Regulatory News

GAO Looks for New Medical Device Recall Standards

June 24, 2011

The U.S. Government Accountability Office (GAO) is demanding that the U.S. Food and Drug Administration (FDA) revise and improve its medical device recall procedures.

The investigation arm of congress, the GAO released a 57-page report on June 21stating that the FDA “has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls. The FDA is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices.”

The FDA issued seven high-risk device recalls thus far in June. Following the release of the GAO report, the FDA released a written statement claiming it launched a program in November designed to improve recall notification and classification and educate the industry about the process. The agency also is preparing guidance for release later this year that will clarify the factors that determine a recall. In addition, the FDA said it has “long used recall data to identify poorly performing devices and device types, as well as to identify manufacturers that do not reliably produce safe and effective products.”

Specifically, the GAO wants the FDA to better identify risks to patients, clarify its recall procedures and assess whether actions taken are sufficient and preventative in a more timely manner. Neglecting to make these changes may increase the risk of unsafe medical devices remaining on the market, according to the GAO.

The report stated that the medical device industry initiated 3,510 recalls between 2005 and 2009—an average of 700 per year. Forty percent of those recalls were for cardiovascular, radiological or orthopedic devices. A staggering 83 percent involved Class II medical devices, representing what the FDA classifies as a moderate health risk to patients, while 14 percent involved high-risk Class III devices such as pacemakers.

“Several gaps in the medical device recall process limited firms’ and the FDA’s abilities to ensure that the highest-risk recalls were implemented in an effective way and timely manner,” the GAO stated in the report. “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.”

As a result of these challenges, FDA officials examining similar situations can reach opposite conclusions regarding recall effectiveness, the report noted.

“We found FDA lacks specific criteria for making decisions about whether recalling firms have adequately completed their recalls—a key oversight activity of the recall process,” the report stated.

The GAO also concluded that on average, the FDA took 192 days to terminate a recall after it was completed, which is more than twice the time outlined in the FDA’s own procedures. For class I recalls, the average was 250 days.

The GAO further claimed that the FDA could not provide “definitive answers” about the common cause of recalls, trends in the number of recalls over time, the variation in the numbers of recalls by classification levels, the types of devices and medical specialties of devices that account for most recalls, or the length of time firms need or use to complete recalls.

This is not the first time the FDA has been criticized for its procedures. In a hearing before the Senate Special Committee on Aging, the GAO’s health care director, Marcia Crosse, claimed that the FDA’s oversight of medical products has been on the GAO’s list of high-risk areas since 2009, after the organization discovered that the FDA was weak in both premarket review and postmarket surveillance. This report, then, suggests that the FDA is under special review.

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