; Nuytinck, Margareta; De Keukeleire, Denis; Bracke, Marc E

2005-01-01

The detection of molecular targets for flavonoids in cell signalling has opened new perspectives for their application in medicine. Both tangeretin, a citrus methoxyflavone, and xanthohumol, the main prenylated chalcone present in hops (Humulus lupulus L.), act on the mitogen-activated protein kinase pathway and await further investigation for administration in vivo. A safety study was designed in laboratory mice orally administered concentrates of purified tangeretin (1 x 10(-4) M) or xanthohumol (5 x 10(-4) M) at libitum for 4 weeks. Blood samples were collected for the analysis of a variety of haematological and biochemical parameters. A reduction of the circulating lymphocyte number was noticed for tangeretin, while all other parameters were unaffected by treatment with either tangeretin or xanthohumol. The parameters encompassed an integrity check of the following tissues and organs: bone marrow, liver, exocrine pancreas, kidneys, muscles, thyroid, ovaries and surrenal cortex. Furthermore, no differences were noted in the metabolism of proteins, lipids, carbohydrates and uric acid, as well as in ion concentrations. All data indicate that oral administration of tangeretin or xanthohumol to laboratory mice does not affect major organ functions and opens the gate for further safety studies in humans.

Thermoregulatory models of safety-for-flight issues for space operations

NASA Astrophysics Data System (ADS)

Pisacane, V. L.; Kuznetz, L. H.; Logan, J. S.; Clark, J. B.; Wissler, E. H.

2006-10-01

This study investigates the use of a mathematical model for thermoregulation as a tool in safety-of-flight issues and proposed solutions for mission operations of the Space Shuttle and the International Space Station. Specifically, this study assesses the effects of elevated cabin temperature and metabolic loads on astronauts wearing the Advanced Crew Escape Suit (ACES) and the Liquid Cooled Ventilation Garment (LCVG). The 225-node Wissler model is validated by comparison with two ground-based human subject tests, firefighters, and surrogate astronauts under anomalous conditions that show good agreement. Subsequent simulations indicate that the performance of the ACES/LCVG is marginal. Increases in either workload or cabin temperature from the nominal will increase rectal temperature, stored heat load, heart rate, and sweating leading to possible deficits in the ability of the astronauts to perform cognitive and motor tasks that could affect the safety of the mission, especially the safe landing of the Shuttle. Specific relationships are given between cabin temperature and metabolic rate that define the threshold for decreased manual dexterity and loss of tracking skills. Model results indicate that the most effective mitigation strategy would be to decrease the LCVG inlet temperature. Methods of accomplishing this are also proposed.

Identifying patient safety problems associated with information technology in general practice: an analysis of incident reports.

PubMed

Magrabi, Farah; Liaw, Siaw Teng; Arachi, Diana; Runciman, William; Coiera, Enrico; Kidd, Michael R

2016-11-01

To identify the categories of problems with information technology (IT), which affect patient safety in general practice. General practitioners (GPs) reported incidents online or by telephone between May 2012 and November 2013. Incidents were reviewed against an existing classification for problems associated with IT and the clinical process impacted. 87 GPs across Australia. Types of problems, consequences and clinical processes. GPs reported 90 incidents involving IT which had an observable impact on the delivery of care, including actual patient harm as well as near miss events. Practice systems and medications were the most affected clinical processes. Problems with IT disrupted clinical workflow, wasted time and caused frustration. Issues with user interfaces, routine updates to software packages and drug databases, and the migration of records from one package to another generated clinical errors that were unique to IT; some could affect many patients at once. Human factors issues gave rise to some errors that have always existed with paper records but are more likely to occur and cause harm with IT. Such errors were linked to slips in concentration, multitasking, distractions and interruptions. Problems with patient identification and hybrid records generated errors that were in principle no different to paper records. Problems associated with IT include perennial risks with paper records, but additional disruptions in workflow and hazards for patients unique to IT, occasionally affecting multiple patients. Surveillance for such hazards may have general utility, but particularly in the context of migrating historical records to new systems and software updates to existing systems. 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/.

The SEURAT-1 approach towards animal free human safety assessment.

PubMed

Gocht, Tilman; Berggren, Elisabet; Ahr, Hans Jürgen; Cotgreave, Ian; Cronin, Mark T D; Daston, George; Hardy, Barry; Heinzle, Elmar; Hescheler, Jürgen; Knight, Derek J; Mahony, Catherine; Peschanski, Marc; Schwarz, Michael; Thomas, Russell S; Verfaillie, Catherine; White, Andrew; Whelan, Maurice

2015-01-01

SEURAT-1 is a European public-private research consortium that is working towards animal-free testing of chemical compounds and the highest level of consumer protection. A research strategy was formulated based on the guiding principle to adopt a toxicological mode-of-action framework to describe how any substance may adversely affect human health.The proof of the initiative will be in demonstrating the applicability of the concepts on which SEURAT-1 is built on three levels:(i) Theoretical prototypes for adverse outcome pathways are formulated based on knowledge already available in the scientific literature on investigating the toxicological mode-of-actions leading to adverse outcomes (addressing mainly liver toxicity);(ii)adverse outcome pathway descriptions are used as a guide for the formulation of case studies to further elucidate the theoretical model and to develop integrated testing strategies for the prediction of certain toxicological effects (i.e., those related to the adverse outcome pathway descriptions);(iii) further case studies target the application of knowledge gained within SEURAT-1 in the context of safety assessment. The ultimate goal would be to perform ab initio predictions based on a complete understanding of toxicological mechanisms. In the near-term, it is more realistic that data from innovative testing methods will support read-across arguments. Both scenarios are addressed with case studies for improved safety assessment. A conceptual framework for a rational integrated assessment strategy emerged from designing the case studies and is discussed in the context of international developments focusing on alternative approaches for evaluating chemicals using the new 21st century tools for toxicity testing.

The role of nutritional research in the success of human space flight.

PubMed

Lane, Helen W; Bourland, Charles; Barrett, Ann; Heer, Martina; Smith, Scott M

2013-09-01

The United States has had human space flight programs for >50 y and has had a continued presence in space since 2000. Providing nutritious and safe food is imperative for astronauts because space travelers are totally dependent on launched food. Space flight research topics have included energy, protein, nutritional aspects of bone and muscle health, and vision issues related to 1-carbon metabolism. Research has shown that energy needs during flight are similar to energy needs on Earth. Low energy intakes affect protein turnover. The type of dietary protein is also important for bone health, plant-based protein being more efficacious than animal protein. Bone loss is greatly ameliorated with adequate intakes of energy and vitamin D, along with routine resistive exercise. Astronauts with lower plasma folate concentrations may be more susceptible to vision changes. Foods for space flight were developed initially by the U.S. Air Force School of Aerospace Medicine in conjunction with the U.S. Army Natick Laboratories and NASA. Hazard Analysis Critical Control Point safety standards were specifically developed for space feeding. Prepackaged foods for the International Space Station were originally high in sodium (5300 mg/d), but NASA has recently reformulated >90 foods to reduce sodium intake to 3000 mg/d. Food development has improved nutritional quality as well as safety and acceptability.

The effect of silver nanoparticles on zebrafish embryonic development and toxicology.

PubMed

Xia, Guangqing; Liu, Tiantian; Wang, Zhenwei; Hou, Yi; Dong, Lihong; Zhu, Junyi; Qi, Jie

2016-06-01

The unique physical and chemical characteristics of nanomaterials, such as the effects of their small size, surface effects, very high rates of reaction, and quantum tunnel effect, have aroused great interest among scholars. However, improper usage has led to an increasing number of nanomaterials entering the environment through various channels, greatly threatening the security of the ecological environment and human health. The urgent need for a scientific assessment of their biosafety can enable nanomaterials to truly benefit humanity. However, the current research in this field is extremely limited with regard to safety standards and waste disposal. In this study, we used silver nanoparticles (nano-Ag) and zebrafish embryos as experimental subjects, and we have reported the deleterious effect on zebrafish embryos treated with different concentrations of nano-Ag, with respect to morphological features (mortality, deformity rate, and heartbeat) and the analysis of expression of relevant genes (sox17, gsc, ntl, otx2); we found a dose-dependent increase in mortality and hatching delay. The results of in situ hybridization indicated that nano-Ag causes a dose-dependent toxicity in embryonic development, and would affect their development and lead to deformity, delayed development, and even death. The safety limit for the concentration of nano-Ag was found to be less than 5 mg/L.

Safety, formulation, and in vitro antiviral activity of the antimicrobial peptide subtilosin against herpes simplex virus type 1

PubMed Central

Torres, Nicolás I.; Noll, Katia Sutyak; Xu, Shiqi; Li, Ji; Huang, Qingrong; Sinko, Patrick J.; Wachsman, Mónica B.; Chikindas, Michael L.

