Educational Webinar: Best Practices for Reprocessing Ultrasound Probes

Good afternoon. Thank you for joining us today. My name is Brandon Martin here at McKesson Medical Surgical, and I'm so excited to welcome you to today's presentation, Best Practices for Reprocessing Ultrasound probes brought to you by Nano Sonics. Before we get started, I'd like to direct your attention to our disclaimer. While you're reviewing that information, I will remind you that this presentation is being recorded. Within a day or two, you can expect to receive a link to download a copy of the presentation. You can also download the slides by following the link under the files pod to the left of your screen. If you have a question, feel free to enter into the Q&A panel at the bottom left corner of your webinar window at any time, and we will do our best to answer at the end of the presentation. Our speaker today is Doctor Daniel Lightfoot. Doctor Lightfoot received his doctorate in Developmental Cellular Molecular biology from the Karolinska Institute in Stockholm, Sweden. Researching aberrant genetic contributions and their effect on stem cell and early embryonic initiation and development, he returned to Southern California to continue his research at the Scripps Research Institute, focusing on fetal brain formation and cephalic cellular differentiation. After leaving academic research, Daniel has held a lab director position in a hospital, science director for an autism advocacy and research nonprofit, science director for a stem cell biotech startup, director of scientific affairs for a rare and ultra rare genetic disease diagnostic company, and as a director of medical affairs for a pharmaceutical company until arriving at Nanosonics. Doctor Lightfoot, thank you so much for being here today. Thank you, I'm very happy to be here. Um, this is a McKesson educational webinar. My name is Daniel Lightfoot, and I'm the director of Medical Affairs for Americas. Uh, for nanosonics, and today we'll be talking about best practices for reprocessing of ultrasound probes. Our learning objectives to broadly discuss the proliferation of ultrasound procedures within medicine, discuss the documented patient outbreaks and infection risks related to improper ultrasound probe reprocessing. Identify federal guidelines, FDA and CDC and the Spalding classification system that define the defection requirements for in the cavity and external ultrasound probes. Describe steps required for reprocessing ultrasound probes including cleaning, disinfection, storage, and traceability, identify factors that are important in the implementation of high-level infection workflow at a healthcare facility. So for part one, we're gonna talk about medical ultrasound. And ultrasound transistors come in many shapes and sizes. Some are placed um on the surface of the skin, some penetrate into into cavity um orifics of the human body. And because of their utility, um, their growth has been astronomical on the field and off to the right it's an older study. It's from 2018, but it shows how often and how much these devices are used as a category of a therapeutic area within the hospital. And you see that the growth of ultrasound procedures has been quite considerable, and ultrasound imaging is now one of the most widely used and rapidly growing diagnostic tools. With nearly 140 million ultrasound procedures performed annually. Again, this was a handful of years ago, so it's much larger, and it's much larger because it's quick, it's fast, and it gives live images and allows you to do uh. Interventions with immediacy without waiting for a singular static image, and diagnostic medical devices such as ultrasound probes are often heavily contaminated after to use because they're going from patient to patient and they're not being properly reprocessed. Let's talk about clinical ultrasound infections. Now, infections can have many routes of transmission, and it can come from the probe, um, it can transport to the patient. The room itself could be the fomite that transfers that pathogen, it can come back to the probe, it could be the practitioner itself, it can transcend to another patient and you have these commonalities. Of vectors and ultrasound probes is one of them, meaning that an ultrasound probe once contaminated, can then transfer through uh different opportunities, whether it's on, as I mentioned, a practitioner or to a patient or to the room itself, and this continues um a pathogenic life within in a hospital environment, and this contributes to overall H HAIs that we see in a clinical setting. So pathogen transmission leads to hospital acquired infections, and HERS infections acquired in a healthcare setting during treatment or other conditions. Um, 35 to 55% of HAIs are preventable with existing evidence-based infection prevention practices. This is a national concern. HAIs is obviously a patient concern, but knowing that about half or up to 50% are preventable. It's a lot of onus on how we approach our clinical practices and how we can prevent them is the crux of this presentation. So reprocessing failures are occurring in facilities. Now what is reprocessing? It's for devices, medical devices that are unique and unique in that they are reusable, and after each use they need to be made patient ready for the next clinical intervention. And from the TJC, this is a publication from 2017, but sadly the data still stands and it's been increasing. 70% of all immediate threat to life declarations were improper sterilation or HLD of reusable devices. That means that pathogens were on these devices. They were never properly disinfected or sterilized, and they were used serially on other patients, meaning that this transducer was a fomite. It was colonized and transformed from patient to patient. And threat to life is, is a heightened case. It's not just an infection providing to an um a poor medical outcome. This is a threat to life. And so 75% documented is a very, very significant number, and the TJC has found noncompliance with infection control standards as the cause. 5 of the 3 of the top 5. Instances of causing HAI's in the hospital by the TJC serially year after year after year, 3 of them relate to reusable medical devices and specifically to high level disinfection. So what does this look like? Studies demonstrate that it's not just the opinion of the TJC studies demonstrate that infection risk from endocavitary and external ultrasound pro procedures do exist. This is a collection of papers. There are sadly many, many more, but I put these up to create a framework for understanding. Now, list with ultrasound probes, uh, gel is often used. And it's a common source of infection, and these are traceable because it's very easy to go back to the gel and find out that that's where the host was, the host organism was before it was transferred to the patient. And so for these, these are more easily tracked and found out. And here's the selection. I want to point out that it involves both external and endocavitary probes, and you see that there's a common theme. You have patients infected in one outbreak, 40, um, another 16 and 6 and 8, and you see a collection of different bacteria. Boldara epica is common. They proliferate well in