Under Pressure - Pack it Up, Wet Packs

0:00that's something we quite often see especially for coming in with new sterilizers and replacing older ones. We use the other conversation of like, you know, here's our factory program cycles. You want to run with those? Are we going to match what your current cycles are? Oh, you have 50-minute dry times and all your sterilization cycles. Why is that? You know, we start looking at that particular issue. Rising above the buzz of ultrasonic cleaners and the clinking of stainless steel are the ideas and voices that are changing an industry. You're listening to the Beyond Clean podcast, the central nexus for the people, processes, and products that are improving our sterile processing world. Each week we speak with frontline technicians, CEOs, engineers, and entrepreneurs with a common goal to help you fight dirty every instrument every time. Whether you're tuning in for education or inspiration, we're glad you did. Now turn on those washers and turn up the volume. It's time to

1:06go Beyond Clean. All right, Clean Freaks, welcome back to another episode of the Beyond Clean podcast. This is season 31 under pressure, everything about steam sterilization. I'm your host Bobby Parker, and joining me for this season and in studio again is our co-host for the season Melissa Morgan. Melissa, welcome back to the studio. Thanks, Bobby. Well, today we've got a bit of an SPD cuss word to deal with, and that's wet packs. My goodness, this has caused a lot of pain for a lot of folks. Yes, and it crosses over into my infection prevention world quite regularly. Well, the guess that we have on the show today is going to be our sterilizer expert from actually last episode, Jason. We're going to spend most of our time in kind of the technical side of wet packs, but I've got 60 seconds here if you want to give the

2:09IP pitch for why wet packs are a patient problem. Yes, so water is never good, right? People don't understand it, but it sure does capture any kind of deaths in organisms, and we'll hold it right on those instruments, deeming them on sterile. Yeah, yeah. Water, water bad is just the way that we're trained in, that's the way to think about it. Absolutely, absolutely. It's got to be dry and less somehow the thing that you're using has meant to have water in it. It always baffled me that we had sterile water. We've got water in bottles, so you can't get it, but my goodness, sterile water is a thing that desperately wants not to stay sterile, so it's a challenge to keep it that way, I'm sure. Well, exciting conversation we've got here in front of us. We'll be right back with Jason after a short break. Are your SPD and OR departments struggling to keep up with demands? Learn how the

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5:15Contact DSI at dsidirect.com to find out more. That's dsidirect.com. From the studios of healthcare HQ, you're listening to Beyond Clean, the global voice of sterile processing. And joining us now in studio is Jason Simon, Senior Product Manager for SPD Equipment at Skytron. And joining us again for the second time, Jason, the Sterilizer Man Simon. Welcome back to the show. Thanks for joining us in the studio again here for part two Jason. Thank you Bobby. Thanks for bringing me back again.

6:17It's got to be true. Yeah, absolutely. Sometimes the conversation is just too good to cut it at one 30 minute show. So if you haven't gotten caught up so far as to what we've been talking about with Jason, I guess I'd invite you to go ahead and hit pause and rewind time for one week. Go back to last week's episode on the show as we introduced steam sterilizers. You know, what's going on in that steam sterilizer? What are some of the parts and components that make up that steam sterilizer? And we ended that conversation around drying and wet packs. And man, that's painful to end a conversation by just saying the word wet pack and see you next time. So I wanted to bring Jason back on to talk with us some more about drying and wet packs. So why don't you get us started right there at the top Jason with definitions? What do we mean when we say that dirty word, wet pack and sterile processing? And why is it such a big deal that makes all of us SPD leaders cringe? Well, thanks Bobby. Yes, wet packs are definitely a nobody likes to

7:22find those in their in their instrumentation for sure. What we define as a wet pack is basically any visible pooling of water that's on the outside of the packaging. That's the most obvious, which is probably more critical and maybe a little more problematic would be the hidden droplets inside the packaging. And those are quite out often found. So, you know, maybe the patient's on the table, for instance, and that could be a show stopper in the OR and that can cause the waves, which obviously nobody wants it's not best for the patient, not best for the facility, causes everybody to scramble and create stress in your life. Yeah, for sure. And yeah, I've I've lived all of those experiences and we're going to talk a little bit into, you know, what's what's next after you find one. But I want to start at with kind of the the sterilizer conversation as to what's going on because steam sterilization is a weird process like it's a really it's a really hot and wet process, but we can't use them until they're not hot and not wet anymore. Talk to us a little bit about the drying phase of a sterilizer like what's going on in

