System Needed to Track Recalled Medical DevicesOct 7, 2009 | Parker Waichman LLP
Even though medical device recalls have increased in recent years, the Food & Drug Administration (FDA) has not devised an effective process for notifying the public about dangerous devices. According to an Associated Press report, lack of such a process has put patients in danger.
In 2008, 2,500 defective medical devices were recalled. More than 1,000 recall notices were sent out in the first seven months of 2009 involving medical devices, and of those recalls, 100 were deemed Class I. A Class I recall is the FDA's most serious recall, and is issued when there is a "reasonable probability of adverse health consequences or death." But finding these recalled devices is no easy task, particularly after they have been implanted into someone's body.
According to the Associated Press, medical device manufacturers generally only track their products as far as the distributor. Hospitals usually track the model and lot numbers of devices implanted at a facility, but that information can be difficult for patients to find. Even doctors aren't always aware that a device has been recalled.
The current situation can have disastrous results for people implanted with defective medical devices. For instance, last October, a New York man who had donated a kidney to his wife died 12 hours after surgery because a surgical clip called the Hem-o-Lok popped off his renal artery. According to the Associated Press, the Hem-o-Lok had been the subject of a recall three years ago, and doctors were warned stop using the fasteners on living kidney donors. It's not clear why, but SUNY Downstate Medical Center and the surgeon who performed the operation were still using the clip.
According to the Associated Press, groups like the Biomedical Research and Education Foundation in Philadelphia have been pushing for patient registries to better track medical devices. Such systems are already in use in Sweden, England and Australia to track artificial joints.
Health reform legislation currently being considered in Congress does include a proposal to set up a comprehensive medical device registry, the Associated Press said. The FDA is also working on a registry for patients with artificial joints and other implants, and is considering assigning each medical device a unique ID number to make them easier to track. The agency has been in talks with the medical device industry regarding these proposals for over a year, the Associated Press said.
Some medical organizations aren't waiting for the federal government to act. According to the Associated Press, Kaiser Permanente health system in California has a registry tracking 75,000 artificial joints. The American Academy of Orthopaedic Surgeons established a nonprofit organization in June with the goal of building a national joint implant registry similar to the Kaiser Permanente system. And the Biomedical Research and Education Foundation has set up a registry that any person can sign up for to automatically get e-mails about potential safety issues with their implant.