Under Pressure - Heavy Metal: Why Weight Limits Matter in Steam Sterilization

0:00some facilities as we were talking have machines that are designed to handle have your loads. You know, there are machines that are floor loaders and things like that. So if they're lucky enough to have that, this may not be as much of an issue, but we really have to follow the IFU's of the sterilizer, of the container manufacturer, of the instruments themselves. You know, we're bound by a lot of these rules and rags for a reason, and it's all for the patient safety. Rising above the buzz of ultrasonic cleaners and the clanking 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

1:02tuning in for education or inspiration, we're glad you did. Now turn on those washers and turn up the volume. It's time to go beyond clean. All right, clean briefs. Welcome back to another episode of the Beyond Clean podcast. You're listening to season 31 under pressure. We're looking at all things, steam sterilization. I'm your host, Bobby Parker. And today's episode, titled Heavy Metal, is all about weight limits. No, not weight limits for the technicians, weight limits for the trays, all the weight limits in the department. Of course, joining us as co-host for the season is the great Melissa Morgan. Melissa, welcome back to the studio. Thank you. Thank you, Bobby. And thank you for not asking me for my weight limit. Oh gosh, yeah, it's not, let's, yeah, it's something I've been working on. I've been working on personally. So yeah, I don't want to go there on the air

2:05just today. Maybe next year, we're recording this coming up on the new year. So maybe it's time for a new resolution about that kind of thing. But hey, Melissa, this topic is one that I know you are really going to enjoy coming from the quality and safety side of things. We're talking about IFUs. Our favorite things, I've been into the operator's manual and see in what the requirements are. And I know how much quality and safety loves, you know, expiration dates, weight limits, things like that. So this ought to be a fun one. Yep, I look forward to it, Bobby, because every time I talk to somebody who's expert in this space, I learn something different and something new. So I think the group's going to really love listening to this one. Well, we've got the right person to do it. Right after this break, we're going to be bringing back a sterile processing educator named Carol Malone. You may have heard of it. We had her a few times here on the show to walk us through weight limits and sterile processing. We'll be right back.

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5:11now is the time to take action and connect with DSI. Contact 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 Carol Malone, sterile processing educator out at a large facility and the Midwest. Good to talk to you again, Carol. We've had you on the show a couple of times but always great to connect again. Thank you. Thank you for having me. As you said, I'm Carol Malone.

6:14I've been a sterile processing educator since gosh 2018 now. Prior to that I ran a couple of SPD departments for about 10 years. So sterile processing is my happy accident and I love to share those stories for another day, but I'm very passionate about what we do. So I'm excited to get into it today. We can't let you off that easy. Everybody finds sterile processing on accident. I have yet to find the person who found SBD on purpose. So what's your accident story? I was actually working in accounting and I, the jobs that I had were eliminated and I was offered a spot running in SBD department. So I walked in day one knowing nothing and here I am today, I think I have a little bit of knowledge and I fell in love with it. I really did. So it's been it's been a journey but it's been a good one. I love that. And educators are some of my favorite folks in SBD. You get to walk that line between being confident about about what you know and also

7:20being curious. Like whenever there's some new anti bacterial resistant organism out there, you educators are the first ones reading that and making sure your department's ready. So yeah, it's going to be it's going to be a good talk today. Carol we're chatting about weight limits in sterile processing for for our trays for our sterilizers and this is one of those topics that we really need to sit down with an educator and get to the bottom of and so looking forward to looking forward to this conversation because it doesn't get talked about enough in my opinion. So if you want to go ahead and get us started here just at the level of definitions, you know, when we talk about weight limits in sterilization, steam sterilization, what are what are some of those factors so those weight limits that we need to be thinking about? Sure, so you know, there's actually two weight considerations. First is the tray load, the tray or load weight itself. You know, the guideline suggests that trays should not exceed 25 pounds. You know, that's that's a

