Welcome back everybody to the second half of our quality course. I hope you enjoyed your lunch break or break and those stellar presentations in the morning we trust that you'll find the afternoon talks equally engaging. The second, the third session today is for about infectious control in GI endoscopy. If the COVID pandemic has taught us anything it's that infections can affect endoscopy unit operators and operations by more than just contaminating the devices, just contaminating the devices, while PPE hand hygiene and environmental hygiene have always been fundamentals to discussions around infectious control in GI endoscopy, the dialogue is largely focused on mitigating endoscope associated infections. The pandemic highlighted the need to establish and maintain a culture of safety in the unit. We want to welcome back Rahul to provide a global overview of infectious control in endoscopy. The audience is yours Rahul. So we'll talk over the next 20 minutes or so sort of on a global overview of infection control and endoscopy and what are the various components of sort of what we need to focus on in terms of infection control and endoscopy. These are my disclosures again. So we'll talk about a framework of evaluating endoscopy related infections, talk about endogenous and exogenous infections, what we can do to prevent infection control or infection transmission during endoscopy, provide a brief overview of endoscope reprocessing but I know Jim is going to talk more about that and bring everything together. So, when we look at the data looking at lapses in ambulatory surgery centers or other centers, you can look at the type of things that show up in terms Now, non-endoscopic, there's a whole host of other things that can happen in a healthcare environment, including IV tubing, multi-dose vials, reuse of needles. These have become fairly uncommon and pretty rare. But again, it's important that we continue to follow the standard precautions. Now, what is the risk of exogenous infections from patient to patient, especially as we look across various organisms? Bacteria, the typical GI gut bacteria, such as Salmonella, Pseudomonas, Helicobacter, and so on and so forth, typically are related to endoscope reprocessing lapses, contaminated equipment, or moisture-rich environments. And the interventions are going to be appropriate high-level disinfection. Same thing with viruses, such as HIV. Obviously, those can happen from needle stick and those kind of things. But when it's related to endoscopes, again, high-level disinfection takes care of this. Same for fungi and parasites. The only really, really rare exception is Creutzfeldt-Jakob disease or prion disease. And there, it's one of those instances where you really have to destroy the endoscope. So when we look at the overall interest as reported by the number of articles that have been reported, you can see that they really peaked in the early 90s and dropped off after 2000. And that is really related to in the mid to late 90s where we standardized reprocessing protocols and the publishing of the reprocessing guidelines and where we went to a standardized reprocessing structure. Now, infection control is obviously a dynamic but multifaceted sort of approach. We start with, at the top, it could be administrative approaches to infection control, as in mandating PPE, things like that, documentation, looking at our inventory, education and training of staff, looking at the physical setting, the procedure room, the reprocessing room, and how the transport is carried out. Quality or QA and QC measures, and then personnel and having the adequate and trained personnel who carry out endoscope reprocessing and technician and bedside cleaning, I think, are all critical aspects of preventing endoscopy-related infections. So when we talk about quality and endoscope reprocessing, I'll touch briefly on that, and I know there's a whole talk on this, we really have to look at the entire spectrum of the flow of the endoscope, because this is really critical for us to do safe endoscopy for our patients. So it starts after the procedure, the bedside pre-cleaning is very, very critical to take out the burden, the bio burden, and then followed by manual cleaning with leak test and brushing and inspection, followed by cleaning and high-level disinfection, whether it's manual or automated, I think, pretty much everybody has moved on to automated reprocessing. And then I think the reprocessing room, the clean room, where the endoscopes are adequately dried, whether by hanging or dedicated drying mechanisms, and then following that is storage, a dedicated cabinet, like I'll show you some pictures of, but also keeping track of when the storage expires, if the endoscope expires and whether it needs to be reprocessed. So I'll just show you some examples of our unit, and just to kind of give you an example of walking you through where facilities and processes can help. This is at the top left-hand corner is a window where on the outside of the window is the endoscopy hallway. Once the procedure is completed, the tech brings the dirty endoscope to this window, and the window is sort of automated to open, and that is received by the reprocessing staff. This goes on to the dirty side for manual re-cleaning, leak testing, things like that. Then it goes into the automated endoscope reprocessing area, and then finally into the clean area. And then, as you can see, there's a dedicated drying cabinet where all the endoscopes are labeled and tagged. It's also important to have, you know, one of the things that I take care of in our unit is endoscope service, things like that. So this is where damage can happen in any part of this process, but also in the drying cabinet, the tip of the endoscope can get banged around, and that can actually be a big infection risk. And then, as you can see, our tech, the adequate sort of PPE, depending on which setting and what they're doing, is, again, very important. Now, when we move on to specialized endoscopes, such as geodinoscopes or echoendoscopes, the story is obviously very different. We have learned a lot in the past few years. As you can see, since about 2010 and even beyond, the interest in endoscope infections, as reported by a number of outbreaks or articles, has really gone up. This has obviously been related to multiple outbreaks across the world from endoscopy units that are being reported. These have been clustered in high-volume endoscopy units, and as you can see, the biggest risk that we talk about is what we call high-concern organisms or typically carbapenem-resistant organisms or multidrug-resistant organisms. Now, these organisms are mostly gut flora. These infections are often distal, either from the urinary tract infection, pneumonia, or sepsis. And there can be a long lag time before clinical symptoms, so connecting the dots can be challenging. Many patients are CRE carriers, so there can be silent carriage of the infections. And then geodinoscope cultures or geodinoscope sampling is a whole different talk by itself. I think it suffices to say that the methods are suboptimal. And when they looked