gel. And metabolize gel and so that's why you see this particular organism being more proliferative when it's associated with contamination with gels, but you also see lepsia pneumonia. And so all of these are serious, um, all of these are known pathogens that have poor and negative medical outcomes, and it comes down to gel and why is gel interesting when it comes to ultrasound reprocessing? Well, because the gel gets on the probe itself and if it's not removed. Then it transfers from patient to patient to patient. So it's not just the gel, it's the gel, and this is that that paradigm I showed earlier, it's the gel contaminating the probe and then a probe then serialally contaminating other things. Now recently, not so long ago, um, there was a multi-state outbreak of bold rea epica, and it was related to contaminated gels. Now, this was, um, many eyes were on this when it was unfolding. Um, I was watching this, and it started off as a recall of a few, um, lots of one product coming from a factory in Canada that made gel. And then very quickly it escalated to a larger lot number, then it then it escalated to every product that that factory made. In the end, they couldn't find out what was the cause, but they could see that the factory was heavily contaminated. In the end, 48 cases were shown. 59 patients across the US um were shown to have boostbilis. Um, and also in Canada, the factory was in Canada. This is just the CDC data, so it's reflective of the US, um, population, and 40 of the cases were bloodstream infections. Now, infections infections associated with the bloodstream are very serious because it affects the entire body. It's global. Once, once in a bloodstream it circulates and populates. And it's also in a pristine environment for growth, and so this was a very serious outbreak um and in the end the factory was shut down by the FDA because they could not find this they track the factory, but they could not find and isolate the cause within the factory, and that factory to this day is still closed. Um, and it's not just infections, but sadly these small medical interventions, small medical interactions, um, can relate to death, and I put up two, specifically there, it's more rare, but it does occur, and one involves a transvaginal probe where a patient was infected with hepatitis B, and then it progressed and they couldn't stop the infection, and that person just came. Another one was with surface probes, again, somewhat a benign visually benign experience. But this patient was infected with bold rea epica. You keep seeing that and you see that it's related to most likely gel. In this case it was and resulted in patient death, and it was just from a surface scan of an ultrasound probe. So medical outcomes can be quite severe and sadly, all of these cases are preventable. Remember, there's about 50% that can be preventable. These are among them. So how do we go about clinical ultrasound infection prevention? How do we address this? Well, first, let's look at the paradigm of infection. And which is exposure, contraction, and expression. Now exposure is the physical transfer of a pathogen. It's from moving from one object to one person to another object to another person, and that's a mechanical process. Um, contraction is that biological organism ingressing into the patient, and once inside, it may proliferate, it may not, it may cause, um, uh, medical, it may cause a phenotype, we have a reaction, it may not, but that expression is the final step, and that's the biological growth and the severity of that expression is the severity of the of the state of the patient. And when we try to address these, you realize that the first step is a mechanical process where the other two are cellular and molecular biological processes, which means that for those two, you're going to need medical intervention and you're going to need pharmaceuticals to address. The first one is mechanical and it's easy and therefore it's easy to address, and the other ones become more moderate and then severe, more difficult for the expression, and you can see where the The paradigm of infection first begins with the ultrasound user and then progresses to your epidemiologist or your general practitioner to address. So how do we stop exposure? Cause if you stop exposure, a mechanical process, contraction and fraction, contraction and expression do not happen and therefore do not exist. Well, about 50 years ago, the Spalding classification system was created. And it's a very simple, concise way of making discernment of how to disinfect reusable medical devices, and it's based on decades of accumulative knowledge in cell biology, molecular biology, pathology, and medicine, and it's an understanding that our skin is the dominant dominant and greatest protector against pathogens. It's no, no surprise, it's also our biggest organ. And so what Spalding understood is that infection risk increases with the decrease of our skin's protection. So if our skin is intact and we're exposed to a pathogen, the risk of contraction is low and therefore expression is low. If our skin is damaged, that skin is compromised. It's not fully intact, and then therefore the risk is heightened. And if it's absent, then it's critical. When is skin absent? Skin is absent when you have an open procedure, when you have permeated or penetrated through the skin, and you have direct access of the internal environment of our sterile tissue to the external environment where pathogens are. And so in such a case, the risk is critical. Well, he realized that if the risk is low, then low level disinfection should be applied. If the risk is high, then high level disinfection and if it's critical. It needs to be sterile. There needs to be a guarantee that there are no pathogens present. So the Spalding classification can be very easily represented and often represented as pyramids, showing non-critical, critical, and semi-critical and critical, and then the level of disinfection off to the right. And it's the cornerstone of infection prevention and has been for almost half a century, and it has been adopted by the FDA, CDC, AME, TJSU, TJCH, and other organizations as the supreme or first step in understanding and addressing infection prevention. And as I mentioned, it's a very simple and rational approach, and it um is devised to protect patients and it's the first step, as I mentioned, in adjustment of infection prevention. And here I want to point out that sterilization guarantees destruction of life. Disinfection does not. So if it is not sterilized. There is going to be some form of life on that device, reusable medical device, and that's gonna be very important in discerning how to address this reprocessing of these devices. So how do we understand this? Well, we look at the biological activity as association with this falling classification. Off to the right you can see on the left column you see sterilization, high level disinfection, intermediate low level, and to the right you kind of see these columns of these organisms and you can see that there's a resilience present that enveloped viruses are fairly easy to kill and most bacteria are. Microbacteria, there is some strong resilience for some of the species. Fungi are more