It's now my pleasure to introduce Dr. Corey L. Ofsted. Dr. Ofsted is the president and CEO of Ofsted and Associates, Inc., where she leads a multidisciplinary team that specializes in designing and conducting real-world studies using gold-standard research methods to validate healthcare guidelines, treatments, and product claims. Today, Dr. Ofsted's talk is entitled Biofilm, Combating Enemy Number One in Infection Control. So, without further ado, it's my pleasure to introduce Corey L. Ofsted. Welcome, everyone. I'm Corey Ofsted, and I work as an independent epidemiologist with a team that designs and conducts real-world studies. I was delighted to hear that ASGE was putting together a masterclass on infection control, and it's been fascinating to hear perspectives from the other speakers. I'm happy to be with you to discuss biofilm and ways to combat it in the field. Here are my disclosures, and I'd like to mention that our research sponsors are not involved in designing or conducting our studies, and the opinions I'm expressing today are my own. I'm fortunate to work with a multidisciplinary team that keeps an eye on the literature, and we've conducted 11 primary studies involving 20 healthcare facilities in 12 states. These studies generally involve visual inspections using lighted magnification and borescopes, as well as microbial cultures and tests for residual soil and retained fluid droplets. In addition, we generally assess for processing practices. In addition, we've performed audits during site visits to more than 60 institutions, and we've also done a couple surveys of ISHA members who are sterile processing professionals in the field. Let's start with three important definitions. When I say organic soil, I'm talking about dirt that can be detected using rapid tests for hemoglobin, carbohydrates, protein, and ATP. Let's take a look at a patient-ready colonoscope that still has substantial soil on it. Can you see it? Here's a closer look at the distal end. You might be noticing several gouges and scratches that could harbor soil or biofilm. Now take a look at the lens. It's covered with scale or something filmy, and there's potentially fluid under it. Next, let's look at the area around the air-water nozzle outlet. Can you see the brown and white debris packed around the edges? Now turn your attention just above that to the outlet of the auxiliary water channel. It's halfway occluded with brown debris. We've learned that it's essential to use magnification when inspecting scopes, and have made it huge in hopes that you can see the brown stuff packed in that water channel outlet. As I mentioned, this is a colonoscope, and I'll let you use your own imagination as you figure out what type of soil might be present in there. It's important to note that this colonoscope was reprocessed in accordance with guidelines and manufacturer instructions. The soil was not visible to the tech when the scope was wet after manual cleaning. Also note that the instructions don't include brushing the water channel because it's too small for a brush to fit in there, so whatever soil gets packed in there during the procedure can only be removed by flushing that channel with cleaning solution and water. That's why it's essential to pre-clean the scope at the bedside and start manual cleaning right away, or it'll be really tough to remove that soil. Given how the outside of that distal end looks, what do you think we found inside the instrument channel when we took a look in there? Well, no surprise, lots of brown stuff. I'd probably refer to this as soil, though there certainly could be biofilm present too, especially in the scratches that have disrupted the channel surface, like here. You might also notice that the channel surface at about 3 o'clock is fuzzy. Our colleagues at UCLA and Stanford call that channel shredding. It probably occurs through normal wear and tear and leaves the surface rough and especially hospitable to retain soil and biofilm. Residual soil can be measured using rapid tests that detect high protein or ATP levels after manual cleaning. This graph illustrates protein we found on bronchoscopes after manual cleaning in three hospitals. That's the green, orange, and pink sections labeled with scopes A, B, and C. Compared with protein found on a bloody gastroscope, that's the red line. Now that scope had been pre-cleaned at the bedside, but it wasn't yet manually cleaned after use. As you can see, site A had far less protein than sites B or C, and B had even more than a dirty gastroscope. Now when we say bioburden, we're not referring to soil. Instead, we're talking about the number of microbes that are detected by cultures. These are commonly referred to as Colony Forming Units or CFU. This photo of microbes found in channel effluent shows substantial bioburden with diverse colonies. A bronchoscope study found that 58% of patient-ready bronchoscopes had culturable microbes or bioburden. The site with the most residual protein after manual cleaning, site B, also had the highest proportion of patient-ready bronchoscopes with bioburden and the scariest bugs, including E. coli shigella, a waterborne pathogen called sphingomonas, and mold. One of the ultrasound scopes, called an ibis, had colonies that were too numerous to count. The presence of a lot of soil and diverse microbes, including waterborne pathogens, provides a great habitat for the development of biofilm. Now let's dive into biofilm, which is a slimy community of microbes that adhere to the surfaces of medical devices. It's extremely difficult or impossible to remove. Thus, it's referred to as Enemy Number One by event organizers. Biofilm starts developing when free-swimming planktonic bacteria in patient secretions, stool, etc., begin to adhere to a surface. In general, bacteria prefer to attach to surfaces rather than float around, so they'll be looking for places to attach to the endoscope as soon as they get on it. Watnick and Coulter said that association with a surface in a structure known as biofilm is the prevailing microbial lifestyle, and they explain that surface association is an efficient means of lingering in a favorable microenvironment