Transportation of Organs by Air: Safety, Quality, and Sustainability Criteria.

PubMed

Mantecchini, L; Paganelli, F; Morabito, V; Ricci, A; Peritore, D; Trapani, S; Montemurro, A; Rizzo, A; Del Sordo, E; Gaeta, A; Rizzato, L; Nanni Costa, A

2016-03-01

The outcomes of organ transplantation activities are greatly affected by the ability to haul organs and medical teams quickly and safely. Organ allocation and usage criteria have greatly improved over time, whereas the same result has not been achieved so far from the transport point of view. Safety and the highest level of service and efficiency must be reached to grant transplant recipients the healthiest outcome. The Italian National Transplant Centre (CNT), in partnership with the regions and the University of Bologna, has promoted a thorough analysis of all stages of organ transportation logistics chains to produce homogeneous and shared guidelines throughout the national territory, capable of ensuring safety, reliability, and sustainability at the highest levels. The mapping of all 44 transplant centers and the pertaining airport network has been implemented. An analysis of technical requirements among organ shipping agents at both national and international level has been promoted. A national campaign of real-time monitoring of organ transport activities at all stages of the supply chain has been implemented. Parameters investigated have been hospital and region of both origin and destination, number and type of organs involved, transport type (with or without medical team), stations of arrival and departure, and shipping agents, as well as actual times of activities involved. National guidelines have been issued to select organ storage units and shipping agents on the basis of evaluation of efficiency, reliability, and equipment with reference to organ type and ischemia time. Guidelines provide EU-level standards on technical equipment of aircrafts, professional requirements of shipping agencies and cabin crew, and requirements on service provision, including pricing criteria. The introduction in the Italian legislation of guidelines issuing minimum requirements on topics such as the medical team, packaging, labeling, safety and integrity, identification, real-time monitoring of temperature, and traceability of the organ during the logistics chain is deemed a valid response to the necessity of improving safety, reliability, and sustainability of organ transplantation activities in Italy. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

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.…

Safety and health in the petrochemical industry in Map Ta Phut, Thailand.

PubMed

Langkulsen, Uma; Vichit-Vadakan, Nuntavarn; Taptagaporn, Sasitorn

2011-01-01

Petrochemical industries are known as sources of many toxic chemicals. Safety and health risks of the petrochemical workers employed at Map Ta Phut Industrial Estate, located in Rayong, Thailand, are potentially high. The research materials consisted of documents emanating from statutory reports on safety in working with toxic chemicals and the results of interviews by questionnaire among 457 petrochemical workers regarding occupational health and safety issues. Most of workers who were working with toxic chemicals had knowledge and awareness of health risks and chemical hazards at work. We found that safe behavior at work through read the safety information among operational workers less than non-operational workers around 10%. Most of workers had perceived occupational health and safety management in their companies. Some companies revealed that they had not been performing biological monitoring of blood or urine for their health examination reports and that workplace exposure monitoring had not correlated well with health examination of workers. Our study suggested that occupational health and safety for petrochemical industries requires standards and guidelines for workers' health surveillance aimed at protection of workers.

Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study.

PubMed

Bokemeyer, Carsten; Gascón, Pere; Aapro, Matti; Ludwig, Heinz; Boccadoro, Mario; Denhaerynck, Kris; Gorray, Michael; Krendyukov, Andriy; Abraham, Ivo; MacDonald, Karen

2017-06-01

In the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC guidelines, but 17.4% were prophylacted below and 26.0% above guideline recommendations. MONITOR-GCSF is a prospective, observational study of 1447 evaluable patients from 140 cancers centers in 12 European countries treated with myelosuppressive chemotherapy for up to 6 cycles receiving biosimilar GCSF prophylaxis. Patients were classified as under-, correctly-, or over-prophylacted with GCSF relative to guideline recommendations based on their chemotherapy risk, individual risk factors, and type of GCSF prophylaxis (primary versus secondary). Differences between under- (17.4%), correctly- (56.6%), or over-prophylacted (26.0%) groups were found in terms of patient risk factors (age, performance status, history of FN, comorbid conditions) as well as prophylaxis patterns (type of prophylaxis, day of GCSF initiation, and GCSF duration). Rates of chemotherapy-induced neutropenia (CIN) (all grades), FN, and CIN-related hospitalizations were consistently lower in over-prophylacted patients relative to under- and correctly-prophylacted patients. No differences were observed between under- and correctly-prophylacted patients except for CIN/FN-related chemotherapy disturbances. No GCSF safety differences were found between groups (except for headaches). The real-world evidence provided by the MONITOR-GCSF study indicates that providing GCSF support may yield better CIN, FN, and CIN/FN-related hospitalization outcomes if patients are prophylacted at levels above guideline recommendations. Patients who are under-prophylacted are at higher risk for disturbances to their chemotherapy regimens. Our findings support the guideline recommendation that CIN/FN risk be assessed at the beginning of each chemotherapy cycle.

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…

Physical Health and Drug Safety in Individuals with Schizophrenia

PubMed Central

Kelly, Martina; Urness, Doug; Teehan, Michael; Ismail, Zahinoor; Gardner, David

2017-01-01

Background: While antipsychotic medications are the mainstay of therapy for individuals with schizophrenia and psychotic disorders, their use is associated with adverse effects on physical health that require the attention and care of prescribers. Methods: We used the ADAPTE process to adapt existing guideline recommendations from the National Institute for Health and Care Excellence (NICE) and Scottish Intercollegiate Guidelines Network (SIGN) guidelines on the dosing of antipsychotics and antipsychotic polypharmacy, screening for adverse effects of antipsychotics, and management of metabolic and extrapyramidal side effects to the Canadian context. Results: Prescribers are encouraged to use the lowest effective dose and to avoid the routine use of multiple antipsychotics. Scheduled monitoring of body mass index, waist circumference, blood pressure, glucose, lipids, prolactin, electrocardiograms, and extrapyramidal symptoms is recommended. Lifestyle interventions are recommended to mitigate antipsychotic-induced weight gain. Prescribers should follow Canadian guidelines on the treatment of obesity, dyslipidemia, and diabetes. Recommendations on antipsychotic drug choice are made for users particularly concerned about extrapyramidal symptoms. Conclusion: Careful monitoring and attention by prescribers may mitigate adverse effects associated with antipsychotic medications. PMID:28718324

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

Sedation in a radiology department--do radiologists follow their own guidelines?

PubMed

Eason, D; Chakraverty, S; Wildsmith, J A W

2011-05-01

The Royal College of Radiologists (RCR) published guidelines in 2003 which aimed to standardise and improve the safety of sedation in the modern Radiology department. As sedation requirements increase, we decided to audit our own departments understandings and practice with respect to sedation. A repeat audit cycle was performed following a re-educational lecture, one year later. Three common sedation case scenarios were incorporated into a questionnaire which detailed questioning on requirements for fasting, monitoring and the order and use of sedation drugs alongside analgesics. These were compared to the 2003 RCR guidelines. The audit was recycled at one year. Despite the RCR guidelines, freely available on the RCR website, there was a persisting variation in practice which revealed a lack of awareness of the requirements for adequate fasting and the importance of giving the opiate before the benzodiazepine (sedative) agent in cases where a combination are chosen. The audit did show a trend towards using shorter acting benzodiazepines, which is in keeping with the guidelines. Monitoring of vital signs was generally, well carried out. General awareness of the RCR guidelines for safe sedation in the Radiology department was initially low and practice found to be variable. Re-education saw some improvements but also, some persisting habitual deviations from the guidelines, particularly with respect to the order in which the opiate and sedative benzodiazepine were given.

French Regulatory practice and experience feedback on steam generator tube integrity

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

Sandon, G.

1997-02-01

This paper summarizes the way the French Safety Authority applies regulatory rules and practices to the problem of steam generator tube cracking in French PWR reactors. There are 54 reactors providing 80% of French electrical consumption. The Safety Authority closely monitors the performance of tubes in steam generators, and requires application of a program which deals with problems prior to the actual development of leakage. The actual rules regarding such performance are flexible, responding to the overall performance of operating steam generators. In addition there is an inservice inspection service to examine tubes during shutdown, and to monitor steam generatorsmore » for leakage during operation, with guidelines for when generators must be pulled off line.« 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.

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.

[Standards and guidelines of radiation protection and safety in dental X-ray examinations].

PubMed

Guo, X L; Li, G; Cheng, Y; Yu, Q; Wang, H; Zhang, Z Y

2017-12-09

With the rapid development of imaging technology, the application of dental imaging in diagnosis, treatment planning, intraoperative surgical navigation, monitoring of treatment or lesion development and assessment of treatment outcomes is playing an essential role in oral healthcare. The increased total number of dental X-ray examinations is accompanied by a relatively significant increase in collective dose to patients as well as to dental healthcare workers, which is harmful to human bodies to a certain degree. Some radiation protection standards and guidelines in dental radiology have been published in European countries, US, Canada and Australia, etc. Adherence to these standards and guidelines helps to achieve images with diagnostic quality and avoid unnecessary and repeated exposures. However, no radiation protection standard or guideline with regard to dental X-ray examinations has been put in force so far in mainland China. Therefore, a literature review on available radiation protection standards and guidelines was conducted to provide reference to the development of radiation protection standards or guidelines in mainland China.

Human Hallucinogen Research: Guidelines for Safety

PubMed Central

Johnson, Matthew W.; Richards, William A.; Griffiths, Roland R.

2010-01-01

There has recently been a renewal of human research with classical hallucinogens (psychedelics). This paper first briefly discusses the unique history of human hallucinogen research, and then reviews the risks of hallucinogen administration and safeguards for minimizing these risks. Although hallucinogens are relatively safe physiologically and are not considered drugs of dependence, their administration involves unique psychological risks. The most likely risk is overwhelming distress during drug action (“bad trip”), which could lead to potentially dangerous behavior such as leaving the study site. Less common are prolonged psychoses triggered by hallucinogens. Safeguards against these risks include the exclusion of volunteers with personal or family history of psychotic disorders or other severe psychiatric disorders, establishing trust and rapport between session monitors and volunteer before the session, careful volunteer preparation, a safe physical session environment, and interpersonal support from at least two study monitors during the session. Investigators should probe for the relatively rare hallucinogen persisting perception disorder in follow up contact. Persisting adverse reactions are rare when research is conducted along these guidelines. Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science. PMID:18593734

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.

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

Tele-monitoring of ventilator-dependent patients: a European Respiratory Society Statement.

PubMed

Ambrosino, Nicolino; Vitacca, Michele; Dreher, Michael; Isetta, Valentina; Montserrat, Josep M; Tonia, Thomy; Turchetti, Giuseppe; Winck, Joao Carlos; Burgos, Felip; Kampelmacher, Michael; Vagheggini, Guido

2016-09-01

The estimated prevalence of ventilator-dependent individuals in Europe is 6.6 per 100 000 people. The increasing number and costs of these complex patients make present health organisations largely insufficient to face their needs. As a consequence, their burden lays mostly over families. The need to reduce healthcare costs and to increase safety has prompted the development of tele-monitoring for home ventilatory assistance.A European Respiratory Society Task Force produced a literature research based statement on commonly accepted clinical criteria for indications, follow-up, equipment, facilities, legal and economic issues of tele-monitoring of these patients.Many remote health monitoring systems are available, ensuring safety, feasibility, effectiveness, sustainability and flexibility to face different patients' needs. The legal problems associated with tele-monitoring are still controversial. National and European Union (EU) governments should develop guidelines and ethical, legal, regulatory, technical, administrative standards for remote medicine. The economic advantages, if any, of this new approach must be compared to a "gold standard" of home care that is very variable among different European countries and within each European country.Much more research is needed before considering tele-monitoring a real improvement in the management of these patients. Copyright ©ERS 2016.

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.

Methods for accurate cold-chain temperature monitoring using digital data-logger thermometers

NASA Astrophysics Data System (ADS)

Chojnacky, M. J.; Miller, W. M.; Strouse, G. F.

2013-09-01

Complete and accurate records of vaccine temperature history are vital to preserving drug potency and patient safety. However, previously published vaccine storage and handling guidelines have failed to indicate a need for continuous temperature monitoring in vaccine storage refrigerators. We evaluated the performance of seven digital data logger models as candidates for continuous temperature monitoring of refrigerated vaccines, based on the following criteria: out-of-box performance and compliance with manufacturer accuracy specifications over the range of use; measurement stability over extended, continuous use; proper setup in a vaccine storage refrigerator so that measurements reflect liquid vaccine temperatures; and practical methods for end-user validation and establishing metrological traceability. Data loggers were tested using ice melting point checks and by comparison to calibrated thermocouples to characterize performance over 0 °C to 10 °C. We also monitored logger performance in a study designed to replicate the range of vaccine storage and environmental conditions encountered at provider offices. Based on the results of this study, the Centers for Disease Control released new guidelines on proper methods for storage, handling, and temperature monitoring of vaccines for participants in its federally-funded Vaccines for Children Program. Improved temperature monitoring practices will ultimately decrease waste from damaged vaccines, improve consumer confidence, and increase effective inoculation rates.

Balancing vancomycin efficacy and nephrotoxicity: should we be aiming for trough or AUC/MIC?

PubMed

Patel, Karisma; Crumby, Ashley S; Maples, Holly D

2015-04-01

Sixty years later, the question that still remains is how to appropriately utilize vancomycin in the pediatric population. The Infectious Diseases Society of America published guidelines in 2011 that provide guidance for dosing and monitoring of vancomycin in adults and pediatrics. However, goal vancomycin trough concentrations of 15-20 μg/mL for invasive infections caused by methicillin-resistant Staphylococcus aureus were based primarily on adult pharmacokinetic and pharmacodynamic data that achieved an area under the curve to minimum inhibitory concentration ratio (AUC/MIC) of ≥400. Recent pediatric literature shows that vancomycin trough concentrations needed to achieve the target AUC/MIC are different than the adult goal troughs cited in the guidelines. This paper addresses several thoughts, including the role of vancomycin AUC/MIC in dosing strategies and safety monitoring, consistency in laboratory reporting, and future directions for calculating AUC/MIC in pediatrics.

Documentation forms for monitoring occupational surveillance of healthcare workers who handle cytotoxic drugs.

PubMed

Parillo, V L

1994-01-01

To develop a procedure for medical surveillance of healthcare workers who handle cytotoxic drugs. Literature review and guidelines published by the Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health. INFORMATION SELECTION: Studies of possible exposure screening tests, congenital defects in offspring, and case studies. Some degree of risk exists in handling cytotoxic drugs, but no reliable screening test for cytotoxic drug exposure has been developed. Reproductive hazards are possible when protective equipment is not used. Areas to be addressed when devising surveillance procedures include who to cover, what baseline data to gather, what periodic monitoring will be necessary (and at what interval it will be conducted), how to handle exposure incidents, and what documentation system will be used. A procedure using a baseline risk factor form and a yearly monitoring questionnaire was devised and implemented. Forms contain documentation of worker teaching. Most often, nurses are the healthcare workers who handle cytotoxic drugs. A consistent approach to monitoring healthcare workers is facilitated by using a defined procedure and standardized forms.

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 and efficacy of blood glucose management practices at a diabetes camp.

PubMed

Gunasekera, Hasantha; Ambler, Geoffrey

2006-10-01

Camps are an important part of diabetic management in children yet data on the safety and efficacy of camps are limited. We assessed the safety and efficacy of blood glucose management guidelines at summer camps for diabetic children. Consistent management guidelines were implemented during 10 consecutive diabetes camps held in the same facility between 1998 and 2002. Using the entire sample of campers aged 9-13 years, we analysed insulin dosage alterations, the frequency of hypoglycaemia (<4 mmol/L), hyperglycaemia (>15 mmol/L) and ketosis and evaluated our overnight management guidelines. The effects of sex, year, age, insulin regimen and duration of diagnosis on hypoglycaemia frequency were determined. Mean insulin doses decreased 19.2% (95% confidence interval 16.9-21.6%) by the last day of camp (day 6) relative to the day prior to camp. Mean blood glucose levels were 11.4 mmol/L before breakfast and the main evening meal, 11.3 mmol/L before bed, 10.8 mmol/L at midnight and 9.4 mmol/L at 3 am. Of the 10 839 readings analysed, 984 (9.1%) were below 4 mmol/L (0.5 per camper/day) with no clinical grade 3 (seizure or coma) hypoglycaemia. Hypoglycaemia frequency was independent of sex, year, age, insulin regimen and duration of diagnosis (all P > 0.05). There were 2570 (23.7%) readings above 15 mmol/L (1.4 per camper/day) but only 42 (0.4%) were associated with significant ketosis. Children at diabetes camps experience considerable blood glucose variability; however, the careful application of monitoring and management guidelines can avoid serious adverse events.

The fetal heart rate collaborative practice project: situational awareness in electronic fetal monitoring-a Kaiser Permanente Perinatal Patient Safety Program Initiative.

PubMed

MacEachin, S Rachel; Lopez, Connie M; Powell, Kimberly J; Corbett, Nancy L

2009-01-01

Electronic fetal monitoring has historically been interpreted with wide variation between and within disciplines on the obstetric healthcare team. This leads to inconsistent decision making in response to tracing interpretation. To implement a multidisciplinary electronic fetal monitoring training program, utilizing the best evidence available, enabling standardization of fetal heart rate interpretation to promote patient safety. Local multidisciplinary expertise along with an outside consultant collaborated over a series of meetings to create a multimedia instructional electronic fetal monitoring training program. After production was complete, a series of conferences attended by nurses, certified nurse midwives, and physician champions, from each hospital, attended to learn how to facilitate training at their own perinatal units. All healthcare personnel across the Kaiser Permanente perinatal program were trained in NICHD nomenclature, emergency response, interpretation guidelines, and how to create local collaborative practice agreements. Metrics for program effectiveness were measured through program evaluations from attendees, the Safety Attitudes Questionnaire. Program evaluations rendered very positive scores from both physicians and clinicians. Comparing baseline to 4 years later, the perception of safety from the staff has increased over 10% in 5 out of the 6 factors analyzed. Active participation from all disciplines in this training series has highlighted the importance of teamwork and communication. The Fetal Heart Rate Collaborative Practice Project continues to evolve utilizing other educational modalities, such as online EFM education and unit-based interdisciplinary tracing reviews.

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 ...

Standardizing care and monitoring for anesthesia or procedural sedation delivered outside the operating room.

PubMed

Eichhorn, Volker; Henzler, Dietrich; Murphy, Michael F

2010-08-01

The purpose of this review is to summarize recommendations for the safe and efficient conductance of sedation and anesthesia at remote locations; and to define safety standards, monitoring techniques, quality of care and procedural eligibility. Anesthesia outside of the operating room is rapidly increasing in numbers, which has seen a growth of older and sicker patients. These circumstances have created a need for guidelines, for both specialist anesthesia providers and nonanesthesia-trained practitioners, that define patient selection, minimum monitoring (hemodynamics and respiration), facility design and equipment, policy framework, recovery facilities and policies. The patient's safety throughout all stages of sedation and/or anesthesia is the most pertinent goal. Recent data emphasize the importance of monitoring pulse oximetry and end-tidal carbon dioxide for any sedating or anesthetic procedure. Substandard monitoring combined with oversedation and subsequent respiratory depression are implicated as the main reasons for catastrophic sedation and anesthetic outcomes at remote locations. Patient selection, procedure appropriateness and location appropriateness are the key elements defining the provision of safe anesthesia care outside the operating room. Titratable, short-acting intravenous drugs are preferred such as propofol and remifentanil.

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.

Neuro-oncology update: radiation safety and nursing care during interstitial brachytherapy

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

Randall, T.M.; Drake, D.K.; Sewchand, W.

Radiation control and safety are major considerations for nursing personnel during the care of patients receiving brachytherapy. Since the theory and practice of radiation applications are not part of the routine curriculum of nursing programs, the education of nurses and other health care professionals in radiation safety procedures is important. Regulatory agencies recommend that an annual safety course be given to all persons frequenting, using, or associated with patients containing radioactive materials. This article presents pertinent aspects of the principles and procedures of radiation safety, the role of personnel dose-monitoring devices, and the value of additional radiation control features, suchmore » as a lead cubicle, during interstitial brain implants. One institution's protocol and procedures for the care of high-intensity iridium-192 brain implants are discussed. Preoperative teaching guidelines and nursing interventions included in the protocol focus on radiation control principles.« less

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.

Latin American and Caribbean countries' baseline clinical and policy guidelines for responding to intimate partner violence and sexual violence against women.

PubMed

Stewart, Donna E; Aviles, Raquel; Guedes, Alessandra; Riazantseva, Ekaterina; MacMillan, Harriet

2015-07-15

Violence against women is a global public health problem with negative effects on physical, mental, and reproductive health. The World Health Organization (WHO) has identified intimate partner violence (IPV) and sexual violence (SV) as major targets for prevention and amelioration and recently developed clinical and policy guidelines to assist healthcare providers. This project was undertaken to determine the 2013 baseline national policies and clinical guidelines on IPV and SV within the Latin American and Caribbean (LAC) region to identify strengths and gaps requiring action. Each Pan American Health Organization/World Health Organization Regional Office for the Americas (PAHO/WHO) country focal point was contacted to request their current national policy and clinical guidelines (protocol) on IPV/SV. We augmented this by searching the internet and the United Nations Women website. Each country's policy and clinical guideline (where available) was reviewed and entered into a scoring matrix based on WHO Clinical and Policy Guidelines. A total score for each heading and subheading was developed by adding positive responses to identify LAC regional strengths and gaps. We obtained 15 national policies and 12 national clinical guidelines (protocols) from a total of 18 countries ("response" rate 66.7%). National policies were comprehensive in terms of physical, emotional, and sexual violence and recommended good intersectoral collaboration. The greatest gap was in the training of health-care providers. National Guidelines for women-centered care for IPV/SV survivors were strong in the vital areas of privacy, confidentiality, danger assessment, safety planning, and supportive reactions to disclosure. The largest gaps noted were again in training healthcare professionals and strengthening monitoring and evaluation of services. Baseline measurement of policy and clinical guidelines for IPV/SV in LAC PAHO/WHO member countries at the time of issuing the 2013 WHO Clinical and Policy Guidelines reveals some important strengths, but also serious gaps that need to be addressed. The most pressing needs are for concerted training initiatives for healthcare providers and strengthening multisectoral monitoring and evaluation of services. A future evaluation of national policies, clinical guidelines, monitoring and evaluation will need to be conducted to measure the progress of the required scaling-up process.

[General Strategies for Implementation of Clinical Practice Guidelines].

PubMed

Valenzuela-Flores, Adriana Abigail; Viniegra-Osorio, Arturo; Torres-Arreola, Laura Laura

2015-01-01

The need to use clinical practice guidelines (CPG) arises from the health conditions and problems that public health institutions in the country face. CPG are informative documents that help improve the quality of care processes and patient safety; having among its objectives, to reduce the variability of medical practice. The Instituto Mexicano del Seguro Social designed a strategic plan for the dissemination, implementation, monitoring and control of CPG to establish an applicable model in the medical units in the three levels of care at the Instituto. This paper summarizes some of the strategies of the plan that were made with the knowledge and experience of clinicians and managers, with which they intend to promote the adoption of the key recommendations of the guidelines, to promote a sense of belonging for health personnel, and to encourage changes in organizational culture.

Hydroxyurea for the Treatment of Sickle Cell Disease: Efficacy, Barriers, Toxicity, and Management in Children

PubMed Central

Strouse, John J.; Heeney, Matthew M.

2012-01-01

Hydroxyurea is the only approved medication in the United States for the treatment of sickle cell anemia (HbSS) and is widely used in children despite an indication limited to adults. We review the evidence of efficacy and safety in children with reference to pivotal adult studies. This evidence and expert opinion form the basis for recommended guidelines for the use of hydroxyurea in children including indications, dosing, therapeutic and safety monitoring, and interventions to improve adherence. However, there are substantial gaps in our knowledge to be addressed by on-going and planned studies in children. PMID:22517797

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.

Implementation of Water Safety Plans (WSPs): A Case Study in the Coastal Area in Semarang City, Indonesia

NASA Astrophysics Data System (ADS)

Budiyono; Ginandjar, P.; Saraswati, L. D.; Pangestuti, D. R.; Martini; Jati, S. P.

2018-02-01

An area of 508.28 hectares in North Semarang is flooded by tidal inundation, including Bandarharjo village, which could affect water quality in the area. People in Bandarharjo use safe water from deep groundwater, without disinfection process. More than 90% of water samples in the Bandaharjo village had poor bacteriological quality. The aimed of the research was to describe the implementation of Water Safety Plans (WSPs) program in Bandarharjo village. This was a descriptive study with steps for implementations adopted the guidelines and tools of the World Health Organization. The steps consist of introducing WSPs program, team building, training the team, examination of water safety before risk assessment, risk assessment, minor repair I, examination of water safety risk, minor repair II (after monitoring). Data were analyzed using descriptive methods. WSPs program has been introduced and formed WSPs team, and the training of the team has been conducted. The team was able to conduct risks assessment, planned the activities, examined water quality, conduct minor repair and monitoring at the source, distribution, and households connection. The WSPs program could be implemented in the coastal area in Semarang, however regularly supervision and some adjustment are needed.

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

Methodology for clinical trials involving patients with cancer who have febrile neutropenia: updated guidelines of the Immunocompromised Host Society/Multinational Association for Supportive Care in Cancer, with emphasis on outpatient studies.

PubMed

Feld, Ronald; Paesmans, Marianne; Freifeld, Alison G; Klastersky, Jean; Pizzo, Philip A; Rolston, Kenneth V I; Rubenstein, Edward; Talcott, James A; Walsh, Thomas J

2002-12-15

Two multinational organizations, the Immunocompromised Host Society and the Multinational Association for Supportive Care in Cancer, have produced for investigators and regulatory bodies a set of guidelines on methodology for clinical trials involving patients with febrile neutropenia. The guidelines suggest that response (i.e., success of initial empirical antibiotic therapy without any modification) be determined at 72 h and again on day 5, and the reasons for modification should be stated. Blinding and stratification are to be encouraged, as should statistical consideration of trials specifically designed for showing equivalence. Patients enrolled in outpatient studies should be selected by use of a validated risk model, and patients should be carefully monitored after discharge from the hospital. Response and safety parameters should be recorded along with readmission rates. If studies use these guidelines, comparisons between studies will be simpler and will lead to further improvements in patient therapy.

Canadian Association of Gastroenterology consensus guidelines on safety and quality indicators in endoscopy

PubMed Central

Armstrong, David; Barkun, Alan; Bridges, Ron; Carter, Rose; de Gara, Chris; Dubé, Catherine; Enns, Robert; Hollingworth, Roger; MacIntosh, Donald; Borgaonkar, Mark; Forget, Sylviane; Leontiadis, Grigorios; Meddings, Jonathan; Cotton, Peter; Kuipers, Ernst J; Valori, Roland

2012-01-01

BACKGROUND: Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and increasing emphasis on health care quality, highlight the need for clearly defined, evidence-based processes to support quality improvement in endoscopy. OBJECTIVE: To identify processes and indicators of quality and safety relevant to high-quality endoscopy service delivery. METHODS: A multidisciplinary group of 35 voting participants developed recommendation statements and performance indicators. Systematic literature searches generated 50 initial statements that were revised iteratively following a modified Delphi approach using a web-based evaluation and voting tool. Statement development and evidence evaluation followed the AGREE (Appraisal of Guidelines, REsearch and Evaluation) and GRADE (Grading of Recommendations, Assessment, Development and Evaluation) guidelines. At the consensus conference, participants voted anonymously on all statements using a 6-point scale. Subsequent web-based voting evaluated recommendations for specific, individual quality indicators, safety indicators and mandatory endoscopy reporting fields. Consensus was defined a priori as agreement by 80% of participants. RESULTS: Consensus was reached on 23 recommendation statements addressing the following: ethics (statement 1: agreement 100%), facility standards and policies (statements 2 to 9: 90% to 100%), quality assurance (statements 10 to 13: 94% to 100%), training, education, competency and privileges (statements 14 to 19: 97% to 100%), endoscopy reporting standards (statements 20 and 21: 97% to 100%) and patient perceptions (statements 22 and 23: 100%). Additionally, 18 quality indicators (agreement 83% to 100%), 20 safety indicators (agreement 77% to 100%) and 23 recommended endoscopy-reporting elements (agreement 91% to 100%) were identified. DISCUSSION: The consensus process identified a clear need for high-quality clinical and outcomes research to support quality improvement in the delivery of endoscopy services. CONCLUSIONS: The guidelines support quality improvement in endoscopy by providing explicit recommendations on systematic monitoring, assessment and modification of endoscopy service delivery to yield benefits for all patients affected by the practice of gastrointestinal endoscopy. PMID:22308578

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…

Flight-deck automation - Promises and problems

NASA Technical Reports Server (NTRS)

Wiener, E. L.; Curry, R. E.

1980-01-01

The paper analyzes the role of human factors in flight-deck automation, identifies problem areas, and suggests design guidelines. Flight-deck automation using microprocessor technology and display systems improves performance and safety while leading to a decrease in size, cost, and power consumption. On the other hand negative factors such as failure of automatic equipment, automation-induced error compounded by crew error, crew error in equipment set-up, failure to heed automatic alarms, and loss of proficiency must also be taken into account. Among the problem areas discussed are automation of control tasks, monitoring of complex systems, psychosocial aspects of automation, and alerting and warning systems. Guidelines are suggested for designing, utilising, and improving control and monitoring systems. Investigation into flight-deck automation systems is important as the knowledge gained can be applied to other systems such as air traffic control and nuclear power generation, but the many problems encountered with automated systems need to be analyzed and overcome in future research.

To What Extent is Drinking Water Tested in Sub-Saharan Africa? A Comparative Analysis of Regulated Water Quality Monitoring.

PubMed

Peletz, Rachel; Kumpel, Emily; Bonham, Mateyo; Rahman, Zarah; Khush, Ranjiv

2016-03-02

Water quality information is important for guiding water safety management and preventing water-related diseases. To assess the current status of regulated water quality monitoring in sub-Saharan Africa, we evaluated testing programs for fecal contamination in 72 institutions (water suppliers and public health agencies) across 10 countries. Data were collected through written surveys, in-person interviews, and analysis of microbial water quality testing levels. Though most institutions did not achieve the testing levels specified by applicable standards or World Health Organization (WHO) Guidelines, 85% of institutions had conducted some microbial water testing in the previous year. Institutions were more likely to meet testing targets if they were suppliers (as compared to surveillance agencies), served larger populations, operated in urban settings, and had higher water quality budgets (all p < 0.05). Our results indicate that smaller water providers and rural public health offices will require greater attention and additional resources to achieve regulatory compliance for water quality monitoring in sub-Saharan Africa. The cost-effectiveness of water quality monitoring should be improved by the application of risk-based water management approaches. Efforts to strengthen monitoring capacity should pay greater attention to program sustainability and institutional commitment to water safety.

To What Extent is Drinking Water Tested in Sub-Saharan Africa? A Comparative Analysis of Regulated Water Quality Monitoring

PubMed Central

Peletz, Rachel; Kumpel, Emily; Bonham, Mateyo; Rahman, Zarah; Khush, Ranjiv

2016-01-01

Water quality information is important for guiding water safety management and preventing water-related diseases. To assess the current status of regulated water quality monitoring in sub-Saharan Africa, we evaluated testing programs for fecal contamination in 72 institutions (water suppliers and public health agencies) across 10 countries. Data were collected through written surveys, in-person interviews, and analysis of microbial water quality testing levels. Though most institutions did not achieve the testing levels specified by applicable standards or World Health Organization (WHO) Guidelines, 85% of institutions had conducted some microbial water testing in the previous year. Institutions were more likely to meet testing targets if they were suppliers (as compared to surveillance agencies), served larger populations, operated in urban settings, and had higher water quality budgets (all p < 0.05). Our results indicate that smaller water providers and rural public health offices will require greater attention and additional resources to achieve regulatory compliance for water quality monitoring in sub-Saharan Africa. The cost-effectiveness of water quality monitoring should be improved by the application of risk-based water management approaches. Efforts to strengthen monitoring capacity should pay greater attention to program sustainability and institutional commitment to water safety. PMID:26950135

Canadian guideline for safe and effective use of opioids for chronic noncancer pain

PubMed Central

Kahan, Meldon; Mailis-Gagnon, Angela; Wilson, Lynn; Srivastava, Anita

2011-01-01

Abstract Objective To provide family physicians with a practical clinical summary of the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, developed by the National Opioid Use Guideline Group. Quality of evidence Researchers for the guideline conducted a systematic review of the literature on the effectiveness and safety of opioids for chronic noncancer pain, and drafted a series of recommendations. A panel of 49 clinicians from across Canada reviewed the draft and achieved consensus on 24 recommendations. Main message Screening for addiction risk is recommended before prescribing opioids. Weak opioids (codeine and tramadol) are recommended for mild to moderate pain that has not responded to first-line treatments. Oxycodone, hydromorphone, and morphine can be tried in patients who have not responded to weaker opioids. A low initial dose and slow upward titration is recommended, with patient education and close monitoring. Physicians should watch for the development of complications such as sleep apnea. The optimal dose is one which improves function or decreases pain ratings by at least 30%. For by far most patients, the optimal dose will be well below a 200-mg morphine equivalent dose per day. Tapering is recommended for patients who have not responded to an adequate opioid trial. Conclusion Opioids play an important role in the management of chronic noncancer pain, but careful prescribing is needed to limit potential harms. The new Canadian guideline provides much-needed guidance to help physicians achieve a balance between optimal pain control and safety. PMID:22084455

Canadian guideline for safe and effective use of opioids for chronic noncancer pain: clinical summary for family physicians. Part 1: general population.

