Safe Medical Devices For Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309096316
Total Pages : 481 pages
Book Rating : 4.17/5 ( download)

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Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher : National Academy Press
ISBN 13 : 9780309097161
Total Pages : 457 pages
Book Rating : 4.69/5 ( download)

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Download or read book Safe Medical Devices for Children written by and published by National Academy Press. This book was released on 2006-01-01 with total page 457 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher :
ISBN 13 :
Total Pages : 64 pages
Book Rating : 4.42/5 ( download)

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Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2008 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.58/5 ( download)

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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 2011-10-25 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.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.60/5 ( download)

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Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : United States Senate
Publisher :
ISBN 13 : 9781691729296
Total Pages : 66 pages
Book Rating : 4.99/5 ( download)

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Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States Senate and published by . This book was released on 2019-09-08 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : United States. Congress
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781984105172
Total Pages : 64 pages
Book Rating : 4.75/5 ( download)

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Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-01-22 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309156297
Total Pages : 322 pages
Book Rating : 4.95/5 ( download)

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Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

Author : Susan Thaul
Publisher :
ISBN 13 :
Total Pages : 22 pages
Book Rating : 4.86/5 ( download)

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Download or read book FDA's Authority to Ensure that Drugs Prescribed to Children are Safe and Effective written by Susan Thaul and published by . This book was released on 2007 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs--the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003--and enacted a new law addressing devices--the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.

Author : Brian Jacobs
Publisher : Elsevier Health Sciences
ISBN 13 : 1455747394
Total Pages : 240 pages
Book Rating : 4.99/5 ( download)

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Download or read book Safety and Reliability in Pediatrics, An Issue of Pediatric Clinics - E-Book written by Brian Jacobs and published by Elsevier Health Sciences. This book was released on 2012-11-14 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Guest Editors have assembled an international list of top experts to present the most current information to pediatricians about patient safety. The issue has a primarily clinical focus with a few articles addressing the business and practice of patient safety. Articles are devoted to the following topics: Developing performance standards and expectations for safety; The role of CPOE in patient safety; The role of smart infusion pumps on patient safety; Abstracted detection of adverse events in children; The role of effective communication (including handoffs) in patient safety; Reducing mortality resulting from adverse events; Optimizing standardization of case reviews (morbidity and mortality rounds) to promote patient safety; Impact of (resident) duty work hours on patient safety; Role of simulation in safety; The role of diagnostic errors in patient safety; The role of collaborative efforts to reduce hospital acquired conditions; Patient safety in ambulatory care; Role of FDA and pediatric safety; and Patient safety through the eyes of a parent.