rather than being swept away by currents. Once bacteria have attached to a surface, they begin to secrete EPS, which is a biopolymer made of polysaccharides, proteins, glycoproteins, and lipids in which biofilm microbes become embedded. This EPS matrix represents the house of the biofilm cells that determines the conditions of life in the biofilm microenvironment with regard to the density, porosity, water content, and mechanical stability of the biofilm, among other things. Biofilm allows diverse microbes to enter and establish residency, and then it actively absorbs and distributes water and nutrients to its inhabitants. In addition, the slimy surface provides a barrier that repels detergents and disinfectants. According to Watnick and Coulter, biofilm is almost invariably a multi-species microbial community harboring bacteria that stay and leave with purpose, share their genetic material at high rates, and fill distinct niches within the biofilm. They note that bacteria distribute themselves according to who survives and thrives in particular microenvironments and who can enter into symbiotic relationships with other groups of bacteria. The bacteria in the biofilm communicate with each other when materials diffuse away from them and enter another cell nearby. Watnick and Coulter noted that there are advantages to living in a city, and biofilm is like a city. People live together because it is advantageous in times of adversity. Similarly, they said, biofilm-associated cells are more resistant to many toxic substances, such as antibiotics, chlorine, and detergents. Nevertheless, when the biofilm is no longer providing the preferred habitat for certain microbes, they may decide it's time to leave and set up households somewhere else. Those microbes migrate to the surface and float away, or they may get carried away when the biofilm is disrupted by mechanical forces, such as the passage of instruments through an endoscope channel or cleaning brushes that break off chunks of the biofilm. Watnick and Coulter went on to say that biofilm fosters the transfer of genetic material, which is truly a scary concept. They said this makes it the perfect milieu for the emergence of new pathogens that have passed down antibiotic resistance, virulence, and environmental survival capabilities, which is why we're here today talking about how this pertains to endoscopy. Michelle Alpha has done some important research to determine the character of biofilm, and her 2019 review on biofilm in instruments is worth reading. She says that biofilm in water pipes and drains forms under continuously hydrated conditions, while build-up biofilm on medical instruments is different and more problematic. She explains that material accumulates during repeated rounds of patient exposure, cleaning, and disinfection or sterilization and storage, and that's exacerbated by incomplete soil removal due to brushes not contacting the surfaces sufficiently, and sheer stress from fluids resulting in stronger biofilm adhesion to surfaces. And then there's exposure to chemicals or heat that fixes organic residues onto device surfaces. These multiple rounds of exposure, fixation, and storage compacts the build-up biofilm and makes it even harder to remove than traditional biofilm. In a study on the viability of bacteria embedded in biofilm, Alpha and her colleagues intentionally grew build-up biofilm in channel segments. They found that bacteria embedded in the biofilm were able to survive 26 weeks of dry storage, and the number of viable culturable bacteria actually increased with longer storage times, which defies conventional wisdom. They concluded that viable but non-culturable bacteria harbored in build-up biofilm recover over time and said, indeed, the level of culturable cells increased dramatically from 1.5 log10 per segment to almost 7 log10 per segment by week 12. Our data suggests that Pseudomonas aeruginosa cells within the dry build-up biofilm were able to repair themselves and attain culturable levels similar to those detected before the final full HLD treatment, which is actually pretty terrifying. Now let's talk about an outbreak that was attributed to biofilm in a bronchoscope. In this situation, 15 bronchoscopy patients were infected with a resistant Pseudomonas aeruginosa. During the outbreak investigation, researchers found that one bronchoscope tested positive for cholestin-resistant Pseudomonas. The reprocessing protocols were revised, but there were 7 more infections after the protocol revisions. Electron microscopy revealed that biofilm had developed in the channel, and they speculated that disinfectants only work on planktonic bacteria, those that are swimming around freely. As we think about combating biofilm on reusable endoscopes, it starts with meticulous reprocessing after every use. This is a simplified depiction of the process that actually involves well over 100 steps for each endoscope. So let's assume that an endoscope surface is entirely free of any kind of soil or bioburden before the procedure. So we do a procedure, and it gets coated with several different kinds of soil and lots of bioburden. The idea is that we're going to do that bedside pretreatment or pre-cleaning, and then we're going to do thorough manual cleaning, and that's going to get rid of all of the soil and most of the microbes. Then, when we subject it to high-level disinfectant or sterilization, it kills all those remaining bioburden bugs, and we're fine to move on to the next patient. In reality, when endoscope surfaces get contaminated with soil and bioburden, the manual cleaning often does not remove all of that, and biofilm begins to develop. That slimy surface creates a barrier, and along come the HLD or sterilization, and they can't get through. People commonly ask me, why is it essential to remove or kill everything on endoscopes, particularly GI scopes that are going into dirty orifices anyway? Well, it's important to eliminate all the microbes because gram-negative bacteria, the bad bugs, can replicate very rapidly, doubling in their number every 20 to 30 minutes once they get on a scope. So let's take a look at how this plays out. If