difficult to kill, non-enveloped viruses, a different type of virus. When you say something kills a virus, you really have to separate between enveloped and non-enveloped, and then spores are the most difficult to kill. All are forms of life, and sterilization is an FDA regulated claim, and the chemistry is an FDA registered steroid. Um, and it, it has complete to near complete biological biocidal activity. Um, HLD, the only difference between sterilization and HLD is the chemistries are the same. Except the time of exposure has been reduced, and that reduction of exposure allows some spores to survive, but all other forms of life are um eradicated. Now this is important for clinical applications because you might not always have the time or the access to sterilization, machinery and processes which are difficult and complicated, and high level disinfection has a role in the clinical setting. Now for LLD and ILD, these are EPA regulated, so this is at the state level, and these chemistries are pesticides. What is a pesticide is pesticide is a chemistry that kills a very specific organism or group of organisms, and that implies that it is incomplete when it comes to biocidal activity and when using an LLD or ILD that you're gonna have microbial life survival and pathogenic life survival. Um, spores are less interesting because spores aren't really shown to be pathogenic in most, um, hosts. There are some oddities in the medical literature, but by and large spores aren't considered pathogenic, and so there's less concern there. But you can see off to the right, the check marks are that guarantee that these organisms, all the organisms within that class are um terminated, and the other ones are some. And so when do you apply and when do you not apply? Well, let's look at ultrasound guided procedures and start addressing functionally how we approach this, these paradigms of the paradigm of affection and spalding and the um kill profiles of the chemistries. Well, when applying the Spalding classification, you see very familiar now, pyramid, and the critical semi-critical and critical for the device classification, and we look at transvaginal probes, for example, we automatically say, well, that's semi-critical because it's touching a mucous membrane. But actually these can also be critical because if it's touching a mucous membrane that's been compromised, then you know, let's say there's a wound, there's um distortion of the cell layer, that this is now exposing critical tissue. And therefore should be sterilized, but these devices are complex medical devices with sensitive electronic equipment inside them, and so they can't survive the sterilization process, which is generally heat. And so the FDA realizes this and they say if the sterilation is not possible, then HLD with a sterile sterile sheet is acceptable. Understand that sterilization is preferred. If you're touching critical according to Spalding. But in this specific case, there is an exception um in that FDA allows that HLD with the sterile sheet. When we look at surface probes, you go, that's non-critical because you're touching uh intact skin, but sometimes you're touching non-incorrecttact skin and so they report semi-critical, and sometimes you're directly touching sterile tissue. And so for these, this unique category of devices, surface transducers, which is a bit of a misnomer, it's just not penetrating, it's on a surface. What that surface is can be sterile tissue, non-intact skin, or intact skin. And so they transcend all three categories of spalding and have therefore two different types of sterilization approaches or disinfection approaches where transvaginal probes only have one due to that exception. So let's relook at um the biocidal activity and just to put a framework and a bit more of a clinical flair to this off to the left you see examples of these categories. So when we say non-enveloped viruses, you can see some of the things we're talking about. Um, so HPV is obviously a very serious, um, pathogen. It's linked to 99%. It's, it's an amazing number. It's linked to over 99 99% of all cervical cancers are linked to HPV and so exposure of a virus. Can have lasting and negative effects on the patient, and once you contract the virus, you have that for the rest of your life. A lot of people don't understand that bacteria, microbacteria, fungi, spores can be removed from your body. viruses cannot. Once exposed, once contracted, it's there for the rest of your life. And for the intermediate and low level, um, processes, these are your EPA regulated, these are your pesticides. You can see that. As before you have a truncated kill profile, and if the hold and wet times are not adhered to, the kill profile is not achieved. So if your wet wipe says 4 minutes and you're not holding that wet for 4 minutes, or if it's 2 minutes or 1 minute depending on your product. You're not getting the kill profile that that device is indicated for according to the IFUs. Now with this under consideration and the clinical application as far as viruses and pathogens. And let's look at how this is applied in a clinical setting. And so for non-clinical procedures, here are three great examples of a probe in a non-critical procedure, and it only requires a little bit disinfection. And what you see is you have the needle distant from the probe, the probe is contacting intact skin. And so there's none of this, there's no touching, and there's no transference, and the skin is intact, so there's no risk of it going into the patient and therefore, low risk of infection means um low level disinfection and a non-critical procedure. Now if we jump to critical procedures, you see almost the same procedure, but now you see the probe on top of the wound, the wound being the puncture site and so now it's touched, what is a wound? It's going through the puncture site is going through the skin. And accessing sterile tissue below, and so you permeated your barrier, your protection from the outside environment to inside environment, you've created a pathway. And therefore it's critical, and the probe is also touching a sterile device. Anything touching a sterile device has to be sterile. If it touches a sterile device, then that sterile device is no longer sterile. And so you see two examples of why this would go from from here. These are non-critical procedures with almost the same procedure here, but different, it's critical. Why would you place the probe so close to the needle? It has to do with vision of death. And so what you're trying to access and see, the more shallow, um, below the skin you're accessing, the less likely the probe's gonna be in contact with the needle. The deeper you go, the closer that transducer is gonna move towards the needle. Now let's look at semi-critical. Um, some of these images might be a little bit difficult to look at. We have, uh, ultrasound probes in, um, the first two pictures directly touching mucous membranes, so that's the eye and the internal mouth. On the left, that's a cataract surgery with a very specialized ultrasound probe, and in the center, you see a drainage. Of an abscess at the back of the oral cavity using a transvaginal probe. Often that happens because there are ultrasound probes that