We know what we're going to talk about. We know who I am. We know my disclosures. So, let's move into the role of reprocessing guidelines. Reprocessing guidelines, they serve as our roadmap for sound clinical practice, right? They provide the framework for a safe environment by reducing and eliminating the potential of pathogen transmission. Guidelines are a key component of the infection control plan that we have. Unfortunately, there's no consensus on reprocessing guidelines. While there are a cornucopia of guidelines that facilities may select to steer their practice, CMS nor accreditation organizations endorse the use of one particular guideline over another. And your unit's policies and procedures are drafted first from the manufacturer's instructions from use and then enhanced by the use of these guidelines. So, which guidelines do you want to choose from? As I shared, there's a cornucopia. The horn is overflowing. We have these guidelines and all of them are relatively new per se, having been updated since 2020. We have the multi-society paper that was last released in 2020. We have our friends from SG&A that came out in 2024. CDC HICPAC is probably the old guys on the paper. They haven't updated their guidelines since 2017. ARN has a new one from 2020. SHEA is still in draft form, I believe. They haven't finalized theirs. APEC, our friends from infection prevention, they have a hybrid of the SG&A guidelines. Our European colleagues have reprocessing guidelines as well. And there's the AIME ST91 that was published in 2021. Other noted guidelines that are often referenced in these guidelines are the British Society guidelines and also the Australian guidelines. So, there are a plethora of guidelines for you to choose from. Through the years, as we mentioned, in 1930, 1980, 1990, these guidelines were all pretty much copies of the MIFUs. But through time, guidelines have evolved to be quite purely from mimicking the manufacturer's IMU to be inclusive of evidence hierarchy and utilizing the GRADE approach to carefully evaluate the strength and evidence of data in research studies and determine the strength and quality of this evidence to make a clinical practice recommendation to include in the guidelines. So, guidelines have evolved quite a bit since 1980, and we see this present in the samples that we have today. So, the core principles of reprocessing guidelines are all rather unique within their writing, though. There are a vast number of similarities of these components to each and every guideline. So, they all have components of staff training and competency evaluation, the construction of reprocessing rooms, when point-of-use treatment is performed, leakage testing of the endoscope after use, the structure of manual cleaning, how the principles of high-level disinfection and sterilization, rinsing and drying the endoscope, storage, surveillance, cleaning of accessory, maintenance and unit leadership. So, they all agree that these should be done. However, the guidelines do vary within their structure. So, when we're talking about staff training and competencies, every policy agrees, every one of these guidelines, that education and training must be done, that there should be a written plan of the infection control policy, that all staff undergo reprocessing training needs to be done, while they do not agree upon how skill verification is done, nor do they agree on the frequency that reprocessing training should be done. However, we do agree that commencement of employment and annual competency evaluation should be done whenever new equipment comes within the reprocessing unit. Some state that updated MIFUs, of course, call for training updates, and whenever there's a noted breach in the reprocessing of instrumentation. Some suggest auditing the reprocessing by direct observation. Other guidelines suggest that both trainers and the managers who oversee reprocessing must be competent to reprocess endoscopes. And some of the guidelines suggest completion of a certification for endoscope reprocessing. Some of the policies direct which certification exam should be performed, while others do not. Okay, moving on to the reprocessing room. All the consensus drives that reprocessing should not be performed in patient care areas, and it needs to be performed in a physically separated room from the procedure area. While a two-room model is the preferred method for designing a reprocessing room, it's not necessary as guidelines support a one-room design. Though all agree, regardless of the room that you utilize, it should permit the unidirectional pathway from the contaminated area to the clean area to prevent the potential of cross-contamination of instrumentation. You've seen this cartoon before of the nine steps of endoscope reprocessing. All agree that these steps must be done, though there's some variance in the literature of the guidelines on how they should be done. We believe at all that it needs to be done precisely after the procedure is complete. The cleaning solution is aspirated through the scope, and the exterior of the endoscope has been cleaned. However, the volume of solution to aspirate often may vary between IFUs. One may state aspirating a large volume of cleaning solution until it appears clear. Others may suggest a simple aspiration of solution for 10 seconds. Others may advise for 20 seconds to aspirate. Leak testing is to be performed on all endoscopes when they enter the reprocessing room prior to manual cleaning. And we all wish to ensure that endoscopes are transferred in a separate