Instrument Sterilization Update: Pouches, Wraps, Cassettes, Indicators and More!

You're listening to the Phil Klein Dental Podcast Thanks for joining us. I'm Dr. Phil Klein. Dental practices rely on the results from CDC -recommended spore tests to assess whether their sterilizers are functioning properly. Today, we'll learn the other critical component of quality assurance. which is sterilization indicators and integrators. Our guest is Mary Govoni, a speaker, author, and consultant on infection prevention control and regulatory compliance. She assists dental teams in achieving compliance with OSHA standards and CDC guidelines, as well as following appropriate infection control protocols. Before we get started, I would like to mention that Mary's webinar titled, Why Are Sterilization Indicators and Integrators So Important for Patient Safety? That webinar is now available as an on -demand webinar on VivaLearning.com. Simply type in the search field Govoni, G-O-V-O-N-I, and you'll see it. It's an excellent webinar for the entire dental team. Highly recommend that. Mary, it's a pleasure to have you on the show. Oh, happy to be here, Phil. Thank you very much. So isn't it enough to spore test the sterilizer weekly to ensure that instruments are safe and sterilized? Yes and no. Certainly doing that weekly spore test, and it makes me cringe thinking that for years we did it just monthly, doing that weekly spore test is certainly an element of quality assurance. But if you think about it, that spore test that's done either at the beginning of the week or the end of the week is really capturing a moment in time. So in that load, I had absolute microbial kill. because perhaps I loaded everything correctly, I'm more careful when I run the spore test, or some people will run the instruments on an empty load, which according to most of the manufacturers, you should not. You've got to have that challenge of more things in the load. So I know it worked at that time, on that cycle, on that sterilizer, but what about the rest of the loads that you run from one week to the next? And there's where we have to have more quality assurance measures, meaning indicators that we use in the sterilizer, in the pouches, and in the sterilizer itself to make sure things are working correctly. So you're saying in the past we did it once a month? That was the typical protocol? Wow. The 1993 CDC guidelines said once a month, and then in 2003, that was changed to weekly. And many people thought, oh my gosh, that's so much. But it's really not enough. In Canada, dental practices have to spore test their sterilizer every single day. And they cannot use that sterilizer on any given day if it hasn't passed a spore test. That's what you need to. sterilizers minimum in your practice. Yeah. So what other protocols should a dental practice follow for monitoring the effectiveness of the sterilization process? Great question. According to the CDC, in the guidelines for disinfection and sterilization, and in the guidelines for infection control in dentistry, they say that it should be a combination monitoring the sterilizer should be a combination of three things one is mechanical monitoring which means that when you run every load you're looking at the gauges and the dials or whatever controls you have and or you're looking at the printout that you get at the end of that load to make sure all the parameters were met the temperature the time and the pressure and then we do chemical monitoring which means that you put some kind of an indicator in the load and in the packages and then biological monitoring which is your sport test so it's a three-pronged process and i know some of these sterilizers have some internet-based feature to them the company that sells you the sterilizer monitors how your sterilizer is behaving are you familiar with that at all i am and i think that they are like the greatest thing since sliced bread because if something's malfunctioning they can alert you right away to say hey you may need to reprocess these items in another sterilizer because something's wrong with your cycle rather than just maybe somebody's not checking the controls and so maybe it's been doing this since the last score test so yes in fact if you look at the um a group called amy which is the association for the advancement of medical instrumentation their standard 79 which speaks to instrument sterilization says that if you don't have some kind of an external printout or you can add one on if you don't have the ability even to add one on if it's not built into your sterilizer they say you shouldn't even use that kind of a sterilizer. So it should have some way to print you out a validation of the load, like a receipt, or connect directly to your spore testing company and let you know that everything is okay. When that monitoring is going on through the internet, is that mechanical monitoring? That is mechanical monitoring, yes. Okay, so that's the one component that you mentioned out of the three, but it doesn't offer anything beyond that. No, it does not, because when you have to do the spore testing, they actually have to be able to incubate and see if anything grows from that test medium. So no, that is mechanical monitoring, but it's mechanical monitoring at its best, at its highest level of efficiency. So