Rounding out all of our talks today, Dr. Pushpak Thonk will be discussing putting it all together, making sense of the multiple reprocessing guidelines. Dr. Thonk is an assistant professor in the Division of Digestive Disease and Nutrition at the University of South Florida in Tampa. He completed his undergraduate in medical education at the University of Miami as part of the combined six-year BSMD program. He completed his internal medicine residency and gastroenterology fellowship from Boston University Medical Center. Dr. Thonk went on to pursue an extra year of training in interventional therapeutic endoscopy at Thomas Jefferson University in Philadelphia. He's a longtime member of ASGE, and given his interest in quality control, he's been a part of the ASGE Quality Assurance and Endoscopy Committee for the past two years, and this has been a specific area of focus for him. Thank you for that introduction, Luke. I have no disclosures. All right, so today we're going to talk about endoscope reprocessing guidelines. As you guys know, there are multiple reprocessing guidelines out there, and they're there because they obviously ensure patient safety and minimize infection risk. They're used for both initial certification and maintenance of accreditation for units. CMS mandates a formal infection control program for your unit, and that program must be based on a nationally recognized infection control guideline. However, CMS does not indicate that there must be a specific infection control guideline that they routinely endorse. Thus, endoscopy units must cite references from specialty societies. There is variability of reprocessing guidelines. Again, there are multiple reprocessing guidelines that exist for endoscope reprocessing. Their reprocessing guidelines committees are often made of physicians, nurses, infection control government agencies, so there's heterogeneity in which reprocessing recommendations are actually followed. As an endoscopy unit, it's important to gain awareness in the areas of consensus and to note that differences are also pretty key. Now, units may be held accountable to national guidelines that are not necessarily applicable. Regulators who use one guideline may penalize a unit if it is using a different guideline, so units might adopt policies from national guidelines. They may not be recognized by surveyors, so it's important for units to respond to regulators. Units should know that they have the latitude to adopt policies most suitable to their setting, and that should help them avoid getting penalized based on different guidelines. As you can see here, there are multiple organizations that have come out with endoscope reprocessing guidelines over the last several years. These documents are excellent. I encourage you to review them when designing policies for your own unit, and we'll try to see if we can summarize some of the documents today. I'm going to talk about some of the major organizations in the United States that have developed guidelines, including the ASG, AAMI, ARN, APIC, the SGNA, and HCPAC, which is actually a branch of the CDC. The aims of today's talk will be to review all these major U.S. endoscope reprocessing guidelines. We're going to examine the similarities and differences among various organizations, and then we'll try to reconcile the recommendations made by the various organizations. Today's talk should hopefully help you improve communication between regulators and endoscopy units. The core principles of infection control, this is something that has already been reviewed today in some of the other talks, but you can see, you know, we're going to talk today about staff training, endoscopy unit layout, pre-cleaning, leak testing, manual cleaning, high-level disinfection, rinsing, drying, storage protocols, cabinet designs, microbiological surveillance, cleaning of accessories, maintenance of endoscope, and endoscopy unit leadership. So, when it comes to staff training and competency, any deviation from the reprocessing can lead to survival of microorganisms and increased risk of infections. Thus, there is universal consensus amongst the guidelines that endoscopy units should have a written endoscope reprocessing policy. All the national guidelines also recommend that staff undergo reprocessing training. You can consider model-specific instructions, and another area of consensus is that competency should be verified and documented before staff are actually allowed to perform high-level disinfection. Now, there are some areas of variation amongst the guidelines. Again, the content of the training may vary. The ASGE does not recommend that staff undergo using training checklists, using a competency-based program, and incorporating staff feedback. Now, while competency must be documented, there remains variation in how competency is actually verified. Some guidelines recommend direct or close observation, while others recommend actually completing a reprocessing certification exam. There's also variation in the frequency of the evaluation. Most organizations do believe that it should be performed when staff start their employment and annually. Another important point to note is if a new endoscope or equipment is brought into the unit, it would be important to train staff at that time. And obviously, if there's an update from a regulatory agency or the manufacturer's instructions for use, and again, if there's a breach in protocol, you should consider further staff training. For the endoscopy unit layout, again, there's