United States has no good system to track medical implants
The San Francisco Chronicle reports that 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. Unfortunately, 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 ailing wife. Twelve hours later, the clip popped off. King bled to death internally in the hospital as his wife lay helplessly nearby. 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.
Clearly, the U.S. needs a better, more aggressive and dynamic system for tracking and alerting people receiving these devices.
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