ASP SUMMIT 2025 Webinar 1 "What’s New on Flexible Endoscopes Reprocessing Guidelines?"

Added: 2026-05-31

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[00:01:34][Music] Hello. Good morning everyone wherever you are in the in the world. So if you are in APEC region or in IMIA we are back to our first ASP summit 2025 webinar series. My name is Jean Alves.

[00:02:10]I'm the ASP global head professional education and it's my big pleasure to kick off today this new series of program featuring six webinars under this topic shine on flexible endoscoping. Before we get introduced um to today uh webinar speaker, I just want to let you know that you're going to have as always these six webinars.

[00:02:37]The next one we'll be sharing with you uh at the end of this uh webinar session but you can also um stick to the rest of the schedule that we have planned with some hot topics on regards flexible and discovery processing that we pretty sure that you would like to know more about it. So before we get introduce you to our moderator and host for today, I would like to share with you some housekeeping tips and rules for you to have a great webinar experience. First, please make sure you switch off any non-essential applications on your device which may be taking away from you the internet bandwidth like the outlook or any others. Uh if by any chance during the webinar you face any um kind of disturbance uh on sound uh or image please refresh your browser window or close and login again. Today webinar will start uh with a 40 minutes presentation followed by 10 minutes Q&A.

[00:03:39]We will conclude webinar with the key take-home messages as always and we will introduce you to the next webinar speaker and topic. This webinar will be finished in one hour for uh respect everybody agenda. If you have any questions for the presenter that are not not answered during the presentation, please make sure you type them on your chat box that you find on the right of your screen. If you are with a mobile device, you will be found them on the bottom part of the screen. In order to make the presentation part of this webinar more interactive, you will also have during this webinar several live pools where we invite you to uh answer the uh speaker questions. You will have few time to do that. So please um uh stay tuned for those questions. Besides this webinar series will having uh simultaneous translation. Just follow the steps um that you find here. Scan the QR code please. uh install interpreation that we'll be using and then select your audio language that uh you you will find on your um on your screen. You can uh connect your phone with your um headsets or just put it on speaker uh to listen to the translation and you also can see the captions on the screen of your um mobile. So, uh, in order to for you to have a better experience, we invite you to maybe to see the the the webinar on the PC and to get your simultaneous translation on your phone, no matter if it is um by having the the sound on your ear pods or the captions on your screen. And by the way, you can select to have it the audio in one language and the captions in the other one. So a lot of flexibility. Don't forget just scan the QR code. So one last point, this webinar will be recorded. So the link uh with the replay will be sent to the resistance early next week. Okay. So now it's my big pleasure to introduce our moderator for today Dr. Carlos Palos that is also the scientific director for this ASP summit 2025 webinar series. Uh those that joined previous webinars already know him. Uh Dr. Carlos, welcome again uh to our uh ASP summit and kicking off this 2025 webinar series.

[00:06:14]Thanks for joining us today and I will hand over now to you. Well, hello everyone. It's a big pleasure to be with you again for the ones that already uh have attended the previous series. So uh welcome again Uh sorry. Uh I think it there was a problem with the micro. Uh I was uh uh welcoming everybody. uh the new colleagues that are attending for the first time and the others that uh uh have been uh attending for the other series since 2020. So uh it's my big pleasure to be here again. I I also want to thank uh ASP summit for this possibility of uh uh taking part of this wonderful experience and we want to make you shine on uh the flexible endoscop process in this year. So uh just to give you a brief summary of who who you are.

[00:07:32]So uh many uh most of you are nurses or uh uh some people from the continuumination systems and uh services and uh um also some physicians which is always very very nice. So uh most of you came from the sterile service departments uh or uh and uh from acute hospitals and um uh most of you have more than 10 years of experience and the most amazing uh thing is that we have um people from all the the the regions mostly from uh uh Middle East uh as as always and also from Europe in this um precise moment for Portugal and uh uh well welcome all you are all welcome in this series. Someone some of you are uh uh attending it online uh but uh probably most of you will attend it uh after because the time your schedule is not so well fit for for for for the the the job that we need to do. So welcome.

[00:08:50]So can you move on for the next slide?

[00:08:53]So it's my big pleasure to have you to present you Mr. David Bellamy which is going to talk about what's new on flexible endoscopy processing guidelines and uh well David Bellamy is uh a very important person so he he has been working more than 20 years on on this field and uh now uh David is since few years ago the vice president of the world federation of hospital sterilization sciences, sterilization, and he also works at the sterilizing uh service department at NS uh uh else in in Australia and uh uh where he is currently the manager. So uh uh David is uh uh uh committed to excellence on sterilization on infection and control education and uh he has a lot of positions on this field uh also in Australia and so it's a big pleasure to count on you with your expertise and uh I end over to you uh for your talk that we are sure that will be a great one.

[00:10:14]Thank you David for being with us.

[00:10:20]Uh thank you Dr. P for the introduction and um thank you ASP Summit uh for the invitation and um what a privilege to kick off this webinar series. I'm generally looking forward to hearing from the experts throughout uh the rest of the series. Sorry, just had to share my screen there. Um so yeah I'm generally looking forward to the insights from the other experts that will be um sharing their series uh throughout the series and their valuable insights I'll be sharing. So today's more about laying the foundation for the series and by highlighting why endoscope reprocessing is such a critical aspect of invent uh infection prevention.

