This is a really important focus. I think delivering high-quality procedures, but also having a high-quality unit that focuses on a culture of safety in terms of infection control and endoscopy is important. My job is to really lay or set up the stage for much deeper conversations that are going to be later in the session, as Jim Collins and others, about how to go about it, the nuts and bolts. My job is to shine a light, really, on the importance of this and how we go about it. These are my disclosures. We'll talk about a little bit of background on why focus on infection in endoscopy is important, what are the framework for evaluating endoscopy infections, both in terms of endogenous infection transmission or exogenous transmission, how do we go about preventing infection transmission. I'll touch briefly on endoscopic reprocessing from a 30,000-foot view before we get into the nuts and bolts later in the session. And hopefully, you'll find this really helpful, this session, and take some practical pointers back to your unit. So we know that infections associated with endoscopy units have received a lot of press. There's multiple studies. There's one study showing the infection control aspects with single-purpose endoscopy ASCs. And then I think everybody is aware, obviously, of the multiple press reports with duodenoscope-associated infections, the super-multidrug-resistant organisms, hepatitis C outbreaks associated. So associated with endoscopy, so this is real, this is important, this has the attention of the national leadership, has the attention of our patients, and really impacts our patients. So when a patient walks into an endoscopy unit, this is the last thing on their mind, and we really should do everything we can that the patient has a safe outcome in terms of infection. So when we look at infection transmission during endoscopy, I think it's helpful, really, to look at this framework where what is the risk of patient-to-patient transmission, whether it be endogenous and exogenous, and we'll get into each of these categories, but what is also the risk of patient-to-staff transmission, which is typically, obviously, exogenous, in that. So let's first focus on the patient-to-staff transmission, which is the smaller risk, really, but when we look, step back and look about it, the procedures that we do, what is the overall risk of infection or bacteremia, which is, you know, when we have bacteremia is when potentially we can have transmission. As you can see, the overall risk is quite low, and maybe with the soft-gel dilation it goes to the 12% to 23% range, but typically it's in the 5% to 6% range with most procedures that we do. Now how does that compare with other things? There's obviously multiple different procedures. Some of the factors which increase bacteremia risk is more involved or, you know, interventional procedures, therapeutic interventions, the presence of malignancy, especially malignancy in the biliary system where there's infection, incomplete biliary or pancreatic drainage, patient factors such as immunosuppressed status, peritoneal dialysis, if you're sampling cystic lesions of the pancreas or mediastinal cysts, and some cardiac conditions. So multiple patient and procedure factors can increase the bacteremia risk over and above the baseline that we talked about, but how does that compare to simple things that we do every day? For example, even brushing and flossing associated with 68% risk of bacteremia or can be. So the point being, as we ground ourselves to the overall risk of bacteremia, it's pretty low with our procedures, but there could be patient factors and procedure factors that can impact the overall risk of bacteremia and the overall risk of infection transmission. Now, there are multiple guidelines, ASG's guidelines about when to give antibiotics. We will not go into each of these sort of recommendations, but I think it's important to know two things. One is, what are the procedures that are associated with the highest risk of transmission and what are the ASG and other society guidelines of when to give it? But also on the other hand, we are dealing with a significant problem of antimicrobial resistance. So antimicrobial stewardship is a very important aspect of today's medicine. So it's striking that balance between the stewardship of antimicrobial use versus adequately protecting your patients for the type of procedure. So the good knowledge of these guidelines and when they're recommended is very important. And really, it has come down to only about three or four instances when you really need to give antibiotics in gastroenterology. So then let's shift focus to patient-to-staff transmission, what we call exogenous infections. This is a small overall risk, but there can be multiple modes of transmission, not just in endoscopy, but in medicine in general. Obviously, needle stick injuries, blood splashes, inhalation, transfer from direct handling of patients. Endoscopy staff can be at higher risk for some infections. For example, there's some studies showing higher rates of Helicobacter pylori among staff who have many years of work experience. And then healthcare workers in general are at higher risk for encountering a number of healthcare-related associated exposures. The overall risk is not well-documented, but it's quite low in terms of influenza, Ebola, and tuberculosis. And so how do we quantify these risks? Because these quantifications are really important to know and to communicate with our staff. For example, percutaneous risk is way less than for HIV, is less than, is about 0.2. Hep B is the highest risk, which is about 