Safe Medical Devices for Children

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Size: 480 pages, 6x9

Publication Year:2005

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Authors:
Marilyn J. Field and Hugh Tilson, Editors, Committee on Postmarket Surveillance of Pediatric Medical Devices
Authoring Organizations

Description:
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 ...
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Table of Contents
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Front Matter	i-xxii
Summary	1-16	(skim)
1 Introduction	17-45	(skim)
2 Medical Devices for Infants, Children, and Adolescents	46-72	(skim)
3 Regulatory Framework for Postmarket Surveillance of Medical Devices	73-111	(skim)
4 Identifying and Understanding Adverse Medical Device Events	112-182	(skim)
5 Monitoring of Postmarket Study Commitments Involving Medical Devices	183-198	(skim)
6 Adequacy of Pediatric Postmarket Surveillance Studies	199-228	(skim)
7 Children and Medical Device Safety: A Shared Responsibility	229-249	(skim)
References	250-278	(skim)
Appendix A Study Origins and Activities	279-287	(skim)
Appendix B Medical Devices for Pediatric Care	288-301	(skim)
Appendix C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context	302-326	(skim)
Appendix D Questions and Methods in Surveillance Programs	327-346	(skim)
Appendix E The Regulatory History of Cerebrospinal Fluid Shunts for Hydrocephalus	347-381	(skim)
Appendix F Cochlear Implants in Children A Review of Reported Complications, Patterns of Device Failure, and Assessment of Current Approaches to Surveillance	382-421	(skim)
Appendix G Glossary and Acronyms	422-432	(skim)
Appendix H Committee Biographical Statements	433-438	(skim)
Index	439-458	(skim)

Description

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.

Authoring Organizations

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