Covalon Technologies Ltd. (COV) Earnings Call Transcript & Summary

March 29, 2023

TSX Venture Exchange CA Health Care Biotechnology special 60 min

Earnings Call Speaker Segments

Katherine Evely

executive
#1

Looks like we've got lots of people getting logged on. So we're just going to wait a few more minutes and then we'll kick things off. Again, I just want to remind everyone to try to pull up that chat. And if it's -- it should be visible on the right-hand side of your screen. If it's not, right top corner, click the chat icon, that will pull it up. We're going to try to use the chat throughout the talk to interact and engage. And if you'd like to give it a test, please feel free to drop a note in and let us know where you're joining from. It's always really fun to see the distribution of attendees across the country and internationally, too. I know on our last webinar, we had a few people joined from international locations, which is always cool. So give the chat a test, and we'll be getting going here in just a few minutes. Thank you. Okay, everyone. We have 1:01 Eastern on the clock, and a great turnout. So let's get started. Again, I just wanted to introduce myself. I'm Kate Evely, Senior Director of Clinical Affairs at Covalon Technologies, and I'm really excited to be hosting today's webinar on protecting central venous access devices from gross contamination. We have a great session for you today and a fantastic speaker who I'm going to get to introducing in just 1 minute. First, just a friendly reminder, if you're having any issues with the platform, any technical difficulties at all, please reach out to us at [email protected]. My colleague, Camilo, and others are monitoring that Inbox, and they'll be able to help provide technical assistance if that's needed. But hopefully, everything has gone smoothly, and you're logged on and ready for today's session. Okay. So without any further delay, I'm going to introduce today's speaker, who, I think, for many of you may need no introduction. Today's speaker, Matt Ostroff is an internationally recognized speaker, a vascular access expert, innovator and researcher. He has published many papers, including ultrasound-guided vascular access, practical solutions to bedside clinical challenges. He's also an active member of the INS, AVA as well as WoCoVA, where I'm sure you've seen some of his work or presentations. I'm going to pass it over to Matt now to cover off a little bit about what we'll be covering today.

Matthew Ostroff

attendee
#2

Thank you so much, and hello, everybody. I wish I could see you all, but I can't. So I'm just going to hope that you're out there. As you can see, I'm in my office. Don't hire somebody that works in the 24/7 because you're lucky if they show up on time. I had a great day today of cases in the morning. And for me to take time out of my day to do a webinar means that, to me, it's something that's really important. And when we talk about gross contamination, when we talk about CLABSIs and the issues that we're dealing with today, it really means a lot to me. Over the years, grown so much from the inserter to now really caring not just about the outcomes, but about the patients behind the outcomes. And it's just -- I think as you get older and practice more, it becomes so much more personal, those outcomes, because nobody can get a hospital-acquired infection unless they come to the hospital, which means that it's really our responsibility. So without further ado today, we're going to speak about the rise of CLABSIs. The impact of the COVID-19 pandemic is really what caused this. I believe it was a turning point for hospitals with regards to surveillance and practice. We're going to talk about the extra luminal sources of CLABSI. I would even like to propose a new term, beyond the catheter. This is the underaddressed external contamination to the extension tubing connections. We're going to go over some case discussions because, as you know, my passion is innovating new solutions for my complex patient population here at St. Joseph's. But these innovations must be kept safe from the insertion site all the way to the infusate bag. We're going to go over some new technology to strengthen the current CLABSI bundles. CLABSI, it's really -- it shouldn't be an issue to react to. It's an issue to prevent, to strategize and to rethink our current practices based on current evidence. And then finally, we're going to share and discuss. But most of all, this webinar is for you, for the attendee, to interact via the chat box with me to discuss your questions, hear your comments and to really make this a collaborative experience because I know if you're viewing at 1:00, then you have a job. So you're taking a break from your job to discuss this. So without further ado, we're going to start with our first poll.

Katherine Evely

executive
#3

Thank you, Matt. And I just want to reiterate that. Thank you, everyone, who's taking the time and what I know are very, very busy schedules to log on today, share and interact. And I think, like Matt said, the goal is to make this as interactive as possible. I think that's how we can all get the most out of it. And it's fantastic to see everyone writing it and letting us know where they're joining from. So let's keep that up, keep using the chat as we go. We're going to be using the chat and also a pooling function. So a very easy, simple tool to get us started, just get us familiarized with the platform and make sure it's working. CLABSIs, an issue in your day-to-day practice. Yes or no? I'm going to start the poll, and what you'll see is a banner will come up on the bottom of your screen, and you can select A or B there. And then the responses are anonymous for all the polls we'll be running. But I'll let you know as the data comes in what it's looking like. Okay? So we're going to get started here right now. You are going to have 20 minutes or -- excuse me, you don't need that time. 20 seconds to answer the poll. Okay. Hopefully, everyone can see that at the bottom of their screen. 10 seconds to go. [Voting]

Katherine Evely

executive
#4

All right, and time is up. So the results of our poll are that over 90% of you said, yes, CLABSIs are an issue you're experiencing in your day-to-day practice. And all I will say before we move on is that certainly reflects the conversations I'm having with clinicians across the country and really globally as well. All right.

Matthew Ostroff

attendee
#5

Can we stay on this slide?

Katherine Evely

executive
#6

Yes, of course.