2013-01-01

In the present study the antiviral properties of the bacteriocin subtilosin against Herpes simplex virus type 1 (HSV-1) and the safety and efficacy of a subtilosin-based nanofiber formulation were determined. High concentrations of subtilosin, the cyclical antimicrobial peptide produced by Bacillus amyloliquefaciens, were virucidal against HSV-1. Interestingly, at non-virucidal concentrations, subtilosin inhibited wild type HSV-1 and aciclovir-resistant mutants in a dose-dependent manner. Although the exact antiviral mechanism is not fully understood, time of addition experiments and western blot analysis suggest that subtilosin does not affect viral multiplication steps prior to protein synthesis. Poly(vinyl alcohol) (PVOH)-based subtilosin nanofibers with a width of 278 nm were produced by the electrospinning process. The retained antimicrobial activity of the subtilosin-based fibers was determined via an agar well diffusion assay. The loading capacity of the fibers was 2.4 mg subtilosin/g fiber, and loading efficiency was 31.6%. Furthermore, the nanofibers with and without incorporated subtilosin were shown to be nontoxic to human epidermal tissues using an in vitro human tissue model. Taking together these results subtilosin-based nanofibers should be further studied as a novel alternative method for treatment and/or control of HSV-1 infection. PMID:23637711

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

Weber, Nicholas D., E-mail: nweber@fhcrc.org; Department of Laboratory Medicine, University of Washington, Seattle, WA 98195; Aubert, Martine, E-mail: maubert@fhcrc.org

Treatment for most persistent viral infections consists of palliative drug options rather than curative approaches. This is often because long-lasting viral DNA in infected cells is not affected by current antivirals, providing a source for viral persistence and reactivation. Targeting latent viral DNA itself could therefore provide a basis for novel curative strategies. DNA cleavage enzymes can be used to induce targeted mutagenesis of specific genes, including those of exogenous viruses. Although initial in vitro and even in vivo studies have been carried out using DNA cleavage enzymes targeting various viruses, many questions still remain concerning the feasibility of thesemore » strategies as they transition into preclinical research. Here, we review the most recent findings on DNA cleavage enzymes for human viral infections, consider the most relevant animal models for several human viral infections, and address issues regarding safety and enzyme delivery. Results from well-designed in vivo studies will ideally provide answers to the most urgent remaining questions, and allow continued progress toward clinical application. - Highlights: • Recent in vitro and in vivo results for DNA cleavage enzymes targeting persistent viral infections. • Analysis of the best animal models for testing enzymes for HBV, HSV, HIV and HPV. • Challenges facing in vivo delivery of therapeutic enzymes for persistent viral infections. • Safety issues to be addressed with proper animal studies.« less

Recent updates on recombinant human growth hormone outcomes and adverse events.

PubMed

Watson, Sara E; Rogol, Alan D

2013-02-01

To provide up-to-date information on outcomes and adverse events associated with the use of recombinant human growth hormone (rhGH). We will focus on patients with Prader Willi Syndrome and Idiopathic Short Stature. We will also discuss recent reports on long-term adverse events from the European database. Prader Willi Syndrome is associated with hypogonadism, which does not appear to be affected by treatment with rhGH. However, there is new evidence that treatment may improve cognition. For patients with Idiopathic Short Stature, the gain in near adult height with treatment with rhGH appears to be 3-4 cm. Although a recent analysis of this group shows that certain patient characteristics may help identify those most likely to have a good response to treatment. Additionally, the safety and appropriateness of growth hormone treatments in Europe study released preliminary data from patients treated in two separate locations that showed conflicting information on risk of mortality from treatment with rhGH. Although we will continue to receive new information regarding the safety and effects of treatment with rhGH, it is important to discuss the risks and benefits with our patients. Additionally, it is incumbent on us to help guide the treatment to those most likely to benefit.

Proceedings of the human factors workshop : improving railroad safety through understanding close calls.

DOT National Transportation Integrated Search

2004-05-01

On April 23 and 24, 2003, the Federal Railroad Administrations Office of Research and Development held a Human Factors Workshop: Improving Railroad Safety Through Understanding Close Calls in Baltimore, Maryland. The purpose of the workshop ...

77 FR 32018 - Safety Zone; Kemah Boardwalk Summer Season Fireworks, Galveston Bay, Kemah, TX

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

... significant effect on the human environment. This rule involves the establishment of a safety zone for the protection of human life. This rule is categorically excluded from further review under paragraph 34(g) of...

International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.

PubMed

2001-07-13

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.

Collaboration and patient safety at an emergency department - a qualitative case study.

PubMed

Pedersen, Anna Helene Meldgaard; Rasmussen, Kurt; Grytnes, Regine; Nielsen, Kent Jacob

2018-03-19

Purpose The purpose of this paper is to examine how conflicts about collaboration between staff at different departments arose during the establishment of a new emergency department and how these conflicts affected the daily work and ultimately patient safety at the emergency department. Design/methodology/approach This qualitative single case study draws on qualitative semi-structured interviews and participant observation. The theoretical concepts "availability" and "receptiveness" as antecedents for collaboration will be applied in the analysis. Findings Close collaboration between departments was an essential precondition for the functioning of the new emergency department. The study shows how a lack of antecedents for collaboration affected the working relation and communication between employees and departments, which spurred negative feelings and reproduced conflicts. This situation was seen as a potential threat for the safety of the emergency patients. Research limitations/implications This study presents a single case study, at a specific point in time, and should be used as an illustrative example of how contextual and situational factors affect the working environment and through that patient safety. Originality/value Few studies provide an in-depth investigation of what actually takes place when collaboration between professional groups goes wrong and escalates, and how problems in collaboration may affect patient safety.

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...

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

ERIC Educational Resources Information Center

Cullen, Joy

1998-01-01

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

School Bus Safety Advisory Committee: 1999 Annual Report.

ERIC Educational Resources Information Center

Lazenberry, Dennis; Anderson, Barbara

This report summarizes the deliberations and recommendations of Minnesota's School Bus Safety Advisory Committee (SBSAC). The committee, which operates under the auspices of the Minnesota Department of Public Safety, is charged to study issues affecting the safety of students on school buses, arrive at consensus on ways to improve student safety…

75 FR 35366 - Pipeline Safety: Applying Safety Regulation to All Rural Onshore Hazardous Liquid Low-Stress Lines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Onshore Hazardous Liquid Low-Stress Lines AGENCY: Pipeline and Hazardous Materials Safety Administration... pipelines to perform a complete ``could affect'' analysis to determine which rural low-stress pipeline...

The Occupational Safety and Health Act: Implications for School Administration.

ERIC Educational Resources Information Center

Licht, Kenneth F.

The Occupational Safety and Health Act (1970) concerns private schools but does not directly affect the operations of public schools or colleges. The intent, however, is to have the States develop and administer their own health and safety programs. Administrators should, therefore, initiate a comprehensive, districtwide safety education and…

30 CFR 77.1606 - Loading and haulage equipment; inspection and maintenance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... maintenance. 77.1606 Section 77.1606 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS... equipment is placed in operation. Equipment defects affecting safety shall be recorded and reported to the...

29 CFR 1960.19 - Other Federal agency standards affecting occupational safety and health.

Code of Federal Regulations, 2010 CFR

2010-07-01

... safety and health. 1960.19 Section 1960.19 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Standards § 1960.19 Other Federal...

29 CFR 1960.19 - Other Federal agency standards affecting occupational safety and health.

Code of Federal Regulations, 2011 CFR

2011-07-01

... safety and health. 1960.19 Section 1960.19 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Standards § 1960.19 Other Federal...

77 FR 75600 - Policy Statement on Occupational Safety and Health Standards for Aircraft Cabin Crewmembers...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... [Docket No. FAA-2012-0953] Policy Statement on Occupational Safety and Health Standards for Aircraft Cabin... announced a proposed policy statement regarding the regulation of some occupational safety and health conditions affecting cabin crewmembers on aircraft by the Occupational Safety and Health Administration. The...

75 FR 5172 - Solicitation of Nominations for Members of the Transit Rail Advisory Committee for Safety

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-01

... reform in this area, convening affected parties now will only help strengthen FTA's decision-making..., major accidents in Chicago, Washington, DC, San Francisco, and Boston have captured the attention of the... affected by rail transit safety requirements. These key constituencies will include, but are not limited to...

Games that ''Work'': Using Computer Games to Teach Alcohol-Affected Children about Fire and Street Safety

ERIC Educational Resources Information Center

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

2007-01-01

Unintentional injuries are a leading cause of death and disability for children. Those with developmental disabilities, including children affected by prenatal alcohol exposure, are at highest risk for injuries. Although teaching safety skills is recommended to prevent injury, cognitive limitations and behavioral problems characteristic of…

The Line Operations Safety Audit Program: Transitioning From Flight Operations to Maintenance and Ramp Operations

DTIC Science & Technology

2011-09-01

Transport Association ( ATA ) Maintenance & Ramp Human Factors Task Force committee members—we are deeply grateful for their contributions in the...6 Air Transport Association ( ATA ) Human Factors Task Force . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Form Development...garnered many valuable les- sons, safety improvements, and significant returns on their investment. 1The FAA ATA Human Factors Taskforce has

[Biomedical foundation for human safety in aviation].

PubMed

Ushakov, I B

2004-01-01

According to the author, preventive medical issues of providing human safety in aviation are related to the fundamental biomedical and socio-psychological problems of human beings in the present-day world. Factual material for analysis was compiled in the study performed at the State Research and Test Institute of Military Medicine. Outlined are main vectors of the future attack on the problem.

Ring the Alarm! A Memo to the Schools on Fire and Human Beings.

ERIC Educational Resources Information Center

Educational Facilities Labs., Inc., New York, NY.

An analysis is presented of the handling of the human elements in fire safety. Emphasis is given to considerations such as how fires kill children, the school's responsibility for fire safety, causes of human failure, and the necessity for organized emergency programs and drills. Also included is a check list of items concerned with protection…

78 FR 40743 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH... Director, NIOSH, on priorities in mine safety and health research, including grants and contracts for such...

