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:
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.
Table of Contents
|2 Medical Devices for Infants, Children, and Adolescents||46-72|
|3 Regulatory Framework for Postmarket Surveillance of Medical Devices||73-111|
|4 Identifying and Understanding Adverse Medical Device Events||112-182|
|5 Monitoring of Postmarket Study Commitments Involving Medical Devices||183-198|
|6 Adequacy of Pediatric Postmarket Surveillance Studies||199-228|
|7 Children and Medical Device Safety: A Shared Responsibility||229-249|
|Appendix A Study Origins and Activities||279-287|
|Appendix B Medical Devices for Pediatric Care||288-301|
|Appendix C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context||302-326|
|Appendix D Questions and Methods in Surveillance Programs||327-346|
|Appendix E The Regulatory History of Cerebrospinal Fluid Shunts for Hydrocephalus||347-381|
|Appendix F Cochlear Implants in Children A Review of Reported Complications, Patterns of Device Failure, and Assessment of Current Approaches to Surveillance||382-421|
|Appendix G Glossary and Acronyms||422-432|
|Appendix H Committee Biographical Statements||433-438|
The National Academies Press (NAP) has partnered with Copyright Clearance Center's Rightslink service to offer you a variety of options for reusing NAP content. Through Rightslink, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Rightslink allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Rightslink you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the National Academies Press (NAP) through Rightslink:
Click here to obtain permission for the above reuses. If you have questions or comments concerning the Rightslink service, please contact:
Rightslink Customer Care
Tel (toll free): 877/622-5543
To request permission to distribute a PDF, please contact our Customer Service Department at 800-624-6242 for pricing.
To request permission to translate a book published by the National Academies Press or its imprint, the Joseph Henry Press, please click here to view more information.