The safety of phosphodiesterase type 5 inhibitors for erectile dysfunction.

PubMed

Ventimiglia, Eugenio; Capogrosso, Paolo; Montorsi, Francesco; Salonia, Andrea

2016-01-01

Phosphodiesterase type 5 inhibitors (PDE5Is) are the leading drugs for the treatment of erectile dysfunction (ED), being recommended as a first line treatment by both the European and US urological guidelines. PDE5Is are highly effective as compared to placebo, well tolerated and have a very low, though not negligible, rate of severe treatment-related adverse events. This paper reviews the safety profile of currently available PDE5Is, comparing them in a broad spectrum ED population and outlining a number of real-life aspects of importance in the real-life everyday clinical setting. Guidelines unanimously agree in considering PDE5Is as first line treatments for ED when well-tolerated and not contraindicated. Despite the fact that no high-grade evidence comparing the efficacy and the safety for PDE5Is is currently available, published data seem to suggest that there are no major differences in their safety profiles. Moreover, although oral PDE5Is were shown to cause more AEs than placebo, they were generally mild and well tolerated.

Rules and guidelines in clinical practice: a qualitative study in operating theatres of doctors' and nurses' views

PubMed Central

McDonald, R; Waring, J; Harrison, S; Walshe, K; Boaden, R

2005-01-01

Background: The current orthodoxy within patient safety research and policy is characterised by a faith in rules based systems which limit the capacity for individual discretion, and hence fallibility. However, guidelines have been seen as stifling innovation and eroding trust. Our objectives were to explore the attitudes towards guidelines of doctors and nurses working together in surgical teams and to examine the extent to which trusting relationships are maintained in a context governed by explicit rules. Methods: Fourteen consultant grade surgeons of mixed specialty, 12 consultant anaesthetists, and 15 nurses were selected to reflect a range of roles. Participant observation was combined with semi-structured interviews. Results: Doctors' views about the contribution of guidelines to safety and to clinical practice differed from those of nurses. Doctors rejected written rules, instead adhering to the unwritten rules of what constitutes acceptable behaviour for members of the medical profession. In contrast, nurses viewed guideline adherence as synonymous with professionalism and criticised doctors for failing to comply with guidelines. Conclusions: While the creation of a "safety culture" requires a shared set of beliefs, attitudes and norms in relation to what is seen as safe clinical practice, differences of opinion on these issues exist which cannot be easily reconciled since they reflect deeply ingrained beliefs about what constitutes professional conduct. While advocates of standardisation (such as nurses) view doctors as rule breakers, doctors may not necessarily regard guidelines as legitimate or identify with the rules written for them by members of other social groups. Future safety research and policy should attempt to understand the unwritten rules which govern clinical behaviour and examine the ways in which such rules are produced, maintained, and accepted as legitimate. PMID:16076795

Evaluation of the Microbiological Status of Raw Beef in Korea: Considering the Suitability of Aerobic Plate Count Guidelines

PubMed Central

Kim, Hye-Jin; Kim, Dongwook; Kim, Hee-Jin; Song, Sung-Ok; Song, Young-Han; Jang, Aera

2018-01-01

This study was conducted to analyze the microbiological contamination status of raw beef distributed in Korea, and evaluate the suitability of current aerobic plate count (APC) guidelines. We analyzed five years (2010-2014) of microbiological monitoring data obtained from the Ministry of Food and Drug Safety and investigated the microbiological status of raw beef collected from meat packing centers and meat shops in the Seoul/Gyeonggi, Gangwon, and Chungcheong regions in August 2015. From 2010-2014, most raw beef (>94%) displayed APC levels of < 1.0 × 106 CFU/g. However, raw beef samples collected from all three regions in August 2015 had comparatively higher APC levels than those reported in previous years. To evaluate the relationship between the APC level and quality, changes in beef loin were evaluated during cold storage for 15 days at 4°C. On day 11, the mean APC level (4.7 × 106 CFU/g) conformed to current guidelines in Korea (1.0 × 107 CFU/g) and the pH value was 5.82. However, the sensory evaluation score for color and overall acceptability was under 3.0, meaning that the beef loin was not acceptable for eating. These results suggest that current APC guideline for raw beef should be lowered to 1.0 × 106 CFU/g to improve both the microbiological safety and palatability of raw beef. PMID:29725223

EAACI Food Allergy and Anaphylaxis Guidelines. Food allergy health-related quality of life measures.

PubMed

Muraro, A; Dubois, A E J; DunnGalvin, A; Hourihane, J O'B; de Jong, N W; Meyer, R; Panesar, S S; Roberts, G; Salvilla, S; Sheikh, A; Worth, A; Flokstra-de Blok, B M J

2014-07-01

Instruments have been developed and validated for the measurement of health-related quality of life in patients with food allergy. This guideline has been prepared by the European Academy of Allergy and Clinical Immunology's (EAACI) Guidelines for Food Allergy and Anaphylaxis Group. It draws on a systematic review of the literature on quality of life instruments for food allergy and the Appraisal of Guidelines for Research & Evaluation (AGREE II) guideline development process. Guidance is provided on the use of such instruments in research, and the current limitations of their use in clinical practice are described. Gaps in current knowledge as well as areas of future interest are also discussed. This document is relevant to healthcare workers dealing with food-allergic patients, scientists engaging in food allergy research and policy makers involved in regulatory aspects concerning food allergy and safety. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Wildland firefighter safety zones: A review of past science and summary of future needs

Treesearch

B. W. Butler

2014-01-01

Current wildland firefighter safety zone guidelines are based on studies that assume flat terrain, radiant heating, finite flame width, constant flame temperature and high flame emissivity. Firefighter entrapments and injuries occur across a broad range of vegetation, terrain and atmospheric conditions generally when they are within two flame heights of the fire....

[How practical guidelines can be applied in poor countries? Example of the introduction of a bronchoscopy unit in Cambodia].

PubMed

Couraud, S; Chan, S; Avrillon, V; Horn, K; Try, S; Gérinière, L; Perrot, É; Guichon, C; Souquet, P-J; Ny, C

2013-10-01

According to UN, Cambodia is one of the poorest countries in the World. Respiratory diseases are current public health priorities. In this context, a new bronchoscopy unit (BSU) was created in the respiratory medicine department of Preah Kossamak hospital (PKH) thanks to a tight cooperation between a French and a Cambodian team. Aim of this study was to describe conditions of introduction of this equipment. Two guidelines for practice are available. They are respectively edited by the French and British societies of pulmonology. These guidelines were reviewed and compared to the conditions in which BS was introduced in PKH. Each item from guidelines was combined to a categorical value: "applied", "adapted" or "not applied". In 2009, 54 bronchoscopies were performed in PKH, mainly for suspicion of infectious or tumour disease. In total, 52% and 46% of the French and British guideline items respectively were followed in this Cambodian unit. Patient safety items are those highly followed. By contrast "staff safety" items were those weakly applied. Implementation of EBS in developing countries seems feasible in good conditions of quality and safety for patients. However, some recommendations cannot be applied due to local conditions. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Manned space flight nuclear system safety. Volume 5: Nuclear System safety guidelines. Part 1: Space base nuclear safety

NASA Technical Reports Server (NTRS)

1972-01-01

The design and operations guidelines and requirements developed in the study of space base nuclear system safety are presented. Guidelines and requirements are presented for the space base subsystems, nuclear hardware (reactor, isotope sources, dynamic generator equipment), experiments, interfacing vehicles, ground support systems, range safety and facilities. Cross indices and references are provided which relate guidelines to each other, and to substantiating data in other volumes. The guidelines are intended for the implementation of nuclear safety related design and operational considerations in future space programs.

Survey of current practice in clinical transvaginal ultrasound scanning in the UK

PubMed Central

Shaw, Adam; Lees, Christoph

2015-01-01

During transvaginal ultrasound scanning, the fetus and other sensitive tissues are placed close to the transducer. Heating of these tissues occurs by direct conduction from the transducer and by absorption of ultrasound in the tissue. The extent of any heating will depend on the equipment and settings used, the duration of the scan, imaging modes and other aspects of scanning practice. To ensure that scans are performed with minimum risk, staff should have an appropriate knowledge of safety and follow guidelines issued by professional bodies. An online survey aiming to document current practice in transvaginal ultrasound in the UK was created and distributed to individuals performing this type of scanning. The survey posed questions about the respondents, the departments where scans were performed, the equipment used, knowledge of ultrasound safety, scanning practice and the frequency, duration and mode of transvaginal ultrasound scans for gynaecology, obstetrics and fertility applications. In all, 294 responses were obtained, mostly from sonographers (94%). From the analysis of the responses, it was clear that there was a good understanding of the general meaning of thermal and mechanical index and high awareness of guidelines issued by professional bodies. However, 40% of respondents stated that they rarely or never monitor Thermal or Mechanical indices during scanning. Scanning practice was consistent in terms of the duration of scans, scan protocols followed and use of imaging modes. The results highlight the importance of continued ultrasound safety training and promotion of safety guidelines to users. PMID:27433250

Topical Treatment of Degenerative Knee Osteoarthritis.

PubMed

Meng, Zengdong; Huang, Rongzhong

2018-01-01

This article reviews topical management strategies for degenerative osteoarthritis (OA) of the knee. A search of Pubmed, Embase and the Cochrane library using MeSH terms including "topical," "treatment," "knee" and "osteoarthritis" was carried out. Original research and review articles on the effectiveness and safety, recommendations from international published guidelines and acceptability studies of topical preparations were included. Current topical treatments included for the management of knee OA include topical nonsteroidal anti-inflammatory drugs, capsaicin, salicylates and physical treatments such as hot or cold therapy. Current treatment guidelines recommend topical nonsteroidal anti-inflammatory drugs as an alternative and even first-line therapy for OA management, especially among elderly patients. Guidelines on other topical treatments vary, from recommendations against their use, to in favor as alternative or simultaneous therapy, especially for patients with contraindications to other analgesics. Although often well-tolerated and preferred by many patients, clinical care still lags in the adoption of topical treatments. Aspects of efficacy, safety and patient quality of life data require further research. Copyright © 2018 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.

Transition to Office-based Obstetric and Gynecologic Procedures: Safety, Technical, and Financial Considerations.

PubMed

Peacock, Lisa M; Thomassee, May E; Williams, Valerie L; Young, Amy E

2015-06-01

Office-based surgery is increasingly desired by patients and providers due to ease of access, overall efficiency, reimbursement, and satisfaction. The adoption of office-based surgery requires careful consideration of safety, efficacy, cost, and feasibility within a providers practice. This article reviews the currently available data regarding patient and provider satisfaction as well as practical considerations of staffing, equipment, and supplies. To aid the practitioner, issues of office-based anesthesia and safety with references to currently available national guidelines and protocols are provided. Included is a brief review of billing, coding, and reimbursement. Technical procedural aspects with information and recommendations are summarized.

Recognition, Investigation and Management of Acute Transfusion Reactions

PubMed Central

Al-Riyami, Arwa Z.; Al-Hashmi, Sabria; Al-Arimi, Zainab; Wadsworth, Louis D.; Al-Rawas, Abdulhakim; Al-Khabori, Murtadha; Daar, Shahina

2014-01-01

The recognition and management of transfusion reactions (TRs) are critical to ensure patient safety during and after a blood transfusion. Transfusion reactions are classified into acute transfusion reactions (ATRs) or delayed transfusion reactions, and each category includes different subtypes. Different ATRs share common signs and symptoms which can make categorisation difficult at the beginning of the reaction. Moreover, TRs are often under-recognised and under-reported. To ensure uniform practice and safety, it is necessary to implement a national haemovigilance system and a set of national guidelines establishing policies for blood transfusion and for the detection and management of TRs. In Oman, there are currently no local TR guidelines to guide physicians and hospital blood banks. This paper summarises the available literature and provides consensus guidelines to be used in the recognition, management and reporting of ATRs. PMID:25097764

NSPWG-recommended safety requirements and guidelines for SEI nuclear propulsion

NASA Technical Reports Server (NTRS)

Marshall, Albert C.; Sawyer, J. C., Jr.; Bari, Robert A.; Brown, Neil W.; Cullingford, Hatice S.; Hardy, Alva C.; Lee, James H.; Mcculloch, William H.; Niederauer, George F.; Remp, Kerry

1992-01-01

An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative (SEI) nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top-level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of safety functional requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top-level safety requirements and guidelines to address these issues. Safety requirements were developed for reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, and safeguards. Guidelines were recommended for risk/reliability, operational safety, flight trajectory and mission abort, space debris and meteoroids, and ground test safety. In this paper the specific requirements and guidelines will be discussed.

Nutraceuticals in Migraine: A Summary of Existing Guidelines for Use.

PubMed

Rajapakse, Thilinie; Pringsheim, Tamara

2016-04-01

The use of nutraceuticals or food/herbal products for health benefits is expanding in adults with migraine as they seek relief from pain in an effective and tolerable manner not always afforded by current conventional pharmacologic therapies. Guidelines from the American Academy of Neurology/American Headache Society, Canadian Headache Society, and European Federation of Neurological Societies have discussed nutraceuticals in varying degrees of detail with at times conflicting recommendations. This review serves to provide a summary of existing guidelines for the use of certain nutraceuticals including riboflavin, coenzyme Q10, magnesium, butterbur, feverfew, and omega-3 polyunsaturated fatty acids. The review will also discuss the regulation of nutraceuticals in North America and the current controversy regarding butterbur and its safety. © 2016 American Headache Society.

Safety and Toxicology of Cannabinoids.

PubMed

Sachs, Jane; McGlade, Erin; Yurgelun-Todd, Deborah

2015-10-01

There is extensive research on the safety, toxicology, potency, and therapeutic potential of cannabis. However, uncertainty remains facilitating continued debate on medical and recreational cannabis policies at the state and federal levels. This review will include a brief description of cannabinoids and the endocannabinoid system; a summary of the acute and long-term effects of cannabis; and a discussion of the therapeutic potential of cannabis. The conclusions about safety and efficacy will then be compared with the current social and political climate to suggest future policy directions and general guidelines.

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

NASA has developed guidelines for development and analysis of safety-critical software. These guidelines have been documented in a Guidebook for Safety Critical Software Development and Analysis. The guidelines represent a practical 'how to' approach, to assist software developers and safety analysts in cost effective methods for software safety. They provide guidance in the implementation of the recent NASA Software Safety Standard NSS-1740.13 which was released as 'Interim' version in June 1994, scheduled for formal adoption late 1995. This paper is a survey of the methods in general use, resulting in the NASA guidelines for safety critical software development and analysis.

Parents' adherence to pediatric health and safety guidelines: Importance of patient-provider relationships.

PubMed

Fuzzell, Lindsay N; LaJoie, A Scott; Smith, Kyle T; Philpott, Sydney E; Jones, Katherine M; Politi, Mary C

2018-05-01

To examine 1) parent-provider communication about pediatric health/safety guidelines, 2) trust in child's provider, 3) comfort discussing guidelines, 4) agreement with guideline advice, 5) self-efficacy following guidelines, and their impact on guideline adherence. 256 parents of children ages 0-6 completed an online survey about sunscreen use, newborn Vitamin K injections, influenza vaccination, routine vaccination, car seats, infant safe sleep, furniture anchoring, large trampoline use, and firearm safety. Multivariable models regressed: 1) communication about each guideline on parents' corresponding guideline adherence; 2) trust, comfort discussing guidelines, agreement with guideline advice, self-efficacy, on parents' total guideline adherence. Communication about furniture anchoring (OR = 2.26), sunscreen (OR = 5.28), Vitamin K injections (OR = 3.20), influenza vaccination (OR = 13.71), routine vaccination (OR = 6.43), car seats (OR = 6.15), and infant safe sleep (OR = 3.40) related to corresponding guideline adherence (ps < 0.05). Firearm safety communication was not related to adherence (OR = 1.11, n.s.). Trampoline communication related to lower likelihood of trampoline guideline adherence (OR = 0.24, p = 0.001). Agreement with guideline advice (β = 0.35), trust (β = 0.34), self-efficacy (β = 0.45), comfort discussing guidelines (β = 0.35) positively related to total guideline adherence (ps < 0.001). Findings underscore the importance of provider communication about health/safety guidelines. Providers should respectfully engage and build relationships with parents to support health/safety guideline adherence. Copyright © 2018. Published by Elsevier B.V.

The Toxic Truth About Carbon Nanotubes in Water Purification: a Perspective View.

PubMed

Das, Rasel; Leo, Bey Fen; Murphy, Finbarr

2018-06-18

Without nanosafety guidelines, the long-term sustainability of carbon nanotubes (CNTs) for water purifications is questionable. Current risk measurements of CNTs are overshadowed by uncertainties. New risks associated with CNTs are evolving through different waste water purification routes, and there are knowledge gaps in the risk assessment of CNTs based on their physical properties. Although scientific efforts to design risk estimates are evolving, there remains a paucity of knowledge on the unknown health risks of CNTs. The absence of universal CNT safety guidelines is a specific hindrance. In this paper, we close these gaps and suggested several new risk analysis roots and framework extrapolations from CNT-based water purification technologies. We propose a CNT safety clock that will help assess risk appraisal and management. We suggest that this could form the basis of an acceptable CNT safety guideline. We pay particular emphasis on measuring risks based on CNT physico-chemical properties such as diameter, length, aspect ratio, type, charge, hydrophobicity, functionalities and so on which determine CNT behaviour in waste water treatment plants and subsequent release into the environment.

Safety and efficacy of physical restraints for the elderly. Review of the evidence.

PubMed Central

Frank, C.; Hodgetts, G.; Puxty, J.

1996-01-01

OBJECTIVE: To critically review evidence on the safety and efficacy of physical restraints for the elderly and to provide family physicians with guidelines for rational use of restraints. DATA SOURCES: Articles cited on MEDLINE (from 1989 to November 1994) and Cinahl (from 1982 to 1994) under the MeSH heading "physical restraints." STUDY SELECTION: Articles that specifically dealt with the safety and efficacy of restraints and current patterns of use, including prevalence, risk factors, and indications, were selected. Eight original research articles were identified and critically appraised. DATA EXTRACTION: Data extracted concerned the negative sequelae of restraints and the association between restraint use and fall and injury rates. General data about current patterns of restraint use were related to safety and efficacy findings. DATA SYNTHESIS: No randomized, controlled trials of physical restraint use were found in the literature. A variety of study design, including retrospective chart review, prospective cohort studies, and case reports, found little evidence that restraints prevent injury. Some evidence suggested that restraints might increase risk of falls and injury. Restraint-reduction programs have not been shown to increase fall or injury rates. Numerous case reports document injuries or deaths resulting from restraint use or misuse. CONCLUSIONS: Although current evidence does not support the belief that restraints prevent falls and injuries and questions their safety, further prospective and controlled studies are needed to clarify these issues. Information from review and research articles was synthesized in this paper to produce guidelines for the safe and rational use of restraints. PMID:8969858

Guidelines and algorithms for managing the difficult airway.

PubMed

Gómez-Ríos, M A; Gaitini, L; Matter, I; Somri, M

2018-01-01

The difficult airway constitutes a continuous challenge for anesthesiologists. Guidelines and algorithms are key to preserving patient safety, by recommending specific plans and strategies that address predicted or unexpected difficult airway. However, there are currently no "gold standard" algorithms or universally accepted standards. The aim of this article is to present a synthesis of the recommendations of the main guidelines and difficult airway algorithms. Copyright © 2017 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Defining the pharmaceutical system to support proactive drug safety.

PubMed

Lewis, Vicki R; Hernandez, Angelica; Meadors, Margaret

2013-02-01

The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement.

Manned space flight nuclear system safety. Voluem 5: Nuclear system safety guidelines. Part 2: Space shuttle/nuclear payloads safety

NASA Technical Reports Server (NTRS)

1972-01-01

The design and operations guidelines and requirements developed in the study of space shuttle nuclear system transportation are presented. Guidelines and requirements are presented for the shuttle, nuclear payloads (reactor, isotope-Brayton and small isotope sources), ground support systems and facilities. Cross indices and references are provided which relate guidelines to each other, and to substantiating data in other volumes. The guidelines are intended for the implementation of nuclear safety related design and operational considerations in future space programs.

Safety aspects of nuclear waste disposal in space

NASA Technical Reports Server (NTRS)

Rice, E. E.; Edgecombe, D. S.; Compton, P. R.

1981-01-01

Safety issues involved in the disposal of nuclear wastes in space as a complement to mined geologic repositories are examined as part of an assessment of the feasibility of nuclear waste disposal in space. General safety guidelines for space disposal developed in the areas of radiation exposure and shielding, containment, accident environments, criticality, post-accident recovery, monitoring systems and isolation are presented for a nuclear waste disposal in space mission employing conventional space technology such as the Space Shuttle. The current reference concept under consideration by NASA and DOE is then examined in detail, with attention given to the waste source and mix, the waste form, waste processing and payload fabrication, shipping casks and ground transport vehicles, launch site operations and facilities, Shuttle-derived launch vehicle, orbit transfer vehicle, orbital operations and space destination, and the system safety aspects of the concept are discussed for each component. It is pointed out that future work remains in the development of an improved basis for the safety guidelines and the determination of the possible benefits and costs of the space disposal option for nuclear wastes.

OSHA safety requirements and the general duty clause.

PubMed

Mills, Anne C; Chillock, Cynthia A; Edelman, Harold; Mills, Shannon E

2005-03-01

Dental offices and clinics are subject to the same general safety requirements as other workplaces. Current guidelines, inspections, education, and training focus on infectious disease as the major workplace hazard for dental health care personnel (DHCP). However, the Occupational Safety and Health Administration has cited an increasing variety and number of general safety hazards during inspections of dental offices. A review of the general safety requirements for personal protective equipment and fire safety as they relate to DHCP follows. The authors discuss the responsibility of both employers and employees to perform workplace hazard evaluation and to implement education, engineering controls, and work practice controls to minimize their exposure to recognized and emerging workplace hazards.

National Children's Center for Rural and Agricultural Health and Safety

MedlinePlus

... Network Grain Safety Model Policy: Youth Employment in Agriculture Agricultural Youth Work Guidelines North American Guidelines for ... Sept. 20 Teaching fall and electrical safety in agriculture: free webinar, Sept. 13 Agricultural Youth Work Guidelines ...

Safety in earth orbit study. Volume 5: Space shuttle payloads: Safety requirements and guidelines on-orbit phase

NASA Technical Reports Server (NTRS)

1972-01-01

Safety requirements and guidelines are listed for the sortie module, upper stage vehicle, and space station for the earth orbit operations of the space shuttle program. The requirements and guidelines are for vehicle design, safety devices, warning devices, operational procedures, and residual hazards.

COMP report: CPQR technical quality control guidelines for low-dose-rate permanent seed brachytherapy.

PubMed

Beaulieu, Luc; Radford, Dee-Ann; Eduardo Villarreal-Barajas, J

2018-03-14

The Canadian Organization of Medical Physicists (COMP), in close partnership with the Canadian Partnership for Quality Radiotherapy (CPQR) has developed a series of Technical Quality Control (TQC) guidelines for radiation treatment equipment. These guidelines outline the performance objectives that equipment should meet in order to ensure an acceptable level of radiation treatment quality. The TQC guidelines have been rigorously reviewed and field tested in a variety of Canadian radiation treatment facilities. The development process enables rapid review and update to keep the guidelines current with changes in technology. This article contains detailed performance objectives and safety criteria for low-dose-rate (LDR) permanent seed brachytherapy. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Site selection plan and installation guidelines for a nationwide differential GPS service

DOT National Transportation Integrated Search

1997-08-05

The Global Positioning System (GPS), in its current form, is used within the transportation industry for vehicle tracking and navigation. With the advent of a nationwide differential GPS (DGPS) service, this role will expand to include public safety,...

Universal Playground Design.

ERIC Educational Resources Information Center

Ensign, Arselia, Ed.

1993-01-01

This publication presents principles of universal playgrounds, designed to maximize accessibility for all children, with and without disabilities. First, the rationale for the universal playground is given including the importance of play and the value of integration. Next current guidelines for playground design are discussed including safety,…

OSHA standard for medical surveillance of hazardous waste workers.

PubMed

Melius, J M

1990-01-01

The increasing amount of work involving hazardous waste sites and the heavy involvement of the federal and state governments in this work have led to the gradual development of guidelines and standards providing for occupational safety and health programs for these sites. On March 6, 1989, the Occupational Safety and Health Administration published its final rule governing occupational safety and health matters at hazardous waste sites and emergency operations. This rule is currently scheduled to take effect on March 6, 1990. This chapter will briefly describe this regulation, particularly its medical surveillance requirements.

Quality and Safety in Health Care, Part XXVI: The Adult Cardiac Surgery Database.

PubMed

Harolds, Jay A

2017-09-01

The Adult Cardiac Surgery Database of the Society of Thoracic Surgeons has provided highly useful information in quality and safety in general thoracic surgery, including ratings of the surgeons and institutions participating in this type of surgery. The Adult Cardiac Surgery Database information is very helpful for writing guidelines and determining optimal protocols and for many research projects. This article discusses the history and current status of this database.

ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.

PubMed

Cavero, Icilio; Crumb, William

2005-05-01

The International Conference on Harmonization (ICH) stems from the initiative of three major world partners (Japan, USA, European Community) who composed a mutually accepted body of regulations concerning the safety, quality and efficacy requirements that new medicines have to meet in order to receive market approval. Documents on non-clinical safety pharmacology already composed by this organisation include two guidelines: the S7A adopted in 2000 and, its companion, the S7B guideline, in a draft form since 2001. The S7A guideline deals with general principles and recommendations on safety pharmacology studies designed to protect healthy volunteers and patients from potential drug-induced adverse reactions. The S7B recommends a general non-clinical testing strategy for determining the propensity of non-cardiovascular pharmaceuticals to delay ventricular repolarisation, an effect that at times progresses into life-threatening ventricular arrhythmia. In the most recent version of this document (June 2004), the strategy proposes experimental assays and a critical examination of other pertinent information for applying an 'evidence of risk' label to a compound. Regrettably, the guideline fails to deal satisfactorily with a number of crucial issues such as scoring the evidence of risk and the clinical consequences of such scoring. However, in the latter case, the S7B relies on the new ICH guideline E14 which is currently in preparation. E14 is the clinical counterpart of the S7B guideline which states that non-clinical data are a poor predictor of drug-induced repolarisation delay in humans. The present contribution summarises and assesses salient aspects of the S7A guideline as its founding principles are also applicable to the S7B guideline. The differences in strategies proposed by the various existing drafts of the latter document are critically examined together with some unresolved, crucial problems. The need for extending the objective of the S7B document to characterise the full electrophysiological profile of new pharmaceuticals is argued as this approach would more extensively assess the non-clinical cardiac safety of a drug. Finally, in order to overcome present difficulties in arriving at the definitive version of the S7B guideline, the Expert Working Group could reflect on the introduction of the S7B guideline recommendations in the S7A document, as originally intended, or on postponing the adoption of an harmonized text until the availability of novel scientific data allows solving presently contentious aspects of this and the E14 guidelines.

Space station pressurized laboratory safety guidelines

NASA Technical Reports Server (NTRS)

Mcgonigal, Les

1990-01-01

Before technical safety guidelines and requirements are established, a common understanding of their origin and importance must be shared between Space Station Program Management, the User Community, and the Safety organizations involved. Safety guidelines and requirements are driven by the nature of the experiments, and the degree of crew interaction. Hazard identification; development of technical safety requirements; operating procedures and constraints; provision of training and education; conduct of reviews and evaluations; and emergency preplanning are briefly discussed.

Nuclear safety considerations in the conceptual design of a fast reactor for space electric power and propulsion

NASA Technical Reports Server (NTRS)

Hsieh, T.-M.; Koenig, D. R.

1977-01-01

Some nuclear safety aspects of a 3.2 mWt heat pipe cooled fast reactor with out-of-core thermionic converters are discussed. Safety related characteristics of the design including a thin layer of B4C surrounding the core, the use of heat pipes and BeO reflector assembly, the elimination of fuel element bowing, etc., are highlighted. Potential supercriticality hazards and countermeasures are considered. Impacts of some safety guidelines of space transportation system are also briefly discussed, since the currently developing space shuttle would be used as the primary launch vehicle for the nuclear electric propulsion spacecraft.

Tranexamic Acid and Trauma: Current Status and Knowledge Gaps with Recommended Research Priorities

DTIC Science & Technology

2013-01-01

Review Article TRANEXAMIC ACID AND TRAUMA: CURRENT STATUS AND KNOWLEDGE GAPS WITH RECOMMENDED RESEARCH PRIORITIES Anthony E. Pusateri,* Richard B...on the use of tranexamic acid (TXA) for trauma reported important survival benefits. Subsequently, successful use of TXA for combat casualties in...refinement of practice guidelines over time. KEYWORDS— Tranexamic acid , trauma, efficacy, safety, research requirements INTRODUCTION Tranexamic acid (TXA

Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial.

PubMed

Emond, Yvette E J J M; Calsbeek, Hiske; Teerenstra, Steven; Bloo, Gerrit J A; Westert, Gert P; Damen, Johan; Wolff, André P; Wollersheim, Hub C

2015-01-08

This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is conducted to identify the compliance with the implementation strategy, as well as an economic evaluation to assess the costs. Data sources are registered clinical data and surveys. There is no form of blinding. The perioperative setting is an unexplored area with respect to implementation issues. This study is expected to yield important new evidence about the effects of a multifaceted approach on guideline adherence in the perioperative care setting. Dutch trial registry: NTR3568.

A critical analysis of Australian policies and guidelines for water immersion during labour and birth.

PubMed

Cooper, Megan; McCutcheon, Helen; Warland, Jane

2017-10-01

Accessibility of water immersion for labour and/or birth is often dependent on the care provider and also the policies/guidelines that underpin practice. With little high quality research about the safety and practicality of water immersion, particularly for birth, policies/guidelines informing the practice may lack the evidence necessary to ensure practitioner confidence surrounding the option thereby limiting accessibility and women's autonomy. The aims of the study were to determine how water immersion policies and/or guidelines are informed, who interprets the evidence to inform policies/guidelines and to what extent the policy/guideline facilitates the option for labour and birth. Phase one of a three-phase mixed-methods study critically analysed 25 Australian water immersion policies/guidelines using critical discourse analysis. Policies/guidelines pertaining to the practice of water immersion reflect subjective opinions and views of the current literature base in favour of the risk-focused obstetric and biomedical discursive practices. Written with hegemonic influence, policies and guidelines impact on the autonomy of both women and practitioners. Policies and guidelines pertaining to water immersion, particularly for birth reflect opinion and varied interpretations of the current literature base. A degree of hegemonic influence was noted prompting recommendations for future maternity care policy and guidelines'. The Human Research Ethics Committee of the University of South Australia approved the research. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Regulatory Compliance in Multi-Tier Supplier Networks

NASA Technical Reports Server (NTRS)

Goossen, Emray R.; Buster, Duke A.

2014-01-01

Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

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

PubMed

Hur, Sun Jin

2017-10-01

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

The Voluntary Use of Physical Education Safety Guidelines in Schools

ERIC Educational Resources Information Center

Rothe, J. Peter

2009-01-01

About 25 percent of child injuries occur in schools, most of them during physical education activities. Physical education safety guidelines are one strategy to reduce the number of student injuries. However, based on the findings of a recent evaluation of provincial safety guidelines, only two-thirds of physical education teachers use the safety…

Efforts to update firefighter safety zone guidelines

Treesearch

Bret Butler

2009-01-01

One of the most critical decisions made on wildland fires is the identification of suitable safety zones for firefighters during daily fire management operations. To be effective (timely, repeatable, and accurate), these decisions rely on good training and judgment, but also on clear, concise guidelines. This article is a summary of safety zone guidelines and the...

Standards Guidelines. Safety in Oregon Schools. OAR 581-22-706.

ERIC Educational Resources Information Center

Oregon State Dept. of Education, Salem.

This document contains guidelines that help Oregon schools meet the components of Oregon Administrative Rule 581-22-706, Emergency Plans and Safety Programs. The standard mandates that Oregon schools shall maintain a comprehensive safety program for all employees and students. School districts may alter the guidelines provided in this guidebook to…

Current Status of Chemical Public Health Risks and Testing Guidelines for Chemical Cardiovascular Safety Assessments

EPA Science Inventory

The cardiovascular system, at all its various developmental and life stages, represents a critical target organ system that can be adversely affected by a variety of chemicals and routes of exposure. A World Health Organization report estimated the impact of environmental chemica...

Exercising for Two. What's Safe for the Active Pregnant Woman?

ERIC Educational Resources Information Center

White, Jacqueline

1992-01-01

Clinical experience and recent research challenge the current standards of exercise duration and intensity for pregnant women. By carefully assessing patients' self-monitoring techniques, physicians can work with active women to create safe exercise programs during pregnancy. Safety guidelines for developing home exercise programs are included.…

Advanced bridge safety initiative, task 1 : development of improved analytical load rating procedures for flat-slab concrete bridges - a thesis and guidelines.

DOT National Transportation Integrated Search

2010-01-01

Current AASHTO provisions for the conventional load rating of flat slab bridges rely on the equivalent strip method : of analysis for determining live load effects, this is generally regarded as overly conservative by many professional : engineers. A...

Possible overexposure of pregnant women to emissions from a walk through metal detector.

PubMed

Wu, Dagang; Qiang, Rui; Chen, Ji; Seidman, Seth; Witters, Donald; Kainz, Wolfgang

2007-10-07

This paper presents a systematic procedure to evaluate the induced current densities and electric fields due to walk-through metal detector (WTMD) exposure. This procedure is then used to assess the exposure of nine pregnant women models exposed to one WTMD model. First, we measured the magnetic field generated by the WTMD, then we extracted the equivalent current source to represent the WTMD emissions and finally we calculated the induced current densities and electric fields using the impedance method. The WTMD emissions and the induced fields in the pregnant women and fetus models are then compared to the ICNIRP Guidelines and the IEEE C95.6 exposure safety standard. The results prove the consistency between maximum permissible exposure (MPE) levels and basic restrictions for the ICNIRP Guidelines and IEEE C95.6. We also found that this particular WTMD complies with the ICNIRP basic restrictions for month 1-5 models, but leads to both fetus and pregnant women overexposure for month 6-9 models. The IEEE C95.6 restrictions (MPEs and basic restrictions) are not exceeded. The fetus overexposure of this particular WTMD calls for carefully conducted safety evaluations of security systems before they are deployed.

Possible overexposure of pregnant women to emissions from a walk through metal detector

NASA Astrophysics Data System (ADS)

Wu, Dagang; Qiang, Rui; Chen, Ji; Seidman, Seth; Witters, Donald; Kainz, Wolfgang

2007-09-01

This paper presents a systematic procedure to evaluate the induced current densities and electric fields due to walk-through metal detector (WTMD) exposure. This procedure is then used to assess the exposure of nine pregnant women models exposed to one WTMD model. First, we measured the magnetic field generated by the WTMD, then we extracted the equivalent current source to represent the WTMD emissions and finally we calculated the induced current densities and electric fields using the impedance method. The WTMD emissions and the induced fields in the pregnant women and fetus models are then compared to the ICNIRP Guidelines and the IEEE C95.6 exposure safety standard. The results prove the consistency between maximum permissible exposure (MPE) levels and basic restrictions for the ICNIRP Guidelines and IEEE C95.6. We also found that this particular WTMD complies with the ICNIRP basic restrictions for month 1-5 models, but leads to both fetus and pregnant women overexposure for month 6-9 models. The IEEE C95.6 restrictions (MPEs and basic restrictions) are not exceeded. The fetus overexposure of this particular WTMD calls for carefully conducted safety evaluations of security systems before they are deployed.

Auto Safety

MedlinePlus

... certified child passenger safety technician to assist you.) Guidelines for Choosing a Safety Seat Choose a seat ... and are between 8 and 12 years old. Guidelines for Choosing a Booster Seat Choose a seat ...

The impact of health information technology on patient safety.

PubMed

Alotaibi, Yasser K; Federico, Frank

2017-12-01

Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety.  This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient's safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes.

The impact of health information technology on patient safety

PubMed Central

Alotaibi, Yasser K.; Federico, Frank

2017-01-01

Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety. This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient’s safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes. PMID:29209664

78 FR 71715 - Amendments to Highway Safety Program Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... promulgate uniform guidelines for State highway safety programs. This notice revises five of the existing... successful and are based on sound science and program administration. The revised guidelines are Guideline No... become effective as of the date of publication of this document in the Federal Register. FOR FURTHER...

Approach to numerical safety guidelines based on a core melt criterion. [PWR; BWR

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

Azarm, M.A.; Hall, R.E.

1982-01-01

A plausible approach is proposed for translating a single level criterion to a set of numerical guidelines. The criterion for core melt probability is used to set numerical guidelines for various core melt sequences, systems and component unavailabilities. These guidelines can be used as a means for making decisions regarding the necessity for replacing a component or improving part of a safety system. This approach is applied to estimate a set of numerical guidelines for various sequences of core melts that are analyzed in Reactor Safety Study for the Peach Bottom Nuclear Power Plant.

Surgical handover in an era of reduced working hours: an audit of current practice.

PubMed

Shafiq-ur-Rehman; Mehmood, Sajid; Ahmed, Jamil; Razzaq, Muhammad Haroon; Khan, Shakeeb; Perry, Eugene Phillip

2012-06-01

To examine the current practice of handover and to record trainees' assessment of handover process. An audit study. Department of General Surgery, Scarborough General Hospital, Scarborough, United Kingdom, from January to April 2010. A paper-based questionnaire containing instruments pertaining to handover guidelines was disseminated to trainees on surgical on-call rota at the hospital. Trainees' responses regarding handover process including information transferred, designated location, duration, structure, senior supervision, awareness of guidelines, formal training, and rating of current handover practice were analysed. A total of 42 questionnaires were returned (response rate = 100%). The trainees included were; registrars 21% (n=9), core surgical trainees 38 % (n=16), and foundation trainees 41% (n=17). Satisfactory compliance (> 80% handover sessions) to RCS guidelines was observed for only five out of nine components. Ninety-five percent of hand over sessions took place at a designated place and two-third lasted less than 20-minutes. Computer generated handover sheet 57% (n=24) was the most commonly practised method of handover. Specialist registrar 69 % (n=29) remained the supervising person in majority of handover sessions. None of the respondents received formal teaching or training in handover, whereas only half of them 48% (n=20) were aware of handover guidelines. Twenty-one percent of the trainees expressed dissatisfaction with the current practice of handover. Current practice of surgical handover lacks structure despite a fair degree of compliance to RCS handover guidelines. A computerised-sheet based structured handover process, subjected to regular audit, would ensure patient safety and continuity of care.

49 CFR 350.327 - How may States qualify for Incentive Funds?

Code of Federal Regulations, 2014 CFR

2014-10-01

... Incentive Funds? (a) A State may qualify for Incentive Funds if it can demonstrate that its CMV safety... recipients. (3) Upload of CMV accident reports in accordance with current FMCSA policy guidelines. (4) Verification of CDLs during all roadside inspections. (5) Upload of CMV inspection data in accordance with...

49 CFR 350.327 - How may States qualify for Incentive Funds?

Code of Federal Regulations, 2013 CFR

2013-10-01

... Incentive Funds? (a) A State may qualify for Incentive Funds if it can demonstrate that its CMV safety... recipients. (3) Upload of CMV accident reports in accordance with current FMCSA policy guidelines. (4) Verification of CDLs during all roadside inspections. (5) Upload of CMV inspection data in accordance with...

49 CFR 350.327 - How may States qualify for Incentive Funds?

Code of Federal Regulations, 2011 CFR

2011-10-01

... Incentive Funds? (a) A State may qualify for Incentive Funds if it can demonstrate that its CMV safety... recipients. (3) Upload of CMV accident reports in accordance with current FMCSA policy guidelines. (4) Verification of CDLs during all roadside inspections. (5) Upload of CMV inspection data in accordance with...

49 CFR 350.327 - How may States qualify for Incentive Funds?

Code of Federal Regulations, 2012 CFR

2012-10-01

... Incentive Funds? (a) A State may qualify for Incentive Funds if it can demonstrate that its CMV safety... recipients. (3) Upload of CMV accident reports in accordance with current FMCSA policy guidelines. (4) Verification of CDLs during all roadside inspections. (5) Upload of CMV inspection data in accordance with...

The Handbook of Psychiatric Drug Therapy for Children and Adolescents.

ERIC Educational Resources Information Center

Theesen, Karen A.

A compilation of literature and clinical wisdom, this handbook provides the reader with current information on the safety and efficacy of the psychotropic agents in the pediatric population. It lists information on the pharmacokinetics, adverse effects, dosing, and suggested monitoring guidelines for children and adolescents. The guide may also be…

Large Aircraft Robotic Paint Stripping (LARPS) system and the high pressure water process

NASA Astrophysics Data System (ADS)

See, David W.; Hofacker, Scott A.; Stone, M. Anthony; Harbaugh, Darcy

1993-03-01

The aircraft maintenance industry is beset by new Environmental Protection Agency (EPA) guidelines on air emissions, Occupational Safety and Health Administration (OSHA) standards, dwindling labor markets, Federal Aviation Administration (FAA) safety guidelines, and increased operating costs. In light of these factors, the USAF's Wright Laboratory Manufacturing Technology Directorate and the Aircraft Division of the Oklahoma City Air Logistics Center initiated a MANTECH/REPTECH effort to automate an alternate paint removal method and eliminate the current manual methylene chloride chemical stripping methods. This paper presents some of the background and history of the LARPS program, describes the LARPS system, documents the projected operational flow, quantifies some of the projected system benefits and describes the High Pressure Water Stripping Process. Certification of an alternative paint removal method to replace the current chemical process is being performed in two phases: Process Optimization and Process Validation. This paper also presents the results of the Process Optimization for metal substrates. Data on the coating removal rate, residual stresses, surface roughness, preliminary process envelopes, and technical plans for process Validation Testing will be discussed.

Advanced missions safety. Volume 2: Technical discussion, Part 2: Experiment safety, guidelines

NASA Technical Reports Server (NTRS)

Hinton, M. G., Jr.

1972-01-01

A technical analysis of a portion of the advanced missions safety study is presented. The potential hazards introduced when experimental equipment is carried aboard the Earth Orbit Shuttle are identified. Safety guidelines and requirements for eliminating or reducing these hazards are recommended.

School Safety Handbook. A Handbook for School Business Officials and School Safety Supervisors. Research Bulletin No. 23.

ERIC Educational Resources Information Center

Haering, Franklin C.

A wide variety of school safety guidelines are included in this handbook. The introduction provides guidelines for delegating responsibility to school personnel. Procedures for developing safety policies and for establishing school safety councils and committees are outlined. A chapter on traffic control specifies procedures for pavement marking…

Principles for the wise use of computers by children.

PubMed

Straker, L; Pollock, C; Maslen, B

2009-11-01

Computer use by children at home and school is now common in many countries. Child computer exposure varies with the type of computer technology available and the child's age, gender and social group. This paper reviews the current exposure data and the evidence for positive and negative effects of computer use by children. Potential positive effects of computer use by children include enhanced cognitive development and school achievement, reduced barriers to social interaction, enhanced fine motor skills and visual processing and effective rehabilitation. Potential negative effects include threats to child safety, inappropriate content, exposure to violence, bullying, Internet 'addiction', displacement of moderate/vigorous physical activity, exposure to junk food advertising, sleep displacement, vision problems and musculoskeletal problems. The case for child specific evidence-based guidelines for wise use of computers is presented based on children using computers differently to adults, being physically, cognitively and socially different to adults, being in a state of change and development and the potential to impact on later adult risk. Progress towards child-specific guidelines is reported. Finally, a set of guideline principles is presented as the basis for more detailed guidelines on the physical, cognitive and social impact of computer use by children. The principles cover computer literacy, technology safety, child safety and privacy and appropriate social, cognitive and physical development. The majority of children in affluent communities now have substantial exposure to computers. This is likely to have significant effects on child physical, cognitive and social development. Ergonomics can provide and promote guidelines for wise use of computers by children and by doing so promote the positive effects and reduce the negative effects of computer-child, and subsequent computer-adult, interaction.

Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack.

PubMed

Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

2016-04-01

Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.

Cytotoxic Drug Dispersal, Cytotoxic Safety, and Cytotoxic Waste Management: Practices and Proposed India-specific Guidelines

PubMed Central

Capoor, Malini R; Bhowmik, Kumar Tapas

2017-01-01

This article deals with practices related to cytotoxic drug dispersal, cytotoxic safety, and cytotoxic waste management and attempts at India-specific guidelines for their dispersal and disposal. The articles related to cytotoxic drug dispersal, cytotoxic safety, and cytotoxic waste management were reviewed from PubMed and their applicability in Indian health-care facilities (HCFs) was also reviewed. All HCFs dealing with cytotoxic drugs should consider cytotoxic policy, patient safety and health-care worker safety, and environmental monitoring program as per the available international guidelines customized as per Indian conditions. Utmost care in handling cytotoxic waste is quintessential. The formation of India-specific cytotoxic guidelines requires the inputs from all stakeholders. Cytotoxic waste, cytotoxic safety, and cytotoxic waste management should be the subject of a national strategy with an infrastructure, cradle-to-grave legislation, competent regulatory authority, and trained personnel. PMID:28900329

Nuclear safety policy working group recommendations on nuclear propulsion safety for the space exploration initiative

NASA Technical Reports Server (NTRS)

Marshall, Albert C.; Lee, James H.; Mcculloch, William H.; Sawyer, J. Charles, Jr.; Bari, Robert A.; Cullingford, Hatice S.; Hardy, Alva C.; Niederauer, George F.; Remp, Kerry; Rice, John W.

1993-01-01

An interagency Nuclear Safety Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative (SEI) nuclear propulsion program. These recommendations, which are contained in this report, should facilitate the implementation of mission planning and conceptual design studies. The NSPWG has recommended a top-level policy to provide the guiding principles for the development and implementation of the SEI nuclear propulsion safety program. In addition, the NSPWG has reviewed safety issues for nuclear propulsion and recommended top-level safety requirements and guidelines to address these issues. These recommendations should be useful for the development of the program's top-level requirements for safety functions (referred to as Safety Functional Requirements). The safety requirements and guidelines address the following topics: reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations.

Calculation of induced current densities for humans by magnetic fields from electronic article surveillance devices

NASA Astrophysics Data System (ADS)

Gandhi, Om P.; Kang, Gang

2001-11-01

This paper illustrates the use of the impedance method to calculate the electric fields and current densities induced in millimetre resolution anatomic models of the human body, namely an adult and 10- and 5-year-old children, for exposure to nonuniform magnetic fields typical of two assumed but representative electronic article surveillance (EAS) devices at 1 and 30 kHz, respectively. The devices assumed for the calculations are a solenoid type magnetic deactivator used at store checkouts and a pass-by panel-type EAS system consisting of two overlapping rectangular current-carrying coils used at entry and exit from a store. The impedance method code is modified to obtain induced current densities averaged over a cross section of 1 cm2 perpendicular to the direction of induced currents. This is done to compare the peak current densities with the limits or the basic restrictions given in the ICNIRP safety guidelines. Because of the stronger magnetic fields at lower heights for both the assumed devices, the peak 1 cm2 area-averaged current densities for the CNS tissues such as the brain and the spinal cord are increasingly larger for smaller models and are the highest for the model of the 5-year-old child. For both the EAS devices, the maximum 1 cm2 area-averaged current densities for the brain of the model of the adult are lower than the ICNIRP safety guideline, but may approach or exceed the ICNIRP basic restrictions for models of 10- and 5-year-old children if sufficiently strong magnetic fields are used.

Calculation of induced current densities for humans by magnetic fields from electronic article surveillance devices.

PubMed

Gandhi, O P; Kang, G

2001-11-01

This paper illustrates the use of the impedance method to calculate the electric fields and current densities induced in millimetre resolution anatomic models of the human body, namely an adult and 10- and 5-year-old children, for exposure to nonuniform magnetic fields typical of two assumed but representative electronic article surveillance (EAS) devices at 1 and 30 kHz, respectively. The devices assumed for the calculations are a solenoid type magnetic deactivator used at store checkouts and a pass-by panel-type EAS system consisting of two overlapping rectangular current-carrying coils used at entry and exit from a store. The impedance method code is modified to obtain induced current densities averaged over a cross section of 1 cm2 perpendicular to the direction of induced currents. This is done to compare the peak current densities with the limits or the basic restrictions given in the ICNIRP safety guidelines. Because of the stronger magnetic fields at lower heights for both the assumed devices, the peak 1 cm2 area-averaged current densities for the CNS tissues such as the brain and the spinal cord are increasingly larger for smaller models and are the highest for the model of the 5-year-old child. For both the EAS devices, the maximum 1 cm2 area-averaged current densities for the brain of the model of the adult are lower than the ICNIRP safety guideline, but may approach or exceed the ICNIRP basic restrictions for models of 10- and 5-year-old children if sufficiently strong magnetic fields are used.

Guidelines for observing child safety seat use

DOT National Transportation Integrated Search

1987-06-01

This manual provides guidelines for collecting observational data needed to assess the use of child safety seats. Specific directions are included for (a) observing child safety seat use, (b) child seats, and (c) instructing observers on how to use s...

Guidelines for overcoming hospital managerial challenges: a systematic literature review

PubMed Central

Crema, Maria; Verbano, Chiara

2013-01-01

Purpose The need to respond to accreditation institutes’ and patients’ requirements and to align health care results with increased medical knowledge is focusing greater attention on quality in health care. Different tools and techniques have been adopted to measure and manage quality, but clinical errors are still too numerous, suggesting that traditional quality improvement systems are unable to deal appropriately with hospital challenges. The purpose of this paper is to grasp the current tools, practices, and guidelines adopted in health care to improve quality and patient safety and create a base for future research on this young subject. Methods A systematic literature review was carried out. A search of academic databases, including papers that focus not only on lean management, but also on clinical errors and risk reduction, yielded 47 papers. The general characteristics of the selected papers were analyzed, and a content analysis was conducted. Results A variety of managerial techniques, tools, and practices are being adopted in health care, and traditional methodologies have to be integrated with the latest ones in order to reduce errors and ensure high quality and patient safety. As it has been demonstrated, these tools are useful not only for achieving efficiency objectives, but also for providing higher quality and patient safety. Critical indications and guidelines for successful implementation of new health managerial methodologies are provided and synthesized in an operative scheme useful for extending and deepening knowledge of these issues with further studies. Conclusion This research contributes to introducing a new theme in health care literature regarding the development of successful projects with both clinical risk management and health lean management objectives, and should address solutions for improving health care even in the current context of decreasing resources. PMID:24307833

Latin-American guidelines for opioid use in chronic nononcologic pain.

PubMed

Lara-Solares, Argelia; Aguayo Zamora, Carlos; Amescua García, César; Garcia, João Batista Santos; Berenguel Cook, María Del Rosario; Bonilla Sierra, Patricia; Campos Kraychete, Durval; Flores Cantisani, José Alberto; Guerrero, Carlos; Guillén Núñez, María Del Rocío; Hernández Castro, John Jairo; Hernández Ortíz, Andrés; Jreige Iskandar, Aziza; Lech, Osvandré; Macías Guerra, Jacqueline; Ramírez Samayoa, Gerardo; Rangel Morillo, Edwin; Rico Pazos, María Antonieta; Sempértegui Gallegos, Manuel

2017-05-01

Latin-American experts in the use of opioids in patients with chronic nononcologic pain (CNOP) have updated existing recommendations to current Latin-American reality. Several key opinion leaders from Latin America participated in a face-to-face meeting in Guatemala (April 2015) to discuss the use of opioids in CNOP. Subgroups of experts worked on specific topics, reviewed the literature and shaped the final manuscript. The expert panel developed guidelines taking into consideration the utility of both opioid and nonopioid analgesics and factors pertaining to their efficacy, safety, adherence, administration and risks for abuse/addiction. Latin-American guidelines for the use of opioids in CNOP should improve pain relief and patients' quality of life by increasing access to these effective agents.

Color Functionality Used in Visual Display for Occupational and Environmental Safety and Managing Color Vision Deficiency.

PubMed

Ochiai, Nobuhisa; Kondo, Hiroyuki

2017-01-01

The effects of color perception are utilized in visual displays for the purpose of safety in the workplace and in daily life. These effects, generally known as color functionality, are divided into four classifications: visibility, legibility, conspicuity and discriminability. This article focuses on the relationship between the color functionality of color schemes used in visual displays for occupational and environmental safety and color vision deficiency (particularly congenital red-green color deficiency), a critical issue in ophthalmology, and examines the effects of color functionality on the perception of the color red in individuals with protan defects. Due to abrupt system reforms, current Japanese clinical ophthalmology finds itself in a situation where it is insufficiently prepared to handle congenital red-green color deficiencies. Indeed, occupational problems caused by color vision deficiencies have been almost completely neglected, and are an occupational safety and health concern that will need to be solved in the future. This report will present the guidelines for the color vision testing established by the British Health and Safety Executive (HSE), a pioneering example of a model meant to solve these problems. Issues relating to the creation of guidelines adapted to Japanese clinical ophthalmology will also be examined, and we will discuss ways to utilize color functionality used in visual displays for occupational and environmental safety to help manage color vision deficiency.