8:24there? How do we get these hot and wet instruments totally dry and then hopefully totally cool before it comes time to handle them and touch them? How do we how do we avoid those wet packs? What's that sterilizer doing? Thanks. Yes, when you find moisture on your packaging or the droplets inside your packaging, now in the OR, what it means is the sterilizers fail to take the moisture that's inside that's doing sterilization inside the packaging that's failing to turn that into vapor and remove it from the packaging. So basically that could, you know, be a result of several different things that may be, you know, not functioning correctly on the sterilizer itself. Probably getting to more what's over causes of those wet packs are going forward too, but the sterilizers primary function after it does the sterilization exposure time is to basically remove all that moisture out of the packaging. So it is left, you know, dry and typically that's done through a vacuum system could be a vacuum pump or a veterinary system that's creating that vacuum

9:29pulling the moisture out, but it's also a combination of the heated dry that helps that moisture turn back into vapor to be slowly pulled out. Right. Yeah. So when you look at the, at the printout strip on your sterilizer after the exposure section during the dry phase, if you look at the pressure, you're right, there's a usually strong vacuum for that whole period of time. We're trying to suck all the steam out to get the, you know, the, the really moist, we'll call it air in quotes away from the instruments and then, yeah, the steam in that jacket keeps it really hot in there. And so you're just letting it cook in there with, you know, the absence of steam and a lot of heat for a long, long period of time to get the thing dry. One of the things that has always puzzled me about this dry time piece is the amount of variability between instruments and the IFUs as to how long they recommend you set that dry time for, you know, from a sterilizer manufacturer's perspective, is that all hogwash or like, is there, is there some value in people

10:31just setting these seemingly arbitrary dry times in their instrument IFUs and like how closely do we need to pay attention to that? Some of it is arbitrary regarding the dry time. I've been on both sides of the fence before on the sterilizer side and the medical device side. Typically what we do under medical device side is just look at sterility because you can use all kinds of different packaging methodologies for your medical device and that's that's really what's driving the dry time the most. So for instance, let me test our light handles of our surgical lights. There's basically an exposure time and a temperature that we test for and the dry time is not really even part of the equation. But once you enter into like if it's in a pill pouch or disposable wrap, something like that, that's when you get into the IFU of that packaging methodology that kind of dictates the dry times. Plus there's also the Amy 79 equation with the recommended parameters for all the cycles there and that's what we typically try to follow in the sterilizer side. Yeah, there's definitely a lot of complexity to it, a lot of documents to look at. You've got the

11:34instrument IFU, the Amy recommendations, you've got the packaging method IFU, you've got the sterilizer user manual, like all these different documents of what my exposure time ought to be, my dry time ought to be and make sure that we're making sure that we're following all of those appropriately. And that dry time piece is the one that I think most people get puzzled about. There's a lot of industry conversations around that dry time. Is it a function of sterility or is it just a function of sterility maintenance? Like if the packaging method can get the thing dry faster than what the instrument says it needs in terms of dry time, is that appropriate? A lot of ideas and conversations around that. Thanks for walking us through mechanically, at least what's going on in that dry time because we want to have dry instruments. A hot wet process is the enemy of sterility maintenance because water does such a good job of carrying microorganisms along that it could potentially pull some through the packaging and contaminate our instruments. So we want it cooled down and we

12:36want it to be all the way dry. And that's why wet packs are such a big issue. All right, so the definition's done. Let's talk a little bit about processes, Jason. So when you've had to be involved with wet packs, either from your days as a lead sterile processing tech or now kind of advising from the sterilizer manufacturer world, what should technicians do if they open up that sterilizer and they discover, oh no, there's some, you know, there's some moisture on the outside of these trays. We got a wet pack here. What's the right right next thing to do? So within any situation, I would say document and investigate. That's probably the most critical steps to take there. Only in certain couple of different ways, if that wet load is found in the SPD, like when the sterilizers first opened, that's a much easier controlled environment. You can easily quarantine the entire loads and, you know, go through the process of repackaging everything and preparing it for a new load. Also do your investigation at that point. What was the root

