Recycling single-use devices raises concerns

updated 8:48 p.m. ET Aug. 11, 2006

Correction: When this story was first published, on July 31, it contained inaccuracies. The Associated Press reported incorrect data about difficulties with the devices. Based on erroneous information supplied by the Food and Drug Administration, the story reported that since early 2004, the FDA had received 13 reports of patient deaths and 421 other trouble reports, including 130 involving serious patient harm.

The FDA said Aug. 10 that, contrary to its initial report, no patient deaths were caused by the reprocessing of single-use devices, and that fewer than 10 serious injuries and fewer than 10 device malfunctions were attributable to reprocessed single-use devices during that period. In addition, the story discussed the case of an infant who was permanently injured by a tracheal tube that was damaged when it was reprocessed by a hospital. The FDA did not regulate reprocessing at hospitals when the infant was injured in 2001, and hasn't authorized reprocessing of tracheal tubes. The story has been revised.

Debate is simmering in the medical community over 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 in early August, 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.

Safe as new?
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 recieved notice of fewer than 10 serious injuries and fewer than 10 device malfunctions that were attributable to reprocessed single-use devices.

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