8:23general rule of thumb but the real limit depends on the sterilizers instructions for use or IFU because some sterilizers are smaller and have specific weights and it could be as low as 17 pounds of tray I have found. So you know, the second consideration is the sterilizers total chamber capacity because each machine has a maximum weight again listed in the IFU. So I'm always very adamant with my sites that I educate to make sure that they're reading the IFUs for their machines because if you're overcrowding your trays you can prevent proper steam circulation and we're going to compromise sterilization just because we didn't know the trays which are heavy. Yeah, well, it's helpful to think about all those categories. Like you mentioned, the one that gets all the attention is that 25 pound tray limit that we talk about all the time and lots of reasons for that. I mean, certainly there's ergonomic reasons for it. We don't be alifting too many heavy trays in my early days in SPD. I got around that by stacking them three high and carrying the

9:25whole stack to the case card. But you know, maybe maybe don't do that. But yeah, those ergonomic considerations. But like you said, there's also packaging method considerations. You know, what does the container say about how heavy its contents could be sterilizer constraints? What does some of these small chamber sterilizers say about how heavy each tray could be? And then that last one is one that I want to make sure we definitely spend a little bit of time on is for our large sterilizers. What is that cumulative weight capacity look like? If you add up the weight of all the trays that get in there, does it exceed the total amount of weight that that sterilizer can handle? So yeah, lots of different angles here. Maybe starting with that last one, Carol, about, you know, these weight capacities for the sterilizer, I've always kind of wondered why do those weight capacities exist? What's the risk of having a chamber that gets overloaded?

10:25So, you know, there's really three main reasons. So the first is steam penetration. Because steam has to reach all the surfaces of the instruments. And overloaded trays, you know, especially if instruments are stacked too tightly, it blocks the pathways. So then the second thing is mechanical safety. You know, sterilizers are designed for certain for certain loads. So too much weight can strain the racks, the doors, the chamber door, you know, and as you said, the people themselves, third is the cycle efficacy, you know, overloading can extend cycle times. And it can prevent the sterilizer from reaching temperature. And again, it's and the pressure throughout the load. So, you know, in short, patient safety is always our top priority. And if we're doing these things or we're going against these things and IFU's our machines, we're really putting patients at risk and the equipment and ourselves. Yeah, that is always the right answer when you're talking about following the IFU as well. We aren't the people who made this thing. So let's trust the scientists who validated this,

11:29put it together, and put patients first. Like do the thing that the company said is safe. And if they say, I'm throwing a number out here, Carol, I probably should have looked up and IFU before we talk. But, you know, if it says 400 pounds to go into the the cycle, then gosh, we should not do 401 just because that's what that's what they that's what they said for for the sterilizer chambers. Yeah, an interesting homework for the audience is to go look at your sterilizer, your steam sterilizer, user manual, and see if you can find a weight limit for total capacity. Not just, you know, the cubic inches that it can hold on that sterilizer card, but but how heavy can the trays be, add them all up together? Because you may find that you're run into that. Carol, in addition to being an educator, you've had some operational work here as well, you know, just working in sterile processing, leading sterile processing. How should departments practically deal with that sterilizer weight consideration? I've not seen anybody putting their

12:35sterilizer card on a bathroom scale to make sure that, you know, that it's within those parameters. Like, how would you, how would you succeed practically at meeting that requirement from the, from the sterilizer manufacturer? There are several things you can do. Obviously, like you said, you want to get into your sterilizer manual and look up what that weight capacity is. A lot of what I've seen are 325 pounds, 375 pounds. So what we want to do is weigh the trays before sterilization. So a simple scale in the department can accomplish this. A lot of our tracking systems do have the ability when we're creating trays or a checking owner trays in for them to be weighed at that time, and then it goes into the tracking system. And then as the sterilizer load is being built, it'll pop up on the screen. I've seen several tracking systems that do that, and it will add the weight as you are building that load. And once you hit that capacity, it should alarm or something should pop up on the screen. Another way we can do it is, you know, label the trays with their weight. So staff can see it at a glance. And again,