just one bacteria, one colony, survived HLD or sterilization and the conditions are right, it will become two colonies in 20 minutes. Each of those will replicate in 20 minutes, becoming four colonies. In an hour, you'll have eight. Each of those will replicate, and in two hours, you'll have 64. By three hours, there's more than 500 colonies, and by four hours, there's more than 4,000 colonies. You end up with more than two million bugs in just under eight hours, even if you just started with one germ. But we're not starting with one germ. We're starting usually with hundreds or thousands of colonies. And moisture is going to facilitate the growth of bacteria, mold, and biofilm. In fact, a recent study at UCLA found that a waterborne bacteria called Pseudomonas replicated rapidly inside wet scopes, and the number of bacterial colonies increased by more than a million per hour when wet scopes were hung in standard storage cabinets. So here's our little germ mascot, and this study shows that when he gets wet, he replicates like crazy. On the other hand, they found that drying out the germs had the opposite effect. In fact, the number of germs actually decreased when the scopes were thoroughly dried in special drying cabinets, showing that drying can actually be a kill step. Over the years, we've seen a lot of wet scopes, and our studies have found that reprocessing does not reliably eliminate microbes. As you can see here, more than half of the scopes reprocessed with HLD still had culturable microbes after they were fully reprocessed. And a study on ureteroscopes found that they still had viable culturable microbes despite being sterilized with hydrogen peroxide gas. You've heard about the concept of enhanced reprocessing methods, and other researchers consistently report that double HLD does not eliminate bacteria, nor does sterilization reliably achieve sterile endoscopes. What's going on here? Those chemistries have been proven to kill the germs that are found growing at cultures, so we've got to look deeper. The truth is that HLD or sterilization cannot be expected to work when conditions are suboptimal, like insufficiently trained personnel, damaged scopes, insufficient cleaning, improperly performed HLD, inadequate drying, or a lack of quality assurance overall. Unfortunately, the conditions are almost always suboptimal, providing a perfect habitat for buildup biofilm development. Let's start by thinking about human factors. Technicians are expected to memorize IFU for diverse endoscopes, and the manufacturer instructions for use are complex and different for each model. This table shows the Olympus Competency Checklist for various models of endoscopes that are commonly in use, and you can see that there's between 67 and 138 steps depending on the scope. The problem is that most personnel receive only cursory training before reprocessing endoscopes independently. In a study we did of over 2,000 reprocessing technicians, we found that about a quarter of them had received less than a day of training, and another 50% or so had received less than a week of training, and they're being expected to do something incredibly complex. In fact, we found that only 46% had competency testing on specific endoscope models, and 17% said there were no competency tests at all, so they're ill-prepared to manage this very complex task. Our ISHM survey identified several factors that contributed to non-adherence with guidelines and manufacturer instructions. First, 70% said they felt pressured to work quickly when reprocessing endoscopes, and about half of them were bothered by odors related to HLD, with 40% saying they felt pain when reprocessing endoscopes. 40% also said that they personally experienced or observed bullying in the workplace, which makes it kind of a hostile environment. The consequences? 50% admitted that they didn't do any visual inspections of endoscopes, 21% admitted they weren't always testing the concentration of the disinfectant, and 17% admitted they skipped steps or did them faster than they should, which creates a very nice habitat for biofilm development. When we observe practices during audits at our study sites, we generally observe that few if any of the steps are done correctly. To combat biofilm, we have to make certain that pre-cleaning is done at the bedside immediately after the procedure is completed, yet this step was being skipped or staff were cutting corners with it at most sites. On top of that, they rarely did a thorough job of manual cleaning, which sets the rest of it up for failure. And fail it did. As you can see here with the bottom line, we've found more than 50% of disinfected scopes harbored microbes in our study sites, and sterilization didn't reliably eliminate microbes either. We're going to talk about manual cleaning and visual inspection in a moment, as those steps are critical to ensuring that the scope is intact and clean before attempting HLD or sterilization. Let's dig into manual cleaning a bit more. This is the mechanical removal of bioburden, organic soil, and other debris. It is performed on the dirty or decontamination side of the reprocessing suite, and it should be performed within one hour after procedural completion. In fact, the IFUs say if it's not initiated within an hour, delayed reprocessing procedures are needed. Manual cleaning involves soaking the device in water with detergent, mechanically scrubbing and brushing the surfaces, both external and internal, and rinsing off the residue and detergent with clean water. It's important to note that if the endoscope doesn't get clean, sterilization or HLD will not work. When we're doing a study, we thoroughly inspect patient-ready endoscopes using light and magnification and borescopes of various sizes. Here's what we find. 100% of the endoscopes have visible defects, in every study, in every institution. And these are not minor problems, as I'll show you in the next series of photos. This photo shows the bending section and distal end of a GI endoscope that we found hanging in a cabinet, ready for use. How's it look to you? From a distance, it may seem fine, so let's take a closer look with better lighting