Categorizing accident sequences in the external radiotherapy for risk analysis

PubMed Central

2013-01-01

Purpose This study identifies accident sequences from the past accidents in order to help the risk analysis application to the external radiotherapy. Materials and Methods This study reviews 59 accidental cases in two retrospective safety analyses that have collected the incidents in the external radiotherapy extensively. Two accident analysis reports that accumulated past incidents are investigated to identify accident sequences including initiating events, failure of safety measures, and consequences. This study classifies the accidents by the treatments stages and sources of errors for initiating events, types of failures in the safety measures, and types of undesirable consequences and the number of affected patients. Then, the accident sequences are grouped into several categories on the basis of similarity of progression. As a result, these cases can be categorized into 14 groups of accident sequence. Results The result indicates that risk analysis needs to pay attention to not only the planning stage, but also the calibration stage that is committed prior to the main treatment process. It also shows that human error is the largest contributor to initiating events as well as to the failure of safety measures. This study also illustrates an event tree analysis for an accident sequence initiated in the calibration. Conclusion This study is expected to provide sights into the accident sequences for the prospective risk analysis through the review of experiences. PMID:23865005

A brief review of the occurrence, use, and safety of food-related nanomaterials.

PubMed

Magnuson, Bernadene A; Jonaitis, Tomas S; Card, Jeffrey W

2011-08-01

Nanotechnology and nanomaterials have tremendous potential to enhance the food supply through novel applications, including nutrient and bioactive absorption and delivery systems; ingredient functionality; improved colors and flavors; microbial, allergen, and contaminant detection and control; and food packaging properties and performance. To determine the current state of knowledge regarding the safety of these potential uses of nanomaterials, an appraisal of the published literature on the safety of food-related nanomaterials was undertaken. A method of assessment of reliability of toxicology studies was developed to conduct this appraisal. The review of the toxicology literature on oral exposure to food-related nanomaterials found that the number of studies is limited. Exposure to nanomaterials in the human food chain may occur not only through intentional uses in food manufacturing, but also via uses in agricultural production and carry over from use in other industries. Although a number of analytical methods are useful in physicochemical characterization of manufactured nanomaterials, new methods may be needed to more fully detect and characterize nanomaterials incorporated into foods and in other media. There is a need for additional toxicology studies of sufficient quality and duration on different types of nanomaterials to further our understanding of the characteristics of nanomaterials that affect safety of oral exposure resulting from use in various food applications. © 2011 Institute of Food Technologists®

Comparative aspects of rodent and nonrodent animal models for mechanistic and translational diabetes research.

PubMed

Renner, Simone; Dobenecker, Britta; Blutke, Andreas; Zöls, Susanne; Wanke, Rüdiger; Ritzmann, Mathias; Wolf, Eckhard

2016-07-01

The prevalence of diabetes mellitus, which currently affects 387 million people worldwide, is permanently rising in both adults and adolescents. Despite numerous treatment options, diabetes mellitus is a progressive disease with severe comorbidities, such as nephropathy, neuropathy, and retinopathy, as well as cardiovascular disease. Therefore, animal models predictive of the efficacy and safety of novel compounds in humans are of great value to address the unmet need for improved therapeutics. Although rodent models provide important mechanistic insights, their predictive value for therapeutic outcomes in humans is limited. In recent years, the pig has gained importance for biomedical research because of its close similarity to human anatomy, physiology, size, and, in contrast to non-human primates, better ethical acceptance. In this review, anatomic, biochemical, physiological, and morphologic aspects relevant to diabetes research will be compared between different animal species, that is, mouse, rat, rabbit, pig, and non-human primates. The value of the pig as a model organism for diabetes research will be highlighted, and (dis)advantages of the currently available approaches for the generation of pig models exhibiting characteristics of metabolic syndrome or type 2 diabetes mellitus will be discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

The use of non-animal alternatives in the safety evaluations of cosmetics ingredients by the Scientific Committee on Consumer Safety (SCCS).

PubMed

Vinardell, M P

2015-03-01

In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g., colourants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers submitted to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition. Copyright © 2014 Elsevier Inc. All rights reserved.

The Microphysiology Systems Database for Analyzing and Modeling Compound Interactions with Human and Animal Organ Models

PubMed Central

Vernetti, Lawrence; Bergenthal, Luke; Shun, Tong Ying; Taylor, D. Lansing

2016-01-01

Abstract Microfluidic human organ models, microphysiology systems (MPS), are currently being developed as predictive models of drug safety and efficacy in humans. To design and validate MPS as predictive of human safety liabilities requires safety data for a reference set of compounds, combined with in vitro data from the human organ models. To address this need, we have developed an internet database, the MPS database (MPS-Db), as a powerful platform for experimental design, data management, and analysis, and to combine experimental data with reference data, to enable computational modeling. The present study demonstrates the capability of the MPS-Db in early safety testing using a human liver MPS to relate the effects of tolcapone and entacapone in the in vitro model to human in vivo effects. These two compounds were chosen to be evaluated as a representative pair of marketed drugs because they are structurally similar, have the same target, and were found safe or had an acceptable risk in preclinical and clinical trials, yet tolcapone induced unacceptable levels of hepatotoxicity while entacapone was found to be safe. Results demonstrate the utility of the MPS-Db as an essential resource for relating in vitro organ model data to the multiple biochemical, preclinical, and clinical data sources on in vivo drug effects. PMID:28781990

Thermoresponsive Polymers with Lower Critical Solution Temperature- or Upper Critical Solution Temperature-Type Phase Behaviour Do Not Induce Toxicity to Human Endothelial Cells.

PubMed

Ji, Yuejia; Zhu, Mengxiang; Gong, Yu; Tang, Haoyu; Li, Juan; Cao, Yi

2017-01-01

Thermoresponsive polymers have gained extensive attention as biomedical materials especially for targeted drug delivery systems. We have recently developed water-soluble polypeptide-based thermoresponsive polymers that exhibit lower critical solution temperature (LCST)- or upper critical solution temperature (UCST)-type phase behaviours. In this study, the toxicity of these polymers to human umbilical vein endothelial cells (HUVECs) was investigated to assess the safety and biocompatibility. Up to 100 μg/ml, thermoresponsive polymers did not induce cytotoxicity to HUVECs, showing as unaltered mitochondrial viability assessed as cell counting kit-8 (CCK-8) assay and membrane integrity assessed as lactate dehydrogenase (LDH) assay. Inflammatory response, assessed as the release of chemokine-soluble monocyte chemotactic protein 1 (sMCP-1) and interleukin-8 (IL-8) as well as cytokine IL-6, was not significantly affected by the polymers. In addition, 1 μM thapsigargin (TG), an endoplasmic reticulum (ER) stress inducer, significantly decreased mitochondrial viability, but did not affect membrane integrity or inflammatory response. The presence of thermoresponsive polymers with LCST-type phase behaviour did not further affect the effects of TG. In conclusion, the thermoresponsive polymers used in this study are not toxic to endothelial cells and therefore could be further considered as safe materials for biomedical applications. © 2016 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

Safety Metrics for Human-Computer Controlled Systems

NASA Technical Reports Server (NTRS)

Leveson, Nancy G; Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems.This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

21 CFR 184.1444 - Maltodextrin.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or...

21 CFR 172.809 - Curdlan.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... available from the Division of Petition Control (HFS-215), Center for Food Safety and Applied Nutrition... the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint...

21 CFR 173.370 - Peroxyacids.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... the Division of Petition Review, Center for Food Safety and Applied Nutrition, Food and Drug... Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the...

21 CFR 172.831 - Sucralose.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint... Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives...

21 CFR 184.1444 - Maltodextrin.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD... for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or...

21 CFR 173.370 - Peroxyacids.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... the Division of Petition Review, Center for Food Safety and Applied Nutrition, Food and Drug... Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the...

Canadian Pacific Railway Investigation of Safety-Related Occurrences Protocol considered helpful by both labor and management.

DOT National Transportation Integrated Search

2006-09-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program sponsored an Alternative Safety Measures Program designed to explore alternative methods for evaluating whether safety programs improve safety outcomes and...

Canadian Pacific Railway mechanical services' 5-Alive safety program shows promise in reducing injuries.

DOT National Transportation Integrated Search

2006-09-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program is sponsoring an Alternative Safety Measures Program to explore alternative methods for evaluating whether safety programs improve safety outcomes and the ...

The interaction between electromagnetic fields at megahertz, gigahertz and terahertz frequencies with cells, tissues and organisms: risks and potential

PubMed Central

Begley, Ryan; Harvey, Alan R.; Hool, Livia; Wallace, Vincent P.

2017-01-01

Since regular radio broadcasts started in the 1920s, the exposure to human-made electromagnetic fields has steadily increased. These days we are not only exposed to radio waves but also other frequencies from a variety of sources, mainly from communication and security devices. Considering that nearly all biological systems interact with electromagnetic fields, understanding the affects is essential for safety and technological progress. This paper systematically reviews the role and effects of static and pulsed radio frequencies (100–109 Hz), millimetre waves (MMWs) or gigahertz (109–1011 Hz), and terahertz (1011–1013 Hz) on various biomolecules, cells and tissues. Electromagnetic fields have been shown to affect the activity in cell membranes (sodium versus potassium ion conductivities) and non-selective channels, transmembrane potentials and even the cell cycle. Particular attention is given to millimetre and terahertz radiation due to their increasing utilization and, hence, increasing human exposure. MMWs are known to alter active transport across cell membranes, and it has been reported that terahertz radiation may interfere with DNA and cause genomic instabilities. These and other phenomena are discussed along with the discrepancies and controversies from published studies. PMID:29212756

Assessing characteristics related to the use of seatbelts and cell phones by drivers: application of a bivariate probit model.