PubMed

Kahan, Meldon; Mailis-Gagnon, Angela; Wilson, Lynn; Srivastava, Anita

2011-11-01

To provide family physicians with a practical clinical summary of the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, developed by the National Opioid Use Guideline Group. Researchers for the guideline conducted a systematic review of the literature on the effectiveness and safety of opioids for chronic noncancer pain, and drafted a series of recommendations. A panel of 49 clinicians from across Canada reviewed the draft and achieved consensus on 24 recommendations. Screening for addiction risk is recommended before prescribing opioids. Weak opioids (codeine and tramadol) are recommended for mild to moderate pain that has not responded to first-line treatments. Oxycodone, hydromorphone, and morphine can be tried in patients who have not responded to weaker opioids. A low initial dose and slow upward titration is recommended, with patient education and close monitoring. Physicians should watch for the development of complications such as sleep apnea. The optimal dose is one which improves function or decreases pain ratings by at least 30%. For by far most patients, the optimal dose will be well below a 200-mg morphine equivalent dose per day. Tapering is recommended for patients who have not responded to an adequate opioid trial. Opioids play an important role in the management of chronic noncancer pain, but careful prescribing is needed to limit potential harms. The new Canadian guideline provides much-needed guidance to help physicians achieve a balance between optimal pain control and safety.

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 ...

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.

Suicide Prevention Guideline Implementation in Specialist Mental Healthcare Institutions in The Netherlands.

PubMed

Mokkenstorm, Jan; Franx, Gerdien; Gilissen, Renske; Kerkhof, Ad; Smit, Johannes Hendrikus

2018-05-03

In The Netherlands, on average 40% of all suicides concern patients treated by mental healthcare institutions (MHIs). Recent evidence indicates that implemented guideline recommendations significantly reduce the odds for patients to die by suicide. Implementation of the multidisciplinary guideline for diagnosis and treatment of suicidal behaviors is a main objective of the Dutch National Suicide Prevention Strategy. To this end, 24 MHIs that collectively reported 73% of patient suicides in 2015 received an educational outreach intervention offered by the national center of expertise. To investigate changes in levels of implementation of guideline recommendations; and to assess the degree of variation on suicide prevention policies and practices between MHIs. Implementation study with a prospective cohort design studying change over time on all domains of a Suicide Prevention Monitor, a guideline-based instrument assessing suicide prevention policies and practices within MHIs. Data were collected in six-month intervals between 2015 and 2017. MHIs improved significantly on four out of ten domains: the development of an organizational suicide prevention policy; monitoring and trend-analysis of suicides numbers; evaluations after suicide; and clinician training. No improvement was measured on the domains pertaining to multi-annual training policies; collaborative care with external partners; recording and evaluation of suicide attempts; routine assessment of suicidality in all patients; safety planning and involving next of kin and carers. Furthermore, marked practice variation between MHIs was found which did not decrease over time. This study shows significant improvement in the implementation of four out of ten guideline-based suicide prevention policies in 24 specialist mental healthcare institutions in The Netherlands. The implementation level of suicide prevention policies and practices still appears to vary significantly between MHIs in The Netherlands.

Suicide Prevention Guideline Implementation in Specialist Mental Healthcare Institutions in The Netherlands

PubMed Central

Franx, Gerdien; Gilissen, Renske; Kerkhof, Ad; Smit, Johannes Hendrikus

2018-01-01

In The Netherlands, on average 40% of all suicides concern patients treated by mental healthcare institutions (MHIs). Recent evidence indicates that implemented guideline recommendations significantly reduce the odds for patients to die by suicide. Implementation of the multidisciplinary guideline for diagnosis and treatment of suicidal behaviors is a main objective of the Dutch National Suicide Prevention Strategy. To this end, 24 MHIs that collectively reported 73% of patient suicides in 2015 received an educational outreach intervention offered by the national center of expertise. Aim: To investigate changes in levels of implementation of guideline recommendations; and to assess the degree of variation on suicide prevention policies and practices between MHIs. Methods: Implementation study with a prospective cohort design studying change over time on all domains of a Suicide Prevention Monitor, a guideline-based instrument assessing suicide prevention policies and practices within MHIs. Data were collected in six-month intervals between 2015 and 2017. Results: MHIs improved significantly on four out of ten domains: the development of an organizational suicide prevention policy; monitoring and trend-analysis of suicides numbers; evaluations after suicide; and clinician training. No improvement was measured on the domains pertaining to multi-annual training policies; collaborative care with external partners; recording and evaluation of suicide attempts; routine assessment of suicidality in all patients; safety planning and involving next of kin and carers. Furthermore, marked practice variation between MHIs was found which did not decrease over time. Conclusion: This study shows significant improvement in the implementation of four out of ten guideline-based suicide prevention policies in 24 specialist mental healthcare institutions in The Netherlands. The implementation level of suicide prevention policies and practices still appears to vary significantly between MHIs in The Netherlands. PMID:29751572

Patient safety in primary care: a survey of general practitioners in The Netherlands.

PubMed

Gaal, Sander; Verstappen, Wim; Wensing, Michel

2010-01-21

Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs) on patient safety were examined. A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. A total of 68 GPs responded (51.5% response rate). None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy makers.

Ketamine for pain management in France, an observational survey.

PubMed

Martinez, Valeria; Derivaux, Benoit; Beloeil, Helene

2015-12-01

Before updating the French guidelines on postoperative pain treatment in 2015, the Pain Committee of the French Society of Anaesthesiology and Intensive Care (SFAR) conducted a survey on the medical use of ketamine in France. An online questionnaire was nationally distributed to members of SFAR, the French Pain Society (SFETD) and the French Society of Emergency Medicine (SFMU). The questionnaire included questions on demographic data, the type of patients for whom ketamine was prescribed, the doses used, the side effects and safety measures associated with the administration of ketamine. A total of 1388 questionnaires were analysed. Ninety-two percent of the responders declared that they used ketamine. Ketamine was widely used as anti-hyperalgesic medication but the modalities of administration and the doses varied greatly and were not in accordance with the guidelines. Despite the lack of evidence and guidelines, ketamine has also been used to treat acute and chronic pain. Doses, duration and localization of the patients during administration have varied greatly. Psychedelic effects and hallucinations are the most feared side effects. In terms of monitoring during ketamine infusion, 15% of physicians declared that no monitoring was necessary while 59%, 55%, 59% and 77% monitored heart rate, SpO2, blood pressure and level of consciousness, respectively. Anaesthesiologists have integrated the benefit of ketamine in preventing hyperalgesia but there is no consensus on doses and duration. For other indications (acute and chronic pain treatment), toxicity and the absence of significant benefit call for guidelines from scientific societies. Copyright © 2015 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns.

PubMed

Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

2017-04-01

Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www.clinicaltrials.gov " and scholar.google, using combination search terms 'pre-exposure prophylaxis', 'safety concerns in the use of pre-exposure prophylaxis', 'truvada use as PrEP', 'guidelines for PrEP use', 'HIV pre-exposure prophylaxis' and 'tenofovir' to identify clinical trials and literature on PrEP. We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was tenofovir disoproxil fumarate/emtricitabine in a combined form as Truvada ® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits observed in clinical trials are maintained in real-world use.

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.

Safety of pandemic H1N1 vaccines in children and adolescents.

PubMed

Wijnans, Leonoor; de Bie, Sandra; Dieleman, Jeanne; Bonhoeffer, Jan; Sturkenboom, Miriam

2011-10-06

During the 2009 influenza A (H1N1) pandemic several pandemic H1N1 vaccines were licensed using fast track procedures, with relatively limited data on the safety in children and adolescents. Different extensive safety monitoring efforts were put in place to ensure timely detection of adverse events following immunization. These combined efforts have generated large amounts of data on the safety of the different pandemic H1N1 vaccines, also in children and adolescents. In this overview we shortly summarize the safety experience with seasonal influenza vaccines as a background and focus on the clinical and post marketing safety data of the pandemic H1N1 vaccines in children. We identified 25 different clinical studies including 10,505 children and adolescents, both healthy and with underlying medical conditions, between the ages of 6 months and 23 years. In addition, large monitoring efforts have resulted in large amounts of data, with almost 13,000 individual case reports in children and adolescents to the WHO. However, the diversity in methods and data presentation in clinical study publications and publications of spontaneous reports hampered the analysis of safety of the different vaccines. As a result, relatively little has been learned on the comparative safety of these pandemic H1N1 vaccines - particularly in children. It should be a collective effort to give added value to the enormous work going into the individual studies by adhering to available guidelines for the collection, analysis, and presentation of vaccine safety data in clinical studies and to guidance for the clinical investigation of medicinal products in the pediatric population. Importantly the pandemic has brought us the beginning of an infrastructure for collaborative vaccine safety studies in the EU, USA and globally. Copyright © 2011 Elsevier Ltd. All rights reserved.

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…

Biomedical surveillance: rights conflict with rights.

PubMed

Atherley, G; Johnston, N; Tennassee, M

1986-10-01

Medical screening and biomedical monitoring violate individual rights. Such conflicts of right with right are acted upon synergistically by uncertainty which, in some important respects, increases rather than decreases as a result of research. Issues of rightness and wrongness, ethical issues, arise because the human beings who are subjects of medical screening and biological monitoring often have little or no option whether to be subjected to them. We identify issues of rightness and wrongness of biomedical surveillance for various purposes of occupational health and safety. We distinguish between social validity and scientific validity. We observe that principles are well established for scientific validity, but not for social validity. We support guidelines as a way forward.

Management plan for White Oak Dam. Revision 1

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

Ahmed, S.B.

1997-03-01

The purpose is to provide operation and maintenance, periodic inspection, and emergency action plans for White Oak Dam in general accordance with the Federal Emergency Management Agency (FEMA) guidelines for dam safety. It must be understood that operations at the site are primarily for purposes of environmental monitoring, environmental protection and waste management operations control. Effluent is generally allowed to flow from the lake at its natural rate by rising above the broad crested weir notch elevation of 744 feet m.s.l.

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.

[Consensus Document on post-exposure prophylaxis against HIV, HBV and HCV in adults and children].

PubMed

2016-02-01

This consensus document is an update of occupational and non-occupational prophylaxis guidelines in HIV-patients, promoting appropriate use of them, from the standpoint of care. This document has been approved by expert panel of SPNS, GESIDA, SEMST and different scientific societies related, after reviewing the results of efficacy and safety clinical trials, cohort and pharmacokinetic studies published in biomedical journals (PubMed and Embase) or presented at conferences and different guidelines. The strength of the recommendation and gradation of their evidence are based on the GRADE system. We have developed recommendations for assessing the risk of transmission in different types of exposure situations in which post-exposure prophylaxis should be recommended, special circumstances to consider, patterns of antiretroviral with the start and duration of early monitoring of tolerance and adherence to treatment, the subsequent monitoring of exposed persons regardless of whether they received post-exposure prophylaxis or not, and the need of psychological support. These new guidelines updated previous recommendations regarding occupational post-exposure prophylaxis and non-occupational, in adults and children. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

TDM in psychiatry and neurology: A comprehensive summary of the consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology, update 2017; a tool for clinicians^.

PubMed

Schoretsanitis, Georgios; Paulzen, Michael; Unterecker, Stefan; Schwarz, Markus; Conca, Andreas; Zernig, Gerald; Gründer, Gerhard; Haen, Ekkerhard; Baumann, Pierre; Bergemann, Niels; Clement, Hans Willi; Domschke, Katharina; Eckermann, Gabriel; Egberts, Karin; Gerlach, Manfred; Greiner, Christine; Havemann-Reinecke, Ursula; Hefner, Gudrun; Helmer, Renate; Janssen, Ger; Jaquenoud-Sirot, Eveline; Laux, Gerd; Messer, Thomas; Mössner, Rainald; Müller, Matthias J; Pfuhlmann, Bruno; Riederer, Peter; Saria, Alois; Schoppek, Bernd; Silva Gracia, Margarete; Stegmann, Benedikt; Steimer, Werner; Stingl, Julia C; Uhr, Manfred; Ulrich, Sven; Waschgler, Roland; Zurek, Gabriela; Hiemke, Christoph

2018-04-01

Therapeutic drug monitoring (TDM) combines the quantification of drug concentrations in blood, pharmacological interpretation and treatment guidance. TDM introduces a precision medicine tool in times of increasing awareness of the need for personalized treatment. In neurology and psychiatry, TDM can guide pharmacotherapy for patient subgroups such as children, adolescents, pregnant women, elderly patients, patients with intellectual disabilities, patients with substance use disorders, individuals with pharmacokinetic peculiarities and forensic patients. Clear indications for TDM include lack of clinical response in the therapeutic dose range, assessment of drug adherence, tolerability issues and drug-drug interactions. Based upon existing literature, recommended therapeutic reference ranges, laboratory alert levels, and levels of recommendation to use TDM for dosage optimization without specific indications, conversion factors, factors for calculation of dose-related drug concentrations and metabolite-to-parent ratios were calculated. This summary of the updated consensus guidelines by the TDM task force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie offers the practical and theoretical knowledge for the integration of TDM as part of pharmacotherapy with neuropsychiatric agents into clinical routine. The present guidelines for TDM application for neuropsychiatric agents aim to assist clinicians in enhancing safety and efficacy of treatment.

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

Suborbital Safety Technical Committee- Summary of Proposed Standards & Guidelines

NASA Astrophysics Data System (ADS)

Quinn, Andy; Atencia Yepez, Amaya; Klicker, Michael; Howard, Diane; Verstraeten, Joram; Other Suborbital Safety TC Members

2013-09-01

There are currently no international safety standards and guidelines to assist designers, operators and authorities in the suborbital domain. There is a launch licensing regime in the United States (US) to assist the forerunners of the suborbital domain however this does not provide a safety approval for the vehicle against set standards or does not have an acceptable level of safety to achieve in terms of design or operation. In Europe a certification framework may be implemented however this (or any regulatory framework) is not in place as yet. This paper summarises the 5 tasks thus far completed by the International Association for the Advancement of Space Safety (IAASS) Suborbital Safety Technical Committee (SS TC) in terms of deriving standards and guidelines for the suborbital domain. The SS TC comprises members from the suborbital industry (US and European vehicle designers), safety experts, legal experts, medical/training experts, prospective spaceport operators and members from the US and European authorities (though these members cannot directly steer the standards and guidelines - they can merely review them for interest and comment on non-policy aspects). The SS TC has been divided into three working groups (WG): Regulatory WG, Technical WG and Operations WG. The 5 tasks that are summarised in this paper include: Regulatory WG - (Task 1) Clarify and promote regulatory framework for suborbital flights (including discussions on Space Law 'v' Air Law for suborbital domain); Technical WG - (Task 1) Defining & Alignment (globally) of Safety Criteria for Suborbital domain using industry best practices, (Task 2) Software/complex hardware certification for suborbital flights; Operations WG - (Task 1) Flight Crew and Spaceflight Participant Medical and Training Standards & Guidelines for suborbital flight, (Task 2) Spaceport Safety Management System. This paper also details the next set of standards and guidelines that will be derived by the SS TC. The paper concludes that these and future IAASS suborbital safety standards and guidelines are needed now and should beconsidered by the industry players before the first commercial flights expected late 2013/early 2014.

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...

Medication and monitoring in palliative sedation therapy: a systematic review and quality assessment of published guidelines.

PubMed

Schildmann, Eva Katharina; Schildmann, Jan; Kiesewetter, Isabel

2015-04-01

Palliative sedation therapy (PST) is increasingly used in patients at the end of life. However, consensus about medications and monitoring is lacking. To assess published PST guidelines with regard to quality and recommendations on drugs and monitoring. We searched CINAHL, the Cochrane Library, Embase, PsycINFO, PubMed, and references of included articles until July 2014. Search terms included "palliative sedation" or "sedation" and "guideline" or "policy" or "framework." Guideline selection was based on English or German publications that included a PST guideline. Two investigators independently assessed the quality of the guidelines according to the Appraisal of Guidelines for Research and Evaluation II instrument (AGREE II) and extracted information on drug selection and monitoring. Nine guidelines were eligible. Eight guidelines received high quality scores for the domain "scope and purpose" (median 69%, range 28-83%), whereas in the other domains the guidelines' quality differed considerably. The majority of guidelines suggest midazolam as drug of first choice. Recommendations on dosage and alternatives vary. The guidelines' recommendations regarding monitoring of PST show wide variation in the number and details of outcome parameters and methods of assessment. The published guidelines on PST vary considerably regarding their quality and content on drugs and monitoring. Given the need for clear guidance regarding PST in patients at the end of life, this comparative analysis may serve as a starting point for further improvement. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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

Patient, Treatment, and Health Care Utilization Variables Associated with Adherence to Metabolic Monitoring Practices in Children and Adolescents Taking Second-Generation Antipsychotics.

PubMed

Coughlin, Mary; Goldie, Catherine Lindsay; Tranmer, Joan; Khalid-Khan, Sarosh; Tregunno, Deborah

2018-04-01

Children and adolescents with a range of psychiatric disorders are increasingly being prescribed atypical or second-generation antipsychotics (SGAs). While SGAs are effective at treating conduct and behavioural symptoms, they infer significant cardiometabolic risk. This study aims to explore what patient, treatment, and health care utilization variables are associated with adherence to Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children (CAMESA) metabolic monitoring guidelines. A retrospective chart review of 294 children and adolescents accessing a large outpatient psychiatry setting within a 2-year study period (2014-2016) was conducted. Baseline and follow-up metabolic monitoring, demographic, treatment, and health care utilization variables were then assessed over a 1-year period of interest. Metabolic monitoring practices did not adhere to CAMESA guidelines and were very poor over the 1-year observation period. There were significant differences between children (ages 4-12 years, n = 99) and adolescents (ages 13-18 years, n = 195). In adolescents, factors associated with any baseline metabolic monitoring were a higher number of psychiatry visits (odds ratio [OR], 1.2; 95% confidence interval [CI], 1.10 to 1.41), longer duration of contact (OR, 14; 95% CI, 2.31 to 82.4), and use of other non-SGA medications (OR, 3.2; 95% CI, 1.17 to 8.94). Among children, having an emergency room visit (OR, 3.4; 95% CI, 1.01 to 11.71) and taking aripiprazole (OR, 7.4; 95% CI, 2.02 to 27.45) increased the odds of receiving baseline metabolic monitoring. Findings from this study highlight the need for better metabolic monitoring for children and adolescents taking SGAs. Enhanced focus on opportunities for multidisciplinary collaboration is needed to improve the quality of care offered to this population.

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

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

Ryan, T.G.

1995-03-01

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

The use of a computerized database to monitor vaccine safety in Viet Nam.

PubMed Central

Ali, Mohammad; Canh, Gia Do; Clemens, John D.; Park, Jin-Kyung; von Seidlein, Lorenz; Minh, Tan Truong; Thiem, Dinh Vu; Tho, Huu Le; Trach, Duc Dang

2005-01-01

Health information systems to monitor vaccine safety are used in industrialized countries to detect adverse medical events related to vaccinations or to prove the safety of vaccines. There are no such information systems in the developing world, but they are urgently needed. A large linked database for the monitoring of vaccine-related adverse events has been established in Khanh Hoa province, Viet Nam. Data collected during the first 2 years of surveillance, a period which included a mass measles vaccination campaign, were used to evaluate the system. For this purpose the discharge diagnoses of individuals admitted to polyclinics and hospitals were coded according to the International Classification of Diseases (ICD)-10 guidelines and linked in a dynamic population database with vaccination histories. A case-series analysis was applied to the cohort of children vaccinated during the mass measles vaccination campaign. The study recorded 107,022 immunizations in a catchment area with a population of 357,458 and confirmed vaccine coverage of 87% or higher for completed routine childhood vaccinations. The measles vaccination campaign immunized at least 86% of the targeted children aged 9 months to 10 years. No medical event was detected significantly more frequently during the 14 days after measles vaccination than before it. The experience in Viet Nam confirmed the safety of a measles vaccination campaign and shows that it is feasible to establish health information systems such as a large linked database which can provide reliable data in a developing country for a modest increase in use of resources. PMID:16193545

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

Leaving patients to their own devices? Smart technology, safety and therapeutic relationships.

PubMed

Ho, Anita; Quick, Oliver

2018-03-06

This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety. Drawing on lessons learned from other direct-to-consumer health products such as genetic testing, this article explores how smart technology can also pose regulatory challenges and encourage overutilization of healthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, the technology and its utilization must be safe. This article argues for unified regulatory guidelines and better education for both healthcare providers and patients regarding the benefits and risks of these devices.

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...

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...

Hazards in the hospital.

PubMed

Seibert, P J

1994-02-01

In an earlier article (JAVMA, Jan 15, 1994), the author outlined some of the first steps necessary in establishing a hospital safety program that will comply with current Occupational Safety and Health Administration (OSHA) guidelines. One of the main concerns of the OSHA guidelines is that there be written plans for managing hazardous materials, performing dangerous jobs, and dealing with other potential safety problems. In this article, the author discusses potentially hazardous situations commonly found in veterinary practices and provides details on how to minimize the risks associated with those situations and how to implement safety procedures that will comply with the OSHA guidelines.

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.

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…

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…

Guidelines for personal exposure monitoring of chemicals: Part V.

PubMed

Hashimoto, Haruo; Yamada, Kenichi; Hori, Hajime; Kumagai, Shinji; Murata, Masaru; Nagoya, Toshio; Nakahara, Hirohiko; Mochida, Nobuyuki

2018-05-25

This Document, "Guidelines for personal exposure monitoring of chemicals" ("this Guideline"), has been prepared by "The Committee for Personal Exposure Monitoring" ("the Committee") of the Expert Division of Occupational Hygiene & Ergonomics, Japan Society for Occupational Health. Considering the background of the growing importance of personal exposure monitoring in risk assessment and the need to prepare for the introduction of monitoring using personal samplers from an administrative perspective in recent years, the Committee was organized in November 2012. The Committee has prepared this Guideline as a "practical guideline" for personal exposure monitoring, so as to offer proposals and recommendations to the members of the Japan Society for Occupational Health and to society in general. The scope of this Guideline covers all chemical substances and all related workplaces regarded as targets for general assessment and the management of risk. It thus is not to be considered to comment on legal regulations and methodology. The main text provides the basic methods and concepts of personal exposure monitoring, while 31 "Appendices" are provided in this Guideline throughout the series; technical descriptions, statistical bases, and actual workplace examples are provided in these appendices, to assist better understanding. The personal exposure monitoring described as per this Guideline is equivalent to an "expert-centered basic method to reasonably proceed with the assessment and management of risk at workplaces." It is considered that practicing and expanding on this method will significantly contribute in reforming the overall framework of occupational hygiene management in Japan.

Guidelines for personal exposure monitoring of chemicals: Part IV.

PubMed

Hashimoto, Haruo; Yamada, Kenichi; Hori, Hajime; Kumagai, Shinji; Murata, Masaru; Nagoya, Toshio; Nakahara, Hirohiko; Mochida, Nobuyuki

2018-03-27

This Document, "Guidelines for personal exposure monitoring of chemicals" ("this Guideline"), has been prepared by "The Committee for Personal Exposure Monitoring" ("the Committee") of the Expert Division of Occupational Hygiene & Ergonomics, Japan Society for Occupational Health. Considering the background of the growing importance of personal exposure monitoring in risk assessment and the need to prepare for the introduction of monitoring using personal samplers from an administrative perspective in recent years, the Committee was organized in November 2012. The Committee has prepared this Guideline as a "practical guideline" for personal exposure monitoring, so as to offer proposals and recommendations to the members of the Japan Society for Occupational Health and to society in general. The scope of this Guideline covers all chemical substances and all related workplaces regarded as targets for general assessment and the management of risk. It thus is not to be considered to comment on legal regulations and methodology. The main text provides the basic methods and concepts of personal exposure monitoring, while 31 "Appendices" are provided in this Guideline throughout the series; technical descriptions, statistical bases, and actual workplace examples are provided in these appendices, to assist better understanding. The personal exposure monitoring described as per this Guideline is equivalent to an "expert-centered basic method to reasonably proceed with the assessment and management of risk at workplaces." It is considered that practicing and expanding on this method will significantly contribute in reforming the overall framework of occupational hygiene management in Japan.

Guidelines for personal exposure monitoring of chemicals: Part III.

PubMed

Hashimoto, Haruo; Yamada, Kenichi; Hori, Hajime; Kumagai, Shinji; Murata, Masaru; Nagoya, Toshio; Nakahara, Hirohiko; Mochida, Nobuyuki

2018-01-25

This Document, "Guidelines for personal exposure monitoring of chemicals" ("this Guideline"), has been prepared by "The Committee for Personal Exposure Monitoring" ("the Committee") of the Expert Division of Occupational Hygiene & Ergonomics, Japan Society for Occupational Health. Considering the background of the growing importance of personal exposure monitoring in risk assessment and the need to prepare for the introduction of monitoring using personal samplers from an administrative perspective in recent years, the Committee was organized in November 2012. The Committee has prepared this Guideline as a "practical guideline" for personal exposure monitoring, so as to offer proposals and recommendations to the members of the Japan Society for Occupational Health and to society in general. The scope of this Guideline covers all chemical substances and all related workplaces regarded as targets for general assessment and the management of risk. It thus is not to be considered to comment on legal regulations and methodology. The main text provides the basic methods and concepts of personal exposure monitoring, while 31 "Appendices" are provided in this Guideline throughout the series; technical descriptions, statistical bases, and actual workplace examples are provided in these appendices, to assist better understanding. The personal exposure monitoring described as per this Guideline is equivalent to an "expert-centered basic method to reasonably proceed with the assessment and management of risk at workplaces." It is considered that practicing and expanding on this method will significantly contribute in reforming the overall framework of occupational hygiene management in Japan.

Guidelines for personal exposure monitoring of chemicals: Part I.

PubMed

Hashimoto, Haruo; Yamada, Kenichi; Hori, Hajime; Kumagai, Shinji; Murata, Masaru; Nagoya, Toshio; Nakahara, Hirohiko; Mochida, Nobuyuki

2017-09-28

This Document, "Guidelines for personal exposure monitoring of chemicals" ("this Guideline"), has been prepared by "The Committee for Personal Exposure Monitoring" ("the Committee") of the Expert Division of Occupational Hygiene & Ergonomics, Japan Society for Occupational Health. Considering the background of the growing importance of personal exposure monitoring in risk assessment and the need to prepare for the introduction of monitoring using personal samplers from an administrative perspective in recent years, the Committee was organized in November 2012. The Committee has prepared this Guideline as a "practical guideline" for personal exposure monitoring, so as to offer proposals and recommendations to the members of the Japan Society for Occupational Health and to society in general. The scope of this Guideline covers all chemical substances and all related workplaces regarded as targets for general assessment and the management of risk. It thus is not to be considered to comment on legal regulations and methodology. The main text provides the basic methods and concepts of personal exposure monitoring, while 31 "Appendices" are provided later in this Guideline throughout the series; technical descriptions, statistical bases, and actual workplace examples are provided in these appendices, to assist better understanding. The personal exposure monitoring described as per this Guideline is equivalent to an "expert-centered basic method to reasonably proceed with the assessment and management of risk at workplaces." It is considered that practicing and expanding on this method will significantly contribute in reforming the overall framework of occupational hygiene management in Japan.

Guidelines for personal exposure monitoring of chemicals: Part II.

PubMed

Hashimoto, Haruo; Yamada, Kenichi; Hori, Hajime; Kumagai, Shinji; Murata, Masaru; Nagoya, Toshio; Nakahara, Hirohiko; Mochida, Nobuyuki

2017-11-25

This Document, "Guidelines for personal exposure monitoring of chemicals" ("this Guideline"), has been prepared by "The Committee for Personal Exposure Monitoring" ("the Committee") of the Expert Division of Occupational Hygiene & Ergonomics, Japan Society for Occupational Health. Considering the background of the growing importance of personal exposure monitoring in risk assessment and the need to prepare for the introduction of monitoring using personal samplers from an administrative perspective in recent years, the Committee was organized in November 2012. The Committee has prepared this Guideline as a "practical guideline" for personal exposure monitoring, so as to offer proposals and recommendations to the members of the Japan Society for Occupational Health and to society in general. The scope of this Guideline covers all chemical substances and all related workplaces regarded as targets for general assessment and the management of risk. It thus is not to be considered to comment on legal regulations and methodology. The main text provides the basic methods and concepts of personal exposure monitoring, while 31 "Appendices" are provided in this Guideline throughout the series; technical descriptions, statistical bases, and actual workplace examples are provided in these appendices, to assist better understanding. The personal exposure monitoring described as per this Guideline is equivalent to an "expert-centered basic method to reasonably proceed with the assessment and management of risk at workplaces." It is considered that practicing and expanding on this method will significantly contribute in reforming the overall framework of occupational hygiene management in Japan.

Promoting safer blood transfusion practice in hospital.

PubMed

Parris, E; Grant-Casey, J

Results from a national comparative audit of bedside transfusion practice show that patients in the UK are at risk of misidentification and poor monitoring when undergoing a blood transfusion. A commonly identified reason for poor compliance with guidelines from the British Committee for Standards in Haematology (BCSH et al 1999) is a lack of awareness of good transfusion practice (National Blood Service (NBS) 2005). This article discusses the implications of the audit findings for the administration of blood at the bedside and examines initiatives to support hospital staff in their efforts to improve blood transfusion safety.

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 – ...

Recall of indoor tanning salon warnings and safety guidelines among a national sample of tanners.

PubMed

Day, Ashley K; Coups, Elliot J; Manne, Sharon L; Stapleton, Jerod L

2016-12-01

Indoor tanning (IT) is a known carcinogen, and regulation has increased across the USA. However, there is minimal point-of-sale regulation for adult users. The purpose of the present study is to explore whether IT users recall being provided with warnings or safety guidelines at tanning salons. A national sample of 273 young adult, female IT users (mean age = 22.26, SD = 2.38) was surveyed regarding the frequency that they recalled being provided with six different warnings and safety guidelines when at tanning salons. Between 65 and 90.1 % of participants reported recalling the various warnings and guidelines. Having very fair skin was reported by 16.8 % of participants, and these high-risk individuals were less likely to recall having read and signed a consent form than other IT users (p = .002). The current level of regulation is insufficient to provide IT users with consistent warnings and safety guidelines at tanning salons.

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.

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 ...

Implications of advanced vehicle technologies for older drivers.

PubMed

Molnar, Lisa J; Eby, David W

2017-09-01

Advances are being made in vehicle technologies that may help older adults compensate for some of the declines in abilities associated with aging. These advances hold promise for increasing vehicle safety, reducing injuries, and making the driving task more comfortable. However, important research gaps remain with regard to how various advanced technologies impact the safety of older drivers, as well as older drivers' perceptions about these technologies. This special issue contains seven original contributions that address these issues. Specific topics include the: congruence of design guidelines with the needs and abilities of older drivers, transfer of control between automated and manual driving, use of in-vehicle monitoring technology, motivations for technology use and assigned meanings, technology valuation, and effects on driving behavior. Copyright © 2017 Elsevier Ltd. All rights reserved.

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…

Occupational Safety Precautions among Nurses at Four Hospitals, Nablus District, Palestine.

PubMed

Al-Khatib, I A; El Ansari, W; Areqat, T A; Darkhawaja, R A; Mansour, S H; Tucktuck, M A; Khatib, J I

2015-10-01

Occupational hazards, exposure to blood and body fluids (BBF) accidents and safety precautions constitute an important public health issue. We assessed the prevalence and determinants of exposure to occupational hazards among nurses, and their knowledge of occupational safety precautions. In a cross-sectional study, we surveyed 332 nurses working in 4 hospitals, Nablus, West Bank, Palestine, by a questionnaire. Bivariate analysis tested the associations between ever exposure and the high likelihood of BBF exposure and the independent socio-demographic and occupational variables. Binary logistic regression analysis was used to assess the associations between the same two exposures and selected independent variables (those significant in the bivariate analysis). Prevalence of ever exposure to BBF was 51.7%, and was associated with working in private and charitable hospitals (OR 2.62, 2.68, respectively), having 4-6 family members (OR 0.52) and "nursing" being as one's top career choice at university (OR 0.48). The prevalence of high likelihood of BBF exposure was 62.2%, and was associated with working in charitable and private hospitals (OR 7.81, 2.43, respectively) and "nursing" being as one's top career choice (OR 0.57). Regarding knowledge, most respondents believed it is necessary to enact laws and regulations regarding occupational safety precautions, reported the use of sharps containers, immediate disinfection after an accident, reporting an accident, and using personal protective equipment. Nurses had adequate knowledge of the risks of their hospital work. Nevertheless, they exhibited high prevalence of exposure to BBF accidents. Future studies are needed to re-evaluate existing occupational safety guidelines in hospitals, establish monitoring and evaluation protocols for health care workers' adherence to the guidelines, and institute well-defined policies for reporting occupational injury incidents so these can be handled appropriately.

