COVID taught us a lot of things, one of which is that infection can affect clinical operations within an endoscopy unit more than just around the endoscope, but in many different ways. And so this has always been on the forefront of our mind and traditionally, you know, we've always worried about reprocessing, but also taking great interest in PPE and unit hygiene and so forth. But really what's come to the forefront in parallel with the pandemic has been this issue of in particular duodenoscope related infections and sort of endoscope transmitted infections in general. And so if nothing else, I feel like this has become a really hot topic and something that is critically important to the practice of endoscopy. And so, and of course reinforces the importance of the culture of safety within all our units. So with that said, I'd like to introduce our next speaker, Dr. Rabia Dillatour, who's an assistant professor of medicine at NYU School of Medicine and is the director of endoscopy at Bellevue Hospital. Dr. Dillatour currently is a member of the multi-society task force on green and sustainable endoscopy, and also is kind enough to serve as a member of the ASGE diversity and inclusion committee. And so we're really delighted to have you with us today to lend us your expertise, Rabia, on these important topics. So with that, I will turn over the floor to you. Thank you so much. Okay. Thank you guys so much for having me. I'm really delighted to talk to you guys today about infection control and endoscopy, a global overview. So to start, I'd like to provide a little background in terms of our objectives. I'll start by providing a little background on this topic and help provide some context for why it's so important. Second, I want to discuss the framework for how we think about infections in endoscopy units, looking both at endogenous and exogenous and iatrogenic endoscopy related infections. And third, what we're going to spend the bulk of the presentation talking about is the risk to patients and to staff, to all of you for contracting an infection while in an endoscopy unit and how this can be prevented and how you can minimize that risk. And lastly, we'll provide, of course, some concluding thoughts. All right. So why is infection control important? You obviously all know the answer to this, but we'll talk a little bit about that. So first, there's a great deal of data that shows there is a variation in infection control and reprocessing within endoscopy units. There are differences between endoscopy units themselves, between the person who's washing the scope, the time of the day, whether it's emergency cases versus regular scheduled cases. There's just a lot of variation in terms of infection control and reprocessing within these units. So this graph here shows data from a study that examined 60 ambulatory surgical centers in four different states to assess their adherence to the recommended infection control practices. Adherence to recommendations for reprocessing of endoscopic equipment was not uniform in over a quarter of the ASCs that they surveyed in this study, and the ASCs demonstrated deficiencies in other areas of infection control. About 20% did not comply with the hand hygiene, and nearly a third were not employing safe infection practices. Second variation has been observed across all endoscopic reprocessing steps, as well as several occupational hazards that have been associated with reprocessing. When manual reprocessing is utilized, only about 1% of reprocessing steps are successfully completed, whereas 75% of reprocessing steps are completed when automated steps are performed. And finally, we have notable examples from the press where infectious outbreaks have occurred, and this can have devastating consequences for the endoscopy unit, especially like we saw with the duodenoscope infections contaminating future patients who had those same scopes used. It became national and international news and ended up really harming the appearance and kind of projected image that we have as advanced endoscopists who are using these scopes, and there were a lot more questions from patients. So this body of literature really illustrates that additional work and attention is needed to help reinforce and standardize our reprocessing and infection control guidelines. So to understand infection risk and endoscopy, it's really critical to have a framework. This illustration here provides a conceptual outline for how infection transmission occurs within endoscopy units. So there's two main modes of transmission, patient-to-patient or staff-to-patient or vice versa. Within these modes, there can be endogenous or exogenous transmission. In the case of endogenous infections, we become infected with our own bacteria, our own microflora, from an area obviously that's full of microflora to an area that might have been stable. Exogenous infections, in contrast, involve a pathogen entering a patient's body from their environment, and they can be introduced iatrogenically through a contaminated device, a healthcare worker's surface, or another vector. So let's look more closely at each of these modes and how we can prevent these risks. So what is the risk of endogenous infection in patients undergoing endoscopy? The majority of studies on this topic are case reports from the literature over the last several decades, and as you can see, they're broken down by type of endoscopic procedure and types of intervention performed within them, and obviously, some have more risks than others. From this data, we note several factors that increase bacteremia. So performing therapeutic maneuvers, of course, will increase your risk of bacteremia, malignancy, incomplete biliary or pancreatic drainage, immunocompromised patients who either may have an inherent immunocompromised or they're on chemotherapy, patients on peritoneal dialysis have an increased risk of bacteremia, mediastinal cysts or cystic lesions that you may pierce that are