when we talk about indicators, tell us what integrating indicators are. Integrators are a higher level of an integrator, meaning they give you more information. So we have two types of integrators that are available for sterilization monitoring, and they're actually called integrating indicators, a type five and a type six. Type five is truly the integrating indicator because it measures all the parameters for sterilization time. temperature, steam penetration, or pressure, as it's referred to a lot. And it will measure those at a high level of predictability to tell you that it is most likely all the microorganisms were killed, but isn't an absolute until it's validated by a spore test. Then a type six integrator is called an emulating integrator. And it is essentially like the equivalent of a spore test, but It's not a substitute for a sport test, and it's used in specific situations, not in dentistry, but in medical kind of situations, that one is used. Yeah, and you go over this in more detail in your webinar that you did. I mentioned in my introduction, the title of that is Why Are Sterilization Indicators and Integrators So Important for Patient Safety? I certainly recommend that to everybody. Just go to VivaLearning .com, look up. Govoni in the search field, G-O-V-O-N-I, and you'll get a full coverage webinar on all the details that Mary just went over. So what options does a dental team have for packaging instruments? We hear so much about packaging, and that's such a big topic when it comes to autoclaves and sterilization. What are the options? Absolutely. And that was a change that we got in the 2003... guidelines from the cdc stating that all items must be packaged prior to sterilization so anything like furs or hand pieces or instruments whatever it is And so there are a lot of options for practices to use. The most common are sterilization pouches. And they usually are made of paper and a plastic-like material. And they put the instruments in and then seal the pouch. And then there are other paper types of pouches that are used for dry heat sterilization. And you can also buy what is like a nylon or looks like plastic tubing that you cut to size and then you seal it at both ends. It's kind of make your own pouch. So let me ask you this. What kind of wrap is appropriate for instrument cassettes or surgical instruments that are bundled? the type of wrap that needs to be used is something first of all that's fda cleared as a csr or a surgical wrap so we can't use butcher paper which i've seen used or brown paper that comes in big rolls that can't be used because it doesn't meet the specifications of when the sterilizer heats up the pores on the fabric will open up and then when things cool down again the pores close on the fabric so that it prevents airborne particles from getting into the cassette. Plus those other papers will tear very easily. So the other thing that I see is a common misconception with wraps is that the instructions for use for the wraps from the manufacturer need to be followed very closely because According to the Food and Drug Administration, the way these items are cleared or approved is that you either need two separate sheets of wrap, or you can look at some manufacturers like Halyard that have one sheet that is actually two sheets fused together. So in that, you can do a single sheet wrap. From some other suppliers, you need to use two sheets of wrap. So that sounds like a huge efficiency factor for doing this day in and day out. You're only doing one pass on that. So there's got to be a return on investment on the Halyard product, I assume. Absolutely. And they've been... manufacturing that CSR rep for years and years and they really got it down to such good quality manufacturing processes and it's such a good quality product that it's also can be used as sort of a barrier to cover countertops or bracket trays in the treatment room as well so that's another advantage of using that wrap The thing to know about whatever type of packaging materials that you're using is there has to be some type of a chemical indicator in that package. And the most common misconception that people have is that if they're using autoclave tape to seal the wrap on their cassettes that that means those instruments are sterile. All it means is they have been through a sterilization cycle. It's a single parameter. only measures the temperature in the sterilizer. What is the protocol for monitoring each sterilizer load of instruments and for each pack of instruments? Great question again. first and foremost the cdc says that an integrating indicator a type 5 indicator should be placed in every sterilizer load because it will measure all the three parameters necessary for sterilization and then you follow the manufacturer of your sterilizers instructions as to where you place that in the load where it will be most challenged and then there needs to be some type of a type three or type four chemical indicator on each package. Now, most practices use the pouches and they use pouches that have internal and external indicators on them. And they'll change color when if the process has been successful. If you use some kind of a packaging material that doesn't have an integrator built in or an indicator, I should say, built in, then you need to place. a strip and