Guideline for the utilization of commercial grade items in nuclear safety related applications: Final report. [Contains Glossary

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

Tulay, M.P.; Yurich, F.J.; Schremser, F.M. Jr.

1988-06-01

This guideline provides direction for the procurement and use of Commercial Grade Items (CGI)in safety-related applications. It is divided into five major sections. A glossary of terms and definitions, an acronym listing, and seven appendices have been included. The glossary defines terms used in this guideline. In certain instances, the definitions may be unique to this guideline. Identification of acronyms utilized in this guideline is also provided. Section 1 provides a background of the commercial grade item issues facing the nuclear industry. It provides a historical perspective of commercial grade item issues. Section 2 discusses the generic process for themore » acceptance of a commercial grade item for safety-related use. Section 3 defines the four distinct methods used to accept commercial grade items for safety-related applications. Section 4 lists specific references that are identified in this guideline. Section 5 is a bibliography of documents that were considered in developed this guideline, but were not directly referenced in the document.« less

Child seat belt guidelines: Examining the 4 feet 9 inches rule as the standard.

PubMed

Morse, Amber M; Aitken, Mary E; Mullins, Samantha H; Miller, Beverly K; Pomtree, Mindy M; Ulloa, Erin M; Montgomery, Jeffrey S; Saylors, Marie E

2017-08-01

Current American Academy of Pediatrics recommendations regarding transition from child safety/booster seat to adult safety belt use indicate that children should be at least 4 feet 9 inches, 8 years old, or 80 pounds. Proper fit in the vehicle seat, assessed with a five-point fit test, should also be met. Although most children reach 4 feet 9 inches around age 8 years, each child and vehicle presents a unique combination; thus a child may not fit appropriately in all vehicle types using only the 4 feet 9 inches requirement. We enrolled children, aged 7 years to 12 years, into our study. Height, weight, and demographic data were obtained. A Child Passenger Safety Technician then performed the five-point fit test in each of a uniform lineup of five vehicles. Data were collected on fit in the standard vehicle seat and also in a booster seat. We set 90% as the threshold proportion of children who meet all criteria for proper fit to validate current recommendations of a height of 4 feet 9 inches. Data were collected on 388 children. The percentage of 90% proper fit was met in the compact car and small sport-utility vehicle (SUV). However, only 80 (77%) of 104 students (p < 0.0001) that were 4 feet 9 inches or higher fit properly in the large SUV, only 87 (83%) of 105 students (p = 0.02) fit properly in the pickup truck, and only 91 (89%) of 102 students (p = 0.74) fit properly in the minivan. Substantial proportions of children meeting current height guidelines for an adult seat belt do not meet safety requirements for fit, especially in larger, commonly used vehicles (large SUVs and trucks). This emphasizes the need for evaluation of fit by a trained personnel and/or development of standard back seat dimensions in all vehicles for maximum safety. Epidemiologic study, level III; Therapeutic study, level V.

Haematopoietic SCT in severe autoimmune diseases: updated guidelines of the European Group for Blood and Marrow Transplantation

PubMed Central

Snowden, J A; Saccardi, R; Allez, M; Ardizzone, S; Arnold, R; Cervera, R; Denton, C; Hawkey, C; Labopin, M; Mancardi, G; Martin, R; Moore, J J; Passweg, J; Peters, C; Rabusin, M; Rovira, M; van Laar, J M; Farge, D

2012-01-01

In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized. PMID:22002489

Safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for adjunctive symptom relief of acute respiratory infections.

PubMed

Kikano, George

2009-05-01

Acute bacterial respiratory infections (ABRIs) require treatment with antibiotics. Although antibiotics may address the underlying pathogenic factors, over-the-counter (OTC) agents can play an adjuvant role in relieving mucus-related symptoms. This complimentary role contributes to the healing process and is supported by current clinical guidelines.

Recommendations for safety testing with the in vivo comet assay.

PubMed

Vasquez, Marie Z

2012-08-30

While the in vivo comet assay increases its role in regulatory safety testing, deliberations about the interpretation of comet data continue. Concerns can arise regarding comet assay publications with limited data from non-blind testing of positive control compounds and using protocols (e.g. dose concentrations, sample times, and tissues) known to give an expected effect. There may be a tendency towards bias when the validation or interpretation of comet assay data is based on results generated by widely accepted but non-validated assays. The greatest advantages of the comet assay are its sensitivity and its ability to detect genotoxicity in tissues and at sample times that could not previously be evaluated. Guidelines for its use and interpretation in safety testing should take these factors into account. Guidelines should be derived from objective review of data generated by blind testing of unknown compounds dosed at non-toxic concentrations and evaluated in a true safety-testing environment, where the experimental design and conclusions must be defensible. However, positive in vivo comet findings with such compounds are rarely submitted to regulatory agencies and this data is typically unavailable for publication due to its proprietary nature. To enhance the development of guidelines for safety testing with the comet assay, and with the permission of several sponsors, this paper presents and discusses relevant data from multiple GLP comet studies conducted blind, with unknown pharmaceuticals and consumer products. Based on these data and the lessons we have learned through the course of conducting these studies, I suggest significant adjustments to the current conventions, and I provide recommendations for interpreting in vivo comet assay results in situations where risk must be evaluated in the absence of carcinogenicity or clinical data. Copyright © 2012 Elsevier B.V. All rights reserved.

Security Personnel Practices and Policies in U.S. Hospitals: Findings From a National Survey.

PubMed

Schoenfisch, Ashley L; Pompeii, Lisa A

2016-06-27

Concerns of violence in hospitals warrant examination of current hospital security practices. Cross-sectional survey data were collected from members of a health care security and safety association to examine the type of personnel serving as security in hospitals, their policies and practices related to training and weapon/restraint tool carrying/use, and the broader context in which security personnel work to maintain staff and patient safety, with an emphasis on workplace violence prevention and mitigation. Data pertaining to 340 hospitals suggest security personnel were typically non-sworn officers directly employed (72%) by hospitals. Available tools included handcuffs (96%), batons (56%), oleoresin capsicum products (e.g., pepper spray; 52%), hand guns (52%), conducted electrical weapons (e.g., TASERs®; 47%), and K9 units (12%). Current workplace violence prevention policy components, as well as recommendations to improve hospital security practices, aligned with Occupational Safety and Health Administration guidelines. Comprehensive efforts to address the safety and effectiveness of hospital security personnel should consider security personnel's relationships with other hospital work groups and hospitals' focus on patients' safety and satisfaction. © 2016 The Author(s).

Using long-acting beta2-agonists safely: What will be the impact of the US Food and Drug Administration's panel recommendations?

PubMed

Smart, Brian A

2009-01-01

The US Food and Drug Administration (FDA) has launched an investigation into the safety of long-acting beta(2)-agonists (LABAs). While the impact of this investigation is yet to be seen, clinicians should be circumspect in the use of these agents and prescribe them according to the recommendations of current asthma guidelines, informing patients and their caretakers about potential risks. As clinical trials attempt to address the question of whether LABAs are safe for use in pediatric and adult populations, current data provide no clear answers. A special hearing of the FDA's Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee attempted to seek consensus on the matter as it reviewed the results of controlled clinical trials and conducted a benefit:risk assessment of LABAs to make recommendations on their safety.

Transcranial Magnetic Stimulation in Child Neurology: Current and Future Directions

PubMed Central

Frye, Richard E.; Rotenberg, Alexander; Ousley, Molliann; Pascual-Leone, Alvaro

2008-01-01

Transcranial magnetic stimulation (TMS) is a method for focal brain stimulation based on the principle of electromagnetic induction, where small intracranial electric currents are generated by a powerful, rapidly changing extracranial magnetic field. Over the past 2 decades TMS has shown promise in the diagnosis, monitoring, and treatment of neurological and psychiatric disease in adults, but has been used on a more limited basis in children. We reviewed the literature to identify potential diagnostic and therapeutic applications of TMS in child neurology and also its safety in pediatrics. Although TMS has not been associated with any serious side effects in children and appears to be well tolerated, general safety guidelines should be established. The potential for applications of TMS in child neurology and psychiatry is significant. Given its excellent safety profile and possible therapeutic effect, this technique should develop as an important tool in pediatric neurology over the next decade. PMID:18056688

76 FR 22342 - National Standard 10 Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-21

... safety of human life at sea.'' NMFS published final guidelines for NS10 in 1998 (63 FR 24212; May 1, 1998... of human life at sea, including whether and to what extent such measures may affect the safety of...; and an explanation that the phrase ``safety of human life at sea'' refers to both the safety of a...

Thermal pasteurization of ready-to-eat foods and vegetables: Critical factors for process design and effects on quality.

PubMed

Peng, Jing; Tang, Juming; Barrett, Diane M; Sablani, Shyam S; Anderson, Nathan; Powers, Joseph R

2017-09-22

Increasing consumer desire for high quality ready-to-eat foods makes thermal pasteurization important to both food producers and researchers. To be in compliance with the Food Safety Modernization Act (FSMA), food companies seek regulatory and scientific guidelines to ensure that their products are safe. Clearly understanding the regulations for chilled or frozen foods is of fundamental importance to the design of thermal pasteurization processes for vegetables that meet food safety requirements. This article provides an overview of the current regulations and guidelines for pasteurization in the U.S. and in Europe for control of bacterial pathogens. Poorly understood viral pathogens, in terms of their survival in thermal treatments, are an increasing concern for both food safety regulators and scientists. New data on heat resistance of viruses in different foods are summarized. Food quality attributes are sensitive to thermal degradation. A review of thermal kinetics of inactivation of quality-related enzymes in vegetables and the effects of thermal pasteurization on vegetable quality is presented. The review also discusses shelf-life of thermally pasteurized vegetables.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

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

Development of an effective risk management system in a teaching hospital.

PubMed

Adibi, Hossein; Khalesi, Nader; Ravaghi, Hamid; Jafari, Mahdi; Jeddian, Ali Reza

2012-09-21

Unsafe health care provision is a main cause of increased mortality rate amongst hospitalized patients all over the world. A system approach to medical error and its reduction is crucial that is defined by clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury. The aim of this study was to develop and implement a risk management system in a large teaching hospital in Iran, especially of the basis of WHO guidelines and patient safety context. WHO draft guideline and patient safety reports from different countries were reviewed for defining acceptable framework of risk management system. Also current situation of mentioned hospital in safety matter and dimensions of patient safety culture was evaluated using HSOPSC questionnaire of AHRQ. With adjustment of guidelines and hospital status, the conceptual framework was developed and next it was validated in expert panel. The members of expert panel were selected according to their role and functions and also their experiences in risk management and patient safety issues. The validated framework consisted of designating a leader and coordinator core, defining communications, and preparing the infrastructure for patient safety education and culture-building. That was developed on the basis of some values and commitments and included reactive and proactive approaches. The findings of reporting activities demonstrated that at least 3.6 percent of hospitalized patients have experienced adverse events and 5.3 percent of all deaths in the hospital related with patient safety problems. Beside the average score of 12 dimensions of patient safety culture was 46.2 percent that was considerably low. The "non-punitive responses to error" had lowest positive score with 21.2 percent. It is of paramount importance for all health organizations to lay necessary foundations in order to identify safety risks and improve the quality of care. Inadequate participation of staff in education, reporting and analyzing, underreporting and uselessness of aggregated data, limitation of human and financial resources, punitive directions and management challenges for solutions were the main executive problems which could affect the effectiveness of system.

Executing Medical Guidelines on the Web: Towards Next Generation Healthcare

NASA Astrophysics Data System (ADS)

Argüello, M.; Des, J.; Fernandez-Prieto, M. J.; Perez, R.; Paniagua, H.

There is still a lack of full integration between current Electronic Health Records (EHRs) and medical guidelines that encapsulate evidence-based medicine. Thus, general practitioners (GPs) and specialised physicians still have to read document-based medical guidelines and decide among various options for managing common non-life-threatening conditions where the selection of the most appropriate therapeutic option for each individual patient can be a difficult task. This paper presents a simulation framework and computational test-bed, called V.A.F. Framework, for supporting simulations of clinical situations that boosted the integration between Health Level Seven (HL7) and Semantic Web technologies (OWL, SWRL, and OWL-S) to achieve content layer interoperability between online clinical cases and medical guidelines, and therefore, it proves that higher integration between EHRs and evidence-based medicine can be accomplished which could lead to a next generation of healthcare systems that provide more support to physicians and increase patients' safety.

Wind/Tornado Guidelines Study

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

Ng, D.S.; Holman, G.S.

1991-10-01

This report documents the strategy employed to develop recommended wind/tornado hazard design guidelines for a New Production Reactor (NRP) currently planned for either the Idaho National Engineering Laboratory (INEL) or the Savannah River (SR) site. The Wind/Tornado Working Group (WTWG), comprising six nationally recognized experts in structural engineering, wind engineering, and meteorology, formulated an independent set of guidelines based on site-specific wind/tornado hazard curves and state-of-the-art tornado missile technology. The basic philosophy was to select realistic wind and missile load specifications, and to meet performance goals by applying conservative structural response evaluation and acceptance criteria. Simplified probabilistic risk analyses (PRAs)more » for wind speeds and missile impact were performed to estimate annual damage risk frequencies for both the INEL and SR sites. These PRAs indicate that the guidelines will lead to facilities that meet the US Department of Energy (DOE) design requirements and that the Nuclear Regulatory Commission guidelines adopted by the DOE for design are adequate to meet the NPR safety goals.« less

Peri-procedural protocols for interventional pain management techniques: a survey of US pain centers.

PubMed

Ahmed, Shihab U; Tonidandel, William; Trella, Jason; Martin, Nicole M; Chang, Yuchiao

2005-04-01

Interventional techniques are now an integral part of chronic pain management. As new procedures are arising at a rapid pace, decisions regarding patient safety and comfort are becoming more challenging. No peri-procedural consensus protocol currently addresses issues such as 1. nulla per os (NPO) status, 2. sedation, 3. monitoring, or 4. recovery. In establishing safety guidelines for interventional pain procedures, the knowledge of current peri-procedural protocols is required. To survey interventional pain practices and to obtain current peri-procedural protocols. We faxed a one-page questionnaire to 105 United States pain practices identified using the directory of the American Pain Society. Fifty-seven academic and private pain practices (54%) responded and were included in the analysis. Monitoring devices such as electrocardiogram (EKG), blood pressure, and pulse oximetry are not universally employed for cervical or lumbar spinal procedures. Even procedures that are often performed by anesthesiologists in operating rooms, such as Bier blocks, are not monitored in a uniform manner when performed in pain clinics. Establishment of intravenous access for procedures also varies among practitioners. Most (72%) practices had treated patients with vasovagal reactions over the past 12 months, but only 42% had simulated cardiac arrests to prepare for these situations. While various trends in peri-procedural care are observable, standards of care are not well established. In order to minimize complications associated with interventional pain management techniques, the pain management community should agree on safety guidelines for all procedures, much as these advocated by the American Society of Anesthesiology for surgical anesthetic care.

An overview of revised NASA safety standard 1740.14

NASA Technical Reports Server (NTRS)

Reynolds, Robert; Eichler, Peter; Johnson, Nicholas

1997-01-01

Following a broad review of the debris control guidelines outside of NASA and according to additional feedback on the guidelines from within NASA, revisions were made to the NASA safety standard 1740.14. The NASA policy to limit the generation of orbital debris on NASA missions, stated in the NASA management instruction 1700.8 and implemented in the form of the NASA safety standard (NSS) 1740.14 is described together with the revisions implemented. The overall direction of the guidelines is the same, but the details of many of the guidelines were changed, including: changes for tether programs and for the control of operational debris. The NASA will continue to review the guidelines as new measurements and improved models of the environment are obtained.

What hospitals need to know about guidelines-A mixed-method analysis of guideline implementation in Dutch hospitals.

PubMed

Blume, Louise H K; van Weert, Nico J H W; Busari, Jamiu O; Stoopendaal, Annemiek M V; Delnoij, Diana M J

2017-12-01

This study provides insight into how Dutch hospitals ensure that guidelines are used in practice and identifies what key messages other hospitals can learn from existing practices. We examine current practices in handling compliance and, therefore, focus on hospitals that reported that they do not experience problems in the implementation of guidelines. A survey of Dutch hospital boards and 9 semistructured interviews were conducted with a purposive sample of 3 hospitals. Interviews were held with 3 representatives of each hospital, specifically, with a member of the board of directors, a member of the executive medical staff, and the manager of the quality and safety department. Hospitals find guidelines necessary and useful. Hospitals have the power to improve implementation if boards of directors and medical staff are committed, intrinsically motivated, cooperate with each other, and use guidelines pragmatically. Even then, they prioritize guidelines, as resources are scarce. Despite their good work, all hospitals in this study appeared to struggle to adhere to guidelines. If hospitals experience problems with guideline implementation, they tend to focus more on external expectations, leading to defensive behaviour. Hospitals that do not experience implementation problems focus more on integrating guidelines into their own policies. © 2017 John Wiley & Sons, Ltd.

Current safety practices in nano-research laboratories in China.

PubMed

Zhang, Can; Zhang, Jing; Wang, Guoyu

2014-06-01

China has become a key player in the global nanotechnology field, however, no surveys have specifically examined safety practices in the Chinese nano-laboratories in depth. This study reports results of a survey of 300 professionals who work in research laboratories that handle nanomaterials in China. We recruited participants at three major nano-research laboratories (which carry out research in diverse fields such as chemistry, material science, and biology) and the nano-chemistry session of the national meeting of the Chinese Chemical Society. Results show that almost all nano-research laboratories surveyed had general safety regulations, whereas less than one third of respondents reported having nanospecific safety rules. General safety measures were in place in most surveyed nano-research laboratories, while nanospecific protective measures existed or were implemented less frequently. Several factors reported from the scientific literature including nanotoxicology knowledge gaps, technical limitations on estimating nano-exposure, and the lack of nano-occupational safety legislation may contribute to the current state of affairs. With these factors in mind and embracing the precautionary principle, we suggest strengthening or providing nanosafety training (including raising risk awareness) and establishing nanosafety guidelines in China, to better protect personnel in the nano-workplace.

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

PubMed Central

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

2013-01-01

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

Child Health Guidelines: Health, Nutrition, Infants and Toddlers. Revised Edition.

ERIC Educational Resources Information Center

Allison, Ursula; And Others

Forms and guidelines presented in this manual were compiled and/or developed by staff of agencies serving nursery schools, group day care centers, and family day care homes. The health and safety guidelines focus on excluding ill children and staff, caring for ill children, safety policies, emergency procedures, fire emergencies, pets, bites, and…

Ultraviolet safety assessments of insect light traps.

PubMed

Sliney, David H; Gilbert, David W; Lyon, Terry

2016-01-01

Near-ultraviolet (UV-A: 315-400 nm), "black-light," electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV "Black-light" ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products.

Safety Precautions for Science.

ERIC Educational Resources Information Center

Folks, John; And Others

Safety information is discussed and outlined in this guide. Areas include: (1) general laboratory safety rules; (2) general rules and guidelines for animals in the elementary classroom; (3) general guidelines for the physical sciences; (4) general rules for using animals in investigations, with specifics on the care and handling of mammals,…

School Safety and Security.

ERIC Educational Resources Information Center

California State Dept. of Education, Sacramento.

This document offers additional guidelines for school facilities in California in the areas of safety and security, lighting, and cleanliness. It also offers a description of technology resources available on the World Wide Web. On the topic of safety and security, the document offers guidelines in the areas of entrances, doors, and controlled…

Expectations for Opioid Therapy

MedlinePlus

... for Providers Guideline Overview Guideline Resources Clinical Tools Posters Videos Mobile App Training for Providers Interactive Training ... few days. Clinician Commitment to Patient Prescription Safety Poster Clinician Commitment to Patient Prescription Safety Poster [PDF – ...

Burn injury models of care: A review of quality and cultural safety for care of Indigenous children.

PubMed

Fraser, Sarah; Grant, Julian; Mackean, Tamara; Hunter, Kate; Holland, Andrew J A; Clapham, Kathleen; Teague, Warwick J; Ivers, Rebecca Q

2018-05-01

Safety and quality in the systematic management of burn care is important to ensure optimal outcomes. It is not clear if or how burn injury models of care uphold these qualities, or if they provide a space for culturally safe healthcare for Indigenous peoples, especially for children. This review is a critique of publically available models of care analysing their ability to facilitate safe, high-quality burn care for Indigenous children. Models of care were identified and mapped against cultural safety principles in healthcare, and against the National Health and Medical Research Council standard for clinical practice guidelines. An initial search and appraisal of tools was conducted to assess suitability of the tools in providing a mechanism to address quality and cultural safety. From the 53 documents found, 6 were eligible for review. Aspects of cultural safety were addressed in the models, but not explicitly, and were recorded very differently across all models. There was also limited or no cultural consultation documented in the models of care reviewed. Quality in the documents against National Health and Medical Research Council guidelines was evident; however, description or application of quality measures was inconsistent and incomplete. Gaps concerning safety and quality in the documented care pathways for Indigenous peoples' who sustain a burn injury and require burn care highlight the need for investigation and reform of current practices. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

Primary battery design and safety guidelines handbook

NASA Technical Reports Server (NTRS)

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

1994-01-01

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

Principles for building public-private partnerships to benefit food safety, nutrition, and health research

PubMed Central

Rowe, Sylvia; Alexander, Nick; Kretser, Alison; Steele, Robert; Kretsch, Molly; Applebaum, Rhona; Clydesdale, Fergus; Cummins, Deborah; Hentges, Eric; Navia, Juan; Jarvis, Ashley; Falci, Ken

2013-01-01

The present article articulates principles for effective public-private partnerships (PPPs) in scientific research. Recognizing that PPPs represent one approach for creating research collaborations and that there are other methods outside the scope of this article, PPPs can be useful in leveraging diverse expertise among government, academic, and industry researchers to address public health needs and questions concerned with nutrition, health, food science, and food and ingredient safety. A three-step process was used to identify the principles proposed herein: step 1) review of existing PPP guidelines, both in the peer-reviewed literature and at 16 disparate non-industry organizations; step 2) analysis of relevant successful or promising PPPs; and step 3) formal background interviews of 27 experienced, senior-level individuals from academia, government, industry, foundations, and non-governmental organizations. This process resulted in the articulation of 12 potential principles for establishing and managing successful research PPPs. The review of existing guidelines showed that guidelines for research partnerships currently reside largely within institutions rather than in the peer-reviewed literature. This article aims to introduce these principles into the literature to serve as a framework for dialogue and for future PPPs. PMID:24117791

Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

PubMed Central

Meyer, Keith C; Nathanson, Ian; Angel, Luis; Bhorade, Sangeeta M; Chan, Kevin M; Culver, Daniel; Harrod, Christopher G; Hayney, Mary S; Highland, Kristen B; Limper, Andrew H; Patrick, Herbert; Strange, Charlie; Whelan, Timothy

2012-01-01

Objectives: Immunosuppressive pharmacologic agents prescribed to patients with diffuse interstitial and inflammatory lung disease and lung transplant recipients are associated with potential risks for adverse reactions. Strategies for minimizing such risks include administering these drugs according to established, safe protocols; monitoring to detect manifestations of toxicity; and patient education. Hence, an evidence-based guideline for physicians can improve safety and optimize the likelihood of a successful outcome. To maximize the likelihood that these agents will be used safely, the American College of Chest Physicians established a committee to examine the clinical evidence for the administration and monitoring of immunosuppressive drugs (with the exception of corticosteroids) to identify associated toxicities associated with each drug and appropriate protocols for monitoring these agents. Methods: Committee members developed and refined a series of questions about toxicities of immunosuppressives and current approaches to administration and monitoring. A systematic review was carried out by the American College of Chest Physicians. Committee members were supplied with this information and created this evidence-based guideline. Conclusions: It is hoped that these guidelines will improve patient safety when immunosuppressive drugs are given to lung transplant recipients and to patients with diffuse interstitial lung disease. PMID:23131960

Guidelines for Reviewers and the Editor at the Nuclear Safety Information Center.

ERIC Educational Resources Information Center

Whetsel, H. B.

The main purpose of this report is to help novice reviewers accelerate their apprenticeship at the Nuclear Safety Information Center, a computerized information service sponsored by the U.S. Atomic Energy Commission. Guidelines for reviewers are presented in Part 1; Part 2 contains guidelines for the novice editor. The goal of the reviewers and…

Recommended child safety seat enforcement guidelines

DOT National Transportation Integrated Search

1989-10-01

The document presents suggestions and examples for planning, developing, implementing and evaluating a local enforcement and public information and education program to increase the use and correct use of child safety seats. The guidelines represent ...

Development of an ergonomics guideline for the furniture manufacturing industry.

PubMed

Mirka, Gary A

2005-03-01

Industry-specific ergonomics guidelines are an important component in the four-pronged approach to workplace ergonomics currently pursued by the United States Occupational Safety and Health Administration. The American Furniture Manufacturers Association has taken the initiative of developing such a guideline for its members. The result of this effort is the "AFMA Voluntary Ergonomics Guideline for the Furniture Manufacturing Industry", a document that includes basic information about ergonomics program components as well as a compilation of work-proven, ergonomics best practices as submitted by members of the furniture manufacturing community. This guideline was developed through an industry-research-government partnership and made strategic use of the unique attributes that each sector brought to this effort. Outlined in this paper are some of the characteristics of this partnership including, the roles played by each, the different motivations for pursuing the guideline, the challenges faced during the development of the document, the successes experienced in this process, as well as a proposed outline for measuring the effectiveness of this effort. The hope is that this summary, and some of the lessons learned contained herein, would be helpful to others considering the prospect of developing such a guideline for their industry.

School Safety Policies With Emphasis on Physical Education, Athletics and Recreation.

ERIC Educational Resources Information Center

American Association for Health, Physical Education, and Recreation, Washington, DC.

This booklet outlines principles of hazard control, school accident problems, and the need for guidelines and policies. Suggested general school safety policies, guidelines for courses in safety education and for the provision of facilities and supplies, policies for the administration of first aid and emergency care, and procedures for reporting…

Ballpoint pen ingestion in a 2-year-old child.

PubMed

Rameau, Anaïs; Anand, Sumeet M; Nguyen, Lily H

2011-07-01

A 2-year-old girl ingested a ballpoint pen, which was found on chest x-ray to have lodged in the lower esophagus and stomach. The pen, which measured nearly 15 cm in length, was removed via rigid esophagoscopy without complication. To the best of our knowledge, this is the longest nonflexible foreign body ingested by a young child ever reported in the English-language literature. We describe the presentation of this case and the current guidelines for safety as enumerated in the Small Parts Regulations established by the U.S. Consumer Product Safety Commission.

Species sensitivity distribution evaluation for selenium in fish eggs: considerations for development of a Canadian tissue-based guideline.

PubMed

DeForest, David K; Gilron, Guy; Armstrong, Sarah A; Robertson, Erin L

2012-01-01

A freshwater Se guideline was developed for consideration based on concentrations in fish eggs or ovaries, with a focus on Canadian species, following the Canadian Council of Ministers of the Environment protocol for developing guideline values. When sufficient toxicity data are available, the protocol recommends deriving guidelines as the 5th percentile of the species sensitivity distribution (SSD). When toxicity data are limited, the protocol recommends a lowest value approach, where the lowest toxicity threshold is divided by a safety factor (e.g., 10). On the basis of a comprehensive review of the current literature and an assessment of the data therein, there are sufficient egg and ovary Se data available for freshwater fish to develop an SSD. For most fish species, Se EC10 values (10% effect concentrations) could be derived, but for some species, only no-observed-effect concentrations and/or lowest-observed-effect concentrations could be identified. The 5th percentile egg and ovary Se concentrations from the SSD were consistently 20 µg/g dry weight (dw) for the best-fitting distributions. In contrast, the lowest value approach using a safety factor of 10 would result in a Se egg and ovary guideline of 2 µg/g dw, which is unrealistically conservative, as this falls within the range of egg and ovary Se concentrations in laboratory control fish and fish collected from reference sites. An egg and ovary Se guideline of 20 µg/g dw should be considered a conservative, broadly applicable guideline, as no species mean toxicity thresholds lower than this value have been identified to date. When concentrations exceed this guideline, site-specific studies with local fish species, conducted using a risk-based approach, may result in higher egg and ovary Se toxicity thresholds. Copyright © 2011 SETAC.

Establishing Teacher Competencies in Early Care and Education: A Review of Current Models and Options for California. Building California's Preschool for All Workforce. A Series of Policy Briefs

ERIC Educational Resources Information Center

Bellm, Dan

2005-01-01

This policy brief provides guidelines grouped into five areas: personal and professional behavior; classroom environment; health, safety and nutrition; working with families and communities; and administration and management. The document discusses the topics that teacher competencies generally cover, options for how they might be developed and…

Thermal Modeling for the Next Generation of Radiofrequency Exposure Limits: Commentary.

PubMed

Foster, Kenneth R; Ziskin, Marvin C; Balzano, Quirino

2017-07-01

This commentary evaluates two sets of guidelines for human exposure to radiofrequency (RF) energy, focusing on the frequency range above the "transition" frequency at 3-10 GHz where the guidelines change their basic restrictions from specific absorption rate to incident power density, through the end of the RF band at 300 GHz. The analysis is based on a simple thermal model based on Pennes' bioheat equation (BHTE) (Pennes 1948) assuming purely surface heating; an Appendix provides more details about the model and its range of applicability. This analysis suggests that present limits are highly conservative relative to their stated goals of limiting temperature increase in tissue. As applied to transmitting devices used against the body, they are much more conservative than product safety standards for touch temperature for personal electronics equipment that are used in contact with the body. Provisions in the current guidelines for "averaging time" and "averaging area" are not consistent with scaling characteristics of the bioheat equation and should be refined. The authors suggest the need for additional limits on fluence for protection against brief, high intensity pulses at millimeter wave frequencies. This commentary considers only thermal hazards, which form the basis of the current guidelines, and excludes considerations of reported "non-thermal" effects of exposure that would have to be evaluated in the process of updating the guidelines.

Carbon Monoxide Poisoning - Multiple Languages

MedlinePlus

... Prevention Guidelines: You Can Prevent Carbon Monoxide Exposure - English PDF Prevention Guidelines: You Can Prevent Carbon Monoxide ... Expand Section Carbon Monoxide - Furnace Safety Fact Sheet - English PDF Carbon Monoxide - Furnace Safety Fact Sheet - العربية ( ...

Ultraviolet safety assessments of insect light traps

PubMed Central

Sliney, David H.; Gilbert, David W.; Lyon, Terry

2016-01-01

ABSTRACT Near-ultraviolet (UV-A: 315–400 nm), “black-light,” electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV “Black-light” ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products. PMID:27043058

Role of ivabradine and heart rate lowering in chronic heart failure: guideline update.

PubMed

Chow, Sheryl L; Page, Robert Lee; Depre, Christophe

2018-06-14

This review summarizes the current management of heart failure (HF) in patients with reduced ejection fraction and the potential role of heart rate lowering agents in select populations, as recommended in the updated guidelines. Areas covered: PubMed was searched for studies that evaluated the role of heart rate lowering or ivabradine in HF management. Expert commentary: Targeting heart rate may offer benefit when added to renin-angiotensin aldosterone antagonists, and beta-blockers. Ivabradine is a heart rate lowering agent that acts on the funny current (I f ) in the sinoatrial node, thereby reducing heart rate without directly affecting cardiac contraction and relaxation. Clinical data from a phase 3 trial demonstrated that ivabradine reduced the composite endpoint of cardiovascular death or hospital admission for worsening systolic HF, while maintaining an acceptable safety profile in patients receiving standard of care therapy. These data, in addition to more recently published guidelines, suggest ivabradine as a promising new treatment option for lowering heart rate after optimizing standard therapy in select patients with chronic HF.

Preventing hospital-acquired venous thromboembolism: Improving patient safety with interdisciplinary teamwork, quality improvement analytics, and data transparency.

PubMed

Schleyer, Anneliese M; Robinson, Ellen; Dumitru, Roxana; Taylor, Mark; Hayes, Kimberly; Pergamit, Ronald; Beingessner, Daphne M; Zaros, Mark C; Cuschieri, Joseph

2016-12-01

Hospital-acquired venous thromboembolism (HA-VTE) is a potentially preventable cause of morbidity and mortality. Despite high rates of venous thromboembolism (VTE) prophylaxis in accordance with an institutional guideline, VTE remains the most common hospital-acquired condition in our institution. To improve the safety of all hospitalized patients, examine current VTE prevention practices, identify opportunities for improvement, and decrease rates of HA-VTE. Pre/post assessment. Urban academic tertiary referral center, level 1 trauma center, safety net hospital; all patients. We formed a multidisciplinary VTE task force to review all HA-VTE events, assess prevention practices relative to evidence-based institutional guidelines, and identify improvement opportunities. The task force developed an electronic tool to facilitate efficient VTE event review and designed decision-support and reporting tools, now integrated into the electronic health record, to bring optimal VTE prevention practices to the point of care. Performance is shared transparently across the institution. Harborview benchmarks process and outcome performance, including patient safety indicators and core measures, against hospitals nationally using Hospital Compare and Vizient data. Our program has resulted in >90% guideline-adherent VTE prevention and zero preventable HA-VTEs. Initiatives have resulted in a 15% decrease in HA-VTE and a 21% reduction in postoperative VTE. Keys to success include the multidisciplinary approach, clinical roles of task force members, senior leadership support, and use of quality improvement analytics for retrospective review, prospective reporting, and performance transparency. Ongoing task force collaboration with frontline providers is critical to sustained improvements. Journal of Hospital Medicine 2016;11:S38-S43. © 2016 Society of Hospital Medicine. © 2016 Society of Hospital Medicine.

Recommendations to Improve Employee Thermal Comfort When Working in 40°F Refrigerated Cold Rooms.

PubMed

Ceballos, Diana; Mead, Kenneth; Ramsey, Jessica

2015-01-01

Cold rooms are commonly used for food storage and preparation, and are usually kept around 40°F following food safety guidelines. Some food preparation employees may spend 8 or more hours inside cold rooms. These employees may not be aware of the risks associated with mildly cold temperatures, dampness, and limited ventilation. We performed an evaluation of cold rooms at an airline catering facility because of concerns with exposure to cold temperatures. We spoke with and observed employees in two cold rooms, reviewed daily temperature logs, evaluated employee's physical activity, work/rest schedule, and protective clothing. We measured temperature, percent relative humidity, and air velocities at different work stations inside the cold rooms. We concluded that thermal comfort concerns perceived by cold room employees may have been the result of air drafts at their workstations, insufficient use of personal protective equipment due to dexterity concerns, work practices, and lack of knowledge about good health and safety practices in cold rooms. These moderately cold work conditions with low air velocities are not well covered in current occupational health and safety guidelines, and wind chill calculations do not apply. We provide practical recommendations to improve thermal comfort of cold room employees. Engineering control recommendations include the redesigning of air deflectors and installing of suspended baffles. Administrative controls include the changing out of wet clothing, providing hand warmers outside of cold rooms, and educating employees on cold stress. We also recommended providing more options on personal protective equipment. However, there is a need for guidelines and educational materials tailored to employees in moderately cold environments to improve thermal comfort and minimize health and safety problems.

Recommendations to Improve Employee Thermal Comfort When Working in 40°F Refrigerated Cold Rooms

PubMed Central

Ceballos, Diana; Mead, Kenneth; Ramsey, Jessica

2015-01-01

Cold rooms are commonly used for food storage and preparation, and are usually kept around 40°F following food safety guidelines. Some food preparation employees may spend 8 or more hours inside cold rooms. These employees may not be aware of the risks associated with mildly cold temperatures, dampness, and limited ventilation. We performed an evaluation of cold rooms at an airline catering facility because of concerns with exposure to cold temperatures. We spoke with and observed employees in two cold rooms, reviewed daily temperature logs, evaluated employee’s physical activity, work/rest schedule, and protective clothing. We measured temperature, percent relative humidity, and air velocities at different work stations inside the cold rooms. We concluded that thermal comfort concerns perceived by cold room employees may have been the result of air drafts at their workstations, insufficient use of personal protective equipment due to dexterity concerns, work practices, and lack of knowledge about good health and safety practices in cold rooms. These moderately cold work conditions with low air velocities are not well covered in current occupational health and safety guidelines, and wind chill calculations do not apply. We provide practical recommendations to improve thermal comfort of cold room employees. Engineering control recommendations include the redesigning of air deflectors and installing of suspended baffles. Administrative controls include the changing out of wet clothing, providing hand warmers outside of cold rooms, and educating employees on cold stress. We also recommended providing more options on personal protective equipment. However, there is a need for guidelines and educational materials tailored to employees in moderately cold environments to improve thermal comfort and minimize health and safety problems. PMID:25961447

Current codex guidelines for assessment of potential protein allergenicity.

PubMed

Ladics, G S

2008-10-01

A rigorous safety assessment process exists for GM crops. It includes evaluation of the introduced protein as well as the crop containing such protein with the goal of demonstrating the GM crop is "as-safe-as" non-transgenic crops in the food supply. One of the major issues for GM crops is the assessment of the expressed protein for allergenic potential. Currently, no single factor is recognized as an identifier for protein allergenicity. Therefore, a weight-of-evidence approach, which takes into account a variety of factors and approaches for an overall assessment of allergenic potential, is conducted [Codex Alimentarious Commission, 2003. Alinorm 03/34: Joint FAO/WHO Food Standard Programme, Codex Alimentarious Commission, Twenty-Fifth Session, Rome, Italy, 30 June-5 July, 2003. Appendix III, Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants, and Appendix IV, Annex on the assessment of possible allergenicity, pp. 47-60]. This assessment is based on what is known about allergens, including the history of exposure and safety of the gene(s) source; protein structure (e.g., amino acid sequence identity to human allergens); stability to pepsin digestion in vitro [Thomas, K. et al., 2004. A multi-laboratory evaluation of a common in vitro pepsin digestion assay protocol used in assessing the safety of novel proteins. Regul. Toxicol. Pharmacol. 39, 87-98]; an estimate of exposure of the novel protein(s) to the gastrointestinal tract where absorption occurs (e.g., protein abundance in the crop, processing effects); and when appropriate, specific IgE binding studies or skin prick testing. Additional approaches may be considered (e.g., animal models; targeted sera screening) as the science evolves; however, such approaches have not been thoroughly evaluated or validated for predicting protein allergenicity.

Regulatory considerations for pluripotent stem cell therapies.

PubMed

Carpenter, Melissa K

2017-01-01

The development of pluripotent stem cell (PSC) therapies is rapidly advancing, and a number of PSC-derived cell products are currently being tested in clinical trials. The biological complexity of these therapies results in specific challenges in complying with regulatory guidelines. This includes the choice of starting material, reproducible and consistent manufacturing, and preclinical safety and efficacy assessment of the PSC-derived product. This review discusses current US cell therapy regulations and strategies for compliance with these regulations when developing PSC-derived products. © 2017 Elsevier B.V. All rights reserved.

Implementation Guidelines for State Safety Oversight of Rail Fixed Guideway Systems

DOT National Transportation Integrated Search

1996-06-01

These guidelines will assist states, oversight agencies, and rail transit agencies in developing safety and security programs to satisfy the requirements of the Federal Transit Administration (FTA). These requirements were published in the Federal Re...

Radiofrequency and Microwave Ablation Compared to Systemic Chemotherapy and to Partial Hepatectomy in the Treatment of Colorectal Liver Metastases: A Systematic Review and Meta-Analysis.

PubMed

Meijerink, Martijn R; Puijk, Robbert S; van Tilborg, Aukje A J M; Henningsen, Kirsten Holdt; Fernandez, Llenalia Garcia; Neyt, Mattias; Heymans, Juanita; Frankema, Jacqueline S; de Jong, Koert P; Richel, Dick J; Prevoo, Warner; Vlayen, Joan

2018-04-17

To assess safety and outcome of radiofrequency ablation (RFA) and microwave ablation (MWA) as compared to systemic chemotherapy and partial hepatectomy (PH) in the treatment of colorectal liver metastases (CRLM). MEDLINE, Embase and the Cochrane Library were searched. Randomized trials and comparative observational studies with multivariate analysis and/or matching were included. Guidelines from National Guideline Clearinghouse and Guidelines International Network were assessed using the AGREE II instrument. The search revealed 3530 records; 328 were selected for full-text review; 48 were included: 8 systematic reviews, 2 randomized studies, 26 comparative observational studies, 2 guideline-articles and 10 case series; in addition 13 guidelines were evaluated. Literature to assess the effectiveness of ablation was limited. RFA + systemic chemotherapy was superior to chemotherapy alone. PH was superior to RFA alone but not to RFA + PH or to MWA. Compared to PH, RFA showed fewer complications, MWA did not. Outcomes were subject to residual confounding since ablation was only employed for unresectable disease. The results from the EORTC-CLOCC trial, the comparable survival for ablation + PH versus PH alone, the potential to induce long-term disease control and the low complication rate argue in favour of ablation over chemotherapy alone. Further randomized comparisons of ablation to current-day chemotherapy alone should therefore be considered unethical. Hence, the highest achievable level of evidence for unresectable CRLM seems reached. The apparent selection bias from previous studies and the superior safety profile mandate the setup of randomized controlled trials comparing ablation to surgery.

NASA Engineering Safety Center NASA Aerospace Flight Battery Systems Working Group 2007 Proactive Task Status

NASA Technical Reports Server (NTRS)

Manzo, Michelle A.

2007-01-01

In 2007, the NASA Engineering Safety Center (NESC) chartered the NASA Aerospace Flight Battery Systems Working Group to bring forth and address critical battery-related performance/manufacturing issues for NASA and the aerospace community. A suite of tasks identifying and addressing issues related to Ni-H2 and Li-ion battery chemistries was submitted and selected for implementation. The current NESC funded are: (1) Wet Life of Ni-H2 Batteries (2) Binding Procurement (3) NASA Lithium-Ion Battery Guidelines (3a) Li-Ion Performance Assessment (3b) Li-Ion Guidelines Document (3b-i) Assessment of Applicability of Pouch Cells for Aerospace Missions (3b-ii) High Voltage Risk Assessment (3b-iii) Safe Charge Rates for Li-Ion Cells (4) Availability of Source Material for Li-Ion Cells (5) NASA Aerospace Battery Workshop This presentation provides a brief overview of the tasks in the 2007 plan and serves as an introduction to more detailed discussions on each of the specific tasks.

Lead exposure among automobile radiator repair workers and their children in New York City.

PubMed

Nunez, C M; Klitzman, S; Goodman, A

1993-05-01

Despite a comprehensive Occupational Safety and Health Administration lead standard, exposure to lead continues in many industries. This paper describes a blood lead screening and education program for automobile radiator repair workers and their families in New York City. Results showed that 67% of automobile radiator repair workers (n = 62) in 89% of the shops tested (n = 24) had blood lead levels in excess of 25 micrograms/dl. The vast majority of workers had never been tested previously, and none had received health and safety training regarding occupational lead exposure. Although none of the workers' children's blood lead levels were in excess of then-current guidelines, several had levels which may be associated with subclinical toxicity and in excess of the revised Centers for Disease Control guidelines of 10 micrograms/dl. This project demonstrates that lead exposure in the automotive radiator repair industry continues to be widespread and that local health departments can assist in hazard identification and remediation.

Resistance training among young athletes: safety, efficacy and injury prevention effects.

PubMed

Faigenbaum, A D; Myer, G D

2010-01-01

A literature review was employed to evaluate the current epidemiology of injury related to the safety and efficacy of youth resistance training. Several case study reports and retrospective questionnaires regarding resistance exercise and the competitive sports of weightlifting and powerlifting reveal that injuries have occurred in young lifters, although a majority can be classified as accidental. Lack of qualified instruction that underlies poor exercise technique and inappropriate training loads could explain, at least partly, some of the reported injuries. Current research indicates that resistance training can be a safe, effective and worthwhile activity for children and adolescents provided that qualified professionals supervise all training sessions and provide age-appropriate instruction on proper lifting procedures and safe training guidelines. Regular participation in a multifaceted resistance training programme that begins during the preseason and includes instruction on movement biomechanics may reduce the risk of sports-related injuries in young athletes. Strategies for enhancing the safety of youth resistance training are discussed.

Resistance training among young athletes: safety, efficacy and injury prevention effects

PubMed Central

Faigenbaum, A D; Myer, G D

2012-01-01

A literature review was employed to evaluate the current epidemiology of injury related to the safety and efficacy of youth resistance training. Several case study reports and retrospective questionnaires regarding resistance exercise and the competitive sports of weightlifting and power-lifting reveal that injuries have occurred in young lifters, although a majority can be classified as accidental. Lack of qualified instruction that underlies poor exercise technique and inappropriate training loads could explain, at least partly, some of the reported injuries. Current research indicates that resistance training can be a safe, effective and worthwhile activity for children and adolescents provided that qualified professionals supervise all training sessions and provide age-appropriate instruction on proper lifting procedures and safe training guidelines. Regular participation in a multifaceted resistance training programme that begins during the preseason and includes instruction on movement biomechanics may reduce the risk of sports-related injuries in young athletes. Strategies for enhancing the safety of youth resistance training are discussed. PMID:19945973

Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

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

Vovk, I.F.; Seitz, R.R.

1995-12-31

The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safetymore » assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.« less

A "good practice" approach to the quality and consistency of morphological examination of the internal head structures of the term rabbit fetus.

PubMed

French, Julian M

2014-07-01

Variation in the interpretation of the regulatory guidelines has resulted in a diversity of techniques employed to examine the internal structures of the foetal rabbit head. Examination of the foetal rabbit brain, using a single transverse section as the sole technique, is considered not to be sufficiently thorough to be regarded as an adequate examination method. It is not compliant with published EPA and OECD guidelines covering required examination of the internal head structures, nor is it considered to conform to the spirit of the safety assessment required by the ICH guideline. Fixation of approximately half of the heads in each litter to allow the examination of multiple transverse sections enables the major structures within the head to be assessed effectively. This method is compliant with current guidelines, represents "good practice" and should be consistently adopted for the examination of the internal head structures of the term rabbit foetus. Copyright © 2014 Elsevier Inc. All rights reserved.

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

PubMed

Wright, Andrew J; Cosentino, A Mel

2015-11-15

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

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

PubMed Central

Huang, Hongyun; Young, Wise; Chen, Lin; Feng, Shiqing; Zoubi, Ziad M. Al; Sharma, Hari Shanker; Saberi, Hooshang; Moviglia, Gustavo A.; He, Xijing; Muresanu, Dafin F.; Sharma, Alok; Otom, Ali; Andrews, Russell J.; Al-Zoubi, Adeeb; Bryukhovetskiy, Andrey S.; Chernykh, Elena R.; Domańska-Janik, Krystyna; Jafar, Emad; Johnson, W. Eustace; Li, Ying; Li, Daqing; Luan, Zuo; Mao, Gengsheng; Shetty, Ashok K.; Siniscalco, Dario; Skaper, Stephen; Sun, Tiansheng; Wang, Yunliang; Wiklund, Lars; Xue, Qun; You, Si-Wei; Zheng, Zuncheng; Dimitrijevic, Milan R.; Masri, W. S. El; Sanberg, Paul R.; Xu, Qunyuan; Luan, Guoming; Chopp, Michael; Cho, Kyoung-Suok; Zhou, Xin-Fu; Wu, Ping; Liu, Kai; Mobasheri, Hamid; Ohtori, Seiji; Tanaka, Hiroyuki; Han, Fabin; Feng, Yaping; Zhang, Shaocheng; Lu, Yingjie; Zhang, Zhicheng; Rao, Yaojian; Tang, Zhouping; Xi, Haitao; Wu, Liang; Shen, Shunji; Xue, Mengzhou; Xiang, Guanghong; Guo, Xiaoling; Yang, Xiaofeng; Hao, Yujun; Hu, Yong; Li, Jinfeng; AO, Qiang; Wang, Bin; Zhang, Zhiwen; Lu, Ming; Li, Tong

2018-01-01

Cell therapy has been shown to be a key clinical therapeutic option for central nervous system diseases or damage. Standardization of clinical cell therapy procedures is an important task for professional associations devoted to cell therapy. The Chinese Branch of the International Association of Neurorestoratology (IANR) completed the first set of guidelines governing the clinical application of neurorestoration in 2011. The IANR and the Chinese Association of Neurorestoratology (CANR) collaborated to propose the current version “Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)”. The IANR council board members and CANR committee members approved this proposal on September 1, 2016, and recommend it to clinical practitioners of cellular therapy. These guidelines include items of cell type nomenclature, cell quality control, minimal suggested cell doses, patient-informed consent, indications for undergoing cell therapy, contraindications for undergoing cell therapy, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, do not charge patients for unproven therapies, basic principles of cell therapy, and publishing responsibility. PMID:29637817

Evolving guidelines in the use of topical nonsteroidal anti-inflammatory drugs in the treatment of osteoarthritis.

PubMed

Balmaceda, Casilda M

2014-01-21

Nonsteroidal anti-inflammatory drugs (NSAIDs) are a standard treatment for osteoarthritis (OA), but the use of oral NSAIDs has been linked to an elevated risk for cardiovascular and gastrointestinal adverse events and renal toxicity. Topical NSAIDs are thought to afford efficacy that is comparable to oral formulations while reducing widespread systemic drug exposure, which may provide a benefit in terms of safety and tolerability. As a result, European treatment guidelines have, for many years, recommended the use of topical NSAIDs as a safe and effective treatment option for OA. Following the recent approval of several topical NSAID formulations by the US Food and Drug Administration, US treatment guidelines are increasingly recommending the use of topical NSAIDs as an alternative therapy and, in some cases, as a first-line option for OA. This commentary summarizes OA treatment guidelines that are currently available and discusses their potential evolution with regard to the increased inclusion of topical NSAIDs.

Evolving guidelines in the use of topical nonsteroidal anti-inflammatory drugs in the treatment of osteoarthritis

PubMed Central

2014-01-01

Background Nonsteroidal anti-inflammatory drugs (NSAIDs) are a standard treatment for osteoarthritis (OA), but the use of oral NSAIDs has been linked to an elevated risk for cardiovascular and gastrointestinal adverse events and renal toxicity. Topical NSAIDs are thought to afford efficacy that is comparable to oral formulations while reducing widespread systemic drug exposure, which may provide a benefit in terms of safety and tolerability. As a result, European treatment guidelines have, for many years, recommended the use of topical NSAIDs as a safe and effective treatment option for OA. Following the recent approval of several topical NSAID formulations by the US Food and Drug Administration, US treatment guidelines are increasingly recommending the use of topical NSAIDs as an alternative therapy and, in some cases, as a first-line option for OA. This commentary summarizes OA treatment guidelines that are currently available and discusses their potential evolution with regard to the increased inclusion of topical NSAIDs. PMID:24444047

Space transportation system payload safety guidelines handbook

NASA Technical Reports Server (NTRS)

1976-01-01

This handbook provides the payload developer with a uniform description and interpretation of the potential hazards which may be caused by or associated with a payload element, operation, or interface with other payloads or with the STS. It also includes guidelines describing design or operational safety measures which suggest means of alleviating a particular hazard or group of hazards, thereby improving payload safety.

Toward best practice in Human Machine Interface design for older drivers: A review of current design guidelines.

PubMed

Young, K L; Koppel, S; Charlton, J L

2017-09-01

Older adults are the fastest growing segment of the driving population. While there is a strong emphasis for older people to maintain their mobility, the safety of older drivers is a serious community concern. Frailty and declines in a range of age-related sensory, cognitive, and physical impairments can place older drivers at an increased risk of crash-related injuries and death. A number of studies have indicated that in-vehicle technologies such as Advanced Driver Assistance Systems (ADAS) and In-Vehicle Information Systems (IVIS) may provide assistance to older drivers. However, these technologies will only benefit older drivers if their design is congruent with the complex needs and diverse abilities of this driving cohort. The design of ADAS and IVIS is largely informed by automotive Human Machine Interface (HMI) guidelines. However, it is unclear to what extent the declining sensory, cognitive and physical capabilities of older drivers are addressed in the current guidelines. This paper provides a review of key current design guidelines for IVIS and ADAS with respect to the extent they address age-related changes in functional capacities. The review revealed that most of the HMI guidelines do not address design issues related to older driver impairments. In fact, in many guidelines driver age and sensory cognitive and physical impairments are not mentioned at all and where reference is made, it is typically very broad. Prescriptive advice on how to actually design a system so that it addresses the needs and limitations of older drivers is not provided. In order for older drivers to reap the full benefits that in-vehicle technology can afford, it is critical that further work establish how older driver limitations and capabilities can be supported by the system design process, including their inclusion into HMI design guidelines. Copyright © 2016 Elsevier Ltd. All rights reserved.

