Associated Press
NEW YORK --- 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."
Not everyone got the message.
Last October, a surgeon in Brooklyn used one of the clips to tie off Michael King's renal artery when he donated a kidney to his wife. Twelve hours later, the clip popped off. Mr. King internally bled to death. He was 29.
Experts say such deaths are the result of a major weakness in the system for recalling thousands of medical devices routinely implanted in people's bodies, ranging 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, the 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 don't have an easy way of knowing where problematic devices are or which patients got them.
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.
Health care reform legislation being considered in Congress includes a proposal to set up the nation's first comprehensive medical device registry, which could be used to locate patients quickly during a recall.
The FDA requires comprehensive tracking of only 14 types of devices, including pacemakers, mechanical heart valves and breast implants. Manufacturers trace other medical products only as far as the distributor. Hospitals record the model and lot numbers of implants, but that information is often buried in billing records or operating-room log books.
Manufacturers send out thousands of letters announcing recalls, and the FDA puts the information on the Web, but the warnings can go unnoticed.
More than 1,000 such recall notices were sent out in the first seven months of 2009. More than 100 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."
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 and are also experiencing a huge surge in use. The agency is also working on a system that would make tracking easier by associating each medical device with a unique ID number.
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