Safety of cardiac devices in children

Implanted cardiac devices have improved and prolonged the lives of countless children. Some of these devices have undergone vigorous pre-market assessment and are US Food and Drug Administration (FDA) approved for use in children; however, many devices are used “off label” following approval in adults. The potential for unrecognized and/or under-estimated long term complications is a very real concern, particularly in children where there are unique constraints related to growth, development and need for prolonged device longevity. Long-term oversight is necessary to identify rare and unanticipated device related complications. Current systems include FDA surveillance via adverse event reporting databases and mandated post-approval studies, as well as device related registries. Adverse event reporting databases have provided important information on rare device-related complications but are hampered by a documented very low rate of reporting. Recently several large registries have been developed to track outcomes, however, registries are inherently more effective at tracking short-term safety and efficacy. Looking forward, it is incumbent on physicians, regulatory agencies, and manufacturers to recognize the potential for rare, but serious, device-related complications and to report such complications to established registries and FDA surveillance databases.