77 FR 11199 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

...The National Highway Traffic Safety Administration (NHTSA) is concerned about the effects of distraction due to drivers' use of electronic devices on motor vehicle safety. Consequently, NHTSA is issuing nonbinding, voluntary NHTSA Driver Distraction Guidelines (NHTSA Guidelines) to promote safety by discouraging the introduction of excessively distracting devices in vehicles. This notice details the contents of the first phase of the NHTSA Driver Distraction Guidelines. These NHTSA Guidelines cover original equipment in-vehicle device secondary tasks (communications, entertainment, information gathering, and navigation tasks not required to drive are considered secondary tasks) performed by the driver through visual-manual means (meaning the driver looking at a device, manipulating a device-related control with the driver's hand, and watching for visual feedback). The proposed NHTSA Guidelines list certain secondary, non-driving related tasks that, based on NHTSA's research, are believed by the agency to interfere inherently with a driver's ability to safely control the vehicle. The Guidelines recommend that those in-vehicle devices be designed so that they cannot be used by the driver to perform such tasks while the driver is driving. For all other secondary, non-driving-related visual-manual tasks, the NHTSA Guidelines specify a test method for measuring the impact of task performance on driving safety while driving and time-based acceptance criteria for assessing whether a task interferes too much with driver attention to be suitable to perform while driving. If a task does not meet the acceptance criteria, the NHTSA Guidelines recommend that in- vehicle devices be designed so that the task cannot be performed by the driver while driving. In addition to identifying inherently distracting tasks and providing a means for measuring and evaluating the level of distraction associated with other non-driving-related tasks, the NHTSA Guidelines contain several design recommendations for in-vehicle devices in order to minimize their potential for distraction. NHTSA seeks comments on these NHTSA Guidelines and any suggestions for how to improve them so as to better enhance motor vehicle safety.

Guidelines for the acceptance of peroxide-containing oral hygiene products. American Dental Association Council on Dental Therapeutics.

PubMed

1994-08-01

Safety and efficacy criteria are defined for oral products containing various forms of peroxides. The guidelines ask for safety and efficacy studies plus observation criteria that include long-term follow-up.

Student Work Safety Guidelines in Roadside Applications and Work Zones : Safety Guidelines for Transportation Researchers

DOT National Transportation Integrated Search

2018-01-01

The Smart City Demonstration Program is intended to improve access through expanded mobility options in major job centers, enhance visitor experience by better connecting visitors to transportation options, stimulate regional economic prosperity and ...

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine].

PubMed

Han, Xue-Jie; Liu, Meng-Yu; Lian, Zhi-Hua; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Jun

2017-09-01

To evaluate the applicability and clinical applications of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine, so as to provide the basis for the revision of the guidelines. This study was completed by the research and promotion base for traditional Chinese medicine(TCM) standard. The methods of applicability evaluation and application evaluation were used in the study. The questionnaires were filled out to evaluate applicability of the guideline, including doctor's familiarity with the guideline,the quality of the guideline, applicable conditions and clinical applications. The prospective case study analysis method was used to evaluate application of the guideline, including evaluation of clinical application compliance and application results(such as clinical effects, safety and economy). There were two parts in the guideline, which were TCM guideline and Western medicine guideline. The results of applicability evaluation showed that there were no obvious differences between TCM guideline and Western medicine guideline in doctor's familiarity with guideline(85.43%, 84.57%) and the use of the guideline(52.10%, 54.47%); the guidelines with good quality, and higher scores in the scope of application and the use of the term rationality(91.94%, 93.35%); the rationality scores of relevant contents in syndrome differentiation and treatment were more than 75%; the applicable conditions were better, and the safety score was the the highest. The comprehensive applicability evaluation showed that the proportion of the application of TCM guideline and Western medicine guideline were 77.73%, 75.46%, respectively. The results of application evaluation showed that there was high degree coincidence between the guideline with its clinical application; except for "other treatment" and "recuperation and prevention" in TCM, other items got high scores which were more than 90%; in the evaluation of application effects, safety of the guideline was best, economy of the guideline was better, and clincal effect was good. The comprehensive application evaluation showed that 75%~80% doctors were satisfied with the guideline. The Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine has been widely used in clinical practice, which is of high quality, high degree of clinical application,good safety and economy. But there were some disadvantages of the guideline such as lack of evidence-based medicine and innovation, which is need to be improved constantly in the guideline revision. Copyright© by the Chinese Pharmaceutical Association.

Risk-Factor Profile of Living Kidney Donors: The Australia and New Zealand Dialysis and Transplant Living Kidney Donor Registry 2004-2012.

PubMed

Clayton, Philip A; Saunders, John R; McDonald, Stephen P; Allen, Richard D M; Pilmore, Helen; Saunder, Alan; Boudville, Neil; Chadban, Steven J

2016-06-01

Recent literature suggests that living kidney donation may be associated with an excess risk of end-stage kidney disease and death. Efforts to maximize access to transplantation may result in acceptance of donors who do not fit within current guidelines, potentially placing them at risk of adverse long-term outcomes. We studied the risk profile of Australian and New Zealand living kidney donors using data from the Australia and New Zealand Dialysis and Transplant Living Kidney Donor Registry over 2004 to 2012. We compared their predonation profile against national guidelines for donor acceptance. The analysis included 2,932 donors (mean age 48.8 ± 11.2 years, range 18-81), 58% female and 87% Caucasian. Forty (1%) had measured glomerular filtration rate less than 80 mL/min; 32 (1%) had proteinuria >300 mg/day; 589 (20%) were hypertensive; 495 (18%) obese; 9 (0.3%) were diabetic while a further 55 (2%) had impaired glucose tolerance; and 218 (7%) were current smokers. Overall 767 donors (26%) had at least one relative contraindication to donation and 268 (9%) had at least one absolute contraindication according to national guidelines. Divergence of current clinical practice from national guidelines has occurred. In the context of recent evidence demonstrating elevated long-term donor risk, rigorous follow-up and reporting of outcomes are now mandated to ensure safety and document any change in risk associated with such a divergence.

What is safety?: Miracles, benefit-risk assessments, and the "right to try".

PubMed

DeTora, Lisa M

2017-07-01

Public discourse is full of quick solutions to health care problems like cancer and rare diseases. Among these is Right to Try legislation for experimental therapies. Right to Try legislation is based on the premise that all experimental agents in clinical trials are safe and guaranteed to produce miracles. Unfortunately, this notion is at odds with expert understanding, which indicates that the benefits and risks of drug products can only be understood together and evaluated incrementally and over time. The current manuscript examines why benefit to risk considerations, a lynchpin of the ethical conduct of clinical research since the Nuremberg Code, might be easily elided from public discourse. This paper considers guidelines for regulatory writing, which routinely separate discussions of effectiveness and safety, as a possible source for some confusion. The internationally-accepted ICH M4E (Common Technical Document) guideline published in 2016 now provides additional guidance for composing Benefits and Risks Conclusions, which weigh and consider effectiveness and safety together. Yet fundamental differences in understanding the "safety" of medicinal products continue to exist between experts in biomedicine, politicians, and healthcare activists. Examining differences in the understanding of "safety" between experts and non-experts also may help explain the source for flawed logic about the safety of investigational products in Right To Try narratives. No drug product is 100% safe. Continuing to weigh benefits and risks together is an important intellectual practice necessary to safeguard human health worldwide, and testing clinical safety is the only way to provide meaningful protections to patients. Science, not miracles, can ensure the protection of patients in clinical research as well as clinical practice. Weighing benefits and risks is an essential intellectual act that informs public health. Science, not miracles, can guide this work. © 2017 John Wiley & Sons Ltd.

A survey of manufacturing and handling practices for monoclonal antibodies by pharmacy, nursing and medical personnel.

PubMed

Alexander, M; King, J; Lingaratnam, S; Byrne, J; MacMillan, K; Mollo, A; Kirsa, S; Green, M

2016-04-01

There is a paucity of data available to assess the occupational health and safety risk associated with exposure to monoclonal antibodies. Industry standards and published guidelines are conflicting or outdated. Guidelines offer contrary recommendations based on an array of methodological approaches. This survey aimed to describe current practices, beliefs and attitudes relating to the handling of monoclonal antibodies by Australian medical, nursing and pharmacy clinicians. An electronic survey was distributed between June and September 2013. Respondents were surveyed on three focus areas: institutional guideline availability and content, current practices and attitudes. Demographic data relating to respondent and primary place of practice were also collected. A total of 222 clinicians completed the survey, with representation from all targeted professional groups and from a variety of geographic locations. 92% of respondents reported that their institution prepared or administered monoclonal antibodies, with 87% specifically handling anti-cancer monoclonal antibodies. Monoclonal antibodies were mostly prepared onsite (84-90%) and mostly within pharmacy clean-rooms (75%) and using cytotoxic cabinets (61%). 43% of respondents reported access to institutional monoclonal antibody handling guidelines with risk reduction strategies including training and education (71%), spill and waste management (71%), procedures for transportation (57%) and restricted handling (50%). Nurses had a stronger preference towards pharmacy manufacturing than both doctors and pharmacists for a range of clinical scenarios. 95% of all respondents identified that professional or regulatory body guidelines are an important resource when considering handling practices. Monoclonal antibodies are most commonly handled according to cytotoxic drug standards and often in the absence of formal guidelines. © The Author(s) 2014.

Occupational health and safety regulations in the dairy industry.

PubMed

Reed, Sue; Douphrate, David I; Lundqvist, Peter; Jarvie, Paul; McLean, Gillian; Koehncke, Niels; Colosio, Claudio; Singh, Tanusha

2013-01-01

The application of occupational health and safety (OHS) legislation in the dairy industry varies throughout the world. Generally there is no specific OHS legislation that applies to the dairy industry and mostly in countries the current OHS legislation applies to all workplaces with specific guidelines that apply to agricultural industries. The main difference between countries is in the application of OHS legislation specifically in relation to the size of the farms. In the USA, the OHS legislation, and therefore enforcement, does not, in most cases, apply to farms with less than 11 employees, whereas in other countries there is no minimum number of employees and in some cases such as the United Kingdom and Australia it covers all people who work on the farm. The other area of difference is in the use and publication of guidelines for the industry; some countries have a wide range of guidelines whereas other counties have few. Generally, this relates to the jurisdiction of the OHS legislation, which in several countries is not at a national level such as USA, Canada, and Australia. The main principal of OHS legislation is that all workplaces, including dairy farms, should be a safe and healthy place to work, and does not vary significantly between the countries reviewed even those with prescriptive legislation.

Quality indicators for the hospital transfusion chain: a national survey conducted in 100 dutch hospitals.

PubMed

Zijlker-Jansen, P Y; Janssen, M P; van Tilborgh-de Jong, A J W; Schipperus, M R; Wiersum-Osselton, J C

2015-10-01

The 2011 Dutch Blood Transfusion Guideline for hospitals incorporates seven internal quality indicators for evaluation of the hospital transfusion chain. The indicators aim to measure guideline compliance as shown by the instatement of a hospital transfusion committee and transfusion safety officer (structural indicators), observance of transfusion triggers and mandatory traceability of labile blood components (process indicators). Two voluntary online surveys were sent to all Dutch hospitals for operational years 2011 and 2012 to assess compliance with the guideline recommendations. Most hospitals had a hospital transfusion committee and had appointed a transfusion safety officer (TSO). In 2012, only 23% of hospitals complied with the recommended minimum of four annual transfusion committee meetings and 8 h/week for the TSO. Compliance with the recommended pretransfusion haemoglobin threshold for RBC transfusion was achieved by 90% of hospitals in over 80% of transfusions; 58% of hospitals measured the pretransfusion platelet count in over 80% of platelet transfusions and 87% of hospitals complied with the legally mandatory traceability of blood components in over 95% of transfusions. With the current blood transfusion indicators, it is feasible to monitor aspects of the quality of the hospital transfusion chain and blood transfusion practice and to assess guideline compliance. The results from this study suggest that there are opportunities for significant improvement in blood transfusion practice in the Netherlands. These indicators could potentially be used for national and international benchmarking of blood transfusion practice. © 2015 International Society of Blood Transfusion.

Evaluating safety performance and developing guidelines for the use of right turn on red (RTOR).

DOT National Transportation Integrated Search

2012-12-01

This research project investigates the safety performance of Right Turn on Red (RTOR) at intersections. Also, new design alternatives, such as dual right-turn lanes and guidelines incorporating the use of RTOR at intersections are evaluated. To this ...

Improvement in safety monitoring of biologic response modifiers after the implementation of clinical care guidelines by a specialty.

PubMed

Hanson, Rebekah L; Gannon, Michael J; Khamo, Nehrin; Sodhi, Monsheel; Orr, Alexander M; Stubbings, JoAnn

2013-01-01

Tumor necrosis factor (TNF)-alpha inhibitors and other biologic response modifiers (BRMs) are frequently used to treat a variety of inflammatory diseases. Use of these agents may increase risk of serious infections, malignancies, and other complications such as worsening symptoms of heart failure or demyelinating disease. Because of these risks, a baseline assessment and routine monitoring have been recommended, but standardized guidelines for monitoring have yet to be established. To measure the compliance with the recommended safety monitoring in the Clinical Care Guidelines for BRMs at the University of Illinois Hospitals and Health Sciences System (UI Health). The Clinical Care Guidelines for BRMs was developed by a committee of pharmacists, nurses, and physicians based on an assessment of published literature and medication labeling. The guidelines included recommendations for safety monitoring prior to BRM therapy, such as the tuberculosis (TB) test, Hepatitis B surface Antigen (HBsAg) test, liver function test (LFT), complete blood count (CBC), up-to-date vaccinations, risk assessment for cancer, pregnancy testing, monitoring for contraindications with concomitant medications, concomitant disease state risk assessment, and patient education. The guidelines were introduced to UI Health in February 2012 by a systemwide email and by in-services given by the health system's Specialty Pharmacy Service. In-services were given in the clinics known to generate large numbers of BRM orders (e.g., gastroenterology and rheumatology) and at the outpatient center for infused therapies. The purpose of the in-services was to introduce providers to the guidelines and encourage their compliance. To ensure that guideline requirements were met when BRMs were ordered, a process was established to identify BRM orders, assess the orders for compliance with 4 of the safety monitoring tests from the guidelines (TB, HBsAg, LFT, and CBC), and make interventions. When necessary, Specialty Pharmacy Services coordinated with the pharmacists and other providers in the clinic to order lab tests and ensure they were completed prior to the start of therapy. Feedback was provided during the study to proactively improve compliance with the guidelines. After completion of the study, a report containing outpatient prescription orders for BRMs (abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, and tocilizumab) from August 2011 through July 2012 was generated from the electronic medical record. Retrospective analyses of completion of safety monitoring were conducted for patients administered BRM treatment. Completion rates were compared before and after implementation of guidelines in February 2012. Completion was considered to have occurred when all 4 safety monitoring tests had been conducted -TB (unless known to be positive from a previous test), HBsAg, LFT, and CBC. Completion data from August 2011 through January 2012 were before the guidelines were implemented, and data from February 2012 through July 2012 were after the guidelines. Chi square analyses were performed on completion frequencies in the patients before and after the guidelines were implemented. Of the 320 unique patient BRM orders evaluated in this study, 195 (61%) were generated in the Rheumatology clinic, 99 (31%) in the Gastroenterology clinic, 21 (6.5%) in the Dermatology clinic, and 5 (1.5%) in the Transplant clinic. Before the guidelines were implemented, 54 ( 31%) of 173 patient orders complied with the safety monitoring by having all 4 clinical tests performed at the appropriate time points. After guideline implementation, 88 (60%) of 147 patient orders were compliant and had all 4 clinical tests conducted, which represents a statistically significant improvement in the rate of compliance (Pearson chi square = 26.43, degrees of freedom (df) = 1, P  less than  0.0001). This significant improvement in compliance rates after guideline implementation was observed in both the new patient group and the patients with continuing prescription orders/treatment changes. There was also an improvement in patients whose prescriptions were dispensed by UI Health and to a lesser degree those whose prescriptions were dispensed by an outside pharmacy. When the new patient group was analyzed separately (n = 92), 50 patients were treated before the guidelines were implemented, and 42 patients were treated after the guidelines were implemented. Compliance rates with safety monitoring in these 2 groups were 52% pre-implementation and 83% post-implementation, which represented a statistically significant improvement in compliance (Pearson chi square = 10.03, df=1, P = 0.0015). Similar results were observed in the second patient subgroup with continuing prescription orders/treatment change (n = 228). A total of 123 patients were treated before the guidelines were implemented, and 105 were treated after the guidelines were implemented. Compliance rates were 23% pre-implementation compared with 50% post-implementation, which represented a statistically significant improvement in compliance (Pearson chi square = 18.99, df = 1, P  less than  0.0001). Given the widespread and long-term use of BRMs, safety monitoring and management should be an important part of a comprehensive medication management program for their use. A coordinated effort may have a significant impact on compliance with safety monitoring guidelines.

Magnetic Resonance Safety

PubMed Central

Sammet, Steffen

2016-01-01

Magnetic Resonance Imaging (MRI) has a superior soft-tissue contrast compared to other radiological imaging modalities and its physiological and functional applications have led to a significant increase in MRI scans worldwide. A comprehensive MRI safety training to protect patients and other healthcare workers from potential bio-effects and risks of the magnetic fields in an MRI suite is therefore essential. The knowledge of the purpose of safety zones in an MRI suite as well as MRI appropriateness criteria is important for all healthcare professionals who will work in the MRI environment or refer patients for MRI scans. The purpose of this article is to give an overview of current magnetic resonance safety guidelines and discuss the safety risks of magnetic fields in an MRI suite including forces and torque of ferromagnetic objects, tissue heating, peripheral nerve stimulation and hearing damages. MRI safety and compatibility of implanted devices, MRI scans during pregnancy and the potential risks of MRI contrast agents will also be discussed and a comprehensive MRI safety training to avoid fatal accidents in an MRI suite will be presented. PMID:26940331

Commercial grade item (CGI) dedication of generators for nuclear safety related applications

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

Das, R.K.; Hajos, L.G.

1993-03-01

The number of nuclear safety related equipment suppliers and the availability of spare and replacement parts designed specifically for nuclear safety related application are shrinking rapidly. These have made it necessary for utilities to apply commercial grade spare and replacement parts in nuclear safety related applications after implementing proper acceptance and dedication process to verify that such items conform with the requirements of their use in nuclear safety related application. The general guidelines for the commercial grade item (CGI) acceptance and dedication are provided in US Nuclear Regulatory Commission (NRC) Generic Letters and Electric Power Research Institute (EPRI) Report NP-5652,more » Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications. This paper presents an application of these generic guidelines for procurement, acceptance, and dedication of a commercial grade generator for use as a standby generator at Salem Generating Station Units 1 and 2. The paper identifies the critical characteristics of the generator which once verified, will provide reasonable assurance that the generator will perform its intended safety function. The paper also delineates the method of verification of the critical characteristics through tests and provide acceptance criteria for the test results. The methodology presented in this paper may be used as specific guidelines for reliable and cost effective procurement and dedication of commercial grade generators for use as standby generators at nuclear power plants.« less

ACOEM practice guidelines: opioids and safety-sensitive work.

PubMed

Hegmann, Kurt T; Weiss, Michael S; Bowden, Kirk; Branco, Fernando; DuBrueler, Kimberly; Els, Charl; Mandel, Steven; McKinney, David W; Miguel, Rafael; Mueller, Kathryn L; Nadig, Robert J; Schaffer, Michael I; Studt, Larry; Talmage, James B; Travis, Russell L; Winters, Thomas; Thiese, Matthew S; Harris, Jeffrey S

2014-07-01

ACOEM has updated the treatment guidelines concerning opioids. This report highlights the safety-sensitive work recommendation that has been developed. Comprehensive literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel to develop evidence-based guidance. A total of 12 moderate-quality studies were identified to address motor vehicle crash risk, and none regarding other work among opioid-using patients. Acute or chronic opioid use is not recommended for patients who perform safety-sensitive jobs. These jobs include operating motor vehicles, other modes of transportation, forklift driving, overhead crane operation, heavy equipment operation and tasks involving high levels of cognitive function and judgment. Quality evidence consistently demonstrates increased risk of vehicle crashes and is recommended as the surrogate for other safety-sensitive work tasks.

Motivation of employers to encourage their employees to use safety belts (phase 2).

DOT National Transportation Integrated Search

1983-08-01

An employer manual is developed which offers guidelines for the elements of a successful safety bell program. The guidelines are based upon the model developed as a result of site visits to successful programs and synthesis of expert opinion. A needs...

International policy and advisory response regarding children's exposure to radio frequency electromagnetic fields (RF-EMF).

PubMed

Redmayne, Mary

2016-01-01

Radiofrequency electromagnetic field (RF-EMF) exposure regulations/guidelines generally only consider acute effects, and not chronic, low exposures. Concerns for children's exposure are warranted due to the amazingly rapid uptake of many wireless devices by increasingly younger children. This review of policy and advice regarding children's RF-EMF exposure draws material from a wide variety of sources focusing on the current situation. This is not a systematic review, but aims to provide a representative cross-section of policy and advisory responses within set boundaries. There are a wide variety of approaches which I have categorized and tabulated ranging from ICNIRP/IEEE guidelines and "no extra precautions needed" to precautionary or scientific much lower maxima and extensive advice to minimize RF-EMF exposure, ban advertising/sale to children, and add exposure information to packaging. Precautionary standards use what I term an exclusion principle. The wide range of policy approaches can be confusing for parents/carers of children. Some consensus among advisory organizations would be helpful acknowledging that, despite extensive research, the highly complex nature of both RF-EMF and the human body, and frequent technological updates, means simple assurance of long-term safety cannot be guaranteed. Therefore, minimum exposure of children to RF-EMF is recommended. This does not indicate need for alarm, but mirrors routine health-and-safety precautions. Simple steps are suggested. ICNIRP guidelines need to urgently publish how the head, torso, and limbs' exposure limits were calculated and what safety margin was applied since this exposure, especially to the abdomen, is now dominant in many children.

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.

Review article: the role of practice guidelines and evidence-based medicine in perioperative patient safety.

PubMed

Crosby, Edward

2013-02-01

The purpose of this narrative review is to discuss the impact of clinical practice guidelines on the outcomes of care and patient safety. The care provided to patients has a high degree of variability, including some care that is discordant with available evidence. This inconsistency has implications for patient safety as some patients receive care that is unlikely beneficial yet may be harmful, while others are denied care that would clearly be helpful. The medical literature is expanding at an alarming rate; its quality and reliability is often poor; study methodology is frequently suboptimal, and reversal is common, even among frequently cited articles. For decades, specialty societies and other agencies have been providing clinical practice guidelines to assist physicians with the integration of evidence into clinical decision-making. Implementation of guidelines has been variable, and their goals are often not achieved due to failed uptake and application. The reasons for this shortcoming are complex and some explanations are valid. Many guidelines have not been evidence-based and many have been methodologically unsound. Physician autonomy likely also plays an important role in guideline uptake; an updated concept of autonomy that embraces appropriate guidelines is long overdue. Under certain conditions, guidelines can add value to care and improve outcomes; they need to be evidence-based, methodologically sound, and appropriately applied to patients and clinical scenarios. Simply summarizing evidence in a guideline is an inadequate process. To achieve the benefit of guidelines, implementation strategies need to be robust.

An interagency space nuclear propulsion safety policy for SEI - Issues and discussion

NASA Technical Reports Server (NTRS)

Marshall, A. C.; Sawyer, J. C., Jr.

1991-01-01

An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of Safety Functional Requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top level safety requirements and guidelines to address these issues. Safety topics include reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations. In this paper the emphasis is placed on the safety policy and the issues and considerations that are addressed by the NSPWG recommendations.

Application of SAE ARP4754A to Flight Critical Systems

NASA Technical Reports Server (NTRS)

Peterson, Eric M.

2015-01-01

This report documents applications of ARP4754A to the development of modern computer-based (i.e., digital electronics, software and network-based) aircraft systems. This study is to offer insight and provide educational value relative to the guidelines in ARP4754A and provide an assessment of the current state-of-the- practice within industry and regulatory bodies relative to development assurance for complex and safety-critical computer-based aircraft systems.

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

EPA Pesticide Factsheets

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

Training Strategies and Materials : Use of Flashing Yellow Operations to Improve Safety at Signals with Protected-Permissive Left Turn (PPLT) Operations

DOT National Transportation Integrated Search

2012-08-01

TxDOT project 0-6568 Use of Flashing Yellow Operations to Improve Safety at Signals with : Protected-Permissive Left Turn (PPLT) Operations has developed guidelines for : implementation of FYA PPLT displays including general guidelines on the F...

Human Factors Guidelines for the Evaluation of the Locomotive Cab

DOT National Transportation Integrated Search

1995-09-01

This document presents human factors guidelines for the evaluation of the locomotive cab. These guidelines are part of : an effort to evaluate working conditions and safety in the locomotive cab. The guidelines will serve as a decision : making tool ...

Communication on Safety of Medicines in Europe: Current Practices and General Practitioners' Awareness and Preferences.

PubMed

de Vries, Sieta T; van der Sar, Maartje J M; Cupelli, Amelia; Baldelli, Ilaria; Coleman, Anna Marie; Montero, Dolores; Šipić, Ivana; Andrić, Adriana; Wennberg, Annika; Ahlqvist-Rastad, Jane; Denig, Petra; Mol, Peter G M

2017-08-01

National competent authorities (NCAs) for medicines coordinate communication relating to the safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regard to reaching general practitioners (GPs). The aim of this study was to assess current European NCA safety communication practices and to investigate European GPs' awareness of and preferences for safety communications on medicines. Web-based surveys were distributed among European NCAs and healthcare professionals (HCPs). The survey among regulators was emailed to a representative of each of the 27 European countries participating in the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. HCPs from nine European countries (Denmark, Spain, Croatia, Ireland, Italy, The Netherlands, Norway, Sweden, and the UK) were asked about their preferences through a link to the survey on websites, in newsletters, and/or in a direct email. From this survey, data from GPs were used and descriptive analyses were conducted. Current NCA practices were reported for 26 countries. In 23 countries (88%), NCAs published direct healthcare professional communications (DHPCs, i.e. urgent communication letters for serious safety issues) on their website in addition to distribution to individual HCPs. Educational materials were available on the NCA's website in 10 countries (40%), and 21 NCAs (81%) indicated they had their own bulletin/newsletter, which is often presented on the NCA's website (15 countries; 60%). More than 90% of the 1766 GPs who completed the survey were aware of DHPCs. The most preferred senders of safety information were NCAs and professional bodies, while the preferred channels for keeping up to date with safety information were medicines reference books and clinical guidelines. GPs found the repetition of safety issues useful (range of 80% in the UK to 97% in Italy). Preference for an electronic copy rather than a hardcopy varied per country (36% in Sweden to 72% in Spain). NCAs use similar methods for safety communications on medicines. Most GPs were aware of urgent communications and preferred similar senders of safety communications; however, their preferences towards the format differed per country.

Nurses' use of hazardous drug-handling precautions and awareness of national safety guidelines.

PubMed

Polovich, Martha; Martin, Susan

2011-11-01

To determine patterns of personal protective equipment (PPE) used by oncology nurses while handling hazardous drugs (HDs) and to assess knowledge of the 2004 National Institute for Occupational Safety and Health (NIOSH) Alert and its effect on precaution use. Descriptive, correlational. The Oncology Nursing Society 31st Annual Congress in Boston, MA, in 2006. 330 nurses who prepared and/or administered chemotherapy. Nurses described HD safe-handling precaution use by self-report survey. The availability and use of biologic safety cabinets and PPE. Respondents were well educated (57% had a bachelor's degree or more), experienced (X = 19, SD = 10.2 years in nursing and X = 12, SD = 7.9 years in oncology), and certified (70%; majority OCN®). Forty-seven percent of respondents were aware of the NIOSH Alert. Thirty-five percent of all participants and 93% of nurses in private practice settings reported preparing chemotherapy. Glove use (95%-100%) was higher than that reported in earlier studies, and gown use for drug preparation (65%), drug administration (50%), and handling excretions (23%) have remained unchanged. Double-gloving was rare (11%-18%). Nurses in private practices were less likely to have chemotherapy-designated PPE available, use PPE, and use spill kits for HD spills. Nurses have adopted glove use for HD handling; however, gown use remains comparatively low. Chemotherapy-designated PPE is not always provided by employers. Nurses lack awareness of current safety guidelines. Nurses must know about the risks of HD exposure and ways to reduce exposure. Employers must provide appropriate PPE and encourage its use. Alternative methods of disseminating safety recommendations are needed.

Extended Venous Thromboembolism Prophylaxis after Radical Cystectomy: A Call for Adherence to Current Guidelines.

PubMed

Klaassen, Zachary; Arora, Karan; Goldberg, Hanan; Chandrasekar, Thenappan; Wallis, Christopher J D; Sayyid, Rashid K; Fleshner, Neil E; Finelli, Antonio; Kutikov, Alexander; Violette, Philippe D; Kulkarni, Girish S

2018-04-01

Radical cystectomy is inherently associated with morbidity. We assess the timing and incidence of venous thromboembolism, review current guideline recommendations and provide evidence for considering extended venous thromboembolism prophylaxis in all patients undergoing radical cystectomy. We searched PubMed® for available literature on radical cystectomy and venous thromboembolism, focusing on incidence and timing, evidence supporting extended venous thromboembolism prophylaxis in patients undergoing radical cystectomy or abdominal oncologic surgery, current guideline recommendations, safety considerations and direct oral anticoagulants. Search terms included "radical cystectomy," "venous thromboembolism," "prophylaxis," and "extended oral anticoagulants" and "direct oral anticoagulants" alone and in combination. Relevant articles were reviewed, including original research, reviews and clinical guidelines. References from review articles and guidelines were also assessed to develop a narrative review. The incidence of symptomatic venous thromboembolism in short-term followup after radical cystectomy is 3% to 11.6%, of which more than 50% of cases will occur after hospital discharge. Meta-analyses of clinical trials in patients undergoing major abdominal oncologic operations suggest a decreased risk of venous thromboembolisms for patients receiving extended (4 weeks) venous thromboembolism prophylaxis. Extended prophylaxis should be considered in all radical cystectomy cases. Although the relative risk of bleeding also increases, the overall net benefit of extended prophylaxis clearly favors use for at least 28 days postoperatively. Extrarenal eliminated prophylaxis agents are preferred given the risk of renal insufficiency in radical cystectomy cases, with newer oral anticoagulants providing an alternative route of administration. Patients undergoing radical cystectomy are at high risk for venous thromboembolism after hospital discharge. There is strong evidence that extended prophylaxis significantly decreases the risk of venous thromboembolism in oncologic surgery cases. Use of extended prophylaxis after radical cystectomy has been poorly adopted, emphasizing the need for better adherence to current urology procedure specific guidelines as extended prophylaxis for radical cystectomy is the standard of care. Specific and rare circumstances may require case by case assessment. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Safety pharmacology--current and emerging concepts.

PubMed

Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor; Alfirevic, Ana; Alhaidari, Mohammad; Atkinson, Jeffrey; Ayala, Mimieveshiofuo; Box, Helen; Cross, Michael; Delaunois, Annie; Dermody, Ailsa; Govindappa, Karthik; Guillon, Jean-Michel; Jenkins, Rosalind; Kenna, Gerry; Lemmer, Björn; Meecham, Ken; Olayanju, Adedamola; Pestel, Sabine; Rothfuss, Andreas; Sidaway, James; Sison-Young, Rowena; Smith, Emma; Stebbings, Richard; Tingle, Yulia; Valentin, Jean-Pierre; Williams, Awel; Williams, Dominic; Park, Kevin; Goldring, Christopher

2013-12-01

Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. Copyright © 2013 Elsevier Inc. All rights reserved.

The safety of ezetimibe and simvastatin combination for the treatment of hypercholesterolemia.

PubMed

Kei, Anastazia A; Filippatos, Theodosios D; Elisaf, Moses S

2016-01-01

In the light of the most recent and stricter dyslipidemia treatment guidelines, the need for combination hypolipidemic therapy is increasing. Ezetimibe plus simvastatin is available as a fixed dose therapy offering an efficient hypolipidemic treatment choice. Based on the positive results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) trial, the use of this drug combination is expected to increase in the next years. This review discusses the current evidence regarding the safety of ezetimibe/simvastatin combination. Current evidence regarding possible associated side effects (musculoskeletal, gastrointestinal, endocrine, hematological, renal, ophthalmologic, allergic, malignancy) and drug interactions of this combination is thoroughly discussed. Ezetimibe and simvastatin treatment, either as a single pill or the combined use of the individual compounds, offers limited additional risk compared with simvastatin monotherapy and comprises a safe and efficient choice for dyslipidemia treatment in high-risk and diabetic patients.

Ebola: Facing a New Transboundary Animal Disease?

PubMed Central

Feldmann, F.; Feldmann, H.

2016-01-01

Ebola viruses are zoonotic pathogens with the potential of causing severe viral hemorrhagic fever in humans and nonhuman primates. Bats have been identified as a reservoir for Ebola viruses but it remains unclear if transmission to an end host involves intermediate hosts. Recently, one of the Ebola species has been found in Philippine pigs raising concerns regarding animal health and food safety. Diagnostics have so far focused on human application, but enhanced pig surveillance and diagnostics, particularly in Asia, for Ebola virus infections seem to be needed to establish reasonable guidelines for public and animal health and food safety. Livestock vaccination against Ebola seems currently not justified but proper preparedness may include experimental vaccine approaches. PMID:23689898

A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

PubMed

Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

2017-09-01

This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

Partnering With a Medical Malpractice Insurer to Improve Patient Safety and Decrease Risk.

PubMed

Keohane, Carol A; Dwyer, Kathy; Boulanger, Jason; Zigmont, Katherine; Babayan, Astrid; Cushing, Elizabeth; Walsh, Brian

Implementing evolving science into clinical practice remains challenging. Assimilating new scientific evidence into clinical protocols and best practice recommendations, in a timely manner, can be difficult. In this article, we examine the value of partnering with a captive medical malpractice insurance company and its Patient Safety Organization to use data and convening opportunities to build upon the principles of implementation science and foster efficient and widespread adoption of the most current evidence-based interventions. Analyses of medical malpractice and root-cause analysis data set the context for this partnership and acted as a catalyst for creating best practice guidelines for adopting therapeutic hypothermia in the treatment of neonatal encephalopathy. What follows is a powerful example of successfully leveraging the collective wisdom of healthcare providers across specialties and institutional lines to move patient safety forward while managing risk.

Health and Safety: Suggested Personnel Policy Guidelines for School Districts.

ERIC Educational Resources Information Center

Oregon State Dept. of Education, Salem. Div. of Administrative Support.

To assist school administrators in meeting state and federal requirements for safety and health programs and procedures related to school district personnel (particularly those requirements resulting from the enactment by the 1973 Oregon Legislative Assembly of laws found in the ORS 654.000 to 654.295, and 654.991), these guidelines were drawn…

A Handbook for Public Playground Safety. Volume II: Technical Guidelines for Equipment and Surfacing.

ERIC Educational Resources Information Center

Consumer Product Safety Commission, Washington, DC.

This handbook suggests safety guidelines for public playground equipment and describes various surfaces used under the equipment and possible injuries resulting from falls. The handbook is intended for use mainly by manufacturers, installers, school and park officials, and others interested in technical criteria for public playground equipment.…

Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

PubMed

Kullak-Ublick, Gerd A; Merz, Michael; Griffel, Louis; Kaplowitz, Neil; Watkins, Paul B

2014-11-01

The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects. Without clearer guidelines, questions regarding liver safety may become a major factor in regulatory approval and ultimately physician uptake of the new treatments. The lack of consensus in defining stopping rules based on serum alanine aminotransferase (ALT) levels underscores the need for precompetitive data sharing to improve our understanding of DILI in these populations and to allow evidence-based rather than empirical definition of stopping rules. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

The potential carcinogenic risk of tanning beds: clinical guidelines and patient safety advice.

PubMed

Mogensen, Mette; Jemec, Gregor Be

2010-10-28

In 2009, the WHO listed ultraviolet (UV) radiation as a group 1 carcinogen. In spite of this, each year, millions of people tan indoor in Western countries. The aim of this review is to summarize evidence of tanning bed carcinogenesis and to present guidelines for use of tanning beds and patient safety advice. A narrative review of the literature was conducted based on both PubMed and Medline searches and on literature review of the retrieved papers. Use of indoor tanning beds represents a significant and avoidable risk factor for the development of both melanoma and nonmelanoma skin cancers. Frequent tanners are more often adolescent females. Tanning beds have additional potential adverse effects such as burns, solar skin damage, infection, and possibly also addictive behavior. The effort in preventing UV light-induced carcinogenesis should currently be aimed at developing new strategies for public health information. Tanning beds are one preventable source of UV radiation. In the majority of people solar UV radiation continues to be the major factor and therefore anti-tanning campaigns must always include sunbathers.

The potential carcinogenic risk of tanning beds: clinical guidelines and patient safety advice

PubMed Central

Mogensen, Mette; Jemec, Gregor BE

2010-01-01

Introduction: In 2009, the WHO listed ultraviolet (UV) radiation as a group 1 carcinogen. In spite of this, each year, millions of people tan indoor in Western countries. The aim of this review is to summarize evidence of tanning bed carcinogenesis and to present guidelines for use of tanning beds and patient safety advice. Methods: A narrative review of the literature was conducted based on both PubMed and Medline searches and on literature review of the retrieved papers. Results: Use of indoor tanning beds represents a significant and avoidable risk factor for the development of both melanoma and nonmelanoma skin cancers. Frequent tanners are more often adolescent females. Tanning beds have additional potential adverse effects such as burns, solar skin damage, infection, and possibly also addictive behavior. Discussion: The effort in preventing UV light-induced carcinogenesis should currently be aimed at developing new strategies for public health information. Tanning beds are one preventable source of UV radiation. In the majority of people solar UV radiation continues to be the major factor and therefore anti-tanning campaigns must always include sunbathers. PMID:21188119

Quality assurance for gamma knives

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

Jones, E.D.; Banks, W.W.; Fischer, L.E.

1995-09-01

This report describes and summarizes the results of a quality assurance (QA) study of the Gamma Knife, a nuclear medical device used for the gamma irradiation of intracranial lesions. Focus was on the physical aspects of QA and did not address issues that are essentially medical, such as patient selection or prescription of dose. A risk-based QA assessment approach was used. Sample programs for quality control and assurance are included. The use of the Gamma Knife was found to conform to existing standards and guidelines concerning radiation safety and quality control of external beam therapies (shielding, safety reviews, radiation surveys,more » interlock systems, exposure monitoring, good medical physics practices, etc.) and to be compliant with NRC teletherapy regulations. There are, however, current practices for the Gamma Knife not covered by existing, formalized regulations, standards, or guidelines. These practices have been adopted by Gamma Knife users and continue to be developed with further experience. Some of these have appeared in publications or presentations and are slowly finding their way into recommendations of professional organizations.« less

South Carolina Industrial Arts Safety Guide. Student Section.

ERIC Educational Resources Information Center

South Carolina State Dept. of Education, Columbia.

This student section of a South Carolina industrial arts safety guide includes guidelines for developing a student safety program and three sections of shop safety practices. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on developing a student safety program. Set forth…

Car Seat Safety

MedlinePlus

... Staying Safe Videos for Educators Search English Español Car Seat Safety KidsHealth / For Parents / Car Seat Safety ... certified child passenger safety technician.) Guidelines for Choosing Car Seats Choose a seat with a label that ...

Screening women for intimate partner violence: Creating proper practice habits.

PubMed

Knox, Beth

2018-05-17

Intimate partner violence continues to be a challenge for advanced practice registered nurses to address and manage in their daily practice. This article reviews current healthcare concerns in heterosexual, bisexual, transgender, and lesbian women, and explores screening guidelines and resources for developing successful screening habits. Additionally, the article discusses how the Transtheoretical Model and Stages of Change offers insight into the behavior of women who experience intimate partner violence and provides safety strategies for these women.

Prioritization Methodology for Chemical Replacement

NASA Technical Reports Server (NTRS)

Cruit, W.; Schutzenhofer, S.; Goldberg, B.; Everhart, K.

1993-01-01

This project serves to define an appropriate methodology for effective prioritization of efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semiquantitative approach derived from quality function deployment techniques (QFD Matrix). This methodology aims to weigh the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives. The results are being implemented as a guideline for consideration for current NASA propulsion systems.

Highway crash rates and age-related driver limitations: Literature review and evaluation of data bases

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

Hu, P.S.; Young, J.R.; Lu, An

1993-08-01

American society is undergoing a major demographic transformation that is resulting in a larger proportion of older individuals in the population. Moreover, recent travel surveys show that an increasing number of older individuals are licensed to drive and that they drive more than their same age cohort a decade ago. However, they continue to take shorter trips than younger drivers and they avoid driving during congested hours. This recent demographic transformation in our society, the graying of America, coupled with the increasing mobility of the older population impose a serious highway safety issue that cannot be overlooked. Some of themore » major concerns are the identification of ``high-risk`` older drivers and the establishment of licensing guidelines and procedures that are based on conclusive scientific evidence. Oak Ridge National Laboratory`s (ORNL) objectives in this project can be characterized by the following tasks: Review and evaluate the 1980 American Association of Motor Vehicle Administrators (AAMVA) and National Highway Traffic Safety Administration (NHTSA) licensing guidelines. Determine whether the license restriction recommended in the 1980 AAMVA and NHTSA guidelines was based on scientific evidence or on judgement of medical advisors. Identify in the scientific literature any medical conditions which are found to be highly associated with highway crashes, and which are not mentioned in the 1980 guidelines. Summarize States` current licensing practices for drivers with age-related physical and mental limitations. Identify potential data sources to establish conclusive evidence on age-related functional impairments and highway crashes.« less

Policy on Hazard Analysis and Critical Control Point (HACCP) and adherence to food preparation guidelines: a cross sectional survey of stakeholders in food service in Kumasi, Ghana.

PubMed

Agyei-Baffour, Peter; Sekyere, Kofi Boateng; Addy, Ernestine Akosua

2013-11-04

Food borne diseases claim more lives and are growing public health concerns. Simple preventive techniques such as adoption and adherence to hazard analysis and critical control point (HACCP) policy can significantly reduce this disease burden. Though food screening and inspection are done, the ultimate regulation, Hazard Analysis and Critical Control Point, which is known and accepted worldwide, appears not to be popular among food operators in Ghana. This paper examines the level of awareness of the existence of policy on hazard analysis and critical control point (HACCP) and its adherence to food preparation guidelines among food service providers in Ghana. The results revealed the mean age of food providers as 33.1 years with a standard deviation of 7.5, range of 18-55 years, more females, in full time employment and with basic education. Of the fifty institutional managers, 42 (84%) were senior officers and had worked for more than five years. Education and type of food operator had strong statistically significant relationship with the implementation of HCCP policy and adherence with food preparation guidelines. The enforcement of HACCP policy and adherence with food safety guidelines was led by the Ghana Tourist Board, Public Health officers, and KMA, respectively. While a majority of food operators 373/450 (83.3%) did not know HACCP policy is part of food safety guidelines, staff of food safety law enforcement 44/50 (88%) confirmed knowing that food operators were not aware of the HACCP policy. The study documents evidence on the practice of food safety principles or HACCP policy or adherence to food preparation guidelines. Existing food safety guidelines incorporate varying principles of HACCP, however, awareness is low among food operators. The implication is that food production is likely to fall short of acceptable standards and not be wholesome putting consumers at health risk. Repeating this study in rural and urban areas in Ghana is necessary to provide much more evidence to inform food safety guidelines. Further studies on chemical analysis of food and implementing training modules on HACCP policy for food producers and law enforcement agencies may be helpful to improve existing situation.

Policy on Hazard Analysis and Critical Control Point (HACCP) and adherence to food preparation guidelines: a cross sectional survey of stakeholders in food service in Kumasi, Ghana

PubMed Central

2013-01-01

Background Food borne diseases claim more lives and are growing public health concerns. Simple preventive techniques such as adoption and adherence to hazard analysis and critical control point (HACCP) policy can significantly reduce this disease burden. Though food screening and inspection are done, the ultimate regulation, Hazard Analysis and Critical Control Point, which is known and accepted worldwide, appears not to be popular among food operators in Ghana. This paper examines the level of awareness of the existence of policy on hazard analysis and critical control point (HACCP) and its adherence to food preparation guidelines among food service providers in Ghana. Results The results revealed the mean age of food providers as 33.1 years with a standard deviation of 7.5, range of 18–55 years, more females, in full time employment and with basic education. Of the fifty institutional managers, 42 (84%) were senior officers and had worked for more than five years. Education and type of food operator had strong statistically significant relationship with the implementation of HCCP policy and adherence with food preparation guidelines. The enforcement of HACCP policy and adherence with food safety guidelines was led by the Ghana Tourist Board, Public Health officers, and KMA, respectively. While a majority of food operators 373/450 (83.3%) did not know HACCP policy is part of food safety guidelines, staff of food safety law enforcement 44/50 (88%) confirmed knowing that food operators were not aware of the HACCP policy. Conclusion The study documents evidence on the practice of food safety principles or HACCP policy or adherence to food preparation guidelines. Existing food safety guidelines incorporate varying principles of HACCP, however, awareness is low among food operators. The implication is that food production is likely to fall short of acceptable standards and not be wholesome putting consumers at health risk. Repeating this study in rural and urban areas in Ghana is necessary to provide much more evidence to inform food safety guidelines. Further studies on chemical analysis of food and implementing training modules on HACCP policy for food producers and law enforcement agencies may be helpful to improve existing situation. PMID:24180236

Hazard Analysis Guidelines for Transit Projects

DOT National Transportation Integrated Search

2000-01-01

These hazard analysis guidelines discuss safety critical systems and subsystems, types of hazard analyses, when hazard analyses should be performed, and the hazard analysis philosophy. These guidelines are published by FTA to assist the transit indus...

Measure Guideline: Combustion Safety for Natural Draft Appliances Using Indoor Air

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

Brand, L.

2014-04-01

This measure guideline covers how to assess and carry out the combustion safety procedures for appliances and heating equipment that uses indoor air for combustion in low-rise residential buildings. Only appliances installed in the living space, or in an area freely communicating with the living space, vented alone or in tandem with another appliance are considered here. A separate measure guideline addresses combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage that use outdoor air for combustion. This document is formore » inspectors, auditors, and technicians working in homes where energy upgrades are being conducted whether or not air infiltration control is included in the package of measures being applied. In the indoor combustion air case, guidelines summarized here are based on language provided in several of the codes to establish minimum requirements for the space using simplified prescriptive measures. In addition, building performance testing procedures are provided by testing agencies. The codes in combination with the test procedures offer comprehensive combustion safety coverage to address safety concerns, allowing inexperienced residential energy retrofit inspectors to effectively address combustion safety issues and allow energy retrofits to proceed.« less

Rowers' Self-Reported Behaviors, Attitudes, and Safety Concerns Related to Exercise, Training, and Competition During Pregnancy.

PubMed

Franklin, Ashley; Mishtal, Joanna; Johnson, Teresa; Simms-Cendan, Judith

2017-08-01

Background The American College of Obstetrics and Gynecology notes that pregnant athletes require more supervision due to their involvement in strenuous training schedules throughout pregnancy. Currently, rowing is not mentioned in the guidelines despite its increasing popularity, high cardiovascular demands, and risk for abdominal trauma. Methods This study aimed to elicit information from competitive female rowers regarding exercise, training, and competition during pregnancy. We administered a survey consisting of 122 items to female Masters rowers in the United States, aged 21 to 49 years, from June to December 2013. Results A total of 224 recreational and elite rowers met the inclusion criteria. Pregnant rowers self-reported high levels of exercise engagement: 85.2% (n/N = 98/115) exercised during any past pregnancy; exercise adherence decreased throughout pregnancy with 51.3%, 42.4%, and 15.7% meeting and/or exceeding national guidelines during the first, second, and third trimesters, respectively. Rowers were significantly (p < 0.001) more likely to state that an activity at a specified intensity and trimester was unsafe if they were younger, had less rowing experience, or were nulliparous. Decreased perceived rowing safety was associated with on-water training, higher intensity exercise, competition, and increasing gestational age. Primary safety concerns were the risk of oar-induced abdominal trauma and physiological effects due to high intensities required by the sport. Novel barriers to exercise in pregnancy included guilt towards the team and a mental barrier due to decreased performance. Healthcare providers are the number one information source for rowers regarding exercise during pregnancy. Conclusion Pregnant rowers are a relevant obstetrics population and have barriers and sport-specific safety concerns not previously identified in the literature. Rowers consider exercising in pregnancy to be important and struggle to meet exercise guidelines like the general population, indicating the need for healthcare providers to provide prenatal and antenatal education and interventions to support exercise during pregnancy even amongst athletes.

Rowers’ Self-Reported Behaviors, Attitudes, and Safety Concerns Related to Exercise, Training, and Competition During Pregnancy

PubMed Central

Mishtal, Joanna; Johnson, Teresa; Simms-Cendan, Judith

2017-01-01

Background The American College of Obstetrics and Gynecology notes that pregnant athletes require more supervision due to their involvement in strenuous training schedules throughout pregnancy. Currently, rowing is not mentioned in the guidelines despite its increasing popularity, high cardiovascular demands, and risk for abdominal trauma. Methods This study aimed to elicit information from competitive female rowers regarding exercise, training, and competition during pregnancy. We administered a survey consisting of 122 items to female Masters rowers in the United States, aged 21 to 49 years, from June to December 2013. Results A total of 224 recreational and elite rowers met the inclusion criteria. Pregnant rowers self-reported high levels of exercise engagement: 85.2% (n/N = 98/115) exercised during any past pregnancy; exercise adherence decreased throughout pregnancy with 51.3%, 42.4%, and 15.7% meeting and/or exceeding national guidelines during the first, second, and third trimesters, respectively. Rowers were significantly (p < 0.001) more likely to state that an activity at a specified intensity and trimester was unsafe if they were younger, had less rowing experience, or were nulliparous. Decreased perceived rowing safety was associated with on-water training, higher intensity exercise, competition, and increasing gestational age. Primary safety concerns were the risk of oar-induced abdominal trauma and physiological effects due to high intensities required by the sport. Novel barriers to exercise in pregnancy included guilt towards the team and a mental barrier due to decreased performance. Healthcare providers are the number one information source for rowers regarding exercise during pregnancy. Conclusion Pregnant rowers are a relevant obstetrics population and have barriers and sport-specific safety concerns not previously identified in the literature. Rowers consider exercising in pregnancy to be important and struggle to meet exercise guidelines like the general population, indicating the need for healthcare providers to provide prenatal and antenatal education and interventions to support exercise during pregnancy even amongst athletes. PMID:28983443

Laboratory Safety Manual for Alabama Schools. Bulletin 1975. No. 20.

ERIC Educational Resources Information Center

Alabama State Dept. of Education, Montgomery.

This document presents the Alabama State Department of Education guidelines for science laboratory safety, equipment, storage, chemical safety, rocket safety, electrical safety, safety with radioisotopes, and safety with biologicals. Also included is a brief bibliography, a teacher's checklist, a listing of laser facts and regulations, and a…

Industrial Arts Safety Guide. Thai. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Thai. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Japanese. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practice in both English and Japanese. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Cambodian. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide includes guidelines for developing a student safety program and three sections of shop safety practices in both English and Cambodian. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Korean. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Korean. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Ilokano. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Ilokano. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Chinese. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Chinese. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Biological effects and physical safety aspects of NMR imaging and in vivo spectroscopy

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

Tenforde, T.S.; Budinger, T.F.

1985-08-01

An assessment is made of the biological effects and physical hazards of static and time-varying fields associated with the NMR devices that are being used for clinical imaging and in vivo spectroscopy. A summary is given of the current state of knowledge concerning the mechanisms of interaction and the bioeffects of these fields. Additional topics that are discussed include: (1) physical effects on pacemakers and metallic implants such as aneurysm clips, (2) human health studies related to the effects of exposure to nonionizing electromagnetic radiation, and (3) extant guidelines for limiting exposure of patients and medical personnel to the fieldsmore » produced by NMR devices. On the basis of information available at the present time, it is concluded that the fields associated with the current generation of NMR devices do not pose a significant health risk in themselves. However, rigorous guidelines must be followed to avoid the physical interaction of these fields with metallic implants and medical electronic devices. 476 refs., 5 figs., 2 tabs.« less

MRI-guided stereotactic neurosurgical procedures in a diagnostic MRI suite: Background and safe practice recommendations.

