We will now move on to one of our last presentations, building on what Corey had mentioned earlier, talking about damage that can happen to endoscopes when they're being used, as well as the biofilm that can develop on it. New technologies have been developed in the sphere of GI endoscopy, and so our next talk is really going to sort of highlight and discuss and dive a little bit more deeply into the data around this, really looking at disposable and detachable endoscopes. They are definitely here, as you heard earlier from Raman, but what should we as endoscopists and endoscopy personnel do with these devices, and how might we incorporate them into our units? And with that, we will begin the presentation. Thank you. Hello, everyone. I hope you've been enjoying today's course. Over the past year, the ASGE updated its multi-society endoscope reprocessing guideline, as well as several new studies have been published, shedding more light on how we might better reprocess endoscopes and reduce infections related to them. Today, I'd like to provide an overview of this work and highlight some best practices on this topic. In particular, I'd like to focus on new technologies in this sphere. Outlined here are my disclosures for today's presentation. There are several objectives I'd like to accomplish by the end of today's talk. First, I'd like to provide some context for why it's important to reduce endoscope-related infections. Specifically, I'll address what is the infectious risk to patients undergoing some particular types of endoscopic procedures, such as an ERCP. Second, I'll discuss factors that contribute to endoscope contamination and strategies employed by other disciplines or specialties that have been aimed to reduce endoscope-related infections. Third, and what I'm going to spend the bulk of the presentation on, are updates related to emerging technologies for endoscopes. Specifically, I'll review single-use endoscopes, detachable distal end caps, and disposable sheaths. In examining each of these three areas, I will focus on data regarding them and how they might be utilized or incorporated into endoscopy units. Finally, I'll provide some concluding thoughts. We'll start with what we know about the infectious risk related to endoscopes. What have we seen over the last few years is a difference between standard forward-viewing endoscopes, such as colonoscopes or upper endoscopes, versus side-viewing endoscopes, such as duodenoscopes. Let's look at these areas a little bit more closely. The graph here shows both published and reported infectious outbreaks related to standard forward-viewing endoscopes. We see a large peak of reported infectious outbreaks up to the 1980s, with a significant decline afterwards. This dramatic change is largely due to standardizing reprocessing protocols and the publishing and wide dissemination of reprocessing guidelines. How do we prevent endoscopy-related infections for our standard forward-viewing endoscopes? There is no one solution. However, key to success in this area is to identify several domains and develop countermeasures or interventions in each of them in order to strengthen infection control practices. There are a number of critical domains that need to be considered. These include examining and developing standards around a strong infection control leadership team, documentation, inventory control, education and training, physical setting of the endoscopy unit and reprocessing areas, quality assurance, and personnel. Let's review the several steps involved in the reprocessing of endoscopes. It's divided into three main buckets, pre-reprocessing, reprocessing, and post-reprocessing. We know that when all of these sequential steps are followed, that infectious risk associated with standards endoscopes is dramatically reduced and prevented. What have we learned from the infectious outbreaks associated with standard endoscopes? First, there are rare reports of infectious outbreaks with the advent of more standardized evidence-based guidelines. Second, infectious outbreaks occur in settings where lapses in reprocessing steps have taken place or universal precautions are not followed. Third, high-level disinfection, when followed correctly, is an incredibly effective modality for reprocessing endoscopes. High-level disinfection essentially terminates infectious outbreaks attributed to the use of standard endoscopes. Now what about more specialized endoscopes, such as a side-viewing endoscope like a duodenoscope or echo endoscope? Using a similar model of examining the literature and reported outbreaks for specialized endoscopes, we see a much different story. Interestingly, we've observed a spike more recently regarding this category of infections. This observation is likely multifactorial, but represents an increase in the frequency and use of these specialized devices in gastroenterology. And also, there is greater transparency in reporting of such infectious outbreaks. Beginning in 2010, there was a sharp uptick in reported infections from multidrug-resistant organisms that pertain to duodenoscope usage. Alarmingly, site-specific investigations of these infectious outbreaks revealed that infectious transmission was occurring despite adherence to manufacturer's reprocessing standards. Outbreaks were predominantly occurring in high-volume endoscopy units in both the United States and Europe. Taken together, the available evidence has allowed us to provide some estimates of what a patient's risk is for contracting an infection when undergoing