NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

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. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for the project.

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.”

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.

RJ34.I57 2005

362.198′92—dc22

2005024875

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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.