13:36that can print out on the barcoded label that comes out of the tracking systems. We could standardize our tray contents so that, you know, we're consistent with packaging, which will reduce surprises and weight fluctuations. We all know that certain trays may come in heavier, and we all have trays, you know, that potentially need to be separated or broken down into multiple trays because they're too heavy. So be conscious of what we have. And we can document her tray and per chamber limits. And I've seen this at several facilities where it's actually posted on the sterilizer, you know, sterilizer one max capacity, 375 pounds, or 12 trays, you know, I don't like to put a tray limit on it, but at least that gives a visual to a technician who's loading a cart as to how many trays can go in a load. Yeah, if you set, like, worst case scenario, if we say our trays are no more than 25 pounds, just divide your weight limit by 25 and say no more than this many trays. You might undershoot it most of the time, but you're never going to overshoot it with that. Yeah, that's a really quick

14:39visual. As people don't have tracking systems, you know, because not everybody does. A lot of the ASCs are smaller hospitals or what have you won't. So that visual is definitely helpful. I think you just brought up a really important point, right? For those large SPD departments, usually their sterilizers have much more capacity, right? And so in those smaller departments, it even becomes more critical. And so, you know, what are the risks for those technicians out there if I have overlaid overloaded trays or cycles in that patient safety space? Well, you know, we talked a little bit about, you know, the steam penetration can't really occur as well or as effectively. So if we're overloading too heavy, we're stressing the machine, penetration isn't happening. Are those trays really sterile? I don't know the answer to that, honestly. Yeah, well, that validation question is an important one. And you said something

15:40a minute ago, Carol, that is a conversation in the industry for sure, is what do you do when you get a tray that comes in that's overweight? You know, maybe it's a big multi-level shoulder tray or something that you weigh it, it's 30 pounds, but it's a loner. And that's the way it was configured to be sterilized. What's your take on that conversation? Do we separate those trays out and kind of create our own configuration? Do we have the arrangement that came from the manufacturer as is? Do we just sterilize it that way? Because that's what they said, even though it's over the recommended weight limit for the packaging system, the sterilizer, and the best practices for ergonomics, do you call the manufacturer and the surgeon say, hey, we will not sterilize this, like what route are you taking to deal with that overloaded vendor tray? So, you know, the first step is really to check the IFU of the machine that you'll use, because we really don't want to go against what the machine manufacturer is telling us to do.

16:44And if the tray exceeds that limit, here's what we could do. We could split the tray, and we could ask the vendor to send instruments in two smaller trays, or we could have them on site split it into two trays. It's possible we could remove non-essential instruments and sterilize those up separately, you know, or use a larger or specialized sterilizer. So, some facilities, I've not seen many, but some facilities, as we were talking, have machines that are designed to handle heavier loads. You know, there are machines that are floor loaders and things like that. So, if they're lucky enough to have that, this may not be as much of an issue, but we really have to follow the IFU's of the sterilizer, of the container manufacturer, of the instruments themselves. You know, we're bound by a lot of these rules and rags for a reason, and it's all through the patient safety. Sure. Yeah, the trouble is I don't, I've not seen, maybe there is one, but I've not seen a container manufacturer out there or a wrap that will, that will recommend greater than 25 pound limit. And so, yeah, you really, you really do kind of have to get creative. One of the things

17:50that I have seen, Garel, I think it was, I don't want to, I don't want to say which company, because I'm going to end up getting it wrong, but they had a validated miscellaneous tray, that was just one of their standard loner trays that was wide open, and they had done some sterilization validations for different types of instruments in it. And it was almost a blessing for their reps to, you know, throw those few extra instruments that the surgeon likes, rather than tossing them on top of the other instruments in whatever tray, as we sometimes see happen, they have a miscellaneous tray that's, you know, validated for their instruments. So if you've got a solution like that, that makes the validation question pretty easy. Like, well, let's just take some of these instruments out, put it in kind of their miscellaneous tray, because we have this validation that it can be sterilized that way, and sterilize them side-by-side in two containers. It just ends up being a different question if you don't have that, and you're kind of creating your own basket, you know, science and reason would tell us that, you know, this perforated basket, or that's being wrapped in this same blue wrap as that one, it's fine,