closed, clearly biohazardous labeled container. Manual steps of reprocessing are here, and these five steps have consensus to be performed. We want to ensure that manual cleaning should follow the MIFU recommendations for the time frame once pre-cleaning and leak testing has been finished. What we're looking for particularly is a manufacturer does advise that from the time endoscope is pre-cleaned, we have 60 minutes to start the manual cleaning process, or we must institute delayed reprocessing protocols. Most reprocessing guidelines favor the use of single-use devices in reprocessing, namely our cleaning brushes. And the quality of rinse water used at the end of manual cleaning to be potable or a sterile water. Now, a point of variety, a variation between the policies, look at endoscope inspection after and during reprocessing. Some guidelines advocate staff to merely just visually inspect the endoscope with the unaided eye, whereas others indicate the use of lit magnification glasses. The FDA suggests the use of five times magnification for standard type instruments and 10 times lit magnification for the inspection of duodenoscopes. The various societies do not agree on the use of borescope examination, though borescope examinations can be used if you write those into your protocols. And as we speak of additional efforts to verify cleaning, and we'll speak more about these voluntary practices later in the presentation as well. Now, high-level disinfection, everyone agrees that HLD should be performed for the MIFU. There's no consensus on chemistry. However, many institutions have moved away from the use of fixative agents, such as glutaraldehyde, and moved toward oxidative agents, such as OPA substances and peracetic acid that move away from the fixative nature of the disinfectant. There's not consensus on monitoring of the minimal effective concentration. Some papers promote the daily use of the test strips, while others advocate the use of test strips with each use. Also, for the preference of AERs, there are some AERs on the market that have modified cycles that some of the steps of manual processing are abbreviated or may be omitted due to the functionality of these being performed in the AERs. So, some guidelines promote the use of these modified cycles, while other guidelines, despite the use of these AERs, promote a redundant action of performing manual reprocessing as well. Rinse water. There's no consensus on the quality of rinse water that's utilized, though most guidelines prefer rinsing with sterile water. Tap water or any other sort of drinkable water is utilized. It should be followed by an alcohol rinse. But of note, what we'll talk about later. AR water should also undergo filtration and periodic microbiological assessment of your rinse water should be performed as well per a few of these guidelines. Now alcohol flushing. The use of 70 to 90 percent alcohol is used as a step to assist in endoscope drying, though the difference includes using alcohol only if the channels are flushed with tap water instead of sterile water. There also has been concern, and it is a component of the standards from our European friends, that alcohol flushing has been admitted due to concern of the protein fixation properties of alcohol that may actually increase the bioburden biofilm formation within the endoscope channels. In drying, various studies have shown that hanging endoscopes alone is inefficient drying. So to augment the drying process, consensus has not been reached, though additional drying has been indicated. Air drying should be formed after high-level disinfection and rinsing of the endoscopes, though there's no consensus on how this should be performed. Optimal storage cabinets features have not yet been determined as well. There is consensus that endoscopes should be stored per MIFU, and the MIFU is quite simple. It just says that the cabinet should be a sufficient height, depth, and width so endoscopes can hang freely, not touch one another, not touch the floor of the cabinet. It should be in a secure location, preferably not within endoscopy rooms or common corridors, and there are vertical and horizontal storage options that are available, but there is no consensus on whether a conventional ventilated or drying cabinet is necessary for endoscope storage. Storage of accessories. Unanimous acceptance that we do not place these accessories back within the endoscope. There's no agreement, however, on whether these accessories should be stored with the designated scope or not. Here's an example of various storage of endoscopes that may be performed. The middle picture shows endoscopes within a drying cabinet that have channel drying capabilities. For those who have not seen the horizontal storage of endoscopes, this is a cabinet that you may see. So endoscopes are stored per IFU, and cabinets should be sufficient dimensions to allow scope storage. In vertical, they need to hang freely and not touch the bottom of the cabinet or each other. Again, endoscope accessory storage, we agree that there's should not be devices placed back within the endoscope. Verification of reprocessing goes with our charting and documentation that units must develop a process for cleaning, verification, and also maintaining documentation of the reprocessing cycle. In reprocessing of accessories, they're also semi-critical devices and should undergo a high-level disinfection after each use. Storage time, hang time, shelf life, whatever you like to call it, there's not a consensus on the maximal storage time. There are some agencies that have a five-day hang time. There's some that have a seven-day hang time. Other documents call for a multi-discipline committee to meet and decide upon the storage of length for your instruments. Surveillance. Now when we speak about surveillance, we have two modalities that we may speak about. First of all was the visual inspection we spoke of, but most often we refer to cleaning verification. These are tests that are performed after manual cleaning and prior to high-level disinfection that will substantiate the efficacy of the manual cleaning process. Most guidelines endorse endoscopy units to develop some sort of cleaning verification endoscopes. However, the FDA has not labeled any of these tests and have not set criteria for the use of these devices yet. They're actively working with manufacturers to do so, though it's a recommendation and not a mandate. Also guidelines suggest that endoscopy units determine the frequency and modality of testing that is done and the following benchmarks that they wish to see for cleaning verification tests. I find cleaning verification tests to be most useful when you're training new staff members to monitor their efficacy and learning process of cleaning endoscopes, kind of like how you use the dye strips, dye tablets on your children when you teach them how to brush their teeth. Surveillance also may include microbiological testing. Some organizations do endorse microbiological testing when suspected or documented infectious outbreaks are present. However, there's not consensus. Performing these tests are often problem-prone due to the fact that they may be easily cross-contaminated and false positives received. Documentation. All our guidelines recommend maintaining some form of documentation regarding the endoscope reprocessing that has been performed. However, there's no consensus on what needs to be documented. Though we all agree patient name, MRI, and endoscope identifier be documented. Some say to include the procedure date and the name of the person performing cleaning and getting to the procedure end time and start for manual cleaning to be documented to be ensured that delayed reprocessing wasn't necessary. Also ensure that endoscopes are tagged or easily identified in some mechanism to ensure that they have been properly cleaned and are ready for patient use. With the use of some cabinetry now, scope cleaning identifiers have gone to the wayside due to these cabinets having ITD capabilities to identify scopes when they're ready for patient use. Maintenance and PM of our endoscopes. We want to follow the IFU. One manufacturer suggests that duodenoscopes are sent in annually or after a hundred uses. Maintain the records for your maintenance and that's performed. There's lack of guidance from some guidelines on the use of loaner instrumentation. We know that loaners need to be reprocessed prior to use, though some guidelines call for borescope examination and culture and hold of these devices before they're placed into service. Unit leadership is crucial to developing which guidelines you wish to use for your facility and should have a multidiscipline approach of infection prevention, risk management, your accreditation team, physician leadership, nursing leadership, end users, as well as the administration from the unit. Duties of the team during an outbreak or a breach and reprocessing are not clearly identified in the guidelines as well, but with any outbreak or a breach we want to notify infection control specialists and notify the FDA through the MAW database. Of course, notifying patients, the physician, public agencies if necessary, and the endoscope manufacturer, AR manufacturer if necessary. Sterilization of endoscopes, though, there is push for sterilization of endoscopes to be performed. There's no consensus on which devices and accessories need to be sterilized. As mentioned in the previous talk, FDA recommends transition to duodenoscopes with disposable end tips and the ASGE multisociety guidelines have nice readings and references for sterilization. Again, repeat HLD has not found to be beneficial to single high-level disinfection for duodenoscopes and also ETO sterilization after a scope has been high-level disinfection has not been shown to be effective routinely. It's only been shown to be effective when there is a ongoing outbreak. So what's in the future? There's several aspects of reprocessing that require further study, namely what type of disinfectant solutions we want to utilize and how often they should be checked, what's the optimal scope hang time, and what are the best ways to verify endoscope reprocessing. These are the tests that are done after manual cleaning has been done. We need organizations to work together and solidify areas of consensus so our policies and our guidelines are more in the same swim lane. And again, to increase collaboration on best practices on guidelines. And in the past 10 years there has been a plethora of research that has done to help guide us on which is the best path for us to take with endoscope reprocessing. The ASGE has a wonderful paper that was written a couple years ago by Dr. Turnack and I believe he's in Tampa that wrote a wonderful paper on endoscope reprocessing and the comparison of the various guidelines. And thank you for your attention and I'd like to introduce you to the best channel brushers between East 89th Street and 105th Street in Cleveland, Ohio.

endoscope reprocessing

guidelines

infection control

staff training

standardized approach

pathogen transmission