United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Health, Education, and Human Services Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1997-01-29 monographic deposited born digital 60 p. GA 1.13:HEHS-97-21 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-97-21 P0b002ee18037af83 f:he97021 DGPO 2010-08-12 2011-03-28 GAOREPORTS-HEHS-97-21 machine generated eng fdlp REPORT GAOREPORTS-HEHS-97-21 HEHS-97-21 Medical equipment Reporting requirements Product safety Consumer protection Statistical methods Food and drug law Hospitals Government information dissemination FDA Medical Device Reporting System FDA Medical Device and Laboratory Problem Reporting Program FDA Manufacturer and User Device Experience System FDA Medical Products Reporting Program FDA MedWatch System FDA Good Manufacturing Practices Compliance Program Letter Report HEHS 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.<p/>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 re* https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-97-21/html/GAOREPORTS-HEHS-97-21.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-97-21/pdf/GAOREPORTS-HEHS-97-21.pdf GAO/HEHS-97-21 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-97-21 Letter Report GAO/HEHS-97-21; Medical Device Reporting: Improvements Needed in FDA's System for Monitoring Problems With Approved Devices; Medical equipment Reporting requirements Product safety Consumer protection Statistical methods Food and drug law Hospitals Government information dissemination FDA Medical Device Reporting System FDA Medical Device and Laboratory Problem Reporting Program FDA Manufacturer and User Device Experience System FDA Medical Products Reporting Program FDA MedWatch System FDA Good Manufacturing Practices Compliance Program