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Public Health Effectiveness of the FDA 510(k) Clearance Process - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Public Health Effectiveness of the FDA 510(k) Clearance Process - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop. Table of ContentsFront Matter1 Introduction2 Legislative History of the Medical Device Amendments of 19763 Premarket Notification4 The Medical Device Industry Innovation Ecosystem5 The Global Framework for Regulation of Medical Devices6 Public CommentsAppendix A: Workshop AgendaAppendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned PapersAppendix C: Premarket Notification: A Key Element of US Medical Device Regulation--Larry Kessler and Philip J. PhillipsAppendix D: Impact of the Regulatory Framework on Medical Device Development and Innovation--David W. Feigal, Jr.

DKK 305.00
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Reducing the Threat of Improvised Explosive Device Attacks by Restricting Access to Explosive Precursor Chemicals - Board On Chemical Sciences And

Reducing the Threat of Improvised Explosive Device Attacks by Restricting Access to Explosive Precursor Chemicals - Board On Chemical Sciences And

Improvised explosive devices (IEDs) are a type of unconventional explosive weapon that can be deployed in a variety of ways, and can cause loss of life, injury, and property damage in both military and civilian environments. Terrorists, violent extremists, and criminals often choose IEDs because the ingredients, components, and instructions required to make IEDs are highly accessible. In many cases, precursor chemicals enable this criminal use of IEDs because they are used in the manufacture of homemade explosives (HMEs), which are often used as a component of IEDs. Many precursor chemicals are frequently used in industrial manufacturing and may be available as commercial products for personal use. Guides for making HMEs and instructions for constructing IEDs are widely available and can be easily found on the internet. Other countries restrict access to precursor chemicals in an effort to reduce the opportunity for HMEs to be used in IEDs. Although IED attacks have been less frequent in the United States than in other countries, IEDs remain a persistent domestic threat. Restricting access to precursor chemicals might contribute to reducing the threat of IED attacks and in turn prevent potentially devastating bombings, save lives, and reduce financial impacts. Reducing the Threat of Improvised Explosive Device Attacks by Restricting Access to Explosive Precursor Chemicals prioritizes precursor chemicals that can be used to make HMEs and analyzes the movement of those chemicals through United States commercial supply chains and identifies potential vulnerabilities. This report examines current United States and international regulation of the chemicals, and compares the economic, security, and other tradeoffs among potential control strategies. Table of ContentsFront MatterSummary1 Introduction2 Precursor Chemicals Used to Make Homemade Explosives3 Domestic Chemical Supply Chain4 International Regulations5 Assessing Possible Control Strategies6 Potential Approaches to Restricting Malicious Actors' Access to Precursor Chemicals: Conclusions and RecommendationsReferencesAppendix A: AcronymsAppendix B: Risk and Risk ManagementAppendix C: History of High-Profile Bombing AttacksAppendix D: Group A Chemical Supply ChainsAppendix E: International QuestionsAppendix F: Training MaterialsAppendix G: Methods and Limitations of Regulatory AssessmentAppendix H: Examples of Retail-Level Control Strategies and Other Measures or ActivitiesAppendix I: Committee Member and Staff Biographies

DKK 370.00
1

Public Health Effectiveness of the FDA 510(k) Clearance Process - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

Public Health Effectiveness of the FDA 510(k) Clearance Process - Institute Of Medicine - Bog - National Academies Press - Plusbog.dk

The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants. Table of ContentsFront Matter1 Introduction2 Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices3 Non–Food and Drug Administration Sources of Adverse Event Data4 Postmarket Surveillance of Medical Devices: Panel Discussion5 Other Select TopicsAppendix A: Workshop AgendaAppendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned PapersAppendix C: 510(k) Premarket Notification Analysis of FDA Recall DataAppendix D: Trustworthy Medical Device Software

DKK 292.00
1

Frontiers of Engineering - National Academy Of Engineering - Bog - National Academies Press - Plusbog.dk

Frontiers of Engineering - National Academy Of Engineering - Bog - National Academies Press - Plusbog.dk

