The evaluation and approval of medical devices used in the United States come under the oversight of the U.S. Food and Drug Administration (FDA). The FDA does not only oversee the approval of medical devices but also oversees the recalls of medical devices, which often are voluntarily initiated by the medical device manufacturers.
Recalls of medical devices are an important tool to protect the safety of people when it is suspected or determined that the medical devices are unsafe or defective. Without the prompt and effective implementation of medical device recalls, there could be serious or lethal consequences as a result of unsafe or defective medical devices. The FDA monitors medical device recalls to insure that they are effective and also to determine when the recalls may be terminated.
The FDA classifies recalls based on the risks associated with the recalled medical device: class I recalls involve the highest risk, including death, followed by class II and class III.
But who oversees the FDA to make sure that the FDA properly oversees medical device recalls?
Recently, the Government Accountability Office (GAO) investigated the numbers and characteristics of medical device recalls and the FDA’s use of such information as well as the extent that the process is effective in implementing and terminating class I recalls. The GAO reviewed medical device recalls that occurred between 2005 and 2009 by reviewing 40% (53) of the class I recalls that occurred during that period of time.
The GAO reported that medical device manufacturers initiated 3,510 medical device recalls between 2005 and 2009. Almost 83% of the recalls were classified as class II (devices that represented a moderate health risk (that is, the probability of serious adverse health consequences was remote)). Of those recalls, just over 40% involved cardiovascular, radiological, or orthopedic devices. The GAO concluded in its review of the FDA’s use of the recall information that the FDA failed to routinely analyze recall data to determine whether there are systemic problems underlying trends in medical device recalls and therefore the FDA is missing an opportunity to use the recall data to proactively identify and address the risks presented by unsafe medical devices.
The GAO also found that manufacturers of high-risk medical devices subject to recalls faced challenges such as locating specific medical devices or their users, thereby limiting their ability to correct or remove all of the recalled medical devices. Compounding the problem was that the FDA’s procedures for overseeing recalls are unclear, resulting in FDA officials examining similar situations sometimes reaching opposite conclusions whether the recall efforts were effective.
The GAO found that the FDA failed to establish criteria based on the nature or the type of the medical devices, for assessing whether the manufacturers of the recalled medical devices corrected or removed a sufficient number of the recalled medical devices. The GAO found that the FDA also failed to decide within its required time frames that the manufacturers of recalled medical devices had taken sufficient actions to prevent a recurrence of the problems that led to the recalls (which would lead to the termination of completed recalls), and that the FDA failed to document its justifications for terminating the recalls.
The GAO concluded that the FDA’s failures may increase the risk that unsafe medical devices could remain on the market. The GAO recommended that the FDA routinely assess information on medical device recalls, develop enhanced procedures and criteria for assessing the effectiveness of recalls, and document its basis for terminating recalls (the U.S. Department of Health and Human Services (HHS) agreed with the GAO’s recommendations).
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