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Used Medical Devices Being Sold on EBay
An employee at SterilMed Inc., a reprocessor of single-use medical devices, cleans used biopsy forceps. Many device manufacturers oppose such reuse.
(By Ben Garvin For The Washington Post)
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Reusing lead introducers is inappropriate and raises concerns about patient safety, said Minneapolis-based Medtronic Inc., a medical maker of such devices.
Once single-use devices are shipped from manufacturers, the device makers ask, how are the instruments handled and resterilized before being sold on eBay and potentially used on patients?
"What quality controls are there throughout the process?" asked Rob Clark, a Medtronic spokesman.
Jim Stewart, an eBay seller in Huntington Beach, Calif., said he shies away from selling reprocessed single-use medical devices but does offer some, including laparoscopic devices used in abdominal surgery. Occasionally, he said, his company, the Granite Group, obtains such devices from hospitals that already had the instruments refurbished. "Ninety-some-odd percent is identified," he said.
Doctors, veterinarians and others buy his goods, which also include circumcision trays, catheters and biopsy instruments, but he said that generally, "we never know who they are." Stewart said he will sometimes ask buyers to verify that they are authorized to make their purchase; for instance, he said he will ask for proof, such as a doctor's license.
EBay requires sellers of medical devices that are state or federally regulated to include a disclaimer saying that buyers should not bid on the medical device unless they are an authorized purchaser. Durzy, the eBay spokesman, said it is the seller's duty to confirm that the buyer is authorized to make the purchase. What, then, constitutes an authorized purchaser? He said to ask the Food and Drug Administration.
Larry Spears, the FDA's deputy director for regulatory affairs in the Office of Compliance in the Center for Devices and Radiological Health, said the federal agency periodically monitors Web sites but does not have specific rules about the sale of reprocessed single-use medical devices on eBay. "That's an area we haven't put any writing on," he said.
Staff researcher Richard Drezen contributed to this report.