and magnification. Here's the adhesive band at the proximal end of the bending section. How's that look to you? When I see something like this, I wince, as adhesive like that has become brittle, and as you can see, chunks have fallen off. We don't know where they went, or when they went there, but we do know that the uneven edges are sharp, and they can cut patients or technicians who handle the scope. In addition, the pitting and gaps underneath the edge of the adhesive provide ideal places for biofilm formation, because the bugs can get out of the way of the mechanical forces that can wash it away during manual cleaning. Now let's look at the adhesive band by the distal end of the scope. It's in really bad shape. It's ideal for soil and biofilm to fester underneath the edges. In some institutions, most of the scopes have gray adhesive bands, and everyone thinks that's okay because all the scopes look that way. But when we look at new scopes, we can see that the distal end is designed to be smooth, with no gaps or cracks in the adhesive junctions, and less opportunities for soil and biofilm to set up a household. Whenever we're not certain about findings from visual inspection, we compare what we're seeing to new scopes, or ones that look different. Here's the 30-centimeter mark of three colonoscopes, and they look fine to me. In contrast, the gastroscope insertion tubes at the same facility looked more like this. Orange? Hmm, that was different, but we weren't sure what was wrong, or even if something was wrong. And then we looked at the rest of the insertion tube, and realized that the 40-centimeter mark and the 50-centimeter mark looked similar, but the 60-centimeter mark was lighter orange, and the 70-centimeter mark was just slightly yellow. In fact, by the 90-centimeter mark, it's barely discolored at all. What the heck's going on here? The technicians were doing the same things when we were processing colonoscopes and gastroscopes, yet the gastroscopes were brown or orange, and the discoloration was worse closer to the distal end, the part that goes further into the patient. Did something about exposure to gastric juices, acid, and bile beginning on the scope or breaking down its surface? We didn't know, so we did some research. When we started this study, the endoscopes had been reprocessed using glutaraldehyde, and according to ESGE's 2018 position statement, glutaraldehyde causes coagulation and fixation of proteins. ESGE says it's adsorbed by the endoscope surfaces and remains after rinsing, even thorough rinsing. They note that the adsorbed glutaraldehyde can react with proteins during examination of the patient, forming large molecules and increasing the protein fixation risk. Here's what really caught my attention. They said deposits on outer surfaces can be visually detected by yellow or brown discoloration of the marking rings up to the point where the endoscope had been inserted into the patient. That sounds like exactly what we observed! A 2019 review by Lichtenstein and Alpha said that this fixation of protein to surfaces by glutaraldehyde fosters biofilm formation. And that's our enemy number one! Now we still don't know why it's worse on the gastroscopes than the colonoscopes, but I think this is a clue about the probable source of that discoloration. Here's a borescope photo showing what it looks like inside a scope reprocessed with glutaraldehyde. As you can see, there's a deep gouge that has what we call tread marks. They're right here. We think that's from instrument passage through the channel. And then there's a big blotch of brown residue here that appears to have invaded the area around the scratch. The truth is we don't know if that's simply brown fluid that invaded the lining of the channel or biofilm that has established itself where the channel surface was disrupted. You might also have noticed another defect at the bottom of the screen. Something that we call filamentous debris, and we'll discuss that in a moment. You may be familiar with the longitudinal study we did with Mike Shaw at the University of Minnesota a few years ago. At the time, we were trying to determine whether damage and debris accumulates over time and whether it was possible to get old scopes clean. During this study, we did three assessments over a seven-month period in an ambulatory surgery center with about 20 GI endoscopes. There were two groups, including a control group where reprocessing included manual cleaning in HLD with glutaraldehyde in an AER, and an intervention group where reprocessing included manual cleaning and then an ATP test for residual soil, then re-cleaning as needed before the scope was placed in a fancy new AER that had an automated cleaning cycle and performed HLD with parasitic acid. So the intervention group essentially got double cleaning in HLD with acid rather than an aldehyde. I'd like to mention that we selected this site in part because they had better adherence to guidelines than almost anywhere we had ever audited, and we did unannounced audits nine times to make sure they maintained their adherence during the study. Here's an adult colonoscope in the control group. This is the inside of the distal end at baseline in April. It's really gross, with lots of brown stuff coating the channel. What's bizarre is that it looked very similar in June and in October. Look at the pattern in the soil or biofilm stuck to the surface. It's the same here, and here, and here. What's not the same is that the scope had begun to develop channel shredding. As you can see, it's present here in October, but we really can't see it earlier. Now most of the control group scopes looked like this throughout the whole study. Now let's look at a pediatric colonoscope in the intervention group. At the baseline in April, the appearance is similar to the control group scopes because this one had been reprocessed the same way with glutaraldehyde until they implemented the intervention after the baseline. Remember, they began doing cleaning verification tests, re-cleaning as necessary, and then using the fancy AER that cleaned it again before parasitic acid HLD. So let's see how this channel is looking