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Archive for Tuesday, October 6, 2009

Medical device recall system flawed

October 6, 2009

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— 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.

No centralized process

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.

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.

Tracking products

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.”

A lawyer for the King family, Jeff Korek, said that in Michael King’s case, the hospital had received a registered letter about the Hem-o-lok recall from the manufacturer, Teleflex Inc. He said it was unclear why the alert was not acted upon. The family is suing the hospital, SUNY Downstate Medical Center and the surgeon.

Teleflex Medical said in a statement that it complied with all FDA regulations by notifying medical centers in writing that the clip, while fine for other types of surgery, should not be used to tie off the renal artery on living kidney donors.

Some potential solutions are in the works.

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.

Thomas Gross, director of post-market surveillance for the FDA’s Center for Devices, said the agency has been in talks with the industry on both projects for more than a year and is making progress.

He said the issue has gained “momentum” both in the agency and the industry, and that the FDA’s new commissioner, Margaret Hamburg, is “putting a priority on post-market safety.”

Jeff Secunda, a vice president of regulatory affairs at AdvaMed, an association that represents medical device companies, said the new ID system being developed by the FDA could be “the answer to everyone’s problem” if combined with better electronic health records.

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