Medical Device Reporting:

Improvements Needed in FDA's System for Monitoring Problems With Approved Devices

HEHS-97-21: Published: Jan 29, 1997. Publicly Released: Jan 29, 1997.

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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.

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 for Executive Action

  1. Status: Closed - Not Implemented

    Comments: FDA says that manufacturers are required to do trend analyses under the new medical device regulation. Because of this requirement and insufficient FDA staff, FDA does not plan to implement this recommendation.

    Recommendation: To improve FDA's adverse event reporting system's ability to serve as an early warning system about medical device problems as intended by SMDA 90, the Commissioner, FDA, should collect and disseminate adverse event trend analysis and corrective actions taken by manufacturers and FDA to the medical device community.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Implemented

    Comments: Under FDA's new medical device regulation, manufacturers are required to document corrective actions and report them to FDA. FDA's Office of Compliance has developed a database for recording corrective actions that were taken as a result of investigations of device problems.

    Recommendation: To improve FDA's adverse event reporting system's ability to serve as an early warning system about medical device problems as intended by SMDA 90, the Commissioner, FDA, should document corrective actions on adverse event reports that result from analysis and investigations of device problems.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Implemented

    Comments: FDA has completed a training program for field staffs that go to user facilities to educate them about their responsibilities under SMDA. FDA has also sent a letter to user facilities that may not be in compliance with SMDA 90.

    Recommendation: To improve FDA's adverse event reporting system's ability to serve as an early warning system about medical device problems as intended by SMDA 90, the Commissioner, FDA, should use reports of death provided by manufacturers and others to identify user facilities that may not be reporting to manufacturers, FDA, or both in violation of SMDA 90.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  4. Status: Closed - Implemented

    Comments: FDA continues to improve the information in its new MAUDE data system, but it has no plans to compile and evaluate statistics on the time it takes to process, review, and act on adverse event reports. However, FDA has instituted a triage system called code blue to flag medical device reports that warrant immediate action. However, at this time CDRH has no plans to evaluate the information.

    Recommendation: To improve FDA's adverse event reporting system's ability to serve as an early warning system about medical device problems as intended by SMDA 90, the Commissioner, FDA, should collect and maintain reliable statistics on the time it takes to process, review, and initiate action an adverse event reports.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  5. Status: Closed - Implemented

    Comments: FDA conducted pilot programs to evaluate the potential effectiveness of an adverse event reporting system for medical devices. Eventually, this resulted in FDA implementing the Medical Product Safety Network (MedSun) in 2010 in order to identify medical device-associated risks. The network includes over 350 health care facilities from all regions of the country. The facilities are primarily hospitals but also include outpatient clinics, nursing homes, home health agencies, and outpatient treatment and diagnostic facilities. MedSun was specifically developed to overcome the under-reporting of medical device problems. Prior to MedSun, FDA received .045 adverse event reports per hospital. In the MedSun system, the average number of reports is about 7.5 per hospital per year. FDA has stated that MedSun reports have contributed substantially to its ability to understand problems with medical devices. MedSun reports have often been the initial signal to FDA that a problem was occurring with the use of a device. Additionally, more than 90 percent of MedSun participants report that participation in the program has improved safety in their facilities. Participants receive device-related information from FDA on their reported issues. Subnetworks have also been developed to better target specific clinical areas in MedSun facilities such as hospital laboratories and neonatal and pediatric intensive care units.

    Recommendation: FDA's study of an adverse event reporting system based on a representative sample of user facilities should focus on whether this approach can provide manufacturers and FDA with the quantity and quality of information needed to rapidly identify and correct problems with devices that have varying usage rates.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

 

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