This volume presents papers on the topics covered at the National Academy of Engineering's 2015 US Frontiers of Engineering Symposium. Every year the symposium brings together 100 outstanding young leaders in engineering to share their cutting-edge research and innovations in selected areas. The 2015 symposium was held September 9-11 at the Arnold and Mabel Beckman center in Irvine, California. The intent of this book is to highlight innovative developments in engineering research and technical work. Table of ContentsFront MatterCYBERSECURITY AND PRIVACYCybersecurity and Privacy-Introduction--David Brumley and Daniela OliveiraSecurity at Different Layers of Abstractions: Application, Operating Systems, and Hardware--Bryan D. PayneComputer Security and Privacy: Where Human Factors Meet Engineering--Franziska RoesnerOn the Technical Debt of Medical Device Security--Kevin FuChallenges of Engineering Cybersecurity: A Government Perspective--Tomas VagounENGINEERING THE SEARCH OF EARTH-LIKE EXOPLANETSEngineering the Search for Earth-like Exoplanets-Introduction--Sara Seager and Mitchell WalkerEngineering the James Webb Space Telescope--Amy LoStarlight Suppression: Technologies for Direct Imaging of Exoplanets--Dmitry SavranskyRealizing Large Structures in Space--Jeremy BanikSensing Controls for Space-based Planet Finding-Jonathan T. BlackOPTICAL AND MECHANICAL METAMATERIALSOptical and Mechanical Metamaterials-Introduction--Jennifer Dionne and Luke SweatlockMaterials by Design: Using Architecture and Nanomaterial Size Effects to Attain Unexplored Properties--Julia GreerMechanical Metamaterials: Design, Fabrication, and Performance--Christopher SpadacciniMetamaterial-based Device Engineering--Andrea AlCatching Light Rays: Refractory Plasmonics for Energy Conversion, Data Storage, and Medical Applications--Alexandra Boltasseva and Urcan GulerFORECASTING NATURAL DISASTERSForecasting Natural Disasters-Introduction--James Done and Amir AghaKouchakAn Integrated Approach to Assess and Manage Hurricane Risk in a Changing Climate--Ning LinMoving from Risk Assessment to Risk Reduction: An Economic Perspective on Decision Making in Natural Disasters--Jeffrey CzajkowskiAPPENDIXESContributorsProgramParticipants

DKK 318.00
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Cost, Effectiveness, and Deployment of Fuel Economy Technologies for Light-Duty Vehicles - Division On Engineering And Physical Sciences - Bog -

Cost, Effectiveness, and Deployment of Fuel Economy Technologies for Light-Duty Vehicles - Division On Engineering And Physical Sciences - Bog -

The light-duty vehicle fleet is expected to undergo substantial technological changes over the next several decades. New powertrain designs, alternative fuels, advanced materials and significant changes to the vehicle body are being driven by increasingly stringent fuel economy and greenhouse gas emission standards. By the end of the next decade, cars and light-duty trucks will be more fuel efficient, weigh less, emit less air pollutants, have more safety features, and will be more expensive to purchase relative to current vehicles. Though the gasoline-powered spark ignition engine will continue to be the dominant powertrain configuration even through 2030, such vehicles will be equipped with advanced technologies, materials, electronics and controls, and aerodynamics. And by 2030, the deployment of alternative methods to propel and fuel vehicles and alternative modes of transportation, including autonomous vehicles, will be well underway. What are these new technologies - how will they work, and will some technologies be more effective than others?Written to inform The United States Department of Transportation's National Highway Traffic Safety Administration (NHTSA) and Environmental Protection Agency (EPA) Corporate Average Fuel Economy (CAFE) and greenhouse gas (GHG) emission standards, this new report from the National Research Council is a technical evaluation of costs, benefits, and implementation issues of fuel reduction technologies for next-generation light-duty vehicles. Cost, Effectiveness, and Deployment of Fuel Economy Technologies for Light-Duty Vehicles estimates the cost, potential efficiency improvements, and barriers to commercial deployment of technologies that might be employed from 2020 to 2030. This report describes these promising technologies and makes recommendations for their inclusion on the list of technologies applicable for the 2017-2025 CAFE standards. Table of ContentsFront MatterSummary1 Introduction2 Technologies for Reducing Fuel Consumption in Spark-Ignition Engines3 Technologies for Reducing Fuel Consumption in Compression-Ignition Diesel Engines4 Electrified Powertrains5 Transmissions6 Non-Powertrain Technologies7 Cost and Manufacturing Considerations for Meeting Fuel Economy Standards8 Estimates of Technology Costs and Fuel Consumption Reduction Effectiveness9 Consumer Impacts and Acceptance Issues10 Overall Assessment of CAFE Program Methodology and DesignAppendix A: Statement of TaskAppendix B: Committee BiographiesAppendix C: Presentations and Committee MeetingsAppendix D: Ideal Thermodynamic Cycles for Otto, Diesel, and Atkinson EnginesAppendix E: SI Engine Definitions and Efficiency FundamentalsAppendix F: Examples of Friction Reduction Opportunities for Main Engine ComponentsAppendix G: Friction Reduction in Downsized EnginesAppendix H: Variable Valve Timing SystemsAppendix I: Variable Valve Lift SystemsAppendix J: Reasons for Potential Differences from NHTSA Estimates for Fuel Consumption Reduction Effectiveness of Turbocharged, Downsized EnginesAppendix K: DOE Research Projects on Turbocharged and Downsized EnginesAppendix L: Relationship between Power and PerformanceAppendix M: HCCI ProjectsAppendix N: Effect of Compression Ratio of Brake Thermal EfficiencyAppendix O: Variable Compression Ratio EnginesAppendix P: Fuel Consumption Impact of Tier 3 Emission StandardsAppendix Q: Examples of EPA's Standards for GasolineAppendix R: Impact of Low Carbon Fuels to Achieve Reductions in GHG Emissions (California LCFS 2007 Alternative Fuels and Cleaner Fossil Fuels CNG, LPG)Appendix S: NHTSA's Estimated Fuel Consumption Reduction Effectiveness of Technologies and Estimated Costs of TechnologiesAppendix T: Derivation of Turbocharged, Downsized Engine Direct Manufacturing CostsAppendix U: SI Engine Pathway NHTSA Estimates Direct Manufacturing Costs and Total CostsAppendix V: SI Engine Pathway NRC Estimates Direct Manufacturing Costs Alternative Pathway, Alternative High CR with Exhaust Scavenging, and Alternative EVAS SuperchargerAppendix W: Technologies, Footprints, and Fuel Economy for Example Passenger Cars, Trucks, and Hybrid Passenger CarsAppendix X: Full System Simulation Modeling of Fuel Consumption ReductionsAppendix Y: Acronym List

