Children are not small adults—a cliché but true. As described above, children, especially infants and young children, differ from adults in ways that extend beyond the obvious difference in size. These differences may have implications for the design and use of devices and for the methods to evaluate their safety and effectiveness before and after marketing.
Developmental differences between children and adults related to the safe and effective use of medical products have been most extensively analyzed and described for drugs. For drugs, scientists and clinicians have constructed a strong rationale for pediatric drug research to assure the safe and effective use of medications with children. Data indicating that some 80 percent of medications listed in the Physician’s Desk Reference lacked any prescribing information for children have also been cited to build the case for such research.
For medical devices, the committee found nothing equivalent to the pharmacology literature on developmental concerns. With drugs, one is generally considering issues along a spectrum: ingestion, bioavailability, action, untoward actions, metabolism, and disposal of metabolites. This is complex enough. With devices, one might be considering physical interactions, metabolic interactions, and growth, among other factors. Box 2.1 summarizes some of the developmental considerations for drugs compared to medical devices.
To the extent that pediatric considerations are known for a medical device, the labeling of the device should reflect that knowledge. In some cases, labeling will state that use of a device is not indicated in those under a certain age or those who are not skeletally mature. In other cases, the labeling may describe adaptations or cautions related to pediatric use.
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