National athletic trainers' association position statement: lightning safety for athletics and recreation.

PubMed

Walsh, K M; Bennett, B; Cooper, M A; Holle, R L; Kithil, R; López, R E

2000-10-01

To educate athletic trainers and others about the dangers of lightning, provide lightning-safety guidelines, define safe structures and locations, and advocate prehospital care for lightning-strike victims. Lightning may be the most frequently encountered severe-storm hazard endangering physically active people each year. Millions of lightning flashes strike the ground annually in the United States, causing nearly 100 deaths and 400 injuries. Three quarters of all lightning casualties occur between May and September, and nearly four fifths occur between 10:00 AM and 7:00 PM, which coincides with the hours for most athletic or recreational activities. Additionally, lightning casualties from sports and recreational activities have risen alarmingly in recent decades. The National Athletic Trainers' Association recommends a proactive approach to lightning safety, including the implementation of a lightning-safety policy that identifies safe locations for shelter from the lightning hazard. Further components of this policy are monitoring local weather forecasts, designating a weather watcher, and establishing a chain of command. Additionally, a flash-to-bang count of 30 seconds or more should be used as a minimal determinant of when to suspend activities. Waiting 30 minutes or longer after the last flash of lightning or sound of thunder is recommended before athletic or recreational activities are resumed. Lightning- safety strategies include avoiding shelter under trees, avoiding open fields and spaces, and suspending the use of land-line telephones during thunderstorms. Also outlined in this document are the prehospital care guidelines for triaging and treating lightning-strike victims. It is important to evaluate victims quickly for apnea, asystole, hypothermia, shock, fractures, and burns. Cardiopulmonary resuscitation is effective in resuscitating pulseless victims of lightning strike. Maintenance of cardiopulmonary resuscitation and first-aid certification should be required of all persons involved in sports and recreational activities.

Fetal monitoring during nonobstetric surgery: revisiting guidelines: a case report.

PubMed

Rothschild, Tod J; Morel, Bruce; Pace, Benjamin; Fuks, Aleksandr M

2015-01-01

Nonobstetric surgery during pregnancy is not an infrequent occurrence. Guidelines for fetal monitoring during nonobstetric surgery are limited. We describe a case of appendectomy during third trimester, complicated by in utero fetal demise (IUFD). A 30-year-old, Caucasian woman underwent open appendectomy for suspected acute appendicitis. The procedure was complicated by IUFD. Fetal monitoring was done prior to but not during surgery. Guidelines for fetal monitoring were revised, recommending continuous electronic fetal monitoring when possible during third trimester nonobstetric surgery after appropriate patient counseling. A subsequent series of 5 uncomplicated appendectomies demonstrated no difficulty in implementing these guidelines. Continuous electronic fetal monitoring during third trimester nonobstetric surgery should be available and implemented after appropriate patient counseling. This approach reduces the risk of fetal mortality.

The effect of terrain slope on firefighter safety zone effectiveness

Treesearch

Bret Butler; J. Forthofer; K. Shannon; D. Jimenez; D. Frankman

2010-01-01

The current safety zone guidelines used in the US were developed based on the assumption that the fire and safety zone were located on flat terrain. The minimum safe distance for a firefighter to be from a flame was calculated as that corresponding to a radiant incident energy flux level of 7.0kW-m-2. Current firefighter safety guidelines are based on the assumption...

Microbial indicators, pathogens and methods for their monitoring in water environment.

PubMed

Saxena, Gaurav; Bharagava, Ram Naresh; Kaithwas, Gaurav; Raj, Abhay

2015-06-01

Water is critical for life, but many people do not have access to clean and safe drinking water and die because of waterborne diseases. The analysis of drinking water for the presence of indicator microorganisms is key to determining microbiological quality and public health safety. However, drinking water-related illness outbreaks are still occurring worldwide. Moreover, different indicator microorganisms are being used in different countries as a tool for the microbiological examination of drinking water. Therefore, it becomes very important to understand the potentials and limitations of indicator microorganisms before implementing the guidelines and regulations designed by various regulatory agencies. This review provides updated information on traditional and alternative indicator microorganisms with merits and demerits in view of their role in managing the waterborne health risks as well as conventional and molecular methods proposed for monitoring of indicator and pathogenic microorganisms in the water environment. Further, the World Health Organization (WHO) water safety plan is emphasized in order to develop the better approaches designed to meet the requirements of safe drinking water supply for all mankind, which is one of the major challenges of the 21st century.

Distribution of persistent organic pollutants (POPS) IN wild Bluefin tuna (Thunnus thynnus) from different FAO capture zones.

PubMed

Chiesa, L M; Labella, G F; Panseri, S; Pavlovic, R; Bonacci, S; Arioli, F

2016-06-01

Residues of environmental contaminants in food represent a concern in food safety programs. In this study, the distribution of persistent organic pollutants (POPs) were evaluated in 79 tuna samples from FAO areas 51 (Indian Ocean), 71 (Pacific Ocean), 34 (Atlantic Ocean), and 37 (Mediterranean Sea). 6 polychlorinated biphenyls (PCBs), 16 organochlorines (OCs) and 7 polybrominated biphenyl ethers (PBDEs) were selected as representative compounds according to EFSA POPs monitoring guidelines. An analytical method, based on Accelerated Solvent Extraction (ASE), with an "in-line" clean-up step and GC-MS/MS detection, was developed, validated and applied. PCBs were detected in all FAO areas, with a prevalence of 100% for most of them. In the FAO area 37, only, all PBDEs were detected. Only 5 OCs were detected. The results showed that POPs contamination of tuna reflects FAO area contamination; in particular FAO area 37 was the most polluted. Moreover, tuna muscle was an appropriate matrix for monitoring contamination and for obtaining information about food safety. Copyright © 2016 Elsevier Ltd. All rights reserved.

77 FR 22282 - Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

...] Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma Contamination... Detection of Mycoplasma Contamination.'' This draft guideline identifies stages of manufacture where... contamination. Because the guidelines apply to final product and master seed/cell testing in veterinary vaccines...

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 ( ...

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

PubMed

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

2018-05-19

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

Systematic Product Development of Control and Diagnosis Functionalities

NASA Astrophysics Data System (ADS)

Stetter, R.; Simundsson, A.

2017-01-01

In the scientific field of systematic product development a wide range of helpful methods, guidelines and tools were generated and published in recent years. Until now little special attention was given to design guidelines aiming at supporting product development engineers to design products that allow and support control or diagnosis functions. The general trend to ubiquitous computing and the first development steps towards cognitive systems as well as a general trend toward higher product safety, reliability and reduced total cost of ownership (TCO) in many engineering fields lead to a higher importance of control and diagnosis. In this paper a first attempt is made to formulate general valid guidelines how products can be developed in order to allow and to achieve effective and efficient control and diagnosis. The guidelines are elucidated on the example of an automated guided vehicle. One main concern of this paper is the integration of control and diagnosis functionalities into the development of complete systems which include mechanical, electrical and electronic subsystems. For the development of such systems the strategies, methods and tools of systematic product development have attracted significant attention during the last decades. Today, the functionality and safety of most products is to a large degree dependent on control and diagnosis functionalities. Still, there is comparatively little research concentrating on the integration of the development of these functionalities into the overall product development processes. The paper starts with a background describing Systematic Product Development. The second section deals with the product development of the sample product. The third part clarifies the notions monitoring, control and diagnosis. The following parts summarize some insights and formulate first hypotheses concerning control and diagnosis in Systematic Product Development.

Using Geographical Information Systems (GIS) as an instrument of water resource management: a case study from a GIS-based Water Safety Plan in Germany.

PubMed

Wienand, I; Nolting, U; Kistemann, T

2009-01-01

Following international developments and the new WHO Drinking Water Guidelines (WHO 2004) a process-orientated concept for risk, monitoring and incident management has been developed and implemented in this study. The concept will be reviewed with special consideration for resource protection (first barrier of the multi-barrier system) and in turn, for the Water Safety Plan (WSP) which adequately considers-beyond the current framework of legal requirements-possible new hygienic-microbiologically relevant risks (especially emerging pathogens) for the drinking water supply. The development of a WSP within the framework of risk, monitoring and incident management includes the application of Geographical Information Systems (GIS). In the present study, GIS was used for visualization and spatial analysis in decisive steps in the WSP. The detailed process of GIS-supported implementation included the identification of local participants and their tasks and interactions as an essential part of risk management. A detailed ecological investigation of drinking water conditions in the catchment area was conducted in addition to hazard identification, risk assessment and the monitoring of control measures. The main task of our study was to find out in which steps of the WSP the implementation of GIS could be integrated as a useful, and perhaps even an essential tool.

EAES recommendations on methodology of innovation management in endoscopic surgery.

PubMed

Neugebauer, Edmund A M; Becker, Monika; Buess, Gerhard F; Cuschieri, Alfred; Dauben, Hans-Peter; Fingerhut, Abe; Fuchs, Karl H; Habermalz, Brigitte; Lantsberg, Leonid; Morino, Mario; Reiter-Theil, Stella; Soskuty, Gabriela; Wayand, Wolfgang; Welsch, Thilo

2010-07-01

Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus of this guideline is patient safety, efficacy, and effectiveness. An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon. The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given. Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.

New guidelines are needed to manage heat stress in elite sports--The Fédération Internationale de Volleyball (FIVB) Heat Stress Monitoring Programme.

PubMed

Bahr, Roald; Reeser, Jonathan C

2012-09-01

There seems to be a discrepancy between the available heat stress guidelines and the actual risk of heat-related illness among professional beach volleyball players competing under hot and humid conditions. To monitor heat stress and record cases of heat-related medical forfeits on the Swatch FIVB Beach Volleyball World Tour. The FIVB Heat Stress Monitoring Protocol covered events on the FIVB Beach Volleyball World Tour and FIVB Beach Volleyball World Championships during the 2009, 2010 and 2011 seasons (51 events, most of these double gender). The protocol consisted of (1) measuring the Wet Bulb Globe Temperature (WBGT) on centre court prior to the start of every match, and (2) recording any heat-related medical forfeits during the tournament. Data were collected during 48 of 51 events. There were nine events where the peak WBGT exceeded the US Navy Black flag conditions of >32.3°C and an additional two events where the peak WBGT exceeded 31°C, (meeting Red flag conditions.) In two events, the average WBGT equalled at least 31°C. One case of a medical forfeit related to heat stress was recorded over the 3-year surveillance period: an athlete whose fluid balance was compromised from a 3-day bout of acute gastroenteritis. The incidence of significant heat illness among athletes competing on the FIVB Beach Volleyball World Tour appears to be quite low, even though weather conditions frequently result in a WBGT index >32°C. Currently available guidelines appear to be inadequate to fully assess the risk of heat stress and too conservative to inform safety decisions in professional beach volleyball.

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...

Efficacy and Safety of Gonadotropin-Releasing Hormone Agonist Treatment to Suppress Puberty in Gender Dysphoric Adolescents.

PubMed

Schagen, Sebastian E E; Cohen-Kettenis, Peggy T; Delemarre-van de Waal, Henriette A; Hannema, Sabine E

2016-07-01

Puberty suppression using gonadotropin-releasing hormone agonists (GnRHas) is recommended by current guidelines as the treatment of choice for gender dysphoric adolescents. Although GnRHas have long been used to treat precocious puberty, there are few data on the efficacy and safety in gender dysphoric adolescents. Therefore, the Endocrine Society guideline recommends frequent monitoring of gonadotropins, sex steroids, and renal and liver function. To evaluate the efficacy and safety of GnRHa treatment to suppress puberty in gender dysphoric adolescents. Forty-nine male-to-female and 67 female-to-male gender dysphoric adolescents treated with triptorelin were included in the analysis. Physical examination, including assessment of Tanner stage, took place every 3 months and blood samples were drawn at 0, 3, and 6 months and then every 6 months. Body composition was evaluated using dual energy x-ray absorptiometry. GnRHa treatment caused a decrease in testicular volume in 43 of 49 male-to-female subjects. In one of four female-to-male subjects who presented at Tanner breast stage 2, breast development completely regressed. Gonadotropins and sex steroid levels were suppressed within 3 months. Treatment did not have to be adjusted because of insufficient suppression in any subject. No sustained abnormalities of liver enzymes or creatinine were encountered. Alkaline phosphatase decreased, probably related to a slower growth velocity, because height SD score decreased in boys and girls. Lean body mass percentage significantly decreased during the first year of treatment in girls and boys, whereas fat percentage significantly increased. Triptorelin effectively suppresses puberty in gender dysphoric adolescents. These data suggest routine monitoring of gonadotropins, sex steroids, creatinine, and liver function is not necessary during treatment with triptorelin. Further studies should evaluate the extent to which changes in height SD score and body composition that occur during GnRHa treatment can be reversed during subsequent cross-sex hormone treatment. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

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.

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.

Pharmacotherapy of post-traumatic stress disorder: going beyond the guidelines.

PubMed

Davidson, Jonathan

2016-11-01

This article discusses the study of Harpaz-Rotem and associates, who examined patterns of medication use in first-diagnosed veterans with post-traumatic stress disorder (PTSD). It considers the difference between practice guidelines and actual prescribing; selectively identifies issues with antidepressants, antipsychotics, benzodiazepines and prazosin; and reviews the possible impact of new medications in the pipeline. In the past 36 months, J.D. has received compensation for consulting with Edgemont, Turing and Tonix Pharmaceuticals; royalties in connection with publications by Springer, Guilford and McFarland Publishers and use of the Connor-Davidson Resilience Scale, Davidson Trauma Scale, Social Phobia Inventory (SPIN) and Mini-SPIN; service on the INTRuST Data Safety and Monitoring Board, University of California, San Diego. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.

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 ...

Air, rail and road: Medical Guidelines for Employees with a History of Cerebrovascular Disease.

PubMed

Klein, Rebecca; Menon, Bijoy K; Rabi, Doreen; Stell, William; Hill, Michael D

2016-10-01

Background An acute medical condition following a previous stroke among those who operate trains, airplanes, and commercial vehicles can result in serious accidents. There are guidelines in place to assist physicians and employers in assessing the risks of returning to work after stroke but the extent and comprehensiveness across nations and among safety-critical occupations are not widely known. Methods Medical guidelines currently in place to regulate safety critical occupations including railway engineers, pilots and commercial vehicle drivers were systematically reviewed. Electronic and hand literature searches as well as review of grey literature for Canada, the USA, the UK, and Australia were conducted. Results There is no consistent set of guidelines that address the risk of a second catastrophic event after an initial cerebrovascular event in those employed in safety critical occupations in the four countries assessed. Some broad principles existed between the different countries and occupations but there was major variation in the approach to cerebrovascular disease and its impact on those working in safety-critical occupations. Conclusions A synthesis of current knowledge would assist in establishing risks of a catastrophic event in those who have already suffered from cerebrovascular illness. This will allow the creation of medical guidelines which could be applied to any safety critical occupation in any nation.

[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.

Appropriateness of Plasma Transfusion: A College of American Pathologists Q-Probes Study of Guidelines, Waste, and Serious Adverse Events.

PubMed

Alcorn, Kirsten; Ramsey, Glenn; Souers, Rhona; Lehman, Christopher M

2017-03-01

- Plasma transfusion guidelines support patient care and safety, management of product wastage, and compliance; yet, there is little information across multiple institutions about use of and adherence to plasma transfusion guidelines. - To survey multiple institutions regarding their plasma transfusion guidelines and compliance, plasma wastage rates, and incidence of transfusion reactions associated with plasma transfusion. - The College of American Pathologists Q-Probes model was used to collect data from 89 participating institutions. Each site was asked to provide data relevant to its most recent 40 adult patient plasma transfusion episodes, and complete a questionnaire regarding plasma transfusion guidelines, utilization and wastage of plasma, and transfusion reactions related to plasma transfusion. - The participating institutions reported a total of 3383 evaluable plasma transfusion episodes with transfusion of 9060 units of plasma. Compliance with institution-specific guidelines was seen in 3018 events (89%). Pretransfusion and posttransfusion coagulation testing was done in 3281 (97%) and 3043 (90%) of these episodes, respectively. Inappropriate criteria were noted for more than 100 transfusion episodes. Thirty-two plasma transfusion episodes (1%) were associated with a transfusion reaction. Serious and fatal reactions were reported. Median plasma wastage rate for the year preceding the study was 4.5%. - Most participating institutions are compliant with plasma transfusion guidelines based on published references, supported by appropriate testing. With transfusions for indications that lack evidence of efficacy and incidence of transfusion reactions, there is an ongoing role for transfusion service leaders to continue to update and monitor plasma transfusion practices.

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.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

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 ...

Guidelines for the care of pregnant women living with HIV and interventions to reduce perinatal transmission: executive summary.

PubMed

Money, Deborah; Tulloch, Karen; Boucoiran, Isabelle; Caddy, Sheila

2014-08-01

This guideline reviews the evidence relating to the care of pregnant women living with HIV and the prevention of perinatal HIV transmission. Prenatal care of pregnancies complicated by HIV infection should include monitoring by a multidisciplinary team with experts in this area. OUTCOMES evaluated include the impact of HIV on pregnancy outcome and the efficacy and safety of antiretroviral therapy and other measures to decrease the risk of vertical transmission. Published literature was retrieved through searches of PubMed and The Cochrane Library in 2012 and 2013 using appropriate controlled vocabulary (HIV, anti-retroviral agents, pregnancy, delivery) and key words (HIV, pregnancy, antiretroviral agents, vertical transmission, perinatal transmission). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English or French. There were no date restrictions. Searches were updated on a regular basis and incorporated in the guideline to June 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1).

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

[Safe Vascular Access - the Guideline of the Association of Anaesthesists of Great Britain and Ireland 2016].

PubMed

Bergmann, Lars

2018-06-01

This guideline was presented in 2016 due to the need for an up to date evidence-based guidance focusing on patient safety. In addition to safety-related aspects of catheter insertion or removal, organisational issues and structured training concepts were discussed. The guideline was created based on the review of current literature as well as expert opinion. The article summarizes and discusses the most important recommendations and the reader is provided with practical advice for catheter insertion or removal with the intention to improve the safety of the patients. Georg Thieme Verlag KG Stuttgart · New York.

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...

Best Practices for Robotic Surgery Programs

PubMed Central

Goldenberg, David; Winder, Joshua S.; Juza, Ryan M.; Lyn-Sue, Jerome R.

2017-01-01

Background and Objectives: Robotic surgical programs are increasing in number. Efficient methods by which to monitor and evaluate robotic surgery teams are needed. Methods: Best practices for an academic university medical center were created and instituted in 2009 and continue to the present. These practices have led to programmatic development that has resulted in a process that effectively monitors leadership team members; attending, resident, fellow, and staff training; credentialing; safety metrics; efficiency; and case volume recommendations. Results: Guidelines for hospitals and robotic directors that can be applied to one's own robotic surgical services are included with examples of management of all aspects of a multispecialty robotic surgery program. Conclusion: The use of these best practices will ensure a robotic surgery program that is successful and well positioned for a safe and productive environment for current clinical practice. PMID:28729780

49 CFR 385.703 - Safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

49 CFR 385.103 - Safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

49 CFR 385.703 - Safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

49 CFR 385.103 - Safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

Developing and Implementing a Quality Assurance Strategy for Electroconvulsive Therapy.

PubMed

Hollingsworth, Jessa; Baliko, Beverly; McKinney, Selina; Rosenquist, Peter

2018-04-17

The literature provides scant guidance in effective quality assurance strategies concerning the use of electroconvulsive therapy (ECT) for the treatment of psychiatric conditions. Numerous guidelines are published that provide guidance in the delivery of care; however, little has been done to determine how a program or facility might ensure compliance to best practice for safety, tolerability, and efficacy in performing ECT. The objective of this project was to create a quality assurance strategy specific to ECT. Determining standards for quality care and clarifying facility policy were key outcomes in establishing an effective quality assurance strategy. An audit tool was developed utilizing quality criteria derived from a systematic review of ECT practice guidelines, peer review, and facility policy. All ECT procedures occurring over a 2-month period of May to June 2017 were retrospectively audited and compared against target compliance rates set for the facility's ECT program. Facility policy was adapted to reflect quality standards, and audit findings were used to inform possible practice change initiatives, were used to create benchmarks for continuous quality monitoring, and were integrated into regular hospital quality meetings. Clarification on standards of care and the use of clinical auditing in ECT was an effective starting point in the development of a quality assurance strategy. Audit findings were successfully integrated into the hospital's overall quality program, and recognition of practice compliance informed areas for future quality development and policy revision in this small community-based hospital in the southeastern United States. This project sets the foundation for a quality assurance strategy that can be used to help monitor procedural safety and guide future improvement efforts in delivering ECT. Although it is just the first step in creating meaningful quality improvement, setting clear standards and identifying areas of greatest clinical need were crucial beginning for this hospital's growing program.

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.

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 ...

Thalidomide and the Titanic: reconstructing the technology tragedies of the twentieth century.

PubMed

Annas, G J; Elias, S

1999-01-01

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the market. New laws regarding abortion and a new technology, ultrasound, make reasonable the approval of thalidomide for patients who suffer from serious conditions it can alleviate. In addition, the FDA and the manufacturer have proposed the most stringent postmarketing monitoring ever used for a prescription drug, including counseling, contraception, and ultrasonography in the event of pregnancy. The Titanic/thalidomide lesson for the FDA and public health is that rules and guidelines alone are not sufficient to guarantee safety. Continuous vigilance will be required to ensure that all reasonable postmarketing monitoring steps are actually taken to avoid predictable and preventable teratogenic disasters.

Trial of a novel endoscopic tattooing biopsy forceps on animal model

PubMed Central

Si, Jian-Min; Sun, Lei-Min; Fan, Yu-Jing; Wang, Liang-Jing

2005-01-01

AIM: To tattoo gastric mucosa with a novel medical device which could be used to monitor and follow-up gastric mucosal lesions. METHODS: Combining endoscopic biopsy with sclerotherapy injection, we designed a new device that could perform biopsy and injection simultaneously. We performed endoscopies on a pig by using a novel endoscope tattoo biopsy forceps for 15 mo. At the same time, we used two-step method combining sclerotherapy injection needle with endoscopic biopsy. The acuity, inflammation and duration of endoscopy were compared between two methods. RESULTS: Compared with the old two-step method, although the inflammation induced by our new device was similar, the duration of procedure was markedly decreased and the acuity of tattooing was better than the old two-step method. All characteristics of the novel device complied with national safety guidelines. Follow-up gastroscopy after 15 mo showed the stained site with injection of 1:100 0.5 mL of India ink was still markedly visible with little inflammatory reaction. CONCLUSION: Endoscopic tattooing biopsy forceps can be widely used in monitoring precancerous lesions. Its safety and effectiveness has been established in animals. PMID:15793881

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.

Guidelines on Good Clinical Laboratory Practice

PubMed Central

Ezzelle, J.; Rodriguez-Chavez, I. R.; Darden, J. M.; Stirewalt, M.; Kunwar, N.; Hitchcock, R.; Walter, T.; D’Souza, M. P.

2008-01-01

A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. PMID:18037599

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

ENVIRONMENTAL MONITORING FOR PUBLIC ACCESS AND COMMUNITY TRACKING (EMPACT) PROGRAM MICROBIOLOGICAL MONITORING OF RECREATIONAL WATER

EPA Science Inventory

Current Environmental Protection Agency (EPA) recommended microbiological monitoring practices for bathing beach water quality were suggested in 1968, as a part of the fecal coliform guideline developed by the Federal Water Pollution Control Administration. The guideline stated ...

National Athletic Trainers' Association Position Statement: Lightning Safety for Athletics and Recreation

PubMed Central

Walsh, Katie M.; Bennett, Brian; Cooper, Mary Ann; Holle, Ronald L.; Kithil, Richard; López, Raul E.

2000-01-01

Objective: To educate athletic trainers and others about the dangers of lightning, provide lightning-safety guidelines, define safe structures and locations, and advocate prehospital care for lightning-strike victims. Background: Lightning may be the most frequently encountered severe-storm hazard endangering physically active people each year. Millions of lightning flashes strike the ground annually in the United States, causing nearly 100 deaths and 400 injuries. Three quarters of all lightning casualties occur between May and September, and nearly four fifths occur between 10:00 AM and 7:00 PM, which coincides with the hours for most athletic or recreational activities. Additionally, lightning casualties from sports and recreational activities have risen alarmingly in recent decades. Recommendations: The National Athletic Trainers' Association recommends a proactive approach to lightning safety, including the implementation of a lightning-safety policy that identifies safe locations for shelter from the lightning hazard. Further components of this policy are monitoring local weather forecasts, designating a weather watcher, and establishing a chain of command. Additionally, a flash-to-bang count of 30 seconds or more should be used as a minimal determinant of when to suspend activities. Waiting 30 minutes or longer after the last flash of lightning or sound of thunder is recommended before athletic or recreational activities are resumed. Lightning- safety strategies include avoiding shelter under trees, avoiding open fields and spaces, and suspending the use of land-line telephones during thunderstorms. Also outlined in this document are the prehospital care guidelines for triaging and treating lightning-strike victims. It is important to evaluate victims quickly for apnea, asystole, hypothermia, shock, fractures, and burns. Cardiopulmonary resuscitation is effective in resuscitating pulseless victims of lightning strike. Maintenance of cardiopulmonary resuscitation and first-aid certification should be required of all persons involved in sports and recreational activities. PMID:16558665

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.…

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…

Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).

PubMed

Biancone, Livia; Annese, Vito; Ardizzone, Sandro; Armuzzi, Alessandro; Calabrese, Emma; Caprioli, Flavio; Castiglione, Fabiana; Comberlato, Michele; Cottone, Mario; Danese, Silvio; Daperno, Marco; D'Incà, Renata; Frieri, Giuseppe; Fries, Walter; Gionchetti, Paolo; Kohn, Anna; Latella, Giovanni; Milla, Monica; Orlando, Ambrogio; Papi, Claudio; Petruzziello, Carmelina; Riegler, Gabriele; Rizzello, Fernando; Saibeni, Simone; Scribano, Maria Lia; Vecchi, Maurizio; Vernia, Piero; Meucci, Gianmichele

2017-04-01

Inflammatory bowel diseases are chronic conditions of unknown etiology, showing a growing incidence and prevalence in several countries, including Italy. Although the etiology of Crohn's disease and ulcerative colitis is unknown, due to the current knowledge regarding their pathogenesis, effective treatment strategies have been developed. Several guidelines are available regarding the efficacy and safety of available drug treatments for inflammatory bowel diseases. Nevertheless, national guidelines provide additional information adapted to local feasibility, costs and legal issues related to the use of the same drugs. These observations prompted the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) to establish Italian guidelines on the safety of currently available treatments for Crohn's disease and ulcerative colitis. These guidelines discuss the use of aminosalicylates, systemic and low bioavailability corticosteroids, antibiotics (metronidazole, ciprofloxacin, rifaximin), thiopurines, methotrexate, cyclosporine A, TNFα antagonists, vedolizumab, and combination therapies. These guidelines are based on current knowledge derived from evidence-based medicine coupled with clinical experience of a national working group. Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

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

PubMed

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

2006-08-01

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

The Growth Hormone Research Society consensus guidelines for the diagnosis and treatment of adult GH deficiency.

PubMed

Hartman, M L

1998-02-01

The Growth Hormone Research Society (GRS) convened a workshop in Port Stephens, Australia in April 1997 to establish consensus guidelines for the diagnosis and treatment of adults with GH deficiency (GHD). Scientists with expertise in the field, representatives from industry involved in the manufacture of GH and representatives from health authorities from a number of countries participated in the workshop. The workshop considered the following questions: (1) How should adult GHD be defined? (2) Who should be tested for adult GHD? (3) How should the diagnosis of adult GHD be established? (4) How should GH and insulin-like growth factor-I (IGF-I) assays be standardized? (5) Who should be treated for adult GHD? (6) What dose of GH should be used for treatment of adult GHD? (7) How should treatment of adult GHD be monitored? (8) What are the contraindications to treatment of adult GHD? (9) What safety issues need to be considered? (10) How long should treatment of adult GHD be continued? The consensus guidelines developed at this workshop and the rationale for some of these recommendations will be reviewed in this paper.

Use of a medication control officer to reduce bias in a clinical trial: lessons learned from the scleroderma lung study.

PubMed

Hsu, Vivien M; Khanna, Dinesh; Smith, Edwin; Filemon, Tan; Whelton, Sean; Lopata, Mel; Davis, John C; Polito, Albert; Heck, Louis; Molitor, Jerry; Abeles, Micha; Granda, Jose; Korn, Joseph; Clements, Philip

2010-02-01

Scleroderma Lung Study (SLS) was designed to evaluate the efficacy and safety of oral cyclophosphamide (CYC) versus placebo taken for 1 year for scleroderma-associated interstitial lung disease. An independent medication control officer (MCO), usually a physician, at each center was assigned to monitor laboratory and clinical toxicity of study medication and regulate its dosing based on these results. By having an MCO who watched and managed toxicity, the study investigators were free to care for study patients and to assess study outcomes without the potential bias of knowing toxicity data (toxicity from cyclophosphamide is distinctive - cytopenias and hematuria in particular). To assess the usefulness of an MCO, whose chief role was to maintain safety while retaining the blinding in the clinical trial. Patients had safety laboratory testing every 2-4 weeks and results were sent directly to the MCO within 2 days of the test. Other clinical adverse events (AEs) were reported by the patient to a nurse coordinator who reported them to the MCO who then managed the AEs to preserve the blinding of investigators caring for the patients. The MCO was provided pre-determined algorithms for dose adjustments of test medication based on the presence and severity of laboratory abnormalities. Safety monitoring by the MCO was effective in the early detection of drug toxicity with provision of appropriate medical intervention on a timely basis. At the same time, investigator blinding appeared to be maintained. The testing of MCO effectiveness in maintaining blinding and consistency was not defined as an a priori hypothesis and thus complete data relating to the efficacy of the MCO were not collected in a prospective fashion. An MCO and pre-specified monitoring and dosing guidelines, coupled with uniform pre-specified responses to AEs, may be used effectively to preserve investigator blinding and provide consistency in response to AEs in a clinical trial setting, even when AEs of the test medication are distinctive.

Spinoff 2009

NASA Technical Reports Server (NTRS)

2009-01-01

Topics covered include: Image-Capture Devices Extend Medicine's Reach; Medical Devices Assess, Treat Balance Disorders; NASA Bioreactors Advance Disease Treatments; Robotics Algorithms Provide Nutritional Guidelines; "Anti-Gravity" Treadmills Speed Rehabilitation; Crew Management Processes Revitalize Patient Care; Hubble Systems Optimize Hospital Schedules; Web-based Programs Assess Cognitive Fitness; Electrolyte Concentrates Treat Dehydration; Tools Lighten Designs, Maintain Structural Integrity; Insulating Foams Save Money, Increase Safety; Polyimide Resins Resist Extreme Temperatures; Sensors Locate Radio Interference; Surface Operations Systems Improve Airport Efficiency; Nontoxic Resins Advance Aerospace Manufacturing; Sensors Provide Early Warning of Biological Threats; Robot Saves Soldier's Lives Overseas (MarcBot); Apollo-Era Life Raft Saves Hundreds of Sailors; Circuits Enhance Scientific Instruments and Safety Devices; Tough Textiles Protect Payloads and Public Safety Officers; Forecasting Tools Point to Fishing Hotspots; Air Purifiers Eliminate Pathogens, Preserve Food; Fabrics Protect Sensitive Skin from UV Rays; Phase Change Fabrics Control Temperature; Tiny Devices Project Sharp, Colorful Images; Star-Mapping Tools Enable Tracking of Endangered Animals; Nanofiber Filters Eliminate Contaminants; Modeling Innovations Advance Wind Energy Industry; Thermal Insulation Strips Conserve Energy; Satellite Respondent Buoys Identify Ocean Debris; Mobile Instruments Measure Atmospheric Pollutants; Cloud Imagers Offer New Details on Earth's Health; Antennas Lower Cost of Satellite Access; Feature Detection Systems Enhance Satellite Imagery; Chlorophyll Meters Aid Plant Nutrient Management; Telemetry Boards Interpret Rocket, Airplane Engine Data; Programs Automate Complex Operations Monitoring; Software Tools Streamline Project Management; Modeling Languages Refine Vehicle Design; Radio Relays Improve Wireless Products; Advanced Sensors Boost Optical Communication, Imaging; Tensile Fabrics Enhance Architecture Around the World; Robust Light Filters Support Powerful Imaging Devices; Thermoelectric Devices Cool, Power Electronics; Innovative Tools Advance Revolutionary Weld Technique; Methods Reduce Cost, Enhance Quality of Nanotubes; Gauging Systems Monitor Cryogenic Liquids; Voltage Sensors Monitor Harmful Static; and Compact Instruments Measure Heat Potential.

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 ...

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

Management guidelines for monitoring use on backcountry trails

Treesearch

R. E. Leonard; H. E. Echelberger; H. J. Plumley; L. W. Van Meter

1980-01-01

This state-of-the-art management guideline describes the importance of knowing backcountry use patterns and the questions that should be asked before embarking on a use-monitoring program. It summarizes information about six techniques for monitoring use of backcountry trails and provides practical information about site suitabilities, installation and maintenance...

Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines.

PubMed

Jefferson, Akilah A; Pearson, Steven D

2017-03-01

Little is known regarding whether Institute of Medicine (IOM) standards for managing conflicts of interest (COI) have been met in the development of recent important clinical guidelines. To evaluate adherence to the IOM standards for limits on commercial COI, guideline development, and evaluation of evidence by the 2013 American College of Cardiology and American Heart Association cholesterol management guideline and the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America hepatitis C virus management guideline. This study was a retrospective document review of the June 2014 print version of the cholesterol guideline and the final September 2015 print version of the hepatitis C virus guideline. Each guideline was assessed for adherence to the IOM standards for commercial COI published in the 2011 special report Clinical Practice Guidelines We Can Trust. The IOM standards call for no commercial COI among guideline committee chairs and cochairs and for less than 50% of committee members to have commercial COI. Guideline and contemporaneous article disclosure statements were used to evaluate adherence to these standards. Each guideline was also reviewed for adherence to other IOM standards for guideline development and evidence review. Among the 16 cholesterol guideline committee members, 7 (44%) disclosed commercial COI, all 7 reported industry-sponsored research, and 6 (38%) also reported consultancy. Of 3 guideline chairs and cochairs, 1 (33%) disclosed commercial COI. Review of contemporaneous articles identified additional commercial COI. Among the 29 hepatitis C virus guideline committee members, 21 (72%) reported commercial COI. Eighteen (62%) disclosed industry-sponsored research, 10 (34%) served on advisory boards, 5 (17%) served on data safety monitoring boards, 3 (10%) were consultants, and 3 (10%) reported other honoraria. Of 6 guideline cochairs, 4 (67%) disclosed commercial COI. All 4 disclosed additional COI in other publications that were not listed in their guideline disclosures. Contemporaneous literature review revealed an additional cochair with commercial COI. Of the 9 IOM guideline development and evidence standards, the cholesterol guideline met 5 (56%), and the hepatitis C virus guideline met them all. Neither the cholesterol guideline nor the hepatitis C virus guideline fully met the IOM standards for commercial COI management, and discordance between committee leader guideline disclosures and those in contemporaneous articles was common. Adherence to additional IOM standards for guideline development and evidence review was mixed. Adoption of consistent COI frameworks across specialty societies may help ensure that clinical guidelines are developed in a transparent and trustworthy manner.

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...

49 CFR 385.715 - Duration of safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

49 CFR 385.117 - Duration of safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

49 CFR 385.117 - Duration of safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

49 CFR 385.715 - Duration of safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

PubMed

Paxton, Elizabeth W; Inacio, Maria Cs; Kiley, Mary-Lou

2012-01-01

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice.

PubMed

Zanichelli, A; Maurer, M; Aberer, W; Caballero, T; Longhurst, H J; Bouillet, L; Fabien, V; Andresen, I

2017-06-01

The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real-world setting. We analyzed safety data from 3025 icatibant-treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off-label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3.1%) were related to icatibant. Serious AEs (SAEs) occurred infrequently. A total of 143 SAEs occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no SAEs related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in AEs occurring in on-label vs off-label icatibant users. © 2016 The Authors. Allergy Published by John Wiley & Sons Ltd.

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…

Control charts for monitoring accumulating adverse event count frequencies from single and multiple blinded trials.

PubMed

Gould, A Lawrence

2016-12-30

Conventional practice monitors accumulating information about drug safety in terms of the numbers of adverse events reported from trials in a drug development program. Estimates of between-treatment adverse event risk differences can be obtained readily from unblinded trials with adjustment for differences among trials using conventional statistical methods. Recent regulatory guidelines require monitoring the cumulative frequency of adverse event reports to identify possible between-treatment adverse event risk differences without unblinding ongoing trials. Conventional statistical methods for assessing between-treatment adverse event risks cannot be applied when the trials are blinded. However, CUSUM charts can be used to monitor the accumulation of adverse event occurrences. CUSUM charts for monitoring adverse event occurrence in a Bayesian paradigm are based on assumptions about the process generating the adverse event counts in a trial as expressed by informative prior distributions. This article describes the construction of control charts for monitoring adverse event occurrence based on statistical models for the processes, characterizes their statistical properties, and describes how to construct useful prior distributions. Application of the approach to two adverse events of interest in a real trial gave nearly identical results for binomial and Poisson observed event count likelihoods. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Understanding and Managing Immune-Related Adverse Events Associated With Immune Checkpoint Inhibitors in Patients With Advanced Melanoma

PubMed Central

Weinstein, Alyona; Gordon, Ruth-Ann; Kasler, Mary Kate; Burke, Matthew; Ranjan, Smita; Hodgetts, Jackie; Reed, Vanessa; Shames, Yelena; Prempeh-Keteku, Nana; Lingard, Karla

2017-01-01

The immune checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab represent a substantial improvement in treating advanced melanoma but are associated with adverse events (AEs) likely related to general immunologic enhancement. To ensure that patients receive optimal benefit from these agents, prompt assessment and treatment of AEs are essential. We review the efficacy and safety profiles of these immune checkpoint inhibitors and describe guidelines for managing immune-related AEs. We also present case studies describing the management of toxicities in patients receiving immune checkpoint inhibitor therapy. These cases illustrate the importance of collecting a detailed medical history when administering immunotherapy, as this information is necessary to establish baseline, inform monitoring, and determine the etiology of symptoms. Advanced practice nurses and physician assistants are uniquely positioned to educate patients on the early recognition of AEs and have an important role in establishing appropriate monitoring and open dialogue among services. PMID:29900017

What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up?

PubMed

Brugada, P

2006-01-01

Due to the increasing number of patients with an implantable cardioverter defibrillator (ICD), new options for ICD patient follow-up management are required. Patients with ICD indication according to the guidelines received an ICD with Home Monitoring technology. The devices enabled the transmission of the relevant episode, therapy, and system integrity data. Patients were followed for 12 months with routine controls every 3 months. The physician analyzed the Home Monitoring data before the routine follow-up visit (FU) and gave a forecast on the necessity of the pending FU, which was compared with the evaluation after the FU. Based on the derived forecast reliability, a patient management scheme was developed and its impact on patient safety was assessed retrospectively. A total of 271 patients were enrolled (40 f, mean age 62+/-12 years, mean LVEF 39+/-15%, 65% ischemic heart disease, 20% cardiomyopathy) and followed for 339+/-109 days. Of 908 pairs of Home Monitoring data and FU data evaluation, 129 there were false negative results for 92 patients. Safety concerns from false negative forecasts can be minimized with a patient management scheme containing the following elements: 1) never skip the first routine FU; 2) never skip a routine FU for a patient having already shown pacing threshold problems; 3) perform FU following hospitalizations; 4) perform FU following episode detection by the ICD; and 5) perform a routine FU if the patient reports symptoms. The retrospective analysis showed, that if the patients had been managed using this scheme, 503 of 1079 routine FU could have been skipped with only one safety concern, a three month delay in the detection of silent paroxysmal atrial fibrillation in one patient. Home Monitoring in ICD therapy over 12 months is feasible. The data transmitted relevantly contribute to a remarkable reduction of follow-up burden and enable the individualization of routine follow-up.

The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

PubMed

Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol

2013-05-01

Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.

What Do We Really Know About the Safety of Tai Chi?: A Systematic Review of Adverse Event Reports in Randomized Trials

PubMed Central

Wayne, Peter M.; Berkowitz, Danielle L.; Litrownik, Daniel E.; Buring, Julie E.; Yeh, Gloria Y.

2014-01-01

Objective Systematically review frequency and quality of adverse event (AE) reports in randomized clinical trials (RCTs) of Tai Chi (TC). Data Sources Electronic searches of PubMed/MEDLINE and additional databases from inception through March 2013 of English-language RCTs. Search terms were tai chi, taiji, tai chi chuan. Data were independently extracted by two investigators. Study Selection We included all available randomized controlled trials (RCTs) that were published in English and used Tai Chi as an intervention. Inclusion and exclusion of studies were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data Extraction Eligible RCTs were categorized with respect to AE reporting: 1) No mention of protocols for monitoring AEs or reports of AEs; 2) Reports of AEs either with or without explicit protocols for monitoring AEs. Data Synthesis 153 eligible RCTs were identified, most targeting older adults. Only 50 eligible trials (33%) included reporting of AEs, and of these, only 18 trials (12% overall) also reported an explicit AE monitoring protocol. Protocols varied with respect to rigor of systematic monitoring in both Tai Chi and comparison groups. Reported AEs were typically minor and expected, and primarily musculoskeletal related (e.g., knee and back pain); no intervention-related serious AEs were reported. Conclusions Tai Chi is unlikely to result in serious adverse events, but may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of Tai Chi. PMID:24878398

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...

Methodological guidelines for developing accident modification functions.

PubMed

Elvik, Rune

2015-07-01

This paper proposes methodological guidelines for developing accident modification functions. An accident modification function is a mathematical function describing systematic variation in the effects of road safety measures. The paper describes ten guidelines. An example is given of how to use the guidelines. The importance of exploratory analysis and an iterative approach in developing accident modification functions is stressed. The example shows that strict compliance with all the guidelines may be difficult, but represents a level of stringency that should be strived for. Currently the main limitations in developing accident modification functions are the small number of good evaluation studies and the often huge variation in estimates of effect. It is therefore still not possible to develop accident modification functions for very many road safety measures. Copyright © 2015 Elsevier Ltd. All rights reserved.

Brain Trauma Foundation Guideline Compliance: Results of a Multidisciplinary, International Survey.

PubMed

Hirschi, Ryan; Rommel, Casey; Letsinger, Joshua; Nirula, Raminder; Hawryluk, Gregory W J

2018-05-09

Brain Trauma Foundation (BTF) guidelines reflect evidence-based best practices in management of traumatic brain injury. The aim of this study was to examine self-reported physician compliance and predictors of compliance related to BTF guidelines. We conducted an international, multidisciplinary survey examining self-reported adherence to BTF guidelines and multiple factors potentially affecting adherence. We also surveyed intracranial pressure monitoring practices. Of 154 physician respondents, 15.9% reported their institutions "always" follow BTF guidelines and 72.2% reported that they follow them "most of the time." Personal volume of traumatic brain injury cases and years in practice were not significantly related to adherence. Reported adherence varied significantly in association with respondent's institutional trauma level (P = 0.0010): 17.3% of practitioners at level I, 13.0% at level II, and 0% at level III trauma centers reported "always" following guidelines. Reported adherence to guidelines also varied significantly in association with provider specialty (P = 0.015) and institutional volume of severe traumatic brain injury cases (P = 0.008). Regarding intracranial pressure monitoring practices, 52% of respondents used external ventricular drains, 21% used intraparenchymal monitors, and 27% had no preference (P < 0.001). Of respondents not routinely using external ventricular drains, 36% claimed to "always" follow guidelines. There was no apparent association between type of intracranial pressure monitoring used and reported guideline adherence. Few respondents reported their institutions "always" follow BTF guidelines. General surgeons and providers at high-volume level I trauma centers were more likely to comply with guidelines. Differences in survey responses based on provider and institutional characteristics may help target educational efforts. Copyright © 2018 Elsevier Inc. All rights reserved.

Pharmacotherapy of post-traumatic stress disorder: going beyond the guidelines

PubMed Central

2016-01-01

Summary This article discusses the study of Harpaz-Rotem and associates, who examined patterns of medication use in first-diagnosed veterans with post-traumatic stress disorder (PTSD). It considers the difference between practice guidelines and actual prescribing; selectively identifies issues with antidepressants, antipsychotics, benzodiazepines and prazosin; and reviews the possible impact of new medications in the pipeline. Declaration of interests In the past 36 months, J.D. has received compensation for consulting with Edgemont, Turing and Tonix Pharmaceuticals; royalties in connection with publications by Springer, Guilford and McFarland Publishers and use of the Connor-Davidson Resilience Scale, Davidson Trauma Scale, Social Phobia Inventory (SPIN) and Mini-SPIN; service on the INTRuST Data Safety and Monitoring Board, University of California, San Diego. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license. PMID:29018563

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...

Space shuttle propulsion systems on-board checkout and monitoring system development study (extension). Volume 2: Guidelines for for incorporation of the onboard checkout and monitoring function on the space shuttle

NASA Technical Reports Server (NTRS)

1972-01-01

Guidelines are presented for incorporation of the onboard checkout and monitoring function (OCMF) into the designs of the space shuttle propulsion systems. The guidelines consist of and identify supporting documentation; requirements for formulation, implementation, and integration of OCMF; associated compliance verification techniques and requirements; and OCMF terminology and nomenclature. The guidelines are directly applicable to the incorporation of OCMF into the design of space shuttle propulsion systems and the equipment with which the propulsion systems interface. The techniques and general approach, however, are also generally applicable to OCMF incorporation into the design of other space shuttle systems.

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

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…

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.

Accidental needle sticks, the Occupational Safety and Health Administration, and the fallacy of public policy.

PubMed

Wolf, Bruce L; Marks, Albert; Fahrenholz, John M

2006-07-01

Current Occupational Safety and Health Administration (OSHA) guidelines mandate the use of safety needles when allergy injections are given. Safety needles for intradermal testing remain optional. Whether safety needles reduce the number of accidental needle sticks (ANSs) in the outpatient setting has yet to be proven. To determine the rate of ANSs with new (safety) needles vs old needles used in allergy immunotherapy and intradermal testing. Allergy practices from 22 states were surveyed by e-mail. Seventy practices (28%) responded to the survey. Twice as many ANSs occurred in practices giving immunotherapy when using new needles vs old needles (P < .01). The rate of ANSs was roughly the same for intradermal testing with new needles vs old needles. These findings further question whether OSHA's guidelines for safety needle use in outpatient practice need revision and if allergy practices might be excluded from the requirement to use safety needles.

Managing NIF safety equipment in a high neutron and gamma radiation environment.

PubMed

Datte, Philip; Eckart, Mark; Jackson, Mark; Khater, Hesham; Manuel, Stacie; Newton, Mark

2013-06-01

The National Ignition Facility (NIF) is a 192 laser beam facility that supports the Inertial Confinement Fusion program. During the ignition experimental campaign, the NIF is expected to perform shots with varying fusion yield producing 14 MeV neutrons up to 20 MJ or 7.1 × 10(18) neutrons per shot and a maximum annual yield of 1,200 MJ. Several infrastructure support systems will be exposed to varying high yield shots over the facility's 30-y life span. In response to this potential exposure, analysis and testing of several facility safety systems have been conducted. A detailed MCNP (Monte Carlo N-Particle Transport Code) model has been developed for the NIF facility, and it includes most of the major structures inside the Target Bay. The model has been used in the simulation of expected neutron and gamma fluences throughout the Target Bay. Radiation susceptible components were identified and tested to fluences greater than 10(13) (n cm(-2)) for 14 MeV neutrons and γ-ray equivalent. The testing includes component irradiation using a 60Co gamma source and accelerator-based irradiation using 4- and 14- MeV neutron sources. The subsystem implementation in the facility is based on the fluence estimates after shielding and survivability guidelines derived from the dose maps and component tests results. This paper reports on the evaluation and implementation of mitigations for several infrastructure safety support systems, including video, oxygen monitoring, pressure monitors, water sensing systems, and access control interfaces found at the NIF.

The natural lifespan of a safety policy: violations and system migration in anaesthesia.

PubMed

de Saint Maurice, Guillaume; Auroy, Yves; Vincent, Charles; Amalberti, René

2010-08-01

Safety rules continue growing rapidly, as if constraining human behaviour was the unique avenue for reaching ultimate safety. Safety rules are essential for a safe system, but their multiplication can have counterproductive effects. To monitor, in an anaesthesia ward, compliance with a process-oriented safety rule, and understand barriers and facilitators which help and hinder physicians from following guidelines. The rule stipulated that the day before surgery anaesthetists had to record in the patient's file the drugs to be used for the anaesthesia (induction, maintenance, airway control). Compliance was assessed before introduction of the rule, immediately after, at 6 months and at 12 months. All medical staff were blinded to the protocol. 717 patient records were included. The results showed an initial compliance with policy, reaching 86% for some items (never 100%). Reduction began within 6 months and returned almost to initial levels within a year. One individual showed poor compliance throughout the study but even initially compliant doctors experienced a reduction. Compliance was higher for complex surgery but lower for unscheduled surgery and when job pressure was greater. Compliance eroded over time. A major trigger of erosion seemed to be lack of continued compliance by a senior member of staff. Rules and procedures constitute fragile safety barriers, and it may be better to forego introducing a new safety rule if it is not considered as a priority by staff and is therefore vulnerable to sacrifice in case of conflict with competitive demands.

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…

Gamma-ray spectra and doses from the Little Boy replica

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

Moss, C.E.; Lucas, M.C.; Tisinger, E.W.

1984-01-01

Most radiation safety guidelines in the nuclear industry are based on the data concerning the survivors of the nuclear explosions at Hiroshima and Nagasaki. Crucial to determining these guidelines is the radiation from the explosions. We have measured gamma-ray pulse-height distributions from an accurate replica of the Little Boy device used at Hiroshima, operated at low power levels near critical. The device was placed outdoors on a stand 4 m from the ground to minimize environmental effects. The power levels were based on a monitor detector calibrated very carefully in independent experiments. High-resolution pulse-height distributions were acquired with a germaniummore » detector to identify the lines and to obtain line intensities. The 7631 to 7645 keV doublet from neutron capture in the heavy steel case was dominant. Low-resolution pulse-height distributions were acquired with bismuth-germanate detectors. We calculated flux spectra from these distributions using accurately measured detector response functions and efficiency curves. We then calculated dose-rate spectra from the flux spectra using a flux-to-dose-rate conversion procedure. The integral of each dose-rate spectrum gave an integral dose rate. The integral doses at 2 m ranged from 0.46 to 1.03 mrem per 10/sup 13/ fissions. The output of the Little Boy replica can be calculated with Monte Carlo codes. Comparison of our experimental spectra, line intensities, and integral doses can be used to verify these calculations at low power levels and give increased confidence to the calculated values from the explosion at Hiroshima. These calculations then can be used to establish better radiation safety guidelines. 7 references, 7 figures, 2 tables.« less

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...

Retrospective application of the "guidelines for monitoring mining subsurface activities for hydrocarbons exploitation, re-injection and storage activities (ILG)": insights from the analysis of 2012-2013 Emilia seismic sequence at the Cavone oilfield pilot site (Italy)

NASA Astrophysics Data System (ADS)

Buttinelli, M.; Chiarabba, C.; Anselmi, M.; Pezzo, G.; Improta, L.; Antoncecchi, I.

2017-12-01

In recent years, the debate on the interactions between wastewater disposal and induced seismicity is increasingly drawing the attention of the scientific community, since injections by high-rate wells have been directly associated to occurrence of even large seismic events. In February 2014, the Italian Ministry of Economic Development (MiSE), within the Commission on Hydrocarbon and Mining Resources (CIRM), issued the "guidelines for monitoring mining subsurface activities for hydrocarbons exploitation, re-injection and storage activities (ILG)". The ILG represent the first action in italy aimed at keeping the safety standards mostly in areas where the underground resources exploitation can induce seismicity, ground deformations and pore pressure changes of the reservoirs. Such guidelines also launched a "traffic light" operating system, for the first time defining threshold values and activation levels for such monitored parameters. To test the ILG implications (in particular of the traffic light system) we select the Cavone oilfield (Northern Italy) as test case, since this area was interested during the 2012-2013 by the Emilia Seismic sequence. Moreover, the potential influence of the Cavone oilfield activities in the 2012 earthquake trigger was debated for a long time within the scientific and not contexts, highlighting the importance of seismic monitoring in hydrocarbons exploitation, re-injection and storage areas. In this work we apply the ILG retrospectively to the Cavone oilfield and surrounding areas, just for the seismicity parameter (pore pressure and ground deformation were not taken into account because out of the traffic light system). Since each seismicity catalogue available for the 2012 sequence represents a different setting of monitoring system, we carefully analyzed how the use of such catalogues impact on the overcoming of the threshold imposed by the ILG. In particular, we focus on the use of 1D and 3D velocity models developed ad hoc or not for the investigated area. Results show that different approaches strongly affect the location of seismic event, therefore generating proper or un-proper warnings applying the traffic light system. Our analysis also highlighted the importance of accounting for local geological complexity in the seismicity location strategy.

Transportation Safety of Lithium Iron Phosphate Batteries - A Feasibility Study of Storing at Very Low States of Charge.

PubMed

Barai, Anup; Uddin, Kotub; Chevalier, Julie; Chouchelamane, Gael H; McGordon, Andrew; Low, John; Jennings, Paul

2017-07-11

In freight classification, lithium-ion batteries are classed as dangerous goods and are therefore subject to stringent regulations and guidelines for certification for safe transport. One such guideline is the requirement for batteries to be at a state of charge of 30%. Under such conditions, a significant amount of the battery's energy is stored; in the event of mismanagement, or indeed an airside incident, this energy can lead to ignition and a fire. In this work, we investigate the effect on the battery of removing 99.1% of the total stored energy. The performance of 8Ah C 6 /LiFePO 4 pouch cells were measured following periods of calendar ageing at low voltages, at and well below the manufacturer's recommended value. Battery degradation was monitored using impedance spectroscopy and capacity tests; the results show that the cells stored at 2.3 V exhibited no change in cell capacity after 90 days; resistance rise was negligible. Energy-dispersive X-ray spectroscopy results indicate that there was no significant copper dissolution. To test the safety of the batteries at low voltages, external short-circuit tests were performed on the cells. While the cells discharged to 2.3 V only exhibited a surface temperature rise of 6 °C, cells at higher voltages exhibited sparks, fumes and fire.

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

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

James, J; Place, V; Panda, A

Purpose: Several institutions have developed MRI guidelines for patients with MR-unsafe or MR-conditional pacemakers. Here we highlight the role of a medical physicist in implementing these guidelines for non-pacemaker dependent patients. Guidelines: Implementing these guidelines requires involvement from several medical specialties and a strong collaboration with the site MRI supervisor to develop a structured workflow. A medical physicist is required to be present during the scan to supervise the MR scanning and to maintain a safety checklist that ensures: 1) uninterrupted patient communication with the technologist, 2) continuous patient physiologic monitoring (e.g. blood pressure and electrocardiography) by a trained nurse,more » 3) redundant patient vitals monitoring (e.g. pulse oximetry) due to the possibility of in vivo electrocardiography reading fluctuations during image acquisition. A radiologist is strongly recommended to be available to review the images before patients are discharged from the scanner. Pacemaker MRI should be restricted to 1.5T field strength. The MRI sequences should be optimized by the physicist with regards to: a) SAR: limited to <1.5 W/Kg for MR-unsafe pacemakers in normal operating mode, b) RF exposure time: <30 min, c) Coils: use T/R coils but not restricted to such, d) Artifacts: further optimization of sequences whenever image quality is compromised due to the pacemaker. In particular, cardiac, breast and left-shoulder MRIs are most susceptible to these artifacts. Possible strategies to lower the SAR include: a) BW reduction, 2) echo-train-length reduction, 3) increase TR, 4) decrease number of averages, 5) decrease flip angle, 6) reduce slices and/or a combination of all the options. Conclusion: A medical physicist in collaboration with the MR supervisor plays an important role in the supervision/implementation of safe MR scanning of pacemaker patients. Developing and establishing a workflow has enabled our institution to scan over 30 patients with pacemakers without complications, including 3 cardiac MR exams.« less

Risk assessment of allergen metals in cosmetic products.

PubMed

Sipahi, Hande; Charehsaz, Mohammad; Güngör, Zerrin; Erdem, Onur; Soykut, Buğra; Akay, Cemal; Aydin, Ahmet

2015-01-01

Cosmetics are one of the most common reasons for hospital referrals with allergic contact dermatitis. Because of the increased use of cosmetics within the population and an increase in allergy cases, monitoring of heavy metals, especially allergen metals, is crucial. The aim of this study was to investigate the concentration of allergen metals, nickel (Ni), cobalt (Co), and chromium (Cr), in the most commonly used cosmetic products including mascara, eyeliner, eye shadow, lipstick, and nail polish. In addition, for safety assessment of cosmetic products, margin of safety of the metals was evaluated. Forty-eight makeup products were purchased randomly from local markets and large cosmetic stores in Istanbul, Turkey, and an atomic absorption spectrometer was used for metal content determination. Risk assessment of the investigated cosmetic products was performed by calculating the systemic exposure dosage (SED) using Scientific Committee on Consumer Safety guideline. According to the results of this investigation in all the samples tested, at least two of the allergen metals, Ni and/or Co and/or Cr were detected. Moreover, 97% of the Ni-detected products, 96% of Cr- and 54% of Co-detected products, contained over 1 μg/g of this metals, which is the suggested ultimate target value for sensitive population and thereby can be considered as the possible allergen. On the basis of the results of this study, SED of the metals was negligible; however, contact dermatitis caused by cosmetics is most probably due to the allergen metal content of the products. In conclusion, to assess the safety of the finished products, postmarketing vigilance and routine monitoring of allergen metals are very important to protect public health.

GEOTHERMAL ENVIRONMENTAL IMPACT ASSESSMENT: GROUND WATER MONITORING GUIDELINES FOR GEOTHERMAL DEVELOPMENT

EPA Science Inventory

This report discusses potential ground water pollution from geothermal resource development, conversion, and waste disposal, and proposes guidelines for developing a ground water monitoring plan for any such development. Geothermal processes, borehole logging, and injection well ...

Considerations for long-term anticoagulant therapy in patients with venous thromboembolism in the novel oral anticoagulant era.

PubMed

Toth, Peter P

2016-01-01

Patients who have had a venous thromboembolic event are generally advised to receive anticoagulant treatment for 3 months or longer to prevent a recurrent episode. Current guidelines recommend initial heparin and an oral vitamin K antagonist (VKA) for long-term anticoagulation. However, because of the well-described disadvantages of VKAs, including extensive food and drug interactions and the need for regular anticoagulation monitoring, novel oral anticoagulants (NOACs) have become an attractive option in recent years. These agents are given at fixed doses and do not require routine coagulation-time monitoring. The NOACs are discussed in this review with regard to the needs of patients on long-term anticoagulation. Current guidelines from Europe and North America that refer to the treatment of deep vein thrombosis and/or pulmonary embolism are included, as well as published randomized Phase III clinical trials of NOACs. PubMed searches were used for sourcing case studies of long-term anticoagulant treatment, and results were filtered for human application and screened for relevance. NOAC-based therapy showed a similar efficacy and safety profile to heparins/VKAs but without the need for regular anticoagulation monitoring or dietary adjustments, and can be taken as a fixed-dose regimen once or twice daily. This represents a significant step forward in facilitating the management of long-term anticoagulation therapy. Furthermore, in the EINSTEIN studies, improved patient satisfaction was documented with the NOAC rivaroxaban, which may result in better adherence to therapy and an overall reduction in the incidence of recurrent venous thromboembolism.

ICPP environmental monitoring report CY-1993: Environmental characterization

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

Not Available

1994-05-01

Summarized in this report are the data collected through Environmental Monitoring programs conducted at the Idaho Chemical Processing Plant (ICPP) by the Environmental Safety & Health (ES&H) Department. This report is published in response to DOE Order 5400.1. This report covers the period from December 21, 1992 through December 20, 1993. The ICPP is responsible for complying with all applicable Federal, State, Local and DOE Rules, Regulations and Orders. Radiological effluent and emissions are regulated by the DOE in accordance with the Derived Concentration Guides (DCGs) as presented in DOE Order 5400.5. The State of Idaho regulates all nonradiological wastemore » resulting from the ICPP operations including all airborne, liquid, and solid waste. The ES&H Department updated the Quality Assurance (QA) Project Plan for Environmental Monitoring activities during the third quarter of 1992. QA activities have resulted in the ICPP`s implementation of the Environmental Protection Agency (EPA) rules and guidelines pertaining to the collection, analyses, and reporting of environmentally related samples. Where no EPA methods for analyses existed for radionuclides, WINCO methods were used.« less

Thalidomide and the Titanic: reconstructing the technology tragedies of the twentieth century.

PubMed Central

Annas, G J; Elias, S

1999-01-01

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the market. New laws regarding abortion and a new technology, ultrasound, make reasonable the approval of thalidomide for patients who suffer from serious conditions it can alleviate. In addition, the FDA and the manufacturer have proposed the most stringent postmarketing monitoring ever used for a prescription drug, including counseling, contraception, and ultrasonography in the event of pregnancy. The Titanic/thalidomide lesson for the FDA and public health is that rules and guidelines alone are not sufficient to guarantee safety. Continuous vigilance will be required to ensure that all reasonable postmarketing monitoring steps are actually taken to avoid predictable and preventable teratogenic disasters. PMID:9987477

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.

Case studies of hydrogen sulphide occupational exposure incidents in the UK.

PubMed

Jones, Kate

2014-12-15

The UK Health and Safety Executive has investigated several incidents of workplace accidents involving hydrogen sulphide exposure in recent years. Biological monitoring has been used in some incidents to determine the cause of unconsciousness resulting from these incidents and as a supporting evidence in regulatory enforcement. This paper reports on three case incidents and discusses the use of biological monitoring in such cases. Biological monitoring has a role in identifying hydrogen sulphide exposure in incidents, whether these are occupational or in the wider environment. Sample type, time of collection and sample storage are important factors in the applicability of this technique. For non-fatal incidents, multiple urine samples are recommended at two or more time points between the incident and 15 h post-exposure. For routine occupational monitoring, post-shift samples should be adequate. Due to endogenous levels of urinary thiosulphate, it is likely that exposures in excess of 12 ppm for 30 min (or 360 ppm/min equivalent) would be detectable using biological monitoring. This is within the Acute Exposure Guideline Level 2 (the level of the chemical in air at or above which there may be irreversible or other serious long-lasting effects or impaired ability to escape) for hydrogen sulphide. Crown Copyright © 2014. Published by Elsevier Ireland Ltd. All rights reserved.

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. ...

Management of Paediatric Ulcerative Colitis, Part 1: Ambulatory Care- an Evidence-Based Guideline from ECCO and ESPGHAN.

PubMed

Turner, Dan; Ruemmele, Frank M; Orlanski-Meyer, Esther; Griffiths, Anne M; Carpi, Javier Martin de; Bronsky, Jiri; Veres, Gabor; Aloi, Marina; Strisciuglio, Caterina; Braegger, Christian P; Assa, Amit; Romano, Claudio; Hussey, Séamus; Stanton, Michael; Pakarinen, Mikko; de Ridder, Lissy; Katsanos, Konstantinos; Croft, Nick; Navas-López, Victor; Wilson, David C; Lawrence, Sally; Russell, Richard K

2018-05-30

The contemporary management of ambulatory ulcerative colitis (UC) continues to be challenging with ∼20% of children needing a colectomy within childhood years. We thus aimed to standardize daily treatment of paediatric UC and inflammatory bowel diseases (IBD)-unclassified through detailed recommendations and practice points. These guidelines are a joint effort of the European Crohn's and Colitis Organization (ECCO) and the Paediatric IBD Porto group of European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). An extensive literature search with subsequent evidence appraisal using robust methodology was performed before two face-to-face meetings. All 40 included recommendations and 86 practice points, were endorsed by 43 experts in Paediatric IBD with at least an 88% consensus rate. These guidelines centre on initial use of mesalamine (including topical), before using steroids, thiopurines and, for more severe disease, anti-TNF. The use of other emerging therapies and the role of surgery are also covered. Algorithms are provided to aid therapeutic decision making based on clinical assessment and the paediatric UC activity index (PUCAI). Advice on contemporary therapeutic targets incorporating the use of calprotectin and the role of therapeutic drug monitoring are presented, as well as other management considerations around pouchitis, extraintestinal manifestations, nutrition, growth, psychology and transition. A brief section on disease classification using the PIBD-classes criteria and IBDU is also part of these guidelines. These guidelines provide a guide to clinicians managing children with UC and IBDU to provide modern management strategies while maintaining vigilance around appropriate outcomes and safety issues.

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.

Deployment Considerations for Low-cost Air Quality Sensor Networks; Examining Spatial Variability of Gas-Phase Pollutants Around a Building in Los Angeles

NASA Astrophysics Data System (ADS)

Collier-Oxandale, A. M.; Hannigan, M.; Casey, J. G.; Johnston, J.; Coffey, E.; Thorson, J.

