No good way of tracking medical implants in U.S.

NEW YORK — Three years ago, the maker of a surgical clip called the Hem-o-lok issued an urgent recall notice. It warned doctors the clips could dislodge in the bodies of living kidney donors, with "serious, even life-threatening consequences."

Not everyone got the message.

Last October, a surgeon used one of the clips to tie off Michael King's renal artery when he donated a kidney to his wife. The clip popped off 12 hours later. King bled to death internally. He was 29.

Experts say such deaths are the result of a major weakness in the nation's 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, 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 in people's bodies 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 alone, 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 reform 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 locate patients quickly during a recall.