at the causes for the geodinoscope-associated infections, there were no obvious failures in geodinoscope reprocessing that were identified. But it was identified that there's so many steps, and really people following those steps can be quite challenging. And there have been obviously a lot of focus on geodinoscope design that we'll talk about. Now, why geodinoscopes? And I think this is somewhat applicable to echoendoscopes also. But it has to do with the complex design of the distal end of the scope because of the need for the elevator mechanism where we hold the wire or we pass accessories, things like that. And behind the elevator is sort of dead space, which can be very hard to clean. The internal working channels are larger, and there can be cracks associated because we pass multiple accessories. And we talked about human factors. The reprocessing steps are complex. And many times we talked about low volume. Many centers don't do multiple ERCPs, so there can be prolonged storage in a non-controlled environment, and then waterborne bacteria. So there was a lot of focus, obviously, on endoscope design. This is a close-up view of a geodinoscope. As you can see, this elevator mechanism here goes up and down, so behind the elevator is the problem area. Now, several aspects have been looked at and solutions have been found. When we reprocess geodinoscopes, a single-use dedicated brush is very important for cleaning the elevator mechanism. The manufacturer's IFU has to be really followed to the T. And staff training and supervision and audit checks and all of these factors are very, very important because these are very high-risk infections. And then routine maintenance is critical. As we were talking about geodinoscopes, ERCPs are tough procedures. They get banged about. They go through multiple cycles of high-level disinfection or sterilization, and they can have these cracks. So careful leak test and visual inspection of the distal end is very important. Now, as we look at geodinoscope-associated infections, I think these are some of the aspects of preventing geodinoscope-associated infections. One is starting at the top is to identify the contaminated geodinoscopes, so culture and quarantine or microbiological surveillance. Again, we don't have time to go into the details of it, but taking stock of where your geodinoscopes are at and getting a baseline assessment of whether they're contaminated or not is important. Then incorporating some of the new reprocessing technologies and the techniques, so pretty much double high-level disinfection has become quite common, where you repeat all the reprocessing steps. And in some units, such as ours, we've gone to universal sterilization of geodinoscopes. We talked about staff training and competency about these specialized scopes. And then the FDA really came out and put out a statement that we need to go back to the drawing board and look at redesign, and the manufacturers have responded with single-use detachable distal caps. And then you throw that away at the end of the procedure, which then exposes the elevator channel for better cleaning. Several companies are coming out or have come out with endoscope sheets that protect the elevator channel and prevent contamination. Like we talked about, these are enhanced reprocessing methods. It could be culturing, ETO sterilization, liquid chemical sterilization, and or repeat high-level disinfection. And the FDA came out and said that one of these has to be implemented for facilities that use geodinoscopes. So this is a survey of geodinoscope reprocessing practices. I'd be interested to see what the panelists and also the audience do at their centers. I think the most common is double HLD. There's surveillance and microbiological culturing. Some centers do liquid chemical sterilization. A minority of centers actually do ETO sterilization of all geodinoscopes. I know Jim's going to talk about this, but this is a very important multi-society guideline that came up on endoscope reprocessing, and this is a very critical document that I would definitely encourage you to read and to implement at your centers. So what's the data on some of these enhanced reprocessing methods? If you start about double HLD, there's good data to show that there's really not that significant benefit, but that sort of seems to be the baseline of what we are doing for geodinoscopes. When we repeat all reprocessing steps, it terminates outbreaks. Sterilization, no benefit in non-outbreak settings. It can terminate outbreaks because then it clearly sterilizes all your endoscopes and takes out those culprit endoscopes, but it's very costly. It's cumbersome. There's environmental concerns. There's really challenges because then you have to send your scopes out to the central sterilization unit, and there can be delays and costs associated with that. Culture and quarantine, it reduces the overall long-term positive cultures and can stop outbreaks because you can recognize the culprit scopes, but I think it's suffice to say that the methods to culture, methods to survey geodinoscopes are still in evolution. Design changes such as single-use geodinoscopes have really brought a new paradigm. They obviously eliminate many of the infectious risks and things like that, but there's concerns with environmental cost and uptake where physicians are used to reusable scopes and the mechanics of the scopes and things like that, but I think all the manufacturers have really made a lot of progress in terms of mechanics of scopes, in terms of environmental concerns, things like that. They're quickly becoming, I think, a viable option. Finally and most importantly, I think staff training, regardless of where we fall in the spectrum of how we reprocess geodinoscopes, I think staff training, competency-based training curriculums, redundancies in terms of reprocessing and quality checks, I think, is one of the most important factors. In summary, I just wanted to shine a spotlight on endoscope-associated but also infection control in endoscopy. There's variation among adherents to recognize the infection control processes and reprocessing protocols. There are a number of modalities, both exogenous and endogenous, where infection transmission can happen, but there are several tools that are available to us to really prevent infections in endoscopy units. Exogenous infections are relatively rare. I think one needs to be aware of where prophylactic antibiotics are recommended and use antibiotics selectively. Patient-to-staff or staff-to-patient transmission can occur. That risk exists, but it can really be significantly reduced by adherence to universal precautions. Then we talked about standard regular endoscopes, reprocessing, handling with regular endoscopes, and then the unique challenges with duodenoscopes and possibly with linear endoscopes, where we enhanced reprocessing, sterilization, new designs, things like that, which are changing how we decrease the risk of infection control in this population. Thank you for your attention.

infection control

endoscopy

PPE

disinfection methods

staff training

continuous improvement