WASHINGTON - A disproportionate number of medical devices recalled because of links to serious health problems or deaths were approved under an abbreviated regulatory process that does not require advance testing on patients, according to a five-year study of device recalls.
The study found that only 21 of the 113 recalls involved products that were approved using a Food and Drug Administration process that included clinical trials. Almost all the rest were cleared for sale under a less stringent procedure, called the 510(k) process, that allows an abbreviated review to be used if the device is deemed similar to a product already on the market.
The findings, published Monday in the Archives of Internal Medicine, show that the FDA's partial update of the 510(k) process last month is inadequate, said Diana Zuckerman, one the study's co-authors.
Medical-device companies have stretched the notion of "similar" far beyond what regulators intended when the law went took effect in 1976, said Zuckerman, president of the National Research Center for Women & Families.
"The law has gotten looser and looser over time," she said.
The FDA should increase the number of devices subjected to the stricter review, known as pre-market approval, or devise a new intermediate category with more rigor than the 510(k) process, said Steven Nissen, a Cleveland Clinic cardiologist and a study co-author.
Nearly a third of medical products recalled from 2005 through 2009, the time covered by the review were cardiovascular devices, chiefly external defibrillators. Despite being categorized as high-risk devices, they were approved under the 510(k) process. Defibrillator failure has been linked to hundreds of deaths.
The findings buttress a 2009 Government Accountability Office report that dozens of high-risk devices did not meet the legal standard for 510(k) expedited review, Nissen said.
The FDA is evaluating high-risk products approved on the 510 (k) track to see if they should be subjected to more rigorous oversight, FDA spokeswoman Karen Riley said in a prepared statement.
Specifically, Riley said, FDA is considering whether to reclassify external defibrillators.
Riley also noted that 19,000 devices were cleared through the 510(k) process in the five years covered by the study and "while even one recall is too many, the 80 recalls should be kept in perspective and represent a small number of devices cleared via this program."
Nissen said the public would never regard that number of failures as acceptable in other endeavors with inherent risk, such as air travel. "I think we need to do better," Nissen said.