ASP SUMMIT 2024 Round Table "Medical Device Reprocessing: ​The Back to the Future"

Added: 2026-05-31

[00:00:01][Music] [Music] [Music] [Music] for [Music] [Music] hello and um welcome everybody for this last series five webinar my name is j mes I'm the ASP Global head of professional education and I'm really happy to start or to finish or to start the year by finishing this series five uh with this amazing round table but first of all I'd like you all to wish you all a happy 2025th full of else uh join and a lot of Unforgettable moments it's my big pleasure to conclude today the SP Series 5 program where we will have deployed five webinars under the topic the medical device repr processing um uh Back to the Future so today we will have a a round table so but before we get introduced to our moderator and host for today I would like to have some housekeeping tips rules uh for we can have a great webinar experience first please make sure you switch off any nonessential applications on your device which may be taking away from you the internet bandwidth like the Outlook or the browse windows for example if by any chance during this webinar you face any sound of video disturbance please refresh your browser window or close and login again today webinar uh format it's a round table featuring all the speakers from this series 5 followed by a 10 minute Q&A session uh with all the participants so please make sure you start to populate your questions on the chat that for we can take them during the as expert piece uh we will conclude the webinar with the Keon messages and we will introduce you of course uh to the webinar series um fact sheet and ebook uh as normal this webinar will finish in one hour to respect everybody agendas so if you have any questions for the presenters please don't forget to pull them on the on the chat if you are on the mobile you will find it on the bottom of the screen one last point this webinar will be recorded and the link will with the reply will be sent to you all registers after um the webinar it's over so now it's my big pleasure to introduce our moderator uh Dr Carlos Palos who is also our scientific director for this ASP series five those who joined previous series and previous webinars you know that by already so please um welcome uh with me Dr Carlos Palos and over to you Carlos yeah thank you J thank you it's a huge pleasure to be here as J said for this last webinar of this webinar series and uh well um it will be I'm sure a quite interesting webinar because it has another format and it will SU uh all the webinars that we had so uh if you can go to the next slide so um so today as we are saying we have a round table with all the speakers that uh have presented the previous webinars unfortunately due to uh personal reasons Dr elizabeta andelo is not with us so I will do um my best for presenting our part so but we will have Dr Philip D Mr water m o STS John prar and Victoria mcon so we are in four continent and three continents today so Europe USA and um and uh and um and Australia the next one and uh so what we have today is a quite interesting number of registrants 77 countries represented s for 74 six questions have been answered uh during the the all webinar series and as you know we are mainly from um nurses infection prevention and control and in contamination areas and um next one so uh uh during this uh months we had uh some feedback from the audience and uh there are some uh ones that we have just highlighted there and uh well it's it's for us it's very nice to understand that we are giving you something that is profitable and that is interesting and that's the way the ASP University works so thank you very much for your feedback and now I I I will talk about the challenge behind Outsourcing uh your medical devices repr processing which is the which was the talk by Dr uh elizabeta so please the next slide so uh the the main ideas uh that we covered were these uh five so the first one is what is outsourcing of the medical devices rep processing and uh you know that Outsourcing is giving to another entity the responsibility and the operationality of doing some work so in the case of medical devices rep processing so it's a huge amount of work um that was usually and previously done at internal Central sterilization uh services and uh why does this happen because we are in a changing World in terms of um uh need for quality improvement uh the shortage of resources just like nurses and Patient Care staff um uh this also the space uh in hospital hits in the facilities that are uh uh really uh doing the uh the the clinical management so we need to sometimes we need to uh think on uh uh doing Outsourcing and so uh this uh allows also up upgrade of sterilization quality and um Global uh uh management of Human Resources but before starting uh a process of Outsourcing in fact we need to uh do a huge uh a very deep uh Hospital needs assessment so why do we need to Out Source uh which are the current needs of the healthcare facility what are the expected developments for the future and so um all if we consider all the aspects uh of the this assessment we we we are able to do the best and to decide between maintaining the uh current situation or uh doing a step away uh uh in terms of uh Outsourcing the other thing is that uh um we should do that uh in a through different steps and we need to do uh operational steps