The Patient Safety Leadership Academy at the University of Pennsylvania: the first cohort's learning experience.

PubMed

Wurster, Angela B; Pearson, Kathy; Sonnad, Seema S; Mullen, James L; Kaiser, Larry R

2007-01-01

We based the Patient Safety Leadership Academy (PSLA) on the premise that improving management skills could improve patient safety and employee satisfaction. Fellows completed baseline surveys on leadership skills knowledge, patient safety knowledge, and program goals. They completed the same surveys 7 months later at the final PSLA session. The fellows also completed a survey assessing how PSLA improved expertise and comparing PSLA to other patient safety learning opportunities. Matched pairs t tests were used to compare baseline and postprogram results. Baseline scores indicated appropriateness of focusing on leadership, with average leadership knowledge (2.48) significantly lower than patient safety knowledge (3.22). For patient safety, postprogram results were significant for 8 of 10 questions. All results were significant for leadership. Fellows also rated skills covered by the curriculum on a scale of 1 to 10. For all areas, the median score for knowledge gained was 7. When compared with other patient safety learning experiences, participants rated PSLA as 4 or 5, where 1 indicated the other experience much more valuable and 5 much more valuable. PSLA demonstrates that leadership skills are perceived as important by physicians and managers in surgical areas. This study demonstrated that a leadership skills approach to patient safety training could improve knowledge in specific leadership areas and general patient safety.

Novel safety floors do not influence early compensatory balance reactions in older adults.

PubMed

Wright, Alexander D; Heckman, George A; McIlroy, William E; Laing, Andrew C

2014-01-01

Novel safety flooring systems are a promising approach for reducing fall-related injuries in seniors, as they have been demonstrated to substantially reduce impact severity during falls, while minimally impairing balance control in community-dwelling older women. This pilot study aimed to characterize the potential effects of flooring conditions on dynamic balance control in retirement home-dwellers with more limited mobility. A tether-release paradigm was used to simulate a trip-type perturbation in 15 seniors across five flooring surfaces (three novel safety floors and one carpet compared to institutional-grade resilient rolled-sheeting). Kinetic and kinematic data tracked the displacement profiles of the underfoot centre-of-pressure and whole-body centre-of-mass, which were used to characterize compensatory balance reactions. Difference tests (ANOVA) found that the onset of the compensatory balance reaction was not associated with floor condition, nor were the timing and magnitude of peak centre-of-pressure excursion (minimum margin of safety) and velocity. Accordingly, the minimum margin of safety of the centre-of-mass was not significantly different across floors. Equivalence tests supported these findings. This study provides evidence that the carpet and novel safety floors tested do not negatively influence characteristics of initial dynamic balance responses following a lean-and-release perturbation compared to an institutional-grade resilient rolled-sheeting surface. In combination with reports of substantial force attenuative properties during fall-related impacts, these findings support the promise of novel safety floors as a biomechanically effective strategy for reducing fall-related injuries. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

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

PubMed

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

2006-11-01

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

Predictors of driving safety in early Alzheimer disease.

PubMed

Dawson, J D; Anderson, S W; Uc, E Y; Dastrup, E; Rizzo, M

2009-02-10

To measure the association of cognition, visual perception, and motor function with driving safety in Alzheimer disease (AD). Forty drivers with probable early AD (mean Mini-Mental State Examination score 26.5) and 115 elderly drivers without neurologic disease underwent a battery of cognitive, visual, and motor tests, and drove a standardized 35-mile route in urban and rural settings in an instrumented vehicle. A composite cognitive score (COGSTAT) was calculated for each subject based on eight neuropsychological tests. Driving safety errors were noted and classified by a driving expert based on video review. Drivers with AD committed an average of 42.0 safety errors/drive (SD = 12.8), compared to an average of 33.2 (SD = 12.2) for drivers without AD (p < 0.0001); the most common errors were lane violations. Increased age was predictive of errors, with a mean of 2.3 more errors per drive observed for each 5-year age increment. After adjustment for age and gender, COGSTAT was a significant predictor of safety errors in subjects with AD, with a 4.1 increase in safety errors observed for a 1 SD decrease in cognitive function. Significant increases in safety errors were also found in subjects with AD with poorer scores on Benton Visual Retention Test, Complex Figure Test-Copy, Trail Making Subtest-A, and the Functional Reach Test. Drivers with Alzheimer disease (AD) exhibit a range of performance on tests of cognition, vision, and motor skills. Since these tests provide additional predictive value of driving performance beyond diagnosis alone, clinicians may use these tests to help predict whether a patient with AD can safely operate a motor vehicle.

How Does Patient Safety Culture in the Surgical Departments Compare to the Rest of the County Hospitals in Xiaogan City of China?

PubMed Central

Wang, Manli; Tao, Hongbing

2017-01-01

Objectives: Patient safety culture affects patient safety and the performance of hospitals. The Hospital Survey on Patient Safety Culture (HSOPSC) is generally used to assess the safety culture in hospitals and unit levels. However, only a few studies in China have measured surgical settings compared with other units in county hospitals using the HSOPSC. This study aims to assess the strengths and weaknesses of surgical departments compared with all other departments in county hospitals in China with HSOPSC. Design: This research is a cross-sectional study. Methods: In 2015, a Chinese translation of HSOPSC was administered to 1379 staff from sampled departments from 19 county hospitals in Xiaogan City (Hubei Province, China) using a simple random and cluster sampling method. Outcome Measures: The HSOPSC was completed by 1379 participants. The percent positive ratings (PPRs) of 12 dimensions (i.e., teamwork within units, organizational learning and continuous improvement, staffing, non-punitive response to errors, supervisor/ manager expectations and actions promoting patient safety, feedback and communication about errors, communication openness, hospital handoffs and transitions, teamwork across hospital units, hospital management support for patient safety, overall perception of safety, as well as frequency of events reported) and the positive proportion of outcome variables (patient safety grade and number of events reported) between surgical departments and other departments were compared with t-tests and X2 tests, respectively. A multiple regression analysis was conducted, with the outcome dimensions serving as dependent variables and basic characteristics and other dimensions serving as independent variables. Similarly, ordinal logistic regression was used to explore the influencing factors of two categorical outcomes. Results: A total of 56.49% of respondents were from surgical departments. The PPRs for “teamwork within units” and “organizational learning and continuous improvement” were ≥75%, which denoted strengths, and the PPRs for “staffing” and “non-punitive response to errors” were ≤50%, which denoted weaknesses in surgical units and other units. Three dimensions for surgical departments were weaker than those for other departments (p < 0.05). The staff from surgical units reported more events compared with the other units, but only a few respondents in surgical settings evaluated patient safety grade as good/excellent. Four dimensions influenced patient safety grade, and three dimensions influenced event reporting in surgical units. Conclusions: Strategies including recruiting workers, using the reporting system, and building a non-punitive culture should be adopted in the surgical units of county hospitals in China to improve safety culture. Supervisors should also prioritise patient safety. PMID:28954427

Negative HPV screening test predicts low cervical cancer risk better than negative Pap test

Cancer.gov

Based on a study that included more than 1 million women, investigators at NCI have determined that a negative test for HPV infection compared to a negative Pap test provides greater safety, or assurance, against future risk of cervical cancer.

The dread factor: how hazards and safety training influence learning and performance.

PubMed

Burke, Michael J; Salvador, Rommel O; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous event/exposure severity in the promotion of safety knowledge and performance. For safety knowledge and safety performance, highly engaging training was considerably more effective than less engaging training when hazardous event/exposure severity was high, whereas highly and less engaging training had comparable levels of effectiveness when hazardous event/exposure severity was low. Implications of these findings for theory testing and incorporating information on objective risk into workplace safety research and practice are discussed.

The Use of Minipigs for Preclinical Safety Assessment by the Pharmaceutical Industry: Results of an IQ DruSafe Minipig Survey.

PubMed

Colleton, Curtis; Brewster, David; Chester, Anne; Clarke, David O; Heining, Peter; Olaharski, Andrew; Graziano, Michael

2016-04-01

The use of minipigs in preclinical safety testing of pharmaceuticals is considered an alternative to the more traditional dog and nonhuman primate (NHP) nonrodent species. Substantial evidence exists to suggest that the anatomy, physiology, and biochemistry of minipigs are similar enough to humans to consider them as valid nonrodent models for pharmaceutical safety testing. Since the utilization of minipigs was last assessed over 5 years ago, the Preclinical Safety Leadership Group (DruSafe) of the International Consortium for Innovation and Quality in Pharmaceutical Development conducted this survey to provide an updated assessment of the utility, perceived value, and impediments to the use of minipigs in preclinical safety testing. Of the 32 participating members of DruSafe, 15 responded to the survey representing both large and small companies. Respondents indicated that the minipig has been utilized mostly for short-term safety assessment studies with dermal, oral, and parenteral routes of administration. Minipigs are widely accepted as appropriate models for cardiovascular assessments and have been used to a limited extent for reproductive toxicology testing. Overall responses indicated that safety testing for large molecules using this species is relatively low due to a lack of background data, reagents or biomarkers, concerns regarding immune system characterization and poor suitability for developmental toxicity assessments. Most companies utilized contract research organizations for definitive safety toxicity assessment studies. Conclusions of this survey indicate that minipig is an acceptable nonrodent species largely limited to studies using small molecules, primarily dermal products, and results are comparable to those reported 5 years ago. © The Author(s) 2016.

How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms.

PubMed

O'Hara, Jane Kathryn; Armitage, Gerry; Reynolds, Caroline; Coulson, Claire; Thorp, Liz; Din, Ikhlaq; Watt, Ian; Wright, John

2017-01-01

Emergent evidence suggests that patients can identify and report safety issues while in hospital. However, little is known about the best method for collecting information from patients about safety concerns. This study presents an exploratory pilot of three mechanisms for collecting data on safety concerns from patients during their hospital stay. Three mechanisms for capturing safety concerns were coproduced with healthcare professionals and patients, before being tested in an exploratory trial using cluster randomisation at the ward level. Nine wards participated, with each mechanism being tested over a 3-month study period. Patients were asked to feed back safety concerns via the mechanism on their ward (interviewing at their bedside, paper-based form or patient safety 'hotline'). Safety concerns were subjected to a two-stage review process to identify those that would meet the definition of a patient safety incident. Differences between mechanisms on a range of outcomes were analysed using inferential statistics. Safety concerns were thematically analysed to develop reporting categories. 178 patients were recruited. Patients in the face-to-face interviewing condition provided significantly more safety concerns per patient (1.91) compared with the paper-based form (0.92) and the patient safety hotline (0.43). They were also significantly more likely to report one or more concerns, with 64% reporting via the face-to-face mechanism, compared with 41% via the paper-based form and 19% via the patient safety hotline. No mechanism differed significantly in the number of classified patient safety incidents or physician-rated preventability and severity. Interviewing at the patient's bedside is likely to be the most effective means of gathering safety concerns from inpatients, potentially providing an opportunity for health services to gather patient feedback about safety from their perspective. 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/.

Adaptation of the ToxRTool to Assess the Reliability of Toxicology Studies Conducted with Genetically Modified Crops and Implications for Future Safety Testing.

PubMed

Koch, Michael S; DeSesso, John M; Williams, Amy Lavin; Michalek, Suzanne; Hammond, Bruce

2016-01-01

To determine the reliability of food safety studies carried out in rodents with genetically modified (GM) crops, a Food Safety Study Reliability Tool (FSSRTool) was adapted from the European Centre for the Validation of Alternative Methods' (ECVAM) ToxRTool. Reliability was defined as the inherent quality of the study with regard to use of standardized testing methodology, full documentation of experimental procedures and results, and the plausibility of the findings. Codex guidelines for GM crop safety evaluations indicate toxicology studies are not needed when comparability of the GM crop to its conventional counterpart has been demonstrated. This guidance notwithstanding, animal feeding studies have routinely been conducted with GM crops, but their conclusions on safety are not always consistent. To accurately evaluate potential risks from GM crops, risk assessors need clearly interpretable results from reliable studies. The development of the FSSRTool, which provides the user with a means of assessing the reliability of a toxicology study to inform risk assessment, is discussed. Its application to the body of literature on GM crop food safety studies demonstrates that reliable studies report no toxicologically relevant differences between rodents fed GM crops or their non-GM comparators.

Inductionless or limited shock testing is possible in most patients with implantable cardioverter- defibrillators/cardiac resynchronization therapy defibrillators: results of the multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations).

PubMed

Day, John D; Doshi, Rahul N; Belott, Peter; Birgersdotter-Green, Ulrika; Behboodikhah, Mahnaz; Ott, Peter; Glatter, Kathryn A; Tobias, Serge; Frumin, Howard; Lee, Byron K; Merillat, John; Wiener, Isaac; Wang, Samuel; Grogin, Harlan; Chun, Sung; Patrawalla, Rob; Crandall, Brian; Osborn, Jeffrey S; Weiss, J Peter; Lappe, Donald L; Neuman, Stacey

2007-05-08

Implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators have relied on multiple ventricular fibrillation (VF) induction/defibrillation tests at implantation to ensure that the device can reliably sense, detect, and convert VF. The ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations) is the first large, multicenter, prospective trial comparing vulnerability safety margin testing versus defibrillation safety margin testing with a single VF induction/defibrillation. A total of 426 patients receiving an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator underwent vulnerability safety margin or defibrillation safety margin screening at 14 J in a randomized order. After this, patients underwent confirmatory testing, which required 2 VF conversions without failure at < or = 21 J. Patients who passed their first 14-J and confirmatory tests, irrespective of the results of their second 14-J test, had their devices programmed to a 21-J shock for ventricular tachycardia (VT) or VF > or = 200 bpm and were followed up for 1 year. Of 420 patients who underwent 14-J vulnerability safety margin screening, 322 (76.7%) passed. Of these, 317 (98.4%) also passed 21-J confirmatory tests. Of 416 patients who underwent 14-J defibrillation safety margin screening, 343 (82.5%) passed, and 338 (98.5%) also passed 21-J confirmatory tests. Most clinical VT/VF episodes (32 of 37, or 86%) were terminated by the first shock, with no difference in first shock success. In all observed cases in which the first shock was unsuccessful, subsequent shocks terminated VT/VF without complication. Although spontaneous episodes of fast VT/VF were limited, there was no difference in the odds of first shock efficacy between groups. Screening with vulnerability safety margin or defibrillation safety margin may allow for inductionless or limited shock testing in most patients.

Automated High-Speed Video Detection of Small-Scale Explosives Testing

NASA Astrophysics Data System (ADS)

Ford, Robert; Guymon, Clint

2013-06-01

Small-scale explosives sensitivity test data is used to evaluate hazards of processing, handling, transportation, and storage of energetic materials. Accurate test data is critical to implementation of engineering and administrative controls for personnel safety and asset protection. Operator mischaracterization of reactions during testing contributes to either excessive or inadequate safety protocols. Use of equipment and associated algorithms to aid the operator in reaction determination can significantly reduce operator error. Safety Management Services, Inc. has developed an algorithm to evaluate high-speed video images of sparks from an ESD (Electrostatic Discharge) machine to automatically determine whether or not a reaction has taken place. The algorithm with the high-speed camera is termed GoDetect (patent pending). An operator assisted version for friction and impact testing has also been developed where software is used to quickly process and store video of sensitivity testing. We have used this method for sensitivity testing with multiple pieces of equipment. We present the fundamentals of GoDetect and compare it to other methods used for reaction detection.

Safety and immunogenicity of a single intramuscular dose of a tetanus-diphtheria toxoid (Td) vaccine (BR-TD-1001) in healthy Korean adult subjects.

PubMed

Hong, Taegon; Chung, Yong-Ju; Kim, Tae-Yeon; Kim, Ik-Hwan; Choe, Yong-Kyung; Lee, Jongtae; Jeon, Sangil; Han, Seunghoon; Yim, Dong-Seok

2015-01-01

BR-TD-1001 was developed as a booster for the immunity maintenance of diphtheria and tetanus. The aim of this study was to evaluate the safety and immunogenicity of BR-TD-1001 (test vaccine) in comparison with placebo and an active comparator in healthy Korean adults. A randomized, double-blind, placebo-controlled, active comparator, phase I clinical trial was conducted. Fifty subjects were randomly assigned to one of 3 treatment groups in a ratio of 2:2:1, and were administered a single intramuscular dose of test vaccine, active comparator, or placebo, respectively. All subjects were monitored for 4 weeks after injection. The antibody titers of the patients 2 and 4 weeks after vaccination were compared with the baseline. The frequencies of all adverse events including adverse drug reactions in the test group were not statistically different from those of the other treatment groups (P = 0.4974, 0.3061). No serious adverse event occurred, and no subject was withdrawn from the study for safety. The seroprotection rates against both tetanus and diphtheria at 4 weeks after vaccination were over 0.95. For anti-tetanus antibody, the geometric mean titer in the test group was significantly higher than those of the other groups (P = 0.0364, 0.0033). The geometric mean titer of anti-diphtheria antibody in the test group was significantly higher than the value of the placebo (P = 0.0347) while it was not for the value of the active comparator (P = 0.8484). In conclusion, BR-TD-1001 was safe, well-tolerated, and showed sufficient immunogenicity as a booster for diphtheria and tetanus.

Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

PubMed

Walczuk, Imko; Eertmans, Frank; Rossel, Bart; Cegielska, Agnieszka; Stockfleth, Eggert; Antunes, Andre; Adriaens, Els

2018-06-01

Cutaneous warts are common skin lesions, caused by human papillomavirus. For years, liquid nitrogen is the cryogen of choice for wart treatment. Alternatively, several cryogenic devices for home treatment are commercially available. The present trial assessed efficacy and safety of a novel nitrous oxide-based cryogenic device for home use (EndWarts Freeze ® in Europe, Compound W ® Nitro-Freeze in the USA). This investigator-blinded, controlled, randomized study compared the nitrous oxide device (test product) with a dimethylether propane-based product (Wartner ® ; comparator 1). Subjects with common or plantar warts (50/50 ratio) were randomized into two groups (n = 58, test product; n = 40, comparator 1). Sequentially, an extra treatment arm (n = 40) was added to compare with a dimethylether-based product with metal nib (Wortie ® ; comparator 2). Main objective implied comparison of the percentage cured subjects after one to maximum three treatments. Efficacy and safety was evaluated by a blinded investigator. After a maximum of three applications, a significantly (p = 0.001) higher cure rate of 70.7% (Intention-to-Treat analysis) was observed with test product versus 46.2% (comparator 1) and 47.5% (comparator 2). Almost three times more subjects were cured after 1 test product application (29.3%), versus comparator 1 (10.4%) and comparator 2 (12.5%). Reported side effects were transient and typical of cryotherapy. All treatments were well-tolerated. The superior cure rates for the test product versus two comparators can be explained by its design. Combination of nitrous oxide (cooling agent), the specific activation method (holding the liquid coolant in the cap), and skin-conforming polyurethane foam, results in higher cooling efficiency (- 80 °C) and more effective wart freezing. This trial demonstrated that the nitrous oxide device is a safe, user-friendly and effective wart treatment for home use, comparing favourably to dimethylether (propane) devices with higher freezing temperature, regardless of the applicator type. Oystershell Laboratories. Clinicaltrials.gov identifier, NCT03129373.

Evaluating Material Flammability in Microgravity and Martian Gravity Compared to the NASA Standard Normal Gravity Test

NASA Technical Reports Server (NTRS)

Oslon, Sandra. L.; Ferkul, Paul

2012-01-01

Drop tower tests are conducted at Martian gravity to determine the flammability of three materials compared to previous tests in other normal gravity and reduced gravity environments. The comparison is made with consideration of a modified NASA standard test protocol. Material flammability limits in the different gravity and flow environments are tabulated to determine the factor of safety associated with normal gravity flammability screening. Previous testing at microgravity and Lunar gravity indicated that some materials burned to lower oxygen concentrations in low gravity than in normal gravity, although the low g extinction limit criteria are not the same as 1g due to time constraints in drop testing. Similarly, the data presented in this paper for Martian gravity suggest that there is a gravity level below Earth s at which materials burn more readily than on Earth. If proven for more materials, this may indicate the need to include a factor of safety on 1g flammability limits.

Comparing NICU teamwork and safety climate across two commonly used survey instruments.

PubMed

Profit, Jochen; Lee, Henry C; Sharek, Paul J; Kan, Peggy; Nisbet, Courtney C; Thomas, Eric J; Etchegaray, Jason M; Sexton, Bryan

2016-12-01

Measurement and our understanding of safety culture are still evolving. The objectives of this study were to assess variation in safety and teamwork climate and in the neonatal intensive care unit (NICU) setting, and compare measurement of safety culture scales using two different instruments (Safety Attitudes Questionnaire (SAQ) and Hospital Survey on Patient Safety Culture (HSOPSC)). Cross-sectional survey study of a voluntary sample of 2073 (response rate 62.9%) health professionals in 44 NICUs. To compare survey instruments, we used Spearman's rank correlation coefficients. We also compared similar scales and items across the instruments using t tests and changes in quartile-level performance. We found significant variation across NICUs in safety and teamwork climate scales of SAQ and HSOPSC (p<0.001). Safety scales (safety climate and overall perception of safety) and teamwork scales (teamwork climate and teamwork within units) of the two instruments correlated strongly (safety r=0.72, p<0.001; teamwork r=0.67, p<0.001). However, the means and per cent agreements for all scale scores and even seemingly similar item scores were significantly different. In addition, comparisons of scale score quartiles between the two instruments revealed that half of the NICUs fell into different quartiles when translating between the instruments. Large variation and opportunities for improvement in patient safety culture exist across NICUs. Important systematic differences exist between SAQ and HSOPSC such that these instruments should not be used interchangeably. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The relationship between labor unions and safety in US airlines: Is there a "union effect?"

NASA Astrophysics Data System (ADS)

Zapf, Renee Catherine

Every airline union claims to work for safety and presents anecdotes where greater airline safety has been achieved through union efforts. The effect unionization has on safety outcomes in U.S. commercial airlines, however, wasn't found to be previously tested. Studies have shown that in industries such as coal mining, retail, and construction, unionization does lead to an increase in safety. This study evaluated the safety rates of 15 major US commercial airlines to compare the difference between unionized and non-unionized airlines. These safety rates were compared based on if and how long each airline's pilots and flight attendants have been unionized, to determine if unionization had an effect on safety outcomes. The 15 airlines included in the study identified as operating most of the years between 1990 and 2013, with annual departures averaging over 130,000, available through the Bureau of Transportation Statistics. Accident and Incident information was acquired through the National Transportation Safety Board database. The number of accident and incidents divided by the total departures at each airline was used as the safety rate. Union websites provided information on unionization at the airlines. Due to the complex nature of the aviation industry, a number of confounding factors could have affected the tests, including mergers, route structures, and legislation. To help control for these confounding factors, this study was limited to airlines with a stable presence in the industry over time, which limited the number of airlines included. No significant difference was found between unionized and non-unionized airlines in this study, though the mean safety rate of unionized airlines was found be better than non-unionized airlines. This study did not take into account safety improvements that were union-backed and eventually required at all airlines, regardless of unionization. Due to the large sample size of the small population the difference in safety rate means could be indicative of greater safety in unionized airlines.

Safety of coronary CT angiography and functional testing for stable chest pain in the PROMISE trial: A randomized comparison of test complications, incidental findings, and radiation dose.

PubMed

Lu, Michael T; Douglas, Pamela S; Udelson, James E; Adami, Elizabeth; Ghoshhajra, Brian B; Picard, Michael H; Roberts, Rhonda; Lee, Kerry L; Einstein, Andrew J; Mark, Daniel B; Velazquez, Eric J; Carter, William; Ridner, Michael; Al-Khalidi, Hussein R; Hoffmann, Udo

Coronary computed tomography angiography (CTA) and functional testing strategies for stable chest pain yield similar outcomes; one aspect that may guide test choice is safety. We compared test safety (test complications, incidental findings, and effective radiation dose) between CTA and functional testing as-tested in PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain). In the subgroup whose physicians intended nuclear stress over other functional tests if randomized to the functional arm, we compared radiation dose of CTA versus nuclear stress and identified characteristics associated with dose. Of 9470 patients, none had major and <1% had minor complications (CTA: 0.8% [37/4633] vs. functional: 0.6% [27/4837]). CTA identified more incidental findings (11.6% [539/4633] vs. 0.7% [34/4837], p < 0.001), most commonly pulmonary nodules (9.4%, 437/4633). CTA had similar 90-day cumulative radiation dose to functional testing. However, in the subgroup whose physicians intended nuclear stress (CTA 3147; nuclear 3203), CTA had lower median index test (8.8 vs. 12.6 mSv, p < 0.001) and 90-day cumulative (11.6 vs. 13.1 mSv, p < 0.001) dose, independent of patient characteristics. The lowest nuclear doses employed 1-day Tc-99m protocols (12.2 mSv). The lowest CTA doses were at sites performing ≥500 CTAs/year (6.9 mSv) and with advanced (latest available) CT scanners (5.5 mSv). Complications were negligibly rare for both CTA and functional testing. CTA detects more incidental findings. Compared to nuclear stress testing, CTA's lower radiation dose, independent of patient characteristics, makes it an attractive test choice. Radiation dose varies with imaging protocol, indicating opportunities to further reduce dose. (ClinicalTrials.gov number, NCT01174550). Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Evaluation of experimental methods for assessing safety for ultrasound radiation force elastography.

PubMed

Skurczynski, M J; Duck, F A; Shipley, J A; Bamber, J C; Melodelima, D

2009-08-01

Standard test tools have been evaluated for the assessment of safety associated with a prototype transducer intended for a novel radiation force elastographic imaging system. In particular, safety has been evaluated by direct measurement of temperature rise, using a standard thermal test object, and detection of inertial cavitation from acoustic emission. These direct measurements have been compared with values of the thermal index and mechanical index, calculated from acoustic measurements in water using standard formulae. It is concluded that measurements using a thermal test object can be an effective alternative to the calculation of thermal index for evaluating thermal hazard. Measurement of the threshold for cavitation was subject to considerable variability, and it is concluded that the mechanical index still remains the preferred standard means for assessing cavitation hazard.

System Vaccinology for the Evaluation of Influenza Vaccine Safety by Multiplex Gene Detection of Novel Biomarkers in a Preclinical Study and Batch Release Test

PubMed Central

Mizukami, Takuo; Momose, Haruka; Kuramitsu, Madoka; Takizawa, Kazuya; Araki, Kumiko; Furuhata, Keiko; Ishii, Ken J.; Hamaguchi, Isao; Yamaguchi, Kazunari

2014-01-01

Vaccines are beneficial and universal tools to prevent infectious disease. Thus, safety of vaccines is strictly evaluated in the preclinical phase of trials and every vaccine batch must be tested by the National Control Laboratories according to the guidelines published by each country. Despite many vaccine production platforms and methods, animal testing for safety evaluation is unchanged thus far. We recently developed a systems biological approach to vaccine safety evaluation where identification of specific biomarkers in a rat pre-clinical study evaluated the safety of vaccines for pandemic H5N1 influenza including Irf7, Lgals9, Lgalsbp3, Cxcl11, Timp1, Tap2, Psmb9, Psme1, Tapbp, C2, Csf1, Mx2, Zbp1, Ifrd1, Trafd1, Cxcl9, β2m, Npc1, Ngfr and Ifi47. The current study evaluated whether these 20 biomarkers could evaluate the safety, batch-to-batch and manufacturer-to-manufacturer consistency of seasonal trivalent influenza vaccine using a multiplex gene detection system. When we evaluated the influenza HA vaccine (HAv) from four different manufactures, the biomarker analysis correlated to findings from conventional animal use tests, such as abnormal toxicity test. In addition, sensitivity of toxicity detection and differences in HAvs were higher and more accurate than with conventional methods. Despite a slight decrease in body weight caused by HAv from manufacturer B that was not statistically significant, our results suggest that HAv from manufacturer B is significantly different than the other HAvs tested with regard to Lgals3bp, Tapbp, Lgals9, Irf7 and C2 gene expression in rat lungs. Using the biomarkers confirmed in this study, we predicted batch-to-batch consistency and safety of influenza vaccines within 2 days compared with the conventional safety test, which takes longer. These biomarkers will facilitate the future development of new influenza vaccines and provide an opportunity to develop in vitro methods of evaluating batch-to-batch consistency and vaccine safety as an alternative to animal testing. PMID:25010690

Intelligent walkers for the elderly: performance and safety testing of VA-PAMAID robotic walker.

PubMed

Rentschler, Andrew J; Cooper, Rory A; Blasch, Bruce; Boninger, Michael L

2003-01-01

A walker that could help navigate and avoid collisions with obstacles could help reduce health costs and increase the quality of care and independence of thousands of people. This study evaluated the safety and performance of the Veterans Affairs Personal Adaptive Mobility Aid (VA-PAMAID). We performed engineering tests on the VA-PAMAID to determine safety factors, including stability, energy consumption, fatigue life, and sensor and control malfunctions. The VA-PAMAID traveled 10.9 km on a full charge and avoided obstacles while traveling at a speed of up to 1.2 m/s. No failures occurred during static stability, climatic, or fatigue testing. Some problems were encountered during obstacle climbing and sensor and control testing. The VA-PAMAID has good range, has adequate reaction time, and is structurally sound. Clinical trials are planned to compare the device to other low-technical adaptive mobility devices.

Tackling Ambulatory Safety Risks Through Patient Engagement: What 10,000 Patients and Families Say About Safety-Related Knowledge, Behaviors, and Attitudes After Reading Visit Notes.

PubMed

Bell, Sigall K; Folcarelli, Patricia; Fossa, Alan; Gerard, Macda; Harper, Marvin; Leveille, Suzanne; Moore, Caroline; Sands, Kenneth E; Sarnoff Lee, Barbara; Walker, Jan; Bourgeois, Fabienne

2018-04-27

Ambulatory safety risks including delayed diagnoses or missed abnormal test results are difficult for clinicians to see, because they often occur in the space between visits. Experts advocate greater patient engagement to improve safety, but strategies are limited. Patient access to clinical notes ("OpenNotes") may help close the safety gap between visits. We surveyed patients and families who logged on to the patient portal and had at least one ambulatory note available in the past 12 months at two academic hospitals during June to September 2016, focusing on patient-reported effects of OpenNotes on safety knowledge, behaviors, and attitudes. A total of 6913 (28%) of 24,722 patients at an adult hospital and 3672 (17%) of 21,579 participants at the children's hospital submitted surveys. Approximately 75% of patients and parents each reported that reading notes helped them understand the reason for both tests and referrals, and approximately 50% felt that it helped them complete tests and referrals. Roughly 75% of participants were more likely to check and understand test results. Overall, 97% of participants reported that trust in the provider, activation, patient-provider goal alignment, and teamwork were each better or the same after reading 1 note or more. Nonwhite participants and those with high school education or less were 30% to 50% more likely to report that reading notes helped them complete tests compared with white and more educated respondents, respectively. Overall, the majority of more than 10,000 patients and parents reported reading notes helped them understand and follow through on tests and referrals. As information transparency spreads, OpenNotes can help activate patients and families, facilitate safety behaviors, and forge stronger partnerships with clinicians.

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

PubMed

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

2017-09-01

The prevalence of sensitive skin among the general population in industrialized countries is reported to be over 50%. Sensitive skin subjects often report significant reactions to contact with cosmetics, soaps and other consumer products. This paper describes the overall skin compatibility and mildness program for a newly developed, lightly fragranced, colorant free laundry product (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent), specially formulated for individuals with sensitive skin. The skin mildness of the product was compared to Arm & Hammer™ Free & Clear liquid laundry detergent with no fragrance or colorant, and an established history of safe use by sensitive skin consumers. The test material was a liquid laundry product with a light scent formulated for sensitive skin consumers (Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent). The product was compared to commercially marketed products for sensitive skin with a history of skin safety in the marketplace, including: a very similar product formulation (Arm & Hammer™ Free & Clear with no fragrance), and several selected competitors' products. Studies were conducted among individuals with self-assessed sensitive skin (based on a questionnaire) using standard protocols for the Human Repeat Insult Patch Test (HRIPT), 10-Day Cumulative Irritation, the Wrist Band Wear test, and the Safety In-Use testing. Responses in all protocols were evaluated by visual scoring of potential dermatologic reactions, and recording any sensory effects at the time of the examination. In addition, sensory effects collected from panelists' daily diaries were also evaluated. The HRIPT confirmed that neither the fragrance alone, nor the product formulation with fragrance, induced contact sensitization in sensitive skin subjects. The 10-Day cumulative irritation study conducted using sensitive skin subjects showed highly favorable skin compatibility, and the test product was comparable to the control product (Arm & Hammer Free & Clear) and other nonirritant controls. In the Wrist Band Wear test, exposure to laundered fabrics under exaggerated conditions gave similar results for the test and control products, with no objective signs of skin irritation, and no self-reported persistent adverse sensory effects. Very mild, transient and isolated sensory effects were noted in daily diaries by a small proportion of subjects, and were similar for the test and control products. The Safety In-Use tests evaluated 4-week exposure to product and laundered fabrics under realistic use conditions. There were no clinically objective signs of skin irritation, and reports of transitory, mild sensory effects were minimal and similar for the test and controls. A comprehensive skin safety program on a lightly scented sensitive skin laundry formulation (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent) conducted among panels of self-assessed sensitive skin subjects demonstrated that the presence of a light fragrance did not adversely impact skin compatibility in any of the testing protocols when the product was compared to a similar product with no fragrance. The lightly fragranced product demonstrated overall skin compatibility and mildness when tested in a self-assessed sensitive skin population, and compared favorably to currently marketed sensitive skin products.

Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.

PubMed

Talukdar, Anjan; Wang, S Keisin; Czosnowski, Lauren; Mokraoui, Nassim; Gupta, Alok; Fajardo, Andres; Dalsing, Michael; Motaganahalli, Raghu

2017-10-01

Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. We report the safety and efficacy of rivaroxaban vs warfarin in patients undergoing peripheral arterial interventions. This single-institution retrospective study analyzed all sequential patients from December 2012 to August 2014 (21 months) who were prescribed rivaroxaban or warfarin after a peripheral arterial procedure. Our study population was then compared using American College of Chest Physicians guidelines with patients then stratified as low, medium, or high risk for bleeding complications. Statistical analyses were performed using the Student t-test and χ 2 test to compare demographics, readmissions because of bleeding, and the need for secondary interventions. Logistic regression models were used for analysis of variables associated with bleeding complications and secondary interventions. The Fisher exact test was used for power analysis. There were 44 patients in the rivaroxaban group and 50 patients in the warfarin group. Differences between demographics and risk factors for bleeding between groups or reintervention rate were not statistically significant (P = .297). However, subgroup evaluation of the safety profile suggests that patients who were aged ≤65 years and on warfarin had an overall higher incidence of major bleeding (P = .020). Patients who were aged >65 years, undergoing open operation, had a significant risk for reintervention (P = .047) when they received rivaroxaban. Real-world experience using rivaroxaban and warfarin in patients after peripheral arterial procedures suggests a comparable safety and efficacy profile. Subgroup analysis of those requiring an open operation demonstrated a decreased bleeding risk when rivaroxaban was used (in those aged <65 years) but an increased risk for secondary interventions. Further studies with a larger cohort are required to validate our results. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Preventing Child Sexual Abuse: Body Safety Training for Young Children in Turkey.

PubMed

Citak Tunc, Gulseren; Gorak, Gulay; Ozyazicioglu, Nurcan; Ak, Bedriye; Isil, Ozlem; Vural, Pinar

2018-01-01

The "Body Safety Training Program" is an education program aimed at ensuring children are informed about their body and acquire self-protection skills. In this study, a total of 83 preschoolers were divided into experimental and control groups; based on a power analysis, 40 children comprised the experimental group, while 43 children comprised the control group. The "Body Safety Training Programme" was translated into Turkish and content validity was determined regarding the language and cultural appropriateness. The "What If Situations Test" (WIST) was administered to both groups before and after the training. Mann-Whitney U Test, Kruskal-Wallis Variance Analysis, and the Wilcoxon Signed Ranks Test were used to compare between the groups and the Spearman correlation analysis was used to determine the strength of the relationship between the dependent and independent variable. The differences between the pretest and posttest scores for the subscales (appropriate recognition, inappropriate recognition, say, do, tell, and reporting skills), and the personal safety questionnaire (PSQ) score means for the children in the experimental group were found to be statistically significant (p < .001). The posttest-pretest difference score means of the experimental group children for WIST saying, doing, telling and reporting, total skills, and PSQ were found to be statistically significant as compared to that of the control group (p < .05). The "Body Safety Training programme" is effective in increasing the child sexual abuse prevention and self-protection skills in Turkish young children.

A maximally selected test of symmetry about zero.

PubMed

Laska, Eugene; Meisner, Morris; Wanderling, Joseph

2012-11-20

The problem of testing symmetry about zero has a long and rich history in the statistical literature. We introduce a new test that sequentially discards observations whose absolute value is below increasing thresholds defined by the data. McNemar's statistic is obtained at each threshold and the largest is used as the test statistic. We obtain the exact distribution of this maximally selected McNemar and provide tables of critical values and a program for computing p-values. Power is compared with the t-test, the Wilcoxon Signed Rank Test and the Sign Test. The new test, MM, is slightly less powerful than the t-test and Wilcoxon Signed Rank Test for symmetric normal distributions with nonzero medians and substantially more powerful than all three tests for asymmetric mixtures of normal random variables with or without zero medians. The motivation for this test derives from the need to appraise the safety profile of new medications. If pre and post safety measures are obtained, then under the null hypothesis, the variables are exchangeable and the distribution of their difference is symmetric about a zero median. Large pre-post differences are the major concern of a safety assessment. The discarded small observations are not particularly relevant to safety and can reduce power to detect important asymmetry. The new test was utilized on data from an on-road driving study performed to determine if a hypnotic, a drug used to promote sleep, has next day residual effects. Copyright © 2012 John Wiley & Sons, Ltd.

Fire Safety Tests for Spherical Resorcinol Formaldehyde Resin: Data Summary Report

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

Kim, Dong-Sang; Peterson, Reid A.; Schweiger, Michael J.

2012-07-30

A draft safety evaluation of the scenario for spherical resorcinol-formaldehyde (SRF) resin fire inside the ion exchange column was performed by the Hanford Tank Waste Treatment and Immobilization Plant (WTP) Fire Safety organization. The result of this draft evaluation suggested a potential change of the fire safety classification for the Cesium Ion Exchange Process System (CXP) emergency elution vessels, equipment, and piping, which may be overly bounding based on the fire performance data from the manufacturer of the ion exchange resin selected for use at the WTP. To resolve this question, the fire properties of the SRF resin were measuredmore » by Southwest Research Institute (SwRI), following the American Society for Testing and Materials (ASTM) standard procedures, through a subcontract managed by Pacific Northwest National Laboratory (PNNL). For some tests, the ASTM standard procedures were not entirely appropriate or practical for the SRF resin material, so the procedures were modified and deviations from the ASTM standard procedures were noted. This report summarizes the results of fire safety tests performed and reported by SwRI. The efforts by PNNL were limited to summarizing the test results provided by SwRI into one consolidated data report. All as-received SwRI reports are attached to this report in the Appendix. Where applicable, the precision and bias of each test method, as given by each ASTM standard procedure, are included and compared with the SwRI test results of the SRF resin.« less

Predictors of driving safety in early Alzheimer disease

PubMed Central

Dawson, J D.; Anderson, S W.; Uc, E Y.; Dastrup, E; Rizzo, M

2009-01-01

Objective: To measure the association of cognition, visual perception, and motor function with driving safety in Alzheimer disease (AD). Methods: Forty drivers with probable early AD (mean Mini-Mental State Examination score 26.5) and 115 elderly drivers without neurologic disease underwent a battery of cognitive, visual, and motor tests, and drove a standardized 35-mile route in urban and rural settings in an instrumented vehicle. A composite cognitive score (COGSTAT) was calculated for each subject based on eight neuropsychological tests. Driving safety errors were noted and classified by a driving expert based on video review. Results: Drivers with AD committed an average of 42.0 safety errors/drive (SD = 12.8), compared to an average of 33.2 (SD = 12.2) for drivers without AD (p < 0.0001); the most common errors were lane violations. Increased age was predictive of errors, with a mean of 2.3 more errors per drive observed for each 5-year age increment. After adjustment for age and gender, COGSTAT was a significant predictor of safety errors in subjects with AD, with a 4.1 increase in safety errors observed for a 1 SD decrease in cognitive function. Significant increases in safety errors were also found in subjects with AD with poorer scores on Benton Visual Retention Test, Complex Figure Test-Copy, Trail Making Subtest-A, and the Functional Reach Test. Conclusion: Drivers with Alzheimer disease (AD) exhibit a range of performance on tests of cognition, vision, and motor skills. Since these tests provide additional predictive value of driving performance beyond diagnosis alone, clinicians may use these tests to help predict whether a patient with AD can safely operate a motor vehicle. GLOSSARY AD = Alzheimer disease; AVLT = Auditory Verbal Learning Test; Blocks = Block Design subtest; BVRT = Benton Visual Retention Test; CFT = Complex Figure Test; CI = confidence interval; COWA = Controlled Oral Word Association; CS = contrast sensitivity; FVA = far visual acuity; JLO = Judgment of Line Orientation; MCI = mild cognitive impairment; MMSE = Mini-Mental State Examination; NVA = near visual acuity; SFM = structure from motion; TMT = Trail-Making Test; UFOV = Useful Field of View. PMID:19204261

Comparative tests of bench equipment for fuel control system testing of gas-turbine engine

NASA Astrophysics Data System (ADS)

Shendaleva, E. V.

2018-04-01

The relevance of interlaboratory comparative researches is confirmed by attention of world metrological community to this field of activity. Use of the interlaboratory comparative research methodology not only for single gages collation, but also for bench equipment complexes, such as modeling stands for fuel control system testing of gas-turbine engine, is offered. In this case a comparative measure of different bench equipment will be the control fuel pump. Ensuring traceability of measuring result received at test benches of various air enterprises, development and introduction of national standards to practice of bench tests and, eventually, improvement of quality and safety of a aircraft equipment is result of this approach.

Lithium-ion batteries for hearing aid applications. II. Pulse discharge and safety tests

NASA Astrophysics Data System (ADS)

Passerini, S.; Coustier, F.; Owens, B. B.

Rechargeable lithium-ion batteries were designed to meet the power requirements of hearing aid devices (HADs). The batteries were designed in a 312-button cell size, compatible with existing hearing aids. The batteries were tested to evaluate the design and the electrochemical performance, as they relate to a typical hearing aid application. The present report covers the pulse capabilities, cycle life and preliminary safety tests. The results are compared with other battery chemistries: secondary lithium-alloy and nickel-metal hydride batteries and primary Zn-air batteries. The cell AC impedance was stable over the frequency range between 1 and 50 kHz, ranging between 5 Ω at the higher frequency and 12 Ω at the lower extreme. Pulse tests were consistent with these values, as the cells were capable of providing a series of 100 mA pulses of 10-s duration. The safety tests suggest that the design is intrinsically safe with respect to the most common types of abuse conditions.

Does user-centred design affect the efficiency, usability and safety of CPOE order sets?

PubMed

Chan, Julie; Shojania, Kaveh G; Easty, Anthony C; Etchells, Edward E

2011-05-01

Application of user-centred design principles to Computerized provider order entry (CPOE) systems may improve task efficiency, usability or safety, but there is limited evaluative research of its impact on CPOE systems. We evaluated the task efficiency, usability, and safety of three order set formats: our hospital's planned CPOE order sets (CPOE Test), computer order sets based on user-centred design principles (User Centred Design), and existing pre-printed paper order sets (Paper). 27 staff physicians, residents and medical students. Sunnybrook Health Sciences Centre, an academic hospital in Toronto, Canada. Methods Participants completed four simulated order set tasks with three order set formats (two CPOE Test tasks, one User Centred Design, and one Paper). Order of presentation of order set formats and tasks was randomized. Users received individual training for the CPOE Test format only. Completion time (efficiency), requests for assistance (usability), and errors in the submitted orders (safety). 27 study participants completed 108 order sets. Mean task times were: User Centred Design format 273 s, Paper format 293 s (p=0.73 compared to UCD format), and CPOE Test format 637 s (p<0.0001 compared to UCD format). Users requested assistance in 31% of the CPOE Test format tasks, whereas no assistance was needed for the other formats (p<0.01). There were no significant differences in number of errors between formats. The User Centred Design format was more efficient and usable than the CPOE Test format even though training was provided for the latter. We conclude that application of user-centred design principles can enhance task efficiency and usability, increasing the likelihood of successful implementation.

Does user-centred design affect the efficiency, usability and safety of CPOE order sets?

PubMed Central

Chan, Julie; Shojania, Kaveh G; Easty, Anthony C

2011-01-01

Background Application of user-centred design principles to Computerized provider order entry (CPOE) systems may improve task efficiency, usability or safety, but there is limited evaluative research of its impact on CPOE systems. Objective We evaluated the task efficiency, usability, and safety of three order set formats: our hospital's planned CPOE order sets (CPOE Test), computer order sets based on user-centred design principles (User Centred Design), and existing pre-printed paper order sets (Paper). Participants 27staff physicians, residents and medical students. Setting Sunnybrook Health Sciences Centre, an academic hospital in Toronto, Canada. Methods Participants completed four simulated order set tasks with three order set formats (two CPOE Test tasks, one User Centred Design, and one Paper). Order of presentation of order set formats and tasks was randomized. Users received individual training for the CPOE Test format only. Main Measures Completion time (efficiency), requests for assistance (usability), and errors in the submitted orders (safety). Results 27 study participants completed 108 order sets. Mean task times were: User Centred Design format 273 s, Paper format 293 s (p=0.73 compared to UCD format), and CPOE Test format 637 s (p<0.0001 compared to UCD format). Users requested assistance in 31% of the CPOE Test format tasks, whereas no assistance was needed for the other formats (p<0.01). There were no significant differences in number of errors between formats. Conclusions The User Centred Design format was more efficient and usable than the CPOE Test format even though training was provided for the latter. We conclude that application of user-centred design principles can enhance task efficiency and usability, increasing the likelihood of successful implementation. PMID:21486886

Are Charter Schools Safer in Deindustrialized Cities with High Rates of Crime? Testing Hypotheses in Detroit

ERIC Educational Resources Information Center

Hamlin, Daniel

2017-01-01

Families in deindustrialized cities with high crime rates report prioritizing school safety when opting for charter schools. Yet, very little research has investigated whether charter schools are safer than traditional public schools. This study compares charter and traditional public schools in Detroit, Michigan, on perceived school safety by…

Preventing passenger vehicle occupant injuries by vehicle design--a historical perspective from IIHS.

PubMed

O'Neill, Brian

2009-04-01

Motor vehicle crashes result in some 1.2 million deaths and many more injuries worldwide each year and is one of the biggest public health problems facing societies today. This article reviews the history of, and future potential for, one important countermeasure-designing vehicles that reduce occupant deaths and injuries. For many years, people had urged automakers to add design features to reduce crash injuries, but it was not until the mid-1960s that the idea of pursuing vehicle countermeasures gained any significant momentum. In 1966, the U.S. Congress passed the National Traffic and Motor Vehicle Safety Act, requiring the government to issue a comprehensive set of vehicle safety standards. This was the first broad set of requirements issued anywhere in the world, and within a few years similar standards were adopted in Europe and Australia. Early vehicle safety standards specified a variety of safety designs resulting in cars being equipped with lap/shoulder belts, energy-absorbing steering columns, crash-resistant door locks, high-penetration-resistant windshields, etc. Later, the standards moved away from specifying particular design approaches and instead used crash tests and instrumented dummies to set limits on the potential for serious occupant injuries by crash mode. These newer standards paved the way for an approach that used the marketplace, in addition to government regulation, to improve vehicle safety designs-using crash tests and instrumented dummies to provide consumers with comparative safety ratings for new vehicles. The approach began in the late 1970s, when NHTSA started publishing injury measures from belted dummies in new passenger vehicles subjected to frontal barrier crash tests at speeds somewhat higher than specified in the corresponding regulation. This program became the world's first New Car Assessment Program (NCAP) and rated frontal crashworthiness by awarding stars (five stars being the best and one the worst) derived from head and chest injury measures recorded on driver and front-seat test dummies. NHTSA later added side crash tests and rollover ratings to the U.S. NCAP. Consumer crash testing spread worldwide in the 1990s. In 1995, the Insurance Institute for Highway Safety (IIHS) began using frontal offset crash tests to rate and compare frontal crashworthiness and later added side and rear crash assessments. Shortly after, Europe launched EuroNCAP to assesses new car performance including front, side, and front-end pedestrian tests. The influence of these consumer-oriented crash test programs on vehicle designs has been major. From the beginning, U.S. NCAP results prompted manufacturers to improve seat belt performance. Frontal offset tests from IIHS and EuroNCAP resulted in greatly improved front-end crumple zones and occupant compartments. Side impact tests have similarly resulted in improved side structures and accelerated the introduction of side impact airbags, especially those designed to protect occupant's heads. Vehicle safety designs, initially driven by regulations and later by consumer demand because of crash testing, have proven to be very successful public health measures. Since they were first introduced in the late 1960s, vehicle safety designs have saved hundreds of thousands of lives and prevented countless injuries worldwide. The designs that improved vehicle crashworthiness have been particularly effective. Some newer crash avoidance designs also have the potential to be effective-e.g., electronic stability control is already saving many lives in single-vehicle crashes. However, determining the actual effectiveness of these new technologies is a slow process and needs real-world crash experience because there are no assessment equivalent of crash tests for crash avoidance designs.

A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients

PubMed Central

Hegg, Roberto; Mattar, André; de Matos, João Nunes; Pedrini, José Luiz; Aleixo, Sabina Bandeira; Rocha, Roberto Odebrecht; Cramer, Renato Peixoto; van-Eyll-Rocha, Sylvie

2016-01-01

OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa's approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima®). PMID:27759847

[Motor skills and safety of patients with bi- or trimalleolar ankle injury : Comparison with healthy, active, age-matched control subjects].

PubMed

Loudovici-Krug, Dana; Benkenstein, Monique; Derlien, Steffen; Best, Norman

2018-06-01

Do patients with bi- or trimalleolar ankle injury show differences in motor skills and safety in comparison with healthy, active, age-matched control subjects? Prospective controlled cross-sectional study. Inclusion of 17 patients with bi- or trimalleolar ankle injury (mean 1.5 years postsurgery) and 23 healthy, active subjects of comparable age (fitness studio). Measurement instruments: motor test procedures and questionnaires. Comparison of patients and control subjects by routine daily motor function: patients < controls with the "timed 'Up & Go' test" (TUG, p = 0.011), the chair rising test and a coordination test using a gymnastic hoop (CRT and GR p > 0.05), fear of falling: patients > controls (p = 0.003) and physical activity: patients < controls (p = 0.032). There were no significant motor deficits in activities of daily life between the patients and controls, only tendencies; however, the patients showed definite limitations with an increased fear of falling and a reduced physical activity compared with the healthy control group. The resulting differences should be positively influenced by appropriate enhancement of training or participation in sports courses. The aim is to achieve a similar quality of life by a perception of safety and trust in one's own motor skills.