[00:11:03]I'll be comparing the key standards and guidelines that are currently available to us and touching on some newly released recommendations and of course the upcoming new ISO guidel guideline that is currently under development. Um, by pulling all this information together from the standards and guidelines that I'll be referencing, uh, I hope to provide some useful reference points, one that, uh, kind of encourages you to reflect on your own practices and consider where updates or improvements might be made. As we all know, endoscope reprocessing is a global topic. Um, and the more we share our knowledge and collaborate, the greater the impact we can have on patient safety and effectiveness. So the first topic will be enhanced cleaning and uh enhanced cleaning and pre-cleaning protocols. And as John said earlier, we're going to start off by having some polls just to gather information on what other countries are doing and what um the practices are. So this is our poll that we'll have up for about 30 seconds. if you can um click and just tick on what your current practices are even if you think what they should be um just so we can gather that information there. So, and no one likes silence. So, and especially me cuz I'm kind of talking to myself, but I know there's so many of you out there. So uh what we'll do is I'll think we'll end it there at 35 seconds and have a look. But with the results as you can see so 89% of us are either thinking that we should do it immediately after the procedure at point of use or we already are doing so. All right. And then there's some other ones there where we have that do it within 2 hours or upon uh arrival at the reprocessing room. So getting into it, let's get started just okay. So while we don't have real precise up to- date minute information or the global statistics on HIS that come from contaminated endoscopes, uh it's difficult to find. There are several studies that indicate significant risks and impacts. uh and studies have shown that and one of the studies that have shown high income countries uh have a prevalence of his of approximately 3 to 12% while in low and middle inome countries that can range from 5 to 19%. And the some of those studies definitely that are out there have shown that there is substantial percentage of hs that come from related to contaminated scopes. So just highlighting a few examples um of why we what why we do what we do and show why it is important. So within this webinar I'll give a few documented examples of breaches. Um and the first one is just a recent one and it was actually one within Australia where we were sent an advisory that there was potential risk of patient infection when the reprocessing procedure was not performed as instruction and this actually led to 120 serious injuries and actually one death due to the infection. So this is showing um why it's a foundation role that cleaning is the cornerstone to prevention in uh infection and particularly with the context of endoscope reprocessing.

[00:14:41]It's kind of not the it's the essential first step in decontamination and of course sterilization and the primary objective is to remove organic and inorganic soils such as blood tissue and protein matter um that can be inhibited in the action of both chemical disinfectants and sterilins. So for residual contamination remains subsequent disinfection and sterilization processes are compromised and can lead to potentially leading to clinical failure like we just showed with the um outbreak. Also one of the most critical risks associated with inadequate cleaning is bofilm development and bofilms can begin to form within minutes on moist contaminated surfaces. Once established they exhibit significant resistance to chemicals including high le level disinfectants and sterilins. So the resistance is due to the polytric substance matrix which protects embedded microorganisms and can harbor pathogens for extended periods. So effective cleaning processes are significantly validated to reduce to to result in a log reduction of microbial load and thereby significantly lowering bio burden. So reducing bio burden is theoretically a benefit but it also has a direct measurable impact on the efficiency of high level disinfection and of course sterilization.

[00:16:07]uh and it is proven in many studies to reduce the risk of hospital uh healthc care associated infections. Just a quick another example of a hepatitis C outbreak that was found in flexible endoscopes used for colonoscopes uh and they found that they were improperly being cleaned. So this led to the transmission of hep virus among multiple patients. And then looking at this study, the lessons that they learned were that they needed to improve the importance of point of use cleaning, highlighting that the importance of thorough manual cleaning prior to disinfection and of course the implementation of standardized protocols and staff training as well as regular audits of the process and procedures to ensure compliance. and that will be highlighted throughout the rest of this um webinar. So to quote a fundamental principle in infection prevention as we all know if it's not clean high level disinfection andor sterilization sterilization cannot be achieved and this is what underscores the cleaning is not an option. It's not negotiable. It's a prerequisite to achieve microbiological safety.

[00:17:19]So what I've kind of done here is on this slide I've put together as best I could um a comparative summary of endoscope pre-cleaning at point of use guidelines based on the key standards and guidelines that I'll be referencing and they are ISO5883-4 the Jenser guidelines that were released in 2025 the Amy ST91 that was from 2021 and AS5369 which was released in 2023.

[00:17:46]So the focus is on pre-cleing at the point of use which is the first critical step in the reprocessing of flexible endoscapes and yes it should be done within the procedure room. Um as we pointed out in the poll that most of us are doing um and some key similarities of all four standards have emphasized the urgency of pre-cleaning to prevent bofilm and soil fixation. So I looked at the aspect of time specific guidance the detail level for bedside practice and compliance of the role and biofilm emphasis role. So the comparison kind of reveals the notable differences in both Jensa and AS5369 where it's recommending pre-cleaning within 15 minutes uh which this is aligning with international best practices and the ST91 however allows up to 30 minutes while ISO 15883-4 provides only a general timing and guidance.

