Three out of four devices recalled in the last five years because of serious risks were given an expedited review by the U.S. Food and Drug Administration or were exempt from review, according to a new study.
The report says that medical devices are either given a premarket approval, which requires clinical testing and inspections, or they are put through the speedier 510(k) process because they are deemed similar to a device already on the marketed and are considered to have low or moderate risk.
Diana M. Zuckerman, of the National Research Center for Women & Families in Washington, and her colleagues looked at device recalls from 2005 to 2009 and determined which approval process was used or if they were exempt from FDA review.
They found 113 recalled devices that could cause serious health problems or death. Twenty one (19 percent) had the more rigorous review and 80 (71 percent) had the expedited one and eight were exempt. They also found some that by law should have gone through the tougher review. The most common high-risk device recalled was heart related.
The report authors said the 510(k) review has been criticized by public health advocates, other federal agencies and medical journals. The courts have also noted shortcomings in the process. But the authors said Congress hasn't given the FDA enough funding to give the higher scrutiny to every device.
The report, posted online and planned for the June 14 issue of Archive of Internal Medicine, concluded that Congressional action or major regulatory changes were due.