Lung Function Measurements in Rodents in Safety Pharmacology Studies

PubMed Central

Hoymann, Heinz Gerd

2012-01-01

The ICH guideline S7A requires safety pharmacology tests including measurements of pulmonary function. In the first step – as part of the “core battery” – lung function tests in conscious animals are requested. If potential adverse effects raise concern for human safety, these should be explored in a second step as a “follow-up study”. For these two stages of safety pharmacology testing, both non-invasive and invasive techniques are needed which should be as precise and reliable as possible. A short overview of typical in vivo measurement techniques is given, their advantages and disadvantages are discussed and out of these the non-invasive head-out body plethysmography and the invasive but repeatable body plethysmography in orotracheally intubated rodents are presented in detail. For validation purposes the changes in the respective parameters such as tidal midexpiratory flow (EF50) or lung resistance have been recorded in the same animals in typical bronchoconstriction models and compared. In addition, the technique of head-out body plethysmography has been shown to be useful to measure lung function in juvenile rats starting from day two of age. This allows safety pharmacology testing and toxicological studies in juvenile animals as a model for the young developing organism as requested by the regulatory authorities (e.g., EMEA Guideline 1/2008). It is concluded that both invasive and non-invasive pulmonary function tests are capable of detecting effects and alterations on the respiratory system with different selectivity and area of operation. The use of both techniques in a large number of studies in mice and rats in the last years have demonstrated that they provide useful and reliable information on pulmonary mechanics in safety pharmacology and toxicology testing, in investigations of respiratory disorders, and in pharmacological efficacy studies. PMID:22973226

Psychosocial safety climate buffers effects of job demands on depression and positive organizational behaviors.

PubMed

Hall, Garry B; Dollard, Maureen F; Winefield, Anthony H; Dormann, Christian; Bakker, Arnold B

2013-01-01

In a general population sample of 2343 Australian workers from a wide ranging employment demographic, we extended research testing the buffering role of psychosocial safety climate (PSC) as a macro-level resource within the health impairment process of the Job Demands-Resources (JD-R) model. Moderated structural equation modeling was used to test PSC as a moderator between emotional and psychological job demands and worker depression compared with control and social support as alternative moderators. We also tested PSC as a moderator between depression and positive organizational behaviors (POB; engagement and job satisfaction) compared with control and social support as moderators. As expected we found PSC moderated the effects of job demands on depression and further moderated the effects of depression on POB with fit to the data that was as good as control and social support as moderators. This study has shown that PSC is a macro-level resource and safety signal for workers acting to reduce demand-induced depression. We conclude that organizations need to focus on the development of a robust PSC that will operate to buffer the effects of workplace psychosocial hazards and to build environments conducive to worker psychological health and positive organizational behaviors.

Autonomous Flight Safety System

NASA Technical Reports Server (NTRS)

Ferrell, Bob; Santuro, Steve; Simpson, James; Zoerner, Roger; Bull, Barton; Lanzi, Jim

2004-01-01

Autonomous Flight Safety System (AFSS) is an independent flight safety system designed for small to medium sized expendable launch vehicles launching from or needing range safety protection while overlying relatively remote locations. AFSS replaces the need for a man-in-the-loop to make decisions for flight termination. AFSS could also serve as the prototype for an autonomous manned flight crew escape advisory system. AFSS utilizes onboard sensors and processors to emulate the human decision-making process using rule-based software logic and can dramatically reduce safety response time during critical launch phases. The Range Safety flight path nominal trajectory, its deviation allowances, limit zones and other flight safety rules are stored in the onboard computers. Position, velocity and attitude data obtained from onboard global positioning system (GPS) and inertial navigation system (INS) sensors are compared with these rules to determine the appropriate action to ensure that people and property are not jeopardized. The final system will be fully redundant and independent with multiple processors, sensors, and dead man switches to prevent inadvertent flight termination. AFSS is currently in Phase III which includes updated algorithms, integrated GPS/INS sensors, large scale simulation testing and initial aircraft flight testing.

New drugs: evidence relating to their therapeutic value after introduction to the market.

PubMed

Ujeyl, Mariam; Schlegel, Claudia; Walter, Siegbert; Gundert-Remy, Ursula

2012-02-01

Drug approval is based on three criteria: quality, efficacy, and safety. We investigated the types of study design and statistical methods employed to demonstrate safety and efficacy of proprietary medicinal products (PMPs) that were approved for use in the European Union through the centralized procedure. We retrospectively analyzed the European Public Assessment Reports of PMPs that the European Medicinal Agency approved, either initially or for extended indications, in 2009 and 2010. Data were analyzed for 39 PMPs: 64% of these were new active substances, and 36% were approved for extended indications. 46% of the PMPs had been studied in an active-control trial. In only 28%, superiority of the new PMPs compared to active control had been tested. 46% of the approvals included testing of a patient-relevant primary endpoint. The median size of population used to demonstrate safety was 1700 persons. The centralized procedure does not require comparative information from active-control trials. Accordingly, as our descriptive analysis revealed, this information is often not available at the time of market introduction. Pivotal studies only rarely clearly demonstrate an added therapeutic value of a new PMP compared to existing alternatives.

A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment

PubMed Central

Nel, Andre E.; Nasser, Elina; Godwin, Hilary; Avery, David; Bahadori, Tina; Bergeson, Lynn; Beryt, Elizabeth; Bonner, James C.; Boverhof, Darrell; Carter, Janet; Castranova, Vince; DeShazo, J. R.; Hussain, Saber M.; Kane, Agnes B.; Klaessig, Fred; Kuempel, Eileen; Lafranconi, Mark; Landsiedel, Robert; Malloy, Timothy; Miller, Mary Beth; Morris, Jeffery; Moss, Kenneth; Oberdorster, Gunter; Pinkerton, Kent; Pleus, Richard C.; Shatkin, Jo Anne; Thomas, Rusty; Tolaymat, Thabet; Wang, Amy; Wong, Jeffrey

2014-01-01

There has been a conceptual shift in toxicological studies from describing what happens to explaining how the adverse outcome occurs, thereby enabling a deeper and improved understanding of how biomolecular and mechanistic profiling can inform hazard identification and improve risk assessment. Compared to traditional toxicology methods, which have a heavy reliance on animals, new approaches to generate toxicological data are becoming available for the safety assessment of chemicals, including high-throughput and high-content screening (HTS, HCS). With the emergence of nanotechnology, the exponential increase in the total number of engineered nanomaterials (ENMs) in research, development, and commercialization requires a robust scientific approach to screen ENM safety in humans and the environment rapidly and efficiently. Spurred by the developments in chemical testing, a promising new toxicological paradigm for ENMs is to use alternative test strategies (ATS), which reduce reliance on animal testing through the use of in vitro and in silico methods such as HTS, HCS, and computational modeling. Furthermore, this allows for the comparative analysis of large numbers of ENMs simultaneously and for hazard assessment at various stages of the product development process and overall life cycle. Using carbon nanotubes as a case study, a workshop bringing together national and international leaders from government, industry, and academia was convened at the University of California, Los Angeles to discuss the utility of ATS for decision-making analyses of ENMs. After lively discussions, a short list of generally shared viewpoints on this topic was generated, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. PMID:23924032

Colorectal Cancer Safety Net: Is It Catching Patients Appropriately?

PubMed

Althans, Alison R; Brady, Justin T; Times, Melissa L; Keller, Deborah S; Harvey, Alexis R; Kelly, Molly E; Patel, Nilam D; Steele, Scott R

2018-01-01

Disparities in access to colorectal cancer care are multifactorial and are affected by socioeconomic elements. Uninsured and Medicaid patients present with advanced stage disease and have worse outcomes compared with similar privately insured patients. Safety net hospitals are a major care provider to this vulnerable population. Few studies have evaluated outcomes for safety net hospitals compared with private institutions in colorectal cancer. The purpose of this study was to compare demographics, screening rates, presentation stage, and survival rates between a safety net hospital and a tertiary care center. Comparative review of patients at 2 institutions in the same metropolitan area were conducted. The study included colorectal cancer care delivered either at 1 safety net hospital or 1 private tertiary care center in the same city from 2010 to 2016. A total of 350 patients with colorectal cancer from each hospital were evaluated. Overall survival across hospital systems was measured. The safety net hospital had significantly more uninsured and Medicaid patients (46% vs 13%; p < 0.001) and a significantly lower median household income than the tertiary care center ($39,299 vs $49,741; p < 0.0001). At initial presentation, a similar percentage of patients at each hospital presented with stage IV disease (26% vs 20%; p = 0.06). For those undergoing resection, final pathologic stage distribution was similar across groups (p = 0.10). After a comparable median follow-up period (26.6 mo for safety net hospital vs 29.2 mo for tertiary care center), log-rank test for overall survival favored the safety net hospital (p = 0.05); disease-free survival was similar between hospitals (p = 0.40). This was a retrospective review, reporting from medical charts. Our results support the value of safety net hospitals for providing quality colorectal cancer care, with survival and recurrence outcomes equivalent or improved compared with a local tertiary care center. Because safety net hospitals can provide equivalent outcomes despite socioeconomic inequalities and financial constraints, emphasis should be focused on ensuring that adequate funding for these institutions continues. See Video Abstract at http://links.lww.com/DCR/A454.

Creating an environment for patient safety and teamwork training in the operating theatre: A quasi-experimental study.

PubMed

Wallin, Carl-Johan; Kalman, Sigridur; Sandelin, Annika; Färnert, May-Lena; Dahlstrand, Ursula; Jylli, Leena

2015-03-01

Positive safety and a teamwork climate in the training environment may be a precursor for successful teamwork training. This pilot project aimed to implement and test whether a new interdisciplinary and team-based approach would result in a positive training climate in the operating theatre. A 3-day educational module for training the complete surgical team of specialist nursing students and residents in safe teamwork skills in an authentic operative theatre, named Co-Op, was implemented in a university hospital. Participants' (n=22) perceptions of the 'safety climate' and the 'teamwork climate', together with their 'readiness for inter-professional learning', were measured to examine if the Co-Op module produced a positive training environment compared with the perceptions of a control group (n=11) attending the conventional curriculum. The participants' perceptions of 'safety climate' and 'teamwork climate' and their 'readiness for inter-professional learning' scores were significantly higher following the Co-Op module compared with their perceptions following the conventional curriculum, and compared with the control group's perceptions following the conventional curriculum. The Co-Op module improved 'safety climate' and 'teamwork climate' in the operating theatre, which suggests that a deliberate and designed educational intervention can shape a learning environment as a model for the establishment of a safety culture.

Determination of minimum height and lateral design load for MASH test level 4 bridge rails.

DOT National Transportation Integrated Search

2011-12-01

The Manual for Assessing Safety Hardware (MASH) prescribes higher design vehicle impact speed and mass for test level 4 barriers compared to its predecessor National Cooperative Highway Research Program (NCHRP) Report 350. This has resulted in a 56 p...

Participation of low-income women in genetic cancer risk assessment and BRCA 1/2 testing: the experience of a safety-net institution.

PubMed

Komenaka, Ian K; Nodora, Jesse N; Madlensky, Lisa; Winton, Lisa M; Heberer, Meredith A; Schwab, Richard B; Weitzel, Jeffrey N; Martinez, Maria Elena

2016-07-01

Some communities and populations lack access to genetic cancer risk assessment (GCRA) and testing. This is particularly evident in safety-net institutions, which serve a large segment of low-income, uninsured individuals. We describe the experience of a safety-net clinic with limited resources in providing GCRA and BRCA1/2 testing. We compared the proportion and characteristics of high-risk women who were offered and underwent GCRA and genetic testing. We also provide a description of the mutation profile for affected women. All 125 patients who were offered GCRA accepted to undergo GCRA. Of these, 72 % had a breast cancer diagnosis, 70 % were Hispanic, 52.8 % were non-English speakers, and 66 % did not have health insurance. Eighty four (67 %) were offered genetic testing and 81 (96 %) agreed. Hispanic women, those with no medical insurance, and those with a family history of breast cancer were significantly more likely to undergo testing (p > 0.01). Twelve of 81 (15 %) patients were found to have deleterious mutations, seven BRCA1, and five BRCA2. Our experience shows that it is possible to offer GCRA and genetic testing even in the setting of limited resources for these services. This is important given that a large majority of the low-income women in our study agreed to undergo counseling and testing. Our experience could serve as a model for similar low-resource safety-net health settings.

The influence of body mass index and gender on the impact attenuation properties of flooring systems.

PubMed

Bhan, Shivam; Levine, Iris; Laing, Andrew C

2013-12-01

The biomechanical effectiveness of safety floors has never been assessed during sideways falls with human volunteers. Furthermore, the influence of body mass index (BMI) and gender on the protective capacity of safety floors is unknown. The purpose of this study was to test whether safety floors provide greater impact attenuation compared with traditional flooring, and whether BMI and gender modify their impact attenuation properties. Thirty participants (7 men and 7 women of low BMI; 7 men and 9 women of high BMI) underwent lateral pelvis release trials on 2 common floors and 4 safety floors. As a group, the safety floors reduced peak force (by up to 11.7%), and increased the time to peak force (by up to 25.5%) compared with a traditional institutional grade floor. Force attenuation was significantly higher for the low BMI group, and for males. Force attenuation was greatest for the low BMI males, averaging 26.5% (SD = 3.0) across the safety floors. These findings demonstrate an overall protective effect of safety floors during lateral falls on the pelvis, but also suggest augmented benefits for frail older adults (often with low body mass) who are at an increased risk of hip fracture.

Operation and Development Status of the Spacecraft Fire Experiments (Saffire)

NASA Technical Reports Server (NTRS)

Ruff, Gary A.; Urban, David L.

2016-01-01

Since 2012, a series of Spacecraft Fire Experiments (Saffire) have been under development by the Spacecraft Fire Safety Demonstration (SFS Demo) project, funded by NASA's Advanced Exploration Systems Division. The overall objective of this project is to reduce the uncertainty and risk associated with the design of spacecraft fire safety systems for NASA's exploration missions. The approach to achieving this goal has been to define, develop, and conduct experiments that address gaps in spacecraft fire safety knowledge and capabilities identified by NASA's Fire Safety System Maturation Team. The Spacecraft Fire Experiments (Saffire-I, -II, and -III) are material flammability tests at length scales that are realistic for a spacecraft fire in low-gravity. The specific objectives of these three experiments are to (1) determine how rapidly a large scale fire grows in low-gravity and (2) investigate the low-g flammability limits compared to those obtained in NASA's normal gravity material flammability screening test. The experiments will be conducted in Orbital ATK's Cygnus vehicle after it has unberthed from the International Space Station. The tests will be fully automated with the data downlinked at the conclusion of the test before the Cygnus vehicle reenters the atmosphere. This paper discusses the status of the Saffire-I, II, and III experiments followed by a review of the fire safety technology gaps that are driving the development of objectives for the next series of experiments, Saffire-IV, V, and VI.

Advanced bridge safety initiative : recommended practices for live load testing of existing flat-slab concrete bridges - task 5.

DOT National Transportation Integrated Search

2012-12-01

Current AASHTO provisions for load rating flat-slab concrete bridges use the equivalent strip : width method, which is regarded as overly conservative compared to more advanced analysis : methods and field live load testing. It has been shown that li...

Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon γ release assay and the tuberculin skin test: a phase 3, double-blind, randomised, controlled trial.

PubMed

Ruhwald, Morten; Aggerbeck, Henrik; Gallardo, Rafael Vázquez; Hoff, Søren T; Villate, José I; Borregaard, Bettine; Martinez, José A; Kromann, Ingrid; Penas, Antón; Anibarro, Luis L; de Souza-Galvão, Maria Luiza; Sánchez, Francisca; Rodrigo-Pendás, Jose Ángel; Noguera-Julian, Antoni; Martínez-Lacasa, Xavier; Tuñez, Maria Victoria; Fernández, Virginia Leiro; Millet, Joan P; Moreno, Antonio; Cobos, Nazaret; Miró, José M; Roldan, Llanos; Orcau, Angels; Andersen, Peter; Caylá, Joan A

2017-04-01

Targeted screening and treatment of Mycobacterium tuberculosis infection substantially reduces the risk of developing active tuberculosis. C-Tb (Statens Serum Institute, Copenhagen, Denmark) is a novel specific skin test based on ESAT-6 and CFP10 antigens. We investigated the safety and diagnostic potential of C-Tb compared with established tests in the contact-tracing setting. Negative controls, close contacts, occasional contacts, and patients with active pulmonary tuberculosis were enrolled at 13 centres in Spain. We compared C-Tb with the QuantiFERON-TB Gold In-Tube ([QFT] Qiagen, Hilden, Germany) interferon γ release assay (IGRA) and the purified protein derivative (PPD) RT 23 tuberculin skin test ([TST] Statens Serum Institute). All participants older than 5 years were tested with QFT. Some participants in the negative control group received C-Tb without the TST to test for potential interactions between C-Tb and PPD RT 23. The rest were randomly assigned in blocks of ten and tested with both C-Tb and TST, with five in each block receiving injection of C-Tb in the right arm and the TST in the left arm and five vice versa. The primary and safety analyses were done in all participants randomly assigned to a group who received any test. This trial is registered with ClinicalTrials.gov, number NCT01631266, and with EudraCT, number 2011-005617-36. From July 24, 2012, to Oct 2, 2014, 979 participants were enrolled, of whom 263 were negative controls, 299 were occasional contacts, 316 were close contacts, and 101 were patients with tuberculosis. 970 (99%) participants completed the trial. Induration sizes were similar for C-Tb and TST, but TST positivity was affected by BCG vaccination status. We found a strong positive trend towards C-Tb test positivity with increasing risk of infection, from 3% in negative controls to 16% in occasional contacts, to 43% in close contacts. C-Tb and QFT results were concordant in 785 (94%) of 834 participants aged 5 years and older, and results did not differ significantly between exposure groups. The safety profile of C-Tb was similar to that for the TST. C-Tb delivered IGRA-like results in a field-friendly format. Being unaffected by BCG vaccination status, the C-Tb skin test might provide more accurate treatment guidance in settings where the TST is commonly used. Statens Serum Institut. Copyright © 2017 Elsevier Ltd. All rights reserved.

Integrated Data Collection Analysis (IDCA) Program - AN and Bullseye Smokeless Powder

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

Sandstrom, Mary M.; Brown, Geoffrey W.; Preston, Daniel N.

The Integrated Data Collection Analysis (IDCA) program is conducting a proficiency study for Small- Scale Safety and Thermal (SSST) testing of homemade explosives (HMEs). Described here are the results for impact, friction, electrostatic discharge, and differential scanning calorimetry analysis of ammonium nitrate (AN) mixed with Bullseye® smokeless powder (Gunpowder). The participants found the AN/Gunpowder to: 1) have a range of sensitivity to impact, comparable to or less than RDX, 2) be fairly insensitive to friction as measured by BAM and ABL, 3) have a range for ESD, from insensitive to more sensitive than PETN, and 4) have thermal sensitivity aboutmore » the same as PETN and Gunpowder. This effort, funded by the Department of Homeland Security (DHS), is putting the issues of safe handling of these materials in perspective with standard military explosives. The study is adding SSST testing results for a broad suite of different HMEs to the literature. Ultimately the study has the potential to suggest new guidelines and methods and possibly establish the SSST testing accuracies needed when developing safe handling practices for HMEs. Each participating testing laboratory uses identical test materials and preparation methods. Note, however, the test procedures differ among the laboratories. The testing performers involved are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Indian Head Division, Naval Surface Warfare Center, (NSWC IHD), Sandia National Laboratories (SNL), and Air Force Research Laboratory (AFRL/RXQL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to compare results when these testing variables cannot be made consistent. Keywords: Small-scale safety testing, proficiency test, impact-, friction-, spark discharge-, thermal testing, round-robin test, safety testing protocols, HME, RDX, potassium perchlorate, potassium chlorate, sodium chlorate, sugar, dodecane, PETN, carbon, ammonium nitrate, Gunpowder, Bullseye® smokeless powder.« less

Preferences among four combination nicotine treatments.

PubMed

Schneider, Nina G; Koury, Margaret A; Cortner, Chris; Olmstead, Richard E; Hartman, Neil; Kleinman, Leonard; Kim, Andrew; Chaya, Craig; Leaf, David

2006-09-01

Acute nicotine replacement treatments (NRTs) are disliked or misused, leading to insufficient nicotine intake and poor outcome. Patches provide steady nicotine but are slow and passive. Combining systems may improve efficacy with acute NRTs tailored for compliance. To test initial reactions to and use preferences among combinations of NRTs. Smokers (n=27) tested four combination NRTs in a 5-day crossover trial: 2/4-mg gum + 15-mg patch (G/P), 2/4-mg lozenges + 15-mg patch (L/P), inhaler + 15-mg patch (I/P), and 10 mg + 15-mg patches (P/P). Subjects rated an NRT combination each day after 5-6 h of use and ranked among the NRTs after testing all treatments. Double-patches (P/P) were ranked highest for "ease of use", "safety", and "use in public". However, for "help to quit", 70% preferred some form of acute-patch combination (A/P) compared to 30% choosing P/P. For "use under stress" (an immediate need), 93% preferred A/P systems compared to 7% choosing P/P. L/P ranked lowest for "ease of use", I/P and L/P were lowest on "safety", and I/P ranked lowest for "use in public". Expectations of NRTs changed with test experience for patches (better) and lozenges (worse). In brief testing, all combinations were acceptable. P/P was favored for ease, safety, and public use, but a majority chose A/P systems for help in quitting and use under stress. Combined use is viable and needs to be made known and accessible to smokers.

Test and model correlation of the atmospheric emission photometric imager fiberglass pedestal

NASA Technical Reports Server (NTRS)

Lee, H. M., III; Barker, L. A.

1990-01-01

The correlation is presented of the static loads testing and finite element modeling for the fiberglass pedestal used on the Atmospheric Emission Photometric Imaging (AEPI) experiment. This payload is to be launched in the space shuttle as part of the ATLAS-1 experiment. Strain gauge data from rosettes around the highly loaded base are compared to the same load case run for the Spacelab 1 testing done in 1981. Correlation of the model and test data was accomplished through comparison of the composite stress invariant using the expected flight loads for the ATLAS-1 mission. Where appropriate, the Tsai-Wu failure criteria was used in the development of the key margins of safety. Margins of safety are all positive for the pedestal and are reported.

[Training in patient safety in medical and nursing schools].

PubMed

Mira, J J; Guilabert, M; Vitaller, J; Ignacio, E

2016-01-01

To compare the information on patient safety received by students of medicine and nursing. Cross-sectional study was conducted using a convenience sample of medical and nursing students of 3 Universities. The Latin Patient Safety Student Information and a test of 5 questions with 5 options were used. A sample of 79 students in each group was enrolled to detect differences of .3 units (bilateral estimation), considering 80% statistical power and 95% confidence interval. A total of 144 students replied (74 nursing and 70 medicine students). Nursing students achieved higher scores in the communication with patients factor (3.8 vs 3.2, P<.001) and proactive attitude to identify risks for patient safety (4.3 vs 3.8, P<.001). Medical students were more aware of the inevitability of adverse events (2.3 vs 3.1, P<.001). Ten (7%) students had only one fault in the test, and only one (1%) answered all questions correctly. The training in patient safety should be improved both in nursing and medicine, although nursing students receive more information. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Technology demonstrator program for Space Station Environmental Control Life Support System

NASA Technical Reports Server (NTRS)

Adams, Alan M.; Platt, Gordon K.; Claunch, William C.; Humphries, William R.

1987-01-01

The main objectives and requirements of the NASA/Marshall Space Flight Center Technology Demonstration Program are discussed. The program consists of a comparative test and a 90-day manned system test to evaluate an Environmental Control and Life Support System (ECLSS). In the comparative test phase, 14 types of subsystems which perform oxygen and water reclamation functions are to be examined in terms of performance maintenance/service requirements, reliability, and safety. The manned chamber testing phase involves a four person crew using a partial ECLSS for 90 days. The schedule for the program and the program hardware requirements are described.

Toxicological safety assessment of genetically modified Bacillus thuringiensis with additional N-acyl homoserine lactonase gene.

PubMed

Peng, Donghai; Zhou, Chenfei; Chen, Shouwen; Ruan, Lifang; Yu, Ziniu; Sun, Ming

2008-01-01

The aim of the present study is to evaluate the toxicology safety to mammals of a genetically modified (GM) Bacillus thuringiensis with an additional N-acyl homoserine lactones gene (aiiA), which possesses insecticidal activity together with restraint of bacterial pathogenicity and is intended for use as a multifunctional biopesticide. Safety assessments included an acute oral toxicity test and 28-d animal feeding study in Wistar rats, primary eye and dermal irritation in Zealand White rabbits, and delayed contact hypersensitivity in guinea pigs. Tests were conducted using spray-dried powder preparation. This GM product showed toxicity neither in oral acute toxicity test nor in 28-d animal feeding test at a dose of 5,000 mg/kg body weight. During the animal feeding test, there were no significant differences in growth, food and water consumption, hematology, blood biochemical indices, organ weights, and histopathology finding between rats in controls and tested groups. Tested animals in primary eye and dermal irritation and delayed contact hypersensitivity test were also devoid of any toxicity compared to controls. All the above results demonstrated that the GM based multifunctional B. thuringiensis has low toxicity and low eye and dermal irritation and would not cause hypersensitivity to laboratory mammals and therefore could be regarded as safe for use as a pesticide.

Comparison of safety, efficacy and tolerability of dexibuprofen and ibuprofen in the treatment of osteoarthritis of the hip or knee.

PubMed

Zamani, Omid; Böttcher, Elke; Rieger, Jörg D; Mitterhuber, Johann; Hawel, Reinhold; Stallinger, Sylvia; Eller, Norbert

2014-06-01

In this observer-blinded, multicenter, non-inferiority study, 489 patients suffering from painful osteoarthritis of the hip or knee were included to investigate safety and tolerability of Dexibuprofen vs. Ibuprofen powder for oral suspension. Only patients who had everyday joint pain for the past 3 months and "moderate" to "severe" global pain intensity in the involved hip/knee of within the last 48 h were enrolled. The treatment period was up to 14 days with a control visit after 3 days. The test product was Dexibuprofen 400 mg powder for oral suspension (daily dose 800 mg) compared to Ibuprofen 400 mg powder for oral suspension (daily dose 1,600 mg). Gastrointestinal adverse drug reactions were reported in 8 patients (3.3 %) in the Dexibuprofen group and in 19 patients (7.8 %) in the Ibuprofen group. Statistically significant non-inferiority was shown for Dexibuprofen. Comparing both groups by a Chi square test showed a statistical significant lower proportion of related gastrointestinal events in the Dexibuprofen group. All analyses of secondary tolerability parameters showed the same result of a significantly better safety profile in this therapy setting for Dexibuprofen compared to Ibuprofen. The sum of pain intensity, pain relief and global assessments showed no significant difference between treatment groups. In summary, analyses revealed at least non-inferiority in terms of efficacy and a statistically significant better safety profile for the Dexibuprofen treatment.

The new car assessment program: does it predict the relative safety of vehicles in actual crashes?

PubMed

Nirula, Ram; Mock, Charles N; Nathens, Avery B; Grossman, David C

2004-10-01

Federal motor vehicle safety standards are based on crash test dummy analyses that estimate the relative risk of traumatic brain injury (TBI) and severe thoracic injury (STI) by quantifying head (Head Injury Criterion [HIC]) and chest (Chest Gravity Score [CGS]) acceleration. The New Car Assessment Program (NCAP) combines these probabilities to yield the vehicle's five-star rating. The validity of the NCAP system as it relates to an actual motor vehicle crash (MVC) remains undetermined. We therefore sought to determine whether HIC and CGS accurately predict TBI and STI in actual crashes, and compared the NCAP five-star rating system to the rates of TBI and/or STI in actual MVCs. We analyzed frontal crashes with restrained drivers from the 1994 to 1998 National Automotive Sampling System. The relationship of HIC and CGS to the probabilities of TBI and STI derived from crash tests were respectively compared with the HIC-TBI and CGS-STI risk relationships observed in actual crashes while controlling for covariates. Receiver operating characteristic curves determined the sensitivity and specificity of HIC and CGS as predictors of TBI and STI, respectively. Estimates of the likelihood of TBI and/or STI (in actual MVCs) were compared with the expected probabilities of TBI and STI (determined by crash test analysis), as they relate to NCAP ratings. The crash tests overestimate TBI likelihood at HIC scores >800 and underestimate it at scores <500. STI likelihood is overestimated when CGS exceeds 40 g. Receiver operating characteristic curves demonstrated poor sensitivity and specificity of HIC and CGS in predicting injury. The actual MVC injury probability estimates did not vary between vehicles of different NCAP rating. HIC and CGS are poor predictors of TBI and STI in actual MVCs. The NCAP five-star rating system is unable to differentiate vehicles of varying crashworthiness in actual MVCs. More sensitive parameters need to be developed and incorporated into vehicle crash safety testing to provide consumers and automotive manufacturers with useful tools with which to measure vehicle safety.

SPES-2, AP600 intergral system test S01007 2 inch CL to core make-up tank pressure balance line break

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

Bacchiani, M.; Medich, C.; Rigamonti, M.

1995-09-01

The SPES-2 is a full height, full pressure experimental test facility reproducing the Westinghouse AP600 reactor with a scaling factor of 1/395. The experimental plant, designed and operated by SIET in Piacenza, consists of a full simulation of the AP600 primary core cooling system including all the passive and active safety systems. In 1992, Westinghouse, in cooperation with ENEL (Ente Nazionale per l` Energia Elettrica), ENEA (Enter per le numove Technlogie, l` Energia e l` Ambient), Siet (Societa Informazioni Esperienze Termoidraulich) and ANSALDO developed an experimental program to test the integrated behaviour of the AP600 passive safety systems. The SPES-2more » test matrix, concluded in November 1994, has examined the AP600 passive safety system response for a range of small break LOCAs at different locations on the primary system and on the passive system lines; single steam generator tube ruptures with passive and active safety systems and a main steam line break transient to demonstrate the boration capability of passive safety systems for rapid cooldown. Each of the tests has provided detailed experimental results for verification of the capability of the analysis methods to predict the integrated passive safety system behaviour. Cold and hot shakedown tests have been performed on the facility to check the characteristics of the plant before starting the experimental campaign. The paper first presents a description of the SPES-2 test facility then the main results of S01007 test {open_quotes}2{close_quotes} Cold Leg (CL) to Core Make-up Tank (CMT) pressure balance line break{close_quotes} are reported and compared with predictions performed using RELAP5/mod3/80 obtained by ANSALDO through agreement with U.S.N.R.C. (U.S. Nuclear Regulatory Commission). The SPES-2 nodalization and all the calculations here presented were performed by ANSALDO and sponsored by ENEL as a part of pre-test predictions for SPES-2.« less

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

PubMed

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

2017-01-01

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

Protection against head injuries should not be optional: a case for mandatory installation of side-curtain air bags.

PubMed

Stuke, Lance E; Nirula, Raminder; Gentilello, Larry M; Shafi, Shahid

2010-10-01

More than 9,000 vehicle occupants die each year in side-impact vehicle collisions, primarily from head injuries. The authors hypothesized that side-curtain air bags significantly improve head and neck safety in side-impact crash testing. Side-impact crash-test data were obtained from the Insurance Institute for Highway Safety, which ranks occupant protection as good, acceptable, marginal, or poor. Vehicles of the same make and model that underwent side-impact crash testing both with and without side-curtain air bags were compared, as well as the protective effect of these air bags on occupants' risk for head and neck injury. Of all the passenger vehicles, 25 models have undergone side-impact crash testing with and without side-curtain air bags by the Insurance Institute for Highway Safety. Only 3 models without side-curtain air bags (12%) provided good head and neck protection for drivers, while 21 cars with side-curtain air bags (84%) provided good protection (P < .001). For rear passengers, the added protection from side-curtain air bags was less dramatic but significant (84% without vs 100% with side-curtain air bags, P = .04). Side-curtain air bags significantly improve vehicle occupant safety in side-impact crash tests. Installation of these air bags should be federally mandated in all passenger vehicles. Copyright © 2010 Elsevier Inc. All rights reserved.

Effectiveness of adverse effects search filters: drugs versus medical devices.

PubMed

Farrah, Kelly; Mierzwinski-Urban, Monika; Cimon, Karen

2016-07-01

The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%-87%) than for drugs (88%-93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%-81%) than in MEDLINE (67%-87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.

Pembrolizumab for Ipilimumab-Resistant Melanoma

Cancer.gov

KEYNOTE-002 was designed to test the safety and efficacy of two doses of pembrolizumab compared with chemotherapy in patients with ipilimumab-resistant melanoma; interim results show that pembrolizumab improves progression-free survival for these patients

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... for a prescription drug may not, either directly or by implication, e.g., by use of comparative test... drug, nor may an advertisement contain a quantitative statement of safety or effectiveness (a) unless...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for a prescription drug may not, either directly or by implication, e.g., by use of comparative test... drug, nor may an advertisement contain a quantitative statement of safety or effectiveness (a) unless...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... for a prescription drug may not, either directly or by implication, e.g., by use of comparative test... drug, nor may an advertisement contain a quantitative statement of safety or effectiveness (a) unless...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... for a prescription drug may not, either directly or by implication, e.g., by use of comparative test... drug, nor may an advertisement contain a quantitative statement of safety or effectiveness (a) unless...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... for a prescription drug may not, either directly or by implication, e.g., by use of comparative test... drug, nor may an advertisement contain a quantitative statement of safety or effectiveness (a) unless...

Defibrillation threshold testing fails to show clinical benefit during long-term follow-up of patients undergoing cardiac resynchronization therapy defibrillator implantation.

PubMed

Michowitz, Yoav; Lellouche, Nicolas; Contractor, Tahmeed; Bourke, Tara; Wiener, Isaac; Buch, Eric; Boyle, Noel; Bersohn, Malcolm; Shivkumar, Kalyanam

2011-05-01

The utility of defibrillation threshold testing in patients undergoing implantable cardioverter-defibrillator (ICD) implantation is controversial. Higher defibrillation thresholds have been noted in patients undergoing implantation of cardiac resynchronization therapy defibrillators (CRT-D). Since the risks and potential benefits of testing may be higher in this population, we sought to assess the impact of defibrillation safety margin or vulnerability safety margin testing in CRT-D recipients. A total of 256 consecutive subjects who underwent CRT-D implantation between January 2003 and December 2007 were retrospectively reviewed. Subjects were divided into two groups based on whether (n= 204) or not (n= 52) safety margin testing was performed. Patient characteristics, tachyarrhythmia therapies, procedural results, and clinical outcomes were recorded. Baseline characteristics, including heart failure (HF) severity, were comparable between the groups. Four cases of HF exacerbation (2%), including one leading to one death, were recorded in the tested group immediately post-implantation. No complications were observed in the untested group. After a mean follow-up of 32 ± 20 months, the proportion of appropriate shocks in the two groups was similar (31 vs. 25%, P = 0.49). There were three cases of failed appropriate shocks in the tested group, despite adequate safety margins at implantation, whereas no failed shocks were noted in the untested group. Survival was similar in the two groups. Defibrillation efficacy testing during implant of CRT-D was associated with increased morbidity and did not predict the success of future device therapy or improve survival during long-term follow-up.

The Safety Attitudes Questionnaire as a Tool for Benchmarking Safety Culture in the NICU

PubMed Central

Profit, Jochen; Etchegaray, Jason; Petersen, Laura A; Sexton, J Bryan; Hysong, Sylvia J; Mei, Minghua; Thomas, Eric J

2014-01-01

background NICU safety culture, as measured by the Safety Attitudes Questionnaire (SAQ), varies widely. Associations with clinical outcomes in the adult ICU setting make the SAQ an attractive tool for comparing clinical performance between hospitals. Little information is available on the use of the SAQ for this purpose in the NICU setting. objectives To determine whether the dimensions of safety culture measured by the SAQ give consistent results when used as a NICU performance measure. methods Cross-sectional survey of caregivers in twelve NICUs, using the six scales of the SAQ: teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. NICUs were ranked by quantifying their contribution to overall risk-adjusted variation across the scales. Spearman Rank Correlation coefficients were used to test for consistency in scale performance. We then examined whether performance in the top four NICUs in one scale predicted top four performance in others. results There were 547 respondents in twelve NICUs. Of fifteen NICU-level correlations in performance ranking, two were greater than 0.7, seven were between 0.4 and 0.69, the six remaining were less than 0.4. We found a trend towards significance in comparing the distribution of performance in the top four NICUs across domains with a binomial distribution p = .051, indicating generally consistent performance across dimensions of safety culture. conclusion A culture of safety permeates many aspects of patient care and organizational functioning. The SAQ may be a useful tool for comparative performance assessments among NICUs. PMID:22337935

Teaching children about bicycle safety: an evaluation of the New Jersey Bike School program.

PubMed

Lachapelle, Ugo; Noland, Robert B; Von Hagen, Leigh Ann

2013-03-01

There are multiple health and environmental benefits associated with increasing bicycling among children. However, the use of bicycles is also associated with severe injuries and fatalities. In order to reduce bicycle crashes, a bicycling education program was implemented in selected New Jersey schools and summer camps as part of the New Jersey Safe Routes to School Program. Using a convenience sample of participants to the program, an opportunistic study was designed to evaluate the effectiveness of two bicycle education programs, the first a more-structured program delivered in a school setting, with no on-road component, and the other a less structured program delivered in a summer camp setting that included an on-road component. Tests administered before and after training were designed to assess knowledge acquired during the training. Questions assessed children's existing knowledge of helmet use and other equipment, bicycle safety, as well as their ability to discriminate hazards and understand rules of the road. Participating children (n=699) also completed a travel survey that assessed their bicycling behavior and their perception of safety issues. Response to individual questions, overall pre- and post-training test scores, and changes in test scores were compared using comparison of proportion, t-tests, and ordinary least-squares (OLS) regression. Improvements between the pre-training and post-training test are apparent from the frequency distribution of test results and from t-tests. Both summer camps and school-based programs recorded similar improvements in test results. Children who bicycled with their parents scored higher on the pre-training test but did not improve as much on the post-training test. Without evaluating long-term changes in behavior, it is difficult to ascertain how successful the program is on eventual behavioral and safety outcomes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study

PubMed Central

Wolf, Luise; Eertmans, Frank; Wolf, Doerte; Rossel, Bart; Adriaens, Els

2016-01-01

Background Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo. Methods This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014—June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10. Results Cure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p < 0.001, 2-sided, 1-sample, chi-square test) with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%). Both products were safe and well tolerated, offering good esthetical effects. Conclusion This study showed that substance-based medical devices (including the tested mineral oil shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because of the physical mode of action. Trial Registration German Clinical Trials Register (DRKS) DRKS00009753 and EudraCT database 2014-002918-23 PMID:27286033

Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

PubMed

Wolf, Luise; Eertmans, Frank; Wolf, Doerte; Rossel, Bart; Adriaens, Els

2016-01-01

Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo. This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014-June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10. Cure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p < 0.001, 2-sided, 1-sample, chi-square test) with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%). Both products were safe and well tolerated, offering good esthetical effects. This study showed that substance-based medical devices (including the tested mineral oil shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because of the physical mode of action. German Clinical Trials Register (DRKS) DRKS00009753 and EudraCT database 2014-002918-23.

Integrated Data Collection Analysis (IDCA) Program - RDX Type II Class 5 Standard, Data Set 1

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

Sandstrom, Mary M.; Brown, Geoffrey W.; Preston, Daniel N.

This document describes the results of the first reference sample material—RDX Type II Class 5—examined in the proficiency study for small-scale safety and thermal (SSST) testing of explosive materials for the Integrated Data Collection Analysis (IDCA) Program. The IDCA program is conducting proficiency testing on homemade explosives (HMEs). The reference sample materials are being studied to establish the accuracy of traditional explosives safety testing for each performing laboratory. These results will be used for comparison to results from testing HMEs. This effort, funded by the Department of Homeland Security (DHS), ultimately will put the issues of safe handling of thesemore » materials in perspective with standard military explosives. The results of the study will add SSST testing results for a broad suite of different HMEs to the literature, potentially suggest new guidelines and methods for HME testing, and possibly establish what are the needed accuracies in SSST testing to develop safe handling practices. Described here are the results for impact, friction, electrostatic discharge, and scanning calorimetry analysis of a reference sample of RDX Type II Class 5. The results from each participating testing laboratory are compared using identical test material and preparation methods wherever possible. Note, however, the test procedures differ among the laboratories. These results are then compared to historical data from various sources. The performers involved are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Air Force Research Laboratory/ RXQL (AFRL), Indian Head Division, Naval Surface Warfare Center, (IHD-NSWC), and Sandia National Laboratories (SNL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to understand how to compare results when test protocols are not identical.« less

9 CFR 113.39 - Cat safety tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Cat safety tests. 113.39 Section 113... Procedures § 113.39 Cat safety tests. The safety tests provided in this section shall be conducted when... recommended for use in cats. (a) The cat safety test provided in this paragraph shall be used when the Master...

Outcomes of anatomical vs. functional testing for coronary artery disease : Lessons from the PROMISE trial.

PubMed

Shah, R; Foldyna, B; Hoffmann, U

2016-08-01

The development of coronary artery disease (CAD) is a major, final common pathway in heart disease worldwide. With a rise in stress testing and increased scrutiny on cost-effectiveness and radiation exposure in medical imaging, a focus on the relative merits of anatomic versus functional characterization of CAD has emerged. In this context, coronary computed tomography angiography (CCTA) is a noninvasive alternative to functional testing as a first-line test for CAD detection but is complimentary in its nature. Here, we discuss the design, results, and implications of the PROMISE trial, a randomized comparative effectiveness study of 10,003 patients across 193 sites in the United States and Canada comparing the prognostic and diagnostic power of CCTA and standard stress testing. Specifically, we discuss the safety (e. g., contrast, radiation exposure) of CCTA versus functional testing in CAD, the need for improved selection for noninvasive testing, the frequency of downstream testing after anatomic or functional imaging, the use of imaging results in clinical management, and novel modalities of CAD risk determination using CCTA. PROMISE demonstrated that in a real-world, low-to-intermediate risk patient population referred to noninvasive testing for CAD, both CCTA and functional testing approaches have similar clinical, economic, and safety-based outcomes. We conclude with open questions in CAD imaging, specifically as they pertain to the utilization of CCTA.

Nurses', physicians' and radiographers' perceptions of the safety of a nurse prescribing of ionising radiation initiative: A cross-sectional survey.

PubMed

Hyde, Abbey; Coughlan, Barbara; Naughton, Corina; Hegarty, Josephine; Savage, Eileen; Grehan, Jennifer; Kavanagh, Eoin; Moughty, Adrian; Drennan, Jonathan

2016-06-01

A new initiative was introduced in Ireland following legislative changes that allowed nurses with special training to prescribe ionising radiation (X-ray) for the first time. A small number of studies on nurse prescribing of ionising radiation in other contexts have found it to be broadly as safe as ionising radiation prescribing by physicians. Sociological literature on perceptions of safety indicates that these tend to be shaped by the ideological position of the professional rather than based on objective evidence. To describe, compare and analyse perceptions of the safety of a nurse prescribing of ionising radiation initiative across three occupational groups: nursing, radiography and medicine. A cross-sectional survey design. Participants were drawn from a range of clinical settings in Ireland. Respondents were 167 health professionals comprised of 49 nurses, 91 radiographers, and 27 physicians out of a total of 300 who were invited to participate. Non-probability sampling was employed and the survey was targeted specifically at health professionals with a specific interest in, or involvement with, the development of the nurse prescribing of ionising radiation initiative in Ireland. Comparisons of perspectives on the safety of nurse prescribing of ionising radiation across the three occupational groups captured by questionnaire were analysed using the Kruskal-Wallis H test. Pairwise post hoc tests were conducted using the Mann-Whitney U test. While the majority of respondents from all three groups perceived nurse prescribing of ionising radiation to be safe, the extent to which this view was held varied. A higher proportion of nurses was found to display confidence in the safety of nurse prescribing of ionising radiation compared to physicians and radiographers with differences between nurses' perceptions and those of the other two groups being statistically significant. That an occupational patterning emerged suggests that perceptions about safety and risk of nurse prescribing of ionising radiation are socially constructed according to the vantage point of the professional and may not reflect objective measures of safety. These findings need to be considered more broadly in the context of ideological barriers to expanding the role of nurses. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

Girerd-Genessay, I; Michel, P

2015-10-01

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

[Safety verification for reuse of PET and glass bottles].

PubMed

Hayashi, Eiichi; Imai, Toshio; Niimi, Hiroji

2011-01-01

In order to verify the safety associated with reusing PET and glass bottles, a challenge test was conducted with five surrogate contaminants: 1,1,1-trichloroethane, chlorobenzene, toluene, benzophenone and phenyl cyclohexane. Bottles were filled with a cocktail solution of these contaminants and stored at 50 °C for 7 days, then washed with water and alkaline solutions. Material and migration tests were conducted at each step. The material test results showed that 430-1,440 µg/g of the contaminants were retained after water washing, and that even after washing with a 3.5% NaOH solution, 225-925 µg/g of the contaminants were retained. The migration tests revealed that 0.095-7.35 µg/mL of the contaminants were eluted. Similar tests were conducted with a soft drink ingredient, limonene. The results revealed that 48 µg/g of limonene was retained even after washing with NaOH solution, and that 0.16 µg/mL of limonene was eluted. Conversely, no contaminants were eluted from glass bottles after washing with the NaOH solution. Thus, from the viewpoint of safety and the preservation of content quality, PET bottles are not considered suitable for reuse when compared with glass bottles.

Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial.

PubMed

Nel, Annaléne; Martins, Janine; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

2018-01-01

Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides.

Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial

PubMed Central

Nel, Annaléne; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

2018-01-01

Background Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. Objectives This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. Methods 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. Results No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. Conclusions The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides. PMID:29813074

75 FR 71693 - Pesticide Program Dialogue Committee; Announcement of New Membership and Notice of Public Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

...; Comparative Safety Statements for Pesticide Product Labeling; and Public Health Work Group. Discussion topics... Century Science and Integrated Testing and Assessment Strategies: Transitioning Research to Regulatory...

Worker rights and health protection for prostitutes: a comparison of The Netherlands, Germany, and Nevada.

PubMed

Seals, Maryann

2015-01-01

I analyze prostitution policy changes regarding worker rights and health protection for legal prostitutes in The Netherlands, Germany, and Nevada to determine whether the changes benefit the prostitutes. I critically analyze and compare laws, government policy briefs, advocacy studies, books, articles, and ethnographic studies. Problems were revealed in recognizing prostitution as legitimate work and in realization of health protection. Health and safety concerns exist in The Netherlands and Germany where policy does not mandate health requirements and condom usage. Nevada law requires safety precautions, health testing, and condom usage, resulting in no legal prostitutes testing positive for HIV.

Visual Advantage of Enhanced Flight Vision System During NextGen Flight Test Evaluation

NASA Technical Reports Server (NTRS)

Kramer, Lynda J.; Harrison, Stephanie J.; Bailey, Randall E.; Shelton, Kevin J.; Ellis, Kyle K.

2014-01-01

Synthetic Vision Systems and Enhanced Flight Vision System (SVS/EFVS) technologies have the potential to provide additional margins of safety for aircrew performance and enable operational improvements for low visibility operations in the terminal area environment. Simulation and flight tests were jointly sponsored by NASA's Aviation Safety Program, Vehicle Systems Safety Technology project and the Federal Aviation Administration (FAA) to evaluate potential safety and operational benefits of SVS/EFVS technologies in low visibility Next Generation Air Transportation System (NextGen) operations. The flight tests were conducted by a team of Honeywell, Gulfstream Aerospace Corporation and NASA personnel with the goal of obtaining pilot-in-the-loop test data for flight validation, verification, and demonstration of selected SVS/EFVS operational and system-level performance capabilities. Nine test flights were flown in Gulfstream's G450 flight test aircraft outfitted with the SVS/EFVS technologies under low visibility instrument meteorological conditions. Evaluation pilots flew 108 approaches in low visibility weather conditions (600 feet to 3600 feet reported visibility) under different obscurants (mist, fog, drizzle fog, frozen fog) and sky cover (broken, overcast). Flight test videos were evaluated at three different altitudes (decision altitude, 100 feet radar altitude, and touchdown) to determine the visual advantage afforded to the pilot using the EFVS/Forward-Looking InfraRed (FLIR) imagery compared to natural vision. Results indicate the EFVS provided a visual advantage of two to three times over that of the out-the-window (OTW) view. The EFVS allowed pilots to view the runway environment, specifically runway lights, before they would be able to OTW with natural vision.

Formal testing and utilization of streaming media to improve flight crew safety knowledge.

PubMed

Bellazzini, Marc A; Rankin, Peter M; Quisling, Jason; Gangnon, Ronald; Kohrs, Mike

2008-01-01

Increased concerns over the safety of air medical transport have prompted development of novel ways to increase safety. The objective of our study was to determine if an Internet streaming media safety video increased crew safety knowledge. 23 out of 40 crew members took an online safety pre-test, watched a safety video specific to our program and completed immediate and long-term post-testing 6 months later. Mean pre-test, post-test and 6 month follow up test scores were 84.9%, 92.3% and 88.4% respectively. There was a statistically significant difference in all scores (p

46 CFR 61.30-20 - Automatic control and safety tests.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Automatic control and safety tests. 61.30-20 Section 61... TESTS AND INSPECTIONS Tests and Inspections of Fired Thermal Fluid Heaters § 61.30-20 Automatic control and safety tests. Operational tests and checks of all safety and limit controls, combustion controls...

Proposed test method for and evaluation of wheelchair seating system (WCSS) crashworthiness.

PubMed

van Roosmalen, L; Bertocci, G; Ha, D R; Karg, P; Szobota, S

2000-01-01

Safety of motor vehicle seats is of great importance in providing crash protection to the occupant. An increasing number of wheelchair users use their wheelchairs as motor vehicle seats when traveling. A voluntary standard requires that compliant wheelchairs be dynamically sled impact tested. However, testing to evaluate the crashworthiness of add-on wheelchair seating systems (WCSS) independent of their wheelchair frame is not addressed by this standard. To address this need, this study developed a method to evaluate the crash-worthiness of WCSS with independent frames. Federal Motor Vehicle Safety Standards (FMVSS) 207 test protocols, used to test the strength of motor vehicle seats, were modified and used to test the strength of three WCSS. Forward and rearward loads were applied at the WCSS center of gravity (CGSS), and a moment was applied at the uppermost point of the seat back. Each of the three tested WCSS met the strength requirements of FMVSS 207. Wheelchair seat-back stiffness was also investigated and compared to motor vehicle seat-back stiffness.

Genotoxicity assessment of Pyungwi-san (PWS), a traditional herbal prescription.

PubMed

Shin, In Sik; Seo, Chang Seob; Ha, Hye Kyung; Lee, Mee Young; Huang, Dae Sun; Huh, Jung Im; Shin, Hyeun-Kyoo

2011-01-27

Pyungwi-san (PWS, Heii-san in Japanese) is a mixture of six herbs and is traditionally used in Northeast Asia (especially Korea and Japan) for the treatment of gastrointestinal disorder, such as dyspepsia and inappetance induced by gastric dilatation and gastrointestinal catarrh. Although PWS is a widely used herbal prescription in Korea and Japan, little information is available in the literature on the safety and toxicity of PWS. As part of a safety evaluation of PWS, the present study evaluated the potential genotoxicity of PWS using a standard battery of test. We prepared PWS using a water extraction method and simultaneously extracted three compounds from PWS using high performance liquid chromatography. The PWS extract that was obtained was assayed for genotoxicity using the standard three tests recommended by the Korea Food and Drug Administration. These tests included the bacterial reverse mutation test (Ames test), the chromosomal aberration test using China hamster lung cells, and the micronucleus test using ICR mice. The Ames test showed that the PWS extract did not induce an increase in the number of revertant colonies compared with vehicle control at any dose in all of tester strains. In the micronucleus test, no significant increase was observed in micronucleated polychromatic erythrocytes (MNPCEs) at any dose of PWS extract compared with vehicle control. Conversely, chromosomal aberration test showed that the PWS extract at a dosage of 4500 μg/mL induced an increase in the number of chromosomal aberrations in the 6 h group with metabolic activation compared with the vehicle control. PWS extract exhibits genotoxicity, based on the results of the chromosomal aberration test. Thus, further detailed experiments will be needed to identify the ingredient responsible for inducing this genotoxicity and to determine its mechanism. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Healthcare professionals' self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in the Netherlands.

