"Medical device recalls nearly doubled in a decade," proclaims The Wall Street Journal's headline--a bit of data the FDA is expected to release Friday that seems likely to travel far on social media. Critics are already making hay, questioning the rigor of pre-market vetting at the FDA.
Here are the numbers: The total number of medical device recalls rose to 1,190 in 2012, up from 604 in 203, Journal reporter Thomas M. Burton wrote. It's a 97% increase over 10 years.
More troubling is the rate of increase in Class I recalls--the FDA's most serious category, reserved for potentially deadly defects. Those numbered 7 in 2003, 57 in 2012, according to the FDA numbers cited by the WSJ. The FDA disclosure came in response to a 2011 report by the Government Accountability Office, which raised concerns over recalls of implantables.
But if the Journal headline sounds like a dispatch from an industry with a growing quality-control problem, consider the denominator. The annual rate of recalls is growing more slowly than the U.S. med tech market as a whole.
U.S. medical device expenditures grew from $73.7 billion in 2001 to $156.3 billion in 2010, according to figures published by AdvaMed. That's a 112% increase over a roughly equivalent 10-year period. The med tech industry trade group cited the U.S. Commerce Department for the 2001 figure and Ernst & Young for the 2010 number.
Steve Silverman, director of the FDA medical device center's office of compliance, put it simply. "The rate of recall lags industry growth," he said, according to the Journal.
Another denominator is the growing number of medical devices on the market. In a statement, Janet Trunzo, AdvaMed's VP for tech and regulatory affairs, said the rate of recalls is low, compared to proliferating medical-device offerings.
"Studies looking at recall data in terms of the overall number of devices on the markets have demonstrated that for products cleared via the 510(k) process--which make up the vast majority of devices on the market--overall recall rates are very low," she said, "in the range of 1.0 to 1.5 percent. For more serious Class I 510(k) recalls, the rates are even lower--in the range of 0.16 to 0.45 percent."
According to the WSJ, the FDA says number of medical devices on the market grew by 25% from 2008 through 2012--a period that includes some of the slowest years for industry growth in the past decade.
That didn't stop Diana Zuckerman, president of the National Research Center for Women & Families, from calling for tighter regulation of medical devices before they are approved for release into the U.S. market. "You have to wonder whether a more rigorous regulatory effort before devices went on the market would have avoided these recalls," she told the WSJ.
FierceMedicalDevices put in a request to Ernst & Young for more apples-to-apples figures, this morning, but it's safe to say that the numbers in the FDA report should come as a surprise to no one. Dog bites man.
- here's the WSJ article (sub. req.)
- read AdvaMed's 2004 report on the med tech industry (via The Lewin Group) (PDF)
- AdvaMed's 2014 report on med tech tax impacts has more on industry size in 2010
- here's Ernst & Young's 2013 Pulse of the Industry report (PDF)
Editor's Note: This story was changed after publication, adding a statement from AdvaMed and replacing a year-2000 market-size figure with a number from 2001. From 2001 to 2010, the U.S. med tech market grew 112%. From 2000 to 2010, it grew 119%, as originally reported here.