in randomized clinical trials and other studies, many centers limit ECMO to use as a rescue therapy when the center’s best efforts to ventilate have failed (Truog, 1998; AAP, 2000a). ECMO also continues as a valuable last resort for infants and small children with acute heart failure who require circulatory support until heart function recovers or a heart transplant can be performed.

When successful, innovative medical devices such as those involved in the ECMO procedure can offer dramatic cures, sustain life until another therapy is available, slow the progression of disease, or ease the distress caused by an incurable condition. Long-term and even relatively short-term exposure to a device—and the surgical or other procedures associated with its use—can, however, alter a child’s development in complex ways. Some of the effects may be suspected in advance, but others may be identified only through careful follow-up monitoring and evaluation. Unwanted developmental outcomes may not be evident for a number of years and thus will not be detected by short-term studies.

Chapter 2 introduced the concepts of children’s growth and development and their active lifestyles and then described some of the physical, cognitive, emotional, behavioral, and social characteristics of children that may affect the design, use, and performance of medical devices. It noted that children’s activities pose a risk of traumatic damage to certain implanted or attached devices. In addition, children’s growth and development may affect the performance of a device. For example, growing tissues may put increased stress on some biomechanical devices. Causation may also operate in the reverse direction, that is, certain devices may interfere with children’s growth.

The legislation that called for this report asked for an assessment of whether postmarket surveillance studies last long enough to evaluate the impact of growth and development for the number of years that a child has an implant. It also asked whether such studies are adequate to assess the effects of children’s active lifestyles on implant longevity and failure rates. These questions reflect awareness that children’s developmental characteristics may affect their experience with an implanted device. They likewise show an understanding that short-term studies of safety and effectiveness are not well suited to determine how children’s growth and development may affect the performance of an implant—and vice versa. The committee interpreted its task to involve specifically an assessment of Section 522 Postmarket Surveillance studies, but it also considered other kinds of studies and sources of information.

The next section of this chapter reports the sparse results of the committee’s search for postmarket studies or other information focused on the two child-centered questions identified in the legislation. The discussion then expands to consider more generally strategies for postmarket evalua-



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