Medical Devices:

FDA Should Enhance Its Oversight of Recalls

GAO-11-468: Published: Jun 14, 2011. Publicly Released: Jun 21, 2011.

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Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device--class I recalls present the highest risk (including death), followed by class II and class III. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies (1) the numbers and characteristics of medical device recalls and FDA's use of this information to aid its oversight, and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. GAO interviewed FDA officials and examined information on medical device recalls initiated and reported from 2005 through 2009, and reviewed FDA's documentation for a sample of 53 (40 percent) of class I recalls initiated during this period.

From 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year. FDA classified the vast majority--nearly 83 percent--as class II, meaning use of these recalled devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote. Just over 40 percent of the recalls involved cardiovascular, radiological, or orthopedic devices. FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls. Thus, FDA is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices. Several gaps in the medical device recall process limited firms' and FDA's abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices. FDA's procedures for overseeing recalls are unclear. As a result, FDA officials examining similar situations sometimes reached opposite conclusions on whether recalls were effective. FDA had also not established criteria, based on the nature or type of devices, for assessing whether firms corrected or removed a sufficient number of recalled devices. Additionally, FDA's decisions to terminate completed recalls--that is, assess whether firms had taken sufficient actions to prevent a recurrence of the problems that led to the recalls--were frequently not made within its prescribed time frames. Finally, FDA did not document its justification for terminating recalls. If unaddressed by FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market. To aid its oversight of the medical device recall process, FDA should routinely assess information on device recalls, develop enhanced procedures and criteria for assessing the effectiveness of recalls, and document the agency's basis for terminating individual recalls. HHS agreed with GAO's recommendations.

Status Legend:

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  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To enhance FDA's oversight of medical device recalls, and in particular, those medical device recalls that pose the highest risk, the Commissioner of FDA should develop explicit criteria for assessing whether recalling firms have performed an effective correction or removal action.

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

    Status: Open

    Comments: FDA told us in 2012 that it will review existing procedures in the Regulatory Procedures Manual and will add a list of specific criteria that districts and/or centers should review before making a determination whether a recall should be terminated. These criteria will include, at a minimum, review of the recalling firm's status report and of FDA's audit check results. Additionally, FDA is developing a recall database data dictionary which will define fields that capture data regarding the effectiveness of a firm?s recall. FDA expects to complete these changes by summer 2013. Also, the Food and Drug Administration Safety and Innovation Act (FDASIA, P. L. 112-144) enacted on July 9, 2012, directed FDA to implement this recommendation.

    Recommendation: To enhance FDA's oversight of medical device recalls, and in particular, those medical device recalls that pose the highest risk, the Commissioner of FDA should clarify procedures for conducting medical device recall audit checks to improve the ability of investigators to perform these checks in a consistent manner.

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

    Status: Open

    Comments: In 2012, FDA said that it is reviewing the recall audit check process and anticipates amending the recall chapters in FDA's Recall Procedures Manual and Investigations Operations Manual by summer 2013 to further clarify the audit check process and endorsing of audit checks. Also, the Food and Drug Administration Safety and Innovation Act (FDASIA, P. L. 112-144) enacted on July 9, 2012, directed FDA to implement this recommendation.

    Recommendation: To enhance FDA's oversight of medical device recalls, and in particular, those medical device recalls that pose the highest risk, the Commissioner of FDA should create a program to routinely and systematically assess medical device recall information, and use this information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. This assessment should be designed, at a minimum, to identify trends in the numbers and types of recalls, devices most frequently being recalled, and underlying causes of recalls.

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

    Status: Open

    Comments: FDA did not provide an update for this recommendation in 2012. However, the Food and Drug Administration Safety and Innovation Act (FDASIA, P. L. 112-144) enacted on July 9, 2012, directed FDA to implement this recommendation.

    Recommendation: To enhance FDA's oversight of medical device recalls, and in particular, those medical device recalls that pose the highest risk, the Commissioner of FDA should document the agency's basis for terminating individual recalls.

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

    Status: Open

    Comments: FDA agreed with this recommendation. In 2012 it said that its Office of Enforcement has begun the process of developing a data dictionary for FDA's recall database, including those data fields that capture recall termination. The use of a data dictionary will lead to more uniform documentation of the data necessary to review prior to recall termination, as well as documenting recall termination decisions. Also, the Food and Drug Administration Safety and Innovation Act (FDASIA, P. L. 112-144) enacted on July 9, 2012, directed FDA to implement this recommendation.

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