Fordbid Validated Field with airSlate SignNow

Fordbid validated field

and my experience what I have seen to be the leading cause of wet pack is oversaturated steam and this is steam coming from a boiler or from a generator the facilities folks that are in charge of those things take care of them and that's their baby and they'll tell you that they've got the best steam that there is you know you don't have to worry about it we test it we test the water and all of these things but that boiler may be across the facility from the sterile processing department there may be pipes that are that are older than we are that are carrying that steam to us and so the longer that that steam has to travel the more energy of losses over that distance millions of patients undergo surgical procedures every single day they place their lives in the hands of health care providers who are committed to delivering safe functional and sterile instrumentation for every surgery working behind the scenes are the technicians who go largely unknown even to the patients whose lives are so dramatically impacted by their work this is beyond clean the global voice of sterile processing join us as we explore this hidden world and introduce you to the unsung heroes who are driving the advancement of our profession and now your host Justin fallin Michael Matthews and Hank bulge this week on beyond clean we speak with Joel Schaffer vice president of engineering and product development for sterile services llc joel has over 15 years of experience working alongside sterile processing Department staff and management growing from an on-site instrument repair technician into a consultative sales representative Joel was able to personally design and manufacture sterile services proprietary autoclave validation tools including an inner lumen sensor unique to surgical instrumentation validation joel is a CRC st and a founding member of the houston ischium chapter with the increased awareness of the steam sterilization processes Joel's ambition is to highlight the role of all hospitals sterile processing departments and the steam sterilization process itself Mike this is going to be a good one I know we've had a couple in the past that are kind of on the perimeter of this kind of conversation but I definitely want to kick it off when we get into it with Joel about autoclave testing and validation so much emphasis needs to be placed on the difference between verification and validation in our worlds we tend to make a lot of assumptions when it comes to our industry and one of the biggest assumptions that we make is you know it revolves around our autoclave we assume that the autoclaves always do exactly what they tell us they're doing and so when we find out that may not always be the case it can kind of be a really scary thing so we really want to dive into that difference like you said between verification and validation and being able to know that what our autoclaves are doing are making our instruments safe for our patients and not make assumptions yep absolutely Mike it's so this is going to be a great one as a reminder you can subscribe to beyond clean on iTunes stitcher Google Play and Spotify or search for beyond clean on your favorite podcast application we can also be heard on the sterile education app available on iTunes and Android follow beyond clean on Twitter at beyond clean info facebook.com slash beyond clean podcast linkedin.com slash company slash beyond clean our Instagram is beyond clean podcast and on YouTube youtube.com slash beyond clean for fighting dirty with Hank bulge and real talk with Bob Mars all season eight episodes will be certified for seee credits in a single package with one quiz and certificate the end of the season select beyond clean podcast episodes are worth points toward the CNO are or cssm credentials through CCI beyond clean also offers clinical education and social media and podcast consulting for vendors along with survey preparation and remote consulting services to hospitals surgery centers and clinics is your facility survey ready email info and beyond clean net for more information and finally we are excited to announce beyond the tour a compelling and gritty new film series that is shining a spotlight on innovators and disruptors in healthcare manufacturing the premiere episode of beyond the tour will release late April so tune in to beyond clean social media pages for details we'll be right back after a short break a skill app a global leader in rigid sterile containers surgical instruments and surgical asset management consulting understands the daily challenges a sterile processing department faces to meet demanding oor schedules backed by more than a century of industry experience and equipped with specialized tools and methodology the ask you lab team is dedicated to helping hospitals optimize their perioperative performance enabling them to operate with greater precision joining us now is Joel Shaffer vice president of engineering and product development for sterile services llc Joel thanks for coming on the show we're really excited to talk to you about autoclave testing and validation today excited to be here thank you for having me why don't we just start at the beginning talk about autoclave testing maybe give a background on that and also validation and why is so little known about it in the United States well testing is really more akin to the daily test that we we all do in a sterile processing departments the biologicals and the bowie discs that's not really a validation per se that's more of a verification with validation is it's an empirical measurement of pressures temperatures and steam saturation that are used to create a three-dimensional map of the environment of the chamber inside of the steam autoclaves during all of the phases of the sterilization cycle these phases are conditioning heat up exposure exhaust and dry and they're all equally important to achieving stability and so let me follow up there then so you're differentiating again verification from a daily test to validation and you know that initial question that Justin asked is your perception that we're getting out in the industry and in a lot of the folks internationally who listen to the podcast is there's a a distinct difference between how folks do autoclave testing and