PubMed

Larson, Paul S; Willie, Jon T; Vadivelu, Sudhakar; Azmi-Ghadimi, Hooman; Nichols, Amy; Fauerbach, Loretta Litz; Johnson, Helen Boehm; Graham, Denise

2017-07-01

The development of navigation technology facilitating MRI-guided stereotactic neurosurgery has enabled neurosurgeons to perform a variety of procedures ranging from deep brain stimulation to laser ablation entirely within an intraoperative or diagnostic MRI suite while having real-time visualization of brain anatomy. Prior to this technology, some of these procedures required multisite workflow patterns that presented significant risk to the patient during transport. For those facilities with access to this technology, safe practice guidelines exist only for procedures performed within an intraoperative MRI. There are currently no safe practice guidelines or parameters available for facilities looking to integrate this technology into practice in conventional MRI suites. Performing neurosurgical procedures in a diagnostic MRI suite does require precautionary measures. The relative novelty of technology and workflows for direct MRI-guided procedures requires consideration of safe practice recommendations, including those pertaining to infection control and magnet safety issues. This article proposes a framework of safe practice recommendations designed for assessing readiness and optimization of MRI-guided neurosurgical interventions in the diagnostic MRI suite in an effort to mitigate patient risk. The framework is based on existing clinical evidence, recommendations, and guidelines related to infection control and prevention, health care-associated infections, and magnet safety, as well as the clinical and practical experience of neurosurgeons utilizing this technology. © 2017 American Society for Healthcare Risk Management of the American Hospital Association.

TU-C-201-03: The Use of Checklists and Audit Tools for Safety and QA

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

Prisciandaro, J.

Recent use of HDR has increased while planning has become more complex often necessitating 3D image-based planning. While many guidelines for the use of HDR exist, they have not kept pace with the increased complexity of 3D image-based planning. Furthermore, no comprehensive document exists to describe the wide variety of current HDR clinical indications. This educational session aims to summarize existing national and international guidelines for the safe implementation of an HDR program. A summary of HDR afterloaders available on the market and their existing applicators will be provided, with guidance on how to select the best fit for eachmore » institution’s needs. Finally, the use of checklists will be discussed as a means to implement a safe and efficient HDR program and as a method by which to verify the quality of an existing HDR program. This session will provide the perspective of expert HDR physicists as well as the perspective of a new HDR user. Learning Objectives: Summarize national and international safety and staffing guidelines for HDR implementation Discuss the process of afterloader and applicator selection for gynecologic, prostate, breast, interstitial, surface treatments Learn about the use of an audit checklist tool to measure of quality control of a new or existing HDR program Describe the evolving use of checklists within an HDR program.« less

Children's Acceptance of Safety Guidelines after Exposure to Televised Dramas Depicting Accidents.

ERIC Educational Resources Information Center

Cantor, Joanne; Omdahl, Becky L.

1999-01-01

Presents a study where grade-school children were exposed to a scene from a movie involving one of two activities (either fire- or water-related activities) and involving one of two outcomes (fatal accidents or neutral events). Finds that watching the dramatized accidents increased students' estimated importance of adopting safety guidelines and…

12 CFR Appendix A to Part 30 - Interagency Guidelines Establishing Standards for Safety and Soundness

Code of Federal Regulations, 2013 CFR

2013-01-01

... establish certain safety and soundness standards by regulation or by guideline for all insured depository... rules and regulations to establish deadlines for submission and review of compliance plans. 2 2 For the Office of the Comptroller of the Currency, these regulations appear at 12 CFR part 30; for the Board of...

12 CFR Appendix A to Part 170 - Interagency Guidelines Establishing Standards for Safety and Soundness

Code of Federal Regulations, 2013 CFR

2013-01-01

... agencies) to establish certain safety and soundness standards by regulation or by guideline for all insured... adopted amendments to their rules and regulations to establish deadlines for submission and review of compliance plans.2 2 For the Office of the Comptroller of the Currency, these regulations appear at 12 CFR...

Occupational Safety and Health in Vocational Education: A Guide for Administrators, Faculty, and Staff.

ERIC Educational Resources Information Center

Godbey, Frank W.

This guide is intended to help administrators at schools having vocational education programs assess their occupational safety and health needs and establish a program to ensure a safer and more healthful work environment. It consists of three sections: (1) administrative guidelines, (2) technical-regulatory guidelines, and (3) a self-evaluation…

A Handbook for Public Playground Safety. Volume I: General Guidelines for New and Existing Playgrounds.

ERIC Educational Resources Information Center

Consumer Product Safety Commission, Washington, DC.

This handbook presents some general guidelines that may be used to increase the safety of public playgrounds. Information is provided about hazards associated with the use of public playground equipment, and suggestions are made to reduce the frequency and severity of injuries. A discussion is presented on playground-related injuries and the…

Safety Guidelines for Field Data Collection

DOT National Transportation Integrated Search

2010-02-01

Safety concerns are always present when personnel are working near or adjacent to a highway. Safety considerations must include the workers as well as the motoring public. Construction safety has received extensive attention, but this research focuse...

Training Requirements in OSHA Standards and Training Guidelines. Revised.

ERIC Educational Resources Information Center

Occupational Safety and Health Administration, Washington, DC.

This guide provides an overview of Occupational Safety and Health Act (OSHA) standards and training guidelines for various industries. The first section introduces the concept of voluntary training guidelines, explaining that the guidelines are designed to help employers determine whether a worksite problem can be solved by training, what training…

49 CFR 350.339 - What are tolerance guidelines?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false What are tolerance guidelines? 350.339 Section 350... MOTOR CARRIER SAFETY ASSISTANCE PROGRAM Funding § 350.339 What are tolerance guidelines? Tolerance guidelines set forth the limited deviations from the FMCSRs allowed in your State's laws and regulations...

Pediatric Nurses' Perceptions of Medication Safety and Medication Error: A Mixed Methods Study.

PubMed

Alomari, Albara; Wilson, Val; Solman, Annette; Bajorek, Beata; Tinsley, Patricia

2018-06-01

This study aims to outline the current workplace culture of medication practice in a pediatric medical ward. The objective is to explore the perceptions of nurses in a pediatric clinical setting as to why medication administration errors occur. As nurses have a central role in the medication process, it is essential to explore nurses' perceptions of the factors influencing the medication process. Without this understanding, it is difficult to develop effective prevention strategies aimed at reducing medication administration errors. Previous studies were limited to exploring a single and specific aspect of medication safety. The methods used in these studies were limited to survey designs which may lead to incomplete or inadequate information being provided. This study is phase 1 on an action research project. Data collection included a direct observation of nurses during medication preparation and administration, audit based on the medication policy, and guidelines and focus groups with nursing staff. A thematic analysis was undertaken by each author independently to analyze the observation notes and focus group transcripts. Simple descriptive statistics were used to analyze the audit data. The study was conducted in a specialized pediatric medical ward. Four key themes were identified from the combined quantitative and qualitative data: (1) understanding medication errors, (2) the busy-ness of nurses, (3) the physical environment, and (4) compliance with medication policy and practice guidelines. Workload, frequent interruptions to process, poor physical environment design, lack of preparation space, and impractical medication policies are identified as barriers to safe medication practice. Overcoming these barriers requires organizations to review medication process policies and engage nurses more in medication safety research and in designing clinical guidelines for their own practice.

75 FR 73946 - Worker Safety and Health Program: Safety Conscious Work Environment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEPARTMENT OF ENERGY 10 CFR Part 851 Worker Safety and Health Program: Safety Conscious Work... Nuclear Regulatory Commission's ``Safety-Conscious Work Environment'' guidelines as a model. DOE published.... Second, not only would instituting a ``Safety-Conscious Work Environment'' by regulation be redundant...

Safety in Academic Chemistry Laboratories. Fourth Edition.

ERIC Educational Resources Information Center

American Chemical Society, Washington, DC.

This booklet provides guidelines for safety in the chemical laboratory. Part I, "Guides for Instructors and Administrators," includes safety rules, safety practices and facilities, preparation for emergencies, safety committees, accident reporting, fire insurance, and listings of some hazardous chemicals. Part II, "Student Guide to…

Assessment of Three “WHO” Patient Safety Solutions: Where Do We Stand and What Can We Do?

PubMed Central

Banihashemi, Sheida; Hatam, Nahid; Zand, Farid; Kharazmi, Erfan; Nasimi, Soheila; Askarian, Mehrdad

2015-01-01

Background: Most medical errors are preventable. The aim of this study was to compare the current execution of the 3 patient safety solutions with WHO suggested actions and standards. Methods: Data collection forms and direct observation were used to determine the status of implementation of existing protocols, resources, and tools. Results: In the field of patient hand-over, there was no standardized approach. In the field of the performance of correct procedure at the correct body site, there were no safety checklists, guideline, and educational content for informing the patients and their families about the procedure. In the field of hand hygiene (HH), although availability of necessary resources was acceptable, availability of promotional HH posters and reminders was substandard. Conclusions: There are some limitations of resources, protocols, and standard checklists in all three areas. We designed some tools that will help both wards to improve patient safety by the implementation of adapted WHO suggested actions. PMID:26900434

Comparison of the diabetes guidelines from the ADA/EASD and the AACE/ACE.

PubMed

Cornell, Susan

To compare recent diabetes guideline updates from the American Diabetes Association-European Association for the Study of Diabetes (ADA/EASD) and the American Association of Clinical Endocrinologists-American College of Endocrinology (AACE/ACE). The ADA/EASD guideline continues to advocate a stepwise approach to glycemic control that initiates with metformin and intensifies treatment incrementally to dual and triple therapy at 3-month intervals until the patient is at their individualized goal. The AACE/ACE guideline provides a broader choice of first-line medications, with a suggested hierarchy of use, and it encourages initial dual and triple therapy if the glycated hemoglobin (A1C) level is high enough at diagnosis (7.5%-9.0% and >9.0%, respectively). Target A1C levels are higher in the ADA/EASD guideline (≤7.0%) compared with the AACE/ACE guideline (≤6.5%), although both statements indicate that targets should be adjusted to specific clinical scenarios based on safety. Both guidelines now include the new sodium-glucose cotransporter-2 inhibitors among their choices of acceptable glucose-lowering medications and endorse the overall cardiovascular and pancreatic safety of incretin therapies, and the safety of pioglitazone vis-a-vis bladder cancer. In practice, the ADA/EASD guidelines tend to be more user-friendly for general practitioners because of the simple stepwise intensification regimen, whereas the AACE/ACE guidelines are more commonly followed by specialists (endocrinologists) because of the more aggressive A1C targets. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Transcranial Direct Current Stimulation in Epilepsy.

PubMed

San-Juan, Daniel; Morales-Quezada, León; Orozco Garduño, Adolfo Josué; Alonso-Vanegas, Mario; González-Aragón, Maricarmen Fernández; Espinoza López, Dulce Anabel; Vázquez Gregorio, Rafael; Anschel, David J; Fregni, Felipe

2015-01-01

Transcranial direct current stimulation (tDCS) is an emerging non-invasive neuromodulation therapy in epilepsy with conflicting results in terms of efficacy and safety. Review the literature about the efficacy and safety of tDCS in epilepsy in humans and animals. We searched studies in PubMed, MedLine, Scopus, Web of Science and Google Scholar (January 1969 to October 2013) using the keywords 'transcranial direct current stimulation' or 'tDCS' or 'brain polarization' or 'galvanic stimulation' and 'epilepsy' in animals and humans. Original articles that reported tDCS safety and efficacy in epileptic animals or humans were included. Four review authors independently selected the studies, extracted data and assessed the methodological quality of the studies using the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions, PRISMA guidelines and Jadad Scale. A meta-analysis was not possible due to methodological, clinical and statistical heterogeneity of included studies. We analyzed 9 articles with different methodologies (3 animals/6 humans) with a total of 174 stimulated individuals; 109 animals and 65 humans. In vivo and in vitro animal studies showed that direct current stimulation can successfully induce suppression of epileptiform activity without neurological injury and 4/6 (67%) clinical studies showed an effective decrease in epileptic seizures and 5/6 (83%) reduction of inter-ictal epileptiform activity. All patients tolerated tDCS well. tDCS trials have demonstrated preliminary safety and efficacy in animals and patients with epilepsy. Further larger studies are needed to define the best stimulation protocols and long-term follow-up. Copyright © 2015 Elsevier Inc. All rights reserved.

Provider Experiences With the Identification, Management, and Treatment of Co-Occurring Chronic Non-cancer Pain and Substance Use in the Safety Net

PubMed Central

Chang, Jamie Suki; Kushel, Margot; Miaskowski, Christine; Ceasar, Rachel; Zamora, Kara; Hurstak, Emily; Knight, Kelly R.

2017-01-01

Background In the US and internationally, providers have adopted guidelines on the management of prescription opioids for chronic non-cancer pain (CNCP). For “high-risk” patients with co-occurring CNCP and a history of substance use, guidelines advise providers to monitor patients using urine toxicology screening tests, develop opioid management plans, and refer patients to substance use treatment. Objective We report primary care provider experiences in the safety net interpreting and implementing guideline recommendations for patients with CNCP and substance use. Methods We interviewed primary care providers who work in the safety net (N=23) on their experiences managing CNCP and substance use. We analyzed interviews using a content analysis method. Results Providers found management plans and urine toxicology screening tests useful for informing patients about clinic expectations of opioid therapy and substance use. However, they described that guideline-based clinic policies had unintended consequences, such as raising barriers to open, honest dialogue about substance use and treatment. While substance use treatment was recommended for “high-risk” patients, providers described lack of integration with and availability of substance use treatment programs. Conclusions Our findings indicate that clinicians in the safety net found guideline-based clinic policies helpful. However, effective implementation was challenged by barriers to open dialogue about substance use and limited linkages with treatment programs. Further research is needed to examine how the context of safety net settings shapes the management and treatment of co-occurring CNCP and substance use. PMID:27754719

Spine concerns in the Special Olympian with Down syndrome.

PubMed

Tassone, James Channing; Duey-Holtz, Allison

2008-03-01

As with any child participating in sports, the safety of The Special Olympian participating in athletics is paramount. The preparticipation medical clearance is necessary to ensure these athletes' safety. In response to evidence that 15% of all individuals with Down syndrome have atlanto-occipital and/or atlanto-axial instability or subluxation, the Special Olympics Inc have additionally mandated preparticipation spine clearance for all individuals with Down syndrome. Spine clearance for the Special Olympian is challenging for the healthcare provider. In addition, controversy has arisen surrounding The Special Olympics Inc policy statement. The purposes of this article are to provide healthcare providers with a review of atlanto-occipital and atlanto-axial instability and subluxation, review spine clearance guidelines, discuss the details and controversy surrounding The Special Olympics Inc mandate, and provide recommendations on how to improve screening and ensure safety of the participants based on the current medical literature.

Effects of Dramatized Depictions of Accidents on Grade School Children's Reception of Safety Guidelines.

ERIC Educational Resources Information Center

Omdahl, Becky L.; Cantor, Joanne

A study examined a format for fear appeal messages that introduced a threat through one medium (i.e., a segment of dramatic television programming) and the recommended action through another medium (i.e., the verbal presentation of safety guidelines by an adult to a child). Subjects, 138 elementary school children from a middle-class elementary…

Loads and low frequency dynamics - An ENVIRONET data base

NASA Technical Reports Server (NTRS)

Garba, John A.

1988-01-01

The loads and low frequency dynamics data base, part of Environet, is described with particular attention given to its development and contents. The objective of the data base is to provide the payload designer with design approaches and design data to meet STS safety requirements. Currently the data base consists of the following sections: abstract, scope, glossary, requirements, interaction with other environments, summary of the loads analysis process, design considerations, guidelines for payload design loads, information data base, and references.

Assessment of Chiropractic Treatment for Low Back Pain, Military Readiness and Smoking Cessation in Military Active Duty Personnel

DTIC Science & Technology

2017-03-01

medical care alone for relief of pain and the improvement in function in active duty military personnel (ages 18-50) with acute , sub- acute and/or...treatment of patients with acute , subacute, and chronic low back pain (LBP) [2–4]. These guidelines are based upon randomized controlled trials (RCTs) that...equina syndrome ) Participant safety. Care outside study scope needed Currently being treated for traumatic brain injury Potential to confound study

'Emerging technologies for the changing global market' - Prioritization methodology for chemical replacement

NASA Technical Reports Server (NTRS)

Cruit, Wendy; Schutzenhofer, Scott; Goldberg, Ben; Everhart, Kurt

1993-01-01

This project served to define an appropriate methodology for effective prioritization of technology efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semiquantitative approach derived from quality function deployment techniques (QFD Matrix). This methodology aims to weight the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives. The results will be implemented as a guideline for consideration for current NASA propulsion systems.

Emerging technologies for the changing global market

NASA Technical Reports Server (NTRS)

Cruit, Wendy; Schutzenhofer, Scott; Goldberg, Ben; Everhart, Kurt

1993-01-01

This project served to define an appropriate methodology for effective prioritization of technology efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semi-quantative approach derived from quality function deployment techniques (QFD Matrix). This methodology aims to weight the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives. The results will be implemented as a guideline for consideration for current NASA propulsion systems.

76 FR 30308 - National Standard 10 Guidelines; Public Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

... Standard 10 Guidelines; Public Meetings AGENCY: National Marine Fisheries Service (NMFS), National Oceanic... to the National Standard 10 (NS10) Guidelines and announced a public meeting to be held on May 19... practicable, promote the safety of human life at sea.'' NMFS published final guidelines for NS10 in 1998 (63...

Updated evidence-based clinical practice guidelines for the diagnosis and management of melanoma: definitive excision margins for primary cutaneous melanoma.

PubMed

Sladden, Michael J; Nieweg, Omgo E; Howle, Julie; Coventry, Brendon J; Thompson, John F

2018-02-19

Definitive management of primary cutaneous melanoma consists of surgical excision of the melanoma with the aim of curing the patient. The melanoma is widely excised together with a safety margin of surrounding skin and subcutaneous tissue, after the diagnosis and Breslow thickness have been established by histological assessment of the initial excision biopsy specimen. Sentinel lymph node biopsy should be discussed for melanomas ≥ 1 mm thickness (≥ 0.8 mm if other high risk features) in which case lymphoscintigraphy must be performed before wider excision of the primary melanoma site. The 2008 evidence-based clinical practice guidelines for the management of melanoma (http://www.cancer.org.au/content/pdf/HealthProfessionals/ClinicalGuidelines/ClinicalPracticeGuidelines-ManagementofMelanoma.pdf) are currently being revised and updated in a staged process by a multidisciplinary working party established by Cancer Council Australia. The guidelines for definitive excision margins for primary melanomas have been revised as part of this process. Main recommendations: The recommendations for definitive wide local excision of primary cutaneous melanoma are: melanoma in situ: 5-10 mm margins invasive melanoma (pT1) ≤ 1.0 mm thick: 1 cm margins invasive melanoma (pT2) 1.01-2.00 mm thick: 1-2 cm margins invasive melanoma (pT3) 2.01-4.00 mm thick: 1-2 cm margins invasive melanoma (pT4) > 4.0 mm thick: 2 cm margins Changes in management as a result of the guideline: Based on currently available evidence, excision margins for invasive melanoma have been left unchanged compared with the 2008 guidelines. However, melanoma in situ should be excised with 5-10 mm margins, with the aim of achieving complete histological clearance. Minimum clearances from all margins should be assessed and stated. Consideration should be given to further excision if necessary; positive or close histological margins are unacceptable.

Periodontal Ligament Stem Cells: Current Status, Concerns, and Future Prospects

PubMed Central

Zhu, Wenjun; Liang, Min

2015-01-01

Periodontal ligament stem cells (PDLSCs), which reside in the perivascular space of the periodontium, possess characteristics of mesenchymal stem cells and are a promising tool for periodontal regeneration. Recently, great progress has been made in PDLSC transplantation. Investigators are attempting to maximize the proliferation and differentiation potential of PDLSCs by modifying culture conditions and applying growth factors. Nevertheless, problems remain. First, incomparability among different studies must be minimized by establishing standard guidelines for culture and identification of PDLSCs. Notably, attention should be paid to the biological safety of PDLSC transplantation. The present review updates the latest findings regarding PDLSCs and discusses standard criteria for culture and identification of PDLSCs. Finally, the review calls for careful consideration of PDLSC transplantation safety. PMID:25861283

Benefits, safety, and prescription of exercise in persons with multiple sclerosis.

PubMed

Motl, Robert W

2014-12-01

Exercise represents a behavioral approach for the restoration of function and management of symptoms among persons with multiple sclerosis (MS). The current paper provides a review on the topic of exercise in MS and is separated into four sections. The first section defines exercise and related constructs. The second section summarizes evidence for the benefits of exercise in MS based on literature reviews and meta-analyses. The third section focuses on the safety of exercise in MS based on the reporting of relapses and other adverse events, and the last section describes guidelines for exercise. The paper concludes with a discussion of major limitations with the existing body of research and highlights some of the pressing areas for future research on exercise in MS.

Infant gastro-oesophageal reflux disease (GORD): Australian GP attitudes and practices.

PubMed

Kirby, Catherine N; Segal, Ahuva Y; Hinds, Rupert; Jones, Kay M; Piterman, Leon

2016-01-01

The aim of this study was to evaluate the attitudes and practices of Australian general practitioners (GPs) regarding infant gastro-oesophageal reflux disease (GORD) diagnosis and management. A national cross-sectional survey, involving a random sample of currently practising Australian GPs (n = 2319) was undertaken between July and September 2011. GPs attitudes and management of infant GORD were surveyed via an online and paper-based 41-item questionnaire. In total, 400 responses were analysed (17.24% response rate). The majority of GPs employed empirical trials of acid-suppression medication and/or lifestyle modifications to diagnose infant GORD. GPs frequently recommended dietary modification despite the belief that they were only moderately effective at best. In addition, GPs frequently prescribed acid-suppression medication, despite concerns regarding their safety in the infant population. Other GP concerns included the lack of clinical guidelines and education for GPs about infant GORD, as well as the level of evidence available for the safety and efficacy of diagnostic tests and treatments. Despite the important role Australian GPs play in the diagnosis and management of infant GORD, high-level evidence-based guidelines for GPs are lacking. Consequently, GPs engage in diagnostic and management practices despite their concerns regarding the safety and effectiveness. © 2015 The Authors. Journal of Paediatrics and Child Health © 2015 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Measure Guideline: Combustion Safety for Natural Draft Appliances Through Appliance Zone Isolation

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

Fitzgerald, J.; Bohac, D.

2014-04-01

This measure guideline covers how to assess and carry out the isolation of natural draft combustion appliances from the conditioned space of low-rise residential buildings. It deals with combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage. This subset of houses does not require comprehensive combustion safety tests and simplified prescriptive procedures can be used to address safety concerns. This allows residential energy retrofit contractors inexperienced in advanced combustion safety testing to effectively address combustion safety issues and allow energy retrofitsmore » including tightening and changes to distribution and ventilation systems to proceed.« less

Evolving therapies for the management of chronic and acute decompensated heart failure.

PubMed

Cook, Jennifer C; Tran, Richard H; Patterson, J Herbert; Rodgers, Jo E

2016-11-01

The pharmacology, clinical efficacy, and safety profiles of evolving therapies for the management of chronic heart failure (HF) and acute decompensated heart failure (ADHF) are described. HF confers a significant financial burden despite the widespread use of traditional guideline-directed medical therapies such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, β-blockers, and aldosterone receptor antagonists, and the rates of HF-related mortality and hospitalization have remained unacceptably high. In response to a demand for novel pharmacologic agents, several therapeutic compounds have recently gained approval or are currently under review by the Food and Drug Administration. Sacubitril-valsartan has demonstrated benefit in reducing cardiovascular mortality and HF-related hospitalizations in clinical trials, while ivabradine and ferric carboxymaltose have proven efficacious in reducing HF-related hospitalizations. Lastly, the role of serelaxin in ADHF is currently under investigation in an ongoing Phase III study. While large, outcome-driven clinical trials are fundamental in informing the clinical application of these therapeutic agents, careful patient selection is imperative to ensuring similar outcomes postmarketing. In addition, optimization of current guideline-directed medical therapy remains essential as new therapies emerge and are incorporated into guideline recommendations. Additional therapeutic agents currently undergoing investigation include bucindolol hydrochloride, cimaglermin alfa, nitroxyl, omecamtiv mecarbil, TRV027, and ularitide. Clinical practitioners should remain abreast of emerging literature so that new therapeutic entities are optimally applied and positive patient outcomes are achieved. Recently introduced agents for the treatment of patients with HF include sacubitril-valsartan, ivabradine, and ferric carboxymaltose. Additional agents worthy of attention include serelaxin and other therapies currently under investigation. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Safety parameter considerations of anodal transcranial Direct Current Stimulation in rats.

PubMed

Jackson, Mark P; Truong, Dennis; Brownlow, Milene L; Wagner, Jessica A; McKinley, R Andy; Bikson, Marom; Jankord, Ryan

2017-08-01

A commonly referenced transcranial Direct Current Stimulation (tDCS) safety threshold derives from tDCS lesion studies in the rat and relies on electrode current density (and related electrode charge density) to support clinical guidelines. Concerns about the role of polarity (e.g. anodal tDCS), sub-lesion threshold injury (e.g. neuroinflammatory processes), and role of electrode montage across rodent and human studies support further investigation into animal models of tDCS safety. Thirty-two anesthetized rats received anodal tDCS between 0 and 5mA for 60min through one of three epicranial electrode montages. Tissue damage was evaluated using hemotoxylin and eosin (H&E) staining, Iba-1 immunohistochemistry, and computational brain current density modeling. Brain lesion occurred after anodal tDCS at and above 0.5mA using a 25.0mm 2 electrode (electrode current density: 20.0A/m 2 ). Lesion initially occurred using smaller 10.6mm 2 or 5.3mm 2 electrodes at 0.25mA (23.5A/m 2 ) and 0.5mA (94.2A/m 2 ), respectively. Histological damage was correlated with computational brain current density predictions. Changes in microglial phenotype occurred in higher stimulation groups. Lesions were observed using anodal tDCS at an electrode current density of 20.0A/m 2 , which is below the previously reported safety threshold of 142.9A/m 2 using cathodal tDCS. The lesion area is not simply predicted by electrode current density (and so not by charge density as duration was fixed); rather computational modeling suggests average brain current density as a better predictor for anodal tDCS. Nonetheless, under the assumption that rodent epicranial stimulation is a hypersensitive model, an electrode current density of 20.0A/m 2 represents a conservative threshold for clinical tDCS, which typically uses an electrode current density of 2A/m 2 when electrodes are placed on the skin (resulting in a lower brain current density). Copyright © 2017 Elsevier Inc. All rights reserved.

Global perspectives on ensuring the safety of pharmaceutical products in the distribution process
.

PubMed

Jeong, Sohyun; Ji, Eunhee

2018-01-01

The distribution of counterfeit or falsified drugs is increasing worldwide. This can contribute to the high burden of disease and cost to society and is of global concern with the worldwide circulation of pharmaceuticals. The preparation and implementation of good distribution practice should be one of the most important aspects of ensuring safe drug circulation and administration. This research aimed to compare and analyze good distribution practice guidelines from advanced countries and international organizations, and to evaluate the status of the current good distribution practice guidelines in the world. Advanced pharmaceutical countries and international organizations, such as the World Health Organization, European Union, Pharmaceutical Inspection Co-operation Scheme, United States of America, Canada, and Australia, which have stable good distribution practice guidelines and public confidence, were included in the analysis. The World Health Organization and European Union guidelines are models for standardized good distribution practice for nations worldwide. The United States of America has a combination of four different series of distribution practices which have a unique structure and detailed content compared to those of other countries. The Canadian guidelines focus on temperature control during storage and transportation. The Australian guidelines apply to both classes of medicinal products and medical devices and need separate standardization. Transparent information about the Internet chain, international cooperation regarding counterfeiting, a high-standard qualification of sellers and customers, and technology to track and trace the whole life cycle of drugs should be the main focus of future good distribution practice guidelines worldwide.
.

Optimizing the Design of Preprinted Orders for Ambulatory Chemotherapy: Combining Oncology, Human Factors, and Graphic Design

PubMed Central

Jeon, Jennifer; White, Rachel E.; Hunt, Richard G.; Cassano-Piché, Andrea L.; Easty, Anthony C.

2012-01-01

Purpose: To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. Methods: Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. Results: The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. Conclusion: Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards. PMID:23077436

Optimizing the design of preprinted orders for ambulatory chemotherapy: combining oncology, human factors, and graphic design.

PubMed

Jeon, Jennifer; White, Rachel E; Hunt, Richard G; Cassano-Piché, Andrea L; Easty, Anthony C

2012-03-01

To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards.

Guidelines for evaluating the efficacy and safety of live anticoccidial vaccines, and obtaining approval for their use in chickens and turkeys.

PubMed

Chapman, H D; Roberts, B; Shirley, M W; Williams, R B

2005-08-01

These guidelines are intended to aid those engaged in poultry research in the design, implementation and interpretation of laboratory, floor-pen and field studies for the assessment of the efficacy and safety of live anticoccidial vaccines for immunization of chickens and turkeys against Eimeria species. In addition to efficacy and safety requirements, manufacture, quality control and licensing considerations are discussed. The guidelines do not address subunit vaccines comprising non-viable material, but many of the principles described will be relevant to such vaccines if they are developed in the future. Guidelines are available in some countries for avian vaccines of bacterial or viral origin but specific standards for anticoccidial vaccines in poultry have not, as far as we know, been produced. Information is provided on general requirements of registration authorities (based upon regulations applicable in the European Union and the USA) for obtaining marketing authorizations for vaccines. These guidelines may assist poultry specialists in providing specific information for administrators involved in the decision-making process leading to registration of new vaccines, and are intended to facilitate the worldwide adoption of consistent, standard procedures.

ACCF/AHA methodology for the development of quality measures for cardiovascular technology: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures.

PubMed

Bonow, Robert O; Douglas, Pamela S; Buxton, Alfred E; Cohen, David J; Curtis, Jeptha P; Delong, Elizabeth; Drozda, Joseph P; Ferguson, T Bruce; Heidenreich, Paul A; Hendel, Robert C; Masoudi, Frederick A; Peterson, Eric D; Taylor, Allen J

2011-09-27

Consistent with the growing national focus on healthcare quality, the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have taken a leadership role over the past decade in developing measures of the quality of cardiovascular care by convening a joint ACCF/AHA Task Force on Performance Measures. The Task Force is charged with identifying the clinical topics appropriate for the development of performance measures and with assembling writing committees composed of clinical and methodological experts in collaboration with appropriate subspecialty societies. The Task Force has also created methodology documents that offer guidance in the development of process, outcome, composite, and efficiency measures. Cardiovascular performance measures using existing ACCF/AHA methodology are based on Class I or Class III guidelines recommendations, usually with Level A evidence. These performance measures, based on evidence-based ACCF/AHA guidelines, remain the most rigorous quality measures for both internal quality improvement and public reporting. However, many of the tools for diagnosis and treatment of cardiovascular disease involve advanced technologies, such as cardiac imaging, for which there are often no underlying guideline documents. Because these technologies affect the quality of cardiovascular care and also have the potential to contribute to cardiovascular health expenditures, there is a need for more critical assessment of the use of technology, including the development of quality and performance measures in areas in which guideline recommendations are absent. The evaluation of quality in the use of cardiovascular technologies requires consideration of multiple parameters that differ from other healthcare processes. The present document describes methodology for development of 2 new classes of quality measures in these situations, appropriate use measures and structure/safety measures. Appropriate use measures are based on specific indications, processes, or parameters of care for which high level of evidence data and Class I or Class III guideline recommendations may be lacking but are addressed in ACCF appropriate use criteria documents. Structure/safety measures represent measures developed to address structural aspects of the use of healthcare technology (e.g., laboratory accreditation, personnel training, and credentialing) or quality issues related to patient safety when there are neither guidelines recommendations nor appropriate use criteria. Although the strength of evidence for appropriate use measures and structure/safety measures may not be as strong as that for formal performance measures, they are quality measures that are otherwise rigorously developed, reviewed, tested, and approved in the same manner as ACCF/AHA performance measures. The ultimate goal of the present document is to provide direction in defining and measuring the appropriate use-avoiding not only underuse but also overuse and misuse-and proper application of cardiovascular technology and to describe how such appropriate use measures and structure/safety measures might be developed for the purposes of quality improvement and public reporting. It is anticipated that this effort will help focus the national dialogue on the use of cardiovascular technology and away from the current concerns about volume and cost alone to a more holistic emphasis on value.

40 CFR 243.201 - Safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 25 2011-07-01 2011-07-01 false Safety. 243.201 Section 243.201 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE STORAGE... Procedures § 243.201 Safety. ...

40 CFR 243.201 - Safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Safety. 243.201 Section 243.201 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE STORAGE... Procedures § 243.201 Safety. ...

78 FR 24817 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

...The National Highway Traffic Safety Administration (NHTSA) is concerned about the effects of distraction on motor vehicle safety due to drivers' use of electronic devices. Consequently, NHTSA is issuing nonbinding, voluntary Driver Distraction Guidelines (NHTSA Guidelines) to promote safety by discouraging the introduction of excessively distracting devices in vehicles. This notice announces the issuance of the final version of the first phase of the NHTSA Guidelines. This first phase applies to original equipment (OE) in-vehicle electronic devices used by the driver to perform secondary tasks (communications, entertainment, information gathering, navigation tasks, etc. are considered secondary tasks) through visual-manual means (i.e., the driver looks at a device, manipulates a device-related control with his or her hand, and/or watches for visual feedback). The NHTSA Guidelines list certain secondary tasks believed by the agency to interfere inherently with a driver's ability to safely control the vehicle. The NHTSA Guidelines recommend that in-vehicle devices be designed so that they cannot be used by the driver to perform these inherently distracting secondary tasks while driving. For all other visual-manual secondary tasks, the NHTSA Guidelines specify a test method for measuring eye glance behavior during those tasks. Eye glance metrics are compared to acceptance criteria to evaluate whether a task interferes too much with driver attention, rendering it unsuitable for a driver to perform while driving. If a task does not meet the acceptance criteria, the NHTSA Guidelines recommend that the task be made inaccessible for performance by the driver while driving. In addition, the NHTSA Guidelines contain several recommendations to limit and reduce the potential for distraction associated with the use of OE in-vehicle electronic devices.

C-B3-03: Development and Pilot Testing of Guidelines to Monitor High-Risk Medications in the Ambulatory Setting

PubMed Central

Tjia, Jennifer; Field, Terry; Garber, Lawrence; Raebel, Marsha; Donovan, Jennifer; Kanaan, Abir; Fischer, Shira; Gagne, Shawn; Zhao, Yanfang; Fuller, Jackie; Gurwitz, Jerry

2010-01-01

Background: Inadequate laboratory monitoring of high-risk medications contributes to preventable adverse drug events. One barrier to appropriate monitoring is lack of standardized monitoring guidelines. The study aims were to develop guidelines to monitor high-risk medications and to assess the prevalence of laboratory testing for these medications in a multispecialty group practice. Methods: We developed guidelines for laboratory monitoring of high-risk medications as part of a patient safety intervention trial. An advisory committee of national experts and local leaders (clinicians, pharmacists, pharmacoepidemiologists, and patient safety experts) used a two-round, internet-based Delphi process to select guideline medications based on the importance of monitoring for efficacy, safety, and drug-drug interactions. Test frequency recommendations were developed by academic pharmacists based on literature review and local interdisciplinary consensus. To estimate the potential impact of the intervention, we determined the prevalence of high-risk drug dispensings and laboratory testing for guideline medications between January 1, 2008 and July 31, 2008. Results: Consensus on medications to include in the guidelines was achieved in two rounds. Final guidelines included 35 drugs/drug classes and 61 laboratory tests. The prevalence of monitoring ranged from <50% to >90%, with infrequently prescribed drugs having a lower prevalence of recommended testing. When more than one test was recommended for a selected medication, monitoring within a medication sometimes differed by > 50%. Conclusions: Even among drugs where there is general consensus that laboratory monitoring is important, prevalence of monitoring is highly variable. Further, infrequently prescribed medications are at higher risk for poor monitoring.

Hydroxychloroquine: balancing the need to maintain therapeutic levels with ocular safety: an update.

PubMed

Abdulaziz, Nada; Shah, Anjali R; McCune, William J

2018-05-01

Antimalarial drugs including chloroquine, its less toxic quinolone-derivative hydroxychloroquine (HCQ), and quinacrine have become cornerstones in the treatment of autoimmune diseases including systemic lupus, rheumatoid arthritis, sarcoidosis, and Sjogren syndrome; cutaneous disorders, antiphospholipid syndrome, and have recently been employed at higher dioses in oncology. Benefits include anti-inflammatory effects, protection against thrombosis, and improved control of hyperglycemia and hyperlipidemia. In general, both the therapeutic advantages and the toxic effects of the drugs correlate with the dose and the duration of therapy. Here we summarize the current literature regarding the administration and the safety profile of HCQ in management of rheumatologic disease and focus on the most recent revised American Academy of Ophthalmology (AAO) guidelines for prevention and detection of hydroxychloroquine retinopathy to help guide therapeutic decision-making for patients. The risk of antimalarial-induced retinal toxicity is better predicted by calculating the daily dosage based on 5 mg/kg total body weight rather than 6.5 mg/kg lean body weight and reducing dosage in patients with risk factors such as renal failure. The risk of retinal toxicity after 5 years is substantially increased even when these guidelines are followed; hence dose reduction is appropriate with long-term use. Newer techniques provide improved detection of early signs of retinal damage. These advances are reflected in the revised AAO guidelines 2016, which are in part based on the retrospective study by Melles and Marmor of HCQ toxicity. The most important changes in practice guidelines include dose calculation based on total body weight, dose reduction after long-term use, and intensified screening with techniques including optical coherence tomography (OCT) after 5 years.

Improved guidelines for estimating the Highway safety manual calibration factors.

DOT National Transportation Integrated Search

2016-01-01

Crash prediction models can be used to predict the number of crashes and evaluate roadway safety. Part C of the first edition of the Highway Safety Manual (HSM) provides safety performance functions (SPFs). The HSM addendum that includes freeway and ...

Handbook for Public Playground Safety.

ERIC Educational Resources Information Center

Consumer Product Safety Commission, Washington, DC.

Playgrounds, being a fundamental part of the childhood experience, should be safe havens for children. This handbook includes technical safety guidelines for designing, constructing, operating, and maintaining public playgrounds. It also includes a "Public Playground Safety Checklist" to highlight some of the most important safety issues…

Can patients be sure they are fully informed when representatives of surgical equipment manufacturers attend their operations?

PubMed Central

Sillender, M

2006-01-01

Objective To determine the practice in UK hospitals regarding the level of patient involvement and consent when representatives of commercial surgical device manufacturers attend and advise during operations. Methods An anonymous postal questionnaire was sent to the senior nurse in charge in all 236 UK gynaecology theatres in 2004. 79/236 (33%) replies were received. Results Operating departments were visited every 2 weeks on average by a representative of the surgical device manufacturer. Actual operations were attended every 10 weeks, although there was much variation. 33/79 (42%) units consistently obtained patient consent for visits, usually orally, whereas 40/79 (51%) units did not. 65/79 (82%) units had no guidelines for surgical device representative visits. 91% of nurses in charge believed that there should be guidelines to protect both patients and staff. 6/79 (8%) units were preparing local guidelines at the time of the survey. Conclusions Currently, patient safety, confidentiality and autonomy are being protected by a minority of NHS operating theatres when surgical device representatives attend surgery. National guidelines would hopefully ensure that fully informed patient consent is obtained and that representatives are fully trained and supervised. PMID:16816038

Guidelines for the evaluation and assessment of the sustainable use of resources and of wastes management at healthcare facilities.

PubMed

Townend, William K; Cheeseman, Christopher R

2005-10-01

This paper presents guidelines that can be used by managers of healthcare facilities to evaluate and assess the quality of resources and waste management at their facilities and enabling the principles of sustainable development to be addressed. The guidelines include the following key aspects which need to be considered when completing an assessment. They are: (a) general management; (b) social issues; (c) health and safety; (d) energy and water use; (e) purchasing and supply; (f) waste management (responsibility, segregation, storage and packaging); (g) waste transport; (h) recycling and re-use; (i) waste treatment; and (j) final disposal. They identify actions required to achieve a higher level of performance which can readily be applied to any healthcare facility, irrespective of the local level of social, economic and environmental development. The guidelines are presented, and the characteristics of facilities associated with sustainable (level 4) and unsustainable (level 0) healthcare resource and wastes management are outlined. They have been used to assess a major London hospital, and this highlighted a number of deficiencies in current practice, including a lack of control over purchasing and supply, and very low rates of segregation of municipal solid waste from hazardous healthcare waste.

Probability of Failure Analysis Standards and Guidelines for Expendable Launch Vehicles

NASA Astrophysics Data System (ADS)

Wilde, Paul D.; Morse, Elisabeth L.; Rosati, Paul; Cather, Corey

2013-09-01

Recognizing the central importance of probability of failure estimates to ensuring public safety for launches, the Federal Aviation Administration (FAA), Office of Commercial Space Transportation (AST), the National Aeronautics and Space Administration (NASA), and U.S. Air Force (USAF), through the Common Standards Working Group (CSWG), developed a guide for conducting valid probability of failure (POF) analyses for expendable launch vehicles (ELV), with an emphasis on POF analysis for new ELVs. A probability of failure analysis for an ELV produces estimates of the likelihood of occurrence of potentially hazardous events, which are critical inputs to launch risk analysis of debris, toxic, or explosive hazards. This guide is intended to document a framework for POF analyses commonly accepted in the US, and should be useful to anyone who performs or evaluates launch risk analyses for new ELVs. The CSWG guidelines provide performance standards and definitions of key terms, and are being revised to address allocation to flight times and vehicle response modes. The POF performance standard allows a launch operator to employ alternative, potentially innovative methodologies so long as the results satisfy the performance standard. Current POF analysis practice at US ranges includes multiple methodologies described in the guidelines as accepted methods, but not necessarily the only methods available to demonstrate compliance with the performance standard. The guidelines include illustrative examples for each POF analysis method, which are intended to illustrate an acceptable level of fidelity for ELV POF analyses used to ensure public safety. The focus is on providing guiding principles rather than "recipe lists." Independent reviews of these guidelines were performed to assess their logic, completeness, accuracy, self- consistency, consistency with risk analysis practices, use of available information, and ease of applicability. The independent reviews confirmed the general validity of the performance standard approach and suggested potential updates to improve the accuracy each of the example methods, especially to address reliability growth.

Safety pharmacology — Current and emerging concepts

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

Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor

2013-12-01

Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combiningmore » toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. - Highlights: • SP — mandatory non-clinical risk assessments performed during drug development. • SP organ system studies ensure the safety of clinical participants in FiH trials. • Frontloading in SP facilitates lead candidate drug selection. • Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests.« less

Guidelines for the selection of chemical protective clothing. 1991 Update: Performance, availability, and sources of chemical protective clothing

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

Johnson, J.S.; Schwope, A.D.; Goydan, R.

1991-12-31

The selection, acquisition, and use of chemical protective clothing (CPC) at Department of Energy (DOE) facilities require up-to-date data and information on the performance, availability, and sources of such clothing. There are hundreds of types and more than one hundred principal manufacturers of CPC. Information on CPC is published in manufacturers` brochures and the technical literature. These information sources, however, have no standard format or terminology for describing products or the results of product testing. Furthermore, the literature and information is continually changing and growing. Consequently, DOE`s industrial hygienists and safety specialists are frequently confounded in their efforts to providemore » effective CPC to workers, by they in the field, the laboratory, or the plant. In recognition of the many advances and changes that have occurred and of the need to provide current information to its health and safety staff, the DOE has updated and modified the key appendices of the Guidelines/Chemical Protective Clothing. The updates appendices compose the majority of this update document, wherein they are called Sections. Each Section begins with a description of its format, content, abbreviations, units, and links with other Sections, as appropriate.« less

Management of Naturally Occurring Radioactive Materials (NORM) in Canada

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

Baweja, Anar S.; Tracy, Bliss L.

2008-08-07

In Canada, nuclear and radiological regulatory responsibilities are shared between the provinces/territories and the federal government. The Canadian Nuclear Safety Commission (CNSC) regulates nuclear fuel cycle materials and man-made radionuclides under the Nuclear Safety and Control Act (2000). The provinces and territories regulate NORM arising from industrial activities, not involving the nuclear fuel cycle materials. Present guideline--Canadian Guidelines for the Management of Naturally Occurring Radioactive Materials (NORM)--was published in 2000 in order to bring uniformity to the management of NORM-related procedures to provide adequate radiation protection for workers and the general public. The basic premise of these guidelines is thatmore » the NORM-related activities should not be posing any greater hazard than those activities regulated under the Nuclear Safety and Control Act; these concepts are described in this paper.« less

Injury risk curves for the WorldSID 50th male dummy.

PubMed

Petitjean, Audrey; Trosseille, Xavier; Praxl, Norbert; Hynd, David; Irwin, Annette

2012-10-01

The development of the WorldSID 50th percentile male dummy was initiated in 1997 by the International Organisation for Standardisation (ISO/TC22/SC12/WG5) with the objective of developing a more biofidelic side impact dummy and supporting the adoption of a harmonised dummy into regulations. The dummy is currently under evaluation at the Working Party on Passive Safety (GRSP) in order to be included in the pole side impact global technical regulation (GTR). Injury risk curves dedicated to this dummy and built on behalf of ISO/TC22/SC12/WG6 were proposed in order to assess the occupant safety performance (Petitjean et al. 2009). At that time, there was no recommendation yet on the injury criteria and no consensus on the most accurate statistical method to be used. Since 2009, ISO/TC22/SC12/WG6 reached a consensus on the definition of guidelines to build injury risk curves, including the use of the survival analysis, the distribution assessment and quality checks. These guidelines were applied to the WorldSID 50th results published in 2009 in order to be able to provide a final set of injury risk curves recommended by ISO/TC22/SC12/WG6. The paper presents the different steps of the guidelines as well as the recommended injury risk curves dedicated to the WorldSID 50th for lateral shoulder load, thoracic rib deflection, abdomen rib deflection and pubic force.

Safety in the Preschool.

ERIC Educational Resources Information Center

Settles, Mimi

Guidelines for safety in the cooperative preschool are outlined, emphasizing control of the physical environment to insure maximum freedom for the children compatible with maximum safety. Building standards are set for stairways, rooms, lavatories, parking lots, harmful supplies, and wading pools. Orientation for safety is discussed in regard to…

Occupational safety and health aspects of corporate social responsibility (CSR) in Japanese companies listed on the Tokyo Stock Exchange (TSE) first section.

PubMed

Kawashita, Futoshi; Taniyama, Yukari; Hwi, Song You; Fujisaki, Takeshi; Kameda, Takashi; Mori, Koji

2005-11-01

Recently, corporate social responsibility (CSR) is becoming widely recognized as an issue for Japanese companies. Corporate responsibility for employees is considered important by various stakeholders, and occupational safety and health is regarded as one of these responsibilities. The present authors examined this issue from the viewpoint of corporate management by analysis of statements found in CSR-related reports. For companies listed on the First Section of the Tokyo Stock Exchange (TSE), we searched for CSR-related reports, and titles and contents, based on two established guidelines: the GRI Sustainability Reporting Guidelines 2002 as the international reference and the Environmental Reporting Guidelines of the Ministry of the Environment, Government of Japan, as the domestic reference. Corporations that published CSR reports were 26.3% (416/1,581) of the total, and large differences were recognized by type of industry. Comparing the numbers of pages for various contents, more concern was shown about the environment than about social activity, indicating the environment to be the main issue of CSR in Japan. In the items included in the guidelines, many matters about occupational accidents were mentioned, but it was found that statements regarding HIV/AIDS, which is not of such strong social concern in Japan, and statements regarding the costs of safety that are difficult to calculate were few. However, statements regarding mental health, which is of high interest socially, were many, even though this issue is not included in the two guidelines used. In revising the guidelines, these matters should be reviewed. In the future, continuance of analysis of CSR-related reports with regard to changes and comparisons with overseas reports will help improve occupational safety and health.

[Implementation of a safety and health planning system in a teaching hospital].

PubMed

Mariani, F; Bravi, C; Dolcetti, L; Moretto, A; Palermo, A; Ronchin, M; Tonelli, F; Carrer, P

2007-01-01

University Hospital "L. Sacco" had started in 2006 a two-year project in order to set up a "Health and Safety Management System (HSMS)" referring to the technical guideline OHSAS 18001:1999 and the UNI and INAIL "Guidelines for a health and safety management system at workplace". So far, the following operations had been implemented: Setting up of a specific Commission within the Risk Management Committee; Identification and appointment of Departmental Representatives of HSMS; Carrying out of a training course addressed to Workers Representatives for Safety and Departmental Representatives of HSMS; Development of an Integrated Informative System for Prevention and Safety; Auditors qualification; Inspection of the Occupational Health Unit and the Prevention and Safety Service: reporting of critical situations and monitoring solutions adopted. Short term objectives are: Self-evaluation through check-lists of each department; Sharing of the Improvement Plan among the departments of the hospital; Planning of Health and Safety training activities in the framework of the Hospital Training Plan; Safety audit.

Treatment recommendations for DSM-5-defined mixed features.

PubMed

Rosenblat, Joshua D; McIntyre, Roger S

2017-04-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) mixed features specifier provides a less restrictive definition of mixed mood states, compared to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), including mood episodes that manifest with subthreshold symptoms of the opposite mood state. A limited number of studies have assessed the efficacy of treatments specifically for DSM-5-defined mixed features in mood disorders. As such, there is currently an inadequate amount of data to appropriately inform evidence-based treatment guidelines of DSM-5 defined mixed features. However, given the high prevalence and morbidity of mixed features, treatment recommendations based on the currently available evidence along with expert opinion may be of benefit. This article serves to provide these interim treatment recommendations while humbly acknowledging the limited amount of evidence currently available. Second-generation antipsychotics (SGAs) appear to have the greatest promise in the treatment of bipolar disorder (BD) with mixed features. Conventional mood stabilizing agents (ie, lithium and divalproex) may also be of benefit; however, they have been inadequately studied. In the treatment of major depressive disorder (MDD) with mixed features, the comparable efficacy of antidepressants versus other treatments, such as SGAs, remains unknown. As such, antidepressants remain first-line treatment of MDD with or without mixed features; however, there are significant safety concerns associated with antidepressant monotherapy when mixed features are present, which merits increased monitoring. Lurasidone is the only SGA monotherapy that has been shown to be efficacious specifically in the treatment of MDD with mixed features. Further research is needed to accurately determine the efficacy, safety, and tolerability of treatments specifically for mood episodes with mixed features to adequately inform future treatment guidelines.

Standard Guidelines of Care: Performing Procedures in Patients on or Recently Administered with Isotretinoin

PubMed Central

Mysore, Venkataram; Mahadevappa, Omprakash H.; Barua, Shyamanta; Majid, Imran; Viswanath, Vishalakshi; Bhat, Ramesh M.; Talwar, Suresh; Thurakkal, Salim; Aurangabadkar, Sanjeev J.; Chatterjee, Manas; Ganjoo, Anil

2017-01-01

Background: Currently, the standard protocol regarding the performance of procedures on patients receiving or having recently received isotretinoin (13-cis-retinoic acid) states that the procedures should not be performed. The recommendations in standard books and drug insert require discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. These recommendations have been followed for over two decades despite little evidence for the stated increased risk of scarring. Objective: The Association of Cutaneous Surgeons (I) constituted a task force to review the evidence and to recommend consensus guidelines regarding the safety of skin procedures, including resurfacing, energy-device treatments, and dermatosurgical procedures in patients with concurrent or recent isotretinoin administration. Materials and Methods: Data were extracted from the literature through a PubMed search using the keywords “isotretinoin,” “safety,” “scarring,” “keloids,” “hypertrophic scarring,” and “pigmentation.” The evidence was then labeled and circulated to all members of task force for review. Results: The task force is of the opinion that there is insufficient evidence to support the current protocol of avoiding and delaying treatments in the patient group under consideration and recommends that the current practice should be discontinued. The task force concludes that performing procedures such as laser hair removal, fractional lasers for aging and acne scarring, lasers for pigmented skin lesions, fractional radio-frequency microneedling, superficial and medium-depth peels, microdermabrasion, dermaroller, biopsies, radio-frequency ablation, and superficial excisions is safe in patients with concurrent or recent isotretinoin administration. PMID:29491653

Breast Cancer Screening and Social Media: a Content Analysis of Evidence Use and Guideline Opinions on Twitter.

