Our next speaker really needs no introduction. So thrilled to have Dr. Doug Adler here. He, as I think you heard, used to be at Utah, but now he's in Colorado, where he's the director of the Center for Advanced Therapeutic Endoscopy at Porter-Evans Hospital. He is, of course, our esteemed editor-in-chief for gastrointestinal endoscopy. And we're just thrilled to have him here, and really thank him for all the talks you're going to be hearing from him over the next day and a half here. So we really appreciate that. But he will be talking about duodenoscope infection risks, reprocessing, and innovative design scopes. So thank you so much, Doug, for taking some of your time to be with us. Thanks everybody. Thanks especially to Uzma and Linda for having me here. So this might get a little controversial. I'm not trying to do that, but it's hard for this topic to kind of not go the way, because people have strong feelings on this. So let's sort of talk about duodenoscope-related infections, sort of where are we now, where are we going, how do people, what are we saying in the literature, and what are people doing in the lab? Because those are two very different things, right? So ignorance is bliss, right? So prior to 2015, none of you thought about this, none, unless you're a tech and you had to spend time in that washroom, right? We just kind of didn't think about the risks of these scopes transmitting infections, and the scope went into the washroom, and it came out sometime later, and we used it again. And that scope room was kind of de facto a black box. Most physicians, myself included, didn't really know what went on there. You know, we handed the scope off, and it got set up, and then we walked in the next room, and there was a scope hanging on the tower, and that's how it was. We didn't really go in there. And it was just kind of assumed that, well, the scope is clean, and I would occasionally remember hearing some of the techs saying, oh, there was a stone in the channel, or there was a stone behind your elevator, and I'd be like, interesting, and that was it, you know? And when I was a fellow, I was not taught to clean an endoscope. So some fellows were taught that, like for night and weekends. I was not. Didn't do that, right? And then everything changed in 2015, right, when all of a sudden, the tsunami of bad news, and more importantly, bad patient outcomes and bad lawsuits hit GI, right? And then all of a sudden, ERCP found itself in the pages of some of the biggest media outlets on planet Earth, the LA Times, the New York Times, right? This is USA Today, right? We all want to be in the paper. We don't want to be in the paper like this, right? And there were real, real injuries. People died. People got very serious infections, and people died. And there were many, many lawsuits over this, some of which are still ongoing, some of which were against physicians, some of which were against hospitals, some of which were against entire hospital systems, some of which were against endoscope manufacturers. And this is all ongoing, right? So this didn't just sort of happen and go away. So then in 2015, in February, the FDA put out this communication that was very, very widely promulgated that sort of acknowledged that the complex design of ERCP scopes may limit their ability to be effectively reprocessed and decontaminated, right, even if the vendor's instructions are very, very carefully followed. And this triggered what I will politely call a rapid response in most labs. I think at the University of Utah, we called it hair on fire, was kind of like, because we had not had an infectious transmission that we knew of, but the hospital was extremely worried, and they convened a tiger team that I was on, which was not fun at all. It involved a lot of meetings with infection control and ID. I don't like meetings with ID, Jesus. And hospital administrators and risk management and the university council. And all of a sudden, we had to kind of look at all of our procedures from top to bottom and work closely with our vendors on how we were going to do things going forward. So we ended up, like a lot of places around the country, implementing all new procedures, right? We had dedicated cleaning staff, not just whoever was around, right, that day. We hired people who did nothing but clean all day long. And let me tell you, good luck filling that position, right? That is a tough gig to fill, right? We started hanging scopes. We didn't use to hang the scopes. They sat coiled on a shelf, right? Remember that? Air drying with forced air. We had to have the GI lab walls taken down so we could have forced air put in. Endoscope culturing, right, routinely. Triggered automatic reprocessing if scopes had gone too long without using, et cetera, et cetera, et cetera. And while we were doing all this, right, bigger forces were in play, right, and vendors started thinking like, well, what are things that we can do, right? So this is kind of where things have landed. And this is sort of where we are still, right, here in December of 2023. You can use reusable scopes made by Olympus Pentax in Fuji with disposable tips, right, which I imagine most of us are probably using to some extent, right? There are still some old regular scopes floating around. I did an ERCP this week with an old-fashioned fully reusable scope because we had a scope break and that's what Olympus sent us and we used it, right? So the nice thing about a reusable tip, sorry, disposable tip on a reusable scope is this was very, very rapidly implemented by all the vendors. They all came out with some version of this and it really, it did not involve a major change to manufacturing. The device essentially felt the same, stayed the same, operated the same. You got a reusable scope and all of its benefits, right? This was very, very, very simple and effective. The downside was, again, still using reusable endoscopes, still risk of transmission of disease between patients, right? Or you could get the fully disposable scope, right? On the one hand, the big pro, and I'll go through all this in detail, no risk of infectious transmission between patients, right? Use that scope once, throw it in the dumper, right, and we'll talk about what that