validation overseas as opposed to in the US do you know the reason for that could you speak to that issue I have not been overseas to see the way that they validate however that my colleagues have and we're pretty well in line with what what they do but I believe the main reason that the US hasn't caught on to it is because really up until this latest version of Amy's SP 79 there hasn't been a standard that mandated anything more than the daily biologicals and chemical indicators and all of those things and like I said those are really a sterility verification and not a validation and I think also that the cost associated with electronic validation which is what we do the tools the software and training of a technician can be cost prohibitive to hospitals you know most hospitals are running on a razor tight budget and they just can't spend the money on something that they're not mandated to do I mean speaking to those mandates then today what you're telling us is there is not a mandate out there to do validation testing except for certain specific circumstances right so what can you outline what the circumstances today are that require you to do true validation testing of your autoclave yes so in the new St 79 in the latest three point three point three point two states did yet and the facilities are required to ensure steam quality by testing the steam to make sure that the saturation level is between 97 and 100 percent that they have less than three and a half percent of non condensable gases and that they're not super heating this thing as well and so when you say super heating obviously you know what you're talking about but when I hear that it sounds like very technical term and it's one that probably my facilities manager would understand what you mean but I'd say a lot of folks on the front lines and may not off the top of the head know what superheated steam is so what is that it's basically steam that is heated above the saturation point beyond a threshold and that threshold that the stated in st 79 is 25 degrees Celsius and so what's tough consequences when that happens when steam is superheated it's too dry and it's creating a suboptimal steam condition it doesn't have the moisture to break through the outer layer of the protein of the spore and and therefore attack this for itself and kill it so Joel this is really interesting stuff because we kind of just assumed that the autoclave always functions properly and we know that the autoclave has on it some sensors that help us determine you know certain things about it like you know the temperature that it holds and the pressure that it holds you know what are the differences between the internal sensors that we we look at kind of as a normal process versus the sensors that you guys are using when you validate these autoclaves and most sterilizers there's one internal sensor and that sensor is calibrated at the factory and then once the autoclave is installed and there's typically not another calibration done it can be done by the technician they usually don't calibrate them unless they're made aware of an issue our sensors that we use are calibrated annually and they're calibrated so within very tight tolerance it's plus or minus 0.9 degrees Fahrenheit on the tolerance and we use multiple sensors so we're not just getting one location of data we're getting data throughout the entire chamber of the autoclave and that's important if you have say a seal that is going bad or that you have valves that are going bad inside of the autoclave we can actually see those issues present themselves before you actually see a failure so following along that are there any sort of warning signs that notify a you know sterile processing technician that say you know hey you probably need to have a you know more stringent verification done on your autoclave or is this something that has to be done completely preventative ly regardless of what you're seeing on your daily tests it should be done regardless of what you're seeing on your daily test those tests are proving that there is lethality they're not validating that you're hitting all of the parameters that ami dictates that you are supposed to be hitting which is the temperature for the time and for the width the steam saturation percentage did they recommend and so Joe obviously in the field y'all are doing these validation tests on existing autoclaves that have been in use you know for a number of years when you're testing an autoclave that has not been validated you know since it was manufactured are you seeing a higher rate of failures or you seen issues like what you're talking about what the valve issues and other things come up that have been in use but not been caught yet a lot of times we do we typically get called in for the more common issues like wet pad fail Bowie dates things of that nature and we help get to the root of the problem if we haven't seen an autoclave before I believe the 30% rate of issues such as the clock being off or the date being off or that maybe it's getting hotter than it's supposed to get or not supposed to get for what it's programmed to yeah so we've got a question actually about the clock and the time settings but before we get to that you mentioned wet pax and you know that's a pretty dirty word and sterile processing if there's one thing that's gonna get some blood pressure up in a sterile processing technician and you know a manager Oh our director no one likes the term are to say no one likes to hear the words wetbacks because that means all kinds of issues it means delays he's obviously first of all but then it means a whole cascade of root cause analysis and really trying to figure out what is the cause of this and not only how we get the trays today we need but how we make sure that tomorrow is not the same issue so when you look at these causes from your perspective and looking at the technical part of steam sterilization what would you what do you see in the data as the cause of wet packs and also how does that impact a failed biological test well in my experience what I have seen to be the leading cause of wet packs is over saturated steam and this is steam coming from a boiler or from a generator facilities folks that are in charge of those things take care of them and that's their baby and they'll tell you that they've got the best