Multi-society guidelines for reprocessing endoscopes date back to 2003, but the latest iteration released in January provides more evidence-based recommendations than before. Increased research on reprocessing of endoscopes triggered by infectious outbreaks related to contaminated duodenoscopes since 2014 provided data for the guidelines authors to develop a comprehensive document.
“There’s probably been more research into the area of endoscope reprocessing in the last five years than in the entire history of GI endoscopes,” said V. Raman Muthusamy, MD, MAS, the medical director of endoscopy at the University of California, Los Angeles Health.
“Traditionally, there’s been this perception that if you follow the manufacturer’s reprocessing instructions, everything will be fine, but the outbreaks happened at very experienced, high-volume centers where they were following protocol and doing all the steps. They weren’t fine,” said Dr. Muthusamy, a co-author of the recently published guidelines (Gastrointest Endosc 2021;93[1]:11-33.e6). “What we wanted to do [with this update] is provide evidence, as much as possible, to answer four key questions and provide guidance in many other areas.”
Emphasis on Training
Emmanuel S. Coronel, MD, an assistant professor of medicine at The University of Texas MD Anderson Cancer Center, in Houston, said the new guidelines make some major improvements to the 2016 set. “While the basic recommendations have not changed,” he said, “the new guidelines do a better job at explaining their recommendations and providing the best available evidence.”
Dr. Coronel said he also appreciates the emphasis on staff training and competency, as well as the overall transparency of the guidelines. Noting that Table 3 of the guidelines is devoted to acknowledging areas that need more research, he said this underscores the recognition “that a lot of these recommendations are not final.”
Despite the need for more data, he called the guidelines document “very comprehensive,” saying “if you study this guideline with your team, you should have a pretty good direction in how to manage your infection control team and your reprocessing steps for your scopes.”
Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions, agreed that the new guidelines contain a vast amount of important updated information, but he pointed out some specific changes he thought could be perceived as a rollback or can be misinterpreted.
Question About Intermediate-Level Disinfection
Although the multi-society’s update defines what “semi-critical devices” are and recommends that they be sterilized or treated with a high-level disinfectant if sterilization is not feasible, it includes a clause stating that “some semi-critical and noncritical devices may undergo intermediate-level disinfection,” Dr. Muscarella said.
“But this clause appears to be new—it’s not in any of the prior multi-society guidelines—and there’s no reference given for it and no description of the specific semi-critical devices the guidelines are referring to,” he added. “Guidelines are updated all the time, but if the rationale for the change is not provided, it can lead to some confusion in the context of reprocessing GI endoscopes.”
The FDA advises thorough cleaning followed by intermediate- or low-level disinfection for noncritical items, not for semi-critical devices such as GI endoscopes, he added.
Explaining the rationale for this guidance on semi-critical devices, lead author of the guideline Luke Day, MD, the chief medical officer of Zuckerberg San Francisco General Hospital, said several members of the group felt it was necessary to include some semi-critical devices.
Dr. Day noted that the information “was taken from the CDC guidance document on disinfection and the Spaulding classification that states, ‘Some items that may come in contact with non-intact skin for a brief period of time … should be treated with intermediate-level disinfection.’ While the CDC states that this ‘brief period of time’ makes it a noncritical device, some debated that this meets the definition of critical,” Dr. Day said. “Hence, we said some semi-critical devices.”
Dr. Muscarella observed that this confusion could have been eliminated if the new guideline had explicitly identified GI endoscopes as semi-critical devices. “All three of the earlier versions—2003, 2011 and 2016—clearly stated this, but not the 2021 guideline, paving the way for the confusion that ‘some’ semi-critical devices can be intermediate-level disinfected,” he said.
Sterilization Versus High-Level Disinfection
In a discussion of the use of EtO sterilization instead of high-level disinfection, the guidelines state that the former should be considered in selected settings (e.g., outbreaks) and patient populations.
But this could appear to stray from the long-standing concept that all patients should receive the same standard of care, Dr. Muscarella said. “Ideally, we want one standard of care; we want it to be consistently high for all patients. We don’t really want to start choosing between disinfection or sterilization depending on what we think may be the status of a patient’s immune system, at least not without sound supporting evidence,” he said. “Otherwise, we can start getting into variations in care.”
Dr. Muthusamy said there are no trials of patients in a non-outbreak setting in which the use of EtO has been shown to be better than high-level disinfection done properly. “But there are data showing that several institutions that had an outbreak were able to contain and stop the outbreak when they switched to EtO.”
He also noted that it is hard to recommend EtO because of issues of availability, toxicity, flammability and cost that make it unfeasible for some institutions.
Role of Alcohol in Drying
Another area of potential confusion Dr. Muscarella discussed relates to drying of endoscopes. The new guidelines point out two benefits of using an alcohol flush in the drying process but ultimately conclude that the data to “strongly support or refute the use of alcohol flushes for the drying of endoscopes” are scarce. However, the 2016 guidelines endorsed the use of a 70% to 90% ethyl or isopropyl alcohol rinse followed by forced-air drying and cited several references to support that advice, Dr. Muscarella said.
“Some other countries’ guidelines do not recommend using alcohol because of concern that it could present potential protein fixation risks,” he added. “I think it’s possible the 2021 guideline may be deferring to another country’s guidelines and practices. The protein fixative properties are valid, but I am unaware of any published reports linking those properties directly to a specific case of infection involving a GI endoscope, while many reports support the use of an alcohol flush and forced air to reduce the risk of an endoscope transmitting waterborne microorganisms.”
Dr. Muthusamy agreed with Dr. Muscarella that the potential problem of protein fixation is largely theoretical but said the evidence to support using alcohol in the drying process is not overwhelming. “We’re not arguing that you should or shouldn’t use alcohol, but [we] don’t see irrefutable benefit one way or the other,” he said. “Ultimately, given this uncertainty, we recommend individualizing your response based on what the manufacturer of your device advises. We would be happy to see further research in this area to make a more definitive recommendation in future guidelines.”
—Monica J. Smith
Dr. Coronel reported a financial relationship with Boston Scientific. Dr. Muscarella reported current and/or recent financial relationships with companies that market single-use flexible endoscopes and/or products for low-temperature sterilization of reusable endoscopes. Dr. Muthusamy reported financial relationships with Boston Scientific and Medivators.
This article is from the September 2021 print issue.