Endoscopy plays a pivotal role in the diagnosis and treatment of various medical conditions but carries with it a potential risk for infection transmission through reusable endoscopes. Concern for patient safety and the need for cost-effective healthcare practices have sparked a long-standing debate surrounding single-use versus reusable endoscopes.
Ten years ago, the initial dynamic—partly driven by industry—was to push the market toward single-use endoscopes, noted Klaus Mergener, MD, PhD, MBA, MASGE, an affiliate professor of medicine at the University of Washington School of Medicine, in Seattle. But single-use endoscopes have significant downsides, he said, and may not be necessary for most patients as long as efforts are focused on optimizing reprocessing and exploring innovation for automated reprocessing products.
When it comes to reusable endoscopes, no single, simple and proven technology or prevention strategy exists to reduce infection transmission, but addressing human error to the extent possible through automated solutions—and investments in more comprehensive training for the necessary human component of endoscope reprocessing—are sorely needed, he said.
“The investment into our reprocessing personnel, and the processes themselves, is often suboptimal,” Dr. Mergener said. “I would encourage everyone to consider increasing their investment in training on the reprocessing step.”
What Started the Debate?
The move toward single-use endoscopes started in 2013 when a few major outbreaks occurred through contaminated duodenoscopes. This infection transmission was first recognized at Virginia Mason in Seattle, then at UCLA Medical Center, in Los Angeles, Dr. Mergener said.
“When people started investigating this, we found out it’s a sizable problem. Many centers were identified, not just in the U.S. but also in Europe, with similar infection transmissions,” he added. It’s estimated that between 2013 and 2016, over 300 infections and 30 deaths were related to multidrug-resistant organisms with duodenoscopes.
Further review of these duodenoscope-associated outbreaks revealed that they occurred despite centers following the manufacturers’ instructions for endoscope cleaning.
“So it wasn’t just a problem with cleaning incorrectly,” Dr. Mergener said. “Even when it was being done correctly, there could still be remaining [bacteria] on endoscopes. That’s what started the single-use movement.”
Proponents of single-use endoscopes argue that they offer several advantages, including eliminating the risk for patient-to-patient transmission of infections (e.g., hepatitis B and C and HIV), which can occur even with stringent reprocessing protocols; eliminating the need for complex and time-consuming reprocessing steps, which reduces the chance of human error during the cleaning and disinfection process, saves valuable staff time and mitigates the potential risks associated with inadequate reprocessing; and potentially providing a more cost-effective option for lower-volume practices. Some argue that while a new endoscope has to be purchased for each procedure, the expenses associated with reprocessing—including staff training, maintenance and repair—can be significant. By eliminating these costs, single-use endoscopes may offer a predictable budgetary model for healthcare facilities and reduce the need for investment in reprocessing equipment.
Recognizing the advantages of single-use endoscopes—and what seemed like an apparent shift toward their use in gastroenterology practice—industry players have invested massively in research and development to enhance their quality and usability, as well as in marketing materials related to these products.
According to Dr. Mergener, because these investments had to be so substantial—and unlikely to be recouped via the sale of duodenoscopes alone—there has been motivation to also explore this topic for upper endoscopy and colonoscopy, even though the infection transmission risk is significantly lower with reusable scopes in these procedures.
“A couple of companies made large investments because they bet single use was the way of the future,” Dr. Mergener said. For a while, “it seemed that all of GI endoscopy would rapidly shift towards only single-use endoscopy to completely eliminate the infection problem,” he added. “But over the last few years, I would say that this outlook has at least been drawn into question. For now, the pendulum has swung back in the other direction towards a more limited adoption of single-use endoscopy, perhaps for smaller niche applications, for example, immunosuppressed patients who are prone to infections.”
Jim Leavitt, MD, the director of clinical innovation for Gastro Health in Miami, noted that most GI practitioners never really made the switch to single-use endoscopes. Significant numbers of disposable endoscopic retrograde cholangiopancreatography scopes are seen due to the issues associated with cleaning the scopes’ elevators, but the overwhelming number of endoscopic procedures are still done with reusable scopes in every setting, he said.