an ERCP. The risk of contracting a low or moderate concern organism is low and ranges from about 0.3 to 4%. This risk increases for high-concern organisms to around 4% to 5%. Finally, using this data, the risk of a patient contracting a high-concern organism during an ERCP ranges from 1 in 106 to 1 in 2,632. In looking more closely at infectious outbreaks attributed to duodenoscopes, we see some trends with respect to clinical characteristics that are different from infections we have seen with other endoscope design models. These clinical characteristics include organisms detected are mostly gut flora, infections are often distal from the site of colonization and include urinary tract infections, pneumonia and sepsis, a long lag time exists before clinical symptoms develop, there's usually a silent carriage of the infection, duodenoscopes are often culture-negative in these settings, and no failures in duodenoscope reprocessing have been identified. Why might we be observing more infections associated with duodenoscopes? There are multiple contributing factors that may explain this observation. First, the distal end of the duodenoscope, shown here on the right, has a complex design potentially making it challenging to clean and reprocess. Second, the internal working channels of duodenoscopes might be areas where damage could occur and not only be difficult to reprocess, but be areas where debris and organisms could collect over time. Third, reprocessing duodenoscopes is a complex process and is ripe for human error or missteps. Fourth, prolonged storage of duodenoscopes can occur in a non-controlled environment which could be a contributing factor. Lastly, the rinsing water used to reprocess duodenoscopes can contain waterborne bacteria. Thus, we see a number of either separate but also interrelated factors that can contribute to duodenoscope contamination with infectious organisms. We have seen that the risk of infection to patients undergoing endoscopy is low. However, this risk appears to be increasing when more specialized endoscopes are utilized, and this increased risk may be due to a difference in their design. Moving on to our second objective, what are strategies employed by other disciplines or specialties that have been utilized to reduce endoscope-related infections? We see there is variation and a lack of adherence to reprocessing steps common for bronchoscopes, cystoscopes, and ureterscopes. Visible damage, irregularities, and residual fluid are noted in a majority of these endoscope designs. Also, suboptimal reprocessing is reported in the urology and pulmonary fields. In fact, a high rate of endoscope bacterial contamination is present despite adequate endoscope reprocessing. For example, in pulmonary literature, a 58% microbial culture positivity rate is reported in bronchoscopes that have undergone high-level disinfection. Similarly, in the urology literature, we see a 13% microbial culture positivity rate after cystoscopes have undergone hydrogen gas peroxide sterilization. In line with this, endoscope wear and tear is reportedly quite common. The pictures highlighted here are just a snapshot of damage that has been observed in urologic and pulmonary endoscopes. Note the red arrows throughout here. Picture and highlight damaged areas observed within other specialty care endoscopes. The damage noted here is a result of these devices being constantly reused and sustaining wear and tear over time. These areas of damage could allow for the buildup of biofilm and thus be a potential source of infectious risk to patients. Given this persistence of bacterial contamination noted in several other specialized endoscopes despite high-level disinfection, how have other specialties addressed this problem? Key to their solution has been a change in technology and a transition to single-use devices, essentially removing any shortcomings of high-level disinfection and the damage the endoscopes may sustain over time. Both pulmonary and urology are quite advanced in this area. Let's look at each a little bit more closely. In pulmonary, we see that multiple single-use bronchoscopes are available and have been evaluated in several clinical settings. These settings include the management of difficult airways, tracheostomy placement, intubation, suction, and applications in the intensive care unit. We see that single-use bronchoscopes have similar maneuverability to reusable bronchoscopes with operator perceptions favoring the single-use device. We also note that single-use bronchoscopes are reportedly more cost-effective than reusable bronchoscopes, but this is usually limited to higher procedure volume settings. In urology, we see that single-use cystoscopes shows comparable maneuverability, imaging, and illumination when compared to standard-of-care flexible reusable cystoscopes. Single-use cystoscopes are noted to reduce procedure time, and reusable cystoscopes appear to be more cost-effective in high-volume procedure centers. Where might there be opportunities to improve or enhance the reprocessing of duodenoscopes? There are several key areas to consider when thinking about eliminating infectious risk to patients. They include new technologies or techniques for endoscope reprocessing, improved methods for identifying contaminated duodenoscopes early on, considering duodenoscope redesign, improving staff training. Lastly, there might be ways in which we can simplify and streamline the reprocessing pathway. We will hear more detail for many of these areas throughout today's