agreement that reprocessing should not be performed in a patient care area. It should be performed in a room that's physically separate from the procedure room, and it's important to use the endoscopy unit and it's important to use a one-way pattern of flow from the contaminated to the clean area, and doing this will help prevent cross-contamination. Here you can see a diagram of two endoscopy processing rooms. The first room you can see is one room, and the second one is two separate rooms, but what you can see is the areas are actually very distinct from one another, and the flow goes from the decontaminated room into the clean workroom, so it's important to keep that workflow. Now, pre-cleaning is the initial step of reprocessing, and it's critical to removing debris and fluid from both the interior and exterior of an endoscope after it's been used. It should begin immediately after procedure is completed, and there's widespread agreement on this. Again, it should be done on both the exterior and interior of the scope. The cleaning solution should be aspirated through the channel of the endoscope, and the endoscope should be transported in a separate, closed, and clearly labeled container, and what this does is it prevents staff from direct contact with the endoscope, so these are all the areas where the guidelines agree. There is variation in terms of the volume of solution that should be aspirated during pre-cleaning. Most guidelines recommend following the manufacturer's instructions for use. The ASGG does recommend aspirating a large volume of solution until it appears clear, and the ASGNA recommends a minimum volume of 200 to 250 cc. There's also variation in terms of pre-cleaning of specific areas of the duodenoscope, specifically the elevator recess, which has been implicated in CRE infections, and again there's a question as to the acceptable time interval in which pre-cleaning should be performed. Leak testing is another important part of the process. Again, leak testing makes sure that there are no defects in the endoscope, specifically where fluid or material could invade and damage the endoscope. It's important to perform leak testing according to manufacturer's instructions for use, and again all guidelines agree that if a scope fails leak test, it must be removed and replaced. The guidelines don't specify whether you need to use an automated system or manual, but again leak testing must be performed. Manual cleaning. When manual cleaning and pre-cleaning are followed, the number of pathogens detected on endoscope can be decreased by up to 99.9 percent, so these are two very very important steps that we're going over. The steps involved in manual cleaning include detaching all devices, submerging the endoscope in an enzymatic cleaning solution, brushing all the channels until they're clear of debris, flushing the channels with enzymatic cleaning solution, and rinsing the endoscopes. Manual. Now there is consensus that manual cleaning should commence once pre-cleaning is finished. Again, the manufacturer's instructions for you should be followed, both with the brushes and the enzymatic cleaning solutions. It's important to note the solutions should not be reused during reprocessing, so once you use it for one scope, you know, don't use it for the next scope. If a time delay does occur between pre-cleaning and manual cleaning, again one should follow the manufacturer's protocols, and ideally within 60 minutes of finishing the procedure. For duodenoscope, it's important to again clean and brush the elevator mechanism. As far as variation in manual cleaning, some organizations favor using single-use brushes, while others accept reusable brushes for cleaning, so there's definitely differences between organizations here. The water that's used for manual cleaning, again, there's no specific water, and this tends to be a theme throughout most of the organizational guidelines. There's no specific water that is most recommended, but some recommend utility water, tap water, or even potable water. Borescopes, so for those of you who don't know, borescopes are actually a slim optical instrument that can be inserted into a lumen of another instrument to examine the inside of it. So in this case, you can insert a borescope through the endoscope channel, and what you're looking for is any damage to the channel and any water or other remaining fluid droplets that you might see. However, there are many questions about borescopes that in the literature still remain unanswered. You know, for example, what is the interpretation of what you find in the examination, what should be done about those findings, and thus there remains a lot of variation in terms of the indications for borescope use based on which guideline you read. And at this time, no guideline specifically recommends the use of borescopes. For high-level disinfection, there is universal agreement that this has to be performed as a component of endoscope reprocessing. Again, you should follow the manufacturer's instructions for use. It's important to note that high-level disinfection solutions need to be tested for a minimum effective concentration, and that's what ensures that the solution will be effective. Now, in terms of what type of solution to use, most organizations do recommend using an FDA-cleared solution, but again, this isn't consistent throughout all guidelines. Many of the guidelines are recommending the use of an automated endoscope reprocessor for high-level disinfection and to consider