78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket... issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of...

Automating the Generation of Heterogeneous Aviation Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.; Pohl, Josef M.

2012-01-01

A safety case is a structured argument, supported by a body of evidence, which provides a convincing and valid justification that a system is acceptably safe for a given application in a given operating environment. This report describes the development of a fragment of a preliminary safety case for the Swift Unmanned Aircraft System. The construction of the safety case fragment consists of two parts: a manually constructed system-level case, and an automatically constructed lower-level case, generated from formal proof of safety-relevant correctness properties. We provide a detailed discussion of the safety considerations for the target system, emphasizing the heterogeneity of sources of safety-relevant information, and use a hazard analysis to derive safety requirements, including formal requirements. We evaluate the safety case using three classes of metrics for measuring degrees of coverage, automation, and understandability. We then present our preliminary conclusions and make suggestions for future work.

33 CFR 169.125 - What classes of ships are required to make reports?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false What classes of ships are required to make reports? 169.125 Section 169.125 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting Systems for the...

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety...

Caring for class III obese patients.

PubMed

Gardner, Lea Anne

2013-11-01

The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, and birthing centers, as well as some abortion facilities, must file information on medical errors.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

77 FR 52219 - Amendment of Class E Airspace; Lewistown, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-29

... Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Lewistown Municipal Airport. This improves the safety and management of Instrument Flight Rules (IFR...) standard instrument approach procedures at the airport. This action is necessary for the safety and...

The Marine Corps Needs a Targeting, Sensors, and Surveillance Systems Operational Integration and Support Team

DTIC Science & Technology

2010-03-02

triggerman is probably still close ; lately all IEDs in the area have been initiated via command-wire. The squad leader sets a cordon, ensures an IED 9...Operational Surveillance System (G-BOSS) with a Class IIIb laser pointer. This class of laser requires users to receive a laser safety class...2) The Keyhole kit of surveillance equipment. Designed to provide “snipers with an increased capability to visually detect the enemy emplacing IEDs

Safety equipment list for the 241-SY-101 RAPID mitigation project

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

MORRIS, K.L.

1999-06-29

This document provides the safety classification for the safety (safety class and safety RAPID Mitigation Project. This document is being issued as the project SEL until the supporting authorization basis documentation, this document will be superseded by the TWRS SEL (LMHC 1999), documentation istlralized. Upon implementation of the authorization basis significant) structures, systems, and components (SSCS) associated with the 241-SY-1O1 which will be updated to include the information contained herein.

Safety and Quality Training Simulator

NASA Technical Reports Server (NTRS)

Scobby, Pete T.

2009-01-01

A portable system of electromechanical and electronic hardware and documentation has been developed as an automated means of instructing technicians in matters of safety and quality. The system enables elimination of most of the administrative tasks associated with traditional training. Customized, performance-based, hands-on training with integral testing is substituted for the traditional instructional approach of passive attendance in class followed by written examination.

Towards an International Classification for Patient Safety: a Delphi survey.

PubMed

Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

2009-02-01

Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. International web-based survey of expert opinion. Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur.

Towards an International Classification for Patient Safety: a Delphi survey

PubMed Central

Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

2009-01-01

Objective Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Design Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. Setting International web-based survey of expert opinion. Participants Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. Results In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. Conclusions The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur. PMID:19147596

Confinement of Radioactive Materials at Defense Nuclear Facilities

DTIC Science & Technology

2004-10-01

The design of defense nuclear facilities includes systems whose reliable operation is vital to the protection of the public, workers, and the...final safety-class barrier to the release of hazardous materials with potentially serious public consequences. The Defense Nuclear Facilities Safety...the public at certain defense nuclear facilities . This change has resulted in downgrading of the functional safety classification of confinement

43 CFR 12.805 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., emergency life safety systems, such as emergency lighting, fire alarm, and audio evacuation systems, which... a duty-free entry certificate is issued). Components of foreign origin of the same class or kind for...

43 CFR 12.805 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., emergency life safety systems, such as emergency lighting, fire alarm, and audio evacuation systems, which... a duty-free entry certificate is issued). Components of foreign origin of the same class or kind for...

76 FR 79563 - Proposed Amendment of Class E Airspace; Sheridan, WY

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to amend Class E airspace at Sheridan County Airport, Sheridan, WY. Decommissioning of the Sheridan Tactical Air Navigation System (TACAN) has made this action necessary for the safety and...

Control of Hazards to Health From Laser Radiation

DTIC Science & Technology

2006-01-01

compared to the calculated AEL. (2) Optically aided viewing. Viewing a laser beam with optical aids (other than ordinary eyeglasses or contact lenses ...resonant optical cavity. TB MED 524 8 b. Lenses , mirrors, cooling systems, shutters, and other accessories may be added to the system to obtain...procedures for laser optical systems (for example, mirrors, prisms, and lenses ) that employ Class 2 and Class 3a lasers, it is always good laser safety

75 FR 57383 - Modification of Class E Airspace; Willcox, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-21

... System (GPS) Standard Instrument Approach Procedures (SIAPs) at Cochise County Airport. This will improve the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective... action is necessary for the safety and management of IFR operations. The FAA has determined this...

75 FR 57375 - Establishment of Class E Airspace; Toledo, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-21

... System (GPS) Standard Instrument Approach Procedure (SIAP) at Ed Carlson Memorial Field-South Lewis County Airport. This will improve the safety and management of Instrument Flight Rules (IFR) operations... is necessary for the safety and management of IFR operations. The FAA has determined this regulation...

Environmental Protection for Hazardous Materials Incidents. Volume 1. Hazardous Materials Incident Management System

DTIC Science & Technology

1990-11-01

radioactive) - Determine class of HAZMAT (Class A Explosive, Class B Explosive, Class C Explosive, Blasting Agent , Flammable Gas , Non- flammable Gas ... agent . Specific health and safety plans related to IRP actions amy be obtained from the same source. 2. Interaction of Fire Departments with the...such as digging near a gas line, a fuel tank, or buried explo- sives, the fire department would be briefed before beginning the work, and, under

78 FR 67299 - Modification of Class E Airspace; Cut Bank, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

...-0664; Airspace Docket No. 13-ANM-22] Modification of Class E Airspace; Cut Bank, MT AGENCY: Federal... Cut Bank, MT, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Cut Bank Municipal Airport. This improves the safety and management of...

76 FR 2000 - Modification of Class E Airspace; Show Low, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-12

...-0903; Airspace Docket No. 10-AWP-16] Modification of Class E Airspace; Show Low, AZ AGENCY: Federal... Show Low, AZ, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures at Show Low Regional Airport. This will improve the safety and...

Shock spectra applications to a class of multiple degree-of-freedom structures system

NASA Technical Reports Server (NTRS)

Hwang, Shoi Y.

1988-01-01

The demand on safety performance of launching structure and equipment system from impulsive excitations necessitates a study which predicts the maximum response of the system as well as the maximum stresses in the system. A method to extract higher modes and frequencies for a class of multiple degree-of-freedom (MDOF) Structure system is proposed. And, along with the shock spectra derived from a linear oscillator model, a procedure to obtain upper bound solutions for maximum displacement and maximum stresses in the MDOF system is presented.

Safe Use of Hydrogen and Hydrogen Systems

NASA Technical Reports Server (NTRS)

Maes, Miguel

2006-01-01

This is a viewgraph presentation that is a course for teaching the safe use of hydrogen. The objectives of the course are 1. To familiarize the student with H2 safety properties 2. To enable the identification, evaluations and addressing of H2 system hazards 3. To teach: a. Safe practices for, b. Design, c. Materials selection, d. H2 system operation, e. Physical principles and empirical observations on which these safe practices are based, f. How to respond to emergency situations involving H2, g How to visualize safety concepts through in-class exercises, h. Identify numerous parameters important to H2 safety.

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.

78 FR 25346 - Petition for Waiver of Compliance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 232, Brake System Safety Standards for Freight and Other Non-Passenger Trains and Equipment; End-of-Train Devices... five cycle trains and requests to extend the required mileage interval of the Class 1A brake tests of...

75 FR 14381 - Amendment of Class E Airspace; Mount Airy, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

... triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also... proposes to amend Class E Airspace at Mount Airy, NC, to accommodate the additional airspace needed for the... enhances the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport...

75 FR 33556 - Proposed Amendment of Class E Airspace; Port Angeles, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-14

... action proposes to amend Class E airspace at William R. Fairchild International Airport, Port Angeles, WA... proposing this action for the safety and management of Instrument Flight Rules (IFR) operations at the... triplicate to the Docket Management System (see ``ADDRESSES'' section for address and phone number). You may...

Medical devices; hematology and pathology devices; classification of cord blood processing system and storage container. Final rule.

PubMed

2007-02-01

The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Critical Characteristics of Radiation Detection System Components to be Dedicated for use in Safety Class and Safety Significant System

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

DAVIS, S.J.

2000-12-28

This document identifies critical characteristics of components to be dedicated for use in Safety Significant (SS) Systems, Structures, or Components (SSCs). This document identifies the requirements for the components of the common, radiation area, monitor alarm in the WESF pool cell. These are procured as Commercial Grade Items (CGI), with the qualification testing and formal dedication to be performed at the Waste Encapsulation Storage Facility (WESF) for use in safety significant systems. System modifications are to be performed in accordance with the approved design. Components for this change are commercially available and interchangeable with the existing alarm configuration This documentmore » focuses on the operational requirements for alarm, declaration of the safety classification, identification of critical characteristics, and interpretation of requirements for procurement. Critical characteristics are identified herein and must be verified, followed by formal dedication, prior to the components being used in safety related applications.« less

Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures. Final order.

PubMed

2016-07-13

The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Plutonium Finishing Plant (PFP) HVAC System Component Index

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

DICK, J.D.

2000-02-28

The Plutonium Finishing Plant (PFP) WAC System includes sub-systems 25A through 25K. Specific system boundaries and justifications are contained in HNF-SD-CP-SDD-005, ''Definition and Means of Maintaining the Ventilation System Confinement Portion of the PFP Safety Envelope.'' The procurement requirements associated with the system necessitates procurement of some system equipment as Commercial Grade Items in accordance with HNF-PRO-268, ''Control of Purchased Items and Services.'' This document lists safety class and safety significant components for the Heating Ventilation Air Conditioning and specifies the critical characteristics for Commercial Grade Items, as required by HNF-PRO-268 and HNF-PRO-1819. These are the minimum specifications that themore » equipment must meet in order to properly perform its safety function. There may be several manufacturers or models that meet the critical characteristics for any one item.« less

Recent developments in high altitude aircraft sampling - Mount St. Helens and stratospheric trace gases

NASA Astrophysics Data System (ADS)

Leifer, R.; Sommers, K. G.; Guggenheim, S. F.; Fisenne, I.

1981-02-01

An ultra-clean, low volume gas sampling system (CLASS), flown aboard a high altitude aircraft (WB-57F), and providing information on stratospheric trace gases is presented. Attention is given to the instrument design and the electronic control design. Since remote operation is mandatory on the WB-57F, a servo pressure transducer, electrical pressure switch for automatic shutdown, and a mechanical safety relief valve were installed on the sampling manifold, indicated on the CLASS flow chart. The electronic control system consists of hermetically sealed solid state timers, relays, and a stepping switch, for controlling the compressor pump and solenoid valves. In designing the automatic control system, vibration, shock, acceleration, extreme low temperature, and aircraft safety were important considerations. CLASS was tested on three separate occasions, and tables of analytical data from these flights are presented. Readiness capability was demonstrated when the Mount St. Helens eruption plume of May 18, 1980, was intercepted, and it was concluded that no large injection of Rn-222 entered the stratosphere or troposphere from the eruption.

How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study

PubMed Central

2016-01-01

Introduction: First-in-class drugs use a unique mechanism of action. This study assessed the therapeutic innovativeness and safety of these drugs approved by Health Canada from 1997–2012. Methods: A list of new drugs was compiled and a database from the Food and Drug Administration was used to determine first-in-class status. Post-market safety warnings and drugs withdrawn for safety reasons were identified from the MedEffect Canada website. Therapeutic innovation evaluations came from the Patented Medicine Prices Review Board (PMPRB) and Prescrire International. The proportion of first-in-class drugs that were innovative was compared to the proportion of non-first-in-class drugs that were innovative. Kaplan–Meier survival curves assessed safety. Results: In all, 462 drugs were approved by Health Canada during the period under study. Among these, 345 were evaluated by PMPRB and/or Prescrire, and first-in-class data were available for 292. Ninety-eight of the 292 were first-in-class and 16 were innovative compared to 9 of 194 drugs that were not-first-in-class. There was no difference in safety between the two groups. Discussion: Overall, the benefit-to-harm ratio of first-in-class drugs, as measured by post-market safety warnings/withdrawals, is better than those that were not-first-in-class. PMID:28032825

Control of Suspect/Counterfeit and Defective Items

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

Sheriff, Marnelle L.

2013-09-03

This procedure implements portions of the requirements of MSC-MP-599, Quality Assurance Program Description. It establishes the Mission Support Alliance (MSA) practices for minimizing the introduction of and identifying, documenting, dispositioning, reporting, controlling, and disposing of suspect/counterfeit and defective items (S/CIs). employees whose work scope relates to Safety Systems (i.e., Safety Class [SC] or Safety Significant [SS] items), non-safety systems and other applications (i.e., General Service [GS]) where engineering has determined that their use could result in a potential safety hazard. MSA implements an effective Quality Assurance (QA) Program providing a comprehensive network of controls and verification providing defense-in-depth by preventingmore » the introduction of S/CIs through the design, procurement, construction, operation, maintenance, and modification of processes. This procedure focuses on those safety systems, and other systems, including critical load paths of lifting equipment, where the introduction of S/CIs would have the greatest potential for creating unsafe conditions.« less

Monitoring drug safety in Astrakhan, Russia.

PubMed

Kirilochev, O O; Dorfman, I P; Umerova, A R

2015-01-01

The problem of drug safety will never disappear as new drugs are delivered in increasing numbers. They have high biological activity and adverse drug reactions (ADR) [1]. Currently, adverse drug reactions are the fourth leading cause of death for patients.There are databases of ADRs (Vigibase, Eudravigilance), but we know that ADR manifestations may vary in different countries and regions, due to the demographic, genetic characteristics of the population and the quality of manufactured drugs [2]. In this regard, the study of the ADR at the regional level is very relevant. We aimed to optimize the work on monitoring drug safety in Astrakhan region through pharmacoepidemiological research and development of computer database for analysis of information coming to the center for drug safety monitoring (CDSM). 1. To study the rates of ADR reporting and the structure in the Astrakhan region at the regional center for drug safety monitoring.2. To analyze the outcomes of registered adverse drug reactions.3. To determine the causality of adverse drug reactions.4. To identify reports on the ineffectiveness of drugs.5. To analyze the rates and structure of ADR reporting for drugs prescribed off-label. We studied spontaneous adverse event reporting. The adverse event reports received by the regional CDSM for the period of 2010 to 2014 was analyzed. The groups of drugs were categorized according by Anatomical Therapeutic Chemical classification system. The data were analyzed using Microsoft Office Excel. The likelihood of whether an ADR was actually due to the drugs was assessed with the Naranjo algorithm. The analysis of the results showed that the establishment of the CDSM in September 2010, contributed to improvement of drug safety monitoring in health facilities of the region. Noteworthy was the increasing the number of adverse event reports in 2011 and 2012, compared with the beginning of the year 2010, when the CDSM was not yet functioning.The decrease of adverse event reporting in 2013 and 2014 was due to the fact that doctors in the region had access to better ADR drug information. Along with the increasing number of adverse event reporting we also noted the increase in the number of health facilities that monitored drug safety. The number of health facilities that reported, doubled from 2010 to 2014. We observed the increase in the number of adverse event reports submitted by pharmaceutical companies. General anti-infective drugs for systemic use (class J) were the most common cause of all registered ADRs (44%). Drugs for treatment of tuberculosis (group J04A) were the cause of adverse drug reactions in 34% of reports. ADRs associated with drugs used for treating diseases of cardiovascular system accounted for 16% of case-reports; drugs belonging to the group of Alimentary tract and metabolism (class A) and to the group of Nervous System (class A) were reported to cause ADRs in 10% of cases each. Type A adverse drug reactions, which are usually a consequence of a drug's primary pharmacological effect, were detected in 45% of cases. These reactions were often registered for drugs affecting cardiovascular system (class C), nervous system (class N), dlood and blood forming organs (class B). Type B ADRs were reported in 54% of cases. These were "idiosyncratic" reactions, which could not be predicted on the basis of the drug's main pharmacological action, were not dose-related and were severe [3]. The most frequent cause of type B adverse drug reactions was the General anti-infective medicines for systemic use (Class J). The fatality rate associated with ADRs was 0.3%. Type A adverse drug reactions resulted in death in 38% of cases. Type B ADR (anaphylactic shock) accounted for 62% of the patient's deaths. The Naranjo scale determined the causality of ADRs. The "definite" ADRs were detected in 14% of reports, "probable" - in 47%, and "possible" - in 39% of cases. The rate of reporting associated with ineffectiveness of drugs amounted to 1%. Most often the lack of therapeutic effect was reported in patients receiving drugs of class C (Cardiovascular system, 31% of all cases of inefficiency of drugs). These drugs were used in accordance with their official instructions for use. The proportion of ADR reports for drugs prescribed off-label was 1.4%. The results substantiate the need to continue drug safety monitoring in the Astrakhan region. We plan to further improve the software for ADR analysis.

Design validation of an eye-safe scanning aerosol lidar with the Center for Lidar and Atmospheric Sciences Students (CLASS) at Hampton University

NASA Astrophysics Data System (ADS)

Richter, Dale A.; Higdon, N. S.; Ponsardin, Patrick L.; Sanchez, David; Chyba, Thomas H.; Temple, Doyle A.; Gong, Wei; Battle, Russell; Edmondson, Mika; Futrell, Anne; Harper, David; Haughton, Lincoln; Johnson, Demetra; Lewis, Kyle; Payne-Baggott, Renee S.

2002-01-01

ITTs Advanced Engineering and Sciences Division and the Hampton University Center for Lidar and Atmospheric Sciences Students (CLASS) team have worked closely to design, fabricate and test an eye-safe, scanning aerosol-lidar system that can be safely deployed and used by students form a variety of disciplines. CLASS is a 5-year undergraduate- research training program funded by NASA to provide hands-on atmospheric-science and lidar-technology education. The system is based on a 1.5 micron, 125 mJ, 20 Hz eye-safe optical parametric oscillator (OPO) and will be used by the HU researchers and students to evaluate the biological impact of aerosols, clouds, and pollution a variety of systems issues. The system design tasks we addressed include the development of software to calculate eye-safety levels and to model lidar performance, implementation of eye-safety features in the lidar transmitter, optimization of the receiver using optical ray tracing software, evaluation of detectors and amplifiers in the near RI, test of OPO and receiver technology, development of hardware and software for laser and scanner control and video display of the scan region.

Coherent lidar airborne wind sensor II: flight-test results at 2 and 10 νm.

PubMed

Targ, R; Steakley, B C; Hawley, J G; Ames, L L; Forney, P; Swanson, D; Stone, R; Otto, R G; Zarifis, V; Brockman, P; Calloway, R S; Klein, S H; Robinson, P A

1996-12-20

The use of airborne laser radar (lidar) to measure wind velocities and to detect turbulence in front of an aircraft in real time can significantly increase fuel efficiency, flight safety, and terminal area capacity. We describe the flight-test results for two coherent lidar airborne shear sensor (CLASS) systems and discuss their agreement with our theoretical simulations. The 10.6-μm CO(2) system (CLASS-10) is a flying brassboard; the 2.02-μm Tm:YAG solid-state system (CLASS-2) is configured in a rugged, light-weight, high-performance package. Both lidars have shown a wind measurement accuracy of better than 1 m/s.

75 FR 81710 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

... clearance by OMB as required by the PRA. Title: Safety Integration Plans. OMB Control Number: 2130-0557... for the development and implementation of safety integration plans (``SIPs'' or ``plans'') by a Class... affected railroads (Class Is and some Class IIs) address critical safety issues unique to the amalgamation...

76 FR 40797 - Establishment of Class E Airspace; Lincoln City, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-12

...This action establishes Class E airspace at Lincoln City, OR, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Samaritan North Lincoln Hospital Heliport. This action also corrects the name of the city were the Heliport is located. This improves the safety and management of Instrument Flight Rules (IFR) operations.

76 FR 21268 - Proposed Establishment of Class E Airspace; Lincoln, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

...This action proposes to establish Class E airspace at Lincoln, OR. Controlled airspace is necessary to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Samaritan North Lincoln Hospital Heliport, Lincoln, OR. The FAA is proposing this action to enhance the safety and management of aircraft operations at the heliport.

78 FR 34554 - Establishment of Class E Airspace; Blue Mesa, CO

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-10

...This action establishes Class E airspace at Blue Mesa VHF Omni-Directional Radio Range/Distance Measuring Equipment (VOR/DME), Blue Mesa, CO, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Denver and Albuquerque Air Route Traffic Control Centers (ARTCCs). This improves the safety and management of IFR operations within the National Airspace System.

76 FR 56967 - Amendment of Class E Airspace; Glendive, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-15

... Positioning System (GPS) standard instrument approach procedures. This improves the safety and management of... Airport, to accommodate IFR aircraft executing RNAV (GPS) standard instrument approach procedures at the...

Commercial Grade Item (CGI) Dedication for Leak Detection Relays

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

KOCH, M.R.; JOHNS, B.R.

1999-12-21

This Test Plan provides a test method to dedicate the leak detection relays used on the new Pumping and Instrumentation Control (PIC) skids. The new skids are fabricated on-site. The leak detection system is a safety class system per the Authorization Basis.

Commercial Grade Item (CGI) Dedication for Leak Detection Relays

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

KOCH, M.R.

2000-02-28

This Test Plan provides a test method to dedicate the leak detection relays used on the new Pumping Instrumentation and Control (PIC) skids. The new skids are fabricated on-site. The leak detection system is a safety class system per the Authorization Basis.

Commercial Grade Item (CGI) Dedication for Leak Detection Relays

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

KOCH, M.R.

1999-08-11

This Test Plan provides a test method to dedicate the leak detection relays used on the new Pumping and Instrumentation Control (PIC) skids. The new skids are fabricated on-site. The leak detection system is a safety class system per the Authorization Basis.

Commercial Grade Item (CGI) Dedication for Leak Detection Relays

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

JOHNS, B.R.

1999-05-05

This Test Plan provides a test method to dedicate the leak detection relays used on the new Pumping and Instrumentation Control (PIC) skids. The new skids are fabricated on-site. The leak detection system is a safety class system per the Authorization Basis.

Commercial Grade Item (CGI) Dedication for Leak Detection Relays

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

KOCH, M.R.

1999-10-26

This Test Plan provides a test method to dedicate the leak detection relays used on the new Pumping and Instrumentation Control (PIC) skids. The new skids are fabricated on-site. The leak detection system is a safety class system per the Authorization Basis.

Commercial Grade Item (CGI) Dedication for Leak Detection Relays

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

JOHNS, B.R.; KOCH, M.R.

2000-01-28

This Test Plan provides a test method to dedicate the leak detection relays used on the new Pumping Instrumentation and Control (PIC) skids. The new skids are fabricated on-site. The leak detection system is a safety class system per the Authorization Basis.

77 FR 45240 - Establishment of Class E Airspace; Quakertown, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... at Quakertown, PA, to accommodate the new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures at Quakertown Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. [[Page 45241...

77 FR 45241 - Establishment of Class E Airspace; Apopka, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... at Apopka, FL, to accommodate the new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures at Orlando Apopka Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. DATES: Effective...

77 FR 45240 - Establishment of Class E Airspace; Arcadia, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... at Arcadia, FL, to accommodate the new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures at Arcadia Municipal Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. DATES...

Asymptotic safety of gravity-matter systems

NASA Astrophysics Data System (ADS)

Meibohm, J.; Pawlowski, J. M.; Reichert, M.

2016-04-01

We study the ultraviolet stability of gravity-matter systems for general numbers of minimally coupled scalars and fermions. This is done within the functional renormalization group setup put forward in [N. Christiansen, B. Knorr, J. Meibohm, J. M. Pawlowski, and M. Reichert, Phys. Rev. D 92, 121501 (2015).] for pure gravity. It includes full dynamical propagators and a genuine dynamical Newton's coupling, which is extracted from the graviton three-point function. We find ultraviolet stability of general gravity-fermion systems. Gravity-scalar systems are also found to be ultraviolet stable within validity bounds for the chosen generic class of regulators, based on the size of the anomalous dimension. Remarkably, the ultraviolet fixed points for the dynamical couplings are found to be significantly different from those of their associated background counterparts, once matter fields are included. In summary, the asymptotic safety scenario does not put constraints on the matter content of the theory within the validity bounds for the chosen generic class of regulators.

Time Factor in the Theory of Anthropogenic Risk Prediction in Complex Dynamic Systems

NASA Astrophysics Data System (ADS)

Ostreikovsky, V. A.; Shevchenko, Ye N.; Yurkov, N. K.; Kochegarov, I. I.; Grishko, A. K.

2018-01-01

The article overviews the anthropogenic risk models that take into consideration the development of different factors in time that influence the complex system. Three classes of mathematical models have been analyzed for the use in assessing the anthropogenic risk of complex dynamic systems. These models take into consideration time factor in determining the prospect of safety change of critical systems. The originality of the study is in the analysis of five time postulates in the theory of anthropogenic risk and the safety of highly important objects. It has to be stressed that the given postulates are still rarely used in practical assessment of equipment service life of critically important systems. That is why, the results of study presented in the article can be used in safety engineering and analysis of critically important complex technical systems.

Undergraduate Organic Chemistry Laboratory Safety

NASA Astrophysics Data System (ADS)

Luckenbaugh, Raymond W.

1996-11-01

Each organic chemistry student should become familiar with the educational and governmental laboratory safety requirements. One method for teaching laboratory safety is to assign each student to locate safety resources for a specific class laboratory experiment. The student should obtain toxicity and hazardous information for all chemicals used or produced during the assigned experiment. For example, what is the LD50 or LC50 for each chemical? Are there any specific hazards for these chemicals, carcinogen, mutagen, teratogen, neurotixin, chronic toxin, corrosive, flammable, or explosive agent? The school's "Chemical Hygiene Plan", "Prudent Practices for Handling Hazardous Chemicals in the Laboratory" (National Academy Press), and "Laboratory Standards, Part 1910 - Occupational Safety and Health Standards" (Fed. Register 1/31/90, 55, 3227-3335) should be reviewed for laboratory safety requirements for the assigned experiment. For example, what are the procedures for safe handling of vacuum systems, if a vacuum distillation is used in the assigned experiment? The literature survey must be submitted to the laboratory instructor one week prior to the laboratory session for review and approval. The student should then give a short presentation to the class on the chemicals' toxicity and hazards and describe the safety precautions that must be followed. This procedure gives the student first-hand knowledge on how to find and evaluate information to meet laboartory safety requirements.

78 FR 78794 - Proposed Establishment of Class E Airspace; Flagstaff, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

...This action proposes to establish Class E airspace at the Flagstaff VHF Omni-Directional Radio Range/Distance Measuring Equipment (VOR/DME) navigation aid, Flagstaff, AZ, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Albuquerque Air Route Traffic Control Center (ARTCC). The FAA is proposing this action to enhance the safety and management of aircraft operations within the National Airspace System.

A Study in Iowa. Teaching Food Safety in Secondary FCS Classes

ERIC Educational Resources Information Center

Ellis, Jason D.; Henroid, Daniel H., Jr.

2005-01-01

Food safety is a significant issue in the United States and yet minimal research has been done on the inclusion of food safety in secondary school curricula. This study examined the feasibility of including food safety in Iowa FCS middle and secondary classes. Teachers reported food safety was important; only a few believed students were…

Laser Safety Evaluation of the MILES and Mini MILES Laser Emitting Components

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

AUGUSTONI, ARNOLD L.

Laser safety evaluation and output emission measurements were performed (during October and November 2001) on SNL MILES and Mini MILES laser emitting components. The purpose, to verify that these components, not only meet the Class 1 (eye safe) laser hazard criteria of the CDRH Compliance Guide for Laser Products and 21 CFR 1040 Laser Product Performance Standard; but also meet the more stringent ANSI Std. z136.1-2000 Safe Use of Lasers conditions for Class 1 lasers that govern SNL laser operations. The results of these measurements confirmed that all of the Small Arms Laser Transmitters, as currently set (''as is''), meetmore » the Class 1 criteria. Several of the Mini MILES Small Arms Transmitters did not. These were modified and re-tested and now meet the Class 1 laser hazard criteria. All but one System Controllers (hand held and rifle stock) met class 1 criteria for single trigger pulls and all presented Class 3a laser hazard levels if the trigger is held (continuous emission) for more than 5 seconds on a single point target. All units were Class 3a for ''aided'' viewing. These units were modified and re-tested and now meet the Class 1 hazard criteria for both ''aided'' as well as ''unaided'' viewing. All the Claymore Mine laser emitters tested are laser hazard Class 1 for both ''aided'' as well as ''unaided'' viewing.« less

Definition and means of maintaining the criticality detectors and alarms portion of the PFP safety envelope

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

White, W.F.

The purpose of this document is to provide the definition and means of maintaining the Safety Envelope (SE) related to the Criticality Alarm System (CAS). This document provides amplification of the Limiting Condition for Operation (LCO) described in the Plutonium Finishing Plant (PFP) Operational Safety Requirements (OSR), WHC-SD-CP-OSR-010, Rev. 0, 1994, Section 3.1.2, Criticality Detectors and Alarms. This document, with its appendices, provides the following: (1) System functional requirements for determining system operability (Section 3); (2) A list of annotated system block diagrams which indicate the safety envelope boundaries (Appendix C); (3) A list of the Safety Class 1 andmore » 2 Safety Envelope (SC-1/2 SE) equipment for input into the Master Component Index (Appendix B); (4) Functional requirements for individual SC-1/2 SE components, including appropriate setpoints and process parameters (Section 6 and Appendix A); (5) A list of the operational, maintenance and surveillance procedures necessary to operate and maintain the SC-1/2 SE components as required by the LCO (Section 6 and Appendix A).« less

78 FR 25384 - Establishment of Class E Airspace; Immokalee, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

... management of Instrument Flight Rules (IFR) operations within the National Airspace System. DATES: Effective... at Immokalee, FL, to accommodate the Area Navigation (RNAV) Global Positioning System (GPS) Standard... Procedures developed for Big Cypress Airfield. This action is necessary for the safety and management of IFR...

76 FR 34196 - Proposed Establishment of Class E Airspace; Forest, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-13

...) Global Positioning System (GPS) Standard Instrument Approach Procedures serving New London Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations...; Airspace Docket No. 11-AEA-11) and be submitted in triplicate to the Docket Management System (see...

78 FR 14473 - Proposed Establishment of Class E Airspace; Sanibel, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

...) Global Positioning System (GPS) special Standard Instrument Approach Procedure (SIAP) serving Sanibel Island Heliport. This action would enhance the safety and airspace management of Instrument Flight Rules...; Airspace Docket No. 12-ASO-18) and be submitted in triplicate to the Docket Management System (see...

76 FR 54155 - Proposed Establishment of Class E Airspace; Danville, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

...) Global Positioning System (GPS) Standard Instrument Approach Procedures at Danville Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the... submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number...

78 FR 14475 - Proposed Establishment of Class E Airspace; Cleveland, TN

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

...) Global Positioning System (GPS) Standard Instrument Approach Procedures at Cleveland Regional Jetport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR...; Airspace Docket No. 12-ASO-47) and be submitted in triplicate to the Docket Management System (see...

76 FR 35370 - Proposed Establishment of Class E Airspace; Copperhill, TN

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-17

...) Global Positioning System (GPS) Standard Instrument Approach Procedures at Martin Campbell Field Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR... submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number...

State of art of seismic design and seismic hazard analysis for oil and gas pipeline system

NASA Astrophysics Data System (ADS)

Liu, Aiwen; Chen, Kun; Wu, Jian

2010-06-01

The purpose of this paper is to adopt the uniform confidence method in both water pipeline design and oil-gas pipeline design. Based on the importance of pipeline and consequence of its failure, oil and gas pipeline can be classified into three pipe classes, with exceeding probabilities over 50 years of 2%, 5% and 10%, respectively. Performance-based design requires more information about ground motion, which should be obtained by evaluating seismic safety for pipeline engineering site. Different from a city’s water pipeline network, the long-distance oil and gas pipeline system is a spatially linearly distributed system. For the uniform confidence of seismic safety, a long-distance oil and pipeline formed with pump stations and different-class pipe segments should be considered as a whole system when analyzing seismic risk. Considering the uncertainty of earthquake magnitude, the design-basis fault displacements corresponding to the different pipeline classes are proposed to improve deterministic seismic hazard analysis (DSHA). A new empirical relationship between the maximum fault displacement and the surface-wave magnitude is obtained with the supplemented earthquake data in East Asia. The estimation of fault displacement for a refined oil pipeline in Wenchuan M S8.0 earthquake is introduced as an example in this paper.

