BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.
Dr. David Lichtenstein
Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.
“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”
After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.
“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.
Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.
“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.
