Recalls of medical devices have doubled in the past decade--the number of recalls grew from 604 in 2003 to 1,190 in 2012, an increase of 97 percent, according to recent a U.S. Food and Drug Administration report.
The rate actually lags the rate of growth in the med tech market overall, as FierceMedicalDevices points out.
Class I recalls-the FDA's most serious category, reserved for potentially deadly defects--rose from seven in 2003 to 57 in 2012.
Meanwhile, U.S. medical device expenditures climbed from $73.7 billion in 2001 to $156.3 billion in 2010--an 112 percent increase. What's more, the number of medical devices on the market grew by 25 percent from 2008 through 2012 alone.
Steve Silverman, director of the FDA medical device center's office of compliance, put it simply to The Wall Street Journal: "The rate of recall lags industry growth."
The FDA attributes the increased number of recalls in part to improved reporting by vendors and to government and industry efforts to improve performance of devices with a history of problems, such as ventilators, infusion pumps and external defibrillators.
Device design, software and non-conforming material or component issues are the most common reasons for recalls, according to the report, which says that as many as 400recalls each year might be prevented if government and vendors would work together.
The FDA in February published a proposed final rule requiring device manufacturers and importers submit adverse event reports for medical devices electronically in a bid to improve its data collection and analysis times.
Meanwhile, a bill that would exempt so-called "health software" and "clinical software" devices from FDA oversight, the PROTECT Act, has alarmed a coalition of influential patient groups, including the National Consumers League, National Physicians Alliance and the National Women's Health Network.
"We are extremely concerned that this bill will deregulate a broad swath of medical devices that rely on software and will create opportunities for rampant 'gaming' to avoid regulation," the groups stated in a letter to Sen. Tom Harkin, D-Iowa, Chairman of the Senate Committee on Health, Education, Labor and Pensions.
To learn more:
- find the report
- see the WSJ article