PubMed

Russo, Brendan J; Kay, Jonathan J; Savolainen, Peter T; Gates, Timothy J

2014-06-01

The effects of cell phone use and safety belt use have been an important focus of research related to driver safety. Cell phone use has been shown to be a significant source of driver distraction contributing to substantial degradations in driver performance, while safety belts have been demonstrated to play a vital role in mitigating injuries to crash-involved occupants. This study examines the prevalence of cell phone use and safety belt non-use among the driving population through direct observation surveys. A bivariate probit model is developed to simultaneously examine the factors that affect cell phone and safety belt use among motor vehicle drivers. The results show that several factors may influence drivers' decision to use cell phones and safety belts, and that these decisions are correlated. Understanding the factors that affect both cell phone use and safety belt non-use is essential to targeting policy and programs that reduce such behavior. Copyright © 2014 Elsevier Ltd. All rights reserved.

BAY 81-8973, a full-length recombinant factor VIII: Human heat shock protein 70 improves the manufacturing process without affecting clinical safety.

PubMed

Maas Enriquez, Monika; Thrift, John; Garger, Stephen; Katterle, Yvonne

2016-11-01

BAY 81-8973 is a full-length, unmodified recombinant human factor VIII (FVIII) approved for the treatment of hemophilia A. BAY 81-8973 has the same amino acid sequence as the currently marketed sucrose-formulated recombinant FVIII (rFVIII-FS) product and is produced using additional advanced manufacturing technologies. One of the key manufacturing advances for BAY 81-8973 is introduction of the gene for human heat shock protein 70 (HSP70) into the rFVIII-FS cell line. HSP70 facilitates proper folding of proteins, enhances cell survival by inhibiting apoptosis, and potentially impacts rFVIII glycosylation. HSP70 expression in the BAY 81-8973 cell line along with other manufacturing advances resulted in a higher-producing cell line and improvements in the pharmacokinetics of the final product as determined in clinical studies. HSP70 protein is not detected in the harvest or in the final BAY 81-8973 product. However, because this is a new process, clinical trial safety assessments included monitoring for anti-HSP70 antibodies. Most patients, across all age groups, had low levels of anti-HSP70 antibodies before exposure to the investigational product. During BAY 81-8973 treatment, 5% of patients had sporadic increases in anti-HSP70 antibody levels above a predefined threshold (cutoff value, 239 ng/mL). No clinical symptoms related to anti-HSP70 antibody development occurred. In conclusion, addition of HSP70 to the BAY 81-8973 cell line is an innovative technology for manufacturing rFVIII aimed at improving protein folding and expression. Improved pharmacokinetics and no effect on safety of BAY 81-8973 were observed in clinical trials in patients with hemophilia A. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Ethical Considerations for Clinical Trials in Inflammatory Bowel Disease

PubMed Central

Becker, Samuel; Siegler, Mark

2014-01-01

Although advancements in the field of inflammatory bowel disease (IBD) include effective therapies for many patients with Crohn’s disease and ulcerative colitis, there remains a large unmet need, and there is a large number of investigational agents in the pipeline. Drug development through clinical trials is critical to understanding the safety and efficacy of new therapies in the affected human population, and the need for ethical trial design is of the utmost importance. This paper explores the ethical issues of clinical trials in IBD, focusing on placebo-controlled trials, vulnerable patients, exposure to monoclonal antibodies, globalization of trials, and surgical advances. PMID:24799837

Fire Safety in the Low-Gravity Spacecraft Environment

NASA Technical Reports Server (NTRS)

Friedman, Robert

1999-01-01

Research in microgravity (low-gravity) combustion promises innovations and improvements in fire prevention and response for human-crew spacecraft. Findings indicate that material flammability and fire spread in microgravity are significantly affected by atmospheric flow rate, oxygen concentration, and diluent composition. This information can lead to modifications and correlations to standard material-assessment tests for prediction of fire resistance in space. Research on smoke-particle changes in microgravity promises future improvements and increased sensitivity of smoke detectors in spacecraft. Research on fire suppression by extinguishing agents and venting can yield new information on effective control of the rare, but serious fire events in spacecraft.

Coastal storm monitoring in Virginia

USGS Publications Warehouse

Wicklein, Shaun M.; Bennett, Mark

2014-01-01

Coastal communities in Virginia are prone to flooding, particularly during hurricanes, nor’easters, and other coastal low-pressure systems. These weather systems affect public safety, personal and public property, and valuable infrastructure, such as transportation, water and sewer, and electric-supply networks. Local emergency managers, utility operators, and the public are tasked with making difficult decisions regarding evacuations, road closures, and post-storm recovery efforts as a result of coastal flooding. In coastal Virginia these decisions often are made on the basis of anecdotal knowledge from past events or predictions based on data from monitoring sites located far away from the affected area that may not reflect local conditions. Preventing flood hazards, such as hurricane-induced storm surge, from becoming human disasters requires an understanding of the relative risks that flooding poses to specific communities. The risk to life and property can be very high if decisions about evacuations and road closures are made too late or not at all.

Adventitious viruses in insect cell lines used for recombinant protein expression.

PubMed

Geisler, Christoph; Jarvis, Donald L

2018-04-01

Insect cells are widely used for recombinant protein expression, typically as hosts for recombinant baculovirus vectors, but also for plasmid-mediated transient transfection or stable genetic transformation. Insect cells are used to express proteins for research, as well as to manufacture biologicals for human and veterinary medicine. Recently, several insect cell lines used for recombinant protein expression were found to be persistently infected with adventitious viruses. This has raised questions about how these infections might affect research performed using those cell lines. Furthermore, these findings raised serious concerns about the safety of biologicals produced using those cell lines. In response, new insect cell lines lacking adventitious viruses have been isolated for use as improved research tools and safer biological manufacturing platforms. Here, we review the scientific and patent literature on adventitious viruses found in insect cell lines, affected cell lines, and new virus-free cell lines. Copyright © 2017 Elsevier Inc. All rights reserved.

Developmental and social-ecological perspectives on children, political violence, and armed conflict.

PubMed

Cummings, E Mark; Merrilees, Christine E; Taylor, Laura K; Mondi, Christina F

2017-02-01

An increasing number of researchers and policymakers have been moved to study and intervene in the lives of children affected by violent conflicts (Masten, 2014). According to a United Nations Children's Fund (2009) report, over 1 billion children under the age of 18 are growing up in regions where acts of political violence and armed conflict are, as Ladds and Cairns (1996, p. 15) put it, "a common occurrence-a fact of life." In recent years, the United Nations Children's Fund, advocacy and human rights groups, journalists, and researchers have drawn public attention to the high rates of child casualties in these regions, and to the plights of those children still caught in the crossfire. It has thus become clear that both the challenges and the stakes are higher than ever to promote the safety and well-being of affected children around the world (Masten & Narayan, 2012; Tol, Jordans, Kohrt, Betancourt, & Komproe, 2012).

Particle swarm optimization based space debris surveillance network scheduling

NASA Astrophysics Data System (ADS)

Jiang, Hai; Liu, Jing; Cheng, Hao-Wen; Zhang, Yao

2017-02-01

The increasing number of space debris has created an orbital debris environment that poses increasing impact risks to existing space systems and human space flights. For the safety of in-orbit spacecrafts, we should optimally schedule surveillance tasks for the existing facilities to allocate resources in a manner that most significantly improves the ability to predict and detect events involving affected spacecrafts. This paper analyzes two criteria that mainly affect the performance of a scheduling scheme and introduces an artificial intelligence algorithm into the scheduling of tasks of the space debris surveillance network. A new scheduling algorithm based on the particle swarm optimization algorithm is proposed, which can be implemented in two different ways: individual optimization and joint optimization. Numerical experiments with multiple facilities and objects are conducted based on the proposed algorithm, and simulation results have demonstrated the effectiveness of the proposed algorithm.

Heat Recovery Incinerator-Equipment Selection and Plant Layout for Safety, Human Engineering and Maintainability.

DTIC Science & Technology

1984-10-01

16 4.2 Solid Waste Receiving and Storage Area ........................ 17 4.3 Equipment Location and Spacing...10OROS (Ccr4n-ifl. **,0d. d - -eet -.d tdonfffy by bltk -P-+) HRI, RAM, Human factors, HRI design, IRI safety, solid waste , energy recovery 10 AOSTNACT...health and safety hazards to individuals hand-sorting the conglomerate of solid waste , the potential of dangerous substances and inflammable or ex

Preclinical modeling highlights the therapeutic potential of hematopoietic stem cell gene editing for correction of SCID-X1.