in June, just a couple of weeks after the intervention was initiated. Wow, the brown stuff is mostly gone, and in October, it's entirely gone. And the channel looks pristine. Well, almost pristine. Can you see the scratches and channel shredding here? At 10 o'clock, well, now look backward and see if it's visible in June or April. There appears to be a little bit of channel disruption in June, but we can't see any in April. So here's another pediatric colonoscope for your consideration. What do you think about that blob in the upper right-hand side of the image? We didn't know what to make of it, but it looked like there may be a big gouge or possibly staining. So we implemented the intervention with the double cleaning and parasitic acid, and here's how it looked a couple weeks later. Yikes! That blob had shrunk, and it now had clearly defined edges and dimension. So guess how it looked in October? Gone. Hmm, we don't know where it went or when it went there, but apparently the extra cleaning and the switch to parasitic acid had dissolved it or removed it. We also noticed that this scub had picked up some damage along the way, with channel shredding evident in October and back in June. But this is kind of creepy. Reprocessing in accordance with the guidelines in the IFU had not removed visible soil or biofilm, yet double cleaning and a different HLD seemed to remove it over a several month period. Now let's look at a few other things we discovered inside scopes during this study. In this photo, you can see a scratch at about 6 o'clock and a little chunk of something at around 3 o'clock. When we take a closer look, we can see that the scratch is jagged and discolored, and the chunk is protruding from a brown spot on the channel wall. We thought it looked like a retained chunk of tissue stuck to the channel with soil. We also thought the shape looked like a tall boot or the outline of Italy. Since we originally thought it was a chunk of tissue adhered to the channel, Mike Shaw decided to retrieve it and send it out for lab test. This video shows him using a snare to try to grab it, while we used our boriscope to videotape the process. As you can see, it rapidly became clear that the tissue was actually several chunks that was the lining of the scope that had been torn away and was flapping around, and the brown discoloration was soil or biofilm affixed to the surface that was no longer intact. He was eventually able to capture the debris, which was confirmed to be the channel lining through electron microscopy. Since then, we've seen channel shredding inside most endoscopes, occasionally with long pieces of filamentous debris that we now know is channel lining that's flapping around in the breeze. Obviously, this is a risky proposition. The debris could fall into a patient, and in any case, the channel is no longer intact and rough surfaces provide ideal attachment points for biofilm. During the final assessment, droplets were visible inside 95% of channels, even though the scopes had been hanging vertically for at least a day. As we saw earlier, the presence of water accelerates microbial growth and provides an ideal environment for the development of biofilm. We noticed that some of the drops were viscous, white, and opalescent, clearly not just water or alcohol left in the channel after the final rinse. So we captured some of the droplets and conducted FTIR tests on them. As you've probably heard, it turned out to be simethicone, and others have since confirmed that simethicone used to reduce foaming and bubbles remains in the channels after reprocessing. Infant gas relief drops and other simethicone products contain sugars, thickeners, binding agents, lubricants, and other substances that aren't approved for use in endoscopes or in surgical sites. These ingredients help create an ideal habitat for biofilm formation. The sugars feed the germs, and the thickeners, waxes, and oils help the bacteria and fungi build walls and a roof to repel the detergent and disinfectants that are used during reprocessing. I'm not really happy about putting sugars into scopes, but the thickeners and binding agents are particularly concerning to me as we think about combating anemia number one, biofilm. It's become clear to me that something like simethicone is necessary to clear out the bubbles in foam during some procedures, but I'd love to see a water-soluble product or something that at least does not contain all this other stuff that fosters biofilm development. So what did we learn from this study? One thing we learned is that endoscopes accumulated damage and debris over time, and most endoscopes were quarantined or repaired during the study. At the final assessment in October, 60% of the scopes had microbial growth, and the patterns weren't really what we expected, as there was growth in 50% of the control group, that's the one with glutaraldehyde, and 70% of the intervention group, which of course looked better as I've shown you. Since then, we've learned that it's more difficult to harvest and grow microbes that are living in biofilm, and our visual inspections indicated there was more soil and biofilm in the control group, so maybe that's why we didn't harvest as much from that group. In any case, we also found that gastroscopes had more growth, at 83% positive, than colonoscopes, where only 50% of them were positive, which again raises the possibility that something odd is happening to scopes used for upper GI procedures. Now let's shift gears. To develop sustainable solutions, we need to understand and address the contributing factors. To prevent biofilm buildup, it's absolutely essential to remove all the soil and bioburden and dry the scope thoroughly before storage. To make sure this is done effectively, the process includes several things I call the pillars of quality assurance. These include visual inspection that should be done at every step along the way, and a leak test that should be done before immersion during manual cleaning to make sure that the body of the scope is intact. Then I think there should be a cleaning verification test that tells the technician whether or not the soil has been removed. And