Sample records for achieve product safety

  1. Achieving Safety through Security Management

    NASA Astrophysics Data System (ADS)

    Ridgway, John

    Whilst the achievement of safety objectives may not be possible purely through the administration of an effective Information Security Management System (ISMS), your job as safety manager will be significantly eased if such a system is in place. This paper seeks to illustrate the point by drawing a comparison between two of the prominent standards within the two disciplines of security and safety management.

  2. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... document, which addresses safety achieved through drug product design, is the first in a series of planned...] Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors... Considerations for Product Design to Minimize Medication Errors.'' The draft guidance provides sponsors of...

  3. Safety issues with herbal products.

    PubMed

    Marrone, C M

    1999-12-01

    To review safety issues associated with the use of herbal products. Literature accessed through MEDLINE and other Internet search engines. Key search terms included herbs, dietary supplements, and safety. A misconception exists among consumers that herbal remedies are safe because they are natural. In an effort to provide healthcare practitioners with information necessary for a patient discussion, a review of safety concerns with herbal products was conducted. Several safety concerns exist with herbal products including lack of safety data, absence of quality-control requirements for potency and purity, and lenient labeling standards.

  4. Expert Consensus Statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation (VNRBD).

    PubMed

    2012-11-01

    All countries face challenges in making sufficient supplies of blood and blood products available and sustainable, while also ensuring the quality and safety of these products in the face of known and emerging threats to public health. Since 1975, the World Health Assembly (WHA) has highlighted the global need for blood safety and availability. WHA resolutions 63·12, 58·13 and 28·72, The Melbourne Declaration on 100% Voluntary Non-Remunerated Donation of Blood and Blood Components and WHO Global Blood Safety Network recommendations have reaffirmed the achievement of 'Self-sufficiency in blood and blood products based on voluntary non-remunerated blood donation (VNRBD)' as the important national policy direction for ensuring a safe, secure and sufficient supply of blood and blood products, including labile blood components and plasma-derived medicinal products. Despite some successes, self-sufficiency is not yet a reality in many countries. A consultation of experts, convened by the World Health Organization (WHO) in September 2011 in Geneva, Switzerland, addressed the urgent need to establish strategies and mechanisms for achieving self-sufficiency. Information on the current situation, and country perspectives and experiences were shared. Factors influencing the global implementation of self-sufficiency, including safety, ethics, security and sustainability of supply, trade and its potential impact on public health, availability and access for patients, were analysed to define strategies and mechanisms and provide practical guidance on achieving self-sufficiency. Experts developed a consensus statement outlining the rationale and definition of self-sufficiency in safe blood and blood products based on VNRBD and made recommendations to national health authorities and WHO. © 2012 World Health Organization. Vox Sanguinis © 2012 International Society of Blood Transfusion.

  5. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains several...

  6. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains several...

  7. Achievements and challenges of Space Station Freedom's safety review process

    NASA Technical Reports Server (NTRS)

    Robinson, David W.

    1993-01-01

    The most complex space vehicle in history, Space Station Freedom, is well underway to completion, and System Safety is a vital part of the program. The purpose is to summarize and illustrate the progress that over one-hundred System Safety engineers have made in identifying, documenting, and controlling the hazards inherent in the space station. To date, Space Station Freedom has been reviewed by NASA's safety panels through the first six assembly flights, when Freedom achieves a configuration known as Man Tended Capability. During the eight weeks of safety reviews spread out over a year and a half, over 200 preliminary hazard reports were presented. Along the way NASA and its contractors faced many challenges, made much progress, and even learned a few lessons.

  8. Achievements and challenges of Space Station Freedom's safety review process

    NASA Astrophysics Data System (ADS)

    Robinson, David W.

    1993-07-01

    The most complex space vehicle in history, Space Station Freedom, is well underway to completion, and System Safety is a vital part of the program. The purpose is to summarize and illustrate the progress that over one-hundred System Safety engineers have made in identifying, documenting, and controlling the hazards inherent in the space station. To date, Space Station Freedom has been reviewed by NASA's safety panels through the first six assembly flights, when Freedom achieves a configuration known as Man Tended Capability. During the eight weeks of safety reviews spread out over a year and a half, over 200 preliminary hazard reports were presented. Along the way NASA and its contractors faced many challenges, made much progress, and even learned a few lessons.

  9. Monitoring product safety in the postmarketing environment.

    PubMed

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

  10. Perceived School and Neighborhood Safety, Neighborhood Violence and Academic Achievement in Urban School Children

    PubMed Central

    AJ, Milam; CDM, Furr-Holden; PJ, Leaf

    2010-01-01

    Community and school violence continue to be a major public health problem, especially among urban children and adolescents. Little research has focused on the effect of school safety and neighborhood violence on academic performance. This study examines the effect of the school and neighborhood climate on academic achievement among a population of 3rd-5th grade students in an urban public school system. Community and school safety were assessed using the School Climate Survey, an annual city-wide assessment of student’s perception of school and community safety. Community violence was measured using the Neighborhood Inventory for Environmental Typology, an objective observational assessment of neighborhood characteristics. Academic achievement was measured using the Maryland State Assessment (MSA), a standardized exam given to all Maryland 3rd-8th graders. School Climate Data and MSA data were aggregated by school and grade. Objective assessments of neighborhood environment and students’ self-reported school and neighborhood safety were both strongly associated with academic performance. Increasing neighborhood violence was associated with statistically significant decreases from 4.2%-8.7% in math and reading achievement; increasing perceived safety was associated with significant increases in achievement from 16%-22%. These preliminary findings highlight the adverse impact of perceived safety and community violence exposure on primary school children’s academic performance. PMID:21197388

  11. 16 CFR 1115.8 - Compliance with product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... applicable mandatory consumer product safety standards and to report to the Commission any products which do.... 1115.8 Section 1115.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SUBSTANTIAL PRODUCT HAZARD REPORTS General Interpretation § 1115.8 Compliance with...

  12. 42 CFR 3.204 - Privilege 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 Privilege of patient safety work product. 3.204... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.204 Privilege of patient safety work product. (a) Privilege...

  13. Consumer product safety: A systems problem

    NASA Technical Reports Server (NTRS)

    Clark, C. C.

    1971-01-01

    The manufacturer, tester, retailer, consumer, repairer disposer, trade and professional associations, national and international standards bodies, and governments in several roles are all involved in consumer product safety. A preliminary analysis, drawing on system safety techniques, is utilized to distinguish the inter-relations of these many groups and the responsibilities that they are or could take for product safety, including the slow accident hazards as well as the more commonly discussed fast accident hazards. The importance of interactive computer aided information flow among these groups is particularly stressed.

  14. The perceived compatibility of safety and production expectations in hazardous occupations.

    PubMed

    McLain, David L; Jarrell, Kimberly A

    2007-01-01

    Safety hazards are unavoidable in many work environments. Employees must be both productive and safe, however, conflicting safety and production demands can negatively affect safety, production, or both. The employee's perception of the compatibility of management's safety and production expectations is a possible predictor of such consequences. This paper defines "safety-production compatibility" and describes how measures of safety-production compatibility, as well as safety pressure and production pressure, were developed. We used LISREL structural equation modeling to test the influences of safety-production compatibility, safety pressure, and production pressure on safe work behavior and interference with performing other work tasks. The 239 study participants were workers employed in diverse but hazardous occupations. Pressure to work safely was positively associated with safe work behavior. The perceived compatibility of safety and production demands positively influenced safe work behavior and reduced the interference of safety hazards performing other tasks. Safety-production compatibility was also found to mediate the relationship between trust in management and safe work behavior. The results of this field study suggest increased compatibility, and thus less conflict, between safety and production demands influences safe work behavior and the interference of safety hazards with performing other work tasks. More broadly, the worker's reaction to multiple work demands is a safety and performance influence. Safety management efforts that focus only on the hazards fail to eliminate many accidents because accidents arise from many factors including technology, safety climate, social influences, production, and safety demands. This study suggests that workers differ in their perception of the compatibility of safety and production demands. These differences will show up in safe work behavior, influencing the effectiveness of safety management efforts and the

  15. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... patient safety work product for the purpose of evaluating the quality, safety, or effectiveness of that... 42 Public Health 1 2012-10-01 2012-10-01 false Confidentiality of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege...

  16. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... patient safety work product for the purpose of evaluating the quality, safety, or effectiveness of that... 42 Public Health 1 2013-10-01 2013-10-01 false Confidentiality of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege...

  17. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... patient safety work product for the purpose of evaluating the quality, safety, or effectiveness of that... 42 Public Health 1 2014-10-01 2014-10-01 false Confidentiality of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege...

  18. Evaluation of Safety, Quality and Productivity in Construction

    NASA Astrophysics Data System (ADS)

    Usmen, M. A.; Vilnitis, M.

    2015-11-01

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

  19. Consumer Product Safety Commission

    MedlinePlus

    ... mail Inside CPSC Accessibility Privacy Policy Budget, Performances & Finance Open Government Freedom of Information (FOIA) Inspector General ... leave the U.S. Consumer Product Safety Commission (CPSC) public website. The link you selected is for a ...

  20. The likelihood of achieving quantified road safety targets: a binary logistic regression model for possible factors.

    PubMed

    Sze, N N; Wong, S C; Lee, C Y

    2014-12-01

    In past several decades, many countries have set quantified road safety targets to motivate transport authorities to develop systematic road safety strategies and measures and facilitate the achievement of continuous road safety improvement. Studies have been conducted to evaluate the association between the setting of quantified road safety targets and road fatality reduction, in both the short and long run, by comparing road fatalities before and after the implementation of a quantified road safety target. However, not much work has been done to evaluate whether the quantified road safety targets are actually achieved. In this study, we used a binary logistic regression model to examine the factors - including vehicle ownership, fatality rate, and national income, in addition to level of ambition and duration of target - that contribute to a target's success. We analyzed 55 quantified road safety targets set by 29 countries from 1981 to 2009, and the results indicate that targets that are in progress and with lower level of ambitions had a higher likelihood of eventually being achieved. Moreover, possible interaction effects on the association between level of ambition and the likelihood of success are also revealed. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Food Safety Practices in the Egg Products Industry.

    PubMed

    Viator, Catherine L; Cates, Sheryl C; Karns, Shawn A; Muth, Mary K; Noyes, Gary

    2016-07-01

    We conducted a national census survey of egg product plants (n = 57) to obtain information on the technological and food safety practices of the egg products industry and to assess changes in these practices from 2004 to 2014. The questionnaire asked about operational and sanitation practices, microbiological testing practices, food safety training for employees, other food safety issues, and plant characteristics. The findings suggest that improvements were made in the industry's use of food safety technologies and practices between 2004 and 2014. The percentage of plants using advanced pasteurization technology and an integrated, computerized processing system increased by almost 30 percentage points. Over 90% of plants voluntarily use a written hazard analysis and critical control point (HACCP) plan to address food safety for at least one production step. Further, 90% of plants have management employees who are trained in a written HACCP plan. Most plants (93%) conduct voluntary microbiological testing. The percentage of plants conducting this testing on egg products before pasteurization has increased by almost 30 percentage points since 2004. The survey findings identify strengths and weaknesses in egg product plants' food safety practices and can be used to guide regulatory policymaking and to conduct required regulatory impact analysis of potential regulations.

  2. Microbial bioinformatics for food safety and production

    PubMed Central

    Alkema, Wynand; Boekhorst, Jos; Wels, Michiel

    2016-01-01

    In the production of fermented foods, microbes play an important role. Optimization of fermentation processes or starter culture production traditionally was a trial-and-error approach inspired by expert knowledge of the fermentation process. Current developments in high-throughput ‘omics’ technologies allow developing more rational approaches to improve fermentation processes both from the food functionality as well as from the food safety perspective. Here, the authors thematically review typical bioinformatics techniques and approaches to improve various aspects of the microbial production of fermented food products and food safety. PMID:26082168

  3. Product Safety, It's No Accident. A Consumer Product Safety Monthly Planning Guide for Community Organizations.

    ERIC Educational Resources Information Center

    Consumer Product Safety Commission, Washington, DC.

    A consumer product safety monthly planning guide for community organizations is provided. The material is organized into suggested monthly topics with seasonal emphasis. Each section highlights selected information about how to identify potential hazards associated with categories of products. Each section also includes recommendaitons of ways to…

  4. 75 FR 29155 - Publicly Available Consumer Product Safety Information Database

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ...The Consumer Product Safety Commission (``Commission,'' ``CPSC,'' or ``we'') is issuing a notice of proposed rulemaking that would establish a publicly available consumer product safety information database (``database''). Section 212 of the Consumer Product Safety Improvement Act of 2008 (``CPSIA'') amended the Consumer Product Safety Act (``CPSA'') to require the Commission to establish and maintain a publicly available, searchable database on the safety of consumer products, and other products or substances regulated by the Commission. The proposed rule would interpret various statutory requirements pertaining to the information to be included in the database and also would establish provisions regarding submitting reports of harm; providing notice of reports of harm to manufacturers; publishing reports of harm and manufacturer comments in the database; and dealing with confidential and materially inaccurate information.

  5. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  6. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  7. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  8. Achievements and Perspectives of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management

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

    Louvat, D.; Lacoste, A.C.

    The Joint Convention on the Safety of Spent Fuel management and on the Safety of Radioactive Waste Management is the first legal instrument to directly address the safety of spent fuel and radioactive waste management on a global scale. The Joint Convention entered into force in 2001. This paper describes its process and its main achievements to date. The perspectives to establish of a Global Waste Safety Regime based on the Joint Convention are also discussed. (authors)

  9. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety Zone; BW PIONEER Floating... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is in...

  10. [Safety monitoring of cell-based medicinal products (CBMPs)].

    PubMed

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

  11. Product safety in Great Britain and the Consumer Protection Act 1987.

    PubMed

    Jenkins, D W; Davies, B T

    1989-09-01

    The Consumer Protection Act 1987 imposes new demands on manufacturers regarding the safety of their products. They can be sued directly by any person injured by their defective goods and prosecuted if they fail to meet the new comprehensive general safety requirement and any other safety provision. Product designers and ergonomists need a sound understanding of and involvement in the legal aspects of product safety. It is now essential to take into account what may reasonably be done with goods, or foreseeable conditions of use, in order to satisfy the test of what is "reasonably safe" and meet the level of safety which "persons generally are entitled to expect" under the law. Any significant progress in product safety will now come through developments in technical standards which will be harmonised throughout the European Community. It is essential that ergonomics considerations be taken into account during the drafting of product specifications if users' interests are to be safeguarded more effectively. Ergonomists will be required to make an even greater contribution in the field of product safety, therefore, by assisting in the determination of the new statutory safety criteria. They are uniquely qualified to ensure that the product user is fully considered at the design and assessment stages which can now be looked upon as an essential pre-requisite of the law and not just sound engineering policy.

  12. A chief safety officer as the driver and guardian of a great safety rating.

    PubMed

    Steck, Oliver; Zenker, Daniel; Beatty, Tom

    2013-02-01

    If the Pharmaceutical Industry were to align to broad metrics that objectively state each product's "Safety Rating" two things would happen. First, Life Sciences companies would refocus dramatically on safety (followed by outcomes). Second, companies that have the highest aggregate "Safety Rating" would enjoy a significant competitive advantage. To achieve and maintain a high safety rating, the role of Safety officer needs to be elevated to the C-Suite.

  13. Preharvest Food Safety Challenges in Beef and Dairy Production.

    PubMed

    Smith, David R

    2016-08-01

    Foods of animal origin, including beef and dairy products, are nutritious and important to global food security. However, there are important risks to human health from hazards that are introduced to beef and dairy products on the farm. Food safety hazards may be chemical, biological, or physical in nature. Considerations about protecting the safety of beef and dairy products must begin prior to harvest because some potential food safety hazards introduced at the farm (e.g., chemical residues) cannot be mitigated by subsequent postharvest food processing steps. Also, some people have preferences for consuming food that has not been through postharvest processing even though those foods may be unsafe because of microbiological hazards originating from the farm. Because of human fallibility and complex microbial ecologies, many of the preharvest hazards associated with beef and dairy products cannot entirely be eliminated, but the risk for most can be reduced through systematic interventions taken on the farm. Beef and dairy farms differ widely in production practices because of differences in natural, human, and capital resources. Therefore, the actions necessary to minimize on-farm food safety hazards must be farm-specific and they must address scientific, political, economic, and practical aspects. Notable successes in controlling and preventing on-farm hazards to food safety have occurred through a combination of voluntary and regulatory efforts.

  14. A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

    PubMed

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered

  15. The influence of farmland pollution on the quality and safety of agricultural products

    NASA Astrophysics Data System (ADS)

    Ma, Z. L.; Li, L. Y.; Ye, C.; Lin, X. Y.; B, C.; Wei

    2018-02-01

    The quality and safety of agricultural products is not only a major livelihood issues for people’s health, but also the main barriers to international trade of agricultural products nowadays. The soil is the foundation to the production of agricultural products and the guarantee of agricultural development. The farmland soil quality is directly related to the quality and safety of agricultural products. Our country’s soil has been polluted by a series of pollution, Such as the excessive discharge of industrial wastes, the encroachment of household waste, and the unreasonable use of pesticides and fertilizers. Soil degradation is a serious threat to the quality and safety of agricultural products, so eliminating soil degradation is the fundamental way out for quality and safety of agricultural products. By analyzing problems of the quality and safety of agricultural products in our country, and exploring the farmland soil influence on the quality and safety of agricultural products. This article provides a reference for improving the control level of quality and safety of agricultural products and the farmland soil quality.

  16. Clinically relevant safety issues associated with St. John's wort product labels.

    PubMed

    Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

    2008-07-17

    St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0-8) for 23.9% completeness. The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of

  17. Clinically relevant safety issues associated with St. John's wort product labels

    PubMed Central

    Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

    2008-01-01

    Background St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues

  18. On the Safety of Machine Learning: Cyber-Physical Systems, Decision Sciences, and Data Products.

    PubMed

    Varshney, Kush R; Alemzadeh, Homa

    2017-09-01

    Machine learning algorithms increasingly influence our decisions and interact with us in all parts of our daily lives. Therefore, just as we consider the safety of power plants, highways, and a variety of other engineered socio-technical systems, we must also take into account the safety of systems involving machine learning. Heretofore, the definition of safety has not been formalized in a machine learning context. In this article, we do so by defining machine learning safety in terms of risk, epistemic uncertainty, and the harm incurred by unwanted outcomes. We then use this definition to examine safety in all sorts of applications in cyber-physical systems, decision sciences, and data products. We find that the foundational principle of modern statistical machine learning, empirical risk minimization, is not always a sufficient objective. We discuss how four different categories of strategies for achieving safety in engineering, including inherently safe design, safety reserves, safe fail, and procedural safeguards can be mapped to a machine learning context. We then discuss example techniques that can be adopted in each category, such as considering interpretability and causality of predictive models, objective functions beyond expected prediction accuracy, human involvement for labeling difficult or rare examples, and user experience design of software and open data.

  19. 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...

  20. Consumer Product Safety Commission. Consumer Education Efforts for Revised Children's Sleepwear Safety Standard.

    ERIC Educational Resources Information Center

    General Accounting Office, Washington, DC. Health, Education, and Human Services Div.

    A study examined the type and extent of consumer education that occurred since the Consumer Product Safety Commission (CPSC) amended the 1972 federal safety standards (effective January 1997) to permit marketing of snug-fitting, nonflame-resistant cotton garments as sleepwear. Three voluntary point-of-sale (POS) practices recognized as important…

  1. The content of the message matters: The differential effects of promotive and prohibitive team voice on team productivity and safety performance gains.

    PubMed

    Li, Alex Ning; Liao, Hui; Tangirala, Subrahmaniam; Firth, Brady M

    2017-08-01

    We propose that it is important to take the content of team voice into account when examining its impact on team processes and outcomes. Drawing on regulatory focus theory (Higgins, 1997), we argue that promotive team voice and prohibitive team voice help teams achieve distinct collective outcomes-that is, team productivity performance gains and team safety performance gains, respectively. Further, we identify mechanisms through which promotive and prohibitive team voices uniquely influence team outcomes as well as boundary conditions for such influences. In data collected from 88 production teams, we found that promotive team voice had a positive association with team productivity performance gains. By contrast, prohibitive team voice had a positive association with team safety performance gains. The relationship between promotive team voice and team productivity performance gains was mediated by team innovation, and the relationship between prohibitive team voice and team safety performance gains was mediated by team monitoring. In addition, the indirect effect of prohibitive team voice on team safety performance gains via team monitoring was stronger when prior team safety performance was lower. We discuss the theoretical and practical implications of these findings. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  2. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

  3. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

  4. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

  5. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

  6. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide...

  7. Adoptable Interventions, Human Health, and Food Safety Considerations for Reducing Sodium Content of Processed Food Products

    PubMed Central

    Allison, Abimbola; Fouladkhah, Aliyar

    2018-01-01

    Although vital for maintaining health when consumed in moderation, various epidemiological studies in recent years have shown a strong association between excess dietary sodium with an array of health complications. These associations are robust and clinically significant for development of hypertension and prehypertension, two of the leading causes of preventable mortality worldwide, in adults with a high-sodium diet. Data from developed nations and transition economies show worldwide sodium intake of higher than recommended amounts in various nations. While natural foods typically contain a moderate amount of sodium, manufactured food products are the main contributor to dietary sodium intake, up to 75% of sodium in diet of American adults, as an example. Lower cost in formulation, positive effects on organoleptic properties of food products, effects on food quality during shelf-life, and microbiological food safety, make sodium chloride a notable candidate and an indispensable part of formulation of various products. Although low-sodium formulation of each product possesses a unique set of challenges, review of literature shows an abundance of successful experiences for products of many categories. The current study discusses adoptable interventions for product development and reformulation of products to achieve a modest amount of final sodium content while maintaining taste, quality, shelf-stability, and microbiological food safety. PMID:29389843

  8. Adoptable Interventions, Human Health, and Food Safety Considerations for Reducing Sodium Content of Processed Food Products.

    PubMed

    Allison, Abimbola; Fouladkhah, Aliyar

    2018-02-01

    Although vital for maintaining health when consumed in moderation, various epidemiological studies in recent years have shown a strong association between excess dietary sodium with an array of health complications. These associations are robust and clinically significant for development of hypertension and prehypertension, two of the leading causes of preventable mortality worldwide, in adults with a high-sodium diet. Data from developed nations and transition economies show worldwide sodium intake of higher than recommended amounts in various nations. While natural foods typically contain a moderate amount of sodium, manufactured food products are the main contributor to dietary sodium intake, up to 75% of sodium in diet of American adults, as an example. Lower cost in formulation, positive effects on organoleptic properties of food products, effects on food quality during shelf-life, and microbiological food safety, make sodium chloride a notable candidate and an indispensable part of formulation of various products. Although low-sodium formulation of each product possesses a unique set of challenges, review of literature shows an abundance of successful experiences for products of many categories. The current study discusses adoptable interventions for product development and reformulation of products to achieve a modest amount of final sodium content while maintaining taste, quality, shelf-stability, and microbiological food safety.

  9. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent...

  10. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  11. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  12. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  13. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  14. 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...

  15. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Achieving production readiness. 321.4 Section 321.4 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS MAINTENANCE OF THE MOBILIZATION BASE (DEPARTMENT OF DEFENSE...

  16. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a... excess of 200 cubic centimeters per minute or a gas leakage rate in excess of 5 cubic feet per minute is...

  17. Product Safety: "An Ounce of Prevention". Health and the Consumer.

    ERIC Educational Resources Information Center

    Florida State Dept. of Education, Tallahassee. Div. of Elementary and Secondary Education.

    Secondary level students learn about product safety in this consumer education learning activity package, which is one of a series. While the majority of products are safe, there remains a small percentage of consumer goods which reach the market place containing a real or potential hazard to the consumer's safety. This module is designed to make…

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

    NASA Technical Reports Server (NTRS)

    Hill, Janice; Victor, Daniel

    2008-01-01

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

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

    PubMed

    Mitropoulos, Panagiotis Takis; Cupido, Gerardo

    2009-01-01

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

  20. [Preclinical evaluation of the safety of biotechnology products: specific aspects].

    PubMed

    Descotes, Jacques; Ravel, Guillaume; Vial, Thierry

    2003-01-01

    Biotechnology-derived products represent a class of increasingly numerous drugs. One of their major characteristics is extreme diversity, which requires specific approaches for the preclinical evaluation of their safety. The selection of relevant animal species is not easy, as most of these products are human-specific. Thus, only one species will often be used, i.e. primates. As most of these products are large molecules, they can be directly immunogenic. When they are human-specific, no animal model is available to predict the risk. Many biotechnology-derived products have an expected influence on the immune system. This must be taken into account in the preclinical strategy of immunotoxicity evaluation that is now required for every new drug. As conventional toxicity testing is generally limited, safety pharmacology studies should include more than the core battery of assays required by current guidelines in order to complement missing data as much as possible. Because of these particularities, a comprehensive investigation of metabolism and pharmacokinetics is not usually needed. Some products can cross-react with cellular components not intended as therapeutic targets. It is, therefore, essential to rule out the risk of possible cross-reactions that can result in adverse effects. Finally, viral safety is a crucial component of the preclinical safety evaluation of these products. Overall, biotechnology-derived products raise specific issues because of their innovative and original characteristics, and it is difficult to address all these issues if not by using a case-by-case approach.

  1. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... railroad operation or categories of operations on which the product is designed to be used, including train... comprehensive description of all hazards to be addressed in the system design and development, mitigation... the safety assurance concepts used in the product design, including an explanation of the design...

  2. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... railroad operation or categories of operations on which the product is designed to be used, including train... comprehensive description of all hazards to be addressed in the system design and development, mitigation... the safety assurance concepts used in the product design, including an explanation of the design...

  3. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... railroad operation or categories of operations on which the product is designed to be used, including train... comprehensive description of all hazards to be addressed in the system design and development, mitigation... the safety assurance concepts used in the product design, including an explanation of the design...

  4. 77 FR 58567 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ...-0006; OMB Number 1014-0008] Information Collection Activities: Well Control and Production Safety... requirements in the regulations under Subpart O, ``Well Control and Production Safety Training.'' This notice... and Production Safety Training. OMB Control Number: 1014-0008. Abstract: The Outer Continental Shelf...

  5. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    PubMed Central

    Vlachojannis, Christian

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  6. [Discussion on agricultural product quality and safety problem from ecological view].

    PubMed

    Xiao, Ming; Dong, Nan; Lyu, Xin

    2015-08-01

    There are many different perspectives about the sustainable agriculture, which had been proposed since the last three decades in the world. While China's ecologists and agronomists proposed a similar concept named 'ecological agriculture'. Although ecological agriculture in China has achieved substantial progress, including theory, models and supporting technologies nearly several decades of practice and development, its application guidance still is not yet clear. The organic agriculture model proposed by European Union is popular, but it is limited in the beneficiary groups and the social and ecological responsibility. In this context, the article based on an ecological point of view, analyzed the shortcomings of ecological imbalance caused by a single mode of agricultural production and the negative impact on the quality of agricultural products, and discussed the core values of ecological agriculture. On this basis, we put forward the concept of sustainable security of agricultural products. Based on this concept, an agricultural platform was established under the healthy ecosysphere environment, and from this agricultural platform, agricultural products could be safely and sustainably obtained. Around the central value of the concept, we designed the agricultural sustainable and security production model. Finally, we compared the responsibility, benefiting groups, agronomic practices selection and other aspects of sustainable agriculture with organic agriculture, and proved the advancement of sustainable agricultural model in agricultural production quality and safety.

  7. Consensus achievement of leadership, organisational and individual factors that influence safety climate: Implications for nursing management.

    PubMed

    Fischer, Shelly A; Jones, Jacqueline; Verran, Joyce A

    2018-01-01

    To validate a framework of factors that influence the relationship of transformational leadership and safety climate, and to enable testing of safety chain factors by generating hypotheses regarding their mediating and moderating effects. Understanding the patient safety chain and mechanisms by which leaders affect a strong climate of safety is essential to transformational leadership practice, education, and research. A systematic review of leadership and safety literature was used to develop an organising framework of factors proposed to influence the climate of safety. A panel of 25 international experts in leadership and safety engaged a three-round modified Delphi study with Likert-scored surveys. Eighty per cent of participating experts from six countries were retained to the final survey round. Consensus (>66% agreement) was achieved on 40 factors believed to influence safety climate in the acute care setting. Consensus regarding specific factors that play important roles in an organisation's climate of safety can be reached. Generally, the demonstration of leadership commitment to safety is key to cultivating a culture of patient safety. Transformational nurse leaders should consider and employ all three categories of factors in daily leadership activities and decision-making to drive a strong climate of patient safety. © 2017 John Wiley & Sons Ltd.

  8. Perceived School and Neighborhood Safety, Neighborhood Violence and Academic Achievement in Urban School Children

    ERIC Educational Resources Information Center

    Milam, A. J.; Furr-Holden, C. D. M.; Leaf, P. J.

    2010-01-01

    Community and school violence continue to be a major public health problem, especially among urban children and adolescents. Little research has focused on the effect of school safety and neighborhood violence on academic performance. This study examines the effect of the school and neighborhood climate on academic achievement among a population…

  9. Assessing safety of herbal products for menopausal complaints: an international perspective.

    PubMed

    Dog, Tieraona Low; Marles, Robin; Mahady, Gail; Gardiner, Paula; Ko, Richard; Barnes, Jo; Chavez, Mary L; Griffiths, James; Giancaspro, Gabriel; Sarma, Nandakumara D

    2010-08-01

    Future research of herbal products for menopausal women should include long-term safety assessments because women may use these products for prolonged periods of time. Growing numbers of women take prescription medications and concurrently use herbal products for alleviation of menopausal symptoms. Because of possible herb-drug interactions, both drug and supplement manufacturers should provide basic pharmacokinetic data to reduce the risk of adverse interactions. In addition, herbal products produced to high quality standards are essential for ensuring consumer safety. Regulatory frameworks must be in place to ensure that herbal ingredients' identities have been verified, that they have been properly quantified per unit dose, that the product is within tolerance limits for contaminants, that the product's safety and effectiveness under the recommended conditions of use have been assessed before sale to the public, and that a system is in place to detect and deal with adverse reactions when they arise. This article explores these and related concerns. Copyright 2010. Published by Elsevier Ireland Ltd.

  10. Design of agricultural product quality safety retrospective supervision system of Jiangsu province

    NASA Astrophysics Data System (ADS)

    Wang, Kun

    2017-08-01

    In store and supermarkets to consumers can trace back agricultural products through the electronic province card to query their origin, planting, processing, packaging, testing and other important information and found that the problems. Quality and safety issues can identify the responsibility of the problem. This paper designs a retroactive supervision system for the quality and safety of agricultural products in Jiangsu Province. Based on the analysis of agricultural production and business process, the goal of Jiangsu agricultural product quality safety traceability system construction is established, and the specific functional requirements and non-functioning requirements of the retroactive system are analyzed, and the target is specified for the specific construction of the retroactive system. The design of the quality and safety traceability system in Jiangsu province contains the design of the overall design, the trace code design and the system function module.

  11. Quality and Safety Aspects of Cereals (Wheat) and Their Products.

    PubMed

    Varzakas, Theo

    2016-11-17

    Cereals and, most specifically, wheat are described in this chapter highlighting on their safety and quality aspects. Moreover, wheat quality aspects are adequately addressed since they are used to characterize dough properties and baking quality. Determination of dough properties is also mentioned and pasta quality is also described in this chapter. Chemometrics-multivariate analysis is one of the analyses carried out. Regarding production weighing/mixing of flours, kneading, extruded wheat flours, and sodium chloride are important processing steps/raw materials used in the manufacturing of pastry products. Staling of cereal-based products is also taken into account. Finally, safety aspects of cereal-based products are well documented with special emphasis on mycotoxins, acrylamide, and near infrared methodology.

  12. Impact of irradiation on the safety and quality of poultry and meat products: a review.

    PubMed

    O'Bryan, Corliss A; Crandall, Philip G; Ricke, Steven C; Olson, Dennis G

    2008-05-01

    For more than 100 years research on food irradiation has demonstrated that radiation will make food safer and improve the shelf life of irradiated foods. Using the current food safety technology, we may have reached the point of diminishing returns even though recent figures from the CDC show a significant drop in the number of foodborne illnesses. However, too many people continue to get sick and die from eating contaminated food. New and under utilized technologies such as food irradiation need to be re-examined to achieve new levels of safety for the food supply. Effects of irradiation on the safety and quality of meat and poultry are discussed. Irradiation control of the principle microbial pathogens including viruses, the differences among at-risk sub-populations, factors affecting the diminished rate of improvement in food safety and published D values for irradiating raw meat and poultry are presented. Currently permitted levels of irradiation are probably not sufficient to control pathogenic viruses. Typical gram-negative spoilage organisms are very sensitive to irradiation. Their destruction leads to a significant increase in the acceptable shelf life. In addition, the destruction of these normal spoilage organisms did not provide a competitive growth advantage for irradiation injured food pathogens. Another of the main focuses of this review is a detailed compilation of the effects of most of the food additives that have been proposed to minimize the negative quality effect of irradiation. Most of the antimicrobials and antioxidants used singly or in combination produced an increased lethality of irradiation and a decrease in oxidation by-products. Combinations of dosage, temperature, dietary and direct additives, storage temperature and packaging atmosphere can produce meats that the average consumer will find indistinguishable from non-irradiated meats. A discussion of the production of unique radiological by-products is also included.

  13. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

  14. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

  15. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

  16. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

  17. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

  18. Adjusting the Passing Scores for Gearing up for Safety: Production Agriculture Safety Training for Youth Curriculum Test Instruments

    ERIC Educational Resources Information Center

    Hoover, William Brian; French, Brian F.; Field, William E.; Tormoehlen, Roger L.

    2012-01-01

    Minimum passing scores for the Gearing Up for Safety: Production Agriculture Safety Training for Youth curriculum (Gearing Up for Safety) were set in 2006 with widely used and established procedures by efforts of subject matter experts (French, Breidenbach et al., 2007; French, Field, and Tormoehlen, 2006, 2007). While providing a research-based…

  19. Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

    PubMed

    Furlan, Giovanni

    2012-08-01

    Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

  20. Achieving compatibility of State and Federal safety requirements

    DOT National Transportation Integrated Search

    1990-08-01

    The Commercial Motor Vehicle Safety Regulatory Review Panel (Safety Panel) has prepared this report in response to Sections 207, 208, and 209 of the Motor Carrier Safety Act of 1984 (Public Law 98-554). This report provides the Secretary of Transport...

  1. Safety and efficacy of personal care products containing colloidal oatmeal.

    PubMed

    Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

    2012-01-01

    Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized. In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin. We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation. Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.

  2. Safety and efficacy of personal care products containing colloidal oatmeal

    PubMed Central

    Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

    2012-01-01

    Background Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized. Methods In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin. Results We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation. Conclusion Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period. PMID:23204849

  3. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  4. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  5. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  6. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  7. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  8. Achieving the Proper Balance between Crew & Public Safety

    NASA Astrophysics Data System (ADS)

    Wilde, P.; Gowan, J.; Silvestri, R.; Stahl, B.; Rosati, P.

    2012-01-01

    A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard, and the design engineers must give these requirements the same consideration as crew safety requirements. For human spaceflight, the primary purpose and operational concept for any flight safety system is to protect the public while maximizing the likelihood of crew survival. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. An overview of existing range and crew safety policy requirements will be presented. Application of these requirements and lessons learned from both the Space Shuttle and Constellation Programs will also be discussed. Using these past programs as examples, the paper will detail operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Crewed vehicle perspectives from the Federal Aviation Administration and Air Force organizations that oversee public safety will be summarized as well. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

  9. 77 FR 10358 - Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

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

  10. Achieving household nutrition security in societies in transition: an overview.

    PubMed

    Gopalan, C

    2001-01-01

    The achievement of nutrition security at the household level involves adequacy of food supply at the national level and equitable distribution of food among the population in accordance with their physiological needs. The emergence of globalization and market liberalization and the increasing power of some transnational corporations that are advocating pharmaceutical shortcuts have raised concerns in many developing countries. In order to achieve adequacy of food production, earlier mistakes (such as a reliance on unsustainable new technologies) need to be corrected and the resultant imbalances with respect to food production need to be reversed. Emerging new technologies, including genetic modifications, need to be effectively harnessed and adapted with due consideration to safety and sustainability. There is a need to collect convincing evidence of the efficacy and safety of genetically modified foods before they can gain general public acceptance. Information technology will play an important role in future programmes of food production and developing countries must strive to achieve access to this technology. There is considerable scope and need for the expansion of agro-based industries in villages and townships. This could create job opportunities and could also lead to better production and more effective utilization of local food resources by the community and reduce the present considerable loss of perishable food items. Household nutrition security means more than avoidance of chronic starvation. Policy makers of developing countries should set, as their target in the next century, the achievement of adequate nutrition rather than mere survival.

  11. Safety and risk assessment of ceramide 3 in cosmetic products.

    PubMed

    Choi, Seul Min; Lee, Byung-Mu

    2015-10-01

    Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. The European space suit, a design for productivity and crew safety

    NASA Astrophysics Data System (ADS)

    Skoog, A. Ingemar; Berthier, S.; Ollivier, Y.

    In order to fulfil the two major mission objectives, i.e. support planned and unplanned external servicing of the COLUMBUS FFL and support the HERMES vehicle for safety critical operations and emergencies, the European Space Suit System baseline configuration incorporates a number of design features, which shall enhance the productivity and the crew safety of EVA astronauts. The work in EVA is today - and will be for several years - a manual work. Consequently, to improve productivity, the first challenge is to design a suit enclosure which minimizes movement restrictions and crew fatigue. It is covered by the "ergonomic" aspect of the suit design. Furthermore, it is also necessary to help the EVA crewmember in his work, by giving him the right information at the right time. Many solutions exist in this field of Man-Machine Interface, from a very simple system, based on cuff check lists, up to advanced systems, including Head-Up Displays. The design concept for improved productivity encompasses following features: • easy donning/doffing thru rear entry, • suit ergonomy optimisation, • display of operational information in alpha-numerical and graphical from, and • voice processing for operations and safety critical information. Concerning crew safety the major design features are: • a lower R-factor for emergency EVA operations thru incressed suit pressure, • zero prebreath conditions for normal operations, • visual and voice processing of all safety critical functions, and • an autonomous life support system to permit unrestricted operations around HERMES and the CFFL. The paper analyses crew safety and productivity criteria and describes how these features are being built into the design of the European Space Suit System.

  13. The European space suit, a design for productivity and crew safety.

    PubMed

    Skoog, A I; Berthier, S; Ollivier, Y

    1991-01-01

    In order to fulfill the two major mission objectives, i.e. support planned and unplanned external servicing of the COLUMBUS FFL and support the HERMES vehicle for safety critical operations and emergencies, the European Space Suit System baseline configuration incorporates a number of design features, which shall enhance the productivity and the crew safety of EVA astronauts. The work in EVA is today--and will be for several years--a manual work. Consequently, to improve productivity, the first challenge is to design a suit enclosure which minimizes movement restrictions and crew fatigue. It is covered by the "ergonomic" aspect of the suit design. Furthermore, it is also necessary to help the EVA crewmember in his work, by giving him the right information at the right time. Many solutions exist in this field of Man-Machine Interface, from a very simple system, based on cuff check lists, up to advanced systems, including Head-Up Displays. The design concept for improved productivity encompasses following features: easy donning/doffing thru rear entry, suit ergonomy optimisation, display of operational information in alpha-numerical and graphical form, and voice processing for operations and safety critical information. Concerning crew safety the major design features are: a lower R-factor for emergency EVA operations thru increased suit pressure, zero prebreath conditions for normal operations, visual and voice processing of all safety critical functions, and an autonomous life support system to permit unrestricted operations around HERMES and the CFFL. The paper analyses crew safety and productivity criteria and describes how these features are being built into the design of the European Space Suit System.

  14. Food safety objective approach for controlling Clostridium botulinum growth and toxin production in commercially sterile foods.

    PubMed

    Anderson, N M; Larkin, J W; Cole, M B; Skinner, G E; Whiting, R C; Gorris, L G M; Rodriguez, A; Buchanan, R; Stewart, C M; Hanlin, J H; Keener, L; Hall, P A

    2011-11-01

    As existing technologies are refined and novel microbial inactivation technologies are developed, there is a growing need for a metric that can be used to judge equivalent levels of hazard control stringency to ensure food safety of commercially sterile foods. A food safety objective (FSO) is an output-oriented metric that designates the maximum level of a hazard (e.g., the pathogenic microorganism or toxin) tolerated in a food at the end of the food supply chain at the moment of consumption without specifying by which measures the hazard level is controlled. Using a risk-based approach, when the total outcome of controlling initial levels (H(0)), reducing levels (ΣR), and preventing an increase in levels (ΣI) is less than or equal to the target FSO, the product is considered safe. A cross-disciplinary international consortium of specialists from industry, academia, and government was organized with the objective of developing a document to illustrate the FSO approach for controlling Clostridium botulinum toxin in commercially sterile foods. This article outlines the general principles of an FSO risk management framework for controlling C. botulinum growth and toxin production in commercially sterile foods. Topics include historical approaches to establishing commercial sterility; a perspective on the establishment of an appropriate target FSO; a discussion of control of initial levels, reduction of levels, and prevention of an increase in levels of the hazard; and deterministic and stochastic examples that illustrate the impact that various control measure combinations have on the safety of well-established commercially sterile products and the ways in which variability all levels of control can heavily influence estimates in the FSO risk management framework. This risk-based framework should encourage development of innovative technologies that result in microbial safety levels equivalent to those achieved with traditional processing methods.