5 to 30%. And HCV is also similar to HIV. Mucus membrane risks are really low, but the risk is really not well-qualified for some of these, for HPV and HCV. So really we talk about needle stick exposures for the three big three, HIV, HPV, and HCV. The overall risk is quite low, but I think this is both for endoscopy, but also in general anywhere in medicine is consistent, rigorous hand hygiene, appropriate PPE, safe medication admission practices, you know, handling of potentially contaminated equipment or surfaces and staff being up-to-date with immunizations for vaccine-preventable diseases. And then if an exposure does happen, having adequate protocols in place and providing post-exposure prophylaxis to your staff. So it's very important to focus on that, protect our staff when they do, you know, when they offer care in endoscopy. So let's shift focus, sticking with exogenous, but what are the risks of exogenous patient-to-patient transmission? The biggest obviously for endoscopy is endoscopic transmission from either inadequate reprocessing of endoscopes or accessories, design limitations, damage of equipment, using damaged equipment, contaminated endoscopes. So you get the theme, you know, our endoscopes can be, our accessories can be the vectors of exogenous patient-to-patient transmission. And can we do everything we can in our power to de-risk these procedures? Non-endoscopic would be things associated with medications, use of multidose vials, IV sedation tubing, you know, sterile water is a big pertinent topic in today's, with the supply shortage, reuse of needles, which is extremely rare in today's day and age. But you know, these are some of the factors that one needs to consider. So what is the risk? The risk is primarily, you know, when you think about bacterial risk such as these bacteria, the gut-related bacteria, Salmonella, Pseudomonas, etc. This is from, you know, lapses in reprocessing, use of contaminated equipment, your growth in moisture-rich environments. And we'll talk about all of this of how it relates to practical measures that you can take. So high-level disinfection is designed to essentially get rid of all of this, but it needs to be done well. Insects and fungi and parasites are all treated with high-level disinfection. And prion-based diseases, I've never seen one, but theoretically they're possible. And this is the one instance where you have to destroy the endoscope that is used. But these are extremely, extremely rare. So what's the risk? You know, this has evolved. As you can see, the number of published studies on outbreaks was quite high up until 1990, and this has fallen. The overall risk has really decreased because we standardized our reprocessing protocols and the first reprocessing guidelines were published around this time. So this has led to a substantial decrease in the overall risk of exogenous infections associated with endoscopy. So infection control, when you think about it, is a really complex process, and running a high-quality endoscopy unit involves paying attention to all of these aspects, you know, in terms of documentation, what is the inventory, what is the education and training of staff, the physical facilities, are we doing QA and QC, are the personnel trained, are they taking the appropriate measures, and the overall administrative oversight of infection control is important. So it is an interrelated set of complex factors to run a high-quality unit. So let's focus a little bit on quality and endoscope reprocessing and how we provide a safe endoscopy for our patients on a consistent basis. So when we look at endoscope reprocessing, and I know Jim will get into this in great detail with the multi-society guidelines, but just to kind of give you an overview, the endoscope reprocessing happens right after you pull the endoscope out of the patient. So that bedside pre-cleaning with an enzymatic detergent is an extremely critical step to take care of the bio-burden associated with our procedures. Following this, the endoscope is transmitted to the dirty room, the quote-unquote dirty room, dirty part of the reprocessing room where the reprocessing technician takes a careful look at the endoscope, does a manual cleaning, does a leak test, passes an endoscope, the channel brush, inspects the channel, inspects the end of the endoscope for any leaks, any damage, and then goes through the pre-cleaning and high-level disinfection with rinsing. Now I put manual or automated reprocessing here because the talk is on global overview and this is a North American audience, but I'll just tell you that the reprocessing quality and criteria vary widely across the globe. Now we are fortunate to be in North America with access to very high-quality endoscope reprocessing facilities, things like that in most units, but across the world, it is a wide spectrum. So there is a separate paper on low-resource and middle-resource income countries that is put out by the Asia-Pacific endoscopy foundation. So there are still multiple, multiple countries where manual reprocessing is performed. So just so that you know that for awareness, but most centers, the vast majority of centers in the United States will do automated reprocessing. And then the drying and moisture control is very important and appropriate storage of endoscopes is also important. So these are just examples, this happens to be our unit, just to kind of give you examples of how at least one setup could be, and every, this is obviously different in every institution and every setup, but the core principles are the same. For example, just to walk you through our unit, this is as if