Defining the Relationship Between Human Error Classes and Technology Intervention Strategies

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.; Rantanen, Esa; Crisp, Vicki K. (Technical Monitor)

2002-01-01

One of the main factors in all aviation accidents is human error. The NASA Aviation Safety Program (AvSP), therefore, has identified several human-factors safety technologies to address this issue. Some technologies directly address human error either by attempting to reduce the occurrence of errors or by mitigating the negative consequences of errors. However, new technologies and system changes may also introduce new error opportunities or even induce different types of errors. Consequently, a thorough understanding of the relationship between error classes and technology "fixes" is crucial for the evaluation of intervention strategies outlined in the AvSP, so that resources can be effectively directed to maximize the benefit to flight safety. The purpose of the present project, therefore, was to examine the repositories of human factors data to identify the possible relationship between different error class and technology intervention strategies. The first phase of the project, which is summarized here, involved the development of prototype data structures or matrices that map errors onto "fixes" (and vice versa), with the hope of facilitating the development of standards for evaluating safety products. Possible follow-on phases of this project are also discussed. These additional efforts include a thorough and detailed review of the literature to fill in the data matrix and the construction of a complete database and standards checklists.

Photovoltaic utility/customer interface study

NASA Astrophysics Data System (ADS)

Eichler, C. H.; Hayes, T. P.; Matthews, M. M.; Wilraker, V. F.

1980-12-01

The technical, economic, and legal and regulatory issues of interconnecting small, privately-owned, on-site photovoltaic generating systems to an electric utility are addressed. Baseline residential, commercial and industrial class photovoltaic systems were developed. Technical issues of concern affecting this interconnection were identified and included fault protection, undervoltage protection, lamp flicker, revenue metering, loss of synchromism, electrical safety, prevention of backfeeding a de-energized utility feeder, effects of on-site generation on utility relaying schemes, effects of power conditioner harmonic distortion on the electric utility, system isolation, electromagnetic interference and site power factor as seen by the utility. Typical interconnection wiring diagrams were developed for interconnecting each class of baseline photovoltaic generating system.

49 CFR 213.347 - Automotive or railroad crossings at grade.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION TRACK SAFETY STANDARDS Train Operations at Track Classes 6 and.../barrier system to address the protection of highway traffic and high speed trains. Trains shall not...-approved warning/barrier system exists on that track segment; and (2) All elements of that warning/barrier...

77 FR 39652 - Proposed Establishment of Class E Airspace; La Belle, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-05

...) Global Positioning System (GPS) Standard Instrument Approach Procedures at La Belle Municipal Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR...; Airspace Docket No. 12-ASO-29) and be submitted in triplicate to the Docket Management System (see...

76 FR 49390 - Proposed Establishment of Class E Airspace; Palmyra, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

...) Global Positioning System (GPS) Standard Instrument Approach Procedures at Reigle Field. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the...; Airspace Docket No. 11-ASO-17) and be submitted in triplicate to the Docket Management System (see...

78 FR 52111 - Proposed Establishment of Class E Airspace; Aliceville, AL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedure (SIAP) serving George Downer Airport. This action would enhance the safety and airspace management of Instrument Flight Rules...; Airspace Docket No. 13-ASO-7) and be submitted in triplicate to the Docket Management System (see ADDRESSES...

78 FR 18269 - Proposed Modification of Class E Airspace; Clifton/Morenci, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... accommodate aircraft using Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Greenlee County Airport. The FAA is proposing this action to enhance the safety and management... be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and...

76 FR 35362 - Proposed Amendment of Class E Airspace; Shelby, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-17

... using Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Shelby Airport. The FAA is proposing this action to enhance the safety and management of aircraft... submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number...

On Space Exploration and Human Error: A Paper on Reliability and Safety

NASA Technical Reports Server (NTRS)

Bell, David G.; Maluf, David A.; Gawdiak, Yuri

2005-01-01

NASA space exploration should largely address a problem class in reliability and risk management stemming primarily from human error, system risk and multi-objective trade-off analysis, by conducting research into system complexity, risk characterization and modeling, and system reasoning. In general, in every mission we can distinguish risk in three possible ways: a) known-known, b) known-unknown, and c) unknown-unknown. It is probably almost certain that space exploration will partially experience similar known or unknown risks embedded in the Apollo missions, Shuttle or Station unless something alters how NASA will perceive and manage safety and reliability

78 FR 46560 - Pipeline Safety: Class Location Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-01

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... class location requirements for gas transmission pipelines. Section 5 of the Pipeline Safety, Regulatory... and, with respect to gas transmission pipeline facilities, whether applying IMP requirements to...

10 CFR 50.69 - Risk-informed categorization and treatment of structures, systems and components for nuclear...

Code of Federal Regulations, 2012 CFR

2012-01-01

..., systems and components for nuclear power reactors. 50.69 Section 50.69 Energy NUCLEAR REGULATORY..., systems and components for nuclear power reactors. (a) Definitions. Risk-Informed Safety Class (RISC)-1... holder of a license to operate a light water reactor (LWR) nuclear power plant under this part; a holder...

10 CFR 50.69 - Risk-informed categorization and treatment of structures, systems and components for nuclear...

Code of Federal Regulations, 2013 CFR

2013-01-01

..., systems and components for nuclear power reactors. 50.69 Section 50.69 Energy NUCLEAR REGULATORY..., systems and components for nuclear power reactors. (a) Definitions. Risk-Informed Safety Class (RISC)-1... holder of a license to operate a light water reactor (LWR) nuclear power plant under this part; a holder...

10 CFR 50.69 - Risk-informed categorization and treatment of structures, systems and components for nuclear...

Code of Federal Regulations, 2014 CFR

2014-01-01

..., systems and components for nuclear power reactors. 50.69 Section 50.69 Energy NUCLEAR REGULATORY..., systems and components for nuclear power reactors. (a) Definitions. Risk-Informed Safety Class (RISC)-1... holder of a license to operate a light water reactor (LWR) nuclear power plant under this part; a holder...

Rule Based System for Medicine Inventory Control Using Radio Frequency Identification (RFID)

NASA Astrophysics Data System (ADS)

Nugraha, Joanna Ardhyanti Mita; Suryono; Suseno, dan Jatmiko Endro

2018-02-01

Rule based system is very efficient to ensure stock of drug to remain available by utilizing Radio Frequency Identification (RFID) as input means automatically. This method can ensure the stock of drugs to remain available by analyzing the needs of drug users. The research data was the amount of drug usage in hospital for 1 year. The data was processed by using ABC classification to determine the drug with fast, medium and slow movement. In each classification result, rule based algorithm was given for determination of safety stock and Reorder Point (ROP). This research yielded safety stock and ROP values that vary depending on the class of each drug. Validation is done by comparing the calculation of safety stock and reorder point both manually and by system, then, it was found that the mean deviation value at safety stock was 0,03 and and ROP was 0,08.

16 CFR 1025.18 - Class actions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL RULES OF PRACTICE FOR ADJUDICATIVE..., regulation, or consumer product safety rule, or (3) Manufacturers, distributors, or retailers, or a... consumer product safety rule. When appropriate, a class may be divided into subclasses and each subclass...

16 CFR § 1025.18 - Class actions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL RULES OF PRACTICE FOR ADJUDICATIVE..., regulation, or consumer product safety rule, or (3) Manufacturers, distributors, or retailers, or a... consumer product safety rule. When appropriate, a class may be divided into subclasses and each subclass...

16 CFR 1025.18 - Class actions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL RULES OF PRACTICE FOR ADJUDICATIVE..., regulation, or consumer product safety rule, or (3) Manufacturers, distributors, or retailers, or a... consumer product safety rule. When appropriate, a class may be divided into subclasses and each subclass...

78 FR 59906 - Pipeline Safety: Class Location Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-30

... 192 [Docket No. PHMSA-2013-0161] Pipeline Safety: Class Location Requirements AGENCY: Pipeline and... Location Requirements,'' seeking comments on whether integrity management program (IMP) requirements, or... for class location requirements. PHMSA has received two requests to extend the comment period to allow...

Design of Critical Components

NASA Technical Reports Server (NTRS)

Hendricks, Robert C.; Zaretsky, Erwin V.

2001-01-01

Critical component design is based on minimizing product failures that results in loss of life. Potential catastrophic failures are reduced to secondary failures where components removed for cause or operating time in the system. Issues of liability and cost of component removal become of paramount importance. Deterministic design with factors of safety and probabilistic design address but lack the essential characteristics for the design of critical components. In deterministic design and fabrication there are heuristic rules and safety factors developed over time for large sets of structural/material components. These factors did not come without cost. Many designs failed and many rules (codes) have standing committees to oversee their proper usage and enforcement. In probabilistic design, not only are failures a given, the failures are calculated; an element of risk is assumed based on empirical failure data for large classes of component operations. Failure of a class of components can be predicted, yet one can not predict when a specific component will fail. The analogy is to the life insurance industry where very careful statistics are book-kept on classes of individuals. For a specific class, life span can be predicted within statistical limits, yet life-span of a specific element of that class can not be predicted.

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

PubMed

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

2017-03-01

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

Guaranteeing safety in spatially situated agents

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

Kohout, R.C.; Hendler, J.A.; Musliner, D.J.

1996-12-31

{open_quote}Mission-critical{close_quotes} systems, which include such diverse applications as nuclear power plant controllers, {open_quotes}fly-by-wire{close_quotes} airplanes, medical care and monitoring systems, and autonomous mobile vehicles, are characterized by the fact that system failure is potentially catastrophic. The high cost of failure justifies the expenditure of considerable effort at design-time in order to guarantee the correctness of system behavior. This paper examines the problem of guaranteeing safety in a well studied class of robot motion problems known as the {open_quotes}asteroid avoidance problem.{close_quotes} We establish necessary and sufficient conditions for ensuring safety in the simple version of this problem which occurs most frequently inmore » the literature, as well as sufficient conditions for a more general and realistic case. In doing so, we establish functional relationships between the number, size and speed of obstacles, the robot`s maximum speed and the conditions which must be maintained in order to ensure safety.« less

Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System. Final order.

PubMed

2018-01-02

The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

PubMed

2017-10-18

The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

PubMed

2018-01-03

The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Biological safety cabinetry.

PubMed Central

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

1991-01-01

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

78 FR 69745 - Safety and Security Plans for Class 3 Hazardous Materials Transported by Rail

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... Security Plans for Class 3 Hazardous Materials Transported by Rail AGENCY: Pipeline and Hazardous Materials... characterization, classification, and selection of a packing group for Class 3 materials, and the corresponding...

77 FR 37362 - Implementation of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-21

...] Implementation of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a Public Safety... public safety answering points (PSAPs) as required by the ``Middle Class Tax Relief and Job Creation Act... Objectives of, the Proposed Rules 21. The ``Middle Class Tax Relief and Job Creation Act of 2012'' requires...

Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

PubMed

2010-11-05

The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

78 FR 31429 - Proposed Amendment of Class E Airspace; Mason, TX

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-24

... new Standard Instrument Approach Procedures (SIAP) at Mason County Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the... safety and management of IFR aircraft in Class E airspace to/from the en route environment. Class E...

30 CFR 20.9 - Class 2 lamps.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Class 2 lamps. 20.9 Section 20.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.9 Class 2 lamps. (a) Safety. (1...

Maximizing Safety, Social Support, and Participation in Walking/Jogging/Running Classes

ERIC Educational Resources Information Center

Consolo, Kitty A.

2007-01-01

Physical education instructors who teach high school or college walking/jogging/running classes, or who include walking or running as a segment of a wellness class, face a particular challenge in trying to meet each student's individual fitness needs while ensuring safety. This article provides strategies for effectively meeting individual needs…

Safety system augmentation at Russian nuclear power plants

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

Scerbo, J.A.; Satpute, S.N.; Donkin, J.Y.

1996-12-31

This paper describes the design and procurement of a Class IE DC power supply system to upgrade plant safety at the Kola Nuclear Power Plant (NPP). Kola NPP is located above the Arctic circle at Polyarnie Zorie, Murmansk, Russia. Kola NPP consists of four units. Units 1 and 2 have VVER-440/230 type reactors: Units 3 and 4 have VVER-440/213 type reactors. The VVER-440 reactor design is similar to the pressurized water reactor design used in the US. This project provided redundant, Class 1E DC station batteries and DC switchboards for Kola NPP, Units 1 and 2. The new DC powermore » supply system was designed and procured in compliance with current nuclear design practices and requirements. Technical issues that needed to be addressed included reconciling the requirements in both US and Russian codes and satisfying the requirements of the Russian nuclear regulatory authority. Close interface with ATOMENERGOPROEKT (AEP), the Russian design organization, KOLA NPP plant personnel, and GOSATOMNADZOR (GAN), the Russian version of US Nuclear Regulatory Commission, was necessary to develop a design that would assure compliance with current Russian design requirements. Hence, this project was expected to serve as an example for plant upgrades at other similar VVER-440 nuclear plants. In addition to technical issues, the project needed to address language barriers and the logistics of shipping equipment to a remote section of the Former Soviet Union (FSU). This project was executed by Burns and Roe under the sponsorship of the US DOE as part of the International Safety Program (INSP). The INSP is a comprehensive effort, in cooperation with partners in other countries, to improve nuclear safety worldwide. A major element within the INSP is the improvement of the safety of Soviet-designed nuclear reactors.« less

76 FR 55232 - Establishment of Class E Airspace; Copperhill, TN

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

...) Standard Instrument Approach Procedures serving Martin Campbell Field Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace... Positioning System (GPS) Standard Instrument Approach Procedures developed for Martin Campbell Field Airport...

78 FR 38197 - Establishment of Class E Airspace; Port Townsend, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-26

... Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Jefferson County International Airport. This improves the safety and management of Instrument Flight Rules... airport, to accommodate IFR aircraft executing new RNAV (GPS) standard instrument approach procedures...

Automatic Identification Systems the Effects of Class B on the Use of Class A Systems

NASA Astrophysics Data System (ADS)

Norris, Andy

2006-05-01

The standards for CSTDMA Class B AIS will shortly be published by the International Electrotechnical Commission and equipment will become available during 2006. The perceived benefits that Class B brings to leisure craft users and its relatively low cost will make it attractive in the market place. A rapid take-up of Class B use can therefore be expected. This paper considers the impact that increased use of Class B will have on users of Class A AIS that are compulsorily fitted to larger vessels to meet the requirements of the International Maritime Organization Safety of Life at Sea convention. The CSTDMA Class B system has been designed to prevent overloading of the AIS VHF data link. This is briefly reviewed but there are a number of other aspects that need to be considered. These include: the increased garbling of Class B messages compared to those of Class A; the problems accruing from the low update rate of Class B information; the increase in display information that will need to be managed; and the possible increase in inappropriate manoeuvres of leisure craft caused by misplaced reliance on AIS. As a result of the investigation the paper highlights the fact that Class B users must not assume that their own presence, in the form of Class B transmissions, will be particularly visible on the bridge of many SOLAS vessels. This will continue to be the case for many years into the future, until such vessels are mandated to carry radar with AIS target overlay capability.

Advanced Range Safety System for High Energy Vehicles

NASA Technical Reports Server (NTRS)

Claxton, Jeffrey S.; Linton, Donald F.

2002-01-01

The advanced range safety system project is a collaboration between the National Aeronautics and Space Administration and the United States Air Force to develop systems that would reduce costs and schedule for safety approval for new classes of unmanned high-energy vehicles. The mission-planning feature for this system would yield flight profiles that satisfy the mission requirements for the user while providing an increased quality of risk assessment, enhancing public safety. By improving the speed and accuracy of predicting risks to the public, mission planners would be able to expand flight envelopes significantly. Once in place, this system is expected to offer the flexibility of handling real-time risk management for the high-energy capabilities of hypersonic vehicles including autonomous return-from-orbit vehicles and extended flight profiles over land. Users of this system would include mission planners of Space Launch Initiative vehicles, space planes, and other high-energy vehicles. The real-time features of the system could make extended flight of a malfunctioning vehicle possible, in lieu of an immediate terminate decision. With this improved capability, the user would have more time for anomaly resolution and potential recovery of a malfunctioning vehicle.

Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms. Final order.

PubMed

2017-12-27

The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the flow cytometric test system for hematopoietic neoplasms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical devices; hematology and pathology devices; classification of early growth response 1 gene fluorescence in-situ hybridization test system for specimen characterization. Final order.

PubMed

2014-09-03

The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Functional design criteria for interim stabilization safety class 1 trip circuit

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

Larson, R.E., Westinghouse Hanford

1996-06-10

This Functional Design Criteria document outlines the basic requirements for the Safety Class 1 Trip Circuit. The objective of the Safety Class 1 Trip Circuit is to isolate the power circuitry to the Class 1 Division 2, Group B or lesser grade electrically fed loads located in the pump pit. The electrically fed load circuits need to have power isolated to them upon receipt of the following conditions, loss of flammable gases being released (above a predetermined threshold), and seismic(greater than 0.12g acceleration) activity. The two circuits requiring power isolation are the pump and heat trace power circuits. The Safetymore » Class 1 Trip Circuit will be used to support salt well pumping in SST`s containing potentially flammable gas-bearing / gas-producing radioactive waste.« less

78 FR 34558 - Modification of Class E Airspace; Clifton/Morenci, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-10

... (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Greenlee County Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the... accommodate IFR aircraft executing RNAV (GPS) standard instrument approach procedures at the airport. This...

76 FR 82113 - Amendment of Class E Airspace; Show Low, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-30

... Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Show Low Regional Airport. This improves the safety and management of Instrument Flight Rules (IFR... executing RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for...

76 FR 57634 - Establishment of Class E Airspace; Chinle, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

...) Global Positioning System (GPS) standard instrument approach procedures at Chinle Municipal Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES... RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the...

76 FR 52230 - Establishment of Class E Airspace; Forest, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

... Instrument Approach Procedures serving New London Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. DATES: Effective... to support the new RNAV GPS standard instrument approach procedures developed for New London Airport...

78 FR 67024 - Modification of Class E Airspace; Prineville, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... Prineville, OR, to accommodate Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Prineville Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. This action also adjusts the geographic coordinates of the...

76 FR 45180 - Modification of Class E Airspace; Alturas, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-28

... Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Alturas Municipal Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, October 20, 2011. The Director of the Federal...

77 FR 44120 - Establishment of Class E Airspace; Roundup, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-27

... at Roundup Airport, Roundup, MT, to accommodate aircraft using new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Roundup Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901...

76 FR 45177 - Establishment of Class E Airspace; Kayenta, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-28

... Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Kayenta Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, October 20, 2011. The Director of the Federal Register...

78 FR 59622 - Establishment of Class E Airspace; Akutan, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-27

... at Akutan Airport, Akutan, AK. Controlled airspace is necessary to accommodate aircraft using the new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at the airport. This action enhances the safety and management of aircraft operations at the airport. DATES...

78 FR 50322 - Amendment of Class E Airspace; Point Thomson, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

... Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures have been established at the airport. This action enhances the safety and management of aircraft operations... Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action modifies the airspace at Point...

Design of 3D simulation engine for oilfield safety training

NASA Astrophysics Data System (ADS)

Li, Hua-Ming; Kang, Bao-Sheng

2015-03-01

Aiming at the demand for rapid custom development of 3D simulation system for oilfield safety training, this paper designs and implements a 3D simulation engine based on script-driven method, multi-layer structure, pre-defined entity objects and high-level tools such as scene editor, script editor, program loader. A scripting language been defined to control the system's progress, events and operating results. Training teacher can use this engine to edit 3D virtual scenes, set the properties of entity objects, define the logic script of task, and produce a 3D simulation training system without any skills of programming. Through expanding entity class, this engine can be quickly applied to other virtual training areas.

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation.

PubMed

Abraham, William T; Kuck, Karl-Heinz; Goldsmith, Rochelle L; Lindenfeld, JoAnn; Reddy, Vivek Y; Carson, Peter E; Mann, Douglas L; Saville, Benjamin; Parise, Helen; Chan, Rodrigo; Wiegn, Phi; Hastings, Jeffrey L; Kaplan, Andrew J; Edelmann, Frank; Luthje, Lars; Kahwash, Rami; Tomassoni, Gery F; Gutterman, David D; Stagg, Angela; Burkhoff, Daniel; Hasenfuß, Gerd

2018-05-05

The authors sought to confirm a subgroup analysis of the prior FIX-HF-5 (Evaluate Safety and Efficacy of the OPTIMIZER System in Subjects With Moderate-to-Severe Heart Failure) study showing that cardiac contractility modulation (CCM) improved exercise tolerance (ET) and quality of life in patients with ejection fractions between 25% and 45%. CCM therapy for New York Heart Association (NYHA) functional class III and IV heart failure (HF) patients consists of nonexcitatory electrical signals delivered to the heart during the absolute refractory period. A total of 160 patients with NYHA functional class III or IV symptoms, QRS duration <130 ms, and ejection fraction ≥25% and ≤45% were randomized to continued medical therapy (control, n = 86) or CCM (treatment, n = 74, unblinded) for 24 weeks. Peak VO 2 (primary endpoint), Minnesota Living With Heart Failure questionnaire, NYHA functional class, and 6-min hall walk were measured at baseline and at 12 and 24 weeks. Bayesian repeated measures linear modeling was used for the primary endpoint analysis with 30% borrowing from the FIX-HF-5 subgroup. Safety was assessed by the percentage of patients free of device-related adverse events with a pre-specified lower bound of 70%. The difference in peak VO 2 between groups was 0.84 (95% Bayesian credible interval: 0.123 to 1.552) ml O 2 /kg/min, satisfying the primary endpoint. Minnesota Living With Heart Failure questionnaire (p < 0.001), NYHA functional class (p < 0.001), and 6-min hall walk (p = 0.02) were all better in the treatment versus control group. There were 7 device-related events, yielding a lower bound of 80% of patients free of events, satisfying the primary safety endpoint. The composite of cardiovascular death and HF hospitalizations was reduced from 10.8% to 2.9% (p = 0.048). CCM is safe, improves exercise tolerance and quality of life in the specified group of HF patients, and leads to fewer HF hospitalizations. (Evaluate Safety and Efficacy of the OPTIMIZER System in Subjects With Moderate-to-Severe Heart Failure; NCT01381172). Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

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

Information Processing Research

DTIC Science & Technology

1992-01-03

structure of instances. Opal provides special graphical objects called "Ag- greGadgets" which are used to hold a collection of other objects (either...available in classes of expert systems tasks, re- late this to the structure of parallel production systems, and incorporate parallel-decomposition...Anantharaman et al. 88]. We designed a new pawn structure algorithm and upgraded the king-safety pattern recog- nizers, which contributed significantly

Experiments with Geometric Non-Linear Coupling for Analytical Validation

DTIC Science & Technology

2010-03-01

maintaining a high safety factor. This is the primary constraint and is very important in keeping the end conditions of the experiment known. 3.1.4...the maximum load case while maintaining a safety factor of at least 2. Figure 3.14: Cable and Winch. The load is measured using a 3,000 lbf...the class and power of this laser, laser eyewear is required for safe use of the system. The Photon 80 can scan at various levels of detail. For

78 FR 10099 - Implementation of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

... of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a Public Safety... establish a do-not-call registry for public safety answering points (PSAP) and prohibit the use of automatic... amended rules are necessary to implement the enforcement provisions of the Middle Class Tax Relief and Job...

Electrician's Mate 3 & 2: Rate Training Manual.

ERIC Educational Resources Information Center

Naval Education and Training Command, Pensacola, FL.

The training manual provides information related to the tasks assigned to the Electrician's Mate Third and Second Class who operate and maintain power and lighting systems and associated equipment. Individual chapters deal with: career challenges for the Electrician's Mate, safety precautions, test equipment, electrical installations, A-C power…

77 FR 65462 - Establishment of Class E Airspace; La Belle, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

...) Standard Instrument Approach Procedures at La Belle Municipal Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. DATES... accommodate the new RNAV GPS Standard Instrument Approach Procedures developed for La Belle Municipal Airport...

78 FR 1750 - Establishment of Class E Airspace; Princeton, KY

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-09

... the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. This action also makes a minor adjustment to the geographic coordinates of the airport... action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with...

78 FR 72010 - Establishment of Class E Airspace; Magee, MS

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-02

... safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. This action also updates the geographic coordinates of the airport. DATES: Effective 0901 UTC.... Subsequent to publication, the FAA found an error in the geographic coordinates of Magee Municipal Airport...

77 FR 16669 - Establishment of Class E Airspace; Bellefonte, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

... at Bellefonte, PA, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures at Bellefonte Airport. This action enhances the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective 0901 UTC, May 31, 2012. The...

76 FR 45177 - Establishment of Class E Airspace; Nephi, UT

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-28

... at Nephi UT, to accommodate aircraft using new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Nephi Municipal Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, October...

75 FR 12974 - Establishment of Class E Airspace; Hailey, ID

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-18

... airspace at Hailey, ID, to accommodate aircraft using the Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedure (SIAP) at Friedman Memorial Airport. This will improve the safety of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective Date: 0901 UTC, June...

76 FR 69608 - Modification of Class E Airspace; Blythe, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-09

... Blythe, CA, to accommodate aircraft using Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Blythe Airport. This action also corrects geographic coordinates in the regulatory text. This improves the safety and management of Instrument Flight Rules (IFR) operations at the...

78 FR 22415 - Amendment of Class E Airspace; Astoria, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... Astoria Regional Airport, Astoria, OR, to accommodate aircraft using Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at the airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, June...

77 FR 55691 - Establishment of Class E Airspace; Circle Town, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Circle Town County Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, November 15, 2012. The Director of the Federal Register approves...

78 FR 22417 - Modification of Class E Airspace; Lakeview, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... Lakeview, OR, to accommodate aircraft using Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Lakeview County Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. This action also corrects the airport name. DATES...

77 FR 55692 - Establishment of Class E Airspace; Fort Garland, CO

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... accommodate aircraft using new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Trinchera Ranch Airstrip Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, November 15, 2012...

Better Safe Than Sorry

ERIC Educational Resources Information Center

Ziff, Stephen J.

1973-01-01

Describes the increased need for emergency lighting equipment for late evening events, adult education evening classes, and for the increasing use of the interior classroom. Explains the difference between central and unit lighting systems; clarifies the specifications in the Occupational Safety and Health Act (OSHA) as they apply to school…

Impact of Passive Safety on FHR Instrumentation Systems Design and Classification

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

Holcomb, David Eugene

2015-01-01

Fluoride salt-cooled high-temperature reactors (FHRs) will rely more extensively on passive safety than earlier reactor classes. 10CFR50 Appendix A, General Design Criteria for Nuclear Power Plants, establishes minimum design requirements to provide reasonable assurance of adequate safety. 10CFR50.69, Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Reactors, provides guidance on how the safety significance of systems, structures, and components (SSCs) should be reflected in their regulatory treatment. The Nuclear Energy Institute (NEI) has provided 10 CFR 50.69 SSC Categorization Guideline (NEI-00-04) that factors in probabilistic risk assessment (PRA) model insights, as well as deterministic insights, throughmore » an integrated decision-making panel. Employing the PRA to inform deterministic requirements enables an appropriately balanced, technically sound categorization to be established. No FHR currently has an adequate PRA or set of design basis accidents to enable establishing the safety classification of its SSCs. While all SSCs used to comply with the general design criteria (GDCs) will be safety related, the intent is to limit the instrumentation risk significance through effective design and reliance on inherent passive safety characteristics. For example, FHRs have no safety-significant temperature threshold phenomena, thus enabling the primary and reserve reactivity control systems required by GDC 26 to be passively, thermally triggered at temperatures well below those for which core or primary coolant boundary damage would occur. Moreover, the passive thermal triggering of the primary and reserve shutdown systems may relegate the control rod drive motors to the control system, substantially decreasing the amount of safety-significant wiring needed. Similarly, FHR decay heat removal systems are intended to be running continuously to minimize the amount of safety-significant instrumentation needed to initiate operation of systems and components important to safety as required in GDC 20. This paper provides an overview of the design process employed to develop a pre-conceptual FHR instrumentation architecture intended to lower plant capital and operational costs by minimizing reliance on expensive, safety related, safety-significant instrumentation through the use of inherent passive features of FHRs.« less

Application of the threshold of toxicological concern approach for the safety evaluation of calendula flower (Calendula officinalis) petals and extracts used in cosmetic and personal care products.

PubMed

Re, T A; Mooney, D; Antignac, E; Dufour, E; Bark, I; Srinivasan, V; Nohynek, G

2009-06-01

Calendula flower (Calendula officinalis) (CF) has been used in herbal medicine because of its anti-inflammatory activity. CF and C. officinalis extracts (CFE) are used as skin conditioning agents in cosmetics. Although data on dermal irritation and sensitization of CF and CFE's are available, the risk of subchronic systemic toxicity following dermal application has not been evaluated. The threshold of toxicological concern (TTC) is a pragmatic, risk assessment based approach that has gained regulatory acceptance for food and has been recently adapted to address cosmetic ingredient safety. The purpose of this paper is to determine if the safe use of CF and CFE can be established based upon the TTC class for each of its known constituents. For each constituent, the concentration in the plant, the molecular weight, and the estimated skin penetration potential were used to calculate a maximal daily systemic exposure which was then compared to its corresponding TTC class value. Since the composition of plant extracts are variable, back calculation was used to determine the maximum acceptable concentration of a given constituent in an extract of CF. This paper demonstrates the utility and practical application of the TTC concept when used as a tool in the safety evaluation of botanical extracts.

49 CFR 213.345 - Vehicle/track system qualification.

Code of Federal Regulations, 2013 CFR

2013-10-01

... in accordance with the requirements of this paragraph (c). (1) Simulations or measurement of wheel/rail forces. For vehicle types intended to operate at track Class 6 speeds, simulations or measurement... exceed the wheel/rail force safety limits specified in § 213.333. Simulations, if conducted, shall be in...

49 CFR 213.345 - Vehicle/track system qualification.

Code of Federal Regulations, 2014 CFR

2014-10-01

... in accordance with the requirements of this paragraph (c). (1) Simulations or measurement of wheel/rail forces. For vehicle types intended to operate at track Class 6 speeds, simulations or measurement... exceed the wheel/rail force safety limits specified in § 213.333. Simulations, if conducted, shall be in...

49 CFR 179.101-1 - Individual specification requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 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) § 179.101-1... than 1/2 inch. 4 Tank cars not equipped with a thermal protection or an insulation system used for the...

49 CFR 179.101-1 - Individual specification requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 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) § 179.101-1... than 1/2 inch. 4 Tank cars not equipped with a thermal protection or an insulation system used for the...

49 CFR 179.101-1 - Individual specification requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 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) § 179.101-1... than 1/2 inch. 4 Tank cars not equipped with a thermal protection or an insulation system used for the...

76 FR 46212 - Proposed Modification of Class E Airspace; Blythe, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-02

... procedures at Blythe Airport. The FAA is proposing this action to enhance the safety and management of... be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and... controlled airspace is necessary to accommodate aircraft using the RNAV (GPS) standard instrument approach...

76 FR 41145 - Proposed Amendment of Class E Airspace; Glendive, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

... procedures at the airport. The FAA is proposing this action to enhance the safety and management of aircraft... submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number.... Controlled airspace is necessary to accommodate aircraft using the RNAV (GPS) standard instrument approach...

76 FR 14820 - Proposed Amendment of Class E Airspace; Waynesboro, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... Instrument Approach Procedures (SIAPs) developed for Eagle's Nest Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport. DATES: 0901... submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number...

76 FR 59013 - Amendment of Class E Airspace; Burlington, VT

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-23

... airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. This action also makes a minor adjustment to the geographic coordinates of the airport and recognizes the name... modified for the safety and management of IFR operations at the airport. The geographic coordinates for...

Identification of multidrug-resistant Salmonella enterica serovar typhimurium isolates that have an antibiotic-induced invasion phenotype

USDA-ARS?s Scientific Manuscript database

Multidrug-resistant (MDR) Salmonella is an important food safety issue in humans and animals. The National Antimicrobial Resistance Monitoring System (NARMS) has reported that 27.3% of Salmonella enterica serotype Typhimurium isolates in humans were resistant to three or more classes of antibiotics...

77 FR 19928 - Amendment of Class E Airspace; Hugo, CO

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-03

.... Decommissioning of the Hugo Tactical Air Navigation System (TACAN) has made this action necessary for the safety... legal description is better clarified at the request of the National Aeronautical Navigation Services... to publication, it was discovered by NANS that the legal description needed editing by removing the...

75 FR 39147 - Establishment of Class E Airspace; Bryce Canyon, UT

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

... E airspace at Bryce Canyon, UT, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) at Bryce Canyon Airport. This will improve the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES...

76 FR 75448 - Establishment of Class D and E Airspace; Frederick, MD

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... and E airspace at Frederick, MD, to accommodate new Area Navigation (RNAV) Global Positioning System... enhances the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport. DATES: Effective 0901 UTC, February 9, 2012. The Director of the Federal Register approves this...

77 FR 49720 - Establishment of Class E Airspace; Chenega Bay, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-17

... at Chenega Bay, AK, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Chenega Bay Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC...

