Report Blames Speedy FDA Clearance for Medical Device
MONDAY, Feb. 14 (HealthDay News) -- Most medical devices
recently recalled by the U.S. Food and Drug Administration for
posing life-threatening or serious safety risks were initially
approved for use by that same agency through an expedited approval
process, new research reveals.
The findings call out for an overhaul of the regulatory process,
to keep unsafe products from reaching the market in the first
place, said the study team, led by Diana M. Zuckerman of the
National Research Center for Women & Families, based in
About one-third of the recalled devices were related to
cardiovascular concerns, although the speedy approval process is
supposedly reserved for products posing only a low or moderate
safety risk, the study authors noted.
Their report is published online Feb. 14 in advance of print
publication June 14 in the
Archives of Internal Medicine.
"The standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life-threatening," the authors noted in a journal news release. "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either Congressional action or major changes in regulatory policy."
The FDA, however, has already taken steps to strengthen its
approval process, according to an agency spokeswoman who noted
these findings are not new.
Medical devices are not subject to the same approval procedures
as prescription medications, the study authors noted. A 1976
amendment to the Food, Drug, and Cosmetics Act allowed for two
types of medical device review processes: one that grants approval
after stringent pre-market testing; the other providing "clearance"
to market a new device if it is "substantially equivalent" in
structure and usage to devices on the market pre-1976.
The latter, much-simplified process, called the "501(k)
provision," was intended to relieve manufacturers from undue
regulatory burdens that might discourage innovation.
The result: Today the 501(k) process is by far the more common
method of clearance for new devices, with only 1 percent of new
medical device reviews subject to the more rigorous pre-market
testing standard, the researchers found.
Eighty of the 113 medical devices recalled by the FDA between
2005 and 2009 received 510(k) clearance, while another eight were
exempt from all regulatory review procedures, the study found.
Moreover, 12 percent of the high-risk recalled devices that got
510(k) clearance should have been subject to rigorous approval
review because they were marketed for risky or life-sustaining
purposes, the authors said.
Karen Riley, an FDA spokeswoman, said that "while even one
recall is too many, the 80 recalls should be kept in perspective
and represent a small number of the devices cleared via this
She said in the study timeframe the FDA cleared more than 19,000
devices using the 510(k) process. And tens of thousands of devices
previously cleared via 510(k) remain on the market, she said.
And while the analysis focuses on "high-risk" recalls, Riley
said a 2010 Institute of Medicine review found that the annual
recall rate for
all 501(k) -cleared devices was actually just 1 percent to
1.5 percent a year.
Furthermore, the FDA is already taking steps recommended by its
Center for Devices and Radiological Health to strengthen the 501(k)
process, Riley said.
Dr. Jerry Avorn, a professor of medicine at Harvard Medical
School in Boston, said it was common knowledge that the standards
of review and approval for the FDA device branch were much looser
than those for its drug branch. "And this paper documents the
results of that worrisome difference in approach," he said.
"The current FDA leadership has been trying to improve the carefulness of device review, and that is very good for patients," Avorn added. "But those attempts have been met by self-serving complaints from the device industry that better review and surveillance will somehow stifle innovation, which is not the case."
Industry innovation and consumer safety are not mutually
exclusive propositions, Avorn suggested.
"We ought to be able to have reasonable standards of safety and effectiveness for devices and innovate at the same time," he said. "There's no need to trade off the welfare of patients."
For more on medical device recalls, visit the
U.S. Food and Drug Administration.
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