PubMed

Piening, Sigrid; Haaijer-Ruskamp, Flora M; de Graeff, Pieter A; Straus, Sabine M J M; Mol, Peter G M

2012-11-01

In Europe, Direct Healthcare Professional Communications (DHPCs) are important tools to inform healthcare professionals of serious, new drug safety issues. However, this tool has not always been successful in effectively communicating the desired actions to healthcare professionals. The aim of this study was to explore healthcare providers' experiences and their preferences for improvement of risk communication, comparing views of general practitioners (GPs), internists, community pharmacists and hospital pharmacists. A questionnaire was developed and pilot tested to assess experiences and preferences of Dutch healthcare professionals with DHPCs. The questionnaire and two reminders were sent to a random sample of 3488 GPs, internists and community and hospital pharmacists in the Netherlands. Descriptive statistics were used to describe demographic characteristics of the respondents. Chi squares, ANOVAs and the Wilcoxon signed rank test were used, when appropriate, to compare healthcare professional groups. The overall response rate was 34% (N = 1141, ranging from 24% for internists to 46% for community pharmacists). Healthcare providers trusted safety information more when provided by the Dutch Medicines Evaluation Board (MEB) than by the pharmaceutical industry. This was more the case for GPs than for the other healthcare professionals. Respondents preferred safety information to be issued by the MEB, the Dutch Pharmacovigilance Center or their own professional associations. The preferred alternative channels of drug safety information were e-mail, medical journals and electronic prescribing systems. Safety information of drugs does not always reach healthcare professionals through DHPCs. To improve current risk communication of drug safety issues, alternative and/or additional methods of risk communication should be developed using electronic methods and medical journals. Moreover, (additional) risk communication coming from an independent source such as the MEB should be considered. Special effort is needed to reach GPs.

Food-safety educational goals for dietetics and hospitality students.

PubMed

Scheule, B

2000-08-01

To identify food-safety educational goals for dietetics and hospitality management students. Written questionnaires were used to identify educational goals and the most important food safety competencies for entry-level dietitians and foodservice managers. The sample included all directors of didactic programs in dietetics approved by the American Dietetic Association and baccalaureate-degree hospitality programs with membership in the Council on Hotel, Restaurant, and Institutional Education. Fifty-one percent of the directors responded. Descriptive statistics were calculated. chi 2 analysis and independent t tests were used to compare educators' responses for discrete and continuous variables, respectively. Exploratory factor analysis grouped statements about food safety competence. Internal consistency of factors was measured using Cronbach alpha. Thirty-four percent of dietetics programs and 70% of hospitality programs required or offered food safety certification. Dietetics educators reported multiple courses with food safety information, whereas hospitality educators identified 1 or 2 courses. In general, the educators rated food-safety competencies as very important or essential. Concepts related to Hazard Analysis and Critical Control Points (HAACP), irradiation, and pasteurization were rated less highly, compared with other items. Competencies related to reasons for outbreaks of foodborne illness were rated as most important. Food safety certification of dietitians and an increased emphasis on HAACP at the undergraduate level or during the practice component are suggested. Research is recommended to assess the level of food-safety competence expected by employers of entry-level dietitians and foodservice managers.

Crashworthiness keeps getting better

DOT National Transportation Integrated Search

2001-03-20

The Insurance Institute for Highway Safety compares results from its 40 mph frontal offset crash tests five years apart. Twice as many vehicles rated "good" overall ratings for 1999-2001 model years as for 1995-1998. Specifies some models that improv...

30 CFR 27.34 - Test for intrinsic safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Test for intrinsic safety. 27.34 Section 27.34 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.34 Test for intrinsic safety...

30 CFR 27.34 - Test for intrinsic safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Test for intrinsic safety. 27.34 Section 27.34 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.34 Test for intrinsic safety...

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

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

PubMed

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

2013-03-01

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

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

PubMed

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

2013-11-01

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

A 90-day safety study in Sprague-Dawley rats fed milk powder containing recombinant human lactoferrin (rhLF) derived from transgenic cloned cattle.

PubMed

Zhou, Cui; Wang, Jian Wu; Huang, Kun Lun; He, XiaoYun; Chen, Xiu Ping; Sun, Hong; Yu, Tian; Che, Hui Lian

2011-10-01

Transgenic cloned animals expressing beneficial human nutritional traits offer a new strategy for large-scale production of some kinds of functional substances. In some cases, the required safety testing for genetically modified (GM) foods do not seem appropriate for human food safety, though regulations do not seem to provide alternatives. A 90-day rat feeding study is the core study for the safety assessment of GM foods. The test material in this 90-day study was prepared nonfat milk powder containing recombinant human lactoferrin (rhLF), which was expressed in transgenic cloned cattle. Groups of 10 male and female Sprague-Dawley rats were given a nutritionally balanced purified diet containing 7.5, 15, or 30% transgenic or conventional milk powder for 90 days. A commercial AIN93G diet was used as an additional control group. Clinical, biological, and pathological parameters were compared between groups. The only significant effect of treatment was higher mean ferritin and Fe(+) concentrations for both male and female rats fed the transgenic milk powder diets, as compared to rats fed nontransgenic milk diets or the commercial diet. The results of the present study are consistent with previous research, which indicates that milk powder containing rhLF derived from healthy transgenic cloned cattle is as safe as conventional milk powder.

Reduced risk of sudden death from chest wall blows (commotio cordis) with safety baseballs.

PubMed

Link, Mark S; Maron, Barry J; Wang, Paul J; Pandian, Natesa G; VanderBrink, Brian A; Estes, N A Mark

2002-05-01

In an experimental model of sudden death from baseball chest wall impact (commotio cordis), we sought to determine if sudden death by baseball impact could be reduced with safety baseballs. Sudden cardiac death can occur after chest wall impact with a baseball (commotio cordis). Whether softer-than-standard (safety) baseballs reduce the risk of sudden death is unresolved from the available human data. In a juvenile swine model, ventricular fibrillation (VF) has been shown to be induced reproducibly by precordial impact with a 30-mph baseball 10 to 30 ms before the T-wave peak, and this likelihood was reduced with the softest safety baseballs (T-balls). To further test whether safety baseballs would reduce the risk of sudden death at velocities more relevant to youth sports competition, we used our swine model of commotio cordis to test baseballs propelled at the 40-mph velocity commonly attained in that sport. Forty animals received up to 3 chest wall impacts at 40 mph during the vulnerable period of repolarization for VF with 1 of 3 different safety baseballs of varying hardness, and also by a standard baseball. Safety baseballs propelled at 40 mph significantly reduced the risk for VF. The softest safety baseballs triggered VF in only 11% of impacts, compared with 19% and 22% with safety baseballs of intermediate hardness, and 69% with standard baseballs. In this experimental model of low-energy chest wall impact, safety baseballs reduced (but did not abolish) the risk of sudden cardiac death. More universal use of these safety baseballs may decrease the risk of sudden death on the playing field for young athletes.

DHS small-scale safety and thermal testing of improvised explosives-comparison of testing performance

NASA Astrophysics Data System (ADS)

Reynolds, J. G.; Sandstrom, M. M.; Brown, G. W.; Warner, K. F.; Phillips, J. J.; Shelley, T. J.; Reyes, J. A.; Hsu, P. C.

2014-05-01

One of the first steps in establishing safe handling procedures for explosives is small-scale safety and thermal (SSST) testing. To better understand the response of improvised materials or homemade explosives (HMEs) to SSST testing, 16 HME materials were compared to three standard military explosives in a proficiency-type round robin study among five laboratories-two DoD and three DOE-sponsored by DHS. The testing matrix has been designed to address problems encountered with improvised materials-powder mixtures, liquid suspensions, partially wetted solids, immiscible liquids, and reactive materials. More than 30 issues have been identified that indicate standard test methods may require modification when applied to HMEs to derive accurate sensitivity assessments needed for developing safe handling and storage practices. This paper presents a generalized comparison of the results among the testing participants, comparison of friction results from BAM (German Bundesanstalt für Materi-alprüfung) and ABL (Allegany Ballistics Laboratory) designed testing equipment, and an overview of the statistical results from the RDX (1,3,5-Trinitroperhydro-1,3,5-triazine) standard tested throughout the proficiency test.

Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.

PubMed

Sorbello, Alfred; Ripple, Anna; Tonning, Joseph; Munoz, Monica; Hasan, Rashedul; Ly, Thomas; Francis, Henry; Bodenreider, Olivier

2017-03-22

We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. All usability test participants cited the tool's ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool's automated literature search relative to a manual 'all fields' PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.

The safety and immunogenicity of influenza vaccine in children with asthma in Mexico.

PubMed

Pedroza, Alvaro; Huerta, José G; Garcia, Maria de la Luz; Rojas, Arsheli; López-Martínez, Irma; Penagos, Martín; Franco-Paredes, Carlos; Deroche, Christele; Mascareñas, Cesar

2009-07-01

The morbidity and mortality associated with influenza is substantial in children with asthma. There are no available data on the safety and immunogenicity of influenza vaccine in children with asthma in Latin America. Furthermore, it is unclear if influenza vaccination may cause asthma exacerbations. We conducted a placebo-controlled trial to investigate the safety and immunogenicity of an inactivated trivalent split virus influenza vaccine in children with asthma in Mexico. We also measured the impact of influenza vaccination on pulmonary function tests in this population. The inactivated influenza vaccine was immunogenic and safe in terms of local and systemic side effects compared to placebo. We observed no significant impact on pulmonary function tests among vaccine recipients. Given the significant morbidity associated with influenza in children, strategies to promote increased influenza vaccination coverage in this high-risk group in Latin America and elsewhere are urgently needed.

Promoting individual learning for trainees with perceived high helplessness: experiences of a safety training program.

PubMed

Kiani, Fariba; Khodabakhsh, Mohamad Reza

2014-01-01

The article arises from a research project investigating the effectiveness of safety training on changing attitudes toward safety issues. Followed by the training intervention was observed that employees' helplessness decreased. The researchers have come to the idea of investigating how safety training can reduce perceived helplessness. Thus, this research examined the effectiveness of safety training on reducing employees' helplessness with attention to the mediating role of attitude toward safety issues. The current study was an experimental study with the control group. A total of 204 (101 experimental group and 103 control group) completed safety attitude questionnaire and perceived helplessness before a safety training course including four 90-min sessions over 4 consecutive days in Esfahan Steel Company in 2012 between October and December. Only members of the experimental group participated in this course. These questionnaires, approximately 30 days later, again were run on members of both groups. Data were analyzed using descriptive indexes, t-, and F-test. RESULTS by comparing the two groups showed that safety training was effective only on individuals with perceived low helplessness (p = 0.02). In individuals with perceived high helplessness, safety training only with changing safety attitudes can reduce the perceived helplessness.

Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making.

PubMed

Hatfield, Laura A; Baugh, Christine M; Azzone, Vanessa; Normand, Sharon-Lise T

2017-07-01

Regulators must act to protect the public when evidence indicates safety problems with medical devices. This requires complex tradeoffs among risks and benefits, which conventional safety surveillance methods do not incorporate. To combine explicit regulator loss functions with statistical evidence on medical device safety signals to improve decision making. In the Hospital Cost and Utilization Project National Inpatient Sample, we select pediatric inpatient admissions and identify adverse medical device events (AMDEs). We fit hierarchical Bayesian models to the annual hospital-level AMDE rates, accounting for patient and hospital characteristics. These models produce expected AMDE rates (a safety target), against which we compare the observed rates in a test year to compute a safety signal. We specify a set of loss functions that quantify the costs and benefits of each action as a function of the safety signal. We integrate the loss functions over the posterior distribution of the safety signal to obtain the posterior (Bayes) risk; the preferred action has the smallest Bayes risk. Using simulation and an analysis of AMDE data, we compare our minimum-risk decisions to a conventional Z score approach for classifying safety signals. The 2 rules produced different actions for nearly half of hospitals (45%). In the simulation, decisions that minimize Bayes risk outperform Z score-based decisions, even when the loss functions or hierarchical models are misspecified. Our method is sensitive to the choice of loss functions; eliciting quantitative inputs to the loss functions from regulators is challenging. A decision-theoretic approach to acting on safety signals is potentially promising but requires careful specification of loss functions in consultation with subject matter experts.

9 CFR 113.40 - Dog safety tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

9 CFR 113.40 - Dog safety tests.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

9 CFR 113.40 - Dog safety tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

9 CFR 113.40 - Dog safety tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

9 CFR 113.40 - Dog safety tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Dog safety tests. 113.40 Section 113... Procedures § 113.40 Dog safety tests. The safety tests provided in this section shall be conducted when... recommended for use in dogs. Serials which are not found to be satisfactory when tested pursuant to the...

Mechanical abuse simulation and thermal runaway risks of large-format Li-ion batteries

NASA Astrophysics Data System (ADS)

Wang, Hsin; Lara-Curzio, Edgar; Rule, Evan T.; Winchester, Clinton S.

2017-02-01

Internal short circuit of large-format Li-ion pouch cells induced by mechanical abuse was simulated using a modified mechanical pinch test. A torsion force was added manually at ∼40% maximum compressive loading force during the pinch test. The cell was twisted about 5° to the side by horizontally pulling a wire attached to the anode tab. The combined torsion-compression force created small failure at the separator yet allowed testing of fully charged large format Li-ion cells without triggering thermal runaway. Two types of commercial cells were tested using 4-6 cells at each state-of-charge (SOC). Commercially available 18 Ahr LiFePO4 (LFP) and 25 Ahr Li(NiMnCo)1/3O2 (NMC) cells were tested, and a thermal runaway risk (TRR) score system was used to evaluate the safety of the cells under the same testing conditions. The aim was to provide the cell manufacturers and end users with a tool to compare different designs and safety features.

A Static Burst Test for Composite Flywheel Rotors

NASA Astrophysics Data System (ADS)

Hartl, Stefan; Schulz, Alexander; Sima, Harald; Koch, Thomas; Kaltenbacher, Manfred

2016-06-01

High efficient and safe flywheels are an interesting technology for decentralized energy storage. To ensure all safety aspects, a static test method for a controlled initiation of a burst event for composite flywheel rotors is presented with nearly the same stress distribution as in the dynamic case, rotating with maximum speed. In addition to failure prediction using different maximum stress criteria and a safety factor, a set of tensile and compressive tests is carried out to identify the parameters of the used carbon fiber reinforced plastics (CFRP) material. The static finite element (FE) simulation results of the flywheel static burst test (FSBT) compare well to the quasistatic FE-simulation results of the flywheel rotor using inertia loads. Furthermore, it is demonstrated that the presented method is a very good controllable and observable possibility to test a high speed flywheel energy storage system (FESS) rotor in a static way. Thereby, a much more expensive and dangerous dynamic spin up test with possible uncertainties can be substituted.

Closed Course Testing of Portable Rumble Strips to Improve Truck Safety at Work Zones

DOT National Transportation Integrated Search

2010-01-01

The purpose of this research was to compare the attention-getting characteristics, movements and vertical displacements of several portable, reusable rumble strips. The attention-getting characteristics and displacement were measured after passes of ...

Department of Homeland Security (DHS) Proficiency Testing on Small-Scale Safety and Thermal Testing of Improvised Explosives

NASA Astrophysics Data System (ADS)

Reynolds, John; Sandstrom, Mary; Brown, Geoffrey; Warner, Kirstin; Phillips, Jason; Shelley, Timothy; Reyes, Jose; Hsu, Peter

2013-06-01

One of the first steps in establishing safe handling procedures for explosives is small-scale safety and thermal (SSST) testing. To better understand the response of improvised materials or HMEs to SSST testing, 18 HME materials were compared to 3 standard military explosives in a proficiency-type round robin study among five laboratories--2 DoD and 3 DOE--sponsored by DHS. The testing matrix has been designed to address problems encountered with improvised materials--powder mixtures, liquid suspensions, partially wetted solids, immiscible liquids, and reactive materials. Over 30 issues have been identified that indicate standard test methods may require modification when applied to HMEs to derive accurate sensitivity assessments needed for development safe handling and storage practices. This presentation will discuss experimental difficulties encountered when testing these problematic samples, show inter-laboratory testing results, show some statistical interpretation of the results, and highlight some of the testing issues. Some of the work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344. LLNL-ABS-617519 (721812).

Vocational Education Safety Instruction Manual.

ERIC Educational Resources Information Center

Cropley, Russell, Ed.; Doherty, Susan Sloan, Ed.

This manual describes four program areas in vocational education safety instruction: (1) introduction to a safety program; (2) resources to ensure laboratory safety; (3) safety program implementation; and (4) safety rules and safety tests. The safety rules and tests included in section four are for the most common tools and machines used in…

46 CFR 61.30-20 - Automatic control and safety tests.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 2 2013-10-01 2013-10-01 false Automatic control and safety tests. 61.30-20 Section 61.30-20 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC... and safety tests. Operational tests and checks of all safety and limit controls, combustion controls...

46 CFR 61.30-20 - Automatic control and safety tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 2 2014-10-01 2014-10-01 false Automatic control and safety tests. 61.30-20 Section 61.30-20 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC... and safety tests. Operational tests and checks of all safety and limit controls, combustion controls...

46 CFR 61.30-20 - Automatic control and safety tests.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Automatic control and safety tests. 61.30-20 Section 61.30-20 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC... and safety tests. Operational tests and checks of all safety and limit controls, combustion controls...

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea...

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea...

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea...

21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each guinea...

Infant toxicology: state of the science and considerations in evaluation of safety.

PubMed

Neal-Kluever, April; Aungst, Jason; Gu, Yan; Hatwell, Karen; Muldoon-Jacobs, Kristi; Liem, Ayesha; Ogungbesan, Adejoke; Shackelford, Mary

2014-08-01

Differences in the physiology and biological susceptibilities of adults and infants have led to growing interest in safety evaluation methods for exposures from infant formula packaging. In addition to potential physiological differences, infants aged 0-6 months may consume a sole source of food, infant formula or breast milk, and consume higher amounts of food relative to body weight compared to adults. While the duration of the exposure is short compared to the expected lifespan of the individual, it occurs during a period of important developmental processes. The purpose of this document is to (1) review key biological and exposure elements that may impact the evaluation of safety for food contact products intended for use by infants, (2) summarize the current reproductive and developmental toxicity testing protocols available, and (3) identify potential data gaps concerning this period of development. Published by Elsevier Ltd.

A study to assess the influence of interprofessional point of care simulation training on safety culture in the operating theatre environment of a university teaching hospital.

PubMed

Hinde, Theresa; Gale, Thomas; Anderson, Ian; Roberts, Martin; Sice, Paul

2016-01-01

Interprofessional point of care or in situ simulation is used as a training tool in our operating theatre directorate with the aim of improving crisis behaviours. This study aimed to assess the impact of interprofessional point of care simulation on the safety culture of operating theatres. A validated Safety Attitude Questionnaire was administered to staff members before each simulation scenario and then re-administered to the same staff members after 6-12 months. Pre- and post-training Safety Attitude Questionnaire-Operating Room (SAQ-OR) scores were compared using paired sample t-tests. Analysis revealed a statistically significant perceived improvement in both safety (p < 0.001) and teamwork (p = 0.013) climate scores (components of safety culture) 6-12 months after interprofessional simulation training. A growing body of literature suggests that a positive safety culture is associated with improved patient outcomes. Our study supports the implementation of point of care simulation as a useful intervention to improve safety culture in theatres.

Safety first: Instrumentality for reaching safety determines attention allocation under threat.

PubMed

Vogt, Julia; Koster, Ernst H W; De Houwer, Jan

2017-04-01

Theories of attention to emotional information suggest that attentional processes prioritize threatening information. In this article, we suggest that attention will prioritize the events that are most instrumental to a goal in any given context, which in threatening situations is typically reaching safety. To test our hypotheses, we used an attentional cueing paradigm that contained cues signaling imminent threat (i.e., aversive noises) as well as cues that allowed participants to avoid threat (instrumental safety signals). Correct reactions to instrumental safety signals seemingly allowed participants to lower the presentation rate of the threat. Experiment 1 demonstrates that attention prioritizes instrumental safety signals over threat signals. Experiment 2 replicates this finding and additionally compares instrumental safety signals to other action-relevant signals controlling for action relevance as cause of the effects. Experiment 3 demonstrates that when actions toward threat signals permit to avoid threat, attention prioritizes threat signals. Taken together, these results support the view that instrumentality for reaching safety determines the allocation of attention under threat. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Analysis of developed transition road safety barrier systems.

PubMed

Soltani, Mehrtash; Moghaddam, Taher Baghaee; Karim, Mohamed Rehan; Sulong, N H Ramli

2013-10-01

Road safety barriers protect vehicles from roadside hazards by redirecting errant vehicles in a safe manner as well as providing high levels of safety during and after impact. This paper focused on transition safety barrier systems which were located at the point of attachment between a bridge and roadside barriers. The aim of this study was to provide an overview of the behavior of transition systems located at upstream bridge rail with different designs and performance levels. Design factors such as occupant risk and vehicle trajectory for different systems were collected and compared. To achieve this aim a comprehensive database was developed using previous studies. The comparison showed that Test 3-21, which is conducted by impacting a pickup truck with speed of 100 km/h and angle of 25° to transition system, was the most severe test. Occupant impact velocity and ridedown acceleration for heavy vehicles were lower than the amounts for passenger cars and pickup trucks, and in most cases higher occupant lateral impact ridedown acceleration was observed on vehicles subjected to higher levels of damage. The best transition system was selected to give optimum performance which reduced occupant risk factors using the similar crashes in accordance with Test 3-21. Copyright © 2013 Elsevier Ltd. All rights reserved.

Attitudes and Opinions of Doctors of Chiropractic Specializing in Pediatric Care Toward Patient Safety: A Cross-sectional Survey.

PubMed

Pohlman, Katherine A; Carroll, Linda; Hartling, Lisa; Tsuyuki, Ross; Vohra, Sunita

2016-09-01

The purpose of this cross-sectional survey was to evaluate attitudes and opinions of doctors of chiropractic (DCs) specializing in pediatric care toward patient safety. The Medical Office Survey on Patient Safety Culture of the Agency for Healthcare Research and Quality was adapted for providers who use spinal manipulation therapy and sent out to 2 US chiropractic organizations' pediatric council members (n = 400) between February and April 2014. The survey measured 12 patient safety dimensions and included questions on patient safety items and quality issues, information exchange, and overall clinic ratings. Data analyses included a percent composite average and a nonrespondent analysis. The response rate was 29.5% (n = 118). Almost one- third of respondents' patients were pediatric (≤17 years of age). DCs with a pediatric certification were 3 times more likely to respond (P < .001), but little qualitative differences were found in responses. The patient safety dimensions with the highest positive composite percentages were Organizational Learning (both administration and clinical) and Teamwork (>90%). Patient Care Tracking/Follow-up and Work Pressure and Pace were patient safety dimensions that had the lowest positive composite scores (<85%). The responses also indicated that there was concern regarding information exchange with insurance/third-party payors. Two quality issues identified for improvement were (1) updating a patient's medication list and (2) following up on critically abnormal results from a laboratory or imaging test within 1 day. The average overall patient safety rating score indicated that 83% of respondents rated themselves as "very good" or "excellent." Compared with 2014 Agency for Healthcare Research and Quality physician referent data from medical offices, pediatric DCs appear to have more positive patient safety attitudes and opinions. Future patient safety studies need to prospectively evaluate safety performance with direct feedback from patients and compare results with these self-assessed safety attitudes, as well as make further use of this survey to develop a comparable database for spinal manipulation providers. Copyright © 2016. Published by Elsevier Inc.

Comparison of intradermal dilutional testing, skin prick testing, and modified quantitative testing for common allergens.

PubMed

Peltier, Jacques; Ryan, Matthew W

2007-08-01

To compare and correlate wheal size using the Multi-Test II applicator with the endpoint obtained by intradermal dilutional testing (IDT) for 5 common allergens. To examine the safety of modified quantitative testing (MQT) for determining immunotherapy starting doses. Prospective comparative clinical study. A total of 134 subjects were simultaneously skin tested for immediate hypersensitivity using the Multi-Test II device and IDT. There was a 77% concordance between results from IDT and results from MQT. When there was a difference, MQT predicted a safer endpoint for starting immunotherapy in all but 2 cases. Wheal size by SPT is predictive of endpoint by IDT. MQT is nearly as effective as formal IDT in determining endpoint. Modified quantitative testing appears to be a safe alternative to IDT for determining starting doses for immunotherapy.

Comparative safety, immunogenicity, and efficacy of several anti‐H5N1 influenza experimental vaccines in a mouse and chicken models (Testing of killed and live H5 vaccine)

PubMed Central

Gambaryan, Alexandra S.; Lomakina, Natalia F.; Boravleva, Elizaveta Y.; Kropotkina, Ekaterina A.; Mashin, Vadim V.; Krasilnikov, Igor V.; Klimov, Alexander I.; Rudenko, Larisa G.

2011-01-01

Please cite this paper as: Gambaryan et al. (2011) Comparative safety, immunogenicity, and efficacy of several anti‐H5N1 influenza experimental vaccines in a mouse and chicken models. Parallel testing of killed and live H5 vaccine. Influenza and Other Respiratory Viruses 6(3), 188–195. Objective  Parallel testing of inactivated (split and whole virion) and live vaccine was conducted to compare the immunogenicity and protective efficacy against homologous and heterosubtypic challenge by H5N1 highly pathogenic avian influenza virus. Method  Four experimental live vaccines based on two H5N1 influenza virus strains were tested; two of them had hemagglutinin (HA) of A/Vietnam/1203/04 strain lacking the polybasic HA cleavage site, and two others had hemagglutinins from attenuated H5N1 virus A/Chicken/Kurgan/3/05, with amino acid substitutions of Asp54/Asn and Lys222/Thr in HA1 and Val48/Ile and Lys131/Thr in HA2 while maintaining the polybasic HA cleavage site. The neuraminidase and non‐glycoprotein genes of the experimental live vaccines were from H2N2 cold‐adapted master strain A/Leningrad/134/17/57 (VN‐Len and Ku‐Len) or from the apathogenic H6N2 virus A/Gull/Moscow/3100/2006 (VN‐Gull and Ku‐Gull). Inactivated H5N1 and H1N1 and live H1N1 vaccine were used for comparison. All vaccines were applied in a single dose. Safety, immunogenicity, and protectivity against the challenge with HPAI H5N1 virus A/Chicken/Kurgan/3/05 were estimated. Results  All experimental live H5 vaccines tested were apathogenic as determined by weight loss and conferred more than 90% protection against lethal challenge with A/Chicken/Kurgan/3/05 infection. Inactivated H1N1 vaccine in mice offered no protection against challenge with H5N1 virus, while live cold‐adapted H1N1 vaccine reduced the mortality near to zero level. Conclusions  The high yield, safety, and protectivity of VN‐Len and Ku‐Len made them promising strains for the production of inactivated and live vaccines against H5N1 viruses. PMID:21951678

Computer-based training for safety: comparing methods with older and younger workers.

PubMed

Wallen, Erik S; Mulloy, Karen B

2006-01-01

Computer-based safety training is becoming more common and is being delivered to an increasingly aging workforce. Aging results in a number of changes that make it more difficult to learn from certain types of computer-based training. Instructional designs derived from cognitive learning theories may overcome some of these difficulties. Three versions of computer-based respiratory safety training were shown to older and younger workers who then took a high and a low level learning test. Younger workers did better overall. Both older and younger workers did best with the version containing text with pictures and audio narration. Computer-based training with pictures and audio narration may be beneficial for workers over 45 years of age. Computer-based safety training has advantages but workers of different ages may benefit differently. Computer-based safety programs should be designed and selected based on their ability to effectively train older as well as younger learners.

Design and testing of safer more effective preservatives for consumer products

USDA-ARS?s Scientific Manuscript database

A comprehensive evaluation of both safety and efficacy of alternative preservatives is crucial to the development of more sustainable composite materials, formulated products, and food packaging. By comparing the antimicrobial activity against Aspergillus brasiliensis (mold) and Pseudomonas aerugino...

Discussion map and cooking classes: testing the effectiveness of teaching food safety to immigrants and refugees.

PubMed

Gold, Abby; Yu, Nan; Buro, Brandy; Garden-Robinson, Julie

2014-01-01

To evaluate the effectiveness of a food safety map as an educational method with English language learners. English language learner community members (n = 73) were assigned randomly to participate in 1 of 3 experimental conditions: food safety map, cooking class, and control. Participants in the food safety map and cooking class conditions completed a pre-education demographic and cooking history questionnaire, a post-education knowledge and intention questionnaire, and a 2-week post-cooking and food safety habits assessment. Participants in the control group received no educational training but completed the pre- and 2-week post-education assessments. The cooking class and the map class were both effective in increasing food safety knowledge. Specifically, by comparing with the control group, they significantly increased participants' knowledge of safely cooking large meat (χ² [df = 2, n = 66] = 40.87; P < .001; V* = .79) and correctly refrigerating cooked food (χ² [df = 2, n = 73] = 24.87, P < .001; V* = .58). The two class types generated similar positive educational effects on boosting food safety behavioral intention (measured right after the class). The data collected 2 weeks after the classes suggested that individuals who took the classes followed the suggested food behaviors more closely than those in the control group (P < .01). The food safety map is simple to use and prepare, beneficial for oral and visual learners, and inexpensive. Compared with a food safety cooking class, the map produces similar learning and behavioral outcomes. Copyright © 2014 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Effect of Kangfuxin Solution on Chemo/Radiotherapy-Induced Mucositis in Nasopharyngeal Carcinoma Patients: A Multicenter, Prospective Randomized Phase III Clinical Study

PubMed Central

Luo, Yangkun; Feng, Mei; Fan, Zixuan; Zhu, Xiaodong; Jin, Feng; Li, Rongqing; Wu, Jingbo; Yang, Xia; Jiang, Qinghua; Bai, Hongfang; Huang, Yecai; Lang, Jinyi

2016-01-01

Objective. To evaluate the efficacy and safety of Kangfuxin Solution, a pure Chinese herbal medicine, on mucositis induced by chemoradiotherapy in nasopharyngeal carcinoma patients. Methods. A randomized, parallel-group, multicenter clinical study was performed. A total of 240 patients were randomized to receive either Kangfuxin Solution (test group) or compound borax gargle (control group) during chemoradiotherapy. Oral mucositis, upper gastrointestinal mucositis, and oral pain were evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and the Verbal Rating Scale (VRS). Results. Of 240 patients enrolled, 215 were eligible for efficacy analysis. Compared with the control group, the incidence and severity of oral mucositis in the test group were significantly reduced (P = 0.01). The time to different grade of oral mucositis occurrence (grade 1, 2, or 3) was longer in test group (P < 0.01), and the accumulated radiation dose was also higher in test group comparing to the control group (P < 0.05). The test group showed lower incidence of oral pain and gastrointestinal mucositis than the control group (P < 0.01). No significant adverse events were observed. Conclusion. Kangfuxin Solution demonstrated its superiority to compound borax gargle on mucositis induced by chemoradiotherapy. Its safety is acceptable for clinical application. PMID:27375766

Safety and efficacy of a non-pesticide-based head lice treatment: results of a randomised comparative trial in children.

PubMed

Greive, Kerryn A; Lui, Ada H; Barnes, Tanya M; Oppenheim, V M Jane

2012-11-01

Increasing resistance to pesticide-based head lice treatments has resulted in the need for alternative products to treat head lice infestations, but there are few clinical studies that have adequately tested these products. This multicentre, randomised, assessor-blind, parallel-group phase IV trial compared the safety and efficacy of a non-pesticide-based head lice shampoo with malathion foam in children. This trial used strict entry criteria, standardised treatment and assessment regimes, sibling control and a primary efficacy end-point defined as the absence of live head lice 21 days after initiating treatment. Repeat insult patch tests were performed to further assess the safety of the non-pesticide-based shampoo. In vitro tests were used to assess its ovicidal and pediculicidal efficacy. A total of 216 children were enrolled, of whom 172 were per-protocol. The non-pesticide-based shampoo was significantly more effective than malathion foam for the intent-to-treat population (62.3 vs 40.4% louse-free, unadjusted P = 0.002; adjusted P = 0.003), as well as for the per-protocol population (67.8 vs 43.0% louse-free, unadjusted P = 0.001; adjusted P = 0.004). Adverse events were limited to itching or stinging. Patch testing with the non-pesticide-based shampoo resulted in no adverse reactions. In vitro tests using body lice demonstrated that the non-pesticide-based shampoo is ovicidal and pediculicidal. The non-pesticide-based shampoo is significantly more effective in eliminating head lice than malathion foam in children, while being associated with a low incidence of mild, transient adverse events. © 2012 Ego Pharmaceuticals Pty Ltd Australasian Journal of Dermatology © 2012 The Australasian College of Dermatologists.

9 CFR 113.41 - Calf safety test.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

9 CFR 113.45 - Sheep safety test.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

78 FR 54510 - New Entrant Safety Assurance Program Operational Test

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-04

...-0298] New Entrant Safety Assurance Program Operational Test AGENCY: Federal Motor Carrier Safety...) announces an operational test of procedural changes to the New Entrant Safety Assurance Program. The operational test began in July 2013 and will be in effect for up to 12 months. It is applicable to new entrant...

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

9 CFR 113.41 - Calf safety test.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

9 CFR 113.45 - Sheep safety test.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

9 CFR 113.38 - Guinea pig safety test.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Guinea pig safety test. 113.38 Section... Standard Procedures § 113.38 Guinea pig safety test. The guinea pig safety test provided in this section... be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals...

Inter-laboratory Comparison of Three Earplug Fit-test Systems

PubMed Central

Byrne, David C.; Murphy, William J.; Krieg, Edward F.; Ghent, Robert M.; Michael, Kevin L.; Stefanson, Earl W.; Ahroon, William A.

2017-01-01

The National Institute for Occupational Safety and Health (NIOSH) sponsored tests of three earplug fit-test systems (NIOSH HPD Well-Fit™, Michael & Associates FitCheck, and Honeywell Safety Products VeriPRO®). Each system was compared to laboratory-based real-ear attenuation at threshold (REAT) measurements in a sound field according to ANSI/ASA S12.6-2008 at the NIOSH, Honeywell Safety Products, and Michael & Associates testing laboratories. An identical study was conducted independently at the U.S. Army Aeromedical Research Laboratory (USAARL), which provided their data for inclusion in this report. The Howard Leight Airsoft premolded earplug was tested with twenty subjects at each of the four participating laboratories. The occluded fit of the earplug was maintained during testing with a soundfield-based laboratory REAT system as well as all three headphone-based fit-test systems. The Michael & Associates lab had highest average A-weighted attenuations and smallest standard deviations. The NIOSH lab had the lowest average attenuations and the largest standard deviations. Differences in octave-band attenuations between each fit-test system and the American National Standards Institute (ANSI) sound field method were calculated (Attenfit-test - AttenANSI). A-weighted attenuations measured with FitCheck and HPD Well-Fit systems demonstrated approximately ±2 dB agreement with the ANSI sound field method, but A-weighted attenuations measured with the VeriPRO system underestimated the ANSI laboratory attenuations. For each of the fit-test systems, the average A-weighted attenuation across the four laboratories was not significantly greater than the average of the ANSI sound field method. Standard deviations for residual attenuation differences were about ±2 dB for FitCheck and HPD Well-Fit compared to ±4 dB for VeriPRO. Individual labs exhibited a range of agreement from less than a dB to as much as 9.4 dB difference with ANSI and REAT estimates. Factors such as the experience of study participants and test administrators, and the fit-test psychometric tasks are suggested as possible contributors to the observed results. PMID:27786602

Improving patient safety culture in Saudi Arabia (2012-2015): trending, improvement and benchmarking.

PubMed

Alswat, Khalid; Abdalla, Rawia Ahmad Mustafa; Titi, Maher Abdelraheim; Bakash, Maram; Mehmood, Faiza; Zubairi, Beena; Jamal, Diana; El-Jardali, Fadi

2017-08-02

Measuring patient safety culture can provide insight into areas for improvement and help monitor changes over time. This study details the findings of a re-assessment of patient safety culture in a multi-site Medical City in Riyadh, Kingdom of Saudi Arabia (KSA). Results were compared to an earlier assessment conducted in 2012 and benchmarked with regional and international studies. Such assessments can provide hospital leadership with insight on how their hospital is performing on patient safety culture composites as a result of quality improvement plans. This paper also explored the association between patient safety culture predictors and patient safety grade, perception of patient safety, frequency of events reported and number of events reported. We utilized a customized version of the patient safety culture survey developed by the Agency for Healthcare Research and Quality. The Medical City is a tertiary care teaching facility composed of two sites (total capacity of 904 beds). Data was analyzed using SPSS 24 at a significance level of 0.05. A t-Test was used to compare results from the 2012 survey to that conducted in 2015. Two adopted Generalized Estimating Equations in addition to two linear models were used to assess the association between composites and patient safety culture outcomes. Results were also benchmarked against similar initiatives in Lebanon, Palestine and USA. Areas of strength in 2015 included Teamwork within units, and Organizational Learning-Continuous Improvement; areas requiring improvement included Non-Punitive Response to Error, and Staffing. Comparing results to the 2012 survey revealed improvement on some areas but non-punitive response to error and Staffing remained the lowest scoring composites in 2015. Regression highlighted significant association between managerial support, organizational learning and feedback and improved survey outcomes. Comparison to international benchmarks revealed that the hospital is performing at or better than benchmark on several composites. The Medical City has made significant progress on several of the patient safety culture composites despite still having areas requiring additional improvement. Patient safety culture outcomes are evidently linked to better performance on specific composites. While results are comparable with regional and international benchmarks, findings confirm that regular assessment can allow hospitals to better understand and visualize changes in their performance and identify additional areas for improvement.

[The economics of preventing psycho-social risks].

PubMed

Golzio, Luigi

2014-01-01

The aim of the essay is to show the SHIELD methodology for helping the firm management to improve the risks prevention policy. It has been tested in the field with positive results. SHIELD is a cost-benefit analysis application to compare prevention and non-prevention costs, which arise from non-market risks. In the economic perspective safety risks (which include psycho-social risks) are non-market ones as they cause injures to workers during the job. SHIELD (Social Health Indicators for Economic Labour Decisions), is the original method proposed by the author. It is a cost benefits analysis application, which compares safety prevention and non-prevention costs. The comparison allow stop management to evaluate the efficiency of the current safety prevention policy as it helps top management to answer to the policy question: how much to invest in prevention costs? The costs comparison is obtained through the reclassification of safety costs between prevention and non-prevention costs (which are composed by claim damages and penalty sanction costs). SHIELD has been tested empirically in four companies operating in the agribusiness sector during a research financed by the Assessorato all'Agricoltura and INAI Regionale of Emilia Romagna Region. Results are postive: it has been found that the increase of prevention costs causes the cut of non-prevention costs in all companies looked into, as assumed by the high reliability organization theory. SHIELD can be applied to all companies which must have an accounting system by law, no matter of the industry they act. Its application has limited costs as SHIELD doesn't need changes in the accounting system. Safety costs sustained by the company are simply reclassified in prevention and non-prevention costs. The comparison of these two costs categories has been appreciated by top management of companies investigated as a useful support to decide the risks prevention policy for the company. The SHIELD original feature compared with others cost benefit analysis application is to compute registered costs in the company accounting system.

Safety validation test equipment operation

NASA Astrophysics Data System (ADS)

Kurosaki, Tadaaki; Watanabe, Takashi

1992-08-01

An overview of the activities conducted on safety validation test equipment operation for materials used for NASA manned missions is presented. Safety validation tests, such as flammability, odor, offgassing, and so forth were conducted in accordance with NASA-NHB-8060.1C using test subjects common with those used by NASA, and the equipment used were qualified for their functions and performances in accordance with NASDA-CR-99124 'Safety Validation Test Qualification Procedures.' Test procedure systems were established by preparing 'Common Procedures for Safety Validation Test' as well as test procedures for flammability, offgassing, and odor tests. The test operation organization chaired by the General Manager of the Parts and Material Laboratory of NASDA (National Space Development Agency of Japan) was established, and the test leaders and operators in the organization were qualified in accordance with the specified procedures. One-hundred-one tests had been conducted so far by the Parts and Material Laboratory according to the request submitted by the manufacturers through the Space Station Group and the Safety and Product Assurance for Manned Systems Office.

Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis

PubMed Central

Colombo, Delia; Zagni, Emanuela; Nica, Mihaela; Rizzoli, Sara; Ori, Alessandra; Bellia, Gilberto

2016-01-01

Background MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity. Methods Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ2 test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ2 test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ2 P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ2 P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males (χ2 test P=0.0246). Conclusion This safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials from a gender-specific perspective. PMID:27695289

Penicillin skin testing is a safe and effective tool for evaluating penicillin allergy in the pediatric population.

PubMed

Fox, Stephanie J; Park, Miguel A

2014-01-01

Penicillin skin testing has been validated in the evaluation of adult patients with penicillin allergy. However, the commercially available benzylpenicilloyl polylysine (Pre-Pen) is not indicated in the pediatric population. Moreover, the safety and validity of penicillin skin testing in the pediatric population has not been well studied. We describe the safety and validity of penicillin skin testing in the evaluation of children with a history of penicillin allergy. Children (<18 years) with a history of penicillin allergy were evaluated with penicillin skin tests and were reviewed for basic demographics, penicillin skin test results, adverse drug reaction to penicillin after penicillin skin test, and adverse reaction to penicillin skin test. By using the χ(2) test, we compared the differences in the proportion of children and adults with a positive penicillin skin test. P value (<.05) was considered statistically significant. The institutional review board approved the study, and all the subjects signed written informed consents. A total of 778 children underwent penicillin skin testing; 703 of 778 patients had a negative penicillin skin test (90.4%), 66 had a positive test (8.5%), and 9 had an equivocal test (1.1%). Children were more likely to have a positive penicillin skin test (P < .0001) compared with adults (64 of 1759 [3.6%]); 369 of 703 patients with negative penicillin skin test (52%) were challenged with penicillin, and 14 of 369 patients (3.8%) had an adverse drug reaction. No adverse reactions to penicillin skin testing were observed. Penicillin skin testing was safe and effective in the evaluation of children with a history of penicillin allergy. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Comparative effectiveness of a serious game and an e-module to support patient safety knowledge and awareness.

PubMed

Dankbaar, Mary E W; Richters, Olivier; Kalkman, Cor J; Prins, Gerrie; Ten Cate, Olle T J; van Merrienboer, Jeroen J G; Schuit, Stephanie C E

2017-02-02

Serious games have the potential to teach complex cognitive skills in an engaging way, at relatively low costs. Their flexibility in use and scalability makes them an attractive learning tool, but more research is needed on the effectiveness of serious games compared to more traditional formats such e-modules. We investigated whether undergraduate medical students developed better knowledge and awareness and were more motivated after learning about patient-safety through a serious game than peers who studied the same topics using an e-module. Fourth-year medical students were randomly assigned to either a serious game that included video-lectures, biofeedback exercises and patient missions (n = 32) or an e-module, that included text-based lectures on the same topics (n = 34). A third group acted as a historical control-group without extra education (n = 37). After the intervention, which took place during the clinical introduction course, before the start of the first rotation, all students completed a knowledge test, a self-efficacy test and a motivation questionnaire. During the following 10-week clinical rotation they filled out weekly questionnaires on patient-safety awareness and stress. The results showed patient safety knowledge had equally improved in the game group and e-module group compared to controls, who received no extra education. Average learning-time was 3 h for the game and 1 h for the e-module-group. The serious game was evaluated as more engaging; the e-module as more easy to use. During rotations, students in the three groups reported low and similar levels of patient-safety awareness and stress. Students who had treated patients successfully during game missions experienced higher self-efficacy and less stress during their rotation than students who treated patients unsuccessfully. Video-lectures (in a game) and text-based lectures (in an e-module) can be equally effective in developing knowledge on specific topics. Although serious games are strongly engaging for students and stimulate them to study longer, they do not necessarily result in better performance in patient safety issues.

Application of Arrester Simulation Device in Training

NASA Astrophysics Data System (ADS)

Baoquan, Zhang; Ziqi, Chai; Genghua, Liu; Wei, Gao; Kaiyue, Wu

2017-12-01

Combining with the arrester simulation device put into use successfully, this paper introduces the application of arrester test in the insulation resistance measurement, counter test, Leakage current test under DC 1mA voltage and leakage current test under 0.75U1mA. By comparing with the existing training, this paper summarizes the arrester simulation device’s outstanding advantages including real time monitoring, multi-type fault data analysis and acousto-optic simulation. It effectively solves the contradiction between authenticity and safety in the existing test training, and provides a reference for further training.

Gas Generation Testing of Spherical Resorcinol-Formaldehyde (sRF) Resin

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

Colburn, Heather A.; Bryan, Samuel A.; Camaioni, Donald M.

This report describes gas generation testing of the spherical resorcinol-formaldehyde (sRF) resin that was conducted to support the technology maturation of the LAWPS facility. The current safety basis for the LAWPS facility is based primarily on two studies that had limited or inconclusive data sets. The two studies indicated a 40% increase in hydrogen generation rate of water (as predicted by the Hu model) with sRF resin over water alone. However, the previous studies did not test the range of conditions (process fluids and temperatures) that are expected in the LAWPS facility. Additionally, the previous studies did not obtain replicatemore » test results or comparable liquid-only control samples. All of the testing described in this report, conducted with water, 0.45M nitric acid, and waste simulants with and without sRF resin, returned hydrogen generation rates that are within the current safety basis for the facility of 1.4 times the Hu model output for water.« less

Hazards of Electromagnetic Radiation to Ordnance (HERO) Safety Test

DTIC Science & Technology

2013-01-10

Ordnance Test Procedure (JOTP)-061 Hazards of Electromagnetic Radiation to...DEPARTMENT OF DEFENSE JOINT ORDNANCE TEST PROCEDURE (JOTP)-061 HAZARDS OF ELECTROMAGNETIC RADIATION TO ORDNANCE (HERO) SAFETY...TEST Joint Services Munition Safety Test Working Group Joint Ordnance Test Procedure (JOTP)-061 Hazards of Electromagnetic Radiation

Naturalistic distraction and driving safety in older drivers.

PubMed

Aksan, Nazan; Dawson, Jeffrey D; Emerson, Jamie L; Yu, Lixi; Uc, Ergun Y; Anderson, Steven W; Rizzo, Matthew

2013-08-01

In this study, we aimed to quantify and compare performance of middle-aged and older drivers during a naturalistic distraction paradigm (visual search for roadside targets) and to predict older drivers performance given functioning in visual, motor, and cognitive domains. Distracted driving can imperil healthy adults and may disproportionally affect the safety of older drivers with visual, motor, and cognitive decline. A total of 203 drivers, 120 healthy older (61 men and 59 women, ages 65 years and older) and 83 middle-aged drivers (38 men and 45 women, ages 40 to 64 years), participated in an on-road test in an instrumented vehicle. Outcome measures included performance in roadside target identification (traffic signs and restaurants) and concurrent driver safety. Differences in visual, motor, and cognitive functioning served as predictors. Older drivers identified fewer landmarks and drove slower but committed more safety errors than did middle-aged drivers. Greater familiarity with local roads benefited performance of middle-aged but not older drivers.Visual cognition predicted both traffic sign identification and safety errors, and executive function predicted traffic sign identification over and above vision. Older adults are susceptible to driving safety errors while distracted by common secondary visual search tasks that are inherent to driving. The findings underscore that age-related cognitive decline affects older drivers' management of driving tasks at multiple levels and can help inform the design of on-road tests and interventions for older drivers.

9 CFR 113.33 - Mouse safety tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

9 CFR 113.33 - Mouse safety tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

9 CFR 113.33 - Mouse safety tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

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

9 CFR 113.33 - Mouse safety tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

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

9 CFR 113.33 - Mouse safety tests.

Code of Federal Regulations, 2014 CFR

2014-01-01

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

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2012 CFR

2012-01-01

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

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2014 CFR

2014-01-01

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

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

9 CFR 113.44 - Swine safety test.

Code of Federal Regulations, 2013 CFR

2013-01-01

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

Social identification moderates the effect of crowd density on safety at the Hajj.

PubMed

Alnabulsi, Hani; Drury, John

2014-06-24

Crowd safety is a major concern for those attending and managing mass gatherings, such as the annual Hajj or pilgrimage to Mecca (also called Makkah). One threat to crowd safety at such events is crowd density. However, recent research also suggests that psychological membership of crowds can have positive benefits. We tested the hypothesis that the effect of density on safety might vary depending on whether there is shared social identification in the crowd. We surveyed 1,194 pilgrims at the Holy Mosque, Mecca, during the 2012 Hajj. Analysis of the data showed that the negative effect of crowd density on reported safety was moderated by social identification with the crowd. Whereas low identifiers reported reduced safety with greater crowd density, high identifiers reported increased safety with greater crowd density. Mediation analysis suggested that a reason for these moderation effects was the perception that other crowd members were supportive. Differences in reported safety across national groups (Arab countries and Iran compared with the rest) were also explicable in terms of crowd identification and perceived support. These findings support a social identity account of crowd behavior and offer a novel perspective on crowd safety management.

Social identification moderates the effect of crowd density on safety at the Hajj

PubMed Central

Alnabulsi, Hani; Drury, John

2014-01-01

Crowd safety is a major concern for those attending and managing mass gatherings, such as the annual Hajj or pilgrimage to Mecca (also called Makkah). One threat to crowd safety at such events is crowd density. However, recent research also suggests that psychological membership of crowds can have positive benefits. We tested the hypothesis that the effect of density on safety might vary depending on whether there is shared social identification in the crowd. We surveyed 1,194 pilgrims at the Holy Mosque, Mecca, during the 2012 Hajj. Analysis of the data showed that the negative effect of crowd density on reported safety was moderated by social identification with the crowd. Whereas low identifiers reported reduced safety with greater crowd density, high identifiers reported increased safety with greater crowd density. Mediation analysis suggested that a reason for these moderation effects was the perception that other crowd members were supportive. Differences in reported safety across national groups (Arab countries and Iran compared with the rest) were also explicable in terms of crowd identification and perceived support. These findings support a social identity account of crowd behavior and offer a novel perspective on crowd safety management. PMID:24927593

A comparison of the legibility and visibility of enamel and reflectorized 1971 Virginia license plates.

DOT National Transportation Integrated Search

1971-01-01

The Safety Section of the Virginia Highway Research. Council carried out observation tests of the legibility and visibility of reflectorized and enamel license plates. The primary objectives were to determine the comparative legibility and visibility...

Nurses' but not supervisors' safety practices are linked with job satisfaction.

PubMed

Hurtado, David A; Kim, Seung-Sup; Subramanian, S V; Dennerlein, Jack T; Christiani, David C; Hashimoto, Dean M; Sorensen, Glorian

2017-10-01

To test the associations of safety practices as reported by nurses and their respective unit supervisors with job satisfaction. Psychosocial workplace factors are associated with job satisfaction; however, it is unknown whether nurses and supervisors accounts of safety practices are differentially linked to this outcome. Cross-sectional study design including nurses (n = 1052) nested in 94 units in two hospitals in Boston (MA, USA). Safety practices refer to the identification and control of occupational hazards at the unit. Safety practices were measured aggregating nurses' responses per unit, and supervisory levels. Individual's job satisfaction for each nurse was the response variable. Supervisors assessed safety practices more favourably than their unit nursing staff. Adjusted random intercept logistic regressions showed that the odds of higher job satisfaction were higher for nurses at units with better safety practices (OR: 1.67, 95% CI: 1.04, 2.68) compared with nurses at units that averaged lower safety practices. Supervisors' reports of safety practices were not correlated with the job satisfaction of their staff. Adequate safety practices might be a relevant managerial role that enhances job satisfaction among nurses. Nursing supervisors should calibrate their safety assessments with their nursing staff to improve nurses' job satisfaction. © 2017 John Wiley & Sons Ltd.

