[PDF] Safe Medical Devices For Children eBook

Author : Institute of Medicine
Publisher : National Academies Press
Page : 481 pages
File Size : 34,7 MB
Release : 2006-01-20
Category : Medical
ISBN : 0309096316

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Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.

Author : United States Senate
Publisher :
Page : 66 pages
File Size : 21,90 MB
Release : 2019-09-08
Category :
ISBN : 9781691729296

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Ensuring safe medicines and medical devices for children: hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007.

Author : Institute of Medicine
Publisher : National Academies Press
Page : 318 pages
File Size : 35,43 MB
Release : 2011-10-25
Category : Medical
ISBN : 0309212456

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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 : United States. Congress
Publisher : Createspace Independent Publishing Platform
Page : 64 pages
File Size : 20,20 MB
Release : 2018-01-22
Category :
ISBN : 9781984105172

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Ensuring safe medicines and medical devices for children : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007.

Author : Institute of Medicine
Publisher : National Academies Press
Page : 135 pages
File Size : 29,63 MB
Release : 2000-04-07
Category : Medical
ISBN : 0309183642

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The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

Author : Institute of Medicine
Publisher : National Academies Press
Page : 442 pages
File Size : 36,2 MB
Release : 2011-04-03
Category : Medical
ISBN : 0309158060

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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Author : U.S. Government Printing Office (Gpo)
Publisher : BiblioGov
Page : 68 pages
File Size : 37,71 MB
Release : 2013-10
Category :
ISBN : 9781294026105

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The United States Government Printing Office (GPO) was created in June 1860, and is an agency of the U.S. federal government based in Washington D.C. The office prints documents produced by and for the federal government, including Congress, the Supreme Court, the Executive Office of the President and other executive departments, and independent agencies. A hearing is a meeting of the Senate, House, joint or certain Government committee that is open to the public so that they can listen in on the opinions of the legislation. Hearings can also be held to explore certain topics or a current issue. It typically takes between two months up to two years to be published. This is one of those hearings.