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 use

  • Pulse oximeter with different sensor attachment for infants

  • Automated external defibrillator with paddles that deliver electrical shocks based on pediatric-specific algorithms

Variations in device use or technique to accommodate developmental differences

  • Adjustment in radiation dose and frequency for computed tomography

  • Shift in implantation site for pacemakers used with young children

  • Use in pediatric cardiac procedures of adult bile duct stents

Variation in device size for use with small patients

  • Bronchoscopes

  • Heart valves

  • Testicular prostheses

keted and then used for longer periods and with larger and more varied populations, including children.

As illustrated in Box S.2, benefits and harms with pediatric use of medical devices may be identified in several ways: (1) a priori based on expert understanding of children’s developmental characteristics and detailed knowledge and modeling of the operating characteristics of a particular device; (2) during the clinical testing of a device with children to demonstrate safety and effectiveness; and (3) as experience with a device accumulates following its entry into the market. At each stage, the key questions are whether the expected benefits of a device, on balance, outweigh expected harms and whether the benefit–harm profile is more favorable than that of available alternatives.

STATEMENT OF TASK

This report responds to a provision in the Medical Device User Fee and Modernization Act of 2002 (P.L. 107–250) that called for the Institute of Medicine (IOM) to assess whether “the system under the Federal Food, Drug, and Cosmetic Act for the postmarket surveillance of medical devices



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