18:53but it does create an interesting conversation about validations and how we can sterilize arrangements of vendor trays. Carol, you know, we've really leaned in on the loners being culprits. In the work you've done, do you find that sometimes that there are certain problems with in-house trays that we kind of ignore that you can shed some light on? Sure. I'll just give you an example. Several years ago, when I was running a department, when I first got there, we had just started kind of weighing trays and figuring things out, and we had a book waltzer, and the book waltzer tray weighed 35 pounds, and I struggled to lift it, and get it up on a wrapper, and when I figured out it was 35 pounds, I very shortly thereafter broke it down into two trays. So, you know, and a lot of the times what will happen is when the trays are made too heavy, it's because, oh, doctor so-and-so likes this instrument, likes that

19:56instrument, all of a sudden they just start throwing all these instruments into this tray to make it quote unquote easier, but what they don't realize is they're making, you know, more metal mass, they're making the trays heavier, so it's putting more physical strain on us, on them, on sterilizers, so I'm all about instrument tri-optimization, honestly, less is more, but yes, I've personally experienced that and personally had to break the trays down, and then I had facilities that had the 17 pound weight capacity as well, so that that took some finagling to get those trays down. Yeah, so those smaller sterilizers, you've mentioned that 17 pound limit a couple of times, is this like what we would typically think of as an immediate used sterilizer chamber, like one of those really small chambers that fit one tray or something a little bit larger than that, but it just says per tray 17 pounds. Correct, it was a full-size sterilizers actually, and until we started really looking at weights and weight capacities, we didn't even realize it, so I was an older facility, but actually there's

21:00a couple, and yeah, until we started looking at this, we had no idea, so that did pose a problem for loner trays, for sure, because a lot of them are pretty much maxed out at the 25 pounds. They sure are. Again, we had to get creative now. Yeah, splitting up an awful lot of trays. And a lot of people don't recognize that if your sterilizer was made between 2006 and 2008, is when that 25 pounds came into play from Amy, and so that influence our manufacturers, but before that, many of those sterilizers that are oftentimes still in place and run in every day have 17 pound weight limits. So if you've got kind of the submarine style handle turn crank on your door, you might want to go with a go look at your eye at you, or if you are with a manufacturer who didn't really change the outside of the machine, but kind of change the inside, you'll run into that problem as well. Yeah, no, that's really fascinating.

22:01So that's sterilizer weights definitely. Do your homework, read your operators manuals, make sure that we're complying with that from a tray drying perspective, with metal mass, we don't want wet packs, and then from that steam penetration perspective that you mentioned, Carol, I'm curious from a packaging perspective, are there any unique weight considerations for individual sterile packaging, whether it's containers, wraps, peel packs, any of that that you want to shed any light on? So yeah, I was doing a little research about containers, and looking in the Amy references, and that we really need to read our IFUs for everything. I know I keep saying that, but when you start reading the IFUs for peel packs and you start reading the IFUs for your blue wrap, and you start reading the IFUs for your containers, you all of a sudden realize, oh my gosh, I'm supposed to be validating all these products to run in my sterilizer, and then I'm supposed to be following weight limits on all these things, and making sure that I'm

23:03loading them correctly. So there's so many rules that we have to follow for all this stuff. So just be vigilant on some containers are very specific, honestly, which I did not realize until I started reading all the IFUs. We've got one packaging story that I learned the hard way related to surprise reading an IFU from some packaging. So we were using a blue wrap from a particular manufacturer that has a lot of different thicknesses of their blue wrap. So we were buying the 36 inch by 36 inch, the 48 by 48. We had our different sizes, and assume that because we had the right sizes, we just order the one that was on our ordering template from supply chain that they could all hold the same amount of weight, come to find out the thickness of the wrap that we had been ordering wasn't the thickest variety. And if you open the IFU from that manufacturer in there, there's a

