The Compliance Divas Podcast
Our podcast covers current topics such as infection prevention and control, OSHA and HIPAA compliance for dentistry. We discuss the latest regulatory information, answer frequently asked questions and give suggestions for dental practices to make compliance easy and sustainable. The Compliance Divas are a trusted source for consistent, accurate information based upon current guidelines, standards, science, and recommendations.
The Compliance Divas Podcast
#98 The Divas Podcast from the Hinman Meeting - Sterilizer Monitoring
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Coming live from the Hinman Meeting, the Divas discuss sterilizer monitoring, also known as spore testing and use of biological indicators as part of the instrument reprocessing protocol. In order to ensure that instruments are safe for reuse, dental teams must verify their heat sterilizers are functioning properly. This episode will discuss the proper method for performing these tests.
Best Practice for Routine Sterilizer Efficacy Monitoring:
https://www.hufriedygroup.com/sites/default/files/2021-07/cro-infosheet-bestpracticesterilizerefficacymonitoring-dlit01600-reva-0421-2104.pdf
CDC Sterilization Monitoring: https://www.cdc.gov/oralhealth/infectioncontrol/faqs/monitoring.html#:~:text=How%20often%20should%20biological%20monitoring,load%20with%20an%20implantable%20device. -
Welcome.
SPEAKER_00I'm Leslie Canum. I'm Mary Gavoni.
SPEAKER_02I'm Linda Harvey. I'm Olivia Juan. And together we are the Compliance Divas. Welcome to the Compliance Divas podcast. I'm Mary Gavoni and my colleagues Linda Harvey, Leslie Canham, and Olivia Wan are live at the Hinman meeting in Atlanta. We want to thank the Hinman Dental Society for the opportunity to be able to record at their meeting. And we have selected a great topic for this particular episode. The compliance divas bring clarity and simplicity to the regulatory world by navigating regulatory compliance to keep you on course. You can subscribe to the compliance divas podcast through your favorite podcast channel or on our website, thecompliancedivas.com. Any resources that we mentioned during this episode can be found on the ComplianceDivas website, thecompliancedivas.com, and you can submit questions by email to support at thecompliancedivas.com. Support testing of sterilizers is a critical component of instrument processing and patient safety in dental practices. But many times it just becomes a sort of a routine or a rote process where we don't necessarily think about all the steps that are involved in getting our spore tests accomplished or processed. And it we want to prevent false positives from the testing process, also known as failures. And so great care should be taken to follow the steps specifically that come from whatever spore testing system that you use. It may be a mail-in system where you get strips that you process and you have a control strip that goes with it, or you may have an in-office system that uses a vial that you process also with a control vial. It doesn't matter necessarily which type of system that you use, but you need to follow it, follow their instructions for use, and also make sure that you are following the instructions for use from your sterilizer manufacturer to make sure that you are placing the spore test in the right location in the sterilizer. In our episode in April, the beginning of April, we are going to discuss more details about sterilizer testing, spore testing with our sustaining sponsor, Hugh Friedi. So watch for that episode. But today I'm going to call on Leslie to list for us some of the first things that you need to do in monitoring a tabletop sterilizer, which is the most commonly one used in dentistry. Leslie?