that uh uh uh consider the specific needs of the healthcare facil facility and uh Elizabeth suggested that we should do solutions that should be proposed as modular and consuma in order to um prove and consider all aspects and uh uh uh change everything that is needed because this is a learning process and everything is not perfect from the start uh defining procedures theability and certifications is also very very important and uh in this case we need to consider um uh the the the the the acquisition of a good man management software system that ensures full transability because as you know uh doing the Outsourcing will uh expose uh the devices for example for transportation and we need to understand every steps in terms of the Circuit of the the the medical devices um allocation uh in order to understand what is not well and correct if needed and finally the most important thing in at the end is is that we need to integrate um the teams the teams from both sides from the healthcare team of the hospital including including the surgeons because they need to to be involved for example in in doing the p packages uh of medical devices for the the different surgeries and also the team of the outsourcer only in that way we need we will succeed um and we will have uh the profits of doing the Outsourcing so uh I'm not so good I'm not perfect as elizabetha but you can see you can read at for example at fact sheet or you can watch again our talk at the first uh webinar of this series and uh remind so uh this is it so now I I joh please let's move to the other slide so these are the references and now I will end over to Philip d uh to which is going and valter and Philip at Paris and valter in in Len in Belgium they will talk about the iso 22441 uh the new standard for H22 sterilization thank you I hand over to you so I start correct yes can you can you hear me yes yeah okay so regarding ISO 22441 until the publication of this standard as you know in 2022 as the international Norms applicable to H22 LTS was the generic Norm ISO 14937 ISO 22441 is the first of a Ser of three international standards which will be dedicated to H22 LTS so two future H22 standards for bacteriological indicators and sterilizer equipments will be mainly intended for manufacturers while while ISO 22441 contains requirements for sterilizer manufacturers medical device manufacturers and end users so of the three H22 standards ASO ISO 22441 is the most important for healthare facilities csds are reminded that documentation and certificate must be made available by the sterilizer manufacturers in particular loads must be defined in accordance with sterilizer manufacturers iused instruction for reprocessing must also be provided and validated by the medical device manufacturers that means sterility and compatibility tests with the Cycles recommended in the instruction rep for reprocessing provided by the medical device manufacturer ISO 22441 like ISO 14937 insist on process validation validation consist of installation operational and performance qualifications qualifications are usually not performed by the cssd but cssd management must verify and sign the reports in practice operational qualification is commonly done with an empty stumber performance qualification is always at half cycle to verify the attainment of the Sal it is done with bis or preferably with B pcds which simulate penetration in of H22 in devices a challenge test speack represents most challenging laws approved by the sterilizer manufacturer for routine control measurements of cycle parameters are systematically systematically sorry controlled and recorded use of bi or BCD is according to applicable regulations or Guidance the H2 to sterilization process is requalified when needed for example after a major repair or periodically usually it's done every year and maintenance contract has been in place so in conclusion compliance uh of an H22 sterilization process to ISO 22441 means execution by the sterilizer manufacturers and by the medical device manufacturer or their respective normative requirements in terms of test and documentation the healthcare facility also contributes to compliance by checking documentation defining load according to validated instructions for reprocessing implementing and Performing validation routin control and maintenance plans thank you for your attention thank you I and over to Belgium wter uh welcome everybody I uh see my cam now I'm there uh so uh if a new Norm is uh is equipped uh within uh the union of course there is always a translation that needs to be made in the daily operational uh processes and practices one of them one of our daily most common um uh processes in this case of course an hydrogen peroxide is your load release that means how I'm going to release my load knowing that there is a new Norm according for the hydrogen peroxide the 22441 uh in this case the 22441 is uh for the first like it's acknowledging that there are within the load release four variables that are important when you look at the parameters of your process that's time temperature pressure and the hydrogen peroxide concentration of course if you use those parameters to do a parametric release uh and in according to your local protocols or your own Protocols of course uh like phip already told you can use bis or CI uh to confirm or to uh make your process more safe when you release it the second thing