[00:18:42]In terms of bedside practice, the detail in the ST91 stands out with uh very high detail followed by Jensa and AS-53 69 both offering high levels where ISO remains a more generalized uh guidance and they all emphasize biofilm prevention. we and and with ST91 you can see they're providing the strongest focus followed closely by Jenser and AS5369 and a moderate emphasis in ISO. So in summary with these all four uh prompt and how and look at effective pre- cleaning at the point of use universally it looks like it's recognized as essential to prevent the bofilm formation ensuring patient safety and protect the integrity of endoscopes while ISO 15883 provides kind of the foundation for how ARS are used um and the others offer a more detailed actionable able guidance with stricter time frames and clearer accountability for bedside practice. Now just looking at the good old manual versus automatic. So this involves a series of critical steps of course manual cleaning, automated processing. It's also increasing that we're also looking at sterilization and of course the validation that forms part of this. So I'm just going to highlight how each of these components is guided by these leading standards and guidelines um just to ensure process integrity. So while manual cleaning remains essential for the complex high-risk instruments, it cannot always be visually inspected and but all reprocessed via machine. So standard like standards like the ST91 and Jensen emphasize manual brushing underwater uh to prevent the aerosolation of contaminated particles and it's a technique particularly relevant in endoscopying. Um also talking a bit later on about tools but using soft bristled brushes to avoid causing any damage to scopes um and the use of removing debris. also for internal channels and lumens. There's also followed by a thorough rinse after an enzyatic soaking to ensure detergent residue is loosened and soils are removed. Also, there are still many discussions about manual the manual step process. uh there is talks about that being automated and that I still feel that manually is a better option but is technology advances we will get more um automation happening there but all the standards agree that it must occur prior to high level disinfection reprocessing and must be performed by a trained personnel under control conditions. So now looking a bit at washer disinfectctors and as these are increasingly being utilized uh this is what forms ISO15883-4 um and that is for how automatic washer disinfectctors for endoscope should perform um as well. So these machines uh provide validated, reproducible and timeefficient processes which typically include pre-rin, detergent wash, thermal disinfection, and they're starting to include a drying plate where standards like ST91 require that washer disinfectctors be re regularly challenged with test soils. Uh and staff must verify that their cycles meet temperature time specifications.

[00:22:21]AS-5369 mandates that all automatic equipment used in Australian healthcare settings must be commissioned, validated and routinely monitored with documentation available for auditing and this is through IQOQ and PQ which is installation qualification, operational qualification and performance qualification which is normally done annually. As we know endoscopes are becoming increasingly complex and the microbial resistance continues to rise. So sterilization is also becoming more critical in reprocessing pathway.

[00:22:57]So traditionally ethylene oxide was about the only way that we could uh sterilize these flexible endoscopes.

[00:23:05]Now we've got or as well as for flathide gas sterilization sorry uh and they have been the preferred and validated methods for achieving sterility in heat sensitive instruments.

[00:23:16]However with the advancements of technology more manufacturers are now validating devices for alternative low temperature sterilization methods such as hydrogen peroxide plasma. Um and this is allowing for a faster turnaround, a less toxic and importantly um of having it a available at a shorter time frame. Also with a sterile cycle, manufacturers of washer disinfectctors are introducing advanced cycles. They're claiming sterility. So that's reaching a sterility assurance level of 10 to the^ of six where this is aligned with the standard benchmark for sterilization. um and a log six reduction in microbi load.

[00:23:59]So these developments are reflecting a growing shift towards integrated validated and efficient sterilization solutions in response to evolving clinical demands and of course invent infection prevention. So with ST 91 and 50 AS5369 they both stress the importance of following device specific IFUS as well.

[00:24:21]So, and that's to select the correct sterilization method, packaging and all the rest of it. Um, and there are companies and manufacturers now that are validating their flexible endoscopes through low temperature hydrogen peroxide. Um, and as well as into the AERS. So these um standards also require that of course they are drying before sterilization as residual moisture can hinder the sterile penetration and promote microbial survival um in the drying phase. So also purging of air and having drying cycles within these ARS are also becoming uh more popular and advancing.

[00:25:05]So just a little another more emerging trend as well uh is that there's a new option in the guidelines for where an endoscope manufacturer has developed a novel approach to endoscope reprocessing. So the system provides in uh endoscope inspection they do the microbiologic testing they do the high level disinfection and they um sterilize with ethylene oxide. These endoscopes are then dispatched to endoscopy units throughout the country in sealed bags and they are sterile bags. Uh and then they go with the microbiological reports uh and ready for immed patient use. Uh they also claim that when stored in their sterile bags the endoscopes have a shelf life of 18 months. So this system has potential advantages for patients in endoscopy units including helping to improve access to endoscopy procedures in regional and remote areas especially here in Australia.

[00:26:04]Uh so looking at um the stages and each stage of the reprocessing of course is detailed by standards and it's designed to protect the patients and ensur compliance. Uh and by integrating best practices from standards and guidelines like these we create a system that is evidence-based, validated, traceable and of course supporting both infection prevention and regulatory uh excellence.

[00:26:32]So now a little look at uh the tools of the trade as you can say. So effective reprocessing begins with selecting and having the right tools and chemicals and using them in a way that aligns with both standards and of course manufacturers IFU. So looking at how these standards and guidelines guide our practices in this area to ensure safe and thorough cleaning.

[00:26:55]Um, enzyatic detergents are increasingly being used as the preferred agent in breaking down the organic soils and proteins and fats. And according to Jenser and ST91, detergent selection should also be based on the device type, level of contamination and whether protein or fat breakdown is actually a priority.

[00:27:17]uh so while highlighting the importance of uh following both device and chemical manufacturer IFUS not only for detergent uh choice but also for clinical parameters such as dilution temperature and contact time. So improper detergent use either being too strong, too weak or incorrect temperature uh can definitely compromise the outcomes or damage our delicate uh endoscopes. So with physical uh physical tools also playing in a part of the process. So you have to make sure they match precisely and are designed to the device and it also says that appropriate size of brushes for internal lumens and intricate grooves are also that they're non- metallic scrapers and soft sponges for fragile or coated surface. So this is also aligning with ISO 15883 which states that manual cleaning tools must not compromise device integrity uh or create risk. And then going into what's new in this kind of field and that's the new and emergency emerging technology of boroscope visual inspection devices. So they are now being strongly recommended and supported by the standards uh especially for complex flexible endoscopes and these tools uh enable internal inspection of the channels after cleaning to d to detect retain soil damage or bofilm formation. So issues that may not be visual during ret reprocessing can be seen by these boroscopes. And as a bit of a best practice tip, there is also a common point across all the standards that I looked at and it's uh strict adherence to the detergents instructions for use.