SPEAKER_00Well, Mary, the first step is always to get acquainted with the products that you're going to be using and also to review the manufacturer's instructions of the sterilizer you're using to make sure that if there's any comment about where to place that spore test strip or that test package, that you will know that in advance. And so once you've become familiar with both your equipment and whatever spore test medium you're going to use, whether it's going to be a mail-away strip or whether it's going to be an on-site test file, be sure and read the instructions. And I want to go just quickly review those steps in case there's anybody that needs a refresher. So you select your sterilization packaging material as well. If you're commonly using the self-seal pouches, then make sure that you put your Spore Test strip or vial into that type of material. If you wrap your pouches or wrap your instruments in cassettes, however, you commonly process instruments, then you would use that type of wrap to wrap your instruments. So let's start out with let's say we have a vial, and we're going to pick again the best type of wrap that represents what we routinely processed. We're going to record the test date on the biological indicator vial and the sterilizer number because many of us do have more than one sterilizer. We'll also indicate the load number as that pertains to your practice. In some larger clinics, they keep track of each load number. And then, of course, the processing date. And I've seen uh the pouches sealed a number of different ways. So we want to make sure that it's sealed correctly. But before we go into sealing the pouch, one additional step that is recommended that we take in the 2008 T C D C guidelines uh regarding sterilization and disinfection is to add something called a type 5 integrator. A type 5 integrator strip uh provides you immediate feedback. Now, it cannot replace spore testing. Many states require that the biological indicator be exactly that, but it does give you an immediate response. And so adding this to the package or the cassette with either your strip or your vial is very important. Now, um you want to also make sure that you run in a load that has instruments in it. You want to have a representative of the type of situation you would have normally. If you run a sport test in an empty sterilizer, that is not the true uh reflection of how your instruments are processed. And uh you want to make sure, again, when you after you have run that uh process, you want to take a quick look at that type 5 integrator to take a look and see if all of the critical variables were met. If not, there may have been an error. And I know that uh, Mary, you're gonna take a little bit more time to talk about placement of the biological indicator and uh what the steps are. Linda's gonna cover that. So I'll leave it to you to bring up the rest of the information.
SPEAKER_02Thank you, Leslie. That was great information. And I think a lot of times um practices, again, just sort of routinely um make up their own process, if you will, for how they place the um biological indicator, the spore test, and may not know that you should also use, according to manufacturer's instructions for use, a chemical integrator in that load. So, Linda, tell us about how do we place these in the load to make sure we're getting the right results from our testing process.
SPEAKER_01Well, that's the next step, Mary, in this whole process of testing our sterilizers is after we've got the test pack assembled, as Leslie mentioned, now we need to figure out we just don't toss it into our sterilizer. We need to have a process and understand the correct method of doing so. So before you toss it into your sterilizer, the first thing you want to do is label the pack and date it. So let's talk about that. If most offices have multiple sterilizers, so we need to be able to distinguish do you call it sterilizer one, sterilizer two, do you call it A or B? How do you how do you name your sterilizers? So that needs to go on the pack as well as the date and the load number and the word test, because that really identifies that it is the test pack. So after sterilization, whoever's unloading that unit will know exactly what the point of having that pack in there was for. So before being, we do all that before it's exposed to the sterilization sterilization cycle. And for pouches, you would write that on the label on the plastic side of the of the pouch. And for a wrap cassette, only write on the indicator tape. Those are the two areas I want to be careful, which is not writing all over the pouch and writing all over the wrap in this for these tests. Next, we want to place this pack into a fully loaded chamber. So, in other words, we're not running it when it's empty or there's no other instruments, and then where we put it in the chamber inside the autoclave is extremely important because you want to put it in the least favorable position. And that is normally in the center of the load towards the front of the chamber. Mary, this is often called the called point, if you will, cold point in the practice in the autoclave. So we want to be sure we're testing at the least favorable point. So, but before we do that, Mary, I want to tell everybody to go back and take a look at the sterilizers operation manual to be sure they're looking for the details for that. Not only are they following the BI test pack directions that Leslie mentioned, but you also want to make sure it coordinates with your particular units and the brand of the models that you have. So once that's all done, go ahead and put it and put it in the cold spot. Now you're ready to run your autoclave, your sterilizer, for the regular cycle that you normally do according to the manufacturer's instructions for use. And then once that's complete and the cycle's all cooled, now you the test pack is back to room temperature. Then you can open it and remove the biological indicator and the type 5 integrating strip and then visually inspect those two items, Mary. So we want to just don't just take it out and toss it and log it and assume it passed. We want to have that visual confirmation as well. So the test vial should be examined to confirm that the chimmel indicator strip turned on the on the label. So that is important at that point. You're looking for that to be sure it's proper. And then if it's the medium in the tube, you're going to crush the indicators. Pardon me, you're going to crush the inner media tube and incubate it for the correct time and temperature according to the product that you have. So that's one or the other, depending on whether you've got the strip, test strip or whether you're using the um in office incubation system. And then you're going to look at your type 5 integrating indicator to make sure that that has and move to the safe zone or or whatever the process indicator is for the strips that you have. There are several different uh brands of integrating strips, pardon me, on the market. So be sure that you're reading that properly once it's processed. And then each day, Mary, you've got to run your test, you know, the same lot, same number, make sure it's all been exposed to the sterilization cycle and always labeled. But I'd like to take a pause here because we're talking about some different things. We're talking about control, Mary, and we're talking about the test BIs. And I know Olivia Juan really wanted to go into that detail more, uh, in greater detail rather, and talking about how to interpret those results. So can I pass this back over to you? And could you share some things with our listeners on that?