that uh is really important and it's the responsibility of of course the the end users is when you go to validation of your process validation is always a really difficult uh part of your uh whole process because you try to find somewhere one way or the other uh the most critical load within a certain process and of course uh the the different loads between between all our these are a little bit different uh for what are you using your hydrogen peroxide uh uh processes for which type of equipment do you use uh the hydrogen peroxide process so that means that in uh looking for a worst case uh you need to make sure that you uh take in account all the possible devices that are uh sterilized within the process or you can use and that's something what's also important what's available is that you can use the process challenge device to are available uh by the the the manufacturers and of course this will always be in concreation with your uh validation company and your manufacturer uh of the of your hydrogen peroxide sterilizer and to end uh of course uh like I already told you uh a lot of uh devices that you want to sterilize in your hydrogen peroxide process uh it's important that you have all the ifus always available so don't sterilize anything in your process uh without acknowledging uh acknowledgement of the manufacturer that it's possible or the manufacturer of hydrogen peroxide sterilizer that will tell you yes you can sterilize this medical device within uh your uh device what's important within in Europe you have of of course the medical device regulation where in very strictly is uh dated stated that the manufacturer of your medical device need to validate it into the uh lastest detail that the process is compatible if you don't have an IU available or the manufacturer hasn't uh validated this himself then of course your responsibility as a CCD or quality management within uh the hospital to validate it and know that this is a really really difficult uh process with a lot of rules and a lot of uh yeah pretty expensive tests so uh if it is not uh done by the manufacturer will be difficult to validate or prove that your process is compatible and at the end if you want to buy now a new hydren peroxide sterilizer know that uh within your tenders that you WR uh road that uh s ISO 2241 and 4937 both are still applicable uh in this process you can use them uh both so that was my uh moment Carlos I give the talk back to you you uh and now and over to uh Alex uh so in order to go on with the Innovations in Airways devices processing so Alex for in Dublin uh thank you Dr Carlos and it's my pleasure to be here today so in my part of uh Summit webinars uh we did an overview of commonly used Airway devices such as Lingus Scopes such as ENT Scopes bronchoscopes I looked a bit into uh an anatomy and components of those instruments which go into a quite critical area of the body and these devices they have been associated with multiple outbreaks uh so outbreaks caused by Common pathogenic microorganisms such as sud the moner genosa such as micro bacteria including micro bacterium tuberculosis mic environmental micro bacteria staila coca Etc and Airway devices they have been involved in loads of outbreaks and we highlighted the scale of the problem in last 10 years in the USA alone There is almost a thousand incident reports related to infection outbreaks caused mostly by bronchoscopes and also real world studies in real World instruments used in clinical settings show that high level disinfection leaves almost half of instruments still contaminated with potentially pathogenic microorganisms even after properly done reprocessing so reprocessing nowadays means uh cleaning disinfection high level disinfection and possibly sterilization this is reliant on good old spolding classification or risk categorization of instruments those instruments which are only Touching The Unbroken skin are considered non-critical just wiped with a disinfectant wipes if instrument is touching a bodily surface from the inside from a mucosal membrane we still assume it is acceptable to high level disinfect and we only mandate sterilization if that instrument becomes invasive or goes into critical area but this qualification classification is um uh getting outdated where is more and more evidence and more and more voices in medical and scientific Community that's spolding classification has to be made more relevant for our understanding of emerging pathogens for impact of biofilms for presence of prons away from the central nervous system if we could go to the next slide there please uh so all in all what we did we we tried to bring together the message our current understanding of emerging pathogens our body of evidence on outbreaks of infections worldwide uh we now realize that biofilms they do grow on instrument surface and imperfect cleaning can lead to Rapid development rapid growth of infectious conglomerate which would transmit pathogenic organisms between patients uh we have now evidence of prons found in lymphatic nodes and in nasal City although this is still a speculation on how much that can contribute to effects 10 20 30 years down the line post procedure but this is something we are now aware of and as you know in Risk Management once we have identified a risk we need to do something to mitigate that risk and success of the contamination cycle what is it it is not