24:03handy little chart that lists all of their models of not the wrap sizes, but the wrap thicknesses, and the recommended weight capacity for each one. And only the thickest one recommended up to 25 pounds, but for the thickness that we were buying, I think it was 17. And then there were some lower than that. And then if you got all the way to the top of the thinnest one, which you might be using for like a little tiny Doppler probes or something like that, it was like three pounds inside of those or something really small. But I had no idea that you had this packaging that looks the same as the one that can hold 25 pounds, but you know, the model that we've bought, only 17. So yeah, definitely read those IFU as I agree with you. Yeah, and along with the wrap, yeah, some of it is so thin you're supposed to double wrap it. I found that out as well. I was like, I do not even know that. Yeah, if it doesn't come in the already double bound, you got to use two sheets for sure.

25:04And does it translate to pill packs in any form or fashion in your research, Carol? As to loading or the way limits in pill packs. Yes, actually. Well, you know, that's also a common misconception. Like, pill packs are not for like one or two lightweight items. And people have been to hospitals across the country, and you'll see, oh, they have rungers, and they have heavier things in there. And my questions always why? And the answer is always, well, we like to see what's in the package when these items really should be blue wrapped based on their weight. And then like, like Bobby just said about the weights for the different items. And I think you're right, we all just get on autopilot, we just grab a wrapper off the rack and just start, you know, or this is this is the tribal knowledge. This is what we do here. This is what I was taught here. So sometimes that is actually the detriment is the tribal knowledge and trying to change the culture and the way things have always been done versus what should be done. Have either of you two seen the really sturdy pill packs that

26:14show up at industry shows from every now and again, like these really large pill packs, you can pill pack a whole like a whole trays worth of instruments inside of Melissa, you're not in your head. Yeah, I've seen them. I always have doubts. Always have doubts for some reason. Well, I'm not going to cast any doubt on the on the claims of the products, because that's not what we're trying to do on the episode today, but that always made me curious, like what we can do from an innovation standpoint to meet those needs. Like Carol, you're talking about the need is, you know, for whatever, for whatever clinical reason, they want to be able to see inside this package. Maybe someday we're going to have some kind of wrap that is clear, but can handle, you know, handle something a whole lot heavier so that the pill pack seems less life or less of a problem, or maybe the pill pack material changes, such, you know, kind of like those, those whole tray pill packs that can handle a whole tray that we can use, even though I imagine that would be quite a bit more expensive, but figuring something out like that. I'm curious as we, you know,

27:17as we move to kind of close the conversation here, Carol, looking towards the future, how do you, do you see technology supporting us complying with, with weight capacity issues, whether it's the standard recommendations or the, or the packaging recommendations of the sterilizer recommendations, how's technology going to support us in this? Well, you know, we touched a little bit on it, technologies making compliance much easier, you know, especially as more and more facilities go to tracking systems, integrating the tray tracking systems, because they can log the tray weights, they can alert staffs when, you know, limits are exceeded, they can store that information, so it doesn't have to be put in every time, you know, and then when the loads are being built, again, it's tracking the load, it's not going to let you exceed that weight limit. I guess there's smart sterilizers out there, you know, as we were talking, you know, things before 2006, 2008, well, now it's 2025, so if you're lucky enough to be getting a new sterilizer, there's smart ones out there that can detect overloading, or even uneven placement and adjust cycles,

