Medical Devices

Manufacturers of critical medical devices, such as heart valves and pacemakers, are required to operate tracking systems to quickly locate and remove defective devices from the market and notify patients who use them. Weak oversight of manufacturer tracking and recall systems, however, threatens the Food and Drug Administration's (FDA) ability to adequately protect the public. FDA's inspections of the tracking systems do not include independent audits to verify the completeness and accuracy of data in the systems. Instead, the inspections focus on reviews of the manufacturers' written standard operating procedures for tracking. Despite good manufacturing practice standards that require FDA to inspect manufacturers of tracked devices at least once every two years, only about half of the 238 manufacturers subject to tracking were inspected during 1996 and 1997. FDA officials said that they plan to revise their inspection program to include an audit plan to better assess manufacturers' compliance with the tracking requirements and redirect FDA's compliance priorities toward high-risk devices, such as implants. The details for most of these plans, however, have yet to be determined. GAO also found that manufacturers and FDA have not acted promptly to correct and remove defective devices from the market. Less than one-third of the 54 recalls initiated from 1994 through 1996 were completed by manufacturers within six months, as specified by FDA's guidelines. FDA has also had problems terminating device recalls in a timely manner.

GAO noted that: (1) there are several weaknesses in FDA's approach for determining whether device manufacturers are operating tracking systems capable of quickly locating and removing defective devices from the market and notifying patients who use them; (2) FDA's inspections of the tracking systems do not include independent audits that could verify the completeness and accuracy of data in the systems; (3) instead, the inspections focus on reviews of the manufacturers' written standard operating procedures for tracking; (4) further, although the good manufactured product standard require FDA to inspect manufacturers of tracked devices at least once every 2 years, only about one-half of the 238 manufacturers subject to tracking were inspected during fiscal year (FY) 1996 and FY 1997; (5) FDA attributed its limited inspection activity to a reduction in field resources; (6) FDA has also not acted to ensure that device tracking continues when establishments go out of business, merge, or are acquired by other entities; (7) FDA officials told GAO they are planning to revise their inspection program to include an audit plan to better assess manufacturers' compliance with the tracking requirements and redirect FDA's compliance priorities toward high-risk devices, such as implant devices; (8) the details for most of these plans, however, have not yet been determined; (9) in GAO's analysis of FDA's recall data, manufacturers and FDA have not acted in a timely manner to correct and remove defective devices from the market; (10) less than one-third of the 54 recalls initiated from FY 1994 through FY 1996 were completed by manufacturers within 6 months, as specified in FDA guidelines; (11) FDA has also had problems terminating device recalls in a timely manner; (12) less than one-half of the 49 recalls reported completed by manufacturers were reviewed and terminated by FDA within the 90-workday standard established by the agency; and (13) FDA officials have identified several factors that may contribute to delays in completing recalls, but an in-depth review of the recall procedures used by manufacturers and FDA has not been conducted.

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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