PubMed

Nastasi, Anthony; Bryant, Tyler; Canner, Joseph K; Dredze, Mark; Camp, Melissa S; Nagarajan, Neeraja

2018-06-01

There is ongoing debate regarding the best mammography screening practices. Twitter has become a powerful tool for disseminating medical news and fostering healthcare conversations; however, little work has been done examining these conversations in the context of how users are sharing evidence and discussing current guidelines for breast cancer screening. To characterize the Twitter conversation on mammography and assess the quality of evidence used as well as opinions regarding current screening guidelines, individual tweets using mammography-related hashtags were prospectively pulled from Twitter from 5 November 2015 to 11 December 2015. Content analysis was performed on the tweets by abstracting data related to user demographics, content, evidence use, and guideline opinions. Standard descriptive statistics were used to summarize the results. Comparisons were made by demographics, tweet type (testable claim, advice, personal experience, etc.), and user type (non-healthcare, physician, cancer specialist, etc.). The primary outcomes were how users are tweeting about breast cancer screening, the quality of evidence they are using, and their opinions regarding guidelines. The most frequent user type of the 1345 tweets was "non-healthcare" with 323 tweets (32.5%). Physicians had 1.87 times higher odds (95% CI, 0.69-5.07) of providing explicit support with a reference and 11.70 times higher odds (95% CI, 3.41-40.13) of posting a tweet likely to be supported by the scientific community compared to non-healthcare users. Only 2.9% of guideline tweets approved of the guidelines while 14.6% claimed to be confused by them. Non-healthcare users comprise a significant proportion of participants in mammography conversations, with tweets often containing claims that are false, not explicitly backed by scientific evidence, and in favor of alternative "natural" breast cancer prevention and treatment. Furthermore, users appear to have low approval and confusion regarding screening guidelines. These findings suggest that more efforts are needed to educate and disseminate accurate information to the general public regarding breast cancer prevention modalities, emphasizing the safety of mammography and the harms of replacing conventional prevention and treatment modalities with unsubstantiated alternatives.

Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.

ERIC Educational Resources Information Center

Renfrew, Malcolm M., Ed.; Palladino, George F.

1980-01-01

Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)

Endovascular therapy of acute ischemic stroke: report of the Standards of Practice Committee of the Society of NeuroInterventional Surgery.

PubMed

Blackham, K A; Meyers, P M; Abruzzo, T A; Albuquerque, F C; Alberquerque, F C; Fiorella, D; Fraser, J; Frei, D; Gandhi, C D; Heck, D V; Hirsch, J A; Hsu, D P; Hussain, M Shazam; Jayaraman, M; Narayanan, S; Prestigiacomo, C; Sunshine, J L

2012-03-01

To summarize and classify the evidence for the use of endovascular techniques in the treatment of patients with acute ischemic stroke. Recommendations previously published by the American Heart Association (AHA) (Guidelines for the early management of adults with ischemic stroke (Circulation 2007) and Scientific statement indications for the performance of intracranial endovascular neurointerventional procedures (Circulation 2009)) were vetted and used as a foundation for the current process. Building on this foundation, a critical review of the literature was performed to evaluate evidence supporting the endovascular treatment of acute ischemic stroke. The assessment was based on guidelines for evidence based medicine proposed by the Stroke Council of the AHA and the University of Oxford, Centre for Evidence Based Medicine (CEBM). Procedural safety, technical efficacy and impact on patient outcomes were specifically examined.

Guidelines for safe work practices in human and animal medical diagnostic laboratories. Recommendations of a CDC-convened, Biosafety Blue Ribbon Panel.

PubMed

Miller, J Michael; Astles, Rex; Baszler, Timothy; Chapin, Kimberle; Carey, Roberta; Garcia, Lynne; Gray, Larry; Larone, Davise; Pentella, Michael; Pollock, Anne; Shapiro, Daniel S; Weirich, Elizabeth; Wiedbrauk, Danny

2012-01-06

Prevention of injuries and occupational infections in U.S. laboratories has been a concern for many years. CDC and the National Institutes of Health addressed the topic in their publication Biosafety in Microbiological and Biomedical Laboratories, now in its 5th edition (BMBL-5). BMBL-5, however, was not designed to address the day-to-day operations of diagnostic laboratories in human and animal medicine. In 2008, CDC convened a Blue Ribbon Panel of laboratory representatives from a variety of agencies, laboratory organizations, and facilities to review laboratory biosafety in diagnostic laboratories. The members of this panel recommended that biosafety guidelines be developed to address the unique operational needs of the diagnostic laboratory community and that they be science based and made available broadly. These guidelines promote a culture of safety and include recommendations that supplement BMBL-5 by addressing the unique needs of the diagnostic laboratory. They are not requirements but recommendations that represent current science and sound judgment that can foster a safe working environment for all laboratorians. Throughout these guidelines, quality laboratory science is reinforced by a common-sense approach to biosafety in day-to-day activities. Because many of the same diagnostic techniques are used in human and animal diagnostic laboratories, the text is presented with this in mind. All functions of the human and animal diagnostic laboratory--microbiology, chemistry, hematology, and pathology with autopsy and necropsy guidance--are addressed. A specific section for veterinary diagnostic laboratories addresses the veterinary issues not shared by other human laboratory departments. Recommendations for all laboratories include use of Class IIA2 biological safety cabinets that are inspected annually; frequent hand washing; use of appropriate disinfectants, including 1:10 dilutions of household bleach; dependence on risk assessments for many activities; development of written safety protocols that address the risks of chemicals in the laboratory; the need for negative airflow into the laboratory; areas of the laboratory in which use of gloves is optional or is recommended; and the national need for a central site for surveillance and nonpunitive reporting of laboratory incidents/exposures, injuries, and infections.

Injury prevention: where do we go from here?

PubMed

Vinger, P F

1999-02-01

Most eye injuries are preventable. Military personnel, workers, athletes, and other spectacle wearers--especially children and the functionally one-eyed--who require protection from impact, should expect that safety eye-wear actually protects. To present to eye care professionals the current state-of-the-art in eye injury prevention. A review of the current eye protection standards, guidelines, and warnings for the activities of daily living, work, hobbies, education, and sports with emphasis on the importance of standards and the role of the recently organized Protective Eyewear Certification Council (PECC). The prescriber and dispenser are obliged to prescribe, fabricate, and dispense safe and effective eyewear. PECC will help the eye care professional fulfill this obligation.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance.

PubMed

Izem, Rima; Sanchez-Kam, Matilde; Ma, Haijun; Zink, Richard; Zhao, Yueqin

2018-03-01

Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. This paper discusses data sources and analysis considerations for safety signal detection after a medical product is approved for marketing. This manuscript is the second in a series of papers from the American Statistical Association Biopharmaceutical Section Safety Working Group. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from passive postmarketing surveillance systems compared to other sources. Signal detection has traditionally relied on spontaneous reporting databases that have been available worldwide for decades. However, current regulatory guidelines and ease of reporting have increased the size of these databases exponentially over the last few years. With such large databases, data-mining tools using disproportionality analysis and helpful graphics are often used to detect potential signals. Although the data sources have many limitations, analyses of these data have been successful at identifying safety signals postmarketing. Experience analyzing these dynamic data is useful in understanding the potential and limitations of analyses with new data sources such as social media, claims, or electronic medical records data.

System Guidelines for EMC Safety-Critical Circuits: Design, Selection, and Margin Demonstration

NASA Technical Reports Server (NTRS)

Lawton, R. M.

1996-01-01

Demonstration of safety margins for critical points (circuits) has traditionally been required since it first became a part of systems-level Electromagnetic Compatibility (EMC) requirements of MIL-E-6051C. The goal of this document is to present cost-effective guidelines for ensuring adequate Electromagnetic Effects (EME) safety margins on spacecraft critical circuits. It is for the use of NASA and other government agencies and their contractors to prevent loss of life, loss of spacecraft, or unacceptable degradation. This document provides practical definition and treatment guidance to contain costs within affordable limits.

Safe sleep, day and night: mothers' experiences regarding infant sleep safety.

PubMed

Lau, Annie; Hall, Wendy

2016-10-01

To explore Canadian mothers' experiences with infant sleep safety. Parents decide when, how and where to place their infants to sleep. It is anticipated that they will follow international Sudden Infant Death Syndrome prevention sleep safety guidelines. Limited evidence is available for how parents take up guidelines; no studies have explored Canadian mothers' experiences regarding infant sleep safety. An inductive qualitative descriptive study using some elements of grounded theory, including concurrent data collection and analysis and memoing. Semi-structured interviews and constant comparative analysis were employed to explore infant sleep safety experiences of 14 Canadian mothers residing in Metro Vancouver. Data collection commenced in December 2012 and ended in July 2013. The core theme, Infant Sleep Safety Cycle, represents a cyclical process encompassing sleep safety from the prenatal period to the first six months of infants' lives. The cyclical process includes five segments: mothers' expectations of sleep safety, their struggles with reality as opposed to maternal visions, modifications of expectations, provision of rationale for choices and shifts in mothers' views of infants' developmental capabilities. Mothers' experiences were influenced by four factors: perceptions of everyone's needs, familial influences, attitudes and judgments from outsiders and resource availability and accessibility. To manage infants' sleep, mothers reframed sleep safety guidelines and downplayed the risk of Sudden Infant Death Syndrome for all forms of sleep at all times. Healthcare providers can support mothers' efforts to manage their infants' sleep challenges. During prenatal and postpartum periods, providers' interventions can influence mothers' efforts to adhere to sleep safety principles. The study findings support healthcare providers' efforts to assist mothers to modify expectations and develop strategies to support sleep safety principles while acknowledging their challenges. © 2016 John Wiley & Sons Ltd.

ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis.

PubMed

Montalban, X; Gold, R; Thompson, A J; Otero-Romero, S; Amato, M P; Chandraratna, D; Clanet, M; Comi, G; Derfuss, T; Fazekas, F; Hartung, H P; Havrdova, E; Hemmer, B; Kappos, L; Liblau, R; Lubetzki, C; Marcus, E; Miller, D H; Olsson, T; Pilling, S; Selmaj, K; Siva, A; Sorensen, P S; Sormani, M P; Thalheim, C; Wiendl, H; Zipp, F

2018-02-01

Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process. This guideline has been developed using the GRADE methodology and following the recently updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. An exhaustive literature search up to December 2016 was performed for each question and the evidence is presented narratively and, when possible, combined in a meta-analysis using a random-effects model. The quality of evidence for each outcome was rated into four categories - very high, high, low and very low - according to the risk of bias. GRADE evidence profiles were created using GRADEprofiler (GRADEpro) software (Version 3.6). The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panellists was reached by use of the modified nominal group technique. A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 20 recommendations were agreed by the guideline working group members after three rounds of consensus. © 2018 European Academy of Neurology and European Committee of Treatment of Research in Multiple Sclerosis.

In vitro genotoxicity testing strategy for nanomaterials and the adaptation of current OECD guidelines

PubMed Central

Doak, S.H.; Manshian, B.; Jenkins, G.J.S.; Singh, N.

2012-01-01

There is a pressing requirement to define a hazard identification and risk management strategy for nanomaterials due to the rapid growth in the nanotechnology industry and their promise of life-style revolutions through the development of wide-ranging nano-containing consumer products. Consequently, a battery of well defined and appropriate in vitro assays to assess a number of genotoxicity endpoints is required to minimise extensive and costly in vivo testing. However, the validity of the established protocols in current OECD recognised genotoxicity assays for nanomaterials is currently being questioned. In this report, we therefore consider the in vitro OECD genotoxicity test battery including the Ames, micronucleus and HPRT forward mutation assays, and their potential role in the safety assessment of nanomaterial induced DNA damage in vitro. PMID:21971291

Healthcare system-wide implementation of opioid-safety guideline recommendations: the case of urine drug screening and opioid-patient suicide- and overdose-related events in the Veterans Health Administration.

PubMed

Brennan, Penny L; Del Re, Aaron C; Henderson, Patricia T; Trafton, Jodie A

2016-12-01

This study provides an example of how healthcare system-wide progress in implementation of opioid-therapy guideline recommendations can be longitudinally assessed and then related to subsequent opioid-prescribed patient health and safety outcomes. Using longitudinal linear mixed effects analyses, we determined that in the Department of Veterans Affairs (VA) healthcare system (n = 141 facilities), over the 4-year interval from 2010 to 2013, a key opioid therapy guideline recommendation, urine drug screening (UDS), increased from 29 to 42 %, with an average within-facility increase rate of 4.5 % per year. Higher levels of UDS implementation from 2010 to 2013 were associated with lower risk of suicide and drug overdose events among VA opioid-prescribed patients in 2013, even after adjusting for patients' 2012 demographic characteristics and medical and mental health comorbidities. Findings suggest that VA clinicians and healthcare policymakers have been responsive to the 2010 VA/Department of Defense (DOD) UDS treatment guideline recommendation, resulting in improved patient safety for VA opioid-prescribed patients.

42 CFR 81.22 - General guidelines for use of NIOSH-IREP.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES GUIDELINES FOR DETERMINING PROBABILITY OF CAUSATION... Probability of Causation § 81.22 General guidelines for use of NIOSH-IREP. DOL will use procedures specified in the NIOSH-IREP Operating Guide to calculate probability of causation estimates under EEOICPA. The...

Continuing Education, Guideline Implementation, and the Emerging Transdisciplinary Field of Knowledge Translation

ERIC Educational Resources Information Center

Davis, Dave

2006-01-01

This article discusses continuing education and the implementation of clinical practice guidelines or best evidence, quality improvement, and patient safety. Continuing education focuses on the perspective of the adult learner and is guided by well-established educational principles. In contrast, guideline implementation and related concepts…

Parameters for determining inoculated pack/challenge study protocols.

PubMed

2010-01-01

The National Advisory Committee on Microbiological Criteria for Foods developed guidelines for conducting challenge studies on pathogen inhibition and inactivation studies in a variety of foods. The document is intended for use by the food industry, including food processors, food service operators, and food retailers; federal, state, and local food safety regulators; public health officials; food testing laboratories; and process authorities. The document is focused on and limited to bacterial inactivation and growth inhibition and does not make specific recommendations with respect to public health. The Committee concluded that challenge studies should be designed considering the most current advances in methodologies, current thinking on pathogens of concern, and an understanding of the product preparation, variability, and storage conditions. Studies should be completed and evaluated under the guidance of an expert microbiologist in a qualified laboratory and should include appropriate statistical design and data analyses. This document provides guidelines for choice of microorganisms for studies, inoculum preparation, inoculum level, methods of inoculation, incubation temperatures and times, sampling considerations, and interpreting test results. Examples of appropriately designed growth inhibition and inactivation studies are provided.

Intravenous immunoglobulin in paediatric neurology: safety, adherence to guidelines, and long-term outcome.

PubMed

Nosadini, Margherita; Mohammad, Shekeeb S; Suppiej, Agnese; Sartori, Stefano; Dale, Russell C

2016-11-01

Intravenous immunoglobulin (IVIG) is an expensive therapy used in immunodeficiency and autoimmune disorders. Increasing demands and consequent shortages result in a need for usage to conform to guidelines. We retrospectively evaluated IVIG use for neuroimmunological indications and adherence to existing guidelines in a major Australian paediatric hospital between 2000 and 2014. One-hundred and ninety-six children (96 male, 100 female; mean age at disease onset 6y 5mo [range 3mo-15y 10mo], mean age at first IVIG dose 7y 2mo [range 3mo-16y 5mo]) received IVIG for neuroimmunological indications during the study period (28.1% had Guillain-Barré syndrome), representing 15.5% of all hospital indications. In total, 1669 IVIG courses were administered (total 57 221g, median 78g/patient, range 12-5748g). The highest median numbers of courses were in chronic inflammatory demyelinating polyneuropathies, opsoclonus-myoclonus ataxia syndrome, suspected immune-mediated epilepsies, and Rasmussen's encephalitis. Adverse reactions occurred in 25.5% of patients, but these were mostly minor. Outcome at follow-up was best in anti-N-methyl-d-aspartate receptor (anti-NMDAR) encephalitis, Guillain-Barré syndrome, and myasthenia gravis, and worst in Rasmussen's encephalitis and epilepsies. The total cost of IVIG was US$2 595 907 (median $3538/patient, range $544-260 766). Of patients receiving IVIG, 45.4% to 57.1% were given the therapy for 'weak' indications or indications 'not listed' in international guidelines. Some entities commonly treated with IVIG in current practice, such as anti-NMDAR encephalitis and transverse myelitis, are not listed in most guidelines. Our study demonstrates that IVIG is generally well tolerated but expensive, and discloses discrepancies between guidelines and clinical practice in paediatric neurology, suggesting both the need for greater adherence to current recommendations, and for recommendations to be updated to accommodate emerging indications. © 2016 Mac Keith Press.

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

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

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

Dressings and Products in Pediatric Wound Care

PubMed Central

King, Alice; Stellar, Judith J.; Blevins, Anne; Shah, Kara Noelle

2014-01-01

Significance: The increasing complexity of medical and surgical care provided to pediatric patients has resulted in a population at significant risk for complications such as pressure ulcers, nonhealing surgical wounds, and moisture-associated skin damage. Wound care practices for neonatal and pediatric patients, including the choice of specific dressings or other wound care products, are currently based on a combination of provider experience and preference and a small number of published clinical guidelines based on expert opinion; rigorous evidence-based clinical guidelines for wound management in these populations is lacking. Recent Advances: Advances in the understanding of the pathophysiology of wound healing have contributed to an ever-increasing number of specialized wound care products, most of which are predominantly marketed to adult patients and that have not been evaluated for safety and efficacy in the neonatal and pediatric populations. This review aims to discuss the available data on the use of both more traditional wound care products and newer wound care technologies in these populations, including medical-grade honey, nanocrystalline silver, and soft silicone-based adhesive technology. Critical Issues: Evidence-based wound care practices and demonstration of the safety, efficacy, and appropriate utilization of available wound care dressings and products in the neonatal and pediatric populations should be established to address specific concerns regarding wound management in these populations. Future Directions: The creation and implementation of evidence-based guidelines for the treatment of common wounds in the neonatal and pediatric populations is essential. In addition to an evaluation of currently marketed wound care dressings and products used in the adult population, newer wound care technologies should also be evaluated for use in neonates and children. In addition, further investigation of the specific pathophysiology of wound healing in neonates and children is indicated to promote the development of wound care dressings and products with specific applications in these populations. PMID:24761363

Precautionary Practices of Respiratory Therapists and Other Health-Care Practitioners Who Administer Aerosolized Medications

PubMed Central

Tsai, Rebecca J; Boiano, James M; Steege, Andrea L; Sweeney, Marie H

2015-01-01

BACKGROUND: Respiratory therapists (RTs) and other health-care workers are potentially exposed to a variety of aerosolized medications. The National Institute for Occupational Safety and Health (NIOSH) Health and Safety Practices Survey of Healthcare Workers describes current exposure control practices and barriers to using personal protective equipment during administration of selected aerosolized medications. METHODS: An anonymous, multi-module, web-based survey was conducted among members of health-care professional practice organizations representing RTs, nurses, and other health-care practitioners. A module on aerosolized medications included submodules for antibiotics (amikacin, colistin, and tobramycin), pentamidine, and ribavirin. RESULTS: The submodules on antibiotics, pentamidine, and ribavirin were completed by 321, 227, and 50 respondents, respectively, most of whom were RTs. The relatively low number of ribavirin respondents precluded meaningful interpretation of these data and may reflect the rare use of this drug. Consequently, analysis focused on pentamidine, classified by NIOSH as a hazardous drug, and the antibiotics amikacin, colistin, and tobramycin, which currently lack authoritative safe handling guidelines. Respondents who administered pentamidine were more likely to adhere to good work practices compared with those who administered the antibiotics. Examples included training received on safe handling procedures (75% vs 52%), availability of employer standard procedures (82% vs 55%), use of aerosol delivery devices equipped with an expiratory filter (96% vs 53%) or negative-pressure rooms (61% vs 20%), and always using respiratory protection (51% vs 13%). CONCLUSIONS: Despite the availability of safe handling guidelines for pentamidine, implementation was not universal, placing workers, co-workers, and even family members at risk of exposure. Although the antibiotics included in this study lack authoritative safe handling guidelines, prudence dictates that appropriate exposure controls be used to minimize exposure to the antibiotics and other aerosolized medications. Employers and employees share responsibility for ensuring that precautionary measures are taken to keep exposures to all aerosolized medications as low as practicable. PMID:26152473

Precautionary Practices of Respiratory Therapists and Other Health-Care Practitioners Who Administer Aerosolized Medications.

PubMed

Tsai, Rebecca J; Boiano, James M; Steege, Andrea L; Sweeney, Marie H

2015-10-01

Respiratory therapists (RTs) and other health-care workers are potentially exposed to a variety of aerosolized medications. The National Institute for Occupational Safety and Health (NIOSH) Health and Safety Practices Survey of Healthcare Workers describes current exposure control practices and barriers to using personal protective equipment during administration of selected aerosolized medications. An anonymous, multi-module, web-based survey was conducted among members of health-care professional practice organizations representing RTs, nurses, and other health-care practitioners. A module on aerosolized medications included submodules for antibiotics (amikacin, colistin, and tobramycin), pentamidine, and ribavirin. The submodules on antibiotics, pentamidine, and ribavirin were completed by 321, 227, and 50 respondents, respectively, most of whom were RTs. The relatively low number of ribavirin respondents precluded meaningful interpretation of these data and may reflect the rare use of this drug. Consequently, analysis focused on pentamidine, classified by NIOSH as a hazardous drug, and the antibiotics amikacin, colistin, and tobramycin, which currently lack authoritative safe handling guidelines. Respondents who administered pentamidine were more likely to adhere to good work practices compared with those who administered the antibiotics. Examples included training received on safe handling procedures (75% vs 52%), availability of employer standard procedures (82% vs 55%), use of aerosol delivery devices equipped with an expiratory filter (96% vs 53%) or negative-pressure rooms (61% vs 20%), and always using respiratory protection (51% vs 13%). Despite the availability of safe handling guidelines for pentamidine, implementation was not universal, placing workers, co-workers, and even family members at risk of exposure. Although the antibiotics included in this study lack authoritative safe handling guidelines, prudence dictates that appropriate exposure controls be used to minimize exposure to the antibiotics and other aerosolized medications. Employers and employees share responsibility for ensuring that precautionary measures are taken to keep exposures to all aerosolized medications as low as practicable. Copyright © 2015 by Daedalus Enterprises.

Cycling in the African American Community : safety training guidelines and findings.

DOT National Transportation Integrated Search

2013-08-01

This report is a program users manual for the Cycling in the African American Community (CAAC) safety training intervention. The CAAC safety training intervention was designed to nudge more African Americans, who are often beginning cyclists...

Recent findings relating to firefighter safety zones

Treesearch

Bret Butler; Russ Parsons; William Mell

2015-01-01

Designation of safety zones is a primary duty of all wildland firefighters. Unfortunately, information regarding what constitutes an adequate safety zone is inadequately defined. Measurements of energy release from wildland fires have been used to develop an empirically based safety zone guideline. The basis for this work is described here.

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

NASA Technical Reports Server (NTRS)

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

1979-01-01

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

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

PubMed

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

Architecture Synthesis and Reduced-Cost Architectures for Human Exploration Missions

NASA Technical Reports Server (NTRS)

Woodcock, Gordon

2004-01-01

Development of architectures for human exploration missions has been pursued in the international aerospace community for a long time. This paper attempts a different approach and way of looking at architectures. Most of the emphasis is on lunar architectures with a brief look at Mars. The first step is to set forth overarching gods in order to understand origins of requirements. Then, principles and guidelines are developed for architecture formulation. It is argued that safety and cost are the primary factors. Alternative mission profiles are examined for adherence to the principles, and specific architectures formulated according to the guidelines. The guidelines themselves indicate preferred evolution paths from lunar to Mars architectures. Results of example calculations are given to illustrate the process, and an evolution path is recommended. Safety and cost criteria tend to conflict, but it is shown that cost-efficient architectures can be enhanced for good safety ratings at modest cost.

Discussions about safety criteria and guidelines for radioactive waste management.

PubMed

Yamamoto, Masafumi

2011-07-01

In Japan, the clearance levels for uranium-bearing waste have been established by the Nuclear Safety Commission (NSC). The criteria for uranium-bearing waste disposal are also necessary; however, the NSC has not concluded the discussion on this subject. Meanwhile, the General Administrative Group of the Radiation Council has concluded the revision of its former recommendation 'Regulatory exemption dose for radioactive solid waste disposal', the dose criteria after the institutional control period for a repository. The Standardization Committee on Radiation Protection in the Japan Health Physics Society (The Committee) also has developed the relevant safety criteria and guidelines for existing exposure situations, which are potentially applicable to uranium-bearing waste disposal. A new working group established by The Committee was initially aimed at developing criteria and guidelines specifically for uranium-bearing waste disposal; however, the aim has been shifted to broader criteria applicable to any radioactive wastes.

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

PubMed

Jones, Christine E; Munoz, Flor M; Spiegel, Hans M L; Heininger, Ulrich; Zuber, Patrick L F; Edwards, Kathryn M; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T

2016-12-01

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. Copyright © 2016. Published by Elsevier Ltd.

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

PubMed Central

Jones, Christine E.; Munoz, Flor M.; Spiegel, Hans M.L.; Heininger, Ulrich; Zuber, Patrick L.F.; Edwards, Kathryn M.; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S.; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M.; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O.; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T.

2017-01-01

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. PMID:27481360

Guidelines for preoperative investigations for elective surgery at Queen Elizabeth Hospital: effects on practices, outcomes, and costs.

PubMed

Nicholls, Judith; Gaskin, Pamela S; Ward, Justin; Areti, Yasodananda K

2016-12-01

We endeavor to assess the impact of introduction of guidelines for preoperative investigations (PIs) on anesthetic practices and costs and compare their efficacy to current practices. A prospective study. Queen Elizabeth Hospital, Barbados. Participants comprised all patients undergoing general, epidural, spinal, and regional anesthesia, with the exception of emergency cases or instances where an anesthesiologist was not required. Introduction of formal guidelines for preoperative investigations. The patterns of preoperative testing were assessed by audit, and this assessment was repeated postintervention. PI guidelines developed were presented to all surgical departments. For younger patients (<60 years), the mean number of tests decreased from 3.42±1.8 in the preguideline group to 2.89±1.98 in the postguideline group (P=.042). The total number of chest x-rays decreased by 14.8% (P=.012) and full blood counts by 7.6% (P=.036). The implementation of PI guidelines led to overall savings of US $7589 per 1000 patients, which is equivalent to (US $40,745.50 per annum). The most notable savings were due to decreased number of chest x-rays. PIs were performed routinely even in the absence of clinical indications. Our findings indicate that introduction of guidelines has reduced the level of preanesthetic investigations to some extent; nevertheless, further change is desirable. In addition, costs to the institution were decreased with no compromise to patient safety. Copyright © 2016 Elsevier Inc. All rights reserved.

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

PubMed Central

Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

2017-01-01

Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD. PMID:28740389

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity.

PubMed

Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

2017-01-01

Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD.

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.

Developing Probabilistic Safety Performance Margins for Unknown and Underappreciated Risks

NASA Technical Reports Server (NTRS)

Benjamin, Allan; Dezfuli, Homayoon; Everett, Chris

2015-01-01

Probabilistic safety requirements currently formulated or proposed for space systems, nuclear reactor systems, nuclear weapon systems, and other types of systems that have a low-probability potential for high-consequence accidents depend on showing that the probability of such accidents is below a specified safety threshold or goal. Verification of compliance depends heavily upon synthetic modeling techniques such as PRA. To determine whether or not a system meets its probabilistic requirements, it is necessary to consider whether there are significant risks that are not fully considered in the PRA either because they are not known at the time or because their importance is not fully understood. The ultimate objective is to establish a reasonable margin to account for the difference between known risks and actual risks in attempting to validate compliance with a probabilistic safety threshold or goal. In this paper, we examine data accumulated over the past 60 years from the space program, from nuclear reactor experience, from aircraft systems, and from human reliability experience to formulate guidelines for estimating probabilistic margins to account for risks that are initially unknown or underappreciated. The formulation includes a review of the safety literature to identify the principal causes of such risks.

49 CFR 374.315 - Transportation of passengers with disabilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY... part 36), incorporating the guidelines established by the Architectural and Transportation Barriers...

Electrical safety during transplantation.

PubMed

Amicucci, G L; Di Lollo, L; Fiamingo, F; Mazzocchi, V; Platania, G; Ranieri, D; Razzano, R; Camin, G; Sebastiani, G; Gentile, P

2010-01-01

Technologic innovations enable management of medical equipment and power supply systems, with improvements that can affect the technical aspects, economics, and quality of medical service. Herein are outlined some technical guidelines, proposed by Istituto Superiore per la Prevenzione e la Sicurezza del Lavoro, for increasing the effectiveness of the power supply system and the safety of patients and surgeons in the operating room, with particular focus on transplantation. The dependence of diagnoses and therapies on operation of the electrical equipment can potentially cause great risk to patients. Moreover, it is possible that faulty electrical equipment could produce current that may flow through the patient. Because patients are particularly vulnerable when their natural protection is considerably decreased, as during transplantation or other surgery, power supply systems must operate with a high degree of reliability and quality to prevent risk, and must be designed to reduce hazards from direct and indirect contact. Reliability of the power supply system is closely related to the quality of the project, choice of materials, and management of the system (eg, quality and frequency of servicing). Among the proposed guidelines, other than normal referencing, are (1) adoption of a monitoring system to improve the quality of the electrical parameters in the operating room, (2) institution of emergency procedures for management of electrical faults, (3) a procedure for management of fires in the operating room, (4) and maintenance interventions and inspections of medical devices to maintain minimal requirements of safety and performance. Copyright 2010 Elsevier Inc. All rights reserved.

The glory of guidelines and the twilight of reality: controversies and challenges in the prevention and treatment of HIV in children.

PubMed

Anderson, Evan J; Yogev, Ram

2012-07-01

Since the discovery of HIV 30 years ago, we have learned much about HIV in children and adolescents. Dramatic declines have occurred in mother-to-child transmission of HIV in resource-rich countries. Resource-poor countries struggle with improving prevention of mother-to-child transmission due to the lack of universal antiretroviral treatment for pregnant and nursing mothers. In children infected with HIV, pharmacokinetic, safety and efficacy data have been determined for many of the older drugs. Data are lacking for the newer, safer and more effective currently available drugs, resulting in the pediatric guidelines lagging behind adult recommendations. Although guidelines for prevention and treatment are helpful, the way they are created causes them to lag behind new scientific evidence, and in some situations they will be confusing or only based on expert opinion. Improving prevention of HIV infection in adolescents and young adults and in treating those who become HIV infected is crucially important. The next 10 years hold tremendous opportunities for improvements in prevention and treatment of HIV in children, adolescents and young adults.

Evolution of topical NSAIDs in the guidelines for treatment of osteoarthritis in elderly patients.

PubMed

Arnstein, Paul M

2012-07-01

Increasing age is the primary predictor of osteoarthritis, the most prevalent painful condition in the US. Because there are no disease-modifying therapies for osteoarthritis, relief of symptoms and maintenance of quality of life through improving joint function become the focus of management. Although highly effective for pain relief, oral nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with systemic adverse reactions that are sometimes treatment limiting, especially for older patients. Thus, osteoarthritis management in elderly populations is shifting away from traditional NSAIDs to therapies that provide comparable pain relief with improved safety. Since the approval by the US Food and Drug Administration of the use of topical NSAIDs to manage osteoarthritis pain, current treatment guidelines put forth by several professional societies have begun to recommend topical NSAIDs as an alternative therapy and, most recently, as first-line therapy for osteoarthritis management in the elderly. This review provides an overview of the various treatment guidelines that are available to assist prescribers in making safe and effective decisions in the treatment of osteoarthritis in this high-risk patient population.

40 CFR 240.209 - Safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 25 2011-07-01 2011-07-01 false Safety. 240.209 Section 240.209 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.209 Safety. ...

System safety engineering analysis handbook

NASA Technical Reports Server (NTRS)

Ijams, T. E.

1972-01-01

The basic requirements and guidelines for the preparation of System Safety Engineering Analysis are presented. The philosophy of System Safety and the various analytic methods available to the engineering profession are discussed. A text-book description of each of the methods is included.

Safety belt and motorcycle helmet use in Virginia : the Summer 2003 update.

DOT National Transportation Integrated Search

2004-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...

Safety belt and motorcycle helmet use in Virginia : the Summer 2005 update.

DOT National Transportation Integrated Search

2005-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration ( NHTSA) published the final guidelines for conducting surveys of belt and helme...

Safety belt and motorcycle helmet use in Virginia : the Summer 2007 update.

DOT National Transportation Integrated Search

2007-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...

Safety belt and motorcycle helmet use in Virginia : the Summer 2004 update.

DOT National Transportation Integrated Search

2004-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...

Safety belt and motorcycle helmet use in Virginia : the Summer 2006 update.

DOT National Transportation Integrated Search

2006-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. In 1992, the National Highway Traffic Safety Administration (NHTSA) published the final guidelines for conducting surveys of belt and helmet...

National Resource Center for Health and Safety in Child Care and Early Education

MedlinePlus

... Health and Safety in Child Care and Early Education (NRC) at the University of Colorado College of ... Safety Performance Standards; Guidelines for Early Care and Education Programs, 3 rd Edition ( CFOC3 ) As a collaborator ...

40 CFR 240.209 - Safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Safety. 240.209 Section 240.209 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.209 Safety. ...

Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.

PubMed

Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na

2015-08-26

The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Investment policy, guidelines help providers control risk.

PubMed

Seidner, A G

1989-03-01

Because the financial markets are volatile, every healthcare organization should establish its own investment policy and guidelines. An investment policy reflects the views of a hospital's board of trustees, and helps the trustees avoid conflict of interest situations. Investment guidelines spell out management's approach to three critical investing components: safety of principal, liquidity, and yield.

A survey of United States dental hygienists' knowledge, attitudes, and practices with infection control guidelines.

PubMed

Garland, Kandis V

2013-06-01

To assess knowledge, attitudes and practices of U.S. dental hygienists with infection control guidelines (ICG). Research has shown improved compliance with specific aspects of dental ICG is needed. This study supports the American Dental Hygienists' Association National Research Agenda's Occupational Health and Safety objective to investigate methods to decrease errors, risks and or hazards in health care. Data are needed to assess compliance, prevention and behavioral issues with current ICG practices. A proportional stratified random sample (n=2,500) was recruited for an online survey. Descriptive statistics summarized demographic characteristics and knowledge, attitudes and practices responses. Spearman's rho correlations determined relationships between knowledge, attitudes and practices responses (p<0.05). Dominant themes were identified from open-ended responses. A 31% response rate (n=765) was attained. Respondents agreed/strongly agreed with familiarity with ICG (86%) and believed ICG are relevant to their patients (88%). Responses indicated low compliance (rarely/never used) with handpiece sterilization (n=209, 31%), utility glove use (n=317, 47%), and pre-procedural rinsing (n=324, 48%). Significant relationships were found between ICG implementation and access to necessary supplies (rs=0.549), supervisors' expectations for using ICG (rs=0.529) and no time to use (rs=-0.537). Themes from comments indicated time is a barrier, and respondents' perceived a need for involvement of all co-workers. Dental hygienists are adhering with most aspects of the ICG. High compliance with ICG among respondents in this study was associated with positive safety beliefs and practices, whereas lower compliance with ICG was associated with less positive safety beliefs and practices. A safety culture appears to be a factor in compliance with ICG.

A comprehensive perinatal patient safety program to reduce preventable adverse outcomes and costs of liability claims.

PubMed

Simpson, Kathleen Rice; Kortz, Carol C; Knox, G Eric

2009-11-01

To achieve the goal of safe care for mothers and infants during labor and birth, Catholic Healthcare Partners (CHP; Cincinnati) conducted on-site risk assessments at the 16 hospitals with perinatal units in 2004-2005, with follow-up visits in 2006 through 2008. ON-SITE RISK ASSESSMENTS: In addition to assessing overall organizational risk, the assessments provided each hospital a gap analysis demonstrating up-to-date and outdated practices and strategies and resources necessary to make all practices consistent with current evidence and national guidelines and standards. CRITICAL ASPECTS OF CLINICAL CARE: Review of claims and near-miss data indicate that fetal assessment, labor induction, and second-stage labor care comprise the majority of risk of perinatal harm. Therefore, these clinical areas were the focus of strategies to promote safety. To promote consistency in knowledge and practice, in 2004 a variety of strategies were recommended, including interdisciplinary fetal monitoring education and routine medical record reviews to monitor ongoing adherence to appropriate practice and documentation. Success in implementing essential structural and process components of the perinatal patient safety program have resulted in improvement from 2003 to 2008 in specific outcomes for the 16 perinatal units surveyed, including reduction of perinatal harm, number of claims, and costs of claims. The program continues to evolve with modifications as needed as more evidence becomes available to guide best perinatal practices and new guidelines/standards are published. A patient safety program guided and supported by a health care system can result in safer clinical environments in individual hospitals and in decreased risk of preventable perinatal harm and liability costs.

Antimicrobial stewardship activities: a survey of Queensland hospitals.

PubMed

Avent, Minyon L; Hall, Lisa; Davis, Louise; Allen, Michelle; Roberts, Jason A; Unwin, Sean; McIntosh, Kylie A; Thursky, Karin; Buising, Kirsty; Paterson, David L

2014-11-01

In 2011, the Australian Commission on Safety and Quality in Health Care (ACSQHC) recommended that all hospitals in Australia must have an Antimicrobial Stewardship (AMS) program by 2013. Nevertheless, little is known about current AMS activities. This study aimed to determine the AMS activities currently undertaken, and to identify gaps, barriers to implementation and opportunities for improvement in Queensland hospitals. The AMS activities of 26 facilities from 15 hospital and health services in Queensland were surveyed during June 2012 to address strategies for effective AMS: implementing clinical guidelines, formulary restriction, reviewing antimicrobial prescribing, auditing antimicrobial use and selective reporting of susceptibility results. The response rate was 62%. Nineteen percent had an AMS team (a dedicated multidisciplinary team consisting of a medically trained staff member and a pharmacist). All facilities had access to an electronic version of Therapeutic Guidelines: Antibiotic, with a further 50% developing local guidelines for antimicrobials. One-third of facilities had additional restrictions. Eighty-eight percent had advice for restricted antimicrobials from in-house infectious disease physicians or clinical microbiologists. Antimicrobials were monitored with feedback given to prescribers at point of care by 76% of facilities. Deficiencies reported as barriers to establishing AMS programs included: pharmacy resources, financial support by hospital management, and training and education in antimicrobial use. Several areas for improvement were identified: reviewing antimicrobial prescribing with feedback to the prescriber, auditing, and training and education in antimicrobial use. There also appears to be a lack of resources to support AMS programs in some facilities. WHAT IS KNOWN ABOUT THE TOPIC?: The ACSQHC has recommended that all hospitals implement an AMS program by 2013 as a requirement of Standard 3 (Preventing and Controlling Healthcare-Associated Infections) of the National Safety and Quality Health Service Standards. The intent of AMS is to ensure appropriate prescribing of antimicrobials as part of the broader systems within a health service organisation to prevent and manage healthcare-associated infections, and improve patient safety and quality of care. This criterion also aligns closely with Standard 4: Medication Safety. Despite this recommendation, little is known about what AMS activities are undertaken in these facilities and what additional resources would be required in order to meet these national standards. WHAT DOES THE PAPER ADD?: This is the first survey that has been conducted of public hospital and health services in Queensland, a large decentralised state in Australia. This paper describes what AMS activities are currently being undertaken, identifies practice gaps, barriers to implementation and opportunities for improvement in Queensland hospitals. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS?: Several areas for improvement such as reviewing antimicrobial prescribing with feedback to the prescriber, auditing, and training and education in antimicrobial use have been identified. In addition, there appears to be a lack of resources to support AMS programs in some facilities.

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.

ACCF/AHA methodology for the development of quality measures for cardiovascular technology: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures.

PubMed

Bonow, Robert O; Douglas, Pamela S; Buxton, Alfred E; Cohen, David J; Curtis, Jeptha P; Delong, Elizabeth; Drozda, Joseph P; Ferguson, T Bruce; Heidenreich, Paul A; Hendel, Robert C; Masoudi, Frederick A; Peterson, Eric D; Taylor, Allen J

2011-09-27

Consistent with the growing national focus on healthcare quality, the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have taken a leadership role over the past decade in developing measures of the quality of cardiovascular care by convening a joint ACCF/AHA Task Force on Performance Measures. The Task Force is charged with identifying the clinical topics appropriate for the development of performance measures and with assembling writing committees composed of clinical and methodological experts in collaboration with appropriate subspecialty societies. The Task Force has also created methodology documents that offer guidance in the development of process, outcome, composite, and efficiency measures. Cardiovascular performance measures using existing ACCF/AHA methodology are based on Class I or Class III guidelines recommendations, usually with Level A evidence. These performance measures, based on evidence-based ACCF/AHA guidelines, remain the most rigorous quality measures for both internal quality improvement and public reporting. However, many of the tools for diagnosis and treatment of cardiovascular disease involve advanced technologies, such as cardiac imaging, for which there are often no underlying guideline documents. Because these technologies affect the quality of cardiovascular care and also have the potential to contribute to cardiovascular health expenditures, there is a need for more critical assessment of the use of technology, including the development of quality and performance measures in areas in which guideline recommendations are absent. The evaluation of quality in the use of cardiovascular technologies requires consideration of multiple parameters that differ from other healthcare processes. The present document describes methodology for development of 2 new classes of quality measures in these situations, appropriate use measures and structure/safety measures. Appropriate use measures are based on specific indications, processes, or parameters of care for which high level of evidence data and Class I or Class III guideline recommendations may be lacking but are addressed in ACCF appropriate use criteria documents. Structure/safety measures represent measures developed to address structural aspects of the use of healthcare technology (e.g., laboratory accreditation, personnel training, and credentialing) or quality issues related to patient safety when there are neither guidelines recommendations nor appropriate use criteria. Although the strength of evidence for appropriate use measures and structure/safety measures may not be as strong as that for formal performance measures, they are quality measures that are otherwise rigorously developed, reviewed, tested, and approved in the same manner as ACCF/AHA performance measures. The ultimate goal of the present document is to provide direction in defining and measuring the appropriate use-avoiding not only underuse but also overuse and misuse-and proper application of cardiovascular technology and to describe how such appropriate use measures and structure/safety measures might be developed for the purposes of quality improvement and public reporting. It is anticipated that this effort will help focus the national dialogue on the use of cardiovascular technology and away from the current concerns about volume and cost alone to a more holistic emphasis on value. Copyright © 2011 American College of Cardiology Foundation and the American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.

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

DTIC Science & Technology

1997-10-01

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

Pediatric extracorporeal shock wave lithotripsy: Predicting successful outcomes.

PubMed

McAdams, Sean; Shukla, Aseem R

2010-10-01

Extracorporeal shock wave lithotripsy (ESWL) is currently a first-line procedure of most upper urinary tract stones <2 cm of size because of established success rates, its minimal invasiveness and long-term safety with minimal complications. Given that alternative surgical and endourological options exist for the management of stone disease and that ESWL failure often results in the need for repeat ESWL or secondary procedures, it is highly desirable to identify variables predicting successful outcomes of ESWL in the pediatric population. Despite numerous reports and growing experience, few prospective studies and guidelines for pediatric ESWL have been completed. Variation in the methods by which study parameters are measured and reported can make it difficult to compare individual studies or make definitive recommendations. There is ongoing work and a need for continuing improvement of imaging protocols in children with renal colic, with a current focus on minimizing exposure to ionizing radiation, perhaps utilizing advancements in ultrasound and magnetic resonance imaging. This report provides a review of the current literature evaluating the patient attributes and stone factors that may be predictive of successful ESWL outcomes along with reviewing the role of pre-operative imaging and considerations for patient safety.

Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development.

PubMed

Siska, William; Gupta, Aradhana; Tomlinson, Lindsay; Tripathi, Niraj; von Beust, Barbara

Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article-related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.

Standards Development Activities at White Sands Test Facility

NASA Technical Reports Server (NTRS)

Baker, D. L.; Beeson, H. D.; Saulsberry, R. L.; Julien, H. L.; Woods, S. S.

2003-01-01

The development of standards and standard activities at the JSC White Sands Test Facility (WSTF) has been expanded to include the transfer of technology and standards to voluntary consensus organizations in five technical areas of importance to NASA. This effort is in direct response to the National Technology Transfer Act designed to accelerate transfer of technology to industry and promote government-industry partnerships. Technology transfer is especially important for WSTF, whose longterm mission has been to develop and provide vital propellant safety and hazards information to aerospace designers, operations personnel, and safety personnel. Meeting this mission is being accomplished through the preparation of consensus guidelines and standards, propellant hazards analysis protocols, and safety courses for the propellant use of hydrogen, oxygen, and hypergols, as well as the design and inspection of spacecraft pressure vessels and the use of pyrovalves in spacecraft propulsion systems. The overall WSTF technology transfer program is described and the current status of technology transfer activities are summarized.

The challenge of effectively communicating patient safety information.

PubMed

Hugman, Bruce; Edwards, I Ralph

2006-07-01

Rational use of drugs and patient safety are seriously compromised by a lack of good information, education and effective communication at all stages of drug development and use. From animal trials through to dispensing, there are misconceptions and opportunities for error which current methods of drug information communication do not adequately address: they do not provide those responsible for prescribing and dispensing drugs with the data and information they need to pass on complex and often changing messages to patients and the public. The incidence of adverse reactions due to the way drugs are used; the variable impact of regulatory guidelines and warnings on prescribing behaviour; drug scares and crises suggest a great gap between the ideals of the safe use of medicines and the reality in homes, clinics and hospitals around the world. To address these challenges, the authors review the several levels at which safety information is generated and communicated, and examine how, at each stage, the content and its significance, and the method of communication can be improved.

A qualitative review of existing national and international occupational safety and health policies relating to occupational sedentary behaviour.

PubMed

Coenen, Pieter; Gilson, Nicholas; Healy, Genevieve N; Dunstan, David W; Straker, Leon M

2017-04-01

Prolonged sedentary time is now recognised as an emergent ergonomics issue. We aimed to review current occupational safety and health policies relevant to occupational sedentary behaviour. An electronic search for documents was conducted on websites of ergonomics and occupational safety and health organisations from 10 countries and six international/pan-European agencies. Additionally, 43 informants (nine countries) were contacted and an international conference workshop held. 119 documents (e.g. legislation, guidelines, codes of practice) were identified. Using a qualitative synthesis, it was observed that many jurisdictions had legal frameworks establishing a duty of care for employers, designers/manufacturers/suppliers and employees. While no occupational authority policies focusing specifically on sedentary behaviour were found, relevant aspects of existing policies were identified. We highlight implications for ergonomics research and practice and recommend the development of policy to specifically address occupational sedentary behaviour and support workplace initiatives to assess and control the risks of this emergent hazard. Copyright © 2016 Elsevier Ltd. All rights reserved.

Implementation Procedure for STS Payloads, System Safety Requirements

NASA Technical Reports Server (NTRS)

1979-01-01

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

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

PubMed

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

2013-12-01

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

Usability and Safety in Electronic Medical Records Interface Design: A Review of Recent Literature and Guideline Formulation.

PubMed

Zahabi, Maryam; Kaber, David B; Swangnetr, Manida

2015-08-01

The objectives of this study were to (a) review electronic medical record (EMR) and related electronic health record (EHR) interface usability issues, (b) review how EMRs have been evaluated with safety analysis techniques along with any hazard recognition, and (c) formulate design guidelines and a concept for enhanced EMR interfaces with a focus on diagnosis and documentation processes. A major impact of information technology in health care has been the introduction of EMRs. Although numerous studies indicate use of EMRs to increase health care quality, there remain concerns with usability issues and safety. A literature search was conducted using Compendex, PubMed, CINAHL, and Web of Science databases to find EMR research published since 2000. Inclusion criteria included relevant English-language papers with subsets of keywords and any studies (manually) identified with a focus on EMR usability. Fifty studies met the inclusion criteria. Results revealed EMR and EHR usability problems to include violations of natural dialog, control consistency, effective use of language, effective information presentation, and customization principles as well as a lack of error prevention, minimization of cognitive load, and feedback. Studies focusing on EMR system safety made no objective assessments and applied only inductive reasoning methods for hazard recognition. On the basis of the identified usability problems and structure of safety analysis techniques, we provide EMR design guidelines and a design concept focused on the diagnosis process and documentation. The design guidelines and new interface concept can be used for prototyping and testing enhanced EMRs. © 2015, Human Factors and Ergonomics Society.

Kaleo's Safe Walking Kit.

ERIC Educational Resources Information Center

Hawaii State Dept. of Education, Honolulu. Office of Instructional Services.

This pedestrian safety kit for kindergarten through the third grade consists of 16 lessons encompassing many safety concepts, guidelines and skills that emphasize pedestrian safety rules, alertness, and responsible reaction to hazardous situations. Lessons include activities of varying difficulty for large group, small group or individual…

Pilot education and safety awareness programs

NASA Technical Reports Server (NTRS)

Shearer, M.; Reynard, W. D.

1984-01-01

Guidelines necessary for the implementation of safety awareness programs for commuter airlines are discussed. A safety office can be viewed as fulfilling either an education and training function or a quality assurance function. Issues such as management structure, motivation, and cost limitations are discussed.

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

PubMed

Patrick Reilly, J

2014-10-01

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

49 CFR 350.333 - What are the guidelines for the compatibility review?

Code of Federal Regulations, 2011 CFR

2011-10-01

... REGULATIONS COMMERCIAL MOTOR CARRIER SAFETY ASSISTANCE PROGRAM Funding § 350.333 What are the guidelines for... Regulation Compatibility Review Law or regulation has same effect as corresponding Federal regulation Applies...

HEW to Set Laboratory Safety Standards.

ERIC Educational Resources Information Center

Chemical and Engineering News, 1978

1978-01-01

Describes Department of Health, Education and Welfare (HEW) proposed guidelines for laboratories using chemical carcinogens. The guidelines are designed to provide protection for laboratory workers and their environment from exposure to all types of carcinogenic agents. (GA)

Assessment of Literature Related to Combustion Appliance Venting Systems

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

Rapp, V. H.; Less, B. D.; Singer, B. C.

In many residential building retrofit programs, air tightening to increase energy efficiency is often constrained by safety concerns with naturally vented combustion appliances. Tighter residential buildings more readily depressurize when exhaust equipment is operated, making combustion appliances more prone to backdraft or spill combustion exhaust into the living space. Several measures, such as installation guidelines, vent sizing codes, and combustion safety diagnostics, are in place with the intent to prevent backdrafting and combustion spillage, but the diagnostics conflict and the risk mitigation objective is inconsistent. This literature review summarizes the metrics and diagnostics used to assess combustion safety, documents theirmore » technical basis, and investigates their risk mitigations. It compiles information from the following: codes for combustion appliance venting and installation; standards and guidelines for combustion safety diagnostics; research evaluating combustion safety diagnostics; research investigating wind effects on building depressurization and venting; and software for simulating vent system performance.« less

The Safety Attitudes of Senior Managers in the Chinese Coal Industry

PubMed Central

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-01-01

Introduction: Senior managers’ attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers′ attitudes towards safety in the Chinese coal industry. Method: We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions: Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers′ safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers′ unions not playing their role effectively. Practical Applications: We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry. PMID:27869654

The Safety Attitudes of Senior Managers in the Chinese Coal Industry.

PubMed

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-11-17

Introduction: Senior managers' attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers' attitudes towards safety in the Chinese coal industry. Method : We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions : Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers' safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers' unions not playing their role effectively. Practical Applications : We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry.

Qualichem In Vivo: A Tool for Assessing the Quality of In Vivo Studies and Its Application for Bisphenol A

PubMed Central

Maxim, Laura; van der Sluijs, Jeroen P.