course, but I want to dive a little bit more deeply into the redesign and new technologies of endoscopes. Along these lines, regulatory bodies have had a high degree of interest around new innovations in endoscopy, especially around duodenoscope redesign. This was evident by the FDA recently recommending that health care facilities transition to using duodenoscopes with either disposable components, including distal end caps, or to fully disposable duodenoscopes when they become available. As an example, the FDA believes the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative designs that make reprocessing easier, more effective, or unnecessary. Let's examine the last part of this sentence in more detail, that is, making reprocessing easier, effective, or unnecessary. We will start with how do we make reprocessing unnecessary? One way to accomplish this goal is with single-use endoscopes. The advantages of this approach are multiple and include it can avoid cross-contamination across patients, they are more modern and might have the latest technology available, there is the ability to customize a single-use device for the end user, there could be ergonomic advantages, and there might be enhanced operational efficiency. Before discussing some of the data around single-use endoscopes, it's first important to identify what would success look like for these devices, especially if we were to transition away from reusable devices. Successful metrics to consider for single-use duodenoscopes or endoscopes include that they are effective and safe at performing endoscopic maneuvers, have similar or better operator experience compared to reusable devices, the learning curve is not significantly steep for all endoscopists to use the devices, they are economically feasible, and they are environmentally sound. Next, I want to review the data around single-use endoscopes, and in particular, single-use duodenoscopes. I think such information and data helps to put them in a better context of deciding whether or not to use them. Currently, there are two FDA-approved single-use duodenoscopes available in the United States. The data on single-use duodenoscopes is limited and continues to emerge. Let's look a little bit more closely at the data around single-use duodenoscopes. Currently, the data on these devices falls into three key buckets. The first, studies that just examine the device by itself, two, studies that compare single-use and reusable duodenoscopes using a simulated model looking at a variety of ERCP maneuvers, and finally, trials that directly compare single-use and reusable duodenoscopes in clinical settings. We'll look at each of these three buckets of studies on single-use duodenoscopes a little bit more closely. We'll start with the first group, that is, looking at studies that examine the single-use duodenoscope just by itself. In this first group of studies that examined the single-use duodenoscope alone, it was a multi-centered site that included six academic medical centers with seven advanced endoscopists performing the procedures. Here, they examined the use of the single-use EXALT Model-D duodenoscope from Boston Scientific that you see here on the right-hand side. The design of the study was that endoscopists performed roll-in maneuvers, which is duodenoscope navigation and visualization of the duodenal papilla only, and this was done in 13 patients. And then the advanced endoscopists completed ERCPs in 60 other patients. The investigators of this study looked at several variables, such as crossover to reusable duodenoscopes to complete the procedure, performance ratings, and adverse events. What did we learn from this initial study? First, there was an incredibly high success rate of biliary cannulation using the single-use duodenoscope, with little need to crossover to reusable duodenoscopes to complete the procedures. Second, let's look more closely at the operability of single-use duodenoscopes. The majority of advanced endoscopists in this study were neutral with respect to several ERCP maneuvers. Essentially, the endoscopists did not rate the single-use duodenoscope any better or worse than a reusable duodenoscope. This was seen in many critical ERCP maneuvers, such as cannulation of the common vial and pancreatic ducts, biliary and pancreatic sphincterotomy, clearance of biliary and pancreatic duct stones, removal and placement of biliary stents, and balloon dilation of strictures. Interestingly, more challenges were reported with the single-use duodenoscopes with pancreatic duct maneuvers. This occurred with stent placement and cannulation of the minor papilla. Now, let's examine the performance characteristics of the single-use duodenoscope. There's a lot here on the slide, but I want to highlight three key points. Endoscopists in this study rated the single-use duodenoscope similar or almost similar to the reusable duodenoscope in a number of areas such as cannulation, image quality, and performing a variety of ERCP maneuvers. Next, satisfaction with the single-use duodenoscope was rated quite high overall. Importantly, there were some areas where single-use duodenoscopes fared poorly, and that was in some cases where image quality became cloudy, the device malfunctioned, and for more difficult ERCP maneuvers. Despite these limitations, single-use duodenoscopes had comparable ratings for performance and operability to reusable devices, and a majority of endoscopists rated them high in terms of satisfaction. Finally, in this single study, adverse event rates were low