their use over manual disinfection, but again, it's not consistent. You know, while all guidelines recommend testing high-level disinfectant solutions for minimum effective concentration, there is variation as to when and how often to test these solutions. So, they could potentially be tested prior to each use. Some recommend testing it at the beginning of the day, and others recommend testing it according to the manufacturer's instructions for use. Obviously, using a disinfectant solution for a longer period risks lowering the minimum effective concentration, so the solution does eventually have to be discarded, and it should be usually discarded at the end of reuse life or when it fails to meet the minimum effective concentration. Regarding sterilization, there's no data clearly demonstrating the superiority of sterilization over high-level disinfection in endoscope contamination rates, and no guidelines specifically recommend sterilization over high-level disinfection for non-duodenoscope endoscopes, as those are typically non-critical devices. But when it comes to duodenoscopes, there is a little bit more variation, and there doesn't seem to be a consensus on whether or not sterilization needs to be performed for duodenoscopes. Most organizations do note that the elevator channel, again, should be cleaned and disinfected, but again, the methods for sterilization are varied. The one thing to note is the FDA does recommend that one supplemental measure be performed to HLD for duodenoscope, so in addition to HLD, there should be either liquid or ethylene oxide sterilization, microbial culturing, or repeat high-level disinfection, so doing one of those additional measures is recommended by the FDA. Looking at the newest ASGE multi-society reprocessing guidelines, interestingly, examining the studies, it shows that repeat HLD actually didn't have an additional benefit compared to single HLD for duodenoscopes. In addition, ethylene sterilization, ethylene oxide sterilization, didn't reduce bacterial contamination rates compared to single HLD, but again, there's more studies that need to come out regarding that, and for now, we would recommend certainly adhering to the FDA's measures. For rinsing and drying, again, there's consensus amongst all guidelines that endoscopes should be rinsed and their channels should be flushed to remove the disinfectant solution after high-level disinfection, and air drying is definitely recommended after high-level disinfection and rinsing of endoscopes. There is variation in the quality of the endoscopes, there is variation in the quality of water used in rinsing and flushing, so some organizations recommend sterile or filtered water. If tap water is used, it should be followed by an alcohol rinse, and water that is used in automatic endoscopic reprocessors should undergo filtration. The role of the alcohol flush in the drying process has been delineated in several of the guidelines. Again, alcohol enhances water purging, it facilitates drying of residual water, it also has antimicrobial properties, so that's the rationale for using it, and again, it can be used as a preliminary step in the endoscopy drying process. However, the WHO does recommend that in countries where endemic prion disease is prevalent to not use alcohol because of its fixative properties. Now, drying plays a crucial role as there have been multiple reports of outbreaks of waterborne organisms tied to inadequate endoscope drying and moisture promoting biofilm formation, and again, we know that hanging alone leads to insufficient drying, so while there's agreement that air drying must be performed after high-level disinfection, there is variation in how that air needs to be delivered. Either you can use continuous forced air delivered by an automated endoscope reprocessor, use a drying apparatus, or air purge cabinet. Again, there's also variation in the type and quality of air used during drying, whether it's instrument or compressed air or filtered or mechanical grade air, there's no consensus there. There's also no consensus on the minimum drying time that's necessary. The ASGE does recommend continuous forced air for at least 10 minutes, and again, if you're going to use an endoscope again immediately, the amount of drying needed is really variable, and there's no official recommendation on this other than that, you know, drying should be complete, but there's no specific time that's given in most guidelines. Endoscopes do have to be stored in a way to promote drying and protect the instrument from damage and theft. They should be stored per manufacturer's instructions for use. There is consensus that cabinets should be sufficient height, depth, and width for secure storage. Cabinets should be in a secure location, not within the procedure room, and if they're stored vertically, they should hang freely and not touch the bottom. You should avoid, endoscopes should also avoid touching each other in the endoscope cabinet. There is variation into what type of endoscope storage you use, so again, there are different types of cabinets that can be used, whether they're conventional, there can be ventilated cabinets that allow air circulation around endoscope, drying cabinets, or cabinets that have high efficiency particulate air or filtered air that provides positive pressure and also allows air circulation around endoscope. There's also variation on whether scopes need to be stored either vertically or horizontally. Obviously, vertical storage minimizes residual