According to Dr. Mergener, physician interest in single-use endoscopy has waned partly because no major outbreaks have been reported in the last few years. “No one doubts that there are potential residual risks with reusable scopes, but every intervention in medicine has its risk,” he added. “The risk of transmitting an infection through an appropriately cleaned [reusable] endoscope seems to be very low and, in most cases, not high enough to justify a paradigm shift to single-use devices.”
Dr. Leavitt agreed, saying that the press attention around these infections may have been overhyped, and scope-to-scope infection transmission remains “very, very uncommon.”
Dr. Mergener maintained that in addition to the benefits of single-use scopes, the downsides of their use also need to be considered. The financial burden associated with single-use devices may outweigh the savings achieved through reduced reprocessing costs, particularly in high-volume endoscopy units.
Critics of single-use endoscopes also cite sustainability and argue that the environmental impact of disposable devices should be taken into consideration. The manufacturing, packaging and disposal of single-use endoscopes contribute to medical waste generation and have potential ecological consequences.
“About 15 million colonoscopies are performed in this country every year,” Dr. Mergener noted. “If you use a new colonoscope for every colonoscopy, for example, there is a significant amount of waste being generated. This becomes a complex equation, of course, as reprocessing materials are also potentially harmful to the environment.”
Quality is another concern, as each single-use endoscope may be difficult to produce with the same high level of quality as a reusable scope, Dr. Mergener said. If image quality or maneuverability of such endoscopes is compromised, procedures may be prolonged or more difficult to perform, putting more burden on patients and potentially generating clinical risks.
The Evolving Landscape Of Endoscope Reprocessing
To address concerns about reusable endoscopes, focus has been placed on improving the effectiveness of endoscope reprocessing protocols. Endoscope reprocessing involves more than 100 individual cleaning steps, so stringent quality control measures, including regular auditing and training programs, are needed to monitor the effectiveness of reprocessing practices and minimize the risk for infection transmission, Dr. Mergener emphasized.
“You can imagine how many of those 100 steps get skipped on a busy day,” he pointed out. “Many doctors are not aware of this, because we rarely clean the endoscope ourselves. We rely on our reprocessing staff, and doctors are often ignorant when it comes to the details of what should happen in the reprocessing room.”
The future of endoscope reprocessing lies in technological advancements and innovation, he said, particularly in replacing human error–prone mechanical reprocessing steps (i.e., brushing of the instrument channel) with automated systems. Some companies have begun to develop and offer such tools and continue to expand their research into alternative cleaning methods for more reliable endoscope reprocessing.
“All the major companies continue to work on this,” Dr. Leavitt agreed. “But still, more resources need to be put into better training for scope reprocessing in order to obtain the desired outcomes and reduce wear and tear on the scopes.”
This debate over the merits of single-use versus reusable endoscopes continues to shape the landscape of GI practice. While single-use endoscopes offer advantages such as infection prevention, concerns about environmental impact and financial feasibility persist. For now, innovations and continuous improvements in endoscope reprocessing seem to be solidifying the continued role of reusable scopes.
“Of course, things could be improved,” Dr. Leavitt noted. “I think we will be seeing some significant improvements, especially in the area of drying the scope’s internal channels directly—as opposed to hanging them up and letting them drip-dry—and in the area of the initial physical cleaning, especially the biopsy channels. I think the physical cleansing process needs to be, and will be, improved.”
“This is one of the areas in endoscopy that we have not paid enough attention to for decades,” Dr. Mergener concluded. “But if we pay attention, invest money and do it better, then not only can we help patients by reducing infection risks, but we can help doctors and their endoscopy centers by further increasing their efficiencies and, therefore, their revenue and profitability.”
—Meg Barbor, MPH
Dr. Leavitt reported no relevant financial disclosures. Dr. Mergener reported financial relationships with Boston Scientific, Fujifilm, Pentax and Sebela. He is a member of the Gastroenterology & Endoscopy News editorial board.
This article is from the December 2023 print issue.