I have to admit that I didn't even know with all these different types of wipes, because there's so many different colors, I didn't realize that there are different wet times for them. So for our audience and for myself, where can we look to see which type of wipes has particular wet times? Is it on the label there? Yeah, it's manufacturer independent. Many of them will post a numerical value, the wet time that needs to be achieved. Others just spell it out in the directions on the label. So buyer beware. I guess it's something that we all need to keep an eye on, especially with, like you said, supply chains. There's always something different in your unit that might be replacing what you're usually used to. So we definitely need to keep an eye on that. Indeed. So we have a lot of questions from our audience in this topic, which I'm happy to see. So we'll go through them one by one. So Jim, just to continue, there was a question that was simply put, is manual cleaning still the most important step with sterilization? Oh, without doubt. Manual cleaning process removes the majority of the bio burden and residue from the procedure. So without effective manual cleaning of the endoscope, we're not reducing the bio burden of that scope, making disinfection more difficult. And Rahul, a question for you. Is there any benefit to doing periodic culturing of standard forward viewing gastroscopes or colon scopes and or processing machinery like your medivators, if you have that, even with a standardized rigorous cleaning process already in place? Yeah, that's a good question. And I think that the answer is no. I'd also be interested in Jim's opinion, but really the culture and quarantine strategy has really been studied in duodenoscopes. The risk of infections associated with gastroscopes and colonoscopes is quite small. And I don't know of any data on culturing or sampling AER equipment. Jim, do you know? That's about the limit of what I know in terms of AER equipment. Yeah, it's dependent upon the manufacturer will offer guidance on culturing of AERs. And that's dependent upon the use of the AER and also the present state of water conditions. If AERs haven't been utilized for a significant amount of time, then culturing is recommended prior to putting the machine into operations, but not routine culturing that I'm aware of. And I agree with the assessment on culturing standard forward viewing gastroscopes or even colonoscopes for the most part is that standard routine culturing hasn't proven to be reliable or hold value at this time. Yeah. Do you think that there's going to be any differences or your thoughts, Rahul, you sort of mentioned about linear EUS scopes? Yeah, linear EUS scopes are interesting. You know, they obviously have the similar design as a duodenoscope, but slightly different. They do have the elevator mechanism. There's data, I think it came out of Mayo, Rochester, but also other places that there can be endoscope associated infections with that. You know, they haven't received the same amount of scrutiny as duodenoscopes. And I think the guidelines haven't really addressed that specifically. Most practices, including ours, don't routinely do anything different for linear echo endoscopes. It could also be related to the type of procedures that we do with them and not just the design of the endoscope. So in our practice, we don't sterilize linear echo endoscopes. And I haven't heard of other practices doing anything different. I think some may be doing double HLD, but that's, Jim, any other thoughts on that? No, I totally agree. That has been my experience as well, that there are some facilities that due to the nature of the elevator-assisted echo endoscope, the linear endoscope, that they are performing two-time HLD just as a safety factor for their own self-assurance. Even though there has been some reports, they have been quite minimal, minimally reported. And there is a practical side to it, right? You know, echo endoscopes are extremely expensive, and a linear endoscope, so if you have a busy EUS practice, you have to balance those competing things in terms of what is the absolute or the risk of infection with standard processing versus if you take the extra steps. And, you know, there is, as with anything, there is a cost component to this that one has to balance with the risk component. So these are decisions that need to be made every day in our practices. In complete agreeance, those EUS endoscopes are quite finicky. They don't like to be manipulated, except during procedures, and the more they are touched, the more they seem to break. And repairs are extremely expensive. Exactly. So thank you for that. Turning our attention more to scope storage, Jim, maybe you can answer this question. Is HEPA-filtered air drying and overnight continuous venting a requirement or just a recommendation? Well, we want to ensure that endoscopes are dry. So we want to ensure that we have proper drying of our lumens of our endoscopes channels, as well as the exterior of the endoscopes. It can be achieved through multiple modalities. We can have simple air from a proper air source do it manually, or they have automated pumps to do so. If you have the ability to have cabinets that offer forced drying, that's wonderful. It eliminates the caregiver time to do another modality. So it's not required, though it will help you fit into the recommendation of that drying of those channels. It's just another modality. And to follow up on that question, sort of in the same idea of hang time of the scope, if it's in a drying cabinet, do you still feel that an expiration time still applies? For example, in this particular person's facility, reprocesses their endoscope, and after seven days of unuse, would it be appropriate to eliminate this if the scopes are kept in a HEPA-filtered drying cabinet until it's used next? Can you comment about that hang time? Can I go first? Whoever. Well, that's a very, very interesting question, and one that needs to be researched, I feel. When we look at the contamination of endoscope for seven days, basically we're looking at also manipulation of other endoscopes within that storage cabinet. So being in a storage cabinet that has forced air drying is good and beautiful. We know that channels are dried effectively, though, and we also have filtered air going through the cabinets. But we also have caregivers going into the cabinets with the potential of contaminating the endoscope's surface through their own contacts, all right? And then you grab a scope, and you touch the other endoscopes in the closet. So I think that's