Medical Device Reporting

The Food and Drug Administration (FDA) is responsible for protecting the American public from unsafe and ineffective medical devices, which range from simple household items, such as thermometers, to implanted heart valves. During the past 15 years, the U.S. medical device industry has grown from 5,900 to 16,900 firms; more than $40 billion was spent on such devices in the United States in 1994. Medical device manufacturers have been required since 1984 to report malfunctions, along with resulting injuries and deaths, to FDA. Hospitals and other facilities, however, were not required to report these cases and rarely did so. As a result, Congress passed the Safe Medical Devices Act of 1990, which expanded the reporting requirements to include user facilities, such as hospitals and nursing homes, and medical device distributors. GAO found that although FDA collects reports from users, hospitals, nursing homes, manufacturers, and others about problems with medical devices, FDA does not act systematically to ensure that reported problems are resolved promptly, thus defeating the system's usefulness as an early warning about defective medical devices.

GAO found that: (1) although the amount of information reported to FDA about medical device problems has increased dramatically since SMDA 90 was enacted, FDA does not systematically act to ensure that the reported problems receive prompt attention and appropriate resolution; (2) as a result, FDA's adverse event reporting system is not providing an early warning about problem medical devices as SMDA 90 intended; (3) during fiscal years (FY) 1991 through 1994, FDA received almost four times as many adverse event reports from device manufacturers as it did during FY 1987 through 1990; (4) however, the extent to which user facility reporting under SMDA 90 directly accounted for the increased volume of reports is unclear because, until recently, FDA did not require manufacturers to disclose whether serious injury reports originated from user facilities or from some other source; (5) this increased volume made it difficult for FDA to process and review reports in a timely manner; (6) to address this problem, FDA chose to give priority to death and serious injury reports, which resulted in its delaying for nearly 2 years processing and reviewing almost 50,000 malfunction reports, which are essential in alerting FDA to potentially serious device problems before they result in death or serious injury; (7) to better manage the reporting workload in the future, FDA has initiated several changes to the adverse event reporting system; (8) FDA has received significantly fewer adverse event reports from user facilities than it expected; (9) much of the information that user facilities did provide was of poor quality and incomplete, in part because FDA did not issue the final medical device reporting regulation in a timely manner or periodically educate user facilities about their responsibilities under SMDA 90; (10) although FDA contends that it notifies manufacturers and user facilities about imminent hazards and industrywide safety concerns, it does not routinely document the corrective actions it takes or those taken by manufacturers to address reported medical device problems; (11) FDA does not keep track of the length of time it takes to process, review, and initiate action on serious device-related problems or the time that elapses before manufacturers resolve the problems; (12) manufacturer and user facility representatives told GAO they do not know how FDA uses adverse event reports to protect the public health; and (13) FDA and representatives of both medical devise users and manufacturers believe that the reporting system is overburdened with reports and data that may not be necessary to detect and resolve device problems.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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