they're usually like paper strips that you place inside of a cassette or inside of a pouch without indicators and that has to go in every single package so then when the sterilization cycle is done the first thing you do is you check your load integrator and see if that passed if it passed the instruments need to be checked but they can be released if the color change didn't happen or the the as they call it a moving front didn't change on your integrating indicator you need to repackage and reprocess all of those instruments so if they're good to go the indicator passed then you check each package individually and if any one of those did not have the appropriate color change then they need to be repackaged and reprocessed. The only exception to doing it immediately would be in a cassette. I wouldn't open up the cassette until I was ready to use it. But I need to remember to check that indicator when I open the cassette to make sure it's safe to use those instruments. And if not, they go back to sterilization and you take another cassette. So it seems like there's a lot of fail safes involved. There's a lot of, it's not an automated thing where it corrects itself, but. There's a lot of warning signs that are going to tell you that, you know, things are not heating up the way they're supposed to. Would you say it's just an extremely safe industry right now as far as that goes? I think it is for the most part. And it's backed by the science. We don't see very many health care associated infections that come from dentistry. Most of the health care associated infections that patients get or are exposed to come in hospital settings or medical settings. And we don't have that kind of data coming out of dentistry. When cassettes came out back in the day, and I know Euphredi was a big company that was selling it, everybody thought everybody was going to be switching to cassette systems. That reached a certain level amongst dentists using that, but it kind of tapered off. And now you say that we're still mostly using paper packages, right? Yes, I would say so. But what I do see are more of the. Larger practices and a lot of the DSO practices are using cassettes because they're so much more efficient and they absolutely are safer for the team. And it saves so much time in handling instruments that once you're finished with treatment, you put the instruments in their places back in the cassette and you close it up, there's no way I can get poked. And all I have to do is take the cassette and take it to the ultrasonic or the instrument washer as one unit, as opposed to individually handling a whole bunch of instruments. More people are seeing the benefit and looking at the fact that there's a pretty good ROI on that investment in cassettes. You know, you have that initial cost to purchase all this, and that's, you know, a lot more expensive than buying paper bags. You're saying the ROI on it certainly justifies doing that because just plain what you said, the efficiency is so important and the safety. From OSHA's standpoint, OSHA must love those cassettes, right, for employee protection. They do. And right now where we're seeing so many dental assistants in particular coming into dental offices as new employees who have very little ROI. no experience, they're certainly going to be at risk of some kind of an injury or perhaps not getting setups packaged correctly if all the instruments are going into pouches. It's just so much quicker and easier to learn how to utilize an instrument management system. rather than handling all kinds of loose instruments. All right. Well, thank you very much, Mary. A lot of great stuff in here. You know, it is encouraging to see all the systems in place that protect our patients, protect our employees from infection, moving from one patient to the other through instruments. I mean, I think we've got that under control. There's ways to spread disease in the dental office, but hopefully not through instruments. That's, you know, aerosols. I think we... did a remarkable job through COVID considering the fact that we had very little notice and very little preparation for that kind of pandemic, which we haven't seen in a century, right? I totally agree. But word to the wise, be prepared for this fall because I'm reading information from public health sites and organizations that are saying that they think we're going to get a triple whammy again this flu season of flu, COVID, and RSV. So don't throw away your N95 masks and don't stop screening patients for respiratory symptoms. Right. No, absolutely. We'll be reaching out to you to get the latest information on this. You can be sure. We'll be calling up Mary Gavone saying, Mary, we need you to talk on Viva Learning and tell us what's up. All right. Well, thank you. I'll be happy to do that. Yeah. Thank you so much for your continual amazing contributions to Viva Learning and the dental community as a whole. And we look forward to your webinar coming up in future podcasts. Thank you so much, Mary. Thank you, Phil. If you've been enjoying our podcast, we'd love to hear your thoughts and feedback by leaving a review on your favorite podcast platform, whether it's Spotify, Apple, Google, or any other platform you listen on. Leaving a review is a fantastic way to support us and help others discover our show.