2017-12-01

The field of low-cost air quality sensing technologies is growing rapidly through the continual development of new sensors, increased research into sensor performance, and more and more community groups utilizing sensors to investigate local issues. However, as this technology is still in an exploratory phase, there are few `best-practices' available to serve as guidelines for these projects and the standardization of some procedures could benefit the research community as a whole. For example, deployment considerations such as where and how to place a monitor at a given location are often determined by accessibility and safety, power-requirements, and what is an ideal for sampling the target pollutant. Using data from multiple gas-phase sensors, we will examine the importance of siting considerations for low-cost monitoring systems. During a sampling campaign in Los Angeles, a subset of monitors was deployed at one field site to explore the variability in air quality sensor data around a single building. The site is a three story, multi-family housing unit in a primarily residential neighborhood that is near two major roadways and other potential sources of pollution. Five low-cost monitors were co-located prior to and following the field deployment. During the approximately 2.5-month deployment, these monitors were placed at various heights above street level, on different sides of the building, and on the roof. In our analysis, we will examine how monitor placement affects a sensor's ability to detect local verses more regional trends and how this building-scale spatial variability changes over time. Additionally, examining data from VOC sensors (quantified for methane and total non-methane hydrocarbon signals) and O3 sensors will allow us to compare the variability of primary and secondary pollutants. An outcome of this analysis may include guidelines or `best practices' for siting sensors that could aid in ensuring the collection of high quality field data. These may be particularly useful in community-based projects where monitor siting is typically a collaborative process.

Understanding the positive benefit:risk profile of alemtuzumab in relapsing multiple sclerosis: perspectives from the Alemtuzumab Clinical Development Program.

PubMed

Havrdova, Eva; Cohen, Jeffrey A; Horakova, Dana; Kovarova, Ivana; Meluzinova, Eva

2017-01-01

The introduction of high-efficacy therapies for relapsing-remitting multiple sclerosis has driven re-evaluation of treatment goals and benefit:risk considerations in treatment choice. In the alemtuzumab Phase II and III clinical trials, patients treated with alemtuzumab 12 mg versus subcutaneous interferon beta-1a demonstrated significantly reduced annualized relapse rates and improved magnetic resonance imaging outcomes, and were significantly more likely to achieve no evidence of disease activity and reduction in brain volume loss. In two of the studies, alemtuzumab-treated patients had a significantly reduced risk of 6-month confirmed disease worsening, compared with subcutaneous interferon beta-1a. Benefits were maintained throughout 5 years, with a majority of patients receiving no alemtuzumab retreatment or other disease-modifying therapy. Trial results support alemtuzumab's manageable, consistent safety profile in relapsing-remitting multiple sclerosis. Infusion-associated reactions, the most frequent adverse events (AEs), can be minimized by corticosteroid pretreatment, monitoring, and symptomatic management. Other AEs include infections and autoimmune events. Oral anti-herpes prophylaxis should be initiated on the first day of each alemtuzumab treatment course and continued according to local guidelines. Overall cancer risk was lower in the alemtuzumab clinical trials than in a reference population; however, continuing surveillance will determine if alemtuzumab may be associated with certain malignancies such as thyroid papillary carcinoma and melanoma, which are currently identified as potential risks. The post-approval risk management strategy includes a safety monitoring program. Autoimmune AEs (thyroid events, immune thrombocytopenia, nephropathies) can be detected in a timely manner with the monitoring program, which includes physician and patient education about the signs and symptoms, monthly renal and hematologic monitoring, and quarterly thyroid function monitoring for 48 months after the last alemtuzumab course. Education, vigilance by physicians and patients, and monthly laboratory monitoring are recommended to maintain alemtuzumab's positive benefit:risk profile.

33 CFR 157.02 - Incorporation by reference: Where can I get a copy of the publications mentioned in this part?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Item 11, Guidelines and Specifications for Oil Discharge Monitoring and Control Systems for Oil Tankers... Monitoring and Control Systems for Oil Tankers (“A.586(14)”), incorporation by reference approved for § 157... 1983, Guidelines for Plan Approval and Installation Survey of Oil Discharge Monitoring and Control...

33 CFR 157.02 - Incorporation by reference: Where can I get a copy of the publications mentioned in this part?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Item 11, Guidelines and Specifications for Oil Discharge Monitoring and Control Systems for Oil Tankers... Monitoring and Control Systems for Oil Tankers (“A.586(14)”), incorporation by reference approved for § 157... 1983, Guidelines for Plan Approval and Installation Survey of Oil Discharge Monitoring and Control...

33 CFR 157.02 - Incorporation by reference: Where can I get a copy of the publications mentioned in this part?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Item 11, Guidelines and Specifications for Oil Discharge Monitoring and Control Systems for Oil Tankers... Monitoring and Control Systems for Oil Tankers (“A.586(14)”), incorporation by reference approved for § 157... 1983, Guidelines for Plan Approval and Installation Survey of Oil Discharge Monitoring and Control...

33 CFR 157.02 - Incorporation by reference: Where can I get a copy of the publications mentioned in this part?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Item 11, Guidelines and Specifications for Oil Discharge Monitoring and Control Systems for Oil Tankers... Monitoring and Control Systems for Oil Tankers (“A.586(14)”), incorporation by reference approved for § 157... 1983, Guidelines for Plan Approval and Installation Survey of Oil Discharge Monitoring and Control...

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.

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…

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.

Breast screen new South wales generally demonstrates good radiologic viewing conditions.

PubMed

Soh, BaoLin Pauline; Lee, Warwick; Diffey, Jennifer L; McEntee, Mark F; Kench, Peter L; Reed, Warren M; Brennan, Patrick C

2013-08-01

This study measured reading workstation monitors and the viewing environment currently available within BreastScreen New South Wales (BSNSW) centres to determine levels of adherence to national and international guidelines. Thirteen workstations from four BSNSW service centres were assessed using the American Association of Physicists in Medicine Task Group 18 Quality Control test pattern. Reading workstation monitor performance and ambient light levels when interpreting screening mammographic images were assessed using spectroradiometer CS-2000 and chroma meter CL-200. Overall, radiologic monitors within BSNSW were operating at good acceptable levels. Some non-adherence to published guidelines included the percentage difference in maximum luminance between pairs of primary monitors at individual workstations (61.5 % or 30.8 % of workstations depending on specific guidelines), maximum luminance (23.1 % of workstations), luminance non-uniformity (11.5 % of workstations) and minimum luminance (3.8 % of workstations). A number of ambient light measurements did not comply with the only available evidence-based guideline relevant to the methodology used in this study. Larger ambient light variations across sites are shown when monitors were switched off, suggesting that differences in ambient lighting between sites can be masked when a standard mammogram is displayed for photometric measurements. Overall, BSNSW demonstrated good adherence to available guidelines, although some non-compliance has been shown. Recently updated United Kingdom and Australian guidelines should help reduce confusion generated by the plethora and sometimes dated nature of currently available recommendations.

Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis.

PubMed

Barrow, Paul

2016-09-01

SWOT analysis was used to gain insights and perspectives into the revision of the ICH S5(R2) guideline on detection of toxicity to reproduction for medicinal products. The current ICH guideline was rapidly adopted worldwide and has an excellent safety record for more than 20 years. The revised guideline should aim to further improve reproductive and developmental (DART) safety testing for new drugs. Alternative methods to animal experiments should be used whenever possible. Modern technology should be used to obtain high quality data from fewer animals. Additions to the guideline should include considerations on the following: limit dose setting, maternal toxicity, biopharmaceuticals, vaccines, testing strategies by indication, developmental immunotoxicity, and male-mediated developmental toxicity. Emerging issues, such as epigenetics and the microbiome, will most likely pose challenges to DART testing in the future. It is hoped that the new guideline will be adopted even outside the ICH regions. Copyright © 2016 Elsevier Inc. All rights reserved.

[Guidelines for monitoring late-onset Pompe disease.Sociedad Española de Medicina Interna (SEMI), Sociedad Española de Neurología (SEN) y Sociedad Española de Neumología y CirugíaTorácica (SEPAR)].

PubMed

Gutiérrez-Rivas, Eduardo; Illa, Isabel; Pascual-Pascual, Samuel I; Pérez-López, Jordi; Vílchez-Padilla, Juan J; Bautista-Lorite, Juan; Barrot, Emilia; López de Munain, Adolfo

2015-04-01

Although treatment with alglucosidase alfa has helped improve the prognosis of patients with late-onset Pompe disease, both the development of the disease and the effectiveness of the treatment need to be monitored on a regular basis. This is the reason that has led a committee of Spanish experts to draw up a series of guidelines on how to follow up these patients. The committee proposes a model of follow-up tests for late-onset Pompe disease. First of all, the nutritional status and swallowing function must be evaluated. Second, and due to the variability of the clinical features, the committee recommends the simultaneous use of several scales to measure different functions and parameters. Thus, muscular force is assessed with the Medical Research Council scale; motor functioning, with the six-minute walk test and timed tests; disability, with the Rasch-built Pompe-specific Activity scale; respiratory functioning, with measurement of the forced vital capacity and oxygen saturation; and fatigue, with the fatigue intensity scale. Lastly, the safety and tolerability of enzyme replacement therapy are controlled by registering and treating the potential side effects and measurement of the anti-alglucosidase alfa antibodies. A number of different general recommendations are also included.

BATHING BEACH MONITORING PROTOCOLS/COMMUNICATING SWIMMING ACTIVITY RISK TO THE PUBLIC

EPA Science Inventory

Current Environmental Protection Agency (EPA) recommended monitoring practices for bathing beach water quality were suggested in 1968, as a part of the fecal coliform guideline developed by the Federal Water Pollution Control Administration. The guideline stated that five water ...

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

State funding of alcohol safety countermeasure programs

DOT National Transportation Integrated Search

1979-09-01

This study was to analyze current State practices in funding State alcohol highway safety programs. The results were intended to provide guidelines for establishing and improving self-sustaining alcohol safety programs. The literature was reviewed an...

A statistical model for predicting muscle performance

NASA Astrophysics Data System (ADS)

Byerly, Diane Leslie De Caix

The objective of these studies was to develop a capability for predicting muscle performance and fatigue to be utilized for both space- and ground-based applications. To develop this predictive model, healthy test subjects performed a defined, repetitive dynamic exercise to failure using a Lordex spinal machine. Throughout the exercise, surface electromyography (SEMG) data were collected from the erector spinae using a Mega Electronics ME3000 muscle tester and surface electrodes placed on both sides of the back muscle. These data were analyzed using a 5th order Autoregressive (AR) model and statistical regression analysis. It was determined that an AR derived parameter, the mean average magnitude of AR poles, significantly correlated with the maximum number of repetitions (designated Rmax) that a test subject was able to perform. Using the mean average magnitude of AR poles, a test subject's performance to failure could be predicted as early as the sixth repetition of the exercise. This predictive model has the potential to provide a basis for improving post-space flight recovery, monitoring muscle atrophy in astronauts and assessing the effectiveness of countermeasures, monitoring astronaut performance and fatigue during Extravehicular Activity (EVA) operations, providing pre-flight assessment of the ability of an EVA crewmember to perform a given task, improving the design of training protocols and simulations for strenuous International Space Station assembly EVA, and enabling EVA work task sequences to be planned enhancing astronaut performance and safety. Potential ground-based, medical applications of the predictive model include monitoring muscle deterioration and performance resulting from illness, establishing safety guidelines in the industry for repetitive tasks, monitoring the stages of rehabilitation for muscle-related injuries sustained in sports and accidents, and enhancing athletic performance through improved training protocols while reducing injury.

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.

The Wiley Protocol: an analysis of ethical issues.

PubMed

Rosenthal, M Sara

2008-01-01

: This review explores the ethical issues surrounding an unregulated protocol that is advertised to women through consumer books, the popular press, and the Internet, known as the Wiley Protocol. : A content analysis of relevant documents was conducted, followed by telephone interviews with investigators and former participants to verify facts. : The Wiley Protocol is an example of unregulated research involving potentially unsafe doses of bioidentical hormones applied to an unselected population of women. This protocol fails to use research ethics guidelines such as informed consent, investigator expertise, sound methodology, standardized data collection, and data safety monitoring. : Clinical ethics breaches include lack of full disclosure of risks, coercive influences, as well as misinformation about the study goals and safety. Breaches of professional ethics include conflicts of interest with respect to financial incentives, patient accrual, and inadequate standards of awareness and proficiency among participating investigators. It appears evident that the failure to regulate nutriceuticals and products of compounding pharmacy has provided the opportunity for these ethical violations.

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.

Post-marketing safety monitoring of a new group B meningococcal vaccine in New Zealand, 2004-2006.

PubMed

McNicholas, Anne; Galloway, Yvonne; Stehr-Green, Paul; Reid, Stewart; Radke, Sarah; Sexton, Kerry; Kieft, Charlotte; Macdonald, Claire; Neutze, Jocelyn; Drake, Ross; Isaac, Dorothy; O'Donnell, Mary; Tatley, Michael; Oster, Philipp; O'Hallahan, Jane

2007-01-01

New Zealand introduced a new outer membrane vesicle vaccine in 2004 to combat an epidemic of group B meningococcal disease. An Independent Safety Monitoring Board oversaw intensive safety monitoring, which included hospital surveillance, health professional reporting (passive and active) and mortality monitoring. With over three million doses administered to individuals aged under 20 years, the monitoring results provide consistent evidence supporting the vaccine's safety.

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)

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.

The arrangement of deformation monitoring project and analysis of monitoring data of a hydropower engineering safety monitoring system

NASA Astrophysics Data System (ADS)

Wang, Wanshun; Chen, Zhuo; Li, Xiuwen

2018-03-01

The safety monitoring is very important in the operation and management of water resources and hydropower projects. It is the important means to understand the dam running status, to ensure the dam safety, to safeguard people’s life and property security, and to make full use of engineering benefits. This paper introduces the arrangement of engineering safety monitoring system based on the example of a water resource control project. The monitoring results of each monitoring project are analyzed intensively to show the operating status of the monitoring system and to provide useful reference for similar projects.

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...

77 FR 37093 - Amendments to Highway Safety Program Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

...: Make. Model year. Vehicle Identification Number. Type of body. License plate number. Name of current.... Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets... Driver Education, Guideline No. 5 Non-Commercial Driver Licenses, Guideline No. 7, Judicial and Court...

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…

PROTECTING HEALTH WITH SAME DAY WATER QUALITY MONITORING RESULTS FOR BATHING BEACHES

EPA Science Inventory

Current US Environmental Protection Agency guidelines recommend the use of cultural methods for E. coli and enterococci to monitor beach water quality. The guidelines recommend a single sample value or a geometric mean value from at least five samples. The single sample guideli...

Adherence to guidelines for creatinine and potassium monitoring and discontinuation following renin–angiotensin system blockade: a UK general practice-based cohort study

PubMed Central

Schmidt, Morten; Bhaskaran, Krishnan; Nitsch, Dorothea; Sørensen, Henrik Toft; Smeeth, Liam; Tomlinson, Laurie A

2017-01-01

Objectives To examine adherence to serum creatinine and potassium monitoring and discontinuation guidelines following initiation of treatment with ACE inhibitors (ACEI) or angiotensin receptor blockers (ARBs); and whether high-risk patients are monitored. Design A general practice-based cohort study using electronic health records from the UK Clinical Practice Research Datalink and Hospital Episode Statistics. Setting UK primary care, 2004–2014. Subjects 223 814 new ACEI/ARB users. Main outcome measures Proportion of patients with renal function monitoring before and after ACEI/ARB initiation; creatinine increase ≥30% or potassium levels >6 mmol/L at first follow-up monitoring; and treatment discontinuation after such changes. Using logistic regression models, we also examined patient characteristics associated with these biochemical changes, and with follow-up monitoring within the guideline recommendation of 2 weeks after treatment initiation. Results 10% of patients had neither baseline nor follow-up monitoring of creatinine within 12 months before and 2 months after initiation of an ACEI/ARB, 28% had monitoring only at baseline, 15% only at follow-up, and 47% both at baseline and follow-up. The median period between the most recent baseline monitoring and drug initiation was 40 days (IQR 12–125 days). 34% of patients had baseline creatinine monitoring within 1 month before initiating therapy, but <10% also had the guideline-recommended follow-up test recorded within 2 weeks. Among patients experiencing a creatinine increase ≥30% (n=567, 1.2%) or potassium level >6 mmol/L (n=191, 0.4%), 80% continued treatment. Although patients with prior myocardial infarction, hypertension or baseline potassium >5 mmol/L were at high risk of ≥30% increase in creatinine after ACEI/ARB initiation, there was no evidence that they were more frequently monitored. Conclusions Only one-tenth of patients initiating ACEI/ARB therapy receive the guideline-recommended creatinine monitoring. Moreover, the vast majority of the patients fulfilling postinitiation discontinuation criteria for creatinine and potassium increases continue on treatment. PMID:28069618

How to monitor patient safety in primary care? Healthcare professionals' views

PubMed Central

Samra, R; Car, J; Majeed, A; Vincent, C

2016-01-01

Summary Objective To identify patient safety monitoring strategies in primary care. Design Open-ended questionnaire survey. Participants A total of 113 healthcare professionals returned the survey from a group of 500 who were invited to participate achieving a response rate of 22.6%. Setting North-West London, United Kingdom. Method A paper-based and equivalent online survey was developed and subjected to multiple stages of piloting. Respondents were asked to suggest strategies for monitoring patient safety in primary care. These monitoring suggestions were then subjected to a content frequency analysis which was conducted by two researchers. Main Outcome measures Respondent-derived monitoring strategies. Results In total, respondents offered 188 suggestions for monitoring patient safety in primary care. The content analysis revealed that these could be condensed into 24 different future monitoring strategies with varying levels of support. Most commonly, respondents supported the suggestion that patient safety can only be monitored effectively in primary care with greater levels of staffing or with additional resources. Conclusion Approximately one-third of all responses were recommendations for strategies which addressed monitoring of the individual in the clinical practice environment (e.g. GP, practice nurse) to improve safety. There was a clear need for more staff and resource set aside to allow and encourage safety monitoring. Respondents recommended the dissemination of specific information for monitoring patient safety such as distributing the lessons of significant event audits amongst GP practices to enable shared learning. PMID:27540488

Research on public participant urban infrastructure safety monitoring system using smartphone

NASA Astrophysics Data System (ADS)

Zhao, Xuefeng; Wang, Niannian; Ou, Jinping; Yu, Yan; Li, Mingchu

2017-04-01

Currently more and more people concerned about the safety of major public security. Public participant urban infrastructure safety monitoring and investigation has become a trend in the era of big data. In this paper, public participant urban infrastructure safety protection system based on smart phones is proposed. The system makes it possible to public participant disaster data collection, monitoring and emergency evaluation in the field of disaster prevention and mitigation. Function of the system is to monitor the structural acceleration, angle and other vibration information, and extract structural deformation and implement disaster emergency communications based on smartphone without network. The monitoring data is uploaded to the website to create urban safety information database. Then the system supports big data analysis processing, the structure safety assessment and city safety early warning.

[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.

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.

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

EVALUATION GUIDELINES FOR ECOLOGICAL INDICATORS

EPA Science Inventory

This document presents fifteen technical guidelines to evaluate the suitability of an ecological indicator for a particular monitoring program. The guidelines are organized within four evaluation phrases: conceptual relevance, feasibility of implementation, response variability...

S3 guidelines for intensive care in cardiac surgery patients: hemodynamic monitoring and cardiocirculary system.

PubMed

Carl, M; Alms, A; Braun, J; Dongas, A; Erb, J; Goetz, A; Goepfert, M; Gogarten, W; Grosse, J; Heller, A R; Heringlake, M; Kastrup, M; Kroener, A; Loer, S A; Marggraf, G; Markewitz, A; Reuter, D; Schmitt, D V; Schirmer, U; Wiesenack, C; Zwissler, B; Spies, C

2010-06-15

Hemodynamic monitoring and adequate volume-therapy, as well as the treatment with positive inotropic drugs and vasopressors are the basic principles of the postoperative intensive care treatment of patient after cardiothoracic surgery. The goal of these S3 guidelines is to evaluate the recommendations in regard to evidence based medicine and to define therapy goals for monitoring and therapy. In context with the clinical situation the evaluation of the different hemodynamic parameters allows the development of a therapeutic concept and the definition of goal criteria to evaluate the effect of treatment. Up to now there are only guidelines for subareas of postoperative treatment of cardiothoracic surgical patients, like the use of a pulmonary artery catheter or the transesophageal echocardiography. The German Society for Thoracic and Cardiovascular Surgery (Deutsche Gesellschaft für Thorax-, Herz- und Gefässchirurgie, DGTHG) and the German Society for Anaesthesiology and Intensive Care Medicine (Deutsche Gesellschaft für Anästhesiologie und lntensivmedizin, DGAI) made an approach to ensure and improve the quality of the postoperative intensive care medicine after cardiothoracic surgery by the development of S3 consensus-based treatment guidelines. Goal of this guideline is to assess the available monitoring methods with regard to indication, procedures, predication, limits, contraindications and risks for use. The differentiated therapy of volume-replacement, positive inotropic support and vasoactive drugs, the therapy with vasodilatators, inodilatators and calcium sensitizers and the use of intra-aortic balloon pumps will also be addressed. The guideline has been developed following the recommendations for the development of guidelines by the Association of the Scientific Medical Societies in Germany (AWMF). The presented key messages of the guidelines were approved after two consensus meetings under the moderation of the Association of the Scientific Medical Societies in Germany (AWMF).

Monitoring and evaluation of patient involvement in clinical practice guideline development: lessons from the Multidisciplinary Guideline for Employment and Severe Mental Illness, the Netherlands.

PubMed

van der Ham, Alida J; van Erp, Nicole; Broerse, Jacqueline E W

2016-04-01

The aim of this study was to gain better insight into the quality of patient participation in the development of clinical practice guidelines and to contribute to approaches for the monitoring and evaluation of such initiatives. In addition, we explore the potential of a dialogue-based approach for reconciliation of preferences of patients and professionals in the guideline development processes. The development of the Multidisciplinary Guideline for Employment and Severe Mental Illness in the Netherlands served as a case study. Methods for patient involvement in guideline development included the following: four patient representatives in the development group and advisory committee, two focus group discussions with patients, a dialogue session and eight case studies. To evaluate the quality of patient involvement, we developed a monitoring and evaluation framework including both process and outcome criteria. Data collection included observations, document analysis and semi-structured interviews (n = 26). The quality of patient involvement was enhanced using different methods, reflection of patient input in the guideline text, a supportive attitude among professionals and attention to patient involvement throughout the process. The quality was lower with respect to representing the diversity of the target group, articulation of the patient perspective in the GDG, and clarity and transparency concerning methods of involvement. The monitoring and evaluation framework was useful in providing detailed insights into patient involvement in guideline development. Patient involvement was evaluated as being of good quality. The dialogue-based approach appears to be a promising method for obtaining integrated stakeholder input in a multidisciplinary setting. © 2015 John Wiley & Sons Ltd.

Space shuttle propulsion systems on-board checkout and monitoring system development study

NASA Technical Reports Server (NTRS)

1971-01-01

Investigations on the fundamental space shuttle propulsion systems program are reported, with emphasis on in-depth reviews of preliminary drafts of the guidelines. The guidelines will be used to incorporate the onboard checkout and monitoring function into the basic design of the propulsion systems and associated interfacing systems. The analysis of checkout and monitoring requirements of the Titan 3 L expandable booster propulsion systems was completed, and the techniques for accomplishing the checkout and monitoring functions were determined. Updating results of the basic study of propulsion system checkout and monitoring is continuing.

An adaptive management process for forest soil conservation.

Treesearch

Michael P. Curran; Douglas G. Maynard; Ronald L. Heninger; Thomas A. Terry; Steven W. Howes; Douglas M. Stone; Thomas Niemann; Richard E. Miller; Robert F. Powers

2005-01-01

Soil disturbance guidelines should be based on comparable disturbance categories adapted to specific local soil conditions, validated by monitoring and research. Guidelines, standards, and practices should be continually improved based on an adaptive management process, which is presented in this paper. Core components of this process include: reliable monitoring...

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.

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...

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. ...

Recommendations for postmarketing surveillance studies in haemophilia and other bleeding disorders.

PubMed

Lassila, R; Rothschild, C; De Moerloose, P; Richards, M; Perez, R; Gajek, H

2005-07-01

Prospective surveillance studies to monitor drug safety in the postapproval period are rarely employed systematically, although they are of greatest value for caregivers, drug users and regulatory authorities. Safety issues have affected not only conventional pharmaceuticals, but also especially coagulation factors in haemophilia treatment. The reputation of postmarketing surveillance (PMS) studies has been questionable, mainly due to their misuse to solicit prescriptions. Other weaknesses include inappropriate design, lack of standardized observation, limited follow-up periods, absence of rigour in identifying potential adverse drug effects, and infrequent publication. Although well-designed clinical trials represent the gold standard for generating sound clinical evidence, a number of aspects would make PMS studies valuable, if properly conducted. One of their main advantages is broader inclusion, and absence of an 'experimental' design. Lack of proper guidelines, and standardization may constitute a reason for the generally low quality of PMS studies. This paper proposes guidelines for haemophilia-specific PMS studies, in order to improve the acceptance of a basically valuable tool. In the absence of consistent regulatory guidance it will be especially important that the design and supervision of PMS studies involves physicians from the beginning. This will not only make such studies more scientifically relevant, but also help to implement them into daily clinical practice. Specifically in haemophilia, PMS studies may provide valuable data on clinical outcomes, or Quality of Life, which is of great importance when considering adequate standards of care in haemophilia patients.

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.

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.

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

Session: Development and application of guidelines for siting, constructing, operating and monitoring wind turbines

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

Manville, Albert; Hueckel, Greg

2004-09-01

This session at the Wind Energy and Birds/Bats workshop consisted of two presentations followed by a discussion/question and answer period. The two papers were: 'Development and Application of USFWS Guidance for Site Evaluation, Siting, Construction, Operation and Monitoring of Wind Turbines' by Albert Manville and 'Wind Power in Washington State' by Greg Hueckel. The session provided a comparison of wind project guidelines developed by the U.S. Fish and Wildlife Service (USFWS) in May 2003 and the Washington State Department of Fish and Wildlife in August 2003. Questions addressed included: is there a need or desire for uniform national or statemore » criteria; can other states learn from Washington State's example, or from the USFWS voluntary guidelines; should there be uniform requirements/guidelines/check-lists for the siting, operation, monitoring, and mitigation to prevent or minimize avian, bat, and other wildlife impacts.« less

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.

PubMed

Yatham, Lakshmi N; Kennedy, Sidney H; Parikh, Sagar V; Schaffer, Ayal; Bond, David J; Frey, Benicio N; Sharma, Verinder; Goldstein, Benjamin I; Rej, Soham; Beaulieu, Serge; Alda, Martin; MacQueen, Glenda; Milev, Roumen V; Ravindran, Arun; O'Donovan, Claire; McIntosh, Diane; Lam, Raymond W; Vazquez, Gustavo; Kapczinski, Flavio; McIntyre, Roger S; Kozicky, Jan; Kanba, Shigenobu; Lafer, Beny; Suppes, Trisha; Calabrese, Joseph R; Vieta, Eduard; Malhi, Gin; Post, Robert M; Berk, Michael

2018-03-01

The Canadian Network for Mood and Anxiety Treatments (CANMAT) previously published treatment guidelines for bipolar disorder in 2005, along with international commentaries and subsequent updates in 2007, 2009, and 2013. The last two updates were published in collaboration with the International Society for Bipolar Disorders (ISBD). These 2018 CANMAT and ISBD Bipolar Treatment Guidelines represent the significant advances in the field since the last full edition was published in 2005, including updates to diagnosis and management as well as new research into pharmacological and psychological treatments. These advances have been translated into clear and easy to use recommendations for first, second, and third- line treatments, with consideration given to levels of evidence for efficacy, clinical support based on experience, and consensus ratings of safety, tolerability, and treatment-emergent switch risk. New to these guidelines, hierarchical rankings were created for first and second- line treatments recommended for acute mania, acute depression, and maintenance treatment in bipolar I disorder. Created by considering the impact of each treatment across all phases of illness, this hierarchy will further assist clinicians in making evidence-based treatment decisions. Lithium, quetiapine, divalproex, asenapine, aripiprazole, paliperidone, risperidone, and cariprazine alone or in combination are recommended as first-line treatments for acute mania. First-line options for bipolar I depression include quetiapine, lurasidone plus lithium or divalproex, lithium, lamotrigine, lurasidone, or adjunctive lamotrigine. While medications that have been shown to be effective for the acute phase should generally be continued for the maintenance phase in bipolar I disorder, there are some exceptions (such as with antidepressants); and available data suggest that lithium, quetiapine, divalproex, lamotrigine, asenapine, and aripiprazole monotherapy or combination treatments should be considered first-line for those initiating or switching treatment during the maintenance phase. In addition to addressing issues in bipolar I disorder, these guidelines also provide an overview of, and recommendations for, clinical management of bipolar II disorder, as well as advice on specific populations, such as women at various stages of the reproductive cycle, children and adolescents, and older adults. There are also discussions on the impact of specific psychiatric and medical comorbidities such as substance use, anxiety, and metabolic disorders. Finally, an overview of issues related to safety and monitoring is provided. The CANMAT and ISBD groups hope that these guidelines become a valuable tool for practitioners across the globe. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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.

Study of status of safe injection practice and knowledge regarding injection safety among primary health care workers in Baglung district, western Nepal.

PubMed

Gyawali, Sudesh; Rathore, Devendra S; Kc, Bhuvan; Shankar, P Ravi

2013-01-03

Unsafe injection practices and injection overuse are widespread in developing countries harming the patient and inviting risks to the health care workers. In Nepal, there is a dearth of documented information about injection practices so the present study was carried out: a) to determine whether the selected government health facilities satisfy the conditions for safe injections in terms of staff training, availability of sterile injectable equipment and their proper disposal after use and b) to assess knowledge and attitudes of healthcare workers in these health care facilities with regard to injection safety. A descriptive cross-sectional mixed type (qualitative and quantitative) survey was carried out from 18th May to 16th June 2012. In-depth interviews with the in-charges were conducted using a semi-structured questionnaire. Observation of the health facilities using a structured observation tool was done. The data were analysed manually by summarizing, tabulating and presenting in various formats. The in-charges (eight males, two females) who participated in the study ranged in age from 30 to 50 years with a mean age of 37.8 years. Severe infection followed by pain was the most important cause for injection use with injection Gentamicin being most commonly prescribed. New single use (disposable) injections and auto-disable syringes were used to inject curative drugs and vaccines respectively. Sufficient safety boxes were also supplied to dispose the used syringe. All health care workers had received full course of Hepatitis B vaccine and were knowledgeable about at least one pathogen transmitted through unsafe injection practices. Injection safety management policy and waste disposal guideline was not available for viewing in any of the facilities. The office staff who disposed the bio-medical wastes did so without taking any safety measures. Moreover, none of these staff had received any formal training in waste management. Certain safe injection practices were noticed in the studied health care facilities but there remain a number of grey areas where unsafe practices still persists placing patient and health workers at risk of associated hazards. Training concentrating on injection safety, guidelines to dispose biomedical waste and monitoring of the activity is needed.

Study of status of safe injection practice and knowledge regarding injection safety among primary health care workers in Baglung district, western Nepal

PubMed Central

2013-01-01

Background Unsafe injection practices and injection overuse are widespread in developing countries harming the patient and inviting risks to the health care workers. In Nepal, there is a dearth of documented information about injection practices so the present study was carried out: a) to determine whether the selected government health facilities satisfy the conditions for safe injections in terms of staff training, availability of sterile injectable equipment and their proper disposal after use and b) to assess knowledge and attitudes of healthcare workers in these health care facilities with regard to injection safety. Methodology A descriptive cross-sectional mixed type (qualitative and quantitative) survey was carried out from 18th May to 16th June 2012. In-depth interviews with the in-charges were conducted using a semi-structured questionnaire. Observation of the health facilities using a structured observation tool was done. The data were analysed manually by summarizing, tabulating and presenting in various formats. Results The in-charges (eight males, two females) who participated in the study ranged in age from 30 to 50 years with a mean age of 37.8 years. Severe infection followed by pain was the most important cause for injection use with injection Gentamicin being most commonly prescribed. New single use (disposable) injections and auto-disable syringes were used to inject curative drugs and vaccines respectively. Sufficient safety boxes were also supplied to dispose the used syringe. All health care workers had received full course of Hepatitis B vaccine and were knowledgeable about at least one pathogen transmitted through unsafe injection practices. Injection safety management policy and waste disposal guideline was not available for viewing in any of the facilities. The office staff who disposed the bio-medical wastes did so without taking any safety measures. Moreover, none of these staff had received any formal training in waste management. Conclusions Certain safe injection practices were noticed in the studied health care facilities but there remain a number of grey areas where unsafe practices still persists placing patient and health workers at risk of associated hazards. Training concentrating on injection safety, guidelines to dispose biomedical waste and monitoring of the activity is needed. PMID:23286907

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

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

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.

Instrumentation Guidelines for the Advanced National Seismic System

USGS Publications Warehouse

Working Group on Instrumentation, Siting

2008-01-01

This document provides guidelines for the seismic-monitoring instrumentation used by long-term earthquake-monitoring stations that will sense ground motion, digitize and store the resulting signals in a local data acquisition unit, and optionally transmit these digital data. These guidelines are derived from specifications and requirements for data needed to address the nation's emergency response, engineering, and scientific needs as identified in U.S. Geological Survey Circular 1188 (1999). Data needs are discussed in terms of national, regional, and urban scales of monitoring in section 3. Functional performance specifications for instrumentation are introduced in section 4.3 and discussed in detail in section 6 in terms of instrument classes and definitions described in section 5. System aspects and testing recommendations are discussed in sections 7 and 8, respectively. Although U.S. Geological Survey Circular 1188 (1999) recommends that the Advanced National Seismic System (ANSS) include portable instrumentation, performance specifications for this element are not specifically addressed in this document. Nevertheless, these guidelines are largely applicable to portable instrumentation. Volcano monitoring instrumentation is also beyond the scope of this document. Guidance for ANSS structural-response monitoring is discussed briefly herein but details are deferred to the ANSS document by the ANSS Structural Response Monitoring Committee (U.S. Geological Survey, 2005). Aspects of station planning, siting, and installation other than instrumentation are beyond the scope of this document.

