Safe Medical Devices for Children

Released on by Institute of Medicine
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  • Safe Medical Devices for Children Book Detail

  • Author : Institute of Medicine
  • Release Date : 2006-01-20
  • Publisher : National Academies Press
  • Genre : Medical
  • Pages : 481
  • ISBN 13 : 0309096316
  • File Size : 70,70 MB
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Safe Medical Devices for Children by Institute of Medicine PDF Summary

Book 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.

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Safe Medical Devices for Children

Safe Medical Devices for Children

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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 an

Medical Devices and the Public's Health

Medical Devices and the Public's Health

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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