We will move into our next roundtable. I think, Eden, were you going to start with some poll questions for the audience? Yes, we have a couple poll questions. We're just going to test your knowledge a little bit. Did you want to read these, Dr. Almonser, or did you want me to? The first question is, at what frequency is the minimum effective concentration testing of a disinfectant solution performed? On each load? Only required on first load of the day, only required on first and last load of the day, only when the disinfectant is changed. How'd we do, Jim? All right, well, I was a little bit surprised at the findings. We do want to make sure that the MEC of the disinfectant is performed on every load that's done. So, we want to ensure that the disinfectant is at the effective concentration for each load. So, the first one is the correct answer. Okay, thank you. I'll move to the next one. So, damaged endoscopes do not pose an infection prevention risk, true or false? And there's your results, Jim. How'd they do? Touché. Well done. Damaged endoscopes are a liability and may present as an infection vector within the endoscopy unit. So, high-level disinfection of endoscopes is often ineffective due to lack of adherence to guidelines, insufficient manual cleaning, inadequate drying before storage, and contaminated rinse water or all of the above. And we'll go ahead and share those results. How'd they do, Jim? They did all right. The correct answer is all of the above. Which one of those factors will contribute to ineffective disinfection being performed? We did receive one in advance, if you'd like me to read it. Why don't you go for it? Okay. So, in this one, I will direct to Jim Collins. Our endoscopy unit is having issues with EGD scopes passing the post-manual cleaning verification test. We use ATP swabs to test the scopes after manual cleaning and before OER use. The EGDs rarely pass the first time around, but the Kolata scopes pass without issues. All scopes pass after the OER, thankfully. I currently have an EGD scope out for inspection to see if we are dealing with internal damage. Any suggestions otherwise? Jim, could you start us off? Yeah, that's a very, very good question, and a question that I have been asked frequently when it comes to use of the OER reprocessor for endoscopes, and especially OER users that are using the modified cleaning process. And why do I say that is if we remember the modified cleaning process for the OER Pro does not call for the rinse after brushing that is performed during endoscope reprocessing. So, it is possible that residual bioburden is retained within the channel of the endoscope when the residual clinical soil testing is being done. Also, we have to remember that the pathogens that are more associated with the upper GI tract, and since we're dealing sometimes with the respiratory tract as well, are a little bit more stickier and have more adherence than the organisms found in the lower tract, such as Pseudomonas per se. So, they may be clinging to the scope itself and are pulled out with the ATP testing. And those are my number two guesses to begin with. It's not uncommon. Sending the endoscope out for inspection is great, especially if you don't have the ability to do a borescope examination of the endoscope as one of your steps of investigation post manual cleaning. Also, things to look at are the, was the case, did the case have a good degree of clinical soil associated with the case, was reprocessing performed within that hour limit by the manufacturer? So, those were things to be, I think, to be considered and following steps to be done were what I would have done. So, can I just, quick question to maybe Jim or anyone else who has some knowledge on this is the, you know, we hear a lot about using a borescope to look inside the scope or using a clangoscope, you know, a disposable clangoscope. I just have no idea what I'm supposed to be looking at. Is there an atlas that's supposed to tell us what we should be looking for? Because if not, it'd be a nice thing to partner with ASG, you know, whoever actually understands that, and just do a quick video atlas of what you should be looking for when you do that because I feel like I'm just going to waste a clangoscope and then not learn anything. Yeah, I totally agree, doctor, that often devices are sold without proper identification of what defects look like within an endoscope. Staining may be referred to as residual soil. The only broad spectrum pictorial of channel damage and channel findings during boroscopic examination is in the AIME document. They have a nice addendum that has some photos, and the vendors all provide photos as well, though I think the development of an educational program that does identify what findings are would be tremendous. But also at this time, there's two factors that manufacturers of endoscopes, they don't call for boroscopic examination of their endoscopes. And also when it comes to residual soil testing of endoscopes, the FDA offers no guidance. There has not been a 510k product that has made to market and professional societies