A new study finds that the majority of high-risk medical device recalls over the past five years involved products subject to the U.S. Food & Drug Administration’s (FDA) streamlined 510(K) approval process. The study is posted online on The Archives of Internal Medicine website.
To be eligible for the 510(K) approval process, manufacturers must only show new product is equivalent to one already on the market – human tests are not required. According to The New York Times, some devices that fall into this category include artificial hips and knees, external defibrillators, and infusion pumps.
For the Archives of Internal Medicine study, researchers analyzed Class I medical device recalls – the FDA’s most serious recall action – from January 2005 through December 2009. Of 113 Class I recall issued during that time, 80 products – 70 percent -were given 510(k) clearance. Only 21 of those products, or 19 percent, were found to have been approved through the more stringent premarket approval process. Eight were exempt from regulation or were merely registered with the FDA.
According to the study, 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 study authors point out, among other things, that more than 20 percent of almost 1 million automated external defibrillators (AEDs) — which are supposed to help resuscitate patients who are having life-threatening abnormal heart rhythms — have been recalled and that some people may have died because of AED malfunctions. About 31 percent of the recalled products were heart devices, including AEDs.
“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 authors said the FDA should require clinical trials in people for more devices rather than letting them through the abbreviated review process.
This is not the first time the 510(K) process has come in for criticism. Last month, the FDA did unveil changes to improve the medical device approval process. The FDA is also reviewing whether certain devices need to be reclassified to require more data.