According to Food and Drug Administration (FDA), some 80,000 medical devices are marketed in the United States, ranging from those as simple as plastic tubing and baby bottle nipples to others as complex as pacemakers or cerebrospinal fluid shunts. Although low-risk devices like plastic tubing need not be evaluated by FDA before going to market, between 55 percent and 60 percent of all devices are considered to be higher risk and require agency review before they can enter the market.
In this IOM study, sponsored by the FDA, the committee was charged with evaluating FDA's postmarket surveillance of medical devices used with children specifically.
The committee found that the FDA lacks effective procedures to monitor the status of safety studies of medical devices and recommended that Congress ensure that the agency establishes a reliable system to track these postmarket studies. The committee also recommended that the information collected by this system be made available to patients, health care providers, and researchers in a format that allows users to find studies that look at studies involving children.
Additionally, the committee found that it was difficult to reliably identify postmarket studies that considered pediatric issues or focused on children. The report recommends that the current 3-year limit on the length of studies ordered after a device is marketed be lifted for appropriate studies involving the effects of children's growth and development. Because children represent a small market for devices, imposing requirements on manufacturers to conduct studies examining their use in pediatric patients could inhibit the development of new equipment for children, the committee acknowledged.
The report also recommended that FDA, the National Institutes of Health, and others set priorities for research on unanswered questions about the safe use of devices with children.