Recycling single-use devices raises concerns

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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.

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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 and MSNBC.com columnist 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.

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