typically sterile can be super infected, and then patients with cardiac conditions can also be at increased risk for bacteremia. So on the previous table, we saw bacteremia rates of 4% to 23%, and it's really important to put this into context of routine daily activity risks for bacteremia. So we note that common activities such as brushing our teeth or chewing have reported high rates of bacteremia, much higher than I previously thought before knowing this fact, but brushing and flossing can have a risk of bacteremia from anywhere from 20% to 68%, toothpicks 20% to 40%, chewing food 7% to 51%. Now this bacteremia obviously is transient, you know, you're not getting septic every time you brush your teeth, and it usually doesn't result in a clinical consequence, and also raises a question if this might be true for observed bacteremia we see in endoscopic procedures. So are all of those potential infections actually of any consequence for the patient? Do they actually cause issues that we need to then correct our behavior for? All right, so how do we prevent endogenous and exogenous endoscopy-related infections? Usually antibiotic prophylaxis during GI endoscopy is there as an option to reduce the risk of significant endogenous infectious complications, and highlighted here are the actual guidelines on this topic. But in general, these guidelines do not recommend the use of prophylactic antibiotics for every case. As you all know, you're not giving antibiotics for every EGD, for every colonoscopy, for every, you know, small polypectomy, but they're supposed to be given out much more judiciously and in much higher risk situations, such as, as you can see here, bile duct obstruction in the absence of cholangitis. If a patient has a very remarkably high bilirubin, you can consider antibiotics essentially like if the bile duct is sealed off by malignancy in mediastinal cysts, like I mentioned, in pancreatic cysts. If you're going to pierce them, there's a risk of superinfection, so we tend to give antibiotics. Patients who are getting PEGS get antibiotics. Any cirrhotic with acute GI bleeding anywhere in their body gets antibiotics, and again peritoneal dialysis in a patient who's undergoing lower GI endoscopy or colonoscopy. Okay, so additionally, there are infectious risks to staff during endoscopy, so all of us, our endoscopy staff, our nurses, our techs, and there are a number of modalities by which staff can be exposed to infections. There is needle stick injuries, blood splashes to the conjunctiva, inhalation of aerosolized microorganisms, especially if the person's not wearing a mask, which you might have seen in the pre-COVID era, or transfer from direct handling of patients or even the scopes themselves. So also, we know endoscopy unit personnel are at higher risk for some types of infection in comparison to other healthcare workers or the general population. For example, there's a higher prevalence of H. pylori infection in endoscopy unit personnel, and healthcare workers at risk for encountering a number of bacterial, fungi, parasitic, and viral infections, particularly those that are spread by respiratory droplets, given the fact that we are essentially performing aerosolizing procedures. So the exact risk is not well-documented, but it is low, seeing as how we are contracting infections every time we perform endoscopy. But in the setting of much more cognizant use of PPE, we are seeing even lower infections. So we can safely scope patients with COVID as long as we have proper PPE and prevent infection risk to the staff. So many of these infectious risks to staff from patients are not entirely quantifiable, like as we already mentioned in the last slide, but in some cases, we do have data available to guide us. Here are the percentage risks of transmission of three concerning pathogens that are very well-known, well-documented, HIV, Hep B, and Hep C. And this varies, obviously, based on the route of exposure. So this really showcases how low the risk is in some cases, and in other cases, not well-known, but mostly depends on the route of transmission, the type, and the source of bodily fluid, and the volume. Okay, so what are the best practices for preventing patient-to-staff transmission of infections? The key to this prevention are universal precautions, and I'll say it again. Universal precautions will protect the staff and also the patient from encountering any of these infections that can be spread in either direction. So this refers to the medical practice of avoiding contact with patients' bodily fluids by means of wearing of non-porous articles, such as medical gloves, goggles, and face shields. And again, we have all seen in the pre-COVID era people performing endoscopies without masks. We always heard, oh, this person doesn't like to wear a mask, and that's just kind of how it was. But in the era of the COVID pandemic, we really are not seeing that anymore, and so that is maybe one silver lining of this, is that we're much more adherent to our PPE. So this can be accomplished in several ways. You have consistent, rigorous hand hygiene, adequate or appropriate PPE, safe medication administration practices to avoid needle sticks, safe handling of potentially contaminated equipment or surfaces, adequate ventilation, and necessary isolation precautions when required. So we do all of our COVID cases, and obviously TB cases, in adequately ventilated rooms with negative pressure, maintenance of a clean and sanitary environment, keeping the staff up to date on immunizations for vaccine and preventable diseases. So most hospitals require a happy immunization documented prior to even onboarding as an employee or staff. If staff are exposed to an infectious organism, then monitoring of them after an exposure and providing post-exposure prophylaxis if indicated. So at our hospital, we send patients to essentially the hospital nurse worker's comp to ensure that they have their blood tested right after a