FDA’s Clearance of Disposable Duodenoscope Is a “Paradigm Shift” in ERCP

Duodenoscopes are used during more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures annually in the United States, according to the US Food and Drug Administration (FDA).¹ However, complex designs that include reusable hard-to-clean components have raised concern, because reusable duodenoscopes have been associated with transmission of infection.

To address this, the FDA cleared marketing for the first fully disposable duodenoscope in December 2019.²

In an interview with Gastroenterology Consultant, Mark Gromski, MD, from the Indiana University School of Medicine, spoke about the importance of the FDA’s recent clearance of the first disposable duodenoscope and how the clearance can impact clinical practice.

The following commentary is based on the transcript of that interview.

A Strong Push

The clearance by the FDA for the marketing of the first fully disposable duodenoscope¹ has been a long time coming. The development of a single-use duodenoscope is in reaction to the recent attention and concern with reusable duodenoscopes, because they have been associated with transmission of infection, with some serious infections having multidrug–resistant organisms. There has been a strong push by agencies and physicians to address the problem of duodenoscopes potentially transmitting bacteria and causing infection. This issue is also what prompted my colleagues and me to conduct a study that compared cleaning techniques for reusable duodenoscopes. We evaluated different cleaning processes to determine which process was better at decreasing the risk of carriage of any bacteria or organisms via reusable duodenoscopes. The study was presented at the American College of Gastroenterology 2019 Annual Meeting and Postgraduate Course.³

A Paradigm Shift

The clearance is a paradigm shift, because up until this point all of the duodenoscopes used in practice have been reusable. In fact, the unique elevator apparatus of the duodenoscope, which is used primarily during ERCP, is likely causing the difficulty in adequate reprocessing after every use. The idea of the single-use duodenoscope is that the package and scope are sterile when you open it, and since you do not use it ever again, the risk of transmitting any infection should be zero.

Impact on Clinical Practice

The extent to which this clearance will disrupt or impact the practice of ERCP is unknown at this point. First, this is the first reusable duodenoscope available on the US market. Secondly, we do not know a lot about it yet. Although it is cleared for use by the FDA, it is not widely commercially available yet. There are a number of variables that will determine how widely this duodenoscope is adopted. The idea of a single-use duodenoscope is fairly revolutionary, and it is important. Whether it will be adopted or how broadly it will be adopted depends on performance, price, and supply. This scope has been used in humans fewer than 100 times. We need to be sure that it performs as well as our reusable workhorse duodenoscope. Because ERCP carries other significant risks—risk of pancreatitis, risk of bleeding, and risk of perforation—we need to make sure that this duodenoscope performs at a level where these risks do not increase. Any significant increase in the risk profile of the procedure from using this new device will not be acceptable. We also do not know firmly what the price of the disposable duodenoscope will be yet, or how adoption may change other cost streams (eg, decreased need for reprocessing materials, reprocessing staff, and more). Additionally, availability and dependable supply is an important consideration. All of these factors will come into play with the disposable duodenoscopes. Right now, our reusable duodenoscopes are hanging in the cabinet. We can pull them out whenever we need to, clean them, and use them again. If there is ever an issue with supply where we do not receive the disposable duodenoscopes—because of a back order, failure to place an order, or the delivery truck broke down—and a disposable duodenoscope is all that we are relying on, then not having them available will be a major risk if a life-threatening pancreatobiliary problem is encountered. These new issues will have to be hammered out, and I believe we will not know the impact the new duodenoscope will have on clinical practice for some time.

Doctor, Patient Considerations for Future Use

One of the key variables for gastroenterologists to consider when choosing whether or not to use this device will be how it will impact the overall ERCP experience. It is possible that the gastroenterologists who are at smaller medical centers that perform ERCP infrequently may not have experienced individuals on the team to clean the reusable duodenoscopes. You are likely to find more skilled scope cleaning technicians that specialize in duodenoscope reprocessing at a high-volume medical center. If a center is not as comfortable or skilled in the multistep process of reprocessing reusable duodenoscopes, then the single-use duodenoscope might be an attractive option. So, the size and volume of the center may play a role in whether doctors decide to use this device. I also think the selection of duodenoscopes may depend on the history of the patient. For instance, if a patient has a history of resistant bacteria in their abdomen or bile ducts, or they are immune-suppressed, a gastroenterologist may choose a single-use duodenoscope, because these patients may be at increased risk of transmitting resistant bacteria or more susceptible to becoming seriously ill if they became infected.

Overall, the development of the single-use duodenoscope is fascinating because this is a new, disruptive technology. Most of its success is to be determined, and many studies will need to be conducted to show how successful these duodenoscopes can be. It will be crucial to determine if there is any change in the procedural risk profile and cost-effectiveness with their use.

Mark Gromski, MD, is an assistant professor of medicine at the Indiana University School of Medicine in Indianapolis, Indiana.

References:

1. The FDA is recommending transition to duodenoscopes with innovative designs to enhance safety: FDA safety communication [press release]. Silver Spring, MD: US Food and Drug Administration; January 17, 2020 https://www.fda.gov/news-events/press-announcements/fda-clears-first-fully-disposable-duodenoscope-eliminating-potential-infections-caused-ineffective. Accessed February 3, 2020.
2. FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing [press release]. Silver Spring, MD: US Food and Drug Administration; December 13, 2019 https://www.fda.gov/news-events/press-announcements/fda-clears-first-fully-disposable-duodenoscope-eliminating-potential-infections-caused-ineffective. Accessed February 3, 2020.
3. 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.