PubMed

Schiroli, Giulia; Ferrari, Samuele; Conway, Anthony; Jacob, Aurelien; Capo, Valentina; Albano, Luisa; Plati, Tiziana; Castiello, Maria C; Sanvito, Francesca; Gennery, Andrew R; Bovolenta, Chiara; Palchaudhuri, Rahul; Scadden, David T; Holmes, Michael C; Villa, Anna; Sitia, Giovanni; Lombardo, Angelo; Genovese, Pietro; Naldini, Luigi

2017-10-11

Targeted genome editing in hematopoietic stem/progenitor cells (HSPCs) is an attractive strategy for treating immunohematological diseases. However, the limited efficiency of homology-directed editing in primitive HSPCs constrains the yield of corrected cells and might affect the feasibility and safety of clinical translation. These concerns need to be addressed in stringent preclinical models and overcome by developing more efficient editing methods. We generated a humanized X-linked severe combined immunodeficiency (SCID-X1) mouse model and evaluated the efficacy and safety of hematopoietic reconstitution from limited input of functional HSPCs, establishing thresholds for full correction upon different types of conditioning. Unexpectedly, conditioning before HSPC infusion was required to protect the mice from lymphoma developing when transplanting small numbers of progenitors. We then designed a one-size-fits-all IL2RG (interleukin-2 receptor common γ-chain) gene correction strategy and, using the same reagents suitable for correction of human HSPC, validated the edited human gene in the disease model in vivo, providing evidence of targeted gene editing in mouse HSPCs and demonstrating the functionality of the IL2RG -edited lymphoid progeny. Finally, we optimized editing reagents and protocol for human HSPCs and attained the threshold of IL2RG editing in long-term repopulating cells predicted to safely rescue the disease, using clinically relevant HSPC sources and highly specific zinc finger nucleases or CRISPR (clustered regularly interspaced short palindromic repeats)/Cas9 (CRISPR-associated protein 9). Overall, our work establishes the rationale and guiding principles for clinical translation of SCID-X1 gene editing and provides a framework for developing gene correction for other diseases. Copyright © 2017 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.

Health risks of genetically modified foods.

PubMed

Dona, Artemis; Arvanitoyannis, Ioannis S

2009-02-01

As genetically modified (GM) foods are starting to intrude in our diet concerns have been expressed regarding GM food safety. These concerns as well as the limitations of the procedures followed in the evaluation of their safety are presented. Animal toxicity studies with certain GM foods have shown that they may toxically affect several organs and systems. The review of these studies should not be conducted separately for each GM food, but according to the effects exerted on certain organs it may help us create a better picture of the possible health effects on human beings. The results of most studies with GM foods indicate that they may cause some common toxic effects such as hepatic, pancreatic, renal, or reproductive effects and may alter the hematological, biochemical, and immunologic parameters. However, many years of research with animals and clinical trials are required for this assessment. The use of recombinant GH or its expression in animals should be re-examined since it has been shown that it increases IGF-1 which may promote cancer.

Impact of Soil Heavy Metal Pollution on Food Safety in China.

PubMed

Zhang, Xiuying; Zhong, Taiyang; Liu, Lei; Ouyang, Xiaoying

2015-01-01

Food safety is a major concern for the Chinese public. This study collected 465 published papers on heavy metal pollution rates (the ratio of the samples exceeding the Grade II limits for Chinese soils, the Soil Environmental Quality Standard-1995) in farmland soil throughout China. The results showed that Cd had the highest pollution rate of 7.75%, followed by Hg, Cu, Ni and Zn, Pb and Cr had the lowest pollution rates at lower than 1%. The total pollution rate in Chinese farmland soil was 10.18%, mainly from Cd, Hg, Cu, and Ni. The human activities of mining and smelting, industry, irrigation by sewage, urban development, and fertilizer application released certain amounts of heavy metals into soil, which resulted in the farmland soil being polluted. Considering the spatial variations of grain production, about 13.86% of grain production was affected due to the heavy metal pollution in farmland soil. These results many provide valuable information for agricultural soil management and protection in China.

Impact of Soil Heavy Metal Pollution on Food Safety in China

PubMed Central

Zhang, Xiuying; Zhong, Taiyang; Liu, Lei; Ouyang, Xiaoying

2015-01-01

Food safety is a major concern for the Chinese public. This study collected 465 published papers on heavy metal pollution rates (the ratio of the samples exceeding the Grade II limits for Chinese soils, the Soil Environmental Quality Standard-1995) in farmland soil throughout China. The results showed that Cd had the highest pollution rate of 7.75%, followed by Hg, Cu, Ni and Zn, Pb and Cr had the lowest pollution rates at lower than 1%. The total pollution rate in Chinese farmland soil was 10.18%, mainly from Cd, Hg, Cu, and Ni. The human activities of mining and smelting, industry, irrigation by sewage, urban development, and fertilizer application released certain amounts of heavy metals into soil, which resulted in the farmland soil being polluted. Considering the spatial variations of grain production, about 13.86% of grain production was affected due to the heavy metal pollution in farmland soil. These results many provide valuable information for agricultural soil management and protection in China. PMID:26252956

Self-reported patient safety competence among Canadian medical students and postgraduate trainees: a cross-sectional survey.

PubMed

Doyle, Patricia; VanDenKerkhof, Elizabeth G; Edge, Dana S; Ginsburg, Liane; Goldstein, David H

2015-02-01

Quality and patient safety (PS) are critical components of medical education. This study reports on the self-reported PS competence of medical students and postgraduate trainees. The Health Professional Education in Patient Safety Survey was administered to medical students and postgraduate trainees in January 2012. PS dimension scores were compared across learning settings (classroom and clinical) and year in programme. Sixty-three percent (255/406) of medical students and 32% (141/436) of postgraduate trainees responded. In general, both groups were most confident in their learning of clinical safety skills (eg, hand hygiene) and least confident in learning about sociocultural aspects of safety (eg, understanding human factors). Medical students' confidence in most aspects of safety improved with years of training. For some of the more intangible dimensions (teamwork and culture), medical students in their final year had lower scores than students in earlier years. Thirty-eight percent of medical students felt they could approach someone engaging in unsafe practice, and the majority of medical students (85%) and postgraduate trainees (78%) agreed it was difficult to question authority. Our results suggest the need to improve the overall content, structure and integration of PS concepts in both classroom and clinical learning environments. Decreased confidence in sociocultural aspects of PS among medical students in the final year of training may indicate that culture in clinical settings negatively affects students' perceived PS competence. Alternatively, as medical students spend more time in the clinical setting, they may develop a clearer sense of what they do not know. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

78 FR 11237 - Public Hearing

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-15

... management of human error in its operations and system safety programs, and the status of PTC implementation... UP's safety management policies and programs associated with human error, operational accident and... Chairman of the Board of Inquiry 2. Introduction of the Board of Inquiry and Technical Panel 3...

21 CFR 172.105 - Anoxomer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200... incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200...

21 CFR 172.105 - Anoxomer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN... by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200... incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200...

78 FR 12065 - National Institute for Occupational Safety and Health Personal Protective Technology for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Personal Protective Technology for Pesticide Handlers... for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION...

42 CFR 85.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND... Occupational Safety and Health Act of 1970 or the Federal Mine Safety and Health Act of 1977 and not defined... Occupational Safety and Health Act of 1970 (29 U.S.C. 651, et seq.). FMSH Act means the Federal Mine Safety and...

42 CFR 85.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND... Occupational Safety and Health Act of 1970 or the Federal Mine Safety and Health Act of 1977 and not defined... Occupational Safety and Health Act of 1970 (29 U.S.C. 651, et seq.). FMSH Act means the Federal Mine Safety and...

75 FR 12554 - Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH... priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C...

42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of patient...

ESA Human rating Requirements:Status

NASA Astrophysics Data System (ADS)

Trujillo, M.; Sgobba, T.

2012-01-01

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

Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies.

PubMed

Brennan, Frank R; Baumann, Andreas; Blaich, Guenter; de Haan, Lolke; Fagg, Rajni; Kiessling, Andrea; Kronenberg, Sven; Locher, Mathias; Milton, Mark; Tibbitts, Jay; Ulrich, Peter; Weir, Lucinda

2015-10-01

Non-clinical safety testing of biopharmaceuticals can present significant challenges to human risk assessment with these often innovative and complex drugs. Hot Topics in this field were discussed recently at the 4th Annual European Biosafe General Membership meeting. In this feature article, the presentations and subsequent discussions from the main sessions are summarized. The topics covered include: (i) wanted versus unwanted immune activation, (ii) bi-specific protein scaffolds, (iii) use of Pharmacokinetic (PK)/Pharmacodynamic (PD) data to impact/optimize toxicology study design, (iv) cytokine release and challenges to human translation (v) safety testing of cell and gene therapies including chimeric antigen receptor T (CAR-T) cells and retroviral vectors and (vi) biopharmaceutical development strategies encompassing a range of diverse topics including optimizing entry of monoclonal antibodies (mAbs) into the brain, safety testing of therapeutic vaccines, non-clinical testing of biosimilars, infection in toxicology studies with immunomodulators and challenges to human risk assessment, maternal and infant anti-drug antibody (ADA) development and impact in non-human primate (NHP) developmental toxicity studies, and a summary of an NC3Rs workshop on the future vision for non-clinical safety assessment of biopharmaceuticals. Copyright © 2015 Elsevier Inc. All rights reserved.

77 FR 14838 - General Electric-Hitachi Global Laser Enrichment LLC, Commercial Laser-Based Uranium Enrichment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

... safety, chemical process safety, fire safety, emergency management, environmental protection... the transportation of SNM of low strategic significance, human factors engineering, and electrical...