75 FR 37294 - Modification of Class E Airspace; Kelso, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-29

... airspace at Kelso, WA, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System... improve the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, September 23, 2010. The Director of the Federal Register approves this...

Cooperative Driver Education and Safety Training. Coordinator's Guide.

ERIC Educational Resources Information Center

Seyfarth, John T.; And Others

Characteristics of the cooperative approach which give this program advantages of low-cost, high-quality, flexible driver-training accessible to more students are: (1) use of technological teaching aids, permitting large class enrollment; (2) shared operating costs and capital investment among cooperating schools or systems; (3) reduced capital…

Teaching Bank Runs through Films

ERIC Educational Resources Information Center

Flynn, David T.

2009-01-01

The author advocates the use of films to supplement textbook treatments of bank runs and panics in money and banking or general banking classes. Modern students, particularly those in developed countries, tend to be unfamiliar with potential fragilities of financial systems such as a lack of deposit insurance or other safety net mechanisms. Films…

The micronucleus test-most widely used in vivo genotoxicity test.

PubMed

Hayashi, Makoto

2016-01-01

Genotoxicity is commonly evaluated during the chemical safety assessment together with other toxicological endpoints. The micronucleus test is always included in many genotoxic test guidelines for long time in many classes of chemicals, e.g., pharmaceutical chemicals, agricultural chemicals, food additives. Although the trend of the safety assessment of chemicals faces to animal welfare and in vitro systems are more welcome than the in vivo systems, the in vivo test systems are paid more attention in the field of genotoxicity because of its weight of evidence. In this review, I will summarize the following points: 1) historical consideration of the test development, 2) characteristics of the test including advantages and limitations, 3) new approaches considering to the animal welfare.

Some Challenges in the Design of Human-Automation Interaction for Safety-Critical Systems

NASA Technical Reports Server (NTRS)

Feary, Michael S.; Roth, Emilie

2014-01-01

Increasing amounts of automation are being introduced to safety-critical domains. While the introduction of automation has led to an overall increase in reliability and improved safety, it has also introduced a class of failure modes, and new challenges in risk assessment for the new systems, particularly in the assessment of rare events resulting from complex inter-related factors. Designing successful human-automation systems is challenging, and the challenges go beyond good interface development (e.g., Roth, Malin, & Schreckenghost 1997; Christoffersen & Woods, 2002). Human-automation design is particularly challenging when the underlying automation technology generates behavior that is difficult for the user to anticipate or understand. These challenges have been recognized in several safety-critical domains, and have resulted in increased efforts to develop training, procedures, regulations and guidance material (CAST, 2008, IAEA, 2001, FAA, 2013, ICAO, 2012). This paper points to the continuing need for new methods to describe and characterize the operational environment within which new automation concepts are being presented. We will describe challenges to the successful development and evaluation of human-automation systems in safety-critical domains, and describe some approaches that could be used to address these challenges. We will draw from experience with the aviation, spaceflight and nuclear power domains.

Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications.

PubMed

Kumar, Uma; Sankalp, Gokhale; Gokhle, Sankalp S; Sreenivas, V; Kaur, Satbir; Misra, Durgaprasanna

2013-04-01

Pulmonary artery hypertension (PAH) remains the leading cause of morbidity and mortality in systemic sclerosis, while Raynaud's phenomenon and digital ulcers significantly add to the morbidity in systemic sclerosis (SSc). This study was undertaken to evaluate the role of sildenafil in PAH, Raynaud's phenomenon, and digital ulcers in systemic sclerosis patients. A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud's phenomenon, digital infarcts, and ulcers in SSc. Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited. Six-minute walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment. All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months. The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud's phenomenon were compared to look for any significant change. Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and mPAP. Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing. Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for SSc-associated PAH, Raynaud's phenomenon, and digital infarcts/ulcers.

Low-Cost, Class D Testing of Spacecraft Photovoltaic Systems Can Reduce Risk

NASA Technical Reports Server (NTRS)

Forgione, Joshua B.; Kojima, Gilbert K.; Hanel, Robert; Mallinson, Mark

2014-01-01

The end-to-end verification of a spacecraft photovoltaic power generation system requires light! A lowcost, portable, and end-to-end photovoltaic-system test appropriate for NASA's new generation of Class D missions is presented. High risk, low-cost, and quick-turn satellites rarely have the resources to execute the traditional approaches from higher-class (A-C) missions. The Class D approach, as demonstrated on the Lunar Atmospheric and Dust Environment Explorer (LADEE), utilizes a portable, metalhalide, theatre lamp for an end-to-end photovoltaic system test. While not as precise and comprehensive as the traditional Large Area Pulsed Solar Simulator (LAPSS) test, the LADEE method leverages minimal resources into an ongoing assessment program that can be applied through numerous stages of the mission. The project takes a true Class D approach in assessing the technical value of a costly, highfidelity performance test versus a simpler approach with less programmatic risk. The resources required are a fraction of that for a LAPSS test, and is easy to repeat due to its portability. Further, the test equipment can be handed down to future projects without building an on-site facility. At the vanguard of Class D missions, the LADEE team frequently wrestled with and challenged the status quo. The philosophy of risk avoidance at all cost, typical to Class A-C missions, simply could not be executed. This innovative and simple testing solution is contextualized to NASA Class D programs and a specific risk encountered during development of the LADEE Electrical Power System (EPS). Selection of the appropriate lamp and safety concerns are discussed, with examples of test results. Combined with the vendor's panellevel data and periodic inspection, the method ensures system integrity from Integration and Test (I&T) through launch. Following launch, mission operations tools are utilized to assess system performance based on a scant amount of available data.

Instrumentation, Control, and Intelligent Systems

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

Not Available

2005-09-01

Abundant and affordable energy is required for U.S. economic stability and national security. Advanced nuclear power plants offer the best near-term potential to generate abundant, affordable, and sustainable electricity and hydrogen without appreciable generation of greenhouse gases. To that end, Idaho National Laboratory (INL) has been charged with leading the revitalization of nuclear power in the U.S. The INL vision is to become the preeminent nuclear energy laboratory with synergistic, world-class, multi-program capabilities and partnerships by 2015. The vision focuses on four essential destinations: (1) Be the preeminent internationally-recognized nuclear energy research, development, and demonstration laboratory; (2) Be a majormore » center for national security technology development and demonstration; (3) Be a multi-program national laboratory with world-class capabilities; (4) Foster academic, industry, government, and international collaborations to produce the needed investment, programs, and expertise. Crucial to that effort is the inclusion of research in advanced instrumentation, control, and intelligent systems (ICIS) for use in current and advanced power and energy security systems to enable increased performance, reliability, security, and safety. For nuclear energy plants, ICIS will extend the lifetime of power plant systems, increase performance and power output, and ensure reliable operation within the system's safety margin; for national security applications, ICIS will enable increased protection of our nation's critical infrastructure. In general, ICIS will cost-effectively increase performance for all energy security systems.« less

75 FR 49868 - Proposed Establishment of Class E Airspace; Kalaupapa, HI

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... Airport. The FAA is proposing this action to enhance the safety and management of aircraft operations at... submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number... comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building...

COURSE OUTLINE FOR FIRST SIX WEEKS FOR SCIENCE-LEVEL II, TALENT PRESERVATION CLASSES.

ERIC Educational Resources Information Center

Houston Independent School District, TX.

THE FIRST 6-WEEK UNIT CONCERNS ANIMAL LIFE, AND TOPICS INCLUDE PROTOZOA, INVERTEBRATES, AND VERTEBRATES. UNIT II, "THE HUMAN BODY", INCLUDES BODY SYSTEMS, HEALTH, AND SAFETY. TEXTBOOK REFERENCES, CONTENT OUTLINE, TEACHING SUGGESTIONS, REFERENCE READINGS, AND AUDIOVISUAL AIDS ARE GIVEN UNDER EACH TOPIC. IT IS SUGGESTED THAT FIRST…

A Study on Run Time Assurance for Complex Cyber Physical Systems

DTIC Science & Technology

2013-04-18

safety verification approach was applied to synchronization of distributed local clocks of the nodes on a CAN bus by Jiang et al. [36]. The class of...mode of interaction between the instrumented system and the checker, we distin- guish between synchronous and asynchronous monitoring. In synchronous ...occurred. Synchronous monitoring may deliver a higher degree of assurance than the asynchronous one, because it can block a dangerous action. However

Monitoring Distributed Real-Time Systems: A Survey and Future Directions

NASA Technical Reports Server (NTRS)

Goodloe, Alwyn E.; Pike, Lee

2010-01-01

Runtime monitors have been proposed as a means to increase the reliability of safety-critical systems. In particular, this report addresses runtime monitors for distributed hard real-time systems. This class of systems has had little attention from the monitoring community. The need for monitors is shown by discussing examples of avionic systems failure. We survey related work in the field of runtime monitoring. Several potential monitoring architectures for distributed real-time systems are presented along with a discussion of how they might be used to monitor properties of interest.

Safety considerations in the pharmacological management of atrial fibrillation.

PubMed

Camm, A John

2008-07-21

The pharmacological management of atrial fibrillation (AF) requires careful consideration from a safety perspective. This article focuses primarily on maintenance therapy using antiarrhythmic drugs (AADs). The foremost safety issue for AADs is the propensity of class IA and III agents to cause torsade de pointes arrhythmias. Class IA drugs, particularly quinidine, can induce torsade de pointes at low or subtherapeutic doses, but higher doses are not necessarily associated with an increased incidence. 'Pure' class III drugs such as dofetilide induce torsade de pointes in a dose-related manner, but some class III agents with more complex actions such as amiodarone have a markedly lower potential to cause this arrhythmia. The risk of torsade de pointes precludes the use of class IA and 'pure' class III agents in patients with left ventricular hypertrophy and bradycardia. Class IC agents may cause sustained monomorphic ventricular tachycardias and are generally precluded in ischaemic and structural heart disease. Advanced heart failure patients may be treated with amiodarone or dofetilide, but most other AADs are unsuitable. The most important extracardiac toxicities occurring with AADs are those of amiodarone. Drug interactions are a significant safety issue in the management of AF, including pharmacokinetic interactions in which plasma levels of the AAD are raised - increasing the risk of proarrhythmia - and concomitant use of drugs that prolong the QT interval. Notwithstanding these considerations, most patients with AF can be considered for rhythm control, provided there is adequate pre-treatment assessment and protocols for initiation, dosing and monitoring are followed with care.

40 CFR 82.70 - Nonessential Class II products and exceptions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... provide for motor vehicle safety in accordance with Federal Motor Vehicle Safety Standards until January 1... 21 CFR 2.125(e); (ii) Lubricants, coatings or cleaning fluids for electrical or electronic equipment...; (iii) Lubricants, coatings or cleaning fluids used for aircraft maintenance, which contain class II...

78 FR 48839 - Proposed Amendment of Class E Airspace; Carlsbad, NM

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-12

... accommodate new Standard Instrument Approach Procedures (SIAP) at Cavern City Air Terminal. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs... the airport, to retain the safety and management of IFR aircraft in Class E airspace to/from the en...

49 CFR 369.4 - Annual reports of Class I carriers of passengers.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 5 2014-10-01 2014-10-01 false Annual reports of Class I carriers of passengers. 369.4 Section 369.4 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS REPORTS OF MOTOR CARRIERS § 369.4 Annual...

Berkeley Lab - Materials Sciences Division

Science.gov Websites

? Click Here! Resources for MSD Safety MSD Safety MSD's Integrated Safety Management Plan [PDF] Safety culture and policies at MSD MSD0010: Integrated Safety Management: Principles and Case Studies Calendar for MSD classes on Integrated Safety Management MSD0015 Handout - Waste Briefing Document [PDF] Waste

Cryptographically supported NFC tags in medication for better inpatient safety.

PubMed

Özcanhan, Mehmet Hilal; Dalkılıç, Gökhan; Utku, Semih

2014-08-01

Reliable sources report that errors in drug administration are increasing the number of harmed or killed inpatients, during healthcare. This development is in contradiction to patient safety norms. A correctly designed hospital-wide ubiquitous system, using advanced inpatient identification and matching techniques, should provide correct medicine and dosage at the right time. Researchers are still making grouping proof protocol proposals based on the EPC Global Class 1 Generation 2 ver. 1.2 standard tags, for drug administration. Analyses show that such protocols make medication unsecure and hence fail to guarantee inpatient safety. Thus, the original goal of patient safety still remains. In this paper, a very recent proposal (EKATE) upgraded by a cryptographic function is shown to fall short of expectations. Then, an alternative proposal IMS-NFC which uses a more suitable and newer technology; namely Near Field Communication (NFC), is described. The proposed protocol has the additional support of stronger security primitives and it is compliant to ISO communication and security standards. Unlike previous works, the proposal is a complete ubiquitous system that guarantees full patient safety; and it is based on off-the-shelf, new technology products available in every corner of the world. To prove the claims the performance, cost, security and scope of IMS-NFC are compared with previous proposals. Evaluation shows that the proposed system has stronger security, increased patient safety and equal efficiency, at little extra cost.

A preliminary appraisal of the safety and operational effects on the regional transportation system caused by new rail-truck intermodal facilities.

DOT National Transportation Integrated Search

2012-07-01

Potential for impacts to a small Kansas city were evaluated in light of a planned rail to truck intermodal facility. The city : of Edgerton, Kansas, was selected for an intermodal terminal in 2006 by a Class I railroad due to its regional proximity t...

49 CFR 213.307 - Class of track: operating speed limits.

Code of Federal Regulations, 2010 CFR

2010-10-01

... conditions are met: (1) The vehicles utilized to carry such freight are of equal dynamic performance and have... distribution and securement in the freight vehicle will not adversely affect the dynamic performance of the... addressing other safety issues presented by the system. (b) If a segment of track does not meet all of the...

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

PubMed Central

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

2016-01-01

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

78 FR 4306 - Amendment of Class D and Class E Airspace; Twentynine Palms, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

... the safety and management of aircraft operations at Twentynine Palms SELF Airport, Twentynine Palms.... SUMMARY: This action amends Class D and Class E airspace at Twentynine Palms SELF Airport, Twentynine... name and geographic coordinates of Twentynine Palms SELF Airport, Twentynine Palms, CA. The Class D...

77 FR 52217 - Amendment of Class D and Class E Airspace; Bozeman, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-29

... Bozeman Yellowstone International Airport. This improves the safety and management of Instrument Flight... Class E airspace at Bozeman Yellowstone International Airport, Bozeman, MT. This action aligns two Class... airspace designated as an extension to Class D, at Bozeman Yellowstone International Airport, Bozeman, MT...

78 FR 50323 - Amendment of Class E Airspace; Lexington, OK

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

...-0272; Airspace Docket No. 13-ASW-10] Amendment of Class E Airspace; Lexington, OK AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action amends Class E airspace at... Class E surface area to a Class E transition area. This action enhances the safety and management of...

Reliability Analysis for AFTI-F16 SRFCS Using ASSIST and SURE

NASA Technical Reports Server (NTRS)

Wu, N. Eva

2001-01-01

This paper reports the results of a study on reliability analysis of an AFTI-16 Self-Repairing Flight Control System (SRFCS) using software tools SURE (Semi-Markov Unreliability Range Evaluator and ASSIST (Abstract Semi-Markov Specification Interface to the SURE Tool). The purpose of the study is to investigate the potential utility of the software tools in the ongoing effort of the NASA Aviation Safety Program, where the class of systems must be extended beyond the originally intended serving class of electronic digital processors. The study concludes that SURE and ASSIST are applicable to reliability, analysis of flight control systems. They are especially efficient for sensitivity analysis that quantifies the dependence of system reliability on model parameters. The study also confirms an earlier finding on the dominant role of a parameter called a failure coverage. The paper will remark on issues related to the improvement of coverage and the optimization of redundancy level.

Certifying Domain-Specific Policies

NASA Technical Reports Server (NTRS)

Lowry, Michael; Pressburger, Thomas; Rosu, Grigore; Koga, Dennis (Technical Monitor)

2001-01-01

Proof-checking code for compliance to safety policies potentially enables a product-oriented approach to certain aspects of software certification. To date, previous research has focused on generic, low-level programming-language properties such as memory type safety. In this paper we consider proof-checking higher-level domain -specific properties for compliance to safety policies. The paper first describes a framework related to abstract interpretation in which compliance to a class of certification policies can be efficiently calculated Membership equational logic is shown to provide a rich logic for carrying out such calculations, including partiality, for certification. The architecture for a domain-specific certifier is described, followed by an implemented case study. The case study considers consistency of abstract variable attributes in code that performs geometric calculations in Aerospace systems.

Safety Characteristics in System Application of Software for Human Rated Exploration Missions for the 8th IAASS Conference

NASA Technical Reports Server (NTRS)

Mango, Edward J.

2016-01-01

NASA and its industry and international partners are embarking on a bold and inspiring development effort to design and build an exploration class space system. The space system is made up of the Orion system, the Space Launch System (SLS) and the Ground Systems Development and Operations (GSDO) system. All are highly coupled together and dependent on each other for the combined safety of the space system. A key area of system safety focus needs to be in the ground and flight application software system (GFAS). In the development, certification and operations of GFAS, there are a series of safety characteristics that define the approach to ensure mission success. This paper will explore and examine the safety characteristics of the GFAS development. The GFAS system integrates the flight software packages of the Orion and SLS with the ground systems and launch countdown sequencers through the 'agile' software development process. A unique approach is needed to develop the GFAS project capabilities within this agile process. NASA has defined the software development process through a set of standards. The standards were written during the infancy of the so-called industry 'agile development' movement and must be tailored to adapt to the highly integrated environment of human exploration systems. Safety of the space systems and the eventual crew on board is paramount during the preparation of the exploration flight systems. A series of software safety characteristics have been incorporated into the development and certification efforts to ensure readiness for use and compatibility with the space systems. Three underlining factors in the exploration architecture require the GFAS system to be unique in its approach to ensure safety for the space systems, both the flight as well as the ground systems. The first are the missions themselves, which are exploration in nature, and go far beyond the comfort of low Earth orbit operations. The second is the current exploration system will launch only one mission per year even less during its developmental phases. Finally, the third is the partnered approach through the use of many different prime contractors, including commercial and international partners, to design and build the exploration systems. These three factors make the challenges to meet the mission preparations and the safety expectations extremely difficult to implement. As NASA leads a team of partners in the exploration beyond earth's influence, it is a safety imperative that the application software used to test, checkout, prepare and launch the exploration systems put safety of the hardware and mission first. Software safety characteristics are built into the design and development process to enable the human rated systems to begin their missions safely and successfully. Exploration missions beyond Earth are inherently risky, however, with solid safety approaches in both hardware and software, the boldness of these missions can be realized for all on the home planet.

Temporal Precedence Checking for Switched Models and its Application to a Parallel Landing Protocol

NASA Technical Reports Server (NTRS)

Duggirala, Parasara Sridhar; Wang, Le; Mitra, Sayan; Viswanathan, Mahesh; Munoz, Cesar A.

2014-01-01

This paper presents an algorithm for checking temporal precedence properties of nonlinear switched systems. This class of properties subsume bounded safety and capture requirements about visiting a sequence of predicates within given time intervals. The algorithm handles nonlinear predicates that arise from dynamics-based predictions used in alerting protocols for state-of-the-art transportation systems. It is sound and complete for nonlinear switch systems that robustly satisfy the given property. The algorithm is implemented in the Compare Execute Check Engine (C2E2) using validated simulations. As a case study, a simplified model of an alerting system for closely spaced parallel runways is considered. The proposed approach is applied to this model to check safety properties of the alerting logic for different operating conditions such as initial velocities, bank angles, aircraft longitudinal separation, and runway separation.

Safety Assessment of Acyl Glucuronides-A Simplified Paradigm.

PubMed

Smith, Dennis A; Hammond, Timothy; Baillie, Thomas A

2018-06-01

While simple O - (ether-linked) and N -glucuronide drug conjugates generally are unreactive and considered benign from a safety perspective, the acyl glucuronides that derive from metabolism of carboxylic acid-containing xenobiotics can exhibit a degree of chemical reactivity that is dependent upon their molecular structure. As a result, concerns have arisen over the safety of acyl glucuronides as a class, several members of which have been implicated in the toxicity of their respective parent drugs. However, direct evidence in support of these claims remains sparse, and due to frequently encountered species differences in the systemic exposure to acyl glucuronides (both of the parent drug and oxidized derivatives thereof), coupled with their instability in aqueous media and potential to undergo chemical rearrangement (acyl migration), qualification of these conjugates by traditional safety assessment methods can be very challenging. In this Commentary, we discuss alternative (non-acyl glucuronide) mechanisms by which carboxylic acids may cause serious adverse reactions, and propose a novel, practical approach to compare systemic exposure to acyl glucuronide metabolites in humans to that in animal species used in preclinical safety assessment based on relative estimates of the total body burden of these circulating conjugates. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

[THE STUDY OF MANIFESTATIONS OF ENVIRONMENTAL HAZARDS AT THE REGIONAL LEVEL].

PubMed

Shmandiy, V M; Kharlamova, E V; Rugas, T E

2015-01-01

Elaborated methodological approaches to the monitoring of the state of ecological safety are based on the use of systems analysis of conditions and consistent patterns of the formation of the ecological danger search for effective means and methods of safety management. Ecological hazard is considered as a hierarchical structure, consisting of types, classes, species and subsubspecies. In industrially developed regions the most significant are technogenic and sociogenic classes. The sociogenic class of danger was proved to be primary in its formation, as the level of environmental awareness is largely determined by the degree of impact on human health and environment, manifestations of the danger of other classes are depend on it. When analyzing the state of danger there was applied the anthropocentric approach. There was used an assembly of characteristics considering the health status of the population of the certain territory under the influence of factors of environmental hazard. On the base of the colligation of literature data and the results of own observations there was suggested a generalized index of the state of the population'S health in socio-economic areas, there were selected zones with differing level of the technogenic loads and also rural areas beyond objects of technogenic impact. On results of studies there was proved the relationship between the level of the environmental hazard and state of the population's in various socio-economic zones.

Impact of Active Control on Passive Safety Response Characteristics of Sodium-Cooled Fast Reactors: II-Model Implementation and Simulations

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

Ponciroli, Roberto; Passerini, Stefano; Vilim, Richard B.

Advanced reactors are often claimed to be passively safe against unprotected upset events. In common practice, these events are not considered in the context of the plant control system, i.e., the reactor is subjected to classes of unprotected upset events while the normally programmed response of the control system is assumed not to be present. However, this approach constitutes an oversimplification since, depending on the upset involving the control system, an actuator does not necessarily go in the same direction as needed for safety. In this work, dynamic simulations are performed to assess the degree to which the inherent self-regulatingmore » plant response is safe from active control system override. The simulations are meant to characterize the resilience of the plant to unprotected initiators. The initiators were represented and modeled as an actuator going to a hard limit. Consideration of failure is further limited to individual controllers as there is no cross-connect of signals between these controllers. The potential for passive safety override by the control system is then relegated to the single-input single-output controllers. Here, the results show that when the plant control system is designed by taking into account and quantifying the impact of the plant control system on accidental scenarios there is very limited opportunity for the preprogrammed response of the control system to override passive safety protection in the event of an unprotected initiator.« less

Impact of Active Control on Passive Safety Response Characteristics of Sodium-Cooled Fast Reactors: II-Model Implementation and Simulations

DOE PAGES

Ponciroli, Roberto; Passerini, Stefano; Vilim, Richard B.

2017-06-21

Advanced reactors are often claimed to be passively safe against unprotected upset events. In common practice, these events are not considered in the context of the plant control system, i.e., the reactor is subjected to classes of unprotected upset events while the normally programmed response of the control system is assumed not to be present. However, this approach constitutes an oversimplification since, depending on the upset involving the control system, an actuator does not necessarily go in the same direction as needed for safety. In this work, dynamic simulations are performed to assess the degree to which the inherent self-regulatingmore » plant response is safe from active control system override. The simulations are meant to characterize the resilience of the plant to unprotected initiators. The initiators were represented and modeled as an actuator going to a hard limit. Consideration of failure is further limited to individual controllers as there is no cross-connect of signals between these controllers. The potential for passive safety override by the control system is then relegated to the single-input single-output controllers. Here, the results show that when the plant control system is designed by taking into account and quantifying the impact of the plant control system on accidental scenarios there is very limited opportunity for the preprogrammed response of the control system to override passive safety protection in the event of an unprotected initiator.« less

The Use of Theatre Tours in Road Safety Education.

ERIC Educational Resources Information Center

Powney, Janet; And Others

The Scottish Road Safety Campaign and the Road Safety Council of Wales have made a large investment in theater tours as a method of providing road safety education. This study aimed to evaluate the effectiveness of a road safety message delivered by a theater group, Road Safety Officers (RSOs), or, teachers for pupils in upper secondary classes.…

Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

PubMed

2004-03-16

The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

[Systemic safety following intravitreal injections of anti-VEGF].

PubMed

Baillif, S; Levy, B; Girmens, J-F; Dumas, S; Tadayoni, R

2018-03-01

The goal of this manuscript is to assess data suggesting that intravitreal injection of anti-vascular endothelial growth factors (anti-VEGFs) could result in systemic adverse events (AEs). The class-specific systemic AEs should be similar to those encountered in cancer trials. The most frequent AE observed in oncology, hypertension and proteinuria, should thus be the most common expected in ophthalmology, but their severity should be lower because of the much lower doses of anti-VEGFs administered intravitreally. Such AEs have not been frequently reported in ophthalmology trials. In addition, pharmacokinetic and pharmacodynamic data describing systemic diffusion of anti-VEGFs should be interpreted with caution because of significant inconsistencies reported. Thus, safety data reported in ophthalmology trials and pharmacokinetic/pharmacodynamic data provide robust evidence that systemic events after intravitreal injection are very unlikely. Additional studies are needed to explore this issue further, as much remains to be understood about local and systemic side effects of anti-VEGFs. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Watch Out! A Teacher's Guide to Traffic Safety.

ERIC Educational Resources Information Center

New York City Board of Education, Brooklyn, NY. Div. of Curriculum and Instruction.

This guide provides teachers with activities that can initiate an awareness of the New York city-wide traffic safety campaign and reinforce safety education. It contains the following: (1) background information on safety rules for teachers; (2) curriculum topics that can include traffic safety issues; (3) class- and school-wide activities for…

77 FR 17362 - Proposed Modification of Class D and Class E Airspace and Revocation of Class E Airspace...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... (IFR) at Bellingham International Airport. This action also would remove Class E airspace designated as an extension to a Class D or E surface area at Bellingham International Airport. This action, initiated by the biennial review of the Bellingham airspace area, would enhance the safety and management of...

Injury Prevention and Safety

MedlinePlus

... The percentage of states that provided funding for staff development or offered staff development on injury prevention and safety to those ... classes or courses with a teacher who received staff development on injury prevention and safety increased from ...

Lidar and Electro-Optics for Atmospheric Hazard Sensing and Mitigation

NASA Technical Reports Server (NTRS)

Clark, Ivan O.

2012-01-01

This paper provides an overview of the research and development efforts of the Lidar and Electro-Optics element of NASA's Aviation Safety Program. This element is seeking to improve the understanding of the atmospheric environments encountered by aviation and to provide enhanced situation awareness for atmospheric hazards. The improved understanding of atmospheric conditions is specifically to develop sensor signatures for atmospheric hazards. The current emphasis is on kinetic air hazards such as turbulence, aircraft wake vortices, mountain rotors, and windshear. Additional efforts are underway to identify and quantify the hazards arising from multi-phase atmospheric conditions including liquid and solid hydrometeors and volcanic ash. When the multi-phase conditions act as obscurants that result in reduced visual awareness, the element seeks to mitigate the hazards associated with these diminished visual environments. The overall purpose of these efforts is to enable safety improvements for air transport class and business jet class aircraft as the transition to the Next Generation Air Transportation System occurs.

77 FR 38227 - Proposed Amendment of Class D and Class E Airspace; Bozeman, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-27

...: This action proposes to modify Class D and Class E airspace at Bozeman Yellowstone International.... This action would also update the airport name to Bozeman Yellowstone International Airport. This action would enhance the safety and management of aircraft operations at the airport. DATES: Comments...

77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... into class II (special controls). FDA is proposing this reclassification on its own initiative based on... categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II...

78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to... controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval...

20 CFR 410.601 - Determinations of disability.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 410.601 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE HEALTH AND SAFETY ACT OF... agreement on behalf of the Commissioner for all individuals in such State, or for such class or classes of... make such determinations, for any class or classes of individuals to which such an agreement is not...

Optical radiation hazards of laser welding processes. Part 1: Neodymium-YAG laser.

PubMed

Rockwell, R J; Moss, C E

1983-08-01

High power laser devices are being used for numerous metalworking processes such as welding, cutting and heat treating. Such laser devices are totally enclosed either by the manufacturer or the end-user. When this is done, the total laser system is usually certified by the manufacturer following the federal requirements of the Code of Federal Regulations (CFR) 1040.10 and 10.40.11 as a Class I laser system. Similarly, the end-user may also reclassify an enclosed high-power laser into the Class I category following the requirements of the American National Standards Institute (ANSI) Z-136.1 (1980) standard. There are, however, numerous industrial laser applications where Class IV systems are required to be used in an unenclosed manner. In such applications, there is concern for both ocular and skin hazards caused by direct and scattered laser radiation, as well as potential hazards caused by the optical radiation created by the laser beam's interaction with the metal (i.e. the plume radiation). Radiant energy measurements are reported for both the scattered laser radiation and the resultant plume radiations which were produced during typical unenclosed Class IV Neodymium-YAG laser welding processes. Evaluation of the plume radiation was done with both radiometric and spectroradiometric measurement equipment. The data obtained were compared to applicable safety standards.

A root cause analysis project in a medication safety course.

PubMed

Schafer, Jason J

2012-08-10

To develop, implement, and evaluate team-based root cause analysis projects as part of a required medication safety course for second-year pharmacy students. Lectures, in-class activities, and out-of-class reading assignments were used to develop students' medication safety skills and introduce them to the culture of medication safety. Students applied these skills within teams by evaluating cases of medication errors using root cause analyses. Teams also developed error prevention strategies and formally presented their findings. Student performance was assessed using a medication errors evaluation rubric. Of the 211 students who completed the course, the majority performed well on root cause analysis assignments and rated them favorably on course evaluations. Medication error evaluation and prevention was successfully introduced in a medication safety course using team-based root cause analysis projects.

[Drug safety warnings in psychiatry: adverse drug reactions' signaling from 2002 to 2014].

PubMed

Prisco, Vincenzo; Iannaccone, Teresa; Tusciano, Adriano; Boccardi, Mariangela; Perris, Francesco; Capuano, Annalisa; Catapano, Francesco; Fabrazzo, Michele

2016-01-01

Monitoring drug-related side effects in psychiatric patients is highly recommended. In fact, frequent exposure to long-term polipharmacotherapy, poor compliance to pharmachological treatment and comorbidity with organic illnesses requiring the prescription of other drugs are causes of pharmacokinetic/pharmacodynamic interactions. These vulnerability factors result in a certain increase in adverse drug reactions (ADRs). This study performes an analysis of Italian Medicine Agency data, in the section "signal analysis", to attempt an assessment of the safety warnings among the different psychotropic drug classes, belonging to the ATC class: N03 (antiepileptics), N05 (antipsychotics), N06 (psycho-analectic drugs). Then we analysed, in a descriptive way, the different association between the drug and the related ADR, evaluating the different safety profiles, in relation to experimental studies, supporting the importance of the signal. In the last years, among the new 25 ADRs, 10 were related to antidepressant drugs (8 SSRI, 1 mirtazapine, 1 agomelatine). In relation to antipsychotic drugs, 6 new correlations were found between drug and ADR onset, mainly among atypical antispychotics. Other correlations (6 above all) were found among antiepileptic drugs. Among benzodiazepines, a signal linked to rabdomylysis onset was found. It is also recommended an evaluation of safety profile in relation to zolpidem prescription. The results of our systematic review are a motivational input, considering the continuous increase of safety warnings, to attentively monitor drug's prescription. Spontaneous ADRs' signaling is a classical system to provide the required attention in relation to a potential risk. The clinician in charge must report this because he is the key figure in the drugs' safety process. In psychiatry, in which a long-term pharmachological therapy is frequent, clinicians are requested to find and signal ADRs to the competent authority.

Creating Lithium-Ion Electrolytes with Biomimetic Ionic Channels in Metal-Organic Frameworks.

PubMed

Shen, Li; Wu, Hao Bin; Liu, Fang; Brosmer, Jonathan L; Shen, Gurong; Wang, Xiaofeng; Zink, Jeffrey I; Xiao, Qiangfeng; Cai, Mei; Wang, Ge; Lu, Yunfeng; Dunn, Bruce

2018-06-01

Solid-state electrolytes are the key to the development of lithium-based batteries with dramatically improved energy density and safety. Inspired by ionic channels in biological systems, a novel class of pseudo solid-state electrolytes with biomimetic ionic channels is reported herein. This is achieved by complexing the anions of an electrolyte to the open metal sites of metal-organic frameworks (MOFs), which transforms the MOF scaffolds into ionic-channel analogs with lithium-ion conduction and low activation energy. This work suggests the emergence of a new class of pseudo solid-state lithium-ion conducting electrolytes. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Middle-class mythology and the Houdini disappearing act: health care and jobs joined at the hip.

