The FDA allows surgery centers to reprocess some single-use items, following a standardized process. But there are some changing market pressures that shed doubt on whether this efficiency is feasible. There also have been problems when surgery centers perform procedures incorrectly.

“The FDA has a standardized process where a single-use item can be repurposed where functional fidelity is established and sterility is established,” says Michael Brenner, MD, FACS, associate professor, department of otolaryngology-head and neck surgery, University of Michigan.

According to FDA standards, repurposing single-use devices is an approved process for these and more single-use devices: coblators and adenoid blades in otolaryngology; laparoscopic trocars and cannulas in general, OB/GYN, and urology; ablation wands, arthroscopic shavers and abraders, drill bits and burs, and tourniquets in orthopedic surgery.1

There have been instances when clinicians or hospitals fail to adhere to FDA standards, creating risk of patient harm, Brenner notes. For example, problems with reuse of single-use items have occurred in clinic settings where physicians were reusing single-use items without following reprocessing standards, says David Chang, MD, FACS, associate professor of otolaryngology-head and neck surgery, University of Missouri. Chang also is the co-chair of the patient safety quality improvement committee of The American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS), which had to take a stand on that issue because of reports of this unsafe practice, Chang reports.

“We didn’t see this in the ambulatory surgery center environment,” he adds. “But some people were looking to cut corners, and they might reuse single-use items that were not approved for reprocessing.” There is a defined pathway for reprocessing single-use items, Chang notes. “You can’t just decide you will do this,” he says. “You have to go through the steps and show that after reprocessing the items are very similar in quality and sterility as the original item was when it came from the manufacturer.”

Reprocessing single-use devices is complicated, Brenner notes. “Single-use devices might have parts that cannot be subjected to autoclave, so you have to figure out a process where you can achieve the same level of rigor to make it free of contaminants,” he says.

There are other concerns, too. “Is the single-use item going to have the same fidelity? Will it work as well?” Brenner asks. “As with any reprocessing, the single-use item might not be reprocessed in a way that gets rid of all potential bacteria and remnant tissue.”

There is no evidence that reprocessing of single-use items leads to more bacterial contamination, but reprocessing these items is more complex. “The real problem is when people do not follow the rule book in reprocessing,” Brenner says. “With single-use devices, you must follow an FDA-compliant process, with someone authorized” to perform the task. On the positive side, reprocessing of single-use items saves money for surgery centers. It also reduces biohazard waste disposal costs, says Kerri Ubaldi, RN, MBA, CPHRM, vice president of operations, Merritt Healthcare in Ridgefield, CT. “If you’re not throwing out these things, then you are decreasing the amount of money spent on disposing of biohazardous waste,” she notes.

Chang wrote an article in 2016 about how the reuse of single-use devices may become part of managing healthcare costs and reducing medical waste.2 In his article, Chang noted that single-use devices reprocessed by third parties cost 50% less, on average, to purchase. Some original equipment manufacturers that made single-use items have gone into the reprocessing business, too.

However, there are logistical problems with reprocessing single-use items, Ubaldi says. For example, manufacturers of single-use items are making it increasingly difficult for other companies to reprocess their products. A manufacturer of a single-use item that is FDA-approved for reprocessing might offer its own reprocessing services and then sell the reprocessed item back to the ASC at a lower cost than the new item, Ubaldi explains. “That will continue,” she predicts. “But it’s probably going to be harder to have other companies reprocess the items.”

In the last year, manufacturers have begun to put microchips in some devices. These chips can render the device unusable after a software update, following reprocessing, Ubaldi warns. The use of a chip can be for patient safety reasons. “They’re doing this to maintain patient safety and make sure devices have not been used multiple times,” Chang explains.

There also is an economic aspect to the practice. A device manufacturer might not want to see the device reprocessed because reusing devices affects their profit margin, Chang adds. “They want to see you buy a new one every time you use it,” he says. “I’m sure there are other economic considerations, but I’d argue this is about patient safety.”

If a tool or product is made for single use, then there can be no contamination from previous uses. “People argue that there is increased patient safety with single-use items,” he says. “Also, labor costs are so high in the United States, in general, that it often becomes more labor-intensive and cost-intensive to hire people to reprocess and clean items so they can be used again.” This is why some surgery center products, such as surgeons’ gowns, that once were reusable are designed to be used once and thrown away today. Operating room drapes, placed as a barrier to isolate the surgical area, is another example. “Thirty years ago, all drapes were cloth and would go in the washing machine,” Chang says. “Now, drapes are disposable.”

Another manufacturers’ trend is to offer contracts that require surgery centers to buy a set amount of disposable items, Ubaldi says. “We try to be as cost-effective as possible, but these changes are making it more difficult because the contracts don’t give us any room to negotiate with other companies to get cheaper pricing,” she adds.

REFERENCES

  1. Chang CWD, Brenner MJ, Shuman EK, Kokoska MS. Reprocessing standards for medical devices and equipment in otolaryngology. Otolaryngol Clin North Am 2019;52:173-183.
  2. Chang CWD. Responsible reuse of single-use devices may become a part of managing healthcare costs and operating sustainably. Bulletin, November 2016:10-14.