all differ on their recommendations of the conduction of residual clinical soil testing of endoscopes after manual cleaning. Thanks, Jim. There's a couple of questions pertaining to disposable duodenoscopes. One from our friend Natalie Cosgrove, and I'll let Rabia and others handle that. But just before going into the questions, just sort of taking a step back, right? And it sounds like, Rabia, you and I may be aligned on our philosophies on disposable duodenoscopes. But sort of taking a step back, a sort of global pandemic occurred, and half of people went like, hmm, you know, I'm not sure that this is going to sort of really change my approach to life here. And then on the flip side, a relatively small number of cases of duodenal, of seri infections occurred, you know, like less than 200 cases worldwide. And it basically seemed like everybody lost their mind and it sort of was a major change in our industry. Now, a lot of good has come from that, right? You know, a lot of the concepts that Jim brought up, which is, you know, let's rethink the process, let's go back to the basics and sort of make sure that we are well trained to do it, make sure that we have sort of a practical guidance that helps us, you know, do the basic things. Of course, that's really important. And in parallel, the advent of the disposable duodenoscope, I think, has major implications in terms of innovation and certain sort of esoteric indications in which it would likely be a game changer. But I guess my question to Rabia and to Raj and others is that, you know, has, especially around the disposable duodenoscope, has this been an overreaction? I mean, is there a rationale for units to completely change their approach on this? So I think it's yes and no, right? I think that there are people who are overreacting and they're using these disposable scopes for every single case. And I don't agree with that. But there are certain patients who may require an extra ounce of protection, those patients who are immunocompromised, you know, with low ANCs. And they may require some extra protection from potential infections that could be catastrophic for them. And so post-transplant patients. And so yes, it's great to have an option for them. But I definitely, it's a yes and a no. So I'll leave it at that. Gotcha. My only statement would be a yes and no also in the fact that I think that I agree with you in most of what you say, except that I think that we do such a poor job of tracking post-ERCP adverse events anyway, that I think we probably undersold the infectious risk of ERCP, either due to the procedure itself, which, you know, you and I could debate forever in terms of stent occlusion, because it's a risk or introduction of pathogens that we don't recognize as iatrogenic. So I think the true risk is probably a little greater than we are appreciated or we can quantify. But your point is still well taken that it may still be too much too soon for the risk that is there. Yeah. So there's a quick question on sort of the disposable duodenoscope caps, and I can handle that really quickly with some additional input from the other experts. But, you know, so the FDA has issued guidance that something needs to change, right? So the traditional design is no longer considered acceptable. But there's a variation there, right? There's a spectrum of what that change is. And one sort of, you know, more practical, more operationalizable solution are these disposable caps, which essentially allow better exposure of the parts of the duodenoscope, particularly behind the elevator, that are thought to be culprit in transmitting infection. And so that's sort of the way of the future. I mean, at some point in time, every unit is going to have to take, is going to have to sort of procure devices that have at least some modification. And the disposable cap is probably the most sort of, you know, practical of those at this time. So I think you'll see that eventually every single unit is going to use one of these sort of modified design according to FDA guidance. Now, the question is, do you take that to the next level and, you know, transition over to a completely disposable practice? And that's where, you know, I personally have reservations for many reasons discussed, including the environmental implications. But anybody else have any other thoughts on the sort of novel design scopes? I guess the only thing I would add is that you sort of said at some point, I think you need to either be doing, I think it's not, the point is now you should be doing disposable duodenoscope caps or disposable duodenoscopes at this point in time. I don't think that there's a good reason not to be using the caps at least. Yeah. And I think before long, we're not, we're not really going to have much of a choice and rightfully so. But the question from Natalie actually is primarily for Rabia, but basically she wants to learn a little bit more about the process of sending the scopes back, the disposable scopes back to the manufacturer. Right. So what are the sort of, what's the process around that? Is there special packaging? Do