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Safe Medical Devices for Children
complex devices used outside the hospital. For chronically ill children reliant on medical devices, psychological and intellectual development (assuming their condition permits it) includes learning how to manage the devices independently and safely. For example, older children who have a tracheostomy can learn to manage a device that permits them to talk with the tracheostomy tube in place.
Sometimes psychosocial development brings risks. For example, older adolescents may be less receptive than children and younger adolescents to parental monitoring of adherence to practices necessary for safe and effective device use. In a similar vein, a clinician in a large pediatric diabetes center has written that “[t]eens are probably the least reliable group to start on the [insulin infusion] pump” because they easily learn to use it but “are typically preoccupied with many other things, and the pump quickly goes down on the priority list” (Ahern, 2001, unpaged).
Risk-taking behavior by adolescents is, generally, a long-standing public health concern (see, e.g., Rolison and Scherman, 2002; Kelley et al., 2004; Steinberg, 2004). Some recent research suggests that the areas of the brain that limit such behavior may not fully mature until a person reaches the mid-twenties (Giedd, 2004).
Finally, one consequence of children’s developmental characteristics is that children often depend on their parents or other adults to provide their medical history to clinicians and to answer and ask questions about a medical problem or its care. Many survey-based measures of pediatric health care quality and outcomes have different forms for children of different ages, and those involving younger children often direct questions at parents (see, e.g., Hermida et al., 1999; Bradlyn et al., 2003; Beal et al., 2004).
Children’s Active Lifestyles
“It has been quite a while since I have had a [hydrocephalus shunt] revision…. There was a period in time when I had five or six in a row, just back to back. The main reason for that [was that] I was racing wheelchair competitively, at the national level, for a while…. The shunt really couldn’t keep up with the strenuous activity. It couldn’t drain the fluid off my brain fast enough…. Eventually, we found a valve that would drain the fluid quick enough.”
Ben Harder, 2004
Another question considered in this report is whether postmarket surveillance studies are adequate to evaluate how children’s active lifestyles may affect failure rates and longevity for implanted devices (see Chapter 6). Although the term active lifestyle may convey an image of a child in motion