[00:29:04]So ensuring that collect a correct dilution ratios, optimal temperature range and minimal contact time for enzyatic uh action. So follow failing to follow these parameters can lead to the protein fixation or it can degrading the device services. So in summary, the right tools and chemicals must be used correctly and fully align with the manufacturer's instructions. And adding things like boroscope to your practices can also enhance um the overall uh process. So our next topic will be drying and storage requirements. So again, uh I think yeah, so we'll be going into another poll and just to find out what everybody's doing again, gathering the information. So how long can a reprocessed flexible endoscope be stored before it must be reprocessed again uh without use of course in your country?

[00:30:09]So again there's 12 hours 24 hours dep depending on the drying cabinet validation or following the manufacturers's uh IFU and facility policy or national standards.

[00:30:28]So, couple of more seconds to get everybody in. Okay, I think I can end the poll now. And um so we had two that were close and sharing. So there's the results there. So 33 of us or 33% depends on drying cabinet validation and 43% follow manufacturer IFU facil uh facility policy or national standards. So and I agree with um our standards do state here um that they it depends on cabinet validation. So yeah so of course depends where you are and what your national standards are.

[00:31:23]So the importance of proper drying uh and it hasn't played a huge part in the past but it's actually becoming a huge player and and very important when it comes to endoscope reprocessing. So um let's talk about the most underestimated but critical step in the reprocessing cycle I feel. So according to ISO 15883 uh drying is not optional. It's an essential component and it should be a validated part of the decontamination process. ST91, Jensa and 5369 all reinforce the same kind of principle that if it's not dry, it's not going to be safe. So with reduced residual moisture, it's not just an inconvenience, but it's definitely a biological hazard.

[00:32:12]studies and many studies have demonstrated that moisture left inside channels um on surfaces can 100% support microbial growth even after high level disinfection or sterilization and this includes bacteria like sudamonotus uh which can persist in damp conditions very nicely. So ST91 specifically cites residual moisture as a contributor to recontamination and failure of microbial surveillance programs. So proper drying definitely does prevent crosscontamination during transport and storage. Uh and also again if one device remains wet it can contaminate the surrounding scopes. So the drying or the drying cabinet or even hands and gloves of the staff that are handling these scopes.

[00:33:02]In addition to infection control, moisture promotes corrosion especially in fine channels or delicate med the delicate medical uh metals that are used in endoscopes. So for each standard I'll just do a quick brief uh overview of what each standard says. Uh ISO 15883 says drying is part of the validated cleaning and disinfection process. It must use filter or medical grade air for internal lumens. Jensa specifies that drying must occur immediately after reprocessing using a validated drying cabinet um and such as those compliant with ISO 16442. ST91 calls out for forced air drying of channels for no less than 10 minutes with routine internal boroscope inspections as well uh to detect any retained moisture or residue. And then AS-5369 aligns with ISAR requires facilities to monitor, document and validate uh the drying procedures particularly for high-risisk semicritical devices. And just giving another real world example um and this comes from a hospital with a pseudo pseudotus outbreak that was actually located in a healthcare facility in Europe. Um and they discovered that their broncoscopes were contaminated due to insufficient drying after the diff disinfection uh which caused severe respiratory infections in patients. So again looking at that study and the lessons that they learned and what they need to improve was ensuring complete drying of internal channels before storage adoption of automated drying systems in reprocessing workflows and of course routine micro testing of the reprocessed devices. So in summary, if it's not if uh drying is not a finishing touch, it's a core infection prevention step and this message remains consistent. If it's not dry, it's not safe. Um and of course proper drying also protects patients, preserves equipment and supports compliance with international standards. Now different drying techniques. So as drying is no longer a secondary task, it's a critical component of a validated reprocessing cycle. So whether manual or mechanical, the goal is the same. Remove all residue moisture, prevent micro growth, and ensure it's stored safely. So air drying is often used for the delicate and heat sensitive instruments, especially where mechanical options are not feasible. However, ISO 15883 warns that passive air drying must occur in controlled clean environment and free for airborne contaminants. So that said, the method can be slow and inconsistent particularly uh for internal lumens and flexible channels.

[00:35:51]So as a result of that both ST91 and Jensa emphasize that uh passive drawing alone is not suitable for high-risk or reusable invasive medical devices.

[00:36:03]Now as we're moving forward the mechanical drying are now prov pro providing more control and or of course a validated approach. So with the washer disinfectctors that have built drying cycles with for steam that can also be coupled with heperiltration and there have been studies that have shown significant reduces with the risk of moisture retention uh before going into the drying cabinets. So once they go into the drying cabinets, we're trying to make sure that we get a uniform drying across external and internal surfaces which is significantly reducing drying time and risk of res residual moisture. So again one of the elements and new emerging kind of things is the and gaining more attention is the heperiltration air during the drying cycle. Both ISO 15883 and ST91 highlight the importance of using clean filtered air especially when drying the internal channels. Um and of course this not improves not only improves the efficacy of drying but also helps minimize airborne contaminants. Jensa recommends heperilter drying cabinets that are compliant with ISO16442 as well that we talked about.