28:22which would be fantastic for everybody to have that automatically happen, so loads don't get rejected. And then, you know, there's automated inventory management that can help distribute instruments across trays to prevent overload, overload, overweight loads, I'm sorry, like I said, I'm a huge fan of instrument tray optimization, less is more in my mind, which is another topic for another day, but getting unused instruments out of trays, you know, instead of just continuously reprocessing them and wearing them down and ruining them when they're not necessary or needed, or use half the time, you know, and looking forward the combination of the digital scales, RFID tracking, smart sterilizers, and so on, really could make exceeding weight limits nearly impossible, you know. Yeah, well, we're recording this, this episode just shy of Christmas in 25, and so I'll add those to the list of the shopping list for the smart sterilizers. No disagreement from us here, by the way, on that instrument optimization piece, like, you know, without spending, you know, a half a million dollars on new equipment,

29:24there is work to be done in finding out what instruments don't need to be in trays, and how to split them up in a way that makes sense that can actually help operations and not just annoy your OR, like they may be pleased to not have to handle so much on the back table. So yeah, really insightful stuff, really fun interview today. I appreciate, I appreciate you, Carol, for bringing an important topic for folks to consider and giving us some IFU homework to make sure that we're doing the right thing from a compliance perspective. Hey, if anybody else wants to continue this conversation with you, would LinkedIn probably be the best way for them to get in touch with you? That would be perfect. Awesome, we'll make sure to include that in the podcast description. Carol, good to talk to you again, as always, thanks for for doing the homework and bringing some research with you, and yeah, thanks for sharing this important topic with the industry. Thanks for having me.

30:28And that was Carol Malone, sterile processing educator out there in the Midwest. And Melissa, you know, we say this on just about every episode about how quickly these things go by and how much we just skim across the surface. But we just covered a lot of really important material in pretty short order around a topic that doesn't get a lot of attention. And I think Carol brought up quite a few good points. If not only the reasons why it's important or why we have these weight limits in place, but also some practical considerations for how to how to find them. And you probably heard from from my tone on the episode. I I guess I didn't realize that there were sterilizers out there that had a tray specific weight limits, even large sterilizers that have that. So definitely some homework to take away from this one. Yeah, I have in my past seen that and it been quite a surprise to the team when they actually

31:29get in there and look at those IFUs because we are so ingrained to think about that 25 pound weight limit. So great information from Carol and definitely some homework for all of us. All right, so real talk for a second. You've experienced that 17 pound problem personally. What should a facility do if they encounter that they they come away from this they they read their their sterilizer IFU and shoot it says that trays shouldn't exceed 17 pounds in their sterilizer like you can't just erase that knowledge. So what do you do at that point? What you mean you don't want us to all pretend we didn't read it. No, no, no. So I think really the most successful thing when you come into that information is really to pull your multidisciplinary team together because this really impacts your OR and your SPD team as well as could potentially impact how your storage is set up and handled and so really getting the

32:36brain trust together to think about okay what are we going to do what can we do because I think it's probably a multi-prone approach. You're going to have to remove instruments you're going to have to think about separating instruments and you're probably going to have to look at what needs to be wrapped versus put in a container and then never forget your manufacturer because maybe there is an updated IFU maybe there's some validation work that they could do for you on site so never leave them out of the responsibility. Yeah well said we love those customer letters if you reach out as long as you've got something in writing you can file in that manager desk that says it is okay to press to be using these then then you're golden so just make sure it's a scientist that writes it is the only tidbit I would say it cannot come from a sales person. You can't get your sales rep who's who's servicing the hospitals in your area oh it'll be fine just 25 pounds is good sign your local sales rep. No local sales rep. Okay well yeah really good conversation today

33:40wish we could could have a part two to that one and dive into some of those practical considerations or or even deeper into the science you know answer in the question like well you know why is steam contact so difficult to do beyond 25 pounds or you know steam density and wet trace lots of yeah lots of things to consider I think later this season we are going to do a little bit with wet packs because you know no no steam sterilization season will be complete with our wet packs episode so maybe we'll maybe we'll pick it up back then but until we talk to you again next time we'll leave you as we always do here at Beyond Clean on behalf of Melissa myself and the whole team here Beyond Clean keep fighting dirt. Thank 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

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