SPEAKER_02Absolutely. Part of the score testing process is utilizing not only the strip or the vial that you place in the sterilizer and run it through a cycle, but also having a control vial or control strip that has not been run, that has viable organisms, so that you can compare the results. What you want is for the control strip to be positive after it has been incubated or run, and you want your vial or your strip that has been run through the sterilizer to be negative. In other words, no microorganisms group. It's important, as you mentioned earlier, Linda, that it comes from the same batch so that we make sure that the same process was followed through in manufacturing and putting together those strips. But always, always run the control or have the control strip ready for or the control vial ready for processing. It's not just about what you run through the sterilizer, it's comparing the results from the two. And also make sure that again, you're following the manufacturer's results. You have to make sure that those control vials or control strips are stored somewhere where they have not been exposed to any conditions like heat or moisture. So they have to be protected so that they are liable. So, Leslie or Linda, anything to add to that?
SPEAKER_00Well, yes, actually, Mary, I wanted to remind everyone that when you have the mail-in package, the mail-in strip, the control strip is in a sealed part of that mail away package. And usually the instructions say don't open it. Um, one of the important parts of the control is that it is from the same batch as the test pack. And so the strip that is the mail away, that's easy. It's already sealed. That the instructions are there, don't open this. Uh, put your strip test strip in and mail it away. But uh, the one part that we may find sometimes some confusion is with the control from a vial. And we want to make sure that we have exactly the same batch because it's important that the test results are reflected from a test vial and a control vial that are the same, the same batch.
SPEAKER_02Thanks, Leslie. Linda, did you have something that you wanted to add?
SPEAKER_01I think Leslie covered it beautifully, Mary. I'd like to see us talk about the record keeping. You know, as compliance experts, that's a really big deal to us. When we someone takes the time to go through all these processes and get it done properly, then what's on the back end with the record keeping? Because we know that some of the different state dental boards are expecting our offices to be keeping these results for a certain number of years. So, what would you like to add to that, Mary?
SPEAKER_02Well, I think that it's very, very important, as you said, for um practices to keep records. The assumption is if you're not logging in those results and you're not keeping track that you're not doing the procedure, you're not following the protocol. So if you're using an office system, you have a logbook that comes from the manufacturer of your system and you can enter the results in that. You can create an electronic log on a computer or you can create paper logs, whatever works best for you. If you are using a mail-in system, then make sure that you are downloading the results. If the test um system that you use provides you the results in a report on, for example, their website, you should always download those. You could save them electronically, but make sure that you have those. And make sure that you are always logging, as I think Linda and Leslie, you both said, you know, which sterilizer and which date, what type of test was done, and what were the results. So make sure you've got good um documentation for um using those. And one other thing, because something came up with a a client that I worked with a while ago, is you know, when when practices are looking at the cost of spore testing, and in previous CDC guidance, we were told um to spore test on a monthly basis, and then the 2003 guidelines from the CDC said to test monthly. And there are still some states that say monthly spore testing is is acceptable. But if you're trying to cut costs, I I've seen some practices use not only the spore strip that goes into the sterilizer, but using the controls as well so they can double their options. And so we don't do that. We don't confuse the controls with the spore strips. We only put the spore strips or the vials in the sterilizer. And I just want to make clear what I um may have stated before. In the in the 1993, which totally seems like a different life, guidelines from CDC, we were told to test monthly. In the 2003 guidelines, we were told to test weekly. Um, and there are still some states that say that you can test monthly, but if you think about it, a month is a long time to go with a malfunctioning sterilizer.