13:38cause of it? Is it something obvious, like loading, where there heavy trays, containers on top of rat packages, on top of peel pouches, things like that. There's a science to loading the sterilizer, where you want to lighter up devices on top. And in that aspect of it, really instrument, for the instruments, I've seen it before, where a very hot sterilization cart pulled out of a finished loads parked underneath the air conditioner vent, turned up a lot of condensation, you know, from rapid temperature changes. So there needs to be the correct environment that the instruments are allowed to cool down in. If it's in the OR, then it's probably a work-critical situation. You got to figure out what's best of the patient at that point. You may have some your own facility protocols and how you treat that situation. So that would probably be first and foremost. If you don't have those protocols, then you're sure back to Amy, which I'm sure you kind of have an open SC79 guidebook right there in your operating room either. But, yeah, generally there'll be a protocol for your facility on how to treat those, you know,

14:42wet droplets in the OR. When you see that, hopefully there's some other sets that are in place that can be brought in, otherwise we go a different direction and then streak into that kind of different facility protocols there. So it's definitely a critical point, Jason, to your thought there that, you know, we really've got to catch this before it gets to the OR in as many of the situations as possible. So, you know, from an operating standpoint, how often do you find that the problem is related to the process in which the SPD team is doing versus equipment failure or steam issues? Sure. I mean, I think the most obvious to look at, at least at the point of use, as was a sterilizer operated correctly. I mentioned the load configurations on it. Did they start the right cycle? I've seen that before where maybe they started a cycle that was intended for media use when it was not package instrumentation. There's other things that can go into the weeds

15:51with, you know, preparing the packaging that they use, you know, towels to whip the moisture away and those plastic insert trays, things like that. And once you've kind of eliminated those issues, especially if it's a one-off, I would think it's more of the operator type problem. If it's a reoccurring issue, then we look at the canacles on the sterilizer, you know, other traps that aren't opening and allowing the kind of state to run through when it's appropriate. Another issue of the vacuum system, I think last session, we talked about a story where the facility lost a water pressure, where all of a sudden it weren't pulling back in, you know, as strong as what they had in the past. And then there's also, you know, facility steam issues, which I think you're getting into your next episode where if there's wet steam being supplied to the sterilizer, that can only, you know, act as so much of a band-aid to try to, you know, leave those in terms of dry when your steam source isn't correct. I typically, when we run into this type of situation is kind of

16:52asked, especially if it's a all of a sudden problem where it wasn't in the past is what's new, what's different? Is there a new technician? Have you installed some new equipment and an apartment that's pulling a lot of steam where he used to have a better supply? So yeah. Yeah, getting to the bottom of it is always everybody's top priority. I mean, Jason, I've known sterile processing leaders who have lost their job from just the overwhelming reaction from surgeons of like wanting there to stop being wet packs, you know, or they open up their vendor trays and now like patients are being impacted, because that was the only one that they had in the house and more time under anesthesia, like really serious consequences, and it goes on for very long at all. It's like, okay, we need to get somebody on top of this. And yeah, my heart goes out to folks like that who are doing the very best that they can to try to get their arms around this wet pack problem. And so there's no doubt that everybody understands

17:54the urgency of how to fix it. It seems like the actual process of figuring out how to fix it is not the easiest. And it never follows a straight line. We did a series on water quality and like finding black specs in your surgical trays from the water quality. And gosh, that is, you know, even more of a witch hunt trying to figure out what of all these contributing factors is doing this to our trays. I feel like wet packs can be that way as well. So I want to dive into those two categories of, you know, maybe some suggestions of employee-related, operator-related issues, and then the other category of what are maybe some of the equipment-related issues. So can you take us a little deeper on what are some of those operator-related issues? You mentioned loading or maybe having a new technician, like what are some of the things that a new technician might do that would result in a wet pack? Good question, Abby. I would say