moisture accumulation, but it may not be necessary if the scope undergoes automated drying first. And again, another area of variation is the storage interval prior to repeating the endoscopy, prior to reusing the scope, and this is commonly referred to as scope hang time. Again, there's no data on the maximal storage time that a scope can be in the storage cabinet, but the SG&A does recommend a maximum of seven days after scope has been reprocessed. There is consensus among endoscopy accessory storage that reusable accessories should be disconnected and removed before storage. These include air-water valves, suction valve caps. The accessories must be properly decontaminated prior to storage, whether you sterilization or high level disinfection and the accessories should not be reinserted into the instrument during storage. There is variation between the guidelines in terms of whether or not the accessories should be stored either with the endoscope or separate from the endoscope. If you are going to start with the endoscope, the accessories should be stored in a separate bag. Verification of reprocessing. There is uniform consensus that units should develop a program for cleaning verification of endoscopes. Units should also maintain documentation of endoscope reprocessing. Looking at microbiological surveillance, this can be accomplished, usually by culturing specific areas on an endoscope or measuring ATP residue as a surrogate for detecting bacteria or bioburden. Again, with microbiological surveillance, you'll detect pathogenic and non-pathogenic organisms in the GI tract, and that will serve as an indicator of inadequate reprocessing or defective devices. But looking at all the different organizations, there's no recommendation for routine endoscope microbiological surveillance, but you can consider it during an infectious outbreak or for quality assurance measures. Looking at ATP, which is a surrogate marker, again, as a substitute for bacterial culture, it's actually not supported by the FDA, and most guidelines don't necessarily promote the use of ATP. There's also no guidance on the modalities, frequency, and the location of endoscope culturing. All of this still remains to be studied further. As far as what defines a positive culture, again, we don't really know what that means in terms of how many colony-forming units does it take to consider a positive culture. Now, if your unit does do this and finds that a culture is positive on a scope, then obviously most organizations recommend a culture in quarantine approach, so that scope should be obviously taken out of service. In terms of verification of reprocessing, now, while most guidelines do recommend a program for cleaning verification, they do defer to endoscopy units for specifics. So it's up to endoscopy units to identify the frequency and modality of testing for surveillance and verification. It's also up to units to determine the benchmarks for cleaning verification, the types of scopes that require verification, what type of system they use for identifying endoscope reprocessing. While ATP and bioburden assessment isn't routinely recommended, some organizations do say that the bioburden assessment can be useful for both training and competency assessment when you're training staff in terms of reprocessing. So there may be a utility there for that. For documentation of reprocessing, it's been suggested that this ensures the quality of endoscope reprocessing and also allows traceability in the event of an outbreak. While all major guidelines recommend maintaining documentation regarding endoscope reprocessing, there is variation in what specifics must be reported. As you can see here, some guidelines recommend, you know, noting the patient name, MRN, and endoscope identifier. Others go a little bit further and also recommend reporting the procedure date and name of person performing the cleaning. And HCPAC, in addition, recommends recording the procedure end time and start time for manual cleaning. But the important point here is that it's important to do the documentation because, again, it'll allow you to trace back a scope in the event of an outbreak. For reprocessing of accessories, it's important to note, to identify accessories, either semi-critical or critical devices. Again, semi-critical devices are those that contact the mucous membrane. Those include water bottles, insufflation suction tubing, valves, buttons. And most semi-critical devices should receive at least high-level disinfection after each patient use. So that means things such as the air-water valve need to be replaced per procedure. Now, reusable water bottles and tubing have to undergo daily high-level disinfection or sterilization. Most organizations, there's consensus that water bottles need to be filled with sterile water. When you're looking at critical devices, those that penetrate the mucosal barrier, those should be cleaned and sterilized. So that includes biopsy forceps, cytology brushes, snares, sphincter tomes. I know a lot of us are now really using mostly single-use or disposable of these items, but if you are using ones that are reusable, it's important to know that these should be sterilized because they penetrate the mucosal barrier. As far as reprocessing of accessories, looking at the variation in different guidelines, again, the methods for reprocessing critical accessories and the need for sterilization is varied. In order to mitigate costs, some units have entertained the possibility of reprocessing