SPEAKER_00Leslie. So one thing I wanted to point out is that obviously check with your own state dental board. So you know you're in compliance with regulations there. So following CDC guidelines and check with your own state dental board. Uh, but also sometimes facilities have their own requirements. For example, uh joint commissions would require a three-year maintenance of uh the spore testing. So we're doing it weekly, but we're also maintaining those records for three years. Some state dental boards say uh maintain your records for one year. So you have to follow whatever your facility uh requires, not only for frequency of testing, but also for how long to maintain the records. And I wanted to point out I had one client who was uh under the microscope of the dental board in California. And uh one of the allegations on his list of offenses that they were citing him for was that uh he had done spore testing, but he had not downloaded those results on paper into like a three-ring binder, which uh what they had said to him was that we don't know if you're looking at the results unless someone has actually taken the time to prove that they've looked at the results. So the only way we know is that you download those results and then put them into a three-ring binder. Someone's looking weekly, and if you download them every month, that's fine, but we want to know. And while there are many fantastic online programs for recording your results, it is important that somebody somewhere is uh marking off on a checklist that they have viewed those results.
SPEAKER_02Such good points, Leslie. Um, and again, can't stress enough how important it is to make sure, especially if there's ever any allegation against a practice for some type of an infectious disease transmission, we have to be able to prove that's a risk management tool, that not only were we performing those tests, but we were reviewing them as well. And if you hear from your mail-in service that you had a positive result, meaning a failure, or you get a positive result from incubating your in-office test, then you need to follow the specific steps as to what to do. And we're going to talk about that in just a second, but Linda had something to share.
SPEAKER_01Mary, I just wanted to mention the importance of standardization in the office because sometimes there's multiple team members that are that are performing these tests, uh, and that can create a problem. I'm thinking of a client that I worked with for a while, busy practice, three doctors, and there was about four different people handling three sterilizers in the practice, and they might have even had four. I'm drawing a blank on that for the moment. But when I went in to start working with them, they explained to me we had these failed tests in the past, and what we decided was there was too many team members, so somebody wasn't doing it the same way, and they were getting errors. And they shrunk it down to only two people that were managing these tests, and so they could get calibrated, standardized, and make sure they were getting it done accurately. So that's another important piece with this.
SPEAKER_02Thank you, Linda. And and sort of tagging onto that, um, practices need to make sure when they register with the mail-in service or they purchase an in-office um system that they make sure that they get the right indicator or the right biological indicator for the type of sterilizer that they have. So the biggest difference would most likely be between a steam sterilizer and a dry heat sterilizer. So there are slight differences. So always make sure that um all of your sterilizers, and many times people have them from different manufacturers, are all listed and they're all um using the appropriate type of um test strip. So, Leslie, how about if we ask you to go through the steps to take if you get a sterilizer spore test failure?