Promoting Individual Learning for Trainees with Perceived High Helplessness: Experiences of a Safety Training Program

PubMed Central

Kiani, Fariba; Khodabakhsh, Mohamad Reza

2014-01-01

Objective: The article arises from a research project investigating the effectiveness of safety training on changing attitudes toward safety issues. Followed by the training intervention was observed that employees’ helplessness decreased. The researchers have come to the idea of investigating how safety training can reduce perceived helplessness. Thus, this research examined the effectiveness of safety training on reducing employees’ helplessness with attention to the mediating role of attitude toward safety issues. Methods: The current study was an experimental study with the control group. A total of 204 (101 experimental group and 103 control group) completed safety attitude questionnaire and perceived helplessness before a safety training course including four 90-min sessions over 4 consecutive days in Esfahan Steel Company in 2012 between October and December. Only members of the experimental group participated in this course. These questionnaires, approximately 30 days later, again were run on members of both groups. Data were analyzed using descriptive indexes, t-, and F-test. Results: Results by comparing the two groups showed that safety training was effective only on individuals with perceived low helplessness (p = 0.02). Conclusion: In individuals with perceived high helplessness, safety training only with changing safety attitudes can reduce the perceived helplessness. PMID:25798170

Applying interprofessional Team-Based Learning in patient safety: a pilot evaluation study.

PubMed

Lochner, Lukas; Girardi, Sandra; Pavcovich, Alessandra; Meier, Horand; Mantovan, Franco; Ausserhofer, Dietmar

2018-03-27

Interprofessional education (IPE) interventions are not always successful in achieving learning outcomes. Team-Based Learning (TBL) would appear to be a suitable pedagogical method for IPE, as it focuses on team performance; however, little is known about interprofessional TBL as an instructional framework for patient safety. In this pilot-study, we aimed to (1) describe participants' reactions to TBL, (2) observe their achievement with respect to interprofessional education learning objectives, and (3) document their attitudinal shifts with regard to patient safety behaviours. We developed and implemented a three-day course for pre-qualifying, non-medical healthcare students to give instruction on non-technical skills related to 'learning from errors'. The course consisted of three sequential modules: 'Recognizing Errors', 'Analysing Errors', and 'Reporting Errors'. The evaluation took place within a quasi-experimental pre-test-post-test study design. Participants completed self-assessments through valid and reliable instruments such as the Mennenga's TBL Student Assessment Instrument and the University of the West of England's Interprofessional Questionnaire. The mean scores of the individual readiness assurance tests were compared with the scores of the group readiness assurance test in order to explore if students learned from each other during group discussions. Data was analysed using descriptive (i.e. mean, standard deviation), parametric (i.e. paired t-test), and non-parametric (i.e. Wilcoxon signed-rank test) methods. Thirty-nine students from five different bachelor's programs attended the course. The participants positively rated TBL as an instructional approach. All teams outperformed the mean score of their individual members during the readiness assurance process. We observed significant improvements in 'communication and teamwork' and 'interprofessional learning' but not in 'interprofessional interaction' and 'interprofessional relationships.' Findings on safety attitudes and behaviours were mixed. TBL was well received by the students. Our first findings indicate that interprofessional TBL seems to be a promising pedagogical method to achieve patient safety learning objectives. It is crucial to develop relevant clinical cases that involve all professions. Further research with larger sample sizes (e.g. including medical students) and more rigorous study designs (e.g. pre-test post-test with a control group) is needed to confirm our preliminary findings.

Development of lightweight fire retardant, low-smoke, high-strength, thermally stable aircraft floor paneling

NASA Technical Reports Server (NTRS)

Arnold, D. B.; Burnside, J. V.; Hajari, J. V.

1976-01-01

Fire resistance mechanical property tests were conducted on sandwich configurations composed of resin-fiberglass laminates bonded with adhesives to Nomex honeycomb core. The test results were compared to proposed and current requirements for aircraft floor panel applications to demonstrate that the fire safety of the airplane could be improved without sacrificing mechanical performance of the aircraft floor panels.

Physical Attributes and NFL Combine Performance Tests Between Italian National League and American Football Players: A Comparative Study.

PubMed

Vitale, Jacopo A; Caumo, Andrea; Roveda, Eliana; Montaruli, Angela; La Torre, Antonio; Battaglini, Claudio L; Carandente, Franca

2016-10-01

Vitale, JA, Caumo, A, Roveda, E, Montaruli, A, La Torre, A, Battaglini, CL, and Carandente, F. Physical attributes and NFL Combine performance tests between Italian National League and American football players: a comparative study. J Strength Cond Res 30(10): 2802-2808, 2016-The purpose of this study was to examine anthropometric measurements and the results of a battery of performance tests administered during the National Football League (NFL) Combine between American football players who were declared eligible to participate in the NFL Combine and football players of a top Italian team (Rhinos Milan). Participants (N = 50) were categorized by position into 1 of 3 groups based on playing position: skill players (SP) included wide receivers, cornerbacks, free safeties, strong safeties, and running backs; big skill players (BSP) consisted of fullbacks, linebackers, tight ends, and defensive ends; lineman (LM) included centers, offensive guards, offensive tackles, and defensive tackles. A 1-way analysis of variance followed by the Tukey-Kramer post hoc test was used for comparisons between Italian players by playing position. Ninety-five percent CIs were used for comparisons between American and Italian football for the NFL Combine performance tests. Significant differences for all the variables between the 3 playing categories were observed among the Italian players; LM had higher anthropometric and body composition values than SP (p < 0.001) and BSP (p < 0.001), whereas LM performed significantly worse in the physical tests, except for the 225-lb bench press test when compared with SP (p < 0.002). American football players presented significantly higher anthropometric values and test performance scores when compared with Italian players. Administrators of professional football teams in Italy need to improve the player's physical attributes, so the gap that currently exists between American and Italian players can be reduced, which could significantly improve the quality of American football in Italy.

Comparison of electrophysiological data from human-induced pluripotent stem cell-derived cardiomyocytes to functional preclinical safety assays.

PubMed

Harris, Kate; Aylott, Mike; Cui, Yi; Louttit, James B; McMahon, Nicholas C; Sridhar, Arun

2013-08-01

Human-induced pluripotent stem cell cardiomyocytes (hiPSC-CMs) are a potential source to develop assays for predictive electrophysiological safety screening. Published studies show that the relevant physiology and pharmacology exist but does not show the translation between stem cell cardiomyocyte assays and other preclinical safety screening assays, which is crucial for drug discovery and safety scientists and the regulators. Our studies are the first to show the pharmacology of ion channel blockade and compare them with existing functional cardiac electrophysiology studies. Ten compounds (a mixture of pure hERG [E-4031 and Cisapride], hERG and sodium [Flecainide, Mexiletine, Quinidine, and Terfenadine], calcium channel blockers [Nifedipine and Verapamil], and two proprietary compounds [GSK A and B]) were tested, and results from hiPSC-CMs studied on multielectrode arrays (MEA) were compared with other preclincial models and clinical drug concentrations and effects using integrated risk assessment plots. All ion channel blockers produced (1) functional effects on repolarization and depolarization around the IC25 and IC50 values and (2) excessive blockade of hERG and/or blockade of sodium current precipitated arrhythmias. Our MEA data show that hiPSC-CMs demonstrate relevant pharmacology and show excellent correlations to current functional cardiac electrophysiological studies. Based on these results, MEA assays using iPSC-CMs offer a reliable, cost effective, and surrogate to preclinical in vitro testing, in addition to the 3Rs (refine, reduce, and replace animals in research) benefit.

Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial.

PubMed

Adkinson, N Franklin; Strauss, William E; Macdougall, Iain C; Bernard, Kristine E; Auerbach, Michael; Kaper, Robert F; Chertow, Glenn M; Krop, Julie S

2018-05-01

Few trials have examined rates of hypersensitivity reactions (HSRs) with intravenous iron formulations used to treat iron deficiency anemia (IDA). This randomized, multicenter, double-blind clinical trial compared the safety, and efficacy of ferumoxytol versus ferric carboxymaltose (FCM), focusing on rates of HSRs and hypotension as the primary end point. Patients with IDA of any etiology in whom oral iron was unsatisfactory or intolerable received ferumoxytol (n = 997) or FCM (n = 1000) intravenously over ≥15 minutes on days 1 and 8 or 9 for total respective doses of 1.02 g and 1.50 g. Composite incidences of moderate-to-severe HSRs, including anaphylaxis, or moderate-to-severe hypotension from baseline to week 5 (primary safety end point) were 0.6% and 0.7% in the ferumoxytol and FCM groups, respectively, with ferumoxytol noninferior to FCM. No anaphylaxis was reported in either group. The secondary safety end point of incidences of moderate-to-severe HSRs, including anaphylaxis, serious cardiovascular events, and death from baseline to week 5 were 1.3% and 2.0% in the ferumoxytol and FCM groups, respectively (noninferiority test P < .0001). Least-squares mean changes in hemoglobin at week 5 were 1.4 g/dL and 1.6 g/dL in the ferumoxytol and FCM groups, respectively (noninferiority test P < .0001). Incidence of hypophosphatemia was 0.4% for ferumoxytol and 38.7% for FCM. © 2018 The Authors American Journal of Hematology Published by Wiley Periodicals, Inc.

Harnessing Scientific Literature Reports for Pharmacovigilance

PubMed Central

Ripple, Anna; Tonning, Joseph; Munoz, Monica; Hasan, Rashedul; Ly, Thomas; Francis, Henry; Bodenreider, Olivier

2017-01-01

Summary Objectives We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers’ capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. Methods A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. Results All usability test participants cited the tool’s ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool’s automated literature search relative to a manual ‘all fields’ PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Conclusions Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction. PMID:28326432

Young Age as a Predictor of Poor Road Safety Practices of Commercial Motorcyclists in Oyo State, Nigeria.

PubMed

Olumide, Adesola O; Owoaje, Eme T

2015-01-01

This study examined the association between young age and poor road safety practices of commercial motorcyclists in Oyo state, Nigeria. A cross-sectional study of 371 commercial motorcyclists selected via a multistage sampling technique was conducted. Information on sociodemographic characteristics and road safety practices (possession of a valid license, helmet use, number of passengers carried per trip, and compliance with 10 selected traffic signs) was obtained with the aid of an interviewer-administered questionnaire. Individual road safety practice items were scored and a total score was obtained giving minimum and maximum obtainable scores of 0 and 35. Respondents with scores ≤ 17.5 (i.e., less than or equal to half of the maximum obtainable score of 35) were categorized as having poor road safety practices. Descriptive statistics, chi-square, and multiple logistic regression tests were conducted. Selected sociodemographic and occupation-related factors were controlled for in the logistic regression analysis. All respondents were male, 80.1% had been riding for commercial purposes for less than 5 years, and 73.0% had other jobs in addition to commercial riding. Road safety practices were generally poor; that is, 84.4% of commercial riders were categorized as having poor road safety practices. Almost all (98.6%) respondents aged < 25 years compared to 84.3% of those aged 25 to <35 years and 76.8% of those ≥35 years had poor road safety practices. This difference was statistically significant. Following logistic regression, younger age (<25 years) remained predictive of poor road safety practices. Motorcyclists aged < 25 years had about 16 times higher odds of having poor road safety practices compared to those aged 35 years and more (odds ratio = 15.72, 95% confidence interval, 1.82-135.91). Most studies conduct only bivariate analysis to test the association between age and road practices of commercial motorcyclists; however, we investigated the influence of potential confounding variables using multivariate analysis. Our findings confirmed young age as a predictor of poor road safety practices among our sample of commercial motorcyclists and emphasizes the need for road safety programs to target this category of riders. The current minimum age for obtaining a rider's license in Nigeria is 18 years; our findings suggest that it might be beneficial to increase the age at which riders in our study area can obtain a commercial rider's license to above 25 years.

Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

PubMed

Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

2012-06-01

This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

Comparative structural neck responses of the THOR-NT, Hybrid III, and human in combined tension-bending and pure bending.

PubMed

Dibb, Alan T; Nightingale, Roger W; Chancey, V Carol; Fronheiser, Lucy E; Tran, Laura; Ottaviano, Danielle; Meyers, Barry S

2006-11-01

This study evaluated the biofidelity of both the Hybrid III and the THOR-NT anthropomorphic test device (ATD) necks in quasistatic tension-bending and pure-bending by comparing the responses of both the ATDs with results from validated computational models of the living human neck. This model was developed using post-mortem human surrogate (PMHS) osteoligamentous response corridors with effective musculature added (Chancey, 2005). Each ATD was tested using a variety of end-conditions to create the tension-bending loads. The results were compared using absolute difference, RMS difference, and normalized difference metrics. The THOR-NT was tested both with and without muscle cables. The THOR-NT was also tested with and without the central safety cable to test the effect of the cable on the behavior of the ATD. The Hybrid III was stiffer than the model for all tension-bending end conditions. Quantitative measurement of the differences in response showed more close agreement between the THOR-NT and the model than the Hybrid III and the model. By contrast, no systematic differences were observed in the head kinematics. The muscle cables significantly stiffened the THOR-NT by effectively reducing the laxity from the occipital condyle (OC) joint. The cables also shielded the OC upper neck load cell from a significant portion of the applied loads. The center safety significantly stiffened the response and decreased the fidelity, particularly in modes of loading in which tensile forces were large and bending moments small. This study compares ATD responses to computational models in which the models include PMHS response corridors while correcting for problems associated with cadaveric muscle. While controversial and requiring considerable diligence, these kinds of approaches show promise in assessing ATD biofidelity.

Advanced Guidance and Control Methods for Reusable Launch Vehicles: Test Results

NASA Technical Reports Server (NTRS)

Hanson, John M.; Jones, Robert E.; Krupp, Don R.; Fogle, Frank R. (Technical Monitor)

2002-01-01

There are a number of approaches to advanced guidance and control (AG&C) that have the potential for achieving the goals of significantly increasing reusable launch vehicle (RLV) safety/reliability and reducing the cost. In this paper, we examine some of these methods and compare the results. We briefly introduce the various methods under test, list the test cases used to demonstrate that the desired results are achieved, show an automated test scoring method that greatly reduces the evaluation effort required, and display results of the tests. Results are shown for the algorithms that have entered testing so far.

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

A statistical simulation model for field testing of non-target organisms in environmental risk assessment of genetically modified plants.

PubMed

Goedhart, Paul W; van der Voet, Hilko; Baldacchino, Ferdinando; Arpaia, Salvatore

2014-04-01

Genetic modification of plants may result in unintended effects causing potentially adverse effects on the environment. A comparative safety assessment is therefore required by authorities, such as the European Food Safety Authority, in which the genetically modified plant is compared with its conventional counterpart. Part of the environmental risk assessment is a comparative field experiment in which the effect on non-target organisms is compared. Statistical analysis of such trials come in two flavors: difference testing and equivalence testing. It is important to know the statistical properties of these, for example, the power to detect environmental change of a given magnitude, before the start of an experiment. Such prospective power analysis can best be studied by means of a statistical simulation model. This paper describes a general framework for simulating data typically encountered in environmental risk assessment of genetically modified plants. The simulation model, available as Supplementary Material, can be used to generate count data having different statistical distributions possibly with excess-zeros. In addition the model employs completely randomized or randomized block experiments, can be used to simulate single or multiple trials across environments, enables genotype by environment interaction by adding random variety effects, and finally includes repeated measures in time following a constant, linear or quadratic pattern in time possibly with some form of autocorrelation. The model also allows to add a set of reference varieties to the GM plants and its comparator to assess the natural variation which can then be used to set limits of concern for equivalence testing. The different count distributions are described in some detail and some examples of how to use the simulation model to study various aspects, including a prospective power analysis, are provided.

A statistical simulation model for field testing of non-target organisms in environmental risk assessment of genetically modified plants

PubMed Central

Goedhart, Paul W; van der Voet, Hilko; Baldacchino, Ferdinando; Arpaia, Salvatore

2014-01-01

Genetic modification of plants may result in unintended effects causing potentially adverse effects on the environment. A comparative safety assessment is therefore required by authorities, such as the European Food Safety Authority, in which the genetically modified plant is compared with its conventional counterpart. Part of the environmental risk assessment is a comparative field experiment in which the effect on non-target organisms is compared. Statistical analysis of such trials come in two flavors: difference testing and equivalence testing. It is important to know the statistical properties of these, for example, the power to detect environmental change of a given magnitude, before the start of an experiment. Such prospective power analysis can best be studied by means of a statistical simulation model. This paper describes a general framework for simulating data typically encountered in environmental risk assessment of genetically modified plants. The simulation model, available as Supplementary Material, can be used to generate count data having different statistical distributions possibly with excess-zeros. In addition the model employs completely randomized or randomized block experiments, can be used to simulate single or multiple trials across environments, enables genotype by environment interaction by adding random variety effects, and finally includes repeated measures in time following a constant, linear or quadratic pattern in time possibly with some form of autocorrelation. The model also allows to add a set of reference varieties to the GM plants and its comparator to assess the natural variation which can then be used to set limits of concern for equivalence testing. The different count distributions are described in some detail and some examples of how to use the simulation model to study various aspects, including a prospective power analysis, are provided. PMID:24834325

A comparative study on the immunogenicity, safety and tolerance of purified duck embryo vaccine (PDEV) manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a randomized simulated post-exposure study in healthy volunteers.

PubMed

Mahendra, Bangalore Jayakrishnappa; Madhusudana, Shampur Narayan; Ashwathnarayana, Doddabele Hanumanthaiah; Sampath, Gadey; datta, Soma Subhra; Sudarshan, Mysore Kalappa; Venkatesh, Gonibeedu Manjunatah; Muhamuda, Kader; Bilagumba, Gangaboraiah; Shamanna, Manjula

2007-12-05

Purified duck embryo vaccine (PDEV, Vaxirab) for rabies prophylaxis is now indigenously manufactured in India under technology transfer from Berna Biotech who made the original PDEV (Lyssavac). In the present study we have compared the two vaccines in terms of safety, immunogenicity and tolerance. The study was conducted in 220 adult healthy volunteers. It was observed that both vaccines produced neutralizing antibody titers (as determined by rapid fluorescent focus inhibition test, RFFIT) more than 0.5 IU/mL (minimum level for seroconversion) on all days tested but the titers on days 90 and 180 were significantly higher with Lyssavac. The adverse reactions produced were slightly more with Lysssavac but both vaccines were well tolerated. In conclusion, the indigenously produced PDEV (Vaxirab) was found to be equally safe and immunogenic as the original PDEV (Lyssavac) manufactured at Switzerland.

76 FR 20672 - Recommendations on In Vitro Ocular Safety Testing Methods and Strategies and Routine Use of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

... certain regulatory testing purposes without the need for animal testing. The Organisation for Economic Co... DEPARTMENT OF HEALTH AND HUMAN SERVICES Recommendations on In Vitro Ocular Safety Testing Methods... Ocular Safety Testing AGENCY: National Institute of Environmental Health Sciences (NIEHS), National...

Verification of MCNP6.2 for Nuclear Criticality Safety Applications

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

Brown, Forrest B.; Rising, Michael Evan; Alwin, Jennifer Louise

2017-05-10

Several suites of verification/validation benchmark problems were run in early 2017 to verify that the new production release of MCNP6.2 performs correctly for nuclear criticality safety applications (NCS). MCNP6.2 results for several NCS validation suites were compared to the results from MCNP6.1 [1] and MCNP6.1.1 [2]. MCNP6.1 is the production version of MCNP® released in 2013, and MCNP6.1.1 is the update released in 2014. MCNP6.2 includes all of the standard features for NCS calculations that have been available for the past 15 years, along with new features for sensitivity-uncertainty based methods for NCS validation [3]. Results from the benchmark suitesmore » were compared with results from previous verification testing [4-8]. Criticality safety analysts should consider testing MCNP6.2 on their particular problems and validation suites. No further development of MCNP5 is planned. MCNP6.1 is now 4 years old, and MCNP6.1.1 is now 3 years old. In general, released versions of MCNP are supported only for about 5 years, due to resource limitations. All future MCNP improvements, bug fixes, user support, and new capabilities are targeted only to MCNP6.2 and beyond.« less

Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study.

PubMed

Tanglertsampan, Chuchai

2012-10-01

Topical minoxidil and oral finasteride have been used to treat men with androgenetic alopecia (AGA). There are concerns about side effects of oral finasteride especially erectile dysfunction. To compare the efficacy and safety of the 24 weeks application of 3% minoxidil lotion (MNX) versus combined 3% minoxidil and 0.1% finasteride lotion (MFX) in men with AGA. Forty men with AGA were randomized treated with MNX or MFX. Efficacy was evaluated by hair counts and global photographic assessment. Safety assessment was performed by history and physical examination. At week 24, hair counts were increased from baseline in both groups. However paired t-test revealed statistical difference only in MFX group (p = 0.044). Unpaired t-test revealed no statistical difference between two groups with respect to change of hair counts at 24 weeks from baseline (p = 0.503). MFX showed significantly higher efficacy than MNX by global photographic assessment (p = 0.003). There was no significant difference in side effects between both groups. Although change of hair counts was not statistically different between two groups, global photographic assessment showed significantly greater improvement in the MFX group than the MNX group. There was no sexual side effect. MFX may be a safe and effective treatment option.

A randomized double-blind controlled trial comparing extra virgin coconut oil with mineral oil as a moisturizer for mild to moderate xerosis.

PubMed

Agero, Anna Liza C; Verallo-Rowell, Vermén M

2004-09-01

Xerosis is a common skin condition (1) characterized by dry, rough, scaly, and itchy skin, (2) associated with a defect in skin barrier function, and (3) treated with moisturizers. People in the tropics have effectively used coconut oil as a traditional moisturizer for centuries. Recently, the oil also has been shown to have skin antiseptic effects. A moisturizer with antiseptic effects has value, but there are no clinical studies to document the efficacy and safety of coconut oil as a skin moisturizer. This study aimed to determine the effectivity and safety of virgin coconut oil compared with mineral oil as a therapeutic moisturizer for mild to moderate xerosis. A randomized double-blind controlled clinical trial was conducted on mild to moderate xerosis in 34 patients with negative patch-test reactions to the test products. These patients were randomized to apply either coconut oil or mineral oil on the legs twice a day for 2 weeks. Quantitative outcome parameters for effectivity were measured at baseline and on each visit with a Corneometer CM825 to measure skin hydration and a Sebumeter SM 810 to measure skin lipids. For safety, transepidermal water loss (TEWL) was measured with a Tewameter TM210, and skin surface hydrogen ion concentration (pH) was measured with a Skin pH Meter PH900. Patients and the investigator separately evaluated, at baseline and at each weekly visit, skin symptoms of dryness, scaling, roughness, and pruritus by using a visual analogue scale and grading of xerosis. Coconut oil and mineral oil have comparable effects. Both oils showed effectivity through significant improvement in skin hydration and increase in skin surface lipid levels. Safety was demonstrated through no significant difference in TEWL and skin pH. Subjective grading of xerosis by the investigators and visual analogue scales used by the patients showed a general trend toward better (though not statistically evident) improvement with coconut oil than with mineral oil. Safety for both was further demonstrated by negative patch-test results prior to the study and by the absence of adverse reactions during the study. Coconut oil is as effective and safe as mineral oil when used as a moisturizer.

Restaurant inspection frequency: The RestoFreq Study.

PubMed

Medu, Olanrewaju; Turner, Hollie; Cushon, Jennifer A; Melis, Deborah; Rea, Leslie; Abdellatif, Treena; Neudorf, Cory O; Schwandt, Michael

2017-03-01

Foodborne illness is an important contributor to morbidity and health system costs in Canada. Using number of critical hazards as a proxy for food safety, we sought to better understand how to improve food safety in restaurants. We compared the current standard of annual inspections to twice-yearly inspections among restaurants "at risk" for food safety infractions. These were restaurants that had three or more elevated-risk inspection ratings in the preceding 36 months. We conducted a two-arm randomized controlled trial between November 2012 and October 2014. The intervention was twice-yearly routine restaurant inspection compared to standard once-yearly routine inspection. Included were all restaurants within Saskatoon Health Region that were assessed as "at risk", with 73 restaurants in the intervention arm and 78 in the control arm. Independent sample t-tests were conducted between groups to compare: i) average number of critical hazards per inspection; and ii) proportion of inspections resulting in a rating indicating an elevated hazard. Over time we noted statistically significant improvements across both study arms, in number of both critical food safety hazards (decreased by 61%) and elevated-risk inspection ratings (decreased by 45%) (p < 0.0001). We observed no significant differences between the two groups pre- or post-intervention. Results suggest increasing the number of annual routine inspections in high-risk restaurants was not associated with a significant difference in measures of compliance with food safety regulations. Findings of this study do not provide evidence supporting increased frequency of restaurant inspection from annually to twice annually.

Near Real-Time Surveillance for Influenza Vaccine Safety: Proof-of-Concept in the Vaccine Safety Datalink Project

PubMed Central

Greene, Sharon K.; Kulldorff, Martin; Lewis, Edwin M.; Li, Rong; Yin, Ruihua; Weintraub, Eric S.; Fireman, Bruce H.; Lieu, Tracy A.; Nordin, James D.; Glanz, Jason M.; Baxter, Roger; Jacobsen, Steven J.; Broder, Karen R.; Lee, Grace M.

2010-01-01

The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent inactivated influenza vaccine during the 2005/06–2007/08 influenza seasons. In self-controlled case series analysis, the risk of adverse events in a prespecified exposure period following vaccination was compared with the risk in 1 control period for the same individual either before or after vaccination. In difference-in-difference analysis, the relative risk in exposed versus control periods each season was compared with the relative risk in previous seasons since 2000/01. The authors used Poisson-based analysis to compare the risk of Guillian-Barré syndrome following vaccination in each season with that in previous seasons. Maximized sequential probability ratio tests were used to adjust for repeated analyses on weekly data. With administration of 1,195,552 doses to children under age 18 years and 4,773,956 doses to adults, no elevated risk of adverse events was identified. Near real-time surveillance for selected adverse events can be implemented prospectively to rapidly assess seasonal and pandemic influenza vaccine safety. PMID:19965887

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

2005-01-01

The National Aeronautics and Space Administration (NASA) Space-Based Telemetry and Range Safety (STARS) study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety [global positioning system (GPS) metric tracking data, flight termination command and range safety data relay] and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California, USA) using the NASA Tracking and Data Relay Satellite System (TDRSS) as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit (RSU) provided real-time video for three days during the historic Global Flyer (Scaled Composites, Mojave, California, USA) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This paper discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

2005-01-01

The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety (global positioning system metric tracking data, flight termination command and range safety data relay) and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California) using the NASA Tracking and Data Relay Satellite System as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit provided real-time video for three days during the historic GlobalFlyer (Scaled Composites, Mojave, California) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This report discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

Evaluation of Human and Anthropomorphic Test Device Finite Element Models under Spaceflight Loading Conditions

NASA Technical Reports Server (NTRS)

Putnam, Jacob P.; Untaroiu, Costin; Somers. Jeffrey

2014-01-01

In an effort to develop occupant protection standards for future multipurpose crew vehicles, the National Aeronautics and Space Administration (NASA) has looked to evaluate the test device for human occupant restraint with the modification kit (THOR-K) anthropomorphic test device (ATD) in relevant impact test scenarios. With the allowance and support of the National Highway Traffic Safety Administration, NASA has performed a series of sled impact tests on the latest developed THOR-K ATD. These tests were performed to match test conditions from human volunteer data previously collected by the U.S. Air Force. The objective of this study was to evaluate the THOR-K finite element (FE) model and the Total HUman Model for Safety (THUMS) FE model with respect to the tests performed. These models were evaluated in spinal and frontal impacts against kinematic and kinetic data recorded in ATD and human testing. Methods: The FE simulations were developed based on recorded pretest ATD/human position and sled acceleration pulses measured during testing. Predicted responses by both human and ATD models were compared to test data recorded under the same impact conditions. The kinematic responses of the models were quantitatively evaluated using the ISO-metric curve rating system. In addition, ATD injury criteria and human stress/strain data were calculated to evaluate the risk of injury predicted by the ATD and human model, respectively. Results: Preliminary results show well-correlated response between both FE models and their physical counterparts. In addition, predicted ATD injury criteria and human model stress/strain values are shown to positively relate. Kinematic comparison between human and ATD models indicates promising biofidelic response, although a slightly stiffer response is observed within the ATD. Conclusion: As a compliment to ATD testing, numerical simulation provides efficient means to assess vehicle safety throughout the design process and further improve the design of physical ATDs. The assessment of the THOR-K and THUMS FE models in a spaceflight testing condition is an essential first step to implementing these models in the computational evaluation of spacecraft occupant safety. Promising results suggest future use of these models in the aerospace field.

A comparison of the presumptive luminol test for blood with four non-chemiluminescent forensic techniques.

PubMed

Webb, Joanne L; Creamer, Jonathan I; Quickenden, Terence I

2006-01-01

Presumptive blood detection tests are used by forensic investigators to detect trace amounts of blood or to investigate suspicious stains. Through the years, a number of articles have been published on the popular techniques of the day. However, there is no single paper that critiques and compares the five most common presumptive blood detection tests currently in use: luminol, phenolphthalein (Kastle-Meyer), leucomalachite green, Hemastix and the forensic light source. The present authors aimed to compare the above techniques with regard to their sensitivity, ease of use and safety. The luminol test was determined to be the most sensitive of the techniques, while Hemastix is a suitable alternative when the luminol test is not appropriate. Copyright 2006 John Wiley & Sons, Ltd.

An open-label pilot study to assess the efficacy and safety of virgin coconut oil in reducing visceral adiposity.

PubMed

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans.

An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

PubMed Central

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

Safety Assurances at Space Test Centres: Lessons Learned

NASA Astrophysics Data System (ADS)

Alarcon Ruiz, Raul; O'Neil, Sean; Valls, Rafel Prades

2010-09-01

The European Space Agency’s(ESA) experts in quality, cleanliness and contamination control, safety, test facilities and test methods have accumulated valuable experience during the performance of dedicated audits of space test centres in Europe over a period of 10 years. This paper is limited to a summary of the safety findings and provides a valuable reference to the lessons learned, identifying opportunities for improvement in the areas of risk prevention measures associated to the safety of all test centre personnel, the test specimen, the test facilities and associated infrastructure. Through the analysis of the audit results the authors present what are the main lessons learned, and conclude how an effective safety management system will contribute to successful test campaigns and have a positive impact on the cost and schedule of space projects.

Mechanical Abuse Simulation and Thermal Runaway Risks of Large-Format Li-ion Batteries

DOE PAGES

Wang, Hsin; Lara-Curzio, Edgar; Rule, Evan; ...

2017-01-11

Internal short circuit of large-format Li-ion cells induced by mechanical abuse was simulated using a modified mechanical pinch test. A torsion force was added manually at ~40% maximum compressive loading force during the pinch test. The cell was twisted about 5 degrees to the side by horizontally pulling a wire attached to the anode tab. The combined torsion-compression force created small enough failure at the separator and allowed testing of fully charged large format Li-ion cells without triggering thermal runaway. Two types of commercial cells were tested using 4-6 cells at each state-of-charge (SOC). The 18 Ah LiFePO 4 (LFP)more » and 25 Ah Li(NiMnCo) 1/3O 2 (NMC) cells were tested and the thermal runaway risk (TRR) score system was used to evaluate the safety risk of the cells under the same testing conditions. The aim is to provide the cell manufacturers and end users a tool to compare different designs and safety features.« less

Mechanical Abuse Simulation and Thermal Runaway Risks of Large-Format Li-ion Batteries

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

Wang, Hsin; Lara-Curzio, Edgar; Rule, Evan

Internal short circuit of large-format Li-ion cells induced by mechanical abuse was simulated using a modified mechanical pinch test. A torsion force was added manually at ~40% maximum compressive loading force during the pinch test. The cell was twisted about 5 degrees to the side by horizontally pulling a wire attached to the anode tab. The combined torsion-compression force created small enough failure at the separator and allowed testing of fully charged large format Li-ion cells without triggering thermal runaway. Two types of commercial cells were tested using 4-6 cells at each state-of-charge (SOC). The 18 Ah LiFePO 4 (LFP)more » and 25 Ah Li(NiMnCo) 1/3O 2 (NMC) cells were tested and the thermal runaway risk (TRR) score system was used to evaluate the safety risk of the cells under the same testing conditions. The aim is to provide the cell manufacturers and end users a tool to compare different designs and safety features.« less

Probable cause in helicopter emergency medical services crashes: what role does ownership play?

PubMed

Habib, Fahim A; Shatz, David; Habib, Aliya I; Bukur, Marko; Puente, Ivan; Catino, Joe; Farrington, Robyn

2014-12-01

The National Transportation Safety Board (NTSB) ranks helicopter emergency medical services (HEMS) as one of the most perilous occupations in the United States, with improvements in its safety of highest priority. As many injured patients are transported by helicopter, this is of particular concern to the trauma community. The use of HEMS is associated with a heightened degree of inherent risk. We hypothesized that this risk is not uniform and varies with the entity providing HEMS, specifically, commercial versus public safety providers. The NTSB accident database was queried to identify all HEMS-involved events for the 15-year period 1998 to 2012. The NTSB investigation report was reviewed to obtain crash details including probable cause. These were analyzed on the basis of HEMS ownership. Statistical analyses were performed using analysis of variance and Fisher's exact test as appropriate. During the study period, 139 (6.8%) of 2,040 crashes involved HEMS and occurred across 134 cities in 37 states, killing 120 and seriously injuring 146. Of these, 118 involved commercial, 14 not-for-profit, and 7 public safety HEMS. Analyzed in 5-year blocks, no decrease in crash incidence was seen (p = 0.7, analysis of variance). Human and pilot errors were significantly more common among commercial HEMS compared with public safety HEMS (91 of 118 vs. 2 of 7, p = 0.013, and 75 of 116 vs. 1 of 7, p = 0.017, Fisher's exact test). Conditions for which training was not adequate, limited resources, inadequate equipment, and the undertaking of suboptimal trips were identified as key factors. Trauma patients were involved in 34 transports (24.5%), with a fatal or serious outcome in 68 crew/patients on 12 flights. Potentially preventable human and pilot error-related HEMS crashes are significantly more frequent among commercial compared with public safety providers. Deficiencies in training, reduced availability of equipment and resources, as well as questionable flight selection seem to play a key role. Epidemiologic study, level III.

46 CFR 61.30-20 - Automatic control and safety tests.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 2 2012-10-01 2012-10-01 false Automatic control and safety tests. 61.30-20 Section 61.30-20 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC TESTS AND INSPECTIONS Tests and Inspections of Fired Thermal Fluid Heaters § 61.30-20 Automatic control and safety tests. Operational tests and check...

Hazardous material transportation safety and security field operational test final detailed test plans : executive summary

DOT National Transportation Integrated Search

2003-09-16

The objective of this Hazardous Material (HazMat) Transportation Safety and Security Field Operational Test (FOT) Final Detailed Test Plans evaluation is to measure the impact of technology solutions on the safety, security, and operational efficienc...

Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

PubMed

Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

2016-11-20

High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

Personal digital assistant-based drug information sources: potential to improve medication safety.

PubMed

Galt, Kimberly A; Rule, Ann M; Houghton, Bruce; Young, Daniel O; Remington, Gina

2005-04-01

This study compared the potential for personal digital assistant (PDA)-based drug information sources to minimize potential medication errors dependent on accurate and complete drug information at the point of care. A quality and safety framework for drug information resources was developed to evaluate 11 PDA-based drug information sources. Three drug information sources met the criteria of the framework: Eprocrates Rx Pro, Lexi-Drugs, and mobileMICROMEDEX. Medication error types related to drug information at the point of care were then determined. Forty-seven questions were developed to test the potential of the sources to prevent these error types. Pharmacists and physician experts from Creighton University created these questions based on the most common types of questions asked by primary care providers. Three physicians evaluated the drug information sources, rating the source for each question: 1=no information available, 2=some information available, or 3 = adequate amount of information available. The mean ratings for the drug information sources were: 2.0 (Eprocrates Rx Pro), 2.5 (Lexi-Drugs), and 2.03 (mobileMICROMEDEX). Lexi-Drugs was significantly better (mobileMICROMEDEX t test; P=0.05; Eprocrates Rx Pro t test; P=0.01). Lexi-Drugs was found to be the most specific and complete PDA resource available to optimize medication safety by reducing potential errors associated with drug information. No resource was sufficient to address the patient safety information needs for all cases.

Wake-Induced Aerodynamics on a Trailing Aircraft

NASA Technical Reports Server (NTRS)

Mendenhall, Michael R.; Lesieutre, Daniel J.; Kelly, Michael J.

2016-01-01

NASA conducted flight tests to measure the exhaust products from alternative fuels using a DC-8 transport aircraft and a Falcon business jet. An independent analysis of the maximum vortex-induced loads on the Falcon in the DC-8 wake was conducted for pre-flight safety analysis and to define safe trail distances for the flight tests. Static and dynamic vortex-induced aerodynamic loads on the Falcon were predicted at a matrix of locations aft of the DC-8 under flight-test conditions, and the maximum loads were compared with design limit loads to assess aircraft safety. Trajectory simulations for the Falcon during close encounters with the DC-8 wake were made to study the vortex-induced loads during traverses of the DC-8 primary trailing vortex. A parametric study of flight traverses through the trailing vortex was conducted to assess Falcon flight behavior and motion characteristics.

Toward a New Gold Standard for Early Safety: Automated Temperature-Controlled hERG Test on the PatchLiner®

PubMed Central

Polonchuk, Liudmila

2012-01-01

The Patchliner® temperature-controlled automated patch clamp system was evaluated for testing drug effects on potassium currents through human ether-à-go-go related gene (hERG) channels expressed in Chinese hamster ovary cells at 35–37°C. IC50 values for a set of reference drugs were compared with those obtained using the conventional voltage clamp technique. The results showed good correlation between the data obtained using automated and conventional electrophysiology. Based on these results, the Patchliner® represents an innovative automated electrophysiology platform for conducting the hERG assay that substantially increases throughput and has the advantage of operating at physiological temperature. It allows fast, accurate, and direct assessment of channel function to identify potential proarrhythmic side effects and sets a new standard in ion channel research for drug safety testing. PMID:22303293

Performance and safety testing of lithium batteries for the Expendable, Mobile, ASW Training Target (EMATT)

NASA Astrophysics Data System (ADS)

Hallal, P. B.; Bis, R. F.

1986-08-01

The developmental EMATT (expendable, mobile, ASW training target) may use a high-energy (lithium/sulfuryl chloride) battery system. Safety problems with the original battery cell design were experienced during early performance and safety testing. After redesign of the battery cell, performance and safety tests were made under specified abuse conditions, as well as under simulated launch conditions. The test results showed that the power system now meets all safety requirements, and that the EMATT vehicle is safe to deploy for its engineering development phase.

Unpacking the Barriers to Reproductive Health Services in Ghana: HIV/STI Testing, Abortion and Contraception.

PubMed

Thatte, Nandita; Bingenheimer, Jeffrey B; Ndiaye, Khadidiatou; Rimal, Rajiv N

2016-06-01

Youth report embarrassment, cost, and poor access as barriers to sexual and reproductive health (SRH) services. Interventions to address barriers like youth friendly services have yet to conclusively demonstrate impact on protective behaviours like condom or contraceptive use. SRH encompasses a range of services so we aimed to assess how perceived barriers differed depending on the service being sought between common services accessed by young people: HIV/STI testing, abortion, and contraception. 1203 Ghanaian youth were interviewed. Data was analysed to identify barriers by service type, demographics, and between high and low HIV prevalence communities. Being embarrassed or shy was the most commonly reported barrier across services. Overall being embarrassed or shy, fear of safety, fear of family finding out and cost were the most reported barriers across all services. Further analysis by service indicated that being embarrassed was a significantly greater barrier for HIV/STI testing and contraception when compared with abortion (p<0.001) and safety concerns and cost were significantly greater barriers for abortion and contraception compared with HIV/STI testing (p<0.001). Efforts to develop interventions that consider the service being sought may help address the range of barriers faced by youth with diverse SRH needs.

75 FR 41531 - Brookwood-Sago Mine Safety Grants

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-16

... stated goals and current reporting period. objectives for improving safety. Conduct and report pre-test and post- test results of trainees. Course evaluations of trainer and training materials. The extent... pre-test and post- and improves safety. educational materials test results of the training materials...

Joint Ordnance Test Procedure (JOTP)-010 Safety and Suitability for Service Assessment Testing for Shoulder Launched Munitions

DTIC Science & Technology

2016-05-09

electromagnetic environment for which they are designed to be used. These tests are performed on a powered weapon during simulated normal operation and are...010B SAFETY AND SUITABILITY FOR SERVICE ASSESSMENT TESTING FOR SHOULDER LAUNCHED MUNITIONS Joint Services Munition Safety Test Working Group JOTP...12 6.8 Test Sample Quantities .......................................................... 13 7. PRE- AND POST - TEST INSPECTIONS

Characterization of nanomaterial test solutions for terrestrial plant dose-response studies: A comparative study of DLS and SAXS

EPA Science Inventory

Industrial applications of nanomaterials have expanded at an increasing rate in recent years, accompanied by the need for comprehensive toxicological assessments to establish environmental health and safety standards. Relatively few studies have examined the effects of nanoparti...

Simulation-Based Testing of Pager Interruptions During Laparoscopic Cholecystectomy.

PubMed

Sujka, Joseph A; Safcsak, Karen; Bhullar, Indermeet S; Havron, William S

2018-01-30

To determine if pager interruptions affect operative time, safety, or complications and management of pager issues during a simulated laparoscopic cholecystectomy. Twelve surgery resident volunteers were tested on a Simbionix Lap Mentor II simulator. Each resident performed 6 randomized simulated laparoscopic cholecystectomies; 3 with pager interruptions (INT) and 3 without pager interruptions (NO-INT). The pager interruptions were sent in the form of standardized patient vignettes and timed to distract the resident during dissection of the critical view of safety and clipping of the cystic duct. The residents were graded on a pass/fail scale for eliciting appropriate patient history and management of the pager issue. Data was extracted from the simulator for the following endpoints: operative time, safety metrics, and incidence of operative complications. The Mann-Whitney U test and contingency table analysis were used to compare the 2 groups (INT vs. NO-INT). Level I trauma center; Simulation laboratory. Twelve general surgery residents. There was no significant difference between the 2 groups in any of the operative endpoints as measured by the simulator. However, in the INT group, only 25% of the time did the surgery residents both adequately address the issue and provide effective patient management in response to the pager interruption. Pager interruptions did not affect operative time, safety, or complications during the simulated procedure. However, there were significant failures in the appropriate evaluations and management of pager issues. Consideration for diversion of patient care issues to fellow residents not operating to improve quality and safety of patient care outside the operating room requires further study. Copyright © 2018. Published by Elsevier Inc.

Using health-system-wide data to understand hepatitis B virus prophylaxis and reactivation outcomes in patients receiving rituximab.

PubMed

Schmajuk, Gabriela; Tonner, Chris; Trupin, Laura; Li, Jing; Sarkar, Urmimala; Ludwig, Dana; Shiboski, Stephen; Sirota, Marina; Dudley, R Adams; Murray, Sara; Yazdany, Jinoos

2017-03-01

Hepatitis B virus (HBV) reactivation in the setting of rituximab use is a potentially fatal but preventable safety event. The rate of HBV screening and proportion of patients at risk who receive antiviral prophylaxis in patients initiating rituximab is unknown.We analyzed electronic health record (EHR) data from 2 health systems, a university center and a safety net health system, including diagnosis grouper codes, problem lists, medications, laboratory results, procedures codes, clinical encounter notes, and scanned documents. We identified all patients who received rituximab between 6/1/2012 and 1/1/2016. We calculated the proportion of rituximab users with inadequate screening for HBV according to the Centers for Disease Control guidelines for detecting latent HBV infection before their first rituximab infusion during the study period. We also assessed the proportion of patients with positive hepatitis B screening tests who were prescribed antiviral prophylaxis. Finally, we characterized safety failures and adverse events.We included 926 patients from the university and 132 patients from the safety net health system. Sixty-one percent of patients from the university had adequate screening for HBV compared with 90% from the safety net. Among patients at risk for reactivation based on results of HBV testing, 66% and 92% received antiviral prophylaxis at the university and safety net, respectively.We found wide variations in hepatitis B screening practices among patients receiving rituximab, resulting in unnecessary risks to patients. Interventions should be developed to improve patient safety procedures in this high-risk patient population.

Establishment of an equivalence acceptance criterion for accelerated stability studies.

PubMed

Burdick, Richard K; Sidor, Leslie

2013-01-01

In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. The objective of such a study is to demonstrate comparability by showing that the stability profiles under nonrecommended storage conditions of two processes are equivalent. Because it is difficult at accelerated conditions to find a direct link to product specifications, and hence product safety and efficacy, an equivalence acceptance criterion is proposed that is based on the statistical concept of effect size. As with all statistical tests of equivalence, it is important to collect input from appropriate subject-matter experts when defining the acceptance criterion.

Application of Poisson random effect models for highway network screening.

PubMed

Jiang, Ximiao; Abdel-Aty, Mohamed; Alamili, Samer

2014-02-01

In recent years, Bayesian random effect models that account for the temporal and spatial correlations of crash data became popular in traffic safety research. This study employs random effect Poisson Log-Normal models for crash risk hotspot identification. Both the temporal and spatial correlations of crash data were considered. Potential for Safety Improvement (PSI) were adopted as a measure of the crash risk. Using the fatal and injury crashes that occurred on urban 4-lane divided arterials from 2006 to 2009 in the Central Florida area, the random effect approaches were compared to the traditional Empirical Bayesian (EB) method and the conventional Bayesian Poisson Log-Normal model. A series of method examination tests were conducted to evaluate the performance of different approaches. These tests include the previously developed site consistence test, method consistence test, total rank difference test, and the modified total score test, as well as the newly proposed total safety performance measure difference test. Results show that the Bayesian Poisson model accounting for both temporal and spatial random effects (PTSRE) outperforms the model that with only temporal random effect, and both are superior to the conventional Poisson Log-Normal model (PLN) and the EB model in the fitting of crash data. Additionally, the method evaluation tests indicate that the PTSRE model is significantly superior to the PLN model and the EB model in consistently identifying hotspots during successive time periods. The results suggest that the PTSRE model is a superior alternative for road site crash risk hotspot identification. Copyright © 2013 Elsevier Ltd. All rights reserved.

The safety of the H1N1 influenza A vaccine in egg allergic individuals.

PubMed

Greenhawt, Matthew J; Chernin, Anna S; Howe, Laura; Li, James T; Sanders, Georgiana

2010-11-01

The safety of H1N1 vaccine is unknown in egg allergic (EA) recipients. To establish the safety of administering H1N1 vaccine and to evaluate the predictability of H1N1 skin testing in EA patients. In a controlled, prospective trial, H1N1 skin testing and vaccination was compared between EA patients (n = 105) and non-EA controls (n = 19). Those with negative H1N1 skin test results received a full H1N1 dose; those with a positive skin test result received a graded challenge (10%, 90%). Booster vaccine, if required, was given as a single dose from a different lot without prior testing. Prick and intradermal test results were positive in 3 (2.4%) of 124 and 41 (33.1%) of 124 study participants, respectively. Forty-one individuals received a 2-step graded vaccine challenge, including 13 of 25 with a history of egg anaphylaxis. No significant allergic reactions resulted from either method of vaccination or from subsequent booster doses. All study participants received the H1N1 vaccine without significant allergic reactions. Skin testing is unnecessary and does not predict vaccine tolerance. All study participants who received a graded challenge tolerated a single dose booster from a different, untested lot, including 7 individuals with a history of egg-induced anaphylaxis. We recommend administration of H1N1 vaccine to EA children without prior skin testing or graded challenge dosing. Copyright © 2010 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

16 CFR 1203.9 - Test headforms.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Test headforms. 1203.9 Section 1203.9 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS The Standard § 1203.9 Test headforms. The headforms used for testing shall be...

Comparison of the efficacy and safety profile of morning administration of controlled-release simvastatin versus evening administration of immediate-release simvastatin in chronic kidney disease patients with dyslipidemia.

PubMed

Yi, Yong Jin; Kim, Hyo Jin; Jo, Sang Kyung; Kim, Sung Gyun; Song, Young Rim; Chung, Wookyung; Han, Kum Hyun; Lee, Chang Hwa; Hwang, Young-Hwan; Oh, Kook-Hwan

2014-08-01

Evening administration of the conventional immediate-release (IR) formulation of simvastatin is recommended because of its short half-life (1.9 hours). In a healthy population, morning administration of a controlled-release (CR) formulation of simvastatin was shown to have equivalent lipid-lowering efficacy and a safety profile similar to that of evening doses of IR simvastatin. The present study aimed to verify noninferiority and to compare the safety of morning administration of CR simvastatin with that of evening administration of IR simvastatin in patients with chronic kidney disease (CKD) who have dyslipidemia. The present study was a prospective, multicenter, double-blind, Phase IV trial with an active comparator. We randomly assigned 122 patients with CKD and dyslipidemia to 1 of 2 drug administration groups: morning administration of CR simvastatin 20 mg (test group) and evening administration of IR simvastatin 20 mg (control group). After 8 weeks, the treatment outcomes and adverse effects of the 2 treatments were compared. The mean (SD) percentage of change in serum LDL-C at the end of treatment was -35.1% (15.7%) for the test group and -35.6% (14.6%) for the control group. The difference between the 2 groups was not significant (P = 0.858). The 95% CI of the difference in the percentage of change of LDL-C between the test and control groups was -6.0 to 5.0. There was no difference in the percentage of change of total cholesterol (-24.3% [12.5%] vs -26.5% [12.0%], P = 0.317), triglyceride (-10.6% [35.1%] vs -12.4% [33.2%], P = 0.575) and HDL-C (10.2% [20.7%] vs 4.5% [11.4%], P = 0.064). Treatment-related adverse events were similar in both groups (10 events in the test group vs 8 events in the control group, P = 0.691). The efficacy of morning administration of CR simvastatin was noninferior to evening administration of IR simvastatin in patients with CKD. Furthermore, the safety profile analysis showed no significant difference between the 2 treatments. Morning administration of CR simvastatin is expected to increase patient compliance and therefore better control of dyslipidemia in CKD patients. Copyright © 2014 The Authors. Published by EM Inc USA.. All rights reserved.

Social media for arthritis-related comparative effectiveness and safety research and the impact of direct-to-consumer advertising.

PubMed

Curtis, Jeffrey R; Chen, Lang; Higginbotham, Phillip; Nowell, W Benjamin; Gal-Levy, Ronit; Willig, James; Safford, Monika; Coe, Joseph; O'Hara, Kaitlin; Sa'adon, Roee

2017-03-07

Social media may complement traditional data sources to answer comparative effectiveness/safety questions after medication licensure. The Treato platform was used to analyze all publicly available social media data including Facebook, blogs, and discussion boards for posts mentioning inflammatory arthritis (e.g. rheumatoid, psoriatic). Safety events were self-reported by patients and mapped to medical ontologies, resolving synonyms. Disease and symptom-related treatment indications were manually redacted. The units of analysis were unique terms in posts. Pre-specified conditions (e.g. herpes zoster (HZ)) were selected based upon safety signals from clinical trials and reported as pairwise odds ratios (ORs); drugs were compared with Fisher's exact test. Empirically identified events were analyzed using disproportionality analysis and reported as relative reporting ratios (RRRs). The accuracy of a natural language processing (NLP) classifier to identify cases of shingles associated with arthritis medications was assessed. As of October 2015, there were 785,656 arthritis-related posts. Posts were predominantly US posts (75%) from patient authors (87%) under 40 years of age (61%). For HZ posts (n = 1815), ORs were significantly increased with tofacitinib versus other rheumatoid arthritis therapies. ORs for mentions of perforated bowel (n = 13) were higher with tocilizumab versus other therapies. RRRs associated with tofacitinib were highest in conditions related to baldness and hair regrowth, infections and cancer. The NLP classifier had a positive predictive value of 91% to identify HZ. There was a threefold increase in posts following television direct-to-consumer advertisement (p = 0.04); posts expressing medication safety concerns were significantly more frequent than favorable posts. Social media is a challenging yet promising data source that may complement traditional approaches for comparative effectiveness research for new medications.

