Safe Medical Devices for Children

Front Matter......Page 2
Preface......Page 8
Acknowledgments......Page 12
Reviewers......Page 14
Contents......Page 16
Boxes, Figures, and Tables......Page 19
Summary......Page 24
1 Introduction......Page 40
2 Medical Devices for Infants, Children, and Adolescents......Page 69
3 Regulatory Framework for Postmarket Surveillance of Medical Devices......Page 96
4 Identifying and Understanding Adverse Medical Device Events......Page 135
5 Monitoring of Postmarket Study Commitments Involving Medical Devices......Page 206
6 Adequacy of Pediatric Postmarket Surveillance Studies......Page 222
7 Children and Medical Device Safety: A Shared Responsibility......Page 252
References......Page 273
Appendixes......Page 302
A Study Origins and Activities......Page 304
B Medical Devices for Pediatric Care......Page 311
C The Dynamics of Pediatric Device Innovation: Putting Evidence in Context......Page 325
D Questions and Methods in Surveillance Programs......Page 350
E The Regulatory History of Cerebrospinal Fluid Shunts for Hydrocephalus......Page 370
F Cochlear Implants in Children: A Review of Reported Complications, Patterns of Device Failure, and Assessment of Current Approaches to Surveillance......Page 405
G Glossary......Page 445
H Committee Biographical Statements......Page 456
Index......Page 462