we are looking out in the hallway into the endoscopy hallway, this glass actually goes up and the dirty endoscopes are brought in a bin and placed on here with a timestamp, the endoscopy reprocessing technician then picks this up, does, goes to the dirty side with the closed bin, which is in a biohazard bag that you can see out in the periphery here, does the manual cleaning, inspection of the endoscope, the leak test, where you can see the sink where the leak test is performed, and this is the dirty side, and then moves it over to the AER area, once the AER processing high-level disinfection is complete, then the endoscope is moved to the clean area, and then we move on to the drying cabinets, and there are multiple different types of drying cabinets, but moisture control is extremely important, as you can see in the background here, every endoscope is labeled and tagged so that we know when it was processed, when is the expiration date, and this is our friendly endoscope reprocessing tech, I think it's important that this is just a picture to highlight appropriate PPE, they have to wear a gown when they're doing it, so really having those established protocols, having QA and QC with repeated checks, and you know, endoscope reprocessing is a tough, tough job with multiple, multiple processes, so there is a high potential for human error, and so constant retraining, constant feedback is a very important aspect of it. So then, we move on to a different story, which is our specialized endoscopes, primarily our duodenoscopes, and I showed you press releases of that, so really the reported outbreaks were quite low, but obviously in the 2015-2016 period, these spiked with the duodenoscope associated infections, which prompted a significant focus on this, more than 30 outbreaks, especially these were clustered in high volume ERCB units, and with very high concern or multi-drug resistant organisms, and you know, the patient risk of contracting a high concern organism was as high as 1 in 100, so these are very serious outbreaks that's led to multiple patient deaths and a lot of focus on duodenoscope associated infections, these were primarily from gut flora, as you can imagine, and infections are often distal from the site of colonization, so this could be patients presenting with multi-drug resistant urinary tract infections, pneumonia, sepsis, there can be a lag time between infections and symptoms, so it was really hard initially to go back and attribute that to duodenoscopes, a lot of patients were carriers of multi-drug resistant organisms, and the duodenoscopes themselves were many times culture negative, and at least in the initial studies, it came out that there was really no failures in duodenoscope reprocessing, I think we have come to recognize that our reprocessing criteria in real world, they're not perfect, there is a failure rate that's identified and generally accepted to be in the 5 to 6% range, so there are multiple factors that contribute to duodenoscope recontamination, I think because the duodenoscope is a very complex instrument with a complex distal end of the duodenoscope, there are multiple, the internal working channels, and the biggest thing is the elevator, which can, behind the elevator, you can have, you can have bio-burden that can stay there and can contribute to infections. The human factors in terms of cleaning, in terms of the damaged areas, and the prolonged storage, especially in instances where, you know, ERCPs are not done on a daily basis, these duodenoscopes can be stored in a cabinet and can get contaminated, so these are all very important factors in assessing duodenoscope associated infections. So, this is a close-up view of the older version of the duodenoscope, and just to kind of highlight why these were associated with significant infection-related issues. For folks who may not be doing ERCPs or familiar with duodenoscopes, this metal piece here is the elevator that helps us raise our accessories and try to, and do these, you know, pass accessories into the bile duct, so this elevator area has been now identified as the, sort of, the area that was associated with the highest risk of contamination, and then, you know, the single-use dedicated brush is critical for cleaning this elevator mechanism. IFUs are complex, but it's very important to follow these manufacturer instructions for use, and then routine maintenance, because there's a high risk of channel damage with duodenoscopes because of all the complex procedures passing the various accessories and things like that, and like with any endoscope, the careful leak test and visual inspection is very important. So, when we look at duodenoscope associated infections, how do we eliminate the infectious risk to patients? I think when these duodenoscope associated infections came out, almost all of our units across the country went through, looked at all their fleet of duodenoscopes, did culture and quarantine, did continuous microbiological surveillance, and then we started new reprocessing techniques. One of those is double high-level disinfection, so you run the endoscope twice through the reprocessing, and you essentially repeat all the reprocessing steps. Some of us went to ethylene oxide sterilization. I think we are one of the units in the country that still do ethylene oxide sterilization. It has its own problems, and we can talk about it. I think there was a lot of focus on staff training, competency, really going back to the instructions for use, making sure that our staff are following each of those steps and not missing any of those steps, and then finally, this has led the FDA