[00:37:20]But I just like to highlight another emerging new technology in this space and it's the drying and storage that's being offered. It's a system that uses a drying component with a so it's a device that has uh laminina air flow followed by a turbulent flow of heated air to dry the endoscope channels. Once that's dry, the instrument is then stored in a single use instrument bag. Then this device creates a plasma containing a few parts per million of ozone molecules. Uh and this is then generated inside the device and then it's uh insulated into the bag. Um so with this system it states that it's got a shelf life of 31 days. Um and it can be as it's sealed it can also be used for transportation u as long as the temperature and humidity is maintained. So this is a new approach different to drying cabinets, but it's using a bag system that has plasma that's inserted into it. So kind of in summary, drying should never be an afterthought. It must be deliberate, documented, and validated. And also with breast practice being the use of course of automated validated systems. So looking at the drying standards and and compliance that we have to adhere to now. So as it's kind of now equally a critical stage in the reprocessing cycle, uh improperly stored scopes are at risk of recontamination and of course being uh into environmental exposure, moisture buildup, um and even it can pretty much make the disinfection phase pointless if it's been recontaminated.

[00:39:03]So they're now defining kind of the environment and physical conditions that are also required for compliant and safe storage of flexible endoscopes. So looking at the recommendations, so uh storing scopes in a clean, dry, well ventilated cabinet, ideally those compliant with ISO 16442. Um but that and these cabinets are designed specifically to maintain controlled air flow, temperature and the humidity with these uh cabinets. also looking at 53 and 69 and Jensa and they also emphasize that drying should occur without delay post-processing temperature must remain stable uh and also using hepoiltration. So as we kind of move forward and then we're getting into maintaining the integrity. So flexible scopes that may be stored unwrapped in drying cabinets provided they are completely dry and used in uh within their validated hang time. If stored outside such systems like with sterile packaging or protective sheath must be used to prevent contamination. Uh and this is kind of particularly highlighted. So there's good references in ST91 around this if that's what you're doing.

[00:40:18]And also Jenser and 5369 caution against any packaging or storing that may restrict air flow or of course uh trap moisture. So lastly, how scopes are physically stored matters just as much.

[00:40:34]According to standards and guidelines, channels must remain open during storage. Caps and plugs must not be blocked for the air flow. Uh things like shelving should be non-p permable smooth. Uh easy to clean. Um, as per the manufacturer's instructions, scopes of course must not touch the floor walls and must have sufficient space to prevent contact between devices. And of course, some facilities may use the scope uh transport or storage cassettes to ensure integrity between point of use and storage uh which is supported, but you also may need to make sure there is some thorough cleaning uh um cleaning that goes with these cassettes.

[00:41:18]So in conclusion, storage is no longer just about putting the scope away. It's kind of more about preserving the integrity of the entire processing effort. Using hepoiltration, proper hanging techniques and documentation, documented hang time all play a part of this.

[00:41:40]So going into handling, transport and expiry control um and looking at so handling and transport practices are often our last link in the reprocessing chain. But any breach in this phase can completely undermine all the other phases what we've just done. It's also going to uh compromise the integrity of course. So the standards and guidelines have now started to clearly define expectations to ensure tra safe transport stock rotation and expiry management of the reprocessed endoscopes and when looking at um transportation.

[00:42:19]So uh 15883 and ST91 both mandate that the reprocessed endoscopes must be transporting clean closed containers on purpose-built trolley uh with physical separation and clean and dirty is identifiable. Um Jensa also goes a little bit further and says that they should be rigid puncture resistant and easy to clean. Look at internal padding or brackets to make sure that the scopes are actually held into place as well.

[00:42:49]So maintaining a disinfected or sterile state of the flexoscope is directly tied to how well not only is it processed but it's also how it's packaged, stored and of course transported. So looking at also in uh expiry control and this is governed by both event related and time related sterility princ principles. So event related sterility endorsed by ST91 and ISO158834 uh-4 permits the use as long as the packaging remains intact and the storage environment remains validated. Uh however AS5369 and Jenser are still kind of recommending set policy based shelf life for within or outside drying cabinets. uh and this would be taking into account of course your own national standards and the organization that determine these times.

[00:43:43]This also can be determined during uh operational qualification andor annual performance qualification. So all expiry dates and handling events must be logged as well uh electronically or manually for traceability and looking at how we manage our scope. So kind of having a first in first out system. Also making sure that we validate our transport protocols, our sterile barrier integrity, clear expiry tracking um and the chain of accountability must be uh visible as well. Okay. So going into another one is the surveillance and the quality assurance of our scopes. So again, just to see what everybody's doing uh throughout there. So we're going to go to another poll and it say and so this one is how often should microbiological surveillance of reprocessed uh endoscopes be conducted in high risk areas? So for ERCPS, gurodinoscopes, broncoscopes like that.

[00:45:04]So monthly was winning by far and now that uh after every procedure is starting to come up as well.

[00:45:12]So all right another few seconds. All right. So I'll end the poll there uh and share the results. So as you can see monthly or defined by the facility risk assessment is at 55% followed by after every procedure which is at 33% and then once a year an infection occurs is a little bit lower. So moving forward now into micro surveillance. So micro surveillance it's an early warning system for endoscope reprocessing. It's not ensuring that it's to ensure that we don't just assume that cleanness. that we can prove it. Uh and the guidance of these all of all the standards and guidelines all emphasize surveillance as a critical component of quality assurance. It's no longer just about ticking a box. It's more about detecting contamination risks um before they impact patients. So the purpose is to kind of provide ongoing assessment of all your environment and equipment uh throughout the reprocessing workflow.

[00:46:21]It looks at practical applications where surveillance activity should target areas of equipment most vulnerable to contamination.

