Endoscopy providers need to upgrade their duodenoscope precleaning and reprocessing methods, facilities and equipment, and devote more resources to ergonomics, proper training and worker retention for those who perform this work, according to a recent survey of reprocessing staff.

Noting that no studies in the existing literature included information from technicians and other staff who do reprocessing, investigator Amanda D. Sivek, PhD, told Priority Report, “It’s really important to get the feedback of the actual people who are doing the work and see what they think affects their workflow, or what’s going on in their work environment that could be improved.”

To bridge the gap in knowledge, Dr. Sivek the principal project engineer at Plymouth Meeting, Pa.–based ECRI, a nonprofit organization that specializes in evaluating the safety of health equipment and practices, and her co-investigators developed the Duodenoscope Reprocessing Workflow and Ergonomic Design Human Factors Survey. The survey asked about the demographics of respondents, and the facilities and processes under which reprocessing takes place. Dr. Sivek’s team incorporated feedback from two experts at the FDA and pilot-tested the survey with 11 healthcare workers who regularly perform endoscopy cleaning and reprocessing (Am J Infect Contr 2022:S0196-6553[22]00055-4).

The researchers—a multidisciplinary team comprised of endoscopy, engineering, human factors and infection control experts from ECRI and Rowan University, in Glassboro, N.J.—emailed the survey to 76 acute care facilities, 245 outpatient endoscopy centers and 264 health systems in the United States, as well as 35 international healthcare organizations, to reach healthcare workers who are regularly involved in precleaning or reprocessing reusable endoscopes. They received 341 completed surveys (82.7% from acute care facilities and 58.4% from urban centers; 44.9% of workers had been doing the task for less than five years).

Under Pressure for Fast Turnover

Dr. Sivek and her team uncovered some trends that she considered alarming, including increased time pressures and shortages of trained staff. For Jim Collins, BS, RN, CNOR, a practice manager for Cleveland Clinic in Cleveland, the most concerning finding is the percentage of respondents who indicated they were operating under increased pressure to work more quickly, and 65% felt that increased time pressure added difficulty to the task at hand.

That pressure, the authors of the survey wrote, “is consistent with a 2019 endoscope reprocessing survey study of International Association of Healthcare Central Service Materiel Management [now the Healthcare Sterile Processing Association] members, which reported that 70% of the respondents felt pressure to work quickly, and 17% of the respondents routinely skipped endoscope IFU [instructions for use] steps due to time pressures” (Am J Infect Control 2020;48[1]:119-121).

Mr. Collins told Priority Report that he found that data point to be very troubling. “There’s always the pressure to do more procedures more quickly. But each step of reprocessing is built upon another step, so if we don’t complete all the steps that are necessary, we place our patients in jeopardy.”

One thing providers could do in the short term, he said, is to increase their scope inventory. “Do they have enough scopes on hand? Their inventory needs to be the right size for their practice.” He also said communication among team members about what’s involved in the cleaning and reprocessing process can help to manage their expectations. “When physicians are educated on what’s involved to provide for them an instrument that is safe for their patient, they tolerate the process being as long as it is.”

Investment in People and Spaces

Another area of concern is difficulty retaining healthcare workers who specialize in this task. Almost half of them had been doing it for less than five years, which indicates a high turnover rate. In addition, many workers reported that they believed they hadn’t received appropriate training. According to the survey responses, nearly 50% believed the training, certification and mentoring they received was moderate at best, with about 10% of respondents saying they had received none at all. Beyond that, Dr. Sivek said, “over 75% of the people performing duodenoscope reprocessing experience fatigue in one or more of their body parts,” which she noted can result in musculoskeletal disorders. This is especially true at reprocessing centers that are exceedingly small. “My colleague has seen basically three people in a closet,” she noted.

Historically, facilities failed to place much importance on, or investment in, reprocessing workspaces, Mr. Collins explained. “Reprocessing stations had been very, very small. They didn’t allow for good workflow [between] dirty to clean. Often, they did not provide unidirectional travel, so there was a high potential to cross-contaminate.”

Endoscopy centers face an inability to recruit, train and retain workers who are knowledgeable and proficient in the proper procedures required to minimize harm to patients. Both Mr. Collins and Dr. Sivek urge all providers to dedicate themselves to regularly update their protocols for reprocessing, invest in reprocessing facilities that provide ample, ergonomically sound and specifically designed spaces to do this work efficiently and effectively. As Dr. Sivek put it succinctly: “Please invest in your endoscope reprocessing people and work environments.”

Change Is Coming

Finally, there are the scopes themselves. The FDA has urged facilities to transition to scopes with disposable endcaps or parts, and Dr. Sivek from ECRI said the group recommends that “facilities make a plan to transition to single-use duodenoscopes or the models with single-use components as soon as they can.”

V. Raman Muthusamy, MD, MAS

But, at this point, most providers continue to use older scopes with no disposable parts. Mr. Collins and Dr. Sivek said the reason for this failure to change is the lack of will or resources to fund the effort. “There is very limited reimbursement for the items,” Mr. Collins said. “It’s a technology that people want to adapt to, but the cost–benefit ratio may not be clear to all facilities.” He added that it must also be considered that these scopes are tools to perform very delicate work, and there is much to be said for working with an instrument that is already familiar to the care provider.

However, according to V. Raman Muthusamy, MD, MAS, the medical director of endoscopy at UCLA Health, in Los Angeles, these factors are changing. For one, he told Priority Report, you can’t buy a new fixed end cap reusable duodenoscope from any of the three major U.S. manufacturers (Fujifilm, Olympus and Pentax); they are only selling duodenoscopes with disposable parts. Furthermore, he said, several manufacturers, including Olympus, are basically doing swap-outs akin to cellphone swaps. Providers can bring in their old reusable fixed end cap duodenoscope and get a new duodenoscope with a disposable tip and/or elevator.

As for whether providers are hesitating because of lack of familiarity with the newer devices, Dr. Muthusamy said that also may be old news. “There have been several studies, and what we’ve basically learned is that the technical success rates and adverse event rates in roughly 400 patients split among four studies, is essentially comparable. The overall endoscopist satisfaction was also nearly equivalent to [that for] the reusable devices.”

To Dr. Muthusamy’s thinking, the problem of early adoption is twofold. One, while the FDA is strongly recommending a rapid transition to the newer equipment, “they still haven’t set a date.” And two, at this moment, the field is stuck in a VHS-or-Betamax moment. “There’s so much innovation, but nobody knows what solution is going to dominate,” he said. “One can’t say for sure, but it is one of those things where you know change is coming, but you don’t know exactly what the change is going to be.”

—W. Harry Fortuna

The sources reported no relevant financial disclosures.