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 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: Closed - Implemented

    Comments: In March 2014, FDA issued a report analyzing medical device recall data as part of a broader initiative to optimize the public health benefits of timely and effective recalls. The report includes detailed information on recalls from fiscal year 2003 through fiscal year 2012 and provides for a systemic and systematic analysis of recall information. For example, it includes data presented in tables, figures, and graphs on the most frequently recalled devices, the time on the market for recalled devices, regulatory violations cited, the risk level associated with the recall, and other trend analyses. FDA has acknowledged that analysis of recall data can assist the agency with refining and explaining observed trends, understanding common causes of device failures, identifying risks posed by certain device types, and enhancing risk-based inspections of firms that manufacture devices. FDA's report states that it will continue to use recall information to better inform decision-making across the total product lifecycle, provide guidance to industry, and target needed interventions. In addition, FDA said that review and analysis of this data will help to guide both it and industry in strategically focusing its efforts that will improve the quality of medical devices and thereby improve patient outcomes.

    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: Closed - Implemented

    Comments: The Food and Drug Administration Safety and Innovation Act (P.L. 112-144), enacted in 2012, contained a requirement that FDA implement this recommendation by clarifying its audit check procedures related to conducting medical device recalls. FDA has since implemented this recommendation. For example, greater specificity regarding a firm's actions in conducting a recall can be now provided on audit check forms and an increased number of categories are available to document audit check findings. Determinations of ineffective recalls now include options to indicate whether its ineffectiveness was attributable to the recalling firm or the consignee. In addition, the audit check process now includes a way for FDA to provide other explanatory information, such as whether or not an establishment carries the recalled product or has gone out of business. An "other" category is also available for elaboration. FDA has also provided new training for its recall coordinators on these clarified procedures.

    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: Closed - Implemented

    Comments: The Food and Drug Administration Safety and Innovation Act (P.L. 112-144) contained a requirement that FDA implement this recommendation and develop explicit criteria for assessing whether recalling firms have perfomed an effective correction or removal action. FDA has now established this criteria. It has set thresholds to determine the expected proportion of distributed devices to be corrected or removed based on the recall classification, which reflects the level of risk associated with the recall. Other criteria include the number of devices distributed, the time elapsed between the first distribution of the device and the initiation of the recall, whether the product was consumable or disposable, and whether the efforts to recall the product included the wholesalers, retailers, or consumers or other end-users. In addition, FDA developed criteria for determining whether the expected proportion of consignees-those who received, purchased, or used the products-were effectively contacted about the recall. These criteria are similar to the criteria for evaluating whether a correction and removal was effective with the number of devices replaced by the number of consignees. Each set of criteria are clearly outlined in two separate matrixes. FDA's use of these criteria should reduce the risk of defective or unsafe medical devices remaining on the market.

    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: Closed - Implemented

    Comments: The Food and Drug Administration Safety and Innovation Act (P.L. 112-144), contained a requirement that FDA implement this recommendation and document its basis for terminating recalls. FDA subsequently developed a standardized recall termination review process. Key to this process is a template FDA designed to document its assessment that a recall was effectively completed. It is based on explicit criteria which were also recently developed, due to a related recommendation contained in this same report. The template ensures the criteria are routinely applied and that FDA's decisions to terminate recalls are documented and archived. In May 2014, FDA reported that it has documented the termination of every Class I, or highest-risk, recall using this template since January 1, 2013. FDA identified several benefits associated with this new process including an increased awareness of device failures that can help minimize risk and avoid future reoccurrences.

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