SEARCH

Entries in 510(k) (1)

Monday
Feb142011

Medical Device Recalls Reveal Cracks in Regulatory Procedures, Researchers Say

Photo Courtesy - Getty Images(CLEVELAND) -- The approval process for medical devices has been the topic of growing scrutiny. Monday, a study published in the Archives of Internal Medicine suggests most medical devices recalled for life-threatening or very serious hazards were cleared by the Food and Drug Administration through an expedited review process called 510(k), or were considered so "low risk" they were exempt from review entirely.

"In my view, the regulatory system is failing," said Dr. Steven Nissen, a co-author of the study and chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen and colleagues examined the number of medical device recalls from 2005 to 2009 and determined which regulatory pathway they had taken -- 510(k) or the more rigorous premarket approval process. Of 113 recalls of devices determined by the FDA to cause serious health problems or death, 80 were cleared through 510(k), and eight were exempt from FDA regulation.

"Some 80 percent or so of devices being recalled were actually never fully clinically tested in people," Nissen said.

It's unclear from Nissen's study how many devices approved through the standard PMA pathway have been recalled.

If a device is shown to be substantially similar to one already on the market, the 510(k) pathway allows its makers to bypass the PMA pathway's rigorous preclinical testing and inspections.

For implantable devices, like an artificial hip or an artificial heart valve, a recall means an operation.

"If you want to take back a heart valve you have to sit down with a patient and say, look, we have two very different, bad choices here. We can wait until your device fails, or we can go in and do an operation and put a new device in," Nissen said. "Those are very difficult choices."

Copyright 2011 ABC News Radio







ABC News Radio