5 Questions About Enhanced Duodenoscope Reprocessing in ERCP

Recent outbreaks of multi–drug-resistant pathogenic organisms (MDROs) transmitted via duodenoscopes has shed light on the urgency of enhanced duodenoscope reprocessing in endoscopic retrograde cholangiopancreatography (ERCP).

The US Food and Drug Administration (FDA) has suggested microbiological culturing of duodenoscopes and reprocessing with repeated high-level disinfection or liquid chemical sterilization.

In a new study, Mark Gromski, MD, assistant professor of medicine at the Indiana University School of Medicine, and colleagues compared the efficacy of reprocessing duodenoscopes with double high-level disinfection vs liquid chemical sterilization.

Results showed that the two reprocessing techniques had a low rate of positive cultures for all organisms, including high-concern organisms.

Gastroenterology Consultant caught up with Dr Gromski about the research, which was recently presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting and Postgraduate Course.

Gastroenterology Consultant: What are the challenges associated with the current design of the duodenoscope, and how have they impacted overall care?

Mark Gromski: The duodenoscopes have a unique design. It is unique because they have protected elevator mechanisms which we think are more difficult to clean. The duodenoscopes have been linked to outbreaks of infections that have been proven to come from the duodenoscopes themselves. This is relatively unique to duodenoscopes, because this has not been found in other types of endoscopes. That is the main problem. The other issue is that despite many modifications and beefing up the way that we currently clean the duodenoscopes, nobody has been able to completely eliminate carriage of some bacteria. There has been a fair amount of press, both within the GI community and also in the lay press, on these issues. Gastroenterologists and our patients are becoming aware of the problem, and it is something that needs to be fixed.

GASTRO CON: What prompted you to conduct the study?

MG: The FDA has given out multiple recommendations to gastroenterologists to try and improve the basic cleaning and safety of these devices. We integrated some of those recommendations into components of the study; we used these added features instead of the usual precleaning and single high-level disinfection. Our study compared double high-level disinfection and liquid chemical sterilization to try and address this problem we are having. One thing to know is that it took a lot of resources to build a system of improving the cleaning of the duodenoscopes. We started addressing this problem prior to 2015, so many years ago. Our surveillance cultures had gotten better even before we began this study.

Key findings, limitations >>

Recent outbreaks of multi–drug-resistant pathogenic organisms (MDROs) transmitted via duodenoscopes has shed light on the urgency of enhanced duodenoscope reprocessing in endoscopic retrograde cholangiopancreatography (ERCP).

The US Food and Drug Administration (FDA) has suggested microbiological culturing of duodenoscopes and reprocessing with repeated high-level disinfection or liquid chemical sterilization.

In a new study, Mark Gromski, MD, assistant professor of medicine at the Indiana University School of Medicine, and colleagues compared the efficacy of reprocessing duodenoscopes with double high-level disinfection vs liquid chemical sterilization.

Results showed that the two reprocessing techniques had a low rate of positive cultures for all organisms, including high-concern organisms.

Gastroenterology Consultant caught up with Dr Gromski about the research, which was recently presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting and Postgraduate Course.

Gastroenterology Consultant: What are the challenges associated with the current design of the duodenoscope, and how have they impacted overall care?

Mark Gromski: The duodenoscopes have a unique design. It is unique because they have protected elevator mechanisms which we think are more difficult to clean. The duodenoscopes have been linked to outbreaks of infections that have been proven to come from the duodenoscopes themselves. This is relatively unique to duodenoscopes, because this has not been found in other types of endoscopes. That is the main problem. The other issue is that despite many modifications and beefing up the way that we currently clean the duodenoscopes, nobody has been able to completely eliminate carriage of some bacteria. There has been a fair amount of press, both within the GI community and also in the lay press, on these issues. Gastroenterologists and our patients are becoming aware of the problem, and it is something that needs to be fixed.

GASTRO CON: What prompted you to conduct the study?

MG: The FDA has given out multiple recommendations to gastroenterologists to try and improve the basic cleaning and safety of these devices. We integrated some of those recommendations into components of the study; we used these added features instead of the usual precleaning and single high-level disinfection. Our study compared double high-level disinfection and liquid chemical sterilization to try and address this problem we are having. One thing to know is that it took a lot of resources to build a system of improving the cleaning of the duodenoscopes. We started addressing this problem prior to 2015, so many years ago. Our surveillance cultures had gotten better even before we began this study.

Key findings, limitations >>