The controversial approval process the Food and Drug Administration uses for most medical devices has in fact enjoyed an "extraordinary safety record" in the past five years, according to a report commissioned by a medical technology industry group.
The report issued Wednesday by Washington, D.C.-based AdvaMed comes at a time when the regulatory pathway for most medical devices is being studied by new leadership at the FDA, as well as the Institute of Medicine, an independent entity that provides advice to policymakers.
At issue is the FDA's 510k approval process, which is the way approximately 73 percent of medical devices get clearance before being marketed in the United States, often without clinical studies to prove the product is safe and effective in patients. Medical device makers must simply prove a product is "substantially equivalent" to one already on the market.
Critics contend the 510(k) process has permitted potentially unsafe products to infiltrate the marketplace.
The consumer group Public Citizen, for example, says more rigorous scientific evidence is needed to prove many 510(k) devices are safe. And the American Association for Justice, a group of plaintiff's lawyers, argues that these devices should be followed more closely once used in patients and that the FDA should have the power to repeal approval if new safety data surfaces showing a product is unsafe.
But the AdvaMed report, conducted by the independent research firm Battelle Memorial Institute, disputes those claims.
"This study provides a terribly useful framework for evaluating these sweeping reforms," said David Nexon, AdvaMed's senior executive vice president. "It's hard to imagine any other regulatory process with as good a record as this."
The 14-page report analyzed recall data culled from public documents and from company safety alerts. Of the 46,690 medical devices cleared through the 510(k) process since 1998, just 77, or 0.16 percent, were part of a Class 1 recall between 2005 and 2010.
A Class 1 recall stems from a malfunction that could result in serious injury or death. AdvaMed officials said the fact that such recalls happened so rarely proves that the vast majority of devices are safe.
Most recalls were attributed to flaws in the design of the device, which AdvaMed conceded may have been detected by clinical studies. But overall, the group contends that requiring medical technology companies to perform more studies prior to FDA approval "would not likely increase device safety."
The study's conclusions are similar to those recently released by University of Minnesota law Prof. Ralph Hall, who found that less than 0.2 percent of 510(k)-cleared devices were part of a Class 1 recall, as well as an analysis performed by Dr. William Maisel of Beth Israel Deaconess Medical Center in Boston.
Maisel, a Harvard Medical School professor who is an expert on medical device safety, was recently named to head the FDA's newly created Center Science Council to guide the agency in science-based decision making. His study was reportedly commissioned by the Institute of Medicine.
It's likely AdvaMed and some bipartisan members of Minnesota's congressional delegation will use these reports in coming months to try to influence the FDA's 510(k) review.
Recently, the agency released more than 70 recommendations that would fundamentally change the 510(k) process. Nexon said the industry applauds some of them, but other recommendations have caused concern.
The public may comment on the proposals until Oct. 4. Meanwhile, the Institute of Medicine's report is expected next year.
Representatives from AdvaMed will present the report's findings in future meetings with FDA Commissioner Dr. Margaret Hamburg and Dr. Jeffrey Shuren, the new head of the agency's device division.
"Over the years, there's been a lot of discussion about the 510(k) process and there's been significant criticism, only none of it has been based on data," Nexon said. "I'm only sorry the FDA didn't have this report available before coming up with their recommendations."
FDA spokeswoman Peper Long said the agency will review the report as well as all other public comments on the 510(k) program.
"The recall rate is generally low, and we strive to do even better," Long said in an e-mail. "But, measuring this recall rate is a rather soft measure of general safety. Also, the study doesn't mention much about the associated benefit of a device, which is part of the equation."
A copy of the AdvaMed report is available at: tinyurl.com/2d2eong
Janet Moore • 612-673-7752