  15. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in...

  16. 78 FR 57570 - Safety Zone; Motion Picture Production; Chicago, Illinois

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ...-AA00 Safety Zone; Motion Picture Production; Chicago, Illinois AGENCY: Coast Guard, DHS. ACTION: Notice... motion picture filming in Calumet Harbor, Chicago, IL from 9 p.m. until 6 a.m., from September 15 through September 29, 2013. This action is necessary and intended to ensure safety of life on navigable waters...

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

    PubMed

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

    2011-10-01

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

  18. Verification and Implementation of Operations Safety Controls for Flight Missions

    NASA Technical Reports Server (NTRS)

    Smalls, James R.; Jones, Cheryl L.; Carrier, Alicia S.

    2010-01-01

    There are several engineering disciplines, such as reliability, supportability, quality assurance, human factors, risk management, safety, etc. Safety is an extremely important engineering specialty within NASA, and the consequence involving a loss of crew is considered a catastrophic event. Safety is not difficult to achieve when properly integrated at the beginning of each space systems project/start of mission planning. The key is to ensure proper handling of safety verification throughout each flight/mission phase. Today, Safety and Mission Assurance (S&MA) operations engineers continue to conduct these flight product reviews across all open flight products. As such, these reviews help ensure that each mission is accomplished with safety requirements along with controls heavily embedded in applicable flight products. Most importantly, the S&MA operations engineers are required to look for important design and operations controls so that safety is strictly adhered to as well as reflected in the final flight product.

  19. 76 FR 67201 - Information Collection Activities: Oil and Gas Production Safety Systems; Submitted for Office of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    .... BOEM-2011-0068; OMB Number 1014-0003] Information Collection Activities: Oil and Gas Production Safety... requirements in the regulations under Subpart H, ``Oil and Gas Production Safety Systems.'' This notice also... Gas Production Safety Systems. Abstract: The Outer Continental Shelf (OCS) Lands Act, as amended (43 U...

  20. [Application of Raman Spectroscopy Technique to Agricultural Products Quality and Safety Determination].

    PubMed

    Liu, Yan-de; Jin, Tan-tan

    2015-09-01

    The quality and safety of agricultural products and people health are inseparable. Using the conventional chemical methods which have so many defects, such as sample pretreatment, complicated operation process and destroying the samples. Raman spectroscopy as a powerful tool of analysing and testing molecular structure, can implement samples quickly without damage, qualitative and quantitative detection analysis. With the continuous improvement and the scope of the application of Raman spectroscopy technology gradually widen, Raman spectroscopy technique plays an important role in agricultural products quality and safety determination, and has wide application prospects. There have been a lot of related research reports based on Raman spectroscopy detection on agricultural product quality safety at present. For the understanding of the principle of detection and the current development situation of Raman spectroscopy, as well as tracking the latest research progress both at home and abroad, the basic principles and the development of Raman spectroscopy as well as the detection device were introduced briefly. The latest research progress of quality and safety determination in fruits and vegetables, livestock and grain by Raman spectroscopy technique were reviewed deeply. Its technical problems for agricultural products quality and safety determination were pointed out. In addition, the text also briefly introduces some information of Raman spectrometer and the application for patent of the portable Raman spectrometer, prospects the future research and application.

  1. Strategies for Science Student Achievement & Productive School Management

    ERIC Educational Resources Information Center

    Johnson, William L.

    2010-01-01

    There is an increasing literature pertaining to student achievement and school productivity. This session will present school and classroom strategies used in high school science classes at Robert E. Lee High School (5A) in Tyler, Texas. This year, 84% of the students at Lee passed the science TAKS test. Lee is also ranked in the top 1500 high…

  2. [Рroblems of ensuring the safety of deep-fried fast food products].

    PubMed

    Simakova, I V; Perkel, R L; Kutkina, M N; Volovey, A G

    There are no doubts that fast-food restaurants, where deep-frying is actively used, are now very popular in Russia. This article focuses on the problems of deep-fried food safety. During deep-frying a considerable amount of fat penetrates the food. That is why the safety of deep-fried food depends on the fat safety and quality, on the level of fat absorption, and on the intensity of oxidative changes of fat during storage. This article contains the results of the research, which demonstrate that in order to insure the safety of fast-food products it is necessary to introduce into normative and technical documents the following standards: peroxide value, acid value, content of oxidation products insoluble in petroleum ether, and content of epoxides in fat phase and to food mass. According to the current norms on content of oxidation products in deep-frying fat and allowed level of fat absorption by a food product equal to 20%, the recommended level of oxidation products insoluble in petroleum ether for French fries is not higher than 0.2% to the food mass. As a temporary measure we can recommend the level of epoxides not higher than 5 mmol/kg to the food mass. It is important to control the content of trans-isomers in deepfrying fat, it must be not higher than 2% of fatty acid mass. In order to lower fat absorption during French fries production it is recommended to use halffinished products of high readiness, and to air fry.

  3. Layoffs and tradeoffs: production, quality, and safety demands under the threat of job loss.

    PubMed

    Probst, Tahira M

    2002-07-01

    Employees often face a conflict between production targets, quality assurance, and adherence to safety policies. In a time when layoffs are on the rise, it is important to understand the effects of employee job insecurity on these potentially competing demands. A laboratory experiment manipulated the threat of layoffs in a simulated organization and assessed its effect on employee productivity, product quality, and adherence to safety policies. Results suggest that student participants faced with the threat of layoffs were more productive, yet violated more safety rules and produced lower quality outputs, than participants in the control condition. Implications for organizations contemplating layoffs and directions for future research are discussed.

  4. Aerospace Safety Advisory Panel

    NASA Technical Reports Server (NTRS)

    1984-01-01

    An assessment of NASA's safety performance for 1983 affirms that NASA Headquarters and Center management teams continue to hold the safety of manned flight to be their prime concern, and that essential effort and resources are allocated for maintaining safety in all of the development and operational programs. Those conclusions most worthy of NASA management concentration are given along with recommendations for action concerning; product quality and utility; space shuttle main engine; landing gear; logistics and management; orbiter structural loads, landing speed, and pitch control; the shuttle processing contractor; and the safety of flight operations. It appears that much needs to be done before the Space Transportation System can achieve the reliability necessary for safe, high rate, low cost operations.

  5. Shelf life and safety concerns of bakery products--a review.

    PubMed

    Smith, James P; Daifas, Daphne Phillips; El-Khoury, Wassim; Koukoutsis, John; El-Khoury, Anis

    2004-01-01

    Bakery products are an important part of a balanced diet and, today, a wide variety of such products can be found on supermarket shelves. This includes unsweetened goods (bread, rolls, buns, crumpets, muffins and bagels), sweet goods (pancakes, doughnuts, waffles and cookies) and filled goods (fruit and meat pies, sausage rolls, pastries, sandwiches, cream cakes, pizza and quiche). However, bakery products, like many processed foods, are subject to physical, chemical and microbiological spoilage. While physical and chemical spoilage limits the shelf life of low and intermediate moisture bakery products, microbiological spoilage by bacteria, yeast and molds is the concern in high moisture products i.e., products with a water activity (a(w)) > 0.85. Furthermore, several bakery products also have been implicated infoodborne illnesses involving Salmonella spp., Listeria monoctyogenes and Bacillus cereus, while Clostridium botulinum is a concern in high moisture bakery products packaged under modified atmospheres. This extensive review is divided into two parts. Part I focuses on the spoilage concerns of low, intermediate and high moisture bakery products while Part II focuses on the safety concerns of high moisture bakery products only. In both parts, traditional and novel methods of food preservation that can be used by the bakery industry to extend the shelf life and enhance the safety of products are discussed in detail.

  6. Process safety improvement--quality and target zero.

    PubMed

    Van Scyoc, Karl

    2008-11-15

    Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.

  7. Microbiological performance of dairy processing plants is influenced by scale of production and the implemented food safety management system: a case study.

    PubMed

    Opiyo, Beatrice Atieno; Wangoh, John; Njage, Patrick Murigu Kamau

    2013-06-01

    The effects of existing food safety management systems and size of the production facility on microbiological quality in the dairy industry in Kenya were studied. A microbial assessment scheme was used to evaluate 14 dairies in Nairobi and its environs, and their performance was compared based on their size and on whether they were implementing hazard analysis critical control point (HACCP) systems and International Organization for Standardization (ISO) 22000 recommendations. Environmental samples from critical sampling locations, i.e., workers' hands and food contact surfaces, and from end products were analyzed for microbial quality, including hygiene indicators and pathogens. Microbial safety level profiles (MSLPs) were constructed from the microbiological data to obtain an overview of contamination. The maximum MSLP score for environmental samples was 18 (six microbiological parameters, each with a maximum MSLP score of 3) and that for end products was 15 (five microbiological parameters). Three dairies (two large scale and one medium scale; 21% of total) achieved the maximum MSLP scores of 18 for environmental samples and 15 for the end product. Escherichia coli was detected on food contact surfaces in three dairies, all of which were small scale dairies, and the microorganism was also present in end product samples from two of these dairies, an indication of cross-contamination. Microbial quality was poorest in small scale dairies. Most operations in these dairies were manual, with minimal system documentation. Noncompliance with hygienic practices such as hand washing and cleaning and disinfection procedures, which is common in small dairies, directly affects the microbial quality of the end products. Dairies implementing HACCP systems or ISO 22000 recommendations achieved maximum MSLP scores and hence produced safer products.

  8. History of plasma-product safety.

    PubMed

    Hoots, W K

    2001-04-01

    The evolution of transfusion or infusion therapies for diseases requiring specific protein replacements (e.g., hemophilia A and B and severe combined immunodeficiency syndrome) was dramatic over the second half of the 20th century. Unfortunately, it was accompanied by extreme manifestations of transfusion-transmitted diseases, such as human immunodeficiency virus (HIV), hepatitis B, and hepatitis C. The milestones of both the replacement therapies and the associated diseases are discussed in this presentation, which focuses on the technologic advances that resulted in even more "pure" replacement therapies for plasma-protein diseases. From donor screening to the development of viral attenuation techniques, every facet of production for these products was impacted by the exigent push for viral safety created by HIV and hepatitis. Almost invariably, this negatively affects total product yield. At the beginning of the 21st century, success in making plasma products safe from recognized and potential pathogens has dramatically increased societal pressures to produce a zero-risk, plasma-derived protein therapy. However, past improvements and low theoretic risks for future pathogen contamination have increased product cost. This is associated with a possible decrease in the overall supply of these plasma proteins because of the reduced numbers of acceptable donors and the loss of protein from expanded attenuation technology. These impacts and the role of dynamic societal and scientific pressures on these decision processes are discussed. Copyright 2001 by W.B. Saunders Company.

  9. Harmonization of legislation and regulations to achieve food safety: US and Canada perspective.

    PubMed

    Keener, Larry; Nicholson-Keener, Sophia M; Koutchma, Tatiana

    2014-08-01

    Trade in food and food ingredients among the nations of the world is rapidly expanding and, with this expansion, new supply chain partners, from globally disparate geographic regions, are being enrolled. Food and food ingredients are progressively sourced more from lesser developed nations. Food safety incidents in the USA and Canada show a high unfavorable correlation between illness outbreaks and imported foods. In the USA, for example, foodborne disease outbreaks caused by imported food appeared to rise in 2009 and 2010, and nearly half of the outbreaks, associated with imported food, implicated foods imported from areas which previously had not been associated with outbreaks. Projecting supply chains into new geographical regions raises serious questions about the capacity of the new supply chain partners to provide the requisite regulatory framework and sufficiently robust public health measures for ensuring the safety of the foods and foodstuffs offered for international trade. The laws, regulation and legislation among the many nations participating in the global food trade are, at best, inconsistent. These inconsistencies frequently give rise to trade disputes and cause large quantities of food to be at risk of destruction on the often dubious pretext that they are not safe. Food safety is often viewed through a political or normative lens. Often as not, this lens has been wrought absent scientific precision. Harmonization of food safety legislation around sound scientific principles, as advocated by the US Food Safety Modernization Act (FSMA), would ultimately promote trade and likely provide for incremental improvement in public health. Among the priority roles of most national governments are the advancement of commerce and trade, preservation of public health and ensuring domestic tranquility. Achieving these priorities is fundamental to creating and preserving the wealth of nations. Countries such as the Netherlands, Canada, Germany, Japan and the USA

  10. National Culture, Creativity, and Productivity: What's the Relationship with Student Achievement?

    ERIC Educational Resources Information Center

    Fang, Zheng; Xu, Xianxuan; Grant, Leslie W.; Stronge, James H.; Ward, Thomas J.

    2016-01-01

    Using Hofstede's culture dimensions and World Values Survey (WVS) dimensions, the study uses a series of multiple regressions to explore the relationship among national culture, creativity as measured by patents, economic productivity as measured by gross domestic product per capita, and student achievement as measured by Trends in International…

  11. Achieving the Proper Balance Between Crew and Public Safety

    NASA Technical Reports Server (NTRS)

    Gowan, John; Silvestri, Ray; Stahl, Ben; Rosati, Paul; Wilde, Paul

    2011-01-01

    A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard, and the design engineers must give these requirements the same consideration as crew safety requirements. For human spaceflight, the primary purpose and operational concept for any flight safety system is to protect the public while maximizing the likelihood of crew survival. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. An overview of existing range and crew safety policy requirements will be presented. Application of these requirements and lessons learned from both the Space Shuttle and Constellation Programs will also be discussed. Using these past programs as examples, the paper will detail operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Manned vehicle perspectives from the Federal Aviation Administration (FAA) and Air Force organizations that oversee public safety will be summarized as well. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

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

    PubMed

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

    2014-07-01

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

  13. Construction of Traceability System for Quality Safety of Cereal and Oil Products

    NASA Astrophysics Data System (ADS)

    Zheng, Huoguo; Liu, Shihong; Meng, Hong; Hu, Haiyan

    After several significant food safety incident, global food industry and governments in many countries are putting increasing emphasis on establishment of food traceability systems. Food traceability has become an effective way in food quality and safety management. The traceability system for quality safety of cereal and oil products was designed and implemented with HACCP and FMECA method, encoding, information processing, and hardware R&D technology etc, according to the whole supply chain of cereal and oil products. Results indicated that the system provide not only the management in origin, processing, circulating and consuming for enterprise, but also tracing service for customers and supervisor by means of telephone, internet, SMS, touch machine and mobile terminal.

  14. Relationships among School Climate, School Safety, and Student Achievement and Well-Being: A Review of the Literature

    ERIC Educational Resources Information Center

    Kutsyuruba, Benjamin; Klinger, Don A.; Hussain, Alicia

    2015-01-01

    School climate, safety and well-being of students are important antecedents of academic achievement. However, school members do not necessarily experience school climate in the same way; rather, their subjective perceptions of the environment and personal characteristics influence individual outcomes and behaviours. Therefore, a closer look at the…

  15. A Collection Scheme for Tracing Information of Pig Safety Production

    NASA Astrophysics Data System (ADS)

    Luo, Qingyao; Xiong, Benhai; Yang, Liang

    This study takes one main production pattern of smallhold pig farming in Tianjin as a study prototype, deeply analyzes characters of informations about tracing inputs including vaccines,feeds,veterinary drugs and supervision test in pig farming, proposesinputs metadata, criteria for integrating inputs event and interface norms for data transmision, developes and completes identification of 2D ear tags and traceability information collection system of pig safety production based on mobile PDA. The system has implemented functions including setting and invalidate of 2D ear tags, collection of tracing inputs and supervision in the mobile PDA and finally integration of tracing events (the epidemic event,feed event,drug event and supervision event) on the traceability data center (server). The PDA information collection system has been applied for demonstration in Tianjin, the collection is simple, convenient and feasible. It could meet with requirements of traceability information system of pig safety production

  16. 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.

  17. Executing effective road safety advertising: are big production budgets necessary?

    PubMed

    Donovan, R J; Jalleh, G; Henley, N

    1999-05-01

    Twelve (12) road safety television commercials (TVCs) ranging in production costs from $A15,000 to $A250,000 (current prices) were evaluated using standard advertising pre-test procedures. The twelve ads covered four road safety behaviours (speeding; drink driving; fatigue; and inattention), and included a variety of executional types within and across behaviours. One ad in each of the four behaviours was an expensive TAC and ($A200,000 or more). The testing procedure assessed respondents' self-reported impact of the ad on their future intentions to comply with the road safety behavior advocated in the ad. Just under 1000 appropriately screened motor vehicle drivers license holders were recruited via street intercept methods and randomly allocated to one of the twelve and exposure conditions. The results showed that while the two best performing ads were highly dramatic TAC ads showing graphic crash scenes, these were also the most expensive ads to produce, and, being 60 and 90 s, the most expensive to air. In several cases, 30 s low cost talking heads testimonials performed equally as well as their far more expensive counterparts. We conclude that big production budgets may not be necessary to create effective road safety advertising.

  18. Solving a product safety problem using a recycled high density polyethylene container

    NASA Technical Reports Server (NTRS)

    Liu, Ping; Waskom, T. L.

    1993-01-01

    The objectives are to introduce basic problem-solving techniques for product safety including problem identification, definition, solution criteria, test process and design, and data analysis. The students are given a recycled milk jug made of high density polyethylene (HDPE) by blow molding. The objectives are to design and perform proper material test(s) so they can evaluate the product safety if the milk jug is used in a certain way which is specified in the description of the procedure for this investigation.

  19. Health, safety, and ecological implications of using biobased floor-stripping products.

    PubMed

    Massawe, Ephraim; Geiser, Kenneth; Ellenbecker, Michael; Marshall, Jason

    2007-05-01

    The main objective of the study reported here was to investigate the ecological, health, and safety (EHS) implications of using biobased floor strippers as alternatives to solvent-based products such as Johnson Wax Professional (Pro Strip). The authors applied a quick EHS-scoring technique developed by the Surface Solution Laboratory (SSL) of the Toxics Use Reduction Institute (TURI) to some alternative, biobased products that had previously performed as well as or close to as well as the currently used product. The quick technique is considered an important step in EHS assessment, particularly for toxics use reduction planners and advocates who may not have the resources to subject many alternative products or processes at once to detailed EHS analysis. Taking this step narrows available options to a manageable number. (Technical-performance experiments were also conducted, but the results are not discussed or reported in this paper). The cost of switching to biobased floor strippers was assessed and compared with the cost of using the traditional product, both at full strength and at the dilution ratios recommended by the respective manufacturers. The EHS analysis was based on a framework consisting of five parameters: volatile organic compounds (VOCs); pH; global-warming potential (GWP); ozone depletion potential (ODP); and safety scores in areas such as flammability, stability, and special hazards, based on ratings from the Hazardous Material Classification System (HMIS) and the National Fire Protection Association (NFPA). Total EHS scores were calculated with data derived from the material safety data sheets. For most cleaning products previously investigated by the TURI SSL, the investigators have demonstrated that the five key parameters used in the study reported here can successfully be used for quick screening of the EHS impacts of cleaning alternatives. All eight biobased, or green, products evaluated in the study had better EHS-screening scores than did

  20. 76 FR 1137 - Publicly Available Consumer Product Safety Information Database: Notice of Public Web Conferences

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ...: Notice of Public Web Conferences AGENCY: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: The Consumer Product Safety Commission (``Commission,'' ``CPSC,'' or ``we'') is announcing two Web conferences... database (``Database''). The Web conferences will be webcast live from the Commission's headquarters in...

  1. Voluntary Product Standard PS 72-76: Toy Safety.

    ERIC Educational Resources Information Center

    National Bureau of Standards (DOC), Washington, DC.

    The purpose of this voluntary product standard is to establish nationally recognized safety requirements and test methods for toys intended for use by children in age groups through 14 years. The standard relates to possible hazards that may not be readily recognized and which may be encountered in,normal use or after reasonably foreseeable abuse.…

  2. Achieving the Proper Balance Between Crew and Public Safety

    NASA Technical Reports Server (NTRS)

    Gowan, John; Rosati, Paul; Silvestri, Ray; Stahl, Ben; Wilde, Paul

    2011-01-01

    A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. Historical examples and lessons learned from both the Space Shuttle and Constellation Programs will be presented. Using these examples as context, the paper will discuss some operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Manned vehicle perspectives from the FAA and Air Force organizations that oversee public safety will also be summarized. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

  3. 16 CFR 1115.5 - Reporting of failures to comply with a voluntary consumer product safety standard relied upon by...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  4. Adapting viral safety assurance strategies to continuous processing of biological products.

    PubMed

    Johnson, Sarah A; Brown, Matthew R; Lute, Scott C; Brorson, Kurt A

    2017-01-01

    There has been a recent drive in commercial large-scale production of biotechnology products to convert current batch mode processing to continuous processing manufacturing. There have been reports of model systems capable of adapting and linking upstream and downstream technologies into a continuous manufacturing pipeline. However, in many of these proposed continuous processing model systems, viral safety has not been comprehensively addressed. Viral safety and detection is a highly important and often expensive regulatory requirement for any new biological product. To ensure success in the adaption of continuous processing to large-scale production, there is a need to consider the development of approaches that allow for seamless incorporation of viral testing and clearance/inactivation methods. In this review, we outline potential strategies to apply current viral testing and clearance/inactivation technologies to continuous processing, as well as modifications of existing unit operations to ensure the successful integration of viral clearance into the continuous processing of biological products. Biotechnol. Bioeng. 2017;114: 21-32. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  5. System safety education focused on flight safety

    NASA Technical Reports Server (NTRS)

    Holt, E.

    1971-01-01

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

  6. Productivity and safety in worker cooperatives and conventional firms.

    PubMed

    Grunberg, L; Everard, J; O'Toole, M

    1984-01-01

    This paper examines the relationship between productivity and workers' safety in firms characterized by very different types of relations in production. Arguments are developed to explain why worker cooperatives are expected to have higher productivity and lower accident rates than conventional capitalist firms. Workers who own and control their firms are expected to have a greater incentive to be efficient and a greater ability to safeguard their health than workers employed under hierarchical and alienating conditions. The hypotheses are tested by comparing carefully matched conventional and cooperative plywood companies. Preliminary results suggest that while cooperatives may be more productive they are not safer, indicating the limits of the isolated cooperative form in capitalist market economies.

  7. Approaches to achieve high-level heterologous protein production in plants.

    PubMed

    Streatfield, Stephen J

    2007-01-01

    Plants offer an alternative to microbial fermentation and animal cell cultures for the production of recombinant proteins. For protein pharmaceuticals, plant systems are inherently safer than native and even recombinant animal sources. In addition, post-translational modifications, such as glycosylation, which cannot be achieved with bacterial fermentation, can be accomplished using plants. The main advantage foreseen for plant systems is reduced production costs. Plants should have a particular advantage for proteins produced in bulk, such as industrial enzymes, for which product pricing is low. In addition, edible plant tissues are well suited to the expression of vaccine antigens and pharmaceuticals for oral delivery. Three approaches have been followed to express recombinant proteins in plants: expression from the plant nuclear genome; expression from the plastid genome; and expression from plant tissues carrying recombinant plant viral sequences. The most important factor in moving plant-produced heterologous proteins from developmental research to commercial products is to ensure competitive production costs, and the best way to achieve this is to boost expression. Thus, considerable research effort has been made to increase the amount of recombinant protein produced in plants. This research includes molecular technologies to increase replication, to boost transcription, to direct transcription in tissues suited for protein accumulation, to stabilize transcripts, to optimize translation, to target proteins to subcellular locations optimal for their accumulation, and to engineer proteins to stabilize them. Other methods include plant breeding to increase transgene copy number and to utilize germplasm suited to protein accumulation. Large-scale commercialization of plant-produced recombinant proteins will require a combination of these technologies.

  8. Safety Issues at the Defense Production Reactors. A Report to the U.S. Department of Energy.

    ERIC Educational Resources Information Center

    National Academy of Sciences - National Research Council, Washington, DC. Commission on Physical Sciences, Mathematics, and Resources.

    This report provides an assessment of safety management, safety review, and safety methodology employed by the Department of Energy (DOE) and private contractors. Chapter 1, "The DOE Safety Framework," examines safety objectives for production reactors and processes to implement the objectives. Chapter 2, "Technical Issues,"…

  9. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

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

    PubMed

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

    2015-10-01

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

  11. Achieving a climate for patient safety by focusing on relationships.

    PubMed

    Manojlovich, Milisa; Kerr, Mickey; Davies, Barbara; Squires, Janet; Mallick, Ranjeeta; Rodger, Ginette L

    2014-12-01

    Despite many initiatives, advances in patient safety remain uneven in part because poor relationships among health professionals have not been addressed. The purpose of this study was to determine whether relationships between health professionals contributed to a patient safety climate, after implementation of an intervention to improve inter-professional collaboration. This was a secondary analysis of data collected to evaluate the Interprofessional Model of Patient Care (IPMPC) at The Ottawa Hospital in Ontario, Canada, which consists of five sites. A series of generalized estimating equation models were generated, accounting for the clustering of responses by site. Thirteen health professionals including physicians, nurses, physiotherapists and others (n = 1896) completed anonymous surveys about 1 year after the IPMPC was introduced. The IPMPC was implemented to improve interdisciplinary collaboration. Reliable instruments were used to measure collaboration, respect, inter-professional conflict and patient safety climate. Collaboration (β = 0.13; P = 0.002) and respect (β = 1.07; P = 0.03) were significant independent predictors of patient safety climate. Conflict was an independent and significant inverse predictor of patient safety climate (β = -0.29; P = 0.03), but did not moderate linkages between collaboration and patient safety climate or between respect and patient safety climate. Through the IPMPC, all health professionals learned how to collaborate and build a patient safety climate, even in the presence of inter-professional conflict. Efforts by others to foster better work relationships may yield similar improvements in patient safety climate. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  12. Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

    PubMed

    Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

    2018-03-01

    Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

  13. Improving Student Concern for Safety in a Production Technology Lab through the Use of Teambuilding.

    ERIC Educational Resources Information Center

    Lacina, Dale Robert

    The effectiveness of team building as a strategy for improving students' concern for safety in a production technology laboratory was examined in a study involving a group of grade 9 and 10 production technology students from an urban, lower-middle-class community in western Illinois. Students' safety test scores, teacher checklists, and…

  14. 77 FR 51912 - Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2012-0618] RIN 1625-AA00 Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY AGENCY.... 165.T01-0618 to read as follows: Sec. 165.T01-0618 Safety Zone; Tom Lyons Productions Fireworks, Long...

  15. Chemical safety of cassava products in regions adopting cassava production and processing--experience from Southern Africa.

    PubMed

    Nyirenda, D B; Chiwona-Karltun, L; Chitundu, M; Haggblade, S; Brimer, L

    2011-03-01

    The cassava belt area in Southern Africa is experiencing an unforeseen surge in cassava production, processing and consumption. Little documentation exists on the effects of this surge on processing procedures, the prevailing levels of cyanogenic glucosides of products consumed and the levels of products commercially available on the market. Risk assessments disclose that effects harmful to the developing central nervous system (CNS) may be observed at a lower exposure than previously anticipated. We interviewed farmers in Zambia and Malawi about their cultivars, processing procedures and perceptions concerning cassava and chemical food safety. Chips, mixed biscuits and flour, procured from households and markets in three regions of Zambia (Luapula-North, Western and Southern) as well as products from the Northern, Central and Southern regions of Malawi, were analyzed for total cyanogenic potential (CNp). Processed products from Luapula showed a low CNp, <10 mg HCN equiv./kg air dried weight, while samples from Mongu, Western Province, exhibited high levels of CNp, varying from 50 to 290 mg HCN equiv./kg. Even the lowest level is five times higher than the recommended safety level of 10mg/kg decided on for cassava flour. Our results call for concerted efforts in promoting gender oriented processing technologies. Copyright © 2010 Elsevier Ltd. All rights reserved.

  16. Comprehensive safety document/product.

    DOT National Transportation Integrated Search

    2013-06-01

    With 100 counties and more than 800 cities, towns, and township governments in North Carolina, there is a tremendous need to : disseminate road safety information at the local level. For safety gains to be made in NC communities there needs to be bot...

  17. A Review of the Poultry Meat Production Industry for Food Safety in Indonesia

    NASA Astrophysics Data System (ADS)

    Wahyono, N. D.; Utami, M. M. D.

    2018-01-01

    Poultry meat is an indispensable source of animal protein in human growth and development, so it is in great demand by people all over the world. Poultry meat has several advantages, namely the quality of nutrition is good enough, delicious taste, relatively affordable price, easy to get and accepted all levels of society with diverse backgrounds. The era of globalization requires competitive products, such as chicken meat in Indonesia, the current chicken meat industry is not only based on high production capacity and decreased production costs but also chicken products are safe to eat. As a consequence of trade liberalization, the poultry industry faces the threat of competition with cheaper products with better quality. The food safety of chicken meat starts from the farm, processing process until consumed. Food safety is a requirement of food products that must be handled by involving government, industry and consumers.

  18. 77 FR 61513 - Information Disclosure Under Section 6(b) of the Consumer Product Safety Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

    ... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1101 Information Disclosure Under Section 6(b) of the Consumer Product Safety Act CFR Correction 0 In Title 16 of the Code of Federal Regulations, Part 1000 to End, revised as of January 1, 2012, on page 147, in Sec. 1101.25 (a) and (b), the words ``5...

  19. Renewable Acrylonitrile Production

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

    Beckham, Gregg T; Karp, Eric M; Eaton, Todd R

    Acrylonitrile (ACN) is a petroleum-derived compound used in resins, polymers, acrylics, and carbon fiber. We present a process for renewable ACN production using 3-hydroxypropionic acid (3-HP), which can be produced microbially from sugars. The process achieves ACN molar yields exceeding 90% from ethyl 3-hydroxypropanoate (ethyl 3-HP) via dehydration and nitrilation with ammonia over an inexpensive titanium dioxide solid acid catalyst. We further describe an integrated process modeled at scale that is based on this chemistry and achieves near-quantitative ACN yields (98 +/- 2%) from ethyl acrylate. This endothermic approach eliminates runaway reaction hazards and achieves higher yields than the standardmore » propylene ammoxidation process. Avoidance of hydrogen cyanide as a by-product also improves process safety and mitigates product handling requirements.« less

  20. 75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and... vaccine annually) and an explanation of how the proposed study will either help support product approval...

  1. Food safety issues associated with products from aquaculture. Report of a Joint FAO/NACA/WHO Study Group.

    PubMed

    1999-01-01

    The past decade has seen rapid expansion in aquaculture production. In the fisheries sector, as in animal production, farming is replacing hunting as the primary food production strategy. In future, farmed fish will be an even more important source of protein foods than they are today, and the safety for human consumption of products from aquaculture is of public health significance. This is the report of a Study Group that considered food safety issues associated with farmed finfish and crustaceans. The principal conclusion was that an integrated approach--involving close collaboration between the aquaculture, agriculture, food safety, health and education sectors--is needed to identify and control hazards associated with products from aquaculture. Food safety assurance should be included in fish farm management and form an integral part of the farm-to-table food safety continuum. Where appropriate, measures should be based on Hazard Analysis and Critical Control Point (HACCP) methods; however, difficulties in applying HACCP principles to small-scale farming systems were recognized. Food safety hazards associated with products from aquaculture differ according to region, habitat and environmental conditions, as well as methods of production and management. Lack of awareness of hazards can hinder risk assessment and the application of risk management strategies to aquaculture production, and education is therefore needed. Chemical and biological hazards that should to be taken into account in public health policies concerning products from aquaculture are discussed in this report, which should be of use to policy-makers and public health officials. The report will also assist fish farmers to identify hazards and develop appropriate hazard-control strategies.

  2. Establishment and implementation of common product assurance and safety requirements for the contractors of the Columbus programme

    NASA Astrophysics Data System (ADS)

    Wessels, H.; Stephan, H. J.

    1991-08-01

    When establishing the Columbus Product Assurance (PA)/safety requirements, the international environment of the Space Station Freedom program has to be taken into account. Considerations given to multiple ways of requirement definition and stages within the European Space Agency (ESA) Procedures, Specifications, and Standards (PSS-01) series of documents and the NASA Space Station requirements are discussed. A series of adaptations introduced by way of tailoring the basic ESA and NASA requirement sets to the Columbus program's needs are described. For the implementation of these tailored requirements, a scheme is developed, which recognizes the PA/safety approach within the European industries by way of various company handbooks and manuals. The changes introduced in the PSS-01 series and the applicable NASA Space Station requirements in recent years, has coincided with the establishment of Columbus PA/safety requirements. To achieve the necessary level of cooperation between ESA and the Columbus industries, a PA Working Group (PAWG) is established. The PAWG supervises the establishement of the Common PA/Safety Plan and the Standards to be used. Due to the high number of European industries participating in the Columbus program, a positive influence on the evolution of the industrial approaches in PA/safety can be expected. Cooperation in the PAWG has brought issues to light which are related to the ESA PSS-01 series and its requirements. Due to the rapid changes of recent years, basic company documentation has not followed the development, specifically as various recent ESA projects use different project specifc issues of the evolving PSS-01 documents.

  3. Safety and health in biomass production, transportation, and storage: a commentary based on the biomass and biofuels session at the 2013 North American Agricultural Safety Summit.

    PubMed

    Yoder, Aaron M; Schwab, Charles; Gunderson, Paul; Murphy, Dennis

    2014-01-01

    There is significant interest in biomass production ranging from government agencies to the private sector, both inside and outside of the traditional production agricultural setting. This interest has led to an increase in the development and production of biomass crops. Much of this effort has focused on specific segments of the process, and more specifically on the mechanics of these individual segments. From a review of scientific literature, it is seen that little effort has been put into identifying, classifying and preventing safety hazards in on-farm biomass production systems. This commentary describes the current status of the knowledge pertaining to health and safety factors of biomass production and storage in the US and identifies areas of standards development that the biomass industry needs from the agricultural safety and health community.

  4. [Storage of plant protection products in farms: minimum safety requirements].

    PubMed

    Dutto, Moreno; Alfonzo, Santo; Rubbiani, Maristella

    2012-01-01

    Failure to comply with requirements for proper storage and use of pesticides in farms can be extremely hazardous and the risk of accidents involving farm workers, other persons and even animals is high. There are still wide differences in the interpretation of the concept of "securing or making safe", by workers in this sector. One of the critical points detected, particularly in the fruit sector, is the establishment of an adequate storage site for plant protection products. The definition of "safe storage of pesticides" is still unclear despite the recent enactment of Legislative Decree 81/2008 regulating health and work safety in Italy. In addition, there are no national guidelines setting clear minimum criteria for storage of plant protection products in farms. The authors, on the basis of their professional experience and through analysis of recent legislation, establish certain minimum safety standards for storage of pesticides in farms.

  5. Safety assessment of personal care products/cosmetics and their ingredients.

    PubMed

    Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However

  6. Safety assessment of personal care products/cosmetics and their ingredients

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

    Nohynek, Gerhard J., E-mail: gnohynec@rd.loreal.co; Antignac, Eric; Re, Thomas

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed,more » the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO{sub 2} and ZnO in

  7. Dermal safety assessment of Arm & Hammer laundry products formulated for sensitive skin.

    PubMed

    Frederick, Douglas M; Vorwerk, Linda; Gupta, Archana; Ghassemi, Annahita

    2017-09-01

    The prevalence of sensitive skin among the general population in industrialized countries is reported to be over 50%. Sensitive skin subjects often report significant reactions to contact with cosmetics, soaps and other consumer products. This paper describes the overall skin compatibility and mildness program for a newly developed, lightly fragranced, colorant free laundry product (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent), specially formulated for individuals with sensitive skin. The skin mildness of the product was compared to Arm & Hammer™ Free & Clear liquid laundry detergent with no fragrance or colorant, and an established history of safe use by sensitive skin consumers. The test material was a liquid laundry product with a light scent formulated for sensitive skin consumers (Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent). The product was compared to commercially marketed products for sensitive skin with a history of skin safety in the marketplace, including: a very similar product formulation (Arm & Hammer™ Free & Clear with no fragrance), and several selected competitors' products. Studies were conducted among individuals with self-assessed sensitive skin (based on a questionnaire) using standard protocols for the Human Repeat Insult Patch Test (HRIPT), 10-Day Cumulative Irritation, the Wrist Band Wear test, and the Safety In-Use testing. Responses in all protocols were evaluated by visual scoring of potential dermatologic reactions, and recording any sensory effects at the time of the examination. In addition, sensory effects collected from panelists' daily diaries were also evaluated. The HRIPT confirmed that neither the fragrance alone, nor the product formulation with fragrance, induced contact sensitization in sensitive skin subjects. The 10-Day cumulative irritation study conducted using sensitive skin subjects showed highly favorable skin compatibility, and the test product was comparable to the control

  8. Overcoming dysfunctional momentum: Organizational safety as a social achievement

    Treesearch

    Michelle A. Barton; Kathleen M. Sutcliffe

    2009-01-01

    Research on organizational safety and reliability largely has emphasized system-level structures and processes neglecting the more micro-level, social processes necessary to enact organizational safety. In this qualitative study we remedy this gap by exploring these processes in the context of wildland fire management. In particular, using interview data gathered from...

  9. Safety aspects of the production of foods and food ingredients from insects.

    PubMed

    Schlüter, Oliver; Rumpold, Birgit; Holzhauser, Thomas; Roth, Angelika; Vogel, Rudi F; Quasigroch, Walter; Vogel, Stephanie; Heinz, Volker; Jäger, Henry; Bandick, Nils; Kulling, Sabine; Knorr, Dietrich; Steinberg, Pablo; Engel, Karl-Heinz

    2017-06-01

    At present, insects are rarely used by the European food industry, but they are a subject of growing interest as an alternative source of raw materials. The risks associated with the use of insects in the production of foods and food ingredients have not been sufficiently investigated. There is a lack of scientifically based knowledge of insect processing to ensure food safety, especially when these processes are carried out on an industrial scale. This review focuses on the safety aspects that need to be considered regarding the fractionation of insects for the production of foods and food ingredients. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial.

    PubMed

    Giugliano, Robert P; Pedersen, Terje R; Park, Jeong-Gun; De Ferrari, Gaetano M; Gaciong, Zbigniew A; Ceska, Richard; Toth, Kalman; Gouni-Berthold, Ioanna; Lopez-Miranda, Jose; Schiele, François; Mach, François; Ott, Brian R; Kanevsky, Estella; Pineda, Armando Lira; Somaratne, Ransi; Wasserman, Scott M; Keech, Anthony C; Sever, Peter S; Sabatine, Marc S

    2017-10-28

    LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). In this prespecified secondary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up. We used multivariable modelling to adjust for baseline factors associated with achieved LDL cholesterol. This trial is registered with ClinicalTrials.gov, number NCT01764633. Between Feb 8, 2013, and June 5, 2015, 27 564 patients were randomly assigned a treatment in the FOURIER study. 1025 (4%) patients did not have an LDL cholesterol measured at 4 weeks and 557 (2%) had already had a primary endpoint event or one of the ten prespecified safety events before the week-4 visit. From the remaining 25 982 patients (94% of those randomly assigned) 13 013 were assigned evolocumab and 12 969 were assigned placebo. 2669 (10%) of 25 982 patients achieved LDL-cholesterol concentrations of less than 0·5 mmol/L, 8003 (31%) patients achieved concentrations between 0·5 and less than 1·3 mmol/L, 3444 (13%) patients achieved concentrations between 1·3 and less than 1·8 mmol/L, 7471 (29%) patients achieved concentrations between 1·8 to less than 2·6 mmol/L, and 4395 (17%) patients achieved

  11. 76 FR 6765 - Consumer Product Safety Act: Notice of Commission Action on the Stay of Enforcement of Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-08

    ... Stay of Enforcement of Testing and Certification Requirements AGENCY: Consumer Product Safety... enforcement of certain testing and certification provisions of section 14 of the Consumer Product Safety Act..., standard, or regulation. For nonchildren's products, the certification must be based on a test of each...

  12. Microbiological quality and safety assessment of lettuce production in Brazil.

    PubMed

    Ceuppens, Siele; Hessel, Claudia Titze; de Quadros Rodrigues, Rochele; Bartz, Sabrina; Tondo, Eduardo César; Uyttendaele, Mieke

    2014-07-02

    The microbiological quality and safety of lettuce during primary production in Brazil were determined by enumeration of hygiene indicators Escherichia coli, coliforms and enterococci and detection of enteric pathogens Salmonella and E. coli O157:H7 in organic fertilizers, soil, irrigation water, lettuce crops, harvest boxes and worker's hands taken from six different lettuce farms throughout the crop growth cycle. Generic E. coli was a suitable indicator for the presence of Salmonella and E. coli O157:H7, while coliforms and enterococci were not. Few pathogens were detected: 5 salmonellae and 2 E. coli O157:H7 from 260 samples, of which only one was lettuce and the others were manure, soil and water. Most (5/7) pathogens were isolated from the same farm and all were from organic production. Statistical analysis revealed the following environmental and agro-technical risk factors for increased microbial load and pathogen prevalence in lettuce production: high temperature, flooding of lettuce fields, application of contaminated organic fertilizer, irrigation with water of inferior quality and large distances between the field and toilets. Control of the composting process of organic fertilizers and the irrigation water quality appear most crucial to improve and/or maintain the microbiological quality and safety during the primary production of lettuce. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. Global harmonization of food safety regulation from the perspective of Korea and a novel fast automatic product recall system.

