GAO to FDA: Strengthen oversight of medical device recalls
The Government Accountability Office (GAO) has recommended that the FDA establish stronger oversight procedures for medical device recalls and better data collection to proactively assess risks, in its June report for the agency. The Department of Health and Human Services has agreed with the GAO’s recommendations.
The GAO analysis of medical device recalls from 2005 through 2009 indicated that 3,510 devices were recalled during that time, an average of just more than 700 per year. The majority of those recalls, 83 percent, according to the organization, were classified by the FDA as Class II, posing a moderate health risk. More than 40 percent of the recalls involved cardiovascular, radiological or orthopedic devices.
The office noted numerous FDA gaps in the oversight of device recalls. “The FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has not routinely analyzed recall data to proactively identify and address the risks presented by unsafe devices,” the GAO noted. “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 and timely manner.”
The report also noted that FDA procedures for overseeing recalls are unclear, and “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.”
The GAO made the following recommendations to the FDA:
“If unaddressed by the FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market,” the GAO concluded.
The full report can be found here.
The GAO analysis of medical device recalls from 2005 through 2009 indicated that 3,510 devices were recalled during that time, an average of just more than 700 per year. The majority of those recalls, 83 percent, according to the organization, were classified by the FDA as Class II, posing a moderate health risk. More than 40 percent of the recalls involved cardiovascular, radiological or orthopedic devices.
The office noted numerous FDA gaps in the oversight of device recalls. “The FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has not routinely analyzed recall data to proactively identify and address the risks presented by unsafe devices,” the GAO noted. “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 and timely manner.”
The report also noted that FDA procedures for overseeing recalls are unclear, and “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.”
The GAO made the following recommendations to the 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.
- Clairfy 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.
“If unaddressed by the FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market,” the GAO concluded.
The full report can be found here.