The single-use versus disposable debate continues in endoscopy, and it applies to the many procedure-associated accessories in addition to the scopes themselves.
Many procedure accessories became single use a long time ago to reduce infection risk, said Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions LLC, in Lansdale, Pa. “The single-use [accessories] not only perform well, but eliminate the risk of cross-infection ... and then reduce all the reprocessing costs. That includes manual staff costs, device transportation costs and materials costs associated with the reprocessing,” Dr. Muscarella, an expert in healthcare infection control, told Gastroenterology & Endoscopy News. “The market [has] really carved out not even just a niche but a real presence for the single-use accessories.”
“What’s more, it was almost impossible to clean the gunk from inside the shaft of reusable biopsy forceps or other types of accessories after a patient procedure,” said Michelle Alfa, MSc, PhD, FCCM, a certified clinical microbiologist and the CEO of AlfaMed Consulting, in Winnipeg, Manitoba. The single-use options “[reduce] the risk of having to reprocess a complex accessory device that really was never designed to be reprocessed.”
FDA Push Toward Single Use
But what about the components that are part of the scopes themselves, such as distal endcaps? The FDA has reiterated their position that it’s just safer for these parts to be disposable. In a safety communication that came out just over a year ago as an update to an earlier safety communication released two years before, the agency drew a line in the sand on disposable components. “Given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or to fully disposable duodenoscopes” (FDA Safety Communication; updated June 30, 2022).
The agency is following accumulating data, which is starting to show reductions in the rates of infection with single-use scopes and components compared with reusable ones. For example, a study published in JAMA earlier this year found a nearly 5% reduction in the rates of infectious material in between uses when endoscopists used duodenoscopes that had disposable elevator caps (JAMA Intern Med 2023;183[3]:191-200).
Having disposable components and accessories eliminates human error, and “[takes] out that whole problem of trying to get adequate cleaning on a lever mechanism. They’ve removed that risk factor,” Dr. Alfa said.
Re-engineering the Future
The lion’s share of the flexible duodenoscope manufacturers have already switched to making at least the endcap disposable, Dr. Alfa noted. “However,” she told Gastroenterology & Endoscopy News, “there has been little progress to change the complex design of the reusable duodenoscopes that would make their narrow channels easier to clean and high-level disinfect or ideally sterilize.” Rather than designing sterile, single-use endoscopes, she said, “an option would be to re-engineer reusable endoscopes, thereby fully automating a reliable cleaning and sterilization process.”
That point is one that Bret T. Petersen, MD, a professor of medicine in the Division of Gastroenterology and Hepatology at Mayo Clinic, in Rochester, Minn., echoed. “I’m sure a durable multiuse device could be designed and constructed that would work far better” than the older models.
Eliminating Costs, but Increasing Waste
So, what are the disadvantages in using disposable accessories or components for these procedures? The answer comes in its usual forms: cost, disposal and labor. With the elimination of sterilization and reprocessing costs for these accessories, price considerations increasingly are not a factor. Even as far back as 2002, Dr. Petersen said, “in our huge practice, we were buying [disposable components] for equivalent or less than we could reprocess them.”
Concerns about the effects on the reprocessing workforce have been raised, but the elimination of the need to sterilize and reprocess these devices doesn’t mean people will necessarily lose their jobs associated with those tasks, Dr. Muscarella said. “Just because you eliminate a reusable accessory and replace it with a disposable counterpart, you still have so much other associated instrumentation that’s still reusable, the notion that you’re going to lose jobs—I don’t see that as having a huge impact today.”
Waste seems to be the biggest drawback. “Endoscopic procedures with disposable accessory devices, along with the accompanying reprocessing requirements for the endoscopes, in general, create more trash than most other medical disciplines,” Dr. Alfa said.
It makes sense to use sterile, single-use endoscopes for certain situations, she said, but if all flexible endoscopes were fully disposable, the waste stream would quickly exceed manageable levels. “Whenever you’re dealing with a disposable device, like a disposable plastic bag that you throw out as opposed to a reusable bag, there are going to be environmental issues that need to be addressed. There may be technology advances that mitigate the effect of single-use items on the environment,” she said. “However, be careful what you wish for because if every flexible endoscope becomes sterile, single use and disposable, there are published studies to show that the environmental impact would be far greater than what is currently happening.”
—W. Harry Fortuna
Dr. Alfa reported financial relationships with HealthMark, Nanosonics and Olympus America. Dr. Muscarella reported a financial relationship with Ambu.
This article is from the September 2023 print issue.