GAO: FDA Can’t Monitor Device Recalls

The Government Accountability Office has weighed in on the failure of the Food and Drug Administration to properly monitor medical device recalls. Its review of the 3,510 recalls between 2005 and 2009 — 40 percent of which were cardiovascular radiological or orthopedic devices — found:

The Government Accountability Office has weighed in on the failure of the Food and Drug Administration to properly monitor medical device recalls. Its review of the 3,510 recalls between 2005 and 2009 — 40 percent of which were cardiovascular radiological or orthopedic devices — found:

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

“The gist of this report is that the FDA can’t tell if recalls of high-risk devices were carried out successfully because it lacks criteria for assessing device recalls and doesn’t routinely review recall data,” said Sen. Charles Grassley, R-Ia., who along with Sen. Herb Kohl, D-Wis., called for the report. “Recalls are typically voluntary, and patients would be better served if the FDA took a thorough approach to post-market surveillance of medical devices.”

Grassley and Kohl said nothing about the single most important step the FDA could take to ensure that manufacturers have no problems in locating the patients who may have received a faulty device — requiring that every manufacturer create a unique bar code identifier for each device and requiring that that bar code become part of a patient’s medical record. If General Mills, a Minneapolis-based firm, can do it for every box of Cheerios, why can’t Medtronic, another Minneapolis-based firm, do it for every stent or pacemaker it makes?

Buried deep in the report, the GAO informs us that the FDA has been working since 2005 on a regulation requiring bar codes on devices. Yet it is still at least 12 to 18 months away. Do you think industry lobbying had anything to do with this glacial pace of regulation? Alas, the Grassley press release makes no reference to mandating bar codes, which is crucial to the FDA’s ability to create a well-functioning and patient-friendly system for recalling potentially faulty devices.