2014-01-01

In regulatory toxicology, quality assessment of in vivo studies is a critical step for assessing chemical risks. It is crucial for preserving public health studies that are considered suitable for regulating chemicals are robust. Current procedures for conducting quality assessments in safety agencies are not structured, clear or consistent. This leaves room for criticism about lack of transparency, subjective influence and the potential for insufficient protection provided by resulting safety standards. We propose a tool called “Qualichem in vivo” that is designed to systematically and transparently assess the quality of in vivo studies used in chemical health risk assessment. We demonstrate its use here with 12 experts, using two controversial studies on Bisphenol A (BPA) that played an important role in BPA regulation in Europe. The results obtained with Qualichem contradict the quality assessments conducted by expert committees in safety agencies for both of these studies. Furthermore, they show that reliance on standardized guidelines to ensure scientific quality is only partially justified. Qualichem allows experts with different disciplinary backgrounds and professional experiences to express their individual and sometimes divergent views—an improvement over the current way of dealing with minority opinions. It provides a transparent framework for expressing an aggregated, multi-expert level of confidence in a study, and allows a simple graphical representation of how well the study integrates the best available scientific knowledge. Qualichem can be used to compare assessments of the same study by different health agencies, increasing transparency and trust in the work of expert committees. In addition, it may be used in systematic evaluation of in vivo studies submitted by industry in the dossiers that are required for compliance with the REACH Regulation. Qualichem provides a balanced, common framework for assessing the quality of studies that may or may not be following standardized guidelines. PMID:24489958

Combustion Safety for Appliances Using Indoor Air (Fact Sheet)

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

Not Available

2014-05-01

This measure guideline covers how to assess and carry out the combustion safety procedures for appliances and heating equipment that uses indoor air for combustion in low-rise residential buildings. Only appliances installed in the living space, or in an area freely communicating with the living space, vented alone or in tandem with another appliance are considered here. A separate measure guideline addresses combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage that use outdoor air for combustion. This document is formore » inspectors, auditors, and technicians working in homes where energy upgrades are being conducted whether or not air infiltration control is included in the package of measures being applied. In the indoor combustion air case, guidelines summarized here are based on language provided in several of the codes to establish minimum requirements for the space using simplified prescriptive measures. In addition, building performance testing procedures are provided by testing agencies. The codes in combination with the test procedures offer comprehensive combustion safety coverage to address safety concerns, allowing inexperienced residential energy retrofit inspectors to effectively address combustion safety issues and allow energy retrofits to proceed.« less

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines

PubMed Central

Ayres, J G; Frost, C D; Holmes, W F; Williams, D R R; Ward, S M

1998-01-01

Objective To evaluate the safety of a non-chlorofluorocarbon metered dose salbutamol inhaler. Design This was a postmarketing surveillance study, conducted under formal guidelines for company sponsored safety assessment of marketed medicines (SAMM). A non-randomised, non-interventional, observational design compared patients prescribed metered doses of salbutamol delivered by inhalers using either hydrofluoroalkane or chlorofluorocarbon as the propellant. Follow up was three months. Setting 646 general practices throughout the United Kingdom. Subjects 6614 patients with obstructive airways disease (1667 patient years of exposure). Main outcome measures Proportions of patients who were: admitted to hospital for respiratory diseases, reported adverse side effects, or withdrew because of adverse affects. Results There were no significant differences between the hydrofluoroalkane (HFA 134a) and chlorofluorocarbon inhaler groups in relation to the proportions of patients admitted to hospital for respiratory diseases (odds ratio 0.75; 95% confidence interval 0.51 to 1.08) or the proportions who reported adverse events (1.01; 0.88 to 1.17). However, more patients using the hydrofluoroalkane inhaler than the chlorofluorocarbon inhaler withdrew because of adverse events (3.8% and 0.9% respectively). Conclusion The hydrofluoroalkane inhaler was as safe as the chlorofluorocarbon inhaler when judged by hospital admissions and adverse affects. The study design successfully fulfilled the recommendations of the guidelines. Differences between postmarketing surveillance studies and randomised clinical trials in assessing safety were identified. These may lead to difficulties in the design of postmarketing surveillance studies. Key messagesCredibility of postmarketing surveillance studies is expected to increase after the introduction of guidelines covering their conduct The study design successfully fulfilled the requirements of these guidelines in terms of the number, rate, and geographical spread of patients recruitedSafety of salbutamol inhalers using hydrofluoroalkane and chlorofluorocarbon as propellants is similarImportant differences in study design/conduct and outcome between a postmarketing surveillance study and a randomised clinical trial merit further consideration. PMID:9756813

[Polish guidelines for the prevention and treatment of venous thromboembolism: 2009 update].

PubMed

Zawilska, Krystyna; Jaeschke, Roman; Tomkowski, Witold; Mayzner-Zawadzka, Ewa; Nizankowski, Rafał; Olejek, Anita; Pasierski, Tomasz; Torbicki, Adam; Undas, Anetta; Jawień, Arkadiusz; Gajewski, Piotr; Sznajd, Jan; Brozek, Jan

2009-01-01

The overall objective of the Polish guidelines for the prevention and treatment of venous thromboembolism is to increase patient benefit and safety by appropriate prevention and treatment of deep vein thrombosis and pulmonary embolism as well as proper management of the complications associated with antithrombotic and thrombolytic therapy. These guidelines apply to adult trauma, cancer, surgical, and medical patients as well as those at increased risk of venous thromboembolism. Specific recommendations have been formulated for pregnant women, patients requiring surgery while receiving long-term oral anticoagulant treatment, and patients undergoing regional anesthesia and/or analgesia. We systematically identified all current clinical practice guidelines concerning the prevention and/or treatment of venous thromboembolism and assessed their methodological quality using the AGREE instrument. We chose to update existing Polish guidelines by adapting the most recent high quality guidelines that we identified to Polish cultural and organizational setting rather than develop all recommendations de novo. We based our recommendations primarily on the 8th edition of the American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines on Antithrombotic and Thrombolytic Therapy and on the European Society of Cardiology (ESC) Guidelines on the Diagnosis and Management of Acute Pulmonary Embolism. To make recommendations regarding specific management issues that had not been addressed in ACCP guidelines, or whenever panel members felt they needed additional information to reach the decision we also consulted guidelines developed by other professional societies and organizations as well as additional sources of evidence. For each recommendation we explicitly assessed its relevance and applicability in the context of health care system in Poland. We adapted recommendations when necessary, explicitly stating the rationale for modification and judgements about the values and preferences we assumed. We developed original recommendations on the use of new oral anticoagulants that have recently become available, following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

Screening Tool for Older Persons' Appropriate Prescriptions for Japanese: Report of the Japan Geriatrics Society Working Group on "Guidelines for medical treatment and its safety in the elderly".

PubMed

Kojima, Taro; Mizukami, Katsuyoshi; Tomita, Naoki; Arai, Hiroyuki; Ohrui, Takashi; Eto, Masato; Takeya, Yasushi; Isaka, Yoshitaka; Rakugi, Hiromi; Sudo, Noriko; Arai, Hidenori; Aoki, Hiroaki; Horie, Shigeo; Ishii, Shinya; Iwasaki, Koh; Takayama, Shin; Suzuki, Yusuke; Matsui, Toshifumi; Mizokami, Fumihiro; Furuta, Katsunori; Toba, Kenji; Akishita, Masahiro

2016-09-01

In 2005, the Japan Geriatrics Society published a list of potentially inappropriate medication that was an extract from the "Guidelines for medical treatment and its safety in the elderly 2005." The 2005 guidelines are due for a revision, and a new comprehensive list of potentially inappropriate medications is required. A total of 15 diseases, conditions and special areas related to their clinical care were selected. We originated clinical questions and keywords for these 15 areas, carried out a systematic review using these search criteria, and formulated guidelines applying the Grading of Recommendations Assessment, Development and Evaluation system advocated by Minds2014. If we did not find good evidence despite the drug being clinically important, we looked for evidence of efficacy and for disease-specific guidelines, and incorporated them into our guidelines. We selected 2098 articles (140 articles per area), and extracted another 186 articles through a manual search. We further added guidelines based on disease entity and made two lists, one of "drugs to be prescribed with special caution" and the other of "drugs to consider starting," primarily considering individuals aged 75 years or older or those who are frail or in need of special care. New lists of potentially inappropriate medications and potential prescribing omissions called "Screening Tool for Older Person's Appropriate Prescriptions for Japanese" were constructed. We anticipate that future studies will highlight more evidence regarding the safety of high-quality drugs, further improving the provision of appropriate medical care for the elderly. Geriatr Gerontol Int 2016: 16: 983-1001. © 2016 Japan Geriatrics Society.

Analysis of child passenger safety restraint use at a pediatric emergency department.

PubMed

Cease, Alan T; King, William D; Monroe, Kathy W

2011-02-01

The objectives of the study were to determine the number of children properly restrained during transit to a pediatric emergency department for care and to ascertain parental knowledge of Alabama laws and American Academy of Pediatrics (AAP) guidelines and where they obtain this information. An emergency department (patient care rooms) waiting area, convenience sample of Alabama parents who have children younger than or 13 years of age were surveyed over a 5-week period. Appropriate use of child passenger safety (CPS) restraints was determined using Alabama law and AAP recommendations. Use of Car Seat Checks provided by Children's Hospital and Safe Kids, knowledge of Alabama laws and CPS guidelines, and the source of information used by parents were ascertained. Among 525 patients identified, 520 (99.0%) participated. Appropriate use per Alabama law and AAP guidelines was 72.3% and 60.6%, respectively; 5.0% were unrestrained. Booster seats were the most commonly misused restraint. Car seats were reportedly used correctly by 81.9%. Parents who had used the Car Seat Checks program had correct booster seat and car seat use rates of 95.8% and 61.5%, respectively. Unfortunately, only 31.2% of patients had knowledge of the Car Seat Checks program, and only 40.6% knew the current law. Most often, parents stated that the hospital where their child was born was the primary (and sometimes only) source of CPS information. This study illustrates the need for improving parental knowledge of appropriate child passenger restraint use (especially booster seats) and Car Seat Checks programs. Car seat program assistance is associated with high levels of appropriate use.

Exercise Guidelines to Promote Cardiometabolic Health in Spinal Cord Injured Humans: Time to Raise the Intensity?

PubMed

Nightingale, Tom E; Metcalfe, Richard S; Vollaard, Niels B; Bilzon, James L

2017-08-01

Spinal cord injury (SCI) is a life-changing event that, as a result of paralysis, negatively influences habitual levels of physical activity and hence cardiometabolic health. Performing regular structured exercise therefore appears extremely important in persons with SCI. However, exercise options are mainly limited to the upper body, which involves a smaller activated muscle mass compared with the mainly leg-based activities commonly performed by nondisabled individuals. Current exercise guidelines for SCI focus predominantly on relative short durations of moderate-intensity aerobic upper-body exercise, yet contemporary evidence suggests this is not sufficient to induce meaningful improvements in risk factors for the prevention of cardiometabolic disease in this population. As such, these guidelines and their physiological basis require reappraisal. In this special communication, we propose that high-intensity interval training (HIIT) may be a viable alternative exercise strategy to promote vigorous-intensity exercise and prevent cardiometabolic disease in persons with SCI. Supplementing the limited data from SCI cohorts with consistent findings from studies in nondisabled populations, we present strong evidence to suggest that HIIT is superior to moderate-intensity aerobic exercise for improving cardiorespiratory fitness, insulin sensitivity, and vascular function. The potential application and safety of HIIT in this population is also discussed. We conclude that increasing exercise intensity could offer a simple, readily available, time-efficient solution to improve cardiometabolic health in persons with SCI. We call for high-quality randomized controlled trials to examine the efficacy and safety of HIIT in this population. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

29 CFR Appendix B to Subpart Y of... - Guidelines for Scientific Diving

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 8 2010-07-01 2010-07-01 false Guidelines for Scientific Diving B Appendix B to Subpart Y of Part 1926 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH..., Subpt. Y, App. B Appendix B to Subpart Y of Part 1926—Guidelines for Scientific Diving Note: The...

Spotlight on fluticasone furoate/umeclidinium/vilanterol in COPD: design, development, and potential place in therapy.

PubMed

Lal, Chitra; Strange, Charlie

2017-01-01

COPD is characterized by persistent airflow obstruction caused by exposure to irritants including cigarette smoke, dust, and fumes. According to the latest GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines, a combination of inhaled corticosteroids, long-acting β 2 agonists, and long-acting muscarinic receptor antagonists can be used for group D COPD patients who are at high risk for exacerbations. Umeclidinium/fluticasone furoate/vilanterol is one such triple-combination therapy currently under development with some completed and several ongoing clinical trials. This review paper summarizes the pharmacologic profiles of these medications and highlights findings from clinical trials, including safety and efficacy data, while speculating on the role of this therapy in current treatment for COPD.

Current concepts of oral and maxillofacial rehabilitation and treatment in aviation.

PubMed

Yuce, Esra; Koçer, Gulperi; Çini, Turan Atila

2016-01-01

Aerospace medicine is the medical discipline responsible for assessing and conserving the health, safety, and performance of individuals involved in air and space travel. With the upward trend in airline travel, flight-related oral conditions requiring treatment have become a source of concern for aircrew members. Awareness and treatment of any potential physiological problems for these aircrews have always been critical components of aviation safety. In a flight situation, oral and maxillofacial problems may in fact become life-threatening clinical conditions. The unusual nature of aerospace medicine requires practitioners to have unique expertise. Special attention to aerospace medicine will open the way for professionals to develop and apply their skills and capabilities. Both dentists and aviators should be aware of the issues involved in aviation dentistry. This article presents the principles of prevention, treatment guidelines, and dental-related flight restrictions.

Ethical concerns and career satisfaction in obstetrics and gynecology: a review of recent findings from the Collaborative Ambulatory Research Network.

PubMed

Farrow, Victoria A; Leddy, Meaghan A; Lawrence, Hal; Schulkin, Jay

2011-09-01

Obstetricians-gynecologists (ob-gyns) are frequently confronted with situations that have ethical implications (e.g., whether to accept gifts or samples from drug companies or disclosing medical errors to patients). Additionally, various factors, including specific job-related tasks, costs, and benefits, may impact ob-gyns' career satisfaction. Ethical concerns and career satisfaction can play a role in the quality of women's health care. This article summarizes the studies published between 2005 and 2009 by the Research Department of the American College of Obstetricians and Gynecologists, which encompass ethical concerns regarding interactions with pharmaceutical representatives and patient safety/medical error reporting, as well as ob-gyn career satisfaction. Additionally, a brief discussion regarding ethical concerns in the ob-gyn field, in general, highlights key topics for the last 30 years. Ethical dilemmas continue to be of concern for ob-gyns. Familiarity with guidelines on appropriate interactions with industry is associated with lower percentages of potentially problematic relationships with pharmaceutical industries. Physicians report that the expense of patient safety initiatives is one of the top barriers for improving patient safety, followed by fear of liability. Overall, respondents reported being satisfied with their careers. However, half of the respondents reported that they were extremely concerned about the impact of professional liability costs on the duration of their careers. Increased familiarity with guidelines may lead to a decreased ob-gyn reliance on pharmaceutical representatives and free samples, whereas specific and practical tools may help them implement patient safety techniques. The easing of malpractice insurance and threat of litigation may enhance career satisfaction among ob-gyns. This article will discuss related findings in recent years. Obstetricians & Gynecologists and Family Physicians. After the completing the CME activity, physicians should be better able to analyze how interactions with pharmaceutical industry may pose ethical dilemmas, examine current barriers to implementing patient safety initiatives, and evaluate the factors that influence career satisfaction among obstetrician-gynecologists.

Dams, Hydrology and Risk in Future River Management

NASA Astrophysics Data System (ADS)

Wegner, D. L.

2017-12-01

Across America there are over 80,000 large to medium dams and globally the number is in excess of 800,000. Currently there are over 1,400 dams and diversion structures being planned or under construction globally. In addition to these documented dams there are thousands of small dams populating watersheds. Governments, agencies, native tribes, private owners and regulators all have a common interest in safe dams. Often dam safety is characterized as reducing structural risk while providing for maximum operational flexibility. In the 1970's there were a number of large and small dam failures in the United States. These failures prompted the federal government to issue voluntary dam safety guidelines. These guidelines were based on historic information incorporated into a risk assessment process to analyze, evaluate and manage risk with the goal to improve the quality of and support of dam management and safety decisions. We conclude that historic and new risks need to be integrated into dam management to insure adequate safety and operational flexibility. A recent assessment of the future role of dams in the United States premises that future costs such as maintenance or removal beyond the economic design life have not been factored into the long-term operations or relicensing of dams. The converging risks associated with aging water storage infrastructure, multiple dams within watersheds and uncertainty in demands policy revisions and an updated strategic approach to dam safety. Decisions regarding the future of dams in the United States may, in turn, influence regional water planning and management. Leaders in Congress and in the states need to implement a comprehensive national water assessment and a formal analysis of the role dams play in our water future. A research and national policy agenda is proposed to assess future impacts and the design, operation, and management of watersheds and dams.

Safety assessment of a novel active ingredient, acetyl aspartic acid, according to the EU Cosmetics Regulation and the Scientific Committee on Consumer Safety guidelines.

PubMed

Daly, P; Moran, G

2015-10-01

Acetyl aspartic acid (A-A-A) was proposed as a new novel active ingredient for use in cosmetics. The safety of A-A-A was assessed by following an in-house-developed 'New Ingredient Testing Strategy', which was designed in accordance with the Scientific Committee on Consumer Safety (SCCS) notes of guidance and the requirements of Annex I of the EU Cosmetics Regulation. The aim of the project was to determine whether A-A-A was safe for use in cosmetics and to determine a maximum permitted safe level in the formulations. A literature review was conducted, consulting over 40 different information sources. This highlighted a number of gaps which required testing data. A-A-A was tested for phototoxicity according to OECD test guideline 432, skin irritation according to OECD test guideline 439 and eye irritation according to OECD test guideline 437. Dermal absorption of A-A-A was measured according to OECD test guideline 428 and was used to calculate the margin of safety (MoS). Finally, A-A-A was tested in a human repeat insult patch test (HRIPT) and a 14-day in-use tolerance study. A-A-A was non-phototoxic and was non-irritating to skin and eyes in in vitro testing. Dermal absorption was calculated to be 5%. The MoS for A-A-A was 351, at a level of 5%, for all cosmetic product types, indicating no systemic safety toxicity concern. A-A-A at 5% under occlusive patch on a panel of 50 adult volunteers induced no skin irritation or allergic reaction in the HRIPT study. Finally, repeated application of A-A-A to the periocular area, twice per day for 14 days, in 21 female volunteers, demonstrated that 1% A-A-A was well tolerated following dermatological and ophthalmological assessment in a cosmetic formulation. A-A-A was assessed as safe by the cosmetic safety assessor for use in cosmetics at a level of 5% in all cosmetic product types, in line with the requirements of the EU Cosmetics Regulation and in accordance with the SCCS notes of guidance. © 2015 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

The safety experience of New Zealand adventure tourism operators.

PubMed

Bentley, Tim A; Page, Stephen; Walker, Linda

2004-01-01

This survey examined parameters of the New Zealand adventure tourism industry client injury risk. The research also sought to establish priorities for intervention to reduce adventure tourism risk, and identify client injury control measures currently in place (or absent) in the New Zealand adventure tourism industry, with a view to establishing guidelines for the development of effective adventure tourism safety management systems. This 2003 survey builds upon an exploratory study of New Zealand adventure tourism safety conducted by us during 1999. A postal questionnaire was used to survey all identifiable New Zealand adventure tourism operators. The questionnaire asked respondents about their recorded client injury experience, perceptions of client injury risk factors, safety management practices, and barriers to safety. Some 27 adventure tourism activities were represented among the responding sample (n=96). The highest client injury risk was reported in the snow sports, bungee jumping and horse riding sectors, although serious underreporting of minor injuries was evident across the industry. Slips, trips and falls (STF) were the major client injury mechanisms, and a range of risk factors for client injuries were identified. Safety management measures were inconsistently applied across the industry. The industry should consider the implications of poor injury reporting standards and safety management practices generally. Specifically, the industry should consider risk management that focuses on minor (e.g., STF) as well as catastrophic events.

Light vehicle forward-looking, rear-end collision warning system performance guidelines

DOT National Transportation Integrated Search

1998-05-01

This document presents performance guidelines for forward-looking, rear-end collision warning systems (abbreviated FCW) for improving vehicular safety by preventing or mitigating vehicular rear-end collisions through driver notification or warning. T...

Safety Standard for Oxygen and Oxygen Systems: Guidelines for Oxygen System Design, Materials Selection, Operations, Storage, and Transportation

NASA Technical Reports Server (NTRS)

1996-01-01

NASA's standard for oxygen system design, materials selection, operation, and transportation is presented. Minimum guidelines applicable to NASA Headquarters and all NASA Field Installations are contained.

Investigation of user stereotypes and preferences

DOT National Transportation Integrated Search

1999-12-01

The presentation of in-vehicle information to the driver is an important issue for highway safety. A review of the guideline literature revealed that although attempts have been made to develop guidelines for in-vehicle information systems, few guide...

Training Guidelines: Bricks Operatives.

ERIC Educational Resources Information Center

Ceramics, Glass, and Mineral Products Industry Training Board, Harrow (England).

This manual offers guidelines for training of personnel involved in the manufacture of bricks, including employment practices; handling and preparation of raw materials; making, drying, firing, sorting, packing, and loading of bricks. A major emphasis is placed on industrial safety. (MF)

ICMR-DBT guidelines for evaluation of probiotics in food.

PubMed

2011-07-01

There has been an increased influx of probiotic products in the Indian market during the last decade. However, there has been no systematic approach for evaluation of probiotics in food to ensure their safety and efficacy. An initiative was, therefore, taken by the Indian Council of Medical Research (ICMR) along with the Department of Biotechnology (DBT) to formulate guidelines for regulation of probiotic products in the country. These guidelines define a set of parameters required for a product/strain to be termed as 'probiotic'. These include identification of the strain, in vitro screening for probiotic characteristics, animal studies to establish safety and in vivo animal and human studies to establish efficacy. The guidelines also include requirements for labeling of the probiotic products with strain specification, viable numbers at the end of shelf life, storage conditions, etc., which would be helpful to the consumers to safeguard their own interest.

Guideline Implementation: Surgical Smoke Safety.

PubMed

Fencl, Jennifer L

2017-05-01

Research conducted during the past four decades has demonstrated that surgical smoke generated from the use of energy-generating devices in surgery contains toxic and biohazardous substances that present risks to perioperative team members and patients. Despite the increase in information available, however, perioperative personnel continue to demonstrate a lack of knowledge of these hazards and lack of compliance with recommendations for evacuating smoke during surgical procedures. The new AORN "Guideline for surgical smoke safety" provides guidance on surgical smoke management. This article focuses on key points of the guideline to help perioperative personnel promote smoke-free work environments; evacuate surgical smoke; and develop education programs and competency verification tools, policies and procedures, and quality improvement initiatives related to controlling surgical smoke. Perioperative RNs should review the complete guideline for additional information and for guidance when writing and updating policies and procedures. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Guideline Implementation: Energy-Generating Devices, Part 2-Lasers.

PubMed

Burlingame, Byron L

2017-04-01

Lasers have been used in the OR for many years and are essential tools in many different types of procedures. However, laser beams that come into contact with unintended targets directly or via reflection can cause injury to patients or personnel or pose other hazards, such as fires. The new AORN "Guideline for safe use of energy-generating devices" provides guidance on the use of all energy-generating devices in the OR. This article focuses on key points of the guideline that address the safe use of lasers. These include the components of the laser safety program, the responsibilities of the personnel in roles specific to use of a laser, laser safety measures, and documentation of laser use. Perioperative RNs should review the complete guideline for additional information and for guidance when writing and updating policies and procedures. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.

ICMR-DBT Guidelines for Evaluation of Probiotics in Food

PubMed Central

Ganguly, N.K.; Bhattacharya, S.K.; Sesikeran, B.; Nair, G.B; Ramakrishna, B.S.; Sachdev, H.P.S.; Batish, V.K.; Kanagasabapathy, A.S.; Muthuswamy, Vasantha; Kathuria, S.C; Katoch, V.M.; Satyanarayana, K.; Toteja, G.S; Rahi, Manju; Rao, Spriha; Bhan, M.K; Kapur, Rajesh; Hemalatha, R

2011-01-01

There has been an increased influx of probiotic products in the Indian market during the last decade. However, there has been no systematic approach for evaluation of probiotics in food to ensure their safety and efficacy. An initiative was, therefore, taken by the Indian Council of Medical Research (ICMR) along with the Department of Biotechnology (DBT) to formulate guidelines for regulation of probiotic products in the country. These guidelines define a set of parameters required for a product/strain to be termed as ‘probiotic’. These include identification of the strain, in vitro screening for probiotic characteristics, animal studies to establish safety and in vivo animal and human studies to establish efficacy. The guidelines also include requirements for labeling of the probiotic products with strain specification, viable numbers at the end of shelf life, storage conditions, etc., which would be helpful to the consumers to safeguard their own interest. PMID:21808130

Modeling Guidelines for Code Generation in the Railway Signaling Context

NASA Technical Reports Server (NTRS)

Ferrari, Alessio; Bacherini, Stefano; Fantechi, Alessandro; Zingoni, Niccolo

2009-01-01

Modeling guidelines constitute one of the fundamental cornerstones for Model Based Development. Their relevance is essential when dealing with code generation in the safety-critical domain. This article presents the experience of a railway signaling systems manufacturer on this issue. Introduction of Model-Based Development (MBD) and code generation in the industrial safety-critical sector created a crucial paradigm shift in the development process of dependable systems. While traditional software development focuses on the code, with MBD practices the focus shifts to model abstractions. The change has fundamental implications for safety-critical systems, which still need to guarantee a high degree of confidence also at code level. Usage of the Simulink/Stateflow platform for modeling, which is a de facto standard in control software development, does not ensure by itself production of high-quality dependable code. This issue has been addressed by companies through the definition of modeling rules imposing restrictions on the usage of design tools components, in order to enable production of qualified code. The MAAB Control Algorithm Modeling Guidelines (MathWorks Automotive Advisory Board)[3] is a well established set of publicly available rules for modeling with Simulink/Stateflow. This set of recommendations has been developed by a group of OEMs and suppliers of the automotive sector with the objective of enforcing and easing the usage of the MathWorks tools within the automotive industry. The guidelines have been published in 2001 and afterwords revisited in 2007 in order to integrate some additional rules developed by the Japanese division of MAAB [5]. The scope of the current edition of the guidelines ranges from model maintainability and readability to code generation issues. The rules are conceived as a reference baseline and therefore they need to be tailored to comply with the characteristics of each industrial context. Customization of these recommendations has been performed for the automotive control systems domain in order to enforce code generation [7]. The MAAB guidelines have been found profitable also in the aerospace/avionics sector [1] and they have been adopted by the MathWorks Aerospace Leadership Council (MALC). General Electric Transportation Systems (GETS) is a well known railway signaling systems manufacturer leading in Automatic Train Protection (ATP) systems technology. Inside an effort of adopting formal methods within its own development process, GETS decided to introduce system modeling by means of the MathWorks tools [2], and in 2008 chose to move to code generation. This article reports the experience performed by GETS in developing its own modeling standard through customizing the MAAB rules for the railway signaling domain and shows the result of this experience with a successful product development story.

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

PubMed

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

2008-07-01

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

GMP-compliant human adipose tissue-derived mesenchymal stem cells for cellular therapy.

PubMed

Aghayan, Hamid-Reza; Goodarzi, Parisa; Arjmand, Babak

2015-01-01

Stem cells, which can be derived from different sources, demonstrate promising therapeutic evidences for cellular therapies. Among various types of stem cell, mesenchymal stem cells are one of the most common stem cells that are used in cellular therapy. Human subcutaneous adipose tissue provides an easy accessible source of mesenchymal stem cells with some considerable advantages. Accordingly, various preclinical and clinical investigations have shown enormous potential of adipose-derived stromal cells in regenerative medicine. Consequently, increasing clinical applications of these cells has elucidated the importance of safety concerns regarding clinical transplantation. Therefore, clinical-grade preparation of adipose-derived stromal cells in accordance with current good manufacturing practice guidelines is an essential part of their clinical applications to ensure the safety, quality, characteristics, and identity of cell products. Additionally, GMP-compliant cell manufacturing involves several issues to provide a quality assurance system during translation from the basic stem cell sciences into clinical investigations and applications. On the other hand, advanced cellular therapy requires extensive validation, process control, and documentation. It also evidently elucidates the critical importance of production methods and probable risks. Therefore, implementation of a quality management and assurance system in accordance with GMP guidelines can greatly reduce these risks particularly in the higher-risk category or "more than minimally manipulated" products.

Assessment of possible allergenicity of hypothetical ORFs in common food crops using current bioinformatic guidelines and its implications for the safety assessment of GM crops.

PubMed

Young, Gregory J; Zhang, Shiping; Mirsky, Henry P; Cressman, Robert F; Cong, Bin; Ladics, Gregory S; Zhong, Cathy X

2012-10-01

Before a genetically modified (GM) crop can be commercialized it must pass through a rigorous regulatory process to verify that it is safe for human and animal consumption, and to the environment. One particular area of focus is the potential introduction of a known or cross-reactive allergen not previously present within the crop. The assessment of possible allergenicity uses the guidelines outlined by the Food and Agriculture Organization (FAO) and World Health Organization's (WHO) Codex Alimentarius Commission (Codex) to evaluate all newly expressed proteins. Some regulatory authorities have broadened the scope of the assessment to include all DNA reading frames between stop codons across the insert and spanning the insert/genomic DNA junctions. To investigate the utility of this bioinformatic assessment, all naturally occurring stop-to-stop frames in the non-transgenic genomes of maize, rice, and soybean, as well as the human genome, were compared against the AllergenOnline (www.allergenonline.org) database using the Codex criteria. We discovered thousands of frames that exceeded the Codex defined threshold for potential cross-reactivity suggesting that evaluating hypothetical ORFs (stop-to-stop frames) has questionable value for making decisions on the safety of GM crops. Copyright © 2012 Elsevier Ltd. All rights reserved.

Impact of closed-system drug transfer device on exposure of environment and healthcare provider to cyclophosphamide in Japanese hospital.

PubMed

Miyake, Tomohiro; Iwamoto, Takuya; Tanimura, Manabu; Okuda, Masahiro

2013-12-01

In spite of current recommended safe handling procedures, the potential for the exposure of healthcare providers to hazardous drugs exists in the workplace. A reliance on biological safety cabinets to provide total protection against the exposure to hazardous drugs is insufficient. Preventing workplace contamination is the best strategy to minimize cytotoxic drug exposure in healthcare providers. This study was conducted to compare surface contamination and personnel exposure to cyclophosphamide before and after the implementation of a closed-system drug transfer device, PhaSeal, under the influence of cleaning according to the Japanese guidelines. Personnel exposure was evaluated by collecting 24 h urine samples from 4 pharmacists. Surface contamination was assessed by the wiping test. Four of 6 wipe samples collected before PhaSeal indicated a detectable level of cyclophosphamide. About 7 months after the initiation of PhaSeal, only one of 6 wipe samples indicated a detectable level of cyclophosphamide. Although all 4 employees who provided urine samples had positive results for the urinary excretion of cyclophosphamide before PhaSeal, these levels returned to minimal levels in 2 pharmacists after PhaSeal. In combination with the biological safety cabinet and cleaning according to the Japanese guidelines, PhaSeal further reduces surface contamination and healthcare providers exposure to cyclophosphamide to almost undetectable levels.

Health and Safety in the Early Childhood Classroom: Guidelines for Curriculum Development

ERIC Educational Resources Information Center

Bales, Diane; Wallinga, Charlotte; Coleman, Mick

2006-01-01

Early childhood teachers have a variety of health and safety resources to draw upon, including information about and educational programs dealing with such issues as fire safety, obesity, and dental hygiene. However, teachers may face a number of challenges when attempting to incorporate health and safety resources into the curriculum. In some…

Safety on the Job. Some Guidelines for Working Safely. Instructor's Edition.

ERIC Educational Resources Information Center

Oklahoma State Dept. of Vocational and Technical Education, Stillwater. Curriculum and Instructional Materials Center.

This teacher's guide was developed to help teachers (especially in Oklahoma) promote safe practices on the job. As a supplement to existing programs in the requirements for job safety, this book can also promote same basic safety attitudes and help support basic safety concepts, with an emphasis on accident prevention. The guide contains eight…

Intravenous rehydration of malnourished children with acute gastroenteritis and severe dehydration: A systematic review

PubMed Central

Houston, Kirsty A.; Gibb, Jack G.; Maitland, Kathryn

2017-01-01

Background: Rehydration strategies in children with severe acute malnutrition (SAM) and severe dehydration are extremely cautious. The World Health Organization (WHO) SAM guidelines advise strongly against intravenous fluids unless the child is shocked or severely dehydrated and unable to tolerate oral fluids. Otherwise, guidelines recommend oral or nasogastric rehydration using low sodium oral rehydration solutions. There is limited evidence to support these recommendations. Methods: We conducted a systematic review of randomised controlled trials (RCTs) and observational studies on 15 th June 2017 comparing different strategies of rehydration therapy in children with acute gastroenteritis and severe dehydration, specifically relating to intravenous rehydration, using standard search terms. Two authors assessed papers for inclusion. The primary endpoint was evidence of fluid overload. Results: Four studies were identified, all published in English, including 883 children, all of which were conducted in low resource settings. Two were randomised controlled trials and two observational cohort studies, one incorporated assessment of myocardial and haemodynamic function. There was no evidence of fluid overload or other fluid-related adverse events, including children managed on more liberal rehydration protocols. Mortality was high overall, and particularly in children with shock managed on WHO recommendations (day-28 mortality 82%). There was no difference in safety outcomes when different rates of intravenous rehydration were compared. Conclusions: The current ‘strong recommendations’ for conservative rehydration of children with SAM are not based on emerging evidence. We found no clinical trials providing a direct assessment of the current WHO guidelines, and those that were available suggested that these children have a high mortality and remain fluid depleted on current therapy. Recent studies have reported no evidence of fluid overload or heart failure with more liberal rehydration regimens. Clinical trials are urgently required to inform guidelines on routes and rates of intravenous rehydration therapy for dehydration in children with SAM. PMID:28944301

Intravenous rehydration of malnourished children with acute gastroenteritis and severe dehydration: A systematic review.

PubMed

Houston, Kirsty A; Gibb, Jack G; Maitland, Kathryn

2017-01-01

Background: Rehydration strategies in children with severe acute malnutrition (SAM) and severe dehydration are extremely cautious. The World Health Organization (WHO) SAM guidelines advise strongly against intravenous fluids unless the child is shocked or severely dehydrated and unable to tolerate oral fluids. Otherwise, guidelines recommend oral or nasogastric rehydration using low sodium oral rehydration solutions. There is limited evidence to support these recommendations. Methods: We conducted a systematic review of randomised controlled trials (RCTs) and observational studies on 15 th June 2017 comparing different strategies of rehydration therapy in children with acute gastroenteritis and severe dehydration, specifically relating to intravenous rehydration, using standard search terms. Two authors assessed papers for inclusion. The primary endpoint was evidence of fluid overload. Results: Four studies were identified, all published in English, including 883 children, all of which were conducted in low resource settings. Two were randomised controlled trials and two observational cohort studies, one incorporated assessment of myocardial and haemodynamic function. There was no evidence of fluid overload or other fluid-related adverse events, including children managed on more liberal rehydration protocols. Mortality was high overall, and particularly in children with shock managed on WHO recommendations (day-28 mortality 82%). There was no difference in safety outcomes when different rates of intravenous rehydration were compared. Conclusions: The current 'strong recommendations' for conservative rehydration of children with SAM are not based on emerging evidence. We found no clinical trials providing a direct assessment of the current WHO guidelines, and those that were available suggested that these children have a high mortality and remain fluid depleted on current therapy. Recent studies have reported no evidence of fluid overload or heart failure with more liberal rehydration regimens. Clinical trials are urgently required to inform guidelines on routes and rates of intravenous rehydration therapy for dehydration in children with SAM.

A systematic review and appraisal of the quality of practice guidelines for the management of Neisseria gonorrhoeae infections.

PubMed

Dickson, Catherine; Arnason, Trevor; Friedman, Dara Spatz; Metz, Gila; Grimshaw, Jeremy M

2017-11-01

Clinical guidelines help ensure consistent care informed by current evidence. As shifts in antimicrobial resistance continue to influence first-line treatment, up-to-date guidelines are important for preventing treatment failure. A guideline's development process will influence its recommendations and users' trust. To assess the quality of current gonorrhoea guidelines' development processes. Multiple databases. Original and current English-language guidelines targeting health professionals and containing treatment recommendations for uncomplicated gonorrhoea in the general adult population. Two appraisers assessed the guidelines independently using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Scores were combined as per the AGREE II users' manual. We identified 10 guidelines meeting the inclusion criteria. The quality of the gonorrhoea treatment guidelines varied. Most scored poorly on Rigour of Development ; information on the evidence review process and methods for formulating recommendations was often missing. The WHO Guidelines for the Treatment of Neisseria gonorrhoeae and UK National Guideline for the Management of Gonorrhoea in Adults scored the highest on Rigour of Development . Methods to address conflicts of interest were often not described in the materials reviewed. Implementation of recommendations was often not addressed. By limiting our study to English-language guidelines, a small number of guidelines we identified were excluded. Our analysis was limited to either published or online materials that were readily available to users. We could not differentiate between items addressed in the development process but not documented from items that were not addressed. Gonorrhoea treatment guidelines may slow antimicrobial resistance. Many current guidelines are not in line with the current guideline development best practices; this might undermine the perceived trustworthiness of guidelines. By identifying current limitations, this study can help improve the quality of future guidelines. 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/.

Playground Safety (For Parents)

MedlinePlus

... on cloudy days to protect against sunburn. Safe Equipment Guidelines Because swings, slides, and climbing equipment are ... clear for other kids to slide down. Climbing Equipment Safety Climbing equipment comes in many shapes and ...

[EBM, guidelines, protocols: knowledge, attitudes and utilization in the era of law on professional responsibility and safety of health care.

PubMed

Minozzi, Silvia; Ruggiero, Francesca; Capobussi, Matteo; González-Lorenzo, Marien; La Regina, Micaela; Squizzato, Alessandro; Moja, Lorenzo; Orlandini, Francesco

2018-05-01

The knowledge of principles and methods of Evidence Based Medicine (EBM) and the use of Clinical Practice Guidelines to inform clinical decisions are recognised as key instruments to improve the quality of care. In Italy the Parliament has revised the legal system that rules the responsibilities of health professionals and health care safety, prescribing health professionals to adhere to guidelines and good practice recommendations. The objective of the study was to evaluate guidelines and clinical pathways developed at local level and to assess knowledge and attitudes of healthcare workers toward EBM and guidelines. At the l'ASL 5 Liguria La Spezia we performed a census of all the documents registered as "guidelines" or "clinical pathways" at the Direzione Generale by the end of May 2016. We assessed their methodological quality by the "Recognition Card for Clinical Pathways Production and Revision Activity" prepared by the Ligurian Region. We conducted semi-structured interviews to assess attitudes and knowledge of healthcare workers. We found 17 clinical pathways, 41% contained organizational/management recommendations, and 59% contained mainly clinical recommendations. 41% was produced by assimilating already existing guidelines. 29% did not describe the method of production. Only one document linked directly each recommendation with scientific evidence. 10 healthcare workers out of 32 invited actually accepted to conduct the interview. Respondents showed a positive attitude toward the EBM and guidelines but a poor knowledge of the methodology of production and the instruments and principles for critical appraising of scientific literature. Nobody knew the GRADE approach. The most relevant barriers identified were: lack of time, poor knowledge of English and statistical methods, poor applicability of the international guidelines to local setting and real patients encountered in clinical practice. Despite the initiatives of the legislator toward civil responsibility and safety of care that should increase the use of guidelines, we found an overall poor knowledge of the concepts of EBM and method of guidelines production. Though the attitudes of responders to the interview were positive, barriers to use seemed to be predominant and considered more as obstacles than as a stimulus. In peripheral settings or in hospitals of medium/small size, clinical guidelines could remain confined to a merely juridical role, with weak impact on professional practice.

Contemporary surgical devices for male stress urinary incontinence: a review of technological advances in current continence surgery.

PubMed

Chung, Eric

2017-07-01

Male stress urinary incontinence (SUI) remains a debilitating condition that adversely impacts all domains of quality of life and is associated with significant social stigma and health economic burden. The incidence of post-prostatectomy urinary incontinence (PPI) depends on the definition of urinary incontinence and the length of patient follow up. In patients with persistent PPI following failure of conservative measures, surgical treatment is recommended although there is no published guideline on when surgery should be performed, and what the best surgical option is. Male slings (MS) can be divided into adjustable or non-adjustable types, and offers an attractive option for patients who wish to avoid mechanical handling during urinary voiding. Published intermediate data supports good safety and efficacy rate in men with mild to moderate degree of SUI. The AMS 800 artificial urinary sphincter (AUS) remains the standard of treatment for complete continence and has the longest efficacy and safety records. Other AUS-like devices are designed to address current AMS 800 limitations but themselves are fraught with their own issues.

An expert system for wind shear avoidance

NASA Technical Reports Server (NTRS)

Stengel, Robert F.; Stratton, D. Alexander

1990-01-01

A study of intelligent guidance and control concepts for protecting against the adverse effects of wind shear during aircraft takeoffs and landings is being conducted, with current emphasis on developing an expert system for wind shear avoidance. Principal objectives are to develop methods for assessing the likelihood of wind shear encounter (based on real-time information in the cockpit), for deciding what flight path to pursue (e.g., takeoff abort, landing go-around, or normal climbout or glide slope), and for using the aircraft's full potential for combating wind shear. This study requires the definition of both deterministic and statistical techniques for fusing internal and external information , for making go/no-go decisions, and for generating commands to the manually controlled flight. The program has begun with the development of the WindShear Safety Advisor, an expert system for pilot aiding that is based on the FAA Windshear Training Aid; a two-volume manual that presents an overview , pilot guide, training program, and substantiating data provides guidelines for this initial development. The WindShear Safety Advisor expert system currently contains over 200 rules and is coded in the LISP programming language.

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

PubMed Central

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

2015-01-01

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

Operational Safety on Airports During Construction

DOT National Transportation Integrated Search

1984-05-31

This advisory circular (AC) sets forth guidelines concerning the operational : safety on airports during construction, to assist airport operators in complying : with Part 139, Certification and Operation: Land Airports Serving Certain Air : Carriers...

WHO consultation on clinical evaluation of vaccines, 17-18 July 2014, WHO Headquarters, Geneva, Switzerland.

PubMed

Knezevic, Ivana; Moorthy, Vasee; Sheets, Rebecca

2015-04-21

A World Health Organization (WHO) consultation on guidelines for National Regulatory Authorities (NRAs) and vaccine manufacturers on clinical evaluation of vaccines was held from 17 to 18 July 2014, to review key scientific challenges that regulators have been facing since the establishment of the WHO Guidelines on Clinical Evaluation of Vaccines. The guidelines, adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2001, have served as the basis for setting or updating national requirements for the evaluation and licensing of a broad range of vaccines as well as for WHO vaccine prequalification. Regulators from Australia, Brazil, China, Canada, Germany, India, Republic of Korea, South Africa, United States of America and the United Kingdom were represented. The International Federation for Pharmaceutical Manufacturers' Association (IFPMA) and the Developing Country Vaccine Manufacturers' Network (DCVMN) provided industry representation. The consultation concluded that the guidelines should be revised to address issues that were raised in the context of vaccines that were the subject of clinical development in the past decade. Although the current guidelines have served well over time, it was recognized that an update would further increase their utility and would help regulators, manufacturers, vaccine developers and academia to respond to the challenging questions regarding the safety, immunogenicity, efficacy and effectiveness of vaccines intended for global use. A summary of the main outcomes of the consultation and proposals for the next steps regarding the guidelines and beyond are provided in this report. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Review of achievements of the OECD Working Party on Manufactured Nanomaterials' Testing and Assessment Programme. From exploratory testing to test guidelines.

PubMed

Rasmussen, Kirsten; González, Mar; Kearns, Peter; Sintes, Juan Riego; Rossi, François; Sayre, Phil

2016-02-01

This paper charts the almost ten years of history of OECD's work on nanosafety, during which the programme of the OECD on the Testing and Assessment of Manufactured Nanomaterials covered the testing of eleven nanomaterials for about 59 end-points addressing physical-chemical properties, mammalian and environmental toxicity, environmental fate and material safety. An overview of the materials tested, the test methods applied and the discussions regarding the applicability of the OECD test guidelines, which are recognised methods for regulatory testing of chemicals, are given. The results indicate that many existing OECD test guidelines are suitable for nanomaterials and consequently, hazard data collected using such guidelines will fall under OECD's system of Mutual Acceptance of Data (MAD) which is a legally binding instrument to facilitate the international acceptance of information for the regulatory safety assessment of chemicals. At the same time, some OECD test guidelines and guidance documents need to be adapted to address nanomaterials while new test guidelines and guidance documents may be needed to address endpoints that are more relevant to nanomaterials. This paper presents examples of areas where test guidelines or guidance for nanomaterials are under development. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Practical guidance for the management of iron deficiency in patients with inflammatory bowel disease

PubMed Central

Niepel, Dorothea; Klag, Thomas; Malek, Nisar P.; Wehkamp, Jan

2018-01-01

Iron deficiency or iron deficiency anemia (IDA) are some of the most common systemic complications of inflammatory bowel diseases (IBD). Symptoms such as fatigue, reduced ability to concentrate and reduced exercise tolerance can mimic common symptoms of IBD and can therefore easily be overseen. Furthermore, clinicians tend to see mild to moderate anemia as an inevitable accompaniment of IBD that is sufficiently explained by the underlying disease and does not require further workup. But in contrast to these clinical routines, current guidelines recommend that any degree of anemia in patients with IBD should be further evaluated and treated. Multiple studies have shown that anemia is a main factor for decreased quality of life (QoL) in patients with IBD. Correction of anemia, however, can significantly improve the QoL of patients with IBD. It is therefore recommended that every patient with IBD is regularly screened for iron deficiency and anemia. If detected, appropriate workup and treatment should be initiated. Over the last years, a number of new diagnostic tools and treatment options have been developed. Multiple studies have demonstrated the safety of newer formulations of intravenous iron in patients with IBD and have compared oral and intravenous iron in various situations. Treatment recommendations have changed and new evidence-based guidelines were developed. However, to date these guidelines are still not widely implemented in clinical practice. The aim of this review is to draw attention to the need for treatment for every level of anemia in patients with IBD and to provide some practical guidance for screening, diagnostics, treatment and follow up of IDA in patients with IBD following current international guidelines. PMID:29760784

[Digital electroencephalography in brain death diagnostics : Technical requirements and results of a survey on the compatibility with medical guidelines of digital EEG systems from providers in Germany].

PubMed

Walter, U; Noachtar, S; Hinrichs, H

2018-02-01

The guidelines of the German Medical Association and the German Society for Clinical Neurophysiology and Functional Imaging (DGKN) require a high procedural and technical standard for electroencephalography (EEG) as an ancillary method for diagnosing the irreversible cessation of brain function (brain death). Nowadays, digital EEG systems are increasingly being applied in hospitals. So far it is unclear to what extent the digital EEG systems currently marketed in Germany meet the guidelines for diagnosing brain death. In the present article, the technical und safety-related requirements for digital EEG systems and the EEG documentation for diagnosing brain death are described in detail. On behalf of the DGKN, the authors sent out a questionnaire to all identified distributors of digital EEG systems in Germany with respect to the following technical demands: repeated recording of the calibration signals during an ongoing EEG recording, repeated recording of all electrode impedances during an ongoing EEG recording, assessability of intrasystem noise and galvanic isolation of measurement earthing from earthing conductor (floating input). For 15 of the identified 20 different digital EEG systems the specifications were provided by the distributors (among them all distributors based in Germany). All of these EEG systems are provided with a galvanic isolation (floating input). The internal noise can be tested with all systems; however, some systems do not allow repeated recording of the calibration signals and/or the electrode impedances during an ongoing EEG recording. The majority but not all of the currently available digital EEG systems offered for clinical use are eligible for use in brain death diagnostics as per German guidelines.

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research☆

PubMed Central

Rossi, Simone; Hallett, Mark; Rossini, Paolo M.; Pascual-Leone, Alvaro

2011-01-01

This article is based on a consensus conference, which took place in Certosa di Pontignano, Siena (Italy) on March 7–9, 2008, intended to update the previous safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical settings. Over the past decade the scientific and medical community has had the opportunity to evaluate the safety record of research studies and clinical applications of TMS and repetitive TMS (rTMS). In these years the number of applications of conventional TMS has grown impressively, new paradigms of stimulation have been developed (e.g., patterned repetitive TMS) and technical advances have led to new device designs and to the real-time integration of TMS with electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Thousands of healthy subjects and patients with various neurological and psychiatric diseases have undergone TMS allowing a better assessment of relative risks. The occurrence of seizures (i.e., the most serious TMS-related acute adverse effect) has been extremely rare, with most of the few new cases receiving rTMS exceeding previous guidelines, often in patients under treatment with drugs which potentially lower the seizure threshold. The present updated guidelines review issues of risk and safety of conventional TMS protocols, address the undesired effects and risks of emerging TMS interventions, the applications of TMS in patients with implanted electrodes in the central nervous system, and safety aspects of TMS in neuroimaging environments. We cover recommended limits of stimulation parameters and other important precautions, monitoring of subjects, expertise of the rTMS team, and ethical issues. While all the recommendations here are expert based, they utilize published data to the extent possible. PMID:19833552

Safety of 8-weeks oral administration of Arctium lappa L.

PubMed

Bok, So-Hyeon; Cho, Seung Sik; Bae, Chun-Sik; Park, Dae-Hun; Park, Kyung-Mok

2017-09-01

Recently, worldwide dietary reference intakes have been considered an important guideline for public health. Some governments and the World Health Organization (WHO) provide guidelines concerning dietary intake. Although an ingredient may have a history of use as a culinary material, changes in the environment over time suggest that the acceptable maximum intake each of food/culinary material should be regularly evaluated. Arctium lappa L. has been used as a culinary material for many centuries in Korea and Japan and some recent studies have reported related therapeutic effects. However, there are no reports on the safety of repeated oral administration. In this study, we evaluated the safety of a 8-weeks repeated oral intake of A. lappa . We concluded that treatment with <250 mg/kg A. lappa , which was within the safety range, resulted in body weight decrease and blood glucose suppression.

Predoctoral and Postdoctoral Education on Cone-Beam Computed Tomography.

PubMed

Buchanan, Allison; Thachil, Karan; Haggard, Chris; Kalathingal, Sajitha

2017-12-01

As the use of cone beam computed tomography (CBCT) in dentistry continues to grow, questions related to appropriate radiation safety, training, and interpretation arise. Recognizing this need, the American Dental Association published an advisory statement for the safe use of CBCT in dentistry and recommended that guidelines for appropriate training be established. The purpose of this study was to assess radiation safety concerns related to CBCT and identify voids in current education on CBCT for the predoctoral dental curriculum and continuing dental education. A survey was mailed to general practitioners, oral surgeons, and periodontists in the Georgia Dental Association (n = 415). One hundred twenty-one surveys were received for a response rate of 29%. Sixty-eight percent of practitioners reported using CBCT, with 89% having used it for over 2 years. Few (12.4%) had experience with CBCT in dental school. Interest in continuing dental education on CBCT was reported at 59.8% and 43.6% for current users and nonusers of CBCT, respectively. Approximately 50% reported using precautionary radiation safety measures, and the methods used were varied. Although a higher survey return rate would allow for stronger evidence, this project identified some areas of education voids including radiation safety and the factors that contribute to patient dose; CBCT basics including instruction on the limitations of CBCT; CBCT anatomy and pathology with additional time dedicated to the paranasal sinuses; and interpretation. Copyright © 2017 Elsevier Inc. All rights reserved.

Prokinetics prescribing in paediatrics: evidence on cisapride, domperidone, and metoclopramide.

PubMed

Mt-Isa, Shahrul; Tomlin, Stephen; Sutcliffe, Alastair; Underwood, Martin; Williamson, Paula; Croft, Nicholas M; Ashby, Deborah

2015-04-01

Domperidone and metoclopramide are prokinetics commonly prescribed off-label to infants and younger children in an attempt to treat gastro-oesophageal reflux symptoms. Another prokinetic drug, cisapride, was used but withdrawn in 2000 in the United Kingdom because of serious arrhythmic adverse events. Medicines and Healthcare Products Regulatory Agency issued safety warnings for domperidone in May 2012 and restricted its indications. We report here national primary care prescribing trends and safety signals of these drugs in children. We used data from the General Practice Research Database between 1990 and 2006 for children <18 years. Descriptive statistics and Poisson regressions were performed to characterise prescribing trends. We examined safety signals in nested case-control studies. The proportion of children <2 years old being prescribed one of the medications doubled during the study period. Prescriptions of domperidone increased 10-fold, mainly following the withdrawal of cisapride in 2000. Prescriptions of metoclopramide did not change significantly. Despite the increase in prescriptions of domperidone, no new safety signals were identified. These data showed dramatic changes in prescribing of cisapride and domperidone despite the lack of good-quality supporting evidence. It is possible that these prescribing trends were influenced by published guidelines. Even if produced without robust efficacy and safety evidence, published guidelines can influence clinicians and consequently affect prescribing. Therefore, improving the evidence base on prokinetics to inform future guidelines is vital. The lack of new safety signals during this period would support the development of suitable powered clinical studies.

Methodologic limitations of prescription opioid safety research and recommendations for improving the evidence base.