19:03the first early operating sterilizer correctly, you know, are they selecting the right cycles programs for load contents that they're running? I like to look at packaging quite a bit too. I mentioned that the towels used to help with the moisture away, especially the certain suspect problematic trays, the heavier plastic molded, multi-tiered instrument sets, those are by and large, the most difficult to try to leave without any droplets after the cycle spun over. If the sterilizer is overly weighted down, you need to look at the eye a few of the sterilizer too, it's been approved to process. When I first started an SP many, many years ago, decades ago, we would fill the sterilizer, and if it came out wet, then we knew not to put as much stuff in next time. Right. Brave Norfolk now already have tray weight limitations, and I have used for sterilizers that there's rules to abide by, and how much you can put in the sterilizer itself. Yeah, that answer the question. Yeah, it does. There are a couple of additional ones that come to mind.

20:05It's funny you mentioned about the tray weight limits on episode four this season. We went all the way down that rabbit hole with Carol talking about that not just the tray weight limits we're familiar with, but like the chamber weight limits of what the sterilizer can handle from a density perspective. There are two kind of, I don't want to call them myths, or old wives tales, but there are two practices, sacred practices in sterile processing that there are different ideas on I want to pitch your way, and they have to do with this wet pack issue. One of them is spacing between trays. Is it ever appropriate for trays to touch? Even rigid containers where the steam enters in through the top and bottom filters, is it okay for their sides to be touching, just thinking about how dense should we load the sterilizer? And the other one is the famous cracked door at the end of the cycle. Do we do it? And for how long? And why? If we need that to get a tray dry, should we have done it in the first place? So I don't know. Well, what's your opinion on those two topics in terms of tray spacing and then the famous cracked door?

21:11So my first go to answer, it's kind of my get out jail free card. As always, look at the eye of you, the medical device, especially when you're looking containers. Do they recommend keeping any space in between the containers themselves? Often most of the containers I believe do not, at this point. But generally, I think ST-79 will refer to one inch of space in between packaging. That doesn't always get followed. I don't know, especially I've still seen some customers that are running double basin sets, which are all kind of stacked, you know, at a 45 degree angle. With a cracked door, that is still a common practice that we see quite a bit here. With modern sterilizers, there's really no purpose. You shouldn't have to do the cracked door, but we seek all kinds of different practices by customers to try to alleviate the potential for wet loads. You mentioned extended dry times earlier. That's something we quite often see,

22:16especially for coming in with new sterilizers and replacing older ones, because they have the conversation of like, you know, here's our factory program cycles. You want to run with those? Are we going to match what your current cycles are? Oh, you have 50-minute dry times in all your sterilization cycles. Why is that? You know, we start looking at that type of issue. I know there are medical devices that have extended dry times, but we're often seeing where customers are extending their dry times like while it was still wet after 40 minutes. Let's try 50. Yeah, well, been there, done that, the department I led. We had a 45-minute dry on every cycle, and we cracked the door after the sterilizer cycle. Partly, just because that was the process we inherited, and nobody really wants to be the one responsible for doing the experiment on whether or not we're going to start having wet loads. You know, like if it ain't broke, don't fix it if the sterilizers aren't being the operational choke point in our workflow, then what advantage do we have for cutting that time down? But since then, I've reflected on that. If we needed an extended

23:20dry time to get dry trays, or we needed to crack the door and let it sit in there and continue to cool down a little bit before bringing it out so that we wouldn't get condensation, then maybe something wasn't right. We should have addressed the root issue rather than live with those processes along the way. So I certainly can understand it, but yeah, people hanging on to those older practices, but it's definitely worth looking into, because yeah, modern sterilizers, you shouldn't have to do the, shouldn't have to do the cracked door. The other crazy one, not crazy, that I was actually the crazy one. The other one that I saw going into another department was seeing our rigid containers stacked on top of one another. I thought, you know, these folks don't know what they're doing. And then I look at the eye of you, it's like, holy cow, you can do that. I had no idea. So yeah, there's some wild things out there. And it just, it kind of turns into micro-cultures at sterile processing departments of what the only right way is to load a sterilizer