actually a sterile instrument or high high level disinfected instrument ultimate measure of successes in the contamination is is a patient who does not get infected the rest of it it just means to the end so to speak so success of the contamination cycle depends on choosing the best option from the options available performing every step of the process to the best of our ability as practitioners and employing most suitable decontamination technique not just in general based on some sort of classification but keeping in mind that your next patient can be immuno compromised could be undergoing chemotherapy and doing everything what is possible to make sure that that patient doesn't contract an infection while being treated so and I suppose that's what that was my part in a webinar uh all the references are here and I hand the floor back to Dr Carlos thank you thank you Alex uh and now let's move to uh Wales to uh John BR gast about the evolution of urogenital medical devices reprocessing thank you for being with us many thanks Dr Carlos and uh good day to everybody uh across the world uh my presentation uh touched on uh the Everlasting issue with the decontamination of uh flexible endoscopes and in particular we looked at the product family of endoscopes that are uh used within urogenital Healthcare uh Diagnostics and procedures as OLG has has touched on uh the guidance for decontamination is historically primarily been based upon uh spaling and uh I think we'll we'll touch on that in a minute I think um the one thing with urogenital uh flexible end the Scopes is the there's an awareness that the design of the Scopes is particularly fragile which which can which can incur damage and damage equals uh infection risks the other thing with this type of procedure is that uh the Scopes enter parts of the body uh that is known to contain low levels of microorganisms so they are designated clean parts of the body rather than other dirtier area so that that elevates the risks and the consequence of disease transmission there's a lot of evidence across the globe uh to to confirm uh transmission using these types of devices and that was presented during my uh presentation but is that the tip of the iceberg I think generally in healthcare we do not undertake routine surveillance post post procedure so we don't know the true facts of the infection uh levels so should we review decontamination procedures uh for such high risk scoups should we go single use should we move towards terminal sterilization o touched on it but is spoiling relevant today you know we've got a far a far greater awareness of microorganisms and I think the surgical devices we are using are a lot more Technical and a lot more uh invasive should should the manufacturers of urogenital endoscopes should they give more consideration to the design making it more robust and decontamination should be a key a key part of that uh consideration and if we think of today you know in 2025 we have a an added Factor sustainability you know we need to make sure we we are our carbon footprint is is is is controlled and I think you know a decontamination process is very heavy on utilities there's a lot of waste so that does become a become a factor so I think my take home message do we always do as we always did or is it time for change and I think I welcome discussion a little bit later thank you everyone thank you very much and now let's fly to Australia uh Victoria uh is going to remind us about sustainability and economics of medical device reprocess Technologies thank you Victoria thank you Dr caros and um thanks to everyone for joining us today or this evening for me um so my contribution to the webinar series was about how we can evaluate different Technologies um for their impact on the climate but also costs um associated with different types of different technology so um I first talked about um addressing the climate impact of healthcare um and that really focused on the fact that um we know Healthcare contributes to um Global uh carbon emissions and that has an impact on health and so there there really is a much greater focus of the need to ensure that Healthcare is not um having a negative impact on health because that's really the opposite of what we want it to do um and so we haven't traditionally included measures of um measures of climate impact in health technology assessment and that that's something that we're trying to do now um as health economists and as people um evaluating different um aspects of the Health Care system and Health Services so after an introduction of of about the climate impact of healthcare I gave a little introduction to um Health economic uh evaluation methods and how you might um be able to use those for evaluating other aspects um so beyond costs and and health outcomes we could also include um carbon emissions related to different Technologies um and so the key uh the key factors to consider in health economic valuation are the are the costs of different treatments and services that are being compared benefits or the outcomes associated with um treatments and services so in this case that might be things like um infection prevention um uh it's also important to think about the time frame for analysis so that could be quite context specific so I won't go into the details about that um and then also you are able to incorporate uh uncertainty in in the estimates