From the AGA Journals

Confronting endoscopic infection control

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Cost, environmental impact remain issues

The future remains to be seen

Solutions surrounding proper endoscope reprocessing and infection prevention have become a major focus of investigation and innovation in endoscope design, particularly related to duodenoscopes. As multiple infectious outbreaks associated with duodenoscopes have been reported, the complex mechanism of the duodenoscope elevator has emerged as the target for modification because it is somewhat inaccessible and difficult to adequately clean.

Jennifer Maranki, MD, MSc, is professor of medicine and director of endoscopy at Penn State Hershey (Pennsylvania) Medical Center

Dr. Jennifer Maranki

As a result of the challenges associated with duodenoscope reprocessing, the FDA recommended additional measures be implemented by facilities to help mitigate the infectious risk of duodenoscopes. Current research is being conducted on novel sterilization techniques as well as several point-of-care reprocessing quality indicators. Despite improvements in reprocessing quality, residual contamination of duodenoscopes led the FDA to recommend in 2019 that all units using duodenoscopes transition to duodenoscopes with disposable design elements. In addition, fully disposable duodenoscopes have been developed, with two types currently available in the United States.

One of the major considerations related to disposable duodenoscopes is the cost. Currently, the savings from removing the need for reprocessing equipment, supplies, and personnel does not balance the cost of the disposable duodenoscope. Studies on the environmental impact of disposable duodenoscopes suggest a major increase in endoscopy-related waste.

In summary, enhanced reprocessing techniques and modified scope design elements may not achieve adequate thresholds for infection prevention. Furthermore, while fully disposable duodenoscopes offer promise, questions remain about overall functionality, cost, and the potentially profound environmental impact. Further research is warranted on feasible solutions for infection prevention, and the issues of cost and environmental impact must be addressed before the widespread adoption of disposable duodenoscopes.

Jennifer Maranki, MD, MSc, is professor of medicine and director of endoscopy at Penn State Hershey (Pennsylvania) Medical Center. She reports being a consultant for Boston Scientific.


 

FROM TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY

Quality indicators in reprocessing

Recently, several quality indicators have been developed to assess the quality of endoscope reprocessing. The indicators, the authors noted, may theoretically allow “for point-of-care assessment of reprocessing quality.” To date, the data to support these indicators are limited.

Adenosine triphosphate testing has been the most widely studied indicator because this can be used to examine the presence of biofilms during endoscope reprocessing via previously established ATP benchmark levels, the authors wrote. Studies that have assessed the efficacy of ATP testing, however, are limited by their use of heterogeneous assays, analytical techniques, and cutoffs for identifying contamination.

Hemoglobin, protein, and carbohydrate are other point-of-care indicators that have previously demonstrated potential capability of assessing the achievement of adequate manual endoscope cleaning before high-level disinfection or sterilization.

Novel disposable duodenoscope technologies

Given that consistent research studies have shown the existence of residual duodenoscope contamination after standard and enhanced reprocessing, there has been increased attention placed on novel disposable duodenoscope technologies. In 2019, the FDA recommended a move toward duodenoscopes with disposable components because it could make reprocessing easier, more effective, or altogether unnecessary. According to the authors, there are currently six duodenoscopes with disposable components that are cleared by the FDA for use. These include three that use a disposable endcap, one that uses a disposable elevator and endcap, and two that are fully disposable. The authors stated that, while “improved access to the elevator facilitated by a disposable endcap may allow for improved cleaning” and reduce contamination and formation of biofilm, there are no data to confirm these proposed advantages.

There are several unanswered questions regarding new disposable duodenoscope technologies, including questions related to the usability, costs, and environmental impact of these technologies. The authors summarized several studies discussing these issues; however, a clear definition or consensus regarding how to approach these challenges has yet to be established. In addition to these unanswered questions, the authors also noted that identifying the acceptable rate of infectious risk associated with disposable duodenoscopes is another “important task” that needs to be accomplished in the near future.

Environmental impact

The authors stated that the health care system in the United States is directly responsible for up to 10% of total U.S. greenhouse emissions. Additionally, the substantial use of chemicals and water in endoscope reprocessing represents a “substantial” concern for the environment. One estimate suggested that a mean of 40 total endoscopies per day generates around 15.78 tons of CO2 per year.

Given the unclear impact disposable endoscopes may have on the environment, the authors suggested that there is a clear need to discover interventions that reduce their potential negative impact. Strategies that reduce the number of endoscopies performed, increased recycling and use of recyclable materials, and use of renewable energy sources in endoscopy units have been proposed.

“The massive environmental impact of gastrointestinal endoscopy as a whole has become increasingly recognized,” the authors wrote, “and further study and interventions directed at improving the environmental footprint of endoscopy will be of foremost importance.”

The authors disclosed no conflicts of interest.

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