SMDA 90 and Related Regulations

To improve the flow of information about medical device problems to FDA’s adverse event reporting system, the Congress passed SMDA  requires the establishment of a network of communication about device-related events among user facilities, distributors, manufacturers, and FDA. To speed processing and analysis of reports, FDA has initiated several changes to its adverse event reporting system. Manufacturer Reports Have Increased Significantly

Manufacturer reports of medical device problems increased dramatically after SMDA  directly accounted for the increased volume of reports because, until recently, FDA did not systematically collect information on the source of complaints. A comparison of two 4-year periods, fiscal years 1987 through 1990 and 1991 through 1994, illustrates the rapid growth of FDA officials believe the upward trend in reporting is due to (1) the unanticipated, large volume of problems associated with silicone gel-filled breast implants, which accounted for nearly one-third of all of the manufacturer event reports submitted to FDA during fiscal years 1992 through 1994, and (2) increased compliance by manufacturers with the 1984 medical device reporting regulation and SMDA . Although FDA assigns malfunction reports a lower priority than reports of death and serious injury, processing malfunction reports quickly is critical because of their potential to alert FDA to device problems that could cause or contribute to a death or serious injury if the malfunction were to recur. Further, user facilities’ reports are often late, inaccurate, or incomplete. User Facilities May Be Underreporting Deaths to FDA

Before SMDA ’s reporting requirements became effective in late 1991, user facilities were not required to submit device-related adverse event reports to manufacturers and FDA. 4). Untimely and poor quality reports limit FDA’s ability to identify device problems and assess the risk to the public health. However, of the 5,199 serious injury and illness reports FDA had received from user facilities as of June 1995, 3,588 (69 percent) did not need to have been sent to FDA because the user facility knew the manufacturer and identified it in the report. Finally, FDA cannot assess its performance as an early warning system for device problems because it does not keep track of the length of time that it takes to review and resolve serious device problems. FDA Does Not Record How Long It Takes to Respond to Reported Device Problems

Maintaining reliable productivity indicators on the length of time FDA takes to process, review, and initiate action on device problems and on the time that passes before manufacturers correct the problems would better ensure that serious device problems are receiving prompt attention. Conclusions

The quantity of information reported to FDA about medical device problems has increased dramatically since SMDA ’s reporting requirements became effective in 1991. Because FDA has not ensured that reported device problems receive prompt attention and appropriate resolution, however, its adverse event reporting system is not providing an early warning about device problems. Furthermore, although FDA’s initiatives may improve its reporting system, they do not address its difficulty in ensuring prompt resolution of device problems, compliance with SMDA document corrective actions on adverse event reports that result from analysis and investigations of device problems; and collect and disseminate adverse event trend analysis and corrective actions taken by manufacturers and FDA to the medical device community. Specifically, FDA believes that (1) medical device reports are supplemental in nature and that its entire postmarket surveillance system, its GMP regulations, and other related activities combined constitute the most comprehensive source of information regarding marketed medical devices; (2) the deficiencies in the adverse event reporting system cited in our report are being corrected; and (3) adverse event reports from all sources are promptly and thoroughly reviewed, and appropriate actions are taken to protect the public health. Scope and Methodology

We conducted our review of the Food and Drug Administration’s (FDA) implementation of the Safe Medical Devices Act of 1990 (SMDA  and to publish the final medical device reporting regulation required by the act.
Why GAO Did This Study

Pursuant to a legislative requirement, GAO reviewed user facilities' compliance with the Safe Medical Devices Act of 1990's (SMDA 90) reporting requirements, focusing on whether: (1) the enactment of SMDA 90 has led to an increase in reporting of device-related adverse events to the Food and Drug Administration (FDA); (2) the amount and quality of information from user facilities have enhanced FDA's ability to quickly identify and take action on device problems; (3) manufacturers and FDA have responded to device problems identified in user facility reports; (4) FDA routinely communicates device problem trends and corrective actions taken to user facilities and the public; and (5) changes need to be made to the user facility reporting requirements and FDA's adverse event reporting system to improve medical device problem reporting.

What GAO Found

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.