that you have for the various inputs um and do a more sophisticated analysis that allows you to take into account the uncertainty that you might have in various um parameters in your model um and come up with something that's useful for decision makers um and one of the key reasons for focusing on health economics alongside the the climate impact is that we are continuing to spend more and more money on health and Health Care um which means that we have been less to spend on other things that are important to us in society so that might be things like roads and education all of those other things that we um take for granted the more we spend on health and Healthcare the less we have to spend on those it's really important to think about um the costs uh and outcomes together um and also of course failing to consider both costs and outcomes might mean that we allocate resources in ways that are inefficient or inequitable uh so then I went through um some of the factors that you might consider um or uh related to sterilizers um relevant to an economic evaluation so those are things like um The Upfront cost of the system the uh the electricity and water consumption things like the capacity of the sterilizer and the cycle length um other other considerations including um environmental um aspects so carbon emissions um that might be related to energy Generation Um making consumables um manufacturing consumables and things like um disposing of waste uh and the these things are increasing the co we know that the cost of water and electricity have increased substantially in the last few years so they've become more important to consider uh I also um looked at the instrument factors that might be um important to reprocessing and some of the others have touched on these things the some of these newer instruments that we're using are really delicate and uh susceptible to high temperature and high high moisture environments uh which means that um different sterilization methods might reduce the impact on those um on those instruments and meaning that they they have a lower likelihood of repair and so the cost associated with um having additional um uh having having to repair instruments or having additional instruments on hand might be might be um reduced in certain certain circumstances and so at the end of my webinar I um talked about how to bring all of this information together um to create a model of um an economic model essentially with an additional um carbon emissions um factors involved um and our analysis found uh that the carbon emissions were much lower for the low temperature system costs uh across the two system when we looked at per instrument or or for a similar volume were were similar but the carbon emissions from the things that we included in our model were um were quite a lot lower and that was largely related to energy and water consumption of of the traditional steam systems so we have still a bit more work to do on that um before we we're ready to um publish the results but um so far we've we we're feeling fairly confident about how that's looking so the take-home messages uh for me are that it is important to Beyond The Upfront cost of the sterilization system in this context if we're evaluating a sterilizer um that there can be really big differences in the water and energy consumption and that's really quite an important thing to take into account in the current environment um the effect of of different sterilization processes has an impact on um instruments which which could be quite important um depending on your your own context um so all of these things have an effect on the cost and carbon footprint um some other things that um we're still yet to to get the full information on uh things like consumables and uh waste associated with those things um but I hope that uh at the end of my webinar uh everyone was able to see how they might be able to use some the of the economic evaluation techniques to assess um decisions in your different contexts and that's me thanks thank you thank you very much um for your um summary and now let's go to the round table so uh the different uh participants will ask uh questions and I'm going to organize these so we have Philip that has one question for uh Victoria so we start by The End by the last because the last it's not the least uh so um Phillip can you go on with your question yes vioria yes based upon what you say what other factors could be considered in determining the environmental impact of medical device reprocessing H thanks pH um so some of the actually one thing that I I forgot to mention when I was speaking just now is that the context um can be really important uh when it comes to things like energy generation so um in for in Australia for example most of our energy is still coal powered which means it generates a lot more carbon emissions than other countries like France where uh lower carbon emission Technologies are used to generate electricity so that's that's something that's really important to keep um in mind when um doing this type of analysis the other things that we are hoping to capture in our piece of work are things like testing and and maintenance requirements because they can also be quite different in different systems and they also require energy and water and and um downtime and consumables and and and all of these types of things um the other thing is alongside