Naturalistic distraction and driving safety in older drivers

PubMed Central

Aksan, Nazan; Dawson, Jeffrey D.; Emerson, Jamie L.; Yu, Lixi; Uc, Ergun Y.; Anderson, Steven W.; Rizzo, Matthew

2013-01-01

Objective This study aimed to quantify and compare performance of middle-aged and older drivers during a naturalistic distraction paradigm (visual search for roadside targets) and predict older driver performance given functioning in visual, motor, and cognitive domains. Background Distracted driving can imperil healthy adults and may disproportionally affect the safety of older drivers with visual, motor, and cognitive decline. Methods Two hundred and three drivers, 120 healthy older (61 men and 59 women, ages 65 years or greater) and 83 middle-aged drivers (38 men and 45 women, ages 40–64 years), participated in an on-road test in an instrumented vehicle. Outcome measures included performance in roadside target identification (traffic signs and restaurants) and concurrent driver safety. Differences in visual, motor, and cognitive functioning served as predictors. Results Older drivers identified fewer landmarks and drove slower but committed more safety errors than middle-aged drivers. Greater familiarity with local roads benefited performance of middle-aged but not older drivers. Visual cognition predicted both traffic sign identification and safety errors while executive function predicted traffic sign identification over and above vision. Conclusion Older adults are susceptible to driving safety errors while distracted by common secondary visual search tasks that are inherent to driving. The findings underscore that age-related cognitive decline affects older driver management of driving tasks at multiple levels, and can help inform the design of on-road tests and interventions for older drivers. PMID:23964422

Evaluating the Cardiovascular Safety of Nonsteroidal Anti-Inflammatory Drugs.

PubMed

Antman, Elliott M

2017-05-23

Some drugs used to treat noncardiovascular conditions may adversely impact the cardiovascular status of individuals both with and without known cardiovascular disease. When the US Food and Drug Administration judges the potential cardiovascular safety signal to be of sufficient concern, it may require the pharmaceutical manufacturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT). Although historically many phase 4 RCTs focused on efficacy (using a superiority design), contemporary phase 4 RCTs often are focused on safety and use a noninferiority design. The choices made by investigators during the planning stage of a postmarketing phase 4 RCT dedicated to the evaluation of cardiovascular safety can influence the ability to compare the standard and test agents. Multiple factors reflecting the conduct of a phase 4 RCT for a general medical condition may influence interpretation of a cardiovascular safety signal. The higher the rates of failure to adhere to the protocol and dropout from the study, the greater the risk of bias. Trials evaluating the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs) when used for arthritis are difficult to conduct and even more challenging to interpret. Concerns include the comparison of drug regimens that do not provide comparable analgesic efficacy and problems with adherence to the protocol and retention in the study. On the basis of phase 4 RCTs of NSAIDs to date, it appears that a comparatively low dose of celecoxib administered to low-risk subjects is associated with approximately the same cardiovascular risk as NSAIDs with less cyclooxygenase-2 inhibitory activity, but at the cost of not controlling arthritic pain as effectively. © 2017 American Heart Association, Inc.

The Spacecraft Fire Experiment (Saffire) - Objectives, Development and Status

NASA Technical Reports Server (NTRS)

Schoren, William; Ruff, Gary A.; Urban, David L.

2016-01-01

Since 2012, the Spacecraft Fire Experiment (Saffire) has been under development by the Spacecraft Fire Safety Demonstration (SFS Demo) project that is funded by NASA's Advanced Exploration Systems Division in the Human Exploration and Operations Mission Directorate. The overall objective of this project is to reduce the uncertainty and risk associated with the design of spacecraft fire safety systems for NASA's exploration missions. This is accomplished by defining, developing, and conducting experiments that address gaps in spacecraft fire safety knowledge and capabilities identified by NASA's Fire Safety System Maturation Team. This paper describes the three Spacecraft Fire Experiments (Saffire-I, -II, and -III) that were developed at NASA-GRC and that will conduct a series of material flammability tests in low-gravity and at length scales that are realistic for a spacecraft fire. The experiments will be conducted in Orbital ATK's Cygnus vehicle after it has unberthed from the International Space Station. The tests will be fully automated with the data downlinked at the conclusion of the test and before the Cygnus vehicle reenters the atmosphere. The objectives of these experiments are to (1) determine how rapidly a large scale fire grows in low-gravity and (2) investigate the low-g flammability limits compared to those obtained in NASA's normal gravity material flammability screening test. The hardware for these experiments has been completed and is awaiting their respective launches, all planned for 2016. This paper will review the objectives of these experiments and how they address several of the knowledge gaps for NASA's exploration missions. The hardware development will be discussed including several novel approaches that were taken for testing and evaluation of these series payloads. The status of the missions and operational status will also be presented.

The impacts of using community health volunteers to coach medication safety behaviors among rural elders with chronic illnesses.

PubMed

Wang, Chi-Jane; Fetzer, Susan J; Yang, Yi-Ching; Wang, Jing-Jy

2013-01-01

It is a challenge for rural health professionals to promote medication safety among older adults taking multiple medications. A volunteer coaching program to promote medication safety among rural elders with chronic illnesses was designed and evaluated. A community-based interventional study randomly assigned 62 rural elders with at least two chronic illnesses to routine care plus volunteer coaching or routine care alone. The volunteer coaching group received a medication safety program, including a coach and reminders by well-trained volunteers, as well as three home visits and five telephone calls over a two-month period. All the subjects received routine medication safety instructions for their chronic illnesses. The program was evaluated using pre- and post-tests of knowledge, attitude and behaviors with regard to medication safety. Results show the volunteer coaching group improved their knowledge of medication safety, but there was no change in attitude after the two-month study period. Moreover, the group demonstrated three improved medication safety behaviors compared to the routine care group. The volunteer coaching program and instructions with pictorial aids can provide a reference for community health professionals who wish to improve the medication safety of chronically ill elders. Copyright © 2013 Mosby, Inc. All rights reserved.

Investigative safety science as a competitive advantage for Pharma.

PubMed

Moggs, Jonathan; Moulin, Pierre; Pognan, Francois; Brees, Dominique; Leonard, Michele; Busch, Steve; Cordier, Andre; Heard, David J; Kammüller, Michael; Merz, Michael; Bouchard, Page; Chibout, Salah-Dine

2012-09-01

Following a US National Academy of Sciences report in 2007 entitled "Toxicity Testing of the 21st Century: a Vision and a Strategy," significant advances within translational drug safety sciences promise to revolutionize drug discovery and development. The purpose of this review is to outline why investigative safety science is a competitive advantage for the pharmaceutical industry. The article discusses the essential goals for modern investigative toxicologists including: cross-species target biology; molecular pathways of toxicity; and development of predictive tools, models and biomarkers that allow discovery researchers and clinicians to anticipate safety problems and plan ways to address them, earlier than ever before. Furthermore, the article emphasizes the importance of investigating unanticipated clinical safety signals through a combination of mechanistic preclinical studies and/or molecular characterization of clinical samples from affected organs. The traditional boundaries between pharma industry teams focusing on safety/efficacy and preclinical/clinical development are rapidly disappearing in favor of translational safety science-centric organizations with a vision of bringing more effective medicines forward safely and quickly. Comparative biology and mechanistic toxicology approaches facilitate: i) identifying translational safety biomarkers; ii) identifying new drug targets/indications; and iii) mitigating off-target toxicities. These value-adding safety science contributions will change traditional toxicologists from side-effect identifiers to drug development enablers.

Testing of Hand-Held Mine Detection Systems

DTIC Science & Technology

2015-01-08

ITOP 04-2-5208 for guidance on software testing . Testing software is necessary to ensure that safety is designed into the software algorithm, and that...sensor verification areas or target lanes. F.2. TESTING OBJECTIVES. a. Testing objectives will impact on the test design . Some examples of...overall safety, performance, and reliability of the system. It describes activities necessary to ensure safety is designed into the system under test

46 CFR 61.40-6 - Periodic safety tests.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 2 2012-10-01 2012-10-01 false Periodic safety tests. 61.40-6 Section 61.40-6 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC TESTS AND INSPECTIONS Design Verification and Periodic Testing of Vital System Automation § 61.40-6 Periodic safety...

46 CFR 61.40-6 - Periodic safety tests.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 2 2013-10-01 2013-10-01 false Periodic safety tests. 61.40-6 Section 61.40-6 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC TESTS AND INSPECTIONS Design Verification and Periodic Testing of Vital System Automation § 61.40-6 Periodic safety...

46 CFR 61.40-6 - Periodic safety tests.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Periodic safety tests. 61.40-6 Section 61.40-6 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC TESTS AND INSPECTIONS Design Verification and Periodic Testing of Vital System Automation § 61.40-6 Periodic safety...

46 CFR 61.40-6 - Periodic safety tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 2 2014-10-01 2014-10-01 false Periodic safety tests. 61.40-6 Section 61.40-6 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC TESTS AND INSPECTIONS Design Verification and Periodic Testing of Vital System Automation § 61.40-6 Periodic safety...

9 CFR 113.39 - Cat safety tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Cat safety tests. 113.39 Section 113.39 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... Seed Virus is tested for safety. (1) The test animals shall be determined to be susceptible to the...

46 CFR 61.40-6 - Periodic safety tests.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Periodic safety tests. 61.40-6 Section 61.40-6 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING PERIODIC TESTS AND INSPECTIONS Design Verification and Periodic Testing of Vital System Automation § 61.40-6 Periodic safety...

Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.

PubMed

2008-03-01

In this report the various elements of the safety and nutritional assessment procedure for genetically modified (GM) plant derived food and feed are discussed, in particular the potential and limitations of animal feeding trials for the safety and nutritional testing of whole GM food and feed. The general principles for the risk assessment of GM plants and derived food and feed are followed, as described in the EFSA guidance document of the EFSA Scientific Panel on Genetically Modified Organisms. In Section 1 the mandate, scope and general principles for risk assessment of GM plant derived food and feed are discussed. Products under consideration are food and feed derived from GM plants, such as maize, soybeans, oilseed rape and cotton, modified through the introduction of one or more genes coding for agronomic input traits like herbicide tolerance and/or insect resistance. Furthermore GM plant derived food and feed, which have been obtained through extensive genetic modifications targeted at specific alterations of metabolic pathways leading to improved nutritional and/or health characteristics, such as rice containing beta-carotene, soybeans with enhanced oleic acid content, or tomato with increased concentration of flavonoids, are considered. The safety assessment of GM plants and derived food and feed follows a comparative approach, i.e. the food and feed are compared with their non-GM counterparts in order to identify intended and unintended (unexpected) differences which subsequently are assessed with respect to their potential impact on the environment, safety for humans and animals, and nutritional quality. Key elements of the assessment procedure are the molecular, compositional, phenotypic and agronomic analysis in order to identify similarities and differences between the GM plant and its near isogenic counterpart. The safety assessment is focussed on (i) the presence and characteristics of newly expressed proteins and other new constituents and possible changes in the level of natural constituents beyond normal variation, and on the characteristics of the GM food and feed, and (ii) the possible occurrence of unintended (unexpected) effects in GM plants due to genetic modification. In order to identify these effects a comparative phenotypic and molecular analysis of the GM plant and its near isogenic counterpart is carried out, in parallel with a targeted analysis of single specific compounds, which represent important metabolic pathways in the plant like macro and micro nutrients, known anti-nutrients and toxins. Significant differences may be indicative of the occurrence of unintended effects, which require further investigation. Section 2 provides an overview of studies performed for the safety and nutritional assessment of whole food and feed. Extensive experience has been built up in recent decades from the safety and nutritional testing in animals of irradiated foods, novel foods and fruit and vegetables. These approaches are also relevant for the safety and nutritional testing of whole GM food and feed. Many feeding trials have been reported in which GM foods like maize, potatoes, rice, soybeans and tomatoes have been fed to rats or mice for prolonged periods, and parameters such as body weight, feed consumption, blood chemistry, organ weights, histopathology etc have been measured. The food and feed under investigation were derived from GM plants with improved agronomic characteristics like herbicide tolerance and/or insect resistance. The majority of these experiments did not indicate clinical effects or histopathological abnormalities in organs or tissues of exposed animals. In some cases adverse effects were noted, which were difficult to interpret due to shortcomings in the studies. Many studies have also been carried out with feed derived from GM plants with agronomic input traits in target animal species to assess the nutritive value of the feed and their performance potential. Studies in sheep, pigs, broilers, lactating dairy cows, and fish, comparing the in vivo bioavailability of nutrients from a range of GM plants with their near isogenic counterpart and commercial varieties, showed that they were comparable with those for near isogenic non-GM lines and commercial varieties. In Section 3 toxicological in vivo, in silico, and in vitro test methods are discussed which may be applied for the safety and nutritional assessment of specific compounds present in food and feed or of whole food and feed derived from GM plants. Moreover the purpose, potential and limitations of the 90-day rodent feeding trial for the safety and nutritional testing of whole food and feed have been examined. Methods for single and repeated dose toxicity testing, reproductive and developmental toxicity testing and immunotoxicity testing, as described in OECD guideline tests for single well-defined chemicals are discussed and considered to be adequate for the safety testing of single substances including new products in GM food and feed. Various in silico and in vitro methods may contribute to the safety assessment of GM plant derived food and feed and components thereof, like (i) in silico searches for sequence homology and/or structural similarity of novel proteins or their degradation products to known toxic or allergenic proteins, (ii) simulated gastric and intestinal fluids in order to study the digestive stability of newly expressed proteins and in vitro systems for analysis of the stability of the novel protein under heat or other processing conditions, and (iii) in vitro genotoxicity test methods that screen for point mutations, chromosomal aberrations and DNA damage/repair. The current performance of the safety assessment of whole foods is mainly based on the protocols for low-molecular-weight chemicals such as pharmaceuticals, industrial chemicals, pesticides, food additives and contaminants. However without adaptation, these protocols have limitations for testing of whole food and feed. This primarily results from the fact that defined single substances can be dosed to laboratory animals at very large multiples of the expected human exposure, thus giving a large margin of safety. In contrast foodstuffs are bulky, lead to satiation and can only be included in the diet at much lower multiples of expected human intakes. When testing whole foods, the possible highest concentration of the GM food and feed in the laboratory animal diet may be limited because of nutritional imbalance of the diet, or by the presence of compounds with a known toxicological profile. The aim of the 90-days rodent feeding study with the whole GM food and feed is to assess potential unintended effects of toxicological and/or nutritional relevance and to establish whether the GM food and feed is as safe and nutritious as its traditional comparator rather than determining qualitative and quantitative intrinsic toxicity of defined food constituents. The design of the study should be adapted from the OECD 90-day rodent toxicity study. The precise study design has to take into account the nature of the food and feed and the characteristics of the new trait(s) and their intended role in the GM food and feed. A 90-day animal feeding trial has a large capacity (sensitivity and specificity) to detect potential toxicological effects of single well defined compounds. This can be concluded from data reported on the toxicology of a wide range of industrial chemicals, pharmaceuticals, food substances, environmental, and agricultural chemicals. It is possible to model the sensitivity of the rat subchronic feeding study for the detection of hypothetically increased amount of compounds such as anti-nutrients, toxicants or secondary metabolites. With respect to the detection of potential unintended effects in whole GM food and feed, it is unlikely that substances present in small amounts and with a low toxic potential will result in any observable (unintended) effects in a 90-day rodent feeding study, as they would be below the no-observed-effect-level and thus of unlikely impact to human health at normal intake levels. Laboratory animal feeding studies of 90-days duration appear to be sufficient to pick up adverse effects of diverse compounds that would also give adverse effects after chronic exposure. This conclusion is based on literature data from studies investigating whether toxicological effects are adequately identified in 3-month subchronic studies in rodents, by comparing findings at 3 and 24 months for a range of different chemicals. The 90-day rodent feeding study is not designed to detect effects on reproduction or development other than effects on adult reproductive organ weights and histopathology. Analyses of available data indicate that, for a wide range of substances, reproductive and developmental effects are not potentially more sensitive endpoints than those examined in subchronic toxicity tests. Should there be structural alerts for reproductive/developmental effects or other indications from data available on a GM food and feed, then these tests should be considered. By relating the estimated daily intake, or theoretical maximum daily intake per capita for a given whole food (or the sum of its individual commercial constituents) to that consumed on average per rat per day in the subchronic 90-day feeding study, it is possible to establish the margin of exposure (safety margin) for consumers. Results obtained from testing GM food and feed in rodents indicate that large (at least 100-fold) 'safety' margins exist between animal exposure levels without observed adverse effects and estimated human daily intake. Results of feeding studies with feed derived from GM plants with improved agronomic properties, carried out in a wide range of livestock species, are discussed. The studies did not show any biologically relevant differences in the parameters tested between control and test animals. (ABSTRACT TRUNCATED)

Role of mixed ion channel effects in the cardiovascular safety assessment of the novel anti-MRSA fluoroquinolone JNJ-Q2.

PubMed

Eichenbaum, G; Pugsley, M K; Gallacher, D J; Towart, R; McIntyre, G; Shukla, U; Davenport, J M; Lu, H R; Rohrbacher, J; Hillsamer, V

2012-07-01

JNJ-Q2, a novel broad-spectrum fluoroquinolone with anti-methicillin-resistant Staphylococcus aureus activity, was evaluated in a comprehensive set of non-clinical and clinical cardiovascular safety studies. The effect of JNJ-Q2 on different cardiovascular parameters was compared with that of moxifloxacin, sparfloxacin and ofloxacin. Through comparisons with these well-known fluoroquinolones, the importance of effects on compensatory ion channels to the cardiovascular safety of JNJ-Q2 was investigated. JNJ-Q2 and comparator fluoroquinolones were evaluated in the following models/test systems: hERG-transfected HEK293 cells sodium channel-transfected CHO cells, guinea pig right atria, arterially perfused rabbit left ventricular wedge preparations and in vivo studies in anaesthetized guinea pigs, anaesthetized and conscious telemetered dogs, and a thorough QT study in humans. The trend for effects of JNJ-Q2 on Tp-Te, QT, QRS and PR intervals in the non-clinical models and the plateau in QTc with increasing plasma concentration in humans are consistent with offsetting sodium and calcium channel activities that were observed in the non-clinical studies. These mixed ion channel activities result in the less pronounced or comparable increase in QTc interval for JNJ-Q2 compared with moxifloxacin and sparfloxacin despite its greater in vitro inhibition of I(Kr). Based on the non-clinical and clinical cardiovascular safety assessment, JNJ-Q2 has a safe cardiovascular profile for administration in humans with comparable or reduced potential to prolong QT intervals, compared with moxifloxacin. The results demonstrate the importance of compensatory sodium and calcium channel activity in offsetting potassium channel activity for compounds with a fluoroquinolone core. © 2012 Janssen Pharmaceutical Companies of Johnson & Johnson. British Journal of Pharmacology © 2012 The British Pharmacological Society.

Validation of a pre-existing safety climate scale for the Turkish furniture manufacturing industry.

PubMed

Akyuz, Kadri Cemil; Yildirim, Ibrahim; Gungor, Celal

2018-03-22

Understanding the safety climate level is essential to implement a proactive safety program. The objective of this study is to explore the possibility of having a safety climate scale for the Turkish furniture manufacturing industry since there has not been any scale available. The questionnaire recruited 783 subjects. Confirmatory factor analysis (CFA) tested a pre-existing safety scale's fit to the industry. The CFA indicated that the structures of the model present a non-satisfactory fit with the data (χ 2  = 2033.4, df = 314, p ≤ 0.001; root mean square error of approximation = 0.08, normed fit index = 0.65, Tucker-Lewis index = 0.65, comparative fit index = 0.69, parsimony goodness-of-fit index = 0.68). The results suggest that a new scale should be developed and validated to measure the safety climate level in the Turkish furniture manufacturing industry. Due to the hierarchical structure of organizations, future studies should consider a multilevel approach in their exploratory factor analyses while developing a new scale.

Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.

PubMed

Moore, Thomas J; Furberg, Curt D

2014-01-01

The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect. Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources. Comparison of drugs that received standard review and those deemed sufficiently innovative to receive expedited review with regard to clinical development and FDA review time, the size and duration of efficacy trials, safety issues, and postmarket follow-up. In 2008, the FDA approved 20 therapeutic drugs, 8 with expedited review and 12 with standard review. The expedited drugs took a median of 5.1 years (range, 1.6-10.6 years) of clinical development to obtain marketing approval compared with 7.5 years (range, 4.7-19.4 years) for the standard review drugs (P = .05). The expedited drugs were tested for efficacy in a median of 104 patients receiving the active drug (range, 23-599), compared with a median of 580 patients (range, 75-1207) for standard review drugs (P = .003). Nonclinical testing showed that 6 therapeutic drugs were animal carcinogens, 5 were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in 5 Boxed Warnings; 8 drugs required risk management plans. The FDA required 85 postmarket commitments. By 2013, 5 drugs acquired a new or expanded Boxed Warning; 26 of 85 (31%) of the postmarketing study commitments had been fulfilled, and 8 (9%) had been submitted for agency review. For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.

Comparing Different Suicide Prevention Measures at Bridges and Buildings: Lessons We Have Learned from a National Survey in Switzerland

PubMed Central

Hemmer, Alexander; Meier, Philipp; Reisch, Thomas

2017-01-01

The goal of the study was to compare the effectiveness of different suicide prevention measures implemented on bridges and other high structures in Switzerland. A national survey identified all jumping hotspots that have been secured in Switzerland; of the 15 that could be included in this study, 11 were secured by vertical barriers and 4 were secured by low-hanging horizontal safety nets. The study made an overall and individual pre-post analysis by using Mantel-Haenszel Tests, regression methods and calculating rate ratios. Barriers and safety nets were both effective, with mean suicide reduction of 68.7% (barriers) and 77.1% (safety nets), respectively. Measures that do not secure the whole hotspot and still allow jumps of 15 meters or more were less effective. Further, the analyses revealed that barriers of at least 2.3 m in height and safety-nets fixed significantly below pedestrian level deterred suicidal jumps. Secured bridgeheads and inbound angle barriers seemed to enhance the effectiveness of the measure. Findings can help to plan and improve the effectiveness of future suicide prevention measures on high structures. PMID:28060950

Rain Simulation for the Test of Automotive Surround Sensors

NASA Astrophysics Data System (ADS)

Hasirlioglu, Sinan; Riener, Andreas; Doric, Igor

2017-04-01

The WHO Global Health Observatory data indicates that over 1.25 million people die in traffic accidents annually. To save lives, car manufacturers spend lot of efforts on the development of novel safety systems aiming to avoid or mitigate accidents and provide maximum protection for vehicle occupants as well as vulnerable road users. All the safety features mainly rely on data from surround sensors such as radar, lidar and camera and intelligent vehicles today use these environmental data for instant decision making and vehicle control. As already small errors in sensor data measurements could lead to catastrophes like major injuries or road traffic fatalities, it is of utmost importance to ensure high reliability and accuracy of sensors and safety systems. This work focuses on the influence of environmental factors such as rain conditions, as it is known that rain drops scatter the electromagnetic waves. The result is incorrect measurements with a direct negative impact on environment detection. To identify potential problems of sensors under varying environmental conditions, systems are today tested in real-world settings with two main problems: First, tests are time-consuming and second, environmental conditions are not reproducible. Our approach to test the influence of weather on automotive sensors is to use an indoor rain simulator. Our artificial rain maker, installed at CARISSMA (Center of Automotive Research on Integrated Safety Systems and Measurement Area), is parametrized with rain characteristics measured in the field using a standard disdrometer. System behavior on artificial rain is compared and validated with natural rainfall. With this simulator it is finally possible to test environmental influence at various levels and under reproducible conditions. This saves lot of efforts required for the test process itself and furthermore has a positive impact on the reliability of sensor systems due to the fact that test driven development is enabled.

[Analysis on the antimicrobial resistance of lactic acid bacteria isolated from the yogurt sold in China].

PubMed

Fan, Qin; Liu, Shuliang; Li, Juan; Huang, Tingting

2012-05-01

To analyze the antimicrobial susceptibility of lactic acid bacteria (LAB) from yogurt, and to provide references for evaluating the safety of LAB and screening safe strains. The sensitivity of 43 LAB strains, including 14 strains of Streptococcus thermophilus, 12 strains of Lactobacillus acidophilus, 9 strains of Lactobacillus bulgaricus and 8 strains of Bifidobacterium, to 22 antibiotics were tested by agar plate dilution method. All 43 LAB strains were resistant to trimethoprim, nalidixic acid, ciprofloxacin, lomefloxacin, danofloxacin and polymyxin E. Their resistances to kanamycin, tetracycline, clindamycin, doxycycline and cephalothin were varied. The sensitivity to other antibiotics were sensitive or moderate. All isolates were multidrug-resistant. The antimicrobial resistance of tested LAB strains was comparatively serious, and continuously monitoring their antimicrobial resistance and evaluating their safety should be strengthened.

Pharmacokinetics and pharmacodynamics of SCT800, a new recombinant FVIII, in hemophilia A mice

PubMed Central

Gu, Ruo-lan; Liu, Liang; Xie, Liang-zhi; Gai, Wen-lin; Cao, Si-shuo; Meng, Zhi-yun; Gan, Hui; Wu, Zhuo-na; Li, Jian; Zheng, Ying; Zhu, Xiao-xia; Dou, Gui-fang

2016-01-01

Aim: SCT800 is a new third-generation recombinant FVIII agent that is undergoing promising preclinical study. This study aimed to investigate the pharmacokinetic and pharmacodynamic profiles of SCT800 in hemophilia A mice. Methods: After hemophilia A mice were intravenously injected with single dose of SCT800 (80, 180, and 280 IU/kg) or the commercially available product Xyntha (280 IU/kg), pharmacokinetics profiles were evaluated based on measuring plasma FVIII: C. For pharmacodynamics study, dose-response curves of SCT800 and Xyntha (1–200 IU/kg) were constructed using a tail bleeding model monitoring both bleeding time and blood loss. Results: Pharmacokinetics profile analysis showed a dose independency of SCT800 ranging from 80 to 280 IU/kg and comparable pharmacokinetic profiles between SCT800 and Xyntha at the doses tested. Pharmacodynamics study revealed comparable ED50 values of SCT800 and Xyntha in the tail bleeding model: 14.78 and 15.81 IU/kg for bleeding time, respectively; 13.50 and 13.58 IU/kg for blood loss, respectively. Moreover, at the doses tested, the accompanying dose-related safety evaluation in the tail bleeding model showed lower hypercoagulable tendency and wider dosage range potential for SCT800 than Xyntha. Conclusion: In hemophilia A mice, SCT800 shows comparable pharmacokinetics and pharmacodynamics to Xyntha at the doses tested, and possibly with better safety properties. PMID:26806305

Delivering on the Promise of CLER: A Patient Safety Rotation That Aligns Resident Education With Hospital Processes.

PubMed

Patel, Ekta; Muthusamy, Veena; Young, John Q

2018-06-01

Residency programs must provide training in patient safety. Yet, significant gaps exist among published patient safety curricula. The authors developed a rotation designed to be scalable to an entire residency, built on sound pedagogy, aligned with hospital safety processes, and effective in improving educational outcomes. From July 2015 to May 2017, each second-year resident completed the two-week rotation. Residents engaged the foundational science asynchronously via multiple modalities and then practiced applying key concepts during a mock root cause analysis. Next, each resident performed a special review of an actual adverse patient event and presented findings to the hospital's Special Review Committee (SRC). Multiple educational outcomes were assessed, including resident satisfaction and attitudes (postrotation survey), changes in knowledge via pre- and posttest, quality of the residents' written safety analyses and oral presentations (per survey of SRC members), and organizational changes that resulted from the residents' reviews. Twenty-two residents completed the rotation. Most components were rated favorably; 80% (12/15 respondents) indicated interest in future patient safety work. Knowledge improved by 44.3% (P < .0001; pretest mean 23.7, posttest mean 34.2). Compared to faculty, SRC members rated the quality of residents' written reviews as superior and the quality of the rated oral presentations as either comparable or superior. The reviews identified a variety of safety vulnerabilities and led to multiple corrective actions. The authors will evaluate the curriculum in a controlled trial with better measures of change in behavior. Further tests of the curriculum's scalability to other contexts are needed.

Insights on in vitro models for safety and toxicity assessment of cosmetic ingredients.

PubMed

Almeida, Andreia; Sarmento, Bruno; Rodrigues, Francisca

2017-03-15

According to the current European legislation, the safety assessment of each individual cosmetic ingredient of any formulation is the basis for the safety evaluation of a cosmetic product. Also, animal testing in the European Union is prohibited for cosmetic ingredients and products since 2004 and 2009, respectively. Additionally, the commercialization of any cosmetic products containing ingredients tested on animal models was forbidden in 2009. In consequence of these boundaries, the European Centre for the Validation of Alternative Methods (ECVAM) proposes a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. Although the use of in vitro cell-based models for the evaluation of absorption and permeability of cosmetic ingredients is widespread, a detailed study on the properties of these platforms and the in vitro-in vivo correlation compared with human data are required. Moreover, additional efforts must be taken to develop in vitro models to predict carcinogenicity, repeat dose toxicity and reproductive toxicity, for which no alternative in vitro methods are currently available. This review paper summarizes and characterizes the most relevant in vitro models validated by ECVAM employed to predict the safety and toxicology of cosmetic ingredients. Copyright © 2017 Elsevier B.V. All rights reserved.

16 CFR Figure 7 to Part 1203 - Typical Test Apparatus for Positional Stability Test

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Typical Test Apparatus for Positional Stability Test 7 Figure 7 to Part 1203 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Pt. 1203, Fig. 7 Figure 7 to Part 1203—Typical Test Apparatus for Positional...

16 CFR Figure 7 to Part 1203 - Typical Test Apparatus for Positional Stability Test

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Typical Test Apparatus for Positional Stability Test 7 Figure 7 to Part 1203 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Pt. 1203, Fig. 7 Figure 7 to Part 1203—Typical Test Apparatus for Positional...

16 CFR Figure 7 to Part 1203 - Typical Test Apparatus for Positional Stability Test

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Typical Test Apparatus for Positional Stability Test 7 Figure 7 to Part 1203 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Pt. 1203, Fig. 7 Figure 7 to Part 1203—Typical Test Apparatus for Positional...

Application of the Life Safety Code to a Historic Test Stand

NASA Technical Reports Server (NTRS)

Askins, Bruce; Lemke, Paul R.; Lewis, William L.; Covell, Carol C.

2011-01-01

NASA has conducted a study to assess alternatives to refurbishing existing launch vehicle modal test facilities as opposed to developing new test facilities to meet the demands of a very fiscally constrained test and evaluation environment. The results of this study showed that Marshall Space Flight Center (MSFC) Test Stand (TS) 4550 could be made compliant, within reasonable cost and schedule impacts, if safety processes and operational limitations were put in place to meet the safety codes and concerns of the Fire Marshall. Trades were performed with key selection criteria to ensure that appropriate levels of occupant safety are incorporated into test facility design modifications. In preparation for the ground vibration tests that were to be performed on the Ares I launch vehicle, the Ares Flight and Integrated Test Office (FITO) organization evaluated the available test facility options, which included the existing mothballed structural dynamic TS4550 used by Apollo and Shuttle, alternative ground vibration test facilities at other locations, and construction of a new dynamic test stand. After an exhaustive assessment of the alternatives, the results favored modifying the TS4550 because it was the lowest cost option and presented the least schedule risk to the NASA Constellation Program for Ares Integrated Vehicle Ground Vibration Test (IVGVT). As the renovation design plans and drawings were being developed for TS4550, a safety concern was discovered the original design for the construction of the test stand, originally built for the Apollo Program and renovated for the Shuttle Program, was completed before NASA s adoption of the currently imposed safety and building codes per National Fire Protection Association Life Safety Code [NFPA 101] and International Building Codes. The initial FITO assessment of the design changes, required to make TS4550 compliant with current safety and building standards, identified a significant cost increase and schedule impact. An effort was launched to thoroughly evaluate the applicable life safety requirements, examine the context in which they were derived, and determine a means by which the TS4550 modifications could be made within budget and on schedule, while still providing the occupants with appropriate levels of safety.

16 CFR 1210.14 - Qualification testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Qualification testing. 1210.14 Section 1210.14 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.14 Qualification testing. (a...

16 CFR 1210.16 - Production testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

16 CFR 1209.34 - Qualification testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

....34 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.34 Qualification testing. (a... labelers, or importers may select samples for qualification testing of a product in any manner they desire. ...

16 CFR 1203.33 - Certification testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Certification testing. 1203.33 Section 1203.33 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Certification § 1203.33 Certification testing. (a) General...

Investigation of the Semicoa SCF9550 and the International Rectifier IRHM57260SE for Single-Event Gate Rapture and Single-Event Burnout : NASA Electronic Parts and Packaging (NEPP) Program Office of Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Scheick, Leif

2011-01-01

Single-event-effect test results for hi-rel total-dose-hardened power MOSFETs are presented in this report. TheSCF9550 from Semicoa and the IRHM57260SE from International Rectifier were tested to NASA test condition/standards and requirements.The IRHM57260SE performed much better when compared to previous testing. These initial results confirm that parts from the Temecula line are marginally comparable to the El Segundo line. The SCF9550 from Semicoa was also tested and represents the initial parts offering from this vendor. Both parts experienced single-event gate rupture (SEGR) and single-event burnout (SEB). All of the SEGR was from gate to drain.

Time pressure in scenario-based online construction safety quizzes and its effect on students' performance

NASA Astrophysics Data System (ADS)

Jaeger, Martin; Adair, Desmond

2017-05-01

Online quizzes have been shown to be effective learning and assessment approaches. However, if scenario-based online construction safety quizzes do not include time pressure similar to real-world situations, they reflect situations too ideally. The purpose of this paper is to compare engineering students' performance when carrying out an online construction safety quiz with time pressure versus an online construction safety quiz without time pressure. Two versions of an online construction safety quiz are developed and administered to randomly assigned engineering students based on a quasi-experimental post-test design. The findings contribute to scenario-based learning and assessment of construction safety in four ways. First, the results confirm earlier findings that 'intrinsic stress' does not seem to impair students' performance. Second, students who carry out the online construction safety quiz with time pressure are less likely to 'learn by trial and error'. Third, students exposed to time pressure appreciate that they become better prepared for real life. Finally, preparing students to work under time pressure is an important industry requirement. The results of this study should encourage engineering educators to explore and implement ways to include time pressure in scenario-based online quizzes and learning.

What can nanosafety learn from drug development? The feasibility of "safety by design".

PubMed

Hjorth, Rune; van Hove, Lilian; Wickson, Fern

2017-04-01

"Safety by design" (SbD) is an intuitively appealing concept that is on the rise within nanotoxicology and nanosafety research, as well as within nanotechnology research policy. It leans on principles established within drug discovery and development (DDD) and seeks to address safety early, as well as throughout product development. However, it remains unclear what the concept of SbD exactly entails for engineered nanomaterials (ENMs) or how it is envisioned to be implemented. Here, we review the concept as it is emerging in European research and compare its resemblance with the safety testing and assessment practices in DDD. From this comparison, it is clear that "safety" is not obtained through DDD, and that SbD should be considered a starting point rather than an end, meaning that products will still need to progress through thorough safety evaluations and regulation. We conclude that although risk reduction is clearly desirable, the way SbD is currently communicated tends to treat safety as an inherent material property and that this is fundamentally problematic as it represents a recasting and reduction of societal issues into technical problems. SbD therefore faces a multitude of challenges, from practical implementation to unrealistic stakeholder expectations.

78 FR 67206 - Qualification Tests for Safety-Related Actuators in Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0079] Qualification Tests for Safety-Related Actuators in..., ``Qualification Tests for Safety-Related Actuators in Nuclear Power Plants.'' This RG is being revised to provide... power plants. This RG is proposed Revision 1 of RG 1.73, ``Qualification Tests of Electric Valve...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-08

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

A clinical trial designed to evaluate the safety and effectiveness of a thermosensitive hydrogel-type cultured epidermal allograft for deep second-degree burns.

PubMed

Yim, Haejun; Yang, Hyeong-Tae; Cho, Yong-Suk; Kim, Dohern; Kim, Jong-Hyun; Chun, Wook; Hur, Jun

2014-12-01

This study is a phase 1 and 2 clinical trial for investigating the safety profile, effective treatment dose and effectiveness of the newly developed thermosensitive hydrogel-type cultured epidermal allograft. For phase 1, the keratinocytes were divided into 3 groups as follows, with 5 patients in each group: (1) low-dose group (6.7×10(6)/1.5mL), (2) medium-dose group (2×10(7)/1.5mL), and (3) high-dose group (6.0×10(7)/1.5mL). The second phase of the trial proceeded with 10 cases after choosing the most effective dose based on the analysis of the first phase. When comparing re-epithelialization time, medium- and high-dose group showed significantly shorter re-epithelialization time than low-dose group (p=0.003 and p=0.002). A total of 15 cases, 5 cases selected from phase 1 and 10 cases test in phase 2 with the medium dose, were compared with the re-epithelialization period. The re-epithelialization period was 9.6±4.0 days in the test site and 12.4±4.8 days in the control site. In the test site, re-epithelialization was 2.8±1.8 days faster than in the control site (p<0.0001). There was no significant adverse reaction in our clinical trial. In conclusion, this new type of CEAllo accelerates wound healing time and shows the safety. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

16 CFR 1204.16 - Production testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

F14A System Safety Program Plan

DTIC Science & Technology

1981-09-03

by block number) Electromagnetic Pulse (EMP) Safety Plans Test Program EMP Testing F14 Aircraft Plans 20 ABSTRACT (Continue on reverse side if...compromising completion of the required experimental tasks. This document addresses the safety aspect of performing an Electromagnetic Pulse (EMP) test

16 CFR 1210.13 - Certification tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Certification tests. 1210.13 Section 1210.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.13 Certification tests. (a) General. As...

16 CFR 1210.13 - Certification tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Certification tests. 1210.13 Section 1210.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.13 Certification tests. (a) General. As...

75 FR 9018 - Pipeline Safety: Random Drug Testing Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-26

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2010-0034] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... pipelines and operators of liquefied natural gas facilities must select and test a percentage of covered...

77 FR 2606 - Pipeline Safety: Random Drug Testing Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2012-0004] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... pipelines and operators of liquefied natural gas facilities must select and test a percentage of covered...

Preliminary safety assessment of C-8 xylitol monoester and xylitol phosphate esters.

PubMed

Silveira, J E P S; Pereda, M C V; Nogueira, C; Dieamant, G; Cesar, C K M; Assanome, K M; Silva, M S; Torello, C O; Queiroz, M L S; Eberlin, S

2016-02-01

Most of the cosmetic compounds with preservative properties available in the market pose some risks concerning safety, such as the possibility of causing sensitization. Due to the fact that there are few options, the proper development of new molecules with this purpose is needed. Xylitol is a natural sugar, and the antimicrobial properties of xylitol-derived compounds have already been described in the literature. C-8 xylitol monoester and xylitol phosphate esters may be useful for the development of skincare products. As an initial screen for safety of chemicals, the combination of in silico methods and in vitro testing can aid in prioritizing resources in toxicological investigations while reducing the ethical and monetary costs that are related to animal and human testing. This study was designed to evaluate the safety of C-8 xylitol monoester and xylitol phosphate esters regarding carcinogenicity, mutagenicity, skin and eye irritation/corrosion and sensitization through alternative methods. For the initial safety assessment, quantitative structure-activity relationship methodology was used. The prediction of the parameters carcinogenicity/mutagenicity, skin and eye irritation/corrosion and sensitization was generated from the chemical structure. The analysis also comprised physical-chemical properties, Cramer rules, threshold of toxicological concern and Michael reaction. In silico results of candidate molecules were compared to 19 compounds with preservative properties that are available in the market. Additionally, in vitro tests (Ames test for mutagenicity, cytotoxicity and phototoxicity tests and hen's egg test--chorioallantoic membrane for irritation) were performed to complement the evaluation. In silico evaluation of both molecules presented no structural alerts related to eye and skin irritation, corrosion and sensitization, but some alerts for micronucleus and carcinogenicity were detected. However, by comparison, C-8 xylitol monoester, xylitol phosphate esters showed similar or better results than the compounds available in the market. Concerning experimental data, phototoxicity and mutagenicity results were negative. As expected for compounds with preservative activity, xylitol-derived substances presented positive result in cytotoxicity test. In hen's egg test, both molecules were irritants. Our results suggested that xylitol-derived compounds appear to be suitable candidates for preservative systems in cosmetics. © 2015 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

High-Throughput Toxicity Testing: New Strategies for Assessing Chemical Safety

EPA Science Inventory

In recent years, the food industry has made progress in improving safety testing methods focused on microbial contaminants in order to promote food safety. However, food industry toxicologists must also assess the safety of food-relevant chemicals including pesticides, direct add...

Safety in the Chemical Laboratory: Safety in the Chemistry Laboratories: A Specific Program.

ERIC Educational Resources Information Center

Corkern, Walter H.; Munchausen, Linda L.

1983-01-01

Describes a safety program adopted by Southeastern Louisiana University. Students are given detailed instructions on laboratory safety during the first laboratory period and a test which must be completely correct before they are allowed to return to the laboratory. Test questions, list of safety rules, and a laboratory accident report form are…

30 CFR 75.1103-11 - Tests of fire hydrants and fire hose; record of tests.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Tests of fire hydrants and fire hose; record of tests. 75.1103-11 Section 75.1103-11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1103-11 Tests of fire hydrants and...

30 CFR 75.1103-11 - Tests of fire hydrants and fire hose; record of tests.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Tests of fire hydrants and fire hose; record of tests. 75.1103-11 Section 75.1103-11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1103-11 Tests of fire hydrants and...

30 CFR 75.1103-11 - Tests of fire hydrants and fire hose; record of tests.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Tests of fire hydrants and fire hose; record of tests. 75.1103-11 Section 75.1103-11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1103-11 Tests of fire hydrants and...

30 CFR 75.1103-11 - Tests of fire hydrants and fire hose; record of tests.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Tests of fire hydrants and fire hose; record of tests. 75.1103-11 Section 75.1103-11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1103-11 Tests of fire hydrants and...

30 CFR 75.1103-11 - Tests of fire hydrants and fire hose; record of tests.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Tests of fire hydrants and fire hose; record of tests. 75.1103-11 Section 75.1103-11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection § 75.1103-11 Tests of fire hydrants and...

Narcotics reduction, quality and safety in gynecologic oncology surgery in the first year of enhanced recovery after surgery protocol implementation.

PubMed

Bergstrom, Jennifer E; Scott, Marla E; Alimi, Yewande; Yen, Ting-Tai; Hobson, Deborah; Machado, Karime K; Tanner, Edward J; Fader, Amanda N; Temkin, Sarah M; Wethington, Stephanie; Levinson, Kimberly; Sokolinsky, Sam; Lau, Brandyn; Stone, Rebecca L

2018-06-01

Enhanced Recovery After Surgery (ERAS) programs are mechanisms for achieving value-based improvements in surgery. This report provides a detailed analysis of the impact of an ERAS program on patient outcomes as well as quality and safety measures during implementation on a gynecologic oncology service at a major academic medical center. A retrospective review of gynecologic oncology patients undergoing elective laparotomy during the implementation phase of an ERAS program (January 2016 through December 2016) was performed. Patient demographics, surgical variables, postoperative outcomes, and adherence to core safety measures, including antimicrobial and venous thromboembolism (VTE) prophylaxis, were compared to a historical patient cohort (January 2015 through December 2015). Statistical analyses were performed using t-tests, Wilcoxon rank sum tests, and Chi squared tests. The inaugural 109 ERAS program participants were compared to a historical patient cohort (n=158). There was no difference in BMI, race, malignancy, or complexity of procedure between cohorts. ERAS patients required less narcotics (70.7 vs 127.4, p=0.007, oral morphine equivalents) and PCA use (32.1% vs. 50.6%, p=0.002). Despite this substantial reduction in narcotics, ERAS patients did not report more pain and in fact reported significantly less pain by postoperative day 3. There were no differences in length of stay (5days), complication rates (13.8% vs. 20.3%, p=0.17) or 30-day readmission rates (9.5 vs 11.9%, p=0.54) between ERAS and historical patients, respectively. Compliance with antimicrobial prophylaxis was 97.2%. However, 33.9% of ERAS patients received substandard preoperative VTE prophylaxis. ERAS program implementation resulted in reductions in narcotic requirements and PCA use without changes in length of stay or readmission rates. Compliance should be diligently audited during the implementation phase of ERAS programs, with special attention to adherence to pre-existing core safety measures. Copyright © 2018 Elsevier Inc. All rights reserved.

A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men.

PubMed

Van Damme, Pierre; Meijer, Chris J L M; Kieninger, Dorothee; Schuyleman, Anne; Thomas, Stephane; Luxembourg, Alain; Baudin, Martine

2016-07-29

A nine-valent human papilloma virus (9vHPV) vaccine has been developed to prevent infections and diseases related to HPV 6/11/16/18 (as per the licensed quadrivalent HPV (qHPV) vaccine) as well as to five additional oncogenic HPV types (HPV 31/33/45/52/58). The 9vHPV vaccine has the potential to prevent 90% of cervical cancers, HPV-related anal, vaginal and vulval cancers and anogenital warts. We compared the immunogenicity and safety of the 9vHPV vaccine versus the qHPV vaccine in 16-26-year-old men. Participants (N=500) were randomised to receive 9vHPV or qHPV vaccines on day 1, month 2 and month 6. Serology testing was performed on day 1 and month 7. HPV type-specific antibody titres (anti-HPV 6/11/16/18/31/33/45/52/58) were determined by competitive Luminex immunoassay and expressed as geometric mean titres and seroconversion rates. Vaccine safety was also assessed. The HPV 6/11/16/18 immune responses elicited by the 9vHPV vaccine were comparable with those elicited by the qHPV vaccine. All participants receiving the 9vHPV vaccine seroconverted for HPV 31/33/45/52/58. The 9vHPV and qHPV vaccines showed comparable safety profiles. In addition to immune responses to HPV 31/33/45/52/58, a three-dose regimen of the 9vHPV vaccine elicited a similar immune response to HPV 6/11/16/18 when compared with the qHPV vaccine in men aged 16-26years. The safety profile was also similar for the two vaccines. The results from this study support extending the efficacy findings with qHPV vaccine to 9vHPV vaccine in men aged 16-26years. NCT02114385. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Non-animal methods to predict skin sensitization (I): the Cosmetics Europe database.

PubMed

Hoffmann, Sebastian; Kleinstreuer, Nicole; Alépée, Nathalie; Allen, David; Api, Anne Marie; Ashikaga, Takao; Clouet, Elodie; Cluzel, Magalie; Desprez, Bertrand; Gellatly, Nichola; Goebel, Carsten; Kern, Petra S; Klaric, Martina; Kühnl, Jochen; Lalko, Jon F; Martinozzi-Teissier, Silvia; Mewes, Karsten; Miyazawa, Masaaki; Parakhia, Rahul; van Vliet, Erwin; Zang, Qingda; Petersohn, Dirk

2018-05-01

Cosmetics Europe, the European Trade Association for the cosmetics and personal care industry, is conducting a multi-phase program to develop regulatory accepted, animal-free testing strategies enabling the cosmetics industry to conduct safety assessments. Based on a systematic evaluation of test methods for skin sensitization, five non-animal test methods (DPRA (Direct Peptide Reactivity Assay), KeratinoSens TM , h-CLAT (human cell line activation test), U-SENS TM , SENS-IS) were selected for inclusion in a comprehensive database of 128 substances. Existing data were compiled and completed with newly generated data, the latter amounting to one-third of all data. The database was complemented with human and local lymph node assay (LLNA) reference data, physicochemical properties and use categories, and thoroughly curated. Focused on the availability of human data, the substance selection resulted nevertheless resulted in a high diversity of chemistries in terms of physico-chemical property ranges and use categories. Predictivities of skin sensitization potential and potency, where applicable, were calculated for the LLNA as compared to human data and for the individual test methods compared to both human and LLNA reference data. In addition, various aspects of applicability of the test methods were analyzed. Due to its high level of curation, comprehensiveness, and completeness, we propose our database as a point of reference for the evaluation and development of testing strategies, as done for example in the associated work of Kleinstreuer et al. We encourage the community to use it to meet the challenge of conducting skin sensitization safety assessment without generating new animal data.

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

PubMed

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

2012-09-01

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

Survey on patient safety climate in public hospitals in China.

PubMed

Zhou, Ping; Bundorf, M Kate; Gu, Jianjun; He, Xiaoyan; Xue, Di

2015-02-07

Patient safety climate has been recognized as a core determinant for improving safety in hospitals. Describing workforce perceptions of patient safety climate is an important part of safety climate management. This study aimed to describe staff's perceptions of patient safety climate in public hospitals in Shanghai, China and to determine how perceptions of patient safety climate differ between different types of workers in the U.S. and China. Survey of employees of 6 secondary, general public hospitals in Shanghai conducted during 2013 using a modified version of the U.S. Patient Safety Climate in Health Care Organizations (PSCHO) tool. The percentage of "problematic responses" (PPRs) was used to measure safety climate, and the PPRs were compared among employees with different job types, using χ (2) tests and multivariate regression models. Perceptions of patient safety climate were relatively positive among hospital employees and similar to those of employees in U.S. hospitals along most dimensions. For workers in Chinese hospitals, the scales of "fear of blame" and "fear of shame" had the highest PPRs, whereas in the United States the scale of "fear of shame" had among the lowest PPRs. As in the United States, hospital managers in China perceived a more positive patient safety climate overall than other types of personnel. "Fear of shame" and "fear of blame" may be important barriers to improvement of patient safety in Chinese hospitals. Research on the effect of patient safety climate on outcomes is necessary to implement effective polices to improve patient safety and quality outcomes in China.

The use of, and perceptions about, dietary supplements among patients with heart failure.

PubMed

Fan, Xiuzhen; Lee, Kyoung Suk; Frazier, Susan K; Lennie, Terry A; Moser, Debra K

2014-08-01

Dietary supplement use is widespread; patterns of use and perceptions about supplements in individuals with heart failure (HF) are not well understood. The purpose of this study was to describe the prevalence, patterns and reasons for use of dietary supplements, and to compare characteristics of, and perceptions about, safety and efficacy between dietary supplement user and non-user participants with HF. Patients with HF (n=99) completed a Dietary Supplement Questionnaire. Descriptive statistics were used to analyze the data. Independent sample t-tests, Fisher's exact test, and Chi square analyses compared dietary supplement users to non-users. More than half of the participants used at least one dietary supplement and almost all patients using dietary supplements reported they had informed their healthcare provider. Dietary supplements were taken to improve intake of dietary components and better individual health state. Participants thought that dietary supplements in general were safer and more effective than current evidence suggests. Users and non-users expressed similar perceptions. Patients who used dietary supplements were older (64±10 years vs 53±12 years) and had a lower body mass index (30.0±6.5 kg/m(2) vs 34.1±8.3 kg/m(2)) compared with patients who did not. Dietary supplement use was common in these participants with HF; global perceptions about safety and efficacy of dietary supplements were similar between users and non-users of dietary supplements. Systematic evaluation of dietary supplement use, with discussion about safety and efficacy may be constructive for patients with HF. © The European Society of Cardiology 2013.