are specific to the oral cavity. They're rare. Um, not all facilities have them and so second best is to use a transvaginal probe. And so you see this often, as I mentioned in a clinical setting, and on the right, um, takes a little bit of thinking to see why this is a semi semi-critical procedure. You see 3 procedures that were conducted on this patient using ultrasound. You can do one is the jugular axis. Uh, the second is the thoracic clavicle. And then the third is the thoracic, um, a lumbar thoracic uh um pulmonary. And so it's a drainage out of the lung. So in each one of these cases, ultrasound had to be used, uh, I'm sorry, not pulmonary respiratory, but the ultrasound had to be used to guide the needle and the drainage ports, and this is not intact skin. So in these cases, this is a semi-critical minimally procedure would require a high level of disinfection. Vascul access is often um done using ultrasound guided procedures, and you can see that there's a strong variance just within this subclass within this therapeutic area. And on the left you see the no touch method being used and then on the right you see two examples where the probe is on top of the needle, on top of the um wound which permeates through the skin. It's also broke the sterile field. Um, sterile fields come in all kinds of sizes. It could be a complete open thorax or it could be a needle puncture. Each has to be addressed because we're addressing infection prevention and once a pathway or portal is created through the skin, um, sterility or high level disinfection is required. Now biopsies um is unique. It's the only exception to the Spalding classification, and it's an exception that was instituted by the FDA um on the images on the right and the left, you see that the probe is on top of the wound, it's touching the, the needle puncture the needle which is sterile, so then automatically say this is minimally critical or and critical in nature and therefore requires sterility or in this case high level inspection because it's an ultrasound probe. But on the right you see a, a gap of space and you say, well, there's the no touch method, it is a biopsy. And so it's not touching the needle, it's not touching the open wound, but Due to the high prevalence of infections related to biopsies, the FDA made a global statement that all biopsies need are semi-critical and critical in nature, and this was to reduce the impact of infections. On the broad human population, again, because biopsies are so strongly associated with infections. And from these images you see that the Spalding classification of a surface ultrasound probe can change throughout the day. For transvaginal probes, it's quite clear. It's gonna be high level disinfected or sterilized and since you can't sterilize it, you're back to the high level disinfection and so you associate these trans, you know, transvaginal, transrectal transesophageal quite. Um, intellectually clearly to high level disinfection, but when you deal with service probes, They're quite dynamic. They could be touching intact skin and then later in the day they could be touching critical tissue or they could be used in a biopsy, and each time they're used, you have to really think about what the tissue is touching and address this through the application of Spalding classification system and probe disinfection is therefore reflected to the tissue the the external probe touches. Again, Spalding. Created the paradigm to reduce risk and that risk is associated with the integrity of your skin. If your skin's intact, Then it's a low risk if your skin is compromised or subverted, subverted meaning it's been removed or um penetrated, then the risk is high or critical. So let's take a review of guidelines and standards that help govern our decision making in this space. And so just as a reminder, here's the falling classification system, and it is the premier and first step in addressment of infection prevention in making decisions towards infection prevention and as related to reprocessing of reusable medical devices. And so there is a lot of A lot of sources of good information, um, a lot of sources of opinion, um, both federal, um, organizational, societal, and it can be a bit of a cacophony of information coming at you and it's hard to discern what what's most important, what is most significant, who should I listen to, who should I not listen to, and so to address this in 2019, the joint commission created the hierarchy of hierarchical approach to standards and guidelines. And what it does is it provides a visual structured pathway of standard and guidance organization depicting a hierarchy of importance of information. Now the key word here is hierarchy because what is higher in the latter is more significant and superior in authority than what is lower. And because of this structure it provides a tool of guidance, conflict resolution through selection and prioritization of the superior source of information. What that means is if you have guidance coming from the FDA, that's the highest in the hierarchy, and you have something coming from, let's say ECRI. Well, that's a little bit farther down, then you're gonna have to choose, have to choose the FDA and this, this, uh, guidance is adopted by the CMST, TJC and acknowledged by the FDA and the CDC. So rules of regulations. So you have the federal, state, and local regulations, that's your FDA and OSHA and Department of Health, um, you have the CMS, these are the um COPs and CFCs that you're probably familiar with. Uh, manufacture IFUs. Now these top three would be considered musts. You have to follow all top three, all these, these guidances from all three in this order of superiority. Now, the latter three are optional. And one is evidence-based guidelines and standards. Um, these are federal and professional standard developed stakeholders like the CDC and PSG, that's the National Public Safety guidance, um, TJC, the Joint Commission, Amy, ECRI, I mentioned earlier, AR and HSPA, who there's a collection of organizations that bring clarity, um, and greater specificity to the guidance provided by the FDA or given by the FDA. They don't contradict. Consensus documents are additional specific clinical information um that is designed to bring clarity and reduce risk. It is the professional opinion of societies and organizations. So these are um societies and organizations that have a specific, um. Uh, point of view on how to address infection prevention, but since it's just the opinion of societies and organizations, it's the furthest down the line as far as external guidance. And then finally um the TJC and the FDA acknowledges that each facility is slightly different, um, and there may be some peculiarity of how the hospital is structured and how things are done, and minor adjustments can be made to address the specificity of a facility. Now, just to put some text in front of you, um, critical devices that contact sterile tissue, this is the opinion of the FDA, the critical devices that contact um normal sterile tissue, um. Are introduced directly, well, it's defining critical devices are introduced directly into the bloodstream or which contact normal sterile tissues. What they're saying here is If the device is