Of 113 medical devices recalled by the FDA between 2005 and 2009 because they were dangerous, 81% had been cleared under a lenient process reserved for devices deemed "substantially equivalent" to others already approved, revealing "critical flaws" in the federal review system.
That's the conclusion of a report in Tuesday's Archives of Internal Medicine that evaluated each medical device. The researchers discovered that these recalled cardiac and other devices were approved without clinical trials or higher levels of scrutiny under 510(k) protocols in which they were deemed similar enough to an already approved device and a few were exempt from the approval process entirely.
"These devices did not undergo clinical testing or premarket inspections, nor were postmarket studies required to determine safety and efficacy," as they would have under the U.S. Food and Drug Administration's higher level "premarket approval" or PMA process that requires clinical testing and inspections, wrote Diana Zuckerman of the National Center for Women & Families.
Zuckerman co-authored the report with Paul Brown of the Center and Steve Nissen, MD, chair of the Department of Cardiovascular Medicine at the Cleveland Clinic.
Additionally, the researchers discovered, 12% of the recalled devices that were approved under the 510(k) process were originally marketed for "risky or life-sustaining Class III (defined as implantable or life-sustaining) indications, which are required by law to undergo a full PMA regulatory review."
These 510(k) approved devices that were recalled "were used by tens of millions of patients, exposing them to potential harm and adding substantial costs to medical care," the authors wrote.