later, a test to ensure that the high-level disinfectant or sterilant was strong enough. Lastly, if the scope is not being put in a special drying cabinet that continuously circulates filtered air throughout the channels, I think you should be doing something to verify that your method of drying was effective. I'd like to unpack a couple of those QA steps, and let's start by talking about the rationale for verifying cleaning effectiveness. The purpose of this is to identify inadequate reprocessing earlier in the process, because the presence of residual soil provides a mechanical barrier between the microbes and reprocessing chemicals. In addition, the soil can bind with HLD and sterilants, reducing their concentration. Further, as you've seen, residual soil can foster biofilm formation. With flexible endoscopes, techs can't disassemble them or see through them to verify that they're clean. Therefore, some other indicator is needed to confirm that soil has been removed from the inside of the scopes. Good biochemical indicators exist and can provide valid, reliable data to support technicians in ensuring that scopes are clean before attempting HLD or sterilization. I'd like to share an example from one of our studies that shows how cleaning verification tests work. In this case, we tested the ATP level on several components of this gastroscope after it had been pre-cleaned at the bedside, and again after it was manually cleaned in accordance with guidelines. We shared the results of the test with the technician, who then cleaned the whole scope more vigorously, and we tested it again after this re-cleaning. I'd like you to notice the patterns. After bedside pre-cleaning, the ATP levels ranged from 1,000 to almost a million. That's no surprise because upper GI procedures are commonly pretty messy. After manual cleaning, the ATP level on every component was lower than it had been, and two of the components had levels below the dotted black line here. That shows the 200 RLU benchmark for organic soil when measured by ATP. The cleanest components were the control handle and the distal end, which are relatively easy to clean and can be visually inspected by the tech. Now look at the pattern for the biopsy cap, suction biopsy channel, and biopsy port. They didn't come anywhere near meeting the benchmark after the first round of manual cleaning, and a second round of vigorous cleaning got a lot more of the soil off, but not enough to meet the benchmark. You may also notice that the ATP levels dropped a bit even for the two components that had met the benchmark after manual cleaning, showing that there was still removable soil there and the tech got it off by cleaning again. Without doing a test for organic soil like this ATP test, the technician would never have known that the scope was still dirty and it would have been exposed to HLD, which would fix the soil to the scope and contribute to biofilm development. In our studies, we found that a bunch of things impact the results of cleaning verification tests, like long, messy procedures, a failure to do the pre-cleaning at the point of care, delayed reprocessing, and damaged scopes, which may not come clean no matter what you do. Sure, it's true that inadequate cleaning by the tech in the decontamination area could play a role, but all this other stuff is on the back of the tech, and that's not fair because even if they work super hard, they may not succeed at cleaning scopes until we address these other factors. Now let's talk about guidelines for drying endoscopes. The new multi-society guideline states that channels should be dried with medical grade forced air for at least 10 minutes after reprocessing, which is going to be quite a change for a lot of people. ESGE states that endoscopes should never be stored wet, and AORN says, The collective evidence shows that effectively drying the internal and external surfaces of the endoscope is as important as effective cleaning and disinfection or sterilization. You may be wondering, where do microbial cultures fit in the QA-QI strategy? Well, in my view, they're in last place, after absolutely everything else is optimal. Don't get me wrong, I think there's a place for microbial cultures, it's just not the first thing to do. First of all, they're extremely hard to do correctly, and they require a lot of time and money. Maybe more importantly, the results can lead to unexpected consequences. One of them may be detecting a profound failure of reprocessing that could have been noticed earlier by using those other quality assurance methods. They may also be inappropriately reassuring due to false negatives, or because you're disregarding warning signs of reprocessing failures by focusing only on superbugs. In my view, if any bugs survive, then any bugs can survive, and you're dodging bullets if it didn't happen to be a superbug. Also, as Michelle Alpha pointed out, normal flora and environmental organisms in biofilm can protect pathogens. Lastly, if you do cultures, you might inadvertently document findings that are discoverable, and I'm not sure you want to go there until you've made sure that your program is in good shape. Let's talk about potential solutions for combating biofilm. Here are some of my ideas about policies. First, convene a multidisciplinary team to identify risk factors and develop QA strategies. The team should involve at least one reprocessing tech and a sterile processing expert. You could develop protocols for handling high-risk situations like long, messy procedures and delayed transport. And then consider the impact of simethicone and other non-soluble substances on biofilm buildup. Of course, the point-of-use pretreatment should be done immediately after procedure completion because that's the foundation for getting the scope clean. And you want to make sure that the reprocessing incorporates those QA steps for every scope, every time. I think it would also be good to consider sterilizing scopes to reduce the risk of the buildup biofilm due to wet-dry cycles. And lastly, arrange for routine inspection and maintenance of your endoscopes so you get the damaged ones out of circulation. Let's wrap up by