DKK 708.00
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Frontiers of Engineering - National Academy Of Engineering - Bog - National Academies Press - Plusbog.dk

Frontiers of Engineering - National Academy Of Engineering - Bog - National Academies Press - Plusbog.dk

This volume presents papers on the topics covered at the National Academy of Engineering's 2014 US Frontiers of Engineering Symposium. Every year the symposium brings together 100 outstanding young leaders in engineering to share their cutting-edge research and innovations in selected areas. The 2014 symposium was held September 11-13 at the National Academies Beckman Center in Irvine California. The topics covered at the 2014 symposium were: co-robotics, battery materials, technologies for the heart, and shale gas and oil. The intent of this book is to convey the excitement of this unique meeting and to highlight innovative developments in engineering research and technical work. Table of ContentsFront MatterCO-ROBOTICSCo-Robotics--Brian Gerkey and Carmel MajidiProgress in Self-Driving Vehicles--Chris UrmsonSafe, Cheap, and Smart: Collaborative Robots in Manufacturing--Matthew WilliamsonPersonalized Medical Robots--Allison M. Okamura and Tania K. MorimotoBATTERY ANXIETYBattery Anxiety--Jeff Sakamoto and Daniel SteingartElectrochemical Prozac: Relieving Battery Anxiety through Life and Safety Research--Alvaro MasiasChallenges in Batteries for Electric Vehicles--Sarah Stewart, Jake Christensen, Nalin Chatururvedi, and Aleksandar KojicLithium Ion Batteries and Their Manufacturing Challenges--Claus DanielTECHNOLOGIES FOR THE HEARTTechnologies for the Heart--Karen Christman and Ashley PetersonThe History of Heart Valves: An Industry Perspective--Erin M. SpinnerEngineering Heart Valve Treatment Strategies for Tomorrow--W. David MerrymanBiomaterials for Treating Myocardial Infarctions--Jason A. Burdick and Shauna M. DorseyRegulatory Perspectives on Technologies for the Heart--Tina M. MorrisonSHALE GAS AND OILShale Gas and Oil--Billy B. Bardin and Christopher W. JonesShale Natural Resources--Stephen IngramMicrobial Ecology of Hydraulic Fracturing--Kelvin B. GregoryThe Shale Gas Revolution: A Methane-to-Organic Chemicals Renaissance?--Eric E. StanglandAPPENDIXESContributorsProgramParticipants

