{"product_id":"safe-medical-devices-for-children-institute-of-medicine-9780309096317","title":"Safe Medical Devices for Children","description":"\u003cp\u003eInnovative 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: \u003c\/p\u003e \u003cul\u003e \u003cli\u003eThe Food and Drug Administration's monitoring and use of adverse event reports\u003c\/li\u003e \u003cli\u003eThe agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing\u003c\/li\u003e \u003cli\u003eThe adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003ePostmarket 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.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0309096316\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780309096317\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e National Academies Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 01\/20\/2006\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 480\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.99lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.30h x 6.68w x 1.19d","brand":"Institute of Medicine","offers":[{"title":"Hardcover","offer_id":48064831652095,"sku":"9780309096317","price":88.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_2f6f0a75-64c7-44bc-9a24-b278204e4de9.jpg?v=1768671326","url":"https:\/\/www.whiterainbookhouse.com\/products\/safe-medical-devices-for-children-institute-of-medicine-9780309096317","provider":"WR Book House","version":"1.0","type":"link"}