    PubMed

    Sohn, Mun-Gi; Oh, Sangsuk

    2014-08-01

    Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market. © 2013 Society of Chemical Industry.

  14. RFID in the blood supply chain--increasing productivity, quality and patient safety.

    PubMed

    Briggs, Lynne; Davis, Rodeina; Gutierrez, Alfonso; Kopetsky, Matthew; Young, Kassandra; Veeramani, Raj

    2009-01-01

    As part of an overall design of a new, standardized RFID-enabled blood transfusion medicine supply chain, an assessment was conducted for two hospitals: the University of Iowa Hospital and Clinics (UIHC) and Mississippi Baptist Health System (MBHS). The main objectives of the study were to assess RFID technological and economic feasibility, along with possible impacts to productivity, quality and patient safety. A step-by-step process analysis focused on the factors contributing to process "pain points" (errors, inefficiency, product losses). A process re-engineering exercise produced blueprints of RFID-enabled processes to alleviate or eliminate those pain-points. In addition, an innovative model quantifying the potential reduction in adverse patient effects as a result of RFID implementation was created, allowing improvement initiatives to focus on process areas with the greatest potential impact to patient safety. The study concluded that it is feasible to implement RFID-enabled processes, with tangible improvements to productivity and safety expected. Based on a comprehensive cost/benefit model, it is estimated for a large hospital (UIHC) to recover investment from implementation within two to three years, while smaller hospitals may need longer to realize ROI. More importantly, the study estimated that RFID technology could reduce morbidity and mortality effects substantially among patients receiving transfusions.

  15. Priming patient safety: A middle-range theory of safety goal priming via safety culture communication.

    PubMed

    Groves, Patricia S; Bunch, Jacinda L

    2018-05-18

    The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.

  16. Tracking the Market Performance of Companies That Integrate a Culture of Health and Safety: An Assessment of Corporate Health Achievement Award Applicants.

    PubMed

    Fabius, Raymond; Loeppke, Ronald R; Hohn, Todd; Fabius, Dan; Eisenberg, Barry; Konicki, Doris L; Larson, Paul

    2016-01-01

    The aim of this study was to assess the hypothesis that stock market performance of companies achieving high scores on either health or safety in the Corporate Health Achievement Award (CHAA) process will be superior to average index performance. The stock market performance of portfolios of CHAA winners was examined under six different scenarios using simulation and past market performance in tests of association framed to inform the investor community. CHAA portfolios out-performed the S&P average on all tests. This study adds to the growing evidence that a healthy and safe workforce correlates with a company's performance and its ability to provide positive returns to shareholders. It advances the idea that a proven set of health and safety metrics based on the CHAA evaluation process merits inclusion with existing measures for market valuation.

  17. Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa.

    PubMed

    Dzingirayi, Garikayi; Korsten, Lise

    2016-07-01

    Growing global consumer concern over food safety in the fresh produce industry requires producers to implement necessary quality assurance systems. Varying effectiveness has been noted in how countries and food companies interpret and implement food safety standards. A diagnostic instrument (DI) for global fresh produce industries was developed to measure the compliancy of companies with implemented food safety standards. The DI is made up of indicators and descriptive grids for context factors and control and assurance activities to measure food safety output. The instrument can be used in primary production to assess food safety performance. This study applied the DI to measure food safety standard compliancy of mushroom farming in South Africa. Ten farms representing almost half of the industry farms and more than 80% of production were independently assessed for their horticultural safety management system (HSMS) compliance via in-depth interviews with each farm's quality assurance personnel. The data were processed using Microsoft Office Excel 2010 and are represented in frequency tables. The diagnosis revealed that the mushroom farming industry had an average food safety output. The farms were implementing an average-toadvanced HSMS and operating in a medium-risk context. Insufficient performance areas in HSMSs included inadequate hazard analysis and analysis of control points, low specificity of pesticide assessment, and inadequate control of suppliers and incoming materials. Recommendations to the industry and current shortcomings are suggested for realization of an improved industry-wide food safety assurance system.

  18. International trade standards for commodities and products derived from animals: the need for a system that integrates food safety and animal disease risk management.

    PubMed

    Thomson, G R; Penrith, M-L; Atkinson, M W; Thalwitzer, S; Mancuso, A; Atkinson, S J; Osofsky, S A

    2013-12-01

    A case is made for greater emphasis to be placed on value chain management as an alternative to geographically based disease risk mitigation for trade in commodities and products derived from animals. The geographic approach is dependent upon achievement of freedom in countries or zones from infectious agents that cause so-called transboundary animal diseases, while value chain-based risk management depends upon mitigation of animal disease hazards potentially associated with specific commodities or products irrespective of the locality of production. This commodity-specific approach is founded on the same principles upon which international food safety standards are based, viz. hazard analysis critical control points (HACCP). Broader acceptance of a value chain approach enables animal disease risk management to be combined with food safety management by the integration of commodity-based trade and HACCP methodologies and thereby facilitates 'farm to fork' quality assurance. The latter is increasingly recognized as indispensable to food safety assurance and is therefore a pre-condition to safe trade. The biological principles upon which HACCP and commodity-based trade are based are essentially identical, potentially simplifying sanitary control in contrast to current separate international sanitary standards for food safety and animal disease risks that are difficult to reconcile. A value chain approach would not only enable more effective integration of food safety and animal disease risk management of foodstuffs derived from animals but would also ameliorate adverse environmental and associated socio-economic consequences of current sanitary standards based on the geographic distribution of animal infections. This is especially the case where vast veterinary cordon fencing systems are relied upon to separate livestock and wildlife as is the case in much of southern Africa. A value chain approach would thus be particularly beneficial to under-developed regions of

  19. Dangerous Products, Dangerous Places: An AARP Report on Home Safety and Older Consumers.

    ERIC Educational Resources Information Center

    Fise, Mary Ellen R.

    This report was written to identify the safety problems confronting older persons and to educate readers about product and home hazards and appropriate preventive measures. It was written for older consumers, their families, policymakers, and manufacturers. Information on the incidence of home accidents and consumer product accidents among the…

  20. Measurement and standardization of eye safety for optical radiation of LED products

    NASA Astrophysics Data System (ADS)

    Mou, Tongsheng; Peng, Zhenjian

    2013-06-01

    The blue light hazard (BLH) to human eye's retina is now a new issue emerging in applications of artificial light sources. Especially for solid state lighting sources based on the blue chip-LED(GaN), the photons with their energy more than 2.4 eV show photochemical effects on the retina significantly, raising damage both in photoreceptors and retinal pigment epithelium. The photobiological safety of artificial light sources emitting optical radiation has gained more and more attention worldwide and addressed by international standards IEC 62471-2006(CIE S009/E: 2002). Meanwhile, it is involved in IEC safety specifications of LED lighting products and covered by European Directive 2006/25/EC on the minimum health and safety requirements regarding the exposure of the workers to artificial optical radiation. In practical applications of the safety standards, the measuring methods of optical radiation from LED products to eyes are important in establishment of executable methods in the industry. In 2011, a new project to develop the international standard of IEC TR62471-4,that is "Measuring methods of optical radiation related to photobiological safety", was approved and are now under way. This paper presents the concerned methods for the assessment of optical radiation hazards in the standards. Furthermore, a retina radiance meter simulating eye's optical geometry is also described, which is a potential tool for blue light hazard assessment of retinal exposure to optical radiation. The spectroradiometric method integrated with charge-coupled device(CCD) imaging system is introduced to provide more reliable results.

  1. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Production Safety... minute or a gas leakage rate in excess of 5 cubic feet per minute is observed, the device shall be... cubic centimeters per minute or a gas leakage rate in excess of 5 cubic feet per minute is observed, the...

  2. A risk-based, product-level approach for assuring aquatic environmental safety of cleaning products in the context of sustainability: The Environmental Safety Check (ESC) scheme of the A.I.S.E. Charter for Sustainable Cleaning.

    PubMed

    Pickup, John Alexander; Dewaele, Joost; Furmanski, Nicola L; Kowalczyk, Agnieszka; Luijkx, Gerard Ca; Mathieu, Sophie; Stelter, Norbert

    2017-01-01

    Cleaning products have long been a focus of efforts to improve sustainability and assure safety for the aquatic environment when disposed of after use. The latter is addressed at ingredient level through environmental risk assessment, including in formal frameworks such as REACH. Nevertheless, in the context of programs to improve overall sustainability, stakeholders demand both environmental safety assurance and progress at product level. Current product-level approaches for aquatic toxicity (e.g., USEtox™, Critical Dilution Volume) can be seen as predominantly hazard-based. The more logical approach would be risk-based, because ecotoxicity is generally threshold-dependent and hazard-based assessment produces conflicts with risk-based learnings. The development of a risk-based approach to assess formulated products is described: the International Association for Soaps, Detergents and Maintenance Products (A.I.S.E.) Charter Environmental Safety Check (ESC), which is consistent with the scientific principles underlying REACH. This is implemented through a simple spreadsheet tool and internal database of ingredient parameters including predicted no-effect concentration (PNEC) and removal rate. A novel feature is applying market volume information for both product types and ingredients to permit a risk-based calculation. To pass the ESC check, the projected environmental safety ratio (PESR) for each ingredient as formulated and dosed (unless cleared by a published risk assessment or exempted as inherently low risk) must be less than 1. The advantages of a risk-based approach are discussed. The strengths and limitations of various possible approaches to standard-setting, product-ranking and driving continuous improvement in respect of potential ecotoxic impacts on the aquatic environment are considered. It is proposed that as ecotoxicity is generally accepted to be threshold-dependent, with no effect below the threshold, the most constructive approach to continuous

  3. Agency perspectives on food safety for the products of animal biotechnology.

    PubMed

    Howard, H J; Jones, K M; Rudenko, L

    2012-08-01

    Animal biotechnology represents one subset of tools among a larger set of technologies for potential use to meet increasing world demands for food. Assisted reproductive technologies (ART) such as artificial insemination and embryo transfer continue to make positive contributions in food animal production. The US Food and Drug Administration (FDA) performed a comprehensive risk assessment to identify potential food consumption or animal health risks associated with animal cloning, an emerging ART. At that time, FDA concluded that animal cloning posed no unique risks either to animal health or to food consumption, and food from animal clones and their sexually reproduced offspring required no additional federal regulation beyond that applicable to conventionally bred animals of the species examined. At this time, no new information has arisen that would necessitate a change in FDA's conclusions on food from animal clones or their sexually reproduced offspring. Use of recombinant DNA technologies to produce genetically engineered (GE) animals represents another emerging technology with potential to impact food animal production. In its regulation of GE animals, FDA follows a cumulative, risk-based approach to address scientific questions related to the GE animals. FDA evaluates data and information on the safety, effectiveness and stability of the GE event. FDA carries out its review at several levels (e.g. molecular biology, animal safety, food safety, environmental safety and claim validation). GE animal sponsors provide data to address risk questions for each level. This manuscript discusses FDA's role in evaluation of animal cloning and GE animals. © 2012 Blackwell Verlag GmbH.

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

    NASA Astrophysics Data System (ADS)

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

    2017-10-01

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

  5. 77 FR 35747 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ...-0061] Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement... Evidential Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR 48705). DATES: Effective Date... Safety Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459...

  6. Comparing Occupational Health and Safety Management System Programming with Injury Rates in Poultry Production.

    PubMed

    Autenrieth, Daniel A; Brazile, William J; Douphrate, David I; Román-Muñiz, Ivette N; Reynolds, Stephen J

    2016-01-01

    Effective methods to reduce work-related injuries and illnesses in animal production agriculture are sorely needed. One approach that may be helpful for agriculture producers is the adoption of occupational health and safety management systems. In this replication study, the authors compared the injury rates on 32 poultry growing operations with the level of occupational health and safety management system programming at each farm. Overall correlations between injury rates and programming level were determined, as were correlations between individual management system subcomponents to ascertain which parts might be the most useful for poultry producers. It was found that, in general, higher levels of occupational health and safety management system programming were associated with lower rates of workplace injuries and illnesses, and that Management Leadership was the system subcomponent with the strongest correlation. The strength and significance of the observed associations were greater on poultry farms with more complete management system assessments. These findings are similar to those from a previous study of the dairy production industry, suggesting that occupational health and safety management systems may hold promise as a comprehensive way for producers to improve occupational health and safety performance. Further research is needed to determine the effectiveness of such systems to reduce farm work injuries and illnesses. These results are timely given the increasing focus on occupational safety and health management systems.

  7. Safety inspection of plant products

    USDA-ARS?s Scientific Manuscript database

    Advances in hyperspectral imaging technology have provided enormous opportunity for the food industry and research community to develop rapid and non-invasive inspection methods for food safety inspection. This chapter reviews and discusses different aspects of using this technology in safety inspec...

  8. Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.

    PubMed

    Tieu, Carolyn; Lucas, Eleanor J; DePaola, Mindi; Rosman, Lori; Alexander, G Caleb

    2018-01-01

    For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017. To summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. We conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018. We included randomized controlled trials (RCTs) comparing safety, clinical efficacy, pharmacokinetics and pharmacodynamics of any biosimilar insulin with a reference product in adults regardless of sample size and location. Two researchers independently reviewed all titles, abstracts and text; extracted data; and performed quality assessments. Efficacy, safety, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. Of 6945 articles screened, 11 studies were included in the data synthesis. LY2963016, Basalog, Basalin, and MK-1293 were compared to Lantus while SAR342434 was compared to Humalog. Three trials enrolled healthy volunteers, five enrolled type 1 diabetics, and two enrolled type 2 diabetics. One study enrolled both healthy and type 1 diabetics. Of the eleven studies, six examined pharmacokinetic and/or pharmacodynamic parameters and five examined clinical efficacy and immunogenicity. All studies included adverse events. All PK and/or PD studies showed that comparable parameters of biosimilar and reference products were within the pre-specified equivalence margins. Clinical studies suggested similar clinical efficacy and immunogenicity. Adverse events were similar between the groups across all studies. Few published studies have compared biosimilar and reference insulins, though those that did suggest that the

  9. 77 FR 45242 - Revisions to Safety Standards for Durable Infant or Toddler Products: Infant Bath Seats and Full...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... direction in the Danny Keysar Child Product Safety Notification Act to issue standards for durable infant or... not usually subject to CPSC's standards, such as child care facilities, family child care homes, and... standard issued under the Danny Keysar Child Product Safety Notification Act was based, the revision...

  10. Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration.

    PubMed

    Robb, Melissa A; Racoosin, Judith A; Worrall, Chris; Chapman, Summer; Coster, Trinka; Cunningham, Francesca E

    2012-11-01

    After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners' Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups.

  11. Safety in the Workplace.

    ERIC Educational Resources Information Center

    Shaw, Richard

    1999-01-01

    Addresses workplace safety needs and tips for helping an organization achieve a high level of safety. Tips include showing administration commitment, establishing retribution-free reporting of safety problems and violations, rewarding excellent safety effort, and allowing no compromises in following safety procedures. (GR)

  12. [Evaluation of efficacy and safety of manidipine hydrochloride among essential hypertensive patients: Substitution from branded product (Calslot) to Generic Product (Manidip)].

    PubMed

    Kobayashi, Hiroko; Obara, Taku; Takahashi, Norio; Takahashi, Takeshi; Igari, Yukie; Oikawa, Takuya; Saito, Shinichiro; Ohkubo, Takayoshi; Imai, Yutaka; Takahashi, Masanobu

    2007-12-01

    Calcium channel blockers are most commonly used in hypertensive patients in Japan. However, information on the efficacy and safety of generic calcium channel blockers is insufficient. The objective of the present study was to retrospectively evaluate the efficacy and safety of manidipine hydrochloride in 21 essential hypertensive patients (mean age; 70.6+/-10.6 years, male/female; 14/7) in Sendai Postal Services Agency Hospital who were switched (substituted) from a brand product (Calslot) to a generic product (Manidip). For this retrospective study, we used data from patient medical records and drug prescription information. Data from patients who were taking both types of manidipine hydrochloride, whose regimen were not changed for > 6 months before and after switching, and who provided informed consent were included in the analysis. Control values of blood pressure were not significantly different between before and after substitution (systolic/diastolic; from 137.9+/-9.1/78.7+/-5.4 mmHg to 137.3+/-9.1/77.8+/-6.3 mmHg, p=0.73/p=0.36). The level of patient compliance for the antihypertensive drugs was also not different between before and after substitution (from 94.0+/-8.8% to 93.1+/-9.6%, p=0.72). There were 8 cases of adverse effects before substitution and 4 after substitution. No patient stopped taking the generic drug due to an adverse effect. In conclusion, significant differences in the efficacy, safety, and patient compliance were not observed between the brand product and generic product among patients who were switched from the brand product to the generic product.

  13. Evaluation of Hygiene and Safety Criteria in the Production of a Traditional Piedmont Cheese.

    PubMed

    Astegiano, Sara; Bellio, Alberto; Adriano, Daniela; Bianchi, Daniela Manila; Gallina, Silvia; Gorlier, Alessandra; Gramaglia, Monica; Lombardi, Giampiero; Macori, Guerrino; Zuccon, Fabio; Decastelli, Lucia

    2014-08-28

    Traditional products and related processes must be safe to protect consumers' health. The aim of this study was to evaluate microbiological criteria of a traditional Piedmont cheese, made by two different cheese producers (A and B). Three batches of each cheese were considered. The following seven samples of each batch were collected: raw milk, milk at 38°C, curd, cheese at 7, 30, 60, 90 days of ripening. During cheese making process, training activities dealing with food safety were conducted. Analyses regarding food safety and process hygiene criteria were set up according to the EC Regulation 2073/2005. Other microbiological and chemical-physical analyses [lactic streptococci, lactobacilli, pH and water activity (A w )] were performed as well. Shiga-toxin Escherichia coli , aflatoxin M1 and antimicrobial substances were considered only for raw milk. All samples resulted negative for food safety criteria; Enterobacteriaceae , E.coli and coagulase-positive staphylococci (CPS) were high in the first phase of cheese production, however they decreased at the end of ripening. A high level of CPS in milk was found in producer A, likewise in some cheese samples a count of >5 Log CFU/g was reached; staphylococcal enterotoxins resulted negative. The pH and A w values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and A w are considered positive factors in order to ensure safety of dairy products. Moreover, training activities play a crucial role to manage critical points and perform corrective action. Responsible application of good manufacturing practices are considered key factors to obtain a high hygienic level in dairy products.

  14. How is success achieved by individuals innovating for patient safety and quality in the NHS?

    PubMed

    Sheard, Laura; Jackson, Cath; Lawton, Rebecca

    2017-09-11

    Innovation in healthcare is said to be notoriously difficult to achieve and sustain yet simultaneously the health service is under intense pressure to innovate given the ever increasing demands placed upon it. Whilst many studies have looked at diffusion of innovation from an organisational perspective, few have sought to understand how individuals working in healthcare innovate successfully. We took a positive deviance approach to understand how innovations are achieved by individuals working in the NHS. We conducted in depth interviews in 2015 with 15 individuals who had received a national award for being a successful UK innovator in healthcare. We invited only those people who were currently (or had recently) worked in the NHS and whose innovation focused on improving patient safety or quality. Thematic analysis was used. Four themes emerged from the data: personal determination, the ability to broker relationships and make connections, the ways in which innovators were able to navigate organisational culture to their advantage and their ability to use evidence to influence others. Determination, focus and persistence were important personal characteristics of innovators as were skills in being able to challenge the status quo. Innovators were able to connect sometimes disparate teams and people, being the broker between them in negotiating collaborative working. The culture of the organisation these participants resided in was important with some being able to use this (and the current patient safety agenda) to their advantage. Gathering robust data to demonstrate their innovation had a positive impact and was seen as essential to its progression. This paper reveals a number of factors which are important to the success of innovators in healthcare. We have uncovered that innovators have particular personal traits which encourage a propensity towards change and action. Yet, for fruitful innovation to take place, it is important for relational networks and

  15. African American Social Work Faculty: Overcoming Existing Barriers and Achieving Research Productivity

    ERIC Educational Resources Information Center

    Allen, Junior Lloyd; Huggins-Hoyt, Kimberly Y.; Holosko, Michael J.; Briggs, Harold E.

    2018-01-01

    Purpose: This study explored the scholarship experiences of top-ranked African American faculty in schools of social work. Method: Qualitative interviews were conducted with N = 10 top-ranked African American faculty identified as achieving considerable productivity and impact of scholarship. Findings: Four major themes were identified, each of…

  16. Effects of genetic, processing, or product formulation changes on efficacy and safety of probiotics.

    PubMed

    Sanders, Mary Ellen; Klaenhammer, Todd R; Ouwehand, Arthur C; Pot, Bruno; Johansen, Eric; Heimbach, James T; Marco, Maria L; Tennilä, Julia; Ross, R Paul; Franz, Charles; Pagé, Nicolas; Pridmore, R David; Leyer, Greg; Salminen, Seppo; Charbonneau, Duane; Call, Emma; Lenoir-Wijnkoop, Irene

    2014-02-01

    Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product formats, or respond to market opportunities. Such changes can alter the expression of physiological traits owing to the live nature of probiotics. In addition, genetic approaches may be used to improve strain attributes. This review explores whether genetic or phenotypic changes, by accident or design, might affect the efficacy or safety of commercial probiotics. We highlight key issues important to determining the need to re-confirm efficacy or safety after strain improvement, process optimization, or product formulation changes. Research pinpointing the mechanisms of action for probiotic function and the development of assays to measure them are greatly needed to better understand if such changes have a substantive impact on probiotic efficacy. © 2014 New York Academy of Sciences.

  17. Gross domestic product, science interest, and science achievement: a person × nation interaction.

    PubMed

    Tucker-Drob, Elliot M; Cheung, Amanda K; Briley, Daniel A

    2014-11-01

    Maximizing science achievement is a critical target of educational policy and has important implications for national and international economic and technological competitiveness. Previous research has identified both science interest and socioeconomic status (SES) as robust predictors of science achievement, but little research has examined their joint effects. In a data set drawn from approximately 400,000 high school students from 57 countries, we documented large Science Interest × SES and Science Interest × Per Capita Gross Domestic Product (GDP) interactions in the prediction of science achievement. Student interest in science is a substantially stronger predictor of science achievement in higher socioeconomic contexts and in higher-GDP nations. Our results are consistent with the hypothesis that in higher-opportunity contexts, motivational factors play larger roles in learning and achievement. They add to the growing body of evidence indicating that substantial cross-national differences in psychological effect sizes are not simply a logical possibility but, in many cases, an empirical reality. © The Author(s) 2014.

  18. 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.

  19. Identifying behaviour patterns of construction safety using system archetypes.

    PubMed

    Guo, Brian H W; Yiu, Tak Wing; González, Vicente A

    2015-07-01

    Construction safety management involves complex issues (e.g., different trades, multi-organizational project structure, constantly changing work environment, and transient workforce). Systems thinking is widely considered as an effective approach to understanding and managing the complexity. This paper aims to better understand dynamic complexity of construction safety management by exploring archetypes of construction safety. To achieve this, this paper adopted the ground theory method (GTM) and 22 interviews were conducted with participants in various positions (government safety inspector, client, health and safety manager, safety consultant, safety auditor, and safety researcher). Eight archetypes were emerged from the collected data: (1) safety regulations, (2) incentive programs, (3) procurement and safety, (4) safety management in small businesses (5) production and safety, (6) workers' conflicting goals, (7) blame on workers, and (8) reactive and proactive learning. These archetypes capture the interactions between a wide range of factors within various hierarchical levels and subsystems. As a free-standing tool, they advance the understanding of dynamic complexity of construction safety management and provide systemic insights into dealing with the complexity. They also can facilitate system dynamics modelling of construction safety process. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Are safety data sheets for cleaning products used in Norway a factor contributing to the risk of workers exposure to chemicals?

    PubMed

    Suleiman, Abdulqadir M; Svendsen, Kristin V H

    2014-10-01

    Cleaning products are considered less hazardous than those used in other sectors. Suppliers and distributors are less conscientious when it comes to informing users on health risks. The aim of the study was to elaborate on the usefulness and clarity of information in the safety data sheets (SDS) for cleaning products, and considering if the use of these SDSs can be seen as a risk factor towards occupational exposure to hazardous chemicals in the sector. Safety data sheets were selected based on the risk level of the product assigned in an industrial sector scheme. 320 SDSs for cleaning products were reviewed. Constituent components found in the products over a given threshold were listed and available information thereof used to assess the perceived non-hazard consideration of the chemicals. The contents of the SDSs was generic and mostly incomplete. Safety measures and health information lacked sufficient specificity despite varying compositions and concentrations of components. There is generally incompatibility between mentioned sections on the suggested non-hazardous nature of the products and health effects. Not all substances used in these products have harmonized classifications, which makes them open to various classification of the products and the suggested safety measures. This results in different companies classifying similar products differently. Risk management measures and suggested personal protective equipment (PPEs) are given haphazardly. Physical properties relevant to risk assessment are not included. The safety data sheets are ambiguous, and they lack relevant and important information. Inadequate information and risk assessment concerning the products can lead to workers being exposed to hazardous chemicals. Underestimation of the hazard contribution of the components of the products and the insufficient, non-objective mention of appropriate control and protective measures are the major contributing elements. There is a need to test the

  1. Occupational health and safety aspects of animal handling in dairy production.

    PubMed

    Lindahl, Cecilia; Lundqvist, Peter; Hagevoort, G Robert; Lunner Kolstrup, Christina; Douphrate, David I; Pinzke, Stefan; Grandin, Temple

    2013-01-01

    Livestock handling in dairy production is associated with a number of health and safety issues. A large number of fatal and nonfatal injuries still occur when handling livestock. The many animal handling tasks on a dairy farm include moving cattle between different locations, vaccination, administration of medication, hoof care, artificial insemination, ear tagging, milking, and loading onto trucks. There are particular problems with bulls, which continue to cause considerable numbers of injuries and fatalities in dairy production. In order to reduce the number of injuries during animal handling on dairy farms, it is important to understand the key factors in human-animal interactions. These include handler attitudes and behavior, animal behavior, and fear in cows. Care when in close proximity to the animal is the key for safe handling, including knowledge of the flight zone, and use of the right types of tools and suitable restraint equipment. Thus, in order to create safe working conditions during livestock handling, it is important to provide handlers with adequate training and to establish sound safety management procedures on the farm.

  2. Addressing Uniqueness and Unison of Reliability and Safety for a Better Integration

    NASA Technical Reports Server (NTRS)

    Huang, Zhaofeng; Safie, Fayssal

    2016-01-01

    Over time, it has been observed that Safety and Reliability have not been clearly differentiated, which leads to confusion, inefficiency, and, sometimes, counter-productive practices in executing each of these two disciplines. It is imperative to address this situation to help Reliability and Safety disciplines improve their effectiveness and efficiency. The paper poses an important question to address, "Safety and Reliability - Are they unique or unisonous?" To answer the question, the paper reviewed several most commonly used analyses from each of the disciplines, namely, FMEA, reliability allocation and prediction, reliability design involvement, system safety hazard analysis, Fault Tree Analysis, and Probabilistic Risk Assessment. The paper pointed out uniqueness and unison of Safety and Reliability in their respective roles, requirements, approaches, and tools, and presented some suggestions for enhancing and improving the individual disciplines, as well as promoting the integration of the two. The paper concludes that Safety and Reliability are unique, but compensating each other in many aspects, and need to be integrated. Particularly, the individual roles of Safety and Reliability need to be differentiated, that is, Safety is to ensure and assure the product meets safety requirements, goals, or desires, and Reliability is to ensure and assure maximum achievability of intended design functions. With the integration of Safety and Reliability, personnel can be shared, tools and analyses have to be integrated, and skill sets can be possessed by the same person with the purpose of providing the best value to a product development.

  3. Quality and safety aspects of meat products as affected by various physical manipulations of packaging materials.

    PubMed

    Lee, Keun Taik

    2010-09-01

    This article explores the effects of physically manipulated packaging materials on the quality and safety of meat products. Recently, innovative measures for improving quality and extending the shelf-life of packaged meat products have been developed, utilizing technologies including barrier film, active packaging, nanotechnology, microperforation, irradiation, plasma and far-infrared ray (FIR) treatments. Despite these developments, each technology has peculiar drawbacks which will need to be addressed by meat scientists in the future. To develop successful meat packaging systems, key product characteristics affecting stability, environmental conditions during storage until consumption, and consumers' packaging expectations must all be taken into consideration. Furthermore, the safety issues related to packaging materials must also be taken into account when processing, packaging and storing meat products.

  4. Exploring Informal Mathematical Products of Low Achievers at the Secondary School Level

    ERIC Educational Resources Information Center

    Karsenty, Ronnie; Arcavi, Abraham; Hadas, Nurit

    2007-01-01

    This article examines the notion of informal mathematical products, in the specific context of teaching mathematics to low achieving students at the secondary school level. The complex and relative nature of this notion is illustrated and some of its characteristics are suggested. These include the use of ad-hoc strategies, mental calculations,…

  5. Dust control products at Hagerman National Wildlife Refuge, Texas: environmental safety and performance

    USGS Publications Warehouse

    Kunz, Bethany K.; Little, Edward E.

    2015-01-01

    Controlling fugitive dust while protecting natural resources is a challenge faced by all managers of unpaved roads. Unfortunately, road managers choosing between dust control products often have little objective environmental information to aid their decisions. To address this information gap, the U.S. Geological Survey and the U.S. Fish and Wildlife Service collaborated on a field test of three dust control products with the objectives of (a) evaluating product performance under real-world conditions, (b) verifying the environmental safety of products identified as practically nontoxic in laboratory tests, and (c) testing the feasibility of several environmental monitoring techniques for use in dust control tests. In cooperation with refuge staff and product vendors, three products (one magnesium chloride plus binder, one cellulose, and one synthetic fluid plus binder) were applied in July 2012 to replicated road sections at the Hagerman National Wildlife Refuge in Texas. These sections were monitored periodically for 12 months after application. Product performance was assessed by mobile-mounted particulate-matter meters measuring production of fugitive dust and by observations of road conditions. Environmental safety was evaluated through on-site biological observations and leaching tests with samples of treated aggregate. All products reduced dust and improved surface condition during those 12 months. Planned environmental measurements were not always compatible with day-to-day refuge management actions; this incompatibility highlighted the need for flexible biological monitoring plans. As one of the first field tests of dust suppressants that explicitly incorporated biological endpoints, this effort provides valuable information for improving field tests and for developing laboratory or semifield alternatives.

  6. Total safety management: An approach to improving safety culture

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

    Blush, S.M.

    A little over 4 yr ago, Admiral James D. Watkins became Secretary of Energy. President Bush, who had appointed him, informed Watkins that his principal task would be to clean up the nuclear weapons complex and put the US Department of Energy (DOE) back in the business of producing tritium for the nation's nuclear deterrent. Watkins recognized that in order to achieve these objectives, he would have to substantially improve the DOE's safety culture. Safety culture is a relatively new term. The International Atomic Energy Agency (IAEA) used it in a 1986 report on the root causes of the Chernobylmore » nuclear accident. In 1990, the IAEA's International Nuclear Safety Advisory Group issued a document focusing directly on safety culture. It provides guidelines to the international nuclear community for measuring the effectiveness of safety culture in nuclear organizations. Safety culture has two principal aspects: an organizational framework conducive to safety and the necessary organizational and individual attitudes that promote safety. These obviously go hand in hand. An organization must create the right framework to foster the right attitudes, but individuals must have the right attitudes to create the organizational framework that will support a good safety culture. The difficulty in developing such a synergistic relationship suggests that achieving and sustaining a strong safety culture is not easy, particularly in an organization whose safety culture is in serious disrepair.« less

  7. The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery.

    PubMed

    Toomey, Paul G; Ross, Sharona B; Choung, Edward; Donn, Natalie; Vice, Michelle; Luberice, Kenneth; Albrink, Michael; Rosemurgy, Alexander S

    2015-01-01

    As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery. LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires. Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0-20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique. In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in performing a more difficult technique to obtain better

  8. Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities.

    PubMed

    Uppal, Navjeet K; Dupuis, Lee L; Parshuram, Christopher S

    2008-01-01

    To describe the provision of pediatric drug safety information in a national formulary of manufacturers' drug product monographs. We performed a cross-sectional evaluation of comprehensive product monographs contained in the 2005 Canadian Compendium of Pharmaceuticals and Specialities (CPS). We abstracted data describing indications for prescription, statements about pediatric safety, available preparations, and provision of dosing guidelines. For each monograph we classified pediatric safety data as either present, present but limited or absent. We then described the pediatric safety data in CPS monographs for drugs listed in the published formulary of the Hospital for Sick Children, Toronto, Ontario, Canada. A total of 2232 product monographs were screened; 684 were excluded and 1548 (66%) were further analyzed. 1462 (94%) had indications that did not exclude children. Pediatric safety information was present in 592 (38%), present but limited in 148 (10%), and absent in 808 (52%) drug monographs. Safety statements were absent in 224 (14%) drug monographs that provided both dosing guidelines and formulations suitable for administration to children, and in 214 (52%) of 411 drugs in the pediatric hospital formulary. We evaluated a widely available national source of pediatric prescribing information. Safety data for children was not mentioned in more than half of the product monographs. Moreover, the provision of safety data was discordant with indications for prescription, the availability of pediatric formulations, and dosing guidelines within the monographs, and with inclusion in a pediatric hospital formulary. Our study suggests that the presentation of pediatric safety data in drug product monographs can be improved to better inform prescribing and to optimize pharmacotherapy in children.

  9. It's No Accident: A Consumer Product Safety Education Curriculum Resource Guide for Teachers of Grades 3 through 6.

    ERIC Educational Resources Information Center

    Consumer Product Safety Commission, Washington, DC.

    This guide for teachers contains product safety information appropriate for young children and suggests learning activities for third through sixth graders. Activities encourage children to examine their home environments for safety hazards and to share this information with family and friends. Unit 1 introduces five basic safety concepts upon…

  10. [Russian and foreign legal-standards bases for guaranteeing the parasitic safety of raw produce and food products].

    PubMed

    Lovgalev, A S

    1998-01-01

    The paper analyzes the standard legal and methodological assurance of the quality and safety of animal food raw materials and foodstuffs (meat, meat products, fish, shellfish, crayfish and their processing products) by the parasitic purity rates according the requirements under the Russian Federation's laws "On Sanitary and Epidemiological Well-Being of the Population", "On Protection of Consumer's Rights", "On Certification of Products and Services", those of SanPiN, such as 2.3.2.560-96 "Sanitary Requirements for the Quality and Safety of Food Raw Materials and Foodstuffs" and 3.2.569-96 "Prevention of Parasitic Diseases in the Russian Federation".

  11. The Readership of Liquor Ads Employing Appeals to Affiliation, Achievement, and Product-Attributes.

    ERIC Educational Resources Information Center

    Reid, Leonard N.; And Others

    A study examined whether advertising appeals based on product affiliation, achievement, and attributes would account for differences in male readership of liquor advertisements. The investigation focused on the relationship between the content of alcholic beverage advertisements and attention engagement, the first state in consumer information…

  12. Factors that contribute to the botulinal safety of reduced-fat and fat-free process chesse products.

    PubMed

    Glass, Kathleen A; Johnson, Eric A

    2004-08-01

    The effects of fat, type of natural cheese, and adjunct process cheese ingredients were evaluated to determine factors that contribute to the botulinal safety of reduced-fat (RF) process cheese products stored at 30 degrees C. In the first set of experiments, pasteurized process cheese products (PPCPs) were formulated using full-fat (FF) Cheddar, 30% RF Cheddar, or skim milk (SM) cheese as cheese-base types and were standardized to 59% moisture, pH 5.75, 2.8 or 3.2% total salts, and 15 to 19% fat. Subsequent trials evaluated the effect of fat levels and adjunct ingredients in PPCPs made with SM, RF, and FF cheese (final fat levels, less than 1, 13, and 24%, respectively). When fat levels of PPCPs were comparable (15.1, 19.1, and 16.2 for product manufactured with SC, RE and FF cheese, respectively), botulinal toxin production was delayed for up to 2 days in PPCPs formulated with SM compared with RF or FF cheese; however, the effect was not statistically significant. When fat levels were reduced to less than 1% in SM PPCPs, toxin production was delayed 2 weeks in products made with SM compared with RF or FF cheese manufactured with 13 or 24% fat, respectively. The antibotulinal effect of adjunct ingredients varied among the products manufactured with different fat levels. Sodium lactate significantly delayed toxin production (P < 0.05) for all fat levels tested, whereas beta-glucan fat replacer did not delay toxin production. An enzyme-modified cheese used as a flavor enhancer significantly delayed toxin production (P < 0.05) in SM (less than 1% fat) products but had little to no inhibitory effect in RF (13% fat) and FF (24% fat) cheese products. Similarly, monolaurin increased the time to detectable toxin in SM products but was ineffective in RF or FF cheese products. These results verify that RF PPCPs exhibit greater safety than FF products and that safety may be enhanced by using certain adjunct ingredients as antimicrobials.

  13. Relating safety, productivity and company type for motor-manual logging operations in the Italian Alps.

    PubMed

    Montorselli, Niccolò Brachetti; Lombardini, Carolina; Magagnotti, Natascia; Marchi, Enrico; Neri, Francesco; Picchi, Gianni; Spinelli, Raffaele

    2010-11-01

    The study compared the performance of four different logging crews with respect to productivity, organization and safety. To this purpose, the authors developed a data collection method capable of providing a quantitative analysis of risk-taking behavior. Four crews were tested under the same working conditions, representative of close-to-nature alpine forestry. Motor-manual working methods were applied, since these methods are still prevalent in the specific study area, despite the growing popularity of mechanical processors. Crews from public companies showed a significantly lower frequency of risk-taking behavior. The best safety performance was offered by the only (public) crew that had been administered formal safety training. The study seems to deny the common prejudice that safety practice is inversely proportional to productivity. Instead, productivity is increased by introducing more efficient working methods and equipment. The quantitative analysis of risk-taking behavior developed in this study can be applied to a number of industrial fields besides forestry. Characterizing risk-taking behavior for a given case may eventually lead to the development of custom-made training programmes, which may address problem areas while avoiding that the message is weakened by the inclusion of redundant information. In the specific case of logging crews in the central Alps, the study suggests that current training courses may be weak on ergonomics, and advocates a staged training programme, focusing first on accident reduction and then expanding to the prevention of chronic illness. 2010 Elsevier Ltd. All rights reserved.

  14. EPSRC Principles of Robotics: commentary on safety, robots as products, and responsibility

    NASA Astrophysics Data System (ADS)

    Boddington, Paula

    2017-04-01

    The EPSRC Principles of Robotics refer to safety. How safety is understood is relative to how tasks are characterised and identified. But the exact task(s) a robot plays within a complex system of agency may be hard to identify. If robots are seen as products, it is nonetheless vital that the safety and other implications of their use in situ must also be considered carefully, and they must be fit for purpose. The Principles identify humans as responsible, rather than robots. We must thus understand how the replacement of human agency by robotic agency may impact upon attributions of responsibility. The Principles seek to fit into existing systems of law and ethics. But these may need development, and in certain context, attention to more local regulations is also needed. A distinction between ethical issues related to the design of robotics, and to their use, may be needed in the Principles.

  15. Safety features of subcritical fluid fueled systems

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

    Bell, C.R.

    1995-10-01

    Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitativemore » in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved is very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible.« less

  16. Effectiveness of creative and productive instructional method towards students' learning achievement in steel structure course

    NASA Astrophysics Data System (ADS)

    Sugiyanto, Pribadi, Supriyanto, Bambang

    2017-09-01

    The purpose of this study was to investigate the effectiveness of Creative & Productive instructional method compared with conventional method. This research was a quasi-experimental study involving all Civil Engineering students at Universitas Negeri Malang who were taking a course of Steel Structure. The students were randomly assigned to two different treatment groups, 30 students in experimental group and 37 students in the control group. It was assumed that these groups were equal in all relevant aspects; they differed only in the treatment administered. We used the t-test to test the hypothesis. The results of this research suggest that: (l) the use of Creative & Productive instructional method can significantly improve students' learning achievement, (2) the use of Creative & Productive instructional method can significantly improve students' retention, (3) students' motivation has a significant effect on their learning achievement, and (4) students' motivation has a significant effect on their retention.

  17. Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

    PubMed

    Kesselheim, A S

    2010-06-01

    In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

  18. The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery

    PubMed Central

    Toomey, Paul G.; Ross, Sharona B.; Choung, Edward; Donn, Natalie; Vice, Michelle; Luberice, Kenneth; Albrink, Michael

    2015-01-01

    Background and Objectives: As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery. Methods: LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires. Results: Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0–20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique. Conclusion: In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in

  19. 77 FR 46764 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0011] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... orphan products. Orphan products are drugs, biologics, medical devices, and medical foods that are...