needle stick and then before putting them on any type of prophylaxis if there's any concern for risk of HIV. So on the other hand, exogenous infections are transmission of foreign bacteria into the body either by the endoscope or by non-endoscopic methods, usually around endoscopy personnel. The potential areas around endoscopy where patients could develop infections include inadequate reprocessing of the scopes or accessories, which is, again, those news headlines we saw with the duodenoscopes not being cleaned well enough and still testing positive in the culture and then having been reused and causing infections in other patients. Design limitations or damage of equipment that can also increase the risk of infections from scopes, contaminated endoscopes, accessories or equipment, and inadequate drying, transfer, or storage of the endoscopes. Like you have a case where you need that one T-scope or that duodenoscope and you're asking them to wash it very quickly and they don't have adequate time to dry it or if it just wasn't stored properly in general. These are all things that can increase the risk of infection. In terms of non-endoscopic areas, these include improper handling of IV sedation tubing, use of multi-dose vials, and the reuse of needles, which, of course, no one does nowadays, but, you know, it's just worth mentioning. All right, so let's look a little more closely at what the risk of exogenous infections are from patient to patient, especially those who are undergoing endoscopy. So this table illustrates reported infectious outbreaks of bacteria, viruses, fungi, and parasites, as well as possible risks of prior disease. All of this data comes from case reports. All right, so in the majority of cases, we see that the transmission of infection was due to lapse in reprocessing or contaminated equipment, but reassuringly, high-level disinfection can actually and does terminate these infectious outbreaks. So what we've seen over the last few years is a difference between standard and forward-viewing endoscopes versus side-viewing endoscopes, versus graph shows published and reported infectious outbreaks related to standard endoscopes, and we're seeing a large peak in the 1980s with a significant decline afterwards in terms of these infections. So this change is largely due to standardizing processing tools and protocols and publishing of reprocessing guidelines. We know that with knowledge and education, we were able to essentially educate ourselves, create a guideline, and we saw significant reduction in the amount of infections as a result of our knowledge and standardization of our reprocessing protocols, as opposed to leaving it up to each individual endoscopy unit or each individual team and allowing them to create their own localized guidelines, we standardized them, and that really resulted in a reduction in infections. So how do we prevent endoscopy-related infections for our standard endoscopes? There's no one single solution. The key to success in this area is to identify several areas and develop countermeasures that we can work on together that kind of complement one another and ensure that everything is done as seamlessly as possible. So there's a number of key elements that need to be considered. These include examining and developing standards around a strong infection control leadership team and having people who are experts in this area or people who are willing to educate themselves in this area kind of take the lead and take ownership of ensuring that things are done properly. Appropriate documentation is important. This goes down to documenting actual infections and having some sort of log to making sure that every time you do a report, you actually put the right scope number in. And that's something we take very seriously in our hospital with our advanced cases after the report of the outbreaks of duodenoscope infections was kind of more well-known. Now we put the actual scope we're using on every single report and make sure that it's exact one. And if it's not in the system, we make sure it gets uploaded to the system when we document it separately in the note because it's so important to know what scope was involved with each single patient. Not only from a patient safety standpoint, but also from a liability standpoint. There are a number of these different things that we can do. So again, control leadership team, documentation, inventory control, education and training, like I mentioned, physical setting, quality assurance, and personnel. So all these things work together to try to prevent endoscopy-related infections. So here's a broad overview of all the different steps involved in the reprocessing of endoscopes. It's divided into three buckets. You have reprocessing, sorry, pre-reprocessing, reprocessing, and post-reprocessing. So we know that when all these sequential steps are followed, the infectious risk associated with standard endoscopes is dramatically reduced. So it's really important to have bedside pre-cleaning. Then you have the actual manual cleaning in the reprocessing room, which is a dirty room. Anyone who enters that room or is working in that room should be gowned and gloved with appropriate PPE to protect themselves. And then the reprocessing room is a clean room where things should be dried. So these things shouldn't all be happening in the same room. It reduces the risk of infection. And then obviously they should be stored in a clean, dry place where hopefully and ideally only the scopes are being stored. And it's not next to or adjacent to many other things that could potentially contaminate the clean scope. Okay. So what about more specialized endoscopes, such as the side-viewing duodenoscope or the linear echo endoscope, both of which that have elevators and also the radial scope, which is more an oblique-viewing scope. So using a similar model of examining literature and reported outbreaks for specialized endoscopes, we see a much different