U.S. Food and Drug Administration’s (FDA’s) overall program of postmarket surveillance. A primary aim of the agency’s adverse event reporting program is to identify serious problems with a device (or its use) that become evident after a device is marketed when—depending on the device—it is used with many more patients, with different patient populations (e.g., children), in different ways (e.g., involving ad hoc modifications for pediatric use), for different purposes, in new and possibly less well-equipped settings, over longer periods, and, sometimes, by less experienced or skilled clinicians and care teams. Systematic clinical studies are often a superior tool for assessing these dimensions of device use, but such studies are not realistic for the entire array of devices that enter the market each year. Moreover, just as premarket studies may fail to detect rare events, so may postmarket clinical studies.

Although FDA is most interested in reports of serious unanticipated events, the adverse event reporting program also collects information that can be useful in understanding certain already recognized risks, for example, patient deaths by entrapment in the rails of hospital beds. In addition, reports of device failures and malfunctions—even when they have not caused harm—can help FDA and manufacturers to detect hazards that arise from aberrations in the manufacturing, distribution, modification, maintenance, storage, or reprocessing of a medical device. Adverse event reports can also lead to improvements in the design of a device. For example, in response to problem reports, manufacturers have redesigned cardiac pacemakers to make them substantially less susceptible to electromagnetic interference from modern necessities such as microwave ovens and cellular telephones (Niehaus and Tebbenjohanns, 2001).

For the most part, the public health goals and the limitations of postmarket surveillance policies and programs apply to both adults and children. Systems that support effective postmarket surveillance for patients generally are the foundation on which additions, adaptations, or emphases suited to children’s particular needs are then built. For example, the FDA guidance on assessment of pediatric medical devices cited in Chapter 2 makes sense only within an already existing structure for evaluating the safety and effectiveness of medical devices.

The first part of this chapter expands on Chapter 3’s description of the FDA program for adverse event reporting. It includes statistics on reports to FDA of adverse device events that involve children and presents examples of actual reports. This discussion is followed by a number of vignettes that illustrate the range of factors and devices that contribute to adverse medical device events with children and the complexities in identifying and understanding these events. Most of the vignettes depict events that result not from single faults or errors but rather from the interplay between weaknesses in some aspect of the design or manufacture of devices and the



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