  20. Investigating the Chemical Safety of Household Products. Teacher's Guide [and] Student Materials.

    ERIC Educational Resources Information Center

    Davison, Phil J.

    This document provides teaching guidelines and student material for a unit intended for use in high school science or consumer programs. Time allotment is from four to six hours of classroom time. The objective of this capsule is to investigate the chemical safety of household products by teaching students how to form a hypothesis through the…

  1. Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.

    PubMed

    Buckley, Lorrene A; Salunke, Smita; Thompson, Karen; Baer, Gerri; Fegley, Darren; Turner, Mark A

    2018-02-05

    A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement. Copyright © 2017 Elsevier B.V. All rights reserved.

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

    PubMed

    Singh, Hardeep; Sittig, Dean F

    2016-04-01

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

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

    PubMed

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

    2012-09-01

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

  4. [Should we establish patient safety leadership walkrounds? A systematic review].

    PubMed

    Girerd-Genessay, I; Michel, P

    2015-10-01

    Used for over a decade, patient safety leadership walkrounds (PSLWs) is a managerial method designed to enhance the implementation of safety measures in hospitals. In order to determine the effect of PSLWs in French hospitals, we reviewed the literature on participant perceptions and the impact of PSLW on the overall culture of safety. We conducted a systematic review of articles assessing the impact of PSLWs on the culture of safety (comparative studies) or the perceptions of caregivers and managers (qualitative studies). Five studies investigating safety culture and three studies investigating participant perception were identified. PSLWs were associated with an improvement in safety culture and the overall safety climate. The presence of caregivers during the PSLWs was important to achieve improvement. PSLWs improved the dialogue between caregivers and managers, and improved knowledge on care safety. Some problems concerning managerial PSLW attendance and counter-productive attitudes have occasionally been reported. PSLWs improve safety culture. Their effectiveness depends on the way they are implemented. They should initially be tested in France to ensure their feasibility and acceptability in our healthcare system. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  5. Mapping medical marijuana: state laws regulating patients, product safety, supply chains and dispensaries, 2017.

    PubMed

    Klieger, Sarah B; Gutman, Abraham; Allen, Leslie; Pacula, Rosalie Liccardo; Ibrahim, Jennifer K; Burris, Scott

    2017-12-01

    (1) To describe open source legal data sets, created for research use, that capture the key provisions of US state medical marijuana laws. The data document how state lawmakers have regulated a medicine that remains, under federal law, a Schedule I illegal drug with no legitimate medical use. (2) To demonstrate the variability that exists across states in rules governing patient access, product safety and dispensary practice. Two legal researchers collected and coded state laws governing marijuana patients, product safety and dispensaries in effect on 1 February 2017, creating three empirical legal data sets. We used summary tables to identify the variation in specific statutory provisions specified in each state's medical marijuana law as it existed on 1 February 2017. We compared aspects of these laws to the traditional Federal approach to regulating medicine. Full data sets, codebooks and protocols are available through the Prescription Drug Abuse Policy System (http://www.pdaps.org/; Archived at http://www.webcitation.org/6qv5CZNaZ on 2 June 2017). Twenty-eight states (including the District of Columbia) have authorized medical marijuana. Twenty-seven specify qualifying diseases, which differ across states. All states protect patient privacy; only 14 protect patients against discrimination. Eighteen states have mandatory product safety testing before any sale. While the majority have package/label regulations, states have a wide range of specific requirements. Most regulate dispensaries (25 states), with considerable variation in specific provisions such as permitted product supply sources number of dispensaries per state and restricting proximity to various types of location. The federal ban in the United States on marijuana has resulted in a patchwork of regulatory strategies that are not uniformly consistent with the approach usually taken by the Federal government and whose effectiveness remains unknown. © 2017 Society for the Study of Addiction.

  6. Food safety and organic meats.

    PubMed

    Van Loo, Ellen J; Alali, Walid; Ricke, Steven C

    2012-01-01

    The organic meat industry in the United States has grown substantially in the past decade in response to consumer demand for nonconventionally produced products. Consumers are often not aware that the United States Department of Agriculture (USDA) organic standards are based only on the methods used for production and processing of the product and not on the product's safety. Food safety hazards associated with organic meats remain unclear because of the limited research conducted to determine the safety of organic meat from farm-to-fork. The objective of this review is to provide an overview of the published results on the microbiological safety of organic meats. In addition, antimicrobial resistance of microbes in organic food animal production is addressed. Determining the food safety risks associated with organic meat production requires systematic longitudinal studies that quantify the risks of microbial and nonmicrobial hazards from farm-to-fork.

  7. Current Status of the Preharvest Application of Pro- and Prebiotics to Farm Animals to Enhance the Microbial Safety of Animal Products.

    PubMed

    Joerger, Rolf D; Ganguly, Arpeeta

    2017-01-01

    The selection of microorganisms that act as probiotics and feed additives that act as prebiotics is an ongoing research effort, but a sizable range of commercial pro-, pre- and synbiotic (combining pro- and prebiotics) products are already available and being used on farms. A survey of the composition of commercial products available in the United States revealed that Lactobacillus acidophilus, Enterococcus faecium, and Bacillus subtilis were the three most common species in probiotic products. Of the nearly 130 probiotic products (also called direct-fed microbials) for which information was available, about 50 also contained yeasts or molds. The focus on these particular bacteria and eukaryotes is due to long-standing ideas about the benefits of such strains, research data on effectiveness primarily in laboratory or research farm settings, and regulations that dictate which microorganisms or feed additives can be administered to farm animals. Of the direct-fed microbials, only six made a claim relating to food safety or competitive exclusion of pathogens. None of the approximately 50 prebiotic products mentioned food safety in their descriptions. The remainder emphasized enhancement of animal performance such as weight gain or overall animal health. The reason why so few products carry food safety-related claims is the difficulties in establishing unambiguous cause and effect relationships between the application of such products in varied and constantly changing farm environments and improved food safety of the end product.

  8. Development of requirements on safety cases of machine industry products for power engineering

    NASA Astrophysics Data System (ADS)

    Aronson, K. E.; Brezgin, V. I.; Brodov, Yu. M.; Gorodnova, N. V.; Kultyshev, A. Yu.; Tolmachev, V. V.; Shablova, E. G.

    2016-12-01

    This article considers security assurance for power engineering machinery in the design and production phases. The Federal Law "On Technical Regulation" and the Customs Union Technical Regulations "On Safety of Machinery and Equipment" are analyzed in the legal, technical, and economic aspect with regard to power engineering machine industry products. From the legal standpoint, it is noted that the practical enforcement of most norms of the Law "On Technical Regulation" makes it necessary to adopt subordinate statutory instruments currently unavailable; moreover, the current level of adoption of technical regulations leaves much to be desired. The intensive integration processes observed in the Eurasian Region in recent years have made it a more pressing task to harmonize the laws of the region's countries, including their technical regulation framework. The technical aspect of analyzing the technical regulation of the Customs Union has been appraised by the IDEF0 functional modeling method. The object of research is a steam turbine plant produced at the turbine works. When developing the described model, we considered the elaboration of safety case (SC) requirements from the standpoint of the chief designer of the turbine works as the person generally responsible for the elaboration of the SC document. The economic context relies on risk analysis and appraisal methods. In their respect, these are determined by the purposes and objectives of analysis, complexity of considered objects, availability of required data, and expertise of specialists hired to conduct the analysis. The article proposes the description of all sources of hazard and scenarios of their actualization in all production phases of machinery life cycle for safety assurance purposes. The detection of risks and hazards allows forming the list of unwanted events. It describes the sources of hazard, various risk factors, conditions for their rise and development, tentative risk appraisals, and

  9. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  10. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  11. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  12. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  13. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  14. Safety warnings and first aid instructions on consumer and pharmaceutical products in Nigeria: has there been an improvement?

    PubMed

    Nonyelum, Stanley Catherine; Nkem, Nwachukwu; Ifeyinwa, Chijoke-Nwauche; Orisakwe, Orish Ebere

    2010-10-01

    To investigate the adequacy of safety warnings and first aid instructions on the labels of pharmaceutical and consumer products in Nigeria. A market basket method (total collection of all available samples) was used to investigate the adequacy of safety warnings and first aid instructions on the labels of 600 pharmaceutical and consumer products in Nigeria. The results showed that 69.8% of the products had adequate warnings whereas 385 (64.1%) of the products screened had legible product warnings. Only 52 (8.7%) of the total number of products had appropriate first aid instructions while only 25 (4.12%) of the products described symptoms and full treatment of poisoning by the product and 319 (53.2%) products surveyed recommended calling a health professional. A total of 31 (5.2%) products had labels that were considered too technical (non English). Of the 600 products, 386 (64.3%) had dosage instructions that were considered adequate while 538 (89.6%) had adequate storage instructions. About 68% of the products had partially correct warnings while 44 or 7.3% had partially correct first aid instructions. Some products had neither warnings nor first aid instructions. This study suggests a not too impressive improvement in the correctness and appropriateness of label information.

  15. Product-based Safety Certification for Medical Devices Embedded Software.

    PubMed

    Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

    2015-01-01

    Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

  16. Fisheries and aquaculture industries involvement to control product health and quality safety to satisfy consumer-driven objectives on retail markets in Europe.

    PubMed

    Roth, Eva; Rosenthal, Harald

    2006-01-01

    Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Käferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union.

  17. 76 FR 50748 - Information Collection Activity: Production Safety Systems, Revision of a Collection; Submitted...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... Production Safety Systems. OMB Control Number: 1010-0059. Abstract: The Outer Continental Shelf (OCS) Lands..., precautions, and techniques sufficient to prevent or minimize the likelihood of blowouts, loss of well control... an identifiable non-Federal recipient above and beyond those which accrue to the public at large...

  18. 75 FR 34360 - Consumer Product Safety Act: Notice of Commission Action on the Stay of Enforcement of Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-17

    ... certification provisions of section 14 of the Consumer Product Safety Act (CPSA) as amended by section 102 of..., the certification must be based on a test of each product or a reasonable testing program. For children's products, the certification must be based on testing conducted by a CPSC-accepted third party...

  19. Unstoppable The Gap Between Public Safety and Traffic Safety in the Age of Driverless Cars

    DTIC Science & Technology

    2017-03-01

    themselves, what will the increase in traffic safety cost society in terms of public safety? • What can public safety and homeland security...industry. Safer products are more marketable products, and companies that work with law enforcement for the benefit of public safety may have an...secondary public safety benefit of crime suppression. Reasonable suspicion to stop a vehicle would be an infrequent occurrence, and the legal authority

  20. Impact of biomarker development on drug safety assessment

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

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

    2010-03-01

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

  1. Can stress in farm animals increase food safety risk?

    PubMed

    Rostagno, Marcos H

    2009-09-01

    All farm animals will experience some level of stress during their lives. Stress reduces the fitness of an animal, which can be expressed through failure to achieve production performance standards, or through disease and death. Stress in farm animals can also have detrimental effects on the quality of food products. However, although a common assumption of a potential effect of stress on food safety exists, little is actually known about how this interaction may occur. The aim of this review was to examine the current knowledge of the potential impact of stress in farm animals on food safety risk. Colonization of farm animals by enteric pathogens such as Escherichia coli O157:H7, Salmonella, and Campylobacter, and their subsequent dissemination into the human food chain are a major public health and economic concern for the food industries. This review shows that there is increasing evidence to demonstrate that stress can have a significant deleterious effect on food safety through a variety of potential mechanisms. However, as the impact of stress is difficult to precisely determine, it is imperative that the issue receives more research attention in the interests of optimizing animal welfare and minimizing losses in product yield and quality, as well as to food safety risks to consumers. While there is some evidence linking stress with pathogen carriage and shedding in farm animals, the mechanisms underlying this effect have not been fully elucidated. Understanding when pathogen loads on the farm are the highest or when animals are most susceptible to infection will help identifying times when intervention strategies for pathogen control may be most effective, and consequently, increase the safety of food of animal origin.

  2. Prospective data mining of six products in the US FDA Adverse Event Reporting System: disposition of events identified and impact on product safety profiles.

    PubMed

    Bailey, Steven; Singh, Ajay; Azadian, Robert; Huber, Peter; Blum, Michael

    2010-02-01

    The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not been elucidated. To analyse the number and types of disproportionately reported product-event combinations (DRPECs), as well as the final disposition of each, in order to understand the potential utility and resource implications of routinely conducting data mining in the US FDA Adverse Event Reporting System (AERS). We generated DRPECs from AERS for six of Wyeth's products, prospectively tracked their dispositions and evaluated the appropriate DRPECs in the company's safety database. We chose EB05 (the lower bound of the 90% confidence interval around the Empirical Bayes Geometric Mean) > or =2 as the appropriate metric, employing stratification based on age, sex and year of report. A total of 861 DRPECs were identified - the average number of DRPECs was 144 per product. The proportion of unique preferred terms (PTs) in AERS for each drug with an EB05 > or =2 was similar across the six products (5.1-8.5%). Overall, 64.0% (551) of the DRPECs were closed after the initial screening (44.8% labelled, 14.3% indication related, 4.9% non-interpretable). An additional 9.9% (85) had been reviewed within the prior year and were not further reviewed. The remaining 26.1% (225) required full case review. After review of all pertinent reports and additional data, it was determined which of the DRPECs necessitated a formal review by the company's ongoing Safety Review Team (SRT) process. In total, 3.6% (31/861) of the DRPECs, yielding 16 medical concepts, were reviewed by the SRT, leading to seven labelling changes. These labelling changes involved 1.9% of all DRPECs generated. Four of the six compounds reviewed as part of this pilot had an identified labelling change. The

  3. Characterization of the animal by-product meal industry in Costa Rica: Manufacturing practices through the production chain and food safety.

    PubMed

    Leiva, A; Granados-Chinchilla, F; Redondo-Solano, M; Arrieta-González, M; Pineda-Salazar, E; Molina, A

    2018-06-01

    Animal by-product rendering establishments are still relevant industries worldwide. Animal by-product meal safety is paramount to protect feed, animals, and the rest of the food chain from unwanted contamination. As microbiological contamination may arise from inadequate processing of slaughterhouse waste and deficiencies in good manufacturing practices within the rendering facilities, we conducted an overall establishment's inspection, including the product in several parts of the process.An evaluation of the Good Manufacturing Practices (GMP) was carried out, which included the location and access (i.e., admission) to the facilities, integrated pest management programs, physical condition of the facilities (e.g., infrastructure), equipments, vehicles and transportation, as well as critical control points (i.e., particle size and temperature set at 50 mm, 133°C at atmospheric pressure for 20 min, respectively) recommended by the OIE and the European Commission. The most sensitive points according to the evaluation are physical structure of the facilities (avg 42.2%), access to the facilities (avg 48.6%), and cleaning procedures (avg 51.4%).Also, indicator microorganisms (Salmonella spp., Clostridium spp., total coliforms, E. coli, E. coli O157:H7) were used to evaluate the safety in different parts of the animal meal production process. There was a prevalence of Salmonella spp. of 12.9, 14.3, and 33.3% in Meat and Bone Meal (MBM), poultry by-products, and fish meal, respectively. However, there were no significant differences (P = 0.73) in the prevalence between the different animal meals, according to the data collected.It was also observed that renderings associated with the poultry industry (i.e., 92.0%) obtained the best ratings overall, which reflects a satisfactory development of this sector and the integration of its production system as a whole.

  4. Characterization of the animal by-product meal industry in Costa Rica: Manufacturing practices through the production chain and food safety

    PubMed Central

    Leiva, A; Granados-Chinchilla, F; Redondo-Solano, M; Arrieta-González, M; Pineda-Salazar, E; Molina, A

    2018-01-01

    ABSTRACT Animal by-product rendering establishments are still relevant industries worldwide. Animal by-product meal safety is paramount to protect feed, animals, and the rest of the food chain from unwanted contamination. As microbiological contamination may arise from inadequate processing of slaughterhouse waste and deficiencies in good manufacturing practices within the rendering facilities, we conducted an overall establishment's inspection, including the product in several parts of the process. An evaluation of the Good Manufacturing Practices (GMP) was carried out, which included the location and access (i.e., admission) to the facilities, integrated pest management programs, physical condition of the facilities (e.g., infrastructure), equipments, vehicles and transportation, as well as critical control points (i.e., particle size and temperature set at 50 mm, 133°C at atmospheric pressure for 20 min, respectively) recommended by the OIE and the European Commission. The most sensitive points according to the evaluation are physical structure of the facilities (avg 42.2%), access to the facilities (avg 48.6%), and cleaning procedures (avg 51.4%). Also, indicator microorganisms (Salmonella spp., Clostridium spp., total coliforms, E. coli, E. coli O157:H7) were used to evaluate the safety in different parts of the animal meal production process. There was a prevalence of Salmonella spp. of 12.9, 14.3, and 33.3% in Meat and Bone Meal (MBM), poultry by-products, and fish meal, respectively. However, there were no significant differences (P = 0.73) in the prevalence between the different animal meals, according to the data collected. It was also observed that renderings associated with the poultry industry (i.e., 92.0%) obtained the best ratings overall, which reflects a satisfactory development of this sector and the integration of its production system as a whole. PMID:29562297

  5. Culture matters: indigenizing patient safety in Bhutan.

    PubMed

    Pelzang, Rinchen; Johnstone, Megan-Jane; Hutchinson, Alison M

    2017-09-01

    Studies show that if quality of healthcare in a country is to be achieved, due consideration must be given to the importance of the core cultural values as a critical factor in improving patient safety outcomes. The influence of Bhutan's traditional (core) cultural values on the attitudes and behaviours of healthcare professionals regarding patient care are not known. This study aimed to explore the possible influence of Bhutan's traditional cultural values on staff attitudes towards patient safety and quality care. Undertaken as a qualitative exploratory descriptive inquiry, a purposeful sample of 94 healthcare professionals and managers were recruited from three levels of hospitals, a training institute and the Ministry of Health. Interviews were transcribed verbatim and analysed using thematic analysis strategies. The findings of the study suggest that Bhutanese traditional cultural values have both productive and counterproductive influences on staff attitudes towards healthcare delivery and the processes that need to be in place to ensure patient safety. Productive influences encompassed: karmic incentives to avoid preventable harm and promote safe patient care; and the prospective adoption of the 'four harmonious friends' as a culturally meaningful frame for improving understanding of the role and importance of teamwork in enhancing patient safety. Counterproductive influences included: the adoption of hierarchical and authoritative styles of management; unilateral decision-making; the legitimization of karmic beliefs; differential treatment of patients; and preferences for traditional healing practices and rituals. Although problematic in some areas, Bhutan's traditional cultural values could be used positively to inform and frame an effective model for improving patient safety in Bhutan's hospitals. Such a model must entail the institution of an 'indigenized' patient safety program, with patient safety research and reporting systems framed around local

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

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

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

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

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

    DOE PAGES

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

    2016-04-07

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

  8. Can the Academic Achievement of Korean Students Be Portrayed as a Product of "Shadow Achievement"?

    ERIC Educational Resources Information Center

    Kim, Hyunjin

    2015-01-01

    The purpose of this study was to investigate the effects of private tutoring expenditure on two types of Korean students' academic achievements as measured by standardized test achievement and by school performance achievement, applying 5-year data from Korean Educational Longitudinal Study (KELS). It was found that private tutoring expenditure…

  9. The availability and validity of safety information of over the counter herbal products for use in diabetes in Sri Lanka: A cross sectional study

    PubMed Central

    Medagama, Arjuna Bandara; Widanapahirana, Heshan; Prasanga, Tharindu

    2015-01-01

    Aims: There is an increase of over-the-counter (OTC) herbal products for use in diabetes mellitus. The aim of this study is to evaluate the safety information provided with OTC herbal remedies intended for diabetic patients in Sri Lanka and to assess the completeness of the information provided. Methods: Inclusion criteria consisted of OTC herbal remedies meant for use in diabetes. They were bought from local Sri Lankan supermarkets and non-ayurvedic pharmacies and product information regarding the risk of hypoglycemia, precautions for use, adverse events, dose, and interactions were assessed using a scoring system. The accuracy of the information was then compared against published data. Results: 11 products fulfilled the inclusion criteria. Five products contained a single constituent and five contained more than one. None had complete and accurate safety information according to our criteria. None specifically warned against the risk of hypoglycemia. 9 out of 11 products (81.8%) carried ≤3 items of the five essential factual information we expected. Hypoglycemic coma, gastrointestinal symptoms, hepatotoxicity, carcinogenesis, and interactions causing elevated drug levels of Carbamazepine were some of the safety information that was missing. Conclusions: Key safety information was absent in most products. Regulation of sale, provision of key safety information and adverse event reporting should be a priority. PMID:26649230

  10. [HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

    PubMed

    Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

    2017-04-01

    In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands

  11. 76 FR 14643 - Hazardous Materials: Safety Requirements for External Product Piping on Cargo Tanks Transporting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

    ... for External Product Piping on Cargo Tanks Transporting Flammable Liquids AGENCY: Pipeline and...) seeking public comment on a proposal to prohibit the transportation of flammable liquids in exposed... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part...

  12. Systems metabolic engineering of microorganisms to achieve large-scale production of flavonoid scaffolds.

    PubMed

    Wu, Junjun; Du, Guocheng; Zhou, Jingwen; Chen, Jian

    2014-10-20

    Flavonoids possess pharmaceutical potential due to their health-promoting activities. The complex structures of these products make extraction from plants difficult, and chemical synthesis is limited because of the use of many toxic solvents. Microbial production offers an alternate way to produce these compounds on an industrial scale in a more economical and environment-friendly manner. However, at present microbial production has been achieved only on a laboratory scale and improvements and scale-up of these processes remain challenging. Naringenin and pinocembrin, which are flavonoid scaffolds and precursors for most of the flavonoids, are the model molecules that are key to solving the current issues restricting industrial production of these chemicals. The emergence of systems metabolic engineering, which combines systems biology with synthetic biology and evolutionary engineering at the systems level, offers new perspectives on strain and process optimization. In this review, current challenges in large-scale fermentation processes involving flavonoid scaffolds and the strategies and tools of systems metabolic engineering used to overcome these challenges are summarized. This will offer insights into overcoming the limitations and challenges of large-scale microbial production of these important pharmaceutical compounds. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. Preclinical safety and efficacy of a new recombinant FIX drug product for treatment of hemophilia B.

    PubMed

    Dietrich, Barbara; Schiviz, Alexandra; Hoellriegl, Werner; Horling, Frank; Benamara, Karima; Rottensteiner, Hanspeter; Turecek, Peter L; Schwarz, Hans Peter; Scheiflinger, Friedrich; Muchitsch, Eva-Maria

    2013-11-01

    Baxter has developed a new recombinant factor IX (rFIX) drug product (BAX326) for treating patients with hemophilia B, or congenital FIX deficiency. An extensive preclinical program evaluated the pharmacokinetics, efficacy, and safety of BAX326 in different species. The efficacy of BAX326 was tested in three mouse models of primary pharmacodynamics: tail-tip bleeding, carotid occlusion, and thrombelastography. The pharmacokinetics was evaluated after a single intravenous bolus injection in mice, rats, and macaques. Toxicity was assessed in rats and macaques, safety pharmacology in rabbits and macaques, and immunogenicity in mice. BAX326 was shown to be efficacious in all three primary pharmacodynamic studies (P ≤ 0.0076). Hemostatic efficacy was dose related and similar for the three lots tested. Pharmacokinetic results showed that rFIX activity and rFIX antigen concentrations declined in a bi-phasic manner, similar to a previously licensed rFIX product. BAX326 was well tolerated in rabbits and macaques at all dose levels; no thrombogenic events and no adverse clinical, respiratory, or cardiovascular effects occurred. BAX326 was also shown to have a similar immunogenicity profile to the comparator rFIX product in mice. These results demonstrate that BAX326 has a favorable preclinical safety and efficacy profile, predictive of a comparable effect to that of the previously licensed rFIX in humans.

  14. Communication of medical product risk: how effective is effective enough?

    PubMed

    Goldman, Stephen A

    2004-01-01

    Ever-increasing attention is being paid worldwide to the safety of medical products, and the risks associated with their use. The integral role of risk communication in overall risk management is demonstrated by several recent market withdrawals of drugs, in which a perceived incapability of healthcare systems to manage well-characterised, avoidable risks was a significant factor. With advances in clinical pharmacology, pharmacogenomics and pharmacoepidemiology expanding our knowledge of medical products, effective delivery of the latest safety-related information to health professionals and consumers becomes even more imperative. In this regard, it is important to evaluate whether current modes of risk communication lead to desired changes in relevant behaviours such as prescribing or drug monitoring, particularly in context with which achieved level of effectiveness is deemed acceptable. This is crucial, as there have been product-specific risk communication efforts that achieved a fair degree of success, yet were not seen as effective enough to prevent market withdrawal of the medical product in question. In the service of improving public health through enhanced risk communication, it is essential to critically assess current methods, both as to results achieved (or not), and whether each method is applicable to the various types of risks associated with medical product use. Furthermore, just as combining methods may well improve overall risk communication, there are societal and psychological factors that must be considered in attempting to maximise effectiveness. However, in assessing risk communication effectiveness, the particular benefit- risk relationship of any individual medical product must also be part of the evaluative process.

  15. Three-color mixing for classifying agricultural products for safety and quality

    NASA Astrophysics Data System (ADS)

    Ding, Fujian; Chen, Yud-Ren; Chao, Kuanglin; Kim, Moon S.

    2006-05-01

    A three-color mixing application for food safety inspection is presented. It is shown that the chromaticness of the visual signal resulting from the three-color mixing achieved through our device is directly related to the three-band ratio of light intensity at three selected wavebands. An optical visual device using three-color mixing to implement the three-band ratio criterion is presented. Inspection through human vision assisted by an optical device that implements the three-band ratio criterion would offer flexibility and significant cost savings as compared to inspection with a multispectral machine vision system that implements the same criterion. Example applications of this optical three-color mixing technique are given for the inspection of chicken carcasses with various diseases and for apples with fecal contamination. With proper selection of the three narrow wavebands, discrimination by chromaticness that has a direct relation with the three-band ratio can work very well. In particular, compared with the previously presented two-color mixing application, the conditions of chicken carcasses were more easily identified using the three-color mixing application. The novel three-color mixing technique for visual inspection can be implemented on visual devices for a variety of applications, ranging from target detection to food safety inspection.

  16. Kansas City Plant Celebrates Safety Milestone

    ScienceCinema

    None

    2017-12-09

    A gang of motorcycle riders arrived at the NNSA's Kansas City Plant on July 1 to help celebrate a significant safety achievement - working nearly five million hours, covering a one-year period without a lost-time injury. The bikers -- some of whom are plant employees -- represent Bikers Against Child Abuse, the local nonprofit selected to receive a $5,000 donation as part of the plant's safety achievement celebration. The organization was selected because it aligns with the plant's community outreach focus on Family Safety & Security and partnership with the plant's union members.

  17. Creation of a Natural Health Products Database for Assessing Safety for Patients with Chronic Kidney Disease or Renal Transplant.

    PubMed

    Leung, Sharon; Shalansky, Karen; Vashisht, Puneet; Leung, Marianna; Marin, Judith G

    2017-01-01

    There is a lack of published safety information on the use of natural health products (NHPs) for patients with chronic kidney disease (CKD) or renal transplant. To create an online database to provide evidence-based safety recommendations for commonly used NHPs, specific to patients with CKD or renal transplant. NHPs used by CKD and transplant patients in British Columbia were identified from the records of the BC Provincial Renal Agency. For each NHP, several databases (MEDLINE, Embase, Lexi-Natural Products, PubMed Dietary Supplement Subset, and Natural Medicines) were searched for any information pertaining to dosage, adverse drug reactions, drug interactions, immunomodulatory effects, and pharmacokinetics in patients with renal disease. Each NHP was given 1 of 4 safety ratings: likely safe, possibly safe, possibly unsafe, and likely unsafe. An NHP was classified as "possibly unsafe" for patients with renal transplant if it had demonstrated in vitro immunomodulatory effects and/or significant interactions with transplant medications due to effects on the cytochrome P450 3A4 isozyme. Of the 19 627 BC-registered patients with renal disease (as of August 2014), 4122 (21%) were using one or more NHPs. The Herbal-CKD website (www.herbalckd.com) was created in 2015 to provide information about 47 commonly used NHPs and 2 known nephrotoxins (aristolochic acid and silver). This website provides a systematic evaluation of safety information for selected NHPs for patients with CKD (both nondialysis and dialysis-dependent) and kidney transplant. The most common NHP safety classification was "possibly safe", reflecting the paucity of studies in renal populations and the availability of safety data for the general population. Limitations of the website include difficulty in interpreting and generalizing the safety literature because most NHP formulations are not standardized, and others are combination products. The website www.herbalckd.com provides an easy-to-use, evidence

  18. Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective.

    PubMed

    Markovic, Ingrid

    2007-09-01

    Leachables are chemical entities that migrate spontaneously from the final container closure system, packaging components and/or processing equipment under recommended conditions of product use and storage. Unlike leachables, extractables are generated under exaggerated temperature and time conditions in the presence of an appropriate solvent. Increasing evidence suggests that leachables may pose a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine dysregulation. These substances may also alter product physico-chemical properties via interaction with the active pharmaceutical ingredient or the excipients in product vehicle, thereby adversely affecting the final product quality. The evaluation of leachable compounds begins with a thorough identification of extractable compounds released from the production and packaging components under exaggerated conditions. The set of observed extractables helps to identify possible targets to be monitored in a subsequent leachables study over extended time periods. Although extractables and leachables also present a challenge for the safe use of device components (e.g., metered dose inhalers, dry powder inhalers, nasal spray devices or various implants), this review focusses on a safety risk assessment for specified therapeutic biological protein products. Regulatory, safety and scientific considerations in evaluating extractables and leachables are discussed, along with strategies for the analytical identification, quantification and monitoring.

  19. Development of a Safety Monitoring and Assurance System for chilled food products.

    PubMed

    Koutsoumanis, K; Taoukis, P S; Nychas, G J E

    2005-04-15

    The principles of a novel chill chain management policy, coded Safety Monitoring and Assurance System (SMAS) for the optimisation of the distribution of chilled food products within the chill chain are developed. In this system, a new approach based on actual risk evaluation at important points of the chill chain is used in order to promote products to the next stage of distribution. This evaluation based on product's time-temperature history, variation in product's characteristics (e.g. a(w), pH, etc.), and the use of predictive models for the growth of food pathogens, allows to give priority to products in such a way that risk at consumption time is minimized. The effectiveness of SMAS was evaluated against the First In First Out (FIFO) approach, the current method for food distribution, in a case study on the risk of listeriosis of cooked ham using the Monte Carlo simulation technique. Furthermore, the two approaches were compared for their effect on the quality of the products in terms of remaining shelf life at the time of consumption. The results showed that following the SMAS approach the risk of listerisosis is significantly lower while the spoiled products at the time of consumption are significantly reduced compared to FIFO approach.

  20. Impact of Investment in Education and Training on Performance in Production, Quality and Safety.

    ERIC Educational Resources Information Center

    Williams, J. Fred; Robinson-Horne, Jacquelyn P.

    This paper reports on a study that sought to determine the relationships between investment in education and training and performance in production, quality, and safety in manufacturing companies in northeast Alabama and northwest Georgia. The study also examined whether company size was a factor in predicting the ratio of the investment. One…

  1. Rodent Control Pesticide Safety Review

    EPA Pesticide Factsheets

    EPA completed a safety review in 2008 of rat and mouse poison products. Many companies' products have our safety measures that reduce risks to humans, pets, and non-target wildlife. Products must be sold with bait stations that securely contain the poison.

  2. Explore The NASA Safety Center

    NASA Image and Video Library

    2015-07-01

    The NASA Safety Center (NSC) reports to NASA’s Office of Safety and Mission Assurance and supports the Safety and Mission Assurance (SMA) requirements of NASA’s portfolio of programs and projects. The NSC focuses on development of the personnel, processes and tools needed for the safe and successful achievement of NASA’s strategic goals.

  3. 76 FR 22019 - Safety Standard for Toddler Beds

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-20

    ... warnings should increase consumers' understanding of the connection between the relevant behaviors and... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1217 RIN 3041-AC79 Safety Standard for Toddler Beds AGENCY: Consumer Product Safety Commission. ACTION: Final rule. SUMMARY: The Consumer Product Safety...

  4. Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland.

    PubMed

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

    The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain.

  5. Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland

    PubMed Central

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

    The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain. PMID:27341034

  6. Safety of High Speed Ground Transportation Systems : Analytical Methodology for Safety Validation of Computer Controlled Subsystems : Volume 2. Development of a Safety Validation Methodology

    DOT National Transportation Integrated Search

    1995-01-01

    This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety cortical functions in high-speed rail or magnetic levitation ...

  7. Fire safety

    Treesearch

    Robert H. White; Mark A. Dietenberger

    1999-01-01

    Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Since basic data on fire behavior of wood products...

  8. [Study on the occupational stress norm and it's application for the marketing group, public service/safety group and production laborer group].

    PubMed

    Yang, Xin-Wei; Wang, Zhi-Ming; Jin, Tai-Yi; Lan, Ya-Jia

    2006-09-01

    A study of the occupational stress norm and it's application for the marketing group, public service/safety group and production laborer group. In this study, cross-sectional study method is used, and a synthetic way of sorting and randomized sampling is adopted to deal with research targets (36 marketing group, 331 public service/safety group, 903 production laborer group). Descriptive statistics for OSI-R scale scores for the marketing group, public service/safety group and production laborer group were modulated. Scale raw score to T-score conversion tables derived from the OSI-R normative sample for marketing group public service/safety group and production laborer group were established. OSI-R profile from for marketing group, public service/safety group and production laborer group were established. For the ORQ and PSQ scales, scores at or above 70 indicate a strong levels of maladaptive stress and strain. Score in the range of 60 to 69 suggest middle levels of maladaptive stress and strain. Score in the range of 40 to 59 indicate normal levels of stress and strain. Score below 40 indicate a relative absence of occupational stress and strain. For the PRQ scales, score below 30 indicate a significant lack of coping resources. Score in the range of 30 to 39 suggest middle deficits in coping resources. Score in the range of 40 to 59 indicate average coping resources. Scores at or above 60 indicate a strong levels of coping resources. The authors combined subjective and objective environment match model of occupational stress. Different intervention measure should be take to reduce the occupational stress so as to improve the work ability.

  9. Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System.

    PubMed

    Jenke, Dennis

    2012-01-01

    An emerging trend in the biotechnology industry is the utilization of plastic components in manufacturing systems for the production of an active pharmaceutical ingredient (API) or a finished drug product (FDP). If the API, the FDP, or any solution used to generate them (for example, process streams such as media, buffers, and the like) come in contact with a plastic at any time during the manufacturing process, there is the potential that substances leached from the plastic may accumulate in the API or FDP, affecting safety and/or efficacy. In this article the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the article outlines the safety assessment process for manufacturing systems, specifically addressing the topics of risk management and the role of compendial testing. Finally, the proper use of vendor-supplied extractables information is considered. Manufacturing suites used to produce biopharmaceuticals can include components that are made out of plastics. Thus it is possible that substances could leach out of the plastics and into manufacturing solutions, and it is further possible that such leachables could accumulate in the pharmaceutical product. In this article, the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the author proposes a process by which the impact on product safety of such leached substances can be assessed.

  10. High Performing Schools in High Risk Environments: A Study on Leadership, School Safety, and Student Achievement at Two Urban Middle Schools in Los Angeles County

    ERIC Educational Resources Information Center

    Frias, Gus

    2010-01-01

    In the United States of America, all students and staff have a constitutional right to attend schools that are safe, secure, and successful. Despite this right, at many public schools, education leaders have failed to ensure the safety and high academic achievement of all students. The purpose of this research study is to expand knowledge about…

  11. A Public-Private Consortium Advances Cardiac Safety Evaluation: Achievements of the HESI Cardiac Safety Technical Committee

    EPA Science Inventory

    The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals. Cardiac safety issues have been and continue to be a major cause of attrition and withdrawal due to Adverse Drug Reactions (ADRs) in pharmaceutical drug developm...

  12. United States import safety, environmental health, and food safety regulation in China.

    PubMed

    Nyambok, Edward O; Kastner, Justin J

    2012-01-01

    China boasts a rapidly growing economy and is a leading food exporter. Since China has dominated world export markets in food, electronics, and toys, many safety concerns about Chinese exports have emerged. For example, many countries have had problems with Chinese food products and food-processing ingredients. Factors behind food safety and environmental health problems in China include poor industrial waste management, the use of counterfeit agricultural inputs, inadequate training of farmers on good farm management practices, and weak food safety laws and poor enforcement. In the face of rising import safety problems, the U.S. is now requiring certification of products and foreign importers, pursuing providing incentives to importers who uphold good safety practices, and considering publicizing the names of certified importers.

  13. Nuclear Safety Information Center, Its Products and Services

    ERIC Educational Resources Information Center

    Buchanan, J. R.

    1970-01-01

    The Nuclear Safety Information Center (NSIC) serves as a focal point for the collection, analysis and dissemination of information related to safety problems encountered in the design, analysis, and operation of nuclear facilities. (Author/AB)

  14. Utah ITS/CVO business plan : using technology to maximize highway safety and improve government and industry productivity

    DOT National Transportation Integrated Search

    1997-12-31

    This plan was produced to maximize highway safety and increase government and industry productivity through the application of Intelligent Transportation System/Commercial Vehicle Operations (ITS/CVO) technologies to support regulatory and enforcemen...

  15. How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study.

    PubMed

    Berger, M; Kooyman, P J; Makkee, M; van der Zee, J S; Sterk, P J; van Dijk, J; Kemper, E M

    2016-08-19

    Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the study. However, there are no specific regulations or guidelines for non-Medicinal Investigational Products (non-MIPs) such as allergens, enriched food supplements, and air pollution components. As a consequence, investigators will avoid clinical research and prefer preclinical models or in vitro testing for e.g. toxicology studies. 1) briefly review the current guidelines and regulations for Investigational Medicinal Products; 2) present a standardised approach to ensure the quality and safety of non-MIPs in human in vivo research; and 3) discuss some lessons we have learned. We propose a practical line of approach to compose a clarifying product dossier (PD), comprising the description of the production process, the analysis of the raw and final product, toxicological studies, and a thorough risk-benefit-analysis. This is illustrated by an example from a human in vivo research model to study exposure to air pollutants, by challenging volunteers with a suspension of carbon nanoparticles (the component of ink cartridges for laser printers). With this novel risk-based approach, the members of competent authorities are provided with standardised information on the quality of the product in relation to the safety of the participants, and the scientific goal of the study.

  16. Preparation, Phytochemical Investigation, and Safety Evaluation of Chlorogenic Acid Products from Eupatorium adenophorum.

    PubMed

    Liu, Boyan; Cao, Lili; Zhang, Lijun; Yuan, Xiaofan; Zhao, Bing

    2016-12-31

    Eupatorium adenophorum is widely distributed throughout the world's tropical and temperate regions. It has become a harmful weed of crops and natural environments. Its leaves contain bioactive compounds such as chlorogenic acid and may be used as feed additives. In this study, chlorogenic acid was extracted and separated from leaves of E. adenophorum . Three chlorogenic acid products were prepared with different purities of 6.11%, 22.17%, and 96.03%. Phytochemical analysis demonstrated that the main toxins of sesquiterpenes were almost completely removed in sample preparation procedure. The three products were evaluated for safety via in vitro and in vivo toxicological studies. All the products exhibited no cytotoxic effects at a dose of 400 μg/mL in an in vitro cell viability assay. When administered in vivo at a single dose up to 1.5 g/kg bw, all three products caused no signs or symptoms of toxicity in mice. These results encourage further exploration of extracts from E. adenophorum in feed additive application.

  17. Motor vehicle safety : comprehensive state programs offer best opportunity for increasing use of safety belts

    DOT National Transportation Integrated Search

    1996-01-01

    This report describes the nation's progress in achieving goals for the use of safety belts in motor vehicles, assesses the strategies used most successfully by some states to increase the use of safety belts, and identifies federal strategies that co...

  18. Achieving compatibility of state and federal safety requirements : a report to the Secretary of Transportation.

    DOT National Transportation Integrated Search

    1990-08-01

    The Commercial Motor Vehicle Safety Regulatory Review Panel (Safety : Panel) has prepared this report in response to Sections 207, 208, and 209 of : the Motor Carrier Safety Act of 1984 (Public Law 98-554). A major goal of the : 1984 Act was to achie...

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

    NASA Astrophysics Data System (ADS)

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

    2018-01-01

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

  20. Climate Change and Food Safety: Beyond Production

    NASA Astrophysics Data System (ADS)

    Ziska, L. H.; Crimmins, A. R.

    2016-12-01

    There is merited interest in determining the extent of climate disruption on agricultural production and food security. However, additional aspects of food security, including food safety, nutrition and distribution have, overall, received less attention. Beginning in 2013, the U.S. Global Change Research Program as part of the ongoing National Climate Assessment, began a directed effort to evaluate the vulnerability of climate change to these under-represented aspects of food security for developed countries. Based on this extensive review of current science, several key findings were developed: (a) Climate change, including rising temperatures and changes in weather extremes, is expected to increase the exposure of food to certain pathogens and toxins; (b) Climate change will increase human exposure to chemical contaminants in food through several pathways; (c) The nutritional value of agriculturally important food crops, including cereals, will decrease in response to the ongoing increase in atmospheric carbon dioxide; (d) Increases in the frequency or intensity of extreme weather events associated with climate change may disrupt food distribution. These findings will be presented as a means to describe the state of the science and expand on food security research in the broader context of public health and climate change.

