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Books > Medicine > General issues > Medical equipment & techniques
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Safe Medical Devices for Children (Hardcover)
Loot Price: R1,557
Discovery Miles 15 570
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Safe Medical Devices for Children (Hardcover)
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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. Table of Contents
Front Matter Summary 1 Introduction 2 Medical Devices for Infants,
Children, and Adolescents 3 Regulatory Framework for Postmarket
Surveillance of Medical Devices 4 Identifying and Understanding
Adverse Medical Device Events 5 Monitoring of Postmarket Study
Commitments Involving Medical Devices 6 Adequacy of Pediatric
Postmarket Surveillance Studies 7 Children and Medical Device
Safety: A Shared Responsibility References Appendix A Study Origins
and Activities Appendix B Medical Devices for Pediatric Care
Appendix C The Dynamics of Pediatric Device Innovation: Putting
Evidence in Context Appendix D Questions and Methods in
Surveillance Programs Appendix E The Regulatory History of
Cerebrospinal Fluid Shunts for Hydrocephalus Appendix F Cochlear
Implants in Children A Review of Reported Complications, Patterns
of Device Failure, and Assessment of Current Approaches to
Surveillance Appendix G Glossary and Acronyms Appendix H Committee
Biographical Statements Index
General
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