DKK 292.00
1

Assessing Medical Preparedness to Respond to a Terrorist Nuclear Event - Committee On Medical Preparedness For A Terrorist Nuclear Event - Bog -

Assessing Medical Preparedness to Respond to a Terrorist Nuclear Event - Committee On Medical Preparedness For A Terrorist Nuclear Event - Bog -

A nuclear attack on a large U.S. city by terrorists—even with a low-yield improvised nuclear device (IND) of 10 kilotons or less—would cause a large number of deaths and severe injuries. The large number of injured from the detonation and radioactive fallout that would follow would be overwhelming for local emergency response and health care systems to rescue and treat, even assuming that these systems and their personnel were not themselves incapacitated by the event. The United States has been struggling for some time to address and plan for the threat of nuclear terrorism and other weapons of mass destruction that terrorists might obtain and use. The Department of Homeland Security recently contracted with the Institute of Medicine to hold a workshop, summarized in this volume, to assess medical preparedness for a nuclear detonation of up to 10 kilotons. This book provides a candid and sobering look at our current state of preparedness for an IND, and identifies several key areas in which we might begin to focus our national efforts in a way that will improve the overall level of preparedness. Table of ContentsFront MatterWorkshop ReportAppendix A: Workshop AgendasAppendix B: Registered Workshop AttendeesAppendix C: Biographical Sketches of Workshop Speakers and PanelistsAppendix D: Biographical Sketches of Committee Members, Consultant, and Staff

DKK 364.00
1

The Use and Storage of Methyl Isocyanate (MIC) at Bayer CropScience - Board On Chemical Sciences And Technology - Bog - National Academies Press -

The Use and Storage of Methyl Isocyanate (MIC) at Bayer CropScience - Board On Chemical Sciences And Technology - Bog - National Academies Press -

The use of hazardous chemicals such as methyl isocyanate can be a significant concern to the residents of communities adjacent to chemical facilities, but is often an integral part of the chemical manufacturing process. In order to ensure that chemical manufacturing takes place in a manner that is safe for workers, members of the local community, and the environment, the philosophy of inherently safer processing can be used to identify opportunities to eliminate or reduce the hazards associated with chemical processing. However, the concepts of inherently safer process analysis have not yet been adopted in all chemical manufacturing plants. The Use and Storage of Methyl Isocyanate (MIC) at Bayer CropScience presents a possible framework to help plant managers choose between alternative processing options-considering factors such as environmental impact and product yield as well as safety- to develop a chemical manufacturing system. In 2008, an explosion at the Bayer CropScience chemical production plant in Institute, West Virginia, resulted in the deaths of two employees, a fire within the production unit, and extensive damage to nearby structures. The accident drew renewed attention to the fact that the Bayer facility manufactured and stores methyl isocyanate, or MIC - a volatile, highly toxic chemical used in the production of carbamate pesticides and the agent responsible for thousands of death in Bhopal, India, in 1984. In the Institute accident, debris from the blast hit the shield surrounding a MIC storage tank, and although the container was not damaged, an investigation by the U.S. Chemical Safety and Hazard Investigation Board found that the debris could have struck a relief valve vent pipe and cause the release of MIC to the atmosphere. The Board's investigation also highlighted a number of weaknesses in the Bayer facility's emergency response systems. In light of these concerns, the Board requested the National Research Council convene a committee of independent experts to write a report that examines the use and storage of MIC at the Bayer facility. The Use and Storage of Methyl Isocyanate (MIC) at Bayer CropScience also evaluates the analyses on alternative production methods for MIC and carbamate pesticides preformed by Bayer and the previous owners of the facility.

DKK 344.00
1

A Review of Methods for Detecting Soreness in Horses - Board On Agriculture And Natural Resources - Bog - National Academies Press - Plusbog.dk

A Review of Methods for Detecting Soreness in Horses - Board On Agriculture And Natural Resources - Bog - National Academies Press - Plusbog.dk

