Hospitals Save Money, But Safety Is Questioned

That is a big change from the late 1980s, when the reprocessing business started as health care costs spiraled. Then, only a handful of small operators, some working out of their garages, refurbished single-use medical devices, at first limiting their work to the resterilization of sutures that had been opened but unused. The industry is expected to surpass $100 million in revenue this year.

Although their reconditioning methods have become much more sophisticated, reprocessors often need to take apart the medical instruments -- many involving small openings and delicate attachments -- to figure out how they are made and how they can be cleaned. While device makers raise questions about such practices, the American Hospital Association has supported reprocessing as far back as 2000, noting the FDA's oversight and the cost savings for hospitals. Reprocessors say their reconditioned devices can cost hospitals about half as much as a new single-use device. New biopsy forceps can cost $60; reused, as little as $15. Hospitals that reuse such devices said that the practice may not directly lead to a discount in a patient's bill but that it allows them to buy additional medical equipment or hire more personnel.

Device makers say the single-use tag is not just a label. "Single-use devices typically contain difficult-to-access areas that create barriers to cleaning and permit blood, tissue or other bodily fluids to contaminate the reprocessed device, allowing potential transmission of viral and bacterial infections," said Stephen J. Ubl, president and chief executive of the Advanced Medical Technology Association, which represents device makers worldwide.

An association that represents reprocessors said there is "no credible evidence" that refurbished single-use devices are riskier than new ones.

Caught in the middle of the debate are patients like Brian D. Reid. The 34-year-old firefighter recently entered Christ Hospital in Cincinnati for a procedure to treat an irregular heartbeat. Reid did not know that a single-use cardiac catheter employed in his procedure had been previously threaded into some else's heart.

"I didn't really have a problem with" it, Reid said after the procedure, when he learned about the reuse.

But, he added, "I don't think there would be any harm with the hospital disclosing that" on the "informed consent" form patients must sign. Reid's form explained that the catheter procedure is "generally considered to be safe," but it noted several risks, from bleeding to a heart attack to death. It did not say that the doctor may place a refurbished single-use medical device in the patient's body.

Reprocessors have changed their position on patient consent in recent months. At first they said they saw no need to inform patients when single-use devices are reused, because they are safe. Now they say they would support such informed consent as long as hospitals also disclose the risks of new devices.

Fed Through a Tube

Susan and Tony Van Duyn think patients should know when single-use devices are reused.

Their 5-year-old son, Sean, lives in his own world. For hours each day, he sits on his knees inches from a television, his sandy blond head tilted to the left, hazel eyes blank, mouth agape, bouncing up and down, clapping to a children's video, "Blue's Clues." It is the only thing he will watch on television. He cannot eat or drink from his mouth, which his family's lawyer says is the result of a failed reprocessed medical device. The hospital and doctors involved in Sean's treatment settled a lawsuit with the family, so no court determined the facts of their case.

Days after his birth in 2000, Sean was rushed to Arnold Palmer Hospital for Children & Women in Orlando because of a brain inflammation. He had neurological damage. During surgery, doctors inserted a tube in Sean's throat to help him breathe. But the tube turned out to be too big and caused an injury to the lining of his airway, the family said in its lawsuit. That required a tracheotomy -- cutting a hole in Sean's throat below his Adam's apple -- in January 2001. A plastic tube was inserted in his throat so he could breathe. Through its in-house sterilization department, hospital records show, the medical facility reprocessed the tracheal tube despite an explicit warning on the packaging from the manufacturer that the device was not to be resterilized.

The hospital does not dispute that it resterilized the device, said its attorney, Richards H. Ford. Two reprocessed tubes were used in Sean's throat for nine months, while he vomited and retched several times a day. The Van Duyns said they repeatedly asked their doctors whether Sean was having a bad reaction to the tubes and whether they should use a new one. They said the doctors told them that Sean was vomiting and retching because of his neurological problems. Sean's dry heaving got so bad at one point that he suffered a hernia, where a portion of his stomach became lodged in his chest cavity.