single-use devices. This approach still remains controversial. So if it's done in your unit, make sure you have a monitoring community with strict protocols that really adhere to FDA guidance. Again, most of the reprocessing guidelines do not really comment on reprocessing single-use devices. Semethicone. Now, this is something that has come up recently because we now know that semethicone droplets may persist in endoscope channels despite high-level disinfection. Semethicone should be administered through the endoscope channel and not in the water jet. So that is what several organizations are recommending. But again, the infection risk of semethicone is actually unknown. And because of this, no organization really knows the optimal concentration, but the ASGE and SG&A do recommend using 0.5% or less. When it comes to maintenance of endoscopes, again, there's consensus that manufacturers' instructions for use should be followed for maintenance and repair, that units should consider maintaining records of preventive maintenance. And most organizations don't have guidelines on loaner devices, but I do think they should take into account regular endoscope reprocessing guidelines should be followed for loaner devices. All guidelines really agree that it takes a good leadership team with a multidisciplinary approach when you're looking at the leadership team in the endoscopy unit. There is variation in terms of who should be comprising this unit and the roles and responsibilities of the leadership team. They do include developing policies with infection prevention specialists, allocating sufficient resources to minimize infection risk during reprocessing, and continuous quality improvement programs for reprocessing. You may need to seek external expertise if you want to formation of a multidisciplinary team is not possible. And as far as duties of the team during an outbreak or a breach, you should notify an infection control specialist and the FDA's MedWatch. The MedWatch is actually the FDA Safety and Adverse Event Reporting Program, so it's important to include them in the event of a breach. And of course, consider, you know, notifying patients, referring physicians, public health agencies, and the endoscope manufacturer. Now, this was sort of a lot to go over, I know, in one talk, and so what I wanted to do for everyone was to put up a table that sort of summarizes everything that I've talked about today. So going over all the areas that we've covered today, again, for staff training and competency, there's consensus that all staff should undergo reprocessing training and competency should be verified. The endoscopy unit layout, endoscopes, really shouldn't, they should not be reprocessed in the patient care area, and they should be instead performed in a designated room, physically separate from the procedure room. For pre-cleaning, again, it should begin immediately after procedure is completed, and during the pre-cleaning process, the endoscope has to be cleaned with this solution, both on the exterior and interior of the endoscope. The cleaning solution should be aspirated through the endoscope during pre-cleaning. And the endoscope needs to be transported in a separate, closed, clearly labeled, and adequately sized container, and that will protect the staff from direct contact with the scope. Leak testing should be performed, again, according to the manufacturer's instructions for use. Those endoscopes failing a leak test should be removed from service and repaired or replaced. And in terms of manual cleaning, the manufacturer's instructions you should be followed for manual cleaning. I'm going to go to the next slide after this because my slide order is a little bit wrong, but again, looking at high-level disinfection, this should be performed as an integral component of reprocessing endoscopes. High-level disinfection solutions need to be tested for minimal effective concentration. Rinsing of endoscopes and flushing of channels needs to occur for the disinfectant solution after removal, after HLD. And air drying is recommended to prevent biofilm buildup after HLD. For endoscope storage, they all should be stored per manufacturer's instructions for use, and the cabinets must be of sufficient height, depth, and width to allow them to be stored securely. If they are stored vertically, again, they should hang freely and not touch the bottom of the cabinet. For endoscope accessory storage, they should be disconnected or removed from the endoscope before high-level disinfection. For verification of reprocessing, again, units need to develop a program for cleaning verification of endoscope, and endoscopy units should maintain documentation regarding endoscope reprocessing. For reprocessing of endoscopic accessories, reusable water bottles and their tubing should undergo daily HLD sterilization. And if you're using simethicone, it should be administered through the working channel and not in the water jet or water pump. For maintenance of endoscopes, again, follow the manufacturer's instructions for use. And again, for endoscopy unit leadership, it's important to have a multidisciplinary approach. So in conclusion, proper reprocessing of endoscopes ensures patient safety. Units must comply with both federal and state regulatory bodies. And as you can see, there's variation that exists in the implementation of these reprocessing guidelines due to the differences that are in all these different organizations. Now, it's important to implement measures where the national