[00:46:30]Uh and it's also it includes post cleaning residues or um that can leave protein microbial residue um and it also monitors the different types as well and different kind of uh testing includes ATP test protein detection swabs or of course our microbial culturing especially uh when you're looking at validating new processes.

[00:46:58]So uh going into micro testing of endoscopes for both the Jenser guidelines and ST91 they both acknowledge that microbial surveillance is a vital tool when verifying the effectiveness of collectible endoscopes.

[00:47:13]Um and however their approaches differ slightly uh in the scope and the frequency. So, Jensa recommends routine uh surveillance as a best practice particularly after high level disinfection and is encouraging following repairs, changes in the equipment or chemicals or of course when breaches are suspected.

[00:47:33]uh it's not mandated for every cycle but it promotes a risk bure uh approach where ST9 ST91 takes more of a perceptive stance advocating for periodic micro testing um of endoscopes and especially for critical scopes and it kind of specifies the frequency and outlines action and thresholds that if the growth is detected aligning with the CDC and the FDA recommendations. So in summary, Jensa kind of emphasizes the surveillance as part of quality improvement, whereas ST91 has established it as a compliance measure with defined protocols, frequencies, and corrective actions. So what's new in this space?

[00:48:18]Well, I don't know if everyone's aware, but there is a new standard coming and it's ISO 25224, which is uh a work in progress. If you Google it and it comes up. So it's an inter international standard that's titled sterilization of healthcare products sampling and culturing for reusable thermoliable flexible endoscopes which is a mouthful but basically it's going to hopefully aimed at uh guiding facilities on how to micro test culturing procedures uh to verify the cleanness of flexible endoscopes but also helping us establish evidence-based thresholds for contamination risk. So it will be part of enhancing our micro surveillance as part of a broader QA program and it also continues to support continuity across the globe practices as well. So going on to kind of what we pulled about but routine testing and the frequency. So as we know routine testing is a critical part of endoscope reprocessing quality systems. Uh it provides objective measurable data to confirm whether cleaning or disinfection processes are effective. Uh and of course standards and guidelines such as the ones we have and been speaking about all emphasize routine uh testing as a surveillance and assurance tool as well to make sure our processes are going well and working well.

[00:49:43]Uh and there's of course several methods for routine testing like protein soil residue test um that are used to verify organic material. Um and then we have our micro swabbing and culturing of endoscope channels valves external surfaces. Um it also has stem to drying cabinets. So we look at um doing micro testing of our drying cabinets as well.

[00:50:09]Um, and so looking at testing, it's no longer a one-off task. It's kind of recommended that it's a structured schedule uh based on scope usage and it should be um part of your policies. It should be part of your QA. Routine interviews documented um in the standards and guidelines suggest time frames depending of course on device type and the patient risk profile as we looked at in that poll as well. It's also about after postmaintenance and repair of endoscopes and ARS. It's kind of uh it's mandated that retesting after equipment services as well and if you're updating to cleaning agents and major procedural changes. So kind of revalidating what the process is if there's big changes. Testing is not just about finding failure though. We don't want to find failure but it's about confirming that the processes are working consistently and that staff competencies are being maintained. If we have um a positive results sometimes then it's also looking at to make sure that we can do some analysis on that.

[00:51:18]So uh even when results fail within acceptable ranges um a cluster of marginal polit positive can trigger a root cause analysis to prevent an outbreak or rectify before it becomes a bigger issue. So routine testing is kind of essential. It's not just for validation but it's for continuous quality assurance. And if we look at integrating with standards and guidelines, um the test kind of gives us confidence that our systems are working and it safeguards our patients kind of. If you're not measuring it, you're not managing it. So it ensures that we're doing both in a measurable and a proactive way. So looking at some quality assurance pro um systems in endoscopy.

[00:52:06]So quality insurance is also looking at that it's a systemwide commitment to safety and compliance and performance again guided by standards and guidelines. It also helps us ensure uh compliance with accreditation and things like that. So QI systems ensure that every stage of the reprocessing is val is validated and a daily process for verification is also kind of a frontline QA measure. So checking washer disinfectctor cycles, chemical concentrate verification, drying unit, airflow testing um and even down to the leak scope uh the scope leak tests uh that all for forms part of a QA. So kind of the aim is simple routing checks like these allow early detection of deviations and confirm the critical control points.

[00:52:58]Um and while failures of contamination events occur, QA or quality assurance demands more than that just we clean it up kind of states that we've got to do a root cause analysis. And an example of this is um where a proactive poly assurance in practice occurred and it's definitely at a hospital that I know which is the one here. But during our routine micro surveillance of our flexible endoscopes, we identified that we had a slight increase in positive results. Even though it was still within our acceptable thresholds, it was notable enough to trigger some kind of root cause analysis. So upon reviewing our processes, we decided to initiate uh some thorough cleaning and disinfection of our drying cabinets as a precautionary measure. All starting there. uh and the of course the affected endoscopes were quarantined, reprocessed under the control condition and stored appropriately. And luckily enough following a second round of micro testing all the scopes returned zero growth and now that it's been a few months after that happened our micro testing has gone back to having nil growth. So this just highlights the value of the surveillance of micro uh micro surveillance but also the quality assurance in systems that are a proactive tools not just for responding to program uh problems but also identifying and mitigating risk before they actually compromise patient safety. So under the standards and guidelines documentation isn't just a formality now it's kind of legal clinically and it's a safety requirement. uh Jensa guidelines emphasize that every step of the reprocessing cycle must be traceable and verifiable. Uh so this is to ensure of course patient safety and through the traceable records. It also provides defensible uh in the case of adverse events and supports accreditation and compliance audits. In the standards they kind of also highlight the importance of life cycle documentation. So from receipt and usage to each cleaning, disinfection, drying and storage event. It can either be done manually or digital logs and can be used um manual logs sorry can be used but digital systems are actually reducing the risk of human error and of course improving uh accessibility. So uh why does good documentation matter?

