This week's report that 80% of medical devices so dangerous that they had to be recalled had been cleared for use under a flawed, federal process (and others were barely reviewed at all) points a damning finger at the U.S. Food and Drug Administration.
Nevertheless, doctors and hospitals should absorb some of the responsibility, too.
These were Class I recalls, the most serious kind, necessary because "there is a reasonable probability that the use of or exposure to a violative (harmful) product will cause serious adverse health consequences or death," according to the FDA definition.
The largest category of these recalls involved 35 devices for cardiac patients, two-thirds of which were approved under the FDA's 510(k) process. That The 510(k) speeds approval for devices considered "substantially equivalent" to other devices approved under the more rigorous, premarket approval process (PMA) and requires little safety documentation and no clinical trials, according to a research paper published this week in the Archives of Internal Medicine.
These are devices classified by the FDA as the most dangerous kind, the type that "pose the greatest potential risk and include such items as implantable pacemakers, stents, heart valves, and human immunodeficiency virus diagnostic tests," wrote the researchers, Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Steven Nissen, MD, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic.