TRENTON, N.J. - For eight months during his infancy, Sean Van Duyn gagged, retched and vomited daily. Now 6, the Winter Haven, Fla., boy still can't eat or drink by mouth, instead being fed by a permanent tube in his belly.
Beset by multiple medical problems in his first months, the boy had to have a breathing tube inserted through a hole cut in his neck. The gagging began and continued until his mother, Susan, discovered the tube was misshaped at the end and had been poking the back of his throat the whole time. The tube was replaced, but by then Sean's developing brain was programmed not to swallow; he still cannot.
The family alleged the injury occurred because the plastic breathing tube's tip had been bent during "reprocessing" -- cleaning and heat sterilization -- done at an Orlando hospital even though the tube was labeled for single use only. They won a confidential settlement from the hospital.
The case has fueled the debate over the safety of reusing surgical blades, forceps and other medical devices. The practice was routine until a couple decades ago, when stronger plastics enabled manufacturers to start making devices designed for single use to cut costs and prevent infection spread in the era of AIDS.
Then hospitals, and eventually specialized companies, started "reprocessing" single-use devices, cutting device costs by about half -- without patients' knowledge.
Federal regulators say reprocessing is safe, but original device manufacturers say they can't guarantee recycled products will work correctly -- and that they are wrongly blamed for malfunctions and patient harm caused by reprocessing.
A federal law taking effect Tuesday, requiring reprocessors to put their company name on recycled devices as well as the packaging, could help determine who's at fault when problems occur. For devices too small to mark, detachable stickers could be transferred to the patient's chart.
"That's like a 'Sue Me!' sticker," and may not be used much, said Josephine Torrente, a lawyer and biomedical engineer who consults for device manufacturers.
Dan Vukelich, executive director of the Association of Medical Device Reprocessors, argues reprocessed products are totally safe because each item is inspected before being shipped.
The device makers and their trade group have been lobbying legislators in several states for bills that protect their interests -- and patients. The battle has a big -- and fast-growing -- financial stake for both sides. Device makers saw combined revenues jump from $48 billion in 2001 to $71 billion last year; reprocessors went from a combined $20 million in 2000 to $87 million in 2004.
Johnson & Johnson subsidiary Ethicon Endo-Surgery is suing the biggest reprocessor, Ascent Healthcare Solutions, for trademark infringement over reprocessing its single-use devices.
"It is impossible to reuse them," said Robert O'Holla, J&J's head of regulatory affairs for medical devices, because they are not designed to be taken apart for cleaning. Yet J&J gets complaints from customers about problems with devices showing excessive wear or bleach on them -- signs of reprocessing.
Ascent Healthcare's regulatory chief, Don Selvey, said only about 2 percent of medical devices -- a category that ranges from MRI machines to reading glasses -- are now reprocessed. He said his company's processes reduce chances of "viable organisms" surviving on devices to one in one million.
Reprocessed devices are soaked in sterilizing solutions, disassembled, blasted clean with a fine powder, reassembled and inspected, then packaged, sterilized and resealed. On average, they're reused three to six times.
"It is as safe and effective as a new device if they meet our requirements," said Larry Spears, compliance chief for medical devices at the Food and Drug Administration.
Since early 2004, when reports of problems with medical devices were first required to note if they had been reprocessed, the FDA has received 13 reports of patient deaths and 421 other trouble reports, including 130 involving serious patient harm, although some may be duplicate reports.
Reprocessors say they must meet stringent FDA standards after first proving they can safely clean and sterilize each type of device. But the manufacturers main trade group, the Advanced Medical Technology Association, notes about half of the reprocessors' applications for reprocessing of individual devices were rejected by FDA, a sign of the difficulty of properly cleaning complex devices.
Rep. Tom Davis, a Virginia Republican who chairs the House Government Reform Committee, said Friday he plans a fall committee hearing to examine the issue.
"It is unclear to us at this time whether FDA is able to accurately track how often something goes wrong because a device meant to be used once was instead reused," Davis wrote in a statement.
Congress also has asked its investigative arm, the Government Accountability Office, to update a June 2000 report which concluded more oversight is needed. GAO is unsure when it will begin investigating.
Ken Hanover, CEO of the seven-hospital Health Alliance of Greater Cincinnati, said his hospitals have used reprocessed devices for about eight years without a problem.
"There's far more risk of medication errors in a hospital than of a problem arising with a reprocessed device," he said, adding that his hospitals "probably" would honor patient requests to have only new devices used on them.
Children's National Medical Center in Washington, on the other hand, doesn't use reprocessed devices, said surgeon in chief Dr. Kurt Newman.
"We want to use the safest and most sterile equipment," he said.
University of Pennsylvania bioethicist Arthur Caplan has "qualms" about the practice, particularly because patients don't give informed consent -- required when deviating from the standard of care raises safety or efficacy concerns.
"I just think people ought to know what's going on," Caplan said.
Susan Van Duyn, Sean's mother, agreed.
"If anybody can learn from the tragedies with Sean, it's worth telling" his story, she said.