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A Systems Comparative Analysis Of Medical Device Regulations In The United States Canada Australia The European Union And Japan
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Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Medical Device Regulations by : Michael Cheng
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Book Synopsis Global Trends 2040 by : National Intelligence Council
Download or read book Global Trends 2040 written by National Intelligence Council and published by Cosimo Reports. This book was released on 2021-03 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The ongoing COVID-19 pandemic marks the most significant, singular global disruption since World War II, with health, economic, political, and security implications that will ripple for years to come." -Global Trends 2040 (2021) Global Trends 2040-A More Contested World (2021), released by the US National Intelligence Council, is the latest report in its series of reports starting in 1997 about megatrends and the world's future. This report, strongly influenced by the COVID-19 pandemic, paints a bleak picture of the future and describes a contested, fragmented and turbulent world. It specifically discusses the four main trends that will shape tomorrow's world: - Demographics-by 2040, 1.4 billion people will be added mostly in Africa and South Asia. - Economics-increased government debt and concentrated economic power will escalate problems for the poor and middleclass. - Climate-a hotter world will increase water, food, and health insecurity. - Technology-the emergence of new technologies could both solve and cause problems for human life. Students of trends, policymakers, entrepreneurs, academics, journalists and anyone eager for a glimpse into the next decades, will find this report, with colored graphs, essential reading.
Book Synopsis Medical Devices by : World Health Organization
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis Medical Devices by : Seeram Ramakrishna
Download or read book Medical Devices written by Seeram Ramakrishna and published by Woodhead Publishing. This book was released on 2015-08-18 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process
Book Synopsis Medical Technology in Japan by : Christa Altenstetter
Download or read book Medical Technology in Japan written by Christa Altenstetter and published by Transaction Publishers. This book was released on 2014-08-31 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Japan is suffering from a “device gap.” Compared to its American and European counterparts, Japan lags in adopting innovative medical devices and making new treatments and procedures available to its patients. Many blame its government and bureaucracy for Japan’s delayed access to modern medicine and new medical devices. Christa Altenstetter examines the contextual social, historical, and political conditions of Japan’s medical field to make sense of the state of the country’s medical profession and its regulatory framework. She explores the development of regulatory frameworks and considers possibilities for eventual reform and modernization. More specifically, Altenstetter looks into how physicians and device companies connect to the government and bureaucracy, the relationships connecting Japanese patients to their medical system and governmental bureaucracy, and how the relationships between policymakers and the medical profession are changing. The issues addressed here are becoming increasingly relevant as numerous countries in Asia, Latin America, and Central and Eastern Europe are only now beginning to regulate medical technology, following the lead of the US and the European Union. Those interested in global medicine and Asian studies will find this book both informative and compelling.
Book Synopsis Importing Into the United States by : U. S. Customs and Border Protection
Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Book Synopsis Handbook of Medical Device Design by : Richard C. Fries
Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
Download or read book Doing Business 2020 written by World Bank and published by World Bank Publications. This book was released on 2019-11-21 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: Seventeen in a series of annual reports comparing business regulation in 190 economies, Doing Business 2020 measures aspects of regulation affecting 10 areas of everyday business activity.
Book Synopsis Strengthening Forensic Science in the United States by : National Research Council
Download or read book Strengthening Forensic Science in the United States written by National Research Council and published by National Academies Press. This book was released on 2009-07-29 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.