contacting critical um sterile tissue, then it must be critical, which means it must be sterilized and the same. Same view, but what is slightly different. The CDC says objects that enter sterile tissue or the vascular system, specifically calling out the vascular system. Again, I mentioned it's the most critical vascular access or anything to do with the vascular system, because once introduced into the vascular system, it goes global within the human body. If it's introduced underneath the skin, it's localized. Let's say in muscle tissue, but in in the blood serra, it it it translates all throughout the body including the brain, and it's also in a fluid that's designed to bring nutrients and oxygen throughout the body, and so it's a perfect environment for pathogens to live and proliferate. And so the CDC is pointing out that extra attention needs to be paid towards the vascular system. Um, and addressment and contact with the vascular system, and Amy brings just a little bit more clarity around clinical critical devices. And mentions sterile fluid pathways, um, again, back to the vascular system. Now I mentioned biopsies were the only exception, and here is the language from the FDA and CDC. CDC followed the FDA in this opinion, uh, for clinical applications of a semi-critical, critical nature, such as biopsies, um, that these should be high level disinfect or sterilized or high level disinfected. Why? Because they're considered semi-critical, critical nature of all biopsies, even if the no touch method is used. And ultrasound probes used during surgical procedures, this is from the CDC that contacts sterile body sites. What sterile body sites that's anything below the skin. Um, you could also argue, um, um, the eyeball as being sterile. The probe should be sterilized between each patient and therefore it's, it's considered critical in nature, sterilization, and at a minimum, the probe should be a high level disinfected and covered with the sterile probe. So this is acknowledgment that these devices can't survive the heat threshold of sterilization and so high level disinfection with the sterile probe is appropriate. So she's, there's a lot of questions around sheets in a clinical setting. And one of the, one of the one of the one of the understandings is visually it looks like a cover. It's something that you'd see, for example, in your kitchen protect food or protect any other item, but they are actually are not indicated to the terminal barrier. What does that mean? It means it is not meant to protect from pathogens and microorganisms and transferring through it. Uh, the reason why is condoms and ultrasound probes, cut sheets that are and sheets that are used in ultrasound probes have a high failure rate, and they have a poor quality manufacturer. Uh, this is just inherent for all sheets. The FDA and CDC recognize this and therefore they encourage and require sheets to be used for uh critical and semi-critical, but it doesn't change Spalding classification. And the the IFUs for sheets specifically call out that this is to reduce soiling on a probe and is not meant as a terminal barrier. Terminal barrier means it's going to protect from pathogens and organisms passing through. And we also see that gouge marks um on transducers are fairly prevalent in the field, and these are from those procedures I showed earlier. Now whenever you see a gauge mark, um, You can deduce what had happened, and it's kind of scary when you do. So each mark on the transducer head means that two holes were placed put into the trans sheath. One is the needle penetrated in, then it hit the sheath, then it hit the head of the transducer, and then penetrating going out. And whatever was on that transducer head and whatever that material is made out of, has now been introduced underneath the skin inside the patient. And you can see, for example, in the orange one, how often that happens. And because of this, Um, these reasons, the FDA and CDC both say that using a sheath, though required for critical procedures, recommended for semi-critical procedures. Um, art is, um, part of your infection prevention approach. It doesn't change the need for disinfecting of the probe, meaning that you would still need to sterilize or high level disinfect these probes prior to use for these very reasons probes fail, they're not manufactured well, they're not designed to be a sterile barrier. They're only designed to reduce soiling, what's soiling, that's predominantly gel, but also could be bodily fluid. And it helps reduce the probe becoming a foamite again transference of organisms from patient to patient. So let's take a look at these clinical workflows, um, specifically around high level disinfection. Now, um, high level disinfection eliminates, as I mentioned, all microbial life, and it occurs after cleaning. First, you have to clean the probe and then you have to disinfect it. If cleaning isn't achieved, then disinfection is not achieved. And that has to do with biofilm, and if it's present on the device, then the chemistry, if you have a film, whether it's chemical or biological chemical being gel predominantly. Or biological, let's say, um, bodily fluid, blood, um, if that's not removed, uh, then the chemistry can't penetrate through the thickness. And therefore microorganisms underneath are still alive. And so many methods of ultrasound probe high level disinfection exist. Um, and the method you select will depend on a variety of factors, um, and the first thing you need to do is check probe compatibility with anything, any HLD solution that you're going to pursue, and to do this, you have to contact, look at the uh manufacturer IFUs and often contact the OEM itself. So on in the US market, here's a collection of all the manual and automated high-level disinfection solutions. Generally speaking, from left to right is how they appeared on the market. First you had the GTA and OPA Soaks, which appeared decades ago, then the gas station was an advancement on that. Astra and ethos are automated silk solutions. The first two are silk solutions. Uh, Trophon is a mist, it's unique, and uh Alt is a foam, it's unique. I'll go through um some of these qualities, but first, let's just look at the manual and discuss. Uh, some discuss some considerations when choosing a manual approach to high-level disinfection. When you do manuals, um, uh, manual silks, and so this is your GTA OPA soaks generally speaking, you have an increased risk of chemical exposure to staff and patients and you have some Um, Clinical consequences that are there, um, that are listed, uh, they require more PPE and are prone to human error. Now there's a connection here. It's These GTAs, OPAs, these are high level disaffecting chemistries, which, as I mentioned earlier, are steroids, just held to a shorter time. So what I mean by that, if you take a probe and you place it into a GTA OPA soak, you can sterilize um the probe in about a day and a half. But if you only treat it for 20 minutes, you'll get a full profile, full pathological kill minus spores, and so that's again the difference between sterilization and high level disinfection. And the more PPE gear you have means that there's a greater risk of harm to you. So a sterilin is a chemical