and comparable to what we see in the literature. Therefore, expert endoscopists used a first-generation single-use duodenoscope to successfully complete ERCP procedures with a wide range of complexity. Now, this initial pilot data on single-use duodenoscopes was promising, but how do single-use duodenoscopes compare directly to reusable duodenoscopes? A second study by Ross and colleagues aimed to answer this question. Their study was a comparative non-blinded bench simulation study where six advanced endoscopists rated one single-use duodenoscope and three reusable duodenoscopes. Here, they performed four ERCP maneuvers using all four duodenoscopes in the simulation model that you see here on the right-hand side. These maneuvers included guide wire locking, plastic and metal scent placement and removal, and basket sweeping. They also, like in this previous study, assessed performance characteristics and satisfaction of all four endoscope models. In a head-to-head comparison of a single-use duodenoscope with current reusable duodenoscope models, we again see some hopeful results in a simulation situation. There were similar procedure completion times with a trend towards longer plastic scent placement and removal times for the single-use duodenoscope. Overall performance ratings for each simulated maneuver were similar and highly rated for all duodenoscopes involved in the study. We did see some variability noted across several quality ratings, such as navigation and pushability ratings were lower for the single-use duodenoscope. Tip control ratings were similar among all the duodenoscope models, and image quality ratings were lower for one reusable duodenoscope compared with the single-use and two other reusable duodenoscope models. Together, this data suggests that, again, in a controlled setting with experts, single-use duodenoscopes are comparable to reusable duodenoscopes in terms of performance and operability. Finally, how do single-use duodenoscopes compare to reusable duodenoscopes in clinical situations? Our most recent and robust data to date on this topic was a randomized controlled trial that compared a single-use duodenoscope, the EXALT Model D, with a reusable duodenoscope. ERCPs were again performed at expert tertiary medical centers and in patients with native papilla. Important outcomes that were demonstrated in this study included biliary cannulation was equivalent between both duodenoscope models, with fewer attempts at successful cannulation using the single-use duodenoscope. Also, there was no statistical difference in the rate of cannulation or the need for advanced cannulation techniques between either model. However, single-use duodenoscopes fared worse with respect to ease of endoscope passage into the stomach, image quality and stability, and air-water button functionality. We also saw in this study there were similar adverse event rates reported between both duodenoscope models. Again, we see that when used by expert advanced endoscopists at high-volume academic medical centers, that single-use duodenoscopes are equivalent in terms of their operability and performance characteristics, and there are no increases in adverse events reported when comparing them to reusable duodenoscopes. What remains to be answered is how would single-use duodenoscopes compare in lower-volume or community-based endoscopy units with proceduralists who may perform far fewer ERCPs in a given year. Another area highlighted by the FDA was to make duodenoscope reprocessing easier and more effective. To address this area, two new technologies have emerged around duodenoscope models. That is, detachable distal end caps and disposable shields. We'll begin by first looking at disposable distal end caps of duodenoscopes. By way of background, the affixed duodenoscope end cap limits accessibility for cleaning of the elevator mechanism and other components of the distal end. This could be an area where bio-burden may develop and build up over time. To address this problem, removable distal end caps have been developed that permit easier access when reprocessing the duodenoscope tip, as well as around and behind the elevator mechanism. Presently, the FDA has cleared several duodenoscopes with disposable components. At the moment, what do we know about the efficacy and safety of detachable duodenoscope distal end caps? On the right-hand side here, we see an illustrative example of what a detachable distal end cap looks like. There has been minimal literature performed on this topic to date, and of the available literature, we see that detachable distal ends may reduce residual bacterial contamination and organic residue. Let's look a little bit more closely at the data on this device. Currently, only one randomized prospective study has been conducted, which was at a single center using 108 duodenoscopes with detachable distal end caps over a five-month period. In this study, investigators compared contamination rates after reprocessing with the removable distal cap detached versus reprocessing with the removable cap attached. We saw two key findings from this study. First, no pathogenic bacteria was isolated in either group. However, we did see in the removable cap attached group that there was one detection of coagulase-negative staphylococcus. Second, and importantly, we saw that there was a reduction in both median ATP relative light unit values and duodenoscopes with RLU values under 40 in the distal cap detached group. This suggests that there was lower bioburden in the detachable