Initiating and Classifying the Recall

During this phase of a device recall, a firm initiates a recall, while FDA  classifies the recall based on health risks presented by use of the device. For class II recalls, FDA recommends  effectiveness checks with 10 percent of such customers and device users,  and 2 percent for class III recalls. As part of its assessment, FDA may  review a corrective and preventive action plan submitted by the recalling  firm that describes the firm’s actions to prevent a recurrence of the  problem that led to the recall. Thus, this phase of the recall process is  important because it provides FDA with the opportunity to determine  whether the firm has taken sufficient corrective and preventive actions. Firms Initiated Several Thousand Medical Device Recalls, but FDA Has Not Routinely Analyzed This Information to Aid Its Oversight of Recalls

From 2005 through 2009, firms initiated 3,510 medical device recalls. Several Thousand Device Recalls Were Initiated; Most Were Class II and Involved Cardiovascular and Radiological Devices

Between January 1, 2005, and December 31, 2009, firms initiated 3,510  device recalls, an average of just over 700 per year. FDA classified the vast majority of all recalls—nearly   83 percent—as class II, meaning use of these devices may cause temporary  adverse health consequences (moderate risk). The number of  class I recalls initiated between 2005 and 2009 ranged from 17 to 41. On  average, over 420 days passed between initiation of a recall and FDA’s  termination. FDA Has Not Routinely Analyzed Data to Identify Systemic Problems Underlying Device Recalls

Although RES contains numerous data elements that would allow for  analyses of recall data, FDA is not effectively using these data to identify  whether there are systemic problems underlying recalls. Gaps in the Medical Device Recall Process Limit the Effective Implementation and Termination of the Highest-Risk Recalls

Gaps in the medical device recall process limit firms’ and FDA’s ability to  ensure that the highest-risk recalls are implemented effectively and  terminated in a timely manner. However, FDA did not always follow its  own procedures and some procedures are unclear. FDA has also not established criteria,  such as thresholds, based on the nature of devices, for assessing whether  firms effectively completed recalls by correcting or removing a sufficient  number of recalled devices. Further, we found that firms face challenges,  such as locating specific devices or users of devices, and often could not  correct or remove all devices. In addition, for a majority of the class I recalls we reviewed, FDA’s actions  to ensure that recalls were complete were inconsistent with its procedures  for overseeing recalls. Also, we found that FDA termination decisions were frequently not made  in a timely manner—within 3 months of the completion of the recall— increasing the risk that unsafe or defective devices remained available for  use. By addressing these weaknesses, FDA could reduce  the risk that defective or unsafe medical devices remain on the market,  potentially endangering public health. Recommendations for Executive Action

To enhance FDA’s oversight of medical device recalls, and in particular,  those medical device recalls that pose the highest risk, we recommend  that the Commissioner of FDA take the following four actions:    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. Develop explicit criteria for assessing whether recalling firms have  performed an effective correction or removal action. Document the agency’s basis for terminating individual recalls.
Why GAO Did This Study

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.

What GAO Found

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.