of a device) and increasing understanding of certain already recognized problems. Adverse event reports may provide the first signal that a problem exists with a device or its use or both. Adverse event reporting is particularly important for medical devices in pediatric use because events involving children are often unusual, are sometimes extreme, and identify problems in a patient population that often has not been studied before a device is marketed.

Certainly, this report and many other analyses of spontaneous event reporting programs across diverse realms make clear that such programs have significant limitations. These limitations include underreporting, poor-quality reports, delayed reports, reports of problems not associated with a device (i.e., false-positive reports), and lack of information needed to compute and compare rates of events. Efforts to investigate a worrisome event report may be frustrated by distance in time and place from the event, with consequent loss of critical information about the circumstances surrounding the event and unavailability of the suspect device or devices for analysis. The adequacy of FDA resources for event analysis is also a concern.

Initiatives to increase the spontaneous reporting of adverse events present a dilemma. On the one hand, there is general agreement that serious events are underreported; on the other hand, there is concern that increased reporting would likely bring an increase in reporting not only of serious events but also of “noise,” that is, reports that are of no real interest, that are so poorly prepared as to be useless, or that do not even involve device problems or adverse events. Such reports waste the resources of all involved.

Nonetheless, the committee believes it is important for FDA to sustain and improve its adverse event reporting program and demonstrate its value. One objective should be to improve links between the reporting program and various FDA databases, including the databases for device recalls, enforcement, and public health notifications. For example, someone reporting or considering reporting a device problem through the online MedWatch option should be able to link easily and clearly to public health or recall notifications related to the device in question.

FDA should also consider how to encourage reporters to identify when an event involves a child. In some cases, a facility reporter or a manufacturer will know that an incident involved a child without having the child’s exact age. It would be desirable to give such reporters an explicit opportunity to mark whether an event involved a child (age unknown). (The committee recognizes that changing the adverse event reporting form is a major, complicated undertaking, but encourages that this change be evaluated the next time that FDA or Congress considers revisions.)

Recommendation 4.1: FDA should collaborate with industry, health care professionals and organizations, and parent and patient advocates to

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