Mark Gromski, MD, on 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 >>
GASTRO CON: What are the key findings from the study that are important for gastroenterologists to know?
MG: One important finding is that there was no difference between the double high‑level disinfection and the liquid chemical sterilization strategies. This tells us that there is not a clear winner or a loser in these 2 strategies. A second takeaway point from the study is that the level of growth of concerning pathogens—organisms that could potentially cause infection or cause harm in a human—was less than 1% with these increased measures. We did not have any infections transmitted to patients. The infection rate is very low, but it is not zero. We also had a relatively low rate of positive cultures. The overall message for gastroenterologists is that whatever you do to clean duodenoscopes, just do it well. And either one of the options that we studied are completely reasonable for the time being.
GASTRO CON: What were the biggest limitations of the study?
MG: The main limitation was the generalizability of the study because we are a very high-volume center—we do almost 3000 of these procedures a year. Other smaller hospitals may perform just 100 or 200 of these procedures annually. It is much more difficult to get a comprehensive program like that together. So, the results may not be generalizable to everyone who performs ERCP.
GASTRO CON: What are the next steps of your research?
MG: The next step is determining the safety profile of the next generation of duodenoscopes. There is a whole new generation of duodenoscopes that have disposable components, or are completely disposable, and the impact of those devices becoming available in the market will be the next area of research.
Reference:
Gromski MA, Sieber MS, Sherman S, Rex DK. Double high-level disinfection vs. sterilization for reprocessing of duodenoscopes used for ERCP: a prospective study [abstract 1]. Am J Gastroenterol. 2019;114(2019 ACG Annual Meeting Abstracts):S1. doi:10.14309/ajg.0000000000000373.
For more from ACG 2019, visit the Resource Center.