By Alec Klein
Washington Post Staff Writer
Thursday, December 22, 2005
Consumers can buy and sell almost anything on eBay, the giant online auctioneer -- including a used tube designed to be inserted into a patient's jugular.
That little-known commodity, a refurbished single-use medical device, was recently offered by a seller who could not be identified, and there was no way of knowing who bought it and whether it was ultimately used on a patient.
Manufacturers of single-use devices say they cannot vouch for the safety of their instruments if they are reconditioned. Those who sell such devices say there is no credible evidence that their refurbished devices are riskier than new devices, and they say they can save hospitals about half the cost of a new device.
But are hospitals buying medical devices on eBay? There is little way to know.
EBay Inc. says it is not its role to oversee the buying and selling of such devices on its service. "We don't take responsibility for items sold on the site," said company spokesman Hani Durzy. "We're a marketplace."
That means buyers and sellers of reprocessed single-use medical devices on eBay operate largely under the radar. In many cases, there is no certain way of knowing where sellers obtained such used medical devices and no sure way of knowing who bought them, interviews and records show.
Among the more visible online marketers is ClearMedical Inc. of Bellevue, Wash., one of the five largest reprocessors in the United States. In a three-month experiment last year, the company said, it operated an eBay virtual "storefront," selling reused single-use medical devices that it considers "non-invasive" because they do not enter the bloodstream when used on patients. That includes pulse oximeter sensors, which measure oxygen in the blood, and compression sleeves, which increase circulation. (One bidder offered $450 for a set of compression sleeves; ClearMedical said that was about a 30 percent discount off the original price.)
Privately held ClearMedical declined to disclose sales results from the test market, but chief executive Gregg Bennett said it went so well, "we have bigger plans in process." He declined to disclose them.
When asked how ClearMedical can know who is buying its devices online, Bennett said his firm can ask buyers to "validate" themselves; a hospital, for example, can furnish a copy of its purchase order, he said. But if individuals want to buy a reprocessed medical device, he said, there is little that can be done to confirm their identity. Bennett added, however, "Nobody's concerned about that here. Why would anyone [outside of the medical field] want to buy one of those devices?"
As it turns out, there is a market for medical devices on the Web. In 2004, an Arizona medical clinic bought a pacemaker on eBay, and it was implanted in a patient. The pacemaker, it was discovered, had been stolen. On eBay, a company called Trimey this year offered for sale devices reprocessed by Phoenix-based Alliance Medical Corp., the nation's biggest reprocessor. That included percutaneous lead introducers -- long, narrow plastic tubes that surgeons insert into a vein, such as the jugular. Such devices are used in cardiac surgery; for example, a surgeon will thread an electrical wire through the lead introducer into a patient's heart, which is used to temporarily pace the heart.
On eBay, the reprocessed device had a starting bid of $4.99 -- at least 20 times lower than the regular cost of a lead introducer package. The eBay seller did not respond to e-mail; there was no telephone listing for Trimey in Mentor, Ohio, where it stated online that it was based; and no incorporation records could be found.
"We don't condone it and certainly don't support" such sales, said Don Selvey, Alliance's vice president of regulatory affairs and quality assurance. Alliance has alerted the online service that reprocessed devices are not to be sold on eBay. Through a spokesman, he also said he did not know where sellers obtained the reprocessed devices.
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.