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Reprocessing surgical tools causes safety concerns
10:51 PM CST on Friday, February 6, 2004
By JANET ST. JAMES / WFAA-TV
American hospitals dump millions of tons of medical waste into landfills each year. Some hospitals are making an effort to cut down on that trash by re-using some materials on patients. It is a very controversial recycling program known as "reprocessing."
For years, hospitals have sterilized blades, scissors, clamps and other sturdy surgical instruments autoclaves until they're safe to use again. Another class of instruments, often delicate, or made of plastic, is labeled "single use only." The packaging warns they should never be re-sterilized and re-used, but in surgeries across the country those instructions are being ignored.
"Reprocessing" is a practice that has divided the medical community.
"The issue is about cleaning and sterilizing it," Dr. William Sutker said. "The more nooks and crannies a piece of equipment has, those things become harder to clean and so the concern is can you actually make them clean or sterile by using a reprocessing procedure." The potential risks helped Dr. William Sutker shape Baylor University Medical Center's policy against re-using "single-use" surgical devices that touch body fluids.
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"The manufacturer won't guarantee anything beyond the first use and so one has to weigh the potential risks and benefits of using a piece of equipment that has not been backed, so to speak, by the manufacturer," Sutker said.
The Association of Medical Device Reprocessors reported that reprocessing is a growing $67 million a year business because recycling saves money. A reprocessed device costs about half as much as a new one.
In the first few months of its fledgling reprocessing program, Texas Osteopathic Medical Center in Fort Worth has saved $11,000.
Supply Chain Consultant Steve Pettigrew predicted,"We hope once the program is totally up and operating to save somewhere in excess of $200,000 every year."
In most cases, one-time use devices are sent to an outside company to be refurbished and sterilized. Safety concerns have prompted the FDA to implement strict regulations.
According to the Association of Medical Device Reprocessors, "reprocessing has an exemplary safety record."
Of 25 North Texas hospitals News 8 surveyed, three reprocess high-risk surgical devices. Infection control director Richard Davis said he was skeptical at first about using reprocessed devices at Osteopathic Medical Center. "It's not just something they clean up and reprocess. They disassemble and reassemble and check every aspect of it," he said.
Patients at Osteopathic are not told if reprocessed devices will be used in their surgery. Davis said he doesn't feel they need to know. But, the Center for Patient Advocacy is so concerned, it had created a form for patients to sign rejecting the use of reprocessed devices.
Baylor's Sutker said he's waiting to be convinced that safety isn't cut along with the costs.
Hospitals are obligated to disclose when a reprocessed device is being used, but only if a patient asks.
