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Author: S. Lori Brown
Publisher: John Wiley & Sons
ISBN: 9780470060865
Category : Medical
Languages : en
Pages : 528
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Book Description
Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry.
Author: S. Lori Brown
Publisher: John Wiley & Sons
ISBN: 9780470060865
Category : Medical
Languages : en
Pages : 528
Get Book Here
Book Description
Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
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.
Author: Steven M. Teutsch
Publisher: Oxford University Press, USA
ISBN: 0195138279
Category : Medical
Languages : en
Pages : 422
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Book Description
"This text presents an organized approach to planning, developing, and implementing public health surveillance systems. It has a broad scope, discussing legal and ethical issues as well as technical problems"--Jacket cover.
Author: Ebbing Lautenbach
Publisher: Cambridge University Press
ISBN: 1107153166
Category : Medical
Languages : en
Pages : 455
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Book Description
A clear, hands-on outline of best practices for infection prevention that directly improve patient outcomes across the healthcare continuum.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318
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Book Description
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.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241565479
Category : Medical
Languages : en
Pages : 0
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Book Description
This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.
Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 0470654759
Category : Medical
Languages : en
Pages : 977
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Book Description
Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.
Author: Michael J. Paul
Publisher: Morgan & Claypool Publishers
ISBN: 1681736101
Category : Computers
Languages : en
Pages : 188
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Book Description
Public health thrives on high-quality evidence, yet acquiring meaningful data on a population remains a central challenge of public health research and practice. Social monitoring, the analysis of social media and other user-generated web data, has brought advances in the way we leverage population data to understand health. Social media offers advantages over traditional data sources, including real-time data availability, ease of access, and reduced cost. Social media allows us to ask, and answer, questions we never thought possible. This book presents an overview of the progress on uses of social monitoring to study public health over the past decade. We explain available data sources, common methods, and survey research on social monitoring in a wide range of public health areas. Our examples come from topics such as disease surveillance, behavioral medicine, and mental health, among others. We explore the limitations and concerns of these methods. Our survey of this exciting new field of data-driven research lays out future research directions.
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 160
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
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Book Description
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.