[00:55:31]It's not just about ticking a box anymore. It's about ensuring accountability as every operator is responsible for their documented actions and through quick traceability of any reprocess instrument that's linked to a patient can prevent escalation uh in the event of an outbreak or the risk of contamination. Also provides legal protection in litigation. Uh and having documented proof of compliance processes can protect uh the facility and its staff. So kind of if it wasn't documented, it didn't happen. So the phase captures the mindset that's required for efficient quality assurance in high risk world and endoscopy reprocessing. Docu documentation is not optional. It's a safety critical system and it should be embedded in your practice as well as international best practice. Okay, going into our last topic which is competency, documentation, traceability. Uh and we'll head to our last poll.

[00:56:34]So how often should staff competency in endoscope reprocessing be formally assessed? Uh so there's the poll and it says once a day uh once during on boarding only every 5 years and is defined by the facility policy and risk level uh only after reprocessing incident.

[00:57:01]David, I kindly ask you for moving more uh quickly this last part because we are uh trying to answer some questions but no problem she's here. Sorry. That's okay. Thank you. All right. So, I'll end the poll as I've been wound up by Dr. Palos. Thank you. Um sharing the results. So, it's a no-brainer. 92% is saying annually or defined by the facility. So, uh going into it, why is it critical? I'll speed it up. No matter how advanced our equipment is or the protocols are, the process is only as safe as the people performing it. Uh so, we need to ensure that our reprocessing staff have an understanding that errors in cleaning, disinfection, drying or storage can result in patient exposure to pathogens. and having competency ensures this consistency, safety and adherence to uh protocols. So there's formal education that form part of this.

[00:58:03]There's also site specific training which covers equipment, safe operating procedures and of course work health and safety and then you've got your annual performance appraisals or through direct observation uh quizzes and skill demonstration. So something that come out of um one of the guidelines was that competency equals knowledge plus skill plus consistency. So quickly talking about ongoing learning. So regular refresh and train to keep up with guidelines and updates in service sessions and external workshops. Um there are also learning platforms as well. So like with from the WFHSS and of course the ASP learning lab um looking at doing internal audits for compliance with protocols, it's not about looking um it's not about finding errors. It's about identifying breaches that that you can have a a um where you can audit and do near misses and and it should trigger root cause analysis. but also encouraging staff to not a culture of blame but a culture of reporting and that's through learning about incident reviews and RCAs as well document essentials. So according to the standards documents must include about verification records. Um you've got all your cleaning logs, sterilization records, any kind of biological indicator results. Also looking at equipment maintenance and calibration schedules um and also you've got your washer sterilization startup process logs as well. Daily checks are recommended and this helps maintain daily operations as well ensuring accuracy and compliance. Um and kind of looking at the drying cabinet pre-checks or pre-use checks are carried out as well. Documenting parameters like temperature, detergent levels, filters status are just some examples of what can be done. And then of course it comes down to legal and accreditation values.

[01:00:04]So clear documentation demonstrates compliance, protects the facility and staff during the audits and incidents as well. And finally going into traceability systems. So traceability systems for me or for what I think is is the corner cornerstone of patient safety. It um makes people more accountable, responsible and if you can't trace it, you can't trust it and you certainly can't defend it. So all four standards require comprehensive traceable uh in in endoscope reprocessing and it ensures that every endoscope can be tracked from patient use to thorough uh to through to each reprocessing step and back into clinical surface. So part of the newer technology that's coming through as well, it talks about you've got RFID or barcoding um that you can use now that some scopes have RFID tags in bed. They're also um can be attached. So that allows more traceability as well. And of course that they're looking at cloud-based which you can actually enter into patient records reprocessing steps alerts for overdue storage and so much more. There is some about mobile integration where staff can scan barcodes and get real time logging and cycle verification. Um and then going into where QA logs, maintenance, micro testing and repairs are also being tracked per scope um and ready available. So traceability is just a process. It's also a promise. A promise that each patient receives uh care with properly clean, disinfect, and safe instruments. And by embedding kind of traceability across the reprocessing journey, we meet not only compliance requirements, but clinical and ethical obligations. So sorry I rushed that last bit, but um these are just some take-home messages that I thought were important and that kind of stick in my head. So first one is with the first topic effective pre-cleaning and enhanced cleaning are essential for decontamination ensuring patient safety by preventing bofilm protecting equipment and supporting high quality work reprocessing workflows. Second one is thorough drying and proper storage of endoscope devices are crucial for preventing microbio survival device damage and recontamination and ensuring patient safety. Third one is microbiological surveillance is a proactive quality assurance approach that ensures effective reprocessing and patient safety through routine monitoring and alignment with the evolving standards. And then lastly, skilled staff precise records and full traceability ensures safe compliance sterilization services ensures audit readiness and enabled fast response to incidents protecting patients and healthcare workers. So uh yeah, thank you very much. Back to you, Dr. Parlo.