an issue that needs to be addressed further. When we looked at the seven-day recommendation, it has the little nuances that if the scope has been properly processed as well as properly stored, then, you know, a seven-day. So there's other factors that go into the environmental factors before you can eliminate that seven-day rule, I feel. Rahul, do you have anything to add to that? No, I think that was well stated. I think most facilities use an expiration date and do that. So it essentially comes down to multi-use cabinets and touching scopes and things like that. To follow up on that, particularly that really vivid picture of someone touching something and then touching a scope and just contaminating everything, another question from the audience said, you know, since the COVID pandemic and really strict requirements of PPE, particularly in the reprocessing stage, can you please talk about what PPE is required to be worn in the procedure room and in reprocessing by all personnels at this point? In the reprocessing room? Both. Maybe you can talk about reprocessing room and Rahul, you can talk about the procedure room? Sure. Well, in the reprocessing room, there's various venues that need to be addressed, okay? Due to the aerosolization that occurs during manual reprocessing as well as in the clean room, we can have aerosolization of chemistries. Even though hair bonnets or hats are not considered PPE, they're recommended to prevent fall-off from falling upon the head of the personnel or caregivers. We also want to ensure that they have proper eye protection on that can be achieved through various means. There's people who wear full face shields. Now, the problem with wearing full face shields is you have to ensure that the shield length is proper to ensure that it goes below the chin, because often caregivers raise their head up, which allows the opportunity to sneak in underneath. If that's the case, then to have a face mask on to protect the mucous membranes or anything from entering there. We want to ensure that they have fluid-resistant gowns on if they're working with wet and manual sinks to ensure that they don't have strikethrough onto their scrub clothing. Their scrub clothing should also be changed into at work and changed out of before they go home, and there shouldn't be self-laundering of these attire. Again, shoe protection is not a PPE, though it's recommended if the shoes you're going to be wearing has potential for spills to be encountered. You don't want to be tracking those spills throughout your department. Dedicated shoes are often recommended as well to be worn, though I still encourage the use of shoe protectors, even on dedicated shoes, just so you don't track those throughout the unit. Yeah, in terms of the procedure room, I think the same sort of principles apply. It really depends on the type of the procedure, your role in terms of what you're doing for the procedure, and also the patient factors, including what kind of infections they have, what immunosuppression, things like that. I don't think we can give a single answer to everything, but in terms of what Jim mentioned, eye protection, I think a cap or head protection is sort of optionally, at least I'm talking in our practice. A mask, eye protection, obviously a proper resistant gown and then shoe covers is typically what we do. Risk of COVID, things like that, that has changed. It has slightly, obviously relaxed a little bit. We are not as paranoid as probably we were a year ago, but N95s proper protection when patients with COVID, especially aerosol generating procedures. So that's sort of the broad overview. I think people have to look at their local set of requirements, local hospital policies, things like that, so. Thank you. So moving on to another set of questions about infectious control. I wanted to mention one of the taboo words that we have come upon recently, simethicone. So I wanted to talk about your thoughts about using simethicone and does it really create too much of a bio burden? Well, we use simethicone in our practice. We have a position created on the workout in California on the safe use of simethicone. We adopted our practice statement upon that document and we've had no problem with residuals. We do have a relatively, a quality program with a residual soil testing done on the endoscopes that haven't revealed any uptake or difference within simethicone or unsimethicone utilized endoscopes. I do believe there was a paper presented at DDW on enhanced drying when simethicone is used to increase that length of drying from 10 to 15 minutes that has been published in that paper, I believe. Yeah, in our practice also, we tend to use simethicone. We tend to put it in the water bottle. I think that was the final set of recommendation or the final decision that was made in terms of how simethicone is used. But again, we have not noticed any significant issues but we obviously are aware of the IFU that was put out. Yeah, I think when that idea came out, we all sort of really got scared and took a step back and then realized how can we do it and use it effectively because there are definitely some times when you really need simethicone and water is just not enough. So we'll stay tuned to that. But thank you, Jim, for telling us about the other kinds of additive infectious control that we can do to address that issue. And I think one of the other last questions is a practical one from one of our audience members. Is it ever safe to take freshly processed scopes without it being placed in a cabinet directly to the procedure room? And I can see that that coming up in very busy endosuites. And again, demand is very high and people are stressed out about processing them quickly. Can you guys comment on that? Well, we want reprocessing to be standardized throughout the facility and throughout the unit. So I know that it may add to the time or a delay for a procedure from starting. So each endoscope deserves the same type of treatment. Each patient deserves the same treated endoscope. So even though we do have technology such as drying cabinets to enhance drying, our practice is when endoscopes are needed that we don't take them from the AER straight to the patient, they're still dried. So if the drying cabinet may take too long, then they may be manually dried through the forced air system we have. Yeah, the same thing, I agree. Okay, great. Also, I think underscores a point that as we talk about infection control, I mean, when I look at it from the perspective as a physician sort of, or a unit manager or things like that, I think one of the things