Restoration of Ecological Infrastructure in Rural Areas after Earthquake – A Case Study from Dujiangyan, Sichuan Province

NASA Astrophysics Data System (ADS)

Fu, Fei

2018-05-01

After Wenchuan and Lushan earthquake, the experience of Sichuan reconstruction planning is an important sample of agricultural village human settlements safety and regional ecological environment restoration. This paper combines the experience of the reconstruction of Dujiangyan after the Wenchuan earthquake - that is, the concept of sustainable ecological restoration as well as the concept of regional ecological restoration, and the post-disaster recovery study on Ya'an Zhougongshan Chengqing Temple and the surrounding environment after Lushan earthquake, trying to integrate into the process of post - disaster ecological restoration. Through a comprehensive assessment of the thinking on the regional scale issues and the impact of rural ecological infrastructure, we proposed macro-cognitive and multi-level measures of ecological restoration projects in order to provide effective methods to restore regional ecological environment and reconstruct sustainable human settlements in affected areas in the latest Jiuzhaigou earthquake.

Examining the Gap between Science and Public Opinion about Genetically Modified Food and Global Warming.

PubMed

McFadden, Brandon R

2016-01-01

There is great uncertainty due to challenges of escalating population growth and climate change. Public perception that diverges from the scientific community may decrease the effectiveness of scientific inquiry and innovation as tools to solve these challenges. The objective of this study was to identify the factors associated with the divergence of public opinion from scientific consensus regarding the safety of genetically modified (GM) foods and human involvement in global warming (GW). Results indicate that the effects of knowledge on public opinion are complex and non-uniform across types of knowledge (i.e., perceived and actual) or issues. Political affiliation affects agreement with science; Democrats were more likely to agree that GM food is safe and human actions cause GW. Respondents who had relatively higher cognitive function or held illusionary correlations about GM food or GW were more likely to have an opinion that differed from the scientific community.

Examining the Gap between Science and Public Opinion about Genetically Modified Food and Global Warming

PubMed Central

McFadden, Brandon R.

2016-01-01

There is great uncertainty due to challenges of escalating population growth and climate change. Public perception that diverges from the scientific community may decrease the effectiveness of scientific inquiry and innovation as tools to solve these challenges. The objective of this study was to identify the factors associated with the divergence of public opinion from scientific consensus regarding the safety of genetically modified (GM) foods and human involvement in global warming (GW). Results indicate that the effects of knowledge on public opinion are complex and non-uniform across types of knowledge (i.e., perceived and actual) or issues. Political affiliation affects agreement with science; Democrats were more likely to agree that GM food is safe and human actions cause GW. Respondents who had relatively higher cognitive function or held illusionary correlations about GM food or GW were more likely to have an opinion that differed from the scientific community. PMID:27829008

Is conflict of interest becoming a challenge for institution-based institutional review boards?

PubMed

Freedman, Ralph S; McKinney, Ross

2013-08-01

Expansion of business relationships between academic institutions and their leaders and industry have become a reality, whereas media attention regarding conflict of interest (COI) at academic institutions has raised concerns about possible erosion of public trust. The Institutional Review Board (IRB) should collaborate with institutional COI committees to ensure that research with human subjects is in compliance with various applicable federal regulations. The IRB and COI committee should take additional independent action as necessary under their separate mandates to protect the welfare, safety, and rights of human subjects and to include limits on protocols affected by significant financial interests of the institution or its decision makers. If unable to review research due to an intrainstitutional conflict, the local IRB should consider transferring the study review and oversight to an external unaffiliated institutional or central IRB. A process for involvement of an executive institutional IRB is proposed. ©2013 AACR.

Bioseguridad in Mexico: Pursuing Security between Local and Global Biologies.

PubMed

Wanderer, Emily Mannix

2017-09-01

In the aftermath of the 2009 outbreak of H1N1 influenza, scientists in Mexico sought to develop bioseguridad, that is, to protect biological life in Mexico by safely conducting research on infectious disease. Drawing on ethnographic research in laboratories and with scientists in Mexico, I look at how scientists make claims about local differences in regulations, infrastructure, bodies, and culture. The scientists working with infectious microbes sought to establish how different microbial ecologies, human immune systems, and political and regulatory systems made the risks of research different in Mexico from other countries. In developing bioseguridad, the idea of globalized biology that animates many public health projects was undermined as scientists attended to the elements of place that affected human health and safety. Scientists argued for the importance of local biologies, generating tension with global public health projects and regulations premised on the universality of biology. © 2016 by the American Anthropological Association.

48 CFR 623.302-70 - Policy.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE... affects the safety and/or health of post personnel, including the handling of hazardous materials, shall comply with the applicable requirements of the Department of State Safety/Health and Environmental...

48 CFR 623.302-70 - Policy.

Code of Federal Regulations, 2012 CFR

2012-10-01

... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE... affects the safety and/or health of post personnel, including the handling of hazardous materials, shall comply with the applicable requirements of the Department of State Safety/Health and Environmental...

29 CFR 1910.4 - Amendments to this part.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS General § 1910.4 Amendments to this part. (a) The Assistant Secretary... protection of the safety or health of the affected employees. ...

29 CFR 1910.4 - Amendments to this part.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS General § 1910.4 Amendments to this part. (a) The Assistant Secretary... protection of the safety or health of the affected employees. ...

29 CFR 1960.34 - General provisions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED... affecting Federal employee safety and health. Both agencies shall establish and publish a joint procedure...

Integrating Safety in the Aviation System: Interdepartmental Training for Pilots and Maintenance Technicians

NASA Technical Reports Server (NTRS)

Mattson, Marifran; Petrin, Donald A.; Young, John P.

2001-01-01

The study of human factors has had a decisive impact on the aviation industry. However, the entire aviation system often is not considered in researching, training, and evaluating human factors issues especially with regard to safety. In both conceptual and practical terms, we argue for the proactive management of human error from both an individual and organizational systems perspective. The results of a multidisciplinary research project incorporating survey data from professional pilots and maintenance technicians and an exploratory study integrating students from relevant disciplines are reported. Survey findings suggest that latent safety errors may occur during the maintenance discrepancy reporting process because pilots and maintenance technicians do not effectively interact with one another. The importance of interdepartmental or cross-disciplinary training for decreasing these errors and increasing safety is discussed as a primary implication.

78 FR 6819 - Patient Safety Organizations: Voluntary Relinquishment From The Connecticut Hospital Association...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

..., Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From The Connecticut Hospital Association Federal Patient Safety...

Human Spaceflight Safety Hearing

NASA Image and Video Library

2009-12-02

U.S. Rep. Gabrielle Giffords, D-Ariz., left, speaks with reitred astronaut Lt. Gen. Thomas Stafford prior to the start of a hearing before the House Subcommitte on Space and Aeronautics regarding Safety of Human Spaceflight on Capitol Hill, Wednesday, Dec. 2, 2009, in Washington. Photo Credit: (NASA/Bill Ingalls)

45 CFR 1321.75 - Licenses and safety.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false Licenses and safety. 1321.75 Section 1321.75 Public Welfare Regulations Relating to Public Welfare (Continued) OFFICE OF HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO STATE...

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

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

Psychology in nuclear power plants: an integrative approach to safety - general statement

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

Shikiar, R.

Since the accident at the Three Mile Island nuclear power plant on March 28, 1979, the commercial nuclear industry in the United States has paid increasing attention to the role of humans in overall plant safety. As the regulatory body with primary responsibility for ensuring public health and safety involving nuclear operations, the United States Nuclear Regulatory Commission (NRC) has also become increasingly involved with the ''human'' side of nuclear operations. The purpose of this symposium is to describe a major program of research and technical assistance that the Pacific Northwest Laboratory is performing for the NRC that deals withmore » the issues of safety at nuclear power plants (NPPs). This program addresses safety from several different levels of analysis, which are all important within the context of an integrative approach to system safety.« less

Does lactobionic acid affect the colloidal structure and skin moisturizing potential of the alkyl polyglucoside-based emulsion systems?

PubMed

Tasic-Kostov, M Z; Reichl, S; Lukic, M Z; Jaksic, I N; Savic, S D

2011-11-01

Moisturizing creams are the most prescribed products in dermatology, essential in maintaining healthy skin as well as in the topical treatment of some diseases. The irritation potential of commonly used emulsifiers and moisturizing ingredients, but also their mutual interactions, could affect the functionality and safety of those dermopharmaceutics. The aim of this study was to promote moisturizing alkyl polyglucoside (APG)-based emulsion as vehicle for lactobionic acid (LA), advantageous representative of the alphahydroxyacids (AHAs)-multifunctional moisturizers, assessing the safety for use (in vitro acute skin irritation test using cytotoxicity assay compared with in vivo data obtained using skin bioengineering methods) and in vivo moisturizing capacity (bioengineering of the skin). In order to investigate possible interactions between APG mild natural emulsifier-based emulsion and LA, a deeper insight into the colloidal structure of the placebo and the emulsion with LA was given using polarization and transmission electron microscopy, rheology, thermal and texture analysis. This study showed that APG-based emulsions could be promoted as safe cosmetic/dermopharmaceutical vehicles and carriers for extremely acidic and hygroscopic AHA class of actives (specifically LA); prospective safety for human use of both APG and LA with the correlation between in vivo and in vitro findings was shown. However, it was revealed that LA strongly influenced the colloidal structure of the emulsion based on APGs and promoted the formation of lamellar structures which reflects onto the mode of water distribution within the cream. The advantageous skin hydrating potential of LA-containing emulsion vs. placebo was unlikely to be achieved, pointing that emulsions stabilized by lamellar liquid crystalline structures probably are not satisfying carriers for highly hygroscopic actives in order to reach the full moisturizing potential. Safe and effective use on dry skin is presumed.