the testing and maintenance is the need for replacement parts um because of course the more often we need to replace Parts the more we we're contributing to carbon footprint and and also C so those would probably be um the two key things to think about the other thing potentially is the um the emissions related to um decontamination of um water that that's used in sterilization systems that's something that's a little bit harder to uh get information on yeah thank you thank you uh because it was something that was missing on this s so it's it was a very nice very nice question from from Philip and yet to Victoria uh I think all EX one question yeah uh yes just a very brief one uh Victoria you mentioned evidence on different impact of sterilization processes and what about evidence on sort of cost per item or impact per item uh using different sterilization processes is there any evidence out there and how does it compare thanks that's a that's a really nice question because the answer is yes there is some um and it's some work that I did a few years ago um so we tried to um estimate the cost per uh instrument sterilized in a low temperature and in in Steam and um so that evidence is in the published literature and that's what we're updating now as part of this process um hoping to U do a more sophisticated analysis than that first one and also update um update the information in there with newer um costs and and outcomes data thank you're looking forward to okay thank you thank you uh now uh I think Victoria you have a questions from to John BR G yes yes yes thank you John I was thinking about because I'm a health Economist and I like to think about um how to evaluate different things I was thinking how do we balance the the infection and and patient safety risk with the additional burden and cost and time of higher levels of of decontamination uh for different devices yeah I think you make a good point Victorian and I think what we see uh like I'm a decontamination advisor and what we see that there does tend to be a different interpretation uh based upon the discipline and uh the individual priority you know some of the clinical teams will have different priorities to to people like myself as decontamination managers but I think I think we know the risks now I think the evidence is out there to say you certainly with endoscopes you know I'm not going into uh ssds Etc because I I firmly believe the the level of risk is less because of the terminal sterilization but we can't really bury our our head in the sand you know we we've got aging populations across Europe and other parts of the world we've got antibiotic resistance you know um I think we we are more vulnerable now than probably we've been for many many years so I understand where you're coming from and I understand the question that we do have to have to balance it but in a perfect world we should be we should be aiming for a goal standard and you know every one of us may be a patient at some point what would you want if you were a patient so you know everybody on the call think of that when when you are uh giving guidance or participating in in in meetings Etc thanks um well Elizabeth has prepared so a questions for for also for for John so I I will I will present the this this question so uh if there is there any literature comparing the total costs of a single use device versus usable one including all steps in the process I think it's very difficult to actually give a give an accurate uh figure I know Victoria probably could you know as as an economist could come up with a you know a a draft and I'm sure other people you know of her uh background could do similar I think the issues you got and I deal with it in my area where you know different departments may have different protocols uh some would use more water than others as as part of the decontamination process because of different machineries Etc so yeah I do think it's very difficult you know cost some departments have a lot of manual input manual equals people people equal equals cost uh utility costs Etc are different in certain parts of of the world so I I think it's difficult to put an actual figure on it transportation is another area you know if it's a central decontamination department or a local decontamination Department that would add cost and carbon Etc to the process I think for me I think you know it needs to be a balanced decision making process say smaller units perhaps not do so many procedures a week there is an argument for you know for single use uh being being the norm high volume departments where we create a lot of wastage you may say Well we'd use reusables you know so I think those things have to be considered and probably one of the main factors for me yeah thank you and uh yes and also consider the the um that reprocessing is um sorry that uh single use uh uh could be not benefit to the to the Environ environmental else of the planet so these are all aspects that needed to be addressed and uh yeah it depends uh on the context on the type of procedures uh and available and and and so on so now uh John I think you have a question to Alex you need to turn on your your micro sorry I do apologize I do apologize thank you Dr Carlos so alls uh do we think we are doing enough to eradicate biofilms when we're processing medical devices um is time of process see is a priority rather than the quality of the