Research Catalog

Title

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.

Author

Institute of Medicine (U.S.). Committee on Postmarket Surveillance of Pediatric Medical Devices.

Publication

Washington, DC : National Academies Press, [2006], ©2006.

Items in the Library & Off-site

Holdings

Details

Additional Authors

• Field, Marilyn J. (Marilyn Jane)
• Tilson, Hugh Hanna.

Description

xxi, 457 pages : illustrations; 24 cm

Subjects

• Equipment Safety > standards
• United States
• Pediatrics > Equipment and supplies > Standards > United States
• Product Surveillance, Postmarketing > standards
• Child
• Pediatrics > United States > Equipment and supplies > Evaluation
• Equipment and Supplies > standards

Note

• "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."

Bibliography (note)

• Includes bibliographical references and index.

Additional Formats (note)

• Also available via the World Wide Web.

System Details (note)

• System requirements: Adobe Acrobat Reader.

Contents

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.

ISBN

• 0309096316 (hardcover)
• 0309097169

LCCN

2005024875

OCLC

• ocm61206076
• SCSB-5221790

Owning Institutions

Columbia University Libraries