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

Code of Federal Regulations, 2013 CFR

2013-07-01

... about safety and environmental pollution; and(2) Ability to request the company's help when necessary... requirements (a) Safety and environmental policy statements (1) Meet the objectives of § 96.230; and(2) Are... and affecting the safety and pollution prevention operations of the company and vessel(s); and (4) A...

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

Code of Federal Regulations, 2014 CFR

2014-07-01

... about safety and environmental pollution; and(2) Ability to request the company's help when necessary... requirements (a) Safety and environmental policy statements (1) Meet the objectives of § 96.230; and(2) Are... and affecting the safety and pollution prevention operations of the company and vessel(s); and (4) A...

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

Code of Federal Regulations, 2011 CFR

2011-07-01

... about safety and environmental pollution; and(2) Ability to request the company's help when necessary... requirements (a) Safety and environmental policy statements (1) Meet the objectives of § 96.230; and(2) Are... and affecting the safety and pollution prevention operations of the company and vessel(s); and (4) A...

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

Code of Federal Regulations, 2012 CFR

2012-07-01

... about safety and environmental pollution; and(2) Ability to request the company's help when necessary... requirements (a) Safety and environmental policy statements (1) Meet the objectives of § 96.230; and(2) Are... and affecting the safety and pollution prevention operations of the company and vessel(s); and (4) A...

An in vitro approach for comparative interspecies metabolism of agrochemicals.

PubMed

Whalley, Paul M; Bartels, Michael; Bentley, Karin S; Corvaro, Marco; Funk, Dorothee; Himmelstein, Matthew W; Neumann, Birgit; Strupp, Christian; Zhang, Fagen; Mehta, Jyotigna

2017-08-01

The metabolism and elimination of a xenobiotic has a direct bearing on its potential to cause toxicity in an organism. The confidence with which data from safety studies can be extrapolated to humans depends, among other factors, upon knowing whether humans are systemically exposed to the same chemical entities (i.e. a parent compound and its metabolites) as the laboratory animals used to study toxicity. Ideally, to understand a metabolite in terms of safety, both the chemical structure and the systemic exposure would need to be determined. However, as systemic exposure data (i.e. blood concentration/time data of test material or metabolites) in humans will not be available for agrochemicals, an in vitro approach must be taken. This paper outlines an in vitro experimental approach for evaluating interspecies metabolic comparisons between humans and animal species used in safety studies. The aim is to ensure, where possible, that all potential human metabolites are also present in the species used in the safety studies. If a metabolite is only observed in human in vitro samples and is not present in a metabolic pathway defined in the toxicological species already, the toxicological relevance of this metabolite must be evaluated. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A risk assessment of topical tretinoin as a potential human developmental toxin based on animal and comparative human data.

PubMed

Johnson, E M

1997-03-01

Although topically applied all-trans-retinoic acid (tretinoin) undergoes minimal absorption and adds negligibly to normal endogenous levels, its safety in humans is occasionally questioned because oral ingestion of retinoids at therapeutic levels is known to entail teratogenic risks. To assess the actual potential for developmental toxicity from treatment with topical tretinoin. Risk assessments were conducted on four known human developmental toxicants (valproic acid, methotrexate, thalidomide, and isotretinoin) and a potential developmental toxicant (acetylsalicylic acid). The margin of safety for each chemical was calculated from the ratio of animal no-observed adverse effect levels to human lowest-observed adverse effect levels or estimated exposure doses. The derived safety margin of more than 100 for topical tretinoin (with 2% absorption) contrasted sharply with the near unity values for valproic acid, methotrexate, thalidomide, and isotretinoin and was larger than that for acetylsalicylic acid. These data support other epidemiologic and animal data that topical tretinoin is not a potential human developmental toxicant.

14 CFR 431.33 - Safety organization.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Safety organization. 431.33 Section 431.33 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... for all mission decisions that may affect public safety. Lines of communication within the applicant's...

14 CFR 431.33 - Safety organization.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Safety organization. 431.33 Section 431.33 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... for all mission decisions that may affect public safety. Lines of communication within the applicant's...

14 CFR 431.33 - Safety organization.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Safety organization. 431.33 Section 431.33 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... for all mission decisions that may affect public safety. Lines of communication within the applicant's...

The Influence of Laboratory Safety on Capital Planning.

ERIC Educational Resources Information Center

Francis, Robert A.

1980-01-01

Discusses state and federal legislation concerning the handling of dangerous materials and its impact on the design of college and university buildings. Lists federal legislation affecting laboratory safety, the objectives of each act, and the influence of each act on laboratory safety. (IRT)

Characterizing and enhancing the safety of future plastic and composite intensive vehicles (PCIVs).

DOT National Transportation Integrated Search

2009-01-01

There is concern that a trend toward smaller, lighter, fuel-efficient vehicles could adversely affect overall fleet safety. Since 2006, the U.S. Congress has directed the National Highway Traffic Safety Administration to examine the possible safet...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

42 CFR 85a.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT § 85a.2 Definitions. Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and...

Ecological Threshold for Toxicological Concern (eco-TTC): exploring the importance of non-standard species

EPA Science Inventory

The Threshold for Toxicological Concern (TTC) is well-established for assessing human safety of indirect food-contact substances and has been applied to a variety of endpoints. Recently, we have proposed an extension to the human safety TTC concept for environmental applications,...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

Pesticide Ingredients

Science.gov Websites

; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife Ingredients Low-Risk Pesticides Organic Pesticide Ingredients Pesticide Incidents Human Exposure Pet Exposure Fact Sheets Types of Pesticides Pest Control Information Pesticide Health and Safety Information

2009 Human Factors and Roadway Safety Workshop : Context and Objectives [SD .WMV (720x480/29fps/37.3 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: Context and Objectives : Mark Lowe, director, Iowa DOT Motor Vehicle Division, speaks on the d...

21 CFR 184.1472 - Menhaden oil.

Code of Federal Regulations, 2010 CFR

2010-04-01

... available from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-200... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Menhaden oil. 184.1472 Section 184.1472 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN...

75 FR 12688 - Safety Zone; Gallants Channel, Beaufort, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-17

... immediate action is needed to ensure the safety of human life and property from the hazards of falling... life and property on navigable waters and due to the hazards associated with potential falling debris... which do not individually or cumulatively have a significant effect on the human environment. This rule...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2010 CFR

2010-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2013 CFR

2013-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2011 CFR

2011-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2014 CFR

2014-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

21 CFR 312.88 - Safeguards for patient safety.

Code of Federal Regulations, 2012 CFR

2012-04-01

... initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Safeguards for patient safety. 312.88 Section 312.88 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

Food Guide Pagoda and the food safety of women: one-year follow-up study on the effects of the 2008 Sichuan Earthquake.

PubMed

Xu, Xianglong; Li, Bing; Bai, Ruixue; Rao, Yunshuang; Liu, Lingli; Reis, Cesar; Sharma, Manoj; Zhao, Yong

2018-01-01

Women are a dominant force in the family's diet and nutrition in China. The shortterm effects of the 2008 Sichuan Earthquake were found. However, the long-term effects of the 2008 Sichuan Earthquake on the food safety, energy, and intake frequency of women remain unclear. This study analyzed the effects of the 2008 Sichuan Earthquake on the dietary behaviors of women one year after the earthquake. In this cross-sectional study, a total of 207 women were selected using the proportional sampling method. Among them, 91 were from the earthquake-affected area and 116 were from the non-affected area. Women from the earthquake-affected area paid significantly more attention to health, diet, food and water safety after the earthquake (p<0.05 for each category) when compared with those from the non-affected area. Women from the earthquake-affected area also had a significantly higher proportion of adequate understanding of low-energy food, properly separated their raw food from cooked food, ate high-energy food, and picky eating habits (p<0.05 for each category) than those from the non-affected area. In addition, women from the earthquake-affected area were more likely to adhere to the 2007 Chinese Food Guide Pagoda (FGP) guidelines for eating rice than those from the non-affected area (OR=2.25, 95% CI [1.13, 4.51]). The female survivors of the 2008 Sichuan Earthquake preferred high-energy food, paid more attention to food safety, and were more likely to adhere to FGP when compared to those that did not undergo the same tragedy.

Model-based safety analysis of human-robot interactions: the MIRAS walking assistance robot.

PubMed

Guiochet, Jérémie; Hoang, Quynh Anh Do; Kaaniche, Mohamed; Powell, David

2013-06-01

Robotic systems have to cope with various execution environments while guaranteeing safety, and in particular when they interact with humans during rehabilitation tasks. These systems are often critical since their failure can lead to human injury or even death. However, such systems are difficult to validate due to their high complexity and the fact that they operate within complex, variable and uncertain environments (including users), in which it is difficult to foresee all possible system behaviors. Because of the complexity of human-robot interactions, rigorous and systematic approaches are needed to assist the developers in the identification of significant threats and the implementation of efficient protection mechanisms, and in the elaboration of a sound argumentation to justify the level of safety that can be achieved by the system. For threat identification, we propose a method called HAZOP-UML based on a risk analysis technique adapted to system description models, focusing on human-robot interaction models. The output of this step is then injected in a structured safety argumentation using the GSN graphical notation. Those approaches have been successfully applied to the development of a walking assistant robot which is now in clinical validation.

