Medical device recalls nearly doubled since 2003, FDA says

The number of annual medical device recalls nearly doubled between fiscal 2003 and 2012, according to a report from the Food and Drug Administration. The agency attributed the increases to enhanced interaction with device manufacturers and device safety initiatives from the FDA's Center for Devices and Radiological Health.

Recalls associated with radiology devices such as linear accelerators and CT scans were the most frequently reported, with more than 250 recalls reported in 2012. Cardiovascular devices, like defibrillators, had the second-highest number of recalls that year, more than 150, the report found. Between 2004 and 2012, approximately 10% of recalls came from products that had received FDA marketing authorization within the past year. Devices that had been on the market for more than 15 years represented another 10% of the recalls.

The FDA report released today (PDF) was conducted, the agency said, to address concerns raised by a 2011 Government Accountability Office report, which called on the FDA to enhance oversight of devices, and particularly medical device recalls that posed the highest risk.

The annual number of Class I recalls, in which the most serious adverse health consequences or death are possible, increased from 7 medical devices in 2003 to 57 in 2012, comprising 5% of the total number of recalls. Class II recalls, those in which a product could cause temporary adverse health consequences, more than doubled, from 460 reports in 2003 to 1,043 in 2012.

“The existence of this report indicates a change in the FDA approach to overseeing recalls,” says Marcia Crosse, director of health care for the GAO and author of the 2011 report. She says, this analysis is a positive sign that the FDA is being more active in its oversight.

Now that the process of issuing recalls has improved, the next step, according to the ECRI Institute, would be to help hospitals more quickly distinguish which ones require immediate attention. “Increasingly we’ve been seeing recalls that are reissuing instructions for use or adding contraindications for an existing product,” explains Eric Sacks, director, healthcare product alerts for the ECRI Institute. Those types of issues, he says, would not necessarily fall within the most serious or high priority class of recalls. “With the huge increase in the number of recalls, one of the things hospitals need to be able to do is to prioritize them.” he said, observing that the FDA classifications sometimes are made months after a recall has been issued.

For the most part though, he agrees the FDA’s increased interaction with the manufacturers is reaping positive benefits.

“I think it’s a tough job that they have,” Sacks says, noting that critics on one side argue products are put on the market too soon, while those on the other that say the agency is slowing down innovation. “But, I think the FDA has stepped up their game in the last decade.”

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