really to mandate that the duodenoscope manufacturers go back and redesign the duodenoscope, and this has led to the introduction of the duodenoscope with the distal cap and the introduction and development of single-use duodenoscopes and single-use endoscopes. So, we talked about all of these, and what we call enhanced reprocessing methods. One could be microbiological culturing and surveillance and quarantine, ethylene oxide sterilization. When it first came out, there was a lot of focus on a liquid chemical sterilant processing system. I think that has really fallen by the wayside, but repeat high-level disinfection has really become sort of the most often go-to enhanced reprocessing system, and a few years ago, there was a survey done by the FDA which showed that the vast majority of centers were really doing high-level disinfection. Some were doing microbiological culturing. Obviously, the numbers are greater than 100 percent because centers were doing a combination of things. Very few were doing ethylene oxide, and very few were not using any enhanced reprocessing methods. I think that underlines how important this problem is and was when it was first identified. So, this led to the multi-society guidelines that Jim will talk about and he was part of, and I'll sort of give a general overview of that. So, what is the current data on all of these enhanced reprocessing methods? You know, they all came out. They're a big burden to endoscopy units. Really, the randomized control trials which showed that in non-outbreak settings, HHLD didn't lead to any significant benefit. In outbreak type of settings, this led to help where you repeat all the reprocessing steps. It terminates the outbreak in cohort studies. Sterilization, ethylene oxide sterilization is not widely available, and there was really no benefit in non-outbreak settings. Again, in outbreak settings, it can terminate outbreaks, but it's costly. It's cumbersome. There's significant environmental concerns. There's concern about carcinogenic impact to staff and damage to endoscopes, really. We went through this initially when we introduced ethylene oxide. Multiple duodenoscopes were damaged because the central processing staff are not very familiar with sterilizing endoscopes, so it required a lot of staff education. The other aspect, the other way to go about it is culture and quarantine. It reduces long-term positive cultures and effective at stopping outbreaks, but it's very hard to sustain, and there is a approximately 5 to 6 percent positive culture rate even with all the steps, so it's really hard to know what to do about it. The other end of the spectrum is single-use duodenoscopes, which are widely available now. They have very favorable performance characteristics and operator experience. There are multiple studies showing that you can do complex endoscopic procedures, safety profile, but there are obviously significant concerns about cost, environmental concerns, though a lot of the manufacturers are addressing the environmental concerns with zero landfill strategies, things like that, but the adoption has been somewhat lukewarm. I think the most important is staff training. I think automating as much as possible, creating workflows for clear, understandable reprocessing instructions. These instructions for use, especially for duodenoscopes, are fairly complex. They're very manufacturer-specific, so whatever manufacturer you use in your endoscopy unit, taking that IFU, really studying that IFU, mapping out those steps, and making sure that staff are constantly trained, and there is an audit system for how the staff are following those IFU steps becomes very, very important. So, I know I talked a lot about sort of infection control in endoscopy, but hopefully that gives you a broad overview and sets the stage for a more detailed conversation. I think the take-home messages are that this is a very important aspect in terms of providing a safe, dependable endoscopy experience for our patients. There's significant variation in terms of the endoscopy unit, in terms of infection control practices, reprocessing protocols. There are a number of endogenous and exogenous modalities by which patients can develop infections, either through endoscopes or endoscopy unit-related infections. We need a multidisciplinary team approach to prevent these infections. We should know about what the antibiotic recommendations are and balance the administration of antibiotics and procedures with overall antimicrobial stewardship, and then we also have to take care of our staff. The staff have a risk of infections, a patient-driven infection, so universal precautions and PPEs and things like that are very important. Specifically for duodenoscopes, we can talk more about it in the discussion section. Duodenoscopes and echoendoscopes probably are a unique problem. Really, I think we have come a long ways since we recognized these multidrug-resistant infections in the 2015-2016 time period. Now pretty much every unit utilizes endoscopes or duodenoscopes with a distal cap. Despite that, I think careful attention to the reprocessing or enhanced reprocessing methods, staff training, maintaining staff competency in this area are very, very important, and some units have adopted the use of single-use duodenoscopes, especially for high-risk patients or patients who have known multidrug-resistant organisms. So those processes, I think establishing workflows in your unit is very important. Thank you very much for your attention.

endoscopy safety

infection control

reprocessing guidelines

duodenoscopes

antimicrobial stewardship

staff training