PubMed

Ehrle, Lynn Howard; Cleveland, Robert W

2010-01-01

Myths have long legs. Once they become integrated into the cultural ethos they are almost impossible to dislodge. The Middle Class Myth is a case in point. Spoken of in reverential terms, the conventional wisdom holds that the U.S. economy is driven by a vast middle class, anchoring its consumer-driven system of goods and services. But contrary to frequent statements by pundits, politicians, and many economists, the middle class has actually disappeared. Another commonly held myth--that the United States has the best health care system in the world--is perpetuated by medical leaders and the mainstream media. Despite huge worker layoffs causing 50 million to be without health insurance, and millions more who are underinsured, the myth persists. A third myth, one currently in vogue among media pundits and politicians, is that health care and jobs are two separate issues and policymakers can deal with them as unrelated to each other, when in reality they are inextricably interwoven--the connective tissue of a physically and mentally robust workforce. The authors use Census Bureau after-tax income and Federal Reserve data to demonstrate that the middle class has disappeared, leaving millions of Americans with little disposable income, meager savings, and no health care safety net.

"Defense-in-Depth" Laser Safety and the National Ignition Facility

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

King, J J

The National Ignition Facility (NIF) is the largest and most energetic laser in the world contained in a complex the size of a football stadium. From the initial laser pulse, provided by telecommunication style infrared nanoJoule pulsed lasers, to the final 192 laser beams (1.8 Mega Joules total energy in the ultraviolet) converging on a target the size of a pencil eraser, laser safety is of paramount concern. In addition to this, there are numerous high-powered (Class 3B and 4) diagnostic lasers in use that can potentially send their laser radiation travelling throughout the facility. With individual beam paths ofmore » up to 1500 meters and a workforce of more than one thousand, the potential for exposure is significant. Simple laser safety practices utilized in typical laser labs just don't apply. To mitigate these hazards, NIF incorporates a multi layered approach to laser safety or 'Defense in Depth.' Most typical high-powered laser operations are contained and controlled within a single room using relatively simplistic controls to protect both the worker and the public. Laser workers are trained, use a standard operating procedure, and are required to wear Personal Protective Equipment (PPE) such as Laser Protective Eyewear (LPE) if the system is not fully enclosed. Non-workers are protected by means of posting the room with a warning sign and a flashing light. In the best of cases, a Safety Interlock System (SIS) will be employed which will 'safe' the laser in the case of unauthorized access. This type of laser operation is relatively easy to employ and manage. As the operation becomes more complex, higher levels of control are required to ensure personnel safety. Examples requiring enhanced controls are outdoor and multi-room laser operations. At the NIF there are 192 beam lines and numerous other Class 4 diagnostic lasers that can potentially deliver their hazardous energy to locations far from the laser source. This presents a serious and complex potential hazard to personnel. Because of this, a multilayered approach to safety is taken. This paper presents the philosophy and approach taken at the NIF in the multi-layered 'defense-in-depth' approach to laser safety.« less

Automatic construction of aerial corridor for navigation of unmanned aircraft systems in class G airspace using LiDAR

NASA Astrophysics Data System (ADS)

Feng, Dengchao; Yuan, Xiaohui

2016-05-01

According to the airspace classification by the Federal Aviation Agency, Class G airspace is the airspace at 1,200 feet or less to the ground, which is beneath class E airspace and between classes B-D cylinders around towered airstrips. However, the lack of flight supervision mechanism in this airspace, unmanned aerial system (UAS) missions pose many safety issues. Collision avoidance and route planning for UASs in class G airspace is critical for broad deployment of UASs in commercial and security applications. Yet, unlike road network, there is no stationary marker in airspace to identify corridors that are available and safe for UASs to navigate. In this paper, we present an automatic LiDAR-based airspace corridor construction method for navigation in class G airspace and a method for route planning to minimize collision and intrusion. Our idea is to combine LiDAR to automatically identify ground objects that pose navigation restrictions such as airports and high-rises. Digital terrain model (DTM) is derived from LiDAR point cloud to provide an altitude-based class G airspace description. Following the FAA Aeronautical Information Manual, the ground objects that define the restricted airspaces are used together with digital surface model derived from LiDAR data to construct the aerial corridor for navigation of UASs. Preliminary results demonstrate competitive performance and the construction of aerial corridor can be automated with much great efficiency.

System design description for portable 1,000 CFM exhauster Skids POR-007/Skid E and POR-008/Skid F

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

Nelson, O.D.

1998-07-25

The primary purpose of the two 1,000 CFM Exhauster Skids, POR-007-SKID E and POR-008-SKID F, is to provide backup to the waste tank primary ventilation systems for tanks 241-C-106 and 241-AY-102, and the AY-102 annulus in the event of a failure during the sluicing of tank 241-C-106 and subsequent transfer of sluiced waste to 241-AY-102. This redundancy is required since both of the tank ventilation systems have been declared as Safety Class systems.

49 CFR 173.124 - Class 4, Divisions 4.1, 4.2 and 4.3-Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... material must be determined using the testing protocol from Figure 14.2 (Flow Chart for Assigning Self... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS... Assignments and Exceptions for Hazardous Materials Other Than Class 1 and Class 7 § 173.124 Class 4, Divisions...

77 FR 49712 - Amendment to Class B Airspace; Salt Lake City, UT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-17

... operating in the vicinity of SLC. The modified Class B airspace areas were designed to ensure all instrument... final Salt Lake City Class B airspace design provides operational and safety benefits to all airspace... Salt Lake City Class B airspace design also incorporated reductions to the northern and southern...

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

PubMed

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

2018-05-19

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

Occupational health: a classic example of class conflict.

PubMed

Kerr, L E

1990-01-01

The history of class conflict in occupational health in the United States is illustrated by the current Pittston Company attack on coal miners' health benefits, the silicosis and asbestosis controversies, the corporate restrictions on state workers' compensation laws, and the unremitting management opposition to the federal Coal Mine Health and Safety Act of 1969 and the Occupational Health and Safety Act of 1970. A positive action program is presented as the basis for convening the long-overdue White House Conference on Occupational Health and Safety. Mining engineers are urged to support that action program to prevent unnecessary work-related death and disability.

Effect of snowboard-related concussion safety education for recognizing possible concussions.

PubMed

Koh, J O

2011-12-01

The aim of this study was to examine the understanding of snowboard-related concussion and to measure the recognition of possible concussion occurrence after an intervention of snowboard-related concussion safety education in snowboarding. Incidence cohort design. 2008-2009 season Gangwon-do Ski resorts, South Korea. A total of 208 university students (female-72; male-136; age-18 to 32) who registered for a snowboarding class and received credit participated in this project. Snowboard-related concussion safety education class was administered for 30 minutes before the snowboard class began. The knowledge of snowboard-related concussion before and after the safety education was evaluated. Concussion data were collected via a self-report case form at the last day of snowboarding class. The incidence of possible concussion and factors associated with concussions were analyzed by χ2 test. The mean score of snowboard-related concussion knowledge improved from fifteen points to eighteen points out of 20 total points possible. Overall the incidence of concussion was 10 per 100 snowboarder-exposures. χ2 tests showed concussion rates to be significantly different in female snowboarders (P=0.00) and in helmet users (P=0.02). The incidence of possible concussion is high among snowboarding class participants. Emphasis should be given for instituting pre-participation balance training, especially for females to reduce falling in snowboarding. To verify the effects of pre-participation balance training and falling results in a concussion, more research is needed in the future.

Magnetically coupled resonance wireless charging technology principles and transfer mechanisms

NASA Astrophysics Data System (ADS)

Zhou, Jiehua; Wan, Jian; Ma, Yinping

2017-05-01

With the tenure of Electric-Vehicle rising around the world, the charging methods have been paid more and more attention, the current charging mode mainly has the charging posts and battery swapping station. The construction of the charging pile or battery swapping station not only require lots of manpower, material costs but the bare conductor is also easy to generate electric spark hidden safety problems, still occupies large space. Compared with the wired charging, wireless charging mode is flexible, unlimited space and location factors and charging for vehicle safety and quickly. It complements the traditional charging methods in adaptability and the independent charge deficiencies. So the researching the wireless charging system have an important practical significance and application value. In this paper, wireless charging system designed is divided into three parts: the primary side, secondary side and resonant coupling. The main function of the primary side is to generate high-frequency alternating current, so selecting CLASS-E amplifier inverter structure through the research on full bridge, half-bridge and power amplification circuit. Addition, the wireless charging system is susceptible to outside interference, frequency drift phenomenon. Combined with the wireless energy transmission characteristics, resonant parts adopt resonant coupling energy transmission scheme and the Series-Series coupling compensation structure. For the electric vehicle charging power and voltage requirements, the main circuit is a full bridge inverter and Boost circuit used as the secondary side.

A Framework for Safe Integration of Small UAS Into the NAS

NASA Technical Reports Server (NTRS)

Logan, Michael J.; Bland, Geoffrey; Murray, Jennifer

2011-01-01

This paper discusses a proposed framework for the safe integration of small unmanned aerial systems (sUAS) into the National Airspace System (NAS). The paper examines the potential uses of sUAS to build an understanding of the location and frequency of potential future flight operations based on the future applications of the sUAS systems. The paper then examines the types of systems that would be required to meet the application-level demand to determine classes of platforms and operations. Finally, a framework is proposed for both airworthiness and operations that attempts to balance safety with utility for these important systems.

77 FR 68070 - Implementing Public Safety Broadband Provisions of the Middle Class Tax Relief and Job Creation...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

...; announcement of effective date. SUMMARY: On October 15, 2012, the Public Safety and Homeland Security Bureau...: Gene Fullano, Federal Communications Commission, Public Safety and Homeland Security Bureau, 445 12th... . SUPPLEMENTARY INFORMATION: On October 15, 2012, the Public Safety and Homeland Security Bureau (Bureau) of the...

19 CFR 12.85 - Coast Guard boat and associated equipment safety standards.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 19 Customs Duties 1 2012-04-01 2012-04-01 false Coast Guard boat and associated equipment safety... SECURITY; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Safety Standards for Boats and Associated Equipment § 12.85 Coast Guard boat and associated equipment safety standards. (a) Applicability of...

19 CFR 12.85 - Coast Guard boat and associated equipment safety standards.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 19 Customs Duties 1 2013-04-01 2013-04-01 false Coast Guard boat and associated equipment safety... SECURITY; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Safety Standards for Boats and Associated Equipment § 12.85 Coast Guard boat and associated equipment safety standards. (a) Applicability of...

19 CFR 12.85 - Coast Guard boat and associated equipment safety standards.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 19 Customs Duties 1 2014-04-01 2014-04-01 false Coast Guard boat and associated equipment safety... SECURITY; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Safety Standards for Boats and Associated Equipment § 12.85 Coast Guard boat and associated equipment safety standards. (a) Applicability of...

19 CFR 12.85 - Coast Guard boat and associated equipment safety standards.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 19 Customs Duties 1 2011-04-01 2011-04-01 false Coast Guard boat and associated equipment safety... SECURITY; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Safety Standards for Boats and Associated Equipment § 12.85 Coast Guard boat and associated equipment safety standards. (a) Applicability of...

19 CFR 12.85 - Coast Guard boat and associated equipment safety standards.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 1 2010-04-01 2010-04-01 false Coast Guard boat and associated equipment safety... SECURITY; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Safety Standards for Boats and Associated Equipment § 12.85 Coast Guard boat and associated equipment safety standards. (a) Applicability of...

Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

PubMed

Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; de Graeff, Pieter A; Mol, Peter G M

2011-11-01

Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. The aim was to evaluate the extent to which regulators and industry have addressed the risk of safety issues for HIV drugs based on prior experience with other drugs in the same class and whether doing so impacts development time of these drugs. HIV drugs receiving ≥1 DHPC in the Netherlands between January 1999 and December 2008 were identified. Each drug with a DHPC ('index' drug) was paired with subsequently approved HIV drug(s) in the same class (Anatomical Therapeutic Chemical [ATC] 4th level) ['follow-on' drugs]. Characteristics of safety issues were extracted from the DHPCs of the 'index' drugs. European Public Assessment Reports (EPARs) were reviewed regarding whether the safety issues had been considered during development and approval. Consideration of previously identified safety issues in 'follow-on' drug applications was assessed regarding attention paid to adverse drug reaction (ADR) symptoms in pre-marketing studies, Summary of Product Characteristics (SmPC) and postmarketing commitments, and whether size of the safety population was in accordance with Regulatory guidelines. 'Index' drugs were also paired with drugs in the same class already on the market ('older' drugs). For 'older' drugs, we identified whether the safety issue led to appropriate changes in the current SmPC (January 2011) compared with the SmPC at the time of marketing authorization. Clinical development time was assessed using time from first patent application to market authorization as proxy, and comparison was made between 'index' and 'follow-on' drugs. For 9 (43%) of the 21 centrally authorized HIV drugs, 11 serious safety issues that required a DHPC were identified. Two drugs were excluded from our analysis (DHPCs related to contamination/medication error). Six 'index' drugs were paired, each with one to six 'follow-on' drugs. Three concerned drug-drug interactions (DDIs); the other three were intracranial haemorrhage, neuromuscular weakness and severe skin/hepatic reactions. All but one 'follow-on' drug had information in the EPAR on that specific ADR (i.e. attention was paid to the ADR). The DDIs were addressed in pre-marketing studies and/or the SmPC. Two of the other ADRs were addressed by postmarketing surveillance commitments; intracranial haemorrhage was not addressed. Three safety issues for two 'index' drugs could not be paired with a 'follow-on' drug as no drug in the same class was approved after the corresponding DHPCs were issued. Five of the nine safety issues were added to at least one of the current SmPCs for the 'older' drugs already on the market at the time of DHPC issue. Two safety issues were already in the SmPC of the 'older' drugs at time of market approval and two were not introduced into the SmPC of 'older' drugs. Population size to assess short-term safety complied with the guidelines for four 'index', seven 'follow-on' and three 'older' drugs; population size to assess long-term safety complied for one, three and two drugs, respectively. For five drugs, EPARs did not provide adequate information on population size. No statistically significant difference in development time between 'index' and 'follow-on' drugs was found. Generally, safety issues were taken into account in the approval process of other drugs in the class. The approaches were different and determined by the nature of the ADR. Taking safety issues into account in the approval process did not seem to impact on the time taken to perform the pre-approval clinical programme.

78 FR 21044 - Amendment of Class D and Class E Airspace; Reading, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

...This action amends Class D and Class E Airspace at Reading, PA, as the SHAPP OM navigation aid has been decommissioned, requiring the modification of Standard Instrument Approach Procedures (SIAPs) at Reading Regional/Carl A. Spaatz Field. This action enhances the safety and management of Instrument Flight Rules (IFR) operations at the airport.

49 CFR 176.400 - Stowage of Division 1.5, Class 4 (flammable solids) and Class 5 (oxidizers and organic peroxides...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 2 2013-10-01 2013-10-01 false Stowage of Division 1.5, Class 4 (flammable solids... Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS CARRIAGE BY VESSEL Detailed Requirements for Class 4 (Flammable...

49 CFR 176.400 - Stowage of Division 1.5, Class 4 (flammable solids) and Class 5 (oxidizers and organic peroxides...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 2 2012-10-01 2012-10-01 false Stowage of Division 1.5, Class 4 (flammable solids... Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS CARRIAGE BY VESSEL Detailed Requirements for Class 4 (Flammable...

49 CFR 176.400 - Stowage of Division 1.5, Class 4 (flammable solids) and Class 5 (oxidizers and organic peroxides...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 2 2014-10-01 2014-10-01 false Stowage of Division 1.5, Class 4 (flammable solids... Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS CARRIAGE BY VESSEL Detailed Requirements for Class 4 (Flammable...

76 FR 77383 - Amendment of Class C Airspace; Palm Beach International Airport, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

...-0527; Airspace Docket No. 11-AWA-2] Amendment of Class C Airspace; Palm Beach International Airport, FL... action modifies the Palm Beach International Airport, FL, Class C airspace area by raising the floor of Class C airspace over Palm Beach County Park Airport. The FAA is taking this action to enhance safety...

78 FR 57789 - Establishment and Modification of Class E Airspace; Oakland, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-20

... Class E airspace at Metropolitan Oakland International Airport, Oakland, CA, to accommodate aircraft... at Metropolitan Oakland International Airport. This action also modifies Class E surface airspace.... This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport...

78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

...: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requirements and... electromagnetic compatibility and electrical safety. Firms are now exempt from 510(k) requirements for vertical... Equipment--Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility...

A sequential-move game for enhancing safety and security cooperation within chemical clusters.

PubMed

Pavlova, Yulia; Reniers, Genserik

2011-02-15

The present paper provides a game theoretic analysis of strategic cooperation on safety and security among chemical companies within a chemical industrial cluster. We suggest a two-stage sequential move game between adjacent chemical plants and the so-called Multi-Plant Council (MPC). The MPC is considered in the game as a leader player who makes the first move, and the individual chemical companies are the followers. The MPC's objective is to achieve full cooperation among players through establishing a subsidy system at minimum expense. The rest of the players rationally react to the subsidies proposed by the MPC and play Nash equilibrium. We show that such a case of conflict between safety and security, and social cooperation, belongs to the 'coordination with assurance' class of games, and we explore the role of cluster governance (fulfilled by the MPC) in achieving a full cooperative outcome in domino effects prevention negotiations. The paper proposes an algorithm that can be used by the MPC to develop the subsidy system. Furthermore, a stepwise plan to improve cross-company safety and security management in a chemical industrial cluster is suggested and an illustrative example is provided. Copyright © 2010 Elsevier B.V. All rights reserved.

A simple approach to industrial laser safety.

PubMed

Lewandowski, Michael A; Hinz, Michael W

2005-02-01

Industrial applications of lasers include marking, welding, cutting, and other material processing. Lasers used in these ways have significant power output but are generally designed to limit operator exposure to direct or scattered laser radiation to harmless levels in order to meet the Federal Laser Product Performance Standard (21CFR1040) for Class 1 laser products. Interesting challenges occur when companies integrate high power lasers into manufacturing or process control equipment. A significant part of the integration process is developing engineering and administrative controls to produce an acceptable level of laser safety while balancing production, maintenance, and service requirements. 3M Company uses a large number of high power lasers in numerous manufacturing processes. Whether the laser is purchased as a Class 1 laser product or whether it is purchased as a Class 4 laser and then integrated into a manufacturing application, 3M Company has developed an industrial laser safety program that maintains a high degree of laser safety while facilitating the rapid and economical integration of laser technology into the manufacturing workplace. This laser safety program is based on the requirements and recommendations contained in the American National Standard for Safe Use of Lasers, ANSI Z136.1. The fundamental components of the 3M program include hazard evaluation, engineering, administrative, and procedural controls, protective equipment, signs and labels, training, and re-evaluation upon change. This program is implemented in manufacturing facilities and has resulted in an excellent history of laser safety and an effective and efficient use of laser safety resources.

Automatisms in EMIR instrument to improve operation, safety and maintenance

NASA Astrophysics Data System (ADS)

Fernández Izquierdo, Patricia; Núñez Cagigal, Miguel; Barreto Rodríguez, Roberto; Martínez Rey, Noelia; Santana Tschudi, Samuel; Barreto Cabrera, Maria; Patrón Recio, Jesús; Garzón López, Francisco

2014-08-01

EMIR is the NIR imager and multiobject spectrograph being built as a common user instrument for the 10-m class GTC. Big cryogenic instruments demand a reliable design and a specific hardware and software to increase its safety and productivity. EMIR vacuum, cooling and heating systems are monitored and partially controlled by a Programmable Logic Controller (PLC) in industrial format with a touch screen. The PLC aids the instrument operator in the maintenance tasks recovering autonomously vacuum if required or proposing preventive maintenance actions. The PLC and its associated hardware improve EMIR safety having immediate reactions against eventual failure modes in the instrument or in external supplies, including hardware failures during the heating procedure or failure in the PLC itself. EMIR PLC provides detailed information periodically about status and alarms of vacuum and cooling components or external supplies.

RELEASE OF DRIED RADIOACTIVE WASTE MATERIALS TECHNICAL BASIS DOCUMENT

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

KOZLOWSKI, S.D.

2007-05-30

This technical basis document was developed to support RPP-23429, Preliminary Documented Safety Analysis for the Demonstration Bulk Vitrification System (PDSA) and RPP-23479, Preliminary Documented Safety Analysis for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Facility. The main document describes the risk binning process and the technical basis for assigning risk bins to the representative accidents involving the release of dried radioactive waste materials from the Demonstration Bulk Vitrification System (DBVS) and to the associated represented hazardous conditions. Appendices D through F provide the technical basis for assigning risk bins to the representative dried waste release accident and associated represented hazardous conditionsmore » for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Packaging Unit (WPU). The risk binning process uses an evaluation of the frequency and consequence of a given representative accident or represented hazardous condition to determine the need for safety structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls. A representative accident or a represented hazardous condition is assigned to a risk bin based on the potential radiological and toxicological consequences to the public and the collocated worker. Note that the risk binning process is not applied to facility workers because credible hazardous conditions with the potential for significant facility worker consequences are considered for safety-significant SSCs and/or TSR-level controls regardless of their estimated frequency. The controls for protection of the facility workers are described in RPP-23429 and RPP-23479. Determination of the need for safety-class SSCs was performed in accordance with DOE-STD-3009-94, Preparation Guide for US. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses, as described below.« less

New laser protective eyewear

NASA Astrophysics Data System (ADS)

McLear, Mark

1996-04-01

Laser technology has significantly impacted our everyday life. Lasers are now used to correct your vision, clear your arteries, and are used in the manufacturing of such diverse products as automobiles, cigarettes, and computers. Lasers are no longer a research tool looking for an application. They are now an integral part of manufacturing. In the case of Class IV lasers, this explosion in laser applications has exposed thousands of individuals to potential safety hazards including eye damage. Specific protective eyewear designed to attenuate the energy of the laser beam below the maximum permissible exposure is required for Class 3B and Class IV lasers according to laser safety standards.

Performance of exhaust-protective (class I) biological 'safety' cabinets.

PubMed Central

Newsom, S W

1979-01-01

Nineteen open-fronted (class I) safety cabinets were subjected to spore containment and airflow tests, which suggested that a flow of 0.75 m/s was the minimum required for safe operation; further tests on three of the cabinets were repeated at different air speeds and confirmed this. The airflow is required to overcome the effect of laboratory or external air currents. Contamination of surfaces (including the operator's hands) by aerosols liberated inside the cabinets was investigated and found to depend more on turbulence within the cabinet (as from a restricted front opening) than on the number of air changes. The findings suggest that the product protection provided by a well-designed class I cabinet might equal that of a class II (laminar flow) unit. Images Fig. 6 PMID:469014

Pain: Systematic Review of Pharmacy Compounding of Pain Medication.

PubMed

Shawaqfeh, Mohammad S; Harrington, Catherine

2018-01-01

There are limited resources available for pharmacists and doctors to reference proper compounded formulas for pain medications. The systematic review discussed within this article provides the foundation for a searchable database, allowing users to find various compounded formulations. It also provides data about the safety and efficacy of the preparations. Compounding information about several drug classes was reviewed. Those drug classes included, but were not limited to, opioids, non-steroidal anti-inflammatory drugs, central nervous system agents, and anesthetics, with evidence that of the various drugs that could be compounded for pain, anesthetics, non-steroidal anti-inflammatory drugs, and opioids ranked highest within the articles researched. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

77 FR 64919 - Proposed Establishment of Class E Airspace; Princeton, KY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

... Class E Airspace; Princeton, KY AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to establish Class E Airspace at Princeton, KY to... serving the Princeton-Caldwell County Airport. This action would enhance the safety and airspace...

A review of the literature pertaining to the efficacy, safety, educational requirements, uses and usage of mechanical adjusting devices

PubMed Central

Taylor, Shane H; Arnold, Nicole D; Biggs, Lesley; Colloca, Christopher J; Mierau, Dale R; Symons, Bruce P; Triano, John J

2004-01-01

Over the past decade, mechanical adjusting devices (MADs) were a major source of debate within the Chiropractors’ Association of Saskatchewan (CAS). Since Saskatchewan was the only jurisdiction in North America to prohibit the use of MADs, the CAS established a committee in 2001 to review the literature on MADs. The committee evaluated the literature on the efficacy, safety, and uses of moving stylus instruments within chiropractic practice, and the educational requirements for chiropractic practice. Following the rating criteria for the evaluation of evidence, as outlined in the Clinical Guidelines for Chiropractic Practice in Canada (1994), the committee reviewed 55 articles – all of which pertained to the Activator. Of the 55 articles, 13 were eliminated from the final study. Of the 42 remaining articles, 6 were rated as class 1 evidence; 11 were rated as class 2 evidence and 25 were rated as class 3 evidence. In this article – the second in a series of two – we review the results of uses and usage, safety and educational requirements. Of the 30 articles designated under the category of usage, 3 were rated as Class 1 evidence; 9 studies were classified as Class 2 evidence and 18 were rated as Class 3 evidence. Overall the committee reached consensus that in clinical practice, there is broad application of these procedures. A minority report was written arguing that the reviewer was unable to reach a conclusion about the use of the Activator Instrument other than it is used as a clinical and research tool. Of the 16 studies that dealt either explicitly or implicitly with safety, 4 were Class 1 evidence; 3 were Class 2 evidence and 9 were Class 3 evidence. Overall the committee reached consensus that the evidence supports that the Activator instrument is safe and has no more relative risk than do manual HVLA procedures. A minority report was written arguing that there is no evidence either to support or refute the view that MAD is safe. Of the 5 studies that dealt with educational requirements, all were Class 3 evidence. Overall the committee reached consensus that there was no evidence in the literature with respect to educational requirements to form any conclusions. A minority report was written offering opinion that there is evidence with respect to educational requirements. PMID:17549227

49 CFR 397.101 - Requirements for motor carriers and drivers.

Code of Federal Regulations, 2010 CFR

2010-10-01

... MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS TRANSPORTATION OF HAZARDOUS MATERIALS; DRIVING AND PARKING RULES Routing of Class 7 (Radioactive..., considering operating necessity and safety, a carrier or any person operating a motor vehicle that contains a...

On the Road to Safety and Health. A Manual for Road Crews.

ERIC Educational Resources Information Center

Chapnick, Ellen P.

This occupational safety and health handbook is designed for use as an educational tool in safety and health training classes for road workers. The first of six major sections, Caution Work Ahead, identifies principles of controlling hazards and discusses how the law can help improve safety and health conditions. Section 2 describes three common…

Design of an Adaptive Human-Machine System Based on Dynamical Pattern Recognition of Cognitive Task-Load.

PubMed

Zhang, Jianhua; Yin, Zhong; Wang, Rubin

2017-01-01

This paper developed a cognitive task-load (CTL) classification algorithm and allocation strategy to sustain the optimal operator CTL levels over time in safety-critical human-machine integrated systems. An adaptive human-machine system is designed based on a non-linear dynamic CTL classifier, which maps a set of electroencephalogram (EEG) and electrocardiogram (ECG) related features to a few CTL classes. The least-squares support vector machine (LSSVM) is used as dynamic pattern classifier. A series of electrophysiological and performance data acquisition experiments were performed on seven volunteer participants under a simulated process control task environment. The participant-specific dynamic LSSVM model is constructed to classify the instantaneous CTL into five classes at each time instant. The initial feature set, comprising 56 EEG and ECG related features, is reduced to a set of 12 salient features (including 11 EEG-related features) by using the locality preserving projection (LPP) technique. An overall correct classification rate of about 80% is achieved for the 5-class CTL classification problem. Then the predicted CTL is used to adaptively allocate the number of process control tasks between operator and computer-based controller. Simulation results showed that the overall performance of the human-machine system can be improved by using the adaptive automation strategy proposed.

An electronic flight bag for NextGen avionics

NASA Astrophysics Data System (ADS)

Zelazo, D. Eyton

2012-06-01

The introduction of the Next Generation Air Transportation System (NextGen) initiative by the Federal Aviation Administration (FAA) will impose new requirements for cockpit avionics. A similar program is also taking place in Europe by the European Organisation for the Safety of Air Navigation (Eurocontrol) called the Single European Sky Air Traffic Management Research (SESAR) initiative. NextGen will require aircraft to utilize Automatic Dependent Surveillance-Broadcast (ADS-B) in/out technology, requiring substantial changes to existing cockpit display systems. There are two ways that aircraft operators can upgrade their aircraft in order to utilize ADS-B technology. The first is to replace existing primary flight displays with new displays that are ADS-B compatible. The second, less costly approach is to install an advanced Class 3 Electronic Flight Bag (EFB) system. The installation of Class 3 EFBs in the cockpit will allow aircraft operators to utilize ADS-B technology in a lesser amount of time with a decreased cost of implementation and will provide additional benefits to the operator. This paper describes a Class 3 EFB, the NexisTM Flight-Intelligence System, which has been designed to allow users a direct interface with NextGen avionics sensors while additionally providing the pilot with all the necessary information to meet NextGen requirements.

A compilation of safety impact information for extractables associated with materials used in pharmaceutical packaging, delivery, administration, and manufacturing systems.

PubMed

Jenke, Dennis; Carlson, Tage

2014-01-01

Demonstrating suitability for intended use is necessary to register packaging, delivery/administration, or manufacturing systems for pharmaceutical products. During their use, such systems may interact with the pharmaceutical product, potentially adding extraneous entities to those products. These extraneous entities, termed leachables, have the potential to affect the product's performance and/or safety. To establish the potential safety impact, drug products and their packaging, delivery, or manufacturing systems are tested for leachables or extractables, respectively. This generally involves testing a sample (either the extract or the drug product) by a means that produces a test method response and then correlating the test method response with the identity and concentration of the entity causing the response. Oftentimes, analytical tests produce responses that cannot readily establish the associated entity's identity. Entities associated with un-interpretable responses are termed unknowns. Scientifically justifiable thresholds are used to establish those individual unknowns that represent an acceptable patient safety risk and thus which do not require further identification and, conversely, those unknowns whose potential safety impact require that they be identified. Such thresholds are typically based on the statistical analysis of datasets containing toxicological information for more or less relevant compounds. This article documents toxicological information for over 540 extractables identified in laboratory testing of polymeric materials used in pharmaceutical applications. Relevant toxicological endpoints, such as NOELs (no observed effects), NOAELs (no adverse effects), TDLOs (lowest published toxic dose), and others were collated for these extractables or their structurally similar surrogates and were systematically assessed to produce a risk index, which represents a daily intake value for life-long intravenous administration. This systematic approach uses four uncertainty factors, each assigned a factor of 10, which consider the quality and relevance of the data, differences in route of administration, non-human species to human extrapolations, and inter-individual variation among humans. In addition to the risk index values, all extractables and most of their surrogates were classified for structural safety alerts using Cramer rules and for mutagenicity alerts using an in silico approach (Benigni/Bossa rule base for mutagenicity via Toxtree). Lastly, in vitro mutagenicity data (Ames Salmonella typimurium and Mouse Lymphoma tests) were collected from available databases (Chemical Carcinogenesis Research Information and Carcinogenic Potency Database). The frequency distributions of the resulting data were established; in general risk index values were normally distributed around a band ranging from 5 to 20 mg/day. The risk index associated with 95% level of the cumulative distribution plot was approximately 0.1 mg/day. Thirteen extractables in the dataset had individual risk index values less than 0.1 mg/day, although four of these had additional risk indices, based on multiple different toxicological endpoints, above 0.1 mg/day. Additionally, approximately 50% of the extractables were classified in Cramer Class 1 (low risk of toxicity) and approximately 35% were in Cramer Class 3 (no basis to assume safety). Lastly, roughly 20% of the extractables triggered either an in vitro or in silico alert for mutagenicity. When Cramer classifications and the mutagenicity alerts were compared to the risk indices, extractables with safety alerts generally had lower risk index values, although the differences in the risk index data distributions, extractables with or without alerts, were small and subtle. Leachables from packaging systems, manufacturing systems, or delivery devices can accumulate in drug products and potentially affect the drug product. Although drug products can be analyzed for leachables (and material extracts can be analyzed for extractables), not all leachables or extractables can be fully identified. Safety thresholds can be used to establish whether the unidentified substances can be deemed to be safe or whether additional analytical efforts need to be made to secure the identities. These thresholds are typically based on the statistical analysis of datasets containing toxicological information for more or less relevant compounds. This article contains safety data for over 500 extractables that were identified in laboratory characterizations of polymers used in pharmaceutical applications. The safety data consists of structural toxicity classifications of the extractables as well as calculated risk indices, where the risk indices were obtained by subjecting toxicological safety data, such as NOELs (no observed effects), NOAELs (no adverse effects), TDLOs (lowest published toxic dose), and others to a systematic evaluation process using appropriate uncertainty factors. Thus the risk index values represent daily exposures for the lifetime intravenous administration of drugs. The frequency distributions of the risk indices and Cramer classifications were examined. The risk index values were normally distributed around a range of 5 to 20 mg/day, and the risk index associated with the 95% level of the cumulative frequency plot was 0.1 mg/day. Approximately 50% of the extractables were in Cramer Class 1 (low risk of toxicity) and approximately 35% were in Cramer Class 3 (high risk of toxicity). Approximately 20% of the extractables produced an in vitro or in silico mutagenicity alert. In general, the distribution of risk index values was not strongly correlated with the either extractables' Cramer classification or by mutagenicity alerts. However, extractables with either in vitro or in silico alerts were somewhat more likely to have low risk index values. © PDA, Inc. 2014.

Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results.

PubMed

Hahn, Rebecca T; Meduri, Christopher U; Davidson, Charles J; Lim, Scott; Nazif, Tamim M; Ricciardi, Mark J; Rajagopal, Vivek; Ailawadi, Gorav; Vannan, Mani A; Thomas, James D; Fowler, Dale; Rich, Stuart; Martin, Randy; Ong, Geraldine; Groothuis, Adam; Kodali, Susheel

2017-04-11

The SCOUT (Percutaneous Tricuspid Valve Annuloplasty System for Symptomatic Chronic Functional Tricuspid Regurgitation) trial is a prospective, single-arm, multicenter, early feasibility study of a novel transcatheter device to plicate the tricuspid annulus (TA) and reduce tricuspid regurgitation (TR). This study tested the feasibility and safety of a novel transcatheter device and assessed its early performance and functional outcomes. Between November 2015 and June 2016, 15 patients with New York Heart Association (NYHA) functional class ≥II and moderate or greater functional TR were enrolled. Primary performance and safety endpoint outcomes were technically successful at 30 days with no reintervention. Echocardiographic measurements (TA diameter, effective regurgitant orifice area [EROA], left ventricular stroke volume [LVSV]) and quality-of-life (QoL) measurements (NYHA functional class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], and 6-min walk test [6MWT]) were performed at baseline and 30 days. All patients (mean 73.2 ± 6.9 years of age, 87% female) underwent successful device implantation with no deaths, strokes, bleeding, tamponade, or valve reintervention. Technical success rate at 30 days was 80%, with 3 single-pledget annular detachments without reintervention. In the remaining 12 patients, there were significant reductions in TA (12.3 ± 3.1 cm 2 to 11.3 ± 2.7 cm 2 , respectively; p = 0.019) and EROA (0.51 ± 0.18 cm 2 vs. 0.32 ± 0.18 cm 2 , respectively; p = 0.020), with significant increase in LVSV (63.6 ± 17.9 ml vs. 71.5 ± 25.7 ml, respectively; p = 0.021). In the intention-to-treat cohort, there were significant improvements in NYHA functional class (≥1 class, p = 0.001), MLHFQ (47.4 ± 17.6 to 20.9 ± 14.8; p < 0.001), and 6MWT (245.2 ± 110.1 to 298.0 m ± 107.6 m; p = 0.008). The 30-day results of the SCOUT trial confirmed the safety of the novel transcatheter device, which reduced TA and EROA, increased LVSV, and improved QoL. (Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign [SCOUT]; NCT02574650.). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

76 FR 3571 - Proposed Establishment of Class E Airspace; Kahului, HI

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

...-1233; Airspace Docket No. 10-AWP-21] Proposed Establishment of Class E Airspace; Kahului, HI AGENCY... action proposes to establish Class E airspace at Kahului Airport, Kahului, HI. Controlled airspace is... procedures at Kahului Airport, Kahului, HI. The FAA is proposing this action to enhance the safety and...

78 FR 48294 - Amendment of Class E Airspace; Mason, TX

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

...-1141; Airspace Docket No. 12-ASW-12] Amendment of Class E Airspace; Mason, TX AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action amends Class E airspace at Mason, TX... Approach Procedures at Mason County Airport. This action enhances the safety and management of Instrument...

49 CFR 179.200 - General specifications applicable to non-pressure tank car tanks (Class DOT-111).

Code of Federal Regulations, 2010 CFR

2010-10-01

... tank car tanks (Class DOT-111). 179.200 Section 179.200 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR TANK CARS Specifications for Non-Pressure Tank Car Tanks (Classes...

49 CFR 179.200 - General specifications applicable to non-pressure tank car tanks (Class DOT-111).

Code of Federal Regulations, 2013 CFR

2013-10-01

... tank car tanks (Class DOT-111). 179.200 Section 179.200 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Non-Pressure Tank Car Tanks (Classes DOT-111AW...

49 CFR 179.103 - Special requirements for class 114A * * * tank car tanks.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Special requirements for class 114A * * * tank car...) PIPELINE AND 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...

49 CFR 179.200 - General specifications applicable to non-pressure tank car tanks (Class DOT-111).

Code of Federal Regulations, 2014 CFR

2014-10-01

... tank car tanks (Class DOT-111). 179.200 Section 179.200 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Non-Pressure Tank Car Tanks (Classes DOT-111AW...

77 FR 42430 - Establishment of Class E Airspace; West Memphis, AR

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-19

... Airport from the Class E airspace of Memphis International Airport, Memphis, TN, has made this action necessary to enhance the safety and management of Instrument Flight Rules (IFR) operations at the airport... airspace surrounding West Memphis Municipal Airport from the Class E airspace area of Memphis International...

77 FR 29920 - Proposed Amendment of Class E Airspace; Lemmon, SD

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

...-0391; Airspace Docket No. 12-AGL-2] Proposed Amendment of Class E Airspace; Lemmon, SD AGENCY: Federal... proposes to amend Class E airspace at Lemmon, SD. Additional controlled airspace is necessary to... Municipal Airport, Lemmon, SD. Controlled airspace is needed for the safety and management of IFR operations...

77 FR 16783 - Proposed Amendment of Class E Airspace; Orlando, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

...-0503; Airspace Docket No. 11-ASO-19] Proposed Amendment of Class E Airspace; Orlando, FL AGENCY... action proposes to amend Class E Airspace at Orlando, FL, as new Standard Instrument Approach Procedures have been developed at Orlando Executive Airport. This action would enhance the safety and airspace...

Nuclear power and probabilistic safety assessment (PSA): past through future applications

NASA Astrophysics Data System (ADS)

Stamatelatos, M. G.; Moieni, P.; Everline, C. J.

1995-03-01

Nuclear power reactor safety in the United States is about to enter a new era -- an era of risk- based management and risk-based regulation. First, there was the age of `prescribed safety assessment,' during which a series of design-basis accidents in eight categories of severity, or classes, were postulated and analyzed. Toward the end of that era, it was recognized that `Class 9,' or `beyond design basis,' accidents would need special attention because of the potentially severe health and financial consequences of these accidents. The accident at Three Mile Island showed that sequences of low-consequence, high-frequency events and human errors can be much more risk dominant than the Class 9 accidents. A different form of safety assessment, PSA, emerged and began to gain ground against the deterministic safety establishment. Eventually, this led to the current regulatory requirements for individual plant examinations (IPEs). The IPEs can serve as a basis for risk-based regulation and management, a concept that may ultimately transform the U.S. regulatory process from its traditional deterministic foundations to a process predicated upon PSA. Beyond the possibility of a regulatory environment predicated upon PSA lies the possibility of using PSA as the foundation for managing daily nuclear power plant operations.

75 FR 35516 - Pipeline Safety: Request for Special Permit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2010-0147] Pipeline Safety: Request for Special Permit AGENCY: Pipeline and Hazardous Materials... with the Class 1 location portion of a 7.4 mile natural gas pipeline to be constructed in Alaska. This...

Decaleside: a new class of natural insecticide targeting tarsal gustatory sites

NASA Astrophysics Data System (ADS)

Rajashekar, Yallappa; Rao, Lingamallu J. M.; Shivanandappa, Thimmappa

2012-10-01

Natural sources for novel insecticide molecules hold promise in view of their eco-friendly nature, selectivity, and mammalian safety. Recent progress in understanding the biology of insect olfaction and taste offers new strategies for developing selective pest control agents. We have isolated two natural insecticidal molecules from edible roots of Decalepis hamiltonii named Decalesides I and II, which are novel trisaccharides, highly toxic to household insect pests and stored-product insects. We have experimentally shown that insecticidal activity requires contact with tarsi on the legs but is not toxic orally. The insecticidal activity of molecules is lost by hydrolysis, and various sugars modify toxic response, showing that the insecticidal activity is via gustatory sites on the tarsi. Selective toxicity to insects by virtue of their gustatory site of action and the mammalian safety of the new insecticides is inherent in their chemical structure with 1-4 or 1-1 α linkage that is easily hydrolyzed by digestive enzymes of mammals. Decalesides represent a new chemical class of natural insecticides with a unique mode of action targeting tarsal chemosensory/gustatory system of insects.

Emergent Properties and Toxicological Considerations for Nanohybrid Materials in Aquatic Systems

PubMed Central

Saleh, Navid B.; Afrooz, A. R. M. Nabiul; Bisesi, Joseph H.; Aich, Nirupam; Plazas-Tuttle, Jaime; Sabo-Attwood, Tara

2014-01-01

Conjugation of multiple nanomaterials has become the focus of recent materials development. This new material class is commonly known as nanohybrids or “horizon nanomaterials”. Conjugation of metal/metal oxides with carbonaceous nanomaterials and overcoating or doping of one metal with another have been pursued to enhance material performance and/or incorporate multifunctionality into nano-enabled devices and processes. Nanohybrids are already at use in commercialized energy, electronics and medical products, which warrant immediate attention for their safety evaluation. These conjugated ensembles likely present a new set of physicochemical properties that are unique to their individual component attributes, hence increasing uncertainty in their risk evaluation. Established toxicological testing strategies and enumerated underlying mechanisms will thus need to be re-evaluated for the assessment of these horizon materials. This review will present a critical discussion on the altered physicochemical properties of nanohybrids and analyze the validity of existing nanotoxicology data against these unique properties. The article will also propose strategies to evaluate the conjugate materials’ safety to help undertake future toxicological research on the nanohybrid material class. PMID:28344229

Teaching About Fire Safety.

ERIC Educational Resources Information Center

Brady, Holly; Arnold, Anne Jurmu

1982-01-01

This unit on fire safety teaches students how to act in or during a fire and presents fire prevention measures that students can implement at home. Two reproducible masters concerning fire safety and prevention are presented along with class activities, student reading resources, and organizations and companies that offer classroom materials about…

Development of a British Road Safety Education Support Materials Curriculum.

ERIC Educational Resources Information Center

Bouck, Linda H.

Road safety education needs to be a vital component in the school curriculum. This paper describes a planned road safety education support materials curriculum developed to aid educators in the Wiltshire County (England) primary schools. Teaching strategies include topic webs, lecture, class discussion, group activities, and investigative learning…

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 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND 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...

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 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND 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...

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...

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Safety relief devices and pressure regulators. 179... HAZARDOUS 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 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND 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...

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...

New Jersey Industrial Arts Education Safety Guide.

ERIC Educational Resources Information Center

Kobylarz, Joseph D.; Olender, Francis B.

This guide was developed to assist the teacher in planning, implementing, revising, or improving safety instruction in industrial arts classes in New Jersey, and has as its theme, "Safety Is Everyone's Responsibility." The guide is organized in seven major sections. The first section explains the purpose of the guide, outlines the…

76 FR 3907 - Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health (NIOSH), Department... for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226... . John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2011-1228 Filed...

Two NextGen Air Safety Tools: An ADS-B Equipped UAV and a Wake Turbulence Estimator

NASA Astrophysics Data System (ADS)

Handley, Ward A.

Two air safety tools are developed in the context of the FAA's NextGen program. The first tool addresses the alarming increase in the frequency of near-collisions between manned and unmanned aircraft by equipping a common hobby class UAV with an ADS-B transponder that broadcasts its position, speed, heading and unique identification number to all local air traffic. The second tool estimates and outputs the location of dangerous wake vortex corridors in real time based on the ADS-B data collected and processed using a custom software package developed for this project. The TRansponder based Position Information System (TRAPIS) consists of data packet decoders, an aircraft database, Graphical User Interface (GUI) and the wake vortex extension application. Output from TRAPIS can be visualized in Google Earth and alleviates the problem of pilots being left to imagine where invisible wake vortex corridors are based solely on intuition or verbal warnings from ATC. The result of these two tools is the increased situational awareness, and hence safety, of human pilots in the National Airspace System (NAS).

ICAROUS - Integrated Configurable Algorithms for Reliable Operations Of Unmanned Systems

NASA Technical Reports Server (NTRS)

Consiglio, María; Muñoz, César; Hagen, George; Narkawicz, Anthony; Balachandran, Swee

2016-01-01

NASA's Unmanned Aerial System (UAS) Traffic Management (UTM) project aims at enabling near-term, safe operations of small UAS vehicles in uncontrolled airspace, i.e., Class G airspace. A far-term goal of UTM research and development is to accommodate the expected rise in small UAS traffic density throughout the National Airspace System (NAS) at low altitudes for beyond visual line-of-sight operations. This paper describes a new capability referred to as ICAROUS (Integrated Configurable Algorithms for Reliable Operations of Unmanned Systems), which is being developed under the UTM project. ICAROUS is a software architecture comprised of highly assured algorithms for building safety-centric, autonomous, unmanned aircraft applications. Central to the development of the ICAROUS algorithms is the use of well-established formal methods to guarantee higher levels of safety assurance by monitoring and bounding the behavior of autonomous systems. The core autonomy-enabling capabilities in ICAROUS include constraint conformance monitoring and contingency control functions. ICAROUS also provides a highly configurable user interface that enables the modular integration of mission-specific software components.

ICAROUS: Integrated Configurable Architecture for Unmanned Systems

NASA Technical Reports Server (NTRS)

Consiglio, Maria C.

2016-01-01

NASA's Unmanned Aerial System (UAS) Traffic Management (UTM) project aims at enabling near-term, safe operations of small UAS vehicles in uncontrolled airspace, i.e., Class G airspace. A far-term goal of UTM research and development is to accommodate the expected rise in small UAS traffic density throughout the National Airspace System (NAS) at low altitudes for beyond visual line-of-sight operations. This video describes a new capability referred to as ICAROUS (Integrated Configurable Algorithms for Reliable Operations of Unmanned Systems), which is being developed under the auspices of the UTM project. ICAROUS is a software architecture comprised of highly assured algorithms for building safety-centric, autonomous, unmanned aircraft applications. Central to the development of the ICAROUS algorithms is the use of well-established formal methods to guarantee higher levels of safety assurance by monitoring and bounding the behavior of autonomous systems. The core autonomy-enabling capabilities in ICAROUS include constraint conformance monitoring and autonomous detect and avoid functions. ICAROUS also provides a highly configurable user interface that enables the modular integration of mission-specific software components.

75 FR 6595 - Proposed Amendment of Class E Airspace; Mapleton, IA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-10

...-1155; Airspace Docket No. 09-ACE-14] Proposed Amendment of Class E Airspace; Mapleton, IA AGENCY... action proposes to amend Class E airspace at Mapleton, IA. Additional controlled airspace is necessary to..., Mapleton, IA. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules...

75 FR 6592 - Proposed Amendment of Class E Airspace; Emmetsburg, IA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-10

...-1153; Airspace Docket No. 09-ACE-13] Proposed Amendment of Class E Airspace; Emmetsburg, IA AGENCY... action proposes to amend Class E airspace at Emmetsburg, IA. Additional controlled airspace is necessary..., Emmetsburg, IA. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules...

76 FR 53353 - Proposed Amendment of Class E Airspace; Carroll, IA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

...-0845; Airspace Docket No. 11-ACE-19] Proposed Amendment of Class E Airspace; Carroll, IA AGENCY... action proposes to amend Class E airspace at Carroll, IA. Decommissioning of the Carroll non-directional beacon (NDB) at Arthur N. Neu Airport, Carroll, IA, has made this action necessary for the safety and...

30 CFR 20.10 - Tests (class 1 and 2 lamps).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Tests (class 1 and 2 lamps). 20.10 Section 20.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.10 Tests (class...

78 FR 25227 - Proposed Amendment of Class E Airspace; Live Oak, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... action proposes to amend Class E Airspace in the Live Oak, FL area, as new Standard Instrument Approach...-0001; Airspace Docket No. 12-ASO-45] Proposed Amendment of Class E Airspace; Live Oak, FL AGENCY... continued safety and management of instrument flight rules (IFR) operations for SIAPs within the Live Oak...

49 CFR 216.15 - Special notice for repairs-track class.

Code of Federal Regulations, 2012 CFR

2012-10-01

... requirements for the class at which the track is being operated, as defined in the Track Safety Standards (49 CFR part 213), he notifies the railroad in writing that the track is being lowered in class and that... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION SPECIAL NOTICE AND EMERGENCY ORDER PROCEDURES: RAILROAD TRACK...

49 CFR 216.15 - Special notice for repairs-track class.

Code of Federal Regulations, 2010 CFR

2010-10-01

... requirements for the class at which the track is being operated, as defined in the Track Safety Standards (49 CFR part 213), he notifies the railroad in writing that the track is being lowered in class and that... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION SPECIAL NOTICE AND EMERGENCY ORDER PROCEDURES: RAILROAD TRACK...

49 CFR 216.15 - Special notice for repairs-track class.

Code of Federal Regulations, 2014 CFR

2014-10-01

... requirements for the class at which the track is being operated, as defined in the Track Safety Standards (49 CFR part 213), he notifies the railroad in writing that the track is being lowered in class and that... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION SPECIAL NOTICE AND EMERGENCY ORDER PROCEDURES: RAILROAD TRACK...

49 CFR 216.15 - Special notice for repairs-track class.

Code of Federal Regulations, 2011 CFR

2011-10-01

... requirements for the class at which the track is being operated, as defined in the Track Safety Standards (49 CFR part 213), he notifies the railroad in writing that the track is being lowered in class and that... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION SPECIAL NOTICE AND EMERGENCY ORDER PROCEDURES: RAILROAD TRACK...

49 CFR 216.15 - Special notice for repairs-track class.

Code of Federal Regulations, 2013 CFR

2013-10-01

... requirements for the class at which the track is being operated, as defined in the Track Safety Standards (49 CFR part 213), he notifies the railroad in writing that the track is being lowered in class and that... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION SPECIAL NOTICE AND EMERGENCY ORDER PROCEDURES: RAILROAD TRACK...

75 FR 6594 - Proposed Amendment of Class E Airspace; Osceola, AR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-10

...-1183; Airspace Docket No. 09-ASW-38] Proposed Amendment of Class E Airspace; Osceola, AR AGENCY... action proposes to amend Class E airspace at Osceola, AR. Decommissioning of the Osceola non-directional beacon (NDB) at Osceola Municipal Airport, Osceola, AR, has made this action necessary for the safety and...

75 FR 43884 - Proposed Amendment of Class E Airspace; Searcy, AR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-27

...-1182; Airspace Docket No. 09-ASW-37] Proposed Amendment of Class E Airspace; Searcy, AR AGENCY: Federal... proposes to amend Class E airspace at Searcy, AR. Decommissioning of the Searcy non-directional beacon (NDB) at Searcy Municipal Airport, Searcy, AR, has made this action necessary for the safety and management...

78 FR 13843 - Proposed Amendment of Class E Airspace; Bend, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-01

...-0026; Airspace Docket No. 13-ANM-3] Proposed Amendment of Class E Airspace; Bend, OR AGENCY: Federal... proposes to modify Class E airspace at Bend, OR to accommodate aircraft departing and arriving under Instrument Flight Rules (IFR) at Bend Municipal Airport. This action would enhance the safety and management...

Semiselective Optoelectronic Sensors for Monitoring Microbes

NASA Technical Reports Server (NTRS)

Tabacco, Mary Beth; Chuang, Han; Taylor,Laura; Russo, Jaime

2003-01-01

Sensor systems are under development for use in real-time detection and quantitation of microbes in water without need for sampling. These systems include arrays of optical sensors; miniature, portable electronic data-acquisition circuits; and optoelectronic interfaces between the sensor arrays and data-acquisition circuits. These systems are intended for original use in long-term, inline monitoring of waterborne micro-organisms in water-reclamation systems aboard future spacecraft. They could also be adapted to similar terrestrial uses with respect to municipal water supplies, stored drinking water, and swimming water; for detecting low-level biological contamination in biotechnological, semiconductor, and pharmaceutical process streams; and in verifying the safety of foods and beverages. In addition, they could be adapted to monitoring of airborne microbes and of surfaces (e.g., to detect and/or quantitate biofilms). The designs of the sensors in these systems are based partly on those of sensors developed previously for monitoring airborne biological materials. The designs exploit molecular- recognition and fluorescence-spectroscopy techniques, such that in the presence of micro-organisms of interest, fluorescence signals change and the changes can be measured. These systems are characterized as semiselective because they respond to classes of micro-organisms and can be used to discriminate among the classes. This semiselectivity is a major aspect of the design: It is important to distinguish between (1) the principle of detection and quantitation of classes of micro-organisms by use of these sensors and (2) the principle of detection and quantitation of individual microbiological species by means of prior immuno-diagnostic and/or molecular-biology techniques. Detection of classes (in contradistinction to species) is particularly valuable when the exact nature of a contaminant is unknown.

Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

PubMed

Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

2018-04-01

Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

Risk Classification and Risk-based Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Leitner, Jesse A.

2014-01-01

Recent activities to revamp and emphasize the need to streamline processes and activities for Class D missions across the agency have led to various interpretations of Class D, including the lumping of a variety of low-cost projects into Class D. Sometimes terms such as Class D minus are used. In this presentation, mission risk classifications will be traced to official requirements and definitions as a measure to ensure that projects and programs align with the guidance and requirements that are commensurate for their defined risk posture. As part of this, the full suite of risk classifications, formal and informal will be defined, followed by an introduction to the new GPR 8705.4 that is currently under review.GPR 8705.4 lays out guidance for the mission success activities performed at the Classes A-D for NPR 7120.5 projects as well as for projects not under NPR 7120.5. Furthermore, the trends in stepping from Class A into higher risk posture classifications will be discussed. The talk will conclude with a discussion about risk-based safety and mission assuranceat GSFC.

Public safety training as a force multiplier.

PubMed

Potter, Anthony N; Woodruff, Craig A

2012-01-01

The training of public safety officers to meet the many and varied demands of today's healthcare environment is the second step in developing and maintaining a world class public safety service. Working closely with the corporate training department, and utilizing the latest adult education techniques, the public safety director can ensure that all officers are capable of meeting the challenges threatening the safety and security of his healthcare facilities. This is the second in a series of articles on all aspects of public safety personnel administration.

Damage-Tolerant, Affordable Composite Engine Cases Designed and Fabricated

NASA Technical Reports Server (NTRS)

Hopkins, Dale A.; Roberts, Gary D.; Pereira, J. Michael; Bowman, Cheryl L.

2005-01-01

An integrated team of NASA personnel, Government contractors, industry partners, and university staff have developed an innovative new technology for commercial fan cases that will substantially influence the safety and efficiency of future turbine engines. This effective team, under the direction of the NASA Glenn Research Center and with the support of the Federal Aviation Administration, has matured a new class of carbon/polymer composites and demonstrated a 30- to 50-percent improvement in specific containment capacity (blade fragment kinetic energy/containment system weight). As the heaviest engine component, the engine case/containment system greatly affects both the safety and efficiency of aircraft engines. The ballistic impact research team has developed unique test facilities and methods for screening numerous candidate material systems to replace the traditional heavy, metallic engine cases. This research has culminated in the selection of a polymer matrix composite reinforced with triaxially braided carbon fibers and technology demonstration through the fabrication of prototype engine cases for three major commercial engine manufacturing companies.

A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

PubMed

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

2010-06-01

As pre-approval trials are inherently limited in assessing the complete benefit-risk profile of a new drug, serious safety issues may emerge once a drug gains widespread use after approval. Regulators face the dilemma of balancing timely market access with the need for complete data on risks. This challenge has led to a life-cycle approach but, so far, few data are available on post-approval safety issues requiring regulatory action. The aim of this study is to determine the frequency, timing and nature of safety issues that necessitated safety-related regulatory action in the form of a Direct Healthcare Professional Communication (DHPC) issued by pharmaceutical companies in collaboration with the Dutch Medicines Evaluation Board during the past decade. All DHPCs issued in the Netherlands from 1 January 1999 to 1 January 2009 were retrospectively collected from the national regulatory authorities. Elapsed time between the approval date and the issue of the DHPC was determined. Characteristics of the action including the nature of the safety issue (according to Medical Dictionary for Regulatory Activities [MedDRA] terminology), type of drug and procedural aspects of the regulatory action taken were reviewed. DHPC characteristics were tabulated and explorative non-parametric tests were performed to study the effect of safety issue, drug class, drug type, orphan drug and first-in-class status on elapsed time from approval to the DHPC. 157 DHPCs were issued concerning 112 different active substances, approximately 9% (112/1200) of active substances available in the Netherlands in 2007. The number of DHPCs issued increased by 2.1 (95% CI 1.2, 3.1; p < 0.001) DHPCs per year over the past decade, reaching a total of 25 in 2008. The median time between approval and DHPC was 5.3 years (range 0.13-48 years). No significant trend in elapsed time to DHPC was observed in relation to the studied years (p = 0.06). One-third of all DHPCs were issued in the first 3 years after approval, but 27% (n = 43/157) of the DHPCs were issued 10 or more years after approval. Timing of DHPCs differed depending on safety issue, drug class, drug type and orphan drug status. DHPCs mostly concerned adverse events in the system organ class of 'cardiac disorders' (15%), 'injury, poisoning and procedural complications' (13%) and 'general disorders and administration site conditions' (10%). In ten cases the drug was eventually withdrawn. Withdrawal occurred a median duration of 2.4 years after registration (range of 1.5-48 years) and was most frequently due to cardiac disorders (including QT interval prolongation; four occasions) and hepatobiliary disorders (two occasions). In the past decade, the number of DHPCs has increased over time. This is likely caused by a multitude of factors: increased risk awareness by the public, media, regulators and other stakeholders; the type of drugs approved, such as orphan drugs and biologicals; and the regulatory process, including conditional approvals. The number of DHPCs may in the future increase further with the possibility of screening large epidemiological databases proactively for adverse drug events. Nine percent of all marketed drugs required a safety-related action. Regulatory action is taken shortly (<3 years) after market approval nearly as often as after intermediate (3-10 years) and long-term (>10 years) market exposure. These findings underline the need for risk management during the whole life cycle of a drug.

Prevention of residential roof fires by use of a class "A" fire rated roof system.

PubMed

Edlich, Richard F; Winters, Kathryne L; Long, William B; Britt, L D

2004-01-01

Because residential roof fires remain a life-threatening danger to residential homeowners in the United States, we describe in detail a national fire prevention program for reducing residential roof fires by use of an Underwriters Laboratories Inc. (UL) and National Fire Protection Association Class A fire rated roof system. This Class A system should comply with the test requirements for fire resistance of roof coverings, as outlined in UL 790 or in ASTM International (ASTM) E-108. Both the Asphalt Roofing Manufacturer's Association (ARMA) and the National Roofing Contractors Association (NRCA) have set up guidelines for selecting a new roof for the homeowner. Class A, fiber-glass-based asphalt roofing shingles represent an overwhelming share of the United States residential roofing market, and, as such, the Class A rated roofing system remains an excellent alternative to wood shingles and shakes. Fortunately, the Class A fire rating is available for certain wood shingle products that incorporate a factory-applied, fire resistant treatment. However, in this circumstance, wood products labeled as Class B shakes or shingles must be installed over spaced or solid sheathing that have been covered either with one layer of 1/4 in. (6.4 mm) thick noncombustible roof board, or with one layer of minimum 72-lb. fiber-glass-based mineral surfaced cap sheet, or with another specialty roofing sheet to obtain the Class A fire rating. Clay, tile, slate, and metal have been assigned Class A fire ratings in the codes (but often without testing). These alternative roofing materials are often considerably more expensive. Proper application, ventilation, and insulation of roofing systems are required to prevent heat and moisture buildup in the attic, which can damage the roofing system, making it more susceptible to water leakage as well as ignition in the event of a fire. The NRCA has devised excellent recommendations for the homeowner to prequalify the contractor. In addition, a warranty for any new roofing material is important for the homeowner to ensure that the roofing can be repaired by the contractor or manufacturer during the specified warranty period, in case of contractor error or a manufacturing defect. In addition, the homeowner should ensure that the warranty is transferable to any future owner of the home to allow the buyer to have the same warranty benefits as the original owner. The State of California has mandated strict roofing requirements to prevent residential fires. In the absence of this legislation in other states, the homeowner must follow the guidelines outlined in this collective review to ensure that a roofing system with Class A fire protection is installed. Other fire safety precautions that should also be considered mandatory are to include smoke alarms, escape plans, and retrofit fire sprinklers.

ASME code considerations for the compact heat exchanger

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

Nestell, James; Sham, Sam

2015-08-31

The mission of the U.S. Department of Energy (DOE), Office of Nuclear Energy is to advance nuclear power in order to meet the nation's energy, environmental, and energy security needs. Advanced high temperature reactor systems such as sodium fast reactors and high and very high temperature gas-cooled reactors are being considered for the next generation of nuclear reactor plant designs. The coolants for these high temperature reactor systems include liquid sodium and helium gas. Supercritical carbon dioxide (sCO₂), a fluid at a temperature and pressure above the supercritical point of CO₂, is currently being investigated by DOE as a workingmore » fluid for a nuclear or fossil-heated recompression closed Brayton cycle energy conversion system that operates at 550°C (1022°F) at 200 bar (2900 psi). Higher operating temperatures are envisioned in future developments. All of these design concepts require a highly effective heat exchanger that transfers heat from the nuclear or chemical reactor to the chemical process fluid or the to the power cycle. In the nuclear designs described above, heat is transferred from the primary to the secondary loop via an intermediate heat exchanger (IHX) and then from the intermediate loop to either a working process or a power cycle via a secondary heat exchanger (SHX). The IHX is a component in the primary coolant loop which will be classified as "safety related." The intermediate loop will likely be classified as "not safety related but important to safety." These safety classifications have a direct bearing on heat exchanger design approaches for the IHX and SHX. The very high temperatures being considered for the VHTR will require the use of very high temperature alloys for the IHX and SHX. Material cost considerations alone will dictate that the IHX and SHX be highly effective; that is, provide high heat transfer area in a small volume. This feature must be accompanied by low pressure drop and mechanical reliability and robustness. Classic shell and tube designs will be large and costly, and may only be appropriate in steam generator service in the SHX where boiling inside the tubes occurs. For other energy conversion systems, all of these features can be met in a compact heat exchanger design. This report will examine some of the ASME Code issues that will need to be addressed to allow use of a Code-qualified compact heat exchanger in IHX or SHX nuclear service. Most effort will focus on the IHX, since the safety-related (Class A) design rules are more extensive than those for important-to-safety (Class B) or commercial rules that are relevant to the SHX.« less

In-Class Simulation of Pooling Safety Stock

ERIC Educational Resources Information Center

Bandy, D. Brent

2005-01-01

In managing business process flows, safety stock can be used to protect against stockouts due to demand variability. When more than one location is involved, the concept of aggregation enables the pooling of demands and associated inventories, resulting in improved service levels without increasing the total level of safety stock. This pooling of…

14 CFR 139.321 - Handling and storing of hazardous substances and materials.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Public protection. (3) Control of access to storage areas. (4) Fire safety in fuel farm and storage areas. (5) Fire safety in mobile fuelers, fueling pits, and fueling cabinets. (6) Training of fueling personnel in fire safety in accordance with paragraph (e) of this section. Such training at Class III...

14 CFR 139.321 - Handling and storing of hazardous substances and materials.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Public protection. (3) Control of access to storage areas. (4) Fire safety in fuel farm and storage areas. (5) Fire safety in mobile fuelers, fueling pits, and fueling cabinets. (6) Training of fueling personnel in fire safety in accordance with paragraph (e) of this section. Such training at Class III...

14 CFR 139.321 - Handling and storing of hazardous substances and materials.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Public protection. (3) Control of access to storage areas. (4) Fire safety in fuel farm and storage areas. (5) Fire safety in mobile fuelers, fueling pits, and fueling cabinets. (6) Training of fueling personnel in fire safety in accordance with paragraph (e) of this section. Such training at Class III...

14 CFR 139.321 - Handling and storing of hazardous substances and materials.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Public protection. (3) Control of access to storage areas. (4) Fire safety in fuel farm and storage areas. (5) Fire safety in mobile fuelers, fueling pits, and fueling cabinets. (6) Training of fueling personnel in fire safety in accordance with paragraph (e) of this section. Such training at Class III...

14 CFR 139.321 - Handling and storing of hazardous substances and materials.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Public protection. (3) Control of access to storage areas. (4) Fire safety in fuel farm and storage areas. (5) Fire safety in mobile fuelers, fueling pits, and fueling cabinets. (6) Training of fueling personnel in fire safety in accordance with paragraph (e) of this section. Such training at Class III...

Berkeley Lab - Materials Sciences Division

Science.gov Websites

Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of ? Click Here! Commitment to Safety at MSD In the Materials Sciences Division, our mission is to do world -class science in a safe environment. We proudly support a strong safety culture in which all staff and

What Can Students Learn about Lab Safety from Mr. Bean?