group. However, we have no studies examining detachable distal end caps removed compared to fixed distal ends of duodenoscopes. Also lacking are studies on the performance, operability, and safety of these devices in clinical settings. Overall, while detachable distal end caps may improve reprocessing and reduce bioburden on duodenoscopes, more data is needed on these devices before their widespread adoption. Lastly, the newest player in this sphere are disposable sheaths. This is a sterile single use disposable endoscopic shield that protects the distal end of a duodenoscope. It is designed to prevent contact between contaminants and reusable endoscope components. The shield has multiple components, which include a lens that fits over the endoscope lens, a port that seals the irrigation insufflation channel openings, and the sheath that fits into the biopsy channel. An early study using benchtop testing in a simulated procedure showed some encouraging results with the shield in place. Here we saw that dye immersion tests revealed a complete seal with no leakage. Rigorous microbial challenge tests showed that the device can both protect against contamination of the duodenoscope by external microbes and shields instruments or accessories from contact with pre-existing microbial biofilm on or around the elevator that may have survived reprocessing. Optical and mechanical performance of the endoscope was not compromised by the addition of the shield. However, in vivo trials are still lacking. Here we have an illustration of the disposable sheet I just discussed. The left side of the screen illustrates the outside in barrier, which is designed to reduce bioburden buildup on the distal end of the duodenoscope. You can see here that the entire outside of the distal end is covered, including the lens that fits over the endoscope lens and port that seals the irrigation insufflation channel openings. The image on the right provides a little more detail regarding the shield itself. The dark gray color highlights the shield that fits nicely over the distal end of the duodenoscope, the outside part of it. We also see the light green, which is the shield that seals the elevator area of the endoscope and provides a sealed passageway, allowing instruments to be passed through the duodenoscope into the patient's GI tract without contacting the elevator area of the endoscope, the inside part of the shield. Again, while a promising technology, the disposable shield requires more testing and clinical settings before its adoption. I've discussed quite a bit regarding the data and benefits of these three new areas of technology, but what about some of the other areas that I raised that need to be considered before adopting these devices, such as the financial and environmental costs? I want to begin by looking at the financial implications of these devices. The table here highlights some of the representative costs of both single-use duodenoscopes and detachable distal ends. We know that reusable duodenoscopes are quite expensive, on the order of $50,000 to $60,000. Now, given these costs of reusable duodenoscopes, does it make financial sense to make the change or to switch to some of the newer technologies that I previously discussed? Let's look at this a little bit more carefully. The graph here highlights an activity-based study performed on single-use duodenoscopes compared to reusable duodenoscopes using varying endoscopy unit volume and infection rates. The authors here estimated the per-procedure costs of an ERCP using a reusable duodenoscope in order to assess the break-even cost for transitioning to single-use duodenoscopes. Each line shown here shows the mean cost of a single-use duodenoscope would have to be in order to make the transition, according to varying infection rates and annual ERCP volume. This analysis suggests that the cost of a single-use duodenoscope varies depending on infection rates and ERCP volume. We see a couple of key findings. First, for low-volume endoscopy centers, that is, those that perform under 50 ERCPs per year, the break-even cost for a single-use duodenoscope was high at around $1,300. For large-volume endoscopy centers, those that perform over 150 ERCPs per year, the break-even cost was lower at around $800. For a large-volume endoscopy center with a lower break-even cost, single-use duodenoscopes would have to be priced much lower to break even on the cost. What are the implications from this study? Well, small-volume endoscopy units that do not want to invest in capital equipment but have the technical expertise are more likely to use single-use duodenoscopes. Procedures that may have to be performed on an emergent basis outside of the endoscopy unit, such as the operating or emergency room, are likely to benefit given the ease and mobility and the lack of need to reprocess the endoscope after an off-site procedure. Given the cost implications, conversion from reusable to single-use duodenoscopes may result in the concentration of ERCP services to large-volume endoscopy centers. Also, there is no data that is available on disposable distal end caps or sheaths as it relates to their financial implications and is an area where more investigation is warranted. Finally, we must consider the environmental impact of single-use endoscopes. If endoscopy units were to make such a transition, the amount of waste generated could be substantial. What are ways in which these risks are being mitigated? Well, we can partner with industry leaders in medical recycling and waste