Medical Device Recalls Growing at Slower Pace Than Industry

Posted in Regulatory and Compliance by Stephen Levy on March 21, 2014

While many media outlets are headlining the top-line numbers in today's FDA report that show that the number of medical device recalls have nearly doubled in the last 10 years, a look underneath the surface reveals that the rate of recalls has actually declined.

FDA's “Medical Device Recall Report”, published by CDRH's Office of Compliance, shows that the total number of recalls increased 97 percent from FY 2003 to FY 2012.

But figures published by the AdvaMed trade association show that in nearly the same timeframe, from CY 2001 to CY 2010, medical device expenditures in the United States rose from $73.7 billion to $156.3 billion. That's a 112 percent increase over a similar span of years. While the 2001 number is from the U.S. Commerce Department, the 2010 number is from Ernst & Young. And although these are AdvaMed's numbers, it was Fierce Medical Devices' Galen Moore who ferreted them out.

The Wall Street Journal quotes Steve Silverman, director, CDRH Office of Compliance, as saying, “The rate of recall lags industry growth.”

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The 20-page FDA report attributes the majority of the rise in recalls to two main classes of manufacturers. They were specifically manufacturers of radiology devices, who were subjected to increased media and FDA attention due to concerns regarding excessive and/or unnecesary radiation exposure, and generally, manufacturers that received 21 CFR 806 observations following FDA inspections. The report goes on to say that FDA believes that firms who received inspectional 806 observations “subsequently improved their recall reporting to FDA.”

The number of Class I recalls began to climb in 2010. In that year, CDRH expanded its focus to additional targeted device areas with high-volume adverse event reports and recurrent recalls, including automatic external defibrillators (AEDs), infusion pumps, and ventilators. According to the report, these few product areas account for 80% of the observed increase in Class I recalls.

The FDA report concludes: “The recall data analysis suggests that the increase in the number of recalls between FY 2003 and FY 2012 can be largely attributed to improved reporting by firms that were cited with 806 reporting violations and by manufacturers of radiology devices. We have seen greater reporting by industry and a more concerted effort by CDRH and industry working together to improve the quality and safety of medical devices.”

And, “Based on the data we have reviewed and our experience, we believe the increase is the result of increased awareness prompted by targeted interactions with industry and individual manufacturers. Moreover, these interactions triggered efforts within industry to improve safety of devices, which are expected to improve device performance over time.”

Stephen Levy is a contributor to Qmed and MPMN.