SPEAKER_00Mary, there is a great table in the CDC guidelines called table 12. We'll make it available on our show notes and on our uh resources page on the compliance diva's website. But uh the steps are very simple. They're outlined here. The suggested protocol for management of a positive biological indicator test, and we're gonna go with a steam sterilizer. That's the most popular one that we are seeing these days. Take the sterilizer out of service. Notify your supervisor or uh your dentist and your infection control department if you happen to be in a larger facility. And any objects other than implantable objects do not need to be recalled simply because of a single positive spore test, unless the sterilizer is or the sterilization procedure is defective. So as soon as possible, repeat a biological indicator test in three consecutive sterilizer cycles. If additional spore tests remain positive, the items should be considered non-sterile and supplies processed since the last acceptable, meaning negative, biological indicator should be recalled. Um the items from the suspected loads should be recalled and, of course, reprocessed. And that means repackaged and reprocessed. It doesn't mean throw them back into a sterilizer with the same cassette wrap or the same pouch that you used before. You have to unwrap them and redo them again. And then the other thing is to note is that uh many times it is operator. Error. So we want to check to ensure that the sterilizer was used correctly. And we look at making sure that the correct time and temperature settings were indicated. If not, we want to repeat using appropriate settings and recall and reprocess all inadequately processed items. And we also want to make sure that the correct biological indicator was used. As you mentioned, there are different types for different types of sterilizers. We have steam, we have chemical vapor, and we have dry heat. So we want to make sure that the right type of test medium was used. If not, then purchase the right type and redo your test again. So if you follow these steps and repeat three biological indicator tests in three consecutive cycles and they're negative, your sterilizer can go right back into service. But if one or more of the indicators are positive, do one or more of the following until the problem is resolved. First, you can request an inspection of the equipment by the sterilizer maintenance personnel or by your dental company that handles your equipment. If you're in a hospital or clinic type setting, you can have the maintenance company that manages your facility inspect and make sure that all of the supplies and all of the products used, like the water, distilled water is being used and steam sterilizers, not tap water or things like that. Discuss the abnormalities with the sterilizer manufacturer and then repeat the biological indicator process using a different manufacturer's biological indicator. So basically, if those things don't work, then the next step would be to close the sterilizer down until the manufacturer can assure that it is properly functioning. So that might mean that it gets picked up and taken back for repairs at the company, and you may have to use a loner sterilizer. Again, we want to make sure that we understand that there are a number of things that can go wrong in the process of loading a sterilizer, overloading, you know, interrupting a cycle. There's lots of things that can cause sterilization failure. And it seems like, by and large, it's almost always operator error that is the reason for a failed spore test. And, you know, it's great to have that indicator strip so you can see that that type 5 indicator strip. It's not replacing spore testing, but it is an eyes on immediate uh result that you can visually see that something is wrong before you either place your vial into the incubator or mail away your strip. One other thing I wanted to mention, it just came to mind a moment ago. I had a client who uh when they when I asked to see their documentation of spore testing, they showed me a three-ring binder that had a bunch of uh integrator strips stapled to the paper. And I said, Well, so where is your spore test? They said, Well, that's what we use for spore test. While type five indicator ships are very, very accurate, they do not replace spore testing. And uh, I think if a dental board had walked into that situation, they would have most certainly cited that particular practice.
SPEAKER_02Oh, that's such a good point that you bring up, Leslie, because I have seen the same thing that and I ask people, oh, yeah, we spore test every load when they put that type 5 integrator in. Like, no, that is not a spore test. It's equivalent, but it's not a substitute for a spore test. So it's also important to note that if your practice is using a pre-vacuum sterilizer, um, you may need to do what's called a Bowie Dick test at the beginning of every day. It's an air removal test to make sure that the air removal or the vacuum process in your sterilizer is working. And that should be done before you run any instruments for the day. So we've brought you a lot of great information today and hopefully some food for thought about um doing some quality control checking on your score testing or sterilization monitoring process for documentation, make sure you're creating the appropriate test pack, placing it in the appropriate place, and so forth. And again, I'll remind you that our April episode, the beginning of the month, will cover even more information and more discussion about the spore testing process, the difference between mail-in and and in-office, and just a whole um bevy of great information. So thank you for joining us for this episode. We hope to have you join us again and/or subscribe to our podcast on your favorite podcast channel. The compliance divas brings clarity and simplicity to compliance by navigating the regulatory world to keep you on course. You may submit questions by email to support at the compliancedivas.com. Any resources that we have mentioned today, and there will be lots of them, um, will be on the resources page on the compliance divas website, the compliancedivas.com, and also in the show notes for the podcast on your favorite podcast channel. So thank you again for joining us. We hope to have you with us again.