considering solutions for combating biofilm that address the human factors we've discussed today. I'd suggest you start by visiting the reprocessing suite and learning what it takes to support you. It'd be great if you asked them to show you how to reprocess a scope and gave it a whirl yourself. That might help you serve as a better advocate for your reprocessing team, helping to ensure that they receive high-quality training and support for continuing education, and providing equipment that can reduce the discomfort and injury they experience when they're trying to reprocess scopes in accordance with guidelines. That includes things like the ergonomic sinks with adjustable height and automated systems for flushing, leak testing, etc. Also, you should consider allocating sufficient time and support for reprocessing quality checks. And this means that we can't anymore have fast turnaround be the number one goal. We want quality to be the number one goal. And we need to shift our culture so that we celebrate when personnel identify factors that contribute to biofilm, so you can together address that and reduce the risk that you're going to be building up that biofilm and having the potential for pathogens being harbored in your scopes. Thank you for joining me for this presentation on biofilm. My contact information is below, and I'd like to draw your attention to the URL at the bottom for educational webinars. We have a series of CE sessions that are put together for reprocessing personnel, and they focus on those quality assurance pillars we discussed, as well as issues like the use of simethicone, how to get scopes dry, etc. I look forward to discussing these findings and other questions you may have. Below is a list of the references for the documents that I cited during this presentation. Thank you so much, Corey. This is Luke. Again, really appreciate that remarkable presentation, especially around biofilm. One of the, you know, I'm always struck by videos or pictures showing the damage the endoscopes as well as, you know, the potential infectious risk. It's always very striking. I'm curious, you talked about a lot of the challenges that endoscopy staff have around sort of, you know, workplace violence, it appears, bullying, and even sort of injuries. I'm wondering what best practices you've seen out there to try to combat a lot of this. You know, a lot of times we always hear that in reprocessing staff are some of the lowest paid individuals in the unit, and, you know, the mistreatment just even makes it worse, but they're key to ensuring that infectious risk is minimized or prevented. So I'm curious what best practices you've seen out there. You know, that's an interesting question. I love it that you're asking about best practices, rather than just for horror stories, because I can tell you some horror stories. And if you'd like, I'll tell you a bullying horror story that we witnessed ourselves. But I've been to two institutions that had really impressive relations with the endo manager, the SPD manager, and the techs. And in both of them, physicians had taken it upon themselves to learn how to reprocess scopes and visited the unit and helped. Helped them with something, advocated for them if the scope was damaged, gave them high fives for doing something well, identifying a scope that failed a leak test or a scope that wouldn't come clean or had damage or something like that. And there's a hospital that we've worked with a lot where one of the docs went through and got officially trained and then spent a couple days slaving away at the sink doing it so the techs would know he knew what it took. And I've done a couple audits there. And it just so happens I'm in there doing an audit and he comes on a walkthrough and tells people how much he appreciates how hard they're working that day and that he knew that they had a lot of cases and he knew it must have been really tough and appreciated them not skipping steps, et cetera. And that's really quite remarkable how then they want to step up. And then they also realize how important they're at the front line. So that's one place. Another place that did a really nice job, it really valued the team and they actually sent everybody for certification. And I think when that happens, if the institution invests in the technicians becoming certified, in this case they certified them all through ISHM, which has sterile processing certification, national board certification, but also they have a endoscope specialty certification. Something shifted in those people. And the truth is they did end up paying them a buck or two an hour more. So it costs a little bit to train them, et cetera. But the techs began to see themselves as true professionals where they had a job that was as serious as being an LPN or a nurse or a surge tech. And when they started to see themselves as professionals and see their responsibility as a licensed professional was to follow guidelines, they stopped skipping steps and cutting corners because they were professionals who knew what to do. And I think that can shift the dynamic if we start to really see the people who do this job as a very highly trained professional that we count them to do a job. So does that help? Yeah, no, I 100% agree with both of those. One, I think it's critically important for everyone to kind of learn the steps and learn how to do them well and just really going to where the work is being done and watching the work and providing that feedback. But then also, I think the reinforcement that their work is important and that they're valuable members of that endoscopy unit or that surgery center's environment. And then, again, I'm a big fan also, too, of structured credentialing. I know Nancy Schlossberg on here is also a big fan. And she's encouraged our staff to do the SG&A reprocessing credentialing pathway. And so I think having those structured programs are incredibly useful because it provides a nice sort of standardized, validated, and also, I think, team-based approach for how to think about reprocessing. Yeah, absolutely. My last question is, again, this is really remarkable. I love the pillars of quality and the