The yearly number of medical device recalls doubled in the past decade, the U.S. Food and Drug Administration (FDA) said in a report released on March 21. The increase in recalls was attributed to more vigilance surrounding radiological imaging and more responsiveness to agency inspections. The report showed that annual recalls surged to almost 1,200 in 2012 from about 600 in 2003. The report was prompted in part by a 2011 Government Accountability Office (GAO) report that called on the FDA to take a more aggressive role in overseeing recalls.
A big part of the rise was attributed to radiological devices — MRI and CT scanners and the like — that increasingly are viewed as overused because of their potential to register false positives and increase cancer risk, according to the FDA. The agency said about 250 recalls involved radiology equipment in 2012, compared with fewer than 50 such recalls in 2003. An especially large increase occurred in the months after an FDA hearing in 2010 on the subject of unnecessary radiation exposure. The report said that some companies conducting recalls during this time period acknowledged to the FDA that they had become more vigilant in reporting recalls.
Another key factor was increased recalls by companies that were cited by the FDA during inspections for violations of the regulatory section — 21 CFR 806 — that governs product removals. Only about 2 percent of manufacturers were found to have shortcomings with how they reported and documented recalls, but the report said those firms accounted for half the increase in the decade-long study period. The FDA said that without recalls related to radiology and 806 inspections, the increase would have been just 27 percent, instead of 97 percent.
The Advanced Medical Technology Association (AvaMed), the device industry’s top trade group, didn’t like the report. It complained that the report lacked complete context, noting that it did not include statistics to show how the amount of devices in the marketplace, as well as their sophistication, had changed from 2003 to 2012. Janet Trunzo, senior executive vice president at AdvaMed, had this to say:
Over the period analyzed by FDA, the number and complexity of medical technologies on the market has grown significantly, but without a denominator, it is difficult to truly know the significance of the agency’s raw recall numbers.
The vast majority of recalls during each year of the time period were of the moderately risky Class II variety. Highly serious Class I events constituted just 5 percent of recalls in 2012, but that was a marked rise from just 1 percent of recalls in 2003. Class III recalls have steadily declined, both as a percentage of all recalls and in their sheer number, and in 2012 accounted for less than 10 percent of removals, according to the report. The top three reasons for recalls — all cited roughly the same number of times — were the presence of a nonconforming material or component, a software defect or a design defect, the report said.
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