More than 80% of medical device recalls between 2005 and 2009 involved products that did not undergo a rigorous, clinical trial testing program prior to approval by the FDA, a new study found.
Among the 113 recalls of devices involving serious health problems or death, only 19% went through a pre-market approval process requiring proof of safety and effectiveness. The vast majority of the devices were approved by the FDA using a less stringent process known as 510 (k).
“The excessive use of the abbreviated approval process has allowed too many devices intended for life-preserving indications to reach the market without adequate clinical testing,” said co-author Steve Nissen. “Unless this system is reformed promptly, we fear that public health will be jeopardized by medical device recalls for life-threatening defects.”
Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, noted that many of the recalls (31%) were cardiac devices, including automatic external defibrillators involved in hundreds of deaths.
Co-author Diana Zuckerman said the FDA is using the less-stringent 510 (k) process to approve 98% of medical devices, including heart valves, glucose meters and artificial hips and knees.
“We think patients will be shocked to learn how often new medical products, using different materials, made by a different manufacturer, are not scientifically tested in humans to see how well they work,” said Zuckerman, of the National Research Center for Women & Families. “Our study shows that as a result, many devices fail and more than 112 million products were recalled in just five years.”
The study was published in the Archives of Internal Medicine.