problems, and they have also expressed concern about the limited testing of device safety and effectiveness with children of different ages (AAP et al., 2004b; FDA, 2004y). These views echo those long expressed about pharmaceuticals for children (AAP, 1977, 1995). Doubtful that government or industry will invest significant resources to develop specialized devices and drugs for children, some children’s hospitals have begun their own programs to do so. For example, Children’s Hospital Boston has announced a Pediatric Product Development Initiative that is focusing on the initial stage of development for pediatric devices that have the potential to attract commercial investors once a promising prototype is produced (Kong, 2004).

Notwithstanding the desirability of medical devices that meet children’s needs, the reality is that children are not the primary patient population for most complex medical devices. Most children living in developed countries are basically healthy. Compared to adults, especially older adults, they are far less likely to die, be hospitalized, or suffer serious illness. In the United States in 2001, people under age 20—who constitute nearly 30 percent of the population—accounted for about 2 percent of deaths and about 11 percent of hospital discharges (excluding newborns) (Arias et al., 2003; Kozak et al., 2004). In 2003, over 80 percent of children had health status reported as “excellent” or “very good” compared to about 65 percent of people aged 18 to 64 and about 39 percent of people aged 65 or over (Schiller et al., 2004).

Children are, however, overrepresented or uniquely represented among certain causes of suffering and death, notably those associated with prematurity and congenital anomalies (a diverse group of malformations, deformations, and chromosomal abnormalities present at birth). In addition, although individuals under age 20 account for about 10 percent of fatal injuries (intentional and unintentional injuries, 2001 data), they account for over one-third of nonfatal injuries (2002 data) (NCIPC, 2001, 2002).

Children, particularly newborns, are also overrepresented or uniquely represented among patients treated with certain medical devices. These devices include infant incubators, devices for closing the patent ductus arteriosus (a congenital blood vessel defect), home apnea monitors, and devices for screening hearing in newborns.

The committee found current data on medical device use by age group to be virtually nonexistent, but children clearly form a small proportion overall of patients in need of or treated with devices for serious medical conditions. One consequence is that manufacturers and others assessing the market for new, refined, or modified devices have weak incentives to focus on children’s special needs and characteristics.

This chapter provides a specific pediatric context for the consideration of postmarket surveillance of medical devices used with children. It reviews definitions of pediatric subgroups (infant, child, adolescent) as well as two terms in the committee’s statement of task—growth and development and



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