ERIC Educational Resources Information Center

Carr, Jeremy M.; Carr, June M.

2016-01-01

Chemical laboratory safety education is often synonymous with boring, dry, drawn-out lectures. In an effort to challenge this norm and stimulate vivid learning opportunities about laboratory safety, college chemistry classes analyzed a short, humorous video clip of a character, named Mr. Bean, who visits a chemistry laboratory and commits several…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-09

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

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

75 FR 67364 - Decision To Evaluate a Petition To Designate a Class of Employees From Clinton Engineering Works...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-02

... AGENCY: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human... Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS [email protected] . John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2010...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-21

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

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

Perception for mobile robot navigation: A survey of the state of the art

NASA Technical Reports Server (NTRS)

Kortenkamp, David

1994-01-01

In order for mobile robots to navigate safely in unmapped and dynamic environments they must perceive their environment and decide on actions based on those perceptions. There are many different sensing modalities that can be used for mobile robot perception; the two most popular are ultrasonic sonar sensors and vision sensors. This paper examines the state-of-the-art in sensory-based mobile robot navigation. The first issue in mobile robot navigation is safety. This paper summarizes several competing sonar-based obstacle avoidance techniques and compares them. Another issue in mobile robot navigation is determining the robot's position and orientation (sometimes called the robot's pose) in the environment. This paper examines several different classes of vision-based approaches to pose determination. One class of approaches uses detailed, a prior models of the robot's environment. Another class of approaches triangulates using fixed, artificial landmarks. A third class of approaches builds maps using natural landmarks. Example implementations from each of these three classes are described and compared. Finally, the paper presents a completely implemented mobile robot system that integrates sonar-based obstacle avoidance with vision-based pose determination to perform a simple task.

Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial).

PubMed

Rogers, Jason H; Thomas, Martyn; Morice, Marie-Claude; Narbute, Inga; Zabunova, Milana; Hovasse, Thomas; Poupineau, Mathieu; Rudzitis, Ainars; Kamzola, Ginta; Zvaigzne, Ligita; Greene, Samantha; Erglis, Andrejs

2015-07-01

MAVERIC (Mitral Valve Repair Clinical Trial) reports the safety and efficacy of the ARTO system in patients with symptomatic heart failure and functional mitral regurgitation (FMR). The ARTO system percutaneously modifies the mitral annulus to improve leaflet coaptation in FMR. The MAVERIC trial is a prospective, nonrandomized first-in-human study. Key inclusion criteria were systolic heart failure New York Heart Association functional classes II to IV, FMR grade ≥2+, left ventricular (LV) ejection fraction ≤40%, LV end-diastolic diameter >50 mm and ≤75 mm. Exclusion criteria were clinical variables that precluded feasibility of the ARTO procedure. Primary outcomes were safety (30-day major adverse events) and efficacy (MR reduction, LV volumes, and functional status). Eleven patients received the ARTO system, and there were no procedural adverse events. From baseline to 30 days, there were meaningful improvements. Effective regurgitant orifice area decreased from 30.3 ± 11.1 mm(2) to 13.5 ± 7.1 mm(2) and regurgitant volumes from 45.4 ± 15.0 ml to 19.5 ± 10.2 ml. LV end-systolic volume index improved from 77.5 ± 24.3 ml/m(2) to 68.5 ± 21.4 ml/m(2), and LV end-diastolic volume index 118.7 ± 28.6 ml/m(2) to 103.9 ± 21.2 ml/m(2). Mitral annular anteroposterior diameter decreased from 45.0 ± 3.3 mm to 38.7 ± 3.0 mm. Functional status was 81.8% New York Heart Association functional class III/IV improving to 54.6% functional class I/II. At 30 days, there were 2 adverse events: 1 pericardial effusion requiring surgical drainage; and 1 asymptomatic device dislodgement. The ARTO system is a novel transcatheter device that can be used safely with meaningful efficacy in the treatment of FMR. (Mitral Valve Repair Clinical Trial [MAVERIC]; NCT02302872). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

AP1000{sup R} nuclear power plant safety overview for spent fuel cooling

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

Gorgemans, J.; Mulhollem, L.; Glavin, J.

2012-07-01

The AP1000{sup R} plant is an 1100-MWe class pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance, safety and costs. The AP1000 design uses passive features to mitigate design basis accidents. The passive safety systems are designed to function without safety-grade support systems such as AC power, component cooling water, service water or HVAC. Furthermore, these passive features 'fail safe' during a non-LOCA event such that DC power and instrumentation are not required. The AP1000 also has simple, active, defense-in-depth systems to support normal plant operations. These active systems provide the first levelmore » of defense against more probable events and they provide investment protection, reduce the demands on the passive features and support the probabilistic risk assessment. The AP1000 passive safety approach allows the plant to achieve and maintain safe shutdown in case of an accident for 72 hours without operator action, meeting the expectations provided in the U.S. Utility Requirement Document and the European Utility Requirements for passive plants. Limited operator actions are required to maintain safe conditions in the spent fuel pool via passive means. In line with the AP1000 approach to safety described above, the AP1000 plant design features multiple, diverse lines of defense to ensure spent fuel cooling can be maintained for design-basis events and beyond design-basis accidents. During normal and abnormal conditions, defense-in-depth and other systems provide highly reliable spent fuel pool cooling. They rely on off-site AC power or the on-site standby diesel generators. For unlikely design basis events with an extended loss of AC power (i.e., station blackout) or loss of heat sink or both, spent fuel cooling can still be provided indefinitely: - Passive systems, requiring minimal or no operator actions, are sufficient for at least 72 hours under all possible pool heat load conditions. - After 3 days, several different means are provided to continue spent fuel cooling using installed plant equipment as well as off-site equipment with built-in connections. Even for beyond design basis accidents with postulated pool damage and multiple failures in the passive safety-related systems and in the defense-in-depth active systems, the AP1000 multiple spent fuel pool spray and fill systems provide additional lines of defense to prevent spent fuel damage. (authors)« less

Comparison of the Safety of Seven Iodinated Contrast Media

PubMed Central

Seong, Jong-Mi; Choi, Nam-Kyong; Lee, Joongyub; Chang, Yoosoo; Kim, Ye-Jee; Yang, Bo Ram; Jin, Xue-Mei; Kim, Ju-Young

2013-01-01

We aimed to determine the characteristic adverse events (AEs) of iodinated contrast media (IOCM) and to compare the safety profiles of different IOCM. This study used the database of AEs reports submitted by healthcare professionals from 15 Regional Pharmacovigilance Centers between June 24, 2009 and December 31, 2010 in Korea. All reports of IOCM, including iopromide, iohexol, iopamidol, iomeprol, ioversol, iobitridol and iodixanol, were analyzed. Safety profiles were compared between different IOCM at the system organ level using the proportional reporting ratio (PRR) and 95% confidence interval (95% CI). Among a total of 48,261 reports, 6,524 (13.5%) reports were related to the use of IOCM. Iopromide (45.5%), iohexol (16.9%), iopamidol (14.3%) and iomeprol (10.3%) were identified as frequently reported media. 'Platelet, bleeding & clotting disorders' (PRR, 29.6; 95%CI, 1.9-472.6) and 'urinary system disorders' (PRR, 22.3; 95% CI, 17.1-29.1) were more frequently reported for iodixanol than the other IOCM. In conclusion, the frequency of AEs by organ class was significantly different between individual media. These differences among different IOCM should be considered when selecting a medium among various IOCM and when monitoring patients during and after its use to ensure optimum usage and patient safety. PMID:24339697

Food safety in food services in Lombardy: proposal for an inspection-scoring model.

PubMed

Balzaretti, Claudia M; Razzini, Katia; Ziviani, Silvia; Ratti, Sabrina; Milicevic, Vesna; Chiesa, Luca M; Panseri, Sara; Castrica, Marta

2017-10-20

The purpose of this study was to elaborate a checklist with an inspection scoring system at national level in order to assess compliance with sanitary hygiene requirements of food services. The inspection scoring system was elaborated taking into account the guidelines drawn up by NYC Department of Food Safety and Mental Hygiene. Moreover the checklist was used simultaneously with the standard inspection protocol adopted by Servizio Igiene Alimenti Nutrizione ( Servizio Igiene Alimenti Nutrizione - Ss. I.A.N) and defined by D.G.R 6 March 2017 - n. X/6299 Lombardy Region. Ss. I.A.N protocol consists of a qualitative response according to which we have generated a new protocol with three different grading: A, B and C. The designed checklist was divided into 17 sections. Each section corresponds to prerequisites to be verified during the inspection. Every section includes the type of conformity to check and the type of violation: critical or general. Moreover, the failure to respect the expected compliance generates 4 severity levels that correspond to score classes. A total of 7 food services were checked with the two different inspection methods. The checklist results generated a food safety score for each food service that ranged from 0.0 (no flaws observed) to 187.2, and generates three grading class: A (0.0-28.0); B (29.0-70.0) and C (>71.00). The results from the Ss. I. A. N grading method and the checklist show positive correlation ( r =0.94, P>0.01) suggesting that the methods are comparable. Moreover, our scoring checklist is an easy and unique method compared to standard and allows also managers to perform effective surveillance programs in food service.

Food safety in food services in Lombardy: proposal for an inspection-scoring model

PubMed Central

Balzaretti, Claudia M.; Razzini, Katia; Ziviani, Silvia; Ratti, Sabrina; Milicevic, Vesna; Chiesa, Luca M.; Panseri, Sara; Castrica, Marta

2017-01-01

The purpose of this study was to elaborate a checklist with an inspection scoring system at national level in order to assess compliance with sanitary hygiene requirements of food services. The inspection scoring system was elaborated taking into account the guidelines drawn up by NYC Department of Food Safety and Mental Hygiene. Moreover the checklist was used simultaneously with the standard inspection protocol adopted by Servizio Igiene Alimenti Nutrizione (Servizio Igiene Alimenti Nutrizione - Ss. I.A.N) and defined by D.G.R 6 March 2017 – n. X/6299 Lombardy Region. Ss. I.A.N protocol consists of a qualitative response according to which we have generated a new protocol with three different grading: A, B and C. The designed checklist was divided into 17 sections. Each section corresponds to prerequisites to be verified during the inspection. Every section includes the type of conformity to check and the type of violation: critical or general. Moreover, the failure to respect the expected compliance generates 4 severity levels that correspond to score classes. A total of 7 food services were checked with the two different inspection methods. The checklist results generated a food safety score for each food service that ranged from 0.0 (no flaws observed) to 187.2, and generates three grading class: A (0.0-28.0); B (29.0-70.0) and C (>71.00). The results from the Ss. I. A. N grading method and the checklist show positive correlation (r=0.94, P>0.01) suggesting that the methods are comparable. Moreover, our scoring checklist is an easy and unique method compared to standard and allows also managers to perform effective surveillance programs in food service. PMID:29564236

Randomized trial of the impact of a sun safety program on volunteers in outdoor venues.

PubMed

Cheng, Shaowei; Guan, Xin; Cao, Mei; Liu, Yalan; Zhai, Siwen

2011-04-01

A suitable sun safety educational program could help the public avoid sun exposure-induced skin damage. The objective of this study was to assess the impact of a sun safety program on volunteers in outdoor venues and explore the most effective sun safety education method in China. An intervention program was implemented to raise knowledge and behavior regarding sun exposure among volunteers in the outdoor competition venues in Beijing, China. Five intervention methods were used, including class education, free sunscreen samples, pamphlets, posters, and newsletters. The self-administered multiple-choice questionnaires were administered before and after the intervention. Two hundred and eighty-five subjects were enrolled, including 107 males (37.5%) and 178 females (62.5%). The intervention group showed improvement in sun safety knowledge and behavior. Other improvements were achieved in the field of sun safety awareness and intended behavior, with most of the items achieving no statistically significant differences. Subgroup A (multi-component interventions, including class education, free sunscreen samples, and written materials) achieved better results than subgroup B (written materials only) to improve sun safety knowledge and awareness. Sun safety education could improve volunteer 's sun safety knowledge and behavior in the outdoor venues in China. Multi-component interventions proved to be the most effective sun safety education method. © 2011 John Wiley & Sons A/S.

9 CFR 381.170 - Standards for kinds and classes, and for cuts of raw poultry.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Standards for kinds and classes, and for cuts of raw poultry. 381.170 Section 381.170 Animals and Animal Products FOOD SAFETY AND... of raw poultry. (a) The following standards specify the various classes of the specified kinds of...

9 CFR 381.170 - Standards for kinds and classes, and for cuts of raw poultry.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Standards for kinds and classes, and for cuts of raw poultry. 381.170 Section 381.170 Animals and Animal Products FOOD SAFETY AND... of raw poultry. (a) The following standards specify the various classes of the specified kinds of...

76 FR 37114 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... determination concerning a petition to add a class of employees from the Linde Ceramics Plant in Tonawanda, New...

77 FR 76490 - Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health...). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of...

76 FR 37114 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... determination concerning a petition to add a class of employees from the Dow Chemical Company in Madison...

77 FR 9251 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health...). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of...

78 FR 98 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health...). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of...

76 FR 37115 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... determination concerning a petition to add a class of employees from the Bliss & Laughlin Steel Company located...

76 FR 37115 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... determination concerning a petition to add a class of employees from the Wah Chang facility in Albany, Oregon...

78 FR 64501 - Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health...). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of...

77 FR 58383 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health...). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of...

78 FR 64502 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health...). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of...

76 FR 37115 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... determination concerning a petition to add a class of employees from the Chapman Valve Manufacturing Company (i...

77 FR 15297 - Proposed Establishment of Class D and E Airspace Amendment of Class E Airspace; East Hampton, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-15

... existing Class E airspace at East Hampton, NY, to accommodate the new air traffic control tower at East... the operation of the new air traffic control tower, and would enhance the safety and management of IFR..., Operations Support Group, Eastern Service Center, Air Traffic Organization, Federal Aviation Administration...

75 FR 27784 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the decision to designate a class of employees from Westinghouse Electric Corp...

75 FR 67364 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the HHS decision to designate a class of employees from the Blockson Chemical...

76 FR 7852 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the HHS decision to designate a class of employees from Texas City Chemicals...

75 FR 27784 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the decision to designate a class of employees from Lawrence Livermore...

76 FR 59701 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the HHS decision to designate a class of employees from the Sandia National...

75 FR 27784 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the decision to designate a class of employees at the Lawrence Berkeley...

76 FR 7852 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the HHS decision to designate a class of employees from BWX Technologies, Inc...

77 FR 45237 - Amendment of Class D and E Airspace; Fort Rucker, AL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

...; Airspace Docket No. 12-ASO-30] Amendment of Class D and E Airspace; Fort Rucker, AL AGENCY: Federal... Class D and E Airspace at Fort Rucker, AL, by updating the geographic coordinates of Cairns Army Air... continued safety and management of instrument flight rules (IFR) operations within the Fort Rucker, AL...

Systems Engineering Approach to Technology Integration for NASA's 2nd Generation Reusable Launch Vehicle

NASA Technical Reports Server (NTRS)

Thomas, Dale; Smith, Charles; Thomas, Leann; Kittredge, Sheryl

2002-01-01

The overall goal of the 2nd Generation RLV Program is to substantially reduce technical and business risks associated with developing a new class of reusable launch vehicles. NASA's specific goals are to improve the safety of a 2nd-generation system by 2 orders of magnitude - equivalent to a crew risk of 1-in-10,000 missions - and decrease the cost tenfold, to approximately $1,000 per pound of payload launched. Architecture definition is being conducted in parallel with the maturating of key technologies specifically identified to improve safety and reliability, while reducing operational costs. An architecture broadly includes an Earth-to-orbit reusable launch vehicle, on-orbit transfer vehicles and upper stages, mission planning, ground and flight operations, and support infrastructure, both on the ground and in orbit. The systems engineering approach ensures that the technologies developed - such as lightweight structures, long-life rocket engines, reliable crew escape, and robust thermal protection systems - will synergistically integrate into the optimum vehicle. To best direct technology development decisions, analytical models are employed to accurately predict the benefits of each technology toward potential space transportation architectures as well as the risks associated with each technology. Rigorous systems analysis provides the foundation for assessing progress toward safety and cost goals. The systems engineering review process factors in comprehensive budget estimates, detailed project schedules, and business and performance plans, against the goals of safety, reliability, and cost, in addition to overall technical feasibility. This approach forms the basis for investment decisions in the 2nd Generation RLV Program's risk-reduction activities. Through this process, NASA will continually refine its specialized needs and identify where Defense and commercial requirements overlap those of civil missions.

Systems Engineering Approach to Technology Integration for NASA's 2nd Generation Reusable Launch Vehicle

NASA Technical Reports Server (NTRS)

Thomas, Dale; Smith, Charles; Thomas, Leann; Kittredge, Sheryl

2002-01-01

The overall goal of the 2nd Generation RLV Program is to substantially reduce technical and business risks associated with developing a new class of reusable launch vehicles. NASA's specific goals are to improve the safety of a 2nd generation system by 2 orders of magnitude - equivalent to a crew risk of 1-in-10,000 missions - and decrease the cost tenfold, to approximately $1,000 per pound of payload launched. Architecture definition is being conducted in parallel with the maturating of key technologies specifically identified to improve safety and reliability, while reducing operational costs. An architecture broadly includes an Earth-to-orbit reusable launch vehicle, on-orbit transfer vehicles and upper stages, mission planning, ground and flight operations, and support infrastructure, both on the ground and in orbit. The systems engineering approach ensures that the technologies developed - such as lightweight structures, long-life rocket engines, reliable crew escape, and robust thermal protection systems - will synergistically integrate into the optimum vehicle. To best direct technology development decisions, analytical models are employed to accurately predict the benefits of each technology toward potential space transportation architectures as well as the risks associated with each technology. Rigorous systems analysis provides the foundation for assessing progress toward safety and cost goals. The systems engineering review process factors in comprehensive budget estimates, detailed project schedules, and business and performance plans, against the goals of safety, reliability, and cost, in addition to overall technical feasibility. This approach forms the basis for investment decisions in the 2nd Generation RLV Program's risk-reduction activities. Through this process, NASA will continually refine its specialized needs and identify where Defense and commercial requirements overlap those of civil missions.

Towards an International Classification for Patient Safety: the conceptual framework.

PubMed

Sherman, Heather; Castro, Gerard; Fletcher, Martin; Hatlie, Martin; Hibbert, Peter; Jakob, Robert; Koss, Richard; Lewalle, Pierre; Loeb, Jerod; Perneger, Thomas; Runciman, William; Thomson, Richard; Van Der Schaaf, Tjerk; Virtanen, Martti

2009-02-01

Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose.

Towards an International Classification for Patient Safety: the conceptual framework

PubMed Central

Sherman, Heather; Castro, Gerard; Fletcher, Martin; Hatlie, Martin; Hibbert, Peter; Jakob, Robert; Koss, Richard; Lewalle, Pierre; Loeb, Jerod; Perneger, Thomas; Runciman, William; Thomson, Richard; Van Der Schaaf, Tjerk; Virtanen, Martti

2009-01-01

Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose. PMID:19147595

System principles, mathematical models and methods to ensure high reliability of safety systems

NASA Astrophysics Data System (ADS)

Zaslavskyi, V.

2017-04-01

Modern safety and security systems are composed of a large number of various components designed for detection, localization, tracking, collecting, and processing of information from the systems of monitoring, telemetry, control, etc. They are required to be highly reliable in a view to correctly perform data aggregation, processing and analysis for subsequent decision making support. On design and construction phases of the manufacturing of such systems a various types of components (elements, devices, and subsystems) are considered and used to ensure high reliability of signals detection, noise isolation, and erroneous commands reduction. When generating design solutions for highly reliable systems a number of restrictions and conditions such as types of components and various constrains on resources should be considered. Various types of components perform identical functions; however, they are implemented using diverse principles, approaches and have distinct technical and economic indicators such as cost or power consumption. The systematic use of different component types increases the probability of tasks performing and eliminates the common cause failure. We consider type-variety principle as an engineering principle of system analysis, mathematical models based on this principle, and algorithms for solving optimization problems of highly reliable safety and security systems design. Mathematical models are formalized in a class of two-level discrete optimization problems of large dimension. The proposed approach, mathematical models, algorithms can be used for problem solving of optimal redundancy on the basis of a variety of methods and control devices for fault and defects detection in technical systems, telecommunication networks, and energy systems.

Pollution reduction technology program for turboprop engines

NASA Technical Reports Server (NTRS)

Tomlinson, J. G.

1977-01-01

The reduction of CO, HC, and smoke emissions while maintaining acceptable NO(x) emissions without affecting fuel consumption, durability, maintainability, and safety was accomplished. Component combustor concept screening directed toward the demonstration of advanced combustor technology required to meet the EPA exhaust emissions standards for class P2 turboprop engines was covered. The combustion system for the Allison 501-D22A engine was used, and three combustor design concepts - reverse flow, prechamber, and staged fuel were evaluated.

Management of nanomaterials safety in research environment.

PubMed

Groso, Amela; Petri-Fink, Alke; Magrez, Arnaud; Riediker, Michael; Meyer, Thierry

2010-12-10

Despite numerous discussions, workshops, reviews and reports about responsible development of nanotechnology, information describing health and environmental risk of engineered nanoparticles or nanomaterials is severely lacking and thus insufficient for completing rigorous risk assessment on their use. However, since preliminary scientific evaluations indicate that there are reasonable suspicions that activities involving nanomaterials might have damaging effects on human health; the precautionary principle must be applied. Public and private institutions as well as industries have the duty to adopt preventive and protective measures proportionate to the risk intensity and the desired level of protection. In this work, we present a practical, 'user-friendly' procedure for a university-wide safety and health management of nanomaterials, developed as a multi-stakeholder effort (government, accident insurance, researchers and experts for occupational safety and health). The process starts using a schematic decision tree that allows classifying the nano laboratory into three hazard classes similar to a control banding approach (from Nano 3--highest hazard to Nano1--lowest hazard). Classifying laboratories into risk classes would require considering actual or potential exposure to the nanomaterial as well as statistical data on health effects of exposure. Due to the fact that these data (as well as exposure limits for each individual material) are not available, risk classes could not be determined. For each hazard level we then provide a list of required risk mitigation measures (technical, organizational and personal). The target 'users' of this safety and health methodology are researchers and safety officers. They can rapidly access the precautionary hazard class of their activities and the corresponding adequate safety and health measures. We succeed in convincing scientist dealing with nano-activities that adequate safety measures and management are promoting innovation and discoveries by ensuring them a safe environment even in the case of very novel products. The proposed measures are not considered as constraints but as a support to their research. This methodology is being implemented at the Ecole Polytechnique de Lausanne in over 100 research labs dealing with nanomaterials. It is our opinion that it would be useful to other research and academia institutions as well.

Management of nanomaterials safety in research environment

PubMed Central

2010-01-01

Despite numerous discussions, workshops, reviews and reports about responsible development of nanotechnology, information describing health and environmental risk of engineered nanoparticles or nanomaterials is severely lacking and thus insufficient for completing rigorous risk assessment on their use. However, since preliminary scientific evaluations indicate that there are reasonable suspicions that activities involving nanomaterials might have damaging effects on human health; the precautionary principle must be applied. Public and private institutions as well as industries have the duty to adopt preventive and protective measures proportionate to the risk intensity and the desired level of protection. In this work, we present a practical, 'user-friendly' procedure for a university-wide safety and health management of nanomaterials, developed as a multi-stakeholder effort (government, accident insurance, researchers and experts for occupational safety and health). The process starts using a schematic decision tree that allows classifying the nano laboratory into three hazard classes similar to a control banding approach (from Nano 3 - highest hazard to Nano1 - lowest hazard). Classifying laboratories into risk classes would require considering actual or potential exposure to the nanomaterial as well as statistical data on health effects of exposure. Due to the fact that these data (as well as exposure limits for each individual material) are not available, risk classes could not be determined. For each hazard level we then provide a list of required risk mitigation measures (technical, organizational and personal). The target 'users' of this safety and health methodology are researchers and safety officers. They can rapidly access the precautionary hazard class of their activities and the corresponding adequate safety and health measures. We succeed in convincing scientist dealing with nano-activities that adequate safety measures and management are promoting innovation and discoveries by ensuring them a safe environment even in the case of very novel products. The proposed measures are not considered as constraints but as a support to their research. This methodology is being implemented at the Ecole Polytechnique de Lausanne in over 100 research labs dealing with nanomaterials. It is our opinion that it would be useful to other research and academia institutions as well. PMID:21143952

49 CFR 213.361 - Right of way.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF TRANSPORTATION TRACK SAFETY STANDARDS Train Operations at Track Classes 6 and Higher § 213.361 Right of way. The track owner in Class 8 and 9 shall submit a barrier plan, termed a “right-of-way plan...

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

ERIC Educational Resources Information Center

Lacina, Dale Robert

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-07

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

77 FR 62461 - Implementing Public Safety Broadband Provisions of the Middle Class Tax Relief and Job Creation...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-15

.... SUMMARY: In this document, the Public Safety and Homeland Security Bureau (Bureau) of the Commission... Spectrum Act) governing deployment of a nationwide public safety broadband network in the 700 MHz band...), and the D Block to the First Responder Network Authority (FirstNet). By eliminating any confusion or...

78 FR 36550 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-18

... Employees to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone 1-877.... John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2013-14389 Filed...

Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

PubMed

Foster, William R; Car, Bruce D; Shi, Hong; Levesque, Paul C; Obermeier, Mary T; Gan, Jinping; Arezzo, Joseph C; Powlin, Stephanie S; Dinchuk, Joseph E; Balog, Aaron; Salvati, Mark E; Attar, Ricardo M; Gottardis, Marco M

2011-04-01

Androgen receptor (AR) antagonists are part of the standard of care for prostate cancer. Despite the almost inevitable development of resistance in prostate tumors to AR antagonists, no new AR antagonists have been approved for over a decade. Treatment failure is due in part to mutations that increase activity of AR in response to lower ligand concentrations as well as to mutations that result in AR response to a broader range of ligands. The failure to discover new AR antagonists has occurred in the face of continued research; to enable progress, a clear understanding of the reasons for failure is required. Non-clinical drug safety studies and safety pharmacology assays were performed on previously approved AR antagonists (bicalutamide, flutamide, nilutamide), next generation antagonists in clinical testing (MDV3100, BMS-641988), and a pre-clinical drug candidate (BMS-501949). In addition, non-clinical studies with AR mutant mice, and EEG recordings in rats were performed. Non-clinical findings are compared to disclosures of clinical trial results. As a drug class, AR antagonists cause seizure in animals by an off-target mechanism and are found in vitro to inhibit GABA-A currents. Clinical trials of candidate next generation AR antagonists identify seizure as a clinical safety risk. Non-clinical drug safety profiles of the AR antagonist drug class create a significant barrier to the identification of next generation AR antagonists. GABA-A inhibition is a common off-target activity of approved and next generation AR antagonists potentially explaining some side effects and safety hazards of this class of drugs. Copyright © 2010 Wiley-Liss, Inc.

Efficacy and safety in pharmacological cardioversion of recent-onset atrial fibrillation: a propensity score matching to compare amiodarone vs class IC antiarrhythmic drugs.

PubMed

Bonora, Antonio; Turcato, Gianni; Franchi, Elena; Taioli, Gabriele; Dilda, Alice; Zerman, Germana; Maccagnani, Antonio; Pistorelli, Claudio; Olivieri, Oliviero

2017-09-01

The acute management of recent-onset (<48 h) atrial fibrillation (AF) is still debated. Aim of our study was to compare efficacy and safety of intravenously administered class IC antidysrhythmic agents vs amiodarone in a propensity score matched series of patients acutely treated for AF in the emergency department. During a 3-year period, we retrospectively evaluated all episodes of recent-onset (<48 h) AF pharmacologically treated for sinus rhythm restoration in the emergency department. By means of a propensity score matching considering the main statistically different covariates, we selected two accurately matched treatment groups. We analysed the differences between amiodarone and class IC group in terms of efficacy and safety that is conversion to sinus rhythm rates within 12 and 48 h after starting treatment, time to conversion, and adverse drug effects. An overall number of 817 episodes of recent-onset AF were collected (amiodarone group = 406, class IC group = 411). After matching, we obtained 358 episodes equally divided (amiodarone group = 179 and class IC group = 179). Conversion rates within 12 h were 139 (53.1 %) in amiodarone group and 95 (72.6 %) in class IC group (p < 0.05). Median time for cardioversion was 420 min (331.6-508.3 CI 95 %) in amiodarone and 55 min (44.9-65.1 CI 95 %) in class IC group (p < 0.05). The incidence of adverse events in both groups was very low and equally distributed (p = ns). Intravenously administration of class IC agents, when compared with amiodarone, proved to be more rapid and effective, and equally safe in the acute management of recent-onset AF.

A Multibacteriocin Cheese Starter System, Comprising Nisin and Lacticin 3147 in Lactococcus lactis, in Combination with Plantaricin from Lactobacillus plantarum

PubMed Central

Mills, S.; Griffin, C.; O'Connor, P. M.; Serrano, L. M.; Meijer, W. C.; Hill, C.

2017-01-01

ABSTRACT Functional starter cultures demonstrating superior technological and food safety properties are advantageous to the food fermentation industry. We evaluated the efficacies of single- and double-bacteriocin-producing starters of Lactococcus lactis capable of producing the class I bacteriocins nisin A and/or lacticin 3147 in terms of starter performance. Single producers were generated by mobilizing the conjugative bacteriophage resistance plasmid pMRC01, carrying lacticin genetic determinants, or the conjugative transposon Tn5276, carrying nisin genetic determinants, to the commercial starter L. lactis CSK2775. The effect of bacteriocin coproduction was examined by superimposing pMRC01 into the newly constructed nisin transconjugant. Transconjugants were improved with regard to antimicrobial activity and bacteriophage insensitivity compared to the recipient strain, and the double producer was immune to both bacteriocins. Bacteriocin production in the starter was stable, although the recipient strain proved to be a more efficient acidifier than transconjugant derivatives. Overall, combinations of class I bacteriocins (the double producer or a combination of single producers) proved to be as effective as individual bacteriocins for controlling Listeria innocua growth in laboratory-scale cheeses. However, using the double producer in combination with the class II bacteriocin producer Lactobacillus plantarum or using the lacticin producer with the class II producer proved to be most effective for reducing bacterial load. As emergence of bacteriocin tolerance was reduced 10-fold in the presence of nisin and lacticin, we suggest that the double producer in conjunction with the class II producer could serve as a protective culture providing a food-grade, multihurdle approach to control pathogenic growth in a variety of industrial applications. IMPORTANCE We generated a suite of single- and double-bacteriocin-producing starter cultures capable of generating the class I bacteriocin lacticin 3147 or nisin or both bacteriocins simultaneously via conjugation. The transconjugants exhibited improved bacteriophage resistance and antimicrobial activity. The single producers proved to be as effective as the double-bacteriocin producer at reducing Listeria numbers in laboratory-scale cheese. However, combining the double producer or the lacticin-producing starter with a class II bacteriocin producer, Lactobacillus plantarum LMG P-26358, proved to be most effective at reducing Listeria numbers and was significantly better than a combination of the three bacteriocin-producing strains, as the double producer is not inhibited by either of the class I bacteriocins. Since the simultaneous use of lacticin and nisin should reduce the emergence of bacteriocin-tolerant derivatives, this study suggests that a protective starter system produced by bacteriocin stacking is a worthwhile multihurdle approach for food safety applications. PMID:28476774

A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes.

PubMed

Hoffman, Keith B; Dimbil, Mo; Kyle, Robert F; Tatonetti, Nicholas P; Erdman, Colin B; Demakas, Andrea; Chen, Dingguo; Overstreet, Brian M

2015-12-01

Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there is an acute need for the development of analytics that reflect drug safety in heterogeneous, real-world populations. To develop a drug safety statistic that estimates downstream medical costs associated with serious adverse events (AEs) and unfavorable patient outcomes associated with the use of 706 FDA-approved drugs. All primary suspect case reports for each drug were collected from the FDA's Adverse Event Reporting System database (FAERS) from 2010-2014. The Medical Dictionary for Regulatory Activities (MedDRA) was used to code serious AEs and outcomes, which were tallied for each case report. Medical costs associated with AEs and poor patient outcomes were derived from Agency for Healthcare Research and Quality (AHRQ) survey data, and their corresponding ICD-9-CM codes were mapped to MedDRA terms. Nonserious AEs and outcomes were not included. For each case report, either the highest AE cost or, if no eligible AE was listed, the highest outcome cost was used. All costed cases were aggregated for each drug and divided by the number of patients exposed to obtain a downstream estimated direct medical cost burden per exposure. Each drug was assigned a corresponding 1-100 point total. The 706 drugs showed an exponential distribution of downstream costs, and the data were transformed using the natural log to approximate a normal distribution. The minimum score was 8.29, and the maximum score was 99.25, with a mean of 44.32. Drugs with the highest individual scores tended to be kinase inhibitors, thalidomide analogs, and endothelin receptor antagonists. When scores were analyzed across Established Pharmacologic Class (EPC), the kinase inhibitor and endothelin receptor antagonist classes had the highest total. However, other EPCs with median scores of 75 and above included hepatitis C virus NS3/4A protease inhibitor, recombinant human interferon beta, vascular endothelial growth factor-directed antibody, and tumor necrosis factor blocker. When Anatomical Therapeutic Chemical classifications were analyzed, antineoplastic drugs were outliers with approximately 80% of their individual scores 60 and above, while approximately 20%-30% of blood and anti-infective drugs had scores of 60 and above. Within-drug class results served to differentiate similar drugs. For example, 6 serotonin reuptake inhibitors had a score range of 35 to 53. This scoring system is based on estimated direct medical costs associated with postmarketing AEs and poor patient outcomes and thereby helps fill a large information gap regarding drug safety in real-world patient populations.