16 CFR 1209.33 - Reasonable testing program.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 1209.33 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.33 Reasonable testing program. (a) General. Section 14(a) of the Consumer Product Safety Act (15 U.S.C. 2063(a)) requires each manufacturer...

Safety, effectiveness and comparability of professional skin cleansers.

PubMed

Terhaer, Flora K; Bock, Meike; Fartasch, Manigé; Gabard, Bernard; Elsner, Peter; Kleesz, Peter; Landeck, Lilla; Pohrt, Ute; Seyfarth, Florian; Schliemann, Sibylle; Diepgen, Thomas L; Zagrodnik, Fred; John, Swen Malte

2010-10-01

There are no widely-accepted methodical specifications with which to objectify cleansing effectiveness and skin compatibility of occuptional skin cleansing products in Europe. Therefore the German Social Insurance Agency (DGUV) initiated a study with the goal to evaluate such products in view of the potency and the safety of hand cleansers. A market analysis was a part of the project. The product descriptions and safety data sheets of 120 products (5-20/manufacturer) of 11 manufacturers were evaluated between 02/2008 and 04/2008. The manufacturers used mainly ingredients of low irritancy. The declaration of the applied ingredients was in the majority of the cases correctly labeled according to the INCI Declaration. Although there was documentation of skin tolerability for most products, the manufacturers used widely differing tests of skin compatibility. Evidences for cleansing effectiveness were not declared or have not been provided. One manufacturer even promised medical effects of its products. There was no uniform general classification of products making it difficult to identify characteristics of cleansers and choose between them. Presently, there are no commonly accepted criteria to classify products in view of cleansing effectiveness und skin compatibility. Generally accepted criteria and test methods are needed for the evaluation of hand cleansers in order to provide the possibility of transparency and comparability. © The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin.

Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System.

PubMed

Li, Dianyou; Zhang, Chencheng; Gault, Judith; Wang, Wei; Liu, Jianmin; Shao, Ming; Zhao, Yanyan; Zeljic, Kristina; Gao, Guodong; Sun, Bomin

2017-01-01

Deep brain stimulation (DBS) is the most commonly performed surgery for the debilitating symptoms of Parkinson disease (PD). However, DBS systems remain largely unaffordable to patients in developing countries, warranting the development of a safe, economically viable, and functionally comparable alternative. To investigate the efficacy and safety of wirelessly programmed DBS of bilateral subthalamic nucleus (STN) in patients with primary PD. Sixty-four patients with primary PD were randomly divided into test and control groups (1:1), where DBS was initiated at either 1 month or 3 months, respectively, after surgery. Safety and efficacy of the treatment were compared between on- and off-medication states 3 months after surgery. Outcome measures included analysis of Unified Parkinson's Disease Rating Scale (UPDRS) scores, duration of "on" periods, and daily equivalent doses of levodopa. All patients were followed up both 6 and 12 months after surgery. Three months after surgery, significant decrease in the UPDRS motor scores were observed for the test group in the off-medication state (25.08 ± 1.00) versus the control group (4.20 ± 1.99). Bilateral wireless programming STN-DBS is safe and effective for patients with primary PD in whom medical management has failed to restore motor function. © 2017 S. Karger AG, Basel.

Neurovirulence safety testing of mumps vaccines--historical perspective and current status.

PubMed

Rubin, S A; Afzal, M A

2011-04-05

Many live, attenuated viral vaccines are derived from wild type viruses with known neurovirulent properties. To assure the absence of residual neurotoxicity, pre-clinical neurovirulence safety testing of candidate vaccines is performed. For mumps virus, a highly neurotropic virus, neurovirulence safety testing is performed in monkeys. However, laboratory studies suggest an inability of this test to correctly discern among virus strains of varying neurovirulence potential in man, and, further, some vaccines found to be neuroattenuated in monkeys were later found to be neurovirulent in humans when administered in large numbers. Over the past decade, concerted efforts have been made to replace monkey-based neurovirulence safety testing with more informative, alternative methods. This review summarizes the current status of mumps vaccine neurovirulence safety testing and insights into models currently approved and those under development. Published by Elsevier Ltd.

Safety culture in a pharmacy setting using a pharmacy survey on patient safety culture: a cross-sectional study in China.

PubMed

Jia, P L; Zhang, L H; Zhang, M M; Zhang, L L; Zhang, C; Qin, S F; Li, X L; Liu, K X

2014-06-30

To explore the attitudes and perceptions of patient safety culture for pharmacy workers in China by using a Pharmacy Survey on Patient Safety Culture (PSOPSC), and to assess the psychometric properties of the translated Chinese language version of the PSOPSC. Cross-sectional study. Data were obtained from 20 hospital pharmacies in the southwest part of China. We performed χ(2) test to explore the differences on pharmacy staff in different hospital and qualification levels and countries towards patient safety culture. We also computed descriptive statistics, internal consistency coefficients and intersubscale correlation analysis, and then conducted an exploratory factor analysis. A test-retest was performed to assess reproducibility of the items. A total of 630 questionnaires were distributed of which 527 were responded to validly (response rate 84%). The positive response rate for each item ranged from 37% to 90%. The positive response rate on three dimensions ('Teamwork', 'Staff Training and Skills' and 'Staffing, Work Pressure and Pace') was higher than that of Agency for Healthcare Research and Quality (AHRQ) data (p<0.05). There was a statistical difference in the perception of patient safety culture at different hospital and qualification levels. The internal consistency of the total survey was comparatively satisfied (Cronbach's α=0.89). The results demonstrated that among the pharmacy staffs surveyed in China, there was a positive attitude towards patient safety culture in their organisations. Identifying perspectives of patient safety culture from pharmacists in different hospital and qualification levels are important, since this can help support decisions about action to improve safety culture in pharmacy settings. The Chinese translation of the PSOPSC questionnaire (V.2012) applied in our study is acceptable. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Effects of context preexposure and delay until anxiety retrieval on generalization of contextual anxiety

PubMed Central

Neueder, Dorothea; Glotzbach-Schoon, Evelyn; Mühlberger, Andreas

2017-01-01

Animal studies suggest that time delay between acquisition and retrieval of contextual anxiety increases generalization. Moreover, such generalization is prevented by preexposure to the context (CTX), presumably due to an improved representation of such context. We investigated whether preexposure and time-passing modulate generalization of contextual anxiety, in humans. On Day 1, 42 participants (preexposure group) explored two virtual offices, while 41 participants (no-preexposure group) explored a virtual stadium. On Day 2 (24 h later), all participants learned to associate one office (CTX+) with unpredictable unconditioned stimuli (USs), and another office (CTX−) with safety. On Day 3, either 24 h (recent test) or 2 wk (remote test) later, participants revisited CTX− and CTX+ without USs, as well as a generalization context (G-CTX). Results revealed successfully conditioned anxiety and anxiety generalization for ratings (G-CTX was as aversive as CTX+ was), while safety generalization was found for startle responses (G-CTX elicited startle attenuation as CTX− did). Time between learning and testing enhanced generalization as reflected by comparable startle responses to all three offices in the remote test. Contextual preexposure facilitated extinction of explicit conditioned anxiety assessed with ratings. These results suggest that memory trace of a context degrades with passage of time in humans like in animals and, consequently, anxiety generalization enhances. After context preexposure, high cognitive processes seem to be crucially involved in facilitating extinction (or safety) learning. PMID:27980075

Test plan and report for Space Shuttle launch environment testing of Bergen cable technology safety cable

NASA Technical Reports Server (NTRS)

Ralph, John

1992-01-01

Bergen Cable Technology (BCT) has introduced a new product they refer to as 'safety cable'. This product is intended as a replacement for lockwire when installed per Aerospace Standard (AS) 4536 (included in Appendix D of this document). Installation of safety cable is reportedly faster and more uniform than lockwire. NASA/GSFC proposes to use this safety cable in Shuttle Small Payloads Project (SSPP) applications on upcoming Shuttle missions. To assure that BCT safety cable will provide positive locking of fasteners equivalent to lockwire, the SSPP will conduct vibration and pull tests of the safety cable.

16 CFR § 1210.14 - Qualification testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Qualification testing. § 1210.14 Section § 1210.14 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.14 Qualification testing. (a...

33 CFR 159.129 - Safety: Ignition prevention test.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety: Ignition prevention test. 159.129 Section 159.129 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.129 Safety: Ignition...

16 CFR § 1210.13 - Certification tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Certification tests. § 1210.13 Section § 1210.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.13 Certification tests. (a...

16 CFR § 1210.16 - Production testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Production testing. § 1210.16 Section § 1210.16 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.16 Production testing. (a...

Safety evaluation of food contact paper and board using chemical tests and in vitro bioassays: role of known and unknown substances.

PubMed

Honkalampi-Hämäläinen, U; Bradley, E L; Castle, L; Severin, I; Dahbi, L; Dahlman, O; Lhuguenot, J-C; Andersson, M A; Hakulinen, P; Hoornstra, D; Mäki-Paakkanen, J; Salkinoja-Salonen, M; Turco, L; Stammati, A; Zucco, F; Weber, A; von Wright, A

2010-03-01

In vitro toxicological tests have been proposed as an approach to complement the chemical safety assessment of food contact materials, particularly those with a complex or unknown chemical composition such as paper and board. Among the concerns raised regarding the applicability of in vitro tests are the effects of interference of the extractables on the outcome of the cytotoxicity and genotoxicity tests applied and the role of known compounds present in chemically complex materials, such as paper and board, either as constituents or contaminants. To answer these questions, a series of experiments were performed to assess the role of natural substances (wood extracts, resin acids), some additives (diisopropylnaphthalene, phthalates, acrylamide, fluorescent whitening agents) and contaminants (2,4-diaminotoluene, benzo[a]pyrene) in the toxicological profile of paper and board. These substances were individually tested or used to spike actual paper and board extracts. The toxic concentrations of diisopropylnaphthalenes and phthalates were compared with those actually detected in paper and board extracts showing conspicuous toxicity. According to the results of the spiking experiments, the extracts did not affect the toxicity of tested chemicals nor was there any significant metabolic interference in the cases where two compounds were used in tests involving xenobiotic metabolism by the target cells. While the identified substances apparently have a role in the cytotoxicity of some of the project samples, their presence does not explain the total toxicological profile of the extracts. In conclusion, in vitro toxicological testing can have a role in the safety assessment of chemically complex materials in detecting potentially harmful activities not predictable by chemical analysis alone.

Design and validation of an intelligent wheelchair towards a clinically-functional outcome.

PubMed

Boucher, Patrice; Atrash, Amin; Kelouwani, Sousso; Honoré, Wormser; Nguyen, Hai; Villemure, Julien; Routhier, François; Cohen, Paul; Demers, Louise; Forget, Robert; Pineau, Joelle

2013-06-17

Many people with mobility impairments, who require the use of powered wheelchairs, have difficulty completing basic maneuvering tasks during their activities of daily living (ADL). In order to provide assistance to this population, robotic and intelligent system technologies have been used to design an intelligent powered wheelchair (IPW). This paper provides a comprehensive overview of the design and validation of the IPW. The main contributions of this work are three-fold. First, we present a software architecture for robot navigation and control in constrained spaces. Second, we describe a decision-theoretic approach for achieving robust speech-based control of the intelligent wheelchair. Third, we present an evaluation protocol motivated by a meaningful clinical outcome, in the form of the Robotic Wheelchair Skills Test (RWST). This allows us to perform a thorough characterization of the performance and safety of the system, involving 17 test subjects (8 non-PW users, 9 regular PW users), 32 complete RWST sessions, 25 total hours of testing, and 9 kilometers of total running distance. User tests with the RWST show that the navigation architecture reduced collisions by more than 60% compared to other recent intelligent wheelchair platforms. On the tasks of the RWST, we measured an average decrease of 4% in performance score and 3% in safety score (not statistically significant), compared to the scores obtained with conventional driving model. This analysis was performed with regular users that had over 6 years of wheelchair driving experience, compared to approximately one half-hour of training with the autonomous mode. The platform tested in these experiments is among the most experimentally validated robotic wheelchairs in realistic contexts. The results establish that proficient powered wheelchair users can achieve the same level of performance with the intelligent command mode, as with the conventional command mode.

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial.

PubMed

Kok, Tim; de Haan, Hein A; van der Meer, Margreet; Najavits, Lisa M; DeJong, Cor A J

2013-06-04

Traumatic experiences and, more specifically, posttraumatic stress disorder (PTSD) are highly prevalent among substance use disorder (SUD) patients. This comorbidity is associated with worse treatment outcomes in substance use treatment programs and more crisis interventions. International guidelines advise an integrated approach to the treatment of trauma related problems and SUD. Seeking Safety is an integrated treatment program that was developed in the United States. The aim of the current study is to test the efficacy of this program in the Netherlands in an outpatient SUD population. A randomized controlled trial (RCT) will be used to test the efficacy of Seeking Safety compared to Cognitive Behavioral Therapy (CBT) in a population of SUD outpatients. Each treatment will consist of 12 group sessions. The primary outcome measure will be substance use severity. Secondary outcome measures are PTSD and trauma symptoms, coping skills, functioning, and cognitions. Questionnaires will be administered at the start of treatment, at the end of treatment (three months after the start of treatment) and at follow-up (six months after the start of treatment). This study protocol presents a RCT in which the efficacy of an integrated treatment for comorbid PTSD and SUD, Seeking Safety, is evaluated in a SUD outpatient population compared to CBT. It is expected that the intervention group will show significantly more improvement in substance use severity compared to the control group at end-of-treatment and at follow-up. Furthermore, a lower drop-out rate is expected for the intervention group. If the intervention proves to be effective, it can be implemented. A cost-effectiveness analysis will be conducted to evaluate the two treatments. The protocol for this study is registered with the Netherlands Trial Register with number NTR3084 and approved by the local medical ethical committee (METC\\11270.haa).

Validating a UAV artificial intelligence control system using an autonomous test case generator

NASA Astrophysics Data System (ADS)

Straub, Jeremy; Huber, Justin

2013-05-01

The validation of safety-critical applications, such as autonomous UAV operations in an environment which may include human actors, is an ill posed problem. To confidence in the autonomous control technology, numerous scenarios must be considered. This paper expands upon previous work, related to autonomous testing of robotic control algorithms in a two dimensional plane, to evaluate the suitability of similar techniques for validating artificial intelligence control in three dimensions, where a minimum level of airspeed must be maintained. The results of human-conducted testing are compared to this automated testing, in terms of error detection, speed and testing cost.

The JRC Nanomaterials Repository: A unique facility providing representative test materials for nanoEHS research.

PubMed

Totaro, Sara; Cotogno, Giulio; Rasmussen, Kirsten; Pianella, Francesca; Roncaglia, Marco; Olsson, Heidi; Riego Sintes, Juan M; Crutzen, Hugues P

2016-11-01

The European Commission has established a Nanomaterials Repository that hosts industrially manufactured nanomaterials that are distributed world-wide for safety testing of nanomaterials. In a first instance these materials were tested in the OECD Testing Programme. They have then also been tested in several EU funded research projects. The JRC Repository of Nanomaterials has thus developed into serving the global scientific community active in the nanoEHS (regulatory) research. The unique Repository facility is a state-of-the-art installation that allows customised sub-sampling under the safest possible conditions, with traceable final sample vials distributed world-wide for research purposes. This paper describes the design of the Repository to perform a semi-automated subsampling procedure, offering high degree of flexibility and precision in the preparation of NM vials for customers, while guaranteeing the safety of the operators, and environmental protection. The JRC nanomaterials are representative for part of the world NMs market. Their wide use world-wide facilitates the generation of comparable and reliable experimental results and datasets in (regulatory) research by the scientific community, ultimately supporting the further development of the OECD regulatory test guidelines. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

29 CFR 1910.7 - Definition and requirements for a nationally recognized testing laboratory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS General.... The application shall be filed with: NRTL Recognition Program, Occupational Safety and Health... safety before it is used. (e) Implementation. A testing organization desiring recognition by OSHA as an...

Safety Issues at the DOE Test and Research Reactors. A Report to the U.S. Department of Energy.

ERIC Educational Resources Information Center

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

This report provides an assessment of safety issues at the Department of Energy (DOE) test and research reactors. Part A identifies six safety issues of the reactors. These issues include the safety design philosophy, the conduct of safety reviews, the performance of probabilistic risk assessments, the reliance on reactor operators, the fragmented…

Evaluation of the "Respect Not Risk" firearm safety lesson for 3rd-graders.

PubMed

Liller, Karen D; Perrin, Karen; Nearns, Jodi; Pesce, Karen; Crane, Nancy B; Gonzalez, Robin R

2003-12-01

The purpose of this study was to evaluate the MORE HEALTH "Respect Not Risk" Firearm Safety Lesson for 3rd-graders in Pinellas County, Florida. Six schools representative of various socioeconomic levels were selected as the test sites. Qualitative and quantitative data were collected. A total of 433 matched pretests/posttests were used to determine the effectiveness of the class in increasing student knowledge about firearm safety. The results revealed a significant increase in the mean scores on the posttest compared with the pretest. Qualitative findings showed the lesson was positively received by both students and teachers, and 65% of responding students reported discussing the lesson with family members. School nurses are encouraged to take a leading role in promoting firearm injury prevention to students.

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

PubMed

Arrieta, Alejandro; Suárez, Gabriela; Hakim, Galed

2018-04-01

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

Perceptions of patient safety culture among healthcare employees in tertiary hospitals of Heilongjiang province in northern China: a cross-sectional study.

PubMed

Li, Ying; Zhao, Yanming; Hao, Yanhua; Jiao, Mingli; Ma, Hongkun; Teng, Baijun; Yang, Kai; Sun, Tongbo; Wu, Qunhong; Qiao, Hong

2018-04-19

Assessing the patient safety culture is necessary for improving patient safety. Research on patient safety culture has attracted considerable attention. Currently, there is little research on patient safety culture in China generally, and in Heilongjiang in northern China specifically. The aim of the study is to explore the perception of healthcare employees about patient safety culture and to determine whether perception differs per sex, age, profession, years of experience, education level and marital status. Cross-sectional study. Thirteen tertiary hospitals in Heilongjiang, northern China. About 1024 healthcare employees. The perception of healthcare employees was measured using the safety attitude questionnaire, which include six dimensions. Higher scores represented more positive attitudes. An analysis of variance was used to compare socio-demographic differences per position, marital status and education; t-tests were used for sex, age and experience. A total of 1024 (85.33%) valid questionnaires were returned. The mean score of the six dimensions was 73.74/100; work conditions (80.19) had the highest score of all the dimensions, and safety climate (70.48) had the lowest. Across distinct dimensions, there were significant differences in perceptions of patient safety culture per sex, age, years of experience, position, marital status and education level (P < 0.05). The findings can help in assessing perceived patient safety culture among healthcare employees and identifying dimensions that require improvement. Interventions aimed at specific socio-demographic groups are necessary to improve patient safety culture.

30 CFR 784.16 - Reclamation plan: Siltation structures, impoundments, and refuse piles.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Resources Conservation Service's Web site athttp://www.info.usda.gov/scripts/lpsiis.dll/TR/TR_210_60.htm... State program approval process engineering design standards that ensure stability comparable to a 1.3 minimum static safety factor in lieu of engineering tests to establish compliance with the minimum static...

30 CFR 780.25 - Reclamation plan: Siltation structures, impoundments, and refuse piles.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Resources Conservation Service's Web site at http://www.info.usda.gov/scripts/lpsiis.dll/TR/TR_210_60.htm... authority may establish through the State program approval process, engineering design standards that ensure stability comparable to a 1.3 minimum static safety factor in lieu of engineering tests to establish...

Comparing in vivo biodistribution with radiolabeling and Franz cell permeation assay to validate the efficacy of both methodologies in the evaluation of nanoemulsions: a safety approach

NASA Astrophysics Data System (ADS)

Cerqueira-Coutinho, C. S.; De Campo, V. E. B.; Rossi, A. L.; Veiga, V. F.; Holandino, C.; Freitas, Z. M. F.; Ricci-Junior, E.; Mansur, C. R. E.; Santos, E. P.; Santos-Oliveira, R.

2016-01-01

The Franz cells permeation assay has been performed for over 25 years. However, the advent of nanotechnology created a whole new world, especially with regard to topical products. In this new global scenario an increasing number of nanostructure-based delivery systems (NDSs) have emerged and a global warning relating to the safety of these NDSs is arising. This work studied the efficacy of the Franz cells assay, comparing it with the radiolabeling biodistribution test. For this purpose a formulation of sunscreen based on an NDS was developed and characterized. The results demonstrated both that the NDS did not present in vitro cytotoxicity and that the radiolabeling biodistribution test is more precise for the evaluation of NDS cosmetics than the Franz cells assay, since it detected the permeation of the NDS at a picogram order. Due to this fact, and considering all the concerns related to NDSs and nanoparticles in general, more precise methods must be used in order to guarantee the safe use of these new classes of products.

Effects of the Sunny Days, Healthy Ways Curriculum on Students in Grades 6–8

PubMed Central

Buller, David B.; Reynolds, Kim D.; Yaroch, Amy; Cutter, Gary R.; Hines, Joan M.; Geno, Cristy R.; Maloy, Julie A.; Brown, Melissa; Woodall, W. Gill; Grandpre, Joseph

2006-01-01

Background There are few effective sun safety education programs for use in secondary schools. The project aims were to create a sun safety curriculum for grades 6–9 and to test whether exposure to the curriculum would increase children’s sun protection behavior. Design A pair-matched group-randomized pretest-posttest controlled trial, with middle schools as the unit of randomization, was performed. Teachers implemented the six-unit sun safety curriculum in 2001–03 and analyses were performed in 2003–04. Setting/participants 2038 children from 30 middle schools in Colorado, New Mexico, and Arizona. Main outcome measures Self-reported sun protection behavior using frequency ratings and diary. Results Compared to control schools, children receiving the curriculum reported more frequent sun protection (p=0.0035), and a greater proportion wore long-sleeved shirts in during recess (p<0.0001) and applied sunscreen (p<0.0001). Exposure to the curriculum improved knowledge (p<0.0001), decreased perceived barriers to using sunscreen (p=0.0046), and enhanced self-efficacy expectations (p=0.0577) about sun safety, and reduced favorable attitudes toward sun tanning (p=0.0026 to <0.0001). In intent-to-treat analyses, the treatment effect was eliminated only under the most conservative assumptions about dropouts. Conclusions Educational approaches to sun safety in middle school may be effective for improving children’s sun safety. Potential trial limitations include measuring short-term outcomes, focusing on young adolescents, using active parental consent, and testing in the American southwest. PMID:16414419

Drug safety data mining with a tree-based scan statistic.

PubMed

Kulldorff, Martin; Dashevsky, Inna; Avery, Taliser R; Chan, Arnold K; Davis, Robert L; Graham, David; Platt, Richard; Andrade, Susan E; Boudreau, Denise; Gunter, Margaret J; Herrinton, Lisa J; Pawloski, Pamala A; Raebel, Marsha A; Roblin, Douglas; Brown, Jeffrey S

2013-05-01

In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs. Copyright © 2013 John Wiley & Sons, Ltd.

The isolated chicken eye test as a suitable in vitro method for determining the eye irritation potential of household cleaning products.

PubMed

Schutte, K; Prinsen, M K; McNamee, P M; Roggeband, R

2009-08-01

Eye irritation is an important endpoint in the safety evaluation of consumer products and their ingredients. Several in vitro methods have been developed and are used by different industry sectors to assess eye irritation. One such in vitro method in use for some time already is the isolated chicken eye test (ICE). This investigation focuses on assessing the ICE as a method to determine the eye irritation potential of household cleaning products, both for product safety assurance prior to marketing and for classification and labeling decisions. The ICE involves a single application of test substances onto the cornea of isolated chicken eyes. Endpoints are corneal swelling, corneal opacity and fluorescein retention. The ICE results were compared to historic LVET data in this study due to availability of such in vivo data and the ability to correlate LVET to human experience data on the outcome of accidental exposures to household cleaning products in general. The results of this study indicate that the ICE test is a useful in vitro method for evaluating the eye irritation/corrosion potential and establishing classification and labeling for household cleaning products. For new product formulations, it is best used as part of a weight-of-evidence approach and benchmarked against data from comparable formulations with known eye irritation/corrosion profiles and market experience.

Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators

PubMed Central

Rengasamy, Samy; Sbarra, Deborah; Nwoko, Julian; Shaffer, Ronald

2015-01-01

Background Surgical N95 filtering facepiece respirators (FFRs), certified by the National Institute for Occupational Safety and Health (NIOSH) as a respirator and cleared by the Food and Drug Administration (FDA) as a surgical mask, are often used to protect from the inhalation of infectious aerosols and from splashes/sprays of body fluids in health care facilities. A shortage of respirators can be expected during a pandemic. The availability of surgical N95 FFRs can potentially be increased by incorporating FDA clearance requirements in the NIOSH respirator approval process. Methods Fluid resistance of NIOSH-approved N95 FFRs, and FDA-cleared surgical N95 FFRs and surgical masks was tested using the ASTM F1862 method at 450 and 635 cm/sec velocities and compared with the results from a third-party independent laboratory. Blood penetration through different layers of filter media of masks were also analyzed visually. Results Four N95 FFR models showed no test failures at both velocities. The penetration results obtained in the NIOSH laboratory were comparable to those from the third-party independent laboratory. The number of respirator samples failing the test increased with increasing test velocity. Conclusions The results indicate that several NIOSH-approved N95 FFR models would likely pass FD clearance requirements for resistance to synthetic blood penetration. PMID:26231551

Healing rate and autoimmune safety of full-thickness wounds treated with fish skin acellular dermal matrix versus porcine small-intestine submucosa: a noninferiority study.

PubMed

Baldursson, Baldur Tumi; Kjartansson, Hilmar; Konrádsdóttir, Fífa; Gudnason, Palmar; Sigurjonsson, Gudmundur F; Lund, Sigrún Helga

2015-03-01

A novel product, the fish skin acellular dermal matrix (ADM) has recently been introduced into the family of biological materials for the treatment of wounds. Hitherto, these products have been produced from the organs of livestock. A noninferiority test was used to compare the effect of fish skin ADM against porcine small-intestine submucosa extracellular matrix in the healing of 162 full-thickness 4-mm wounds on the forearm of 81 volunteers. The fish skin product was noninferior at the primary end point, healing at 28 days. Furthermore, the wounds treated with fish skin acellular matrix healed significantly faster. These results might give the fish skin ADM an advantage because of its environmental neutrality when compared with livestock-derived products. The study results on these acute full-thickness wounds might apply for diabetic foot ulcers and other chronic full-thickness wounds, and the shorter healing time for the fish skin-treated group could influence treatment decisions. To test the autoimmune reactivity of the fish skin, the participants were tested with the following ELISA (enzyme-linked immunosorbent assay) tests: RF, ANA, ENA, anti ds-DNA, ANCA, anti-CCP, and anticollagen I and II. These showed no reactivity. The results demonstrate the claims of safety and efficacy of fish skin ADM for wound care. © The Author(s) 2015.

Moxifloxacin in Pediatric Patients with Complicated Intra-Abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study.

PubMed

Wirth, Stefan; Emil, Sherif G S; Engelis, Arnis; Digtyar, Valeri; Criollo, Margarita; DiCasoli, Carl; Stass, Heino; Willmann, Stefan; Nkulikiyinka, Richard; Grossmann, Ulrike

2018-01-18

This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intra-abdominal infections (cIAIs). In this multicenter, randomized, double-blind, controlled study, 451 pediatric patients aged 3 months to 17 years with cIAIs were treated with intravenous/oral MXF (N = 301) or comparator (COMP, intravenous ertapenem followed by oral amoxicillin/clavulanate; N = 150) for 5 to 14 days. Doses of MXF were selected based on the results of a Phase 1 study in pediatric patients (NCT01049022). The primary endpoint was safety, with particular focus on cardiac and musculoskeletal safety; clinical and bacteriological efficacy at test of cure were also investigated. The proportion of patients with adverse events (AEs) was comparable between the two treatment arms (MXF: 58.1% and COMP: 54.7%). The incidence of drug-related AEs was higher in the MXF arm than the COMP arm (14.3% and 6.7%, respectively). No cases of QTc interval prolongation-related morbidity or mortality were observed. The proportion of patients with musculoskeletal AEs was comparable between treatment arms; no drug-related events were reported. Clinical cure rates were 84.6% and 95.5% in the MXF and COMP arms, respectively, in patients with confirmed pathogen(s) at baseline. MXF treatment was well tolerated in children with cIAIs. However, a lower clinical cure rate was observed with MXF treatment compared with COMP. This study does not support a recommendation of MXF for children with cIAIs when alternative more efficacious antibiotics with better safety profile are available.

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the potential and demonstrate the utilities of CBSAF and are not intended for thorough studies of collision avoidance and runway incursions safety, which are extremely challenging problems. Further development and thorough validations are required to allow CBSAF to reach implementation phases, e.g. addressing the issues of limited scalability and subjectivity.

Performance and Safety Evaluations of Moli Spinel Lithium-Ion Cells

NASA Technical Reports Server (NTRS)

Jevarajan, Judith; Cook, Joseph S.; Collins, Jacob

2005-01-01

The current spike obtained during the hard external short test is small (8.2 A) compared to those obtained from a LiCoO2 system (60 to 80 A). The simulated internal short did not result in an explosion or fire as it does with the LiCoO2 systems. The temperatures obtained during the heat-to-vent test are not very high compared to the cobaltate cells. The cells do not retain capacity very well, but the capacity can be recovered with cycling. The spinel cells are much safer under abuse conditions than the lithium-ion cells with other transition metal oxides.

16 CFR 1213.4 - Test methods.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Test methods. 1213.4 Section 1213.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR ENTRAPMENT HAZARDS IN BUNK BEDS § 1213.4 Test methods. (a) Guardrails (see § 1213.3(a)(6...

16 CFR 1213.4 - Test methods.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Test methods. 1213.4 Section 1213.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR ENTRAPMENT HAZARDS IN BUNK BEDS § 1213.4 Test methods. (a) Guardrails (see § 1213.3(a)(6...

16 CFR 1213.4 - Test methods.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Test methods. 1213.4 Section 1213.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR ENTRAPMENT HAZARDS IN BUNK BEDS § 1213.4 Test methods. (a) Guardrails (see § 1213.3(a)(6...

16 CFR 1213.4 - Test methods.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Test methods. 1213.4 Section 1213.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR ENTRAPMENT HAZARDS IN BUNK BEDS § 1213.4 Test methods. (a) Guardrails (see § 1213.3(a)(6...

78 FR 25488 - Qualification Tests for Safety-Related Actuators in Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0079] Qualification Tests for Safety-Related Actuators in... regulatory guide (DG), DG-1235, ``Qualification Tests for Safety-Related Actuators in Nuclear Power Plants...-251- 7495, email: [email protected] . Both of the Office of Nuclear Regulatory Research, U.S. Nuclear...

16 CFR 1205.33 - Certification testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Certification testing. 1205.33 Section 1205.33 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR WALK-BEHIND POWER LAWN MOWERS Certification § 1205.33 Certification testing. (a) General. Manufacturers and importers shall either...

Development of ergonomics audits for bagging, haul truck and maintenance and repair operations in mining.

PubMed

Dempsey, Patrick G; Pollard, Jonisha; Porter, William L; Mayton, Alan; Heberger, John R; Gallagher, Sean; Reardon, Leanna; Drury, Colin G

2017-12-01

The development and testing of ergonomics and safety audits for small and bulk bag filling, haul truck and maintenance and repair operations in coal preparation and mineral processing plants found at surface mine sites is described. The content for the audits was derived from diverse sources of information on ergonomics and safety deficiencies including: analysis of injury, illness and fatality data and reports; task analysis; empirical laboratory studies of particular tasks; field studies and observations at mine sites; and maintenance records. These diverse sources of information were utilised to establish construct validity of the modular audits that were developed for use by mine safety personnel. User and interrater reliability testing was carried out prior to finalising the audits. The audits can be implemented using downloadable paper versions or with a free mobile NIOSH-developed Android application called ErgoMine. Practitioner Summary: The methodology used to develop ergonomics audits for three types of mining operations is described. Various sources of audit content are compared and contrasted to serve as a guide for developing ergonomics audits for other occupational contexts.

Novel Polymer Aerogel toward High Dimensional Stability, Mechanical Property, and Fire Safety.

PubMed

Shang, Ke; Yang, Jun-Chi; Cao, Zhi-Jie; Liao, Wang; Wang, Yu-Zhong; Schiraldi, David A

2017-07-12

Inorganc silica-based aerogels, the earliest and widely used aerogels, have poorer mechanical properties than their organic substitutes, which are flammable. In this study, a novel polymeric aerogel with high strength, inherent flame retardancy, and cost-effectiveness, which is based on poly(vinyl alcohol) (PVA) cross-linked with melamine-formaldehyde (MF), was prepared under aqueous condition with an ecofriendly freeze-drying and postcuring process. Combined with the additional rigid MF network and benifited from the resulting unique infrastructure of inter-cross-linked flexible PVA segments and rigid MF segments, PVA-based aerogels exibited a significantly decreased degradation rate and sharply decreased peak heat release rate (PHRR) in cone calorimeter tests (by as much as 83%) compared with neat PVA. The polymer aerogels have a limiting oxygen index (LOI) as high as 36.5% and V-0 rating in UL-94 test. Furthermore, the aerogel samples exposured to harsh temperatures maintain their dimensions (<10% change), original mechanical strength and fire safety. Therefore, this work provides a novel stragegy for preparing pure organic polymeric aerogel materials with high mechanical strength, dimensional stability, and fire safety.

Development and Validation of a Short-Form Safety Net Medical Home Scale.

PubMed

Nocon, Robert S; Gunter, Kathryn E; Gao, Yue; Lee, Sang Mee; Chin, Marshall H

2017-12-01

To develop a short-form Safety Net Medical Home Scale (SNMHS) for assessing patient-centered medical home (PCMH) capability in safety net clinics. National surveys of federally qualified health centers (FQHCs). Interviews with FQHC directors. We constructed three short-form SNMHS versions and examined correlations with full SNMHS and related primary care assessments. We tested usability with FQHC directors and reviewed scale development with an advisory group. Federally qualified health center surveys were administered in 2009 and 2013, by mail and online. Usability testing was conducted through telephone interviews with FQHC directors in 2013. Six-, 12-, and 18-question short-form SNMHS versions had Pearson correlations with full scale of 0.84, 0.92, and 0.96, respectively. All versions showed a level of convergent validity with other primary care assessment scales comparable to the full SNMHS. User testers found short forms to be low-burden, though missing some PCMH concepts. Advisory group members expressed caution over missing concepts and appropriate use of short-form self-assessments. Short-form versions of SNMHS showed strong correlations with full scale and may be useful for brief assessment of safety net PCMH capability. Each short-form SNMHS version may be appropriate for different research, quality improvement, and assessment purposes. © Health Research and Educational Trust.

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting.

PubMed

Ward, Jane K; McEachan, Rosemary R C; Lawton, Rebecca; Armitage, Gerry; Watt, Ian; Wright, John

2011-05-27

Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS), and a patient incident reporting tool (PIRT) - to help the NHS prevent patient safety incidents by learning more about when and why they occur. To develop the PMOS 1) literature will be reviewed to identify similar measures and key contributory factors to error; 2) four patient focus groups will ascertain practicality and feasibility; 3) 25 patient interviews will elicit approximately 60 items across 10 domains; 4) 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis.To develop the PIRT 1) individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2) nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50) will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their priorities for patient safety. A patient panel will provide steering to the research. The PMOS and PIRT aim to provide a reliable means of eliciting patient views about patient safety. Both interventions are likely to have relevance and practical utility for all NHS hospital trusts.

Spacecraft Fire Safety

NASA Technical Reports Server (NTRS)

Margle, Janice M. (Editor)

1987-01-01

Fire detection, fire standards and testing, fire extinguishment, inerting and atmospheres, fire-related medical science, aircraft fire safety, Space Station safety concerns, microgravity combustion, spacecraft material flammability testing, and metal combustion are among the topics considered.

A Novel Lithium-ion Laminated Pouch Cell Tested For Performance And Safety

NASA Technical Reports Server (NTRS)

Jeevarajan, Judith A.; Inoue, Takefumi

2006-01-01

A new Li-ion 4.0 Ah pouch cell from GS Yuasa has been tested to determine its performance and safety. The cell is of a laminate pouch design with liquid electrolyte. The rate, thermal and vacuum performance capabilities have been tested to determine the optimum parameters. Under vacuum conditions, the cells were cycled under restrained and unrestrained configurations. The burst pressure of the laminate pouch was also determined. The overcharge, overdischarge into reversal and external short circuit safety tests were also performed to determine the cell s tolerance to abuse. Key Words: Li-ion, safety, vacuum test, abuse, COTS batteries, rate capability

Life prediction and reliability assessment of lithium secondary batteries

NASA Astrophysics Data System (ADS)

Eom, Seung-Wook; Kim, Min-Kyu; Kim, Ick-Jun; Moon, Seong-In; Sun, Yang-Kook; Kim, Hyun-Soo

Reliability assessment of lithium secondary batteries was mainly considered. Shape parameter (β) and scale parameter (η) were calculated from experimental data based on cycle life test. We also examined safety characteristics of lithium secondary batteries. As proposed by IEC 62133 (2002), we had performed all of the safety/abuse tests such as 'mechanical abuse tests', 'environmental abuse tests', 'electrical abuse tests'. This paper describes the cycle life of lithium secondary batteries, FMEA (failure modes and effects analysis) and the safety/abuse tests we had performed.

The effect of cap lamp lighting on postural control and stability

PubMed Central

Sammarco, John J.; Pollard, Jonisha P.; Porter, William L.; Dempsey, Patrick G.; Moore, Caitlin T.

2015-01-01

Researchers at the National Institute for Occupational Safety and Health (NIOSH) are conducting mine illumination research with the objective of improving miner safety. Slips, trips, and falls (STFs) are the second leading accident class (18.1%, n = 2,374) of nonfatal lost-time injuries at underground mines (MSHA, 2005–2009). Factors contributing to STFs include recognition of hazards as well as postural balance and age. Improved lighting may enable better hazard recognition and reduce the impact of postural balance and age. Previous research has shown that cap lamp technology that used light-emitting diodes (LEDs) has improved hazard detection. This study was an initial investigation to determine if cap lamp lighting significantly influences measures of static postural stability (displacement and velocity of center of pressure). Results of this investigation showed no significant differences in the balance measures of interest between cap lamps tested. However, balance was shown to significantly decline (p < 0.05) when tested in an underground coal mine compared to the laboratory testing condition. Relevance to industry: Underground coal mine workers wear cap lamps on their hard hats as their primary light source to illuminate nearby areas where their vision is directed. Proper illumination may improve miner safety by improving their STF hazard recognition and balance. PMID:26472917

Effect of the New York State cigarette fire safety standard on ignition propensity, smoke constituents, and the consumer market.

PubMed

Connolly, G N; Alpert, H R; Rees, V; Carpenter, C; Wayne, G F; Vallone, D; Koh, H

2005-10-01

This study examines empirical evidence from the New York experience testing tobacco industry arguments made in opposition to fire safety standards for cigarettes. Percentages of cigarettes exhibiting full length burns (FLBs), cigarette sales before and following the implementation of the New York standards, a sample of retail cigarette prices, brand availability, and selected smoke constituent yields were compared between cigarettes sold in New York and two other states. Cigarette paper analysis was conducted on cigarettes sold in New York. New York cigarette brands averaged 10.0% FLBs as compared to 99.8% for California and Massachusetts brands. Reduced ignition propensity (RIP) appears to have been achieved by cigarette paper banding. Cigarette sales, prices, and brand availability do not appear to have been affected by the New York standards. Yields of the majority of smoke constituents tested did not differ substantially between RIP cigarettes sold in New York as compared to the same brands sold in Massachusetts. Average yields of tar, carbon monoxide, and two compounds were slightly higher, the yields of seven compounds were higher for one brand only, and nicotine was lower, among New York brands tested. RIP cigarette brands have been designed to meet the New York fire safety standards. Their introduction has not affected cigarette sales or prices in New York. There is no evidence that the small increases in smoke constituent yields affect the already highly toxic nature of cigarette smoke. Data on smoking caused fires, deaths, and injuries dating from after the change in law are not yet available. Such data will be able to address the question of whether the demonstrated reduced ignition standards are associated with reduced fires and injuries. Based on the New York experience, prior industry objections to producing RIP cigarettes are unfounded. Other states and nations should adopt similar standards.

Randomized, controlled pilot study comparing large-volume paracentesis using wall suction and traditional glass vacuum bottle methods.

PubMed

Konerman, Monica A; Price, Jennifer; Torres, Dawn; Li, Zhiping

2014-09-01

Large-volume paracentesis (LVP) can be time and labor intensive depending on the amount of ascites removed and the method of drainage. Wall suction has been adopted as the preferred method of drainage at many centers, though the safety and benefits of this technique have not been formally evaluated. The primary objective of this study was to define the cost and time savings of wall suction over the traditional glass vacuum bottle method for ascites drainage. The secondary objective was to compare the safety profile and patient satisfaction using these two techniques. We conducted a randomized, controlled pilot study of the wall suction versus vacuum bottle methods for LVP in hospitalized patients. All LVPs were performed under ultrasound guidance by a single proceduralist. Patients with at least 4 liters removed received 25% intravenous albumin, 8 g/liter fluid removed. Demographic, clinical characteristics, and procedure details were recorded. Laboratory and hemodynamic data were recorded for 24 h prior to and 24-48 h post LVP. An electronic chart review was conducted to evaluate procedure-related complications. Data were compared using Fisher's exact test, t test, or Mann-Whitney U test. Thirty-four patients were randomized to wall suction at 200 mmHg (n = 17) or glass vacuum bottle drainage (n = 17). Wall suction was significantly faster and less costly than vacuum bottle drainage (7 versus 15 min, p = 0.002; $4.59 versus $12.73, p < 0.001). There were no differences in outcomes at 24 and 48 h post LVP, or at 60-day follow up. Performing LVP using wall suction resulted in significantly shorter procedure time and supply cost savings. There were no differences in outcomes between the groups, suggesting equivalent safety, though larger studies powered to detect small differences are needed. Given its efficiency, convenience, and cost effectiveness, wall suction may be a superior method of ascites drainage for LVP.

16 CFR Figures 3 and 4 to Part 1204 - High Voltage Test Facility and Antenna System Test Setup

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false High Voltage Test Facility and Antenna System Test Setup 3 Figures 3 and 4 to Part 1204 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR OMNIDIRECTIONAL CITIZENS BAND BASE STATION ANTENNAS Pt. 1204, Figs. 3, 4 Figures 3 and 4...

Improving Elementary School Quality Through the Use of a Social-Emotional and Character Development Program: A Matched-Pair, Cluster-Randomized, Controlled Trial in Hawai’i

PubMed Central

Snyder, Frank J.; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J.; Flay, Brian R.

2012-01-01

BACKGROUND School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai’i trial included 20 racially/ethnically diverse schools and was conducted from 2002–2003 through 2005–2006. METHODS School-level archival data, collected by the Hawai’i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. RESULTS Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. CONCLUSIONS School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. PMID:22142170

Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i.

PubMed

Snyder, Frank J; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J; Flay, Brian R

2012-01-01

School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools and was conducted from 2002-2003 through 2005-2006. School-level archival data, collected by the Hawai'i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. © 2011, American School Health Association.

Topical colloidal silver as an anti-biofilm agent in a Staphylococcus aureus chronic rhinosinusitis sheep model.

PubMed

Rajiv, Sukanya; Drilling, Amanda; Bassiouni, Ahmed; James, Craig; Vreugde, Sarah; Wormald, Peter-John

2015-04-01

Treatment of recalcitrant chronic rhinosinusitis (CRS) is a challenge with increasing antibiotic resistance, leading to re-emergence of topical therapies. The aim of this study was to assess safety and efficacy of topical colloidal silver solution for the treatment of Staphylococcus aureus biofilms in a sheep model. In the safety study, normal saline (control) and 30-ppm colloidal silver solution (test) was used to flush the frontal sinuses for 14 days in 8 sheep (4 sheep each). In the efficacy study, following frontal sinus infection with Staphylococcus aureus, sheep were treated with either control saline or topical silver solution of varying concentrations (30 ppm/20 ppm/10 ppm/5 ppm) for 5 days, with 4 sheep in each group. Blood silver level, full blood counts, and biochemical parameters were analyzed in both safety and efficacy studies. Sinus tissue was harvested for histological examination and ciliary structure analysis in safety and for biofilm biomass quantification by fluorescence in situ hybridization (FISH) technique and COMSTAT 2 software in the efficacy study. Results were analyzed using appropriate statistical tests. Sheep treated with silver showed a significant decrease in biofilm biomass (0.004, 0.004, 0.004, and 0.007, in the 4 silver-treated groups, respectively) compared to saline control (0.175), p < 0.001. Although average blood silver levels were higher in the treated groups compared to controls (p < 0.05), blood counts and biochemical parameters were normal. Histology and ciliary structure analysis did not show any difference between control and treatment groups. Topical colloidal silver solution has effective antibiofilm activity in Staphylococcus aureus CRS in a sheep model and appears safe. © 2015 ARS-AAOA, LLC.

The S.A.C.S. (Satisfaction-Anatomy-Continence-Safety) score for evaluating pelvic organ prolapse surgery: a proposal for an outcome-based scoring system.

PubMed

Mearini, Luigi; Zucchi, Alessandro; Nunzi, Elisabetta; Di Biase, Manuel; Bini, Vittorio; Costantini, Elisabetta

2015-07-01

To date, there is no overall consensus on the definition of cure after surgery for pelvic organ prolapse (POP). The aim of the study was to design and test the scoring system S.A.C.S. (Satisfaction-Anatomy-Continence-Safety) to assess and compare the outcomes of POP repair. A total of 233 women underwent open sacrocolpopexy. The S.A.C.S. outcome scoring system was scheduled at 24 months of follow-up, and each component was detected according to: Satisfaction by mean of Patient Global Improvement Inventory scale, Anatomy by mean of POP Quantification system and bulge symptom, Continence by mean of pad use, and Safety by mean of the Clavien-Dindo classification of surgical complications. Each component produced a binary nominal categorical variable (1 or 0), with a total score of 4 representing cure. As a comparative tool, patients answered a simple yes/no question: "If you had to undergo surgery all over again, would you still do it?". The degree of concordance was estimated using Cohen's Kappa test. According to the S.A.C.S. scoring system, only 160 patients (68.6 %) reached the maximum score of cure. Sensitivity of the S.A.C.S. score was 74.1 %, specificity was 90 %, total diagnostic capacity was 75.5 %. The S.A.C.S. score internal consistency was good; the k-coefficient was higher for the satisfaction component of the score (k = 0.560). This study proposes an original, simple post-operative scoring system integrating satisfaction, anatomy, continence, and safety reports for patients undergoing surgery for POP, providing a complete, although perfectible, method to accurately report outcomes in all clinical scenarios.

Accuracy and Safety of External Ventricular Drain Placement by Physician Assistants and Nurse Practitioners in Aneurysmal Acute Subarachnoid Hemorrhage.

PubMed

Enriquez-Marulanda, Alejandro; Ascanio, Luis C; Salem, Mohamed M; Maragkos, Georgios A; Jhun, Ray; Alturki, Abdulrahman Y; Moore, Justin M; Ogilvy, Christopher S; Thomas, Ajith J

2018-06-11

In the current dynamic health environment, increasing number of procedures are being completed by advanced practitioners (nurse practitioners and physician assistants). This is the first study to assess the clinical outcomes and safety of external ventricular drain (EVD) placements by specially trained advanced practitioners. Compare the safety and outcomes of EVD placement by advanced practitioners in patients with subarachnoid hemorrhage (SAH). A cohort comparison study was performed from an aneurysmal SAH database selecting patients treated with EVD from a single major academic institution in the USA between June 2007 and June 2017. Safety, accuracy, and complications of EVD placement were compared between advanced practitioners and neurosurgical physicians (attending neurosurgeon and subspecialty clinical fellow). Statistical analysis was performed using the Mann-Whitney test for continuous variables and χ 2 test for categorical variables, with p values set at < 0.05 for significance. We identified 203 patients for this cohort with 238 EVD placements; eighty-seven (36.6%) placements were performed by advanced practitioners and 151 (63.4%) by neurosurgeons. Most of the ventriculostomies were placed in the emergency room (n = 114; 47.9%). Additional procedures performed concurrently with the EVD placements were significantly higher among the physicians' group (21.8 vs. 4.6%; p < 0.001). Bedside placement and usage of Ghajar guide were significantly higher among advanced practitioner's (58.3 vs. 98.9 and 9.9 vs. 64.4%, respectively, with a p < 0.001 for both). There were, however, no significant differences in terms of the number of attempts for insertion, intraprocedural complications, tract hemorrhages, accuracy, infection rates, catheter dislodgments, and need for repositioning/replacement of EVD. After appropriate training, EVD placement can be safely performed by advanced practitioners with an adequate accuracy of placement.

[Use of complementary tests in emergencies and their relation with patient safety incidents].

PubMed

Alcaraz-Martínez, J; Aranaz-Andrés, J M; Cantero-Sandoval, A; Piñera-Salmerón, P; Mas-Luzón, J; Serrano-Martínez, J A; González Garro, E

To analyse the use of complementary tests and their relationship with safety incidents in hospital emergency departments. An analysis was performed on 935 patients seen in the 9 hospital emergency departments. The source of data used for the detection of incidents were: emergency department clinical record and reports, together with face-to-face observation in the department, plus a telephone survey of the patient or family member at one week after the care. Statistical tests used: The Student t test for quantitative variables, Chi squared test for qualitative variables, and the ANOVA test. A peripheral venous catheter was used in 397 patients (42.4% (95% CI; 39.3-45.5%)), with a variability with significant differences between hospitals (P<.01), with a range of use from 37% to 81.8%. It was also observed that in 23.4% (95% CI; 19.2-27.6%) of the cases, the catheter was not used after the first blood draw. Radiological tests were requested for 351 patients, 37.7% (95% CI; 34.6-40.8%), also with significant differences between hospitals (P<.01), ranging from 24.6 to 65, 1%. Incidents were detected in 95 (10.2%) patients (95% CI; 8.3-12.1%) in the all the study centres. A higher proportion of safety incidents have been observed in patients where peripheral venous catheter has been used (12.8%) than in those in whom they had not been used (8.5%) (P=.03), as well as in patients on whom an x-ray was requested (12.8%) compared to those who did not (8.64%) (P=.04). A longer stay was also observed in cases with an incident (mean 248.9minutes) than in those where there were none (mean 164.1minutes) (P<.001). No statistically significant differences were found in the other parameters studied. A relationship was observed between the use of a peripheral venous catheter (many of them without use) and radiological tests and the occurrence of safety incidents in the Emergency Departments. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Adjustable bipod flexures for mounting mirrors in a space telescope.

PubMed

Kihm, Hagyong; Yang, Ho-Soon; Moon, Il Kweon; Yeon, Jeong-Heum; Lee, Seung-Hoon; Lee, Yun-Woo

2012-11-10

A new mirror mounting technique applicable to the primary mirror in a space telescope is presented. This mounting technique replaces conventional bipod flexures with flexures having mechanical shims so that adjustments can be made to counter the effects of gravitational distortion of the mirror surface while being tested in the horizontal position. Astigmatic aberration due to the gravitational changes is effectively reduced by adjusting the shim thickness, and the relation between the astigmatism and the shim thickness is investigated. We tested the mirror interferometrically at the center of curvature using a null lens. Then we repeated the test after rotating the mirror about its optical axis by 180° in the horizontal setup, and searched for the minimum system error. With the proposed flexure mount, the gravitational stress at the adhesive coupling between the mirror and the mount is reduced by half that of a conventional bipod flexure for better mechanical safety under launch loads. Analytical results using finite element methods are compared with experimental results from the optical interferometer. Vibration tests verified the mechanical safety and optical stability, and qualified their use in space applications.