that we don't talk enough about is having an adequate fleet of endoscopes to really facilitate proper and standardized infection control practices. So if your endoscopy unit is having those challenges, things like that, then it's time to step back and look at why and maybe sort of expanding that fleet to take away those day-to-day pressures. Exactly, totally agree. And I think that's what one of the Ofsted studies when it looked at the human factors when reprocessing techs were forced to work more quickly that the fleet of endoscopes on hand could be beneficial to increase that number for the overall unit operation and efficiency. Yeah, I think that's where data from your endoscopy team can really help where you can bring that to the table and talk to the stakeholders that you have to discuss to increase that fleet. Because I can tell you that it's definitely not an easy conversation to have, but important, obviously. And so I think data, data collection and times and going back to that efficiency talk that we had this morning together so that we can really all be on the same page in terms of infection quality and efficiency quality. Yeah, one last point I wanted to add to that and I'd be interested to see what Jim thinks. One of the things that we also don't focus on and as it relates to endoscope performance but also infection control is our overall feed age, the age of our endoscopes. And we haven't really focused much on that but it's another important component because the risk of damage to the endoscopes increases and potentially your risk of infection. Though it hasn't really been shown in studies but it stands to reason. Totally agree that one would think that the older your fleet of endoscope is that these endoscopes have encountered more damage through more use. And the other component of that is, well, if my endoscopes are old and it's been reserviced approximately two years ago, then I have a pre-authorized, pre-certified endoscope now. So perhaps that doesn't play a factor in it though there are no studies that show the benefits of or the repair structure of appliances that have been damaged in their repairs during their use life. Yeah, I think that makes perfect sense. And maybe something that we can study and target maybe testing, residual testing on those older scopes and collecting data to see, hey, if the dials aren't slow or working or not as responsive, maybe it's translating to reprocessing issues. So I think that's a highlight onto something that we can look towards in the future. Thank you for bringing that up. And we do have two case studies. If we'd like to bring one of those up, we have about five minutes before break. Should we bring up case one? Thanks. So infectious control case one, during a routine maintenance check on an endoscopy washer, the biomedical engineer notes that the intake valve controlling the amount of disinfectant into the washer was not functioning properly. And there may have been inadequate disinfection for multiple endoscope cleaning cycles. What should be done? Jim, what do you think? What do I think? What a conundrum, huh? Well, personally, I think that what I would do in my own practice is that we do have a breach of reprocessing that has been noticed. We do know that the volume of disinfectant that goes into the AER is important due to the fact that we have to have surface contact with the disinfectant on the surface of the endoscopes. So the improper amount may not have contacted all the exterior surfaces of the endoscope. I'm pretty confident about the interior of the endoscope being cleaned through channel flushing. So with that being said, I really think that I would gather my reprocessing logs, find out which endoscopes were affected and find out which patients were affected. This would mean not the reprocessing cycle, but also the next patient which that device was utilized upon. I would check with my infectious disease doctor what our next course of process should be and act upon her recommendations. So probably would be patient notification and probably the offering of serological testing for that patient. Rahul, do you have anything to add to that plan? No, I think that makes sense. It's also the patient stratification. I think looking at the patient factors, if there were any patients on that list who may have had high risk organisms or other things, so patient factors I think would be important. We did have a question pop in. How often do you recommend Resi testing, EGD and colonoscopes? Not sure if we answered that earlier. Well, there is a debate on residual clinical soil testing after manual cleaning that's been poised. So I'm aware of facilities that do it with every endoscope and they have gastroscopes that have a higher positive find than colonoscopes. It's not related to any type of reprocessing tech or any type of case that has been done. There's other facilities that utilize modified cleaning claims from AERs that would make a residual soil testing after a modified cleaning method rather in material and not hold much value. And also when we look at these tests, most of these tests are structured to just review the working channel of the endoscopes. And we know that there are cracks and crevices and creases within endoscopes, the dials, the controls. We have to ensure that at the distal tip of the endoscope where we have rather loose fitting and the bending section that needs to be closely observed as well. So at this time, there is not a standard for residual soil testing to be done. Other than when we review high-risk endoscopes that have been classified as those elevator-assisted endoscopes and other type of endoscopes. So our practice, we do not routinely utilize it at all our facilities. I think a follow-up question to this case that an audience member had asked is, wouldn't the multiple endoscope cleaning testing after every endoscope reprocess in the AER have caught this type of deficiency before it got to this point? This is in case one? We could have had a, we could have a properly disinfected endoscope each and every time just due to the spraying action of the AERs, their sprays. We always look for the bowl, the reservoir filling as well. Though to do residual soil testing may have not produced us a positive find. Again, most soil testing are done for channels which probably and more likely were highly disinfected because if there was a deficiency in disinfectant, then usually alarms go off that don't facilitate the operation of the AER. So, I don't know.

infection control

endoscopy procedures

manual cleaning

bio burden

PPE

disinfectant intake valve