24:20until you get out there, the field, you start seeing some things. Melissa, you're traveling to all kinds of facilities. You know exactly what I'm talking about. And you know, don't, don't tempt fate, because if you're the one that pulls out that wet load, it's because you change what they've been doing. So, but what I do find, and Jason, I think you highlighted this was it's a failure in a different state. It's more like, well, we've gotten too much weight in the chamber itself versus the way in which we've managed to not crack the door. And the 50 minute dry time is something I have seen quite frequently and programmed sterilizers to do myself. So I will take that one home. Well, it's kind of like the elephant repellent. You know, if you spray elephant repellent on you and you don't get charged by an elephant, it must be working. You know, it's like when are you going to stop spraying it? So yeah, if you're doing the 50 minute dry and you're not getting wet loads, who wants to change it? Well, okay, so we talked a little bit about kind of the operational things that might cause a wet pack. Let's let's circle back and dive into the other

25:25side of it. What are some of the equipment things that might cause a wet pack? You know, there's a lot of conversations around steam traps and steam drains and heat exchangers and words that I hear service, service folks throw around to one another talking about sterilizers that, I don't know, from a, from a clinical perspective, we just push the button and kind of hope the mechanics of the thing work. Like, so what could go wrong on a sterilizer that might cause a wet pack? A lot of things. And I was in the same boat. I knew the business end of a sterilizer very well in the clinical background to exactly what was supposed to work and I've learned much more on the side of the curtain as well too. But so there are steam, pneumatic valves or solenoids that are used to turn steam flow on and off. If those are binding up or not closing completely, that can allow additional steam moisture through when it's not supposed to vacuum systems, either I mentioned vacuum pumps or venturi systems that are used to push water through to pull vacuum down from the chamber. If you've lost that water pressure or if something is compromised in

26:30that vacuum system where it's not pulling an efficient vacuum anymore, I've seen leak tests and boidic tests passed with regularity. You can still find issues with the vacuum system that's not adequately pulling a vacuum to dry at the M2. That's a more challenging device and I think it's probably why leak tests are being enforced now in the last couple of years more than they were in the past. And then there's other smaller mechanical things that I still don't completely understand 100%, but I think I know enough to be dangerous as far as like the traps and allowing that condensate after it turns from steam back into water, it's basically what condensate that needs to be drained out of the jacket where typically most sterilizers are pulling steam from to put it into the chamber and replace the steam back into the jacket. There are some sterilizers out in the market that use segmented or partial steam jackets around their chambers that are

27:34a little more prone to temperature variants within the chamber as well. And so that's very important for operation of sterilizers to have uniform temperature within the chamber. So if you're sterilizing it 270 degrees if you have a spot that's a few degrees cooler than that that doesn't sound like much of that can actually cause issues of unwanted compensation. So that sterilizing technology or our process is a bit of round. It's the way it's been. There's you know a little bit of advancement in that technology, but is there more technology to come or advancements that we see in the future that could maybe prevent wet packs? Yeah, we're tackling that in a couple of fronts, Melissa. We can look at kind of controlling the utility variables a little bit better. So internal water recirculation systems that can establish a supply of waters you're

28:39not as dependent on the incoming water supply in order to pull that back in. We've seen that with especially here in the North Sea winter with water rain breaks and things like that that can affect water pressure. We also look at manufacturers testing as well like we're going through validation right now for actual full container loads to really test the you know we already have to do the 25 pound process challenge device, but doing further testing and looking at mixed loads and what are the results from matter? Are we getting the results you want to and then writing the high view for the sterilizer appropriately? So Jason just a wrap here thinking about thinking about wet packs and equipment and you know you mentioned differences in chambers and some of this some of this newer technology out there like and I think we ended this last episode the same way if a facility was out there trying to find like what equipment is going to give me the best success with

29:40respect to instrument drying like are they all pretty much the same or are there distinctive features that people ought to pay attention to on their shopping list? The features probably aren't the things that make the brochure that most of the users are actually looking at it's more of the mechanical stuff I mentioned the water recirculation system the full steam jacket you know those type of the quality of the materials that are going to the sterilizer itself operational controls can have an effect on it as well too are you able to control the amount of vacuum they're pulling it's affected by the atmospheric pressure that you're looking at in your hospital but there are differences in the sterilizers we've certainly had customers that have came in and the sterilizers more of a commodity you know they're all same I have to differ a little bit to other advantages once the sterilizer with the other yeah for sure I mean in some senses the technology is all the same way back from the pressure