organizations agree. And you should note that surveyors may hold units accountable to guidelines that are not applicable. So units can respond to surveyors by showing compliance with a nationally recognized organizational guideline. And this should help you really navigate the surveying process and give you enough information to go back to the surveyors and say, hey, we're using this guideline for this reason, and sort of prevent any penalties that you may undergo. These are my references. And thank you all for listening today. I appreciate your time. A couple of questions that have come up. One in the chat box is, do you discard at end of life, the detergents or the disinfectants, even if they're still meeting MEC? So meaning if it's expired, but it still meets the MEC, do you discard them? Yeah, I will tell you, in our unit, we do discard them. We look at the expiration date, because it's unknown if the efficacy really lasts beyond the expiration date, even if it does meet MEC. So we err on the side of safety. But looking at the organizational guidelines, I don't think there's an exact recommendation for that. I'm not sure what your experience has been, Luke. We do the exact same thing. If it's expired by the date, even if it's still meeting MEC, we discard it, because I think that's in line with the instructions we've been given by the manufacturer. So we err on a more cautious side. One question I have pushed back. Given that there's so many guidelines out there, so many reprocessing guidelines, and while it's great to see there's a lot of consensus, there are a lot of variations. I'm curious what your advice would be to a new leader in an endoscopy unit of how to sort of go, since you were allowed to choose which guideline you'd like to implement, how would you sort of go about that process in thinking about it? Yeah, that's an excellent question, Luke. I think there are obviously a lot of options to choose from when it comes to different endoscope reprocessing guidelines. I know for our unit, we typically look at the ASGE guidelines, just because they use a multidisciplinary approach. They've gotten, you know, inclusion from a lot of the other guidelines that I've mentioned in this talk, whether it's the SG&A or AIME. They've signed on to the document. So that, to me, you know, gives me a little bit more clout from that perspective. I also think it's important to note, if your unit falls within endoscopy or if it falls within surgery. So, for example, you know, I work at two different centers. One is an endoscopy unit within the hospital, and actually the guidelines we adhere to are a little bit different because we actually fall under the auspices of the OR. And that's where, you know, our unit coordinators or our nurse manager is using things from AIME and the AORN, as opposed to ASG. I think the most important thing to really note is whatever policy that you institute, you really know where it's coming from, because when regulators come back to you, then you can say, you know, this is sort of where, you know, where we're getting this from. Thank you. Another question, and this gets asked quite a bit all the time. Why sterile water in the water bottles when the data shows that it's not necessarily sterile? Is this an unnecessary expense? Do you see an increased role for the sterile water in the biliary tract? Yeah, again, this is an excellent question, and I honestly don't know if I have the answer to it. You know, I think a lot of the studies that have been done have been done with sterile water. You're right that there's no great data. But I think most of the guidelines want to err on this air safety because there's at least standardization when you're using sterile water as opposed to something else. In terms of the biliary tract, I know we do use sterile water often for, you know, cholangioscopy to visualize, and when we do use it, we actually still use antibiotics and give them to patients because we still think there may be, you know, some seeding that may be occurring. But that's sort of our practice. I guess one final question I have. In looking at all the guidelines and seeing the variations, I guess, what was the one variation that stuck out the most to you that you were most surprised by that seemed to be like there was really just no agreement among any of the societies or any of the guidelines on? Yeah, that's a good question, Luke. You know, I think one of the things where I was really surprised not to see any kind of agreement was really on microbiological surveillance. It seems to be a topic that I think is very important because we need to figure out a way to verify reprocessing, but really there was no consensus amongst any of the guidelines based on that. And so it really is often left up to the units in terms of how to do that, and I think there's not that much guidance on it, especially since, you know, the FDA is not even recommending using ATP, you know, to look at bio burden. I think that area, I think, could certainly use a lot more work, I think, maybe even between the guidelines, but even more studies. Great. Well, thank you so much, Pushback. Really appreciate, again, that really just extensive overview, and I think it's something that's needed to be done for quite some time, so really appreciate you discussing it and helping us digest it during your talk today. Thank you so much, Luke.

reprocessing guidelines

endoscopes

patient safety

infection risk

CMS

formal infection control program

specialty societies

consensus areas