Medical Devices:

FDA Can Improve Oversight of Tracking and Recall Systems

HEHS-98-211: Published: Sep 24, 1998. Publicly Released: Oct 28, 1998.

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Pursuant to a congressional request, GAO provided information on whether the Food and Drug Administration (FDA) is providing adequate oversight of the tracking systems of high-risk device manufacturers and whether recalls of devices are executed promptly, focusing on whether: (1) FDA ensures that manufacturers operate tracking systems that are capable of tracking devices through the distribution chain to end users; and (2) device manufacturers and FDA are executing recalls of tracked devices 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 for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA has completed revisions to the Compliance Policy Guide. The Guide now includes requirements that inspectors verify the tracking systems of device manufacturers during routine inspections.

    Recommendation: To improve FDA's ability to monitor manufacturer compliance with the medical device tracking regulation and conduct recalls of tracked devices in a timely manner, the Commissioner of FDA should develop and implement a plan to verify the completeness and accuracy of data in the tracking systems of device manufacturers to ensure that the systems can trace devices through the chain of distribution to end users.

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

  2. Status: Closed - Not Implemented

    Comments: FDA and the industry do not appear likely to agree on a method of financing this type of effort.

    Recommendation: To improve FDA's ability to monitor manufacturer compliance with the medical device tracking regulation and conduct recalls of tracked devices in a timely manner, the Commissioner of FDA should take steps to recover the medical device tracking records of manufacturers that have failed and have not provided such information to FDA and report to Congress on the results of its assessment of options for covering the costs of operating a device tracking system for failed establishments.

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

  3. Status: Closed - Not Implemented

    Comments: FDA believes that the legal obligation of tracking is continuous.

    Recommendation: To improve FDA's ability to monitor manufacturer compliance with the medical device tracking regulation and conduct recalls of tracked devices in a timely manner, the Commissioner of FDA should revise the medical device tracking regulation to require an establishment that acquires the right to manufacture another establishment's tracked device either through merger or acquisition to immediately notify FDA that it has assumed the tracking obligations of the former establishment.

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

  4. Status: Closed - Implemented

    Comments: FDA has implemented a new recall process and it has delegated to District Recall Coordinators the authority to classify Class II and III recalls and to submit recall information electronically. A new computer model assists the district office staff in determining the current status of recalls.

    Recommendation: To improve FDA's ability to monitor manufacturer compliance with the medical device tracking regulation and conduct recalls of tracked devices in a timely manner, the Commissioner of FDA should examine the reasons for delays in completing recalls of tracked devices and develop and implement strategies for improving the timeliness of recalls.

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

 

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