Decreasing Malpractice Claims by Reducing Preventable Perinatal Harm.

PubMed

Riley, William; Meredith, Les W; Price, Rebecca; Miller, Kristi K; Begun, James W; McCullough, Mac; Davis, Stanley

2016-12-01

To evaluate the association of improved patient safety practices with medical malpractice claims and costs in the perinatal units of acute care hospitals. Malpractice and harm data from participating hospitals; litigation records and medical malpractice claims data from American Excess Insurance Exchange, RRG, whose data are managed by Premier Insurance Management Services, Inc. (owned by Premier Inc., a health care improvement company). A quasi-experimental prospective design to compare baseline and postintervention data. Statistical significance tests for differences were performed using chi-square, Wilcoxon signed-rank test, and t-test. Claims data were collected and evaluated by experienced senior claims managers through on-site claim audits to evaluate claim frequency, severity, and financial information. Data were provided to the analyzing institution through confidentiality contracts. There is a significant reduction in the number of perinatal malpractice claims paid, losses paid, and indemnity payments (43.9 percent, 77.6 percent, and 84.6 percent, respectively) following interventions to improve perinatal patient safety and reduce perinatal harm. This compares with no significant reductions in the nonperinatal claims in the same hospitals during the same time period. The number of perinatal malpractice claims and dollar amount of claims payments decreased significantly in the participating hospitals, while there was no significant decrease in nonperinatal malpractice claims activity in the same hospitals. © Health Research and Educational Trust.

Improving Exercise Performance with an Accelerometer-Based Smartphone App: A Randomized Controlled Trial.

PubMed

Bittel, Daniel C; Bittel, Adam J; Williams, Christine; Elazzazi, Ashraf

2017-05-01

Proper exercise form is critical for the safety and efficacy of therapeutic exercise. This research examines if a novel smartphone application, designed to monitor and provide real-time corrections during resistance training, can reduce performance errors and elicit a motor learning response. Forty-two participants aged 18 to 65 years were randomly assigned to treatment and control groups. Both groups were tested for the number of movement errors made during a 10-repetition set completed at baseline, immediately after, and 1 to 2 weeks after a single training session of knee extensions. The treatment group trained with real-time, smartphone-generated feedback, whereas the control subjects did not. Group performance (number of errors) was compared across test sets using a 2-factor mixed-model analysis of variance. No differences were observed between groups for age, sex, or resistance training experience. There was a significant interaction between test set and group. The treatment group demonstrated fewer errors on posttests 1 and 2 compared with pretest (P < 0.05). There was no reduction in the number of errors on any posttest for control subjects. Smartphone apps, such as the one used in this study, may enhance patient supervision, safety, and exercise efficacy across rehabilitation settings. A single training session with the app promoted motor learning and improved exercise performance.

16 CFR § 1213.4 - Test methods.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Test methods. § 1213.4 Section § 1213.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR ENTRAPMENT HAZARDS IN BUNK BEDS § 1213.4 Test methods. (a) Guardrails (see § 1213.3(a)(6...

16 CFR Figure 9 to Part 1203 - Impact Test Apparatus

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Impact Test Apparatus 9 Figure 9 to Part 1203 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Pt. 1203, Fig. 9 Figure 9 to Part 1203—Impact Test Apparatus ER10MR98...

16 CFR Figure 9 to Part 1203 - Impact Test Apparatus

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Impact Test Apparatus 9 Figure 9 to Part 1203 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Pt. 1203, Fig. 9 Figure 9 to Part 1203—Impact Test Apparatus ER10MR98...

Assuring the safety of genetically modified (GM) foods: the importance of an holistic, integrative approach.

PubMed

Cockburn, Andrew

2002-09-11

Genes change continuously by natural mutation and recombination enabling man to select and breed crops having the most desirable traits such as yield or flavour. Genetic modification (GM) is a recent development which allows specific genes to be identified, isolated, copied and inserted into other plants with a high level of specificity. The food safety considerations for GM crops are basically the same as those arising from conventionally bred crops, very few of which have been subject to any testing yet are generally regarded as being safe to eat. In contrast a rigorous safety testing paradigm has been developed for GM crops, which utilises a systematic, stepwise and holistic approach. The resultant science based process, focuses on a classical evaluation of the toxic potential of the introduced novel trait and the wholesomeness of the transformed crop. In addition, detailed consideration is given to the history and safe use of the parent crop as well as that of the gene donor. The overall safety evaluation is conducted under the concept known as substantial equivalence which is enshrined in all international crop biotechnology guidelines. This provides the framework for a comparative approach to identify the similarities and differences between the GM product and its comparator which has a known history of safe use. By building a detailed profile on each step in the transformation process, from parent to new crop, and by thoroughly evaluating the significance from a safety perspective, of any differences that may be detected, a very comprehensive matrix of information is constructed which enables the conclusion as to whether the GM crop, derived food or feed is as safe as its traditional counterpart. Using this approach in the evaluation of more than 50 GM crops which have been approved worldwide, the conclusion has been that foods and feeds derived from genetically modified crops are as safe and nutritious as those derived from traditional crops. The lack of any adverse effects resulting from the production and consumption of GM crops grown on more than 300 million cumulative acres over the last 5 years supports these safety conclusions.

Reliability enhancement of APR + diverse protection system regarding common cause failures

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

Oh, Y. G.; Kim, Y. M.; Yim, H. S.

2012-07-01

The Advanced Power Reactor Plus (APR +) nuclear power plant design has been developed on the basis of the APR1400 (Advanced Power Reactor 1400 MWe) to further enhance safety and economics. For the mitigation of Anticipated Transients Without Scram (ATWS) as well as Common Cause Failures (CCF) within the Plant Protection System (PPS) and the Emergency Safety Feature - Component Control System (ESF-CCS), several design improvement features have been implemented for the Diverse Protection System (DPS) of the APR + plant. As compared to the APR1400 DPS design, the APR + DPS has been designed to provide the Safety Injectionmore » Actuation Signal (SIAS) considering a large break LOCA accident concurrent with the CCF. Additionally several design improvement features, such as channel structure with redundant processing modules, and changes of system communication methods and auto-system test methods, are introduced to enhance the functional reliability of the DPS. Therefore, it is expected that the APR + DPS can provide an enhanced safety and reliability regarding possible CCF in the safety-grade I and C systems as well as the DPS itself. (authors)« less

Healthy Choices for Every Body Adult Curriculum Improves Participants' Food Resource Management Skills and Food Safety Practices.

PubMed

Adedokun, Omolola A; Plonski, Paula; Jenkins-Howard, Brooke; Cotterill, Debra B; Vail, Ann

2018-06-01

To evaluate the impact of the University of Kentucky's Healthy Choices for Every Body (HCEB) adult nutrition education curriculum on participants' food resource management (FRM) skills and food safety practices. A quasi-experimental design was employed using propensity score matching to pair 8 intervention counties with 8 comparison counties. Independent-samples t tests and ANCOVA models compared gains in FRM skills and food safety practices between the intervention and comparison groups (n = 413 and 113, respectively). Propensity score matching analysis showed a statistical balance and similarities between the comparison and intervention groups. Food resource management and food safety gain scores were statistically significantly higher for the intervention group (P < .001), with large effect sizes (d = 0.9) for both variables. The group differences persisted even after controlling for race and age in the ANCOVA models. The HCEB curriculum was effective in improving the FRM skills and food safety practices of participants. Copyright © 2018 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Maintenance of safety behaviors via response-produced stimuli.

PubMed

Angelakis, Ioannis; Austin, Jennifer L

2015-11-01

Animal studies suggest that safety behaviors may be maintained by internally or externally produced safety signals, which function as positive reinforcers. We designed two experiments to test this phenomenon with humans. Participants played a computerized game in which they could earn or lose treasures by clicking on a map. In baseline, losses could be postponed by pressing a pedal that also produced a blue bar at the bottom of the screen. During test conditions, no losses were programmed, and pedal presses turned the bar from yellow to blue (Test 1) or blue to yellow (Test 2). In Experiment 2, new participants were exposed to the same conditions but were given information about the safety of the test environment. In both experiments, participants engaged in high rates of pedal pressing when presses were followed by blue bars, suggesting the bar functioned as a safety signal. We discuss how these findings may relate to safety behaviors commonly observed in certain mental health disorders. © The Author(s) 2015.

The Inside Information about Safety Surfacing.

ERIC Educational Resources Information Center

Thompson, Donna; Hudson, Susan

2003-01-01

Tested the impact attenuation characteristics of safety surfaces used in indoor child care play settings. Found that the most common surfaces used were indoor/outdoor carpet, various types of mats, and safety floor tiles. Nearly 60 percent of tested materials had a critical fall height of 1 foot or less. Concluded that carpet, safety tile, and…

Safety culture assessment in petrochemical industry: a comparative study of two algerian plants.

PubMed

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-06-01

To elucidate the relationship between safety culture maturity and safety performance of a particular company. To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

Safety Culture Assessment in Petrochemical Industry: A Comparative Study of Two Algerian Plants

PubMed Central

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-01-01

Background To elucidate the relationship between safety culture maturity and safety performance of a particular company. Methods To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. Results The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. Conclusion The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance. PMID:25180135

Comprehension of hazard communication: effects of pictograms on safety data sheets and labels.

PubMed

Boelhouwer, Eric; Davis, Jerry; Franco-Watkins, Ana; Dorris, Nathan; Lungu, Claudiu

2013-09-01

The United Nations has proposed the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals to make hazard communication more uniform and to improve comprehension. Two experiments were conducted to test whether the addition of hazard and precautionary pictograms to safety data sheets and product labels would improve the transfer of information to users compared to safety data sheets and product labels containing text only. Additionally, naïve users, workers, and experts were tested to determine any potential differences among users. The effect of adding pictograms to safety data sheets and labels was statistically significant for some conditions, but was not significant across all conditions. One benefit of the addition of pictograms was that the time to respond to the survey questions decreased when the pictograms were present for both the SDS and the labels. GHS format SDS and labels do provide benefits to users, but the system will need further enhancements and modifications to continue to improve the effectiveness of hazard communication. The final rule to modify the HCS to include the Globally Harmonized System (GHS) for the Classification and Labelling of Chemicals announced by OSHA (2012b) will change the information content of every chemical SDS and label used in commerce. This study suggests that the inclusion of GHS hazard pictograms and precautionary pictograms to SDS and labels may benefit the user. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Assessing Knowledge Retention of an Immersive Serious Game vs. a Traditional Education Method in Aviation Safety.

PubMed

Chittaro, Luca; Buttussi, Fabio

2015-04-01

Thanks to the increasing availability of consumer head-mounted displays, educational applications of immersive VR could now reach to the general public, especially if they include gaming elements (immersive serious games). Safety education of citizens could be a particularly promising domain for immersive serious games, because people tend not to pay attention to and benefit from current safety materials. In this paper, we propose an HMD-based immersive game for educating passengers about aviation safety that allows players to experience a serious aircraft emergency with the goal of surviving it. We compare the proposed approach to a traditional aviation safety education method (the safety card) used by airlines. Unlike most studies of VR for safety knowledge acquisition, we do not focus only on assessing learning immediately after the experience but we extend our attention to knowledge retention over a longer time span. This is a fundamental requirement, because people need to retain safety procedures in order to apply them when faced with danger. A knowledge test administered before, immediately after and one week after the experimental condition showed that the immersive serious game was superior to the safety card. Moreover, subjective as well as physiological measurements employed in the study showed that the immersive serious game was more engaging and fear-arousing than the safety card, a factor that can contribute to explain the obtained superior retention, as we discuss in the paper.

Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial.

PubMed

Overton, Edgar Turner; Stapleton, Jack; Frank, Ian; Hassler, Shawn; Goepfert, Paul A; Barker, David; Wagner, Eva; von Krempelhuber, Alfred; Virgin, Garth; Meyer, Thomas Peter; Müller, Jutta; Bädeker, Nicole; Grünert, Robert; Young, Philip; Rösch, Siegfried; Maclennan, Jane; Arndtz-Wiedemann, Nathaly; Chaplin, Paul

2015-04-01

Background.  First- and second-generation smallpox vaccines are contraindicated in individuals infected with human immunodeficiency virus (HIV). A new smallpox vaccine is needed to protect this population in the context of biodefense preparedness. The focus of this study was to compare the safety and immunogenicity of a replication-deficient, highly attenuated smallpox vaccine modified vaccinia Ankara (MVA) in HIV-infected and healthy subjects. Methods.  An open-label, controlled Phase II trial was conducted at 36 centers in the United States and Puerto Rico for HIV-infected and healthy subjects. Subjects received 2 doses of MVA administered 4 weeks apart. Safety was evaluated by assessment of adverse events, focused physical exams, electrocardiogram recordings, and safety laboratories. Immune responses were assessed using enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT). Results.  Five hundred seventy-nine subjects were vaccinated at least once and had data available for analysis. Rates of ELISA seropositivity were comparably high in vaccinia-naive healthy and HIV-infected subjects, whereas PRNT seropositivity rates were higher in healthy compared with HIV-infected subjects. Modified vaccinia Ankara was safe and well tolerated with no adverse impact on viral load or CD4 counts. There were no cases of myo-/pericarditis reported. Conclusions.  Modified vaccinia Ankara was safe and immunogenic in subjects infected with HIV and represents a promising smallpox vaccine candidate for use in immunocompromised populations.

Investigating the relationship between jobs-housing balance and traffic safety.

PubMed

Xu, Chengcheng; Li, Haojie; Zhao, Jingya; Chen, Jun; Wang, Wei

2017-10-01

This study aimed to investigate the effects of jobs-housing balance on traffic safety. The crash, demographic characteristics, employment, road network, household characteristics and traffic data were collected from the Los Angeles in 2010. One-way ANOVA tests indicated that the jobs-housing ratio significantly affects traffic safety in terms of crash frequency at traffic analysis zone (TAZ). To quantify the safety impacts of jobs-housing balance, the semi-parametric geographically weighted Poisson regression (S-GWPR) was further used to link crash frequency at TAZ with jobs-housing ratio and other contributing factors. The S-GWPR provides better fitness to the data than do the generalized linear regression, as the S-GWPR accounts for the spatial heterogeneity. The S-GWPR results showed that the jobs-housing relationship has a significant association with crash frequency at TAZ when the factors of traffic, network, and household characteristics are controlled. Crash frequency at TAZ level increases with an increase in the jobs-housing ratio. To further investigate the interactive effects between jobs-housing ratio and other factors, a comparative analysis was conducted to compare the variable elasticities under different jobs-housing ratios. The results indicate considerable interactive effects that traffic conditions and road network characteristics have different effects on crash frequency under various jobs-housing ratios. Copyright © 2017 Elsevier Ltd. All rights reserved.

Simulation of crash tests for high impact levels of a new bridge safety barrier

NASA Astrophysics Data System (ADS)

Drozda, Jiří; Rotter, Tomáš

2017-09-01

The purpose is to show the opportunity of a non-linear dynamic impact simulation and to explain the possibility of using finite element method (FEM) for developing new designs of safety barriers. The main challenge is to determine the means to create and validate the finite element (FE) model. The results of accurate impact simulations can help to reduce necessary costs for developing of a new safety barrier. The introductory part deals with the creation of the FE model, which includes the newly-designed safety barrier and focuses on the application of an experimental modal analysis (EMA). The FE model has been created in ANSYS Workbench and is formed from shell and solid elements. The experimental modal analysis, which was performed on a real pattern, was employed for measuring the modal frequencies and shapes. After performing the EMA, the FE mesh was calibrated after comparing the measured modal frequencies with the calculated ones. The last part describes the process of the numerical non-linear dynamic impact simulation in LS-DYNA. This simulation was validated after comparing the measured ASI index with the calculated ones. The aim of the study is to improve professional public knowledge about dynamic non-linear impact simulations. This should ideally lead to safer, more accurate and profitable designs.

Safety and Suitability for Service Assessment Testing for Aircraft Launched Munitions

DTIC Science & Technology

2013-07-01

2013 12 benefits in terms of cost and test efficiency that tend to associate the Analytical S3 Test Approach with complex missile systems and the... systems containing expensive, non-safety related components. c. When using the Analytical S3 Test Approach for aircraft launched bombs, full BTCA is...establish safety margin of the system . Details of the Empirical Test Flow with full and reduced BTCA options are provided in Appendix B, Annexes 3 and

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.

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

PubMed

Teoh, Eric R; Kidd, David G

2017-12-01

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

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

PubMed Central

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

2013-01-01

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

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

PubMed

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

2013-01-01

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

Rural roadway safety perceptions among rural teen drivers living in and outside of towns.

PubMed

Ramirez, Marizen; Roth, Lisa; Young, Tracy; Peek-Asa, Corinne

2013-01-01

To compare perceptions about rural road and general driving behaviors between teens who live in- and out-of-town from rural communities in Iowa. A cross-sectional survey was conducted with 160 teens anticipating their Intermediate License within 3 months upon enrollment into this study. Self-administered surveys were used to collect demographics and driving exposures (eg, frequency of driving, age when first drove unsupervised). Two Likert scales were included to measure agreement with safe driving behaviors on rural roads and general safe driving behaviors (eg, speeding, seat belt use). T-tests were calculated comparing mean composite scores between in- and out-of-town teens, and between mean rural road and general driving safety attitude scores. A linear regression multivariable model was constructed to identify predictors of the rural road score. While the majority of teens endorsed rural road and general safe driving behaviors, up to 40% did not. Thirty-two percent did not believe the dangers of animals on rural roads, and 40% disagreed that exceeding the speed limit is dangerous. In-town teens were less safety conscious about rural road hazards with a significantly lower mean composite score (4.4) than out-of-town teens (4.6); mean scores for general driving behaviors were similar. Living out-of-town and owning one's own car were significant predictors of increased rural road safety scores. Rural, in-town teens have poorer safety attitudes about rural roadway hazards compared with out-of-town teens. Interventions that involve education, parental supervision, and practice on rural roads are critical for preventing teen crashes on rural roads. No claim to original US government works.

Study on the immunological safety of universal plasma in the Chinese population in vitro.

PubMed

Chen, Guanyi; Zhu, Liguo; Wang, Shufang; Zhuang, Yuan; Yu, Yang; Wang, Deqing

2017-04-01

The prepared procedure for universal plasma in the Chinese population has been developed. However, the immunological safety with the level of antibodies, soluble immune complexes and complements is necessary to investigate. The universal plasma was pooled at the optimal ratio of A:B:AB=6:2.5:1.5 at 22°C for 1 hour. The titer of IgM antibodies was detected by saline agglutination, and the titer of IgG antibodies was detected by a Polybrene test after IgM destroyed by 2-mereaptoethanol. The hemolysis extent of RBC was investigated by an extracorporal hemolysis test, and the concentration of free-hemoglobin was determined by the ortho-tolidine method. The levels of CIC-C1q, C3b and TCC (C5-9) were tested using an enzyme linked immunosorbent assay (ELISA). The titer of IgM and IgG in universal plasma was lower than 2 and 4, respectively. The hemolysis of the universal plasma with A, B and AB group RBCs was negative with values of 5.5, 6.8 and 5.7, respectively. The level of CIC-C1q and TCC (C5-9) in universal plasma was comparable to that in A or B type pooled plasma, but CIC-C1q was lower than that and TCC (C5-9) was higher than that in AB type pooled plasma. The level of complement C3b was comparable to that in A type pooled plasma, but lower than that in B type pooled plasma and higher than that in AB type pooled plasma. The results of this study demonstrated that the immunological levels were within an acceptable range and confirmed the safety in vitro. Copyright © 2016 Elsevier Ltd. All rights reserved.

Proceedings of Cabin Safety Conference and Workshop Held on December 11-14, 1984.

DTIC Science & Technology

1985-08-01

Department of Transportation in the interest of information exchange. The United States Govern- - ment assumes no liability for its contents or use ...presently used FR urethane foam. Tests were also performed to study and compare the behavior of FR cushions with various blocking layers. The tests were... guinea pigs in front of such a large audience. (Pause: As cast returns to seats) Now, let’s get back to the real world. The FAA’s recent staff study

Performance of a New HPV Cervi-Collect Collection and Transportation Kit

PubMed Central

Chernesky, M.; Huang, S.; Jang, D.; Erickson, B.; Salituro, J.; Engel, H.; Gilchrist, J.; Neuscheler, P.; Mak, W. B.; Abravaya, K.

2012-01-01

Background. Liquid-based Pap (L-Pap) media are used for Pap and human papillomavirus (HPV) testing. Objectives. To compare RealTime High Risk (HR) HPV testing of a new collection kit (Cervi-Collect) and PreservCyt L-Pap specimens. To determine ease of use and safety of Cervi-Collect. Methods. L-Pap samples (n = 203) were tested with HC2 and RealTime HR HPV and Cervi-Collect with RealTime HR HPV. Discordant samples were genotyped. Results. L-Pap and Cervi-Collect specimens tested by RealTime HR HPV showed 93.1% agreement (Kappa 0.86). RealTime HR HPV and HC2 on L-Pap had 90.3% agreement (Kappa 0.80). RealTime HR HPV on Cervi-Collect and HC2 on L-Pap showed 88.2% agreement (Kappa 0.76). Sixteen of 21 samples which were HC2 negative and RealTime HR HPV positive on L-Pap or Cervi-Collect contained HR HPV genotypes. Eleven healthcare collectors were in strong agreement on a usability and safety questionnaire. Conclusion. Cervi-Collect samples were easy to collect and showed strong agreement with L-Pap samples tested with RealTime HR HPV or HC2. PMID:22174716

Crash Testing in the Lab: Putting a New Stop to the CO2 Car!

ERIC Educational Resources Information Center

Decker, Rob

2005-01-01

Every year in the United States, the federal government, insurance companies and automobile manufacturers wreck hundreds of cars for safety-testing purposes. All this crashing comes in an effort to rate vehicular safety for the public. Inspired by numerous movies with car chases, dramatic wrecks and television commercials showing car safety tests,…

16 CFR 1209.36 - Production testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

76 FR 72929 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... proposed information collection project: ``Medical Office Survey on Patient Safety Culture Comparative... Medical Office Survey on Patient Safety Culture Comparative Database. The Agency for Healthcare Research... Patient Safety Culture (Medical Office SOPS) Comparative Database. The Medical Office SOPS Comparative...

SAFETY GUIDES FOR YOU--IN THE PRIMARY GRADES.

ERIC Educational Resources Information Center

WALKER, LUVERNE CRABTREE

THIS SAFETY INSTRUCTIONAL GUIDE FOR PRIMARY-GRADE TEACHERS PRESENTS NINE DIFFERENT SAFETY UNITS, INCLUDING TRAFFIC SAFETY, PLAYTIME SAFETY, SAFE EATING AND DRINKING HABITS, SAFE CLOTHING, HOME SAFETY, ANIMAL SAFETY, CIVIL DEFENSE SECURITY, AND TESTING SAFETY PRACTICES. EACH UNIT STRESSES THE REASONS FOR ACCENTING SAFETY, WHAT TO KNOW AND DO, AND…

Non-clinical and Pre-clinical Testing to Demonstrate Safety of the Barostim Neo Electrode for Activation of Carotid Baroreceptors in Chronic Human Implants

PubMed Central

Wilks, Seth J.; Hara, Seth A.; Ross, Erika K.; Nicolai, Evan N.; Pignato, Paul A.; Cates, Adam W.; Ludwig, Kip A.

2017-01-01

The Barostim neo™ electrode was developed by CVRx, Inc.to deliver baroreflex activation therapy (BAT)™ to treat hypertension and heart failure. The neo electrode concept was designed to deliver electrical stimulation to the baroreceptors within the carotid sinus bulb, while minimizing invasiveness of the implant procedure. This device is currently CE marked in Europe, and in a Pivotal (akin to Phase III) Trial in the United States. Here we present the in vitro and in vivo safety testing that was completed in order to obtain necessary regulatory approval prior to conducting human studies in Europe, as well as an FDA Investigational Device Exemption (IDE) to conduct a Pivotal Trial in the United States. Stimulated electrodes (10 mA, 500 μs, 100 Hz) were compared to unstimulated electrodes using optical microscopy and several electrochemical techniques over the course of 27 weeks. Electrode dissolution was evaluated by analyzing trace metal content of solutions in which electrodes were stimulated. Lastly, safety testing under Good Laboratory Practice guidelines was conducted in an ovine animal model over a 12 and 24 week time period, with results processed and evaluated by an independent histopathologist. Long-term stimulation testing indicated that the neo electrode with a sputtered iridium oxide coating can be stimulated at maximal levels for the lifetime of the implant without clinically significant dissolution of platinum or iridium, and without increasing the potential at the electrode interface to cause hydrolysis or significant tissue damage. Histological examination of tissue that was adjacent to the neo electrodes indicated no clinically significant signs of increased inflammation and no arterial stenosis as a result of 6 months of continuous stimulation. The work presented here involved rigorous characterization and evaluation testing of the neo electrode, which was used to support its safety for chronic implantation. The testing strategies discussed provide a starting point and proven framework for testing new neuromodulation electrode concepts to support regulatory approval for clinical studies. PMID:28824361

16 CFR 1204.15 - Qualification testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Qualification testing. 1204.15 Section 1204.15 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR OMNIDIRECTIONAL CITIZENS BAND BASE STATION ANTENNAS Certification § 1204.15...

16 CFR 1204.14 - Certification tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Certification tests. 1204.14 Section 1204.14 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR OMNIDIRECTIONAL CITIZENS BAND BASE STATION ANTENNAS Certification § 1204.14 Certification...

49 CFR 193.2321 - Nondestructive tests.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 3 2012-10-01 2012-10-01 false Nondestructive tests. 193.2321 Section 193.2321 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...

49 CFR 193.2321 - Nondestructive tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Nondestructive tests. 193.2321 Section 193.2321 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...

16 CFR 1210.14 - Qualification testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

....14 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.14 Qualification testing. (a... accordance with § 1210.4. (b) Product modifications. If any changes are made to a product after initial...

Lithium cell technology and safety report of the Tri-Service Lithium Safety Committee

NASA Technical Reports Server (NTRS)

Reiss, E.

1980-01-01

The organization of the Tri-Service Lithium Safety Committee is described. The following areas concerning lithium batteries are discussed: transportation--DOT Exemption 7052, FAA; disposal; storage; individual testing/test results; and battery design and usage.

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

Berardinelli, S.P.; Rusczek, R.A.; Mickelsen, R.L.

The National Institute for Occupational Safety and Health (NIOSH), in cooperation with Monsanto Chemical Company, conducted an on-site evaluation of chemical protective clothing at Monsanto's Nitro, West Virginia plant. The Monsanto plant manufactures additives for the rubber industry including antioxidants, pre-vulcanization inhibitors, accelerators, etc. This survey evaluated six raw materials that have a potential for skin absorption: aniline, cyclohexylamine, diisorpropylamine, tertiary butylamine, morpholine and carbon disulfide. Five generic glove materials were tested against these chemicals; nitrile, neoprene, polyvinylchloride, natural latex and natural rubber. The NIOSH chemical permeation portable test system was used to generate breakthrough time data. The results weremore » compared to permeation data reported in the literature that were obtained by using the ASTM F739-85 test method. The test data demonstrated that aniline has too low a vapor pressure for reliable analysis on the portable direct reading detectors used. The chemical permeation test system, however provided comparable, reliable permeation data for the other tested chemicals. Monsanto has used this data to better select chemical protective clothing for its intended use.« less

Prospective safety performance evaluation on construction sites.

PubMed

Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

2015-05-01

This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

Longitudinal safety evaluation of connected vehicles' platooning on expressways.

PubMed

Rahman, Md Sharikur; Abdel-Aty, Mohamed

2018-08-01

Connected vehicles (CV) technology has recently drawn an increasing attention from governments, vehicle manufacturers, and researchers. One of the biggest issues facing CVs popularization associates it with the market penetration rate (MPR). The full market penetration of CVs might not be accomplished recently. Therefore, traffic flow will likely be composed of a mixture of conventional vehicles and CVs. In this context, the study of CV MPR is worthwhile in the CV transition period. The overarching goal of this study was to evaluate longitudinal safety of CV platoons by comparing the implementation of managed-lane CV platoons and all lanes CV platoons (with same MPR) over non-CV scenario. This study applied the CV concept on a congested expressway (SR408) in Florida to improve traffic safety. The Intelligent Driver Model (IDM) along with the platooning concept were used to regulate the driving behavior of CV platoons with an assumption that the CVs would follow this behavior in real-world. A high-level control algorithm of CVs in a managed-lane was proposed in order to form platoons with three joining strategies: rear join, front join, and cut-in joint. Five surrogate safety measures, standard deviation of speed, time exposed time-to-collision (TET), time integrated time-to-collision (TIT), time exposed rear-end crash risk index (TERCRI), and sideswipe crash risk (SSCR) were utilized as indicators for safety evaluation. The results showed that both CV approaches (i.e., managed-lane CV platoons, and all lanes CV platoons) significantly improved the longitudinal safety in the studied expressway compared to the non-CV scenario. In terms of surrogate safety measures, the managed-lane CV platoons significantly outperformed all lanes CV platoons with the same MPR. Different time-to-collision (TTC) thresholds were also tested and showed similar results on traffic safety. Results of this study provide useful insight for the management of CV MPR as managed-lane CV platoons. Copyright © 2017 Elsevier Ltd. All rights reserved.

Certification of highly complex safety-related systems.

PubMed

Reinert, D; Schaefer, M

1999-01-01

The BIA has now 15 years of experience with the certification of complex electronic systems for safety-related applications in the machinery sector. Using the example of machining centres this presentation will show the systematic procedure for verifying and validating control systems using Application Specific Integrated Circuits (ASICs) and microcomputers for safety functions. One section will describe the control structure of machining centres with control systems using "integrated safety." A diverse redundant architecture combined with crossmonitoring and forced dynamization is explained. In the main section the steps of the systematic certification procedure are explained showing some results of the certification of drilling machines. Specification reviews, design reviews with test case specification, statistical analysis, and walk-throughs are the analytical measures in the testing process. Systematic tests based on the test case specification, Electro Magnetic Interference (EMI), and environmental testing, and site acceptance tests on the machines are the testing measures for validation. A complex software driven system is always undergoing modification. Most of the changes are not safety-relevant but this has to be proven. A systematic procedure for certifying software modifications is presented in the last section of the paper.

Structural Monitoring and Field Test for Kao Ping Hsi Cable-Stayed Bridge in Taiwan

NASA Astrophysics Data System (ADS)

Chen, Chern-Hwa

2010-05-01

This work applies system identification techniques to analyze the measured data from structural monitoring system and field test for Kao Ping Hsi cable-stayed bridge in Taiwan. The continuous wavelet transform algorithm can be used to identify the dynamic characteristics of the cable-stayed bridge under environmental vibration. The identified results with traffic flow were compared with those obtained from ambient vibration test. The excellent agreement both the identified results from different traffic conditions indicates that the traffic flow would not significantly change the natural frequencies of the cable-stayed bridge. The modal parameters identified from the field vibration test will be compared with those used in the finite element analysis. The results obtained herein will be used as the damage detection for monitoring the long-term safety of the Kao Ping Hsi cable-stayed bridge by using structural monitoring system.

Rocket propulsion hazard summary: Safety classification, handling experience and application to space shuttle payload

NASA Technical Reports Server (NTRS)

Pennington, D. F.; Man, T.; Persons, B.

1977-01-01

The DOT classification for transportation, the military classification for quantity distance, and hazard compatibility grouping used to regulate the transportation and storage of explosives are presented along with a discussion of tests used in determining sensitivity of propellants to an impact/shock environment in the absence of a large explosive donor. The safety procedures and requirements of a Scout launch vehicle, Western and Eastern Test Range, and the Minuteman, Delta, and Poseidon programs are reviewed and summarized. Requirements of the space transportation system safety program include safety reviews from the subsystem level to the completed payload. The Scout safety procedures will satisfy a portion of these requirements but additional procedures need to be implemented to comply with the safety requirements for Shuttle operation from the Eastern Test Range.

AGRICULTURAL CHEMICAL SAFETY ASSESSMENT: A MULTISECTOR APPROACH TO THE MODERNIZATION OF HUMAN SAFETY REQUIREMENTS.

EPA Science Inventory

Better understanding of toxicological mechanisms, enhanced testing capabilities, and demands for more sophisticated data for safety and health risk assessment have generated international interest in improving the current testing paradigm for agricultural chemicals. To address th...

Ending the use of animals in toxicity testing and risk evaluation.

PubMed

Rowan, Andrew N

2015-10-01

This article discusses the use of animals for the safety testing of chemicals, including pharmaceuticals, household products, pesticides, and industrial chemicals. It reviews changes in safety testing technology and what those changes mean from the perspective of industrial innovation, public policy and public health, economics, and ethics. It concludes that the continuing use of animals for chemical safety testing should end within the decade as cheaper, quicker, and more predictive technologies are developed and applied.

14 CFR 417.115 - Tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Tests. 417.115 Section 417.115 Aeronautics... TRANSPORTATION LICENSING LAUNCH SAFETY Launch Safety Responsibilities § 417.115 Tests. (a) General. All flight... re-testing necessary to ensure reliable operation. A launch operator must— (1) Coordinate test plans...

14 CFR 417.115 - Tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Tests. 417.115 Section 417.115 Aeronautics... TRANSPORTATION LICENSING LAUNCH SAFETY Launch Safety Responsibilities § 417.115 Tests. (a) General. All flight... re-testing necessary to ensure reliable operation. A launch operator must— (1) Coordinate test plans...

14 CFR 417.115 - Tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Tests. 417.115 Section 417.115 Aeronautics... TRANSPORTATION LICENSING LAUNCH SAFETY Launch Safety Responsibilities § 417.115 Tests. (a) General. All flight... re-testing necessary to ensure reliable operation. A launch operator must— (1) Coordinate test plans...

14 CFR 417.115 - Tests.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Tests. 417.115 Section 417.115 Aeronautics... TRANSPORTATION LICENSING LAUNCH SAFETY Launch Safety Responsibilities § 417.115 Tests. (a) General. All flight... re-testing necessary to ensure reliable operation. A launch operator must— (1) Coordinate test plans...

14 CFR 417.115 - Tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Tests. 417.115 Section 417.115 Aeronautics... TRANSPORTATION LICENSING LAUNCH SAFETY Launch Safety Responsibilities § 417.115 Tests. (a) General. All flight... re-testing necessary to ensure reliable operation. A launch operator must— (1) Coordinate test plans...

24 CFR 3280.209 - Fire testing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Fire testing. 3280.209 Section 3280... DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.209 Fire testing. All fire testing conducted in accordance with this subpart shall be performed by nationally recognized testing...

24 CFR 3280.209 - Fire testing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Fire testing. 3280.209 Section 3280... DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.209 Fire testing. All fire testing conducted in accordance with this subpart shall be performed by nationally recognized testing...

24 CFR 3280.209 - Fire testing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Fire testing. 3280.209 Section 3280... DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.209 Fire testing. All fire testing conducted in accordance with this subpart shall be performed by nationally recognized testing...

24 CFR 3280.209 - Fire testing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Fire testing. 3280.209 Section 3280... DEVELOPMENT MANUFACTURED HOME CONSTRUCTION AND SAFETY STANDARDS Fire Safety § 3280.209 Fire testing. All fire testing conducted in accordance with this subpart shall be performed by nationally recognized testing...

Initial Efficacy of a Cardiac Rehabilitation Transition Program: Cardiac TRUST

PubMed Central

Zullo, Melissa; Boxer, Rebecca; Moore, Shirley M.

2012-01-01

Patients recovering from cardiac events are increasingly using postacute care, such as home health care and skilled nursing facility services. The purpose of this pilot study was to test the initial efficacy, feasibility, and safety of a specially designed postacute care transitional rehabilitation intervention for cardiac patients. Cardiac Transitional Rehabilitation Using Self- Management Techniques (Cardiac TRUST) is a family-focused intervention that includes progressive low-intensity walking and education in self-management skills to facilitate recovery following a cardiac event. Using a randomized two-group design, exercise self-efficacy, steps walked, and participation in an outpatient cardiac rehabilitation program were compared in a sample of 38 older adults; 17 who received the Cardiac TRUST program and 21 who received usual care only. At discharge from postacute care, the intervention group had a trend for higher levels of self-efficacy for exercise outcomes (X=39.1, SD=7.4) than the usual care group (X=34.5; SD=7.0) (t-test 1.9, p=.06). During the 6 weeks following discharge, compared with the usual care group, the intervention group had more attendance in out-patient cardiac rehabilitation (33% compared to 11.8%, F=7.1, p=.03) and a trend toward more steps walked during the first week (X=1,307, SD=652 compared to X=782, SD=544, t-test 1.8, p=.07). The feasibility of the intervention was better for the home health participants than for those in the skilled nursing facility and there were no safety concerns. The provision of cardiac-focused rehabilitation during postacute care has the potential to bridge the gap in transitional services from hospitalization to outpatient cardiac rehabilitation for these patients at high risk for future cardiac events. Further evidence of the efficacy of Cardiac TRUST is warranted. PMID:22084960

Safety and efficacy of antioxidants-loaded nanoparticles for an anti-aging application.

PubMed

Felippi, Cândice C; Oliveira, Dileusa; Ströher, Alessandra; Carvalho, Anderson R; Van Etten, Eliana A M Aquino; Bruschi, Márcia; Raffin, Renata P

2012-04-01

The aim of this work was to perform a pilot study on the safety and efficacy of nanoparticle formulation for cosmetic application. The encapsulated actives in the nanoparticles were a blend of coenzyme Q10, retinyl palmitate, tocopheryl acetate, grape seed oil and linseed oil. The nanoparticle suspension was characterized in terms of pH and particle size. For the safety assessment, alternative methods as cytotoxicity and HET CAM were used. The clinical skin compatibility tests were also performed. The efficacy was evaluated in healthy volunteers presenting different degrees of periorbital wrinkles. Skin hydration was performed by corneometry. The nanoparticles presented narrow size around 140 nm and pH close to neutral and were suitable to cutaneous application. The alternative tests demonstrated that the nanoparticles did not present potential to induce skin irritant effects, cytotoxicity or generate oxidative stress. The clinical assays confirmed the in vitro results, demonstrating the safety of the nanoparticles, which were not irritant, sensitizing and comedogenic. Furthermore, the exposure to UVA light did not cause photoxicity. Regarding the efficacy, nanoparticles presented significant reduction in wrinkle degree after 21 days of application compared to the control. The volunteers could differentiate the nanoparticles and the control product by means of subjective analyses. In conclusion, the nanoparticles containing antioxidant actives were safe for topical use and presented anti-aging activity in vivo and are suitable to be used as cosmetic ingredient.

Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines.

PubMed

Osselaere, A; Devreese, M; Watteyn, A; Vandenbroucke, V; Goossens, J; Hautekiet, V; Eeckhout, M; De Saeger, S; De Baere, S; De Backer, P; Croubels, S

2012-08-01

Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.44±0.70 mg/kg of feed and 7.54±2.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans.

16 CFR 1211.5 - General testing parameters.

Code of Federal Regulations, 2012 CFR

2012-01-01

... § 1211.4(c) for compliance with the Standard for Safety for Tests for Safety-Related Controls Employing... vibration level of 5g is to be used for the Vibration Test. (6) When a Computational Investigation is... tested. (8) The Endurance test is to be conducted concurrently with the Operational test. The control...

16 CFR § 1211.5 - General testing parameters.

Code of Federal Regulations, 2013 CFR

2013-01-01

... covered by § 1211.4(c) for compliance with the Standard for Safety for Tests for Safety-Related Controls... vibration level of 5g is to be used for the Vibration Test. (6) When a Computational Investigation is... tested. (8) The Endurance test is to be conducted concurrently with the Operational test. The control...

16 CFR 1211.5 - General testing parameters.

Code of Federal Regulations, 2011 CFR

2011-01-01

... § 1211.4(c) for compliance with the Standard for Safety for Tests for Safety-Related Controls Employing... vibration level of 5g is to be used for the Vibration Test. (6) When a Computational Investigation is... tested. (8) The Endurance test is to be conducted concurrently with the Operational test. The control...

16 CFR 1211.5 - General testing parameters.

Code of Federal Regulations, 2014 CFR

2014-01-01

... § 1211.4(c) for compliance with the Standard for Safety for Tests for Safety-Related Controls Employing... vibration level of 5g is to be used for the Vibration Test. (6) When a Computational Investigation is... tested. (8) The Endurance test is to be conducted concurrently with the Operational test. The control...

[Pharmacotherapy of attention deficit hyperactivity disorder in children: the results of a multicenter double-blind placebo-controlled study of hopantenic acid].

PubMed

Zavadenko, N N; Suvorinova, N Yu; Vakula, I N; Malinina, E V; Kuzenkova, L M

To assess the efficacy and safety of hopantenic acid (pantogam) compared to placebo in the treatment of attention deficit hyperactivity disorder (ADHD) in children, aged from 6 to 12 years, during 4 month in the prospective multicenter comparative double-blind placebo-controlled study in parallel groups. One hundred patients enrolled in the safety assessment population were stratified into two equal pantogam and placebo groups. Eighty-nine patients who completed the study in according to the protocol were included in the efficacy assessment group: 45 in the pantogam group and 44 in the placebo group. Pantogam was administered in tablets (250 mg) in the therapeutic dose 30 mg/kg of body mass, divided into 2 doses, during 4 month. Patient's state was assessed by the total score on ADHD-DSM-IV, CGI-S WFIRS-P and results of the Toulouse-Piéron test for sustained attention. There was a trend towards an increase in the percentage of patients with positive changes (a decrease in the total ADHD-DSM-IV by ≥25%) in the end of the 3rd and 4th month in the pantogam group (treatment response was 66.7 and 68.9%, respectively) compared to the placebo group (treatment response was 52.3 and 61.4%, respectively). A significant decrease in disease severity assessed by the CGI-S was noted in the pantogam group compared to the placebo group. After 4 month of treatment with pantogam, the severity of functional disturbances was reduced by 4 out of 6 WFIRS-P domains: Family, School and learning, Child's self-concept and Risky activities. Pantogam improved the measures of sustained attention (accuracy and speed) in the Toulouse-Piéron test. The drug used in mean daily dose 30 mg/kg during 4 month had a favorable safety profile which did not differ from that of placebo.

How Agricultural Media Cover Safety Compared with Periodicals in Two Other Hazardous Industries.

PubMed

Marolf, Amanda; Heiberger, Scott; Evans, James; Joseph, Lura

2017-01-26

This analysis featured a uniquely broad look at challenges and potentials for engaging agricultural and other industrial media more effectively in covering safety. It involved a content analysis of selected industry periodicals serving agriculture, mining, and transportation, which are three of the nation's most hazardous industries, in terms of human safety. Use of the social amplification of risk framework (SARF) provided insight on safety coverage. In particular, it tested previous research indicating that media coverage tends to amplify (increase) more than attenuate (decrease) a sense of risk. Analysis involved 18 periodicals (9 agriculture, 7 transportation, and 2 mining) spanning a five-year period from 2008 to 2012. Full-text digital analysis identified terms found in safety articles across all three industries. A manual review of articles revealed the quantity and nature of safety coverage within and among these industries. Results identified 528 safety-related articles published during the period. Transportation and mining periodicals averaged more than twice as many safety articles as the agricultural periodicals. The amount of coverage within the three industries also varied greatly. Findings on the nature of coverage supported previous media research within the SARF. Coverage across all three industries was clearly oriented more to amplifying than to attenuating risk. This study adds to the understanding of variations, commonalities, challenges, and potentials for enhancing safety coverage by media serving these three industries. It also provides direction for engaging industry media more effectively in the public safety mission. The authors recommend seven areas of opportunity for further research. Copyright© by the American Society of Agricultural Engineers.

An examination of the comfort and convenience of 1979 safety belt systems

DOT National Transportation Integrated Search

1979-01-01

The study examines the comfort and convenience aspects of safety belt systems in 1979 model cars and the user and system characteristics which affect safety belt comfort and convenience. The test design required that each of 114 test participants sit...

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

PubMed

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

2013-01-01

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

9 CFR 113.205 - Newcastle Disease Vaccine, Killed Virus.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... A serial found unsatisfactory by a prescribed test shall not be released. (a) Safety test. The prechallenge part of the potency test in paragraph (b) of this section shall constitute a safety test. If.... If unfavorable reactions which are not attributable to the product occur, the test shall be declared...

9 CFR 114.9 - Outline of Production guidelines.

Code of Federal Regulations, 2010 CFR

2010-01-01

... each satisfactory test. A. Purity. B. Safety. C. Potency. D. Other tests. VI. Post preparatory steps. A... test. A. Purity. B. Safety. C. Potency. D. Moisture, if desiccated. E. Any other tests. VI. Post.... Potency. D. Any other tests. E. Include any additional pertinent information. IV. Post preparatory steps...

9 CFR 114.9 - Outline of Production guidelines.

Code of Federal Regulations, 2012 CFR

2012-01-01

... each satisfactory test. A. Purity. B. Safety. C. Potency. D. Other tests. VI. Post preparatory steps. A... test. A. Purity. B. Safety. C. Potency. D. Moisture, if desiccated. E. Any other tests. VI. Post.... Potency. D. Any other tests. E. Include any additional pertinent information. IV. Post preparatory steps...

9 CFR 114.9 - Outline of Production guidelines.

Code of Federal Regulations, 2013 CFR

2013-01-01

... each satisfactory test. A. Purity. B. Safety. C. Potency. D. Other tests. VI. Post preparatory steps. A... test. A. Purity. B. Safety. C. Potency. D. Moisture, if desiccated. E. Any other tests. VI. Post.... Potency. D. Any other tests. E. Include any additional pertinent information. IV. Post preparatory steps...

9 CFR 114.9 - Outline of Production guidelines.

Code of Federal Regulations, 2011 CFR

2011-01-01

... each satisfactory test. A. Purity. B. Safety. C. Potency. D. Other tests. VI. Post preparatory steps. A... test. A. Purity. B. Safety. C. Potency. D. Moisture, if desiccated. E. Any other tests. VI. Post.... Potency. D. Any other tests. E. Include any additional pertinent information. IV. Post preparatory steps...

9 CFR 114.9 - Outline of Production guidelines.

Code of Federal Regulations, 2014 CFR

2014-01-01

... each satisfactory test. A. Purity. B. Safety. C. Potency. D. Other tests. VI. Post preparatory steps. A... test. A. Purity. B. Safety. C. Potency. D. Moisture, if desiccated. E. Any other tests. VI. Post.... Potency. D. Any other tests. E. Include any additional pertinent information. IV. Post preparatory steps...

16 CFR 1203.15 - Positional stability test (roll-off resistance).

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Positional stability test (roll-off... SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS The Standard § 1203.15 Positional stability test (roll-off resistance). (a) Test equipment. (1) Headforms. The test headforms shall comply with the...

16 CFR 1203.15 - Positional stability test (roll-off resistance).

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Positional stability test (roll-off... SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS The Standard § 1203.15 Positional stability test (roll-off resistance). (a) Test equipment. (1) Headforms. The test headforms shall comply with the...

16 CFR 1203.15 - Positional stability test (roll-off resistance).

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Positional stability test (roll-off... SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS The Standard § 1203.15 Positional stability test (roll-off resistance). (a) Test equipment. (1) Headforms. The test headforms shall comply with the...

49 CFR 199.119 - Reporting of anti-drug testing results.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Reporting of anti-drug testing results. 199.119... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.119 Reporting of anti-drug testing results. (a) Each large operator...

49 CFR 199.119 - Reporting of anti-drug testing results.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 3 2012-10-01 2012-10-01 false Reporting of anti-drug testing results. 199.119... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.119 Reporting of anti-drug testing results. (a) Each large operator...

49 CFR 199.109 - Review of drug testing results.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Review of drug testing results. 199.109 Section... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.109 Review of drug testing results. (a) MRO appointment. Each operator shall...

49 CFR 199.109 - Review of drug testing results.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Review of drug testing results. 199.109 Section... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.109 Review of drug testing results. (a) MRO appointment. Each operator shall...

49 CFR 199.109 - Review of drug testing results.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 3 2012-10-01 2012-10-01 false Review of drug testing results. 199.109 Section... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.109 Review of drug testing results. (a) MRO appointment. Each operator shall...

49 CFR 199.109 - Review of drug testing results.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Review of drug testing results. 199.109 Section... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.109 Review of drug testing results. (a) MRO appointment. Each operator shall...

49 CFR 199.119 - Reporting of anti-drug testing results.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Reporting of anti-drug testing results. 199.119... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.119 Reporting of anti-drug testing results. (a) Each large operator...

75 FR 76078 - Pipeline Safety: Random Drug Testing Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-07

... PHMSA-2010-0323] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... testing. SUMMARY: PHMSA has determined that the minimum random drug testing rate for covered employees... employees for random drug testing. Pursuant to 49 CFR 199.105(c)(2), (3), and (4), the PHMSA Administrator's...

49 CFR 199.119 - Reporting of anti-drug testing results.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Reporting of anti-drug testing results. 199.119... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.119 Reporting of anti-drug testing results. (a) Each large operator...

49 CFR 199.109 - Review of drug testing results.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Review of drug testing results. 199.109 Section... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.109 Review of drug testing results. (a) MRO appointment. Each operator shall...

49 CFR 199.119 - Reporting of anti-drug testing results.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Reporting of anti-drug testing results. 199.119... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.119 Reporting of anti-drug testing results. (a) Each large operator...

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

PubMed

Bates, Jonathan; Parzynski, Craig S; Dhruva, Sanket S; Coppi, Andreas; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Shaw, Richard E; Warner, Frederick; Krumholz, Harlan M; Ross, Joseph S

2018-06-12

To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates. Copyright © 2018 John Wiley & Sons, Ltd.

Equivalence Testing as a Tool for Fatigue Risk Management in Aviation.

PubMed

Wu, Lora J; Gander, Philippa H; van den Berg, Margo; Signal, T Leigh

2018-04-01

Many civilian aviation regulators favor evidence-based strategies that go beyond hours-of-service approaches for managing fatigue risk. Several countries now allow operations to be flown outside of flight and duty hour limitations, provided airlines demonstrate an alternative method of compliance that yields safety levels "at least equivalent to" the prescriptive regulations. Here we discuss equivalence testing in occupational fatigue risk management. We present suggested ratios/margins of practical equivalence when comparing operations inside and outside of prescriptive regulations for two common aviation safety performance indicators: total in-flight sleep duration and psychomotor vigilance task reaction speed. Suggested levels of practical equivalence, based on expertise coupled with evidence from field and laboratory studies, are ≤ 30 min in-flight sleep and ± 15% of reference response speed. Equivalence testing is illustrated in analyses of a within-subjects field study during an out-and-back long-range trip. During both sectors of their trip, 41 pilots were monitored via actigraphy, sleep diary, and top of descent psychomotor vigilance task. Pilots were assigned to take rest breaks in a standard lie-flat bunk on one sector and in a bunk tapered 9 from hip to foot on the other sector. Total in-flight sleep duration (134 ± 53 vs. 135 ± 55 min) and mean reaction speed at top of descent (3.94 ± 0.58 vs. 3.77 ± 0.58) were equivalent after rest in the full vs. tapered bunk. Equivalence testing is a complimentary statistical approach to difference testing when comparing levels of fatigue and performance in occupational settings and can be applied in transportation policy decision making.Wu LJ, Gander PH, van den Berg M, Signal TL. Equivalence testing as a tool for fatigue risk management in aviation. Aerosp Med Hum Perform. 2018; 89(4):383-388.

Multidisciplinary Testing of Floor Pads on Stability, Energy Absorption, and Ease of Hospital Use for Enhanced Patient Safety.