PubMed

Ranapurwala, Shabbar I; Naumann, Rebecca B; Austin, Anna E; Dasgupta, Nabarun; Marshall, Stephen W

2018-06-03

The ongoing opioid epidemic has claimed more than a quarter million Americans' lives over the past 15 years. The epidemic began with an escalation of prescription opioid deaths and has now evolved to include secondary waves of illicit heroin and fentanyl deaths, while the deaths due to prescription opioid overdoses are still increasing. In response, the Centers for Disease Control and Prevention (CDC) moved to limit opioid prescribing with the release of opioid prescribing guidelines for chronic noncancer pain in March 2016. The guidelines represent a logical and timely federal response to this growing crisis. However, CDC acknowledged that the evidence base linking opioid prescribing to opioid use disorders and overdose was grades 3 and 4. Motivated by the need to strengthen the evidence base, this review details limitations of the opioid safety studies cited in the CDC guidelines with a focus on methodological limitations related to internal and external validity. Internal validity concerns were related to poor confounding control, variable misclassification, selection bias, competing risks, and potential competing interventions. External validity concerns arose from the use of limited source populations, historical data (in a fast-changing epidemic), and issues with handling of cancer and acute pain patients' data. We provide a nonexhaustive list of 7 recommendations to address these limitations in future opioid safety studies. Strengthening the opioid safety evidence base will aid any future revisions of the CDC guidelines and enhance their prevention impact. Copyright © 2018 John Wiley & Sons, Ltd.

Safety Precautions. Child Health and Safety Series (Module I).

ERIC Educational Resources Information Center

Iscoe, Louise; And Others

This manual for parents and child care personnel in day care homes and centers provides guidelines and information on indoor and outdoor safety precautions, emergency preparation and first aid. Contents focus on monitoring arrivals and departures, prevention of suffocation and strangulation, control of pets and other animals, preventing and…

Marginal lung donors: A diminishing margin of safety?

PubMed

Botha, Phil; Fisher, Andrew J; Dark, John H

2006-11-27

Lung donor shortages have resulted in the critical appraisal of cadaveric donor acceptability criteria and the gradual relaxation of once strict guidelines. Many centers have reported their results with these "extended criteria" donors and an increasing number of multicenter registry studies have also been published. The results have been contradictory and leave many questions unanswered. Important new data has however come to light since the last review of the subject by the International Society for Heart and Lung Transplantation Pulmonary Council. We review the current literature focusing on recent developments in the pursuit of an expanded lung donor pool with acceptable outcomes.

Comprehensive Review of Ultraviolet Radiation and the Current Status on Sunscreens

PubMed Central

Moon, Summer; Armstrong, Frank

2012-01-01

In the past, manufacturers’ labeling of sunscreen varied greatly, confusing the consumers regarding efficacy and the appropriate photoprotection provided by their products. Therefore, in June 2011, the United States Food and Drug Administration issued new guidelines for sunscreen labeling. Sunscreen products are over-the-counter drugs; therefore, they are regulated by the United States Food and Drug Administration to determine safety, efficacy, and labeling. This article discusses ultraviolet radiation and the positive and negative effects of ultraviolet radiation, provides a review of sunscreens, and discusses the new United States Food and Drug Administration regulations for sunscreens. PMID:23050030

[Error prevention through management of complications in urology: standard operating procedures from commercial aviation as a model].

PubMed

Kranz, J; Sommer, K-J; Steffens, J

2014-05-01

Patient safety and risk/complication management rank among the current megatrends in modern medicine, which has undoubtedly become more complex. In time-critical, error-prone and difficult situations, which often occur repeatedly in everyday clinical practice, guidelines are inappropriate for acting rapidly and intelligently. With the establishment and consistent use of standard operating procedures like in commercial aviation, a possible strategic approach is available. These medical aids to decision-making - quick reference cards - are short, optimized instructions that enable a standardized procedure in case of medical claims.

Editorial: ERCP-Related Radiation Cataractogenesis: Is It Time to Be Concerned?

PubMed

Mekaroonkamol, Parit; Keilin, Steven

2017-05-01

With the growing number of fluoroscopic guided endoscopic procedures, radiation-related risk needs to be further assessed. Recent evidence indicates that radiation cataractogenesis occurs at a lower dose threshold than previously believed. While body aprons and thyroid shields are well-established standard protection during fluoroscopy, ocular safety and the use of protective eyewear are not as well defined. This prospective study answered two important questions: Does the standard body dosimeter provide an accurate ocular dosimetry? And what is the time of fluoroscopy needed to warrant using lens protection? It also raises the question whether current guidelines need to be updated.

Advice for Travellers to Tropical and Subtropical Countries

PubMed Central

Lawee, David; Scapattura, Philip

1985-01-01

Travellers to areas where political instability, poverty or inadequate public health measures render them at risk of exposure to infections and diseases they are unlikely to meet at home should seek prophylaxis and protection before departure. Inoculation is the best form of protection for certain diseases; since protocols change frequently, a reliable local source of current information should be found. Prophylaxis against malaria involves both mechanical protection against mosquito bites, and appropriate chemoprophylaxis. Water safety must be considered where chlorinated water is not available; a protocol for decontamination is presented, and guidelines for avoiding gastrointestinal disorders are listed. PMID:21274125

Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing

PubMed Central

Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S.

2011-01-01

Background Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Methods and Findings Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1–14). Six “teaser” advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Conclusions Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information. PMID:21858076

Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

PubMed

Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S

2011-01-01

Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.

Complex mixtures in industrial workspaces: lessons for indoor air quality evaluations.

PubMed

Lippy, B E; Turner, R W

1991-11-01

Acceptable occupational exposure levels for hundreds of airborne concentrations of dusts, vapors, fumes, and gases have been set by consensus organizations and regulatory bodies for decades. These levels have established tremendous precedent and are tempting reference values in the relatively new field of indoor air quality evaluations where validated criteria are greatly needed. The American Conference of Government Industrial Hygienists (ACGIH) has been the most visible and productive group setting these guidelines for industrial exposure. The ACGIH Chemical Substances Committee has published an annual list of threshold limit values (TLVs) for more than 40 years. Currently the list covers more than 400 substances. In 1989, the Occupational Safety and Health Administration (OSHA) published updated permissible exposure limits (PELs) for approximately 600 substances. Most PELs before this update were adopted from the 1968 ACGIH list of TLVs and consensus standards of the American Standards Association. This OSHA update has resulted in reductions of 212 PELs and the addition of 164 new levels. The magnitude of the problem of protecting workers can be seen by the small fraction that the OSHA PELs represent of the more than 60,000 entries in the National Institute for Occupational Safety and Health's Registry of Toxic Effects of Chemical Substances. None of these levels, whether guidelines or regulatory requirements, are established based on any possible synergistic effect with other chemicals. The only guidance given by the ACGIH for synergistic effects is that such cases must be determined individually. Clearly, there are major drawbacks in using occupational standards and guidelines for evaluating the health effects of chemical agents that can be found in office settings, often in concentrations orders of magnitude less than what is routinely measured in the workplace. These guidelines are even less valuable when the concern is the complex mixing of chemicals in nonoccupational environments.

Lasers for vascular lesions: standard guidelines of care.

PubMed

Srinivas, C R; Kumaresan, M

2011-01-01

Lasers are a good therapeutic tool for congenital and acquired vascular lesions. Technological advances in lasers have reduced the adverse effects and increased the efficacy. MACHINES: Among the various lasers used for treating vascular lesions, pulsed dye laser (PDL) has the best efficacy and safety data. The other machines that are widely available are Nd:YAG laser and intense pulse light (IPL). RATIONALE AND SCOPE OF GUIDELINE: Much variation exists in different machines and techniques, and therefore, establishing standard guidelines has limitations. The guidelines recommended here indicate minimum standards of care for lasers on vascular lesions based on current evidence. Laser may be administered by a dermatologist, who has received adequate background training in lasers during post-graduation or later at a center that provides education and training in lasers, or in focused workshops, which provide such trainings. He/she should have adequate knowledge of the lesions being treated, machines, parameters, cooling systems, and aftercare. The procedure may be performed in the physician's minor procedure room with adequate laser safety measures. PWS, hemangioma, facial telangiectasia, rosacea, spider angioma, pyogenic granuloma, venous lakes, leg veins. Absolute: Active local infection, photo-aggravated skin diseases, and medical conditions. Relative: Unstable vitiligo, psoriasis, keloid and keloidal tendencies, patient on isotretinoin, patient who is not cooperative or has unrealistic expectation. Patient selection should be done after detailed counseling with respect to the course of lesions, different treatment options, possible results, cost, need for multiple treatments, and possible postoperative complications. TREATMENT SESSIONS: The number of treatments per lesion varies from 2 to 12 or more at 6-8 week intervals. All lesions may not clear completely even after multiple sessions in many cases. Hence, a realistic expectation and proper counseling is very important. Laser parameters vary with area, type of lesion, skin color, depth of the lesion, and machine used. A test spot may be performed to determine individual specifications. Pain, edema, purpura, bleeding, scarring, postinflammatory hyperpigmentation/hypopigmentation, and atrophy changes.

Diet during pregnancy: Women's knowledge of and adherence to food safety guidelines.

PubMed

Bryant, Jamie; Waller, Amy; Cameron, Emilie; Hure, Alexis; Sanson-Fisher, Rob

2017-06-01

As a precaution against acquiring food-borne illnesses, guidelines recommend women avoid some foods during pregnancy. To examine among women receiving antenatal care: (i) level of knowledge and self-reported adherence to guidelines about foods that should be avoided during pregnancy; and (ii) associated socio-demographic characteristics. Women attending a public outpatient clinic who were: pregnant or had recently given birth; 18 years or older; able to complete an English language survey with minimal assistance; and had at least one prior antenatal appointment for their current pregnancy, were asked to complete a cross-sectional survey. In total 223 women (64% consent rate) participated. Knowledge of foods to avoid during pregnancy was poor, with 83% of women incorrectly identifying at least one unsafe food as safe to consume. The average knowledge score for foods to avoid during pregnancy was 7.9 (standard deviation = 3.4; median = 9; interquartile range: 6-11; n = 218) out of a possible score of 12. Having more general practice (GP) visits for antenatal care and fewer tertiary antenatal visits were significantly associated with higher knowledge. Women with a higher number of GP visits and those receiving care in a high-risk clinic were more likely to be adherent to guidelines. The majority of pregnant women have poor knowledge of food avoidance guidelines and continue to consume foods that put them at risk. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Improving opioid safety practices in primary care: protocol for the development and evaluation of a multifaceted, theory-informed pilot intervention for healthcare providers

PubMed Central

Leece, Pamela; Buchman, Daniel Z; Hamilton, Michael; Timmings, Caitlyn; Shantharam, Yalnee; Moore, Julia; Furlan, Andrea D

2017-01-01

Introduction In North America, drug overdose deaths are reaching unprecedented levels, largely driven by increasing prescription opioid-related deaths. Despite the development of several opioid guidelines, prescribing behaviours still contribute to poor patient outcomes and societal harm. Factors at the provider and system level may hinder or facilitate the application of evidence-based guidelines; interventions designed to address such factors are needed. Methods and analysis Using implementation science and behaviour change theory, we have planned the development and evaluation of a comprehensive Opioid Self-Assessment Package, designed to increase adherence to the Canadian Opioid Guideline among family physicians. The intervention uses practical educational and self-assessment tools to provide prescribers with feedback on their current knowledge and practices, and resources to improve their practice. The evaluation approach uses a pretest and post-test design and includes both quantitative and qualitative methods at baseline and 6 months. We will recruit a purposive sample of approximately 10 family physicians in Ontario from diverse practice settings, who currently treat patients with long-term opioid therapy for chronic pain. Quantitative data will be analysed using basic descriptive statistics, and qualitative data will be analysed using the Framework Method. Ethics and dissemination The University Health Network Research Ethics Board approved this study. Dissemination plan includes publications, conference presentations and brief stakeholder reports. This evidence-informed, theory-driven intervention has implications for national application of opioid quality improvement tools in primary care settings. We are engaging experts and end users in advisory and stakeholder roles throughout our project to increase its national relevance, application and sustainability. The performance measures could be used as the basis for health system quality improvement indicators to monitor opioid prescribing. Additionally, the methods and approach used in this study could be adapted for other opioid guidelines, or applied to other areas of preventive healthcare and clinical guideline implementation processes. PMID:28446522

Research and guidelines for implementing Fatigue Risk Management Systems for the French regional airlines.

PubMed

Cabon, Philippe; Deharvengt, Stephane; Grau, Jean Yves; Maille, Nicolas; Berechet, Ion; Mollard, Régis

2012-03-01

This paper describes research that aims to provide the overall scientific basis for implementation of a Fatigue Risk Management System (FRMS) for French regional airlines. The current research has evaluated the use of different tools and indicators that would be relevant candidates for integration into the FRMS. For the Fatigue Risk Management component, results show that biomathematical models of fatigue are useful tools to help an airline to prevent fatigue related to roster design and for the management of aircrew planning. The Fatigue Safety assurance includes two monitoring processes that have been evaluated during this research: systematic monitoring and focused monitoring. Systematic monitoring consists of the analysis of existing safety indicators such as Air Safety Reports (ASR) and Flight Data Monitoring (FDM). Results show a significant relationship between the hours of work and the frequency of ASR. Results for the FDM analysis show that some events are significantly related to the fatigue risk associated with the hours of works. Focused monitoring includes a website survey and specific in-flight observations and data collection. Sleep and fatigue measurements have been collected from 115 aircrews over 12-day periods (including rest periods). Before morning duties, results show a significant sleep reduction of up to 40% of the aircrews' usual sleep needs leading to a clear increase of fatigue during flights. From these results, specific guidelines are developed to help the airlines to implement the FRMS and for the airworthiness to oversight the implementation of the FRMS process. Copyright © 2011 Elsevier Ltd. All rights reserved.

77 FR 15452 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-15

... proposed NHTSA Guidelines are meant to promote safety by discouraging the introduction of excessively... your statement or other material (e.g., film clips and slides) so that it can be placed into the docket...

NASA safety manual. Volume 9: Fire protection

NASA Technical Reports Server (NTRS)

1985-01-01

Requirements are identified and guidelines are provided for implementing a comprehensive fire protection program. These requirements and guidelines are applicable to NASA headquarters and field installations. Portions also can be applied to NASA contractor operations within the scope of the contract.

[On improvement of the mechanism for establishing and changing indicators of quality and food safety in the regulatory and legal acts of the Eurasian Economical Union].

PubMed

Arnautov, O V

2016-01-01

In accordance with the Treaty on the Eurasian Economic Union (EAEU) to ensure the sanitary and epidemiological welfare of the population within the Union, a coordinated policy in agreed policy in the sphere of application of sanitary measures is carried out. Sanitary measures are the obligatory requirements and procedures, including requirements for the final product, processing methods, production, transportation, storage and disposal, sampling procedures, methods of research (tests), risk assessment, the state registration, requirements for packaging directly aimed at ensuring the safety of products (goods) in order to protect human welfare, and they should be applied on the basis having a scientific explanation, and only to the extent that is necessary to protect human welfare. Sanitary measures applied within the Union should be based on international and regional standards, guidelines and (or) the recommendations, except when they based on appropriate scientific studies and explanations. In this case sanitary measures which could provide a higher level of sanitary protection are introduced. At present, the mechanism of the development, justification and approval of common sanitary and epidemiological requirements (ESR) and procedures of the Eurasian Economic Commission (the Commission) is not installed. The absence of a clear mechanism for the development, approval and implementation of the ESR to the products (goods) on the basis having a scientific explanation on the one hand could lead to the creation of unjustified barriers to foreign and mutual trade, on the other--to weaken the level of safety for human life and health of products (goods) placed on markets of the Union. In order to bring the regulatory legal acts of the Customs Union in accordance with the Treaty on the Eurasian Economic Union the Commission in cooperation with the competent authorities of the Member States in the field of sanitary and epidemiological welfare developed the project of Guidelines for development, approval, modification and application of common sanitary epidemiological and hygienic requirements and procedures (hereinafter--Guidelines) which is currently undergoing approval procedures. The project envisages that the Uniform sanitary requirements are established on the basis of scientific research, including the evaluation of the risk of harmful effects of the environment on the human factors, taking into consideration the analysis of international experience in order to harmonize common sanitary requirements with international standards, guidelines and (or) recommendations. Adoption of the draft Guidelines, as well as the application of common methodologies of risk assessment and the hygienic standardization in establishing and justifying safety performance of products (goods) in the Eurasian Economic Union allow quickly and transparently develop, validate, coordinate and approve the Uniform sanitary and epidemiological and hygienic requirements and procedures for sanitary inspection (control) of products (goods) and include them into technical regulations Union.

Nuclear energy acceptance and potential role to meet future energy demand. Which technical/scientific achievements are needed?

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

Schenkel, Roland

25 years after Chernobyl, the Fukushima disaster has changed the perspectives of nuclear power. The disaster has shed a negative light on the independence, reliability and rigor of the national nuclear regulator and plant operator and the usefulness of the international IAEA guidelines on nuclear safety. It has become clear that, in the light of the most severe earthquake in the history of Japan, the plants at Fukushima Daiichi were not adequately protected against tsunamis. Nuclear acceptance has suffered enormously and has changed the perspectives of nuclear energy dramatically in countries that have a very risk-sensitive population, Germany is anmore » example. The paper analyses the reactions in major countries and the expected impact on future deployment of reactors and on R and D activities. On the positive side, the disaster has demonstrated a remarkable robustness of most of the 14 reactors closest to the epicentre of the Tohoku Seaquake although not designed to an event of level 9.0. Public acceptance can only be regained with a rigorous and worldwide approach towards inherent reactor safety and design objectives that limit the impact of severe accidents to the plant itself (like many of the new Gen III reactors). A widespread release of radioactivity and the evacuation (temporary or permanent) of the population up to 30 km around a facility are simply not acceptable. Several countries have announced to request more stringent international standards for reactor safety. The IAEA should take this move forward and intensify and strengthen the different peer review mission schemes. The safety guidelines and peer reviews should in fact become legally binding for IAEA members. The paper gives examples of the new safety features developed over the last 20 years and which yield much safer reactors with lesser burden to the environment under severe accident conditions. The compatibility of these safety systems with the current concepts for fusion-fission hybrids, which have recently been proposed for energy production, is critically reviewed. There are major challenges remaining that are shortly outlined. Scientific/technical achievements that are required in the light of the Fukushima accident are highlighted.« less

Nuclear energy acceptance and potential role to meet future energy demand. Which technical/scientific achievements are needed?

NASA Astrophysics Data System (ADS)

Schenkel, Roland

2012-06-01

25 years after Chernobyl, the Fukushima disaster has changed the perspectives of nuclear power. The disaster has shed a negative light on the independence, reliability and rigor of the national nuclear regulator and plant operator and the usefulness of the international IAEA guidelines on nuclear safety. It has become clear that, in the light of the most severe earthquake in the history of Japan, the plants at Fukushima Daiichi were not adequately protected against tsunamis. Nuclear acceptance has suffered enormously and has changed the perspectives of nuclear energy dramatically in countries that have a very risk-sensitive population, Germany is an example. The paper analyses the reactions in major countries and the expected impact on future deployment of reactors and on R&D activities. On the positive side, the disaster has demonstrated a remarkable robustness of most of the 14 reactors closest to the epicentre of the Tohoku Seaquake although not designed to an event of level 9.0. Public acceptance can only be regained with a rigorous and worldwide approach towards inherent reactor safety and design objectives that limit the impact of severe accidents to the plant itself (like many of the new Gen III reactors). A widespread release of radioactivity and the evacuation (temporary or permanent) of the population up to 30 km around a facility are simply not acceptable. Several countries have announced to request more stringent international standards for reactor safety. The IAEA should take this move forward and intensify and strengthen the different peer review mission schemes. The safety guidelines and peer reviews should in fact become legally binding for IAEA members. The paper gives examples of the new safety features developed over the last 20 years and which yield much safer reactors with lesser burden to the environment under severe accident conditions. The compatibility of these safety systems with the current concepts for fusion-fission hybrids, which have recently been proposed for energy production, is critically reviewed. There are major challenges remaining that are shortly outlined. Scientific/technical achievements that are required in the light of the Fukushima accident are highlighted.

77 FR 10542 - Revision of the National Preparedness for Response Exercise Program (PREP) Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... request for comments. SUMMARY: The National Preparedness for Response Exercise Program (PREP) is designed... Hazardous Materials Safety Administration (PHMSA), and Department of the Interior's Bureau of Safety and...

ITS logical architecture : volume 3, data dictionary.

DOT National Transportation Integrated Search

1981-01-01

The objective of the research effort was to develop an empirically and experiencially based model pedestrian safety program which cities can use as guidelines for pedestrian safety program planning, implementation, and evaluation. The basis of these ...

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

PubMed

Chen, Zhao; Jiang, Xiuping

2017-03-01

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

Examining the safety of PPAR agonists - current trends and future prospects.

PubMed

Bortolini, Michele; Wright, Matthew B; Bopst, Martin; Balas, Bogdana

2013-01-01

The peroxisome proliferator-activated receptor (PPAR)-α and -γ agonists, fibrates and glitazones, are effective treatments for dyslipidemia and type 2 diabetes mellitus, respectively, but exhibit class-related, as well as compound-specific safety characteristics. This article reviews the profiles of PPAR-α, PPAR-γ, and dual PPAR-α/γ agonists with regard to class-related and compound-specific efficacy and adverse effects. We explore how learnings from first-generation drugs are being applied to develop safer PPAR-targeted therapies. The finding that rosiglitazone may increase risk for cardiovascular events has led to regulatory guidelines requiring demonstration of cardiovascular safety in appropriate outcome trials for new type 2 diabetes mellitus drugs. The emerging data on the possibly increased risk of bladder cancer with pioglitazone may prompt the need for post-approval safety studies for new drugs. Since PPAR-α and -γ affect key cardiometabolic risk factors (diabetic dyslipidemia, insulin resistance, hyperglycemia, and inflammation) in a complementary fashion, combining their benefits has emerged as a particularly attractive option. New PPAR-targeted therapies that balance the relative potency and/or activity toward PPAR-α and -γ have shown promise in retaining efficacy while reducing potential side effects.

A parenteral nutrition use survey with gap analysis.

PubMed

Boullata, Joseph I; Guenter, Peggi; Mirtallo, Jay M

2013-03-01

Parenteral nutrition (PN) is a high-alert medication for which safe practice guidelines are available. Recent adverse events associated with PN have been widely reported. A survey of current practices was indicated as new guidelines are being considered. A web-based survey consisting of 70 items was made available for the month of August 2011. Respondents provided answers to questions that addressed all aspects of the PN use process. There were a total of 895 respondents to the survey, including dietitians, nurses, pharmacists, and physicians. They predominantly represented hospital settings (89%), with 44% from academic institutions. Most organizations use a once-daily PN admixture with 21% outsourcing preparation. Electronic PN order entry is available in one-third of organizations, and the use of standardized order sets prevails. Unfortunately, electronic interfaces between computer systems remain infrequent, meaning that at least one transcription step is required by most in the PN use process. There are a wide variety of methods for ordering PN components, many of which are inconsistent with safe practices. Most organizations dedicate a pharmacist to review the PN orders, many of which require clarifications. Documentation at each step of the PN use process with oversight to identify deviations from best practice recommendations is infrequent. A significant proportion (44%) does not track PN-related medication errors. The survey data are a valuable snapshot of current practices with PN. Poor compliance with some of the safe practice guidelines continues. This will help guide new safety initiatives for the PN use process.

Report on SARS backfit evaluation, Catalytic, Inc. Solvent Refined Coal Pilot Plant, Wilsonville, Alabama

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

Meyer, A.F. Jr.

1980-07-02

A site visit was made in company with the DOE-OPTA-EA Safety and Health Official for the purpose of providing that official with technical assistance in evaluating the validity of an earlier DOE-OPTA recommendation exempting this facility from the Safety and Analysis and Review backfit requirements of DOE Order 5481.1. A further purpose of the visit was to assess and evaluate the occupational safety and health program at this facility, as compared with the criteria and guidelines contained in ASFE Order 5481.1. Adequate documentation regarding compliance with codes, standards, and regulations were observed at this facility. There is in existence anmore » ongoing continuous safety analysis effort for both modifications or additions to this facility. Adequate environmental safeguards and plans and procedures were observed. The SARS backfit exemption is appropriate. The occupational safety and health program is in many ways a model for the scope of work and nature of hazards involved, and is consistent with ASFE guidelines and statutory requirements.« less

Guidelines for Theatre Safety.

ERIC Educational Resources Information Center

Texas Education Agency, Austin. Div. of Curriculum Development.

Prepared to help school administrators and theatre arts teachers establish and maintain a safe environment for the actors, technicians, and audience members who participate in educational theatre programs, this guide is divided into two major sections. The first section presents administrative guidelines covering recommended procedures, teacher…

Blood-Borne Pathogens: Guidelines for Athletic Trainers.

ERIC Educational Resources Information Center

Journal of Athletic Training, 1995

1995-01-01

These guidelines cover athletic trainers and blood-borne pathogens at athletic events, student athletic trainer education, universal precautions and Occupational Safety and Health Administration regulations, medical records and confidentiality, infected athletic trainers, human immunodeficiency virus (HIV) and Hepatitis B Virus (HBV) testing, HBV…

Regulatory forum opinion piece*: supporting the need for international harmonization of safety assessments for food flavoring substances.

PubMed

Konishi, Yoichi; Hayashi, Shim-Mo; Fukushima, Shoji

2014-08-01

The advancement of technology and the growth of international commerce underscore the need for global harmonization of regulatory safety requirements and their assessment pertaining to consumer products such as drugs, medical devices, and food. This need is particularly relevant when safety requirements involve time-intensive and costly animal safety studies. Here we present the current regulatory requirements in Europe, the United States, and Japan for flavoring substances (FSs) used in foods and point out significant differences relevant to the international standardization for safety assessments that in our opinion need to be addressed and overcome. The safety assessments that are carried out for FSs in various countries are influenced by divergent definitions of FS, by the information required and available for regulatory submission, and by different regulatory procedures, including the use of decision tree approaches. The European Food Safety Authority (EFSA), the Expert Panel of the U.S. Flavor and Extract Manufacturers Association (FEMA), and the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) are making efforts to improve and harmonize the safety assessment of FSs. The application of in silico methods such as quantitative structure-activity relationships and read-across strategies relying on expert input are useful as a first-step screening of the assessment. Application of the Threshold of Toxicological Concern (TTC) approach permits conclusions that are compatible with the risk assessment approaches currently used by international advisory committees. The Japanese Regulatory Authority, on the other hand, does not yet consider in silico methods but still requires in vivo and in vitro genotoxicity test data as well as repeat-dose 90-day toxicity data in at least one species, to be submitted as the first step in the safety assessment of FSs. With this article, we echo requests that have been made for xenobiotics by the pharmaceutical industry worldwide, extending them to food-related products, especially FSs. We encourage regulatory agencies to adopt globally harmonized safety assessment procedures, regulatory guidelines, and review practices for FSs to foster global trade and to reduce costs and laboratory animal use. © 2013 by The Author(s).

Rubber dam application in endodontic practice: an update on critical educational and ethical dilemmas.

PubMed

Ahmed, H M A; Cohen, S; Lévy, G; Steier, L; Bukiet, F

2014-12-01

Proper isolation is an essential prerequisite for successful endodontic treatment. This article aims to provide an update on the prevalence of rubber dam (RD) use, and the role of education along with attitudes of general dental practitioners (GDPs) and patients towards the application of RD in endodontics. Critical ethical issues are also highlighted. Using certain keywords, an electronic search was conducted spanning the period from January 1983 to April 2013 to identify the available related investigations, and the pooled data were then analysed. The results show that although RD is the Standard of Care in endodontic practice, there is a clear discrepancy in what GDPs are taught in dental school and what they practice after graduation. There is little scientific evidence to support the application of RD; however, patient safety and clinical practice guidelines indicate that it is unnecessary and unethical to consider a cohort study to prove what is already universally agreed upon. A few clinical situations may require special management which should be highlighted in the current guidelines. This would pave the way for clear and straightforward universal guidelines. © 2014 Australian Dental Association.

Use of portable ladders - field observations and self-reported safety performance in the cable TV industry.

PubMed

Chang, Wen-Ruey; Huang, Yueng-Hsiang; Brunette, Christopher; Lee, Jin

2017-11-01

Portable ladders incidents remain a major cause of falls from heights. This study reported field observations of environments, work conditions and safety behaviour involving portable ladders and their correlations with self-reported safety performance. Seventy-five professional installers of a company in the cable and other pay TV industry were observed for 320 ladder usages at their worksites. The participants also filled out a questionnaire to measure self-reported safety performance. Proper setup on slippery surfaces, correct method for ladder inclination setup and ladder secured at the bottom had the lowest compliance with best practices and training guidelines. The observation compliance score was found to have significant correlation with straight ladder inclined angle (Pearson's r = 0.23, p < 0.0002) and employees' self-reported safety participation (r = 0.29, p < 0.01). The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours. Practitioner Summary: A checklist was used while observing professional installers of a cable company for portable ladder usage at their worksites. Items that had the lowest compliance with best practices and training guidelines were identified. The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours.

Safety in Academic Chemistry Laboratories: Volume 1. Accident Prevention for College and University Students, 7th Edition.

ERIC Educational Resources Information Center

American Chemical Society, Washington, DC.

This book contains volume 1 of 2 and describes safety guidelines for academic chemistry laboratories to prevent accidents for college and university students. Contents include: (1) "Your Responsibility for Accident Prevention"; (2) "Guide to Chemical Hazards"; (3) "Recommended Laboratory Techniques"; and (4) "Safety Equipment and Emergency…

Fire! Fire Prevention and Safety: A Teacher's Handbook.

ERIC Educational Resources Information Center

New York City Board of Education, Brooklyn, NY. Div. of Educational Planning and Support.

In this curriculum guide, guidelines for teaching children about fire safety and related topics and activities representing an interdisciplinary approach to fire safety are outlined. Major fire hazards and methods of dealing with them are described. Possible sites for field trips and films relating to fire are listed. The rules of the New York…

Safety in Academic Chemistry Laboratories: Volume 2. Accident Prevention for Faculty and Administrators, 7th Edition.

ERIC Educational Resources Information Center

American Chemical Society, Washington, DC.

This book contains volume 2 of 2 and describes safety guidelines for academic chemistry laboratories to prevent accidents for college and university students. Contents include: (1) "Organizing for Accident Prevention"; (2) "Personal Protective Equipment"; (3) "Labeling"; (4) "Material Safety Data Sheets (MSDSs)"; (5) "Preparing for Medical…

Steering Kids to Traffic Safety.

ERIC Educational Resources Information Center

PTA Today, 1991

1991-01-01

Guidelines to help parents explain traffic safety to children cover the following: school bus safety (e.g., remain seated, do not shout); walking (e.g., obey traffic signals, cross at crosswalks); driving (e.g., wear seatbelts, enter and exit from the curb side); and biking (e.g., wear helmets, do not ride at night). (SM)

77 FR 26725 - Changes to FSIS Traceback, Recall Procedures for Escherichia coli O157:H7 Positive Raw Beef...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2011-0009] Changes... Availability of Compliance Guidelines AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice. SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing proposed new procedures that it intends to...

77 FR 58089 - Availability of FSIS Salmonella Compliance Guidelines for Small and Very Small Meat and Poultry...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-19

... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2012-0024... That Produce Ready-to- Eat Products AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of availability. SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing the availability of a...

Control centers design for ergonomics and safety.

PubMed

Quintana, Leonardo; Lizarazo, Cesar; Bernal, Oscar; Cordoba, Jorge; Arias, Claudia; Monroy, Magda; Cotrino, Carlos; Montoya, Olga

2012-01-01

This paper shows the general design conditions about ergonomics and safety for control centers in the petrochemical process industry. Some of the topics include guidelines for the optimized workstation design, control room layout, building layout, and lighting, acoustical and environmental design. Also takes into account the safety parameters in the control rooms and centers design. The conditions and parameters shown in this paper come from the standards and global advances on this topic on the most recent publications. And also the work was supplemented by field visits of our team to the control center operations in a petrochemical company, and technical literature search efforts. This guideline will be useful to increase the productivity and improve the working conditions at the control rooms.

An Investigation into Dental Local Anaesthesia Teaching in United Kingdom Dental Schools.

PubMed

Oliver, Graham; DavidD, Ailsa; Bell, Christopher; Robb, Nigel

2016-01-01

To review the current teaching of the use and administration of local anaesthesia in United Kingdom dental schools, along with their local guidelines and protocols. A qualitative and quantitative questionnaire was sent to sixteen UK dental schools to probe the methods of local anaesthetic teaching within each school. 14 of the 16 schools replied and the responses show a variety of practices being taught in the dental schools. 2% Lidocaine 1:80,000 Adrenaline is the first choice local anaesthetic solution for the majority of clinical situations. 2% Lidocaine with 1:80,000 Adrenaline remains the gold standard dental local anaesthetic with teaching about its safety and uses in all but a few situations. Most are taught the use of additional aids such as safety syringes and topical anaesthesia. There is variation with regards to the use of alternative anaesthetic agents.

The Health Risks of Belgian Illicit Indoor Cannabis Plantations.

PubMed

Vanhove, Wouter; Cuypers, Eva; Bonneure, Arne-Jan; Gotink, Joachim; Stassen, Mirna; Tytgat, Jan; Van Damme, Patrick

2018-04-10

We assessed the prevalence of potential health hazards to intervention staff and cannabis growers in Belgian indoor cannabis plantations. Surface mold swab samples were taken at 16 Belgian indoor plantations contained mostly Penicillium sp. and Aspergillus sp. However, their precise health impact on intervention staff and illicit growers is unclear as no molds spore concentrations were measured. Atmospheric gas monitoring in the studied cannabis plantations did not reveal dangerous toxic substances. Health symptoms were reported by 60% of 221 surveyed police, but could not be linked to specific plantation characteristics. We conclude that Belgian indoor cannabis plantations pose a potential health threat to growers and intervention staff. AS there are currently no clear safety guidelines for seizure and dismantling of Belgian indoor cannabis plantations, we recommend first responders to follow strict safety rules when entering the growth rooms, which include wearing appropriate personal protective equipment. © 2018 American Academy of Forensic Sciences.

Staff nurses as antimicrobial stewards: An integrative literature review.

PubMed

Monsees, Elizabeth; Goldman, Jennifer; Popejoy, Lori

2017-08-01

Guidelines on antimicrobial stewardship emphasize the importance of an interdisciplinary team, but current practice focuses primarily on defining the role of infectious disease physicians and pharmacists; the role of inpatient staff nurses as antimicrobial stewards is largely unexplored. An updated integrative review method guided a systematic appraisal of 13 articles spanning January 2007-June 2016. Quantitative and qualitative peer-reviewed publications including staff nurses and antimicrobial knowledge or stewardship were incorporated into the analysis. Two predominant themes emerged from this review: (1) nursing knowledge, education, and information needs; and (2) patient safety and organizational factors influencing antibiotic management. Focused consideration to empower and educate staff nurses in antimicrobial management is needed to strengthen collaboration and build an interprofessional stewardship workforce. Further exploration on the integration and measurement of nursing participation is needed to accelerate this important patient safety initiative. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Consensus Recommendations on Sulfonylurea and Sulfonylurea Combinations in the Management of Type 2 Diabetes Mellitus – International Task Force

PubMed Central

Kalra, Sanjay; Bahendeka, Silver; Sahay, Rakesh; Ghosh, Sujoy; Md, Fariduddin; Orabi, Abbas; Ramaiya, Kaushik; Al Shammari, Sameer; Shrestha, Dina; Shaikh, Khalid; Abhayaratna, Sachitha; Shrestha, Pradeep K.; Mahalingam, Aravinthan; Askheta, Mazen; A. Rahim, Aly Ahmed; Eliana, Fatimah; Shrestha, Hari K.; Chaudhary, Sandeep; Ngugi, Nancy; Mbanya, Jean Claude; Aye, Than Than; Latt, Tint Swe; Akanov, Zhanay A.; Syed, Abbas Raza; Tandon, Nikhil; Unnikrishnan, A. G.; Madhu, S. V.; Jawa, Ali; Chowdhury, Subhankar; Bajaj, Sarita; Das, Ashok Kumar

2018-01-01

For decades, sulfonylureas (SUs) have been important drugs in the antidiabetic therapeutic armamentarium. They have been used as monotherapy as well as combination therapy. Focus on newer drugs and concerns about the risk of severe hypoglycemia and weight gain with some SUs have led to discussion on their safety and utility. It has to be borne in mind that the adverse events associated with SUs should not be ascribed to the whole class, as many modern SUs, such as glimepiride and gliclazide modified release, are associated with better safety profiles. Furthermore, individualization of treatment, using SUs in combination with other drugs, backed with careful monitoring and patient education, ensures maximum benefits with minimal side effects. The current guidelines, developed by experts from Africa, Asia, and the Middle East, promote the safe and smart use of SUs in combination with other glucose-lowering drugs. PMID:29535952

A nationwide postal questionnaire survey: the presence of airway guidelines in anaesthesia department in Sweden.

PubMed

Knudsen, Kati; Pöder, Ulrika; Högman, Marieann; Larsson, Anders; Nilsson, Ulrica

2014-01-01

In Sweden, airway guidelines aimed toward improving patient safety have been recommended by the Swedish Society of Anaesthesia and Intensive Care Medicine. Adherence to evidence-based airway guidelines is known to be generally poor in Sweden. The aim of this study was to determine whether airway guidelines are present in Swedish anaesthesia departments. A nationwide postal questionnaire inquiring about the presence of airway guidelines was sent out to directors of Swedish anaesthesia departments (n = 74). The structured questionnaire was based on a review of the Swedish Society of Anaesthesia and Intensive Care voluntary recommendations of guidelines for airway management. Mean, standard deviation, minimum/maximum, percentage (%) and number of general anaesthesia performed per year as frequency (n), were used to describe, each hospital type (university, county, private). For comparison between hospitals type and available written airway guidelines were cross tabulation used and analysed using Pearson's Chi-Square tests. A p- value of less than 0 .05 was judged significant. In total 68 directors who were responsible for the anaesthesia departments returned the questionnaire, which give a response rate of 92% (n 68 of 74). The presence of guidelines showing an airway algorithm was reported by 68% of the departments; 52% reported having a written patient information card in case of a difficult airway and guidelines for difficult airways, respectively; 43% reported the presence of guidelines for preoperative assessment; 31% had guidelines for Rapid Sequence Intubation; 26% reported criteria for performing an awake intubation; and 21% reported guidelines for awake fibre-optic intubation. A prescription for the registered nurse anaesthetist for performing tracheal intubation was reported by 24%. The most frequently pre-printed preoperative elements in the anaesthesia record form were dental status and head and neck mobility. Despite recommendations from the national anaesthesia society, the presence of airway guidelines in Swedish anaesthesia departments is low. From the perspective of safety for both patients and the anaesthesia staff, airway management guidelines should be considered a higher priority.

Renal function, nephrogenic systemic fibrosis and other adverse reactions associated with gadolinium-based contrast media.

PubMed

Canga, Ana; Kislikova, Maria; Martínez-Gálvez, María; Arias, Mercedes; Fraga-Rivas, Patricia; Poyatos, Cecilio; de Francisco, Angel L M

2014-01-01

Nephrogenic systemic fibrosis is a fibrosing disorder that affects patients with impaired renal function and is associated with the administration of gadolinium-based contrast media used in MRI. Despite being in a group of drugs that were considered safe, report about this potentially serious adverse reaction was a turning point in the administration guidelines of these contrast media. There has been an attempt to establish safety parameters to identify patients with risk factors of renal failure. The close pharmacovigilance and strict observation of current regulations, with special attention being paid to the value of glomerular filtration, have reduced the published cases involving the use of gadolinium-based contrast media. In a meeting between radiologists and nephrologists we reviewed the most relevant aspects currently and recommendations for its prevention.

Management of hepatitis C infection in the era of direct-acting antiviral therapy

NASA Astrophysics Data System (ADS)

Zain, L. H.; Sungkar, T.

2018-03-01

Hepatitis C viral infection globally affects millions of people and commonly results in debilitating complications and mortality. Initial mainstay therapy consisted of pegylated interferon α (pegIFNα) with additional ribavirin that showed unsatisfactory cure rate, common side effects and complicated dosing, contributing to high discontinuation rate. Over the last few years, newer antivirals have been extensively studied, that are Direct-Acting Antivirals (DAAs). Specifically targeting viral protein mainly during replication phase, DAAs showed greater cure rate (commonly measured as sustained virologic response), improved safety profile and shorter treatment duration compared to traditional interferon-ribavirin therapy. Current guidelines have also included Interferon-free, often ribavirin-free, DAAs combinations that suggest promising outcomes. The current review highlights development of rapidly growing hepatitis C treatment including DAAs recommendations.

The Role of Patient Safety in the Device Purchasing Process

DTIC Science & Technology

2005-05-01

Juliana J. Brixey, Danielle Paige, James P. Turley Abstract To examine how patient safety considerations are incorporated into medical device...Despite the general awareness of patient safety, its importance, and its role in medical device comparisons and purchasing decisions, this study...into the medical device purchasing process. We presently have a set of guidelines in development to help hospitals better emphasize patient safety

European Workshop Industrical Computer Science Systems approach to design for safety

NASA Technical Reports Server (NTRS)

Zalewski, Janusz

1992-01-01

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

Site Operators License: Guidelines for Applicants

DOT National Transportation Integrated Search

1995-08-08

The U. S. Department of Transportation's Office of Commercial Space : Transportation (OCST) issues site operator licenses based on the site : operator's demonstration of the ability to ensure public safety and the : safety of property, both on and of...

Surrogate Safety Assessment Model (SSAM)--software user manual

DOT National Transportation Integrated Search

2008-05-01

This document presents guidelines for the installation and use of the Surrogate Safety Assessment Model (SSAM) software. For more information regarding the SSAM application, including discussion of theoretical background and the results of a series o...

Safety of 8-weeks oral administration of Arctium lappa L.

PubMed Central

Bok, So-Hyeon; Cho, Seung Sik; Bae, Chun-Sik

2017-01-01

Recently, worldwide dietary reference intakes have been considered an important guideline for public health. Some governments and the World Health Organization (WHO) provide guidelines concerning dietary intake. Although an ingredient may have a history of use as a culinary material, changes in the environment over time suggest that the acceptable maximum intake each of food/culinary material should be regularly evaluated. Arctium lappa L. has been used as a culinary material for many centuries in Korea and Japan and some recent studies have reported related therapeutic effects. However, there are no reports on the safety of repeated oral administration. In this study, we evaluated the safety of a 8-weeks repeated oral intake of A. lappa. We concluded that treatment with <250 mg/kg A. lappa, which was within the safety range, resulted in body weight decrease and blood glucose suppression. PMID:29046701

Ultrafast Ultrasound Imaging of Ocular Anatomy and Blood Flow

PubMed Central

Urs, Raksha; Ketterling, Jeffrey A.; Silverman, Ronald H.

2016-01-01

Purpose Ophthalmic ultrasound imaging is currently performed with mechanically scanned single-element probes. These probes have limited capabilities overall and lack the ability to image blood flow. Linear-array systems are able to detect blood flow, but these systems exceed ophthalmic acoustic intensity safety guidelines. Our aim was to implement and evaluate a new linear-array–based technology, compound coherent plane-wave ultrasound, which offers ultrafast imaging and depiction of blood flow at safe acoustic intensity levels. Methods We compared acoustic intensity generated by a 128-element, 18-MHz linear array operated in conventionally focused and plane-wave modes and characterized signal-to-noise ratio (SNR) and lateral resolution. We developed plane-wave B-mode, real-time color-flow, and high-resolution depiction of slow flow in postprocessed data collected continuously at a rate of 20,000 frames/s. We acquired in vivo images of the posterior pole of the eye by compounding plane-wave images acquired over ±10° and produced images depicting orbital and choroidal blood flow. Results With the array operated conventionally, Doppler modes exceeded Food and Drug Administration safety guidelines, but plane-wave modalities were well within guidelines. Plane-wave data allowed generation of high-quality compound B-mode images, with SNR increasing with the number of compounded frames. Real-time color-flow Doppler readily visualized orbital blood flow. Postprocessing of continuously acquired data blocks of 1.6-second duration allowed high-resolution depiction of orbital and choroidal flow over the cardiac cycle. Conclusions Newly developed high-frequency linear arrays in combination with plane-wave techniques present opportunities for the evaluation of ocular anatomy and blood flow, as well as visualization and analysis of other transient phenomena such as vessel wall motion over the cardiac cycle and saccade-induced vitreous motion. PMID:27428169

Emergency management of severe hyperkalemia: Guideline for best practice and opportunities for the future.

PubMed

Rossignol, Patrick; Legrand, Matthieu; Kosiborod, Mikhail; Hollenberg, Steven M; Peacock, W Frank; Emmett, Michael; Epstein, Murray; Kovesdy, Csaba P; Yilmaz, Mehmet Birhan; Stough, Wendy Gattis; Gayat, Etienne; Pitt, Bertram; Zannad, Faiez; Mebazaa, Alexandre

2016-11-01

Hyperkalemia is a common electrolyte disorder, especially in chronic kidney disease, diabetes mellitus, or heart failure. Hyperkalemia can lead to potentially fatal cardiac dysrhythmias, and it is associated with increased mortality. Determining whether emergency therapy is warranted is largely based on subjective clinical judgment. The Investigator Network Initiative Cardiovascular and Renal Clinical Trialists (INI-CRCT) aimed to evaluate the current knowledge pertaining to the emergency treatment of hyperkalemia. The INI-CRCT developed a treatment algorithm reflecting expert opinion of best practices in the context of current evidence, identified gaps in knowledge, and set priorities for future research. We searched PubMed (to August 4, 2015) for consensus guidelines, reviews, randomized clinical trials, and observational studies, limited to English language but not by publication date. Treatment approaches are based on small studies, anecdotal experience, and traditional practice patterns. The safety and real-world effectiveness of standard therapies remain unproven. Prospective research is needed and should include studies to better characterize the population, define the serum potassium thresholds where life-threatening arrhythmias are imminent, assess the potassium and electrocardiogram response to standard interventions. Randomized, controlled trials are needed to test the safety and efficacy of new potassium binders for the emergency treatment of severe hyperkalemia in hemodynamically stable patients. Existing emergency treatments for severe hyperkalemia are not supported by a compelling body of evidence, and they are used inconsistently across institutions, with potentially significant associated side effects. Further research is needed to fill knowledge gaps, and definitive clinical trials are needed to better define optimal management strategies, and ultimately to improve outcomes in these patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Disaster Preparedness and Recovery.

ERIC Educational Resources Information Center

Grams, Theodore C. W.

Intended to be used in conjunction with the Portland State University handbook entitled "Safety Guidelines and Emergency Procedures," this manual provides guidelines to be followed in the event of library emergencies involving fire, flood, fumes, smoke, and water leakage, with special attention given to the processes required for the…

Anticoagulation management in the ambulatory surgical setting.

PubMed

Eisenstein, Diana Hill

2012-04-01

Many people receiving maintenance anticoagulation therapy require surgery each year in ambulatory surgery centers. National safety organizations focus attention toward improving anticoagulation management, and the American College of Chest Physicians has established guidelines for appropriate anticoagulation management to balance the risk of thromboembolism when warfarin is discontinued with the risk of bleeding when anticoagulation therapy is maintained. The guidelines recommend that patients at high or moderate risk for thromboembolism should be bridged with subcutaneous low-molecular-weight heparin or IV unfractionated heparin with the interruption of warfarin, and low-risk patients may require subcutaneous low-molecular-weight heparin or no bridging with the interruption of warfarin. The guidelines recommend the continuation of warfarin for patients who are undergoing minor dermatologic or dental procedures or cataract removal. The literature reveals, however, that there is not adequate adherence to these recommendations and guidelines. Management of anticoagulation therapy by a nurse practitioner may improve compliance and safety in ambulatory surgery centers. Copyright © 2012 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Workplace violence among female sex workers who use drugs in Vancouver, Canada: does client-targeted policing increase safety?

PubMed

Prangnell, Amy; Shannon, Kate; Nosova, Ekaterina; DeBeck, Kora; Milloy, M-J; Kerr, Thomas; Hayashi, Kanna

2018-02-01

Workplace violence, by clients or predators, poses serious negative health consequences for sex workers. In 2013, the Vancouver (British Columbia), Canada Police Department changed their guidelines with the goal of increasing safety for sex workers by focusing law enforcement on clients and third parties, but not sex workers. We sought to examine the trends and correlates of workplace violence among female sex workers (FSW) before and after the guideline change, using data collected from prospective cohorts of persons who use illicit drugs in Vancouver, Canada. Among 259 FSW, 21.0% reported workplace violence at least once during the study period between 2008 and 2014. There was no statistically significant change in rates of workplace violence after the guideline change. In our multivariable analysis, daily heroin use was independently associated with workplace violence. The 2013 policing guideline change did not appear to have resulted in decreased reports of workplace violence. Increased access to opioid agonist therapies may reduce workplace violence among drug-using FSW.

American Society for Radiation Oncology (ASTRO) and American College of Radiology (ACR) Practice Guideline for the Performance of High-Dose-Rate Brachytherapy

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

Erickson, Beth A.; Demanes, D. Jeffrey; Ibbott, Geoffrey S.

2011-03-01

High-Dose-Rate (HDR) brachytherapy is a safe and efficacious treatment option for patients with a variety of different malignancies. Careful adherence to established standards has been shown to improve the likelihood of procedural success and reduce the incidence of treatment-related morbidity. A collaborative effort of the American College of Radiology (ACR) and American Society for Therapeutic Radiation Oncology (ASTRO) has produced a practice guideline for HDR brachytherapy. The guideline defines the qualifications and responsibilities of all the involved personnel, including the radiation oncologist, physicist and dosimetrists. Review of the leading indications for HDR brachytherapy in the management of gynecologic, thoracic, gastrointestinal,more » breast, urologic, head and neck, and soft tissue tumors is presented. Logistics with respect to the brachytherapy implant procedures and attention to radiation safety procedures and documentation are presented. Adherence to these practice guidelines can be part of ensuring quality and safety in a successful HDR brachytherapy program.« less

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

PubMed

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

2014-08-01

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

Human Factors Engineering Guidelines for Overhead Cranes

NASA Technical Reports Server (NTRS)

Chandler, Faith; Delgado, H. (Technical Monitor)

2001-01-01

This guideline provides standards for overhead crane cabs that can be applied to the design and modification of crane cabs to reduce the potential for human error due to design. This guideline serves as an aid during the development of a specification for purchases of cranes or for an engineering support request for crane design modification. It aids human factors engineers in evaluating existing cranes during accident investigations or safety reviews.

Recommended safety guides for industrial laboratories and shops

NASA Technical Reports Server (NTRS)

Allison, W. W.

1971-01-01

Booklet provides references to 29 publications providing information on hazard control and approved safety practices. Areas include pressurized gas and vacuum systems. Guidelines are presented for safeguarding facilities where machinery, equipment, electrical devices, or hazardous chemicals are used.

Field evaluation of highway safety hardware maintenance guidelines.

DOT National Transportation Integrated Search

1987-01-01

The objective of this study was to evaluate with field tests, a procedure developed for the Federal Highway Administration for determining frequencies at which highway safety hardware needs to be inspected and repaired. The frequencies arrived at wer...

Lubiprostone: pharmacokinetic, pharmacodynamic, safety and regulatory aspects in the treatment of constipation-predominant irritable bowel syndrome.

PubMed

Raschi, Emanuel; De Ponti, Fabrizio

2014-02-01

Lubiprostone acts locally (apical membrane of human intestinal epithelial cells) as a highly selective type-2 chloride channel activator. It was approved in the USA for chronic idiopathic constipation (January 2006) and in women aged ≥ 18 years suffering from irritable bowel syndrome with constipation (IBS-C) (April 2008). So far, the only other pro-secretory medication approved in IBS-C and currently available in USA and Europe (since August and November 2012, respectively) is linaclotide. This review outlines the regulatory history, pharmacokinetic, pharmacodynamic and safety data in the treatment of IBS-C with a European perspective. It is based on publicly available data, namely, published literature, drug labels and the FDA's spontaneous reporting system. Although interesting pharmacodynamic data suggest that lubiprostone may have additional mechanisms of action, its beneficial effects in IBS-C must be confirmed in the actual clinical scenario taking into account the new version of European Medicines Agency's guideline. This is especially important with regard to duration of studies (recommended to be at least 6 months) to adequately assess long-term sustained efficacy, withdrawal, rebound and safety. Further research is warranted in uncertain areas (i.e., males, pediatric and elderly patients). On the basis of current data, it is still too early to draw definite conclusions on the overall risk-benefit balance for IBS-C.

NASA Aerospace Flight Battery Program: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries; Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries; Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop). Volume 1, Part 1

NASA Technical Reports Server (NTRS)

Manzo, Michelle A.; Brewer, Jeffrey C.; Bugga, Ratnakumar V.; Darcy, Eric C.; Jeevarajan, Judith A.; McKissock, Barbara I.; Schmitz, Paul C.