process uh then this this is very good because In fairness it's very hard to find what you are not looking for and uh why am I saying it like that because if we look into type of tests we do protein tests ATP tests Colony counts they are not really designed to detect biofilms the only mention of bofilm detection is in iso1 15883 for endoscope forer disinfectors where you sort of have to prove that your machine is working against s monus orosa biofil on self- disinfection cycle which doesn't include testing and the Scopes themselves so from the testing point of view we don't have requirements and I think we are not doing enough and also keeping in mind dry biofilms cuz wet biofilms they would shed microorganisms you can pick them up as colony count on microbiological tests but dry biofilms may be not shedding you do your protein you do your ATP and you don't notice anything you assume your instruments are fine however they may not be fine after all so I agree we are we are not doing enough and one of the reasons well time consideration is one but another reason is we are not yet probably aware sufficiently aware of unique challenges posed by biofilms and unique ways which we still have to develop to find them where they may be present so I hope it answers that thank you V you Al you also have a question to Alex we need to be brief in the absolutely uh like uh you were always talking about your Airways Airway medical device do you think that there is a need for a new kind of classification uh for this kind of medical devices well I personally yes wter personally think that spolding classification as it was developed what is it more than 70 years ago doesn't really reflect the realities of modern instruments the complexity and our understanding of pathogens however to change spoing classification that's that's a massive task something which only could be done on a global scale with likes of World Health Organization and now as as we all know with USA stepping out of world Health Organization it sort of complicates things even further uh but on the optimistic note I think we have we seen a slow shift where there is more and more sterilization is done on devices which were previously high level disinfected now it becomes more common place to uh disinfect Bron to sterilize bronchoscopes to sterilize urogenital devices so maybe instead of massive Global overhaul of a guidelines we will slowly but surely increase prevalence of sterilization in what is now considered semi-critical would be sort of sneaky way in into quality improvement That's My Hope um I think now there is uh yeah it was Elizabeth's question for vter so if there is a delay in annual validation which tests do you suggest use for controlling the correct functioning of the the equipments this is a very good question it's uh it's also a question what I will end with a very clear answer at the end uh it's so that validation is a really important step in your uh quality uh followup of your uh equipment of course and with within your quality system if you have a certified quality system um in your procedure there will always be uh if you say I do my validation annually then you always have a date that it can be prolonged if there is an issue so you say by example uh if it is yearly May uh the validation may be postponed for six weeks or a month or two months if there is something happening uh if the revalidation isn't done within that extended extended already extended period I think the only correct answer is that at that moment you will put out of office uh put out of service that that uh equipment because you don't have any uh quality assurance anymore for that uh equipment of course if you want you can do all kind of tests with all kind of uh worst case loads that you already have in place for the validation but you're not the validation company uh you don't possibly you probably don't have the equipment to do the correct testing uh with data loggers with uh thermocouples that are necessary so so my uh in my opinion if you have uh postponed already and you don't have the time to validate at that moment you put out of office out of work your equipment yeah yeah thank you and uh I have one question for Philip Philip how does ISO 22441 link with the other ISO the 14937 uh if and if we do see an overlap or contradic with any requirements because this seems somehow complicated but can you can you Philip explain as your position well thank you Carlos it's this is in fact a question which is often asked um as you know ISO 14937 is the sterilization process nor which is applicable to sterilization modalities which do not have a dedicated Norm but in addition to that it also sets a common normative framework for all sterilization modalities so ISO 22441 like corresponding process norms for steam EO or other sterilization modalities add a layer of details specific to the technology that they cover but they cannot and do not contradict ISO 14 937 principles Okay so so that's why we need to understand more the the these both both these uh isos and and understand and know better the the the new Riso and that's why we had a h specific webinar for that so now um I have one question from from from the the attendees uh so Hospital leads constantly review of standard operational procedures based on new standards but maybe it's time to also update the spaling system which might be not be relevant for today's