Hospitals Save Money, But Safety Is Questioned

"Nobody's track record is perfect," he said.

At the Hospitals

The big three reprocessors say they perform a great service for hospitals, noting that they reduced hospital waste by 935 tons in 2004, the first year such numbers were tabulated.

Kenneth Hanover, president and chief executive of the Health Alliance of Greater Cincinnati, a chain of six hospitals, said that device makers threatened to charge his facilities more if they reprocessed devices but that he ignored them. His hospital chain has been reusing single-use devices, including catheters and biopsy forceps, for several years, reprocessed principally through Alliance. Asked whether the hospital chain has encountered any problems with reprocessed devices, Hanover said none had been brought to his attention. This year alone, he said, the chain will save about $1 million through reprocessing, which he said means it can buy more surgical devices and other medical equipment.

Aside from saving hospitals money, reprocessors stress that they follow strict cleaning and sterilization procedures and say they test every device they recondition. They also note that Congress's investigative arm, the Government Accountability Office, "found little available evidence of harm from reuse" when it looked into the matter in 2000. The GAO also said that "reprocessing is not invariably safe." In addition, the FDA requires reprocessors to register with it and submit paperwork validating the safety and effectiveness of their work and periodically inspects reprocessors' facilities.

The big three said they are paid per device reprocessed. If they are not able to recondition a single-use device, they say, they will absorb the cost. They said the system does not create an incentive to return to a hospital a reprocessed device that is not fully sterile or functional. Their business, they say, depends on their reputation for safe reprocessing.

"We're only as good as the last device we deliver to that customer, so it has to function appropriately," Vanguard's Salomon said.

Several hospitals vouch for the reprocessors' work. That includes the Mayo Foundation. In a recent letter, an official from its Jacksonville, Fla., clinic informed manufacturers' sales representatives that it was about to begin reusing single-use devices by hiring Alliance, citing the practice's safety and "the dramatic reduction in our supply costs that will occur." The clinic asked the sales reps to "not speak negatively to any surgeon, nurse or other employee about [single-use device] reprocessing while on hospital property."

Erik Kaldor, a spokesman for the Jacksonville Mayo Clinic, explained the letter was written to remind "sales reps from these companies who may not welcome our policies" to not speak poorly about reprocessing because they are trying to sell new devices. He said the Mayo Clinic in Rochester, Minn., also reprocesses single-use devices.

The Johns Hopkins Hospital in Baltimore said it also has just begun reprocessing single-use devices through Vanguard. John D. Hundt, Hopkins's administrator of surgery, said its operating rooms intend to refurbish about 30,000 single-use devices, including drill bits, burs and blades, in the first year.

But Shannon J. Tillman, president and chief executive of Millstone Medical Outsourcing LLC, one of the few reprocessing firms that works with device makers, questions how the others do their job. Tillman's firm has access to the device makers' original product design requirements. Most other reprocessors do not have those documents, but they say they have sophisticated research and development departments to assess how a device was made.

Still, Tillman said, "I think it would be very difficult" for another reprocessor to recondition a single-use device without the original manufacturer's help, given the complexity of the product's material and design. Working in concert with a device maker is "much less risky," he said.

"How do you know for sure," Tillman asked, "what you put back in the hands" of a doctor?

Staff researcher Richard Drezen contributed to this report.