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

    PubMed Central

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

    2016-01-01

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

  2. Life cycle assessment of a road safety product made with virgin and recycled HDPE.

    PubMed

    Simões, Carla L; Xará, Susana M; Bernardo, C A

    2011-04-01

    The present study aims at evaluating the potential environmental impact of using recycled high-density polyethylene (HDPE) in the production of an anti-glare lamella (AGL), a road safety device currently manufactured from virgin (not recycled) polymer. The impact was evaluated using the life cycle assessment (LCA) technique and comparing two alternative systems: current AGL, manufactured from virgin HDPE, and optional AGL, made with recycled HDPE obtained from post-consumer packages. The AGL manufacturing phase was found to be responsible for most of the impacts in both systems, with the production of the raw material being the largest contributor for that phase. The present study makes a contribution to the problem of developing value-added products made from post-consumer polymeric recyclates.

  3. Understanding patient safety performance and educational needs using the 'Safety-II' approach for complex systems.

    PubMed

    McNab, Duncan; Bowie, Paul; Morrison, Jill; Ross, Alastair

    2016-11-01

    Participation in projects to improve patient safety is a key component of general practice (GP) specialty training, appraisal and revalidation. Patient safety training priorities for GPs at all career stages are described in the Royal College of General Practitioners' curriculum. Current methods that are taught and employed to improve safety often use a 'find-and-fix' approach to identify components of a system (including humans) where performance could be improved. However, the complex interactions and inter-dependence between components in healthcare systems mean that cause and effect are not always linked in a predictable manner. The Safety-II approach has been proposed as a new way to understand how safety is achieved in complex systems that may improve quality and safety initiatives and enhance GP and trainee curriculum coverage. Safety-II aims to maximise the number of events with a successful outcome by exploring everyday work. Work-as-done often differs from work-as-imagined in protocols and guidelines and various ways to achieve success, dependent on work conditions, may be possible. Traditional approaches to improve the quality and safety of care often aim to constrain variability but understanding and managing variability may be a more beneficial approach. The application of a Safety-II approach to incident investigation, quality improvement projects, prospective analysis of risk in systems and performance indicators may offer improved insight into system performance leading to more effective change. The way forward may be to combine the Safety-II approach with 'traditional' methods to enhance patient safety training, outcomes and curriculum coverage.

  4. The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

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

    Hughes, P. J.; Westwood, R.N; Mark, R. T.

    2006-07-01

    The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety casesmore » for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)« less

  5. Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

    PubMed

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

  6. Control of Listeria species food safety at a poultry food production facility.

    PubMed

    Fox, Edward M; Wall, Patrick G; Fanning, Séamus

    2015-10-01

    Surveillance and control of food-borne human pathogens, such as Listeria monocytogenes, is a critical aspect of modern food safety programs at food production facilities. This study evaluated contamination patterns of Listeria species at a poultry food production facility, and evaluated the efficacy of procedures to control the contamination and transfer of the bacteria throughout the plant. The presence of Listeria species was studied along the production chain, including raw ingredients, food-contact, non-food-contact surfaces, and finished product. All isolates were sub-typed by pulsed-field gel electrophoresis (PFGE) to identify possible entry points for Listeria species into the production chain, as well as identifying possible transfer routes through the facility. The efficacy of selected in-house sanitizers against a sub-set of the isolates was evaluated. Of the 77 different PFGE-types identified, 10 were found among two or more of the five categories/areas (ingredients, food preparation, cooking and packing, bulk packing, and product), indicating potential transfer routes at the facility. One of the six sanitizers used was identified as unsuitable for control of Listeria species. Combining PFGE data, together with information on isolate location and timeframe, facilitated identification of a persistent Listeria species contamination that had colonized the facility, along with others that were transient. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Building the Child Safety Collaborative Innovation and Improvement Network: How does it work and what is it achieving?

    PubMed

    Leonardo, Jennifer B; Spicer, Rebecca S; Katradis, Maria; Allison, Jennifer; Thomas, Rebekah

    2018-06-01

    This study investigated whether the Child Safety Collaborative Innovation and Improvement Network (CS CoIIN) framework could be applied in the field of injury and violence prevention to reduce fatalities, hospitalizations and emergency department visits among 0-19 year olds. Twenty-one states/jurisdictions were accepted into cohort 1 of the CS CoIIN, and 14 were engaged from March 2016 through April 2017. A quality improvement framework was used to test, implement and spread evidence-based change ideas (strategies and programs) in child passenger safety, falls prevention, interpersonal violence prevention, suicide and self-harm prevention and teen driver safety. Outcome and process measure data were analyzed using run chart rules. Descriptive data were analyzed for participation measures and descriptive statistics were produced. Qualitative data were analyzed to identify key themes. Seventy-six percent of CS CoIIN states/jurisdictions were engaged in activities and used data to inform decision making. Within a year, states/jurisdictions were able to test and implement evidence-based change ideas in pilot sites. A small group showed improvement in process measures and were ready to spread change ideas. Improvement in outcome measures was not achieved; however, 25% of states/jurisdictions identified data sources and reported on real-time outcome measures. Evidence indicates the CS CoIIN framework can be applied to make progress on process measures, but more time is needed to determine if this will result in progress on long-term outcome measures of fatalities, hospitalizations and emergency department visits. Seventeen states/jurisdictions will participate in cohort 2. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Approach for validating actinide and fission product compositions for burnup credit criticality safety analyses

    DOE PAGES

    Radulescu, Georgeta; Gauld, Ian C.; Ilas, Germina; ...

    2014-11-01

    This paper describes a depletion code validation approach for criticality safety analysis using burnup credit for actinide and fission product nuclides in spent nuclear fuel (SNF) compositions. The technical basis for determining the uncertainties in the calculated nuclide concentrations is comparison of calculations to available measurements obtained from destructive radiochemical assay of SNF samples. Probability distributions developed for the uncertainties in the calculated nuclide concentrations were applied to the SNF compositions of a criticality safety analysis model by the use of a Monte Carlo uncertainty sampling method to determine bias and bias uncertainty in effective neutron multiplication factor. Application ofmore » the Monte Carlo uncertainty sampling approach is demonstrated for representative criticality safety analysis models of pressurized water reactor spent fuel pool storage racks and transportation packages using burnup-dependent nuclide concentrations calculated with SCALE 6.1 and the ENDF/B-VII nuclear data. Furthermore, the validation approach and results support a recent revision of the U.S. Nuclear Regulatory Commission Interim Staff Guidance 8.« less

  9. 77 FR 35745 - Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ..., battery powered device with a semiconductor sensor. (2) Alcohol Countermeasure Systems Corp., submitted...-0062] Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in... Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956). DATES: Effective...

  10. 78 FR 37706 - Safety Standards for Infant Walkers and Infant Swings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ... Danny Keysar Child Product Safety Notification Act, if ASTM revises the underlying voluntary standard... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1216 and 1223 Safety Standards for Infant Walkers... the Danny Keysar Child Product Safety Notification Act, the U.S. Consumer Product Safety Commission...

  11. Application of Modern Tools and Techniques for Mine Safety & Disaster Management

    NASA Astrophysics Data System (ADS)

    Kumar, Dheeraj

    2016-04-01

    The implementation of novel systems and adoption of improvised equipment in mines help mining companies in two important ways: enhanced mine productivity and improved worker safety. There is a substantial need for adoption of state-of-the-art automation technologies in the mines to ensure the safety and to protect health of mine workers. With the advent of new autonomous equipment used in the mine, the inefficiencies are reduced by limiting human inconsistencies and error. The desired increase in productivity at a mine can sometimes be achieved by changing only a few simple variables. Significant developments have been made in the areas of surface and underground communication, robotics, smart sensors, tracking systems, mine gas monitoring systems and ground movements etc. Advancement in information technology in the form of internet, GIS, remote sensing, satellite communication, etc. have proved to be important tools for hazard reduction and disaster management. This paper is mainly focused on issues pertaining to mine safety and disaster management and some of the recent innovations in the mine automations that could be deployed in mines for safe mining operations and for avoiding any unforeseen mine disaster.

  12. Increasing Patient Safety by Closing the Sterile Production Gap-Part 1. Introduction.

    PubMed

    Agalloco, James P

    2017-01-01

    Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high population of a resistant biological indicator is required. The origin of this misconception is unclear, but it has resulted in sterilization conditions that are extremely harsh (15 min at 121 °C, of F 0 > 8 min), which limit the use of terminal sterilization to extremely heat-stable formulations. These articles outline the artificial nature of the process constraints and describe a scientifically sound means to expand the use of terminal sterilization by identifying the correct process goal-destruction of the bioburden present in the container prior to sterilization. Recognition that the true intention is bioburden destruction in routine products allows for the use of reduced conditions (lower temperatures, shorter process dwell, or both) without added patient risk. By focusing attention on the correct process target, lower time-temperature conditions can be used to expand the use of terminal sterilization to products unable to withstand the harsh conditions that have been mistakenly applied. The first article provides the background and describes the benefits to patient, producer, and regulator. The second article includes validation and operational advice that can be used in the implementation. LAY ABSTRACT: Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient

  13. Increasing Patient Safety by Closing the Sterile Production Gap-Part 2. Implementation.

    PubMed

    Agalloco, James P

    2017-01-01

    Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high concentration of a resistant biological indicator is required. The origin of this misconception is unclear, but it has resulted in sterilization conditions that are extremely harsh (15 min at 121 °C, of F 0 >8 min), which limit the use of terminal sterilization to extremely heat-stable formulations. These articles outline the artificial nature of the process constraints and describe a scientifically sound means to expand the use of terminal sterilization by identifying the correct process goal-the destruction of the bioburden present in the container prior to sterilization. Recognition that the true intention is bioburden destruction in routine products allows for the use of reduced conditions (lower temperatures, shorter process dwell, or both) without added patient risk. By focusing attention on the correct process target, lower time-temperature conditions can be used to expand the use of terminal sterilization to products unable to withstand the harsh conditions that have been mistakenly applied. The first article provides the background, and describes the benefits to patient, producer, and regulator. The second article includes validation and operational advice that can be used in the implementation. LAY ABSTRACT: Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious

  14. Evaluation of the efficiency and safety in cosmetic products.

    PubMed

    Uckaya, Meryem; Uckaya, Fatih; Demir, Nazan; Demir, Yasar

    2016-02-29

    Chemicals used in cosmetics have to interact with enzymes for beneficial or destroy purpose after they enter in our body. Active sections of enzymes that catalyze reactions have three dimensions and they are active optically. When these limitations of catalytic sections are considered, it may be considered that defining geometric specifications of chemical materials and functional groups they contain may contribute on safety evaluations of cosmetic products. In this study, defining similarities and differences of geometric structures of chemicals that are prohibited to be used in cosmetic products and chemical that are allowed to be used by using group theory and analyze of functional groups that are often encountered in these chemicals are aimed. Molecule formulas related to chemical material of, 276 pieces chemicals that are prohibited to be used in cosmetic products and 65 pieces chemicals that are allowed, are used as the material. Two and three-dimension structures of these formulas are drawn and types and quantity of functional groups they contain are defined. And as a method, freeware (Free Trial) version of "Chem-BioOffice Ultra 13.0 Suite" chemical drawing program to draw two and three-dimension of formulas, "Campus-Licensed" version that are provided for use by our university of "Autodesk 3DS Max" for three-dimension drawings are used. In order to analyze geometric specifications of drawn molecules according to Group Theory and define type and quantity of available functional groups, Excel applications developed by Prof. Dr. Yaşar Demir are used. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

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

    Jordan, Scott A., E-mail: scott.jordan@hc-sc.gc.c; Cunningham, David G.; Marles, Robin J.

    Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantitymore » and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.« less

  16. Efficacy and safety of azathioprine and dapsone as an adjuvant in the treatment of bullous pemphigoid.

    PubMed

    Tirado-Sánchez, A; Díaz-Molina, V; Ponce-Olivera, R M

    2012-01-01

    Bullous pemphigoid is a chronic, blistering and autoimmune disease, common in old age. The treatment usually includes systemic steroids, however, these cause high morbidity rates, and then different products that function as adjuvants have been tried. At present, there are no studies to determine which adjuvant offers a better efficacy and safety profile. We performed a retrospective study which included the records of patients with bullous pemphigoid, treated either with azathioprine or dapsone. We evaluated the time to achieve complete remission, the time to inhibit disease progression, and the control of pruritus. Fifteen records of patients were selected, eight (53%) treated with azathioprine and seven (47%) with dapsone. Complete remission was achieved at week six in both groups. We found no difference in the inhibition of disease progression (p=0.083). Pruritus was controlled at four weeks of treatment in both treatments. Both products are effective as adjuvant in the treatment of bullous pemphigoid, with an acceptable safety profile. Copyright © 2010 SEICAP. Published by Elsevier Espana. All rights reserved.

  17. The business case for patient safety.

    PubMed

    Hwang, Raymond W; Herndon, James H

    2007-04-01

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

  18. Analysis of Scientific Production in Food Science from 2003 to 2013.

    PubMed

    Guerrero-Bote, Vicente P; Moya-Anegón, Félix

    2015-12-01

    Food Science is an active discipline in scientific research. The improvements in Food Technology constitute a challenge for society to eradicate hunger, while achieving food safety. This work analyses the scientific production in Food Science of the 25 countries with the greatest output in this subject area in the period 2003 to 2013. The growth of China's production was striking, with the country becoming top-ranked by the end of the period. Some developing countries (such as Nigeria) achieved a major increase in production but reducing their proportion of scientific collaboration and their works' impact. There appear to be 2 international collaboration networks that get good results--one European and the other Pacific. © 2015 Institute of Food Technologists®

  19. Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

    PubMed

    Vujić, Mario; Pollak, Lea

    2015-12-01

    The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

  20. Intravenous medication safety and smart infusion systems: lessons learned and future opportunities.

    PubMed

    Keohane, Carol A; Hayes, Judy; Saniuk, Catherine; Rothschild, Jeffrey M; Bates, David W

    2005-01-01

    The Institute of Medicine report To Err Is Human: Building a Safe Health System greatly increased national awareness of the need to improve patient safety in general and medication safety in particular. Infusion-related errors are associated with the greatest risk of harm, and "smart" (computerized) infusion systems are currently available that can avert high-risk errors and provide previously unavailable data for continuous quality improvement (CQI) efforts. As healthcare organizations consider how to invest scarce dollars, infusion nurses have a key role to play in assessing need, evaluating technology, and selecting and implementing specific products. This article reviews the need to improve intravenous medication safety. It describes smart infusion systems and the results they have achieved. Finally, it details the lessons learned and the opportunities identified through the use of smart infusion technology at Brigham and Women's Hospital in Boston, Massachusetts.

  1. Reliability and safety of the electrical power supply complex of the Hanford production reactors

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

    Robbins, F.D.

    Safety has been and must continue to be the inviolable modulus by which the operation of a nuclear reactor must be judged. A malfunction in any reactor may well result in a release of fission products which may dissipate over a wide geographical area. Such dissipation may place the health, happiness and even the lives of the people in the region in serious jeopardy. As a result, the property damage and liability cost may reach astronomical values in the order of magnitude of billions of dollars. Reliability of the electrical network is an indispensable factor in attaining a high ordermore » of safety assurance. Progress in the peaceful use of atomic energy may take the form of electrical power generation using the nuclear reactor as a source of thermal energy. In view of these factors it seems appropriate and profitable that a critical engineering study be made of the safety and reliability of the Hanford reactors without regard to cost economics. This individual and independent technical engineering analysis was made without regard to Hanford traditional engineering and administration assignments. The main objective has been to focus attention on areas which seem to merit further detailed study on conditions which seem to need adjustment but most of all on those changes which will improve reactor safety. This report is the result of such a study.« less

  2. Preharvest food safety.

    PubMed

    Childers, A B; Walsh, B

    1996-07-23

    Preharvest food safety is essential for the protection of our food supply. The production and transport of livestock and poultry play an integral part in the safety of these food products. The goals of this safety assurance include freedom from pathogenic microorganisms, disease, and parasites, and from potentially harmful residues and physical hazards. Its functions should be based on hazard analysis and critical control points from producer to slaughter plant with emphasis on prevention of identifiable hazards rather than on removal of contaminated products. The production goal is to minimize infection and insure freedom from potentially harmful residues and physical hazards. The marketing goal is control of exposure to pathogens and stress. Both groups should have functional hazard analysis and critical control points management programs which include personnel training and certification of producers. These programs must cover production procedures, chemical usage, feeding, treatment practices, drug usage, assembly and transportation, and animal identification. Plans must use risk assessment principles, and the procedures must be defined. Other elements would include preslaughter certification, environmental protection, control of chemical hazards, live-animal drug-testing procedures, and identification of physical hazards.

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

    NASA Technical Reports Server (NTRS)

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

    2011-01-01

    unrtainties represents a method of probabilistic thinking wherein the analyst and decision makers recognize possible outcomes other than the outcome perceived to be "most likely." Without this type of analysis, it is not possible to determine the worth of an analysis product as a basis for making decisions related to safety and mission success. In line with these considerations the handbook does not take a hazard-analysis-centric approach to system safety. Hazard analysis remains a useful tool to facilitate brainstorming but does not substitute for a more holistic approach geared to a comprehensive identification and understanding of individual risk issues and their contributions to aggregate safety risks. The handbook strives to emphasize the importance of identifying the most critical scenarios that contribute to the risk of not meeting the agreed-upon safety objectives and requirements using all appropriate tools (including but not limited to hazard analysis). Thereafter, emphasis shifts to identifying the risk drivers that cause these scenarios to be critical and ensuring that there are controls directed toward preventing or mitigating the risk drivers. To address these and other areas, the handbook advocates a proactive, analytic-deliberative, risk-informed approach to system safety, enabling the integration of system safety activities with systems engineering and risk management processes. It emphasizes how one can systematically provide the necessary evidence to substantiate the claim that a system is safe to within an acceptable risk tolerance, and that safety has been achieved in a cost-effective manner. The methodology discussed in this handbook is part of a systems engineering process and is intended to be integral to the system safety practices being conducted by the NASA safety and mission assurance and systems engineering organizations. The handbook posits that to conclude that a system is adequately safe, it is necessary to consider a set of safety claims that

  4. 75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... safety reporting for human drug products: Janet Norden, Center for Drug Evaluation and Research, Food and... for Biologics Evaluation and Research, Food and Drug Administration,1401 Rockville Pike, suite 200N..., 2003. At the request of industry, and to provide all interested persons additional time to comment, the...

  5. Food Safety Knowledge, Behavior, and Attitudes of Vendors of Poultry Products Sold at Pennsylvania Farmers' Markets

    ERIC Educational Resources Information Center

    Scheinberg, Joshua; Radhakrishna, Rama; Cutter, Catherine N.

    2013-01-01

    A needs assessment survey was developed to assess the knowledge and attitudes of poultry vendors at farmers' markets in Pennsylvania, on food safety, regulation, and poultry production. Vendors were administered a 32-question paper survey, in person, during market hours. The results revealed critical vendor practices and identified important…

  6. Managing safety and quality through the red meat chain.

    PubMed

    Desmarchelier, P; Fegan, N; Smale, N; Small, A

    2007-09-01

    To successfully manage food safety and quality risks in meat production, a holistic approach is required. The ideal would be a fully integrated assurance system, with effective controls applied at all stages. However, the red meat industry is by nature somewhat fragmented, and a truly integrated system is not at present achievable in all but a few operations. This paper describes a variety of assurance initiatives, and explores how targeted research and development can be used to augment assurance programmes by providing underpinning knowledge, using the Australian beef and lamb industry as an example.

  7. Factors influencing patient safety in Sweden: perceptions of patient safety officers in the county councils

    PubMed Central

    2013-01-01

    Background National, regional and local activities to improve patient safety in Sweden have increased over the last decade. There are high ambitions for improved patient safety in Sweden. This study surveyed health care professionals who held key positions in their county council’s patient safety work to investigate their perceptions of the conditions for this work, factors they believe have been most important in reaching the current level of patient safety and factors they believe would be most important for achieving improved patient safety in the future. Methods The study population consisted of 218 health care professionals holding strategic positions in patient safety work in Swedish county councils. Using a questionnaire, the following topics were analysed in this study: profession/occupation; number of years involved in a designated task on patient safety issues; knowledge/overview of the county council’s patient safety work; ability to influence this work; conditions for this work; and the importance of various factors for current and future levels of patient safety. Results The response rate to the questionnaire was 79%. The conditions that had the highest number of responses in complete agreement were “patients’ involvement is important for patient safety” and “patient safety work has good support from the county council’s management”. Factors that were considered most important for achieving the current level of patient safety were root cause and risk analyses, incident reporting and the Swedish Patient Safety Law. An organizational culture that encourages reporting and avoids blame was considered most important for improved patient safety in the future, closely followed by improved communication between health care practitioners and patients. Conclusion Health care professionals with important positions in the Swedish county councils’ patient safety work believe that conditions for this work are somewhat constrained. They attribute

  8. Child-safety Containers/Devices and Compounding.

    PubMed

    Allen, Loyd V

    2017-01-01

    The U.S. Consumer Product Safety Commission has been around since it was created in 1972 through the Consumer Product Safety Act. Its purpose is to protect "against unreasonable risks of injuries associated with consumer products." Manufactured drugs must meet the standards unless specifically exempted. Dispensing and compounding pharmacists must also meet the standards. Due to a smaller market size, compliant products to meet the U.S. Consumer Product Safety Commission's standards to aid compounding pharmacists have been slow in coming. However, now there are numerous different products, some introduced recently, which make it easier for compounding pharmacists to comply with the standards. The new technologies are innovative and serve a great need. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  9. Review of health safety aspects of nanotechnologies in food production.

    PubMed

    Bouwmeester, Hans; Dekkers, Susan; Noordam, Maryvon Y; Hagens, Werner I; Bulder, Astrid S; de Heer, Cees; ten Voorde, Sandra E C G; Wijnhoven, Susan W P; Marvin, Hans J P; Sips, Adriënne J A M

    2009-02-01

    Due to new, previously unknown, properties attributed to engineered nanoparticles many new products are introduced in the agro-food area. Nanotechnologies cover many aspects, such as disease treatment, food security, new materials for pathogen detection, packaging materials and delivery systems. As with most new and evolving technologies, potential benefits are emphasized, while little is known on safety of the application of nanotechnologies in the agro-food sector. This review gives an overview of scientific issues that need to be addressed with priority in order to improve the risk assessment for nanoparticles in food. The following research topics are considered to contribute pivotally to risk assessment of nanotechnologies and nanoparticles in food products. Set a definition for NPs to facilitate regulatory discussions, prioritization of research and exchange of study results. Develop analytical tools for the characterization of nanoparticles in complex biological matrices like food. Establish relevant dose metrics for nanoparticles used for both interpretation of scientific studies as well as regulatory frameworks. Search for deviant behavior (kinetics) and novel effects (toxicity) of nanoparticles and assess the validity of currently used test systems following oral exposure. Estimate the consumer exposure to nanoparticles.

  10. Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products.

    PubMed

    Baldziki, Mike; Brown, Jeff; Chan, Hungching; Cheetham, T Craig; Conn, Thomas; Daniel, Gregory W; Hendrickson, Mark; Hilbrich, Lutz; Johnson, Ayanna; Miller, Steven B; Moore, Tom; Motheral, Brenda; Priddy, Sarah A; Raebel, Marsha A; Randhawa, Gurvaneet; Surratt, Penny; Walraven, Cheryl; White, T Jeff; Bruns, Kevin; Carden, Mary Jo; Dragovich, Charlie; Eichelberger, Bernadette; Rosato, Edith; Sega, Todd

    2015-01-01

    The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.

  11. Parallel computation safety analysis irradiation targets fission product molybdenum in neutronic aspect using the successive over-relaxation algorithm

    NASA Astrophysics Data System (ADS)

    Susmikanti, Mike; Dewayatna, Winter; Sulistyo, Yos

    2014-09-01

    One of the research activities in support of commercial radioisotope production program is a safety research on target FPM (Fission Product Molybdenum) irradiation. FPM targets form a tube made of stainless steel which contains nuclear-grade high-enrichment uranium. The FPM irradiation tube is intended to obtain fission products. Fission materials such as Mo99 used widely the form of kits in the medical world. The neutronics problem is solved using first-order perturbation theory derived from the diffusion equation for four groups. In contrast, Mo isotopes have longer half-lives, about 3 days (66 hours), so the delivery of radioisotopes to consumer centers and storage is possible though still limited. The production of this isotope potentially gives significant economic value. The criticality and flux in multigroup diffusion model was calculated for various irradiation positions and uranium contents. This model involves complex computation, with large and sparse matrix system. Several parallel algorithms have been developed for the sparse and large matrix solution. In this paper, a successive over-relaxation (SOR) algorithm was implemented for the calculation of reactivity coefficients which can be done in parallel. Previous works performed reactivity calculations serially with Gauss-Seidel iteratives. The parallel method can be used to solve multigroup diffusion equation system and calculate the criticality and reactivity coefficients. In this research a computer code was developed to exploit parallel processing to perform reactivity calculations which were to be used in safety analysis. The parallel processing in the multicore computer system allows the calculation to be performed more quickly. This code was applied for the safety limits calculation of irradiated FPM targets containing highly enriched uranium. The results of calculations neutron show that for uranium contents of 1.7676 g and 6.1866 g (× 106 cm-1) in a tube, their delta reactivities are the still

  12. Production and evaluation of children's dietary life safety index data on metropolitan cities and provinces in Korea

    PubMed Central

    Choi, Young-Sun; Lee, Jung-Sug; Kim, Hye-Young; Kwak, Tong-Kyung; Chung, Hae Rang; Kwon, Sehyug; Choi, Youn-Ju; Lee, Soon-Kyu

    2012-01-01

    This pilot study was performed to produce data of the Children's Dietary Life Safety (CDLS) Index which is required by the Special Act on Safety Management of Children's Dietary Life and to evaluate the CDLS Index for 7 metropolitan cities and 9 provinces in Korea. To calculate the CDLS Index score, data regarding the evaluation indicators in the children's food safety domain and children's nutrition safety domain were collected from the local governments in 2009. For data regarding the indicators in the children's perception & practice domain, a survey was conducted on 2,400 5th grade children selected by stratified sampling in 16 local areas. Relative scores of indicators in each domain were calculated using the data provided by local governments and the survey, the weights are applied on relative scores, and then the CDLS Index scores of local governments were produced by adding scores of the 3 domains. The national average scores of the food safety domain, the nutrition safety domain and the perception and practice domain were 23.74 (14.67-26.50 on a 40-point scale), 16.65 (12.25-19.60 on a 40-point scale), and 14.88 (14.16-15.30 on a 20-point scale), respectively. The national average score of the CDLS Index which was produced by adding the scores of the three domains was 55.27 ranging 46.44-58.94 among local governments. The CDLS Index scores produced in this study may provide the motivation for comparing relative accomplishment and for actively achieving the goals through establishment of the target value by local governments. Also, it can be used as useful data for the establishment and improvement of children's dietary life safety policy at the national level. PMID:23346305

  13. INMARSAT-C SafetyNET

    Science.gov Websites

    Tsunamis 406 EPIRB's National Weather Service Marine Forecasts INMARSAT-C SafetyNET Marine Forecast Offices greater danger near shore or any shallow waters? NATIONAL WEATHER SERVICE PRODUCTS VIA INMARSAT-C SafetyNET Inmarsat-C SafetyNET is an internationally adopted, automated satellite system for promulgating

  14. The Occupational Safety and Health Act: Its Goals and Its Achievements. Evaluative Studies Series.

    ERIC Educational Resources Information Center

    Smith, Robert Stewart

    The safety and health mandate of the Occupational Safety and Health Act of 1970 is examined in reference to its effectiveness in reducing injuries and its consistency with the goal of promoting general welfare. Chapter 1 describes the essential features of the act and its administration to date, and analyzes the mandate as revealed by legislative…

  15. Capturing Essential Information to Achieve Safe Interoperability.

    PubMed

    Weininger, Sandy; Jaffe, Michael B; Rausch, Tracy; Goldman, Julian M

    2017-01-01

    In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a "patient-controlled analgesia safety interlock" are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical

  16. Nuclear Safety

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

    Silver, E G

    This document is a review journal that covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

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

    NASA Astrophysics Data System (ADS)

    Mikula, J. F. Kip

    2005-12-01

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

  18. Report: EPA Should Assess Needs and Implement Management Controls to Ensure Effective Incorporation of Chemical Safety Research Products

    EPA Pesticide Factsheets

    Report #17-P-0294, June 23, 2017. With management controls that ensure the collaborative development of research products and prioritize chemical safety research needs, the EPA would be better able to conduct faster chemical risk assessments.

  19. Foundations for High Achievement: Safety, Civility, Literacy. K-12 Public Education.

    ERIC Educational Resources Information Center

    Colorado State Dept. of Education, Denver. Research and Evaluation Unit.

    The state of Colorado has set high standards for students based on three fundamental principles: safety, civility, and literacy. How these standards were integrated into the schools is the subject of this report. It opens with an overview of the foundations of academic success and the process involved in implementing standards-based education. The…

  20. 33 CFR 6.14-1 - Safety measures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Safety measures. 6.14-1 Section 6... Vessels in Port § 6.14-1 Safety measures. The Commandant, in order to achieve the purposes of this part, may prescribe such conditions and restrictions relating to the safety of waterfront facilities and...

  1. Trampoline Safety in Childhood and Adolescence

    MedlinePlus

    ... ABBREVIATIONS AAP — American Academy of Pediatrics NEISS — National Electronic Injury Surveillance System USCPSC — US Consumer Product Safety ... US Consumer Product Safety Com- mission ’ s (USCPSC) National Electronic Injury Surveillance System (NEISS). 6 Trampoline injuries increased ...

  2. 75 FR 53701 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0394] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01); Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug...

  3. Optimization of safety on pavement preservation projects.

    DOT National Transportation Integrated Search

    2011-01-01

    To achieve a goal of reducing highway crash fatalities by 4% each year to improve roadway safety, the Georgia Department of Transportation (GDOT) is actively seeking opportunities to incorporate safety improvements into its current pavement preservat...

  4. 9 CFR 113.41 - Calf safety test.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Calf safety test. 113.41 Section 113.41 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Procedures § 113.41 Calf safety test. The calf safety test provided in this section shall be conducted when...

  5. 9 CFR 113.45 - Sheep safety test.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Sheep safety test. 113.45 Section 113.45 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Procedures § 113.45 Sheep safety test. The sheep safety test provided in this section shall be conducted when...

  6. 9 CFR 113.41 - Calf safety test.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Calf safety test. 113.41 Section 113.41 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Procedures § 113.41 Calf safety test. The calf safety test provided in this section shall be conducted when...

  7. 9 CFR 113.45 - Sheep safety test.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Sheep safety test. 113.45 Section 113.45 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Procedures § 113.45 Sheep safety test. The sheep safety test provided in this section shall be conducted when...

  8. Emission measurement and safety assessment for the production process of silicon nanoparticles in a pilot-scale facility

    NASA Astrophysics Data System (ADS)

    Wang, Jing; Asbach, Christof; Fissan, Heinz; Hülser, Tim; Kaminski, Heinz; Kuhlbusch, Thomas A. J.; Pui, David Y. H.

    2012-03-01

    Emission into the workplace was measured for the production process of silicon nanoparticles in a pilot-scale facility at the Institute of Energy and Environmental Technology e.V. (IUTA). The silicon nanoparticles were produced in a hot-wall reactor and consisted of primary particles around 60 nm in diameter. We employed real-time aerosol instruments to measure particle number and lung-deposited surface area concentrations and size distribution; airborne particles were also collected for off-line electron microscopic analysis. Emission of silicon nanoparticles was not detected during the processes of synthesis, collection, and bagging. This was attributed to the completely closed production system and other safety measures against particle release which will be discussed briefly. Emission of silicon nanoparticles significantly above the detection limit was only observed during the cleaning process when the production system was open and manually cleaned. The majority of the detected particles was in the size range of 100-400 nm and were silicon nanoparticle agglomerates first deposited in the tubing then re-suspended during the cleaning process. Appropriate personal protection equipment is recommended for safety protection of the workers during cleaning.

  9. 78 FR 40146 - Patient Safety Organizations: Voluntary Relinquishment From Northern Metropolitan Patient Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    .... The delisting was effective at 12:00 Midnight ET (2400) on May 29, 2013. ADDRESSES: Both directories... (2400) on May 29, 2013. Northern Metropolitan Patient Safety Institute has patient safety work product...

  10. Microbiological Food Safety Status of Commercially Produced Tomatoes from Production to Marketing.

    PubMed

    van Dyk, Brigitte N; de Bruin, Willeke; du Plessis, Erika M; Korsten, Lise

    2016-03-01

    Tomatoes have been implicated in various microbial disease outbreaks and are considered a potential vehicle for foodborne pathogens. Traceback studies mostly implicate contamination during production and/or processing. The microbiological quality of commercially produced tomatoes was thus investigated from the farm to market, focusing on the impact of contaminated irrigation and washing water, facility sanitation, and personal hygiene. A total of 905 samples were collected from three largescale commercial farms from 2012 through 2014. The farms differed in water sources used (surface versus well) and production methods (open field versus tunnel). Levels of total coliforms and Escherichia coli and prevalence of E. coli O157:H7 and Salmonella Typhimurium were determined. Dominant coliforms were identified using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. No pathogens or E. coli were detected on any of the tomatoes tested throughout the study despite the high levels of coliforms (4.2 to 6.2 log CFU/g) present on the tomatoes at the market. The dominant species associated with tomatoes belonged to the genera Enterobacter, Klebsiella, and Citrobacter. Water used on the farm for irrigation considered not fit for purpose according to national agricultural irrigation standards, with high E. coli levels resulting from either a highly contaminated source water (river water at 3.19 log most probable number [MPN]/100 ml) or improper storage of source water (stored well water at 1.72 log MPN/100 ml). Salmonella Typhimurium was detected on two occasions on a contact surface in the processing facility of the first farm in 2012. Contact surface coliform counts were 2.9 to 4.8 log CFU/cm(2). Risk areas identified in this study were water used for irrigation and poor sanitation practices in the processing facility. Implementation of effective food safety management systems in the fresh produce industry is of the utmost importance to ensure product

  11. Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

    PubMed

    Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

    2009-04-01

    To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

  12. Moving forward with safety culture.

    PubMed

    Weber, Michael

    2012-04-01

    Radiation safety and protection of people are shared goals of the Health Physics Society (HPS) and the U.S. Nuclear Regulatory Commission (NRC). A positive safety culture contributes to achieving radiation safety and protection of people, which are important to both the HPS and the NRC. Through unprecedented collaboration and engagement with diverse stakeholders, the NRC and the stakeholders developed a Safety Culture Policy Statement. The policy statement defines safety culture and describes the traits of a positive safety culture. Consideration of both safety and security issues and the interface of safety and security are underlying principles that support the policy. Examination of significant events, both within the nuclear industry and in society at large, illustrates how weaknesses in these traits can contribute to the occurrence and consequences of safety incidents, including serious injury and loss of life. With the policy statement in place, the NRC is moving forward with outreach and education about safety culture. Health physicists and other radiation safety specialists play an essential role in enhancing safety culture.

  13. 'It's a matter of patient safety': understanding challenges in everyday clinical practice for achieving good care on the surgical ward - a qualitative study.

    PubMed

    Jangland, Eva; Nyberg, Berit; Yngman-Uhlin, Pia

    2017-06-01

    Surgical care plays an important role in the acute hospital's delivery of safe, high-quality patient care. Although demands for effectiveness are high in surgical wards quality of care and patient safety must also be secured. It is therefore necessary to identify the challenges and barriers linked to quality of care and patient safety with a focus on this specific setting. To explore situations and processes that support or hinder good safe patient care on the surgical ward. This qualitative study was based on a strategic sample of 10 department and ward leaders in three hospitals and six surgical wards in Sweden. Repeated reflective interviews were analysed using systematic text condensation. Four themes described the leaders' view of a complex healthcare setting that demands effectiveness and efficiency in moving patients quickly through the healthcare system. Quality of care and patient safety were often hampered factors such as a shift of care level, with critically ill patients cared for without reorganisation of nurses' competencies on the surgical ward. There is a gap between what is described in written documents and what is or can be performed in clinical practice to achieve good care and safe care on the surgical ward. A shift in levels of care on the surgical ward without reallocation of the necessary competencies at the patient's bedside show consequences for quality of care and patient safety. This means that surgical wards should consider reviewing their organisation and implementing more advanced nursing roles in direct patient care on all shifts. The ethical issues and the moral stress on nurses who lack the resources and competence to deliver good care according to professional values need to be made more explicit as a part of the patient safety agenda in the surgical ward. © 2016 Nordic College of Caring Science.

  14. Shelf-Stable Food Safety

    MedlinePlus

    ... Forms Standard Forms FSIS United States Department of Agriculture Food Safety and Inspection Service About FSIS District ... plants by inspectors from the U.S. Department of Agriculture's Food Safety and Inspection Service. Products made into ...

  15. Environment, Safety & Health at SLAC

    Science.gov Websites

    and safety of our staff, the community, and the environment as we carry out our scientific mission. We believe that safety, science, productivity, and quality are mutually supportive, and that safety is to protect our resources and biota. See the SLAC Environment, Safety and Health Policy for more

  16. Achieving waste to energy through sewage sludge gasification using hot slags: syngas production

    NASA Astrophysics Data System (ADS)

    Sun, Yongqi; Nakano, Jinichiro; Liu, Lili; Wang, Xidong; Zhang, Zuotai

    2015-06-01

    To relieve the environmental issues of sewage sludge (SS) disposal and greenhouse gas (GHG) emission in China, we proposed an integrated method for the first time to simultaneously deal with these two problems. The hot slags below 920 °C could act as a good heat carrier for sludge gasification and the increasing CO2 concentration in CO2/O2 atmospheres enhanced the production of CO and H2 at 400-800 °C. Three stages of syngas release were clearly identified by Gaussian fittings, i.e., volatile release, char transformation and fixed carbon reaction. Additionally, the effect of sulfur retention of slags and the synergy effect of the stabilization of toxic elements in the solid residuals were discovered in this study. Furthermore, a novel prototype of multiple industrial and urban systems was put forward, in which the produced CO + H2 could be utilized for direct reduced iron (DRI) production and the solid residuals of sludge ash and glassy slags would be applied as cementitious materials. For a steel plant with an annual production of crude steel of 10 million tons in China, the total annual energy saving and GHG emission reduction achieved are 3.31*105 tons of standard coal and 1.74*106 tons of CO2, respectively.

  17. 9 CFR 113.33 - Mouse safety tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Mouse safety tests. 113.33 Section 113... Procedures § 113.33 Mouse safety tests. One of the mouse safety tests provided in this section shall be... or more ingredients makes the biological product lethal or toxic for mice but not lethal or toxic for...

  18. 9 CFR 113.33 - Mouse safety tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Mouse safety tests. 113.33 Section 113... Procedures § 113.33 Mouse safety tests. One of the mouse safety tests provided in this section shall be... or more ingredients makes the biological product lethal or toxic for mice but not lethal or toxic for...

  19. 9 CFR 113.33 - Mouse safety tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Mouse safety tests. 113.33 Section 113... Procedures § 113.33 Mouse safety tests. One of the mouse safety tests provided in this section shall be... or more ingredients makes the biological product lethal or toxic for mice but not lethal or toxic for...

  20. 9 CFR 113.33 - Mouse safety tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Mouse safety tests. 113.33 Section 113... Procedures § 113.33 Mouse safety tests. One of the mouse safety tests provided in this section shall be... or more ingredients makes the biological product lethal or toxic for mice but not lethal or toxic for...

  1. 9 CFR 113.33 - Mouse safety tests.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Mouse safety tests. 113.33 Section 113... Procedures § 113.33 Mouse safety tests. One of the mouse safety tests provided in this section shall be... or more ingredients makes the biological product lethal or toxic for mice but not lethal or toxic for...

  2. 9 CFR 113.44 - Swine safety test.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

  3. 9 CFR 113.44 - Swine safety test.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

  4. 9 CFR 113.44 - Swine safety test.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

  5. 9 CFR 113.44 - Swine safety test.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

  6. 9 CFR 113.44 - Swine safety test.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Swine safety test. 113.44 Section 113... Procedures § 113.44 Swine safety test. The swine safety test provided in this section shall be conducted when.... (1) Inject each of two swine of the minimum age for which the product is recommended with the...