medical devices or technology so uh the question is how do we change these or get it updating for more than day challenges and uh well uh Alex already talked about that but uh uh so feel free to answer to this uh important and some kind challenging question I will try to answer a little bit uh Carlos uh it's so that within quality uh Management Systems you always uh work in Improvement of of types and like it's always done uh norms and and and existing historical uh yeah classifications change really really slow and like all like already told it's you need to look it at a global scale so you know it won't be changed uh in really rapidly or in a in a few times so but within your uh quality you always can do better than what described in the Norms so if you're uh if you're convinced that you need to sterilize something that may be in the Norms is is good for high level this infection is enough then why not if the medical device manufactur says you can sterilize it and maybe that's the the the thing that's going on that we can talk with manufacturers say yes we want to sterilize something that may be uh now booked as something that needs to be high level disinfected so I think you can make that movement yourself and you don't need to wait for changes into the norms and to the just do the best thing and put your quality on top yeah thank you thank you for this does anyone of the others want to comment uh maybe I would add a few oh sorry go ahead go ahead no no no no I was just holding to you yes okay no I no just to add to what V said we are in the moving words and there are many things which were defined at the time of the sponding classification Creations which are obviously not anymore today today and a good example of that are flexible oscope and when the word Federation guidelines were recently revised we hesitated on how uh critical scops should be classified and we made a decision to classify them as critical devices based upon the fact that they are in between um you know critical devices and semic critical devices and it's likely that in the Futures more and more um flexible oscope will go into the direction of crial devices requiring sterilization for example again it's not a just an example yeah thank you very much so I need I think we we we we need to um to to wrap up and uh I I want to thank you again all of you all the colleagues that are in this round table um uh sharing your knowledge with with all of us I I want to thank also to the attendees that have been with us uh believing that uh they uh are um uh profiting uh from our uh webinars and I want to thank once again to ISP University in the name of John for inviting me for being the scientific director of this webinar series and also to all the staff of the ASP that allows um that makes possible to have these webinars with such a quality uh just uh special thanks to Christina and also to the teams that are working on the art for producing uh these webinars uh um in a such lovely way so thank you very much to all of you and um I end over to to Z and uh uh wish you a good uh 2025 uh uh for you and your your families and your uh on all levels thank you very much thank you Dr Carlos um and of course thanks all our speakers it's it's I think we could have this round take going on for two more hours we have so many questions that we could do to each one of us so um again i' like to thank to all the speakers again for their insightful resume um and Dr paulos thanks also for the acknowledgements and of course as you know uh by the end uh of each webinar we have some survey uh I kindly ask you to invest some of your time like two three minutes to not only to evaluate this webinar series but also uh we gave also always the opportunity for you to populate some of the topics that you would like to be covered in following Series so because we are preparing the next one please make sure you populate some of your ideas or some of your topics that are really overwhelm you during your daily base process so um uh by the end of this webinar as you know we will send the recording but also the fact sheet resume where you can find not only the fact sheets from this series but also the the statistics and the questions to give you also a snapshop about uh what is the the the status of the the our audience in each of these topics so please uh make sure you you you you visit her uh and you if you if you are not registered please registered at ASP University to get um access to this and any other um educational assets that we have available as always uh next month um not February I apolog my apologies so in next month we always um do our uh ebook so stay tuned we're going to have um based on the content that has been deployed and presented by our uh guest speakers we will do um uh ebook that will resume uh all these um medical devisor processing Back to the Future uh series five from thep Summit so always um please uh get in touch with us you you have our contacts you can visit us at ESP University and thanks once again for your attention attendance and participation today I wish you a lovely uh day week and of course 2025th Year and I hope to see you um in the next webinar series six uh with a different format that you will be noticed soon so stay tuned for the upcoming Communications and that's it thanks for everybody and thanks Carlos and our panel speakers [Music] [Music] [Music] [Music] [Music] [Music]