designed to kill life. That's its purpose. You are alive. So it's designed to kill you as well. Um, and so therefore you have to have a high level of PPE when using in in um manipulating these chemistry. So you have gloves, eye protection, protective gowns, and some people, you know, might even have shoe covers. Um, ventilation is also uh something to be considered because of the fumes. And for all these reasons, there's been a call um to remove this this approach uh of high level disinfection within the clinical setting. Also to consider is, because of the hazardness associated with these chemistries that they can't be done anywhere near the patient, and so they have to go to a different area for processing. This means that the probe has to be transferred from one area to the other, you use it in a clinical setting, then it has to go elsewhere for reprocessing, uh, to, you know, the microbial reduction. Uh, well, in this case, uh, pathological kill, full pathological pill, and then you have to deal with traceability. This is important as far as, um, pathogenic. Um, tracing, which is associated with outbreaks, and, and you know the addressment of the papers I showed earlier on, that was achieved through traceability where somebody was affected. They noticed it and they found all these other patients and that had to do with traceability, like what gel was used, what probe was used, who was it used on when, and are able to find other patients and treat them either before or get to them, get medical interventions earlier because of traceability. So it's an important step in in addressment of infection prevention once it goes beyond. Um, the first step in The infection paradigm and that's exposure. Once it's down to um aggression and expression, time is very, very critical in improving medical outcomes. And in some cases, you can see that the probe can't even be, some probes can't be submerged fully, so you see at the bottom that that one cannot and only the very tip. And in this image I showed earlier, only half the device is being disinfected, which means the other half is not. There's some fantastic studies that show that, well, once you do this, that pathogens that are on the handle very easily migrate up to the area that's touching the patient, and so it's not really a good solution if you can't submerge the entire um device into um the solution in order to address killing of all pathogens. If there's no contact with the chemistry of the pathogens, there's no chemical kill. Um, no biological kill, and if you only are disinfecting half of it, then it's very easy to see that the other half is going to just be a foam mite and transfer pathogens to the other half that just was. And so when we look at um HLD foam, this was a study that came out of Europe, and it was a fantastic study and it shows the limitations of manual processes and it shows that what they did is they took people that were very experienced with the product. This is your HLD foam, and they I've been working with that. Form of that modality of high level disinfection for years. And what they did is they said, well, we're going to use a blue dye that comes with the kit, and the point of the blue dye is to is to apply it just like you would apply the foam, but it allows you to see what areas you're covering and not covering in order to make you better at applying the foam. You can see it's a very, very um subjective approach. It's very manual. And so what was really, really brilliant about this study is, though the users of the foam were experts, they gave them um eye protection that was blue in color, which means they could not see the blue dye in the probe. So they weren't aware of where they're applying it, which would be more in line with actually applying the phone. And so after going through many probes and handing it off, saying, OK, I'm in with no time constraints, they said, OK, I'm gonna hand this off and then It's, it's completely high level disinfected. They took off the goggles and you can see all the areas where the chemistry never contacted. If there's no contact with the chemistry, there's no disinfection. So you can see anywhere there's regression, um, a dimple or um um a cavity on the probe this wasn't touched. That means that there's pathogens are still there. There's microorganisms are still there, and you also see that in the upper left corner picture you can see even the seam between the 22 sides of the device. Wasn't penetrated there. um, it was in other areas and you can see that there's a great limitation of doing a manual process. Now what is high level disinfection? It's the eradication of all life minus spores. So obviously this didn't achieve disinfection, high level disinfection. If you're only disinfecting half a probe or a part of the probe, that probe is not high level disinfectant because you did not eradicate all organisms on that device. Which is the definition of high level dysfection. All that was achieved was microbial reduction. But not eradication. And so for all these reasons, automated is highly promoted by the FDA CDC, highly encouraged by the FDA CDC, AME, TDC, and others, World Health Organization. So let's look at some of the solutions you see on the market as far as automation, and this is your Astro and your ethos, which are automated silks. So these are using the same chemistries as the devices on the left, but it's doing it completely automated and an enclosed fashion, and then Trophon, um, which is a mist, which is unique on the market. And so some things to consider when you look at automated workflows is they are consistent and reproducible, they're automated, reduces human error because you're doing, you're not requiring, you're not required on the skill of the user. The machine does all the work. It's limited to no exposure to disinfection chemistry. It depends if it's a closed or sealed system, your Astra and your ethos are closed or covered. And the trophine is a sealed system. So one offers strong protection against it, the other offers complete protection against the chemistries. What are high level disinfection chemistries? There's sterilins, sterilists are designed to kill life. You're alive, so this, this is significant, um, and minimal PPE required is, you see with, with these devices because they are closed or sealed systems. Um, and in some cases they, and these can be since they are sealed and closed, they can be a point of care. So I mentioned earlier with these other devices, with the other manual processes, these are open systems, which means the chemistry is in the environment. It's either a vat of liquid that is vaping off or it's a foam that produces a gas, chlorine dioxide is a gas that that fills the room. And so you can't have patients anywhere near that, um, with these solutions, you could put it in the patient room. And they also offer automated traceability, so there are no errors and gaps in in traceability, which is important when you're dealing outbreaks, and they create more efficient um work flows and as I mentioned that these are strongly encouraged by um both national and international organizations. So I mentioned point of care. Um, a great thing is that streamlines workflows. Um, it makes life for the sonographer much