Reused Devices Attract Entrepreneurs, Scrutiny

The settlement did not seem to shake the company. A year later, Sullivan sold Recovery Engineering to Procter & Gamble Co. for about $265 million, and he said he is proud of the safety record he has established at SterilMed.

'Imperfect System'

Until recently, the FDA acknowledged, it did little to monitor reprocessors other than conduct periodic inspections of their facilities. But then Congress's investigative arm looked into the growing practice. Its 2000 report concluded that there was little evidence of harm from reuse, but it suggested that the FDA provide more oversight. "Reprocessing is not invariably safe, and relatively little is known about the practice of [single-use device] reprocessing in health care institutions," the report said.

That year, the FDA took its first concrete action, offering industry guidelines calling on reprocessors to demonstrate the safety and effectiveness of their reconditioned instruments. In 2002, reprocessors were required to submit data that showed their work produced safe and sterile devices.

That requirement gave reprocessors a boost. Many hospitals, concerned about the additional FDA paperwork, decided to get out of the business of reprocessing, shuttering their own in-house sterilization departments and handing the refurbishing work over to the reprocessors, which say that on average they save hospitals half the cost of a new device.

The FDA acknowledges that issues of oversight remain. The federal agency said it relies on doctors to voluntarily report problems with faulty medical devices. Medical facilities are required to report to the FDA deaths but not device malfunctions. And the FDA did not ask whether device problems involved reprocessing until it changed its complaint form in 2003, and it gave firms until last year to modify their reporting practices.

Even when medical professionals do report problems with reprocessing, in many cases the information does not include names, dates, locations and other basic data, FDA documents show. Until a change in law in August, refurbished single-use devices did not typically carry the name of the reprocessor on the instrument itself; it was usually on only the outside packaging, which was frequently discarded by the time the device ended up on the operating-room table. That meant doctors and nurses often did not know that the device in question had been reprocessed.

In addition, the FDA said in a written response to questions that there is "no routine or standard inspection schedule" but that it will examine a reprocessor based in part on whether it hears of complaints or injuries associated with its devices. The federal agency said there is no set number of inspectors assigned to reprocessors.

"It is an imperfect system," said Spears of the FDA.

Still, he said, the federal agency has made great strides in the past several years, adding that additional regulation or oversight is unnecessary. The reprocessors say they already face as much -- or more -- regulatory scrutiny than the device makers. The reprocessors' trade group said it has adopted a strict "Commitment to Patient Safety" that "requires its members to meet or exceed all federal standards for safety."

Some think more oversight is needed. Massachusetts has introduced a bill that would require hospitals in that state to obtain permission from patients before using a refurbished single-use device on them. U.S. hospitals are not required to obtain such patient consent. The Massachusetts Medical Device Industry Council said not enough has been done to "protect patients from potential contamination and injury from reprocessed" single-use devices. The trade group said the savings hospitals accrue from reprocessing "may come at the price of jeopardizing patient safety."

Staff researcher Richard Drezen contributed to this report.