The use of biomarkers in occupational health research, practice, and policy.

PubMed

Schulte, P A; Hauser, J E

2012-08-13

Biomarkers are potentially useful tools for occupational health and safety research, practice, and policy. However, the full realization of this potential has not been achieved. In this paper, the progress made in these three usage areas is reviewed to identify what efforts can be taken to realize the full promise of biomarkers. Biomarker uses are described by a diverse taxonomy that builds on the categories of exposure, effect and susceptibility, and the continuum between exposure and disease prognosis. The most significant uses of biomarkers in occupational health have been in biological monitoring of workers. Other important uses have been in enhancing research and assessing mechanisms of action of occupational toxicants at low exposures. Seven critical areas will influence the extent to which the potential of biomarkers in occupational health and safety is realized. These include: (1) adequate investment in validation; (2) obtaining international agreement on exposure guidelines; (3) exploring the utility of biomarkers in regulation; (4) applying biomarkers to critical occupational safety and health questions; (5) developing the exposome; (6) utilizing biomarkers to address emerging occupational health issues; and (7) continuing to address the ethical and social justice issues related to biomarkers. Overall, if biomarkers are to make a major contribution to occupational health and safety then a more holistic approach to bringing them from the laboratory to practice will be needed. Published by Elsevier Ireland Ltd.

Kaiser Permanente implant registries benefit patient safety, quality improvement, cost-effectiveness.

PubMed

Paxton, Elizabeth W; Kiley, Mary-Lou; Love, Rebecca; Barber, Thomas C; Funahashi, Tadashi T; Inacio, Maria C S

2013-06-01

In response to the increased volume, risk, and cost of medical devices, in 2001 Kaiser Permanente (KP) developed implant registries to enhance patient safety and quality, and to evaluate cost-effectiveness. Using an integrated electronic health record system, administrative databases, and other institutional databases, orthopedic, cardiology, and vascular implant registries were developed in 2001, 2006, and 2011, respectively. These registries monitor patients, implants, clinical practices, and surgical outcomes for KP's 9 million members. Critical to registry success is surgeon leadership and engagement; each geographical region has a surgeon champion who provides feedback on registry initiatives and disseminates registry findings. The registries enhance patient safety by providing a variety of clinical decision tools such as risk calculators, quality reports, risk-adjusted medical center reports, summaries of surgeon data, and infection control reports to registry stakeholders. The registries are used to immediately identify patients with recalled devices, evaluate new and established device technology, and identify outlier implants. The registries contribute to cost-effectiveness initiatives through collaboration with sourcing and contracting groups and confirming adherence to device formulary guidelines. Research studies based on registry data have directly influenced clinical best practices. Registries are important tools to evaluate longitudinal device performance and safety, study the clinical indications for and outcomes of device implantation, respond promptly to recalls and advisories, and contribute to the overall high quality of care of our patients.

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...

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.

Evaluation and control of microbial and chemical contamination in dialysis water plants of Italian nephrology wards.

PubMed

Totaro, M; Casini, B; Valentini, P; Miccoli, M; Giorgi, S; Porretta, A; Privitera, G; Lopalco, P L; Baggiani, A

2017-10-01

Patients receiving haemodialysis are exposed to a large volume of dialysis fluid. The Italian Society of Nephrology (ISN) has published guidelines and microbial quality standards on dialysis water (DW) and solutions to ensure patient safety. To identify microbial and chemical hazards, and evaluate the quality of disinfection treatment in DW plants. In 2015 and 2016, water networks and DW plants (closed loop and online monitors) of nine dialysis wards of Italian hospitals, hosting 162 dialysis beds overall, were sampled on a monthly basis to determine the parameters provided by ISN guidelines. Chlorinated drinking water was desalinated by reverse osmosis and distributed to the closed loop which feeds all online monitors. Disinfection with peracetic acid was performed in all DW plants on a monthly basis. Over the 24-month study period, seven out of nine DW plants (78%) recorded negative results for all investigated parameters. Closed loop contamination with Burkholderia cepacia was detected in a DW plant from January 2015 to March 2015. Pseudomonas aeruginosa was isolated from March 2016 to May 2016 in the closed loop of another DW plant. These microbial contaminations were eradicated by shock disinfection with sodium hypochlorite and peracetic acid, followed by water flushing. These results highlight the importance of chemical and physical methods of DW disinfection. The maintenance of control measures in water plants hosted in dialysis wards ensures a microbial risk reduction for all dialysis patients. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Medical management of adult transsexual persons.

PubMed

Knezevich, Emily L; Viereck, Laura K; Drincic, Andjela T

2012-01-01

Gender identity disorder (GID), or transsexualism, is an increasingly recognized medical condition with an expanding body of medical literature to support the use of established therapeutic guidelines. Transsexualism can be effectively managed through exogenous cross-sex hormone administration used to induce development of desired sex characteristics, as well as use of other agents, such as aldosterone antagonists, aimed at decreasing physical characteristics of the undesired sex. Many complications can arise with the use of the available therapies, and these must be considered before determining the appropriate course of action. This review describes methods, including both pharmacotherapy and surgical interventions, for effective medical management of both male and female adults with GID. In addition, specific goals of therapy as well as safety aspects with long-term use of pharmacotherapeutic agents are discussed. This review also discusses some special considerations for treating patients with significant, yet common, comorbid diseases such as human immunodeficiency virus infection, acquired immunodeficiency syndrome, and viral hepatitis, as these conditions may complicate the clinical course and preclude some patients from using certain therapies. Pharmacist involvement in the management of transsexualism can be extremely beneficial to patients and other health care providers. Pharmacists can help determine the appropriate therapy, optimize dosages, monitor for adverse effects, and educate patients on what to expect during their therapy. Pharmacists should become knowledgeable about guidelines and current literature on transsexualism, understand the monitoring parameters for safe and effective therapy, and establish themselves as partners in the collaborative management of this disorder. © 2012, Pharmacotherapy Publications, Inc.

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

Adherence to guidelines for creatinine and potassium monitoring and discontinuation following renin-angiotensin system blockade: a UK general practice-based cohort study.

PubMed

Schmidt, Morten; Mansfield, Kathryn E; Bhaskaran, Krishnan; Nitsch, Dorothea; Sørensen, Henrik Toft; Smeeth, Liam; Tomlinson, Laurie A

2017-01-09

To examine adherence to serum creatinine and potassium monitoring and discontinuation guidelines following initiation of treatment with ACE inhibitors (ACEI) or angiotensin receptor blockers (ARBs); and whether high-risk patients are monitored. A general practice-based cohort study using electronic health records from the UK Clinical Practice Research Datalink and Hospital Episode Statistics. UK primary care, 2004-2014. 223 814 new ACEI/ARB users. Proportion of patients with renal function monitoring before and after ACEI/ARB initiation; creatinine increase ≥30% or potassium levels >6 mmol/L at first follow-up monitoring; and treatment discontinuation after such changes. Using logistic regression models, we also examined patient characteristics associated with these biochemical changes, and with follow-up monitoring within the guideline recommendation of 2 weeks after treatment initiation. 10% of patients had neither baseline nor follow-up monitoring of creatinine within 12 months before and 2 months after initiation of an ACEI/ARB, 28% had monitoring only at baseline, 15% only at follow-up, and 47% both at baseline and follow-up. The median period between the most recent baseline monitoring and drug initiation was 40 days (IQR 12-125 days). 34% of patients had baseline creatinine monitoring within 1 month before initiating therapy, but <10% also had the guideline-recommended follow-up test recorded within 2 weeks. Among patients experiencing a creatinine increase ≥30% (n=567, 1.2%) or potassium level >6 mmol/L (n=191, 0.4%), 80% continued treatment. Although patients with prior myocardial infarction, hypertension or baseline potassium >5 mmol/L were at high risk of ≥30% increase in creatinine after ACEI/ARB initiation, there was no evidence that they were more frequently monitored. Only one-tenth of patients initiating ACEI/ARB therapy receive the guideline-recommended creatinine monitoring. Moreover, the vast majority of the patients fulfilling postinitiation discontinuation criteria for creatinine and potassium increases continue on treatment. 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/.

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…

GPs' understanding and practice of safety netting for potential cancer presentations: a qualitative study in primary care.

PubMed

Evans, Julie; Ziebland, Sue; MacArtney, John I; Bankhead, Clare R; Rose, Peter W; Nicholson, Brian D

2018-05-08

Safety netting is a diagnostic strategy used in UK primary care to ensure patients are monitored until their symptoms or signs are explained. Despite being recommended in cancer diagnosis guidelines, little evidence exists about which components are effective and feasible in modern-day primary care. To understand the reality of safety netting for cancer in contemporary primary care. A qualitative study of GPs in Oxfordshire primary care. In-depth interviews with a purposive sample of 25 qualified GPs were undertaken. Interviews were recorded and transcribed verbatim, and analysed thematically using constant comparison. GPs revealed uncertainty about which aspects of clinical practice are considered safety netting. They use bespoke personal strategies, often developed from past mistakes, without knowledge of their colleagues' practice. Safety netting varied according to the perceived risk of cancer, the perceived reliability of each patient to follow advice, GP working patterns, and time pressures. Increasing workload, short appointments, and a reluctance to overburden hospital systems or create unnecessary patient anxiety have together led to a strategy of selective active follow-up of patients perceived to be at higher risk of cancer or less able to act autonomously. This left patients with low-risk-but-not-no-risk symptoms of cancer with less robust or absent safety netting. GPs would benefit from clearer guidance on which aspects of clinical practice contribute to effective safety netting for cancer. Practice systems that enable active follow-up of patients with low-risk-but-not-no-risk symptoms, which could represent malignancy, could reduce delays in cancer diagnosis without increasing GP workload. © British Journal of General Practice 2018.

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 ...

Does it work? Monitoring the effectiveness of stream management practices in Alaska.

Treesearch

Jonathan Thompson

2006-01-01

The condition of aquatic habitat and the health of aquatic species, particularly salmon, are a significant concern in the Pacific Northwest. Land management agencies use fish and riparian guidelines intended to maintain or improve aquatic habitat. Gauging whether or not those guidelines are effectively meeting their objectives requires careful monitoring of stream...

Guidelines of the previous consensus conference and recent developments.

PubMed

Beck, I T

1997-09-01

This article reviews the major changes that have occurred since the last Canadian consensus conference on gastroesophageal reflux disease (GERD), which was held four years ago. There were developments in the understanding of the pathophysiology of this disease and improvements in the methods of its investigation and management. Esophageal and extraesophageal complications have also been better defined. Since 1992 new knowledge on nitric oxide has been gained and several new inflammatory cytokines have been developed. Improved understanding of the mechanism of the hypersensitive esophagus helped to explain the presence of clinical symptoms with normal endoscopic findings. This also improved interpretation of the role of 24 h pH monitoring and 24 h pH with motility recording. There is better understanding of the role of H2 receptor antagonists and prokinetics and an increasing confidence in the long term safety of proton pump inhibitors (PPIs). The most important changes occurred in surgery with the introduction of laparoscopic fundoplication. Patients with Barrett's esophagus who are too ill for esophagectomy may now be enrolled in surveillance because it is possible to deal with dysplasia and small cancers with photodynamic therapy. As an introductory lecture to the consensus conference, this article also deals with the subject of health economics and discusses the necessity and the dangers involved in devising treatment guidelines. It indicates that guidelines change with advancing knowledge, and emphasizes that physicians' primary duty is toward their patients. Therefore, guidelines devised here should be adjusted to the individual needs of patients. Organizational aspects of the present conference are also described.

[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.

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2007-01-01

NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those requirements. This allows the projects leeway to meet these requirements in many forms that best suit a particular project's needs and safety risk. In other words, it tells the project what to do, not how to do it. This update also incorporated advances in the state of the practice of software safety from academia and private industry. It addresses some of the more common issues now facing software developers in the NASA environment such as the use of Commercial-Off-the-Shelf Software (COTS), Modified OTS (MOTS), Government OTS (GOTS), and reused software. A team from across NASA developed the update and it has had both NASA-wide internal reviews by software engineering, quality, safety, and project management. It has also had expert external review. This presentation and paper will discuss the new NASA Software Safety Standard, its organization, and key features. It will start with a brief discussion of some NASA mission failures and incidents that had software as one of their root causes. It will then give a brief overview of the NASA Software Safety Process. This will include an overview of the key personnel responsibilities and functions that must be performed for safety-critical software.

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...

Guidance on Noncorticosteroid Systemic Immunomodulatory Therapy in Noninfectious Uveitis: Fundamentals Of Care for UveitiS (FOCUS) Initiative.

PubMed

Dick, Andrew D; Rosenbaum, James T; Al-Dhibi, Hassan A; Belfort, Rubens; Brézin, Antoine P; Chee, Soon Phaik; Davis, Janet L; Ramanan, Athimalaipet V; Sonoda, Koh-Hei; Carreño, Ester; Nascimento, Heloisa; Salah, Sawsen; Salek, Sherveen; Siak, Jay; Steeples, Laura

2018-05-01

An international, expert-led consensus initiative to develop systematic, evidence-based recommendations for the treatment of noninfectious uveitis in the era of biologics. The availability of biologic agents for the treatment of human eye disease has altered practice patterns for the management of noninfectious uveitis. Current guidelines are insufficient to assure optimal use of noncorticosteroid systemic immunomodulatory agents. An international expert steering committee comprising 9 uveitis specialists (including both ophthalmologists and rheumatologists) identified clinical questions and, together with 6 bibliographic fellows trained in uveitis, conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol systematic review of the literature (English language studies from January 1996 through June 2016; Medline [OVID], the Central Cochrane library, EMBASE, CINAHL, SCOPUS, BIOSIS, and Web of Science). Publications included randomized controlled trials, prospective and retrospective studies with sufficient follow-up, case series with 15 cases or more, peer-reviewed articles, and hand-searched conference abstracts from key conferences. The proposed statements were circulated among 130 international uveitis experts for review. A total of 44 globally representative group members met in late 2016 to refine these guidelines using a modified Delphi technique and assigned Oxford levels of evidence. In total, 10 questions were addressed resulting in 21 evidence-based guidance statements covering the following topics: when to start noncorticosteroid immunomodulatory therapy, including both biologic and nonbiologic agents; what data to collect before treatment; when to modify or withdraw treatment; how to select agents based on individual efficacy and safety profiles; and evidence in specific uveitic conditions. Shared decision-making, communication among providers and safety monitoring also were addressed as part of the recommendations. Pharmacoeconomic considerations were not addressed. Consensus guidelines were developed based on published literature, expert opinion, and practical experience to bridge the gap between clinical needs and medical evidence to support the treatment of patients with noninfectious uveitis with noncorticosteroid immunomodulatory agents. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. 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.

49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been performed...

National survey of cardiologists' standard of practice for continuous ST-segment monitoring.

PubMed

Sandau, Kristin E; Sendelbach, Sue; Frederickson, Joel; Doran, Karen

2010-03-01

Continuous ST-segment monitoring can be used to detect early and transient cardiac ischemia. The American Heart Association and American Association of Critical-Care Nurses recommend its use among specific patients, but such monitoring is routine practice in only about half of US hospitals. To determine cardiologists' awareness and practice standards regarding continuous ST-segment monitoring and the physicians' perceptions of appropriate patient selection, benefits and barriers, and usefulness of this technology. An electronic survey was sent to a random sample of 915 US cardiologists from a pool of 4985 certified cardiologists. Of 200 responding cardiologists, 55% were unaware of the consensus guidelines. Of hospitals where respondents admitted patients, 49% had a standard of practice for using continuous ST-segment monitoring for cardiac patients. Most cardiologists agreed or strongly agreed that patients in the cardiovascular laboratory (87.5%) and intensive care unit (80.5%) should have such monitoring. Cardiologists routinely ordered ST monitoring for patients with acute coronary syndrome (67%) and after percutaneous coronary intervention (60%). The primary factor associated with higher perceptions for benefits, clinical usefulness, and past use of continuous ST-segment monitoring was whether or not hospitals in which cardiologists practiced had a standard of practice for using this monitoring. A secondary factor was awareness of published consensus guidelines for such monitoring. Respondents (55%) were unaware of published monitoring guidelines. Hospital leaders could raise awareness by multidisciplinary review of evidence and possibly incorporating continuous ST-segment monitoring into hospitals' standards of practice.

76 FR 16795 - The National Antimicrobial Resistance Monitoring System Strategic Plan 2011-2015; Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

....fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/default.htm , http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm062630.htm , http://www.fda.gov/AnimalVeterinary/Safety...

Renal function monitoring in heart failure – what is the optimal frequency? A narrative review

PubMed Central

Wright, David; Devonald, Mark Alexander John; Pirmohamed, Munir

2017-01-01

The second most common cause of hospitalization due to adverse drug reactions in the UK is renal dysfunction due to diuretics, particularly in patients with heart failure, where diuretic therapy is a mainstay of treatment regimens. Therefore, the optimal frequency for monitoring renal function in these patients is an important consideration for preventing renal failure and hospitalization. This review looks at the current evidence for optimal monitoring practices of renal function in patients with heart failure according to national and international guidelines on the management of heart failure (AHA/NICE/ESC/SIGN). Current guidance of renal function monitoring is in large part based on expert opinion, with a lack of clinical studies that have specifically evaluated the optimal frequency of renal function monitoring in patients with heart failure. Furthermore, there is variability between guidelines, and recommendations are typically nonspecific. Safer prescribing of diuretics in combination with other antiheart failure treatments requires better evidence for frequency of renal function monitoring. We suggest developing more personalized monitoring rather than from the current medication‐based guidance. Such flexible clinical guidelines could be implemented using intelligent clinical decision support systems. Personalized renal function monitoring would be more effective in preventing renal decline, rather than reacting to it. PMID:28901643

Multidisciplinary Optimization of Oral Chemotherapy Delivery at the University of Wisconsin Carbone Cancer Center.

PubMed

Mulkerin, Daniel L; Bergsbaken, Jason J; Fischer, Jessica A; Mulkerin, Mary J; Bohler, Aaron M; Mably, Mary S

2016-10-01

Use of oral chemotherapy is expanding and offers advantages while posing unique safety challenges. ASCO and the Oncology Nursing Society jointly published safety standards for administering chemotherapy that offer a framework for improving oral chemotherapy practice at the University of Wisconsin Carbone Cancer Center. With the goal of improving safety, quality, and uniformity within our oral chemotherapy practice, we conducted a gap analysis comparing our practice against ASCO/Oncology Nursing Society guidelines. Areas for improvement were addressed by multidisciplinary workgroups that focused on education, workflows, and information technology. Recommendations and process changes included defining chemotherapy, standardizing patient and caregiver education, mandating the use of comprehensive electronic order sets, and standardizing documentation for dose modification. Revised processes allow pharmacists to review all orders for oral chemotherapy, and they support monitoring adherence and toxicity by using a library of scripted materials. Between August 2015 and January 2016, revised processes were implemented across the University of Wisconsin Carbone Cancer Center clinics. The following are key performance indicators: 92.5% of oral chemotherapy orders (n = 1,216) were initiated within comprehensive electronic order sets (N = 1,315), 89.2% compliance with informed consent was achieved, 14.7% of orders (n = 193) required an average of 4.4 minutes review time by the pharmacist, and 100% compliance with first-cycle monitoring of adherence and toxicity was achieved. We closed significant gaps between institutional practice and published standards for our oral chemotherapy practice and experienced steady improvement and sustainable performance in key metrics. We created an electronic definition of oral chemotherapies that allowed us to leverage our electronic health records. We believe our tools are broadly applicable.

Multidisciplinary Optimization of Oral Chemotherapy Delivery at the University of Wisconsin Carbone Cancer Center

PubMed Central

Bergsbaken, Jason J.; Fischer, Jessica A.; Mulkerin, Mary J.; Bohler, Aaron M.; Mably, Mary S.

2016-01-01

Purpose: Use of oral chemotherapy is expanding and offers advantages while posing unique safety challenges. ASCO and the Oncology Nursing Society jointly published safety standards for administering chemotherapy that offer a framework for improving oral chemotherapy practice at the University of Wisconsin Carbone Cancer Center. Methods: With the goal of improving safety, quality, and uniformity within our oral chemotherapy practice, we conducted a gap analysis comparing our practice against ASCO/Oncology Nursing Society guidelines. Areas for improvement were addressed by multidisciplinary workgroups that focused on education, workflows, and information technology. Recommendations and process changes included defining chemotherapy, standardizing patient and caregiver education, mandating the use of comprehensive electronic order sets, and standardizing documentation for dose modification. Revised processes allow pharmacists to review all orders for oral chemotherapy, and they support monitoring adherence and toxicity by using a library of scripted materials. Results: Between August 2015 and January 2016, revised processes were implemented across the University of Wisconsin Carbone Cancer Center clinics. The following are key performance indicators: 92.5% of oral chemotherapy orders (n = 1,216) were initiated within comprehensive electronic order sets (N = 1,315), 89.2% compliance with informed consent was achieved, 14.7% of orders (n = 193) required an average of 4.4 minutes review time by the pharmacist, and 100% compliance with first-cycle monitoring of adherence and toxicity was achieved. Conclusion: We closed significant gaps between institutional practice and published standards for our oral chemotherapy practice and experienced steady improvement and sustainable performance in key metrics. We created an electronic definition of oral chemotherapies that allowed us to leverage our electronic health records. We believe our tools are broadly applicable. PMID:27858570

Development of a safe ground to space laser propagation system for the optical communications telescope laboratory

NASA Technical Reports Server (NTRS)

Wu, Janet P.

2003-01-01

Furthering pursuits in high bandwidth communications to future NASA deep space and neat-Earth probes, the Jet Propulsion Laboratory (JPL) is building the Optical communications Telescope Laboratory (OCTL) atop Table Mountain in Southern California. This R&D optical antenna will be used to develop optical communication strategies for future optical ground stations. Initial experiments to be conducted include propagating high-powered, Q-switched laser beams to retro-reflecting satellites. Yet laser beam propagation from the ground to space is under the cognizance of various government agencies, namely: the Occupational Safety and Health Administration (ISHA) that is responsible for protecting workforce personnel; the Federal Aviation Administration (FAA) responsible for protecting pilots and aircraft; and the Laser Clearinghouse of Space Command responsible for protecting space assets. To ensure that laser beam propagation from the OCTL and future autonomously operated ground stations comply with the guidelines of these organizations, JPL is developing a multi-tiered safety system that will meet the coordination, monitoring, and reporting functions required by the agencies. At Tier 0, laser operators will meet OSHA safety standards for protection and access to the high power lasers area will be restricted and interlocked. Tier 1, the area defined from the telescope dome out to a range of 3.4-km, will utilize long wave infrared camera sensors to alert operators of at risk aircraft in the FAA controlled airspace. Tier 2, defined to extend from 3.4-km out to the aircraft service ceiling in FAA airspace, will detect at risk aircraft by radar. Lastly, beam propagation into space, defined as Tier 3, will require coordination with the Laser Clearinghouse. A detailed description of the four tiers is presented along with the design of the integrated monitoring and beam transmission control system.

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.

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.

S3 guidelines for intensive care in cardiac surgery patients: hemodynamic monitoring and cardiocirculary system

PubMed Central

Carl, M.; Alms, A.; Braun, J.; Dongas, A.; Erb, J.; Goetz, A.; Goepfert, M.; Gogarten, W.; Grosse, J.; Heller, A. R.; Heringlake, M.; Kastrup, M.; Kroener, A.; Loer, S. A.; Marggraf, G.; Markewitz, A.; Reuter, D.; Schmitt, D. V.; Schirmer, U.; Wiesenack, C.; Zwissler, B.; Spies, C.

2010-01-01

Hemodynamic monitoring and adequate volume-therapy, as well as the treatment with positive inotropic drugs and vasopressors are the basic principles of the postoperative intensive care treatment of patient after cardiothoracic surgery. The goal of these S3 guidelines is to evaluate the recommendations in regard to evidence based medicine and to define therapy goals for monitoring and therapy. In context with the clinical situation the evaluation of the different hemodynamic parameters allows the development of a therapeutic concept and the definition of goal criteria to evaluate the effect of treatment. Up to now there are only guidelines for subareas of postoperative treatment of cardiothoracic surgical patients, like the use of a pulmonary artery catheter or the transesophageal echocardiography. The German Society for Thoracic and Cardiovascular Surgery (Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie, DGTHG) and the German Society for Anaesthesiology and Intensive Care Medicine (Deutsche Gesellschaft für Anästhesiologie und lntensivmedizin, DGAI) made an approach to ensure and improve the quality of the postoperative intensive care medicine after cardiothoracic surgery by the development of S3 consensus-based treatment guidelines. Goal of this guideline is to assess the available monitoring methods with regard to indication, procedures, predication, limits, contraindications and risks for use. The differentiated therapy of volume-replacement, positive inotropic support and vasoactive drugs, the therapy with vasodilatators, inodilatators and calcium sensitizers and the use of intra-aortic balloon pumps will also be addressed. The guideline has been developed following the recommendations for the development of guidelines by the Association of the Scientific Medical Societies in Germany (AWMF). The presented key messages of the guidelines were approved after two consensus meetings under the moderation of the Association of the Scientific Medical Societies in Germany (AWMF). PMID:20577643

Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

PubMed

Collier, Sue; Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P; McCrae, John; McCorkindale, Sheila; Leather, David

2017-03-01

The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

An Operational Safety and Health Program.

ERIC Educational Resources Information Center

Uhorchak, Robert E.

1983-01-01

Describes safety/health program activities at Research Triangle Institute (North Carolina). These include: radioisotope/radiation and hazardous chemical/carcinogen use, training, monitoring, disposal; chemical waste management; air monitoring and analysis; medical program; fire safety/training, including emergency planning; Occupational Safety and…

Pressure ulcer guideline development and dissemination in Europe.

PubMed

Meesterberends, Esther; Halfens, Ruud; Lohrmann, Christa; de Wit, Rianne

2010-06-01

To explore the current state of pressure ulcer guideline development and dissemination, from national to local level (i.e. nursing homes) in six European countries: England, Germany, Italy, the Netherlands, Portugal and Sweden. Pressure ulcers are a persistent problem in healthcare institutions. Their prevalence is influenced by many factors, one of them being the development and dissemination of pressure ulcer guidelines. These are difficult and complex processes and it is not clear whether they differ between European countries. Literature review and semi-structured interviews. Interviews were conducted in six countries at national and nursing home level. Four countries had national pressure ulcer prevention and treatment guidelines. Portugal had no national guidelines and Sweden had shifted the responsibility to regional level. All participating nursing homes had pressure ulcer guidelines except those in Portugal. Control and monitoring of guideline dissemination was carried out only in Sweden and England. All countries studied have national or regional pressure ulcer prevention and treatment guidelines, except Portugal. Portugal is also the only country where none of the nursing homes included had pressure ulcer guidelines. Because the dissemination of such guidelines does not imply actual implementation, further research should focus on the implementation process. Clinical guidelines, like pressure ulcer guidelines, are important tools in guiding the care processes in healthcare institutions. Successful dissemination of guidelines from national level to individual healthcare institutions is a first and necessary step in actually applying them. Monitoring of the guideline dissemination process is therefore essential.

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

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

Keeping Up with the Diabetes Technology: 2016 Endocrine Society Guidelines of Insulin Pump Therapy and Continuous Glucose Monitor Management of Diabetes.

PubMed

Galderisi, Alfonso; Schlissel, Elise; Cengiz, Eda

2017-09-23

Decades after the invention of insulin pump, diabetes management has encountered a technology revolution with the introduction of continuous glucose monitoring, sensor-augmented insulin pump therapy and closed-loop/artificial pancreas systems. In this review, we discuss the significance of the 2016 Endocrine Society Guidelines for insulin pump therapy and continuous glucose monitoring and summarize findings from relevant diabetes technology studies that were conducted after the publication of the 2016 Endocrine Society Guidelines. The 2016 Endocrine Society Guidelines have been a great resource for clinicians managing diabetes in this new era of diabetes technology. There is good body of evidence indicating that using diabetes technology systems safely tightens glycemic control while managing both type 1 and type 2 diabetes. The first-generation diabetes technology systems will evolve as we gain more experience and collaboratively work to improve them with an ultimate goal of keeping people with diabetes complication and burden-free until the cure for diabetes becomes a reality.

A Systems Approach to Evaluating Ionizing Radiation: Six Focus Areas to Improve Quality, Efficiency, and Patient Safety

PubMed Central

Mower, Laura; Bushe, Chris

2015-01-01

Abstract: Ionizing radiation is an essential component of the care process. However, providers and patients may not be fully aware of the risks involved, the level of ionizing radiation delivered with various procedures, or the potential for harm through incidental overexposure or cumulative dose. Recent high-profile incidents demonstrating the devastating short-term consequences of radiation overexposure have drawn attention to these risks, but applicable solutions are lacking. Although various recommendations and guidelines have been proposed, organizational variability challenges providers to identify their own practical solutions. To identify potential failure modes and develop solutions to preserve patient safety within a large, national healthcare system, we assembled a multidisciplinary team to conduct a comprehensive analysis of practices surrounding the delivery of ionizing radiation. Workgroups were developed to analyze existing culture, processes, and technology to identify deficiencies and propose solutions. Six focus areas were identified: competency and certification; equipment; monitoring and auditing; education; clinical pathways; and communication and marketing. This manuscript summarizes this comprehensive, multidisciplinary, and systemic analysis of risk and provides examples to illustrate how these focus areas can be used to improve the use of ionizing radiation. The proposed solutions, once fully implemented, may advance patient safety and care. PMID:26042626

Good manufacturing practice and viral safety.

PubMed

Kerner, B

1995-07-01

The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.

Characterization of exposure to silver nanoparticles in a manufacturing facility

NASA Astrophysics Data System (ADS)

Park, Junsu; Kwak, Byoung Kyu; Bae, Eunjoo; Lee, Jeongjin; Kim, Younghun; Choi, Kyunghee; Yi, Jongheop

2009-10-01

An assessment of the extent of exposure to nanomaterials in the workplace will be helpful in improving the occupational safety of workers. It is essential that the exposure data in the workplace are concerned with risk management to evaluate and reduce worker exposure. In a manufacturing facility dealing with nanomaterials, some exposure data for gas-phase reactions are available, but much less information is available regarding liquid-phase reactions. Although the potential for inhaling nanomaterials in a liquid-phase process is less than that for gas-phase, the risks of exposure during wet-chemistry processes are not negligible. In this study, we monitored and analyzed the exposure characteristics of silver nanoparticles during a liquid-phase process in a commercial production facility. Based on the measured exposure data, the source of Ag nanoparticles emitted during the production processes was indentified and a mechanism for the growth of Ag nanoparticle released is proposed. The data reported in this study could be used to establish occupational safety guidelines in the nanotechnology workplace, especially in a liquid-phase production facility.

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.

Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study

PubMed Central

Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David

2016-01-01

Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. PMID:27804174

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 ...

A Novel Series Connected Batteries State of High Voltage Safety Monitor System for Electric Vehicle Application

PubMed Central

Jiaxi, Qiang; Lin, Yang; Jianhui, He; Qisheng, Zhou

2013-01-01

Batteries, as the main or assistant power source of EV (Electric Vehicle), are usually connected in series with high voltage to improve the drivability and energy efficiency. Today, more and more batteries are connected in series with high voltage, if there is any fault in high voltage system (HVS), the consequence is serious and dangerous. Therefore, it is necessary to monitor the electric parameters of HVS to ensure the high voltage safety and protect personal safety. In this study, a high voltage safety monitor system is developed to solve this critical issue. Four key electric parameters including precharge, contact resistance, insulation resistance, and remaining capacity are monitored and analyzed based on the equivalent models presented in this study. The high voltage safety controller which integrates the equivalent models and control strategy is developed. By the help of hardware-in-loop system, the equivalent models integrated in the high voltage safety controller are validated, and the online electric parameters monitor strategy is analyzed and discussed. The test results indicate that the high voltage safety monitor system designed in this paper is suitable for EV application. PMID:24194677

A novel series connected batteries state of high voltage safety monitor system for electric vehicle application.

PubMed

Jiaxi, Qiang; Lin, Yang; Jianhui, He; Qisheng, Zhou

2013-01-01

Batteries, as the main or assistant power source of EV (Electric Vehicle), are usually connected in series with high voltage to improve the drivability and energy efficiency. Today, more and more batteries are connected in series with high voltage, if there is any fault in high voltage system (HVS), the consequence is serious and dangerous. Therefore, it is necessary to monitor the electric parameters of HVS to ensure the high voltage safety and protect personal safety. In this study, a high voltage safety monitor system is developed to solve this critical issue. Four key electric parameters including precharge, contact resistance, insulation resistance, and remaining capacity are monitored and analyzed based on the equivalent models presented in this study. The high voltage safety controller which integrates the equivalent models and control strategy is developed. By the help of hardware-in-loop system, the equivalent models integrated in the high voltage safety controller are validated, and the online electric parameters monitor strategy is analyzed and discussed. The test results indicate that the high voltage safety monitor system designed in this paper is suitable for EV application.