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

    PubMed

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

    2006-08-01

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

  8. Patient safety goals for the proposed Federal Health Information Technology Safety Center.

    PubMed

    Sittig, Dean F; Classen, David C; Singh, Hardeep

    2015-03-01

    The Office of the National Coordinator for Health Information Technology is expected to oversee creation of a Health Information Technology (HIT) Safety Center. While its functions are still being defined, the center is envisioned as a public-private entity focusing on promotion of HIT related patient safety. We propose that the HIT Safety Center leverages its unique position to work with key administrative and policy stakeholders, healthcare organizations (HCOs), and HIT vendors to achieve four goals: (1) facilitate creation of a nationwide 'post-marketing' surveillance system to monitor HIT related safety events; (2) develop methods and governance structures to support investigation of major HIT related safety events; (3) create the infrastructure and methods needed to carry out random assessments of HIT related safety in complex HCOs; and (4) advocate for HIT safety with government and private entities. The convening ability of a federally supported HIT Safety Center could be critically important to our transformation to a safe and effective HIT enabled healthcare system. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  9. Microbiological Food Safety Surveillance in China

    PubMed Central

    Pei, Xiaoyan; Li, Ning; Guo, Yunchang; Liu, Xiumei; Yan, Lin; Li, Ying; Yang, Shuran; Hu, Jing; Zhu, Jianghui; Yang, Dajin

    2015-01-01

    Microbiological food safety surveillance is a system that collects data regarding food contamination by foodborne pathogens, parasites, viruses, and other harmful microbiological factors. It helps to understand the spectrum of food safety, timely detect food safety hazards, and provide relevant data for food safety supervision, risk assessment, and standards-setting. The study discusses the microbiological surveillance of food safety in China, and introduces the policies and history of the national microbiological surveillance system. In addition, the function and duties of different organizations and institutions are provided in this work, as well as the generation and content of the surveillance plan, quality control, database, and achievement of the microbiological surveillance of food safety in China. PMID:26343705

  10. Next-generation sequencing: the future of molecular genetics in poultry production and food safety.

    PubMed

    Diaz-Sanchez, S; Hanning, I; Pendleton, Sean; D'Souza, Doris

    2013-02-01

    The era of molecular biology and automation of the Sanger chain-terminator sequencing method has led to discovery and advances in diagnostics and biotechnology. The Sanger methodology dominated research for over 2 decades, leading to significant accomplishments and technological improvements in DNA sequencing. Next-generation high-throughput sequencing (HT-NGS) technologies were developed subsequently to overcome the limitations of this first generation technology that include higher speed, less labor, and lowered cost. Various platforms developed include sequencing-by-synthesis 454 Life Sciences, Illumina (Solexa) sequencing, SOLiD sequencing (among others), and the Ion Torrent semiconductor sequencing technologies that use different detection principles. As technology advances, progress made toward third generation sequencing technologies are being reported, which include Nanopore Sequencing and real-time monitoring of PCR activity through fluorescent resonant energy transfer. The advantages of these technologies include scalability, simplicity, with increasing DNA polymerase performance and yields, being less error prone, and even more economically feasible with the eventual goal of obtaining real-time results. These technologies can be directly applied to improve poultry production and enhance food safety. For example, sequence-based (determination of the gut microbial community, genes for metabolic pathways, or presence of plasmids) and function-based (screening for function such as antibiotic resistance, or vitamin production) metagenomic analysis can be carried out. Gut microbialflora/communities of poultry can be sequenced to determine the changes that affect health and disease along with efficacy of methods to control pathogenic growth. Thus, the purpose of this review is to provide an overview of the principles of these current technologies and their potential application to improve poultry production and food safety as well as public health.

  11. 16 CFR 1209.36 - Production testing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.36 Production testing. (a) General... manufactured to demonstrate that the product being manufactured is substantially similar to the product which...

  12. Assessment of Contributions to Patient Safety Knowledge by the Agency for Healthcare Research and Quality-Funded Patient Safety Projects

    PubMed Central

    Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

    2009-01-01

    Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108

  13. Capturing Essential Information to Achieve Safe Interoperability

    PubMed Central

    Weininger, Sandy; Jaffe, Michael B.; Rausch, Tracy; Goldman, Julian M.

    2016-01-01

    In this article we describe the role of “clinical scenario” information to assure the safety of interoperable systems, as well as the system’s ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets (MDIDSa) and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a “Patient-controlled analgesia safety interlock” are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a Learning Health System to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A web-based research tool for implementing a means of acquiring and managing this

  14. The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety.

    PubMed

    O'Connor, A M; Sargeant, J M; Gardner, I A; Dickson, J S; Torrence, M E; Dewey, C E; Dohoo, I R; Evans, R B; Gray, J T; Greiner, M; Keefe, G; Lefebvre, S L; Morley, P S; Ramirez, A; Sischo, W; Smith, D R; Snedeker, K; Sofos, J; Ward, M P; Wills, R

    2010-01-01

    The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that may not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A two-day consensus meeting was held on November 18-19, 2008 in Chicago, IL, United States of America, to achieve the objective. Prior to the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock-production specialists, journal editors, assistant editors, and associate editors. Prior to the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines For Randomized Control Trials) statement for livestock and food safety (LFS) and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional sub-item was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

  15. The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety.

    PubMed

    O'Connor, A M; Sargeant, J M; Gardner, I A; Dickson, J S; Torrence, M E; Dewey, C E; Dohoo, I R; Evans, R B; Gray, J T; Greiner, M; Keefe, G; Lefebvre, S L; Morley, P S; Ramirez, A; Sischo, W; Smith, D R; Snedeker, K; Sofos, J; Ward, M P; Wills, R

    2010-01-01

    The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that might not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on November 18-19, 2008 in Chicago, IL, to achieve the objective. Before the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Before the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items would need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional subitem was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

  16. The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety.

    PubMed

    O'Connor, A M; Sargeant, J M; Gardner, I A; Dickson, J S; Torrence, M E; Dewey, C E; Dohoo, I R; Evans, R B; Gray, J T; Greiner, M; Keefe, G; Lefebvre, S L; Morley, P S; Ramirez, A; Sischo, W; Smith, D R; Snedeker, K; Sofos, J N; Ward, M P; Wills, R

    2010-01-01

    The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that may not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A two-day consensus meeting was held on November 18-19, 2008 in Chicago, Ill, United States of America, to achieve the objective. Prior to the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Prior to the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety (LFS) and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional sub-item was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

  17. Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement.

    PubMed

    Hilton, Said; Sattler, Gerhard; Berg, Anna-Karin; Samuelson, Ulf; Wong, Cindy

    2018-02-01

    Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect. To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement. Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product. A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated. Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect.

  18. Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement

    PubMed Central

    Sattler, Gerhard; Berg, Anna-Karin; Samuelson, Ulf; Wong, Cindy

    2018-01-01

    BACKGROUND Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect. OBJECTIVE To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement. MATERIALS AND METHODS Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product. RESULTS A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated. CONCLUSION Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect. PMID:29059146

  19. Embedding 'speaking up' into systems for safe healthcare product development and marketing surveillance.

    PubMed

    Edwards, Brian; Hugman, Bruce; Tobin, Mary; Whalen, Matthew

    2012-04-01

    Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust.The focus here is on what can be done within a healthcare product organization (HPO) to achieve actionable, sustainable policies and practices such as leadership, management, and supervision role-modelling of best practice; ongoing process review and improvements in every department; protection of those who report concerns through robust policies endorsed at Board level throughout an organization to eliminate the fear of retaliation; training in open, non-defensive team-working principles; and mediation structure and process for resolution of differences of opinion or interpretation of contradictory and volatile data.Based on analyses of other safety systems, workplace silence and interpersonal breakdowns are warning signs of defective systems underlying poor compliance and compromising safety. Remedying the situation requires attention to the root causes underlying such symptoms of dysfunction, especially the human factor, i.e. those factors that influence human performance. It is essential that leadership and management listen to employees' concerns about systems and processes, assess them impartially and reward contributions that improve safety.Fundamentally, the safety, transparency, and trustworthiness of HPOs, both commercial and regulatory, can be judged by the extent of the freedom of their staff to 'speak up' when the time is right. This, in turn, consolidates the trust of external stakeholders in the safety of a system and its products. The promotion of 'speaking up' in an organization provides an important safeguard against the risk of poor compliance and the undermining of societal confidence in the safety of healthcare products.

  20. Ares I-X Range Safety Analyses Overview

    NASA Technical Reports Server (NTRS)

    Starr, Brett R.; Gowan, John W., Jr.; Thompson, Brian G.; Tarpley, Ashley W.

    2011-01-01

    Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

  1. Biological safety cabinetry.

    PubMed Central

    Kruse, R H; Puckett, W H; Richardson, J H

    1991-01-01

    The biological safety cabinet is the one piece of laboratory and pharmacy equipment that provides protection for personnel, the product, and the environment. Through the history of laboratory-acquired infections from the earliest published case to the emergence of hepatitis B and AIDS, the need for health care worker protection is described. A brief description with design, construction, function, and production capabilities is provided for class I and class III safety cabinets. The development of the high-efficiency particulate air filter provided the impetus for clean room technology, from which evolved the class II laminar flow biological safety cabinet. The clean room concept was advanced when the horizontal airflow clean bench was manufactured; it became popular in pharmacies for preparing intravenous solutions because the product was protected. However, as with infectious microorganisms and laboratory workers, individual sensitization to antibiotics and the advent of hazardous antineoplastic agents changed the thinking of pharmacists and nurses, and they began to use the class II safety cabinet to prevent adverse personnel reactions to the drugs. How the class II safety cabinet became the mainstay in laboratories and pharmacies is described, and insight is provided into the formulation of National Sanitation Foundation standard number 49 and its revisions. The working operations of a class II cabinet are described, as are the variations of the four types with regard to design, function, air velocity profiles, and the use of toxins. The main certification procedures are explained, with examples of improper or incorrect certifications. The required levels of containment for microorganisms are given. Instructions for decontaminating the class II biological safety cabinet of infectious agents are provided; unfortunately, there is no method for decontaminating the cabinet of antineoplastic agents. Images PMID:2070345

  2. Occupational Safety and Health Professionals

    ERIC Educational Resources Information Center

    Wash, Pat

    1975-01-01

    The growing concern for safety in both the workplace and in consumer products will create many new jobs through the mid-1980's--especially in private industry. The largest number of safety professionals are safety engineers; others include fire protection engineers, industrial hygienists, loss control and occupational health consultants, and…

  3. Achieving waste to energy through sewage sludge gasification using hot slags: syngas production

    PubMed Central

    Sun, Yongqi; Nakano, Jinichiro; Liu, Lili; Wang, Xidong; Zhang, Zuotai

    2015-01-01

    To relieve the environmental issues of sewage sludge (SS) disposal and greenhouse gas (GHG) emission in China, we proposed an integrated method for the first time to simultaneously deal with these two problems. The hot slags below 920 °C could act as a good heat carrier for sludge gasification and the increasing CO2 concentration in CO2/O2 atmospheres enhanced the production of CO and H2 at 400–800 °C. Three stages of syngas release were clearly identified by Gaussian fittings, i.e., volatile release, char transformation and fixed carbon reaction. Additionally, the effect of sulfur retention of slags and the synergy effect of the stabilization of toxic elements in the solid residuals were discovered in this study. Furthermore, a novel prototype of multiple industrial and urban systems was put forward, in which the produced CO + H2 could be utilized for direct reduced iron (DRI) production and the solid residuals of sludge ash and glassy slags would be applied as cementitious materials. For a steel plant with an annual production of crude steel of 10 million tons in China, the total annual energy saving and GHG emission reduction achieved are 3.31*105 tons of standard coal and 1.74*106 tons of CO2, respectively. PMID:26074060

  4. Achieving waste to energy through sewage sludge gasification using hot slags: syngas production.

    PubMed

    Sun, Yongqi; Nakano, Jinichiro; Liu, Lili; Wang, Xidong; Zhang, Zuotai

    2015-06-15

    To relieve the environmental issues of sewage sludge (SS) disposal and greenhouse gas (GHG) emission in China, we proposed an integrated method for the first time to simultaneously deal with these two problems. The hot slags below 920 °C could act as a good heat carrier for sludge gasification and the increasing CO2 concentration in CO2/O2 atmospheres enhanced the production of CO and H2 at 400-800 °C. Three stages of syngas release were clearly identified by Gaussian fittings, i.e., volatile release, char transformation and fixed carbon reaction. Additionally, the effect of sulfur retention of slags and the synergy effect of the stabilization of toxic elements in the solid residuals were discovered in this study. Furthermore, a novel prototype of multiple industrial and urban systems was put forward, in which the produced CO + H2 could be utilized for direct reduced iron (DRI) production and the solid residuals of sludge ash and glassy slags would be applied as cementitious materials. For a steel plant with an annual production of crude steel of 10 million tons in China, the total annual energy saving and GHG emission reduction achieved are 3.31*10(5) tons of standard coal and 1.74*10(6) tons of CO2, respectively.

  5. 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.

  6. Should Anthroposophic Medicinal Products Be Regulated in Europe?

    PubMed

    Michaux, Geneviève

    2017-03-01

    European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

  7. An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses--Criticality (keff) Predictions

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

    Scaglione, John M; Mueller, Don; Wagner, John C

    2011-01-01

    One of the most significant remaining challenges associated with expanded implementation of burnup credit in the United States is the validation of depletion and criticality calculations used in the safety evaluation - in particular, the availability and use of applicable measured data to support validation, especially for fission products. Applicants and regulatory reviewers have been constrained by both a scarcity of data and a lack of clear technical basis or approach for use of the data. U.S. Nuclear Regulatory Commission (NRC) staff have noted that the rationale for restricting their Interim Staff Guidance on burnup credit (ISG-8) to actinide-only ismore » based largely on the lack of clear, definitive experiments that can be used to estimate the bias and uncertainty for computational analyses associated with using burnup credit. To address the issue of validation, the NRC initiated a project with the Oak Ridge National Laboratory to (1) develop and establish a technically sound validation approach (both depletion and criticality) for commercial spent nuclear fuel (SNF) criticality safety evaluations based on best-available data and methods and (2) apply the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The purpose of this paper is to describe the criticality (k{sub eff}) validation approach, and resulting observations and recommendations. Validation of the isotopic composition (depletion) calculations is addressed in a companion paper at this conference. For criticality validation, the approach is to utilize (1) available laboratory critical experiment (LCE) data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the French Haut Taux de Combustion (HTC) program to support validation of the principal actinides and (2) calculated sensitivities, nuclear data uncertainties, and the limited available

  8. Digital drug safety surveillance: monitoring pharmaceutical products in twitter.

    PubMed

    Freifeld, Clark C; Brownstein, John S; Menone, Christopher M; Bao, Wenjie; Filice, Ross; Kass-Hout, Taha; Dasgupta, Nabarun

    2014-05-01

    Traditional adverse event (AE) reporting systems have been slow in adapting to online AE reporting from patients, relying instead on gatekeepers, such as clinicians and drug safety groups, to verify each potential event. In the meantime, increasing numbers of patients have turned to social media to share their experiences with drugs, medical devices, and vaccines. The aim of the study was to evaluate the level of concordance between Twitter posts mentioning AE-like reactions and spontaneous reports received by a regulatory agency. We collected public English-language Twitter posts mentioning 23 medical products from 1 November 2012 through 31 May 2013. Data were filtered using a semi-automated process to identify posts with resemblance to AEs (Proto-AEs). A dictionary was developed to translate Internet vernacular to a standardized regulatory ontology for analysis (MedDRA(®)). Aggregated frequency of identified product-event pairs was then compared with data from the public FDA Adverse Event Reporting System (FAERS) by System Organ Class (SOC). Of the 6.9 million Twitter posts collected, 4,401 Proto-AEs were identified out of 60,000 examined. Automated, dictionary-based symptom classification had 86 % recall and 72 % precision [corrected]. Similar overall distribution profiles were observed, with Spearman rank correlation rho of 0.75 (p < 0.0001) between Proto-AEs reported in Twitter and FAERS by SOC. Patients reporting AEs on Twitter showed a range of sophistication when describing their experience. Despite the public availability of these data, their appropriate role in pharmacovigilance has not been established. Additional work is needed to improve data acquisition and automation.

  9. Overall requirements for an advanced underground coal extraction system. [environment effects, miner health and safety, production cost, and coal conservation

    NASA Technical Reports Server (NTRS)

    Goldsmith, M.; Lavin, M. L.

    1980-01-01

    Underground mining systems suitable for coal seams expoitable in the year 2000 are examined with particular relevance to the resources of Central Appalachia. Requirements for such systems may be summarized as follows: (1) production cost; (2)miner safety; (3) miner health; (4) environmental impact; and (5) coal conservation. No significant trade offs between production cost and other performance indices were found.

  10. 16 CFR 1210.16 - Production testing.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Production testing. 1210.16 Section 1210.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.16 Production testing. (a) General...

  11. 16 CFR 1209.35 - Product specification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product specification. 1209.35 Section 1209.35 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.35 Product specification. (a...

  12. Effects of an onion by-product on bioactivity and safety markers in healthy rats.

    PubMed

    Roldán-Marín, Eduvigis; Krath, Britta N; Poulsen, Morten; Binderup, Mona-Lise; Nielsen, Tom H; Hansen, Max; Barri, Thaer; Langkilde, Søren; Cano, M Pilar; Sánchez-Moreno, Concepción; Dragsted, Lars O

    2009-12-01

    Onions are excellent sources of bioactive compounds including fructo-oligosaccharides (FOS) and polyphenols. An onion by-product was characterised in order to be developed as a potentially bioactive food ingredient. Our main aim was to investigate whether the potential health and safety effects of this onion by-product were shared by either of two derived fractions, an extract containing the onion FOS and polyphenols and a residue fraction containing mainly cell wall materials. We report here on the effects of feeding these products on markers of potential toxicity, protective enzymes and gut environment in healthy rats. Rats were fed during 4 weeks with a diet containing the products or a control feed balanced in carbohydrate. The onion by-product and the extract caused anaemia as expected in rodents for Allium products. No other toxicity was observed, including genotoxicity. Glutathione reductase (GR) and glutathione peroxidase (GPx1) activities in erythrocytes increased when rats were fed with the onion extract. Hepatic gene expression of Gr, Gpx1, catalase, 5-aminolevulinate synthase and NAD(P)H:quinone oxidoreductase was not altered in any group of the onion fed rats. By contrast, gamma-glutamate cysteine ligase catalytic subunit gene expression was upregulated but only in rats given the onion residue. The onion by-products as well as the soluble and insoluble fractions had prebiotic effects as evidenced by decreased pH, increased butyrate production and altered gut microbiota enzyme activities. In conclusion, the onion by-products have no in vivo genotoxicity, may support in vivo antioxidative defence and alter the functionality of the rat gut microbiota.

  13. African fermented dairy products - Overview of predominant technologically important microorganisms focusing on African Streptococcus infantarius variants and potential future applications for enhanced food safety and security.

    PubMed

    Jans, Christoph; Meile, Leo; Kaindi, Dasel Wambua Mulwa; Kogi-Makau, Wambui; Lamuka, Peter; Renault, Pierre; Kreikemeyer, Bernd; Lacroix, Christophe; Hattendorf, Jan; Zinsstag, Jakob; Schelling, Esther; Fokou, Gilbert; Bonfoh, Bassirou

    2017-06-05

    Milk is a major source of nutrients, but can also be a vehicle for zoonotic foodborne diseases, especially when raw milk is consumed. In Africa, poor processing and storage conditions contribute to contamination, outgrowth and transmission of pathogens, which lead to spoilage, reduced food safety and security. Fermentation helps mitigate the impact of poor handling and storage conditions by enhancing shelf life and food safety. Traditionally-fermented sour milk products are culturally accepted and widely distributed in Africa, and rely on product-specific microbiota responsible for aroma, flavor and texture. Knowledge of microbiota and predominant, technologically important microorganisms is critical in developing products with enhanced quality and safety, as well as sustainable interventions for these products, including Africa-specific starter culture development. This narrative review summarizes current knowledge of technologically-important microorganisms of African fermented dairy products (FDP) and raw milk, taking into consideration novel findings and taxonomy when re-analyzing data of 29 publications covering 25 products from 17 African countries. Technologically-important lactic acid bacteria such as Lactococcus lactis and Streptococcus infantarius subsp. infantarius (Sii), Lactobacillus spp. and yeasts predominated in raw milk and FDP across Africa. Re-analysis of data also suggests a much wider distribution of Sii and thus a potentially longer history of use than previously expected. Therefore, evaluating the role and safety of African Sii lineages is important when developing interventions and starter cultures for FDP in Africa to enhance food safety and food security. In-depth functional genomics, epidemiologic investigations and latest identification approaches coupled with stakeholder involvement will be required to evaluate the possibility of African Sii lineages as novel food-grade Streptococcus lineage. Copyright © 2017 The Authors. Published by

  14. Safety and feasibility of achieving lower systolic blood pressure goals in persons with type 2 diabetes: the SANDS trial.

    PubMed

    Weir, Matthew R; Yeh, Fawn; Silverman, Angela; Devereux, Richard B; Galloway, James M; Henderson, Jeffrey A; Howard, William J; Russell, Marie; Wilson, Charlton; Ratner, Robert; Sorkin, John; Umans, Jason G; Fleg, Jerome L; Stylianou, Mario; Lee, Elisa; Howard, Barbara V

    2009-10-01

    The Stop Atherosclerosis in Native Diabetics Study (SANDS) was a randomized open-label clinical trial in type 2 diabetics designed to examine the effects of intensive reduction of blood pressure, aggressive vs standard goals (< or =115/75 mm Hg vs < or =130/80 mm Hg), and low-density lipoprotein (LDL) cholesterol on the composite outcome of change in carotid intimal-medial thickness and cardiovascular events. The study demonstrated that in conjunction with a lower LDL cholesterol target of 70 mg/dL, aggressive systolic blood pressure-lowering resulted in a reduction in carotid intimal-medial thickness and left ventricular mass without measurable differences in cardiovascular events. The blood pressure treatment algorithm included renin-angiotensin system blockade, with other agents added if necessary. The authors conclude that both standard and more aggressive systolic blood pressure reduction can be achieved with excellent safety and good tolerability in patients with type 2 diabetes mellitus.

  15. Laboratory safety handbook

    USGS Publications Warehouse

    Skinner, E.L.; Watterson, C.A.; Chemerys, J.C.

    1983-01-01

    Safety, defined as 'freedom from danger, risk, or injury,' is difficult to achieve in a laboratory environment. Inherent dangers, associated with water analysis and research laboratories where hazardous samples, materials, and equipment are used, must be minimized to protect workers, buildings, and equipment. Managers, supervisors, analysts, and laboratory support personnel each have specific responsibilities to reduce hazards by maintaining a safe work environment. General rules of conduct and safety practices that involve personal protection, laboratory practices, chemical handling, compressed gases handling, use of equipment, and overall security must be practiced by everyone at all levels. Routine and extensive inspections of all laboratories must be made regularly by qualified people. Personnel should be trained thoroughly and repetitively. Special hazards that may involve exposure to carcinogens, cryogenics, or radiation must be given special attention, and specific rules and operational procedures must be established to deal with them. Safety data, reference materials, and texts must be kept available if prudent safety is to be practiced and accidents prevented or minimized.

  16. 16 CFR 1204.16 - Production testing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Production testing. 1204.16 Section 1204.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR OMNIDIRECTIONAL CITIZENS BAND BASE STATION ANTENNAS Certification § 1204.16 Production testing...

  17. Introduction to Preharvest Food Safety.

    PubMed

    Torrence, Mary E

    2016-10-01

    This introductory article provides an overview of preharvest food safety activities and initiatives for the past 15 years. The section on traditional areas of preharvest food safety focuses on significant scientific advancements that are a culmination of collaborative efforts (both public health and agriculture) and significant research results. The highlighted advancements provide the foundation for exploring future preharvest areas and for improving and focusing on more specific intervention/control/prevention strategies. Examples include Escherichia coli and cattle, Salmonella and Campylobacter in poultry, and interventions and prevention and control programs. The section on "nontraditional" preharvest food safety areas brings attention to potential emerging food safety issues and to future food safety research directions. These include organic production, the FDA's Produce Rule (water and manure), genomic sequencing, antimicrobial resistance, and performance metrics. The concluding section emphasizes important themes such as strategic planning, coordination, epidemiology, and the need for understanding food safety production as a continuum. Food safety research, whether at the pre- or postharvest level, will continue to be a fascinating complex web of foodborne pathogens, risk factors, and scientific and policy interactions. Food safety priorities and research must continue to evolve with emerging global issues, emerging technologies, and methods but remain grounded in a multidisciplinary, collaborative, and systematic approach.

  18. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY COMPOUNDING...

  19. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY COMPOUNDING...

  20. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY COMPOUNDING...

  1. John M. Eisenberg Patient Safety and Quality Awards.

    PubMed

    2009-12-01

    The Joint Commission Journal on Quality and Patient Safety is honored to publish articles on the recipients of the annual John M. Eisenberg Patient Safety and Quality Awards. This year, a new category was created: individual achievement at the international level.

  2. 16 CFR 1207.9 - Product certification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification. 1207.9 Section 1207.9 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR SWIMMING POOL SLIDES § 1207.9 Product certification. (a) Certification shall be in accordance...

  3. Perspectives on achieving sustainable energy production and use

    EPA Science Inventory

    The traditional definition of sustainability calls for polices and strategies that meet society's present needs without compromising the ability of future generations to meet their own needs. Achieving operational sustainability requires three critical elements: advances in scien...

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

    PubMed

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

    2016-05-01

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

  5. Consumption Safety of Pastries, Confectioneries, and Potato Products as Related to Fat Content.

    PubMed

    Żbikowska, Anna; Rutkowska, Jarosława; Kowalska, Małgorzata

    2015-01-01

    To determine the content of the main groups of fatty acids in pastries, confectionery, and potato products, paying special attention to trans fatty acids and the products of fat oxidation and hydrolysis, as factors affecting the safety of consumption. A total of 157 products were collected in Poland in 2009-2010. In fats extracted from samples, products of oxidation and hydrolysis were assayed using peroxide (PV), anisidine (AnV), and acid (AV) values. The fatty acid (FA) composition, especially the trans FAs (TFAs) content, was determined by gas chromatography. When assessing the TFA intake, Household Budget Surveys were considered. Highest content of fat was found for wafers with filling and crisps (32.3% and 29.3%, respectively). In 4 out of 9 groups of pastry and confectionery products studied, the quality of fat was decreased due to an excessive oxidation, as evidenced by a substantial content of secondary products of fat oxidation. The extracted fat was rich in SFA (on average, 50 g SFA/100 g FA) except fries and mixes. A great diversity of TFA content in fat of the products was found (0.1-24.8 g TFA/100 g FA). Wafers were characterized by the highest average content of TFA in the group of pastries (1.94 g TFA/100 g of product). Products of natural origin supplied 0.496 g of TFA per day, and those of industrial origin supplied about 1.5 g. The average TFA consumption, about 2 g/day, does not seem to affect health. However, an excessive consumption of pastry and confectionery products may present a risk, due not only to TFA but also to a high consumption of toxic secondary oxidation lipid products. Moreover, because 75% of TFAs in the diet were isomers of industrial origin, their further limitation and monitoring of their level in food seems highly recommendable.

  6. Complying with the Occupational Safety and Health Administration's Bloodborne Pathogens Standard: implementing needleless systems and intravenous safety devices.

    PubMed

    Marini, Michelle A; Giangregorio, Maeve; Kraskinski, Joanna C

    2004-03-01

    Preventing the transmission of bloodborne pathogens to healthcare workers has been a mission and a challenge of the healthcare industry for over 20 years. The development of the Occupational Safety and Health Administration Bloodborne Pathogens Standard in 1991 and the passing of the Needlestick Safety Act in 2000 mandated hospitals to develop an Exposure Control Plan to protect workers from these pathogens. Children's Hospital Boston began implementation of a needleless system in 1993. Employees readily accepted these systems into practice, because they were convenient and easy to use. A marked decrease in exposures to bloodborne pathogens naturally followed, which is consistent with the national data. The transition to intravenous (i.v.) safety devices at Children's Hospital began in 2000 and proved to be more of a challenge. First, the clinicians must choose a safety product, which requires developing and implementing a trial plan with potential catheters. This selection process is especially difficult in pediatrics where successful placement of the smallest-gauge catheter, no. 24, is imperative. After choosing an i.v. safety product, successful transition is dependent upon the thoroughness of i.v. safety device training and a commitment by the clinicians to the use of these products. Although the number of needlestick injuries and subsequent transmission of bloodborne pathogens have been further reduced with the use of i.v. safety devices, needlestick injuries still occur. This results from a lack of familiarity with the engineering of the device and therefore poor technique or a failure to activate the safety mechanism. Staff resistance due to loss of expertise with the new device and patient care concerns are additional barriers to the use of these new products. Addressing these obstacles and providing adequate training for all clinicians were required for successful implementation of these i.v. safety devices.

  7. Vision Zero--a road safety policy innovation.

    PubMed

    Belin, Matts-Åke; Tillgren, Per; Vedung, Evert

    2012-01-01

    The aim of this paper is to examine Sweden's Vision Zero road safety policy. In particular, the paper focuses on how safety issues were framed, which decisions were made, and what are the distinctive features of Vision Zero. The analysis reveals that the decision by the Swedish Parliament to adopt Vision Zero as Sweden's road safety policy was a radical innovation. The policy is different in kind from traditional traffic safety policy with regard to problem formulation, its view on responsibility, its requirements for the safety of road users, and the ultimate objective of road safety work. The paper briefly examines the implications of these findings for national and global road safety efforts that aspire to achieving innovative road safety policies in line with the Decade of Action for Road Safety 2011-2020, declared by the United Nations General Assembly in March 2010.

  8. Twenty-Two Years of U.S. Meat and Poultry Product Recalls: Implications for Food Safety and Food Waste.

    PubMed

    Gorton, Acton; Stasiewicz, Matthew J

    2017-04-01

    The U.S. Department of Agriculture, Food Safety and Inspection Service maintains a recall case archive of meat and poultry product recalls from 1994 to the present. In this study, we collected all recall records from 1994 to 2015 and extracted the recall date, meat or poultry species implicated, reason for recall, recall class, and pounds of product recalled and recovered. Of a total of 1,515 records analyzed, the top three reasons for recall were contamination with Listeria, undeclared allergens, and Shiga toxin-producing Escherichia coli . Class I recalls (due to a hazard with a reasonable probability of causing adverse health consequences or death) represented 71% (1,075 of 1,515) of the total recalls. The amounts of product recalled and recovered per event were approximately lognormally distributed. The mean amount of product recalled and recovered was 6,800 and 1,000 lb (3,087 and 454 kg), respectively (standard deviation, 1.23 and 1.56 log lb, respectively). The total amount of product recalled in the 22-year evaluation period was 690 million lb (313 million kg), and the largest single recall involved 140 million lb (64 million kg) (21% of the total). In every data category subset, the largest recall represented >10% of the total product recalled in the set. The amount of product recovered was known for only 944 recalls. In 12% of those recalls (110 of 944), no product was recovered. In the remaining recalls, the median recovery was 29% of the product. The number of recalls per year was 24 to 150. Recall counts and amounts of product recalled over the 22-year evaluation period did not regularly increase by year, in contrast to the regular increase in U.S. meat and poultry production over the same time period. Overall, these data suggest that (i) meat and poultry recalls were heavily skewed toward class I recalls, suggesting recalls were focused on improving food safety, (ii) numbers of products and amounts of each product recalled were highly variable but did

  9. Obstetric Safety and Quality.

    PubMed

    Pettker, Christian M; Grobman, William A

    2015-07-01

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

  10. 60th Anniversary of electricity production from light water reactors: Historical review of the contribution of materials science to the safety of the pressure vessel

    NASA Astrophysics Data System (ADS)

    van Duysen, J. C.; Meric de Bellefon, G.

    2017-02-01

    The first light water nuclear reactor dedicated to electricity production was commissioned in Shippingport, Pennsylvania in the United States in 1957. Sixty years after the event, it is clear that this type of reactor will be a major source of electricity and one of the key solutions to limit climate change in the 21st century. This article pays homage to the teams that contributed to this achievement by their involvement in research and development and their determination to push back the frontiers of knowledge. Via a few examples of scientific or technological milestones, it describes the evolution of ideas, models, and techniques during the last 60 years, and gives the current state-of-the-art in areas related to the safety of the reactor pressure vessel. Among other topics, it focuses on vessel manufacturing, steel fracture mechanics analysis, and understanding of irradiation-induced damage.

  11. Applying Toyota production system techniques for medication delivery: improving hospital safety and efficiency.

    PubMed

    Newell, Terry L; Steinmetz-Malato, Laura L; Van Dyke, Deborah L

    2011-01-01

    The inpatient medication delivery system used at a large regional acute care hospital in the Midwest had become antiquated and inefficient. The existing 24-hr medication cart-fill exchange process with delivery to the patients' bedside did not always provide ordered medications to the nursing units when they were needed. In 2007 the principles of the Toyota Production System (TPS) were applied to the system. Project objectives were to improve medication safety and reduce the time needed for nurses to retrieve patient medications. A multidisciplinary team was formed that included representatives from nursing, pharmacy, informatics, quality, and various operational support departments. Team members were educated and trained in the tools and techniques of TPS, and then designed and implemented a new pull system benchmarking the TPS Ideal State model. The newly installed process, providing just-in-time medication availability, has measurably improved delivery processes as well as patient safety and satisfaction. Other positive outcomes have included improved nursing satisfaction, reduced nursing wait time for delivered medications, and improved efficiency in the pharmacy. After a successful pilot on two nursing units, the system is being extended to the rest of the hospital. © 2010 National Association for Healthcare Quality.

  12. Materials-related issues in the safety and licensing of nuclear fusion facilities

    NASA Astrophysics Data System (ADS)

    Taylor, N.; Merrill, B.; Cadwallader, L.; Di Pace, L.; El-Guebaly, L.; Humrickhouse, P.; Panayotov, D.; Pinna, T.; Porfiri, M.-T.; Reyes, S.; Shimada, M.; Willms, S.

    2017-09-01

    Fusion power holds the promise of electricity production with a high degree of safety and low environmental impact. Favourable characteristics of fusion as an energy source provide the potential for this very good safety and environmental performance. But to fully realize the potential, attention must be paid in the design of a demonstration fusion power plant (DEMO) or a commercial power plant to minimize the radiological hazards. These hazards arise principally from the inventory of tritium and from materials that become activated by neutrons from the plasma. The confinement of these radioactive substances, and prevention of radiation exposure, are the primary goals of the safety approach for fusion, in order to minimize the potential for harm to personnel, the public, and the environment. The safety functions that are implemented in the design to achieve these goals are dependent on the performance of a range of materials. Degradation of the properties of materials can lead to challenges to key safety functions such as confinement. In this paper the principal types of material that have some role in safety are recalled. These either represent a potential source of hazard or contribute to the amelioration of hazards; in each case the related issues are reviewed. The resolution of these issues lead, in some instances, to requirements on materials specifications or to limits on their performance.

  13. Analytical methodology for safety validation of computer controlled subsystems. Volume 1 : state-of-the-art and assessment of safety verification/validation methodologies

    DOT National Transportation Integrated Search

    1995-09-01

    This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety critical functions in high-speed rail or magnetic levitation ...

  14. Ares I-X Range Safety Flight Envelope Analysis

    NASA Technical Reports Server (NTRS)

    Starr, Brett R.; Olds, Aaron D.; Craig, Anthony S.

    2011-01-01

    Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

  15. Opinion of the Scientific Committee on Consumer safety (SCCS) - Opinion on the safety of the use of Methylisothiazolinone (MI) (P94), in cosmetic products (sensitisation only).

    PubMed

    Giménez-Arnau, A M

    2016-04-01

    The information provided does not support the safe use of MI as a preservative in rinse-off cosmetic products up to a concentration limit of 100 ppm from the view of induction of contact allergy. For rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for the consumer from the point of view of induction of contact allergy. The information provided does not support the safe use of MI as a preservative in leave-on hair cosmetic products up to a concentration limit of 100 ppm from the point of view of induction of contact allergy. The concerns and opinions raised in SCCS Opinion SCCS/1521/13 (12 December 2013 with revision 27 March 2014) remain. The results of the recent Scandinavian study do not support safety of MI in rinse-off products at either 100 ppm or at 50 ppm for elicitation or induction. Copyright © 2016. Published by Elsevier Inc.

  16. Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

    NASA Technical Reports Server (NTRS)

    Ancel, Ersin; Shih, Ann T.

    2014-01-01

    NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

  17. Risk assessment of low-level chemical exposures from consumer products under the U.S. Consumer Product Safety Commission chronic hazard guidelines.

    PubMed Central

    Babich, M A

    1998-01-01

    The U.S. Consumer Product Safety Commission (CPSC) is an independent regulatory agency that was created in 1973. The CPSC has jurisdiction over more the 15,000 types of consumer products used in and around the home or by children, except items such as food, drugs, cosmetics, medical devices, pesticides, certain radioactive materials, products that emit radiation (e.g., microwave ovens), and automobiles. The CPSC has investigated many low-level exposures from consumer products, including formaldehyde emissions from urea-formaldehyde foam insulation and pressed wood products, CO and NO2 emmissions from combustion appliances, and dioxin in paper products. Many chemical hazards are addressed under the Federal Hazardous Substances Act (FHSA), which applies to acute and chronic health effects resulting from high- or low-level exposures. In 1992 the Commission issued guidelines for assessing chronic hazards under the FHSA, including carcinogenicity, neurotoxicity, reproductive/developmental toxicity, exposure, bioavailability, risk assessment, and acceptable risk. The chronic hazard guidelines describe a series of default assumptions, which are used in the absence of evidence to the contrary. However, the guidelines are intended to be sufficiently flexible to incorporate the latest scientific information. The use of alternative procedures is permissible, on a case-by-case basis, provided that the procedures used are scientifically defensible and supported by appropriate data. The application of the chronic hazard guidelines in assessing the risks from low-level exposures is discussed. PMID:9539035

  18. [Innovative technology and blood safety].

    PubMed

    Begue, S; Morel, P; Djoudi, R

    2016-11-01

    If technological innovations are not enough alone to improve blood safety, their contributions for several decades in blood transfusion are major. The improvement of blood donation (new apheresis devices, RFID) or blood components (additive solutions, pathogen reduction technology, automated processing of platelets concentrates) or manufacturing process of these products (by automated processing of whole blood), all these steps where technological innovations were implemented, lead us to better traceability, more efficient processes, quality improvement of blood products and therefore increased blood safety for blood donors and patients. If we are on the threshold of a great change with the progress of pathogen reduction technology (for whole blood and red blood cells), we hope to see production of ex vivo red blood cells or platelets who are real and who open new conceptual paths on blood safety. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  19. 9 CFR 113.39 - Cat safety tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Cat safety tests. 113.39 Section 113.39 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Seed Virus is tested for safety. (1) The test animals shall be determined to be susceptible to the...

  20. An investigation into online videos as a source of safety hazard reports.

    PubMed

    Nasri, Leila; Baghersad, Milad; Gruss, Richard; Marucchi, Nico Sung Won; Abrahams, Alan S; Ehsani, Johnathon P

    2018-06-01

    Despite the advantages of video-based product reviews relative to text-based reviews in detecting possible safety hazard issues, video-based product reviews have received no attention in prior literature. This study focuses on online video-based product reviews as possible sources to detect safety hazards. We use two common text mining methods - sentiment and smoke words - to detect safety issues mentioned in videos on the world's most popular video sharing platform, YouTube. 15,402 product review videos from YouTube were identified as containing either negative sentiment or smoke words, and were carefully manually viewed to verify whether hazards were indeed mentioned. 496 true safety issues (3.2%) were found. Out of 9,453 videos that contained smoke words, 322 (3.4%) mentioned safety issues, vs. only 174 (2.9%) of the 5,949 videos with negative sentiment words. Only 1% of randomly-selected videos mentioned safety hazards. Comparing the number of videos with true safety issues that contain sentiment words vs. smoke words in their title or description, we show that smoke words are a more accurate predictor of safety hazards in video-based product reviews than sentiment words. This research also discovers words that are indicative of true hazards versus false positives in online video-based product reviews. Practical applications: The smoke words lists and word sub-groups generated in this paper can be used by manufacturers and consumer product safety organizations to more efficiently identify product safety issues from online videos. This project also provides realistic baselines for resource estimates for future projects that aim to discover safety issues from online videos or reviews. Copyright © 2018 National Safety Council and Elsevier Ltd. All rights reserved.

  1. Fire safety: A case study of technology transfer

    NASA Technical Reports Server (NTRS)

    Heins, C. F.

    1975-01-01

    Two basic ways in which NASA-generated technology is being used by the fire safety community are described. First, improved products and systems that embody NASA technical advances are entering the marketplace. Second, NASA test data and technical information related to fire safety are being used by persons concerned with reducing the hazards of fire through improved design information and standards. The development of commercial fire safety products and systems typically requires adaptation and integration of aerospace technologies that may not have been originated for NASA fire safety applications.

  2. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

    PubMed

    Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

    2013-01-26

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug

  3. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

    PubMed Central

    2013-01-01

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug

  4. School Safety Project: Product Evaluation, 1990-1991.

    ERIC Educational Resources Information Center

    Saginaw Public Schools, MI. Dept. of Evaluation Services.