they need to be stored somewhere? And if you have to store them, where do you do that? And will they, will they pick up the tab on the, on the return, like, like Lululemon will, for example? Yes. It's like Amazon Prime. No, I'm just kidding. You have to procure a specific collection bin. And my advice to you would be reach out to your rep, reach out to your rep today and ask about getting that bin. So I expected that when our scopes came and it came separately, you know, in this huge package, obviously it's like the size of a recycling bin and one of those Slim Jim containers. And you just have to make sure you talk to your rep about the steps because they could vary from site to site. But basically you just get the container and then they should walk you through all of the remaining steps. But you just let the surgical solutions people know not to throw or not surgical solutions, whatever you use in your hospital, not to throw away that scope because you know, you're not physically going to be taking it yourself to keep it basically wrapped up in whatever bag or container they use and then put it into the collection container. And then when that collection container is full, you reach out to your rep and they usually pick it up or they may have a system in place. It depends on your volume. So again, we're not using these for every single case, but when we do, we want them to be recycled essentially, that's what they're doing. And I was told, and I obviously don't have proof of this, but I was told by our rep that, you know, 90% of the parts are being reused and recycled for new things, not necessarily another duodenoscope, but they're being recycled. So that is obviously very processing, but it doesn't eliminate the carbon emissions that are utilized to actually create that scope, which is something that needs to be considered as well. Every time you use it, if it's a patient who just has a stone and they have no risk factors, like, do we really need to be using a disposable scope for that patient? And my concern is that if this becomes a status quo, other companies are going to have dollar signs in their eyes and start trying to manufacture disposable upper and, you know, colonoscopes. And I know that they're already working on those and I just really would, I would be sad to see our industry go in that direction. I think that would be really bad for the environment. Yeah, and it's happening quite commonly in bronchoscopy as well. So, yeah, so, you know, the trend, the sort of, you know, almost the writing is on the wall and I think it's important that we are mindful about the potential implications of that. Having said that, though, I mean, until this most recent sort of outbreak or the recent sort of outbreaks, there had been no meaningful sort of disruptive innovations in endoscope technology. And so, again, you know, I don't see the value personally in sort of day-to-day clinical operations, but the concept that specialty design scopes for specific indications might, you know, sort of be routine part of clinical practice or in particular at-risk patients or scopes that are designed for some of our colleagues who may not have the same physical abilities or physical characteristics as us. All that, I think, brings value with it. And so, for that reason, I think it's something that we can embrace. But the scope of the problem, so to speak, you know, doesn't seem to justify such a radical change in our approach, particularly considering, you know, the greenhouse emissions and so forth. If we have two minutes, Eden, let's just finish off a question for Jim primarily and others. But this question pertains to sort of at the end of reprocessing. Is there an objective test that we should be performing to document that the endoscope is now no longer at risk for transmitting infection to the next patient? Is there something that is guideline-recommended that endoscopy units should be doing on an every-case basis? Well, presently, the guidelines from the first aid leaders, be it ASGE multi-society paper, AORN, SG&A, AIME, APEC, even the CDC through HCPAC, there is not a formalized test to be done at the completion of endoscope reprocessing that validates the scope. Absolutely certain to be utilized for a patient unless you wish to do culture and hold, and that is by means the only way that we're going to certify that the scope is pathogenic-free and able to be utilized with the utmost confidence. So, unfortunately, that's where it's at right now. And there are some infectious disease doctors that believe that our culturing and holding methodology isn't a very good practice at all, too. So, just due to the fact that we still have storage issues until next use and also potential contamination during setup. So, unless we have an open package of a sterile item or even an item out of the reusable product, there's really, I mean, a single-use product, there's no guarantee. Perfect. So, I think with that, unless there are any additional thoughts, we'll conclude the session.

reprocessing

medical scopes

disposable duodenoscopes

endoscope cleaning

endoscope drying