steam that there is you know you don't have to worry about it we test it we test the water and all of these things but that boiler maybe across the facility from the sterile processing department there may be pipes that are that are older than we are that are carrying that steam to us and so the longer that that steam has to travel the more energy of losses over that distance and if you factor in things like improper insulation the steam traps that are along the way that are designed to catch the condensation it does get filled up they're not being properly maintained then that super saturated steam just keeps flowing on it ends up getting injected into your autoclave so now you have really wet steam and honor that sounds kind of weird but what steam is you know the super saturated steam and that predisposes you to have wet hats and it's harder for that autoclave to get rid of all of that extra moisture now if you factor in the human element say the technician didn't drive the instruments off fully before they they put them in the autoclave or they didn't crack the door open which I know some people don't like that some people do like that let the load normalize to the room temperature a little bit before you pull it out certainly don't pull it up under an air-conditioner event you don't want to do that you know don't touch on things like that that can also lead to wet packs but if you have an environment that is super saturated to begin with then you're just a recipe for wet loads and so how does all all of that impact in the biological question when you're looking at fill be eyes fail be eyes is another another one it's contentious with the staff if the steam is supersaturated it can insulate the biological and not allow and that seemed to penetrate see that biological to kill the spores and so it's basically like soaking in water and trying to sterilize it at the same time and it just kind of acts like a blanket that insulates it so that's one cause that would cause the bi to fail another one that's really more common that I see is that the technician that's put two biological into the incubator didn't break the interval properly they don't get the right read off on it so it does it does come back to human internet and so you know going back and this may be a question that you don't want to answer or can't answer but it's not often that we get folks who know the intricacies of steam sterilization on the show so it's whole bi question biologicals it is a contentious issue especially when we're looking at this from an international perspective and again you know referencing and 120 countries that listen to the podcast there's a lot of folks out there that are not even using biologicals at all and then here we are in the US having a conversation about what do you do for biological fails so you know they're probably sitting over there thinking well it does really matter because we're not use them anyways if it fails if it doesn't fail you know it's not impacting the way that they do quality management of their autoclaves do you have an opinion on that you know again looking at this from if the autoclave has been validated with all the sensing technologies that you're referencing I know from the regulatory standpoint or the other recommendation standards out there very specific toward biologicals but aside what's your perspective on that debate I believe biologicals are a great tool for daily verification of lethality and that once again I don't believe that they prove that you're you're reaching the parameters satisfied by a need for the parameters for sterilization I'm not going to get into a argument with the big biological manufacturers I'm not ready to take on that battle I think they have their place but I think verification is also it's a high level test that it leaves nothing to be deciphered it's the data is the data and the data doesn't lie and so it's seeking you all the parameters are met then there's no reason for it to not be an effective sterilization cycle we've all heard of biologicals that have tested that the lethality was reached and we know that but load aborted in the middle of the exposure phase yeah I haven't personally witnessed that but I have heard stories similar to that from various people so I don't know that the biological czar the end all yet all and I don't know that taking empirical data is cost-effective for a hospital to do on a daily basis I think it's more of a kind of like you have to invalidate all of your other equipment in the hospital at least once a year you know the autoclave should be done as well Joe we've heard a certain term on a couple of instances and we've heard it in previous podcasts with Jonathan Wilder and with Rene this this idea of non condensable gases can you explain to us what a non condensable gas is number one and then number two why is that a threat to the sterilization process simply put a non condensable gas is just air a word carbon dioxide one of the two and what it does is it forms a pocket that prohibits the sterilants from penetrating that pocket of air and so if that pocket of air is over where your instrumentation is that you're trying to sterilize it's insulated from sterilant and so you're not gonna have an effective sterilant contact on that instrumentation so I think this is kind of a terrifying issue when you consider the fact that it's very realistic that your biological may pass and your autoclave may say that everything has gone well but there is a pocket in place maybe just position perfectly over that laparoscopic set or perfectly over the those total knee instruments that prevents that from actually being sterilized and yet we may not know anything about it so what can we do as technicians or managers to help prevent that from being an issue in our hospitals I can say that in all of the time that I've been doing this I have never experienced a non compressed gas pocket on any of our sensors meaning that none of our sensors have been insulated from you know steam penetration because of design condense castles typically does be at the upper end of the autoclave chamber near the top that would be forced to the top or forced to the bottom your temperature probe that's it's in a drain that's the factory-installed temperature probe would probably pick that up but we haven't we have never seen