    A districtwide school safety project implemented in Saginaw, Michigan, in 1990-91, the third year of its operation, is evaluated in this report. The project is evaluated on the basis of the following objectives: employment and training of home-school liaison officers; establishment of an advisory council; development and implementation of…

  5. NACA Wartime Safety Poster

    NASA Image and Video Library

    1945-04-21

    One of many safety posters produced by NACA artists during World War II. The Aircraft Engine Research Laboratory established a Safety Office in 1942 to coordinate and oversee safety-related activities. The lab struggled to maintain a full staff during the war when military research projects were at a peak. NACA management mandated six-day work weeks without overtime and the elimination of holidays. As such, workplace injuries were a serious threat to maintaining productivity needed to sustain the military’s aeronautics efforts.

  6. Commentary: Status of road safety in Asia.

    PubMed

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

    2016-01-01

    The objective of this article is to assess the status of road safety in Asia and present accident and injury prevention strategies based on global road safety improvement experiences and discuss the way forward by indicating opportunities and countermeasures that could be implemented to achieve a new level of safety in Asia. This study provides a review and analyses of data in the literature, including from the World Health Organization (WHO) and World Bank, and a review of lessons learned from best practices in high-income countries. In addition, an estimation of costs due to road transport injuries in Asia and review of future trends in road transport is provided. Data on the global and Asian road safety problem and status of prevention strategies in Asia as well as recommendations for future actions are discussed. The total number of deaths due to road accidents in the 24 Asian countries, encompassing 56% of the total world population, is 750,000 per year (statistics 2010). The total number of injuries is more than 50 million, of which 12% are hospital admissions. The loss to the economy in the 24 Asian countries is estimated to around US$800 billion or 3.6% of the gross domestic product (GDP). This article clearly shows that road safety is causing large problems and high costs in Asia, with an enormous impact on the well-being of people, economy, and productivity. In many Asian low- and middle-income countries, the yearly number of fatalities and injuries is increasing. Vulnerable road users (pedestrians, cyclists, and motorcyclists combined) are particularly at risk. Road safety in Asia should be given rightful attention, including taking powerful, effective actions. This review stresses the need for reliable accident data, because there is considerable underreporting in the official statistics. Reliable accident data are imperative to determine evidence-based intervention strategies and monitor the success of these interventions and analyses. On the other

  7. 16 CFR § 1210.16 - Production testing.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Production testing. § 1210.16 Section § 1210.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.16 Production testing. (a...

  8. Technology and Tool Development to Support Safety and Mission Assurance

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh

    2017-01-01

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

  9. Safety leadership: application in construction site.

    PubMed

    Cooper, Dominic

    2010-01-01

    The extant safety literature suggests that managerial Safety Leadership is vital to the success and maintenance of a behavioral safety process. The current paper explores the role of Managerial Safety Leadership behaviors in the success of a behavioral safety intervention in the Middle-East with 47,000 workers from multiple nationalities employed by fourteen sub-contractors and one main contractor. A quasi-experimental repeating ABABAB, within groups design was used. Measurement focused on managerial Safety Leadership and employee safety behaviors as well as Corrective Actions. Data was collected over 104 weeks. During this time, results show safety behavior improved by 30 percentage points from an average of 65% during baseline to an average of 95%. The site achieved 121 million man-hours free of lost-time injuries on the longest run. Stepwise multiple regression analyses indicated 86% of the variation in employee safety behavior was associated with senior, middle and front-line manager's Safety Leadership behaviors and the Corrective Action Rate. Approximately 38% of the variation in the Total Recordable Incident Rate (TRIR) was associated with the Observation rate, Corrective Action Rate and Observers Records of managerial safety leaders (Visible Ongoing Support). The results strongly suggest manager's Safety Leadership influences the success of Behavioral Safety processes.

  10. Application of an Informatics-Based Decision-Making Framework and Process to the Assessment of Radiation Safety in Nanotechnology

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

    Hoover, Mark D.; Myers, David S.; Cash, Leigh J.

    The National Council on Radiation Protection and Measurements (NCRP) has established NCRP Scientific Committee 2-6 to develop a report on the current state of knowledge and guidance for radiation safety programs involved with nanotechnology. Nanotechnology is the understanding and control of matter at the nanoscale, at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications. While the full report is in preparation, this article presents and applies an informatics-based decision-making framework and process through which the radiation protection community can anticipate that nano-enabled applications, processes, nanomaterials, and nanoparticles are likely to become present or are alreadymore » present in radiation-related activities; recognize specific situations where environmental and worker safety, health, well-being, and productivity may be affected by nano-related activities; evaluate how radiation protection practices may need to be altered to improve protection; control information, interpretations, assumptions, and conclusions to implement scientifically sound decisions and actions; and confirm that desired protection outcomes have been achieved. This generally applicable framework and supporting process can be continuously applied to achieve health and safety at the convergence of nanotechnology and radiation-related activities.« less

  11. Application of an informatics-based decision-making framework and process to the assessment of radiation safety in nanotechnology.

    PubMed

    Hoover, Mark D; Myers, David S; Cash, Leigh J; Guilmette, Raymond A; Kreyling, Wolfgang G; Oberdörster, Günter; Smith, Rachel; Cassata, James R; Boecker, Bruce B; Grissom, Michael P

    2015-02-01

    The National Council on Radiation Protection and Measurements (NCRP) established NCRP Scientific Committee 2-6 to develop a report on the current state of knowledge and guidance for radiation safety programs involved with nanotechnology. Nanotechnology is the understanding and control of matter at the nanoscale, at dimensions between ∼1 and 100 nm, where unique phenomena enable novel applications. While the full report is in preparation, this paper presents and applies an informatics-based decision-making framework and process through which the radiation protection community can anticipate that nano-enabled applications, processes, nanomaterials, and nanoparticles are likely to become present or are already present in radiation-related activities; recognize specific situations where environmental and worker safety, health, well-being, and productivity may be affected by nano-related activities; evaluate how radiation protection practices may need to be altered to improve protection; control information, interpretations, assumptions, and conclusions to implement scientifically sound decisions and actions; and confirm that desired protection outcomes have been achieved. This generally applicable framework and supporting process can be continuously applied to achieve health and safety at the convergence of nanotechnology and radiation-related activities.

  12. Application of an Informatics-Based Decision-Making Framework and Process to the Assessment of Radiation Safety in Nanotechnology

    DOE PAGES

    Hoover, Mark D.; Myers, David S.; Cash, Leigh J.; ...

    2015-01-01

    The National Council on Radiation Protection and Measurements (NCRP) has established NCRP Scientific Committee 2-6 to develop a report on the current state of knowledge and guidance for radiation safety programs involved with nanotechnology. Nanotechnology is the understanding and control of matter at the nanoscale, at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications. While the full report is in preparation, this article presents and applies an informatics-based decision-making framework and process through which the radiation protection community can anticipate that nano-enabled applications, processes, nanomaterials, and nanoparticles are likely to become present or are alreadymore » present in radiation-related activities; recognize specific situations where environmental and worker safety, health, well-being, and productivity may be affected by nano-related activities; evaluate how radiation protection practices may need to be altered to improve protection; control information, interpretations, assumptions, and conclusions to implement scientifically sound decisions and actions; and confirm that desired protection outcomes have been achieved. This generally applicable framework and supporting process can be continuously applied to achieve health and safety at the convergence of nanotechnology and radiation-related activities.« less

  13. 77 FR 52272 - Safety Standard for Play Yards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-29

    ... Standard for Play Yards AGENCY: Consumer Product Safety Commission. ACTION: Notice of proposed rulemaking... to amend the play yard mandatory standard. This proposed rule would address the hazards associated... Improvement Act of 2008 (CPSIA), also known as the ``Danny Keysar Child Product Safety Notification Act...

  14. 9 CFR 113.39 - Cat safety tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Cat safety tests. 113.39 Section 113... Procedures § 113.39 Cat safety tests. The safety tests provided in this section shall be conducted when... recommended for use in cats. (a) The cat safety test provided in this paragraph shall be used when the Master...

  15. [Expert investigation on food safety standard system framework construction in China].

    PubMed

    He, Xiang; Yan, Weixing; Fan, Yongxiang; Zeng, Biao; Peng, Zhen; Sun, Zhenqiu

    2013-09-01

    Through investigating food safety standard framework among food safety experts, to summarize the basic elements and principles of food safety standard system, and provide policy advices for food safety standards framework. A survey was carried out among 415 experts from government, professional institutions and the food industry/enterprises using the National Food Safety Standard System Construction Consultation Questionnaire designed in the name of the Secretariat of National Food Safety Standard Committee. Experts have different advices in each group about the principles of food product standards, food additive product standards, food related product standards, hygienic practice, test methods. According to the results, the best solution not only may reflect experts awareness of the work of food safety standards situation, but also provide advices for setting and revision of food safety standards for the next. Through experts investigation, the framework and guiding principles of food safety standard had been built.

  16. Bioluminescence lights the way to food safety

    NASA Astrophysics Data System (ADS)

    Brovko, Lubov Y.; Griffiths, Mansel W.

    2003-07-01

    The food industry is increasingly adopting food safety and quality management systems that are more proactive and preventive than those used in the past which have tended to rely on end product testing and visual inspection. The regulatory agencies in many countries are promoting one such management tool, Hazard Analysis Critical Control Point (HACCP), as a way to achieve a safer food supply and as a basis for harmonization of trading standards. Verification that the process is safe must involve microbiological testing but the results need not be generated in real-time. Of all the rapid microbiological tests currently available, the only ones that come close to offering real-time results are bioluminescence-based methods. Recent developments in application of bioluminescence for food safety issues are presented in the paper. These include the use of genetically engineered microorganisms with bioluminescent and fluorescent phenotypes as a real time indicator of physiological state and survival of food-borne pathogens in food and food processing environments as well as novel bioluminescent-based methods for rapid detection of pathogens in food and environmental samples. Advantages and pitfalls of the methods are discussed.

  17. Why system safety programs can fail

    NASA Technical Reports Server (NTRS)

    Hammer, W.

    1971-01-01

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

  18. Human aspects of mission safety

    NASA Technical Reports Server (NTRS)

    Connors, Mary M.

    1989-01-01

    Recent discussions of psychology's involvement in spaceflight have emphasized its role in enhancing space living conditions and incresing crew productivity. While these goals are central to space missions, behavioral scientists should not lose sight of a more basic flight requirement - that of crew safety. This paper examines some of the processes employed in the American space program in support of crew safety and suggests that behavioral scientists could contribute to flight safety, both through these formal processes and through less formal methods. Various safety areas of relevance to behavioral scientists are discussed.

  19. Safe laser application requires more than laser safety

    NASA Astrophysics Data System (ADS)

    Frevel, A.; Steffensen, B.; Vassie, L.

    1995-02-01

    An overview is presented concerning aspects of laser safety in European industrial laser use. Surveys indicate that there is a large variation in the safety strategies amongst industrial laser users. Some key problem areas are highlighted. Emission of hazardous substances is a major problem for users of laser material processing systems where the majority of the particulate is of a sub-micrometre size, presenting a respiratory hazard. Studies show that in many cases emissions are not frequently monitored in factories and uncertainty exists over the hazards. Operators of laser machines do not receive adequate job training or safety training. The problem is compounded by a plethora of regulations and standards which are difficult to interpret and implement, and inspectors who are not conversant with the technology or the issues. A case is demonstrated for a more integrated approach to laser safety, taking into account the development of laser applications, organizational and personnel development, in addition to environmental and occupational health and safety aspects. It is necessary to achieve a harmonization between these elements in any organization involved in laser technology. This might be achieved through establishing technology transfer centres in laser technology.

  20. Integrating health and safety in the workplace: how closely aligning health and safety strategies can yield measurable benefits.

    PubMed

    Loeppke, Ronald R; Hohn, Todd; Baase, Catherine; Bunn, William B; Burton, Wayne N; Eisenberg, Barry S; Ennis, Trish; Fabius, Raymond; Hawkins, R Jack; Hudson, T Warner; Hymel, Pamela A; Konicki, Doris; Larson, Paul; McLellan, Robert K; Roberts, Mark A; Usrey, Cary; Wallace, Joseph A; Yarborough, Charles M; Siuba, Justina

    2015-05-01

    To better understand how integrating health and safety strategies in the workplace has evolved and establish a replicable, scalable framework for advancing the concept with a system of health and safety metrics, modeled after the Dow Jones Sustainability Index. Seven leading national and international programs aimed at creating a culture of health and safety in the workplace were compared and contrasted. A list of forty variables was selected, making it clear there is a wide variety of approaches to integration of health and safety in the workplace. Depending on how well developed the culture of health and safety is within a company, there are unique routes to operationalize and institutionalize the integration of health and safety strategies to achieve measurable benefits to enhance the overall health and well-being of workers, their families, and the community.

  1. Food Supply and Food Safety Issues in China

    PubMed Central

    Lam, Hon-Ming; Remais, Justin; Fung, Ming-Chiu; Xu, Liqing; Sun, Samuel Sai-Ming

    2013-01-01

    Food supply and food safety are major global public health issues, and are particularly important in heavily populated countries such as China. Rapid industrialisation and modernisation in China are having profound effects on food supply and food safety. In this Review, we identified important factors limiting agricultural production in China, including conversion of agricultural land to other uses, freshwater deficits, and soil quality issues. Additionally, increased demand for some agricultural products is examined, particularly those needed to satisfy the increased consumption of animal products in the Chinese diet, which threatens to drive production towards crops used as animal feed. Major sources of food poisoning in China include pathogenic microorganisms, toxic animals and plants entering the food supply, and chemical contamination. Meanwhile, two growing food safety issues are illegal additives and contamination of the food supply by toxic industrial waste. China’s connections to global agricultural markets are also having important effects on food supply and food safety within the country. Although the Chinese Government has shown determination to reform laws, establish monitoring systems, and strengthen food safety regulation, weak links in implementation remain. PMID:23746904

  2. 21 CFR 314.540 - Postmarketing safety reporting.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Postmarketing safety reporting. 314.540 Section... New Drugs for Serious or Life-Threatening Illnesses § 314.540 Postmarketing safety reporting. Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting...

  3. GOES-R Space Weather Data: Achieving User Ready Products

    NASA Astrophysics Data System (ADS)

    Rowland, W. F.; Tilton, M.; Redmon, R. J.; Goodman, S. J.; Comerford, M.

    2017-12-01

    Forecasters and the science community will rely on improved Space Weather products from the next generation of Geostationary Operational Environmental Satellite (GOES-R Series) for decades to come. Many issues must be successfully addressed in order to produce useful products. The instruments themselves and their basic scientific measurements (Level 1b data, i.e. L1b) must be calibrated and validated. Algorithms must be created to transform L1b into the specific environmental parameters that are of interest to forecasters and the community (Level 2+, i.e. L2+). In the case of Space Weather data, because the L2+ products are not generated within the core GOES-R Ground Segment, a separate system had to be developed in order to implement the L2+ products. Finally, the products must be made available to real time and retrospective users, as well as preserved for future generations. We give an overview of the path to production of the GOES-R Space Weather products, and the role of the National Centers for Environmental Information (NCEI) in this process.

  4. 78 FR 52239 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... Environmental Enforcement 30 CFR Part 250 Oil and Gas and Sulphur Operations on the Outer Continental Shelf--Oil and Gas Production Safety Systems; Proposed Rule #0;#0;Federal Register / Vol. 78 , No. 163 / Thursday...] RIN 1014-AA10 Oil and Gas and Sulphur Operations on the Outer Continental Shelf--Oil and Gas...

  5. Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

    PubMed Central

    Sekine, S; Pinnow, EE; Wu, E; Kurtzig, R; Hall, M; Dal Pan, GJ

    2016-01-01

    In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

  6. Software development for safety-critical medical applications

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1992-01-01

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

  7. New Advances in Infant Feeding: New Products and Novel Technologies.

    PubMed

    Pina-Pérez, Maria C; Martínez, Antonio; Rodrigo, Dolores

    2017-01-01

    Breastfeeding is the best way to provide ideal food for infants. However, there are many situations in which breastfeeding is unviable (maternal illness, hygiene problems, intravenous feeding requirement, storage). Safe, efficient, and nutritious products should be offered by the industry to mothers and healthcare professionals as an alternative. The present review aims to update the state of the art regarding the most innovative developments in infant feeding formulation and, the promising novel technologies that are being investigated to achieve a balance between the microbiological stability, organoleptic and nutritional value of baby food. The research lines included in the present systematic review are focused on both, the most innovative ingredients and emergent technologies applied increasing the offer of tailor-made nutritional profiled products with improved quality and safety. According to the reviewed research and recently published patents the current emergence of a new generation of infant products is remarkable, with specific product lines aimed at infants at different stages of development and affected by several disorders (low-weight babies, premature neonates, allergenic patients), with special emphasis on the application of novel technologies (e.g. High Hydrostatic Pressure (HHP) and microencapsulation) as potential techniques to ensure the microbiological safety of developed products, and the improvement of their nutritional value, complementary to the addition of functional ingredients, such as omega 3 and 6 fatty acids, amino acids, prebiotics and probiotics, and medicinal herb supplementation (e.g. lemon balm, royal jelly). The present research work provides a general view of recent advances in infant products processing and formulation focusing on the technological effects and quality/safety developments. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  8. Safety of tomatillos and products containing tomatillos canned by the water-bath canning method.

    PubMed

    McKee, L H; Remmenga, M D; Bock, M A

    1998-01-01

    Three studies were conducted to evaluate the safety of tomatillos and products containing tomatillos canned by the water-bath processing method. In the first study, plain tomatillos were processed for 25, 37.5, 50 and 62.5 min. In the second study, five tomatillo/onion combinations were prepared while five tomatillo/green chile combinations were prepared in the third study. pH evaluations were conducted to determine safety in all studies using pH 4.2 as the cut-off value. No differences in the pH of plain tomatillos were detected due to processing time. All jars of plain tomatillos had pH values below 4.1. All combinations of tomatillos/onions and tomatillos/green chile containing more than 50% tomatillo had pH values below the 4.2 cut-off value. Results of the three studies indicate (1) acidification of plain tomatillos is probably unnecessary for canning by the water-bath processing method and (2) combinations of acidic tomatillos and low-acid onions or green chile must contain more than 50% tomatillos to have a pH low enough for safe water-bath processing.

  9. 77 FR 63800 - Proposed Extension of Approval of Information Collection; Comment Request-Safety Standard for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection; Comment Request--Safety Standard for Walk-Behind Power Lawn Mowers AGENCY: Consumer Product Safety.... Chapter 35), the Consumer Product Safety Commission (CPSC) requested comments on a proposed extension of...

  10. The conception of fashion products for children: reflections on safety parameters.

    PubMed

    Prete, Lígia Gomes Pereira; Emidio, Lucimar de Fátima Bilmaia; Martins, Suzana Barreto

    2012-01-01

    The purpose of this study is to reflect on safety requirements for children's clothing, based on the standardization proposed by the ABNT (Technical Standardization Brazilian Association). Bibliographic research and case studies were considered on writing this work. We also discuss the importance of adding other safety requirements to the current standardization, as well as the increasing of the actual age range specified by the ABNT, following the children's clothing safety standardizations in Portugal and the United States, also stated here.

  11. 76 FR 14592 - Safety Management System; Withdrawal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

    ...-06A] RIN 2120-AJ15 Safety Management System; Withdrawal AGENCY: Federal Aviation Administration (FAA... (``product/ service providers'') to develop a Safety Management System (SMS). The FAA is withdrawing the... management with a set of robust decision-making tools to use to improve safety. The FAA received 89 comments...

  12. How Close We Are to Achieving Commercially Viable Large-Scale Photobiological Hydrogen Production by Cyanobacteria: A Review of the Biological Aspects

    PubMed Central

    Sakurai, Hidehiro; Masukawa, Hajime; Kitashima, Masaharu; Inoue, Kazuhito

    2015-01-01

    Photobiological production of H2 by cyanobacteria is considered to be an ideal source of renewable energy because the inputs, water and sunlight, are abundant. The products of photobiological systems are H2 and O2; the H2 can be used as the energy source of fuel cells, etc., which generate electricity at high efficiencies and minimal pollution, as the waste product is H2O. Overall, production of commercially viable algal fuels in any form, including biomass and biodiesel, is challenging, and the very few systems that are operational have yet to be evaluated. In this paper we will: briefly review some of the necessary conditions for economical production, summarize the reports of photobiological H2 production by cyanobacteria, present our schemes for future production, and discuss the necessity for further progress in the research needed to achieve commercially viable large-scale H2 production. PMID:25793279

  13. The Emergency Medical Services Safety Champions

    PubMed Central

    Patterson, P. Daniel; Anderson, Michelle S.; Zionts, Nancy D.; Paris, Paul M.

    2014-01-01

    The overarching mission of prehospital Emergency Medical Services (EMS) is to deliver life-saving care for people when their needs are greatest. Fulfilling this mission is challenged by threats to patient and provider safety. The EMS setting is high-risk because care is delivered rapidly in the out-of-hospital setting where patient-benefiting resources are limited. There is growing evidence that safety culture varies widely across EMS agencies. A poor safety culture may manifest as error in medication, back injuries, and other poor outcomes for patient and provider. Recently, federal and national leaders of EMS (i.e., the National Highway Traffic Safety Administration) have made improving EMS safety culture a national priority. Unfortunately, there are few initiatives that can help local EMS leaders achieve that priority. We describe the successful EMS Champs Fellowship program supported by the Jewish Healthcare Foundation (JHF) designed to train EMS leaders to improve safety for patients and providers. PMID:23150883

  14. The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety by modifying the CONSORT statement.

    PubMed

    O'Connor, A M; Sargeant, J M; Gardner, I A; Dickson, J S; Torrence, M E; Dewey, C E; Dohoo, I R; Evans, R B; Gray, J T; Greiner, M; Keefe, G; Lefebvre, S L; Morley, P S; Ramirez, A; Sischo, W; Smith, D R; Snedeker, K; Sofos, J; Ward, M P; Wills, R

    2010-03-01

    The conduct of randomized controlled trials in livestock with production, health and food-safety outcomes presents unique challenges that may not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on 18-19 November 2008 in Chicago, IL, USA, to achieve the objective. Prior to the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock-production specialists, journal editors, assistant editors and associate editors. Prior to the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist and an additional sub-item was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health and food-safety outcomes.

  15. Quality and safety of herbal medical products: regulation and the need for quality assurance along the value chains.

    PubMed

    Heinrich, Michael

    2015-07-01

    Herbal medicines and products derived from them are a diverse group of products for which different (and often limited) levels of evidence are available. As importantly, such products generally vary in their composition and are at the end of an often poorly understood value chain, which often links producers in biodiversity rich countries with the large markets in the North. This paper discusses the current regulatory framework of such herbal medical products (with a focus on the UK) and using examples from our own metabolomic research on Curcumal longa L. (turmeric, Zingiberaceae) how value chains impact on the composition and quality (and thus the safety) of such products. Overall, our recent research demonstrates the need for studying the links between producers and consumers of commodities produced in provider countries and that plant metabolomics offer a novel way of assessing the chemical variability along a value chain. © 2015 The British Pharmacological Society.

  16. Achieving Energy Efficiency Through Real-Time Feedback

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

    Nesse, Ronald J.

    2011-09-01

    Through the careful implementation of simple behavior change measures, opportunities exist to achieve strategic gains, including greater operational efficiencies, energy cost savings, greater tenant health and ensuing productivity and an improved brand value through sustainability messaging and achievement.

  17. 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.

  18. DOE explosives safety manual

    NASA Astrophysics Data System (ADS)

    1990-05-01

    The Department of Energy (DOE) policy requires that all activities be conducted in a manner that protects the safety of the public and provides a safe and healthful workplace for employees. DOE has also prescribed that all personnel be protected in any explosives operation undertaken. The level of safety provided shall be at least equivalent to that of the best industrial practice. The risk of death or serious injury shall be limited to the lowest practicable minimum. DOE and contractors shall continually review their explosives operations with the aim of achieving further refinements and improvements in safety practices and protective features. This manual describes the Department's explosive safety requirements applicable to operations involving the development, testing, handling, and processing of explosives or assemblies containing explosives. It is intended to reflect the state-of-the-art in explosives safety. In addition, it is essential that applicable criteria and requirements for implementing this policy be readily available and known to those responsible for conducting DOE programs. This document shall be periodically reviewed and updated to establish new requirements as appropriate. Users are requested to submit suggestions for improving the DOE Explosives Safety Manual through their appropriate Operations Office to the Office of Quality Programs.

  19. [The Polish Task Force position statement on safety of biologic treatment with monoclonal antibodies and soluble receptors].

    PubMed

    Jahnz-Rozyk, Karina; Wiesik-Szewczyk, Ewa

    2014-07-01

    The introduction of biologic therapies for treatment in many fields of medicine such as rheumatology oncology, dermatology, hematology and allergology, became one of the most important achievements of the modem medicine. The first biological therapeutics have already reached patent expiration date and corresponding biosimilars were approved by EMA (European Medicine Agency) and FDA (Food and Drug Administration). Many more biosimilar products are currently under review for marketing authorization around the world. The approval of products similar, but not identical to already known innovative biologics, due to complexity of structure and manufacturing technology, stirs a lot of discussions regarding safety concerns related to differences in posttranslational processing and in immunogenicity between reference and biosimilar products, and relevance of these differences to the clinical practice. Critical issues involve extrapolation to different clinical indication, automatic substitution and switching. Despite EMA recommendation and advocacy for biosimilars, it is beyond this regulatory authority to establish definitive regulation for each EU member, which it is expected to be country related. The aim of the study was an attempt to define the stance regarding particular aspects of biological treatment conducted in Poland is undertaken. The Task Force of 13 experts involved in various aspects of biologic therapies in Poland was established. A modified Delphi voting was performed to achieve consensus regarding the most important aspects of biologic treatment in Poland, with particular concern of biosimilars. Ten final statements were discussed and voted upon. The statements cover general aspects of biosimilars including expected cost-benefit ratios, extrapolation of clinical indications, interchange switching, patient information and requirement of patient consent. The state of post marketing pharmacovigilance of biologics (innovative ones as well as biosimilars) was

  20. A simple approach to industrial laser safety.

    PubMed

    Lewandowski, Michael A; Hinz, Michael W

    2005-02-01

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

  1. Food safety - the roles and responsibilities of different sectors

    NASA Astrophysics Data System (ADS)

    Karabasil, N.; Bošković, T.; Dimitrijević, M.; Vasilev, D.; Đorđević, V.; Lakićević, B.; Teodorović, V.

    2017-09-01

    Serbia is a relatively small country but with a long tradition in food production, especially meat and meat products. Serbia, as part of its open negotiation process as a candidate country with the European Union (EU), started to harmonise its legislation with the EU, and has published a set of laws and regulations relating to the hygiene of food production and food safety, the official control of production and the welfare of animals. Therefore, the food safety system in Serbia is based on principles established in the EU. There is a need for cooperation of different sectors (government, food business operators and consumers) in the management of food safety, and every sector has its role and responsibility. This paper aims to provide analytical support for the process of upgrading safety and quality in Serbia’s food sector and explains the roles and responsibilities of different sectors in the food chain.

  2. Safety assessments and public concern for genetically modified food products: the American view.

    PubMed

    Harlander, Susan K

    2002-01-01

    In the relatively short time since their commercial introduction in 1996, genetically modified (GM) crops have been rapidly adopted in the United States GM crops are regulated through a coordinated framework developed in 1992 and administered by three agencies-the US Department of Agriculture (USDA) that ensures the products are safe to grow, the Environmental Protection Agency (EPA) that ensures the products are safe for the environment, and the Food and Drug Administration (FDA) that ensures the products are safe to eat. Rigorous food and environmental safety assessments must be completed before GM crops can be commercialized. Fifty-one products have been reviewed by the FDA, including several varieties of corn, soybeans, canola, cotton, rice, sugar beets, potatoes, tomatoes, squash, papaya, and flax. Because FDA considers these crops "substantially equivalent" to their conventional counterparts, no special labeling is required for GM crops in the United States and they are managed as commodities with no segregation or identity preservation. GM crops have thus made their way through commodity distribution channels into thousands of ingredients used in processed foods. It has been estimated that 70% to 85% of processed foods on supermarket shelves in the United States today contain one or more ingredients potentially derived from GM crops. The food industry and retail industry have been monitoring the opinions of their consumers on the GM issue for the past several years. Numerous independent groups have also surveyed consumer concerns about GM foods. The results of these surveys are shared and discussed here.

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

    PubMed Central

    Page, Marianne; Rackliff, Lucy

    2006-01-01

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

  4. Patient safety: the landscape of the global research output and gender distribution.

    PubMed

    Schreiber, Moritz; Klingelhöfer, Doris; Groneberg, David A; Brüggmann, Doerthe

    2016-02-12

    Patient safety is a crucial issue in medicine. Its main objective is to reduce the number of deaths and health damages that are caused by preventable medical errors. To achieve this, it needs better health systems that make mistakes less likely and their effects less detrimental without blaming health workers for failures. Until now, there is no in-depth scientometric analysis on this issue that encompasses the interval between 1963 and 2014. Therefore, the aim of this study is to sketch a landscape of the past global research output on patient safety including the gender distribution of the medical discipline of patient safety by interpreting scientometric parameters. Additionally, respective future trends are to be outlined. The Core Collection of the scientific database Web of Science was searched for publications with the search term 'Patient Safety' as title word that was focused on the corresponding medical discipline. The resulting data set was analysed by using the methodology implemented by the platform NewQIS. To visualise the geographical landscape, state-of-the-art techniques including density-equalising map projections were applied. 4079 articles on patient safety were identified in the period from 1900 to 2014. Most articles were published in North America, the UK and Australia. In regard to the overall number of publications, the USA is the leading country, while the output ratio to the population of Switzerland was found to exhibit the best performance. With regard to the ratio of the number of publications to the Gross Domestic Product (GDP) per Capita, the USA remains the leading nation but countries like India and China with a low GDP and high population numbers are also profiting. Though the topic is a global matter, the scientific output on patient safety is centred mainly in industrialised countries. 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/

  5. A feasibility study for Arizona's roadway safety management process using the Highway Safety Manual and SafetyAnalyst : final report.

    DOT National Transportation Integrated Search

    2016-07-01

    To enable implementation of the American Association of State Highway Transportation (AASHTO) Highway Safety Manual using : SaftetyAnalyst (an AASHTOWare software product), the Arizona Department of Transportation (ADOT) studied the data assessment :...

  6. Identification and Analysis of Labor Productivity Components Based on ACHIEVE Model (Case Study: Staff of Kermanshah University of Medical Sciences)

    PubMed Central

    Ziapour, Arash; Khatony, Alireza; Kianipour, Neda; Jafary, Faranak

    2015-01-01

    Identification and analysis of the components of labor productivity based on ACHIEVE model was performed among employees in different parts of Kermanshah University of Medical Sciences in 2014. This was a descriptive correlational study in which the population consisted of 270 working personnel in different administrative groups (contractual, fixed- term and regular) at Kermanshah University of Medical Sciences (872 people) that were selected among 872 people through stratified random sampling method based on Krejcie and Morgan sampling table. The survey tool included labor productivity questionnaire of ACHIEVE. Questionnaires were confirmed in terms of content and face validity, and their reliability was calculated using Cronbach’s alpha coefficient. The data were analyzed by SPSS-18 software using descriptive and inferential statistics. The mean scores for labor productivity dimensions of the employees, including environment (environmental fit), evaluation (training and performance feedback), validity (valid and legal exercise of personnel), incentive (motivation or desire), help (organizational support), clarity (role perception or understanding), ability (knowledge and skills) variables and total labor productivity were 4.10±0.630, 3.99±0.568, 3.97±0.607, 3.76±0.701, 3.63±0.746, 3.59±0.777, 3.49±0.882 and 26.54±4.347, respectively. Also, the results indicated that the seven factors of environment, performance assessment, validity, motivation, organizational support, clarity, and ability were effective in increasing labor productivity. The analysis of the current status of university staff in the employees’ viewpoint suggested that the two factors of environment and evaluation, which had the greatest impact on labor productivity in the viewpoint of the staff, were in a favorable condition and needed to be further taken into consideration by authorities. PMID:25560364

  7. Identification and analysis of labor productivity components based on ACHIEVE model (case study: staff of Kermanshah University of Medical Sciences).

    PubMed

    Ziapour, Arash; Khatony, Alireza; Kianipour, Neda; Jafary, Faranak

    2014-12-15

    Identification and analysis of the components of labor productivity based on ACHIEVE model was performed among employees in different parts of Kermanshah University of Medical Sciences in 2014. This was a descriptive correlational study in which the population consisted of 270 working personnel in different administrative groups (contractual, fixed- term and regular) at Kermanshah University of Medical Sciences (872 people) that were selected among 872 people through stratified random sampling method based on Krejcie and Morgan sampling table. The survey tool included labor productivity questionnaire of ACHIEVE. Questionnaires were confirmed in terms of content and face validity, and their reliability was calculated using Cronbach's alpha coefficient. The data were analyzed by SPSS-18 software using descriptive and inferential statistics. The mean scores for labor productivity dimensions of the employees, including environment (environmental fit), evaluation (training and performance feedback), validity (valid and legal exercise of personnel), incentive (motivation or desire), help (organizational support), clarity (role perception or understanding), ability (knowledge and skills) variables and total labor productivity were 4.10±0.630, 3.99±0.568, 3.97±0.607, 3.76±0.701, 3.63±0.746, 3.59±0.777, 3.49±0.882 and 26.54±4.347, respectively. Also, the results indicated that the seven factors of environment, performance assessment, validity, motivation, organizational support, clarity, and ability were effective in increasing labor productivity. The analysis of the current status of university staff in the employees' viewpoint suggested that the two factors of environment and evaluation, which had the greatest impact on labor productivity in the viewpoint of the staff, were in a favorable condition and needed to be further taken into consideration by authorities.

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

    PubMed Central

    Singh, Hardeep

    2016-01-01

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

  9. Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand.

    PubMed

    Rychert, Marta; Wilkins, Chris; Witten, Karen

    2017-09-01

    New Zealand's Psychoactive Substances Act (2013) established the world's first regulated market for 'low risk' psychoactive products ('legal highs'). Under an interim PSA regime, 47 existing products were permitted to be continued to be sold. To explore issues with the implementation of regulatory systems to monitor the safety of products on the legal market under the interim Psychoactive Substances Act regime. Semi-structured interviews with 30 key stakeholders, including industry, government agency, health and drug service professionals were conducted, transcribed and analysed thematically. In retrospect stakeholders questioned the decision to approve strong synthetic cannabinoid smoking products, noting their health risks because of product formulation, inconsistent manufacturing practices and smoking as the means of administration. Industry actors claimed the decision to approve synthetic cannabinoid smokeable products prevented potentially safer products from gaining market share. The system for withdrawing approved products which were subsequently found to be harmful was criticised for the poor quality of data available, limited engagement with health professionals and the slowness of product withdrawal. Many of the problems with the regime were attributed to the urgency under which the legal market under the interim Psychoactive Substances Act was established and implemented. The selection of 'safer' products, implementation of the product monitoring system, and engagement with health professionals may have benefited from more time and resources. An incremental approach to establishing the new market may have made the regulatory management of the new regime more workable. [Rychert M, Wilkins C, Witten K. Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  10. Striving for safety: communicating and deciding in sociotechnical systems

    PubMed Central

    Flach, John M.; Carroll, John S.; Dainoff, Marvin J.; Hamilton, W. Ian

    2015-01-01

    How do communications and decisions impact the safety of sociotechnical systems? This paper frames this question in the context of a dynamic system of nested sub-systems. Communications are related to the construct of observability (i.e. how components integrate information to assess the state with respect to local and global constraints). Decisions are related to the construct of controllability (i.e. how component sub-systems act to meet local and global safety goals). The safety dynamics of sociotechnical systems are evaluated as a function of the coupling between observability and controllability across multiple closed-loop components. Two very different domains (nuclear power and the limited service food industry) provide examples to illustrate how this framework might be applied. While the dynamical systems framework does not offer simple prescriptions for achieving safety, it does provide guides for exploring specific systems to consider the potential fit between organisational structures and work demands, and for generalising across different systems regarding how safety can be managed. Practitioner Summary: While offering no simple prescriptions about how to achieve safety in sociotechnical systems, this paper develops a theoretical framework based on dynamical systems theory as a practical guide for generalising from basic research to work domains and for generalising across alternative work domains to better understand how patterns of communication and decision-making impact system safety. PMID:25761155

  11. Learning from error: leading a culture of safety.

    PubMed

    Gibson, Russell; Armstrong, Alexander; Till, Alex; McKimm, Judy

    2017-07-02

    A recent shift towards more collective leadership in the NHS can help to achieve a culture of safety, particularly through encouraging frontline staff to participate and take responsibility for improving safety through learning from error and near misses. Leaders must ensure that they provide psychological safety, organizational fairness and learning systems for staff to feel confident in raising concerns, that they have the autonomy and skills to lead continual improvement, and that they have responsibility for spreading this learning within and across organizations.

  12. Safety interventions on the labor and delivery unit.

    PubMed

    Kacmar, Rachel M

    2017-06-01

    The present review highlights recent advances in efforts to improve patient safety on labor and delivery units and well tolerated care for pregnant patients in general. Recent studies in obstetric patient safety have a broad focus but repetitive themes for interdisciplinary training include: simulating critical events, having open multidisciplinary communication, frequent reviews of cases of maternal morbidity, and implementing maternal early warning systems. The National Partnership for Maternal Safety is also active in promoting care bundles across many topics on maternal safety. A culture of safety is the goal for all obstetric units. Achieving that ideal requires multidisciplinary collaboration, frequent reassessment for areas of improvement, and a culture of openness to change when improvement opportunities arise.

  13. A primer on criticality safety

    DOE PAGES

    Costa, David A.; Cournoyer, Michael E.; Merhege, James F.; ...

    2017-05-01

    Criticality is the state of a nuclear chain reacting medium when the chain reaction is just self-sustaining (or critical). Criticality is dependent on nine interrelated parameters. Moreover, we design criticality safety controls in order to constrain these parameters to minimize fissions and maximize neutron leakage and absorption in other materials, which makes criticality more difficult or impossible to achieve. We present the consequences of criticality accidents are discussed, the nine interrelated parameters that combine to affect criticality are described, and criticality safety controls used to minimize the likelihood of a criticality accident are presented.

  14. Shared Learning and the Drive to Improve Patient Safety: Lessons Learned from the Pittsburgh Regional Healthcare Initiative

    DTIC Science & Technology

    2005-01-01

    the environmental, cultural, and infrastructure changes in health care that will be necessary to achieve significant, widespread patient safety...to improved patient outcomes. Achievement of improved patient safety requires enhanced health care leadership commitment and learning systems that... health care organizations and practitioners to work together to identify and solve patient safety problems. Providing safe care requires a learning

  15. A Parent's Guide to Achievement Matters Most: Maryland's Plan for PreK-12 Education, 2002-2003.

    ERIC Educational Resources Information Center

    Maryland State Dept. of Education, Baltimore.

    To raise the achievement of every student in the state, Maryland implemented "Achievement Matters Most," a new plan for public elementary and secondary schools that sets goals in the areas of achievement, teaching, testing, safety, and family involvement in schools. This guide for parents outlines the goals and characteristics of the…

  16. Systematic Product Development of Control and Diagnosis Functionalities

    NASA Astrophysics Data System (ADS)

    Stetter, R.; Simundsson, A.

    2017-01-01

    In the scientific field of systematic product development a wide range of helpful methods, guidelines and tools were generated and published in recent years. Until now little special attention was given to design guidelines aiming at supporting product development engineers to design products that allow and support control or diagnosis functions. The general trend to ubiquitous computing and the first development steps towards cognitive systems as well as a general trend toward higher product safety, reliability and reduced total cost of ownership (TCO) in many engineering fields lead to a higher importance of control and diagnosis. In this paper a first attempt is made to formulate general valid guidelines how products can be developed in order to allow and to achieve effective and efficient control and diagnosis. The guidelines are elucidated on the example of an automated guided vehicle. One main concern of this paper is the integration of control and diagnosis functionalities into the development of complete systems which include mechanical, electrical and electronic subsystems. For the development of such systems the strategies, methods and tools of systematic product development have attracted significant attention during the last decades. Today, the functionality and safety of most products is to a large degree dependent on control and diagnosis functionalities. Still, there is comparatively little research concentrating on the integration of the development of these functionalities into the overall product development processes. The paper starts with a background describing Systematic Product Development. The second section deals with the product development of the sample product. The third part clarifies the notions monitoring, control and diagnosis. The following parts summarize some insights and formulate first hypotheses concerning control and diagnosis in Systematic Product Development.

  17. Ethylene Production Maximum Achievable Control Technology (MACT) Compliance Manual

    EPA Pesticide Factsheets

    This July 2006 document is intended to help owners and operators of ethylene processes understand and comply with EPA's maximum achievable control technology standards promulgated on July 12, 2002, as amended on April 13, 2005 and April 20, 2006.