PubMed

Crane, Barbara; Goodworth, Adam D; Liquori, Melissa; Ghosh, Suhash; Certo, Catherine; McCafferty, Lorraine

2016-09-01

A major improvement in hospital safety could be realized if serious injury did not accompany falls. We studied several commercially available floor pads made of different materials to determine which (if any) would be practical in a hospital room and reduce injury without posing a threat to the balance of patients. A multidisciplinary approach was undertaken to (1) measure upper and lower body motion in 17 young (<50 years) and 17 older (>55 years) adults during an instrumented sit to stand test from a hospital bed onto the different floor pads, (2) predict the energy dissipation available in floor pads by quantifying the relative mechanical properties, and (3) obtain professional feedback from hospital nurses via a questionnaire (8 questions) following a period of working on the different floor pads. Five floor pads, composed of foam, gel, and/or rubber were tested. All pads were compared with a typical hospital floor (concrete covered with linoleum tiles, considered the control). All of the pads subject to mechanical testing showed at least 3 times more energy absorption compared with the control. Balance testing showed that three of the pads resulted in minimal or no significant increases in body motion during sit-to-stand. Nursing feedback revealed that only 2 of these 3 pads may be feasible for hospital room use: one made primarily of firm rubber and one made of foam. Floor pads do exist that show promise for hospital use that absorbing energy without major impacts on balance during sit-to-stand. Although only commercially available pads were investigated, results may inform the design and multidisciplinary testing of other floor surfaces.

A controlled study on batted ball speed and available pitcher reaction time in slowpitch softball

PubMed Central

McDowell, M; Ciocco, M

2005-01-01

Objectives: To investigate safety risks in slowpitch softball by conducting laboratory and experimental studies on the performance of high tech softball bats with polyurethane softballs. To compare the results with the recommended safety standards. Methods: ASTM standard compression testing of seven softball models was conducted. Using these seven softball models, bat/ball impact testing was performed using seven adult male softball players and six high tech softball bat models to determine mean batted ball speeds. Over 500 bat/ball impact measurements were recorded and analysed. Available pitcher reaction time was calculated from the mean batted ball speed measurements. Results: According to the United States Specialty Sports Association and the Amateur Softball Association, the maximum initial batted ball speed should be 137.2 km/h, which corresponds to a minimum pitcher reaction time of 0.420 second. These experiments produced mean batted ball speeds of 134.0–159.7 km/h, which correspond to available pitcher reaction times of 0.409–0.361 second. Conclusion: The use of high tech softball bats with polyurethane softballs can result in batted ball speeds that exceed the recommended safety limits, which correspond to decreased available pitcher reaction times. PMID:15793092

Evaluation of Margins of Safety in Brazed Joints

NASA Technical Reports Server (NTRS)

Flom, Yury; Wang, Len; Powell, Mollie M.; Soffa, Matthew A.; Rommel, Monica L.

2009-01-01

One of the essential steps in assuring reliable performance of high cost critical brazed structures is the assessment of the Margin of Safety (MS) of the brazed joints. In many cases the experimental determination of the failure loads by destructive testing of the brazed assembly is not practical and cost prohibitive. In such cases the evaluation of the MS is performed analytically by comparing the maximum design loads with the allowable ones and incorporating various safety or knock down factors imposed by the customer. Unfortunately, an industry standard methodology for the design and analysis of brazed joints has not been developed. This paper provides an example of an approach that was used to analyze an AlBeMet 162 (38%Be-62%Al) structure brazed with the AWS BAlSi-4 (Al-12%Si) filler metal. A practical and conservative interaction equation combining shear and tensile allowables was developed and validated to evaluate an acceptable (safe) combination of tensile and shear stresses acting in the brazed joint. These allowables are obtained from testing of standard tensile and lap shear brazed specimens. The proposed equation enables the assessment of the load carrying capability of complex brazed joints subjected to multi-axial loading.

Impulse Flashover Tests at Edgar Beauchamp High Voltage Test Facility, Dixon, California, in Support of Cutler Insulator Failure Investigation

DTIC Science & Technology

2006-07-01

sites. The strength member of the safety core insulators is a fiberglass belt wrapped around pins in the end fittings. Porcelain tubes cover the belt... porcelain tube and heavily tracked the fiberglass belt but left the belt intact structurally (Figure 1). Figure 1. Cutler safety core insulator ...fail-safe insulators . For these tests, the porcelain tube of the safety core insulator was replaced with a plastic see-through tube. The test report [5

Ares-I-X Vehicle Preliminary Range Safety Malfunction Turn Analysis

NASA Technical Reports Server (NTRS)

Beaty, James R.; Starr, Brett R.; Gowan, John W., Jr.

2008-01-01

Ares-I-X is the designation given to the flight test version of the Ares-I rocket (also known as the Crew Launch Vehicle - CLV) being developed by NASA. As part of the preliminary flight plan approval process for the test vehicle, a range safety malfunction turn analysis was performed to support the launch area risk assessment and vehicle destruct criteria development processes. Several vehicle failure scenarios were identified which could cause the vehicle trajectory to deviate from its normal flight path, and the effects of these failures were evaluated with an Ares-I-X 6 degrees-of-freedom (6-DOF) digital simulation, using the Program to Optimize Simulated Trajectories Version 2 (POST2) simulation framework. The Ares-I-X simulation analysis provides output files containing vehicle state information, which are used by other risk assessment and vehicle debris trajectory simulation tools to determine the risk to personnel and facilities in the vicinity of the launch area at Kennedy Space Center (KSC), and to develop the vehicle destruct criteria used by the flight test range safety officer. The simulation analysis approach used for this study is described, including descriptions of the failure modes which were considered and the underlying assumptions and ground rules of the study, and preliminary results are presented, determined by analysis of the trajectory deviation of the failure cases, compared with the expected vehicle trajectory.

Defining and Measuring Safety Climate: A Review of the Construction Industry Literature.

PubMed

Schwatka, Natalie V; Hecker, Steven; Goldenhar, Linda M

2016-06-01

Safety climate measurements can be used to proactively assess an organization's effectiveness in identifying and remediating work-related hazards, thereby reducing or preventing work-related ill health and injury. This review article focuses on construction-specific articles that developed and/or measured safety climate, assessed safety climate's relationship with other safety and health performance indicators, and/or used safety climate measures to evaluate interventions targeting one or more indicators of safety climate. Fifty-six articles met our inclusion criteria, 80% of which were published after 2008. Our findings demonstrate that researchers commonly defined safety climate as perception based, but the object of those perceptions varies widely. Within the wide range of indicators used to measure safety climate, safety policies, procedures, and practices were the most common, followed by general management commitment to safety. The most frequently used indicators should and do reflect that the prevention of work-related ill health and injury depends on both organizational and employee actions. Safety climate scores were commonly compared between groups (e.g. management and workers, different trades), and often correlated with subjective measures of safety behavior rather than measures of ill health or objective safety and health outcomes. Despite the observed limitations of current research, safety climate has been promised as a useful feature of research and practice activities to prevent work-related ill health and injury. Safety climate survey data can reveal gaps between management and employee perceptions, or between espoused and enacted policies, and trigger communication and action to narrow those gaps. The validation of safety climate with safety and health performance data offers the potential for using safety climate measures as a leading indicator of performance. We discuss these findings in relation to the related concept of safety culture and offer suggestions for future research and practice including (i) deriving a common definition of safety climate, (ii) developing and testing construction-specific indicators of safety climate, and (iii) focusing on construction-specific issues such as the transient workforce, subcontracting, work organization, and induction/acculturation processes. © The Author 2016. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

Analysis of car-to-bicycle approach patterns for developing active safety devices.

PubMed

Matsui, Yasuhiro; Oikawa, Shoko; Hitosugi, Masahito

2016-05-18

To reduce the severity of injuries and the number of cyclist deaths in traffic accidents, active safety devices providing cyclist detection are considered to be effective countermeasures. The features of car-to-bicycle collisions need to be known in detail to develop such safety devices. The study investigated near-miss situations captured by drive recorders installed in passenger cars. Because similarities in the approach patterns between near-miss incidents and real-world fatal cyclist accidents in Japan were confirmed, we analyzed the 229 near-miss incident data via video capturing bicycles crossing the road in front of forward-moving cars. Using a video frame captured by a drive recorder, the time to collision (TTC) was calculated from the car's velocity and the distance between the car and bicycle at the moment when the bicycle initially appeared. The average TTC in the cases where bicycles emerged from behind obstructions was shorter than that in the cases where drivers had unobstructed views of the bicycles. In comparing the TTC of car-to-bicycle near-miss incidents to the previously obtained results of car-to-pedestrian near-miss incidents, it was determined that the average TTC in car-to-bicycle near-miss incidents was significantly longer than that in car-to-pedestrian near-miss incidents. When considering the TTC in the test protocol of evaluation for safety performance of active safety devices, we propose individual TTCs for evaluation of cyclist and pedestrian detections, respectively. In the test protocols, the following 2 scenarios should be employed: bicycle emerging from behind an unobstructed view and bicycle emerging from behind obstructions.

30 CFR 56.12028 - Testing grounding systems.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Testing grounding systems. 56.12028 Section 56.12028 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity § 56...

30 CFR 56.12028 - Testing grounding systems.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Testing grounding systems. 56.12028 Section 56.12028 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity § 56...

30 CFR 56.12028 - Testing grounding systems.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Testing grounding systems. 56.12028 Section 56.12028 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity § 56...

30 CFR 56.12028 - Testing grounding systems.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Testing grounding systems. 56.12028 Section 56.12028 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity § 56...

30 CFR 56.12028 - Testing grounding systems.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Testing grounding systems. 56.12028 Section 56.12028 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity § 56...

Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial

PubMed Central

Overton, Edgar Turner; Stapleton, Jack; Frank, Ian; Hassler, Shawn; Goepfert, Paul A.; Barker, David; Wagner, Eva; von Krempelhuber, Alfred; Virgin, Garth; Meyer, Thomas Peter; Müller, Jutta; Bädeker, Nicole; Grünert, Robert; Young, Philip; Rösch, Siegfried; Maclennan, Jane; Arndtz-Wiedemann, Nathaly; Chaplin, Paul

2015-01-01

Background. First- and second-generation smallpox vaccines are contraindicated in individuals infected with human immunodeficiency virus (HIV). A new smallpox vaccine is needed to protect this population in the context of biodefense preparedness. The focus of this study was to compare the safety and immunogenicity of a replication-deficient, highly attenuated smallpox vaccine modified vaccinia Ankara (MVA) in HIV-infected and healthy subjects. Methods. An open-label, controlled Phase II trial was conducted at 36 centers in the United States and Puerto Rico for HIV-infected and healthy subjects. Subjects received 2 doses of MVA administered 4 weeks apart. Safety was evaluated by assessment of adverse events, focused physical exams, electrocardiogram recordings, and safety laboratories. Immune responses were assessed using enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT). Results. Five hundred seventy-nine subjects were vaccinated at least once and had data available for analysis. Rates of ELISA seropositivity were comparably high in vaccinia-naive healthy and HIV-infected subjects, whereas PRNT seropositivity rates were higher in healthy compared with HIV-infected subjects. Modified vaccinia Ankara was safe and well tolerated with no adverse impact on viral load or CD4 counts. There were no cases of myo-/pericarditis reported. Conclusions. Modified vaccinia Ankara was safe and immunogenic in subjects infected with HIV and represents a promising smallpox vaccine candidate for use in immunocompromised populations. PMID:26380340

[Tolerance, safety and efficacy of the one-day preparation of PEG3350 + bisacodyl compared to 2 days of PEG3350 + bisacodyl in pediatric patients].

PubMed

Portillo Canizalez, Ligia Marcela; Blanco Rodriguez, Gerardo; Teyssier Morales, Gustavo; Penchyna Grub, Jaime; Trauernicht Mendieta, Sean; Zurita-Cruz, Jessie Nallely

Multiple intestinal preparations have been used in children undergoing colonoscopy, with variable limitation due to acceptance, tolerance, and proper cleaning. The objective of this study was to compare the tolerability, safety and efficacy of the colonoscopy preparation with 1 day with PEG 3350 (poliethylenglycol) (4g/kg/day) + bisacodyl compared to 2 days of preparation with PEG 3350 (2g/kg/day) + bisacodyl in pediatric patients. A clinical, randomized, and blind trial was performed. Patients aged 2 to 18 years scheduled for colonoscopy were included. Patients were randomized into two groups: 1 day of preparation with PEG 3350 4g/kg/day + bisacodyl and 2 days of preparation with PEG 3350 2g/kg/day + bisacodyl. Through a questionnaire, physical examination and endoscopic evaluation (Boston scale), the tolerance, safety and efficacy of the 2 preparations to be evaluated were determined. Student's t test was performed for quantitative variables and χ 2 for qualitative variables. There were no significant differences in compliance rates, adverse effects, and extent of colonoscopic evaluation. Tolerance and safety between the intestinal preparation for 1-day colonoscopy with PEG 3350 (4g/kg/day) + bisacodyl and the 2-day preparation with PEG 3350 (2g/kg/day) + bisacodyl were similar. The quality of cleanliness was good in both groups, being partially more effective in the 1-day group with PEG 3350 (4g/kg/day). Copyright © 2017 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

Laboratory testing of alcohol safety interlock systems employing divided attention tests

DOT National Transportation Integrated Search

1975-12-01

Author's abstract: Prototype Alcohol Safety Interlock Systems employing measurements of tracking ability, reaction time, and response accuracy to discern alcohol impairment were submitted to laboratory testing. These systems were modified versions of...

Promoting young children's interpersonal safety knowledge, intentions, confidence, and protective behavior skills: Outcomes of a randomized controlled trial.

PubMed

White, Codi; Shanley, Dianne C; Zimmer-Gembeck, Melanie J; Walsh, Kerryann; Hawkins, Russell; Lines, Katrina; Webb, Haley

2018-06-11

Promoting young children's interpersonal safety knowledge, intentions confidence and skills is the goal of many child maltreatment prevention programs; however, evaluation of their effectiveness has been limited. In this study, a randomized controlled trial was conducted examining the effectiveness of the Australian protective behaviors program, Learn to be safe with Emmy and friends™ compared to a waitlist condition. In total, 611 Australian children in Grade 1 (5-7 years; 50% male) participated, with assessments at Pre-intervention, Post-intervention and a 6-month follow-up. This study also included a novel assessment of interpersonal safety skills through the Observed Protective Behaviors Test (OPBT). Analyses showed participating in Learn to be safe with Emmy and friends™ was effective post-program in improving interpersonal safety knowledge (child and parent-rated) and parent-rated interpersonal safety skills. These benefits were retained at the 6-month follow-up, with participating children also reporting increased disclosure confidence. However, Learn to be safe with Emmy and friends™ participation did not significantly impact children's disclosure intentions, safety identification skills, or interpersonal safety skills as measured by the OPBT. Future research may seek to evaluate the effect of further parent and teacher integration into training methods and increased use of behavioral rehearsal and modelling to more effectively target specific disclosure intentions and skills. Copyright © 2018 Elsevier Ltd. All rights reserved.

Safety status system for operating room devices.

PubMed

Guédon, Annetje C P; Wauben, Linda S G L; Overvelde, Marlies; Blok, Joleen H; van der Elst, Maarten; Dankelman, Jenny; van den Dobbelsteen, John J

2014-01-01

Since the increase of the number of technological aids in the operating room (OR), equipment-related incidents have come to be a common kind of adverse events. This underlines the importance of adequate equipment management to improve the safety in the OR. A system was developed to monitor the safety status (periodic maintenance and registered malfunctions) of OR devices and to facilitate the notification of malfunctions. The objective was to assess whether the system is suitable for use in an busy OR setting and to analyse its effect on the notification of malfunctions. The system checks automatically the safety status of OR devices through constant communication with the technical facility management system, informs the OR staff real-time and facilitates notification of malfunctions. The system was tested for a pilot period of six months in four ORs of a Dutch teaching hospital and 17 users were interviewed on the usability of the system. The users provided positive feedback on the usability. For 86.6% of total time, the localisation of OR devices was accurate. 62 malfunctions of OR devices were reported, an increase of 12 notifications compared to the previous year. The safety status system was suitable for an OR complex, both from a usability and technical point of view, and an increase of reported malfunctions was observed. The system eases monitoring the safety status of equipment and is a promising tool to improve the safety related to OR devices.

Quality and safety attributes of afghan raisins before and after processing

PubMed Central

McCoy, Stacy; Chang, Jun Won; McNamara, Kevin T; Oliver, Haley F; Deering, Amanda J

2015-01-01

Raisins are an important export commodity for Afghanistan; however, Afghan packers are unable to export to markets seeking high-quality products due to limited knowledge regarding their quality and safety. To evaluate this, Afghan raisin samples from pre-, semi-, and postprocessed raisins were obtained from a raisin packer in Kabul, Afghanistan. The raisins were analyzed and compared to U.S. standards for processed raisins. The samples tested did not meet U.S. industry standards for embedded sand and pieces of stem, total soluble solids, and titratable acidity. The Afghan raisins did meet or exceed U.S. Grade A standard for the number of cap-stems, percent damaged, crystallization levels, moisture content, and color. Following processing, the number of total aerobic bacteria, yeasts, molds, and total coliforms were within the acceptable limits. Although quality issues are present in the Afghan raisins, the process used to clean the raisins is suitable to maintain food safety standards. PMID:25650241

Testing Electronic Algorithms to Create Disease Registries in a Safety Net System

PubMed Central

Hanratty, Rebecca; Estacio, Raymond O.; Dickinson, L. Miriam; Chandramouli, Vijayalaxmi; Steiner, John F.; Havranek, Edward P.

2008-01-01

Electronic disease registries are a critical feature of the chronic disease management programs that are used to improve the care of individuals with chronic illnesses. These registries have been developed primarily in managed care settings; use in safety net institutions—organizations whose mission is to serve the uninsured and underserved—has not been described. We sought to assess the feasibility of developing disease registries from electronic data in a safety net institution, focusing on hypertension because of its importance in minority populations. We compared diagnoses obtained from algorithms utilizing electronic data, including laboratory and pharmacy records, against diagnoses derived from chart review. We found good concordance between diagnoses identified from electronic data and those identified by chart review, suggesting that registries of patients with chronic diseases can be developed outside the setting of closed panel managed care organizations. PMID:18469416

Evaluation of World Health Organization Multi-Professional Patient Safety Curriculum Topics in Nursing Education: Pre-test, post-test, none-experimental study.

PubMed

Mansour, Mansour; Skull, Alice; Parker, Michael

2015-01-01

The Multi-professional Patient Safety Curriculum Guide was launched by the World Health Organization to develop a patient safety-friendly curriculum in health education. The aim of this study was to evaluate the impact of teaching related to two topics from the Patient Safety Curriculum Guide on student nurses' knowledge and attitudes toward patient safety. A pretest, posttest, nonexperimental design was used. Patient safety education questionnaires were distributed to a convenience sample of 181 nursing students before the intervention, and 141 questionnaires after the intervention in one university in the East of England. The intervention consisted of two face-to-face lectures and one facilitated group work discussion. Seventy-one responses from pre- and posttest stages were matched. Paired t test, McNemar's test, and frequency measures were used for data analysis. The findings suggest that there are statistically significant differences in the subscales of the error and patient safety and personal influence over safety. The differences in the students' answers on patient safety knowledge before and after the interventions were not statistically significant. Although the student nurses highly commended the teaching delivered in this study, the use of experimental design in future curriculum evaluation may provide a more complementary insight to the findings of this study. Copyright © 2015 Elsevier Inc. All rights reserved.

Evidence-based guideline update: determining brain death in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology.

PubMed

Wijdicks, Eelco F M; Varelas, Panayiotis N; Gronseth, Gary S; Greer, David M

2010-06-08

To provide an update of the 1995 American Academy of Neurology guideline with regard to the following questions: Are there patients who fulfill the clinical criteria of brain death who recover neurologic function? What is an adequate observation period to ensure that cessation of neurologic function is permanent? Are complex motor movements that falsely suggest retained brain function sometimes observed in brain death? What is the comparative safety of techniques for determining apnea? Are there new ancillary tests that accurately identify patients with brain death? A systematic literature search was conducted and included a review of MEDLINE and EMBASE from January 1996 to May 2009. Studies were limited to adults. In adults, there are no published reports of recovery of neurologic function after a diagnosis of brain death using the criteria reviewed in the 1995 American Academy of Neurology practice parameter. Complex-spontaneous motor movements and false-positive triggering of the ventilator may occur in patients who are brain dead. There is insufficient evidence to determine the minimally acceptable observation period to ensure that neurologic functions have ceased irreversibly. Apneic oxygenation diffusion to determine apnea is safe, but there is insufficient evidence to determine the comparative safety of techniques used for apnea testing. There is insufficient evidence to determine if newer ancillary tests accurately confirm the cessation of function of the entire brain.

76 FR 47262 - Brookwood-Sago Mine Safety Grants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... industry during the current reporting period. Pre-test and post- test results of trainees. Course... funding ends. 2. Agency creates training Increase number of Pre-test and post- materials and improves quality educational test results of the safety. materials developed. training materials. Provide quality...

77 FR 38751 - Codification of Animal Testing Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-29

... Animal Testing Policy AGENCY: Consumer Product Safety Commission. ACTION: Proposed Statement of Policy on Animal Testing SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) proposes to codify its statement of policy on animal testing, as amended, which was previously published in the Federal...

77 FR 5023 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-01

... proposed information collection project: ``Medical Office Survey on Patient Safety Culture Comparative... . SUPPLEMENTARY INFORMATION: Proposed Project Medical Office Survey on Patient Safety Culture Comparative Database... AHRQ Medical Office Survey on Patient Safety Culture (Medical Office SOPS) Comparative Database. The...

Have pedestrian subsystem tests improved passenger car front shape?

PubMed

Li, Guibing; Wang, Fang; Otte, Dietmar; Cai, Zhihua; Simms, Ciaran

2018-06-01

Subsystem impactor tests are the main approaches for evaluation of safety performance of vehicle front design for pedestrian protection in legislative regulations. However, the main aspects of vehicle safety for pedestrians are shape and stiffness, and though it is clear that subsystem impact tests encourage lower vehicle front stiffness, it is unclear whether they promote improved vehicle front shapes for pedestrian protection. The purpose of this paper is therefore to investigate the effects of European pedestrian safety regulations on passenger car front shape and pedestrian injury risk using recent German In-Depth Accident Study (GIDAS) pedestrian collision data and numerical simulations. Firstly, a sample of 579 pedestrian collision cases involving 190 different car models between 2000-2015 extracted from the GIDAS was used to compare front-end shapes of passenger cars manufactured before and after the legislative pedestrian safety regulations were introduced in Europe. The focus was on changes in passenger car front shape and differences in pedestrian AIS2+ (Abbreviated Injury Scale at least level 2) leg, pelvis/femur and head injury risk observed in collisions. Multi-body simulations were also used to assess changes in vehicle aggressivity due to the observed changes in vehicle shape. The results show that newer passenger cars tend to have a flatter and wider bumper, higher bonnet leading edge, shorter and steeper bonnet and a shallower windscreen. Both the collision data and the numerical simulations indicate that newer passenger car front bumper designs are significantly safer for pedestrians' legs. However, the results also show that the higher bonnet leading edge in newer passenger cars is poor for pedestrian pelvis/femur protection, even though newer cars show an obviously lower AIS2+ injury risk to younger pedestrians in collisions. Newer cars have a lower AIS2+ head injury risk for pedestrians in collisions, but the numerical analysis indicate that this is not likely due to shape changes in passenger car fronts. Overall, the introduction of pedestrian safety regulations has resulted in reductions in pedestrian injury risk, but further benefits would accrue from tests which promote a lower bonnet leading edge. The influence of vehicle shape on pedestrian head injury risk remains unclear. Copyright © 2018 Elsevier Ltd. All rights reserved.

Aerospace Threaded Fastener Strength in Combined Shear and Tension Loading

NASA Technical Reports Server (NTRS)

Steeve, B. E.; Wingate, R. J.

2012-01-01

A test program was initiated by Marshall Space Flight Center and sponsored by the NASA Engineering and Safety Center to characterize the failure behavior of a typical high-strength aerospace threaded fastener under a range of shear to tension loading ratios for both a nut and an insert configuration where the shear plane passes through the body and threads, respectively. The testing was performed with a customized test fixture designed to test a bolt with a single shear plane at a discrete range of loading angles. The results provide data to compare against existing combined loading failure criteria and to quantify the bolt strength when the shear plane passes through the threads.

Safety assessment for EPS electron-proton spectrometer

NASA Technical Reports Server (NTRS)

Gleeson, P.

1971-01-01

A safety analysis was conducted to identify the efforts required to assure relatively hazard free operation of the EPS and to meet the safety requirements of the program. Safety engineering criteria, principles, and techniques in applicable disciplines are stressed in the performance of the system and subsystem studies; in test planning; in the design, development, test, evaluation, and checkout of the equipment; and the operating procedures for the EPS program.

Patient safety culture in Norwegian primary care: a study in out-of-hours casualty clinics and GP practices.

PubMed

Bondevik, Gunnar Tschudi; Hofoss, Dag; Hansen, Elisabeth Holm; Deilkås, Ellen Catharina Tveter

2014-09-01

This study aimed to investigate patient safety attitudes amongst health care providers in Norwegian primary care by using the Safety Attitudes Questionnaire, in both out-of-hours (OOH) casualty clinics and GP practices. The questionnaire identifies five major patient safety factors: Teamwork climate, Safety climate, Job satisfaction, Perceptions of management, and Working conditions. Cross-sectional study. Statistical analysis included multiple linear regression and independent samples t-tests. Seven OOH casualty clinics and 17 GP practices in Norway. In October and November 2012, 510 primary health care providers working in OOH casualty clinics and GP practices (316 doctors and 194 nurses) were invited to participate anonymously. To study whether patterns in patient safety attitudes were related to professional background, gender, age, and clinical setting. The overall response rate was 52%; 72% of the nurses and 39% of the doctors answered the questionnaire. In the OOH clinics, nurses scored significantly higher than doctors on Safety climate and Job satisfaction. Older health care providers scored significantly higher than younger on Safety climate and Working conditions. In GP practices, male health professionals scored significantly higher than female on Teamwork climate, Safety climate, Perceptions of management and Working conditions. Health care providers in GP practices had significant higher mean scores on the factors Safety climate and Working conditions, compared with those working in the OOH clinics. Our study showed that nurses scored higher than doctors, older health professionals scored higher than younger, male GPs scored higher than female GPs, and health professionals in GP practices scored higher than those in OOH clinics - on several patient safety factors.

Evaluating SafeClub: can risk management training improve the safety activities of community soccer clubs?

PubMed

Abbott, K; Klarenaar, P; Donaldson, A; Sherker, S

2008-06-01

To evaluate a sports safety-focused risk-management training programme. Controlled before and after test. Four community soccer associations in Sydney, Australia. 76 clubs (32 intervention, 44 control) at baseline, and 67 clubs (27 intervention, 40 control) at post-season and 12-month follow-ups. SafeClub, a sports safety-focused risk-management training programme (3x2 hour sessions) based on adult-learning principles and injury-prevention concepts and models. Changes in mean policy, infrastructure and overall safety scores as measured using a modified version of the Sports Safety Audit Tool. There was no significant difference in the mean policy, infrastructure and overall safety scores of intervention and control clubs at baseline. Intervention clubs achieved higher post-season mean policy (11.9 intervention vs 7.5 controls), infrastructure (15.2 vs 10.3) and overall safety (27.0 vs 17.8) scores than did controls. These differences were greater at the 12-month follow-up: policy (16.4 vs 7.6); infrastructure (24.7 vs 10.7); and overall safety (41.1 vs 18.3). General linear modelling indicated that intervention clubs achieved statistically significantly higher policy (p<0.001), infrastructure (p<0.001) and overall safety (p<0.001) scores compared with control clubs at the post-season and 12-month follow-ups. There was also a significant linear interaction of time and group for all three scores: policy (p<0.001), infrastructure (p<0.001) and overall safety (p<0.001). SafeClub effectively assisted community soccer clubs to improve their sports safety activities, particularly the foundations and processes for good risk-management practice, in a sustainable way.

Is there agreement between worker self and supervisor assessment of worker safety performance? An examination in the construction industry.

PubMed

Xia, Nini; Griffin, Mark A; Wang, Xueqing; Liu, Xing; Wang, Dan

2018-06-01

Individual safety performance (behavior) critically influences safety outcomes in high-risk workplaces. Compared to the study of generic work performance on different measurements, few studies have investigated different measurements of safety performance, typically relying on employees' self-reflection of their safety behavior. This research aims to address this limitation by including worker self-reflection and other (i.e., supervisor) assessment of two worker safety performance dimensions, safety compliance and safety participation. A sample of 105 workers and 17 supervisors in 17 groups in the Chinese construction industry participated in this study. Comparisons were made between worker compliance and participation in each measurement, and between workers' and supervisors' assessment of workers' compliance and participation. Multilevel modeling was adopted to test the moderating effects on the worker self-reflection and supervisor-assessment relationship by group safety climate and the work experience of supervisors. Higher levels of safety compliance than participation were found for self-reflection and supervisor assessment. The discrepancy between the two measurements in each safety performance dimension was significant. The work experience of supervisors attenuated the discrepancy between self- and supervisor-assessment of compliance. Contrary to our expectations, the moderating effect of group safety climate was not supported. The discrepancy between worker self- and supervisor-assessment of worker safety performance, thus, suggests the importance of including alternative measurements of safety performance in addition to self-reflection. Lower levels of participation behavior in both raters suggest more research on the motivators of participatory behavior. Practical applications The discrepancy between different raters can lead to negative reactions of ratees, suggesting that managers should be aware of that difference. Assigning experienced supervisors as raters can be effective at mitigating interrater discrepancy and conflicts in the assessment of compliance behavior. Copyright © 2018 National Safety Council and Elsevier Ltd. All rights reserved.

Feasibility and safety of exercise stress testing using an anti-gravity treadmill with Tc-99m tetrofosmin single-photon emission computed tomography (SPECT) myocardial perfusion imaging: A pilot non-randomized controlled study.

PubMed

Daly, Patrick; Kayse, Regina; Rudick, Steven; Robbins, Nathan; Scheler, Jennifer; Harris, David; O'Donnell, Robert; Dwivedi, Alok K; Gerson, Myron C

2017-08-31

Exercise is the AHA/ACC guideline-recommended stress modality for myocardial perfusion imaging, but many patients are unable to exercise to target heart rate on a conventional treadmill. We examined the feasibility and safety of stress imaging using an anti-gravity treadmill in patients with perceived poor exercise capacity. 49 patients were recruited for stress testing by anti-gravity treadmill (n = 29) or to a regadenoson control group (n = 20). Seventeen anti-gravity test patients (59%) reached target heart rate obviating the need for a pharmacologic stress agent. Adverse effects of the anti-gravity treadmill were limited to minor muscle aches in 5 subjects. Stress myocardial perfusion image quality judged by 3 blinded readers on a 5-point scale was comparable for the anti-gravity treadmill (4.30 ± SD 0.87) vs pharmacologic stress (4.28 ± SD 0.66). Stress testing using an anti-gravity treadmill is feasible and may help some patients safely achieve target heart rate.

Half a decade of mini-pool nucleic acid testing: Cost-effective way for improving blood safety in India

PubMed Central

Chandrashekar, Shivaram

2014-01-01

Background and Objectives: It is well established that Nucleic acid testing (NAT) reduces window phase of transfusion transmissible infections (TTI) and helps improve blood safety. NAT testing can be done individually or in pools. The objectives of this study were to determine the utility, feasibility and cost effectiveness of an in-house minipool-NAT(MP-NAT). Materials and Methods: Blood donors were screened by history, tested by ELISA and sero-negative samples were subjected to an in-house NAT by using reverse transcriptase-polymerase chain reaction (RT-PCR). Testing was done in mini-pools of size eight (8). Positive pools were repeated with individual samples. Results: During the study period of Oct 2005-Sept 2010 (5 years) all blood donors (n=53729) were screened by ELISA. Of which 469 (0.87%) were positive for HIV-1, HBV or HCV. Sero-negative samples (n=53260) were screened by in-house MP-NAT. HIV-NAT yield was 1/53260 (n=1) and HBV NAT yield (n=2) was 1/26630. Conclusion: NAT yield was lower than other India studies possibly due to the lower sero-reactivity amongst our donors. Nevertheless it intercepted 9 lives including the components prepared. The in-house assay met our objective of improving blood safety at nominal cost and showed that it is feasible to set up small molecular biology units in medium-large sized blood banks and deliver blood within 24-48 hours. The utility of NAT (NAT yield) will vary based on the donor population, the type of serological test used, the nature of kit employed and the sensitivity of NAT test used. The limitations of our in-house MP-NAT consisted of stringent sample preparation requirements, with labor and time involved. The benefits of our MP-NAT were that it acted as a second level of check for ELISA tests, was relatively inexpensive compared to ID-NAT and did not need sophisticated equipment. PMID:24678172

49 CFR 179.100-19 - Tests of safety relief valves.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Tests of safety relief valves. 179.100-19 Section... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

49 CFR 179.100-19 - Tests of safety relief valves.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Tests of safety relief valves. 179.100-19 Section... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120) § 179.100-19...

49 CFR 179.100-19 - Tests of safety relief valves.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Tests of safety relief valves. 179.100-19 Section... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120) § 179.100-19...

49 CFR 179.100-19 - Tests of safety relief valves.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Tests of safety relief valves. 179.100-19 Section... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120) § 179.100-19...

78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

... for Safety--Collateral Standard: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair Lifts'') must validate electromagnetic...: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

46 CFR 162.018-8 - Procedure for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Center, for re-approval. (c) Pre-approval tests. (1) Prior to approval of safety relief valves by the...) Reports of conducted tests on designs of safety relief valves different from those previously approved... approval of a new design or type of safety relief valve shall submit in quadruplicate detail drawings...

16 CFR 1210.12 - Certificate of compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 1210.12 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.12 Certificate of compliance. (a..., based on a reasonable testing program or a test of each product, as required by §§ 1210.13-1210.14 and...

30 CFR 77.502-2 - Electric equipment; frequency of examination and testing.

Code of Federal Regulations, 2010 CFR

2010-07-01

... and testing. 77.502-2 Section 77.502-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL MINES Electrical Equipment-General § 77.502-2 Electric equipment...

The development and validation of a psychological contract of safety scale.

PubMed

Walker, Arlene

2010-08-01

This paper builds on previous research by the author and describes the development and validation of a new measure of the psychological contract of safety. The psychological contract of safety is defined as the beliefs of individuals about reciprocal safety obligations inferred from implicit and explicit promises. A psychological contract is established when an individual believes that perceived employer and employee safety obligations are contingent on each other. A pilot test of the measure is first undertaken with participants from three different occupations: nurses, construction workers, and meat processing workers (N=99). Item analysis is used to refine the measure and provide initial validation of the scale. A larger validation study is then conducted with a participant sample of health care workers (N=424) to further refine the measure and to determine the psychometric properties of the scale. Item and correlational analyses produced the final employer and employee obligations scales, consisting of 21 and 17 items, respectively. Factor analyses identified two underlying dimensions in each scale comparable to that previously established in the organizational literature. These transactional and relational-type obligations provided construct validity of the scale. Internal consistency ratings using Cronbach's alpha found the components of the psychological contract of safety measure to be reliable. The refined and validated psychological contract of safety measure will allow investigation of the positive and negative outcomes associated with fulfilment and breach of the psychological contract of safety in future research. 2010 Elsevier Ltd. All rights reserved.

An evaluation of two conducted electrical weapons and two probe designs using a swine comparative cardiac safety model.

PubMed

Dawes, Donald Murray; Ho, Jeffrey D; Moore, Johanna C; Miner, James R

2013-09-01

Despite human laboratory and field studies that have demonstrated a reasonable safety profile for TASER brand conducted electrical weapons (CEW), the results of some swine studies and arrest related deaths temporal to the use of the CEWs continue to raise questions regarding cardiac safety. TASER International, Inc., has released a new CEW, the TASER X2, touted to have a better safety profile than its long-standing predecessor, the TASER X26. We have developed a model to assess the relative cardiac safety of CEWs and used it to compare the TASER X2 and the TASER X26. This safety model was also used to assess the relative safety of an experimental probe design as compared to the standard steel probe. Our results suggest that the TASER X2 has an improved safety margin over the TASER X26. The new probe design also has promise for enhanced cardiac safety, although may have some disadvantages when compared to the existing design which would make field use impractical.

Measurement, testing, and safety technology: A compilation

NASA Technical Reports Server (NTRS)

1974-01-01

Methods and techniques in the related areas of measurement, testing, and safety are presented. Measuring techniques and devices and testing methods and devices are described. Articles on equipment modifications or procedures are included. Patent information is presented.

Drug-device trials for infectious diseases: CDRH perspective.

PubMed

Meier, Kristen L; Gitterman, Steven

2011-05-01

Assessing the performance of new diagnostic tests for infectious diseases has traditionally focused on comparing the new assay against a reference standard such as culture. In this paper, we suggest that clinical trial designs with both a diagnostic and therapeutic component may be necessary to evaluate the safety and effectiveness of nonmicrobiologically based assays, with a specific emphasis on the test/marker-stratified design. General design challenges for trials of infectious diseases that simultaneously study both diagnostic and therapeutic components (eg, both devices and drugs) are also discussed.

A noise control package for vibrating screens1),2)

PubMed Central

Lowe, M. Jenae; Yantek, David S.; Yang, Junyi; Schuster, Kevin C.; Mechling, Jessie J.

2015-01-01

Hearing loss was the second-most common illness reported to the Mine Safety and Health Administration (MSHA) in 2009. Furthermore, between 2000 and 2010, 30% of all noise-related injury complaints reported to MSHA were for coal preparation plant employees. Previous National Institute for Occupational Safety and Health (NIOSH) studies have shown that vibrating screens are key noise sources to address in order to reduce coal preparation plant noise. In response, NIOSH researchers have developed a suite of noise controls for vibrating screens consisting of constrained layer damping (CLD) treatments, a tuned mechanism suspension, an acoustic enclosure, and spring inserts. Laboratory testing demonstrates that this noise control suite reduces the A-weighted sound power level of the vibrating screen by 6 dB. To provide a comparison to laboratory results and prove durability, field testing of two noise controls was performed on a vibrating screen in a working coal preparation plant. The spring inserts and CLD treatments were selected due to their ease of installation and practicability. Field testing of these controls yielded reductions that were comparable to laboratory results. PMID:26257468

78 FR 46338 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the... Safety Culture Comparative Database Request for information collection approval. The Agency for... on Patient Safety Culture (Hospital SOPS) Comparative Database; OMB NO. 0935-0162, last approved on...

77 FR 4038 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

... proposed information collection project: ``Nursing Home Survey on Patient Safety Culture Comparative...: Proposed Project Nursing Home Survey on Patient Safety Culture Comparative Database The Agency for... Nursing Home Survey on Patient Safety Culture (Nursing Home SOPS) Comparative Database. The Nursing Home...

Patient Safety in Medical Education: Students’ Perceptions, Knowledge and Attitudes

PubMed Central

Nabilou, Bahram; Feizi, Aram; Seyedin, Hesam

2015-01-01

Patient safety is a new and challenging discipline in the Iranian health care industry. Among the challenges for patient safety improvement, education of medical and paramedical students is intimidating. The present study was designed to assess students’ perceptions of patient safety, and their knowledge and attitudes to patient safety education. This cross-sectional analytical study was conducted in 2012 at Urmia University of Medical Sciences, West Azerbaijan province, Iran. 134 students studying medicine, nursing, and midwifery were recruited through census for the study. A questionnaire was used for collecting data, which were then analyzed through SPSS statistical software (version 16.0), using Chi-square test, Spearman correlation coefficient, F and LSD tests. A total of 121 questionnaires were completed, and 50% of the students demonstrated good knowledge about patient safety. The relationships between students’ attitudes to patient safety and years of study, sex and course were significant (0.003, 0.001 and 0.017, respectively). F and LSD tests indicated that regarding the difference between the mean scores of perceptions of patient safety and attitudes to patient safety education, there was a significant difference among medical and nursing/midwifery students. Little knowledge of students regarding patient safety indicates the inefficiency of informal education to fill the gap; therefore, it is recommended to consider patient safety in the curriculums of all medical and paramedical sciences and formulate better policies for patient safety. PMID:26322897

Estimation of adhesive bond strength in laminated safety glass using guided mechanical waves

NASA Astrophysics Data System (ADS)

Huo, Shihong

Laminated safety glass is used in the automobile industry and in architectural applications. Laminated safety glass consists of a plastic interlayer, such as a layer of poly vinyl butyral (PVB) or Butacite, surrounded by two adjacent glass plates. The glass can be float glass, plate glass, tempered glass, or sheet glass, and the plastic interlayer is made of a viscoelastic material with relatively high damping. The level of adhesive bond strength between the plastic interlayer and the two adjacent glass plates has a significant role in the penetration resistance against flying objects and is a critical parameter towards ensuring the proper performance of safety glass. Therefore, estimation and control of adhesive bond levels in laminated safety glass is a critical issue. There are several destructive testing procedures used to quantify the adhesion level in laminated safety glass. These tests include the tension test, the peel test, the impact test, and the pummel test. All these tests have drawbacks including the pummel test method, which has been the most widely used in industry for over 80 years. The primary drawbacks of the pummel test method are that it is destructive and subjective (i.e., involves individual human judgment), which precludes this method for use as an on-line test method for quality control. Consequently, a quantitative nondestructive testing method to evaluate adhesion levels would be an asset to the laminated safety glass industry. In this study, adhesion levels in laminated safety glass samples, i.e., windshields, have been assessed using the guided mechanical wave method. To study the adhesive bond strength analytically, the imperfect interfaces between the plastic interlayer and the two adjacent glass plates in laminated safety glass are modeled using a bed of longitudinal and shear springs, and their stiffness characteristics are estimated using fracture mechanics and atomic force microscopy (AFM) surface measurements. The atomic force microscopy measurements are used to estimate the contact area at the imperfect interfaces between the plastic interlayer and the two adjacent glass plates for each of the laminates. The spring layers are then embedded in the global matrix method, which is used to predict the guided wave dispersion behavior of the laminated system. Based upon the guided wave energy velocity predictions for each of the laminates with different levels of adhesion, the S0 mode was selected as the most promising for use in nondestructively estimating adhesion levels in laminated safety glass. The predicted energy velocities (obtained using this multilayered model) were validated using guided wave energy velocity experimental measurements. The experimentally obtained velocity measurements are in good agreement with the predicted values. Guided wave attenuation in laminated safety glass is primarily due to the viscoelastic material properties of the PVB plastic interlayer. The attenuation properties of S1 mode were also explored to estimate the adhesive bond strength between the plastic interlayer and the two adjacent glass plates. Results show that the combination of both the energy velocity and attenuation methods has promise towards replacing the pummel test method to estimate the adhesion level in laminated safety glass.

Productivity and safety in worker cooperatives and conventional firms.

PubMed

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

1984-01-01

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

Knowledge, attitude, and practice (KAP) of 'teaching laboratory' technicians towards laboratory safety and waste management: a pilot interventional study.

PubMed

El-Gilany, A-H; El-Shaer, S; Khashaba, E; El-Dakroory, S A; Omar, N

2017-06-01

A quasi-experimental study was performed on 20 technicians working in the Faculty of Medicine, Mansoura University, Egypt. The knowledge, attitude, and practice (KAP) of laboratory technicians was measured before and two months after enrolling them in an intervention programme about laboratory best practice procedures. The programme addressed laboratory safety and medical waste management. The assessment was performed using a validated Arabic self-administered questionnaire. Pre- and post-intervention scores were compared using non-parametric tests. There are significant increases in the scores of KAP after implementation of the training programme. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

A novel active heads-up display for driver assistance.

PubMed

Doshi, Anup; Cheng, Shinko Yuanhsien; Trivedi, Mohan Manubhai

2009-02-01

In this paper, we introduce a novel laser-based wide-area heads-up windshield display which is capable of actively interfacing with a human as part of a driver assistance system. The dynamic active display (DAD) is a unique prototype interface that presents safety-critical visual icons to the driver in a manner that minimizes the deviation of his or her gaze direction without adding to unnecessary visual clutter. As part of an automotive safety system, the DAD presents alerts in the field of view of the driver only if necessary, which is based upon the state and pose of the driver, vehicle, and environment. This paper examines the effectiveness of DAD through a comprehensive comparative experimental evaluation of a speed compliance driver assistance system, which is implemented on a vehicular test bed. Three different types of display protocols for assisting a driver to comply with speed limits are tested on actual roadways, and these are compared with a conventional dashboard display. Given the inclination, drivers who are given an overspeed warning alert reduced the time required to slow down to the speed limit by 38% (p < 0.01) as compared with the drivers not given the alert. Additionally, certain alerts decreased distraction levels by reducing the time spent looking away from the road by 63% (p < 0.01). Ultimately, these alerts demonstrate the utility and promise of the DAD system.

A Survey of Residents' Perceptions of the Effect of Large-Scale Economic Developments on Perceived Safety, Violence, and Economic Benefits.

PubMed

Fabio, Anthony; Geller, Ruth; Bazaco, Michael; Bear, Todd M; Foulds, Abigail L; Duell, Jessica; Sharma, Ravi

2015-01-01

Emerging research highlights the promise of community- and policy-level strategies in preventing youth violence. Large-scale economic developments, such as sports and entertainment arenas and casinos, may improve the living conditions, economics, public health, and overall wellbeing of area residents and may influence rates of violence within communities. To assess the effect of community economic development efforts on neighborhood residents' perceptions on violence, safety, and economic benefits. Telephone survey in 2011 using a listed sample of randomly selected numbers in six Pittsburgh neighborhoods. Descriptive analyses examined measures of perceived violence and safety and economic benefit. Responses were compared across neighborhoods using chi-square tests for multiple comparisons. Survey results were compared to census and police data. Residents in neighborhoods with the large-scale economic developments reported more casino-specific and arena-specific economic benefits. However, 42% of participants in the neighborhood with the entertainment arena felt there was an increase in crime, and 29% of respondents from the neighborhood with the casino felt there was an increase. In contrast, crime decreased in both neighborhoods. Large-scale economic developments have a direct influence on the perception of violence, despite actual violence rates.

Development and evaluation of a finite element model of the THOR for occupant protection of spaceflight crewmembers.

PubMed

Putnam, Jacob B; Somers, Jeffrey T; Wells, Jessica A; Perry, Chris E; Untaroiu, Costin D

2015-09-01

New vehicles are currently being developed to transport humans to space. During the landing phases, crewmembers may be exposed to spinal and frontal loading. To reduce the risk of injuries during these common impact scenarios, the National Aeronautics and Space Administration (NASA) is developing new safety standards for spaceflight. The Test Device for Human Occupant Restraint (THOR) advanced multi-directional anthropomorphic test device (ATD), with the National Highway Traffic Safety Administration modification kit, has been chosen to evaluate occupant spacecraft safety because of its improved biofidelity. NASA tested the THOR ATD at Wright-Patterson Air Force Base (WPAFB) in various impact configurations, including frontal and spinal loading. A computational finite element model (FEM) of the THOR to match these latest modifications was developed in LS-DYNA software. The main goal of this study was to calibrate and validate the THOR FEM for use in future spacecraft safety studies. An optimization-based method was developed to calibrate the material models of the lumbar joints and pelvic flesh. Compression test data were used to calibrate the quasi-static material properties of the pelvic flesh, while whole body THOR ATD kinematic and kinetic responses under spinal and frontal loading conditions were used for dynamic calibration. The performance of the calibrated THOR FEM was evaluated by simulating separate THOR ATD tests with different crash pulses along both spinal and frontal directions. The model response was compared with test data by calculating its correlation score using the CORrelation and Analysis rating system. The biofidelity of the THOR FEM was then evaluated against tests recorded on human volunteers under 3 different frontal and spinal impact pulses. The calibrated THOR FEM responded with high similarity to the THOR ATD in all validation tests. The THOR FEM showed good biofidelity relative to human-volunteer data under spinal loading, but limited biofidelity under frontal loading. This may suggest a need for further improvements in both the THOR ATD and FEM. Overall, results presented in this study provide confidence in the THOR FEM for use in predicting THOR ATD responses for conditions, such as those observed in spacecraft landing, and for use in evaluating THOR ATD biofidelity. Copyright © 2015 Elsevier Ltd. All rights reserved.

Comparing non-safety with safety device sharps injury incidence data from two different occupational surveillance systems.

PubMed

Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J

2017-06-01

The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations

PubMed Central

Kim, Seung Won; Kim, Bae-Hwan

2016-01-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials. PMID:27437094

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations.

PubMed

Kim, Seung Won; Kim, Bae-Hwan

2016-07-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials.

Safety Communication Tools and Healthcare Professionals' Awareness of Specific Drug Safety Issues in Europe: A Survey Study.

PubMed

de Vries, Sieta T; van der Sar, Maartje J M; Coleman, Anna Marie; Escudero, Yvette; Rodríguez Pascual, Alfonso; Maciá Martínez, Miguel-Ángel; Cupelli, Amelia; Baldelli, Ilaria; Šipić, Ivana; Andrić, Adriana; Michan, Line; Denig, Petra; Mol, Peter G M

2018-07-01

National competent authorities (NCAs) use Direct Healthcare Professional Communications (DHPCs) to communicate new drug safety issues to healthcare professionals (HCPs). More knowledge is needed about the effectiveness of DHPCs and the extent to which they raise awareness of new safety issues among HCPs. The objective was to assess and compare general practitioners' (GPs'), cardiologists', and pharmacists' familiarity with DHPCs as communication tools, their awareness of specific drug safety issues, and the sources through which they had become aware of the specific issues. GPs, cardiologists, and pharmacists from nine European countries (Croatia, Denmark, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the UK) completed a web-based survey. The survey was conducted in the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Respondents were asked about their familiarity with DHPCs in general and their awareness of safety issues that had recently been communicated and involved the following drugs: combined hormonal contraceptives, diclofenac, valproate, and ivabradine. Those HCPs who were aware of the specific safety issues were subsequently asked to indicate the source through which they had become aware of them. Differences between professions in familiarity with DHPCs and awareness were tested using a Pearson χ 2  test per country and post hoc Pearson χ 2  tests in the case of statistically significant differences. Of the 3288 included respondents, 54% were GPs, 40% were pharmacists, and 7% were cardiologists. The number of respondents ranged from 67 in Denmark to 916 in Spain. Most respondents (92%) were familiar with DHPCs, with one significant difference between the professions: pharmacists were more familiar than GPs in Italy (99 vs 90%, P = 0.004). GPs' awareness ranged from 96% for the diclofenac issue to 70% for the ivabradine issue. A similar pattern was shown for pharmacists (91% aware of the diclofenac issue to 66% of the ivabradine issue). Cardiologists' awareness ranged from 91% for the ivabradine issue to 34% for the valproate issue. Overall, DHPCs were a common source through which GPs (range: 45% of those aware of the contraceptives issue to 60% of those aware of the valproate issue), cardiologists (range: 33% for the contraceptives issue to 61% for the valproate issue), and pharmacists (range: 41% for the contraceptives issue to 51% for the ivabradine issue) had become aware of the specific safety issues, followed by information on websites or in newsletters. GPs, cardiologists, and pharmacists were to a similar extent (highly) familiar with DHPCs, but they differed in awareness levels of specific safety issues. Cardiologists were less aware of safety issues associated with non-cardiology drugs even if these had cardiovascular safety concerns. This implies that additional strategies may be needed to reach specialists when communicating safety issues regarding drugs outside their therapeutic area but with risks related to their field of specialisation. DHPCs were an important source for the different professions to become aware of specific safety issues, but other sources were also often used. NCAs should consider the use of a range of sources when communicating important safety issues to HCPs.