active lifestyle. It also discusses ways in which the design and use of devices have been modified (or cannot yet be successfully modified) to accommodate children’s special characteristics. The concluding section describes how problems with pediatric use of medical devices may be identified: a priori based on a combination of expert understanding of children’s developmental characteristics and detailed knowledge of the operating characteristics of a particular device; during the clinical testing of a device with children to demonstrate safety and effectiveness to the U.S. Food and Drug Administration (FDA); and as experience with a device accumulates following its entry into the market.


Infant, Child, Adolescent

As described in Chapter 1, this report generally uses the term children broadly to include all pediatric age groups. Definitions vary for the subgroups infant, child, and adolescent and tend to reflect the concerns and purposes of those developing them. The definitions serve primarily as general guides that encourage attention by clinicians, researchers, policymakers, and others to developmental differences—physical, cognitive, and psychological—within young populations and between younger and older populations.

In guidance documents on pediatric drug testing and assessment of pediatric medical devices, the FDA has defined infants as those younger than 2 years of age (FDA, 1994, 2004p; ICH, 2000).2 The discussion of drug testing notes that this is a period of rapid development in the central nervous system, immune system, renal and hepatic pathways of drug clearance, and body size. While this development is underway, products that are reasonably safe for adults and even older children may be riskier, even lethal, for babies. (An example is verapamil, an antiarrhythmic medication that should be avoided in the young infant.)

The guidance for medical devices does not single out infancy as a period of particular vulnerability, although instances of vulnerability can be cited. For example, studies have repeatedly found infection rates for implanted cerebrospinal fluid shunts to be higher in premature neonates than in other children (see, e.g., McGirt et al., 2003). With respect to certain medical procedures, however, infancy may be a preferred time for interven-


In contrast to FDA, the Centers for Disease Control and Prevention (CDC) defines infant as someone in the period from birth through the first year of life (age 0 to <1 year of age). The CDC definition reflects the agency’s particular interest in data to guide policies and programs to reduce infant mortality. Children under age 1 account for half of all deaths among those under age 20 (Arias et al., 2003).

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