No system tracks faulty medical devices in U.S.

updated 8:33 a.m. ET Oct. 6, 2009

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 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.

Recalled devices soaring
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.

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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.

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.

Unnoticed warnings
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 operating-room log books.

Manufacturers send out thousands of letters announcing recalls, and the FDA puts the information on the Web, but the warnings sometimes 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 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."

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"Trying to get all that product out of the market is a real effort," said Tim Ulatowski, director of compliance for the FDA's Center for Devices and Radiological Health.

Dr. Bruce Moskowitz, chairman of the research foundation and an internist in Palm Beach, Fla., said he got a recall notice in February warning about external defibrillators, the paddles doctors use to shock a heart that has stopped beating. The defibrillators had a remote chance of blowing a fuse, delivering a low shock or shutting down in the cold.

The letter included a list of thousands of serial numbers, each representing a flawed device, but no information on who might have bought them or where.

"I couldn't do anything with it," he said. "So they are still out there."

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