77 FR 50417 - Proposed Amendment of Class D and Class E Airspace; Lewiston, ID

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-21

... Class E airspace extending upward from 700 feet above the surface and 1,200 feet above the surface, and...,200 feet above the surface area to enhance safety in the Lewiston-Nez Pearce County Airport, Lewiston... extending upward from 700 feet above the surface at Lewiston-Nez Perce County Airport, Lewiston, ID (77 FR...

75 FR 27785 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the decision to designate a class of employees from Area IV of the Santa...

76 FR 7852 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the HHS decision to designate a class of employees from Simonds Saw and Steel...

75 FR 27784 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health... concerning the final effect of the decision to designate a class of employees from the Nevada Test Site as an...

Automated validation of patient safety clinical incident classification: macro analysis.

PubMed

Gupta, Jaiprakash; Patrick, Jon

2013-01-01

Patient safety is the buzz word in healthcare. Incident Information Management System (IIMS) is electronic software that stores clinical mishaps narratives in places where patients are treated. It is estimated that in one state alone over one million electronic text documents are available in IIMS. In this paper we investigate the data density available in the fields entered to notify an incident and the validity of the built in classification used by clinician to categories the incidents. Waikato Environment for Knowledge Analysis (WEKA) software was used to test the classes. Four statistical classifier based on J48, Naïve Bayes (NB), Naïve Bayes Multinominal (NBM) and Support Vector Machine using radial basis function (SVM_RBF) algorithms were used to validate the classes. The data pool was 10,000 clinical incidents drawn from 7 hospitals in one state in Australia. In first part of the study 1000 clinical incidents were selected to determine type and number of fields worth investigating and in the second part another 5448 clinical incidents were randomly selected to validate 13 clinical incident types. Result shows 74.6% of the cells were empty and only 23 fields had content over 70% of the time. The percentage correctly classified classes on four algorithms using categorical dataset ranged from 42 to 49%, using free-text datasets from 65% to 77% and using both datasets from 72% to 79%. Kappa statistic ranged from 0.36 to 0.4. for categorical data, from 0.61 to 0.74. for free-text and from 0.67 to 0.77 for both datasets. Similar increases in performance in the 3 experiments was noted on true positive rate, precision, F-measure and area under curve (AUC) of receiver operating characteristics (ROC) scores. The study demonstrates only 14 of 73 fields in IIMS have data that is usable for machine learning experiments. Irrespective of the type of algorithms used when all datasets are used performance was better. Classifier NBM showed best performance. We think the classifier can be improved further by reclassifying the most confused classes and there is scope to apply text mining tool on patient safety classifications.

U.S. Food Safety and Inspection Service testing for Salmonella in selected raw meat and poultry products in the United States, 1998 through 2003: analysis of set results.

PubMed

Naugle, Alecia Larew; Barlow, Kristina E; Eblen, Denise R; Teter, Vanessa; Umholtz, Robert

2006-11-01

The U.S. Food Safety and Inspection Service (FSIS) tests sets of samples of selected raw meat and poultry products for Salmonella to ensure that federally inspected establishments meet performance standards defined in the pathogen reduction-hazard analysis and critical control point system (PR-HACCP) final rule. In the present report, sample set results are described and associations between set failure and set and establishment characteristics are identified for 4,607 sample sets collected from 1998 through 2003. Sample sets were obtained from seven product classes: broiler chicken carcasses (n = 1,010), cow and bull carcasses (n = 240), market hog carcasses (n = 560), steer and heifer carcasses (n = 123), ground beef (n = 2,527), ground chicken (n = 31), and ground turkey (n = 116). Of these 4,607 sample sets, 92% (4,255) were collected as part of random testing efforts (A sets), and 93% (4,166) passed. However, the percentage of positive samples relative to the maximum number of positive results allowable in a set increased over time for broilers but decreased or stayed the same for the other product classes. Three factors associated with set failure were identified: establishment size, product class, and year. Set failures were more likely early in the testing program (relative to 2003). Small and very small establishments were more likely to fail than large ones. Set failure was less likely in ground beef than in other product classes. Despite an overall decline in set failures through 2003, these results highlight the need for continued vigilance to reduce Salmonella contamination in broiler chicken and continued implementation of programs designed to assist small and very small establishments with PR-HACCP compliance issues.

Examining markers of safety in homecare using the international classification for patient safety

PubMed Central

2013-01-01

Background Homecare is a growth enterprise. The nature of the care provided in the home is growing in complexity. This growth has necessitated both examination and generation of evidence around patient safety in homecare. The purpose of this paper is to examine the findings of a recent scoping review of the homecare literature 2004-2011 using the World Health Organization International Classification for Patient Safety (ICPS), which was developed for use across all care settings, and discuss the utility of the ICPS in the home setting. The scoping review focused on Chronic Obstructive Pulmonary Disease (COPD), and Congestive Heart Failure (CHF); two chronic illnesses commonly managed at home and that represent frequent hospital readmissions. The scoping review identified seven safety markers for homecare: Medication mania; Home alone; A fixed agenda in a foreign language; Strangers in the home; The butcher, the baker, the candlestick maker; Out of pocket: the cost of caring at home; and My health for yours: declining caregiver health. Methods The safety markers from the scoping review were mapped to the 10 ICPS high-level classes that comprise 48 concepts and address the continuum of health care: Incident Type, Patient Outcomes, Patient Characteristics, Incident Characteristics, Contributing Factors/Hazards, Organizational Outcomes, Detection, Mitigating Factors, Ameliorating Actions, and Actions Taken to Reduce Risk. Results Safety markers identified in the scoping review of the homecare literature mapped to three of the ten ICPS classes: Incident Characteristics, Contributing Factors, and Patient Outcomes. Conclusion The ICPS does have applicability to the homecare setting, however there were aspects of safety that were overlooked. A notable example is that the health of the caregiver is inextricably linked to the wellbeing of the patient within the homecare setting. The current concepts within the ICPS classes do not capture this, nor do they capture how care responsibilities are shared among patients, caregivers, and providers. PMID:23705841

47 CFR 87.171 - Class of station symbols.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES... the aviation services are: Symbol and class of station AX—Aeronautical fixed AXO—Aeronautical...—Aeronautical search and rescue FAS—Aviation support FAT—Flight test FAW—Automatic weather observation GCO...

Software IV and V Research Priorities and Applied Program Accomplishments Within NASA

NASA Technical Reports Server (NTRS)

Blazy, Louis J.

2000-01-01

The mission of this research is to be world-class creators and facilitators of innovative, intelligent, high performance, reliable information technologies that enable NASA missions to (1) increase software safety and quality through error avoidance, early detection and resolution of errors, by utilizing and applying empirically based software engineering best practices; (2) ensure customer software risks are identified and/or that requirements are met and/or exceeded; (3) research, develop, apply, verify, and publish software technologies for competitive advantage and the advancement of science; and (4) facilitate the transfer of science and engineering data, methods, and practices to NASA, educational institutions, state agencies, and commercial organizations. The goals are to become a national Center Of Excellence (COE) in software and system independent verification and validation, and to become an international leading force in the field of software engineering for improving the safety, quality, reliability, and cost performance of software systems. This project addresses the following problems: Ensure safety of NASA missions, ensure requirements are met, minimize programmatic and technological risks of software development and operations, improve software quality, reduce costs and time to delivery, and improve the science of software engineering

Mechanical code comparator

DOEpatents

Peter, Frank J.; Dalton, Larry J.; Plummer, David W.

2002-01-01

A new class of mechanical code comparators is described which have broad potential for application in safety, surety, and security applications. These devices can be implemented as micro-scale electromechanical systems that isolate a secure or otherwise controlled device until an access code is entered. This access code is converted into a series of mechanical inputs to the mechanical code comparator, which compares the access code to a pre-input combination, entered previously into the mechanical code comparator by an operator at the system security control point. These devices provide extremely high levels of robust security. Being totally mechanical in operation, an access control system properly based on such devices cannot be circumvented by software attack alone.

76 FR 59502 - Establishment of Class E Airspace; Gordonsville, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... at Gordonsville, VA, to accommodate the new Standard Instrument Approach Procedures serving Gordonsville Municipal Airport. This action enhances the safety and airspace management of Instrument Flight... approach procedures developed for Gordonsville Municipal Airport. This action is necessary for the safety...

Fire in the Shop!

ERIC Educational Resources Information Center

Campbell, Clifton P.; Buchanan, Joseph P.

1977-01-01

Fire emergency preparedness measures to take to prevent school fires and to protect against injury and minimize damage when fire does occur are presented. Includes fire safety practices, extinguishers for different classes of fires and their use, and the need for fire safety training in schools. (MF)

Onboard Monitoring and Reporting for Commercial Motor Vehicle Safety Final Report

DOT National Transportation Integrated Search

2008-02-01

This Final Report describes the process and product from the project, Onboard Monitoring and Reporting for Commercial Motor Vehicle Safety (OBMS), in which a prototypical suite of hardware and software on a class 8 truck was developed and tested. The...

A tri-fold hybrid classification approach for diagnostics with unexampled faulty states

NASA Astrophysics Data System (ADS)

Tamilselvan, Prasanna; Wang, Pingfeng

2015-01-01

System health diagnostics provides diversified benefits such as improved safety, improved reliability and reduced costs for the operation and maintenance of engineered systems. Successful health diagnostics requires the knowledge of system failures. However, with an increasing system complexity, it is extraordinarily difficult to have a well-tested system so that all potential faulty states can be realized and studied at product testing stage. Thus, real time health diagnostics requires automatic detection of unexampled system faulty states based upon sensory data to avoid sudden catastrophic system failures. This paper presents a trifold hybrid classification (THC) approach for structural health diagnosis with unexampled health states (UHS), which comprises of preliminary UHS identification using a new thresholded Mahalanobis distance (TMD) classifier, UHS diagnostics using a two-class support vector machine (SVM) classifier, and exampled health states diagnostics using a multi-class SVM classifier. The proposed THC approach, which takes the advantages of both TMD and SVM-based classification techniques, is able to identify and isolate the unexampled faulty states through interactively detecting the deviation of sensory data from the exampled health states and forming new ones autonomously. The proposed THC approach is further extended to a generic framework for health diagnostics problems with unexampled faulty states and demonstrated with health diagnostics case studies for power transformers and rolling bearings.

47 CFR 80.159 - Operator requirements of Title III of the Communications Act and the Safety Convention.

Code of Federal Regulations, 2012 CFR

2012-10-01

... radiotelegraph auto alarm must carry a radio officer holding a first or second class radiotelegraph operator's... radiotelegraph station does not have an auto alarm, a second radio officer who holds a first or second class...

47 CFR 80.159 - Operator requirements of Title III of the Communications Act and the Safety Convention.

Code of Federal Regulations, 2011 CFR

2011-10-01

... radiotelegraph auto alarm must carry a radio officer holding a first or second class radiotelegraph operator's... radiotelegraph station does not have an auto alarm, a second radio officer who holds a first or second class...

7 CFR 1940.302 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Emergency circumstance. One involving an immediate or imminent danger to public health or safety. (b...-354 1940-21, “Environmental Assessment of Class I Action,” (3) Environmental Assessment for Class II Actions (exhibit H of this subpart), and (4) Environmental Impact Statements (EIS). (c) Flood or flooding...

78 FR 32085 - Amendment of Class E Airspace; Eureka, NV

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-29

... instrument approach procedures at the airport. This improves the safety and management of Instrument Flight... aircraft using the RNAV (GPS) standard instrument approach procedures at Eureka Airport. Class E airspace...) standard instrument approach procedures at the airport. Additional controlled airspace extending upward...

47 CFR 80.159 - Operator requirements of Title III of the Communications Act and the Safety Convention.

Code of Federal Regulations, 2010 CFR

2010-10-01

... radiotelegraph auto alarm must carry a radio officer holding a first or second class radiotelegraph operator's... radiotelegraph station does not have an auto alarm, a second radio officer who holds a first or second class...

Radon safety in terms of energy efficiency classification of buildings

NASA Astrophysics Data System (ADS)

Vasilyev, A.; Yarmoshenko, I.; Zhukovsky, M.

2017-06-01

According to the results of survey in Ekaterinburg, Russia, indoor radon concentrations above city average level have been found in each of the studied buildings with high energy efficiency class. Measures to increase energy efficiency were confirmed to decrease the air exchange rate and accumulation of high radon concentrations indoors. Despite of recommendations to use mechanical ventilation with heat recovery as the main scenario for reducing elevated radon concentrations in energy-efficient buildings, the use of such systems did not show an obvious advantage. In real situation, mechanical ventilation system is not used properly both in the automatic and manual mode, which does not give an obvious advantage over natural ventilation in the climate of the Middle Urals in Ekaterinburg. Significant number of buildings with a high class of energy efficiency and built using modern space-planning decisions contributes to an increase in the average radon concentration. Such situation contradicts to “as low as reasonable achievable” principle of the radiation protection.

A safety evaluation of budesonide MMX for the treatment of ulcerative colitis.

PubMed

Bezzio, Cristina; Festa, Stefano; Zerboni, Giulia; Papi, Claudio; Manes, Gianpiero; Saibeni, Simone

2018-04-01

Budesonide belongs to low-bioavailability steroids class. A novel oral formulation of budesonide, which uses the Multi-Matrix System (MMX) for delivering drugs to the colon, is now available as a possible treatment of ulcerative colitis patients intolerant or not-responding to first-line therapy with 5-ASA. Areas covered: in this review we present information about the development and the use of budesonide MMX and we provide data about its mechanism of action as well as, pharmacodynamics and pharmacokynetics. Moreover, we present the available literature data about the efficacy and, mainly, the safety of budesonide-MMX. Expert opinion: budesonide-MMX is a new therapeutic option in mild-to-moderate UC patients. Its good safety profile in clinical trials undoubtedly represents a strength for a possible wide use in clinical practice, mainly if it will be confirmed by post-marketing data. Other indications, such as treatment of colonic Crohn's disease, could theoretically be considered, if sustained by reliable scientific data.

A Case for Revisiting the Safety of Pesticides: A Closer Look at Neurodevelopment

PubMed Central

Colborn, Theo

2006-01-01

The quality and quantity of the data about the risk posed to humans by individual pesticides vary considerably. Unlike obvious birth defects, most developmental effects cannot be seen at birth or even later in life. Instead, brain and nervous system disturbances are expressed in terms of how an individual behaves and functions, which can vary considerably from birth through adulthood. In this article I challenge the protective value of current pesticide risk assessment strategies in light of the vast numbers of pesticides on the market and the vast number of possible target tissues and end points that often differ depending upon timing of exposure. Using the insecticide chlorpyrifos as a model, I reinforce the need for a new approach to determine the safety of all pesticide classes. Because of the uncertainty that will continue to exist about the safety of pesticides, it is apparent that a new regulatory approach to protect human health is needed. PMID:16393651

Food safety issues affecting the dairy beef industry.

PubMed

Stefan, G

1997-12-01

The ability of dairy farmers to market cull cows and veal calves may be affected by the final rule on Pathogen Reduction and HACCP (Hazard Analysis Critical Control Points) Systems, a sweeping reform of USDA food safety regulations that was published on July 25, 1996. Although the regulations apply only to slaughter and processing plants handling meat and poultry, the rule will have an impact on food animal producers, including dairy farmers. Under this regulation, plant operators are required to evaluate potential hazards and to devise and implement controls that are appropriate for each product and plant to prevent or reduce those hazards. Processing plants may need to consider the potential hazards associated with incoming animals, such as illegal drug residues, which may result in marked changes in the relationships among some producers, livestock markets, and slaughter plants. Such information may actually improve the marketability of some animal classes because documentation will help the packer ensure the safety of products for sale to domestic and foreign markets. Dairy scientists are in an excellent position to explain the food safety issues to dairy farmers and to help develop the appropriate strategies that are necessary to guide the changes needed. These scientists can be conduits for information, the research leaders for practical solutions to reduce public health risks, and valuable resources to help farmers adjust to the impact of these new in-plant regulatory systems.

Defining the Relationship Between Human Error Classes and Technology Intervention Strategies

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.; Rantanen, Eas M.

2003-01-01

The modus operandi in addressing human error in aviation systems is predominantly that of technological interventions or fixes. Such interventions exhibit considerable variability both in terms of sophistication and application. Some technological interventions address human error directly while others do so only indirectly. Some attempt to eliminate the occurrence of errors altogether whereas others look to reduce the negative consequences of these errors. In any case, technological interventions add to the complexity of the systems and may interact with other system components in unforeseeable ways and often create opportunities for novel human errors. Consequently, there is a need to develop standards for evaluating the potential safety benefit of each of these intervention products so that resources can be effectively invested to produce the biggest benefit to flight safety as well as to mitigate any adverse ramifications. The purpose of this project was to help define the relationship between human error and technological interventions, with the ultimate goal of developing a set of standards for evaluating or measuring the potential benefits of new human error fixes.

76 FR 41397 - Establishment of Class E Airspace; Florence, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... (GPS) standard instrument approach procedures at Florence Municipal Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901...) standard instrument approach procedures at the airport. This action is necessary for the safety and...

Multisensory cueing for enhancing orientation information during flight.

PubMed

Albery, William B

2007-05-01

The U.S. Air Force still regards spatial disorientation (SD) and loss of situational awareness (SA) as major contributing factors in operational Class A aircraft mishaps ($1M in aircraft loss and/or pilot fatality). Air Force Safety Agency data show 71 Class A SD mishaps from 1991-2004 in both fixed and rotary-wing aircraft. These mishaps resulted in 62 fatalities and an aircraft cost of over $2.OB. These losses account for 21 % of the USAF's Class A mishaps during that 14-yr period. Even non-mishap SD events negatively impact aircrew performance and reduce mission effectiveness. A multisensory system has been developed called the Spatial Orientation Retention Device (SORD) to enhance the aircraft attitude information to the pilot. SORD incorporates multisensory aids including helmet mounted symbology and tactile and audio cues. SORD has been prototyped and demonstrated in the Air Force Research Laboratory at Wright-Patterson AFB, OH. The technology has now been transitioned to a Rotary Wing Brownout program. This paper discusses the development of SORD and a potential application, including an augmented cognition application. Unlike automatic ground collision avoidance systems, SORD does not take over the aircraft if a pre-set altitude is broached by the pilot; rather, SORD provides complementary attitude cues to the pilot via the tactile, audio, and visual systems that allow the pilot to continue flying through disorienting conditions.

Canoeing.

ERIC Educational Resources Information Center

Little, Mildred J.; Smith, Carole F.

Designed to be used in conjunction with the book "Canoeing", published by the American Red Cross in 1977, the teaching packet provides assistance in organizing and teaching a basic canoeing class. The packet lists 20 class objectives and details essential and recommended equipment and safety precautions. The packet contains a 15-day unit…

78 FR 48078 - Proposed Amendment of Class E Airspace; Tazewell, TN

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to amend Class E Airspace at Tazewell, TN, as new Standard Instrument Approach Procedures have been developed at New Tazewell Municipal Airport. This action would enhance the safety and...

77 FR 75596 - Proposed Amendment of Class E Airspace; Morrisville, VT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to amend Class E Airspace at Morrisville, VT, as the Morrisville-Stowe Non-Directional... developed at Morrisville-Stowe State Airport. This action would enhance the safety and airspace management...

78 FR 52717 - Proposed Modification of Class E Airspace; Prineville, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to modify Class E airspace at Prineville, OR, to accommodate aircraft using Area... proposing this action to enhance the safety and management of aircraft operations at the airport. DATES...

78 FR 40078 - Proposed Establishment of Class E Airspace; Cody, WY

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-03

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to establish Class E airspace at the Cody VHF Omni-Directional Radio Range/Distance... proposing this action to enhance the safety and management of aircraft operations within the National...

77 FR 49400 - Proposed Amendment of Class E Airspace; Marysville, OH

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to amend Class E airspace at Marysville, OH. Additional controlled airspace is necessary... taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for...

49 CFR 107.109 - Application for renewal.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (Attention: General Approvals and Permits, PHH-31), Pipeline and Hazardous Materials Safety Administration, U... authorized in subchapter C. (6) When a Class 1 material is forbidden for transportation by aircraft, except... special permit to transport such Class 1 material on passenger-carrying or cargo-only aircraft with a...

49 CFR 107.105 - Application for special permit.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., must: (i) Be submitted to the Associate Administrator for Hazardous Materials Safety (Attention...; and (13) When a Class 1 material is forbidden for transportation by aircraft except under a special... special permit to transport such Class 1 material on passenger-carrying or cargo-only aircraft with a...

49 CFR 179.300-8 - Tank heads.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Multi-Unit Tank Car Tanks (Classes DOT-106A and 110AW) § 179.300-8 Tank heads. (a) Class DOT-110A tanks shall...

49 CFR 179.300-6 - Thickness of plates.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Multi-Unit Tank Car Tanks (Classes DOT-106A and 110AW) § 179.300-6 Thickness of plates. (a) For class DOT...

49 CFR 179.300-8 - Tank heads.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Multi-Unit Tank Car Tanks (Classes DOT-106A and 110AW) § 179.300-8 Tank heads. (a) Class DOT-110A tanks shall...

49 CFR 176.320 - Use of hand flashlights.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Requirements for Class 3 (Flammable) and Combustible Liquid Materials § 176.320 Use of hand flashlights. Each hand flashlight used on deck near or in any hold or compartment containing a Class 3 (flammable) liquid... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY...

49 CFR 176.320 - Use of hand flashlights.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Requirements for Class 3 (Flammable) and Combustible Liquid Materials § 176.320 Use of hand flashlights. Each hand flashlight used on deck near or in any hold or compartment containing a Class 3 (flammable) liquid... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY...

49 CFR 176.320 - Use of hand flashlights.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Requirements for Class 3 (Flammable) and Combustible Liquid Materials § 176.320 Use of hand flashlights. Each hand flashlight used on deck near or in any hold or compartment containing a Class 3 (flammable) liquid... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY...

49 CFR 176.320 - Use of hand flashlights.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Requirements for Class 3 (Flammable) and Combustible Liquid Materials § 176.320 Use of hand flashlights. Each hand flashlight used on deck near or in any hold or compartment containing a Class 3 (flammable) liquid... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY...

49 CFR 176.320 - Use of hand flashlights.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Requirements for Class 3 (Flammable) and Combustible Liquid Materials § 176.320 Use of hand flashlights. Each hand flashlight used on deck near or in any hold or compartment containing a Class 3 (flammable) liquid... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY...

75 FR 29655 - Amendment of Class E Airspace; Batesville, AR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

...-1177; Airspace Docket No. 09-ASW-34] Amendment of Class E Airspace; Batesville, AR AGENCY: Federal... Batesville, AR. Decommissioning of the Independence County non-directional beacon (NDB) at Batesville Regional Airport, Batesville, AR, has made this action necessary to enhance the safety and management of...

75 FR 68416 - Establishment of Class E Airspace; Berryville, AR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-08

...-0690; Airspace Docket No. 10-ASW-2] Establishment of Class E Airspace; Berryville, AR AGENCY: Federal... for Berryville, AR, to accommodate Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAP) at Carroll County Airport, Berryville, AR. The FAA is taking this action to enhance the safety...

47 CFR 97.501 - Qualifying for an amateur operator license.

Code of Federal Regulations, 2010 CFR

2010-10-01

....501 Section 97.501 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL... must pass, or otherwise receive examination credit for, the following examination elements: (a) Amateur Extra Class operator: Elements 2, 3, and 4; (b) General Class operator: Elements 2 and 3; (c) Technician...

The Long Range Reconnaissance and Observation System (LORROS) with the Kollsman, Inc. Model LH-40, Infrared (Erbium) Laser Rangefinder hazard analysis and safety assessment.

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

Augustoni, Arnold L.

A laser hazard analysis and safety assessment was performed for the LH-40 IR Laser Rangefinder based on the 2000 version of the American National Standard Institute's Standard Z136.1, for the Safe Use of Lasers and Z136.6, for the Safe Use of Lasers Outdoors. The LH-40 IR Laser is central to the Long Range Reconnaissance and Observation System (LORROS). The LORROS is being evaluated by the Department 4149 Group to determine its capability as a long-range assessment tool. The manufacture lists the laser rangefinder as 'eye safe' (Class 1 laser classified under the CDRH Compliance Guide for Laser Products and 21more » CFR 1040 Laser Product Performance Standard). It was necessary that SNL validate this prior to its use involving the general public. A formal laser hazard analysis is presented for the typical mode of operation.« less

76 FR 36014 - Proposed Amendment of Class C Airspace; Palm Beach International Airport, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-21

... Park Airport (LNA) from 1,200 feet MSL to 1,600 feet MSL. The FAA is proposing this action to enhance... floor of Class C airspace to 1,600 feet MSL within an area overlying, and to the south of, the Palm... of LNA is at 1,200 feet MSL. Raising the Class C floor as proposed would enhance safety by providing...

Lithium ion cell safety

NASA Astrophysics Data System (ADS)

Tobishima, Shin-ichi; Takei, Koji; Sakurai, Yoji; Yamaki, Jun-ichi

The safety characteristics of recent commercial lithium ion cells are examined in relation to their use for cellular phones. These are prismatic cells with an aluminum cell housing (can) and a 500-600 mA h capacity. They have one of two types of 4-V class cathodes, lithium cobalt oxide (LiCoO 2) or lithium manganese oxide (LiMn 2O 4). This report provides results of the safety tests that we performed on lithium ion cells and outlines our views regarding their safety.

Life Cycle Systems Engineering Approach to NASA's 2nd Generation Reusable Launch Vehicle

NASA Technical Reports Server (NTRS)

Thomas, Dale; Smith, Charles; Safie, Fayssal; Kittredge, Sheryl

2002-01-01

The overall goal of the 2nd Generation RLV Program is to substantially reduce technical and business risks associated with developing a new class of reusable launch vehicles. NASA's specific goals are to improve the safety of a 2nd- generation system by 2 orders of magnitude - equivalent to a crew risk of 1 -in- 10,000 missions - and decrease the cost tenfold, to approximately $1,000 per pound of payload launched. Architecture definition is being conducted in parallel with the maturating of key technologies specifically identified to improve safety and reliability, while reducing operational costs. An architecture broadly includes an Earth-to-orbit reusable launch vehicle, on-orbit transfer vehicles and upper stages, mission planning, ground and flight operations, and support infrastructure, both on the ground and in orbit. The systems engineering approach ensures that the technologies developed - such as lightweight structures, long-life rocket engines, reliable crew escape, and robust thermal protection systems - will synergistically integrate into the optimum vehicle. Given a candidate architecture that possesses credible physical processes and realistic technology assumptions, the next set of analyses address the system's functionality across the spread of operational scenarios characterized by the design reference missions. The safety/reliability and cost/economics associated with operating the system will also be modeled and analyzed to answer the questions "How safe is it?" and "How much will it cost to acquire and operate?" The systems engineering review process factors in comprehensive budget estimates, detailed project schedules, and business and performance plans, against the goals of safety, reliability, and cost, in addition to overall technical feasibility. This approach forms the basis for investment decisions in the 2nd Generation RLV Program's risk-reduction activities. Through this process, NASA will continually refine its specialized needs and identify where Defense and commercial requirements overlap those of civil missions.

The roles of garment design and scene complexity in the daytime conspicuity of high-visibility safety apparel.

PubMed

Sayer, James R; Buonarosa, Mary Lynn

2008-01-01

This study examines the effects of high-visibility garment design on daytime pedestrian conspicuity in work zones. Factors assessed were garment color, amount of background material, pedestrian arm motion, scene complexity, and driver age. The study was conducted in naturalistic conditions on public roads in real traffic. Drivers drove two passes on a 31-km route and indicated when they detected pedestrians outfitted in the fluorescent garments. The locations of the vehicle and the pedestrian were recorded. Detection distances between fluorescent yellow-green and fluorescent red-orange garments were not significantly different, nor were there any significant two-way interactions involving garment color. Pedestrians were detected at longer distances in lower complexity scenes. Arm motion significantly increased detection distances for pedestrians wearing a Class 2 vest, but had little added benefit on detection distances for pedestrians wearing a Class 2 jacket. Daytime detection distances for pedestrians wearing Class 2 or Class 3 garments are longest when the complexity of the surround is low. The more background information a driver has to search through, the longer it is likely to take the driver to locate a pedestrian--even when wearing a high-visibility garment. These findings will provide information to safety garment manufacturers about characteristics of high-visibility safety garments which make them effective for daytime use.

Firearms training: what is actually taught?

PubMed

Hemenway, David; Rausher, Steven; Violano, Pina; Raybould, Toby A; Barber, Catherine W

2017-10-07

Firearm safety instructors and public health professionals are natural allies in the quest to prevent firearm injuries. We audited basic firearm classes to provide information that can help familiarise public health professionals and others with the content covered. With the advice of expert instructors, we created an audit form. Volunteers audited 20 basic firearm classes in seven north-eastern states. All trainers covered a wide variety of safety issues. Some specific basics were covered in 90+% of the classes, including how to safely load/unload a gun, keeping your finger off the trigger until ready to shoot, and being aware of your target and what is behind it. In 50%-75% of the classes, the trainer covered topics such as operating a safety, clearing jams and cartridge malfunctions, and recommended storing guns unloaded and locked when not in use. Few instructors covered firearm suicide prevention (10%) or domestic violence (10%). Most encouraged gun ownership, gun carrying, gun use in self-defence and membership in a gun rights group. From a public health standpoint, we would like to see more instructors covering topics such as firearm suicide and alternatives to gun use in self-defence, and to recommend safer storage of firearms. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Exploring the application of latent class cluster analysis for investigating pedestrian crash injury severities in Switzerland.

PubMed

Sasidharan, Lekshmi; Wu, Kun-Feng; Menendez, Monica

2015-12-01

One of the major challenges in traffic safety analyses is the heterogeneous nature of safety data, due to the sundry factors involved in it. This heterogeneity often leads to difficulties in interpreting results and conclusions due to unrevealed relationships. Understanding the underlying relationship between injury severities and influential factors is critical for the selection of appropriate safety countermeasures. A method commonly employed to address systematic heterogeneity is to focus on any subgroup of data based on the research purpose. However, this need not ensure homogeneity in the data. In this paper, latent class cluster analysis is applied to identify homogenous subgroups for a specific crash type-pedestrian crashes. The manuscript employs data from police reported pedestrian (2009-2012) crashes in Switzerland. The analyses demonstrate that dividing pedestrian severity data into seven clusters helps in reducing the systematic heterogeneity of the data and to understand the hidden relationships between crash severity levels and socio-demographic, environmental, vehicle, temporal, traffic factors, and main reason for the crash. The pedestrian crash injury severity models were developed for the whole data and individual clusters, and were compared using receiver operating characteristics curve, for which results favored clustering. Overall, the study suggests that latent class clustered regression approach is suitable for reducing heterogeneity and revealing important hidden relationships in traffic safety analyses. Copyright © 2015 Elsevier Ltd. All rights reserved.

10 CFR 72.70 - Safety analysis report updating.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.70 Section 72.70 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Records...

76 FR 14799 - Amendment of Class E Airspace; Newport, VT

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... cancellation of the NDB approach. Controlled airspace is necessary for the safety and management of IFR... Instrument Approach Procedures (SIAPs) have been developed for Newport State Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport. DATES...

Evaluating the potential safety benefits of electronic hours-of-service recorders final report.

DOT National Transportation Integrated Search

2014-04-01

The purpose of the current study was to assess the benefits of installed electronic hours-of-service recorders : (EHSRs) on safety and hours-of-service (HOS) violations related to Class 7 and 8 trucks as they operated during : normal revenue service....

10 CFR 72.124 - Criteria for nuclear criticality safety.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Criteria for nuclear criticality safety. 72.124 Section 72.124 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C...

10 CFR 72.124 - Criteria for nuclear criticality safety.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Criteria for nuclear criticality safety. 72.124 Section 72.124 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C...

10 CFR 72.124 - Criteria for nuclear criticality safety.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Criteria for nuclear criticality safety. 72.124 Section 72.124 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C...

10 CFR 72.124 - Criteria for nuclear criticality safety.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Criteria for nuclear criticality safety. 72.124 Section 72.124 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C...

10 CFR 72.124 - Criteria for nuclear criticality safety.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Criteria for nuclear criticality safety. 72.124 Section 72.124 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C...