30:42cooker days like we're just getting saturated steam onto the instruments but the method of delivery and certainly the complexity for how we how we dry those I could I could see there being a conversation there and something something to look at and to study and then just to underline one more time something that came from last episode is you know the most the most hilarious thing to hear is we've got wet pack issues I think I need a new sterilizer like that that's almost never the answer like let's fix the conditions for the wet pack so that the equipment that we have put into yeah put into that that situation that Cyrillus is going to be able to succeed well Jason really interesting conversation great stuff thanks for being willing to come back and talk to us about about wet pack searches I feel like we've given people kind of the laundry list of of where issues might come from but there's even another conversation to have after this one of like how do you do the investigation yeah thanks for thanks for giving us the sterilizer definitions on the topic today thank you Bobby thank you most absolutely and if you want to continue this conversation

31:48with Jason we'll make sure to get his contact information and linked in in the in the session description I'm sure that Jason would love to continue that conversation with you there we'll catch you next time Jason thanks all right thank you both and that was Jason Simon senior product manager for SPD equipment at Skytron talking us through sterilizer dry times and and those always hard to pin down wet packs gosh I it is a fun topic Melissa I feel like dry times is the the one part of steam sterilization that I don't fully have my have my mind wrapped around just yet like there's a lot there's a lot that's going on in there it may be the most boring part of the cycle you know like there's not not a lot of excitement happening is just sitting there drying but there's a lot that lot that can go wrong a lot of parts

32:51that are involved in making sure that it happens right and gosh answering where the wet pack came from is never a simple answer well and you know I'm guilty of the 50 minute dry time because you know if you have to redo it that extra 10 minutes in the sterilizer is way less than having to redo a whole load yeah yeah I feel that and you know how do you what when you're when you're in a position of having the security of everything's working like how do you find the courage to start changing things you know and I guess you've got to just look at your documentation make sure everything is right in terms of what you're changing it to and then pick a small scale way to do it maybe pick one of your sterilizers and and open everything that comes out of that sterilizer try it at different times of day try it while all the rest of them are running and see if you can get it to fail you know I'm sure there's a wise way to make that switch but yeah I

33:53I don't know what I was running an SPD I did the same thing I think the one that did actually contribute to to workflow issues though was the cracked door at the end I think we probably would have changed some of that because it adds an extra 20 minutes or so to your to your cooldown time to leave it in the chamber and you know I haven't gotten this question answered for me yet but if if it did at the end of the cycle have a wet tray in there and you are able to dry it up by leaving it inside the chamber with the door cracks for 20 minutes like is that a patient risk like is that an issue for us to be still drying trays after the door is open it just it seems like it would be better for us to just pull the trays out of the sterilizer if that's how the sterilizers meant to operate and identify the issues and work on the issues rather than masking it with a cracked door but anyway that's my soapbox for today well the infection preventionist in me says if you have to

34:55crack the door then you're probably doing it wrong to serve yeah so yeah let's let's bust the cracked door mess right now okay well there there there it is if if that's that's your process today make sure to talk with talk with a sterilization expert have your have your steam sterilizer manufacturer come look at it or your service person read your operator manual make sure that you make wise decisions about how you're going to change your processes but yeah definitely a red flag to to look into if that's still your process today well that's going to do it for today's episode we we've loved having you listeners with us here on this journey through steam sterilization we'll be back again next week to talk about the facilities management team and steam quality I think it's going to be a really fun one so until we talk to you again next time we'll leave you as we always do here at Beyond Clean keep fighting dirty

35:58thank you for listening to this week's episode of Beyond Clean as a reminder you can help support us by subscribing to Beyond Clean on your favorite podcast app or by downloading the smartphone app on iphone or android simply search for Beyond Clean in the app store or google play the best thing about downloading the smartphone app is that you can access bonus content for certain episodes and view episodes in certain categories like articles on the go and vendor spotlights are you following us on LinkedIn or Facebook yet if you are in do 11 episode or post then let your social network know about it like comment or share our posts along with your thoughts and keep the conversation going if you have any topics or guests that you would like to recommend for a future episode just send us an email to info at beyondclean.net we look forward to hearing from you