Book Synopsis Plastics in Medical Devices by : Vinny R. Sastri
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by William Andrew. This book was released on 2021-11-24 with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt: Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. The book also covers other key aspects in detail, including regulations, compliance, purchasing controls and supplier controls, and process validation. This updated edition has been thoroughly revised with regard to new plastic materials, applications and requirements. This is a valuable resource for engineers, scientists and managers involved in the design and manufacture of medical devices. - Presents detailed coverage of commercially available plastics used in medical device applications, organized by polymer type and supported by data - Includes up-to-date regulatory requirements and practical information on purchasing and supplier controls, process validation and risk management - Supports the development, marketing and commercialization of medical devices and materials for use in medical devices
Book Synopsis Stem Cell Therapies by : Adam C. Berger
Download or read book Stem Cell Therapies written by Adam C. Berger and published by National Academy Press. This book was released on 2014-06-18 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes, and spinal cord injury. Clinical trials of stem cell treatments are under way in countries around the world, but the evidence base to support the medical use of stem cells remains limited. Despite this paucity of clinical evidence, consumer demand for treatments using stem cells has risen, driven in part by a lack of available treatment options for debilitating diseases as well as direct-to-consumer advertising and public portrayals of stem cell-based treatments. Clinics that offer stem cell therapies for a wide range of diseases and conditions have been established throughout the world, both in newly industrialized countries such as China, India, and Mexico and in developed countries such as the United States and various European nations. Though these therapies are often promoted as being established and effective, they generally have not received stringent regulatory oversight and have not been tested with rigorous trials designed to determine their safety and likely benefits. In the absence of substantiated claims, the potential for harm to patients - as well as to the field of stem cell research in general - may outweigh the potential benefits. To explore these issues, the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research held a workshop in November 2013. "Stem Cell Therapies" summarizes the workshop. Researchers, clinicians, patients, policy makers, and others from North America, Europe, and Asia met to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from treatments that are dangerous or ineffective or by steering them toward treatments that are effective. This report discusses the current environment in which patients are receiving unregulated stem cell offerings, focusing on the treatments being offered and their risks and benefits. The report considers the evidence base for clinical application of stem cell technologies and ways to assure the quality of stem cell offerings.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Book Synopsis Anesthesia Equipment E-Book by : Jan Ehrenwerth
Download or read book Anesthesia Equipment E-Book written by Jan Ehrenwerth and published by Elsevier Health Sciences. This book was released on 2013-03-12 with total page 770 pages. Available in PDF, EPUB and Kindle. Book excerpt: Anesthesia Equipment: Principles and Applications, 2nd Edition, by Dr. Jan Ehrenwerth and Dr. James B. Eisenkraft, offers expert, highly visual, practical guidance on the full range of delivery systems and technology used in practice today. It equips you with the objective, informed answers you need to ensure optimal patient safety. Consult this title on your favorite e-reader with intuitive search tools and adjustable font sizes. Elsevier eBooks provide instant portable access to your entire library, no matter what device you're using or where you're located. Make informed decisions by expanding your understanding of the physical principles of equipment, the rationale for its use, delivery systems for inhalational anesthesia, systems monitoring, hazards and safety features, maintenance and quality assurance, special situations/equipment for non-routine adult anesthesia, and future directions for the field. Ensure patient safety with detailed advice on risk management and medicolegal implications of equipment use. Apply the most complete and up-to-date information available on machines, vaporizers, ventilators, breathing systems, vigilance, ergonomics, and simulation. Visualize the safe and effective use of equipment thanks to hundreds of full-color line drawings and photographs. Access the complete text and images online, fully searchable, at www.expertconsult.com.
Book Synopsis Health Technology Assessment in Japan by : Isao Kamae
Download or read book Health Technology Assessment in Japan written by Isao Kamae and published by Springer Nature. This book was released on 2019-09-03 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: Representing the first book on the topic, this work offers the reader an introduction to the Japanese systems for health technology assessment (HTA) officially introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2016. Policy and guidelines are discussed, with the relevant methods and conditions of cost-effectiveness analysis explained alongside. Numerous instructive examples and exercises, ranging from basic to advanced, impart valuable knowledge and insight on the quantitative methods for economic evaluation, which will appeal to both beginners and experts. This guidebook is authored by Japan’s foremost expert in HTA and pharmacoeconomics, with a view to strengthening the reader’s expertise in value-based healthcare and decision-making. The methods presented are essential to informing regulatory, local and patient decisions; as such, the book is equally recommended to industry and government, as well as academia, and anyone with an interest in Japanese HTA.
Book Synopsis Cleaner, Greener, Healthier by : David R. Boyd
Download or read book Cleaner, Greener, Healthier written by David R. Boyd and published by UBC Press. This book was released on 2015-09-01 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite Canada’s enduring image as a natural paradise, every year thousands of Canadians become ill or die prematurely as a result of exposure to environmental hazards. Canadians understand that their health is inextricably linked to the health of the environment and are deeply concerned about the impacts of toxic substances on themselves and their children. In Cleaner, Greener, Healthier, David R. Boyd sets out to remedy Canada’s environmental health problems. He begins by assessing the environmental burden of disease, identifies its unequal distribution along racial and socio-economic lines, and estimates the associated economic costs. He then compares Canadian environmental laws and policies with those in the United States, Australia, and the European Union, delivering a provocative diagnosis of the root causes of Canada’s second-rate standards. Finally, drawing on strategies that protect citizens in other countries, Boyd prescribes legal remedies that will enable Canada to catch up with the world’s environmental leaders while delivering substantial health and economic benefits.