easier and it reduces the number of probes in your required inventory because the probe never leaves the room. And because it never leaves the room and you don't have to deal with traceability of the probe, traceability is not only at the clinical um procedure, but also if that probe transport needs to be transported to another facility or to another area of the hospital, all of that has to be traced according to the TJC and Amy. And therefore not having to transport the probe greatly reduces the burden on SPD staff and improves their workflow. Um, and in some places you only may need one transducer to maintain patient flow um work flow in that clinical room. Again, greatly reducing Um, inventory and reducing costs. Now, This is a bit busy, I know, but I'm gonna step through this, and this is the last slide and there's a lot here, so we're gonna spend a little bit of time here, and this is just a summary of HLD modalities that I ran through, um, all of the modalities approved by the FDA. Um, and they all have a variance in qualities, but done correctly, if the IFUs are specifically followed, they can achieve high level disinfection. But there's a lot of qualifiers I just said, and, and I'll go through these qualifiers and I associated these as colors, and basically there are general improvements experienced by the user a patient when you're transitioning from a darker to a lighter hue. So if you take, for example, efficacy, well, although the manual processes do achieve HLD, it's variable on user. If someone is following the IFUs correctly. And they're being diligent about how to apply the higher level disinfection chemistries, then then HLD is achieved. If it's not, then they aren't. And so efficacy is variable, but for automated solutions, um, The brilliance there is that it's automated and controlled by programs and therefore you achieve, you have that reproducibility and you achieve HLV at every cycle assuming the cycle passed. HPV efficacy, and I brought up HPV earlier. And this is um because of its link to cancer and its prevalence in the human population. Um, for me, from a medical perspective, this is concerning and so with GTAs and OPAs, there's limited evidence that it can kill HPV. Now that's earlier I said that all HLD modalities can um kill all life. Well, it turns out HPV has a resistance towards the GTA and OPA method of action, and there's questions of whether or not it can or can't. It's a scientific debate and so there's evidence that makes one question if it is achieving HLD specific to that one specific organism. But oxidative chemistries that you see like H2O2 or parasitic acid. Um, those are certainly capable and chlorine dioxide, um, are certainly capable of killing HPV. And so you see that for Astra ethos, ethos has a question mark, and yes, depending on if you put what chemistry you put in there, um, Astra, if you put parasitic acid, which I most often see, then it would be addressing HPV well. um, and enveloping modality, I mentioned this around foam. So with liquids, and if you place the device fully into reprocesible device um fully into the chemistry. Yeah, all surfaces are in contact with the chemistry, which means disinfection is occurring. It's driving the chemical reaction. Now with foam, and I showed you that blue that study with the blue dye, you could see that not all surfaces were covered. And so there's a question on whether or not HLD is achieved, and it's based on the user. It's certainly capable of choosing HLD scientifically, but in clinically it's just dependent on the user and so therefore you have to know. Um, with an asterisk, um, safety. So with open chemistries I mentioned, these are dangerous chemicals. You don't want to be around them. If it's open, it means you're being exposed. Um, if it's covered, it means you're being protected. If it's sealed or um if it's completely closed like in a trophon, you have no contact with the chemistry, so you're protective, and you can see that reflected in the PPE that's required according to IFUs. The more gear you have to don in order to address, use these devices, the more at risk you are of exposure. And being hurt by these chemistries. And so off to the right, you only see gloves because it's a closed system. All the other ones are some level of exposure. Point of care, you can't use open chemistries in a clinical environment. Astro and ethos, you can, I put it as variable because most often these two devices are seen in sterile processing departments because they require plumbing, um, both, um, water in and refuse out, and so it's harder to address this so you can at point of care. Trophon is just a plug-in device. No plumbing is required. Um, some are mobile, some aren't. Tris obviously is foam, it's mobile. Trophon has a cart. The other ones require, um, secluded areas or they're fixated because of plumbing, traceability, you have variants if you want paper, all are fine, um, or some offer digital applications, and the time associated with HLD is these are about times and so for the soakings it's about 12 minutes. For automated soakings about 16 to 18. Um, trisol's 2 minutes trophon 7, and the risk of residue with liquid chemistries is a greater risk that residue will be um left on a device. So how does that happen after all of these procedures, or IP you say that you take a dry cloth and you wipe it. With liquid chemistries while they're liquid at room temperature, and so they can reside in some of those niches and some of those um depressions that you saw on the devices. And so if that is taken and comes in contact with the patient where you just touched the patient with a sterilin, which is harmful and therefore there's a higher risk of residue, it's, it's a manual process for all of these. um, with Trophon, it's a mist. And so at room temperature, it's a mist, so it's gonna vape off, um, and so there's just a lower risk that there's going to be residue, and then chemical wastes, um, these are dangerous chemistries, they require some level of handling both um before use and after use. Uh, with tristool, it's quite low, um, because it's a low volume and it's chlorine dioxide, which is a gas, um, and so the chemical waste is, is low. With trofine, hydrogen peroxide is broken down to oxygen and water, so nothing harmful. And then there's so there's no chemical waste with that device at all. Um, and with that, it's. Understanding first how you address infection prevention with the paradigm of infection. You have exposure, contraction, and then expression, applying molding, and then looking at your devices and discerning what that device is going to touch prior to the procedure discerns how you're gonna disinfect it. And once you realize that you need a high level of disinfect, you have decisions to be made, you want to go manual or automated, and what what are the qualities that best fit, um, your clinical workflows, and this table is fairly helpful. It's generalized, but it gets across the ideas and this is based off the I have use of the device. And with that, I'll say thank you and open up for any questions you may have. Thank you so much, Doctor Lightfoot. Truly a fascinating topic. Um, just a reminder, if you have a question, please find the Q&A window at the bottom left