During the last century and today, the Tennessee walking horse has been used primarily for pleasure and show competition. Unique and natural to the breed is a smooth four-beat "running walk" gait. In the 1950s the accentuated or exaggerated running walk, known as the "big lick" became popular at high-level competitions. The combination of exaggerated high-action step in front and long stride behind is still considered desirable in today's horse show competitions, and it is often achieved through soring. Soring is the practice of applying a substance or mechanical device to the lower limb of a horse that will create enough pain that the horse will exaggerate its gait to relieve the discomfort. In 1970 Congress put into law the Horse Protection Act (HPA) to specifically address the practice of soring by prohibiting the showing, exhibition, or sale of Tennessee walking horses that are found to be sore. Sadly, soring is still being done even after 50 years of HPA enforcement. This report reviews the methods for detecting soreness in horses, in hopes of advancing the goal of ultimately eliminating the act of soring in horses and improving the welfare of Tennessee walking horses. A Review of Methods for Detecting Soreness in Horses examines what is known about the quality and consistency of available methods to identify soreness in horses; identifies potential new and emerging methods, approaches, and technologies for detecting hoof and pastern pain and its causes; and identifies research and technology needs to improve the reliability of methods to detect soreness. This independent study will help ensure that HPA inspection protocols are based on sound scientific principles that can be applied with consistency and objectivity. Table of ContentsFront MatterSummary1 Introduction2 Methods Used to Identify Soreness in Walking Horses3 New and Emerging Methods, Approaches, and Technologies for Detecting Pain and Its Causes4 Review of the Scar Rule for Determining Compliance with the Horse Protection ActAppendix A: Biographical Sketches of Committee MembersAppendix B: Open Session and Webinar AgendasAppendix C: The Horse Protection Act of 1970 - Regulations

DKK 331.00
1

Reusable Elastomeric Respirators in Health Care - Health And Medicine Division - Bog - National Academies Press - Plusbog.dk

Reusable Elastomeric Respirators in Health Care - Health And Medicine Division - Bog - National Academies Press - Plusbog.dk

Protecting the health and safety of health care workers is vital to the health of each of us. Preparing for and responding to a future influenza pandemic or to a sustained outbreak of an airborne transmissible disease requires a high-level commitment to respiratory protection for health care workers across the wide range of settings in which they work and the jobs that they perform. Keeping health care workers healthy is an ethical commitment both in terms of addressing the occupational risks faced by health care workers and of providing for the continuity of patient care and services needed to maintain the health of individuals and communities. During a public health emergency, challenges will arise concerning the availability of respiratory protective devices (i.e., respirators). Reusable respirators (specifically, reusable half-facepiece elastomeric respirators) are the standard respiratory protection device used in many industries, and they provide an option for use in health care that has to date not been fully explored. The durability and reusability of elastomeric respirators make them desirable for stockpiling for emergencies, where the need for large volumes of respirators can be anticipated. However, they are used infrequently in health care. Reusable Elastomeric Respirators in Health Care explores the potential for the use of elastomeric respirators in the U.S. health care system with a focus on the economic, policy, and implementation challenges and opportunities. This report examines the practicability of elastomeric use in health care on a routine basis and during an influenza pandemic or other large aerosol-transmissible outbreak, when demand for respiratory protective devices by U.S. health care personnel may be larger than domestic supplies. The report also addresses the issues regarding emergency stockpile management of elastomeric respiratory protective devices. Table of ContentsFront MatterSummary1 Introduction2 Elastomeric Respirators3 Implementing Reusable Elastomeric Respirators in Health Care Settings: Routine and Surge Use4 Research and Development5 Next Steps and RecommendationsAppendix A: Meeting AgendasAppendix B: Committee Biographical Sketches

DKK 370.00
1

Conflict of Interest in Medical Research, Education, and Practice - Board On Health Sciences Policy - Bog - National Academies Press - Plusbog.dk

Conflict of Interest in Medical Research, Education, and Practice - Board On Health Sciences Policy - Bog - National Academies Press - Plusbog.dk

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine. Table of ContentsFront MatterSummary1 Introduction2 Principles for Identifying and Assessing Conflicts of Interest3 Policies on Conflict of Interest: Overview and Evidence4 Conflicts of Interest in Biomedical Research5 Conflicts of Interest in Medical Education6 Conflicts of Interest and Medical Practice7 Conflicts of Interest and Development of Clinical Practice Guidelines8 Institutional Conflicts of Interest9 Role of Supporting OrganizationsReferencesAppendix A: Study ActivitiesAppendix B: U.S. Public Health Service Regulations: Objectivity in Research (42 CFR 50)Appendix C: Conflict of Interest in Four Professions: A Comparative AnalysisAppendix D: How Psychological Research Can Inform Policies for Dealing with Conflicts of Interest in MedicineAppendix E: The Pathway from Idea to Regulatory Approval: Examples for Drug DevelopmentAppendix F: Model for Broader DisclosureAppendix G: Committee BiographiesIndex

DKK 545.00
1