[Immunogenicity of biosimilars].

PubMed

van Aerts, L A G J M; Franken, A A M; Leufkens, H G M

2016-01-01

Biosimilars of more complex recombinant protein drugs, such as monoclonal antibodies and fusion proteins, are entering the market. The manufacturer should demonstrate that its product does not show any relevant differences in terms of quality characteristics, biological activity, safety and efficacy compared to the reference product, as outlined in EMA guidelines. This should be established with an extensive comparability exercise. One aspect that is subject to particular scrutiny is the immunogenicity of the biosimilar and the reference medicinal product. For three cases, one etanercept and two infliximab biosimilars, we describe how data are assessed and an opinion is reached by authorities. Not in all cases unanimity exists whether all remaining uncertainties on biosimilarity have been resolved satisfactorily before marketing authorisation. The Dutch Medicines Evaluation Board therefore emphasises that even after marketing authorisation, biosimilars and other biologicals should be properly monitored.

Preliminary Thermal Characterization of a Fully-Passive Wireless Backscattering Neuro-Recording Microsystem

NASA Technical Reports Server (NTRS)

Schwerdt, H. N.; Xu, W.; Shekhar, S.; Chae, J.; Miranda, F. A.

2011-01-01

We present analytical and experimental thermal characteristics of a battery-less, fully-passive wireless backscattering microsystem for recording of neuropotentials. A major challenge for cortically implantable microsystems involves minimizing the heat dissipated by on-chip circuitry, which can lead to permanent brain damage. Therefore, knowledge of temperature changes induced by implantable microsystems while in operation is of utmost importance. In this work, a discrete diode appended to the neuro-recording microsystem has been used to indirectly monitor the aforesaid temperature changes. Using this technique, the maximum temperature rise measured for the microsystem while in operation was 0.15 +/- 0.1 C, which is significantly less than current safety guidelines. Specific absorption ratio (SAR) due to the microsystem was also computed to further demonstrate fully-passive functionality of the neuro-recording microsystem.

Improving nurses' knowledge of continuous ST-segment monitoring.

PubMed

Chronister, Connie

2014-01-01

Continuous ST-segment monitoring can result in detection of myocardial ischemia, but in clinical practice, continuous ST-segment monitoring is conducted incorrectly and underused by many registered nurses (RNs). Many RNs are unable to correctly institute ST-segment monitoring guidelines because of a lack of education. To evaluate whether an educational intervention, provided to 32 RNs, increases knowledge and correct clinical decision making (CDM) for the use of continuous ST-segment monitoring. At a single institution, an ST-segment monitoring class was provided to RNs in 2 cardiovascular units. Knowledge and correct CDM instruments were used for a baseline pretest and subsequent posttest after ST-segment monitoring education. Statistical significance between pretest and posttest scores for knowledge and correct CDM practice was noted with dependent t tests (P = .0001). Many RNs responsible for electrocardiographic monitoring are not aware of evidence-based ST-segment monitoring practice guidelines and cannot properly place precordial leads needed for ST-segment monitoring. Knowledge and correct CDM with ST-segment monitoring can be improved with focused education.

An Advisory Committee for the Regulation of Innovation in Gynaecologic Practice: Development and Implementation.

PubMed

Farrell, Scott A; Van Eyk, Nancy

2016-08-01

The fundamental precepts that underpin the delivery of all medical care are safety and efficacy. Although these precepts, in theory, are accepted without challenge, in many settings where clinical care is delivered, there is a lack of formal oversight necessary to ensure their implementation in practice. Even though most medical specialties have national bodies that provide guidelines for good medical practice, and hospital accreditation makes reference to dissemination of such guidelines, there is usually not a mechanism to monitor medical uptake and adherence to good practice in the day-to-day delivery of care. Most hospitals require approval by an institutional review board before research protocols can be undertaken, but regional health authorities and hospitals do not usually have formal processes in place to regulate the adoption of new technologies into clinical practice. Recognizing the lack of a formal process at the hospital level to guide and regulate the introduction of new technologies or procedures, we set out to establish an oversight process to fill this gap. A committee was established to oversee innovation in the Gynaecology Division of our hospital. We describe here the establishment of this committee, the tools the committee used, and the processes used for the committee to do its work. We conclude that formal, local oversight of medical innovation is indispensible for ensuring the high standards of medical practice necessary to optimize patient safety. Copyright © 2016 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

Applying openEHR's Guideline Definition Language to the SITS international stroke treatment registry: a European retrospective observational study.

PubMed

Anani, Nadim; Mazya, Michael V; Chen, Rong; Prazeres Moreira, Tiago; Bill, Olivier; Ahmed, Niaz; Wahlgren, Nils; Koch, Sabine

2017-01-10

Interoperability standards intend to standardise health information, clinical practice guidelines intend to standardise care procedures, and patient data registries are vital for monitoring quality of care and for clinical research. This study combines all three: it uses interoperability specifications to model guideline knowledge and applies the result to registry data. We applied the openEHR Guideline Definition Language (GDL) to data from 18,400 European patients in the Safe Implementation of Treatments in Stroke (SITS) registry to retrospectively check their compliance with European recommendations for acute stroke treatment. Comparing compliance rates obtained with GDL to those obtained by conventional statistical data analysis yielded a complete match, suggesting that GDL technology is reliable for guideline compliance checking. The successful application of a standard guideline formalism to a large patient registry dataset is an important step toward widespread implementation of computer-interpretable guidelines in clinical practice and registry-based research. Application of the methodology gave important results on the evolution of stroke care in Europe, important both for quality of care monitoring and clinical research.

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

Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

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

O, J.M.; Higgins, J.; Stephen Fleger - NRC

The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodicmore » update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.« 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…

Guidelines and standard procedures for continuous water-quality monitors: Station operation, record computation, and data reporting

USGS Publications Warehouse

Wagner, Richard J.; Boulger, Robert W.; Oblinger, Carolyn J.; Smith, Brett A.

2006-01-01

The U.S. Geological Survey uses continuous water-quality monitors to assess the quality of the Nation's surface water. A common monitoring-system configuration for water-quality data collection is the four-parameter monitoring system, which collects temperature, specific conductance, dissolved oxygen, and pH data. Such systems also can be configured to measure other properties, such as turbidity or fluorescence. Data from sensors can be used in conjunction with chemical analyses of samples to estimate chemical loads. The sensors that are used to measure water-quality field parameters require careful field observation, cleaning, and calibration procedures, as well as thorough procedures for the computation and publication of final records. This report provides guidelines for site- and monitor-selection considerations; sensor inspection and calibration methods; field procedures; data evaluation, correction, and computation; and record-review and data-reporting processes, which supersede the guidelines presented previously in U.S. Geological Survey Water-Resources Investigations Report WRIR 00-4252. These procedures have evolved over the past three decades, and the process continues to evolve with newer technologies.

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.

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.

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...

CSHM: Web-based safety and health monitoring system for construction management.

PubMed

Cheung, Sai On; Cheung, Kevin K W; Suen, Henry C H

2004-01-01

This paper describes a web-based system for monitoring and assessing construction safety and health performance, entitled the Construction Safety and Health Monitoring (CSHM) system. The design and development of CSHM is an integration of internet and database systems, with the intent to create a total automated safety and health management tool. A list of safety and health performance parameters was devised for the management of safety and health in construction. A conceptual framework of the four key components of CSHM is presented: (a) Web-based Interface (templates); (b) Knowledge Base; (c) Output Data; and (d) Benchmark Group. The combined effect of these components results in a system that enables speedy performance assessment of safety and health activities on construction sites. With the CSHM's built-in functions, important management decisions can theoretically be made and corrective actions can be taken before potential hazards turn into fatal or injurious occupational accidents. As such, the CSHM system will accelerate the monitoring and assessing of performance safety and health management tasks.

A Smartphone-Based Driver Safety Monitoring System Using Data Fusion

PubMed Central

Lee, Boon-Giin; Chung, Wan-Young

2012-01-01

This paper proposes a method for monitoring driver safety levels using a data fusion approach based on several discrete data types: eye features, bio-signal variation, in-vehicle temperature, and vehicle speed. The driver safety monitoring system was developed in practice in the form of an application for an Android-based smartphone device, where measuring safety-related data requires no extra monetary expenditure or equipment. Moreover, the system provides high resolution and flexibility. The safety monitoring process involves the fusion of attributes gathered from different sensors, including video, electrocardiography, photoplethysmography, temperature, and a three-axis accelerometer, that are assigned as input variables to an inference analysis framework. A Fuzzy Bayesian framework is designed to indicate the driver’s capability level and is updated continuously in real-time. The sensory data are transmitted via Bluetooth communication to the smartphone device. A fake incoming call warning service alerts the driver if his or her safety level is suspiciously compromised. Realistic testing of the system demonstrates the practical benefits of multiple features and their fusion in providing a more authentic and effective driver safety monitoring. PMID:23247416

[Perception of health and safety risks among workers pathology laboratories].

PubMed

Alvarado-Cabrero, Isabel; Valencia-Cedillo, Raquel

2015-01-01

Health care workers are experiencing increasing numbers of occupational illnesses. Safety practices in anatomical pathology laboratories (APL) are crucial to prevent unnecessary exposures to both chemical and biological agents. The main goal of this study was to determine if pathologists perceptions and actual practice mirror regulatory guidelines. Current available recommendations for APL were reviewed and used to construct an online survey distributed to pathologists. The survey was completed by 121 participants. Eighty-seven (72 %) of respondents reported receiving inadequate safety training. Most pathologists (82 %) were not well-informed about biosafety practices. Sixty-three (52 %) participants felt that the risks of chemical and infectious disease exposures in the APL were low. Most respondents reported having a needle stick or cut (71 %). Eighty-six (71 %) of participants reported musculo skeletal problems. This study indicated that there is a need for improving training in anatomical pathology safety practices in Mexican laboratories as daily practices do not reflected current guidelines.

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

EPA OFFICE OF RESEARCH AND DEVELOPMENT GUIDELINES FOR TECHNICAL EVALUATION OF ECOLOGICAL INDICATORS

EPA Science Inventory

EPA's Office of Research and Development (ORD) has prepared fifteen technical guidelines to evaluate the suitability of an ecological indicator in a monitoring program. The guidelines were fashioned to provide a consistent framework for indicator review and to provide direction f...

STRATEGIES FOR EVALUATING INDICATORS BASED ON GUIDELINES FROM THE ENVIRONMENTAL PROTECTION AGENCY'S OFFICE OF RESEARCH AND DEVELOPMENT.

EPA Science Inventory

The Environmental Protection Agency's Office of Research and Development (ORD) has prepared technical guidelines to evaluate the suitability of ecological indicators for monitoring programs. The guidelines were adopted by ORD to provide a consistent framework for indicator review...

Monitoring Haloperidol Plasma Concentration and Associated Adverse Events in Critically Ill Children With Delirium: First Results of a Clinical Protocol Aimed to Monitor Efficacy and Safety.

PubMed

Slooff, Valerie D; van den Dungen, Desley K; van Beusekom, Babette S; Jessurun, Naomi; Ista, Erwin; Tibboel, Dick; de Wildt, Saskia N

2018-02-01

As delirium in critically ill children is increasingly recognized, more children are treated with the antipsychotic drug haloperidol, while current dosing guidelines are lacking solid evidence and appear to be associated with a high risk of adverse events. We aim to report on the safety and efficacy of a recently implemented clinical dose-titration protocol with active monitoring of adverse events. From July 2014 until June 2015, when a potential delirium was identified by regular delirium scores and confirmed by a child psychiatrist, haloperidol was prescribed according to the Dutch Pediatric Formulary. Daily, adverse events were systematically assessed, haloperidol plasma concentrations were measured, and delirium symptoms followed. Dependent on the clinical response, plasma concentration, and adverse event, the dose was adjusted. A 28-bed tertiary PICU in the Netherlands. All patients admitted to the PICU diagnosed with delirium. Treatment with haloperidol according to a dose-titration protocol MEASUREMENTS AND MAIN RESULTS:: Thirteen children (median age [range] 8.3 yr [0.4-13.8 yr]) received haloperidol, predominantly IV (median dose [range] 0.027 mg/kg/d [0.005-0.085 mg/kg/d]). In all patients, pediatric delirium resolved, but five of 13 patients developed possible adverse event. These were reversed after biperiden (n = 2), discontinuing (n = 3), and/or lowering the dose (n = 3). Plasma concentrations were all below the presumed therapeutic threshold of 3-12 µg/L. Prospective systematic monitoring of adverse event in critically ill children receiving haloperidol revealed a significant proportion of possible adverse events. Adverse event developed despite low plasma concentrations and recommended dose administration in the majority of the patients. Our data suggest that haloperidol can potentially improve pediatric delirium, but it might also put patients at risk for developing adverse events.

Monitoring therapeutic anticoagulation with low molecular weight heparins: is it useful or misleading?

PubMed

Hammerstingl, C

2008-10-01

Weight adapted low molecular weight heparin (LMWH) treatment is recommended as initial anticoagulant therapy of deep vein thrombosis, pulmonary embolism, in patients with myocardial ischemia or when oral anticoagulation (OAC) must be interrupted peri- operatively. Traditionally unfractioned heparin (UFH) was used as standard short acting anticoagulant, with the therapy monitored by frequent laboratory testing. Currently LMWH have broadly replaced UFH as first- choice anticoagulant due to more preferable pharmacokinetics and a better safety profile. Therapeutic anticoagulation with LMWH can be achieved by subcutaneous weight adapted application and measurement of anti-factor Xa- activity (anti-Xa) has been established as gold standard for LMWH- monitoring. However, since almost all LMWH dosing regimens have been developed empirically without laboratory monitoring, there is still a debate ongoing about the usefulness and impact of anti-Xa-testing. Data are lacking that prove a clear correlation between obtained levels of anti-Xa and the patients' clinical outcome. Newer methods have been developed aiming to determine a broader spectrum of LMWH depending anticoagulant activity. Even though there are some promising preliminary results, these alternative methods are not ready for routine clinical use yet. Nevertheless, current guidelines advise determination of anti-Xa in special patient populations with markedly altered LMWH metabolism or to exclude residual LMWH- activity before surgery at very high risk of bleeding. The aim of this article is to review critically the usefulness of anti- Xa guidance of LMWH- therapy and to give new perspectives on upcoming methods of LMWH- monitoring.

Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline.

PubMed

Peters, Anne L; Ahmann, Andrew J; Battelino, Tadej; Evert, Alison; Hirsch, Irl B; Murad, M Hassan; Winter, William E; Wolpert, Howard

2016-11-01

To formulate clinical practice guidelines for the use of continuous glucose monitoring and continuous subcutaneous insulin infusion in adults with diabetes. The participants include an Endocrine Society-appointed Task Force of seven experts, a methodologist, and a medical writer. The American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology co-sponsored this guideline. The Task Force developed this evidence-based guideline using the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned one systematic review and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Continuous subcutaneous insulin infusion and continuous glucose monitoring have an important role in the treatment of diabetes. Data from randomized controlled trials are limited on the use of medical devices, but existing studies support the use of diabetes technology for a wide variety of indications. This guideline presents a review of the literature and practice recommendations for appropriate device use.

Monitoring circuit for reactor safety systems

DOEpatents

Keefe, Donald J.

1976-01-01

The ratio between the output signals of a pair of reactor safety channels is monitored. When ratio falls outside of a predetermined range, it indicates that one or more of the safety channels has malfunctioned.

49 CFR 193.2635 - Monitoring corrosion control.

Code of Federal Regulations, 2010 CFR

2010-10-01

....2635 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES: FEDERAL SAFETY STANDARDS Maintenance § 193.2635 Monitoring corrosion control...

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…

Revision of OECD Guidelines for Genotoxicity Testing: Current Status and Next Steps

EPA Science Inventory

Over the past 30 years, assays have been developed to evaluate chemical genotoxicity. OECD Genotoxicity Test Guidelines (TG) describe assay procedures for regulatory safety testing. Since the last OECD TG revision (1997), there has been tremendous scientific and technological pro...

Renal function monitoring in heart failure - what is the optimal frequency? A narrative review.

PubMed

Al-Naher, Ahmed; Wright, David; Devonald, Mark Alexander John; Pirmohamed, Munir

2018-01-01

The second most common cause of hospitalization due to adverse drug reactions in the UK is renal dysfunction due to diuretics, particularly in patients with heart failure, where diuretic therapy is a mainstay of treatment regimens. Therefore, the optimal frequency for monitoring renal function in these patients is an important consideration for preventing renal failure and hospitalization. This review looks at the current evidence for optimal monitoring practices of renal function in patients with heart failure according to national and international guidelines on the management of heart failure (AHA/NICE/ESC/SIGN). Current guidance of renal function monitoring is in large part based on expert opinion, with a lack of clinical studies that have specifically evaluated the optimal frequency of renal function monitoring in patients with heart failure. Furthermore, there is variability between guidelines, and recommendations are typically nonspecific. Safer prescribing of diuretics in combination with other antiheart failure treatments requires better evidence for frequency of renal function monitoring. We suggest developing more personalized monitoring rather than from the current medication-based guidance. Such flexible clinical guidelines could be implemented using intelligent clinical decision support systems. Personalized renal function monitoring would be more effective in preventing renal decline, rather than reacting to it. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

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

Systems safety monitoring using the National Full-Scale Aerodynamic Complex Bar Chart Monitor

NASA Technical Reports Server (NTRS)

Jung, Oscar

1990-01-01

Attention is given to the Bar Chart Monitor system designed for safety monitoring of all model and facility test-related articles in wind tunnels. The system's salient features and its integration into the data acquisition system are discussed.

Fasting guidelines for diabetic children and adolescents

PubMed Central

Azad, Kiswhar; Mohsin, Fauzia; Zargar, Abdul Hamid; Zabeen, Bedowra; Ahmad, Jamal; Raza, Syed Abbas; Tayyeb, Samin; Bajaj, Sarita; Ishtiaq, Osama; Kalra, Sanjay

2012-01-01

Fasting during the month of Ramadan, the ninth month of Islamic lunar calendar, is obligatory for all healthy adult and adolescent Muslims from the age of 12 years. Fasting starts from early dawn (Sohur/Sehri) till sunset (Iftar). During this period one has to abstain from eating and drinking. Islam has allowed many categories of people to be exempted from fasting, for example, young children, travelers, the sick, the elderly, pregnant, and lactating women. According to expert opinion, patients with type 1 diabetes (type 1 DM) who fast during Ramadan are at a very high risk to develop adverse events. However, some experienced physicians are of the opinion that fasting during Ramadan is safe for type 1 DM patients, including adolescents and older children, with good glycemic control who do regular self-monitoring and are under close professional supervision. The strategies to ensure safety of type 1 diabetic adolescents who are planning to fast include the following: Ramadan-focused medical education, pre-Ramadan medical assessment, following a healthy diet and physical activity pattern, modification in insulin regimen, and blood glucose monitoring as advised by the physician. PMID:22837907

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model.

PubMed

Ali, Mohammad; Rath, Barbara; Thiem, Vu Dinh

2015-01-01

Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.

U.S. EPA OFFICE OF RESEARCH AND DEVELOPMENT GUIDELINES FOR TECHNICAL EVALUATION OF ECOLOGICAL INDICATORS

EPA Science Inventory

EPA's Office of Research and Development (ORD) has prepared fifteen technical guidelines to evaluate the suitability of an ecological indicator in a monitoring program. The guidelines were fashioned to provide a consistent framework for indicator review and to provide direction f...

Measurement guidelines for the sequestration of forest carbon

Treesearch

Timothy R.H. Pearson; Sandra L. Brown; Richard A. Birdsey

2007-01-01

Measurement guidelines for forest carbon sequestration were developed to support reporting by public and private entities to greenhouse gas registries. These guidelines are intended to be a reference for designing a forest carbon inventory and monitoring system by professionals with a knowledge of sampling, statistical estimation, and forest measurements. This report...

Advances in analytical technologies for environmental protection and public safety.

PubMed

Sadik, O A; Wanekaya, A K; Andreescu, S

2004-06-01

Due to the increased threats of chemical and biological agents of injury by terrorist organizations, a significant effort is underway to develop tools that can be used to detect and effectively combat chemical and biochemical toxins. In addition to the right mix of policies and training of medical personnel on how to recognize symptoms of biochemical warfare agents, the major success in combating terrorism still lies in the prevention, early detection and the efficient and timely response using reliable analytical technologies and powerful therapies for minimizing the effects in the event of an attack. The public and regulatory agencies expect reliable methodologies and devices for public security. Today's systems are too bulky or slow to meet the "detect-to-warn" needs for first responders such as soldiers and medical personnel. This paper presents the challenges in monitoring technologies for warfare agents and other toxins. It provides an overview of how advances in environmental analytical methodologies could be adapted to design reliable sensors for public safety and environmental surveillance. The paths to designing sensors that meet the needs of today's measurement challenges are analyzed using examples of novel sensors, autonomous cell-based toxicity monitoring, 'Lab-on-a-Chip' devices and conventional environmental analytical techniques. Finally, in order to ensure that the public and legal authorities are provided with quality data to make informed decisions, guidelines are provided for assessing data quality and quality assurance using the United States Environmental Protection Agency (US-EPA) methodologies.

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.

Infection control in healthcare settings: perspectives for mfDNA analysis in monitoring sanitation procedures.

PubMed

Valeriani, Federica; Protano, Carmela; Gianfranceschi, Gianluca; Cozza, Paola; Campanella, Vincenzo; Liguori, Giorgio; Vitali, Matteo; Divizia, Maurizio; Romano Spica, Vincenzo

2016-08-09

Appropriate sanitation procedures and monitoring of their actual efficacy represent critical points for improving hygiene and reducing the risk of healthcare-associated infections. Presently, surveillance is based on traditional protocols and classical microbiology. Innovation in monitoring is required not only to enhance safety or speed up controls but also to prevent cross infections due to novel or uncultivable pathogens. In order to improve surveillance monitoring, we propose that biological fluid microflora (mf) on reprocessed devices is a potential indicator of sanitation failure, when tested by an mfDNA-based approach. The survey focused on oral microflora traces in dental care settings. Experimental tests (n = 48) and an "in field" trial (n = 83) were performed on dental instruments. Conventional microbiology and amplification of bacterial genes by multiple real-time PCR were applied to detect traces of salivary microflora. Six different sanitation protocols were considered. A monitoring protocol was developed and performance of the mfDNA assay was evaluated by sensitivity and specificity. Contaminated samples resulted positive for saliva traces by the proposed approach (CT < 35). In accordance with guidelines, only fully sanitized samples were considered negative (100 %). Culture-based tests confirmed disinfectant efficacy, but failed in detecting incomplete sanitation. The method provided sensitivity and specificity over 95 %. The principle of detecting biological fluids by mfDNA analysis seems promising for monitoring the effectiveness of instrument reprocessing. The molecular approach is simple, fast and can provide a valid support for surveillance in dental care or other hospital settings.

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...

Differences in national legislation for the implementation of lead regulations included in the European directive for the protection of the health and safety of workers with occupational exposure to chemical agents (98/24/EC).

PubMed

Taylor, Andrew; Angerer, Jurgen; Arnaud, Josiane; Claeys, Françoise; Kristiansen, Jesper; Mazarrasa, Olav; Menditto, Antonio; Patriarca, Marina; Pineau, Alain; Valkonen, Sinikka; Weykamp, Cas

2007-01-01

The European Council Directive 98/24 on the protection of the health and safety of workers exposed to chemical agents sets out provisions for environmental and biological monitoring, making specific reference to binding limit values and health surveillance measures for those with exposure to lead To compare how the Directive has been implemented at a national level in EU countries and to determine whether workers receive equivalent protection. Information on selected key issues was collected from 14 EU countries by means of a structured questionnaire. National occupational exposure limit values generally reflect that set by the Directive (0.15 mg/m(3)), but in five cases lower limits are set. National binding biological limit values range from 20 microg/100 ml blood in one country up to 80 microg/100 ml blood in others. The risk to the unborn child is generally recognised with specific measures for women of child-bearing potential or those that are pregnant or breast feeding. In only three countries are special arrangements included for young workers. Limits at which medical surveillance is put into effect are more consistent at 40 microg/100 ml in most countries. The Directive also refers to guidelines for health surveillance but none have been issued with respect to lead. Thus monitoring strategies and requirements for analytical performance vary considerably. The results of this survey suggest that protection of workers against the risk of exposure to lead at work is far from uniform across the European Union. Such disparity may also have implications on the requirements set at national level for laboratories measuring lead in blood and/or air. In the interest of harmonisation within the EU, further consideration should be given to the Annex II of the EC Directive 98/24, taking into account the suggestions for lower binding limit values for lead; this should include full guidelines for medical surveillance and requirements for laboratories should be issued.

Prescriber Compliance With Liver Monitoring Guidelines for Pazopanib in the Postapproval Setting: Results From a Distributed Research Network.

PubMed

Shantakumar, Sumitra; Nordstrom, Beth L; Hall, Susan A; Djousse, Luc; van Herk-Sukel, Myrthe P P; Fraeman, Kathy H; Gagnon, David R; Chagin, Karen; Nelson, Jeanenne J

2017-04-20

Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines. Over a 4-year period, a distributed network approach was used across 3 databases: US Veterans Affairs Healthcare System, a US outpatient oncology community practice database, and the Dutch PHARMO Database Network. Measures of prescriber compliance were designed using the original pazopanib label guidelines for liver monitoring. Results from the VA (n = 288) and oncology databases (n = 283) indicate that prescriber liver chemistry monitoring was less than 100%: 73% to 74% compliance with baseline testing and 37% to 39% compliance with testing every 4 weeks. Compliance was highest near drug initiation and decreased over time. Among patients who should have had weekly testing, the compliance was 56% in both databases. The more serious elevations examined, including combinations of liver enzyme elevations meeting the laboratory definition of Hy's law were infrequent but always led to appropriate discontinuation of pazopanib. Only 4 patients were identified for analysis in the Dutch database; none had recorded baseline testing. In this population-based study, prescriber compliance was reasonable near pazopanib initiation but low during subsequent weeks of treatment. This study provides information from real-world community practice settings and offers feedback to regulators on the effectiveness of label monitoring guidelines.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Pharmacist-led implementation of a vancomycin guideline across medical and surgical units: impact on clinical behavior and therapeutic drug monitoring outcomes

PubMed Central

Phillips, Cameron J; Gordon, David L

2015-01-01

Background Vancomycin is the antibiotic of choice for the treatment of serious infections such as methicillin-resistant Staphylococcus aureus (MRSA). Inappropriate prescribing of vancomycin can lead to therapeutic failure, antibiotic resistance, and drug toxicity. Objective To examine the effectiveness of pharmacist-led implementation of a clinical practice guideline for vancomycin dosing and monitoring in a teaching hospital. Methods An observational pre–post study design was undertaken to evaluate the implementation of the vancomycin guideline. The implementation strategy principally involved education, clinical vignettes, and provision of pocket guidelines to accompany release of the guideline to the hospital Intranet. The target cohort for clinical behavioral change was junior medical officers, as they perform the majority of prescribing and monitoring of vancomycin in hospitals. Assessment measures were recorded for vancomycin prescribing, therapeutic drug monitoring, and patient outcomes. Results Ninety-nine patients, 53 pre- and 46 post-implementation, were included in the study. Prescribing of a loading dose increased from 9% to 28% (P=0.02), and guideline adherence to starting maintenance dosing increased from 53% to 63% (P=0.32). Dose adjustment by doctors when blood concentrations were outside target increased from 53% to 71% (P=0.12), and correct timing of initial concentration measurement increased from 43% to 57% (P=0.23). Appropriately timed trough concentrations improved from 73% to 81% (P=0.08). Pre-dose (trough) concentrations in target range rose from 33% to 44% (P=0.10), while potentially toxic concentrations decreased from 32% to 21% (P=0.05) post-implementation. Infection cure rates for patients increased from 85% to 96% (P=0.11) after the guideline was implemented. Conclusion The implementation strategy employed in this study demonstrated potential effectiveness, and should prompt additional larger studies to optimize strategies that will translate into improved clinical practice using vancomycin. PMID:29354529

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.

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

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - Current challenges and approaches.

PubMed

Broschard, Thomas H; Glowienke, Susanne; Bruen, Uma S; Nagao, Lee M; Teasdale, Andrew; Stults, Cheryl L M; Li, Kim L; Iciek, Laurie A; Erexson, Greg; Martin, Elizabeth A; Ball, Douglas J

2016-11-01

Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies may be performed as a risk mitigation activity to identify potential leachables for dosage forms with a high degree of concern associated with the route of administration. To address safety concerns, approaches to toxicological safety evaluation of extractables and leachables have been developed and applied by pharmaceutical and biologics manufacturers. Details of these approaches may differ depending on the nature of the final drug product. These may include application, the formulation, route of administration and length of use. Current regulatory guidelines and industry standards provide general guidance on compound specific safety assessments but do not provide a comprehensive approach to safety evaluations of leachables and/or extractables. This paper provides a perspective on approaches to safety evaluations by reviewing and applying general concepts and integrating key steps in the toxicological evaluation of individual extractables or leachables. These include application of structure activity relationship studies, development of permitted daily exposure (PDE) values, and use of safety threshold concepts. Case studies are provided. The concepts presented seek to encourage discussion in the scientific community, and are not intended to represent a final opinion or "guidelines." Copyright © 2016 Elsevier Inc. All rights reserved.

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…

Development of the laboratory prototype "CavyPool" for assessing treatments and materials for swimming pools.

PubMed

Valeriani, F; Gianfranceschi, G; Vitali, M; Protano, C; Romano Spica, V

2017-01-01

Hygiene and surveillance in swimming pools are established by WHO Guidelines and national laws. Progress in water management and pool construction is revolutionizing the field, introducing new materials, systems, disinfection procedures or monitoring markers. Innovation advances challenge the upgrading of safety and quality in pools and the appropriate implementation of guidelines. In order to provide a device for laboratory test, a prototype was realized and applied to study and compare swimming pool materials and treatments. A pool scale-model was engineered and evaluated by computational fluid dynamics algorithms. An automated real time monitoring assured steady state. Critical control points along the water circuit were made accessible to allow the placing of different biocides or water sampling. Simulations were safely performed in a standard hood. Materials for pool surfaces and pipelines were evaluated for biofilm formation under different disinfection conditions. Adherent microorganisms were assayed by mfDNA analysis using real time PCR. The prototype reached the steady state within 5-25 hours under different conditions, showing chemical, physical and fluid-dynamic stability. A method was optimized for testing materials showing their different response to biofilm induction. Several innovative PVC samples displayed highest resistance to bacterial adhesion. A device and method was developed for testing swimming pool hygienic parameters in laboratory. It allowed to test materials for pools hygiene and maintenance, including biofilm formation. It can be applied to simulate contaminations under different water treatments or disinfection strategies. It may support technical decisions and help policymakers in acquiring evidences for comparing or validating innovative solutions.

Improving Evaluation to Address the Unintended Consequences of Health Information Technology:. a Position Paper from the Working Group on Technology Assessment & Quality Development.

PubMed

Magrabi, F; Ammenwerth, E; Hyppönen, H; de Keizer, N; Nykänen, P; Rigby, M; Scott, P; Talmon, J; Georgiou, A

2016-11-10

With growing use of IT by healthcare professionals and patients, the opportunity for any unintended effects of technology to disrupt care health processes and outcomes is intensified. The objectives of this position paper by the IMIA Working Group (WG) on Technology Assessment and Quality Development are to highlight how our ongoing initiatives to enhance evaluation are also addressing the unintended consequences of health IT. Review of WG initiatives Results: We argue that an evidence-based approach underpinned by rigorous evaluation is fundamental to the safe and effective use of IT, and for detecting and addressing its unintended consequences in a timely manner. We provide an overview of our ongoing initiatives to strengthen study design, execution and reporting by using evaluation frameworks and guidelines which can enable better characterization and monitoring of unintended consequences, including the Good Evaluation Practice Guideline in Health Informatics (GEP-HI) and the Statement on Reporting of Evaluation Studies in Health Informatics (STARE-HI). Indicators to benchmark the adoption and impact of IT can similarly be used to monitor unintended effects on healthcare structures, processes and outcome. We have also developed EvalDB, a web-based database of evaluation studies to promulgate evidence about unintended effects and are developing the content for courses to improve training in health IT evaluation. Evaluation is an essential ingredient for the effective use of IT to improve healthcare quality and patient safety. WG resources and skills development initiatives can facilitate a proactive and evidence-based approach to detecting and addressing the unintended effects of health IT.

Improving Evaluation to Address the Unintended Consequences of Health Information Technology:

PubMed Central

Ammenwerth, E.; Hyppönen, H.; de Keizer, N.; Nykänen, P.; Rigby, M.; Scott, P.; Talmon, J.; Georgiou, A.