75 FR 13668 - Amendment of Class E Airspace; Cedar Rapids, IA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-23

...-0916; Airspace Docket No. 09-ACE-12] Amendment of Class E Airspace; Cedar Rapids, IA AGENCY: Federal... Cedar Rapids, IA, to accommodate Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAPs) at The Eastern Iowa Airport, Cedar Rapids, IA. The FAA is taking this action to enhance the safety...

75 FR 37292 - Amendment of Class E Airspace; Cherokee, IA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-29

...-0085; Airspace Docket No. 10-ACE-1] Amendment of Class E Airspace; Cherokee, IA AGENCY: Federal... Cherokee, IA. Decommissioning of the Pilot Rock non-directional beacon (NDB) at Cherokee County Regional Airport, Cherokee, IA has made this action necessary to enhance the safety and management of Instrument...

76 FR 73501 - Amendment of Class E Airspace; Carroll, IA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

...-0845; Airspace Docket No. 11-ACE-19] Amendment of Class E Airspace; Carroll, IA AGENCY: Federal... Carroll, IA. Decommissioning of the Carroll non-directional beacon (NDB) at Arthur N. Neu Airport, Carroll, IA, has made this action necessary to enhance the safety and management of Instrument Flight Rule...

76 FR 75446 - Amendment of Class E Airspace; Mercury, NV

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

...-0894; Airspace Docket No. 11-AWP-14] Amendment of Class E Airspace; Mercury, NV AGENCY: Federal... Mercury, Desert Rock Airport, Mercury, NV. Decommissioning of the Mercury Non-Directional Beacon (NDB) at Mercury, Desert Rock Airport has made this action necessary for the safety and management of Instrument...

An analysis of the alcohol curriculum used in the driver education program of the Fairfax Alcohol Safety Action project.

DOT National Transportation Integrated Search

1974-01-01

In this study, ten classes of driver education students from two Fairfax County high schools received materials from a new alcohol curriculum in conjunction with regular driver education training. Eight classes of students from two other Fairfax Coun...

78 FR 48081 - Proposed Establishment of Class E Airspace; McConnellsburg, PA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

... AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to establish Class E Airspace at McConnellsburg, PA, to accommodate a new Area...) serving Fulton County Medical Center Heliport. This action would enhance the safety and airspace...

78 FR 48841 - Proposed Amendment of Class E Airspace; Kankakee, IL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-12

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to amend Class E airspace at Kankakee, IL. Additional controlled airspace is necessary to... taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for...

77 FR 56796 - Proposed Amendment of Class E Airspace; Sault Ste Marie, ON

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-14

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to amend Class E airspace at Sault Ste Marie, ON. Changes to controlled airspace are... action to enhance the safety and management of Instrument Flight Rules (IFR) operations at the airport...

76 FR 38582 - Proposed Amendment of Class E Airspace; Clemson, SC

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

...: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This action proposes to amend Class E Airspace at Clemson, SC, as a runway extension requires amended Standard Instrument Approach Procedures at Oconee County Regional Airport. This action would enhance the safety and...

Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

PubMed

2014-01-23

The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

75 FR 51177 - Revocation of Class E Airspace; Eastsound, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-19

... airspace at Orcas Island Airport, Eastsound, WA. Controlled airspace already exists in the Eastsound, WA area that accommodates the safety and management of aircraft operations at Orcas Island Airport. DATES... Regulations (14 CFR) part 71 by removing Class E surface airspace at Orcas Island Airport, Eastsound, WA...

76 FR 43820 - Amendment of Class E Airspace; Drummond Island, MI

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

...-0609; Airspace Docket No. 10-AGL-9] Amendment of Class E Airspace; Drummond Island, MI AGENCY: Federal... Drummond Island, MI, to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at Drummond Island Airport. The FAA is taking this action to enhance the safety and management of Instrument...

49 CFR 107.107 - Application for party status.

Code of Federal Regulations, 2011 CFR

2011-10-01

... for Hazardous Materials Safety (Attention: General Approvals and Permits, PHH-31), Pipeline and... with § 105.40 of part. (5) For a Class 1 material that is forbidden for transportation by aircraft... from an applicant for party status to a special permit to transport such Class 1 material on passenger...

76 FR 16348 - Proposed Amendment of Class E Airspace; Duluth, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

... proposes to amend Class E airspace at Duluth, MN, to accommodate new Standard Instrument Approach Procedures at Duluth International Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: 0901 UTC. Comments must be...

76 FR 66854 - Amendment of Class E Airspace; Nuiqsut, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-28

... Nuiqsut, AK, to accommodate the amendment of two standard instrument approach procedures at the Nuiqsut Airport. The FAA is taking this action to enhance safety and management of Instrument Flight Rules (IFR..., Nuiqsut, AK, to accommodate the amendment of a two standard instrument approach procedures. The Class E...

75 FR 66302 - Establishment of Class E Airspace; Kaiser/Lake Ozark, MO

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

... Class E airspace for the Kaiser/Lake Ozark, MO, area to accommodate Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAP) at Camdenton Memorial Airport, Camdenton, MO. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport...

75 FR 34393 - Proposed Establishment of Class E Airspace; Port Clarence, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

...: This action proposes to establish Class E airspace at Port Clarence Coast Guard Station (CGS), AK. The... approach procedure. This instrument approach development at the Port Clarence CGS Airport has made this action necessary to enhance safety and management of Instrument Flight Rules (IFR) operations. DATES...

75 FR 42 - Establishment of Class E Airspace; Spencer, WV

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-04

... Aviation Administration (FAA), DOT. ACTION: Direct final rule; confirmation of effective date. SUMMARY: This action confirms the effective date of a direct final rule published in the Federal Register that establishes Class E Airspace at Spencer, WV. This action enhances the safety and airspace management of Boggs...

76 FR 54149 - Proposed Amendment of Class E Airspace; Kipnuk, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

... proposes to revise Class E airspace at Kipnuk, AK. The amendment of two standard instrument approach procedures at the Kipnuk Airport has made this action necessary to enhance safety and management of.... ADDRESSES: Send comments on the proposal to the Docket Management Facility, U.S. Department of...

76 FR 49386 - Proposed Amendment of Class E Airspace; Nuiqsut, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

... proposes to revise Class E airspace at Nuiqsut AK. The amendment of two standard instrument approach procedures at the Nuiqsut Airport has made this action necessary to enhance safety and management of.... ADDRESSES: Send comments on the proposal to the Docket Management Facility, U.S. Department of...

77 FR 29873 - Establishment of Class E Airspace; Eldon, MO

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... at Eldon, MO. Controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at Eldon Model Airpark. The FAA is taking this action to enhance the safety... Federal Register a notice of proposed rulemaking (NPRM) to establish Class E airspace at Eldon Model...

77 FR 61248 - Establishment of Class E Airspace; Deer Lodge, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

...-0379; Airspace Docket No. 12-ANM-7 Establishment of Class E Airspace; Deer Lodge, MT AGENCY: Federal... at Deer Lodge-City- County Airport, Deer Lodge, MT. Controlled airspace is necessary to accommodate... procedures at Deer Lodge-City-County Airport. This improves the safety and management of Instrument Flight...

76 FR 43576 - Amendment of Class E Airspace; Hannibal, MO

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

...-0046; Airspace Docket No. 11-ACE-1] Amendment of Class E Airspace; Hannibal, MO AGENCY: Federal... Hannibal, MO. Decommissioning of the Hannibal non-directional beacon (NDB) at Hannibal Regional Airport, Hannibal, MO, has made this action necessary to enhance the safety and management of Instrument Flight Rule...

76 FR 1999 - Establishment of Class E Airspace; Panguitch, UT

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-12

... Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action will establish Class E... the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective... found merit in this comment, and will incorporate this change in the final rule. With the exception of...

75 FR 29656 - Amendment of Class E Airspace; Magnolia, AR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

...-1179; Airspace Docket No. 09-ASW-35] Amendment of Class E Airspace; Magnolia, AR AGENCY: Federal... airspace for Magnolia, AR. Decommissioning of the Magnolia non-directional beacon (NDB) at Magnolia Municipal Airport, Magnolia, AR has made this action necessary to enhance the safety and management of...

75 FR 29656 - Amendment of Class E Airspace; Mountain View, AR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

...-1181; Airspace Docket No. 09-ASW-36] Amendment of Class E Airspace; Mountain View, AR AGENCY: Federal... Mountain View, AR. Decommissioning of the Wilcox non-directional beacon (NDB) at Mountain View Wilcox Memorial Field Airport, Mountain View, AR, has made this action necessary to enhance the safety and...

78 FR 18801 - Establishment of Class E Airspace; Beeville, TX

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-28

... Instrument Approach Procedures at Chase Field Industrial Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport. DATES: Effective... Federal Register a notice of proposed rulemaking (NPRM) to establish Class E airspace at Chase Industrial...

49 CFR 176.168 - Transport of Class 1 (explosive) materials in vehicle spaces.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 2 2012-10-01 2012-10-01 false Transport of Class 1 (explosive) materials in vehicle spaces. 176.168 Section 176.168 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS CARRIAGE BY VESSEL Detailed...

77 FR 41259 - Modification of Class E Airspace; Plentywood, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... Plentywood Sher-Wood Airport, Plentywood, MT. Controlled airspace is necessary to accommodate aircraft using... Plentywood Sher-Wood Airport. This improves the safety and management of Instrument Flight Rules (IFR... modifying Class E airspace extending upward from 700 feet above the surface at Plentywood Sher-Wood Airport...

Generic oncology drugs: are they all safe?

PubMed

Yang, Y Tony; Nagai, Sumimasa; Chen, Brian K; Qureshi, Zaina P; Lebby, Akida A; Kessler, Samuel; Georgantopoulos, Peter; Raisch, Dennis W; Sartor, Oliver; Hermanson, Terhi; Kane, Robert C; Hrushesky, William J; Riente, Joshua J; Norris, LeAnn B; Bobolts, Laura R; Armitage, James O; Bennett, Charles L

2016-11-01

Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel). We also review regulatory reports from Japan and the USA, countries with the largest pharmaceutical expenditures. Empirical studies did not identify safety concerns in the USA, Canada, the EU, and Japan, where regulations and enforcement are strong. Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist. Regulatory agencies should collaboratively develop procedures to monitor the production, shipment, storage, and post-marketing safety of generic oncology drugs. Regulatory agencies for each country should also aim towards identical definitions of bioequivalence, the cornerstone of regulatory approval. Copyright © 2016 Elsevier Ltd. All rights reserved.

78 FR 63860 - Amendment of Class D Airspace; Kwajalein Island, Marshall Islands, RMI

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

...This action amends the Kwajalein Island Class D airspace description by amending the geographic coordinates for Bucholz Army Airfield (AAF), Kwajalein Island, Marshall Islands, RMI. The Bucholz AAF geographic coordinates information was updated in the Kwajalein Island Class E airspace descriptions in 2011, but was inadvertently overlooked in the Kwajalein Island Class D airspace description. This action ensures the safety of aircraft operating in the Kwajalein Island airspace area. This is an administrative action and does not affect the operating requirements of the airspace.

Long-term outcomes following high intensity focused ultrasound ablation for atrial fibrillation.

PubMed

Davies, Edward J; Bazerbashi, Samer; Asopa, Sanjay; Haywood, Guy; Dalrymple-Hay, Malcolm

2014-01-01

The aim of this study is to assess the safety and efficacy of the Epicor high intensity focused ultrasound (St. Jude, Inc.®, Minneapolis, MN, USA) system using seven-day ambulatory electrocardiogram (ECG) monitoring over a two-year follow-up period. One hundred and ten patients undergoing ablation were included from a single center between January 2006 and December 2009. Rhythm was assessed using seven-day ambulatory ECG or permanent pacemaker interrogation. Seventeen patients were lost to follow-up, seven through death. Results were reported according to atrial fibrillation (AF) class preoperatively: paroxysmal, persistent, and long-standing persistent (LSP). Forty-nine percent of patients remained in sinus rhythm at greater than two years. The percentage of patients in sinus rhythm according to preoperative AF class were 81% (paroxysmal AF), 56% (persistent AF), and 18% (long-standing AF). The class of AF prior to surgery, left atrium size, and body mass index determined the long-term outcome. There were no procedure-related complications. We conclude that high intensity focused ultrasound ablation for atrial fibrillation using the Epicor system is safe and effective for surgical patients with paroxysmal AF. The persistent and LSP AF results suggest that alternative ablation strategies should be considered for these patients. © 2013 Wiley Periodicals, Inc.

Classification of Unmanned Aircraft Systems. UAS Classification/Categorization for Certification

NASA Technical Reports Server (NTRS)

2004-01-01

Category, class, and type designations are primary means to identify appropriate aircraft certification basis, operating rules/limitations, and pilot qualifications to operate in the National Airspace System (NAS). The question is whether UAS fit into existing aircraft categories or classes, or are unique enough to justify the creation of a new category/class. In addition, the characteristics or capabilities, which define when an UAS becomes a regulated aircraft, must also be decided. This issue focuses on UAS classification for certification purposes. Several approaches have been considered for classifying UAS. They basically group into either using a weight/mass basis, or a safety risk basis, factoring in the performance of the UAS, including where the UAS would operate. Under existing standards, aircraft must have a Type Certificate and Certificate of Airworthiness, in order to be used for "compensation or hire", a major difference from model aircraft. Newer technologies may make it possible for very small UAS to conduct commercial services, but that is left for a future discussion to extend the regulated aircraft to a lower level. The Access 5 position is that UAS are aircraft and should be regulated above the weight threshold differentiating them from model airplanes. The recommended classification grouping is summarized in a chart.

The Safety of Small Containers for Flammable Fluids.

ERIC Educational Resources Information Center

Shanley, Edward S.

1988-01-01

Highlights aspects of safety that are unfamiliar to most laypersons and to many chemists as well. Presents findings that may lend themselves to presentation in chemistry classes. Details flammability tests, vapor space hazards, and the special case of gasoline containers. Provides experimental data relating vent area and internal pressure. (CW)

78 FR 41290 - Establishment of Class E Airspace; Elbow Lake, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-10

...) Standard Instrument Approach Procedures at Elbow Lake Municipal--Pride of the Prairie Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the... instrument approach procedures at the airport. This action enhances the safety and management of IFR...

78 FR 31430 - Proposed Establishment of Class E Airspace; Wagner, SD

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-24

... accommodate new Standard Instrument Approach Procedures (SIAP) at Wagner Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs... approach procedures at the airport. Controlled airspace is needed for the safety and management of IFR...

78 FR 52716 - Proposed Amendment of Class E Airspace; Del Rio, TX

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

..., Del Rio, TX. An additional segment to the north is needed to contain approach category E military aircraft conducting circling approaches to the airport, to retain the safety and management of IFR aircraft... to enhance the safety and management of Instrument Flight Rules (IFR) operations for instrument...

78 FR 33019 - Proposed Amendment of Class E Airspace; Commerce, TX

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-03

... accommodate new Standard Instrument Approach Procedures (SIAPs) at Commerce Municipal Airport (AAF). The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR... airport to provide adequate controlled airspace for the safety and management of IFR operations at the...

78 FR 76055 - Establishment of Class E Airspace; Donlin Creek, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-16

...) standard instrument approach procedures at Donlin Creek Airport. This improves the safety and management of...-miles northwest of the airport to accommodate new RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations. The FAA has...

78 FR 67298 - Establishment of Class E Airspace; Ennis, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... instrument approach procedures at Ennis-Big Sky Airport. This improves the safety and management of...) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations. The FAA has determined this regulation only involves an established body of...

77 FR 19076 - Establishment of Class E Airspace; Marion, AL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-30

... Instrument Approach Procedures serving Vaiden Field. This action enhances the safety and airspace management... accommodate the new RNAV GPS Standard Instrument Approach Procedures developed for Vaiden Field. This action is necessary for the safety and management of IFR operations at the airport. The FAA has determined...

78 FR 67297 - Establishment of Class E Airspace; Curtis, NE

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the... Instrument Approach Procedures at Curtis Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport. DATES: Effective date...

The Skipper's Course.

ERIC Educational Resources Information Center

Coast Guard, Washington, DC.

This book is a self-instructional program for learning boating safety rules and practices. A "quick quiz" is presented at the end of each topic of information (usually every page), and a review concludes each of the major sections, which are: (1) Prelude to Boating--overview, classes of boats, safe boat trailering; (2) Safety Afloat--presailing…

Safety First!

ERIC Educational Resources Information Center

Longfield, Judith

2006-01-01

In this article, the author relates how a hands-on chemistry investigation provided her the inspiration to develop an effective safety lesson for her third grade chemistry class. She began the lesson by demonstrating the use of pH indicator paper to show that ordinary household (white) vinegar was an acid. With the students, she wondered aloud…

Bicycle Safety: A Balancing Act.

ERIC Educational Resources Information Center

Cinque, Chris

1989-01-01

In an effort to reduce deaths and serious injuries among bicyclists, physicians and bicycling organizations are promoting safety skill classes. Children are at especially high risk of accidents and need proper training and education. Helmets and other protective gear are considered crucial equipment, and common sense and alertness are important.…

Deriving exposure limits

NASA Astrophysics Data System (ADS)

Sliney, David H.

1990-07-01

Historically many different agencies and standards organizations have proposed laser occupational exposure limits (EL1s) or maximum permissible exposure (MPE) levels. Although some safety standards have been limited in scope to manufacturer system safety performance standards or to codes of practice most have included occupational EL''s. Initially in the 1960''s attention was drawn to setting EL''s however as greater experience accumulated in the use of lasers and some accident experience had been gained safety procedures were developed. It became clear by 1971 after the first decade of laser use that detailed hazard evaluation of each laser environment was too complex for most users and a scheme of hazard classification evolved. Today most countries follow a scheme of four major hazard classifications as defined in Document WS 825 of the International Electrotechnical Commission (IEC). The classifications and the associated accessible emission limits (AEL''s) were based upon the EL''s. The EL and AEL values today are in surprisingly good agreement worldwide. There exists a greater range of safety requirements for the user for each class of laser. The current MPE''s (i. e. EL''s) and their basis are highlighted in this presentation. 2. 0

NGSLR Safety Handbook

NASA Technical Reports Server (NTRS)

McGarry, Jan

2015-01-01

NASA's Next Generation Satellite Laser Ranging (NGSLR) station is the prototype for NASA's Satellite Laser Ranging (SLR) systems which will be deployed around the world in the coming decade. The NGSLR system will be an autonomous, photon-counting SLR station with an expected absolute range accuracy of better than one centimeter and a normal point (time-averaged) range precision better than one millimeter. The system provides continuous (weather permitting), 24 hour tracking coverage to an existing constellation of approximately two dozen artificial satellites equipped with passive retroreflector arrays, using pulsed, 532 nm, class IV laser systems. Current details on the approved laser systems can be found in the Appendix 1 of this document. This safety plan addresses the potential hazards to emitted laser radiation, which can occur both inside and outside the shelter. Hazards within the shelter are mitigated through posted warning signs, activated warning lights, procedural controls, personal protective equipment (PPE), laser curtains, beam blocking systems, interlock controls, pre-configured laser control settings, and other controls discussed in this document. Since the NGSLR is a satellite tracking system, laser hazards exist outside the shelter to personnel on the shelter roof and to passing aircraft. Potential exposure to personnel outside the system is mitigated through the use of posted warning signs, access control, procedural controls, a stairwell interlock, beam attenuation/blocking devices, and a radar based aircraft detection system.

Survival of fecal coliforms in dry-composting toilets.

PubMed

Redlinger, T; Graham, J; Corella-Barud, V; Avitia, R

2001-09-01

The dry-composting toilet, which uses neither water nor sewage infrastructure, is a practical solution in areas with inadequate sewage disposal and where water is limited. These systems are becoming increasingly popular and are promoted to sanitize human excreta and to recycle them into fertilizer for nonedible plants, yet there are few data on the safety of this technology. This study analyzed fecal coliform reduction in approximately 90 prefabricated, dry-composting toilets (Sistema Integral de Reciclamiento de Desechos Orgánicos [SIRDOs]) that were installed on the U.S.-Mexico border in Ciudad Juárez, Chihuahua, Mexico. The purpose of this study was to determine fecal coliform reduction over time and the most probable method of this reduction. Biosolid waste samples were collected and analyzed at approximately 3 and 6 months and were classified based on U.S. Environmental Protection Agency standards. Results showed that class A compost (high grade) was present in only 35.8% of SIRDOs after 6 months. The primary mechanism for fecal coliform reduction was found to be desiccation rather than biodegradation. There was a significant correlation (P = 0.008) between classification rating and percent moisture categories of the biosolid samples: drier samples had a greater proportion of class A samples. Solar exposure was critical for maximal class A biosolid end products (P = 0.001). This study only addressed fecal coliforms as an indicator organism, and further research is necessary to determine the safety of composting toilets with respect to other pathogenic microorganisms, some of which are more resistant to desiccation.

Survival of Fecal Coliforms in Dry-Composting Toilets

PubMed Central

Redlinger, Thomas; Graham, Jay; Corella-Barud, Verónica; Avitia, Raquel

2001-01-01

The dry-composting toilet, which uses neither water nor sewage infrastructure, is a practical solution in areas with inadequate sewage disposal and where water is limited. These systems are becoming increasingly popular and are promoted to sanitize human excreta and to recycle them into fertilizer for nonedible plants, yet there are few data on the safety of this technology. This study analyzed fecal coliform reduction in approximately 90 prefabricated, dry-composting toilets (Sistema Integral de Reciclamiento de Desechos Orgánicos [SIRDOs]) that were installed on the U.S.-Mexico border in Ciudad Juárez, Chihuahua, Mexico. The purpose of this study was to determine fecal coliform reduction over time and the most probable method of this reduction. Biosolid waste samples were collected and analyzed at approximately 3 and 6 months and were classified based on U.S. Environmental Protection Agency standards. Results showed that class A compost (high grade) was present in only 35.8% of SIRDOs after 6 months. The primary mechanism for fecal coliform reduction was found to be desiccation rather than biodegradation. There was a significant correlation (P = 0.008) between classification rating and percent moisture categories of the biosolid samples: drier samples had a greater proportion of class A samples. Solar exposure was critical for maximal class A biosolid end products (P = 0.001). This study only addressed fecal coliforms as an indicator organism, and further research is necessary to determine the safety of composting toilets with respect to other pathogenic microorganisms, some of which are more resistant to desiccation. PMID:11526002

Comparative hazard evaluation of near-infrared diode lasers.

PubMed

Marshall, W J

1994-05-01

Hazard evaluation methods from various laser protection standards differ when applied to extended-source, near-infrared lasers. By way of example, various hazard analyses are applied to laser training systems, which incorporate diode lasers, specifically those that assist in training military or law enforcement personnel in the proper use of weapons by simulating actual firing by the substitution of a beam of near-infrared energy for bullets. A correct hazard evaluation of these lasers is necessary since simulators are designed to be directed toward personnel during normal use. The differences among laser standards are most apparent when determining the hazard class of a laser. Hazard classification is based on a comparison of the potential exposures with the maximum permissible exposures in the 1986 and 1993 versions of the American National Standard for the Safe Use of Lasers, Z136.1, and the accessible emission limits of the federal laser product performance standard. Necessary safety design features of a particular system depend on the hazard class. The ANSI Z136.1-1993 standard provides a simpler and more accurate hazard assessment of low-power, near-infrared, diode laser systems than the 1986 ANSI standard. Although a specific system is evaluated, the techniques described can be readily applied to other near-infrared lasers or laser training systems.

76 FR 70051 - Establishment of Class D and Amendment of Class E Airspace; Los Angeles, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... FAA considered non- rulemaking solutions but found they did not provide the equivalent level of safety... Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057... Letter of Agreement between Los Angeles Air Traffic Control Tower and hang gliding operators will be...

Voices of Teacher Candidates of Color on White Race Evasion: "I Worried about My Safety!"

ERIC Educational Resources Information Center

Amos, Yukari Takimoto

2016-01-01

This qualitative study investigated the negative impacts minority teacher candidates receive from white teacher candidates in a required multicultural education class. The findings reveal that four teacher candidates of color had difficulty positioning themselves among the overwhelming silencing power of whiteness in the class. The white students…

75 FR 63730 - Proposed Establishment of Class E Airspace; Panguitch, UT

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... include a portion extending upward from 1,200 feet above the surface at Panguitch Municipal Airport... controlled airspace from 700 feet above the surface. The FAA has reassessed the proposal to include Class E airspace 700 feet and 1,200 feet above the surface to further the safety and management of Instrument...

78 FR 48300 - Establishment of Class E Airspace; Mahnomen, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

... E5 Mahnomen, MN [New] Mahnomen County Airport, MN (Lat. 47[deg]15'38'' N., long. 95[deg]55'41'' W... Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action establishes Class E airspace... safety and management of Instrument Flight Rule (IFR) operations at the airport. DATES: Effective date...

77 FR 5429 - Proposed Modification of the Atlanta Class B Airspace Area; GA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-03

.... Aircraft are then normally assigned 5,000 feet, or higher, upon initial contact with departure control. The... foot floor would produce a safer airspace environment for aircraft arriving at the world's busiest... containment of aircraft within Class B airspace, reduce controller workload and enhance safety in the Atlanta...

49 CFR 176.108 - Supervision of Class 1 (explosive) materials during loading, unloading, handling and stowage.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Supervision of Class 1 (explosive) materials during loading, unloading, handling and stowage. 176.108 Section 176.108 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS...

30 CFR 75.505 - Mines classed gassy; use and maintenance of permissible electric face equipment.

Code of Federal Regulations, 2014 CFR

2014-07-01

... permissible electric face equipment. 75.505 Section 75.505 Mineral Resources MINE SAFETY AND HEALTH... Electrical Equipment-General § 75.505 Mines classed gassy; use and maintenance of permissible electric face... provision of law and was required to use permissible electric face equipment and to maintain such equipment...

30 CFR 75.505 - Mines classed gassy; use and maintenance of permissible electric face equipment.

Code of Federal Regulations, 2012 CFR

2012-07-01

... permissible electric face equipment. 75.505 Section 75.505 Mineral Resources MINE SAFETY AND HEALTH... Electrical Equipment-General § 75.505 Mines classed gassy; use and maintenance of permissible electric face... provision of law and was required to use permissible electric face equipment and to maintain such equipment...

30 CFR 75.505 - Mines classed gassy; use and maintenance of permissible electric face equipment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... permissible electric face equipment. 75.505 Section 75.505 Mineral Resources MINE SAFETY AND HEALTH... Electrical Equipment-General § 75.505 Mines classed gassy; use and maintenance of permissible electric face... provision of law and was required to use permissible electric face equipment and to maintain such equipment...

30 CFR 75.505 - Mines classed gassy; use and maintenance of permissible electric face equipment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... permissible electric face equipment. 75.505 Section 75.505 Mineral Resources MINE SAFETY AND HEALTH... Electrical Equipment-General § 75.505 Mines classed gassy; use and maintenance of permissible electric face... provision of law and was required to use permissible electric face equipment and to maintain such equipment...

30 CFR 75.505 - Mines classed gassy; use and maintenance of permissible electric face equipment.

Code of Federal Regulations, 2013 CFR

2013-07-01

... permissible electric face equipment. 75.505 Section 75.505 Mineral Resources MINE SAFETY AND HEALTH... Electrical Equipment-General § 75.505 Mines classed gassy; use and maintenance of permissible electric face... provision of law and was required to use permissible electric face equipment and to maintain such equipment...

78 FR 25383 - Amendment of Class E Airspace; West Palm Beach, FL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

...-0922; Airspace Docket No. 12-ASO-38] Amendment of Class E Airspace; West Palm Beach, FL AGENCY: Federal... West Palm Beach, FL area, as new Standard Instrument Approach Procedures (SIAPs) have been developed at Palm Beach County Park Airport. Airspace reconfiguration is necessary for the continued safety and...

46 CFR 56.30-10 - Flanged joints (modifies 104.5.1(a)).

Code of Federal Regulations, 2010 CFR

2010-10-01

... 104.5.1(a)). (a) Flanged or butt-welded joints are required for Classes I and I-L piping for nominal... Marine Safety Center. Pressure temperature ratings of the appropriate ANSI/ASME standard must not be... service pressure-temperature ratings for flanges of class 300 and lower, within the temperature...

Achieving Recognition as a World Class Airport through Education and Training. Sorenson Best Paper Award Recipient.

ERIC Educational Resources Information Center

Quilty, Stephen M.

2003-01-01

The International Civil Aviation Organization has standards for airport certification that require education and training of personnel. The American Association of Airport Executives offers accreditation and certification in airport operations and safety that can meet the needs of world-class airports. (Contains 18 references.) (SK)

76 FR 67055 - Amendment of Class E Airspace; Valley City, ND

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

...-0605; Airspace Docket No. 11-AGL-13] Amendment of Class E Airspace; Valley City, ND AGENCY: Federal... Valley City, ND. Decommissioning of the Valley City non-directional beacon (NDB) at Barnes County Municipal Airport, Valley City, ND, has made this action necessary to enhance the safety and management of...

49 CFR 176.172 - Structural serviceability of freight containers and vehicles carrying Class 1 (explosive...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 2 2012-10-01 2012-10-01 false Structural serviceability of freight containers and vehicles carrying Class 1 (explosive) materials on ships. 176.172 Section 176.172 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS...

77 FR 9251 - Designation of a Class of Employees for Addition to the Special Exposure Cohort

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health (NIOSH), Centers for..., for a number of work days aggregating at least 250 work days, occurring either solely under this...

75 FR 13671 - Establishment of Class E Airspace; West Bend, WI

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-23

...-1149; Airspace Docket No. 09-AGL-33] Establishment of Class E Airspace; West Bend, WI AGENCY: Federal... West Bend, WI to accommodate Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAPs) at West Bend Municipal Airport, West Bend, WI. The FAA is taking this action to enhance the safety and...

Environmental Assessment for Construction of Visiting Quarters - Phases One and Two, MacDill AFB, Florida

DTIC Science & Technology

2011-07-13

kilometers of a Class I area ; therefore, the PSD regulations do not apply. Affected Environment Environmental Assessment for Construction of...Federal agencies, to the extent permitted by law and mission, to identify and assess environmental health and safety risks that might...disproportionate risks . The order defines environmental health and safety risks as “ risks to health or to safety that are attributable to products or

Oxidation reaction of polyether-based material and its suppression in lithium rechargeable battery using 4 V class cathode, LiNi1/3Mn1/3Co1/3O2.

PubMed

Kobayashi, Takeshi; Kobayashi, Yo; Tabuchi, Masato; Shono, Kumi; Ohno, Yasutaka; Mita, Yuichi; Miyashiro, Hajime

2013-12-11

The all solid-state lithium battery with polyether-based solid polymer electrolyte (SPE) is regarded as one of next-generation lithium batteries, and has potential for sufficient safety because of the flammable-electrolyte-free system. It has been believed that polyether-based SPE is oxidized at the polymer/electrode interface with 4 V class cathodes. Therefore, it has been used for electric devices such as organic transistor, and lithium battery under 3 V. We estimated decomposition reaction of polyether used as SPE of all solid-state lithium battery. We first identified the decomposed parts of polyether-based SPE and the conservation of most main chain framework, considering the results of SPE analysis after long cycle operations. The oxidation reaction was found to occur slightly at the ether bond in the main chain with the branched side chain. Moreover, we resolved the issue by introducing a self-sacrificing buffer layer at the interface. The introduction of sodium carboxymethyl cellulose (CMC) to the 4 V class cathode surface led to the suppression of SPE decomposition at the interface as a result of the preformation of a buffer layer from CMC, which was confirmed by the irreversible exothermic reaction during the first charge, using electrochemical calorimetry. The attained 1500 cycle operation is 1 order of magnitude longer than those of previously reported polymer systems, and compatible with those of reported commercial liquid systems. The above results indicate to proceed to an intensive research toward the realization of 4 V class "safe" lithium polymer batteries without flammable liquid electrolyte.

Combination use of medicines from two classes of renin-angiotensin system blocking agents: risk of hyperkalemia, hypotension, and impaired renal function.

PubMed

Esteras, Raquel; Perez-Gomez, Maria Vanessa; Rodriguez-Osorio, Laura; Ortiz, Alberto; Fernandez-Fernandez, Beatriz

2015-08-01

European and United States regulatory agencies recently issued warnings against the use of dual renin-angiotensin system (RAS) blockade therapy through the combined use of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs) or aliskiren in any patient, based on absence of benefit for most patients and increased risk of hyperkalemia, hypotension, and renal failure. Special emphasis was made not to use these combinations in patients with diabetic nephropathy. The door was left open to therapy individualization, especially for patients with heart failure, when the combined use of an ARB and ACEI is considered absolutely essential, although renal function, electrolytes and blood pressure should be closely monitored. Mineralocorticoid receptor antagonists were not affected by this warning despite increased risk of hyperkalemia. We now critically review the risks associated with dual RAS blockade and answer the following questions: What safety issues are associated with dual RAS blockade? Can the safety record of dual RAS blockade be improved? Is it worth trying to improve the safety record of dual RAS blockade based on the potential benefits of the combination? Is dual RAS blockade dead? What is the role of mineralocorticoid antagonists in combination with other RAS blocking agents: RAAS blockade?