of your screen. Uh, we do have a few questions that have come in. Um, I think you may have touched on some of these throughout the presentation, but it's still a good opportunity to, uh, kind of summarize. Um, so, Could you just kind of briefly kind of pull together uh uh just maybe uh, uh, a brief summation of when, uh, I should definitely use a high-level disinfect for a probe. So that's a good question. This this comes up a lot. It's in the problem comes mostly around service transducers because it's often less clear on how you proceed. And I direct you to the Spalding classification is our goal as infection preventionists or as members of the medical community is to not do harm and not expose, and one of those things is not to expose patients to pathogens. And so our step, that first step is mechanical, um, and the other two are, are, um, cell and molecular biology and they're left to um epidemiologists and pharmaceutical interventions and so with a keen interest on preventing the, the second two steps. We look at devices and apply the Spalding classification system, and we look at the skin, and we say, well, OK, if the skin's intact. And it is, and the device is not touching any any intervening any intervening devices such as a needle. It's not breaking the sterile barrier. It's not touching sterile tissue, then that's non-critical. Every other and one only require low level disinfection, which is a partial, it's a microbial reduction. It's a process of microbial reduction, but for high level disinfection, um, anything that poses risks, so even if you're uncertain. That a procedure might escalate or if you're certain that it's gonna touch a needle, um, let's say you're doing a procedure that's quite deep into the tissue, you know, that the transducer is gonna be on top of the puncture site, breaking the sterile field, touching the intervening device which is a needle, sterile intervening device. Um, in all these cases, you would apply high level disinfection and as a reminder that a sheath doesn't change this process, and that's directed from both the FDA and CDC. Um, for reasons I, I mentioned earlier. Actually that answers our uh our other question is uh if uh if a probe sheet, um, when using a probe sheet is low level disinfection ever sufficient, and it sounds like according to the FDA that that is not the case. Yeah, it's not surprising that this question came up um also it's, it's one of these areas that Um, sheets are visually deceiving, um, you know, you look at it almost like a Ziploc bag or saran wrap, you think it's providing protection, but it's actually not. Pathogens can transfer through, um, the plastic, and it has to do with poor size and it has to do with how these how these devices, well, um how the um sheets are made and condoms are made, even if you pull out any condom, it says that it will. Um, even from a cell point of view, um, so if you look at a condom from a human reproductive, um, uh, process that it can't even guarantee that an entire cell won't go through a condom. Uh, and so microorganisms are much, much smaller than a cell, fractions of a small, um, size, and so these do permeate through, though it looks like they won't. And then also knowing that their manufacturing processes aren't, um, Consistent, um, but they're also not meant to be a terminal barrier. That's the key word, terminal barrier. Uh, that these are meant to just reduce soiling on sheets and I mean on probes, and this is important because that helps the reduction of soiling helps reducing biofilm or chemical film, um, being nascent onto the surface of the device, which is a whole another problem, and so it is very helpful in addressing infection prevention, but it doesn't change the Spalding classification system. Um, so just kind of uh an extension of that, so if I were ever to see like blood or fluid or any other sort of matter on a probe, is that, does that automatically sign that we should utilize high level disinfection? It's, yeah, these are all, all, all um common questions. So when you see blood on a on a probe, um, it's recommended that you go to ILD. Now I didn't discuss about much about intermediate level dis disinfection. Um, remember that low level and intermediate level dysfection are both regulated by the APA and they both um involve pesticides. Um, to get, um, for a wipe, um, which most often is how we address a little little disinfection, to get an indication for intermediate, it has to kill tuberculosis, and that's defining difference between an ILD and LLDh LLDs have a slightly higher kill profile in general. There's still only microbit reduction and fall far short of the steroids um kill profile. And when you see blood on a probe, one would often want to lean towards ILD minimally, um, though LLD is OK. Uh, but if you look at, um, Some point of infection prevention, there's a few other considerations that we, you might not know, um. What is in the blood serum the patient you dealt with and so high level disinfection might be a better course in order to break any potential transference from one patient to the other, and that's the whole point of infection prevention is to stop transference. And so when probes get quite dirty, um, I would lean towards high level disinfection, but it's not required. But then also prior to that procedure. If it was bloody, the question you should ask was, if it did it touch sterile tissue in that process, and should I have high level disinfected the device earlier or did I? Um, and so if you see procedures in your facility that often escalate where the intent is that it's gonna be a low level procedure, but then they get messy, they progress, um, you never can fully predict what's gonna happen clinically. Um, there is an argument there that you should high level disinfect these probes, um, out of, um, caution towards the patient. And again, it's, it's the view we're in the business of infection prevention. That's step one. Um, step 2. And 3, expression and aggression and expression, that's infection management, and that's for the MDs. Um, we need to pay attention to the first step, and so for these cases, if I see a lot of bloody probes in a, in a facility, I start thinking that maybe they should be HLDing far more often than they are. Excellent. Uh, as we near the end of the hour, uh, I just wanna be respectful of everyone's time. If we weren't able to get to your question, uh, we will definitely be sharing those with Doctor Lightfoot, and we'll do our best to, uh, reach out to you in the coming days. Uh, we will be sharing the slides and the recording of this presentation, so watch your inbox for that in the next couple of days. Uh, and for a full list of our upcoming events, we do, uh, invite you to visit us at MMS.mcKesson.com/learning-ebinars. You can register for a future webinar, share with your colleagues, or sign up to receive regular updates on our webinar schedule. Doctor Lightfoot, thank you again for joining us today and sharing your time and expertise. I really appreciate it. This was a fascinating topic. Thank you very much and very happy to be part of the McKesson community, um, and looking forward to potentially more webinars in the future. Thank you all. Thank you so much. Have a great day everybody.