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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.
AdvaMed has been more critical of the proposal for a national medical device registry, saying it would be too costly and require doctors to gather information on products unlikely to pose a safety hazard.
Secunda said incidents in which patients have been hurt because of difficulty with a recall are extremely rare.
Yet mistakes do happen.
Premier Inc., an alliance of 2,200 U.S. hospitals, said it examined one recent recall and found that even after a device with a potentially dangerous flaw was pulled from the market, doctors at more than 40 hospitals implanted it in at least 50 patients.
"This is not just an issue in the United States. This is an issue across the globe," said the group's chief information officer, Joe Pleasant.
Not content to wait for government action, some medical organizations have been trying to develop tracking programs on their own.
The Kaiser Permanente health system in California has a registry keeping tabs on 75,000 artificial joints. It also gives doctors valuable information on how often they break down.
"Within 24 hours, we get a printout, by patient and by doctor, of who has those implants," said Dr. Thomas Barber, an orthopedic surgeon, associate physician in chief of the Oakland Medical Center and a board member at the American Academy of Orthopaedic Surgeons.
Without that system, he said, hospitals can have a much tougher time. Many, he said, still keep track of implants using a system involving stickers, provided by the manufacturers, pasted into the pages of operating room log books.
"When there is a recall, hospitals have to manually go through the implant log by hand," he said.
The American Academy of Orthopaedic Surgeons established a nonprofit organization in June with the goal of building a national joint implant registry similar to the Kaiser Permanente system.
The research foundation in Philadelphia launched a device registry last spring geared toward patients. Any person can sign up for free to automatically get e-mails about potential safety issues with their implant.
For King's still-distraught widow, ShellyAnn King, any reforms will come too late.
The 31-year-old New Yorker had wanted a new kidney so she could get off dialysis and eventually have a baby with her husband.
Thanks to her husband's sacrifice, she is healthy now, but she said every day is "torment and torture."
"I don't want any family to go through what we're going through," she said. "I don't want another husband or wife to feel this unnecessary grief. It should have been prevented."
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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