story. Interestingly, we've observed a spike in the recent decades regarding this category of infections. This observation is likely multifactorial, but it represents an increase in the frequency and the use of these specialized procedures in GI and also greater transparency in reporting them. So I'm sure that there were infections, you know, in the 70s, 80s, and 90s that we just never heard of because people weren't necessarily reporting them to some national database or even documenting them or studying them and reporting in, you know, different studies, retrospective studies what had happened. But in the 2010s, we obviously were doing that. It became national news. People were studying it. We now have stricter protocols about actually culturing our scopes. At my hospital, we culture our duodenoscopes every single week. And if there's any evidence of, you know, higher than a certain CFU or colony forming unit on the elevator, we have to kind of reevaluate our practices and have an entire multidisciplinary meeting about what and how we can do to improve that. And in the meantime, all the scopes are being double-washed. So, you know, there's definitely a lot more reporting and a lot more, I guess, accountability and transparency, like we mentioned, in terms of what is going on and what we're doing about it. So beginning in 2010, as we were just talking about, there was a sharp uptick in reported infections from multidrug-resistant organisms pertaining to duodenoscope use. Alarmingly, site-specific investigations of these infectious outbreaks revealed that infectious transmission was occurring despite adherence to the manufacturer's reprocessing standards. So these outbreaks were reported between 2012 and 2015. They were predominantly occurring in high-volume centers in the U.S. and in Europe. And taken together, the available evidence has allowed us to provide some estimates of patient risk as it pertains to duodenoscopes. So the actual risk of contracting a low-to-moderate concern organism is quite low, and it ranges from 0.3 to 4.4 percent. The risk increases slightly for high-concern organisms, such as CREs or MDROs, to around 4 to 5 percent, so, you know, one in every 20 patients. And finally, using this data, the risk of a patient contracting a higher-risk organism during ERCP ranges from 1 to 1,060 to 1 in about 2,600. So it's not an insignificant number. So looking more closely at infectious outbreaks attributed to duodenoscopes have illustrated some trends among clinical characteristics. So these characteristics include organisms which are mostly gut flora, infections which are distal from the colonization site, including urinary tract infections, pneumonia, and sepsis. Long lag time exists before any clinical symptoms develop, so any kind of bug that has, you know, a period of time where you contract it, and then there's a period of time where you have you're asymptomatic, kind of like COVID, and then your clinical symptoms develop, those are also characteristics that can increase. Silent carriage of the infection, carriage of the infection, of course. Duodenoscopes are often culture negative, another important note, and no failures in duodenoscope reprocessing were identified. Okay. So why do we think we're observing more infections associated with duodenoscopes? We already mentioned some of the reasons. You know, perhaps it's just more reporting, more transparency, but there's multiple factors that could explain this observation. First, the distal end of the duodenoscope, which is shown here in the top right photo, has a complex design which includes an elevator, which we already mentioned, and that potentially makes it more challenging to disinfect. It can essentially trap different bacteria and virus and fungi and parasites there, and so it's higher risk. Second, the internal working channels of duodenoscopes might be areas where damage could occur and might not only be difficult to reprocess, but also be an area where debris and organisms can collect over time. And third, reprocessing duodenoscopes is a very complex process, and it's just very rare for missteps and human error. That's another thing, you know, it's an area for improvement where you can provide adequate education to the people who are reprocessing your scopes and make sure that they know that for duodenoscopes, there's some extra steps involved and some extra TLC involved to make sure that the duodenoscopes are clean. Fourth, and prolonged storage in a non-controlled environment might be a factor. And lastly, the rinsing water used to reprocess duodenoscopes can contain waterborne bacteria, which is also important. And so we do see a number of interrelated factors that can contribute to, you know, the duodenoscope having a higher risk of infection than, let's say, your upper endoscope. Okay, so there's multiple opportunities to improve or enhance the reprocessing of duodenoscopes and reduce or eliminate the risk of infection to patients. And these include new technologies or techniques for endoscope reprocessing, better methods to identify contaminated endoscopes or duodenoscopes early on, like I mentioned, we culture ours weekly, considering duodenoscope redesign, which would be a partnership with industry, improving staff training, like we mentioned, in terms of making sure that your scopes are clean properly. And lastly, ways in which we might simplify and streamline the reprocessing pathway. You know, educational science, things that we can do to make sure that this is just done properly, because it just seems like a really low-hanging fruit to improve quality in your endoscope unit and improve patient safety. So let's examine these a little bit more, and hopefully we're doing okay on time. I'm almost done, I promise. Okay, so the enhanced reprocessing methods include supplemental measures for facilities and staff that reprocess duodenoscopes they should consider. Again, culturing, like I mentioned, using ethylene oxide sterilization, the