that occur within the killing field if you will deposits killing field I like that term we need to get a graphic out there I just pulled that one out of the air all right well you know let's do that that can be your show graphic if we can't get it together how's that now a large part obviously of this podcast is is to equip folks who listen to it with the tools to take it back to their department and protect the patient better and of course we call it fighting dirty you know social media posts and everything but one of the things that you reference is that divide or that misunderstanding between a facilities team plant engineering and a sterile processing team and and I know is a sterile processing leader because I'm not the expert when it comes to facilities management I would feel a little unequipped or unconfident you know to speak to that guy who says oh no no no we got great steam we got perfect steam everything's great it's my baby too you know say uh I don't believe you're you don't know what you're talking about or maybe you're wrong if there's someone out here listening today who feels like they may have an issue where would you turn them to get educated on these topics what are some resources that they could reach out to or leverage you know even to bring in some experts like yourself to have this deeper conversation what would you say to those folks yes I would I would start off by listening to the two-part podcast that you guys did with Jonathon Wilder I learned a ton from that and I'm sure everybody else will as well you could definitely reach out to my company or any other company that you may find that does the same type of validation my question would be to the facilities people where are you testing this email because you may be testing it right there at the boiler but that steam has to travel through all these pipes to get to my autoclave and how do you know the end result is the same as where it starts because honestly that's where it's important that steam may be going to the kitchen may be going to the laundry and to the sterile processing Department and in my opinion the most important customer there's a sterile processing department so Joel is we kind of wrap this up the last thing we want to ask you is can you tell us some common myths in the industry that are related to autoclave validation like what are some things to look out for one of the jobs I feel like beyond clean has is to sort of reset or level set some of the dollars that's out there you know a great one that comes to mind all the time is that you can't use stainless steel brushes on to brush surgical instruments and you know you just have to make sure that it's not on a coated instrument and you want to educate people that way what are some myths related to autoclave validation that people need to be aware of probably the biggest myth is that the time and date settings on the autoclave which print out on the autoclave receipt those aren't important and the reality is that if you know heaven forbid something bad were to happen that and legal gets involved that the receipts from that autoclave is a legal document so the time and date settings are very important I would also say that that be eyes and Bowie dicks monitor all the parameters necessary for sterile nation is another one they don't speak to steam saturation or the non condensable gases or the exposure time they just they just let you know that it that either the there was a robust vacuum or that it got hot enough to kill the bacillus tara at the mahvelous those are probably the two the two biggest ones excellent joel really great interview they always go by so fast lots of good information there i always love it when a guest on the show plugs a former episode too you might have been the first one to do that so thank you thank you for definitely shouting out to some of our previous guests we've had many great ones you've been a very good one today and just once again thank you for coming on the show well thank you for having me I'm super excited to be a part of this I think what you guys do is amazing and just thank you for from all of us I know it's a lot of work that you put into it but it's it doesn't go unnoticed thank you for that that was Joel Shaffer vice president of engineering and product development for sterols Services LLC and Hank I think even just the last thing that we talked about the time and date settings you know very important especially if you get pulled into any kind of legal action and then I loved what you said about the dirty word and sterile processing being wet pacts well yeah anytime anyone talks about the legal aspect of anything Justin it throws me back into my short stint in law school and I will say short because I did not graduate but I learn enough to know that lawyers will come and they'll dig and they'll dig until they find something it's either there maybe even not there sometimes and in the world of sterile processing there's a lot of true documentation that's got to be correct and it doesn't take a lot to set an attorney off on a on a goose chase you know to find something that we could have fixed if we would have known that it was a problem so yeah that's a great point that he brought up and it's a good reminder that we're operating in a world even though those envelopes go in a filing cabinet and I go off-site for a number of years that true value there that has got to be correct or it could come back and bite us in the butt absolutely and it's also becoming much more prevalent we see these lawsuits all the time now the world is taking notice of sterile processing but it does also increase your liability and you know people are going to go in and dig and so we know it's serious businesses people's lives that's going to do it for this week's show as reminder you can help support us by subscribing to beyond clean on iTunes and stitcher and now also on Google Play and Spotify simply search for beyond clean podcast we'd appreciate a rating and a review because your feedback is important to the show and if you have any topics that you'd like us to cover on a future episode or if you'd like to share a picture anonymously on our Instagram page just send an email to info at beyond clean net on behalf of Hank Mike and myself thank you for listening to another edition of beyond clean [Music] you