  18. Abuse liability assessment of tobacco products including potential reduced exposure products.

    PubMed

    Carter, Lawrence P; Stitzer, Maxine L; Henningfield, Jack E; O'Connor, Rich J; Cummings, K Michael; Hatsukami, Dorothy K

    2009-12-01

    The harm produced by tobacco products is a result of frequent use of a highly toxic product. Reducing the adverse public health impact of tobacco products might be most effectively achieved by reducing the likelihood of their use and the toxicity of the products. Products that retain some characteristics of cigarettes but have been altered with the intention of reducing toxicity have been referred to as modified risk tobacco products or potential reduced exposure products (MRTP/PREP). Evaluation of their content, emission, and toxicity is discussed in other articles in this special issue. Here, we discuss the methodology that has been used to examine the likelihood of abuse or addiction. Abuse liability assessment (ALA) methodology has been used by the Food and Drug Administration (FDA) and other drug regulatory agencies world-wide for decades to assess the risks posed by a wide variety of pharmacologically active substances. ALA is routinely required among other evaluations of safety during the pre-market assessment of new drugs, and is continually adapted to meet the challenges posed by new drug classes and drug formulations. In the 2009 law giving FDA regulation over tobacco products, FDA is now required to evaluate new tobacco products including MRTP/PREPs to determine their risk for abuse and toxicity at the population level. This article describes the traditional tools and methods of ALA that can be used to evaluate new tobacco and nicotine products including MRTP/PREPs. Such ALA data could contribute to the scientific foundation on which future public policy decisions are based.

  19. Evaluation of the AHRQ Patient Safety Initiative: Synthesis of Findings

    PubMed Central

    Farley, Donna O; Damberg, Cheryl L

    2009-01-01

    Objective To present overall findings from the 4-year evaluation of the national patient safety initiative operated by the Agency for Healthcare Research and Quality (AHRQ). Data Sources Interviews with AHRQ staff, grantees, and other patient safety stakeholders; published materials; and internal AHRQ documents. Study Design The evaluation was structured to address a system framework of five components involved in improving safety. The initiative's contributions to improving each system component were assessed qualitatively, comparing results from three separate analyses—AHRQ's achievement of its patient safety goals, our own assessment of the initiative's activities, and independent stakeholder ratings of AHRQ's contributions. Findings and Conclusions AHRQ has faced a daunting challenge for improving patient safety, given the complex problems of the U.S. health care system and the limited resources AHRQ has had to address them. The patient safety initiative achieved strongest progress for its contributions to knowledge of patient safety epidemiology and effective practices, where AHRQ has considerable experience, and to strengthening infrastructure to support adoption of safe practices. Progress was slower in establishing a national monitoring capability and dissemination of safe practices for adoption. AHRQ needs to expand efforts to apply new knowledge for stimulating use of safe practices in the field. PMID:21456115

  20. Mushroom as a product and their role in mycoremediation

    PubMed Central

    2014-01-01

    Mushroom has been used for consumption as product for a long time due to their flavor and richness in protein. Mushrooms are also known as mycoremediation tool because of their use in remediation of different types of pollutants. Mycoremediation relies on the efficient enzymes, produced by mushroom, for the degradation of various types of substrate and pollutants. Besides waste degradation, mushroom produced a vendible product for consumption. However, sometimes they absorb the pollutant in their mycelium (biosorption process) and cannot be consumed due to absorbed toxicants. This article reviews the achievement and current status of mycoremediation technology based on mushroom cultivation for the remediation of waste and also emphasizes on the importance of mushroom as product. This critical review is also focused on the safety aspects of mushroom cultivation on waste. PMID:24949264

  1. Safety and business benefit analysis of NASA's aviation safety program

    DOT National Transportation Integrated Search

    2004-09-20

    NASA Aviation Safety Program elements encompass a wide range of products that require both public and private investment. Therefore, two methods of analysis, one relating to the public and the other to the private industry, must be combined to unders...

  2. Costs and benefits of communicating product safety information to the public via the Internet.

    PubMed

    Saoutert, Erwan; Andreasen, Ina

    2006-04-01

    Procter & Gamble (P&G) developed Science-in-the-Box (SIB; www.scienceinthebox.com) after discussions with their stakeholders as to how the consumer products company could better communicate key environmental performance and safety information to the public. A series of workshops enabled P&G to understand that consumers and other key business decision makers wanted meaningful information about the science behind P&G products. In addition, it was clear that making such information available would produce business benefits by encouraging long-term relationships with decision makers ranging from consumers and retailers to policy makers and nongovernmental organizations. These benefits were not necessarily quantifiable in the short term, but they still had to be balanced by the costs in terms of resource commitment and potential intellectual property issues. Since its inception in September 2002, SIB has successfully reached key target audiences and built improved credibility and confidence in P&G products and approaches. The website is now available in English, French, Spanish, German, and Italian and is used by consumers, journalists, teachers, scientists, and policy makers. Several user surveys carried out during the initial developmental period, together with unsolicited e-mail feedback, have demonstrated that SIB has successfully created a platform for continuous dialogue with consumers and other interested parties.

  3. The case of the high-risk safety product.

    PubMed

    Chew, W B; Blodgett, T B; Wallin, W R; Meyers, G C; Holden, B; Johnson, E W; Smith, N C; Ducker, W

    1992-01-01

    After several days of meetings, J.F. Winchester, president of MDC Industries, felt no closer to a decision. MDC, a manufacturer of wall and ceiling panels, was considering whether to exercise an option to buy a new and safer wallboard technology. The product was being touted as revolutionary, but, Winchester wondered, could MDC afford to carry the flag? According to its inventor, Robert Goerner, Smoke-Safe would be a vast improvement over standard safety-rated wallboard. With almost the same flame-retardant properties, Smoke-Safe had the advantage of giving off almost no fumes or smoke in fire tests. And, Winchester knew, most fire-related deaths are from smoke, not flames. Indeed, the numbers were grimly persuasive: 82% of fire-related injuries involving standard panels were caused by smoke inhalation. What's more, Smoke-Safe would cost about the same to manufacture as MDC's current wallboard. But MDC had several other good options for spending the $5 million Goerner was asking; building plastics was only one of its profit centers. And the prospect of launching a campaign to change building codes in order to market Smoke-Safe, which could spark a fight with competitors, was daunting. Since its current wallboard gave MDC only 18% of the wallboard market, many industry insiders speculated whether MDC had the market clout to influence major cities to revise their codes. Six experts in marketing, law, and ethics advise MDC Industries on how it can balance ethical and business imperatives in making its decision.

  4. Performance of Compiler-Assisted Memory Safety Checking

    DTIC Science & Technology

    2014-08-01

    software developer has in mind a particular object to which the pointer should point, the intended referent. A memory access error occurs when an ac...Performance of Compiler-Assisted Memory Safety Checking David Keaton Robert C. Seacord August 2014 TECHNICAL NOTE CMU/SEI-2014-TN...based memory safety checking tool and the performance that can be achieved with two such tools whose source code is freely available. The note then

  5. Safety Psychology Applicating on Coal Mine Safety Management Based on Information System

    NASA Astrophysics Data System (ADS)

    Hou, Baoyue; Chen, Fei

    In recent years, with the increase of intensity of coal mining, a great number of major accidents happen frequently, the reason mostly due to human factors, but human's unsafely behavior are affected by insecurity mental control. In order to reduce accidents, and to improve safety management, with the help of application security psychology, we analyse the cause of insecurity psychological factors from human perception, from personality development, from motivation incentive, from reward and punishment mechanism, and from security aspects of mental training , and put forward countermeasures to promote coal mine safety production,and to provide information for coal mining to improve the level of safety management.

  6. Marketing a managed care plan: achieving product differentiation.

    PubMed

    Romeo, N C

    1996-01-01

    The health care marketplace is changing dramatically, even without federal reform measures. This is a volatile, yet promising, time to market a managed care plan. Before marketing the product, it is critical that the competition is thoroughly evaluated and consumer and employer needs are researched. The final product should be distinguishable from the competition and address market needs. Promotion can then begin, utilizing a proactive public relations and advertising campaign in addition to traditional methods of marketing.

  7. Safety of herbal products in Thailand: an analysis of reports in the thai health product vigilance center database from 2000 to 2008.

    PubMed

    Saokaew, Surasak; Suwankesawong, Wimon; Permsuwan, Unchalee; Chaiyakunapruk, Nathorn

    2011-04-01

    The use of herbal products continues to expand rapidly across the world and concerns regarding the safety of these products have been raised. In Thailand, Thai Vigibase, developed by the Health Product Vigilance Center (HPVC) under the Thai Food and Drug Administration, is the national database that collates reports from health product surveillance systems and programmes. Thai Vigibase can be used to identify signals of adverse events in patients receiving herbal products. The purpose of the study was to describe the characteristics of reported adverse events in patients receiving herbal products in Thailand. Thai Vigibase data from February 2000 to December 2008 involving adverse events reported in association with herbal products were used. This database includes case reports submitted through the spontaneous reporting system and intensive monitoring programmes. Under the spontaneous reporting system, adverse event reports are collected nationwide via a national network of 22 regional centres covering more than 800 public and private hospitals, and health service centres. An intensive monitoring programme was also conducted to monitor the five single herbal products listed in the Thai National List of Essential Medicines (NLEM), while another intensive monitoring programme was developed to monitor the four single herbal products that were under consideration for inclusion in the NLEM. The database contained patient demographics, adverse events associated with herbal products, and details on seriousness, causality and quality of reports. Descriptive statistics were used for data analyses. A total of 593 reports with 1868 adverse events involving 24 different products were made during the study period. The age range of individuals was 1-86 years (mean 47 years). Most case reports were obtained from the intensive monitoring programme. Of the reports, 72% involved females. The herbal products for which adverse events were frequently reported were products containing

  8. Food safety considerations for innovative nutrition solutions.

    PubMed

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

    2015-07-01

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

  9. 9 CFR 113.40 - Dog safety tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

  10. 9 CFR 113.40 - Dog safety tests.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

  11. 9 CFR 113.40 - Dog safety tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

  12. 9 CFR 113.40 - Dog safety tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

  13. 9 CFR 113.40 - Dog safety tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

  14. Implementation of a patient safety program at a tertiary health system: A longitudinal analysis of interventions and serious safety events.

    PubMed

    Cropper, Douglas P; Harb, Nidal H; Said, Patricia A; Lemke, Jon H; Shammas, Nicolas W

    2018-04-01

    We hypothesize that implementation of a safety program based on high reliability organization principles will reduce serious safety events (SSE). The safety program focused on 7 essential elements: (a) safety rounding, (b) safety oversight teams, (c) safety huddles, (d) safety coaches, (e) good catches/safety heroes, (f) safety education, and (g) red rule. An educational curriculum was implemented focusing on changing high-risk behaviors and implementing critical safety policies. All unusual occurrences were captured in the Midas system and investigated by risk specialists, the safety officer, and the chief medical officer. A multidepartmental committee evaluated these events, and a root cause analysis (RCA) was performed. Events were tabulated and serious safety event (SSE) recorded and plotted over time. Safety success stories (SSSs) were also evaluated over time. A steady drop in SSEs was seen over 9 years. Also a rise in SSSs was evident, reflecting on staff engagement in the program. The parallel change in SSEs, SSSs, and the implementation of various safety interventions highly suggest that the program was successful in achieving its goals. A safety program based on high-reliability organization principles and made a core value of the institution can have a significant positive impact on reducing SSEs. © 2018 American Society for Healthcare Risk Management of the American Hospital Association.

  15. Safety halls--an evaluation.

    PubMed

    Nyberg, Anders; Gregersen, Nils Petter; Nolén, Sixten; Engström, Inger

    2005-01-01

    In most countries, drivers licensing systems usually include teaching some aspects of using safety equipment (e.g., airbags and seat belts). However, there is now evidence worldwide that such education is inadequate, as indicated by, for example, the overrepresentation of young drivers who do not use seat belts. A randomized controlled study was conducted in Sweden to evaluate the effects of visiting a facility known as a "safety hall" in combination with the mandatory skid training. The results were assessed to determine the effects of the knowledge and attitudes of learner drivers in the following subjects: airbags, securing loads, seat belts, sitting posture, speed, and tires. An experimental group and a control group comprising 658 and 668 learners, respectively, answered identical questionnaires on three different occasions (pretest, posttest 1, and posttest 2). The results show that, for most of the topics considered, knowledge and attitudes in both groups were better at posttest 2 than at the pretest, and in general, the best knowledge and attitudes were found in the experimental group. The combined safety/skid training seems to have had the greatest effect on seat belts and loads. The findings also indicate that the safety halls can be further improved to achieve an even better effect. The use of safety halls has improved the knowledge and attitudes of learner drivers concerning several important areas related to traffic safety. Since knowledge and attitudes are important predictors of behavior, implementing safety halls can be expected to lead to improvements, especially regarding the use of safety belts and securing loads.

  16. 77 FR 71561 - Health and Safety Data Reporting; Addition of Certain Chemicals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

    ... be, incorporated into consumer products to report certain unpublished health and safety studies to... the submission of TSCA section 8(d) health and safety studies from processors and distributors of... be, incorporated into consumer products to report certain unpublished health and safety studies to...

  17. Effect of motivational group interviewing-based safety education on Workers' safety behaviors in glass manufacturing.

    PubMed

    Navidian, Ali; Rostami, Zahra; Rozbehani, Nasrin

    2015-09-19

    Worker safety education using models that identify and reinforce factors affecting behavior is essential. The present study aimed to determine the effect of safety education based on motivational interviewing on awareness of, attitudes toward, and engagement in worker safety in the glass production industry in Hamedan, Iran, in 2014. This was a quasi-experimental interventional study including a total of 70 production line workers at glass production facilities in Hamedan. The workers were randomly assigned to either an intervention or a control group, with 35 workers in each group. Participants in the control group received four one-hour safety education sessions, in the form of traditional lectures. Those in the intervention group received four educational sessions based on motivational group interviewing, which were conducted in four groups of eight to ten participants each. The instruments used included a researcher-developed questionnaire with checklists addressing safety awareness, and attitude and performance, which were completed before and 12 weeks after the intervention. The data were analyzed using descriptive statistics, independent and paired t-tests, and chi-squared tests. Having obtained the differences in scores before and after the intervention, we determined mean changes in the scores of awareness, attitude, and use of personal protective equipment among workers who underwent motivational group interviewing (3.74 ± 2.16, 1.71 ± 3.16, and 3.2 ± 1.92, respectively, p < 0.05). These scores were significantly greater than those of control workers who underwent traditional educational sessions (1.28 ± 1.93, 1.1 ± 3.07, and 0.2 ± 1.26, respectively). Our findings revealed that incorporation of motivational interviewing principles into safety education programs had the positive effect of enhancing workers' knowledge, attitude, and, particularly, implementation of safe behaviors. The application of this advisory approach

  18. Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

    PubMed Central

    Wang, J; Johnson, T; Sahin, L; Tassinari, MS; Anderson, PO; Baker, TE; Bucci-Rechtweg, C; Burckart, GJ; Chambers, CD; Hale, TW; Johnson-Lyles, D; Nelson, RM; Nguyen, C; Pica-Branco, D; Ren, Z; Sachs, H; Sauberan, J; Zajicek, A; Ito, S; Yao, LP

    2017-01-01

    This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants. PMID:28510297

  19. Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

    PubMed

    Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi

    2018-03-01

    Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.

  20. The Safety of Crowds

    ERIC Educational Resources Information Center

    Dron, Jon

    2007-01-01

    If we assume that learning is best achieved in a social setting, then a vital aspect of any learning environment is its ability to support the development of trust. Trust takes many forms, from helping to identify the validity or the effectiveness of a learning resource to feelings of safety and reliance on support from fellow learners and…

  1. Outsource Power, Import Safety? Challenges and Opportunities of the U.S.-China Food Safety Regulatory Cooperation.

    PubMed

    Lin, Ching-Fu

    The United States has a high stake in China’s serious food safety problem, as food products of Chinese origin have dominated the U.S. food market in numerous areas and continue to grow. The conclusion of the U.S.-China Food Safety Agreement (“the Agreement”) has allowed FDA to strengthen regulatory cooperation with its Chinese counterpart in various aspects. The Agreement also paves the way for the implementation of the new regulatory tools incorporated in FSMA, especially in the cross-border context. However, both the Agreement and FSMA have certain crucial limitations that may create future hurdles to effective implementation in the U.S.-China cooperation. This paper therefore endeavors to first examine China’s governance challenges over food safety, with a focus on the 2009 Food Safety Law, the 2015 Amendment, and the fundamental problem of “thin” rule of law. This paper moves to analyze the U.S.-China Food Safety Agreement, reviewing the agreement’s strengths and weaknesses. It further assesses FSMA’s innovative institutional design to regulate imported food products and its limitations. However, both the U.S.-China Food Safety Agreement and FSMA arguably create a regulatory dilemma for FDA when addressing imported food safety, due to structural mismatch between the broad scope of power granted to FDA and the long chain of power outsourcing to governments or private companies as primary “regulators.” Neither the Agreement nor FSMA give FDA adequate capacity to closely oversee such “agents” along the chain of power outsourcing. Framing the U.S.-China food safety cooperation as a multilayer structure that “outsources power” to “import safety,” this paper concludes by stressing the need for a robust accountability and effective mechanism for U.S.-China food safety cooperation.

  2. Critical Review of Commercial Secondary Lithium-Ion Battery Safety Standards

    NASA Astrophysics Data System (ADS)

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

    2010-09-01

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

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

    PubMed

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

    2009-01-01

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

  4. Randomized trial of the impact of a sun safety program on volunteers in outdoor venues.

    PubMed

    Cheng, Shaowei; Guan, Xin; Cao, Mei; Liu, Yalan; Zhai, Siwen

    2011-04-01

    A suitable sun safety educational program could help the public avoid sun exposure-induced skin damage. The objective of this study was to assess the impact of a sun safety program on volunteers in outdoor venues and explore the most effective sun safety education method in China. An intervention program was implemented to raise knowledge and behavior regarding sun exposure among volunteers in the outdoor competition venues in Beijing, China. Five intervention methods were used, including class education, free sunscreen samples, pamphlets, posters, and newsletters. The self-administered multiple-choice questionnaires were administered before and after the intervention. Two hundred and eighty-five subjects were enrolled, including 107 males (37.5%) and 178 females (62.5%). The intervention group showed improvement in sun safety knowledge and behavior. Other improvements were achieved in the field of sun safety awareness and intended behavior, with most of the items achieving no statistically significant differences. Subgroup A (multi-component interventions, including class education, free sunscreen samples, and written materials) achieved better results than subgroup B (written materials only) to improve sun safety knowledge and awareness. Sun safety education could improve volunteer 's sun safety knowledge and behavior in the outdoor venues in China. Multi-component interventions proved to be the most effective sun safety education method. © 2011 John Wiley & Sons A/S.

  5. Perinatal Safety: From Concept to Nursing Practice

    PubMed Central

    Kennedy, Holly Powell

    2010-01-01

    Communication and teamwork problems are leading causes of documented preventable adverse outcomes in perinatal care. An essential component of perinatal safety is the organizational culture in which clinicians work. Clinicians’ individual and collective authority to question the plan of care and take action to change the direction of a clinical situation in the patient’s best interest can be viewed as their “agency for safety.” However, collective agency for safety and commitment to support nurses in their advocacy role is missing in many perinatal care settings. This paper draws from Organizational Accident Theory, High Reliability Theory, and Symbolic Interactionism to describe the nurse’s role in maintaining safety during labor and birth in acute care settings, and suggests actions for supporting the perinatal nurse at individual, group, and systems levels to achieve maximum safety in perinatal care. PMID:20147827

  6. Perinatal safety: from concept to nursing practice.

    PubMed

    Lyndon, Audrey; Kennedy, Holly Powell

    2010-01-01

    Communication and teamwork problems are leading causes of documented preventable adverse outcomes in perinatal care. An essential component of perinatal safety is the organizational culture in which clinicians work. Clinicians' individual and collective authority to question the plan of care and take action to change the direction of a clinical situation in the patient's best interest can be viewed as their "agency for safety." However, collective agency for safety and commitment to support nurses in their role of advocacy is missing in many perinatal care settings. This article draws from Organizational Accident Theory, High Reliability Theory, and Symbolic Interactionism to describe the nurse's role in maintaining safety during labor and birth in acute care settings and suggests actions for supporting the perinatal nurse at individual, group, and systems levels to achieve maximum safety in perinatal care.

  7. 30 CFR 27.34 - Test for intrinsic safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Test for intrinsic safety. 27.34 Section 27.34 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.34 Test for intrinsic safety...

  8. 30 CFR 27.34 - Test for intrinsic safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Test for intrinsic safety. 27.34 Section 27.34 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.34 Test for intrinsic safety...

  9. Human food safety and environmental hazards associated with the use of methyltestosterone and other steroids in production of all-male tilapia.

    PubMed

    Mlalila, Nichrous; Mahika, Charles; Kalombo, Lonji; Swai, Hulda; Hilonga, Askwar

    2015-04-01

    In recent years, all-male cultures of Nile tilapia (Oreochromis niloticus) have been the most preferred mode of production in aquaculture industry. All-male individuals achieve higher somatic growth rate and shut high energy losses associated with gonadal development and reproduction. The economic advantages of culturing all-male tilapia have led to the development of procedures for producing unisex cultures, using 17α-methyltestosterone (MT). Despite widespread use of the MT in tilapia farming, the implications of hormone treatment in relation to human health and the environment have raised a number of concerns in the scientific community. In this review, the hormonal application processes, economic and ecological significance of MT, food safety and residual MT, comparative uses of steroids in aquaculture, animal husbandry, and medicine have been briefly reviewed for regulatory guidelines, and finally, future research perspectives have been addressed. The review can be used as policy-making guidelines in aquaculture framework development as can be emphasized in African continent, among others. The most important conclusion to draw is that the quantity of MT used in conventional practice is large compared to the actual dose required for sex reversal, fish produced are safe for human consumptions, and the environmental hazards should be further emphasized.

  10. Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP).

    PubMed

    Zscharnack, Matthias; Krause, Christoph; Aust, Gabriela; Thümmler, Christian; Peinemann, Frank; Keller, Thomas; Smink, Jeske J; Holland, Heidrun; Somerson, Jeremy S; Knauer, Jens; Schulz, Ronny M; Lehmann, Jörg

    2015-05-20

    The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols. The study provides a strategy to address the safety aspects of biodistribution and tumorigenicity of ATMPs under good laboratory practice (GLP) conditions avoiding cell product manipulation. Moreover, the strategy was applied on a human ATMP for cartilage repair. The testing strategy addresses biodistribution and tumorigenicity using a multi-step analysis without any cell manipulation to exclude changes of test item characteristics. As a safeguard measurement for meeting regulatory expectations, the project design and goals were discussed continuously with the regulatory authority using a staggered scientific advice concept. Subsequently, the strategy was applied to co.don chondrosphere® (huChon spheroid), a tissue-engineered matrix-free ATMP of human normal chondrocytes. In both the biodistribution and tumorigenicity studies, huChon spheroids were implanted subcutaneously into 40 immunodeficient mice. Biodistribution was studied 1 month after implantation. A skin disc containing the huChon spheroid, two surrounding skin rings and selected organs were analyzed by validated, gender-specific, highly-sensitive triplex qPCR and by immunohistochemistry (IHC). No human DNA was detected in distant skin rings and analyzed organs. IHC revealed no direct or indirect indications of cell migration. Tumorigenicity was assessed 6 months after huChon spheroid implantation by palpation, macroscopic inspection, histology and IHC. No mice from the huChon spheroid group developed a tumor at the implantation site. In two mice, benign tumors were detected that were negative for HLA-ABC, suggesting that they were of spontaneous murine origin. In summary, the presented strategy using a multi-step analysis was confirmed to be suitable for safety studies of ATMPs.

  11. 77 FR 63800 - Proposed Extension of Approval of Information Collection; Comment Request-Safety Standard for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection; Comment Request--Safety Standard for Automatic Residential Garage Door Operators AGENCY: Consumer Product... 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (CPSC) requested comments on a...

  12. MRSA decontamination using octenidine-based products.

    PubMed

    Danilevicius, Mindaugas; Juzéniené, Audra; Juzénaité-Karneckiené, Indré; Veršinina, Anželika

    Methicillin-resistant Staphylococcus aureus (MRSA) infections are an increasing problem worldwide with a high risk of severe illness and mortality in hospitalised patients. Patients with chronic wounds are at particular risk of developing MRSA infections. As octenidine-based products have shown promising success in decontamination in the past, the aim of the present study was to determine its efficacy, safety, and tolerability in decontaminating hospitalised MRSA-positive patients. From 1 April 2011 until 9 November 2012, 36 patients were screened MRSA-positive at the Republican Vilnius University Hospital, Vilnius, Lithuania. At least three swab tests were performed for each patient to screen for MRSA, one from each nostril and one from the perineum. In patients with wounds, an additional swab was taken from the wound surface. In the affected patients octenidine-based products were used in one or two cycles of 7 days each. In addition, adverse events were recorded and the tolerability was assessed using a 4-point scale ranging from 'very good' to 'poor'. Complete decontamination was achieved in 24 patients (67%) following treatment with the octenidine-based products. None of the patients experienced side-effects or secondary symptoms such as skin irritation or allergic reactions during the course of the study. In addition, octenidine was very well tolerated in the majority of patients (n=31; 86%). The results demonstrate that octenidine-based products are highly efficient in the multifaceted decontamination of hospitalised MRSA-positive patients. Having a range of products that can be used for full body decontamination (including the scalp and nasal passages) is of particular significance when developing an MRSA decontamination protocol, as multiple parts of the body can be affected. Combined with a favourable safety and tolerability profile, octenidine-based products thus represent a good choice in multifaceted MRSA decontamination regimes, which are necessary to

  13. Abuse Liability Assessment of Tobacco Products Including Potential Reduced Exposure Products (PREPs)

    PubMed Central

    Carter, Lawrence P.; Stitzer, Maxine L.; Henningfield, Jack E.; O'Connor, Rich J.; Cummings, K. Michael; Hatsukami, Dorothy K.

    2009-01-01

    The harm produced by tobacco products is a result of frequent use of a highly toxic product. Reducing the adverse public health impact of tobacco products might be most effectively achieved by reducing the likelihood of their use and the toxicity of the products. Products that retain some characteristics of cigarettes, but have been altered with the intention of reducing toxicity have been referred to as modified risk tobacco products or potential reduced exposure products (MRTP/PREPS). Evaluation of their content, emission, and toxicity is discussed in other articles in this special issue. Here, we discuss the methodology that has been used to examine the likelihood of abuse or addiction. Abuse liability assessment (ALA) methodology has been used by the Food and Drug Administration (FDA) and other drug regulatory agencies world-wide for decades to assess the risks posed by a wide variety of pharmacologically active substances. ALA is routinely required among other evaluations of safety during the premarket assessment of new drugs, and is continually adapted to meet the challenges posed by new drug classes and drug formulations. In the 2009 law giving FDA regulation over tobacco products, FDA is now required to evaluate new tobacco products including MRTP/PREPs to determine their risk for abuse and toxicity at the population level. This paper describes the traditional tools and methods of ALA that can be used to evaluate new tobacco and nicotine products including MRTP/PREPs. Such ALA data could contribute to the scientific foundation on which future public policy decisions are based. PMID:19959676

  14. A Parent's Guide to Achievement Matters Most: Maryland's Plan for PreK-12 Education, 2002-2003. (Arabic)

    ERIC Educational Resources Information Center

    Maryland State Dept. of Education, Baltimore.

    To raise the achievement of every student in the state, Maryland implemented "Achievement Matters Most," a new plan for public elementary and secondary schools that sets goals in the areas of achievement, teaching, testing, safety, and family involvement in schools. This Arabic-language guide for parents outlines the goals and…

  15. A Parent's Guide to Achievement Matters Most: Maryland's Plan for PreK-12 Education, 2002-2003. (Gujarati).

    ERIC Educational Resources Information Center

    Maryland State Dept. of Education, Baltimore.

    To raise the achievement of every student in the state, Maryland implemented "Achievement Matters Most," a new plan for public elementary and secondary schools that sets goals in the areas of achievement, teaching, testing, safety, and family involvement in schools. This Gujarati-language guide for parents outlines the goals and…

  16. A Parent's Guide to Achievement Matters Most: Maryland's Plan for PreK-12 Education, 2002-2003. (Chinese)

    ERIC Educational Resources Information Center

    Maryland State Dept. of Education, Baltimore.

    To raise the achievement of every student in the state, Maryland implemented "Achievement Matters Most," a new plan for public elementary and secondary schools that sets goals in the areas of achievement, teaching, testing, safety, and family involvement in schools. This Chinese-language guide for parents outlines the goals and…

  17. A Parent's Guide to Achievement Matters Most: Maryland's Plan for PreK-12 Education, 2002-2003. (Urdu)

    ERIC Educational Resources Information Center

    Maryland State Dept. of Education, Baltimore.

    To raise the achievement of every student in the state, Maryland implemented "Achievement Matters Most," a new plan for public elementary and secondary schools that sets goals in the areas of achievement, teaching, testing, safety, and family involvement in schools. This Urdu-language guide for parents outlines the goals and…

  18. A Parent's Guide to Achievement Matters Most: Maryland's Plan for PreK-12 Education, 2002-2003. (Korean).

    ERIC Educational Resources Information Center

    Maryland State Dept. of Education, Baltimore.

    To raise the achievement of every student in the state, Maryland implemented "Achievement Matters Most," a new plan for public elementary and secondary schools that sets goals in the areas of achievement, teaching, testing, safety, and family involvement in schools. This Korean-language guide for parents outlines the goals and…

  19. A Parent's Guide to Achievement Matters Most: Maryland's Plan for PreK-12 Education, 2002-2003. (Russian).

    ERIC Educational Resources Information Center

    Maryland State Dept. of Education, Baltimore.

    To raise the achievement of every student in the state, Maryland implemented "Achievement Matters Most," a new plan for public elementary and secondary schools that sets goals in the areas of achievement, teaching, testing, safety, and family involvement in schools. This Russian-language guide for parents outlines the goals and…

  20. [Replacement of dogs as research animals for the approval testing of plant protection products].

    PubMed

    Box, Rainer J

    2006-01-01

    The replacement of animal testing using dogs for the registration of plant protection products requires a long-term step-by-step procedure. The first goal should be to achieve international agreement on using only one single study in dogs. This would result in a significant short-term reduction of the use of dogs for this purpose. The competent working groups both in the EU and the United States EPA have declared this to be their intended aim. In this context, the 90-day study is to be the preferred study from the scientific as well as the animal welfare points of view. It is proposed to set up an international expert task force within the next 12 months, which should seek to initiate a process of international harmonization of the testing requirements following the example of the International Conference of Harmonization of Technical Requirements for Medical Products, ICH. The goal should be to achieve international agreement on only one single study with dogs within the next 2 to 3 years. In addition, other valid scientific procedures, with which the use of dogs for testing can be reduced, should be critically assessed. A complete replacement of the use of dogs for plant protection product testing is suggested to take place at a later stage. This may be achieved by either deriving safety threshold values by applying a safety factor to chronic NOAEL values obtained in studies using rats for those groups of substances, for which there is evidence that the dog is the more sensitive species, or by combining the chronic rat study with other animal tests stipulated for the registration of pesticides.

  1. The melamine incident: implications for international food and feed safety.

    PubMed

    Gossner, Céline Marie-Elise; Schlundt, Jørgen; Ben Embarek, Peter; Hird, Susan; Lo-Fo-Wong, Danilo; Beltran, Jose Javier Ocampo; Teoh, Keng Ngee; Tritscher, Angelika

    2009-12-01

    A major food safety incident in China was made public in September 2008. Kidney and urinary tract effects, including kidney stones, affected about 300,000 Chinese infants and young children, with six reported deaths. Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein content. Subsequently, melamine has been detected in many milk and milk-containing products, as well as other food and feed products, which were also exported to many countries worldwide. The melamine event represents one of the largest deliberate food contamination incidents. We provide a description and analysis of this event to determine the global implications on food and feed safety. A series of factors, including the intentional character of the milk contamination, the young age of the population affected, the large number of potentially contaminated products, the global distribution of these products, and the delay in reporting led this event to take on unexpected proportions. This incident illustrated the complexity of international trade of food products and food ingredients that required immediate actions at international level. Managing food-safety events should be done internationally and early on as soon as multinational consequences are expected. Collaboration between food-safety authorities worldwide is needed to efficiently exchange information and to enable tracking and recalling of affected products to ensure food safety and to protect public health.

  2. Food-packaging interactions influencing quality and safety.

    PubMed

    Hotchkiss, J H

    1997-01-01

    Interactions between foods and packaging can be detrimental to quality and/or safety. Changes in product flavour due to aroma sorption and the transfer of undesirable flavours from packaging to foods are important mechanisms of deterioration when foods are packaged in polymer-based materials. Careful consideration must be given to those factors affecting such interactions when selecting packaging materials in order to maximize product quality, safety, and shelf-life while minimizing undesirable changes. Product considerations include sensitivity to flavour and related deteriorations, colour changes, vitamin loss, microbial activity, and amount of flavour available. Storage considerations include temperature, time, and processing method. Polymer considerations include type of polymer and processing method, volume or mass of polymer to product ratio, and whether the interaction is Fickian or non-Fickian. Methodology to determine the extent of such interactions must be developed. Direct interactions between food and packaging are not necessarily detrimental. The same principles governing undesirable interactions can be used to affect desirable outcomes. Examples include films which directly intercept or absorb oxygen, inhibit microorganisms, remove undesirable flavours by sorption, or indicate safety and product shelf-life.

  3. Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

    PubMed

    Pauwels, Marleen; Rogiers, Vera

    2004-06-15

    Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

  4. 77 FR 32146 - Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 40-9086; NRC-2010-0143] Safety Evaluation Report... Deconversion Plant (FEP/DUP) and will be located in Lea County, New Mexico. The NRC has prepared a Safety..., Deconversion and Enrichment Branch, Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material...

  5. Quantifying Faculty Productivity in Japan: Development and Application of the Achievement-Motivated Key Performance Indicator. Research & Occasional Paper Series: CSHE.8.16

    ERIC Educational Resources Information Center

    Aida, Misako; Watanabe, Satoshi P.

    2016-01-01

    Universities throughout the world are trending toward more performance based methods to capture their strengths, weaknesses and productivity. Hiroshima University has developed an integrated objective measure for quantifying multifaceted faculty activities, namely the "Achievement-Motivated Key Performance Indicator" (A-KPI), in order to…

  6. Relationship between the Wide Range Achievement Test 3 and the Wechsler Individual Achievement Test.

    PubMed

    Smith, T D; Smith, B L

    1998-12-01

    The present study examined the relationship between the Wide Range Achievement Test 3 and the Wechsler Individual Achievement Test for a sample of children with learning disabilities in two rural school districts. Data were collected for 87 school children who had been classified as learning disabled and placed in special education resource services. Pearson product-moment correlations between scores on the two measures were significant and moderate to high; however, mean scores were not significantly different on Reading, Spelling, and Arithmetic subtests of the Wide Range Achievement Test 3 compared to those for the basic Reading, Spelling, and Mathematics Reasoning subtests of the Wechsler Individual Achievement Test. Although there were significant mean differences between scores on Reading and Reading Comprehension and on Arithmetic and Numerical Operations, magnitudes were small. It appears that the two tests provide similar results when screening for reading, spelling, and arithmetic.

  7. Globalisation and blood safety.

    PubMed

    Farrugia, Albert

    2009-05-01

    Globalisation may be viewed as the growing interdependence of countries worldwide through the increasing volume and variety of cross-border transactions in goods and services, and also through the more rapid and widespread diffusion of technology. Globalisation is not just an economic phenomenon, although it is frequently described as such, but includes commerce, disease and travel, and immigration, and as such it affects blood safety and supply in various ways. The relatively short travel times offered by modern aviation can result in the rapid spread of blood-borne pathogens before measures to counteract transmission can be put in place; this would have happened with SARS if the basic life cycle of the SARS virus included an asymptomatic viraemia. This risk can be amplified by ecological factors which effect the spread of these pathogens once they are transferred to a naïve ecosystem, as happened with West Nile Virus (WNV) in North America. The rationalization and contraction of the plasma products industry may be viewed as one aspect of globalisation imposed by the remorseless inevitability of the market; the effect of this development on the safety and supply of products has yet to be seen, but the oversight and assurance of a shrinking number of players will present particular challenges. Similarly, the monopolization of technology, through patent enforcement which puts access beyond the reach of developing countries, can have an effect on blood safety. The challenges presented to blood safety by globalisation are heightening the tensions between the traditional focus on the product safety - zero risk paradigm and the need to view the delivery of safe blood as an integrated process. As an illustration of this tension, donor deferral measures imposed by globalisation-induced risks such as vCJD and WNV have resulted in the loss of the safest and most committed portion of the blood donor population in many Western countries, leading to an increased risk to

  8. 16 CFR 1302.4 - Banned hazardous products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... flammable contact adhesive and similar liquid or semiliquid consumer product as defined in § 1302.3 (b... hazardous product. In addition, any other extremely flammable contact adhesive and similar liquid or... 1302.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS...

  9. 16 CFR 1302.4 - Banned hazardous products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... flammable contact adhesive and similar liquid or semiliquid consumer product as defined in § 1302.3 (b... hazardous product. In addition, any other extremely flammable contact adhesive and similar liquid or... 1302.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS...

  10. 16 CFR 1302.4 - Banned hazardous products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... flammable contact adhesive and similar liquid or semiliquid consumer product as defined in § 1302.3 (b... hazardous product. In addition, any other extremely flammable contact adhesive and similar liquid or... 1302.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS...

  11. 9 CFR 113.38 - Guinea pig safety test.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

  12. 9 CFR 113.38 - Guinea pig safety test.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

  13. 9 CFR 113.38 - Guinea pig safety test.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

  14. 9 CFR 113.38 - Guinea pig safety test.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

  15. 9 CFR 113.38 - Guinea pig safety test.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

  16. 77 FR 60686 - Proposed Extension of Approval of Information Collection; Comment Request-Safety Standard for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-04

    ... CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2013-0001] Proposed Extension of Approval of... AGENCY: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: As required by the Paperwork Reduction Act (44 U.S.C. chapter 35), the Consumer Product Safety Commission (CPSC or Commission) requests...

  17. Ethics and choosing appropriate means to an end: problems with coal mine and nuclear workplace safety.

    PubMed

    Shrader-Frechette, Kristin; Cooke, Roger

    2004-02-01

    A common problem in ethics is that people often desire an end but fail to take the means necessary to achieve it. Employers and employees may desire the safety end mandated by performance standards for pollution control, but they may fail to employ the means, specification standards, necessary to achieve this end. This article argues that current (de jure) performance standards, for lowering employee exposures to ionizing radiation, fail to promote de facto worker welfare, in part because employers and employees do not follow the necessary means (practices known as specification standards) to achieve the end (performance standards) of workplace safety. To support this conclusion, the article argues that (1) safety requires attention to specification, as well as performance, standards; (2) coal-mine specification standards may fail to promote performance standards; (3) nuclear workplace standards may do the same; (4) choosing appropriate means to the end of safety requires attention to the ways uncertainties and variations in exposure may mask violations of standards; and (5) correcting regulatory inattention to differences between de jure and de facto is necessary for achievement of ethical goals for safety.

  18. Quality Control: (Material) Safety Data Sheets.

    PubMed

    Allen, Loyd V

    2017-01-01

    Safety Data Sheets (formerly Material Safety Data Sheets) are a system for cataloging information on chemicals, chemical compounds, and chemical mixtures and include instructions for the safe use and potential hazards associated with a particular material or product. At present, there are 16 sections of Safety Data Sheets, and these sections are discussed in this article. Two United States Pharmacopeia compounding-related chapters (<795> and <800>) refer to Safety Data Sheets, and this article provides a brief discussion on the terminology contained within those chapters. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  19. Two-color mixing for classifying agricultural products for safety and quality

    NASA Astrophysics Data System (ADS)

    Ding, Fujian; Chen, Yud-Ren; Chao, Kuanglin; Chan, Diane E.

    2006-02-01

    We show that the chromaticness of the visual signal that results from the two-color mixing achieved through an optically enhanced binocular device is directly related to the band ratio of light intensity at the two selected wavebands. A technique that implements the band-ratio criterion in a visual device by using two-color mixing is presented here. The device will allow inspectors to identify targets visually in accordance with a two-wavelength band ratio. It is a method of inspection by human vision assisted by an optical device, which offers greater flexibility and better cost savings than a multispectral machine vision system that implements the band-ratio criterion. With proper selection of the two narrow wavebands, discrimination by chromaticness that is directly related to the band ratio can work well. An example application of this technique for the inspection of carcasses chickens of afficted with various diseases is given. An optimal pair of wavelengths of 454 and 578 nm was selected to optimize differences in saturation and hue in CIE LUV color space among different types of target. Another example application, for the detection of chilling injury in cucumbers, is given, here the selected wavelength pair was 504 and 652 nm. The novel two-color mixing technique for visual inspection can be included in visual devices for various applications, ranging from target detection to food safety inspection.

  20. Safety in the wood products industry

    Treesearch

    Judd H. Michael; Janice K. Wiedenbeck; Janice K. Wiedenbeck

    2004-01-01

    The wood products industry has historically been considered to be one of the most dangerous for manufacturing employees. Workers are exposed to hazards ranging from falling trees to debarkers to saws to nail guns, while often working under pressures for high productivity. Compounding the danger from these hazards are the mentally and physically challenging working...

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