2016-01-01

Summary Background and objectives With growing use of IT by healthcare professionals and patients, the opportunity for any unintended effects of technology to disrupt care health processes and outcomes is intensified. The objectives of this position paper by the IMIA Working Group (WG) on Technology Assessment and Quality Development are to highlight how our ongoing initiatives to enhance evaluation are also addressing the unintended consequences of health IT. Methods Review of WG initiatives Results We argue that an evidence-based approach underpinned by rigorous evaluation is fundamental to the safe and effective use of IT, and for detecting and addressing its unintended consequences in a timely manner. We provide an overview of our ongoing initiatives to strengthen study design, execution and reporting by using evaluation frameworks and guidelines which can enable better characterization and monitoring of unintended consequences, including the Good Evaluation Practice Guideline in Health Informatics (GEP-HI) and the Statement on Reporting of Evaluation Studies in Health Informatics (STARE-HI). Indicators to benchmark the adoption and impact of IT can similarly be used to monitor unintended effects on healthcare structures, processes and outcome. We have also developed EvalDB, a web-based database of evaluation studies to promulgate evidence about unintended effects and are developing the content for courses to improve training in health IT evaluation. Conclusion Evaluation is an essential ingredient for the effective use of IT to improve healthcare quality and patient safety. WG resources and skills development initiatives can facilitate a proactive and evidence-based approach to detecting and addressing the unintended effects of health IT. PMID:27830232

Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain

PubMed Central

Chou, Roger; Fanciullo, Gilbert J.; Fine, Perry G.; Adler, Jeremy A.; Ballantyne, Jane C.; Davies, Pamela; Donovan, Marilee I.; Fishbain, David A.; Foley, Kathy M.; Fudin, Jeffrey; Gilson, Aaron M.; Kelter, Alexander; Mauskop, Alexander; O'Connor, Patrick G.; Passik, Steven D.; Pasternak, Gavril W.; Portenoy, Russell K.; Rich, Ben A.; Roberts, Richard G.; Todd, Knox H.; Miaskowski, Christine

2014-01-01

Use of chronic opioid therapy for chronic noncancer pain has increased substantially. The American Pain Society and the American Academy of Pain Medicine commissioned a systematic review of the evidence on chronic opioid therapy for chronic noncancer pain and convened a multidisciplinary expert panel to review the evidence and formulate recommendations. Although evidence is limited, the expert panel concluded that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic noncancer pain. However, opioids are also associated with potentially serious harms, including opioid-related adverse effects and outcomes related to the abuse potential of opioids. The recommendations presented in this document provide guidance on patient selection and risk stratification; informed consent and opioid management plans; initiation and titration of chronic opioid therapy; use of methadone; monitoring of patients on chronic opioid therapy; dose escalations, high-dose opioid therapy, opioid rotation, and indications for discontinuation of therapy; prevention and management of opioid-related adverse effects; driving and work safety; identifying a medical home and when to obtain consultation; management of breakthrough pain; chronic opioid therapy in pregnancy; and opioid-related polices. Perspective: Safe and effective chronic opioid therapy for chronic noncancer pain requires clinical skills and knowledge in both the principles of opioid prescribing and on the assessment and management of risks associated with opioid abuse, addiction, and diversion. Although evidence is limited in many areas related to use of opioids for chronic noncancer pain, this guideline provides recommendations developed by a multidisciplinary expert panel following a systematic review of the evidence. PMID:19187889

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...

Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder

PubMed Central

Lam, Raymond W.; McIntyre, Roger S.; Tourjman, S. Valérie; Bhat, Venkat; Blier, Pierre; Hasnain, Mehrul; Jollant, Fabrice; Levitt, Anthony J.; MacQueen, Glenda M.; McInerney, Shane J.; McIntosh, Diane; Milev, Roumen V.; Müller, Daniel J.; Parikh, Sagar V.; Pearson, Norma L.; Ravindran, Arun V.; Uher, Rudolf

2016-01-01

Background: The Canadian Network for Mood and Anxiety Treatments (CANMAT) conducted a revision of the 2009 guidelines by updating the evidence and recommendations. The scope of the 2016 guidelines remains the management of major depressive disorder (MDD) in adults, with a target audience of psychiatrists and other mental health professionals. Methods: Using the question-answer format, we conducted a systematic literature search focusing on systematic reviews and meta-analyses. Evidence was graded using CANMAT-defined criteria for level of evidence. Recommendations for lines of treatment were based on the quality of evidence and clinical expert consensus. “Pharmacological Treatments” is the third of six sections of the 2016 guidelines. With little new information on older medications, treatment recommendations focus on second-generation antidepressants. Results: Evidence-informed responses are given for 21 questions under 4 broad categories: 1) principles of pharmacological management, including individualized assessment of patient and medication factors for antidepressant selection, regular and frequent monitoring, and assessing clinical and functional outcomes with measurement-based care; 2) comparative aspects of antidepressant medications based on efficacy, tolerability, and safety, including summaries of newly approved drugs since 2009; 3) practical approaches to pharmacological management, including drug-drug interactions and maintenance recommendations; and 4) managing inadequate response and treatment resistance, with a focus on switching antidepressants, applying adjunctive treatments, and new and emerging agents. Conclusions: Evidence-based pharmacological treatments are available for first-line treatment of MDD and for management of inadequate response. However, given the limitations of the evidence base, pharmacological management of MDD still depends on tailoring treatments to the patient. PMID:27486148

[Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

PubMed

Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

2008-03-01

Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

Natural and anthropogenic radionuclide activity concentrations in the New Zealand diet.

PubMed

Pearson, Andrew J; Gaw, Sally; Hermanspahn, Nikolaus; Glover, Chris N

2016-01-01

To support New Zealand's food safety monitoring regime, a survey was undertaken to establish radionuclide activity concentrations across the New Zealand diet. This survey was undertaken to better understand the radioactivity content of the modern diet and also to assess the suitability of the current use of milk as a sentinel for dietary radionuclide trends. Thirteen radionuclides were analysed in 40 common food commodities, including animal products, fruits, vegetables, cereal grains and seafood. Activity was detected for (137)Caesium, (90)Strontium and (131)Iodine. No other anthropogenic radionuclides were detected. Activity concentrations of the three natural radionuclides of Uranium and the daughter radionuclide (210)Polonium were detected in the majority of food sampled, with a large variation in magnitude. The maximum activity concentrations were detected in shellfish for all these radionuclides. Based on the established activity concentrations and ranges, the New Zealand diet contains activity concentrations of anthropogenic radionuclides far below the Codex Alimentarius guideline levels. Activity concentrations obtained for milk support its continued use as a sentinel for monitoring fallout radionuclides in terrestrial agriculture. The significant levels of natural and anthropogenic radionuclide activity concentrations detected in finfish and molluscs support undertaking further research to identify a suitable sentinel for New Zealand seafood monitoring. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Detection of hydrogen peroxide based on long-path absorption spectroscopy using a CW EC-QCL

NASA Astrophysics Data System (ADS)

Sanchez, N. P.; Yu, Y.; Dong, L.; Griffin, R.; Tittel, F. K.

2016-02-01

A sensor system based on a CW EC-QCL (mode-hop-free range 1225-1285 cm-1) coupled with long-path absorption spectroscopy was developed for the monitoring of gas-phase hydrogen peroxide (H2O2) using an interference-free absorption line located at 1234.055 cm-1. Wavelength modulation spectroscopy (WMS) with second harmonic detection was implemented for data processing. Optimum levels of pressure and modulation amplitude of the sensor system led to a minimum detection limit (MDL) of 25 ppb using an integration time of 280 sec. The selected absorption line for H2O2, which exhibits no interference from H2O, makes this sensor system suitable for sensitive and selective monitoring of H2O2 levels in decontamination and sterilization processes based on Vapor Phase Hydrogen Peroxide (VPHP) units, in which a mixture of H2O and H2O2 is generated. Furthermore, continuous realtime monitoring of H2O2 concentrations in industrial facilities employing this species can be achieved with this sensing system in order to evaluate average permissible exposure levels (PELs) and potential exceedances of guidelines established by the US Occupational Safety and Health Administration for H2O2.

Gap Between Official Guidelines and Clinical Practice for the Treatment of Rheumatoid Arthritis in São Paulo, Brazil.

PubMed

de Camargo, Iara Alves; Almeida Barros, Bruna Cipriano; do Nascimento Silveira, Miriam Sanches; Osorio-de-Castro, Claudia Garcia Serpa; Guyatt, Gordon; Lopes, Luciane Cruz

2016-05-01

Biological agents used for the treatment of rheumatoid arthritis (RA) are associated with serious adverse events. Guidelines provide standards for the prescribing and monitoring of these drugs. In São Paulo, health litigation for access to medicines has fueled the demand for biological therapy. The extent to which biological agents are being appropriately prescribed and patients are being appropriately monitored is uncertain. Our goal was to determine whether RA clinical guidelines are being translated into clinical practice for patients receiving treatment as a result of lawsuits against the government. We identified patients through records of the State Secretary of Health of São Paulo from 2003 to 2011. We consulted guidelines from 5 countries and chose those recommendations endorsed by all of the guidelines reviewed as standards. Pharmacy records provided data regarding biologic use. The guidelines recommended the use of biological agents only when patients had been receiving treatment with at least 1 disease-modifying antirheumatic drug (DMARD) and recommended annual monitoring of laboratory blood tests. Of the 238 patients identified in the database, 216 patients were interviewed, and 124 (57.4%) patients were still using biological agents at the time of the survey. Of the patients interviewed, 167 patients (77.3%) started biological treatment when using ≥2 DMARDs before, 22 patients (10.2%) were using 1 DMARD before, and 27 patients (12.5%) had never taken a DMARD. Of the 124 patients still taking biological drugs, 117 patients (94.3%) had visited a doctor at least once per year, but 28 patients (22.6%) did not undergo the recommended laboratory blood testing. Only 43 of the 124 patients (34.7%) still taking biological agents met the guideline criteria for both the use of previous agents and the appropriate monitoring. An important gap between clinical practice and the national guidelines exists among treatments prescribed for plaintiffs obtaining medicines for RA in São Paulo. The results suggest the need for intervention by health authorities. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

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...

Guidelines for the specification of blue safety flags in railroad operations

DOT National Transportation Integrated Search

2010-12-01

Blue flag protection in the railroad industry provides safety to workers from the inadvertent movement of equipment on which they : are working. Current Federal regulations provide minimum specifications for the devices that can be used as blue flags...

Health-Based Cyanotoxin Guideline Values Allow for Cyanotoxin-Based Monitoring and Efficient Public Health Response to Cyanobacterial Blooms

PubMed Central

Farrer, David; Counter, Marina; Hillwig, Rebecca; Cude, Curtis

2015-01-01

Human health risks from cyanobacterial blooms are primarily related to cyanotoxins that some cyanobacteria produce. Not all species of cyanobacteria can produce toxins. Those that do often do not produce toxins at levels harmful to human health. Monitoring programs that use identification of cyanobacteria genus and species and enumeration of cyanobacterial cells as a surrogate for cyanotoxin presence can overestimate risk and lead to unnecessary health advisories. In the absence of federal criteria for cyanotoxins in recreational water, the Oregon Health Authority (OHA) developed guideline values for the four most common cyanotoxins in Oregon’s fresh waters (anatoxin-a, cylindrospermopsin, microcystins, and saxitoxins). OHA developed three guideline values for each of the cyanotoxins found in Oregon. Each of the guideline values is for a specific use of cyanobacteria-affected water: drinking water, human recreational exposure and dog recreational exposure. Having cyanotoxin guidelines allows OHA to promote toxin-based monitoring (TBM) programs, which reduce the number of health advisories and focus advisories on times and places where actual, rather than potential, risks to health exist. TBM allows OHA to more efficiently protect public health while reducing burdens on local economies that depend on water recreation-related tourism. PMID:25664510

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

Quality of clinical practice guidelines in delirium: a systematic appraisal

PubMed Central

Marchington, Katie L; Agar, Meera; Davis, Daniel H J; Sikora, Lindsey; Tsang, Tammy W Y

2017-01-01

Objective To determine the accessibility and currency of delirium guidelines, guideline summary papers and evaluation studies, and critically appraise guideline quality. Design Systematic literature search for formal guidelines (in English or French) with focus on delirium assessment and/or management in adults (≥18 years), guideline summary papers and evaluation studies. Full appraisal of delirium guidelines published between 2008 and 2013 and obtaining a ‘Rigour of Development’ domain screening score cut-off of >40% using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Data sources Multiple bibliographic databases, guideline organisation databases, complemented by a grey literature search. Results 3327 database citations and 83 grey literature links were identified. A total of 118 retrieved delirium guidelines and related documents underwent full-text screening. A final 21 delirium guidelines (with 10 being >5 years old), 12 guideline summary papers and 3 evaluation studies were included. For 11 delirium guidelines published between 2008 and 2013, the screening AGREE II ‘Rigour’ scores ranged from 3% to 91%, with seven meeting the cut-off score of >40%. Overall, the highest rating AGREE II domains were ‘Scope and Purpose’ (mean 80.1%, range 64–100%) and ‘Clarity and Presentation’ (mean 76.7%, range 38–97%). The lowest rating domains were ‘Applicability’ (mean 48.7%, range 8–81%) and ‘Editorial Independence’ (mean 53%, range 2–90%). The three highest rating guidelines in the ‘Applicability’ domain incorporated monitoring criteria or audit and costing templates, and/or implementation strategies. Conclusions Delirium guidelines are best sourced by a systematic grey literature search. Delirium guideline quality varied across all six AGREE II domains, demonstrating the importance of using a formal appraisal tool prior to guideline adaptation and implementation into clinical settings. Adding more knowledge translation resources to guidelines may improve their practical application and effective monitoring. More delirium guideline evaluation studies are needed to determine their effect on clinical practice. PMID:28283488

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.

77 FR 62224 - Hanford Tank Farms Flammable Gas Safety Strategy

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-12

... believes that actions are necessary to install real time monitoring to measure tank ventilation flowrates... monitoring. In its August letter, the Board noted that DOE's SAC for flammable gas monitoring exhibited a... flammable gas monitoring, it remained inadequate as a credited safety control. The SAC is less reliable than...

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...

Understanding of safety monitoring in clinical trials by individuals with CF or their parents: A qualitative analysis.

PubMed

Kern-Goldberger, Andrew S; Hessels, Amanda J; Saiman, Lisa; Quittell, Lynne M

2018-03-14

Recruiting both pediatric and adult participants for clinical trials in CF is currently of paramount importance as numerous new therapies are being developed. However, recruitment is challenging as parents of children with CF and adults with CF cite safety concerns as a principal barrier to enrollment. In conjunction with the CF Foundation (CFF) Data Safety Monitoring Board (DSMB), a pilot brochure was developed to inform patients and parents of the multiple levels of safety monitoring; the CFF simultaneously created an infographic representing the safety monitoring process. This study explores the attitudes and beliefs of CF patients and families regarding safety monitoring and clinical trial participation, and elicits feedback regarding the educational materials. Semi-structured interviews were conducted using a pre-tested interview guide and audio-recorded during routine CF clinic visits. Participants included 5 parents of children with CF <16years old; 5 adolescents and young adults with CF 16-21years old; and 5 adults with CF ≥22years old from pediatric and adult CF centers. The study team performed systematic text condensation analysis of the recorded interviews using an iterative process. Four major thematic categories with subthemes emerged as supported by exemplar quotations: attitudes toward clinical trials, safety values, conceptualizing the safety monitoring process, and priorities for delivery of patient education. Participant feedback was used to revise the pilot brochure; text was shortened, unfamiliar words clarified (e.g., "pipeline"), abbreviations eliminated, and redundancy avoided. Qualitative analysis of CF patient and family interviews provided insights into barriers to participation in clinical trials, safety concerns, perspectives on safety monitoring and educational priorities. We plan a multicenter study to determine if the revised brochure reduces knowledge, attitude and practice barriers regarding participation in CF clinical trials. Copyright © 2018 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Success, failures and costs of implementing standards in the USA--lessons for infection control.

PubMed

McGowan, J E

1995-06-01

In the US, extensive standards for performance and 'guidelines for practice' have been instituted by a number of governmental and non-governmental agencies. New governmental plans for health care depend heavily on practice guidelines, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has been especially enthusiastic about continuous quality improvement. Monitoring the appropriateness of care and altering physician practice appeals to insurance carriers and health care management organizations. Some initial data exist to show that the quality of health care has been enhanced by these regulations. The total cost for health care administration in 1990 in the USA was 24.8% of each hospital's spending for health care. Much of this was associated with spending for new initiatives in practice guidelines, physician profiling, quality assurance, and the like. Few data exist to show that the quality of health care or hospital infection control has been enhanced by these expenditures. Regulations and guidelines also have proliferated in infection control. Guides from the JCAHO have been expanded, and recent mandates from the Occupational Health and Safety Administration (OSHA) for protecting employees from blood-borne and respiratory pathogens promise to be especially costly for health care organizations to implement. Little data exist to show that the quality of infection control has been enhanced by these regulations. Standards are difficult to develop, because the science to back them up often is lacking, interpretation of validating data is imprecise, and inherent biological variation makes exceptions common. Seven lessons are important for those developing standards today. These include focusing on objective measures of the impact of the standard, clearly indicating the degree of scientific validity, making the development process inclusive, allowing for local variation, making sure that funding is provided for mandated standards, considering non-scientific implications of standards, and remaining involved in the process after the guideline is developed. Infection control workers should make sure that standards developed take the lessons above into account before they are promulgated.

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

When human immunodeficiency virus (HIV) treatment goals conflict with guideline-based opioid prescribing: A qualitative study of HIV treatment providers.

PubMed

Starrels, Joanna L; Peyser, Deena; Haughton, Lorlette; Fox, Aaron; Merlin, Jessica S; Arnsten, Julia H; Cunningham, Chinazo O

2016-01-01

Human immunodeficiency virus (HIV)-infected patients have a high prevalence of chronic pain and opioid use, making HIV care a critical setting for improving the safety of opioid prescribing. Little is known about HIV treatment providers' perspectives about opioid prescribing to patients with chronic pain. The authors administered a questionnaire and conducted semistructured telephone interviews with 18 HIV treatment providers (infectious disease specialists, general internists, family medicine physicians, nurse practitioners, and physician assistants) in Bronx, NY. Open-ended interview questions focused on providers' experiences, beliefs, and attitudes about opioid prescribing and about the use of guideline-based opioid prescribing practices (conservative prescribing, and monitoring for and responding to misuse). Transcripts were thematically analyzed using a modified grounded theory approach. Eighteen HIV treatment providers included 13 physicians, four nurse practitioners, and one physician assistant. They were 62% female, 56% white, and practiced as HIV treatment providers for a mean of 14.6 years. Most reported always or almost always using opioid treatment agreements (56%) and urine drug testing (61%) with their patients on long-term opioid therapy. HIV treatment providers tended to view opioid prescribing for chronic pain within the "HIV paradigm," a set of priorities and principles defined by three key themes: (1) primacy of HIV goals, (2) familiarity with substance use, and (3) the clinician as ally. The HIV paradigm sometimes supported, and sometimes conflicted with, guideline-based opioid prescribing practices. For HIV treatment providers, perceived alignment with the HIV paradigm determined whether and how guideline-based opioid prescribing practices were adopted. For example, the primacy of HIV goals superseded conservative opioid prescribing when providers prescribed opioids with the goal of retaining patients in HIV care. These findings highlight unique factors in HIV care that influence adoption of guideline-based opioid prescribing practices. These factors should be considered in future research and initiatives to address opioid prescribing in HIV care.

Monitors.

ERIC Educational Resources Information Center

Powell, David

1984-01-01

Provides guidelines for selecting a monitor to suit specific applications, explains the process by which graphics images are produced on a CRT monitor, and describes four types of flat-panel displays being used in the newest lap-sized portable computers. A comparison chart provides prices and specifications for over 80 monitors. (MBR)

75 FR 45144 - Recovery Fact Sheet 9580.203, Debris Monitoring

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

...] Recovery Fact Sheet 9580.203, Debris Monitoring AGENCY: Federal Emergency Management Agency, DHS. ACTION... accepting comments on Recovery Fact Sheet 9580.203, Debris Monitoring. DATES: Comments must be received by... guidelines. Specifically, the fact sheet provides information on debris monitoring roles and responsibilities...

Design and implementation of the GLIF3 guideline execution engine.

PubMed

Wang, Dongwen; Peleg, Mor; Tu, Samson W; Boxwala, Aziz A; Ogunyemi, Omolola; Zeng, Qing; Greenes, Robert A; Patel, Vimla L; Shortliffe, Edward H

2004-10-01

We have developed the GLIF3 Guideline Execution Engine (GLEE) as a tool for executing guidelines encoded in the GLIF3 format. In addition to serving as an interface to the GLIF3 guideline representation model to support the specified functions, GLEE provides defined interfaces to electronic medical records (EMRs) and other clinical applications to facilitate its integration with the clinical information system at a local institution. The execution model of GLEE takes the "system suggests, user controls" approach. A tracing system is used to record an individual patient's state when a guideline is applied to that patient. GLEE can also support an event-driven execution model once it is linked to the clinical event monitor in a local environment. Evaluation has shown that GLEE can be used effectively for proper execution of guidelines encoded in the GLIF3 format. When using it to execute each guideline in the evaluation, GLEE's performance duplicated that of the reference systems implementing the same guideline but taking different approaches. The execution flexibility and generality provided by GLEE, and its integration with a local environment, need to be further evaluated in clinical settings. Integration of GLEE with a specific event-monitoring and order-entry environment is the next step of our work to demonstrate its use for clinical decision support. Potential uses of GLEE also include quality assurance, guideline development, and medical education.

For Sale: Subliminal Bias in Textbooks

ERIC Educational Resources Information Center

Britton, Gwyneth E.; Lumpkin, Margaret C.

1977-01-01

Discusses the fact that, although publishers have acknowledged the problem of sex bias in textbooks in the United States, guidelines lack specifics, timetables, and procedures for monitoring content and enforcing compliance with the guidelines. (MB)

Crew/Automation Interaction in Space Transportation Systems: Lessons Learned from the Glass Cockpit

NASA Technical Reports Server (NTRS)

Rudisill, Marianne

2000-01-01

The progressive integration of automation technologies in commercial transport aircraft flight decks - the 'glass cockpit' - has had a major, and generally positive, impact on flight crew operations. Flight deck automation has provided significant benefits, such as economic efficiency, increased precision and safety, and enhanced functionality within the crew interface. These enhancements, however, may have been accrued at a price, such as complexity added to crew/automation interaction that has been implicated in a number of aircraft incidents and accidents. This report briefly describes 'glass cockpit' evolution. Some relevant aircraft accidents and incidents are described, followed by a more detailed description of human/automation issues and problems (e.g., crew error, monitoring, modes, command authority, crew coordination, workload, and training). This paper concludes with example principles and guidelines for considering 'glass cockpit' human/automation integration within space transportation systems.

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...

Firefighter Safety Zone: The effect of terrain slope of separation distance

Treesearch

Bret Butler; Jason Forthofer

2010-01-01

Perhaps 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 good judgement. The current safety zone guidelines used in the US (see fig. 1) and published in the...

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

Development of a guideline for treatment of deep and superficial venous thrombosis in the emergency department.

PubMed

Tosone, Nancy C; Costanzo, Cindy

2012-01-01

Patients with DVT, aged 45.64 years, often present to the ED, with an annual cost of $1.5-$3.2 billion per year. This paper describes the process used to implement an evidence-based guideline on deep venous thrombosis (DVT) for the emergency department (ED). Specific aims were to (a) conduct an organizational assessment of DVT treatment practices; (b) compare organizational results with evidence-based treatment guidelines; (c) develop recommendations for the treatment of DVT for ED discharge; and (d) conduct an interdisciplinary evaluation of the evidence-based guideline. A retrospective review of 149 records of adults in an urban Midwestern ED in 2010 was undertaken. Differences in provider practices were identified. A guideline was developed that included clinical management, social/financial concerns, patient education, anticoagulation monitoring, and outpatient follow-up. Implementation and evaluation were accomplished through electronic and paper communication, medical record monitoring, and patient call back. Evaluation also included simulation exercises with an interdisciplinary team.

76 FR 65753 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at...) re-issued Draft Regulatory Guide, DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear... Revision 4A to Nuclear Management and Resources Council (NUMARC) 93-01, ``Industry Guideline for Monitoring...

A sensor monitoring system for telemedicine, safety and security applications

NASA Astrophysics Data System (ADS)

Vlissidis, Nikolaos; Leonidas, Filippos; Giovanis, Christos; Marinos, Dimitrios; Aidinis, Konstantinos; Vassilopoulos, Christos; Pagiatakis, Gerasimos; Schmitt, Nikolaus; Pistner, Thomas; Klaue, Jirka

2017-02-01

A sensor system capable of medical, safety and security monitoring in avionic and other environments (e.g. homes) is examined. For application inside an aircraft cabin, the system relies on an optical cellular network that connects each seat to a server and uses a set of database applications to process data related to passengers' health, safety and security status. Health monitoring typically encompasses electrocardiogram, pulse oximetry and blood pressure, body temperature and respiration rate while safety and security monitoring is related to the standard flight attendance duties, such as cabin preparation for take-off, landing, flight in regions of turbulence, etc. In contrast to previous related works, this article focuses on the system's modules (medical and safety sensors and associated hardware), the database applications used for the overall control of the monitoring function and the potential use of the system for security applications. Further tests involving medical, safety and security sensing performed in an real A340 mock-up set-up are also described and reference is made to the possible use of the sensing system in alternative environments and applications, such as health monitoring within other means of transport (e.g. trains or small passenger sea vessels) as well as for remotely located home users, over a wired Ethernet network or the Internet.

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

Immunotherapy safety: a prospective multi-centric monitoring study of biologically standardized therapeutic vaccines for allergic diseases.

PubMed

Moreno, C; Cuesta-Herranz, J; Fernández-Távora, L; Alvarez-Cuesta, E

2004-04-01

The fear of side-effects has led to strict regulations preventing a more widespread use of specific immunotherapy (SIT) in some countries, in spite of the low risk of systemic reactions (SRs) reported in well-controlled studies. The goal of the study was to carry out a prospective and multi-centric trial to evaluate the safety, risk factors and compliance degree of commercially available SIT. The study was carried out in 14 allergy departments from Spain. Four-hundred and eighty-eight patients with rhinitis and/or asthma were submitted to treatment with biologically standardized allergen extracts commercially available. They were administered following the European Academy of Allergy and Clinical Immunology guidelines. Four hundred and twenty-three patients (86.7%) completed the treatment and remained under control at the end of the trial. Out of 17,526 administered doses, 17,368 doses (99.1%) were not associated with a reaction. Eighteen patients (3.7%) experienced 53 (0.3% of the doses) SRs. All immediate SRs were mild or moderate and responded well to ordinary treatment measures. There were no fatal reactions, anaphylactic shock or life-threatening reactions. A higher ratio of SRs was found among asthmatic and dust mite allergic patients, although multi-variable logistic analysis did not demonstrate any risk factor associated with SRs. There was also a subgroup of patients at risk for recurrent reactions, and therefore 40% of SRs had been avoided if the maximal number of SRs had been previously limited to only three SRs. This multi-centric study showed that SIT was a safe treatment with a very good compliance. Future guidelines of SIT should limit the maximal number of SRs.

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.

Safety and operational analysis of 4-lane to 3-lane conversions (road diets) in Michigan.

DOT National Transportation Integrated Search

2012-01-10

Road diets, specifically 4-to-3 lane conversions, implemented in various locations in Michigan were studied to determine the safety- and delay-related impacts, develop crash modification factors (CMFs), and develop guidelines that would be useful in ...

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 is t...

Safety of high-speed guided ground transportation systems : collision avoidance and accident survivability : volume 3 : accident survivability

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 is to...

Fight Fire with These Safety Strategies.

ERIC Educational Resources Information Center

Jackson, Lisa M.

1998-01-01

Provides expert guidelines on ways to keep schools and children safe from building fires, such as maintenance of exits for easy egress in emergencies, maintaining fire-protection systems, and utilizing evacuation planning and drilling. Highlights fire-safety ideas as part of school-building and renovation projects. (GR)

Comparison of the operational and safety characteristics of the single point urban and diamond interchanges.

DOT National Transportation Integrated Search

1996-01-01

The purpose of this study was to evaluate and compare the safety and operational characteristics of the single point urban interchange (SPUI) and the diamond interchange (DI) and develop guidelines that identify traffic and/or geometric conditions th...

Safety of High Speed and Ground Guided Transportation Systems: Collision Avoidance and Accident Survivability: Volume 1: Collision Threat

DOT National Transportation Integrated Search

1993-03-01

This report is the first of four volunes 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...

Safety of high-speed guided ground transportation : collision avoidance and accident survivability : volume 1 : collision threat

DOT National Transportation Integrated Search

1993-03-01

This report is the first 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 is to...

Training Requirements in OSHA Standards and Training Guidelines.

ERIC Educational Resources Information Center

Occupational Safety and Health Administration, Washington, DC.

This booklet contains Occupational Safety and Health Administration (OSHA) training requirements, excerpted from OSHA standards. The booklet is designed to help employers, safety and health professionals, training directors, and others who need to know training requirements. (Requirements for posting information, warning signs, labels, and the…

Safety of high-speed guided ground transportation systems : collision avoidance and accident survivability : volume 2 : collision avoidance

DOT National Transportation Integrated Search

1993-03-01

This report is the second 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 is t...

Guidelines for Improved Rapid Transit Tunneling Safety and Environmental Impact : Volume 1. Safety.

DOT National Transportation Integrated Search

1977-01-01

Two of the major objectives of the Urban Mass Transportation Administration Tunneling Program are to lower subway construction costs and reduce construction hazards and damage to the environment. This study consists of a two-volume report and aims to...

Integrating Occupational Safety and Health into TAFE Courses: Policy Guidelines.

ERIC Educational Resources Information Center

Hill, Graham L.; Mageean, Pauline

Intended to help administrators, curriculum developers, and teachers integrate occupational health and safety into Australian vocational courses on bricklaying, metal fabrication, and horticulture, this document suggests specific policies and provides further amplification concerning three general policies for that integration. The three general…

Pesticide poisoning and its related factors among Korean farmers.

PubMed

Shin, D C; Kim, H J; Jung, S H; Park, C Y; Lee, S Y; Kim, C B

1998-01-01

This study has been carried out to assess the health damages due to pesticide use and its related risk factors among Korean farmers. Data regarding pesticide handling and poisoning symptoms were collected by means of a questionnaire filled in by 1,032 farmers from two provinces. The results showed that during summer farming 21.9% of the subjects experienced suspected pesticide poisoning. 18.8% mild poisoning, and 2% more serious poisoning. Univariate and logistic regression analyses between "no poisoning", including the "suspected poisoning" and "poisoning" groups, were performed to select significant variables related to pesticide poisoning. Four variables were significantly associated: sex, days of consecutive pesticide use, hours of pesticide use per day, having received safety education (weakly associated), and compliance with safety guidelines for application. Safety education was weakly associated with poisoning, while age, education, wearing protective gear, and compliance with safety guidelines for personal hygiene after pesticide use were not significant risk factors to determine pesticide poisoning.

Neonatal Cranial Ultrasound: Are Current Safety Guidelines Appropriate?

PubMed

Lalzad, Assema; Wong, Flora; Schneider, Michal

2017-03-01

Ultrasound can lead to thermal and mechanical effects in interrogated tissues. We reviewed the literature to explore the evidence on ultrasound heating on fetal and neonatal neural tissue. The results of animal studies have suggested that ultrasound exposure of the fetal or neonatal brain may lead to a significant temperature elevation at the bone-brain interface above current recommended safety thresholds. Temperature increases between 4.3 and 5.6°C have been recorded. Such temperature elevations can potentially affect neuronal structure and function and may also affect behavioral and cognitive function, such as memory and learning. However, the majority of these studies were carried out more than 25 y ago using non-diagnostic equipment with power outputs much lower than those of modern machines. New studies to address the safety issues of cranial ultrasound are imperative to provide current clinical guidelines and safety recommendations. Copyright © 2016 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.

Enabling Self-Monitoring Data Exchange in Participatory Medicine.

PubMed

Lopez-Campos, Guillermo; Ofoghi, Bahadorreza; Martin-Sanchez, Fernando

2015-01-01

The development of new methods, devices and apps for self-monitoring have enabled the extension of the application of these approaches for consumer health and research purposes. The increase in the number and variety of devices has generated a complex scenario where reporting guidelines and data exchange formats will be needed to ensure the quality of the information and the reproducibility of results of the experiments. Based on the Minimal Information for Self Monitoring Experiments (MISME) reporting guideline we have developed an XML format (MISME-ML) to facilitate data exchange for self monitoring experiments. We have also developed a sample instance to illustrate the concept and a Java MISME-ML validation tool. The implementation and adoption of these tools should contribute to the consolidation of a set of methods that ensure the reproducibility of self monitoring experiments for research purposes.

77 FR 12907 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-02

... impact of task performance while driving on driving safety and time-based acceptance criteria for... feedback). The proposed NHTSA Guidelines list certain secondary, non-driving related tasks that, based on... cannot be used by the driver to perform such tasks while the driver is driving. For all other secondary...