diagram that you showed. I mean, I think it's very illustrative and gives a nice visual representation of how we can think about improving infection control and minimizing infections in endoscopy. I'm curious, have you seen this process implemented anywhere or any sort of groups out there where you've seen this done successfully and kind of sort of what were their challenges in being able to implement it? Because this would definitely be a culture change, I think, in all sort of not only GI, but I think in other disciplines as well that use endoscopes. Yeah, actually, we've been doing a lot of collaboration with a site that I can name because they come out of the closet. It's a hospital in Iowa. On our webinar portal, so we have continuing education webinars that are available free for nurses and reprocessing techs. We have a couple of webinars that were filmed in this particular hospital, and they have an incredible head of sterile processing and collaboration with the various teams. They have implemented things like they have ergonomic sinks that move up and down because they realized that the staff couldn't even do the leak tests and the manual cleaning and the visual inspection if they didn't have sinks and counters at the right height, because you can't inspect something visual if you don't get it to the right height to your eyes. And for very short or very tall people, that wasn't working out so well. So they got grants and got the ergonomic sinks. They do clean verification tests, every scope, every time. They're doing visual inspection. They actually worked with us to develop a workshop that is being delivered through APIC, that's the Infection Prevention Association, at their national conference in a couple of weeks, and they taught a class on leak testing. And it's amazing. We got some great video footage there because they were actually videoing a lot of leak tests, and they found a scope that there were no bubbles that came out the sides of the bending section when you did the leak test straight. So you pressurize the scope, put it in the water, and you're watching for bubbles or none. And then when they angulated that distal end, bubbles shot out of the side of the bending section. It's really a beautiful video of that. Amazing. We could see the bubbles. But they've been doing tons of this, engaging the whole team, sort of like Nancy talks about, engaging the whole team to be involved in troubleshooting and that sort of thing. We just, one of our CE webinars with them was on splashes generated in the decontamination unit. And we had five of their technicians participate in doing experiments and study on splash demolition. When you engage them as professionals, you see everybody step up to the plate, and the level of concern and the level of engagement just skyrockets. So I think that team building concept and that involvement concept is great. But you can see some of their work in our webinars if you're interested. Thank you. And I completely agree. I think the engagement piece is really critical in ensuring that everyone on the team feels valuable, but also that they're engaged in the work that they do. So again, I really appreciate you highlighting that. Sorry, it's Nancy. I do have a question for you. With all, we know that the, I always said endoscope should be clear so you could see what was going on inside them as well as the channels. But one of the other nooks and crannies are the buttons, the air water button and the suction button. Of course, everybody now has disposable ones. Oh, they don't. No, they don't. Well, we keep hearing more pressure. You have to have these for whatever reason. If you can afford to have them, should you have them? I mean, it's just one more thing that adds to a cost per procedure. In my opinion, yes. Part of that is, in one of the first studies we did, it was at Mayo Clinic, we actually did tests and looked for protein ATP and visible soil, et cetera, on the valves and caps. Those were by far the most highly contaminated components of any component. So as you guys know, we found a lot of stuff in channels and ports. That ain't nothing compared to what's on the valves and caps. And we've also done some photography of valves and buttons using magnification and special lighting. And I'll tell you that we've never seen a clean one. Those little rubber gasket things, if you look up underneath them with magnification, it's nasty. And I don't know if anyone, when they're cleaning them, if they actually do activate the button on the valve to get the little pole to line up and get up underneath there, there's like a wire spring thing up in there. I've never seen, when we've audited manual cleaning, I've never seen anyone use a brush to clean those things. They just throw them in a basin of detergent, kind of give them a little jiggle, and then throw them in the AER. Sometimes in a little baggie, other times they just throw them in the body of the basin. And the soil that gets on them, particularly the suction valve, yuck. I don't know. I'd love to do a study focused on those things, though, because I think that that would give the evidence. I don't know of any published evidence, Nancy, other than that one study that we did where we included that. And then because they were so nasty, we just said, eh, we'll photograph them, but we're not going to bother because cultures are really expensive. So we haven't done a systematic study. I'd love to do one. No, thank you. I'm glad to say that for every model that has an available one, we're using it. But there's still some that don't have, the last I looked. And a lot of the hospitals that we've been going to are still using old, beat up reusable. So it is not universal that people have shipped it out to some groups. Yes, no, that was just a question of what you think of it. And I do think in the old days, at least you could put those buttons in an ultrasonic, which helped at least loosen things. But nobody ever does that. Yeah, no, I haven't seen them treated that way ever.

Dr. Corey L. Ofsted

Ofsted and Associates, Inc.

Biofilm

Infection Control

Medical Devices

Endoscopes

Reprocessing

Quality Assurance

Collaboration