use of liquid chemical sterile processing system, or repeat high-level disinfection. So a lot of places are now washing scopes twice, just as standard. And that's something that you can consider doing if you want to try to prevent infections. It's definitely something that we do from time to time. We don't do it regularly, but it's a consideration. All right, so recent outbreaks of infections in endoscopy units that have been traced to duodenoscopes have prompted the FDA to issue advice on possible supplemental measures to consider, and those were them. But, you know, this is a graph just showing you how these different interventions can actually help. And percentage of practices that are actually doing them. So, again, the double high-level disinfection is probably the most common one. It's the easiest one to do. The surveillance microbiological culturing is the second one that we often do, and most frequent one that we do, about half of practices are doing it. And that's, again, just to keep an eye out, the liquid chemical sterilization is about a third. And then the ethylene oxide sterilization is 12%, and none is about 10%. So, again, these are all practices that I think, especially high-volume centers that use those duodenoscopes a lot, really need to consider doing if they're not already very important to try to prevent infection. Okay, so current data on enhanced reprocessing methods. Given these recommendations, your next question and all of our next question is, what does the data tell us in terms of, are these methods really effective? So, looking at only repeating the high-level disinfection process, we see research in this area has been limited to non-outbreak settings and across three randomized trials that there was really no benefit of double high-level disinfection versus other interventions. But that being said, again, these were centers where they did not have outbreaks. So, it's hard to say, and we do it, especially if we see that we're getting back positive cultures. So, it's just something to know. I mean, I have a very high-volume center, and we kind of rotate between three to four duodenoscopes, depending on if one is out. And so, that being said, we do tend to do some double high-level disinfection. So, what about if one repeats all of the reprocessing steps a second time? This will add more reprocessing time, but it could be more beneficial. So, the data here has been limited to only outbreak settings. And while this process terminated the outbreaks, there was a low culture positivity rate and low rate of concerning organisms. So, they weren't sure if it was overkill, but still, it definitely is important to consider, especially if you're in an outbreak setting. In non-outbreak settings, recent data from a randomized controlled trial showed no difference in detecting multidrug-resistant organisms or bacterial contamination between sterilization and double high-level disinfection and high-level disinfection. So, it's interesting that there was this trend to detect a higher rate of non-pathogenic organisms in duodenoscopes in this study. And sterilization has been effective in outbreak settings at terminating the outbreak, although this has only been in non-randomized studies. So, one area that gained a great deal of attention early in the infectious outbreaks that we mentioned between 2012 and 2015 was related duodenoscopes, was culturing areas of an endoscope and then removing that endoscope from use. Such a culture and quarantine program is effective at reducing positive cultures, but long-term impact is really not clear. And so, you know, more study needs to be done in terms of this process. So, finally, just as there are single-use accessories for endoscopy, there has been some discussion around single-use endoscopes and single-use duodenoscopes. And, you know, they're out in the market. You know, you have the Exalt Scope, and, you know, I know other companies are working on developing these. So, essentially, this would be sterile endoscopes that could be removed from a pouch for one-time use, and they have favorable performance characteristics. The operator experience is okay, and the safety profile has also been found to be, you know, okay, favorable. So, together, while all this work is promising, there still needs to be continued adherence to reprocessing protocols and ensuring staff are well-trained and have ongoing competency assessment to maintain, you know, best practices to minimize this group of infections. All right. So, in summary, we've covered a number of topics around infection transmission and endoscopy. There's definitely variation noted from unit to unit and between person cleaning the scopes to the next person, a number of modalities by which patients can develop different types of endoscopy unit and endoscope-related infections we reviewed. We reviewed preventing infections in endoscopy units and how that requires a multidisciplinary team and systematic approach. We also reviewed endogenous-related infections, how they're rare, and how prophylactic antibiotics are not routinely recommended for all cases. They should be used judiciously. I don't know why I'm having so much trouble with that word, judiciously for specific cases. Additionally, infection can occur between endoscopy unit staff and patients undergoing procedures, so the risk can be really reduced with universal protocols and using PPE. And then compliance with rigorous standard reprocessing guidelines, including high-level disinfection, considerably reduces the risk of endoscope-related infections. So, all of this just reiterates a multifaceted approach is really required to address this type of infection, and more work and research are definitely needed before we can create a unified national or international guideline on how we should proceed. Thank you for your time.

infection control

endoscopy units

duodenoscope-related infections

reprocessing guidelines

transmission modes

universal precautions