2010-01-01

This NASA Aerospace Flight Battery Systems Working Group was chartered within the NASA Engineering and Safety Center (NESC). The Battery Working Group was tasked to complete tasks and to propose proactive work to address battery related, agency-wide issues on an annual basis. In its first year of operation, this proactive program addressed various aspects of the validation and verification of aerospace battery systems for NASA missions. Studies were performed, issues were discussed and in many cases, test programs were executed to generate recommendations and guidelines to reduce risk associated with various aspects of implementing battery technology in the aerospace industry. This document contains Part 1 - Volume I: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries, Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries, and Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop).

NASA Battery Working Group - 2007-2008: Battery Task Summary Report

NASA Technical Reports Server (NTRS)

Manzo, Michelle

2008-01-01

This presentation provides a summary of the 2007-2008 NASA Battery Working Group efforts completed in support of the NASA Engineering Safety Center (NESC). The effort covered a series of pro-active tasks that address the following: Binding Procurements -- guidelines related to requirements for the battery system that should be considered at the time of contract award Wet Life of Ni-H2 Batteries -- issues/strategies for effective storage and impact of long-term storage on performance and life Generic Guidelines for Lithium-ion Safety, Handling and Qualification -- Standardized approaches developed and risk assessments (1) Lithium-ion Performance Assessment -- survey of manufacturers and capabilities to meet mission needs. Guidelines document generated (2) Conditions Required for using Pouch Cells in Aerospace Missions -- focus on corrosion, thermal excursions and long-term performance issues. Document defining requirements to maintain performance and life (3) High Voltage Risk Assessment -- focus on safety and abuse tolerance of battery module assemblies. Recommendations of features required for safe implementation (4) Procedure for Determination of Safe Charge Rates -- evaluation of various cell chemistries and recommendation of safe operating regimes for specific cell designs

Guidelines for Safety in the Gastrointestinal Endoscopy Unit

PubMed Central

Calderwood, Audrey H.; Chapman, Frank J.; Cohen, Jonathan; Cohen, Lawrence B.; Collins, James; Day, Lukejohn W.; Early, Dayna S.

2014-01-01

EXECUTIVE SUMMARY Historically, safety in the gastrointestinal (GI) endoscopy unit has focused on infection control, particularly around the reprocessing of endoscopes. Two highly publicized outbreaks where the transmission of infectious agents were related to GI endoscopy have highlighted the need to address potential gaps along the endoscopy care continuum that could impact patient safety. PMID:24485393

Workplace Health and Safety across the Vocational/Technical Curriculum.

ERIC Educational Resources Information Center

Ryan, Thomas; Hinkley, Carl

This document contains the outcomes of a pilot project to develop materials and methods of integrating occupational health and safety into the curriculum of the technologies at a technical college. Section I is a model of how to integrate health and safety into a vocational-technical curriculum. Based on the Outcomes-Based Guidelines developed by…

Occupational Safety and Health Program Guidelines for Colleges and Universities. An Administrative Resource Manual.

ERIC Educational Resources Information Center

Godbey, Frank W.; Hatch, Loren L.

Designed as an aid for establishing and strengthening occupational safety and health programs on college and university campuses, this administrator guide is divided into four chapters. The first chapter defines and gives background information on the Occupational Safety and Health Act (OSHA). In addition, it presents a discussion of what the OSHA…

Planning for Safety on the Jobsite. Safety in Industry, Construction Industry Series.

ERIC Educational Resources Information Center

Occupational Safety and Health Administration, Washington, DC.

Work injuries and their monetary losses in the construction industry can be effectively prevented only through an aggressive and well-planned safety effort. The purpose of this bulletin is to provide guidelines to aid the construction contractor in complying with legal requirements and in attaining the objective of keeping costly accidents and…

42 CFR 488.110 - Procedural guidelines.

Code of Federal Regulations, 2012 CFR

2012-10-01

... resident care situations that you believe might pose a serious threat to a resident's health or safety. Add... 42 Public Health 5 2012-10-01 2012-10-01 false Procedural guidelines. 488.110 Section 488.110 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

Student Searches: Policy Guidelines for Secondary Principals.

ERIC Educational Resources Information Center

Stader, David L.

2002-01-01

Notes that students' legitimate expectations of privacy and school officials' need to maintain school discipline and safety often collide. Outlines guidelines for searching in the following instances: student lockers; drug dogs; student trips; strip searches; and urinalysis. Suggests that training for all administrators, faculty, and staff in the…

Life in a Regulated Environment: Do You Comply with Environmental Laws?

ERIC Educational Resources Information Center

McKeague, Kevin J.

1994-01-01

Discusses the following issues: (1) implications of the Americans with Disabilities Act; (2) Asbestos Hazard Emergency Response Act regulations; (3) new lead guidelines; (4) requirements regarding underground storage tanks; (5) potential indoor air quality requirements; and (6) Occupational Safety and Health Administration guidelines. (MLF)

29 CFR Appendix A to Subpart R of... - Guidelines for Establishing the Components of a Site-specific Erection Plan: Non-mandatory...

Code of Federal Regulations, 2013 CFR

2013-07-01

... R of Part 1926 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH.... 1926, Subpt. R, App. A Appendix A to Subpart R of Part 1926—Guidelines for Establishing the Components...

29 CFR Appendix A to Subpart R of... - Guidelines for Establishing the Components of a Site-specific Erection Plan: Non-mandatory...

Code of Federal Regulations, 2010 CFR

2010-07-01

... R of Part 1926 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH.... 1926, Subpt. R, App. A Appendix A to Subpart R of Part 1926—Guidelines for Establishing the Components...

29 CFR Appendix A to Subpart R of... - Guidelines for Establishing the Components of a Site-specific Erection Plan: Non-mandatory...

Code of Federal Regulations, 2014 CFR

2014-07-01

... R of Part 1926 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH.... 1926, Subpt. R, App. A Appendix A to Subpart R of Part 1926—Guidelines for Establishing the Components...

29 CFR Appendix A to Subpart R of... - Guidelines for Establishing the Components of a Site-specific Erection Plan: Non-mandatory...

Code of Federal Regulations, 2011 CFR

2011-07-01

... R of Part 1926 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH.... 1926, Subpt. R, App. A Appendix A to Subpart R of Part 1926—Guidelines for Establishing the Components...

29 CFR Appendix A to Subpart R of... - Guidelines for Establishing the Components of a Site-specific Erection Plan: Non-mandatory...

Code of Federal Regulations, 2012 CFR

2012-07-01

... R of Part 1926 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH.... 1926, Subpt. R, App. A Appendix A to Subpart R of Part 1926—Guidelines for Establishing the Components...

Spotlight on isavuconazole in the treatment of invasive aspergillosis and mucormycosis: design, development, and place in therapy

PubMed Central

2018-01-01

In recent decades, important advances have been made in the diagnosis and treatment of invasive aspergillosis (IA) and mucormycosis. One of these advances has been the introduction of isavuconazole, a second-generation broad spectrum triazole with a favorable pharmacokinetic and safety profile and few drug–drug interactions. Phase III trials in patients with IA and mucormycosis demonstrated that isavuconazole has similar efficacy to voriconazole for the treatment of IA (SECURE trial) and liposomal amphotericin B for the treatment of mucormycosis (VITAL trial with subsequent case–control analysis) and a favorable safety profile with significantly fewer ocular, hepatobiliary, and skin and soft tissue adverse events compared to voriconazole. As a result, recent IA guidelines recommend isavuconazole (together with voriconazole) as gold standard treatment for IA in patients with underlying hematological malignancies. In contrast to liposomal amphotericin B, isavuconazole can be safely administered in patients with reduced renal function and is frequently used for the treatment of mucormycosis in patients with reduced renal function. Updated guidelines on mucormycosis are needed to reflect the current evidence and give guidance on the use of isavuconazole for mucormycosis. Studies are needed to evaluate the role of isavuconazole for 1) anti-mold prophylaxis in high-risk patients, 2) salvage treatment for IA and mucormycosis, and 3) treatment for other mold infections such as Scedosporium apiospermum. PMID:29750016

Biosimilars and non-innovator biotherapeutics in India: an overview of the current situation.

PubMed

Malhotra, Hemant

2011-09-01

Globally, a large number of blockbuster biotherapeutic molecules are going off patent in the next few years. For emerging economies, like India, it is imperative to be able to provide safe and cost effective drugs for its huge, non-insured and poor population. India has a robust pharmaceutical industry including the biopharmaceutical sector which is actively engaged in the production and marketing of 'non-innovator' or 'copy' biotherapeutic products These products are approved through an abbreviated route which relies on limited safety and efficacy data enabling the local companies to keep the production costs low and pass on the price benefit to the patient and make the product affordable to the masses. Some of the available products may not be truly 'similar' and may be of suspect quality. The WHO [1] and the European Medicines Agency (EMA) [2] have published guidelines for the development and marketing of biosimilar products. These products, as stated in both guidelines undergo extensive head-to-head comparability testing with the reference biotherapeutic product (RBP) to show their similarity to the RBP in terms of quality, efficacy and safety. Regulators and administrators of different countries need to strike a balance in cost-to-benefit versus risks that are perceived for these products, keeping in mind global regulatory issues. Copyright © 2011. Published by Elsevier Ltd.

Spotlight on isavuconazole in the treatment of invasive aspergillosis and mucormycosis: design, development, and place in therapy.

PubMed

Jenks, Jeffrey D; Salzer, Helmut Jf; Prattes, Juergen; Krause, Robert; Buchheidt, Dieter; Hoenigl, Martin

2018-01-01

In recent decades, important advances have been made in the diagnosis and treatment of invasive aspergillosis (IA) and mucormycosis. One of these advances has been the introduction of isavuconazole, a second-generation broad spectrum triazole with a favorable pharmacokinetic and safety profile and few drug-drug interactions. Phase III trials in patients with IA and mucormycosis demonstrated that isavuconazole has similar efficacy to voriconazole for the treatment of IA (SECURE trial) and liposomal amphotericin B for the treatment of mucormycosis (VITAL trial with subsequent case-control analysis) and a favorable safety profile with significantly fewer ocular, hepatobiliary, and skin and soft tissue adverse events compared to voriconazole. As a result, recent IA guidelines recommend isavuconazole (together with voriconazole) as gold standard treatment for IA in patients with underlying hematological malignancies. In contrast to liposomal amphotericin B, isavuconazole can be safely administered in patients with reduced renal function and is frequently used for the treatment of mucormycosis in patients with reduced renal function. Updated guidelines on mucormycosis are needed to reflect the current evidence and give guidance on the use of isavuconazole for mucormycosis. Studies are needed to evaluate the role of isavuconazole for 1) anti-mold prophylaxis in high-risk patients, 2) salvage treatment for IA and mucormycosis, and 3) treatment for other mold infections such as Scedosporium apiospermum .

Integrated information systems for electronic chemotherapy medication administration.

PubMed

Levy, Mia A; Giuse, Dario A; Eck, Carol; Holder, Gwen; Lippard, Giles; Cartwright, Julia; Rudge, Nancy K

2011-07-01

Chemotherapy administration is a highly complex and distributed task in both the inpatient and outpatient infusion center settings. The American Society of Clinical Oncology and the Oncology Nursing Society (ASCO/ONS) have developed standards that specify procedures and documentation requirements for safe chemotherapy administration. Yet paper-based approaches to medication administration have several disadvantages and do not provide any decision support for patient safety checks. Electronic medication administration that includes bar coding technology may provide additional safety checks, enable consistent documentation structure, and have additional downstream benefits. We describe the specialized configuration of clinical informatics systems for electronic chemotherapy medication administration. The system integrates the patient registration system, the inpatient order entry system, the pharmacy information system, the nursing documentation system, and the electronic health record. We describe the process of deploying this infrastructure in the adult and pediatric inpatient oncology, hematology, and bone marrow transplant wards at Vanderbilt University Medical Center. We have successfully adapted the system for the oncology-specific documentation requirements detailed in the ASCO/ONS guidelines for chemotherapy administration. However, several limitations remain with regard to recording the day of treatment and dose number. Overall, the configured systems facilitate compliance with the ASCO/ONS guidelines and improve the consistency of documentation and multidisciplinary team communication. Our success has prompted us to deploy this infrastructure in our outpatient chemotherapy infusion centers, a process that is currently underway and that will require a few unique considerations.

Industrial machine systems risk assessment: a critical review of concepts and methods.

PubMed

Etherton, John R

2007-02-01

Reducing the risk of work-related death and injury to machine operators and maintenance personnel poses a continuing occupational safety challenge. The risk of injury from machinery in U.S. workplaces is high. Between 1992 and 2001, there were, on average, 520 fatalities per year involving machines and, on average, 3.8 cases per 10,000 workers of nonfatal caught-in-running-machine injuries involving lost workdays. A U.S. task group recently developed a technical reference guideline, ANSI B11 TR3, "A Guide to Estimate, Evaluate, & Reduce Risks Associated with Machine Tools," that is intended to bring machine tool risk assessment practice in the United States up to or above the level now required by the international standard, ISO 14121. The ANSI guideline emphasizes identifying tasks and hazards not previously considered, particularly those associated with maintenance; and it further emphasizes teamwork among line workers, engineers, and safety professionals. The value of this critical review of concepts and methods resides in (1) its linking current risk theory to machine system risk assessment and (2) its exploration of how various risk estimation tools translate into risk-informed decisions on industrial machine system design and use. The review was undertaken to set the stage for a field evaluation study on machine risk assessment among users of the ANSI B11 TR3 method.

Activating knowledge for patient safety practices: a Canadian academic-policy partnership.

PubMed

Harrison, Margaret B; Nicklin, Wendy; Owen, Marie; Godfrey, Christina; McVeety, Janice; Angus, Val

2012-02-01

Over the past decade, the need for healthcare delivery systems to identify and address patient safety issues has been propelled to the forefront. A Canadian survey, for example, demonstrated patient safety to be a major concern of frontline nurses (Nicklin & McVeety 2002). Three crucial patient safety elements, current knowledge, resources, and context of care have been identified by the World Health Organization (WHO 2009). To develop strategies to respond to the scope and mandate of the WHO report within the Canadian context, a pan-Canadian academic-policy partnership has been established. This newly formed Pan-Canadian Partnership, the Queen's Joanna Briggs Collaboration for Patient Safety (referred throughout as "QJBC" or "the Partnership"), includes the Queen's University School of Nursing, Accreditation Canada, the Canadian Patient Safety Institute (CPSI), the Canadian Institutes of Health Research, and is supported by an active and committed advisory council representing over 10 national organizations representing all sectors of the health continuum, including patients/families advocacy groups, professional associations, and other bodies. This unique partnership is designed to provide timely, focused support from academia to the front line of patient safety. QJBC has adopted an "integrated knowledge translation" approach to identify and respond to patient safety priorities and to ensure active engagement with stakeholders in producing and using available knowledge. Synthesis of evidence and guideline adaptation methodologies are employed to access quantitative and qualitative evidence relevant to pertinent patient safety questions and subsequently, to respond to issues of feasibility, meaningfulness, appropriateness/acceptability, and effectiveness. This paper describes the conceptual grounding of the Partnership, its proposed methods, and its plan for action. It is hoped that our journey may provide some guidance to others as they develop patient safety models within their own arenas. ©2011 Sigma Theta Tau International.

Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

PubMed

Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; de Graeff, Pieter A; Mol, Peter G M

2011-11-01

Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. The aim was to evaluate the extent to which regulators and industry have addressed the risk of safety issues for HIV drugs based on prior experience with other drugs in the same class and whether doing so impacts development time of these drugs. HIV drugs receiving ≥1 DHPC in the Netherlands between January 1999 and December 2008 were identified. Each drug with a DHPC ('index' drug) was paired with subsequently approved HIV drug(s) in the same class (Anatomical Therapeutic Chemical [ATC] 4th level) ['follow-on' drugs]. Characteristics of safety issues were extracted from the DHPCs of the 'index' drugs. European Public Assessment Reports (EPARs) were reviewed regarding whether the safety issues had been considered during development and approval. Consideration of previously identified safety issues in 'follow-on' drug applications was assessed regarding attention paid to adverse drug reaction (ADR) symptoms in pre-marketing studies, Summary of Product Characteristics (SmPC) and postmarketing commitments, and whether size of the safety population was in accordance with Regulatory guidelines. 'Index' drugs were also paired with drugs in the same class already on the market ('older' drugs). For 'older' drugs, we identified whether the safety issue led to appropriate changes in the current SmPC (January 2011) compared with the SmPC at the time of marketing authorization. Clinical development time was assessed using time from first patent application to market authorization as proxy, and comparison was made between 'index' and 'follow-on' drugs. For 9 (43%) of the 21 centrally authorized HIV drugs, 11 serious safety issues that required a DHPC were identified. Two drugs were excluded from our analysis (DHPCs related to contamination/medication error). Six 'index' drugs were paired, each with one to six 'follow-on' drugs. Three concerned drug-drug interactions (DDIs); the other three were intracranial haemorrhage, neuromuscular weakness and severe skin/hepatic reactions. All but one 'follow-on' drug had information in the EPAR on that specific ADR (i.e. attention was paid to the ADR). The DDIs were addressed in pre-marketing studies and/or the SmPC. Two of the other ADRs were addressed by postmarketing surveillance commitments; intracranial haemorrhage was not addressed. Three safety issues for two 'index' drugs could not be paired with a 'follow-on' drug as no drug in the same class was approved after the corresponding DHPCs were issued. Five of the nine safety issues were added to at least one of the current SmPCs for the 'older' drugs already on the market at the time of DHPC issue. Two safety issues were already in the SmPC of the 'older' drugs at time of market approval and two were not introduced into the SmPC of 'older' drugs. Population size to assess short-term safety complied with the guidelines for four 'index', seven 'follow-on' and three 'older' drugs; population size to assess long-term safety complied for one, three and two drugs, respectively. For five drugs, EPARs did not provide adequate information on population size. No statistically significant difference in development time between 'index' and 'follow-on' drugs was found. Generally, safety issues were taken into account in the approval process of other drugs in the class. The approaches were different and determined by the nature of the ADR. Taking safety issues into account in the approval process did not seem to impact on the time taken to perform the pre-approval clinical programme.

A review of cyberbullying legislation in Qatar: Considerations for policy makers and educators.

PubMed

Foody, Mairéad; Samara, Muthanna; El Asam, Aiman; Morsi, Hisham; Khattab, Azhar

Cyberbullying is a worldwide problem affecting mental health, education, safety and general well-being for individuals across the globe. Despite the widespread availability of the Internet, research into prevalence rates of cyberbullying in Qatar is lacking and legislating for the crime has been slow to develop. Recently there have been some positive initiatives in the country such as a Cybercrime Prevention Law, the development of a National ICT Strategy, and a website detailing safe practice guidelines for Internet usage. However, the implementation and usage of these initiatives are still limited and there is a lack of awareness of cyberbullying in Qatar. As a result, the risk factors and consequences among school-aged children are unknown. The current paper presents an evaluation of the legislative and public policy solutions to cyberbullying available in Qatar, and outlines the critical challenges that could potentially face educators in shaping best practice guidelines for the future. Copyright © 2016 Elsevier Ltd. All rights reserved.

Updates in vaccination: Recommendations for adult inflammatory bowel disease patients

PubMed Central

Chaudrey, Khadija; Salvaggio, Michelle; Ahmed, Aftab; Mahmood, Sultan; Ali, Tauseef

2015-01-01

Treatment regimens for inflammatory bowel disease (IBD) incorporate the use of a variety of immunosuppressive agents that increase the risk of infections. Prevention of many of these infections can be achieved by the timely and judicious use of vaccinations. IBD patients tend to be under-immunized. Some of the contributing factors are lack of awareness regarding the significance of vaccinating IBD patients, misperception about safety of vaccinations in immunocompromised patients, ambiguity about the perceived role of the gastroenterologist in contrast to the primary care physician and unavailability of vaccination guidelines focused on IBD population. In general, immunocompetent IBD patients can be vaccinated using standard vaccination recommendations. However there are special considerations for IBD patients receiving immunosuppressive therapy, IBD travelers and pregnant women with IBD. This review discusses current vaccination recommendations with updates for adult IBD patients. Centers for Disease Control and Prevention 2013 vaccination guidelines with 2014 updates and the Advisory Committee on Immunization Practices recommendations have been highlighted as a primary source of recommendations. PMID:25805924

Rules of the Road for Transporting Children--Guidelines for Developing a Motor Vehicle Safety Program.

ERIC Educational Resources Information Center

Hooker, Bruce; Gearhart, Kentin

1999-01-01

Discusses safety issues for child care centers that provide transportation for children. Notes the importance of vehicle usage and control, driver qualifications, vehicle maintenance, child securement, accident procedures, and driver education and training. (JPB)

Safety and Guidelines for Marked and Unmarked Pedestrian Crosswalks at Unsignalized Intersections in Nevada

DOT National Transportation Integrated Search

2012-09-01

This report examines two aspects of marked and unmarked crosswalks at unsignalized intersections. Firstly, the report assesses the safety performance of marked/unmarked crosswalks in Nevada through comparing pedestrian-related crash rates. In which, ...

23 CFR 655.604 - Achieving basic uniformity.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS... system should be based on inventories made in accordance with the Highway Safety Program Guideline 21, “Roadway Safety.” These inventories provide the information necessary for programming traffic control...

Corporate incentives for promoting safety belt use : rationale, guidelines, and examples

DOT National Transportation Integrated Search

1982-10-01

This manual was designed to teach the corporate executive successful strategies for implementing and evaluating a successful industry-based program to motivate employee safety belt use. A rationale is given for the general approach; and specific guid...

23 CFR 1205.4 - Funding requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 23 Highways 1 2012-04-01 2012-04-01 false Funding requirements. 1205.4 Section 1205.4 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GUIDELINES HIGHWAY SAFETY PROGRAMS; DETERMINATIONS OF EFFECTIVENESS § 1205.4 Funding requirements...

23 CFR 1205.4 - Funding requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 23 Highways 1 2011-04-01 2011-04-01 false Funding requirements. 1205.4 Section 1205.4 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GUIDELINES HIGHWAY SAFETY PROGRAMS; DETERMINATIONS OF EFFECTIVENESS § 1205.4 Funding requirements...

23 CFR 1205.4 - Funding requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Funding requirements. 1205.4 Section 1205.4 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GUIDELINES HIGHWAY SAFETY PROGRAMS; DETERMINATIONS OF EFFECTIVENESS § 1205.4 Funding requirements...

Alternative models in developmental toxicology.

PubMed

Lee, Hyung-yul; Inselman, Amy L; Kanungo, Jyotshnabala; Hansen, Deborah K

2012-02-01

In light of various pressures, toxicologists have been searching for alternative methods for safety testing of chemicals. According to a recent policy in the European Union (Regulation, Evaluation Authorisation and Restriction of Chemicals, REACH), it has been estimated that over the next twelve to fifteen years, approximately 30,000 chemicals may need to be tested for safety, and under current guidelines such testing would require the use of approximately 7.2 million laboratory animals [ Hofer et al. 2004 ]. It has also been estimated that over 80% of all animals used for safety testing under REACH legislation would be used for examining reproductive and developmental toxicity [Hofer et al., 2004]. In addition to REACH initiatives, it has been estimated that out of 5,000 to 10,000 new drug entities that a pharmaceutical company may start with, only one is finally approved by the Food and Drug Administration at a cost of over one billion dollars [ Garg et al. 2011 ]. A large portion of this cost is due to animal testing. Therefore, both the pharmaceutical and chemical industries are interested in using alternative models and in vitro tests for safety testing. This review will examine the current state of three alternative models - whole embryo culture (WEC), the mouse embryonic stem cell test (mEST), and zebrafish. Each of these alternatives will be reviewed, and advantages and disadvantages of each model will be discussed. These models were chosen because they are the models most commonly used and would appear to have the greatest potential for future applications in developmental toxicity screening and testing.

Manual on the proper use of lutetium-177-labeled somatostatin analogue (Lu-177-DOTA-TATE) injectable in radionuclide therapy (2nd ed.).

PubMed

Hosono, Makoto; Ikebuchi, Hideharu; Nakamura, Yoshihide; Nakamura, Nobutaka; Yamada, Takahiro; Yanagida, Sachiko; Kitaoka, Asami; Kojima, Kiyotaka; Sugano, Hiroyasu; Kinuya, Seigo; Inoue, Tomio; Hatazawa, Jun

2018-04-01

Here we present the guideline for the treatment of neuroendocrine tumors using Lu-177-DOTA-TATE on the basis of radiation safety aspects in Japan. This guideline was prepared by a study supported by Ministry of Health, Labour, and Welfare, and approved by Japanese Society of Nuclear Medicine. Lu-177-DOTA-TATE treatment in Japan should be carried out according to this guideline. Although this guideline is applied in Japan, the issues for radiation protection shown in this guideline are considered internationally useful as well. Only the original Japanese version is the formal document.

Transcranial Electrical Neuromodulation Based on the Reciprocity Principle

PubMed Central

Fernández-Corazza, Mariano; Turovets, Sergei; Luu, Phan; Anderson, Erik; Tucker, Don

2016-01-01

A key challenge in multi-electrode transcranial electrical stimulation (TES) or transcranial direct current stimulation (tDCS) is to find a current injection pattern that delivers the necessary current density at a target and minimizes it in the rest of the head, which is mathematically modeled as an optimization problem. Such an optimization with the Least Squares (LS) or Linearly Constrained Minimum Variance (LCMV) algorithms is generally computationally expensive and requires multiple independent current sources. Based on the reciprocity principle in electroencephalography (EEG) and TES, it could be possible to find the optimal TES patterns quickly whenever the solution of the forward EEG problem is available for a brain region of interest. Here, we investigate the reciprocity principle as a guideline for finding optimal current injection patterns in TES that comply with safety constraints. We define four different trial cortical targets in a detailed seven-tissue finite element head model, and analyze the performance of the reciprocity family of TES methods in terms of electrode density, targeting error, focality, intensity, and directionality using the LS and LCMV solutions as the reference standards. It is found that the reciprocity algorithms show good performance comparable to the LCMV and LS solutions. Comparing the 128 and 256 electrode cases, we found that use of greater electrode density improves focality, directionality, and intensity parameters. The results show that reciprocity principle can be used to quickly determine optimal current injection patterns in TES and help to simplify TES protocols that are consistent with hardware and software availability and with safety constraints. PMID:27303311

Transcranial Electrical Neuromodulation Based on the Reciprocity Principle.

PubMed

Fernández-Corazza, Mariano; Turovets, Sergei; Luu, Phan; Anderson, Erik; Tucker, Don

2016-01-01

A key challenge in multi-electrode transcranial electrical stimulation (TES) or transcranial direct current stimulation (tDCS) is to find a current injection pattern that delivers the necessary current density at a target and minimizes it in the rest of the head, which is mathematically modeled as an optimization problem. Such an optimization with the Least Squares (LS) or Linearly Constrained Minimum Variance (LCMV) algorithms is generally computationally expensive and requires multiple independent current sources. Based on the reciprocity principle in electroencephalography (EEG) and TES, it could be possible to find the optimal TES patterns quickly whenever the solution of the forward EEG problem is available for a brain region of interest. Here, we investigate the reciprocity principle as a guideline for finding optimal current injection patterns in TES that comply with safety constraints. We define four different trial cortical targets in a detailed seven-tissue finite element head model, and analyze the performance of the reciprocity family of TES methods in terms of electrode density, targeting error, focality, intensity, and directionality using the LS and LCMV solutions as the reference standards. It is found that the reciprocity algorithms show good performance comparable to the LCMV and LS solutions. Comparing the 128 and 256 electrode cases, we found that use of greater electrode density improves focality, directionality, and intensity parameters. The results show that reciprocity principle can be used to quickly determine optimal current injection patterns in TES and help to simplify TES protocols that are consistent with hardware and software availability and with safety constraints.

National Electrical Code in Power Engineering Course for Electrical Engineering Curriculum

ERIC Educational Resources Information Center

Azizur, Rahman M. M.

2011-01-01

In order to ensure the safety of their inhabitants and properties, the residential, industrial and business installations require complying with NEC (national electrical code) for electrical systems. Electrical design engineers and technicians rely heavily on these very important design guidelines. However, these design guidelines are not formally…

Guidelines for Out-of-School Experiences.

ERIC Educational Resources Information Center

Queen's Univ., Kingston (Ontario). Science Resource Centre.

As a mechanism by which policy for out-of-school experiences is carried out, these guidelines developed for Bruce County Schools, Canada, in 1972-73 are intended to insure pupil safety and set forth teacher responsibility during educational outings and excursions for students of all levels. Included are administrative procedures for obtaining…

78 FR 36698 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three...

Guidelines for the use of no U-turn and no left-turn signs.

DOT National Transportation Integrated Search

1994-01-01

The objective of this study was to establish a set of written guidelines identifying traffic and road conditions where No U-Turn and No Left Turn signs should be installed. The effect of these signs on traffic safety was also investigated. A question...

[Infection prevention in Dutch hospitals; results say more than process indicators].

PubMed

Bonten, Marc J M; Friedrich, Alexander; Kluytmans, Jan A J W; Vandenbroucke-Grauls, Christina M J E; Voss, Andreas; Vos, Margreet C

2014-01-01

The Dutch Health Care Inspectorate investigated the preparedness of Dutch hospitals for the emergence of antibiotic resistance, and concluded that hospitals are not well prepared and are insufficiently aware that infection prevention is a prerequisite for patient safety. These conclusions are based on observations of process indicators of current practice guidelines, without including the available outcome indicators that demonstrate the persistently low incidence of infections with antibiotic resistant bacteria in Dutch hospitals. The conclusions may have negative effects on the quality of infection prevention in Dutch hospitals. Therefore, it is advisable to use outcome indicators rather than process indicators to evaluate the quality of infection prevention.

Plumbing of hospital premises is a reservoir for opportunistically pathogenic microorganisms: a review.

PubMed

Williams, Margaret M; Armbruster, Catherine R; Arduino, Matthew J

2013-01-01

Several bacterial species that are natural inhabitants of potable water distribution system biofilms are opportunistic pathogens important to sensitive patients in healthcare facilities. Waterborne healthcare-associated infections (HAI) may occur during the many uses of potable water in the healthcare environment. Prevention of infection is made more challenging by lack of data on infection rate and gaps in understanding of the ecology, virulence, and infectious dose of these opportunistic pathogens. Some healthcare facilities have been successful in reducing infections by following current water safety guidelines. This review describes several infections, and remediation steps that have been implemented to reduce waterborne HAIs.

[Skin and tissue bank: Operational model for the recovery and preservation of tissues and skin allografts].

PubMed

Martínez-Flores, Francisco; Sandoval-Zamora, Hugo; Machuca-Rodriguez, Catalina; Barrera-López, Araceli; García-Cavazos, Ricardo; Madinaveitia-Villanueva, Juan Antonio

2016-01-01

Tissue storage is a medical process that is in the regulation and homogenisation phase in the scientific world. The international standards require the need to ensure safety and efficacy of human allografts such as skin and other tissues. The activities of skin and tissues banks currently involve their recovery, processing, storage and distribution, which are positively correlated with technological and scientific advances present in current biomedical sciences. A description is presented of the operational model of Skin and Tissue Bank at INR as successful case for procurement, recovery and preservation of skin and tissues for therapeutic uses, with high safety and biological quality. The essential and standard guidelines are presented as keystones for a tissue recovery program based on scientific evidence, and within an ethical and legal framework, as well as to propose a model for complete overview of the donation of tissues and organ programs in Mexico. Finally, it concludes with essential proposals for improving the efficacy of transplantation of organs and tissue programs. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

The emergence of international food safety standards and guidelines: understanding the current landscape through a historical approach.

PubMed

Ramsingh, Brigit

2014-07-01

Following the Second World War, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) teamed up to construct an International Codex Alimentarius (or 'food code') which emerged in 1963. The Codex Committee on Food Hygiene (CCFH) was charged with the task of developing microbial hygiene standards, although it found itself embroiled in debate with the WHO over the nature these standards should take. The WHO was increasingly relying upon the input of biometricians and especially the International Commission on Microbial Specifications for Foods (ICMSF) which had developed statistical sampling plans for determining the microbial counts in the final end products. The CCFH, however, was initially more focused on a qualitative approach which looked at the entire food production system and developed codes of practice as well as more descriptive end-product specifications which the WHO argued were 'not scientifically correct'. Drawing upon historical archival material (correspondence and reports) from the WHO and FAO, this article examines this debate over microbial hygiene standards and suggests that there are many lessons from history which could shed light upon current debates and efforts in international food safety management systems and approaches.

Mesenchymal stromal cell-based therapy: Regulatory and translational aspects in gastroenterology.

PubMed

Dothel, Giovanni; Raschi, Emanuel; Rimondini, Roberto; De Ponti, Fabrizio

2016-11-07

The past decade has witnessed an outstanding scientific production focused towards the possible clinical applications of mesenchymal stromal cells (MSCs) in autoimmune and chronic inflammatory diseases. This raised the need of novel standards to adequately address quality, efficacy and safety issues of this advanced therapy. The development of a streamlined regulation is currently hampered by the complexity of analyzing dynamic biological entities rather than chemicals. Although numerous pieces of evidence show efficacy in reducing intestinal inflammation, some inconsistencies between the mechanisms of action of rodent vs human MSCs suggest caution before assigning translational value to preclinical studies. Preliminary evidence from clinical trials showed efficacy of MSCs in the treatment of fistulizing Crohn's disease (CD), and preparations of heterologous MSCs for CD treatment are currently tested in ongoing clinical trials. However, safety issues, especially in long-term treatment, still require solid clinical data. In this regard, standardized guidelines for appropriate dosing and methods of infusion could enhance the likelihood to predict more accurately the number of responders and the duration of remission periods. In addition, elucidating MSC mechanisms of action could lead to novel and more reliable formulations such as those derived from the MSCs themselves ( e.g ., supernatants).

A parametric study of golf car and personal transport vehicle braking stability and their deficiencies.

PubMed

Seluga, Kristopher J; Baker, Lowell L; Ojalvo, Irving U

2009-07-01

This paper describes research and parametric analyses of braking effectiveness and directional stability for golf cars, personal transport vehicles (PTVs) and low speed vehicles (LSVs). It is shown that current designs, which employ brakes on only the rear wheels, can lead to rollovers if the brakes are applied while traveling downhill. After summarizing the current state of existing safety standards and brake system designs, both of which appear deficient from a safety perspective, a previously developed dynamic simulation model is used to identify which parameters have the greatest influence on the vehicles' yaw stability. The simulation results are then used to parametrically quantify which combination of these factors can lead to yaw induced rollover during hard braking. Vehicle velocity, steering input, path slope and tire friction are all identified as important parameters in determining braking stability, the effects of which on rollover propensity are presented graphically. The results further show that when vehicles are equipped with front brakes or four-wheel brakes, the probability of a yaw induced rollover is almost entirely eliminated. Furthermore, the parametric charts provided may be used as an aid in developing guidelines for golf car and PTV path design if rear brake vehicles are used.

ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use.

PubMed

Waldman, Abigail; Bolotin, Diana; Arndt, Kenneth A; Dover, Jeffrey S; Geronemus, Roy G; Chapas, Anne; Iyengar, Sanjana; Kilmer, Suzanne L; Krakowski, Andrew C; Lawrence, Naomi; Prather, Heidi B; Rohrer, Thomas E; Schlosser, Bethanee J; Kim, John Y S; Shumaker, Peter R; Spring, Leah K; Alam, Murad

2017-10-01

Currently, the isotretinoin (13-cis-retinoic acid) package insert contains language advising the discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. It is common practice to follow this standard because of concerns regarding reports of sporadic adverse events and increased risk of scarring. To develop expert consensus regarding the safety of skin procedures, including resurfacing, energy device treatments, and incisional and excisional procedures, in the setting of concurrent or recent isotretinoin use. The American Society for Dermatologic Surgery authorized a task force of content experts to review the evidence and provide guidance. First, data were extracted from the literature. This was followed by a clinical question review, a consensus Delphi process, and validation of the results by peer review. The task force concluded that there is insufficient evidence to justify delaying treatment with superficial chemical peels and nonablative lasers, including hair removal lasers and lights, vascular lasers, and nonablative fractional devices for patients currently or recently exposed to isotretinoin. Superficial and focal dermabrasion may also be safe when performed by a well-trained clinician.

In-space propellant logistics and safety

NASA Technical Reports Server (NTRS)

1971-01-01

Preliminary guidelines for the basic delivery system and safety aspects of the space shuttle configuration in connection with the transport, handling, storage, and transfer of propellants are developed. It is shown that propellants are the major shuttle space load and influence shuttle traffic modeling significantly.

Safe Use of Pesticides, Guidelines. Occupational Safety and Health Series No. 38.

ERIC Educational Resources Information Center

International Labour Office, Geneva (Switzerland).

This document provides guidance on the safe use of pesticides in agricultural work. General principles are given and followed by more detailed safety requirements for the various pesticide application techniques. Finally, the medical aspects of pesticides are considered. (BB)

Fire safety of passenger trains : phase I : material evaluation (cone calorimeter)

DOT National Transportation Integrated Search

1999-01-01

As part of the passenger equipment rulemaking required by Congress, the Federal Railroad Administration (FRA) has proposed that its existing fire safety guidelines be made mandatory. A major conclusion of a FRA-funded 1993 study by the National Insti...

Safety of High Speed Guided Ground Transportation Systems: Collision Avoidance and Accident Survivability Volume 4: Proposed Specifications

DOT National Transportation Integrated Search

1993-03-01

This report is the fourth of four volumes concerned with developing safety guidelines and specifications for high-speed : guided ground transportation (HSGGT) collision avoidance and accident survivability. The overall approach taken in this : study ...

23 CFR 655.604 - Achieving basic uniformity.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS TRAFFIC OPERATIONS Traffic Control Devices on Federal-Aid and Other Streets and Highways § 655.604... the Highway Safety Program Guideline 21, “Roadway Safety.” Highway planning and research funds and...

23 CFR 655.604 - Achieving basic uniformity.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS TRAFFIC OPERATIONS Traffic Control Devices on Federal-Aid and Other Streets and Highways § 655.604... the Highway Safety Program Guideline 21, “Roadway Safety.” Highway planning and research funds and...

Safety of High Speed and Guided Ground Transportation Systems: Collision Avoidance and Accident Survivability: Volume 3

DOT National Transportation Integrated Search

1993-03-01

This report is the third of four volumes concerned with developing safety guidelines and specifications for high-speed : guided ground transportation (HSGGT) collision avoidance and accident survivability. The overall approach taken in : this study i...

Frequency Analysis of Failure Scenarios from Shale Gas Development.

PubMed

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

2018-04-29

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

Frequency Analysis of Failure Scenarios from Shale Gas Development

PubMed Central

Abualfaraj, Noura; Olson, Mira S.

2018-01-01

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

Food safety management systems performance in African food processing companies: a review of deficiencies and possible improvement strategies.

PubMed

Kussaga, Jamal B; Jacxsens, Liesbeth; Tiisekwa, Bendantunguka Pm; Luning, Pieternel A

2014-08-01

This study seeks to provide insight into current deficiencies in food safety management systems (FSMS) in African food-processing companies and to identify possible strategies for improvement so as to contribute to African countries' efforts to provide safe food to both local and international markets. This study found that most African food products had high microbiological and chemical contamination levels exceeding the set (legal) limits. Relative to industrialized countries, the study identified various deficiencies at government, sector/branch, retail and company levels which affect performance of FSMS in Africa. For instance, very few companies (except exporting and large companies) have implemented HACCP and ISO 22000:2005. Various measures were proposed to be taken at government (e.g. construction of risk-based legislative frameworks, strengthening of food safety authorities, recommend use of ISO 22000:2005, and consumers' food safety training), branch/sector (e.g. sector-specific guidelines and third-party certification), retail (develop stringent certification standards and impose product specifications) and company levels (improving hygiene, strict raw material control, production process efficacy, and enhancing monitoring systems, assurance activities and supportive administrative structures). By working on those four levels, FSMS of African food-processing companies could be better designed and tailored towards their production processes and specific needs to ensure food safety. © 2014 Society of Chemical Industry.

Electromagnetic pulse-induced current measurement device

NASA Astrophysics Data System (ADS)

Gandhi, Om P.; Chen, Jin Y.

1991-08-01

To develop safety guidelines for exposure to high fields associated with an electromagnetic pulse (EMP), it is necessary to devise techniques that would measure the peak current induced in the human body. The main focus of this project was to design, fabricate, and test a portable, self-contained stand-on device that would measure and hold the peak current and the integrated change Q. The design specifications of the EMP-Induced Current Measurement Device are as follows: rise time of the current pulse, 5 ns; peak current, 20-600 A; charge Q, 0-20 microcoulombs. The device uses a stand-on parallel-plate bilayer sensor and fast high-frequency circuit that are well-shielded against spurious responses to high incident fields. Since the polarity of the incident peak electric field of the EMP may be either positive or negative, the induced peak current can also be positive or negative. Therefore, the device is designed to respond to either of these polarities and measure and hold both the peak current and the integrated charge which are simultaneously displayed on two separate 3-1/2 digit displays. The prototype device has been preliminarily tested with the EMP's generated at the Air Force Weapons Laboratory (ALECS facility) at Kirtland AFB, New Mexico.

The efficacy and safety of a proposed herbal moisturising cream for dry skin and itch relief: a randomised, double-blind, placebo-controlled trial--study protocol.

PubMed

Lee, Dong-Hyo; Seo, Eun-Sung; Hong, Jin-Tae; Lee, Gang-Tai; You, Young-Kyoung; Lee, Kun-Kook; Jo, Ga-Won; Kim, Nam-Kwen

2013-11-25

Moisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics. This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs. This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ health-related quality of life questionnaires to assess changes in the quality of life. The results of this study will be used to present the evidence needed to request advertising/display allowances, in compliance with the recently amended Cosmetics Act for advertisement in Korea. Current Controlled Trials ISRCTN46216631.

Recommendations for the ethical use and design of artificial intelligent care providers.

PubMed

Luxton, David D

2014-09-01

This paper identifies and reviews ethical issues associated with artificial intelligent care providers (AICPs) in mental health care and other helping professions. Specific recommendations are made for the development of ethical codes, guidelines, and the design of AICPs. Current developments in the application of AICPs and associated technologies are reviewed and a foundational overview of applicable ethical principles in mental health care is provided. Emerging ethical issues regarding the use of AICPs are then reviewed in detail. Recommendations for ethical codes and guidelines as well as for the development of semi-autonomous and autonomous AICP systems are described. The benefits of AICPs and implications for the helping professions are discussed in order to weigh the pros and cons of their use. Existing ethics codes and practice guidelines do not presently consider the current or the future use of interactive artificial intelligent agents to assist and to potentially replace mental health care professionals. AICPs present new ethical issues that will have significant ramifications for the mental health care and other helping professions. Primary issues involve the therapeutic relationship, competence, liability, trust, privacy, and patient safety. Many of the same ethical and philosophical considerations are applicable to use and design of AICPs in medicine, nursing, social work, education, and ministry. The ethical and moral aspects regarding the use of AICP systems must be well thought-out today as this will help to guide the use and development of these systems in the future. Topics presented are relevant to end users, AI developers, and researchers, as well as policy makers and regulatory boards. Published by Elsevier B.V.

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 required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

Evaluating the safety risk of roadside features for rural two-lane roads using reliability analysis.

PubMed

Jalayer, Mohammad; Zhou, Huaguo

2016-08-01

The severity of roadway departure crashes mainly depends on the roadside features, including the sideslope, fixed-object density, offset from fixed objects, and shoulder width. Common engineering countermeasures to improve roadside safety include: cross section improvements, hazard removal or modification, and delineation. It is not always feasible to maintain an object-free and smooth roadside clear zone as recommended in design guidelines. Currently, clear zone width and sideslope are used to determine roadside hazard ratings (RHRs) to quantify the roadside safety of rural two-lane roadways on a seven-point pictorial scale. Since these two variables are continuous and can be treated as random, probabilistic analysis can be applied as an alternative method to address existing uncertainties. Specifically, using reliability analysis, it is possible to quantify roadside safety levels by treating the clear zone width and sideslope as two continuous, rather than discrete, variables. The objective of this manuscript is to present a new approach for defining the reliability index for measuring roadside safety on rural two-lane roads. To evaluate the proposed approach, we gathered five years (2009-2013) of Illinois run-off-road (ROR) crash data and identified the roadside features (i.e., clear zone widths and sideslopes) of 4500 300ft roadway segments. Based on the obtained results, we confirm that reliability indices can serve as indicators to gauge safety levels, such that the greater the reliability index value, the lower the ROR crash rate. Copyright © 2016 Elsevier Ltd. All rights reserved.

A nationwide postal questionnaire survey: the presence of airway guidelines in anaesthesia department in Sweden

PubMed Central

2014-01-01

Background In Sweden, airway guidelines aimed toward improving patient safety have been recommended by the Swedish Society of Anaesthesia and Intensive Care Medicine. Adherence to evidence-based airway guidelines is known to be generally poor in Sweden. The aim of this study was to determine whether airway guidelines are present in Swedish anaesthesia departments. Methods A nationwide postal questionnaire inquiring about the presence of airway guidelines was sent out to directors of Swedish anaesthesia departments (n = 74). The structured questionnaire was based on a review of the Swedish Society of Anaesthesia and Intensive Care voluntary recommendations of guidelines for airway management. Mean, standard deviation, minimum/maximum, percentage (%) and number of general anaesthesia performed per year as frequency (n), were used to describe, each hospital type (university, county, private). For comparison between hospitals type and available written airway guidelines were cross tabulation used and analysed using Pearson’s Chi-Square tests. A p- value of less than 0 .05 was judged significant. Results In total 68 directors who were responsible for the anaesthesia departments returned the questionnaire, which give a response rate of 92% (n 68 of 74). The presence of guidelines showing an airway algorithm was reported by 68% of the departments; 52% reported having a written patient information card in case of a difficult airway and guidelines for difficult airways, respectively; 43% reported the presence of guidelines for preoperative assessment; 31% had guidelines for Rapid Sequence Intubation; 26% reported criteria for performing an awake intubation; and 21% reported guidelines for awake fibre-optic intubation. A prescription for the registered nurse anaesthetist for performing tracheal intubation was reported by 24%. The most frequently pre-printed preoperative elements in the anaesthesia record form were dental status and head and neck mobility. Conclusions Despite recommendations from the national anaesthesia society, the presence of airway guidelines in Swedish anaesthesia departments is low. From the perspective of safety for both patients and the anaesthesia staff, airway management guidelines should be considered a higher priority. PMID:24708670

A labor perspective on workplace reproductive hazards: past history, current concerns, and positive directions.

PubMed

Graham, T; Lessin, N; Mirer, F

1993-07-01

The Supreme Court's March 1991 ruling in United Automobile Workers (UAW) versus Johnson Controls barring corporate "fetal protection policies" was a major victory for women's employment rights and has health and safety implications for both sexes. However, 2 years after the Court's decision, the union's work is far from over. The UAW has yet to see what policy Johnson Controls will implement in place of the old one. Formulating solutions to the concerns of workers who are exposed daily to reproductive health hazards on the job will continue to be on labor's agenda. Preventing hazardous exposures is the first priority. This goal would be furthered by setting occupational health and safety standards designed to protect workers' general and reproductive health. Support for the Comprehensive Occupational Safety and Health Reform Act (COSHRA) would also positively affect health and safety in the workplace. Where hazards have not yet been abated, the framework of transfers and income protections for all workers with temporary job restrictions should be examined. The Legal/Labor Working Group convened at the Occupational and Environmental Reproductive Hazards Working Conference authored guidelines for developing a model reproductive hazards policy. These recommendations can serve as a guide for implementation of nondiscriminatory and health-protective policies by employers.

A labor perspective on workplace reproductive hazards: past history, current concerns, and positive directions.

PubMed Central

Graham, T; Lessin, N; Mirer, F

1993-01-01

The Supreme Court's March 1991 ruling in United Automobile Workers (UAW) versus Johnson Controls barring corporate "fetal protection policies" was a major victory for women's employment rights and has health and safety implications for both sexes. However, 2 years after the Court's decision, the union's work is far from over. The UAW has yet to see what policy Johnson Controls will implement in place of the old one. Formulating solutions to the concerns of workers who are exposed daily to reproductive health hazards on the job will continue to be on labor's agenda. Preventing hazardous exposures is the first priority. This goal would be furthered by setting occupational health and safety standards designed to protect workers' general and reproductive health. Support for the Comprehensive Occupational Safety and Health Reform Act (COSHRA) would also positively affect health and safety in the workplace. Where hazards have not yet been abated, the framework of transfers and income protections for all workers with temporary job restrictions should be examined. The Legal/Labor Working Group convened at the Occupational and Environmental Reproductive Hazards Working Conference authored guidelines for developing a model reproductive hazards policy. These recommendations can serve as a guide for implementation of nondiscriminatory and health-protective policies by employers. PMID:8243392

Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.

PubMed

Roberts, Stanley A; Andrews, Paul A; Blanset, Diann; Flagella, Kelly M; Gorovits, Boris; Lynch, Carmel M; Martin, Pauline L; Kramer-Stickland, Kimberly; Thibault, Stephane; Warner, Garvin

2013-12-01

Antibody drug conjugates (ADCs) include monoclonal antibodies that are linked to cytotoxic small molecules. A number of these agents are currently being developed as anti-cancer agents designed to improve the therapeutic index of the cytotoxin (i.e., cytotoxic small molecule or cytotoxic agent) by specifically delivering it to tumor cells. This paper presents primary considerations for the nonclinical safety evaluation of ADCs and includes strategies for the evaluation of the entire ADC or the various individual components (i.e., antibody, linker or the cytotoxin). Considerations are presented on how to design a nonclinical safety assessment program to identify the on- and off-target toxicities to enable first-in-human (FIH) studies. Specific discussions are also included that provide details as to the need and how to conduct the studies for evaluating ADCs in genetic toxicology, tissue cross-reactivity, safety pharmacology, carcinogenicity, developmental and reproductive toxicology, biotransformation, toxicokinetic monitoring, bioanalytical assays, immunogenicity testing, test article stability and the selection of the FIH dose. Given the complexity of these molecules and our evolving understanding of their properties, there is no single all-encompassing nonclinical strategy. Instead, each ADC should be evaluated on a case-by-case scientifically-based approach that is consistent with ICH and animal research guidelines. Copyright © 2013 Elsevier Inc. All rights reserved.

A new intervention for people with borderline personality disorder who are also parents: a pilot study of clinician acceptability.

PubMed

McCarthy, Kye L; Lewis, Kate L; Bourke, Marianne E; Grenyer, Brin F S

2016-01-01

Engaging parents who have a personality disorder in interventions designed to protect children from the extremes of the disorder supports both parenting skills and healthy child development. In line with evidence-based guidelines, a 'Parenting with Personality Disorder' brief intervention was developed, focusing on child safety, effective communication and parenting strategies. Ratings of acceptability for the brief intervention model were given by 168 mental health clinicians who attended training. Changes in clinician attitudes, knowledge and skills were also assessed following training. Providing clinicians treating personality disorder clients with additional skills to address parenting was well received and filled a gap in service provision. Clinicians reported improvements in clinical skills, knowledge, willingness and confidence to intervene in parenting issues with clients. Qualitative responses endorsed three major modes of learning: case study analysis, reflective learning activities, and skills-based intervention practices. Current treatment guidelines emphasise addressing parenting, but no evidence-based therapy includes specific parenting skills. This brief intervention model improved skills, efficacy and willingness to intervene. This approach can be readily added to current evidence-based therapy protocols and promises to improve client functioning and protect children from the extremes of the disorder. Clinical trials are now required to validate the approach in the field.

The Role of Ivabradine in the Management of Angina Pectoris.

PubMed

Giavarini, Alessandra; de Silva, Ranil

2016-08-01

Stable angina pectoris affects 2-4 % of the population in Western countries and entails an annual risk of death and nonfatal myocardial infarction of 1-2 % and 3 %, respectively. Heart rate (HR) is linearly related to myocardial oxygen consumption and coronary blood flow, both at rest and during stress. HR reduction is a key target for the prevention of ischemia/angina and is an important mechanism of action of drugs which are recommended as first line therapy for the treatment of angina in clinical guidelines. However, many patients are often unable to tolerate the doses of beta blocker or non-dihydropyridine calcium antagonists required to achieve the desired symptom control. The selective pacemaker current inhibitor ivabradine was developed as a drug for the management of patients with angina pectoris, through its ability to reduce HR specifically. The available data suggest that ivabradine is a well-tolerated and effective anti-anginal agent and it is recommended as a second-line agent for relief of angina in guidelines. However, recent clinical trials of ivabradine have failed to show prognostic benefit and have raised potential concerns about safety. This article will review the available evidence base for the current role of ivabradine in the management of patients with symptomatic angina pectoris in the context of stable coronary artery disease.