means. But nobody else gets that scope, right? That is major expense, very, very significant expense to the entire healthcare system, the end user, right, Boston, Ambu, et cetera, right? This is a real engineering challenge, right, to make a one-time instrument that works as well as a device that is meant to be used a thousand times. There's a significant environmental impact that I will talk about in detail and there are real concerns about the equivalency of these devices. So just with regards to duodenoscopes, in the United States today there are two on the market, the Exalt from Boston Scientific, you guys all know this, and the Ascope Duodeno by Ambu, which people just refer to as the Ambu scope, essentially. This is a photo from the very, very first Ambu ERCP ever done in a human being, and I know because I did it. So that was a patient with pancreatic cancer, and there you can see how different that looks, right? You know, like they didn't make the last 10 centimeters of the scope really opaque, so you could sort of see all the innards there working around. So it was very, very different. The first time we saw that, none of us expected that. So the current state of affairs is that the Boston Exalt scope is widely available, and I imagine your Boston reps have made it very, very clear to you they want you to use this device. The Ambu Ascope Duodeno has seen very little clinical implementation or adoption. They had an initial burst of activity in 2020 and 2021, and the company has gotten kind of quiet in the last 12 to 24 months. In June of 2020, CMS approved the Medicare transitional pass-through payment, which is to essentially facilitate new devices into the market, which is an upcharge that you can get. And then there was the so-called NTAP, the new technology add-on payment, right? So again, there are financial incentives to use these devices, and my hospital came to me officially and said, use disposable scopes as much as possible because we make more money on it. And that was very directly communicated to us from the highest possible levels in the system. These add-on payments initially applied to Medicare, but commercial payers are starting to get aboard with this as well. And many of you guys probably don't know that there's a new ICD-10 code if you're using a disposable scope, right? Probation may know, because if you're using a disposable scope, probation will ask you that, and then it should put in that code, XFJD8A7. So then you got to kind of ask, well, how well do these things work, right? And Andy Ross over at Virginia Mason, which had one of the most well-publicized infectious outbreaks and transmission episodes, they did a benchtop study that was published in CGH a couple of years ago, and they were like, well, it seems to work pretty well on a benchtop. And then Raman Muthusamy that same year, looking at in the hands of experts when they took these devices through basic ERCP maneuvers, they seemed to work pretty well, and this was all sort of glad-handled and pat on the back, and everything seemed to be kind of going down the track in a nice direction. This is one of my papers from my group, and we did a meta-analysis looking at outcomes, behavioral and technical outcomes in people using disposable scopes, and again, pretty positive stuff, right? 95% successful cannulation rate, post-ERCP pancreatitis 2%, adverse events 7%, right? This looked pretty good, and I think this was about 700 patients, 642. And then this was another study from our group looking at a MAUD analysis, right, and we looked at MAUD, for those of you who don't know, the MAUD database, which is free, it's the FDA's device registry, you can look at patient-related adverse events and device failures for any device on the market. We did a MAUD database analysis, and we looked at both single-use duodenoscopes and duodenoscopes with detachable caps, and yeah, there were some adverse events and some patients got hurt. A lot of it was what you would expect, like the cap fell off or the cap cut the patient or the disposable scope had a perforation. But overall, there was nothing really glaring, and it was fairly positive, and it was kind of what you would expect when a large number of physicians are using a large number of devices and a large number of people. The literature seemed really positive, right? Sounds good, right? And then many of you guys know I'm pretty active on Twitter, follow me on Twitter. And I posted this poll, and I was really, really surprised by this poll on Twitter. So I asked, I said, I'm very interested in disposable ERCP scope usage and adoption. What is your experience? Bad. Hashtag G.I. Twitter. That's where we all kind of live on G.I. Twitter. And the overwhelming response was, have not, will not use. And it was interesting, and the comments were very, very hostile. And I was really taken aback like this, like the comments against disposable scopes were very, very, very negative, and that kind of made me think like, oh, something is happening out there, right? So again, if these things are so great, why are so many people so opposed to them? So a couple of real-world observations from somebody who's done a large number of disposable ERCPs and talked to a lot of people. There is an intense perception, despite published data, that these instruments do not have the subtlety or fine mechanical control of a reusable instrument, right? And that is true. I think that's a fair statement. Like, you can't make something for $3,000 that's as good as something that costs $60,000. Like, that would be, you know, that's hard to do. The optical quality is also not as good, whether you're using the Ambu or the Boston scope. It's just not the same as your Olympus or your Pentax or your Fuji scope. I imagine most of you guys, if you've used a disposable scope, would agree with that, right? And a lot of this sort of comes into play when you're deciding what to do. And I think one or two of the speakers already kind of mentioned that they're using disposable scopes for like straightforward cases, stent pulls, right? And the vendors say you can use any disposable scope in any setting, right? So again, if you're putting a plastic stent in somebody with a bile leak post coli, sure, that's not a