FDA’s Medical Device Recall Process Under Fire from GAO

A new report from the US Government Accountability Office (GAO) has found that the Food and Drug Administration (FDA) has not consistently analyzed medical device recall data to see whether trends in these recalls point to underlying systemic risks.

Examining the FDA’s recall initiations between 2005 and 2009, the GAO found that the agency typically used recall data to monitor individual device recalls and manufacturers, but not to identify broader risks posed by types of devices being recalled.

“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,” states the report. Some firms affected by high-risk recalls had difficulties locating all devices or device users, due partially to unclear recall oversight procedures at the FDA, according to the GAO.

The GAO lists several problems stemming from this issue:

  • FDA officials examining similar recall efforts reached opposite conclusions regarding recall effectiveness
  • The agency has not set criteria for assessing whether firms corrected or removed adequate numbers of recalled devices
  • FDA decisions to terminate completed recalls were not made within prescribed time frames
  • FDA officials provided no documented justification for why recalls were terminated

 

The GAO report provides three recommendations for improving the FDA’s recall process. First, the agency should implement a program to assess medical device recall data on a systematic basis in order to identify strategies to minimize health risks posed by unsafe medical devices.

Second, the FDA should clarify procedures for carrying out recall audit checks in order to ensure that investigators can carry out their tasks more effectively

Third, the agency should set explicit criteria for evaluating the effectiveness of recall efforts carried out by manufacturers.

This new report follows testimony by GAO health care division director Mary Crosse in a US Senate hearing in April in which the director leveled a similar critique of the agency’s recall process.

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