While many media outlets are headlining the top-line numbers in an FDA report that shows that the number of medical device recalls has nearly doubled in the last 10 years, a look underneath the surface reveals that the rate of recalls has actually declined.
The FDA's “Medical Device Recall Report,” published by the CDRH's Office of Compliance, shows that the total number of recalls increased 97 percent from fiscal year 2003 to 2012.
But figures published by the AdvaMed trade association show that in nearly the same timeframe, from calendar year 2001 to 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 US 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.”
For the full story, see EETimes sister site Qmed.
— Stephen Levy is a contributor to Qmed and MPMN.