IS REUSE OF DEVICES ILL-ADVISED?
August 4, 2006
A recent court case is fueling the debate over the safety of reusing surgical blades, forceps and other medical devices.
- The practice was routine until a couple of decades ago, when stronger plastics enabled manufacturers to start making devices designed for single use to cut costs and prevent the spread of infection in the era of AIDS.
- Then hospitals, and eventually specialized companies, started "reprocessing" single-use devices, cutting the costs of the devices 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 that took effect Tuesday, which requires 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.
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.
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 1 million.
Source: Linda A. Johnson, "Is reuse of devices ill-advised?" Associated Press/wnbc.com, August 1, 2006.
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