Three years ago, the maker of a surgical clip called the Hem-o-lok issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge in their bodies, with “serious, even life-threatening consequences.”
Experts say deaths resulting from missed recalls are the result of a major weakness in the nation’s system for recalling thousands of medical devices routinely implanted in people’s bodies, from screws and plates to artificial knees and hips.
“There is no system for being informed of what the problems are with the products you have in your body. Even your physician may not know,” said Terry Fadem, president of the Biomedical Research and Education Foundation in Philadelphia.
Unlike the auto industry, medical equipment makers have no centralized system for tracking products throughout their life span. That means in some instances, manufacturers do not have an easy way of knowing where problematic devices are or which patients got them.
Meanwhile, the number of items implanted is soaring, as is the number of recalls. Nearly 2,500 medical devices were recalled for potential safety problems in fiscal 2008, according to the Food and Drug Administration. That was nearly double the number reported the previous year and a 164 percent increase since 2000.
In 2006, surgeons implanted a million hip and knee replacements, according to the American Academy of Orthopaedic Surgeons. That number is expected to quadruple by 2030.
Fadem’s foundation and other groups have been pushing for years for better tracking of devices, hoping to create something like the patient registries used in Sweden, England and Australia to keep tabs on artificial joints.
Health care overhaul legislation being considered in Congress includes a proposal to set up the nation’s first comprehensive medical device registry. Doctors say its primary use would be to uncover safety problems, but it could also be used to find patients quickly during a recall.
The. FDA currently requires comprehensive tracking of only 14 types of devices, including pacemakers, mechanical heart valves and breast implants. The agency says it is working toward better registration and tracking of other devices.
Manufacturers trace many other medical products only as far as the distributor. Finding them again is not always easy, particularly after they have been implanted into someone’s body. Hospitals record the model and lot numbers of implants, but that information is often buried deep in billing records or log books.
Manufacturers send out thousands of letters about recalls, and the FDA puts the information online, but the warnings can go unnoticed.
More than 1,000 such recall notices were sent out in the first seven months of 2009 involving devices such as tracheal tubes, catheters, pacemakers, prosthetic hips, screws, pain pumps and pieces of artificial spine. More than 1,00 were ranked as “Class 1” recalls by the FDA, which involve a defect serious enough to create a “reasonable probability of adverse health consequences or death.”
Premier Inc., an alliance of 2,200 U.S. hospitals, said it examined one recent recall and found that even after a device with a potentially dangerous flaw was pulled from the market, doctors at more than 40 hospitals implanted it in at least 50 patients.
The FDA has been laying the groundwork for a registry of patients with artificial joints, which are more prone to breakage than other types of implants. The agency is also working on a system that would make tracking easier by associating each device with an ID number.