[01:02:59]Thank you. First of all, I I want to thank you for your uh extensive coverage of all the um endoscopic processing because it is a complex one. it has a lot of steps and sometimes some of the steps are somehow u I didn't say forgotten but sometimes not so considerate so uh even which is absolutely needed and also the transportation the things about microbiology testing and uh uh all the traceability issues and also of course the training of the healthcare personnel are uh essential are crucial for uh uh uh assurance of the quality and the safety of these procedures and sometimes as the um as the experience have have shown us we have from time to time problems outbreaks related with use of of endoscopes. Not only docopes which are of course the most important in terms of risk but also other endoscopes and uh you should uh all the attendees should uh uh take a look at the references in order to uh complement uh your talk because we could be here for the entire day talking on this uh with your enthusiasm. Thank you. The other thing I want to to say is to apologize because we had some technical issues in the beginning and uh I hope that the experience with the translation system uh has been a good one. So it is the first time that we are uh uh company which is working with us. Uh and uh all your feedback will be very important to understand um uh the quality of all these new things. Um I I have now uh a lot of questions but uh I will uh uh ask you uh just two and for the others uh we will send you the answers uh through uh uh the systems uh when we are going to feedback you with the fact sheet and so on. Uh so the first question is how often should staff competency in the endoscope reprocessing be formally assessed. So it's it's a very important question because of the formally sometimes something are informal. So for example, if you are in a process of accreditation, you lose the the the the evidence that that that that time that person that team has been in fact um uh uh uh having education.

[01:06:19]Yeah. So this is a hard one and it depends on your facility but looking at of course if there is kind of a breach or a new process then it would it would be formally assessed. um having some kind of fact sheet or something that goes with that new process. Um and then with the cleaning and because endoscopes are so complex and I think the the foundation is having an understanding of why we're doing it and what we're doing and the importance of doing it. I think that um competency should be done uh probably more than um what it's being done. I know definitely here but uh there's no definite answer and it would come down to standards but I know with the standards and the guidelines we follow um our staff that are reprocessing um have to do it regularly and and have an annual base competency that's formally addressed.

[01:07:11]Yeah. uh I think it's the question that uh uh most people answered that it was uh annually uh annually done and the second question is um uh what do you think uh about if uh low temperature stabilization using uh the hydrogen peroxide can replace ethylen oxide for all flexible and those scopes uh it's increasing definitely increasing um as companies are now and the manufacturers of scopes are moving forward um I know some of the newer ones that are coming out can go through lowtemp hydrogen peroxide but it will increase currently no I don't think it can replace ethylene oxide for all flexible endoscopes looking at the manufacturer's IFU will hopefully show that but it's definitely increasing and I think it will become uh the popular or the most used valid uh sterilizing method in the future.

[01:08:22]Yeah, it it should be and uh also what about a a HLD?

[01:08:33]So, can you hear me? What HL uh uh if it can in the near future? So what do you think about that? So do you think uh so the question is does ster will sterilizing replace HLD? Is that what you're asking Dr. Bos?

[01:08:54]Yeah. Yeah. Yeah. Yeah. I think HLD will always form a part. I think that it's a good part to have um for me and for what I see in the future. Uh with the the complexity of these devices, us not being able to with visually inspect these lumens, I think HLD will go hand inhand with sterilization. So I think it'll form part. So it will be a HLD process followed by sterilization and that just gives better assurance, better compliance and and patient safety overall. So for my for myself in my own facility, I sterilize our broncoscopes and things like that after um high level disinfection. So I'm hoping it would increase and be incorporated with sterilization. Yeah. Yeah.

[01:09:46]So we have new challenges on on on this and we need to improve all the steps uh starting with the the the cleaning because without proper cleaning we won't have adequate reprocessing. Um we hear some questions uh also about some very interesting questions about uh about um about uh uh the new ways of for example uh uh cleaning. Um but uh as I told uh we are going to answer that on the on the directly with the the attendees. Well, from from my side, I just to thank uh Mr. David Balami in Australia and also to say good all the Australians that are in fact uh watching the the the webinar in live and uh you are thank you very much pleasure to count on you and huge honor to to have someone as important as you are and thank you for your excellent talk and I I hand off hand and over to John uh to uh close the the this webinar. Thank you very much. Thank you Dr. Palos and thank you everyone.

[01:11:18]Thank you again Carlos and Mr. Bellamy for your insightful presentation.

[01:11:24]I'm positive it was very beneficial for our audience today. Um thanks to Palos also to moderate this webinar. So be because we are running late. So just to let you know that next webinar will take place on June 26, same time. Actually we're going to have another session but is for North American Latam that will be uh deployed at uh 5 uh p.m. Central Europe time. So if you are on uh Europe and you cannot make the first one, you have another option. So we're going to have the pleasure to have with us on June 26 Mrs. Karovstead that will uh from Karovstead an associating corporation.

[01:12:08]So you I think Ki does need presentations. Everybody knows her. So we will um as well as David of course.

[01:12:18]Uh so we will be um having the webinar with her about the endoscope processing effectiveness a reality check and call to action for clinicians and infection preventionists. So good thing she will uh publish this paper um early next month and she will be presenting at API national conference. So uh so stay tuned. So, as always, uh we're going to have um uh the I will invite you to take a few minutes of your time to uh go through our survey. Okay? You're going to receive it on the same email with all the assets. Uh make sure you you just take and invest minutes of your time just to let us know your experience especially as Dr. Paul has mentioned about also what can we improve and what was your experience with the um simultaneous translation. Finally um as I mentioned at the beginning early uh next week you're going to receive an email where you find not only your certificate but also this webinar recording the podcast and the fact sheet with the key take-h home message and key highlights from this session. Um so please uh stay tuned to it and we will add the questions answers that we had no chance to respond today. So for us thanks for attending uh uh and to participate today. I wish you all a lovely week and I hope to see you all in the next webinar.

[01:14:28]Heat. Hey, Heat.

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