[...]... mar1 2 SAFE MEDICAL DEVICES FOR CHILDREN BOX S.1 Design or Adaptation of Medical Devices for Use with Children Devices unique to children • Infant incubators • Bililights (for treating neonatal jaundice) • Newborn hearing screener Devices developed primarily for children but also used with adults • Atrial septal defect occluder • Cerebrospinal fluid shunt Same core device, different accessories for pediatric... Pediatric Use of Medical Devices (with Examples), 3 1.1 Examples of Life-Saving and Life-Sustaining Medical Devices for Children, 20 Categories of Medical Devices for Purposes of FDA Scientific Review, 31 1.2 2.1 2.2 2.3 3.1 3.2 3.3 3.4 Examples of Developmental Considerations or Potential Complications for Drugs and Devices, 57 Design or Adaptation of Medical Devices for Use with Children, 58 Identifying... primarily for use with children Often, however, devices used with children have been initially developed for, tested with, and most frequently employed to treat adults, who constitute a much larger market for medical services than children Sometimes it is obvious that a device developed for adults is not—in that form—suitable for some children, for example, when an implanted device is too large for infants... INFANTS, CHILDREN, AND ADOLESCENTS Definitions, 48 FDA Guidance on Assessment of Pediatric Medical Devices, 54 Device Design, Device Use, and Developmental Differences, 55 Identifying Problems or Concerns with Medical Devices Used with Children, 69 3 REGULATORY FRAMEWORK FOR POSTMARKET SURVEILLANCE OF MEDICAL DEVICES Organization of FDA for Medical Device Regulation, 74 Basics of Premarket Regulation of Medical. .. partly because the market for most medical products is concentrated among adults, especially older adults Moreover, discussions of medical product regulation and patient safety focus more on pharmaceuticals than on medical devices and more on the assessment of products prior to marketing than on the subsequent surveillance of product performance 4 SAFE MEDICAL DEVICES FOR CHILDREN During the course... define a research agenda and priorities for the evaluation of the short- and longterm safety and effectiveness of medical devices used with growing and developing children The expanding use of electronic patient information systems presents opportunities to strengthen studies of device outcomes and also improve surveil- 8 SAFE MEDICAL DEVICES FOR CHILDREN lance for adverse events Capitalizing on these... Attention to Pediatric Issues In addition to calling for this study, Congress has directed attention to pediatric device safety in other ways, for example, by directing FDA to 10 SAFE MEDICAL DEVICES FOR CHILDREN prepare reports on premarket assessment of pediatric medical devices, barriers to pediatric device development, and pediatric expertise for device safety advisory panels Also as directed by Congress,... 222 7 CHILDREN AND MEDICAL DEVICE SAFETY: A SHARED RESPONSIBILITY FDA Performance of Postmarket Surveillance of Medical Devices, 232 Resources to Support Postmarket Device Surveillance, 238 Tensions in Public Policy and Device Innovation, 240 Shared Responsibilities for Medical Device Safety, 241 REFERENCES 199 229 250 APPENDIXES A B C Study Origins and Activities Medical Devices for Pediatric Care... effective regulatory program for evaluating and monitoring the safety of medical devices in general is a necessary foundation for efforts to safeguard children in particular This basic foundation then requires the addition of pediatric expertise and resources • The regulation of medical devices reasonably differs from the regulation of drugs Medical devices are more variable than drugs in their mode of operation,... initiatives that focus on children tend not to feature medical devices Still, even programs that focus on adults, drug safety, or other topics may encourage practices, procedures, and ways of thinking that can— indirectly or directly—help create an environment that promotes the safe use and design of medical devices for children For example, increased expertise in root cause analysis of medical errors and . Medical Devices for Children, 20 1.2 Categories of Medical Devices for Purposes of FDA Scientific Review, 31 2.1 Examples of Developmental Considerations or Potential Complica- tions for Drugs and Devices, . 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. of Medical Device Regulation, 36 Medical Device Regulation in Context, 41 2 MEDICAL DEVICES FOR INFANTS, CHILDREN, AND ADOLESCENTS 46 Definitions, 48 FDA Guidance on Assessment of Pediatric Medical