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Library of Congress Cataloging-in-Publication Data
Institute of Medicine (U.S.). Committee on Postmarket Surveillance of Pediatric Medical Devices.
Safe medical devices for children / Committee on Postmarket Surveillance of Pediatric Medical Devices, Board on Health Sciences Policy ; Marilyn J. Field and Hugh Tilson, editors ; Institute of Medicine of the National Academies.—1st ed.
p. ; cm.
“This study was supported by Contract No. 223-01-2460, Task Order No. 11 between the National Academy of Sciences and the U.S. Food and Drug Administration.”
ISBN 0-309-09631-6 (hardcover)
1. Pediatrics—Equipment and supplies—Standards—United States. 2. Pediatrics—United States—Equipment and supplies—Evaluation.
[DNLM: 1. Product Surveillance, Postmarketing—standards—Child—United States. 2. Equipment Safety—standards—Child—United States. 3. Equipment and Supplies—standards—Child—United States. WS 26 I61s 2005] I. Field, Marilyn J. (Marilyn Jane) II. Tilson, Hugh Hanna. III. Title.
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Copyright 2006 by the National Academy of Sciences. All rights reserved.
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Front Cover Photographs:
Top row, second from left: CO2SMO® Capnograph/Pulse Oximeter (Used with permission of Respironics, Inc., Murrysville, PA).
Top row, fourth from left: SJM Regent® Valve (Courtesy of St. Jude Medical, Inc.).
Second row, second from left: Vertical Expandable Prosthetic Titanium Rib (VEPTR) (Courtesy of Robert M. Campbell, M.D., Thoracic Institute, CHRISTUS Santa Rosa Children’s Hospital).
Second row, fourth from left: Auria BTE Processor (Courtesy of Advanced Bionics Corporation).
Third row, first from left: Medtronic Paradigm® 515 insulin pump and Paradigm Link™ monitor (Reproduced with permission of Medtronic, Inc.).
Third row, fourth from left: Courtesy of the National Center on Physical Activity and Disability.