According to the GAO, the FDA does a piss-poor job of analyzing its recalls:
Cardiac devices are the most common source of FDA device recalls, a new report from the Government Accountability Office (GAO) has found [1]. What’s more, the FDA is not taking full advantage of the data it collects from medical-device recalls to prevent safety problems before they arise, the report concludes.
Rather than pursuing a strictly case-by-case approach to overseeing recalls, the FDA “could take a more proactive approach to its oversight,” GAO states in its report. “The agency has a plethora of data available on thousands of recalls but, at present, is not effectively reviewing and analyzing these data in a systematic manner. More routine analyses of these data could help the FDA identify trends in the numbers and types of devices being recalled, as well as the underlying causes of device recalls.”
And I thought, Well, quit cutting their budget then. Turns out the FDA didn’t actually understand the full capabilities of their database.
“In fact, FDA officials appeared to be unaware of RES’s capability to generate summary data.” The GAO reports that when its investigators requested certain RES data from the FDA, the FDA staff was unable to extract these data themselves and initially indicated that obtaining the data was impossible. But then, two months later, FDA officials were able to meet GAOs request with the help of an outside contractor.
Where have I seen this story before? This is not limited to government. Company gets a system with all kinds of bells and whistles – hurry, hurry, hurry to implement it, but doesn’t bother getting enough (or the right) people trained on it. Or the one “super-user” who was the sole go-to person on the software leaves the company. Or, there is very little money allocated for training of internal staff at all, and the company depends on the original vendor to provide that service, but the cost to bring them in after the initial contract has completed is so high, who can afford it?
And then there’s this:
Frequent critic of FDA’s recall system Dr Rita Redberg (University of California, San Francisco) told heartwire, “The fact that there isn’t currently any system for systematically looking at the number of serious adverse events is clearly a problem that is acknowledged in this report.” Redberg said that when she wrote about the series of adverse events with inferior vena cava filters in the Archives of Internal Medicine in 2010, the FDA’s inability to monitor adverse-event reports was “shockingly brought to my realization. . . . I asked [the FDA] why they waited until we ran the story to issue a warning since [adverse-event] reports had been coming in for about 10 years, and they said they hadn’t been aware of all of those reports because they don’t have a system for flagging when serious adverse events are coming in on these devices.
“The FDA is obviously seriously underfunded for its work, and a priority has not been tracking device problems and recalls,” she said. “Industry largely sets the agenda, and their agenda is focused on faster device approvals, but there has unfortunately been woefully little attention on the risks and the problems that happen after device approval.”
Money. Desire for, on one part. Lack of, on the other.
The GAO report concludes with several key recommendations, including that the FDA create a program to routinely and systematically assess device-recall data to proactively identify strategies for mitigating device-related health risks. The FDA has said in response that it plans to perform a “systematic evaluation of potential recall analyses,” looking at recall processing times, device types, types of device failures, quality of recall notifications, and other elements that affect public risk.
The GAO also asks the FDA to clarify its procedures for medical-device recall audit checks, to develop explicit criteria for assessing the effectiveness of recalls, and to do a better job of documenting its reasons for terminating a recall once it has decided the recall is complete. These are all areas the FDA now says it is addressing.
Okay, Congress, give them the money to do this. Quit cutting their budget!
And just once, could industry not come up with a knee-jerk nothing-to-see-here reaction? It just makes you guys look bad.
Janet Trunzo, executive VP for technology and regulatory affairs at AdvaMed, a trade organization for the medical-device industry, told heartwire in an email that “nothing in the GAO report suggests a lack of diligence or inadequacy in medical technology companies’ implementation of recalls.”
She also points out that in addition to its recall authority, the FDA has comprehensive quality system requirements, mandatory adverse-event reporting requirements, and authority to order companies to conduct postmarket surveillance. However, AdvaMed agrees with the GAO that “the FDA could do more to enhance the clarity and consistency of its recall process, and we are pleased that the agency has a number of initiatives under way in this area.”