management to offer some sustainability solutions. We can destroy potential contaminants through incineration. Some manufacturers of single-use duodenoscopes are offering a recycle-by-mail program. Repurposed material from single-use duodenoscopes are not used in other medical devices or future duodenoscopes. In conclusion, we covered a number of areas. Endoscopy units vary in adhering to recognized infection control practices and reprocessing protocols. Duodenoscope-related infections are an ongoing and possibly under-recognized issue for endoscopy units. Preventing infections in endoscopy units requires a multidisciplinary team approach. There are a number of critical sequential steps that must be followed in the reprocessing of duodenoscopes. Namely, we must focus on automation and mistake-proofing of reprocessing steps, as well as ensuring there is continual competency-based training of reprocessing staff. Multiple new duodenoscope devices and technologies have emerged over the last five years and could potentially eliminate exogenous ERCP-related risk of infection. Single-use duodenoscopes demonstrate comparable effectiveness as reusable duodenoscopes, but more data are needed outside of large academic endoscopy centers. Disposable distal end caps and shields may facilitate and enhance duodenoscope reprocessing, but the literature on this topic is scant and more work is needed. Post-marketing surveillance, culture studies, patient infection analyses, and direct comparison of these newer technologies with reusable duodenoscopes are needed, and future studies need to address data regarding the functionality, medical economics, and environmental impact of these new devices. Thank you very much for your time today. One question that's come in is, is there a role for requesting manufacturers use better materials to decrease wear, tear, or biofilm from developing? It's a fantastic question. I think it really highlights the need for engaging our endoscope manufacturers in this discussion, especially as it relates to infection control. We realize that there are probably some areas where they could have improvements, especially about how do we minimize wear and tear, what's acceptable wear and tear, and then also I think what's the sort of requisite maintenance that we need to have on our endoscopes. So as an example, one of the interventions that developed after several of the outbreaks from the duodenoscopes is more maintenance was required by the endoscope manufacturers on devices. Clear guidance was put out, and so more devices were being sent back in for repairs or actually for replacement, and we actually saw a decline in some endoscopy-related infections due to duodenoscopes when more of this maintenance was employed. So this definitely, I think, highlights the need to have a good relationship between the manufacturers and to the endoscopy units. I definitely think it's also an area where research can be done in terms of, you know, how do we develop, you know, more standardization around maintenance? How do we sort of optimize the use of horoscopes in terms of, you know, when we see something, what are the implications of that, and what should be our standards in terms of acting upon them? And then I think also really working with the manufacturers about how do we sort of do, as Corey alluded to earlier, is how do we do our quality assurance testing along various parts of the reprocessing pathway? I think the two go hand-in-hand together, and so I definitely think there's a role and also a need for it as well. Well, Luke, do you think that as we get new and more innovative scopes and ways to reprocess them, that people are going to have to think about, if you're redesigning your storage and your scope storage, that things might change? That you no longer need these big, gigantic cabinets, which I fear that because we're like, redesign. I said, you know, you guys, you got to think about when we get to when they actually put the, start building this thing in three years, things may be totally different. Yeah, no, that's a great point, Nancy. I think not only just the storage cabinets, but also, I think, you know, reprocessing areas that goes with it as well. How might that change? I definitely think it's an area of exploration, and I'm not aware of anything or any literature that's looked at it, but I think it really highlights, you know, sort of where we potentially might be moving in endoscopy, such as we saw with urology and pulmonary, that there probably will be a place for single-use devices. Where that's going to land, I think, is a little unclear, and then how that will directly impact the operations of the endoscopy unit is also, I think, even more uncertain. The other question is, is, you know, I sort of see it as a race between sort of the single-use devices versus the disposable end caps, in terms of sort of, you know, where endoscopies might be transitioning to. It seems like a lot of the endoscope manufacturers have moved more towards the distal ends being removable or detachable, and sort of being that is sort of the first step towards addressing some of the infection control problems we're seeing, but you raise a great point in terms of, you know, I think our flow and even the setup of endoscopy units might drastically change as these newer technologies evolve and become more part of the main practice that we have.

endoscope-related infections

new technologies

GI endoscopy

disposable endoscopes

detachable endoscopes

endoscope contamination

reducing infections