problem, right? What if you're doing pancreatoscopy or doing EHL, right? What about a minor papilla case? Linda, would you want to do a minor papilla case with a disposable scope? Definitely not. Right? What if it's a failed ERCP, failed on the outside, and they call you up and they say, hey, I couldn't get in, could you try on this patient, right? Or what if it's post-surgical anatomy, right, a Bill Roth II, right? I mean, these scopes have a very, very different mechanical feel. I can tell you that our fellows hate the disposable scopes. They hate it. They really, really, really do not want to use it. When we hang it, I definitely hear it from the fellows. So again, a Toyota Prius and a Tesla Roadster are both cars, right? And if you're just driving to the Safeway to pick up a loaf of bread, they're both going to work, right? But the Tesla Roadster can do a lot of things that the Toyota Prius cannot do. And I think that that is, to some extent, what we are figuring out as these scopes are rolled out to us around the country and around the world, right? The other thing is that the environmental impact of this is almost certainly astronomical. And this is something that we have only a little bit of data on, right? So I'm not the oldest person in the room here. I don't think so, but I'm close to the oldest person in the room. But younger people tend to be more worried about the environment than older people, right? And when I talk to, like, the fellows, like, they're really, really, really worried about the environmental impact. And it is weird when you just take the scope at the end of the procedure and you just drop it in a bin. It's like Boston gave us a bin that we have. And, you know, Boston has a reprocessing program in place. I'm just going to read this to you. It's from their website. We offer a sustainability program for our U.S. customers who choose to adopt the Exalt Model D duodenoscope and work closely with medical-grade recyclers and waste management experts to potentially eliminate any incremental landfill impact associated with single-use endoscopes. But the carbon footprint of these devices is significant. Many don't believe that a reprocessing program is sound or even can be sound, right? And depending on where you look, there's either somewhere between half a million and one million ERCPs done in the United States every year, right? So just imagine what that would mean if we went fully disposable, right? Those are all duodenoscopes, right? Like this is kind of like, you know, what you worry about, like, is this what's going to happen, right? There was a really, really nice paper in GIE last year that looked at this, and I encourage you guys all to read this because this was, I think, for a lot of people, very, very eye-opening. But the take-home point is that the carbon emissions of doing an ERCP with the duodenoscope that's disposable is 24 to 47 times greater. Think about that. That's an enormous carbon impact, right? I felt guilty about the carbon that my plane released into the air to fly me here yesterday, but I mean, that's a lot of carbon, right? So again, it's because it's all wasted, and you have to manufacture every single time over and over and over and over and over because there's a lot of carbon used up and dumped into the atmosphere through the manufacturing process, right? So again, like a reusable duodenoscope can very, very easily live a thousand procedures or more, right, versus one. And this is coming from somebody who uses a lot of disposable scopes, and I talk with Boston and Ambu about this sort of stuff all the time, but I mean, like, we have to really, really pay attention to this stuff, right? There's also a disposable gastroscope that is now FDA-approved, right? We got 510 clearance last year, so has anybody used this yet, right? This isn't coming, it's here, right? So these companies are moving very, very, very aggressively into this space. I assume the next 12 to 24 months, we'll see multiple other disposable instruments on the market from multiple vendors. So I think these devices are here to stay, right? And for example, if you look at your pulmonologists, probably half or more of their broncs are done with disposable scopes already. So just look at that. It's a much simpler device. But again, you can see. Disposable instruments, the EGD scopes and the ERCP scopes appear to be adequate for straightforward procedures, right? Mohammed Othman did an ESD with the disposable EGD scope that he published in GIE a little while ago. Now again, that's Mohammed Othman, right? Maybe not everybody is going to feel comfortable doing that, right? It's unclear if disposable instruments will ever get beyond use in very straightforward procedures, complex ERCPs, endoscopic ultrasound, third space procedures, right? I do a lot of third space procedure. Not sure how I would feel about that with a disposable scope, right? And colonoscopy. Colonoscopy is obviously a very, very subtle procedure. And a lot of these disposable instruments are very stiff in comparison. Now the vendors are not dumb, right? They hear all of this, right? I was once with one of our vendors and we were doing a disposable scope and he said to me, he said, how's the scope? And I said, it's really stiff. And he said, well, do you mean like the wheels or the shaft or the torque? And I was like, yes, you know? And he was like, mm-hmm, you know? And you know that they must hear that from everyone. And again, the people at Boston and Ambu are not dumb, right? And they are working very, very hard to improve the optics and the mechanical properties and the feel, right? And they want to diminish that Tesla versus Prius gap, right? That the end user has in their mind. And again, I think the big problem is the environmental impact, right? You guys have all seen Wall-E, right? I kind of worry like one day it's going to be like Wall-E. We're just going to be like driving home and there'll be heaps of duodenoscopes on the side of the road, right? Where's Eva? So that's kind of where we are there. So I'll leave that there and I'll open it up to questions. Thank you guys very much.

duodenoscope-related infections

reprocessing

innovative design scopes

cleaning procedures

disposable tips

research