The Government Accountability Office (GAO) has released it's recommendations to FDA on medical device. In it, GAO recommends that FDA establish stronger oversight procedures for medical device recalls and better data collection to actively assess risks.The report is called "FDA Should Enhance Its Oversight of Recalls" (pdf) and it has been received by Health and Human Services.

According to the analysis, between 2005 and 2009, 3510 devices were recalled, an average of just more than 700 per year. The majority of those recalls, 83%, were classified by FDA as Class II, posing a moderate health risk. More than 40% of the recalls involved cardiovascular, radiological, or orthopedic devices.

The office noted serious problems with FDA's oversight process. Specifically, "it has not routinely analyzed recall data to proactively identify and address the risks presented by unsafe devices."The report says that gaps in the recall process limit the abilities of FDA and companies "to ensure that the highest-risk recalls were implemented in an effective and timely manner."

Further, the report says FDA's oversight procedures are unclear and do not include adequate measurement criteria on whether firms were successful at implementing the recalls, meaning FDA officials were unable to judge the whether "firms corrected or removed a sufficient number of recalled devices."

GAO made several recommendations to FDA:

• 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.
• Clarify procedures for conducting medical device recall audit checks to improve the ability of investigators to perform these checks in a consistent manner.
• 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.

 —Heather Thompson