Evaluating Models of Human Performance: Safety-Critical Systems Applications

NASA Technical Reports Server (NTRS)

Feary, Michael S.

2012-01-01

This presentation is part of panel discussion on Evaluating Models of Human Performance. The purpose of this panel is to discuss the increasing use of models in the world today and specifically focus on how to describe and evaluate models of human performance. My presentation will focus on discussions of generating distributions of performance, and the evaluation of different strategies for humans performing tasks with mixed initiative (Human-Automation) systems. I will also discuss issues with how to provide Human Performance modeling data to support decisions on acceptability and tradeoffs in the design of safety critical systems. I will conclude with challenges for the future.

Safety through Education and Training.

ERIC Educational Resources Information Center

Thorburn, S.

1990-01-01

Addresses the need for safety education as a continuous process through elementary and secondary phases of education in the context of human risk within modern society. Discusses the teaching of safety subjects in civil engineering curriculum. (YP)

Risk Management in the Human Spaceflight Program

NASA Technical Reports Server (NTRS)

Hoffman, William

2009-01-01

The contents include:1) NASA Mission and Organization; 2) Major Mission Failures and Causes; 3) Cultural Changes Resulting from Failures; 3) Safety at NASA Today; 4) Best Safety Practices; 5) Safety Challenges; and 6) Future Commitment.

Microgravity, stem cells, and embryonic development: challenges and opportunities for 3D tissue generation

NASA Astrophysics Data System (ADS)

Andreazzoli, Massimiliano; Angeloni, Debora; Broccoli, Vania; Demontis, Gian C.

2017-04-01

Space is a challenging environment for the human body, due to the combined effects of reduced gravity (microgravity) and cosmic radiation. Known effects of microgravity range from the blood redistribution that affects the cardiovascular system and the eye to muscle wasting, bone loss, anemia and immune depression. About cosmic radiation, the shielding provided by the spaceship hull is far less efficient than that afforded at ground level by the combined effects of the Earth atmosphere and magnetic field. The eye and its nervous layer (the retina) are affected by both microgravity and heavy ions exposure. Considering the importance of sight for long-term manned flights, visual research aimed at devising measures to protect the eye from environmental conditions of the outer space represents a special challenge to meet. In this review we focus on the impact of microgravity on embryonic development, discussing the roles of mechanical forces in the context of the neutral buoyancy the embryo experiences in the womb. At variance with its adverse effects on the adult human body, simulated microgravity may provide a unique tool for understanding the biomechanical events involved in the development and assembly in vitro of three-dimensional (3D) ocular tissues. Prospective benefits are the development of novel safety measures to protect the human eye from cosmic radiation in microgravity during long-term manned spaceflights in the outer space, as well as the generation of human 3D-retinas with its supporting structures to develop innovative and effective therapeutic options for degenerative eye diseases.

Chitosan Dilutable and Dilactin Forte: Assessment of Their Efficiency for Safety and Quality of Foodstuff

NASA Astrophysics Data System (ADS)

Iurchikova, N.; Khlebosolova, O.

2018-01-01

The modern natural food preservatives used to process and store foodstuff allow to ensure its safety and high quality. Chitosan and dilactin-forte are among such medicines. These preservatives are not only safe, but also are beneficial to a human body in virtue of their effects onto human digestive system. The article describes the results of the research conducted to identify the impact of these natural preservatives on safety of carrot (Daucus carota subsp. sativus)

Sociotechnical attributes of safe and unsafe work systems.

PubMed

Kleiner, Brian M; Hettinger, Lawrence J; DeJoy, David M; Huang, Yuang-Hsiang; Love, Peter E D

2015-01-01

Theoretical and practical approaches to safety based on sociotechnical systems principles place heavy emphasis on the intersections between social-organisational and technical-work process factors. Within this perspective, work system design emphasises factors such as the joint optimisation of social and technical processes, a focus on reliable human-system performance and safety metrics as design and analysis criteria, the maintenance of a realistic and consistent set of safety objectives and policies, and regular access to the expertise and input of workers. We discuss three current approaches to the analysis and design of complex sociotechnical systems: human-systems integration, macroergonomics and safety climate. Each approach emphasises key sociotechnical systems themes, and each prescribes a more holistic perspective on work systems than do traditional theories and methods. We contrast these perspectives with historical precedents such as system safety and traditional human factors and ergonomics, and describe potential future directions for their application in research and practice. The identification of factors that can reliably distinguish between safe and unsafe work systems is an important concern for ergonomists and other safety professionals. This paper presents a variety of sociotechnical systems perspectives on intersections between social--organisational and technology--work process factors as they impact work system analysis, design and operation.

Potential safety benefits of intelligent cruise control systems.

PubMed

Chira-Chavala, T; Yoo, S M

1994-04-01

Potential safety impact of a hypothetical intelligent cruise control system (ICCS) is evaluated in terms of changes in traffic accidents and some traffic operation characteristics affecting safety. The analysis of changes in traffic accidents is accomplished by in-depth examinations of police accident reports for four major counties in California. The evaluation of changes in traffic operation characteristics affecting safety is accomplished by vehicle simulation. The accident analysis reveals that the use of the hypothetical ICCS could potentially reduce traffic accidents by up to 7.5%. Preliminary vehicle simulation results based on a 10-vehicle convoy indicate that the use of the hypothetical ICCS could reduce frequencies of hard acceleration and deceleration, enhance speed harmonization among vehicles, and reduce incidence of "less-safe" headway.

The Impact of Participatory Safety Rules Revision on Incident Rates, Liability Claims, and Safety Culture in the U.S. Railroad Industry

DOT National Transportation Integrated Search

2007-07-01

The Federal Railroad Administration Human Factors Research and Development Program sponsored a lessons learned study to examine the impact of safety rules revision on safety culture, incident rates, and liability claims in the railroad industry. Safe...

78 FR 6819 - Patient Safety Organizations: Voluntary Relinquishment From the BREF PSO

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

..., Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... (AHRQ), HHS. ACTION: Notice of delisting. SUMMARY: The Patient Safety and Quality Improvement Act of...

42 CFR 3.208 - Continued protection of patient safety work product.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Continued protection of patient safety work product. 3.208 Section 3.208 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and...

Professional Preparation for Careers in Safety.

ERIC Educational Resources Information Center

Della-Giustina, Daniel

There has been a long existing need for individuals with extensive training and concentration in safety studies. The foundation areas upon which a curriculum for training safety practitioners is based should include: (1) trends in accident prevention and control; (2) safety analysis of human and machine tasks; (3) hazard identification and control…

78 FR 64504 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or..., Number 177, Pages 56235-56236. Contact Person for More Information: Price Connor, Ph.D., NIOSH Health...

Safety of capsule endoscopy using human body communication in patients with cardiac devices.

PubMed

Chung, Joo Won; Hwang, Hye Jin; Chung, Moon Jae; Park, Jeong Youp; Pak, Hui-Nam; Song, Si Young

2012-06-01

The MiroCam (IntroMedic, Ltd., Seoul, Korea) is a small-bowel capsule endoscope that uses human body communication to transmit data. The potential interactions between cardiac devices and the capsule endoscope are causes for concern, but no data are available for this matter. This clinical study was designed to evaluate the potential influence of the MiroCam capsules on cardiac devices. Patients with cardiac pacemakers or implantable cardiac defibrillators referred for evaluation of small bowel disease were prospectively enrolled in this study. Before capsule endoscopy, a cardiologist checked baseline electrocardiograms and functions of the cardiac devices. Cardiac rhythms were continuously monitored by 24-h telemetry during capsule endoscopy in the hospital. After completion of procedures, functions of the cardiac devices were checked again for interference. Images from the capsule endoscopy were reviewed and analyzed for technical problems. Six patients, three with pacemakers and three with implantable cardiac defibrillators, were included in the study. We identified no disturbances in the cardiac devices and no arrhythmias detected on telemetry monitoring during capsule endoscopy. No significant changes in the programmed parameters of the cardiac devices were noted after capsule endoscopy. There were no imaging disturbances from the cardiac devices on capsule endoscopy. Capsule endoscopy using human body communication to transmit data was safely performed in patients with cardiac pacemakers or implantable cardiac defibrillators. Images from the capsule endoscopy were not affected by cardiac devices. A further large-scale study is required to confirm the safety of capsule endoscopy with various types of cardiac devices.

An examination of the comfort and convenience of 1979 safety belt systems

DOT National Transportation Integrated Search

1979-01-01

The study examines the comfort and convenience aspects of safety belt systems in 1979 model cars and the user and system characteristics which affect safety belt comfort and convenience. The test design required that each of 114 test participants sit...

Operational and safety characteristics of lane widths : final report.

DOT National Transportation Integrated Search

2015-01-15

The primary goal of this study was to investigate and assess the effect of lane widths on the safety and : operation of highways in South Carolina. Because of the many site conditions that affect safety and : operations on roadways, this type of rese...

29 CFR 1910.5 - Applicability of standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS General § 1910.5 Applicability of standards. (a) Except as provided in... enforce standards or regulations affecting occupational safety or health. (c)(1) If a particular standard...

29 CFR 1910.5 - Applicability of standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS General § 1910.5 Applicability of standards. (a) Except as provided in... enforce standards or regulations affecting occupational safety or health. (c)(1) If a particular standard...