Matthew Ostroff

attendee
#7

Yes. So everybody that's answering this, there are so many different types of challenges depending on whether you're an inpatient or an outpatient, whether you're receiving continuous or intermittent therapy. So like, for example, in my work environment, we're challenged with the critically ill patient that may have more than one source of infection that can translocate, right, from wounds, from sputum, from feces into the bloodstream of our patients through the central line catheters. And then we have our long-term patients who are difficult access. They're receiving intermittent infusions, or the patients that are continuous infusion, such as the total parenteral. So it's just so complex. But the one thing for me that remains the same and that's the causative factors that lead to the bloodstream infections, what we can prevent, the intrinsic and extrinsic causes. Thanks for staying on that slide for me. So as we move forward, CLABSI, it's a serious potential safety issue. And you've probably seen, there's a great patient safety video, and I believe it's from one of the big companies out there. But when I saw this slide in the statistics that we were talking about, I thought what if we could change the way that this slide is red. So what I'd like to do is change the first slide that we read and say, patients in the United States develop an average of 31,000 CLABSIs a year. Patients in the intensive care unit develop CLABSI, and it's been increasing from 47% to 65% from 2019 to 2020. Children are at the highest risk for CLABSI. And children in the intensive care unit have higher rates of CLABSI than adult patients in the ICU. They're very, very chilling statistics. Just moving to the next slide. So what are the consequences of CLABSI? We know this, right? Regardless of the cause of CLABSI, they have serious impacts. When we look at increased use of antibiotics, hospitals are actually really making strides with this with pharmacy stewardships to limit the duration of the broad-spectrum antibiotics so that we can quickly locate the specific antibiotic and convert even IV to oral therapy when possible. But with the increasing rate of diabetes, renal failure, peripheral vascular and arterial disease and intravenous drug use disorder because I don't call it addiction. It really is a disorder that these patients suffer from. The rates of osteomyelitis, endocarditis, infected implantable devices and sepsis are just a continual battle that require intravenous IV antibiotics at this time. The greatest problem is that it increases their length of hospital stay. And although our noncritical patients complain, or when I say complain, they're aware that their hospital stay is rushed. We try to get our patients out as quickly as possible, that's to prevent them from being exposed to any other risks for hospital-acquired infections. So while they may feel rushed out, we're trying actually to keep them safe for the most part. And on the flip side, when a patient does develop a CLABSI, their hospital duration -- stay in the hospital is extended. And then there are risk for even other complications is exponentially rising. Line removal and treatment days. So those of us that are from the needle side of this conversation, I have one view on this and those of us that are on the infection prevention side have another view. And it's very challenging and complex, right? We have the patients who have a central line and peripheral access that's not being removed. That's something that we can solve. We can take out the other peripheral access once we have central lines because that places the patient at a greater risk for infection because there are all these other sites that bacteria can get into the blood. We then have the patients who can downgrade to peripheral access who have that central line in place. And then whether it's the nurse or the vascular team or whoever is available can place that peripheral IV, we can then remove that central line. Those are 2 things that I'm completely on board with that we can fix: removing peripherals with central access and downgrading to peripheral access when it's appropriate. But then we have our difficult access patients. They end up with the central line, and it's left in place for a couple of reasons. One, we can establish peripheral access even if that's all that the patient requires; and two, this is after the family are so afraid that if we remove that central line access, we won't be able to reestablish access, whether it's via peripheral, midline, PICC line or an additional central access. So we've got that line removal just conundrum that I think we're all in. What I find is important for line removal and treatment days is accurate documentation. We have our teams that round on the patients. They're assessing why is the line imperative to keep or how can we get it out. And I find it important to document why we can't get it out if it's supposed to come out. I always say, look, one of the indications for central access is difficult access, not necessarily central line medication, not necessarily long-term antibiotics. But if you have extremely poor peripheral access, then that is an indication, whether it's peripherally inserted central access or centrally inserted access, to have that central line. So line removal and treatment delays are one of our big challenges. Sepsis and death. It's not our fault. A lot goes into it, right, insertion, care and maintenance, being transported all over the hospital, surgeries, all these things. But the fact that our procedure that we do on someone, our device that we need for our patient can actually result in death. It's a lot of weight. It's a lot of weight to hold, and we see this. You hear about the stories. You see it posted on social media sites. CLABSI should be a never-death event. And it's not. And that's why we need to constantly focus on what are we doing now that's right, what could we be doing more, because in my personal opinion, one death is too many deaths. It's one thing to be sick, to be septic, to go to the ICU and get cared for. But to die from a hospital-acquired infection is, in my opinion, just not okay. So estimated cost of CLABSI. God, for -- ever since I got into this profession, everyone's talking about $10,000, $25,000, $35,000, $96,000. I never understood it. Everybody justifies it in a different way. Oh, well, the cost of this and the antibiotic. Until you really break it down and you go well, if they got transferred to the ICU, you know how much at night that hospital bed stay is. That hospital bed, not the IV, not the infection, not the antibiotics, not the physicians, not the diagnostic tools that you need to do. The bed that night is close to $10,000 a night in the ICU. So when you start to look at hospital length of stay, what room and unit that you're on, the diagnostic test of physicians and the specialists that are involved. Sometimes the CT scans, the MRIs, the surgical interventions that are required. $96,000 really isn't so far fetched of the cost of a CLABSI. And we know that we're dealing with thousands and thousands in the United States a year. So it really is an economic burden. Increased clinician workload stress. This is huge. Septic patients require attention. They require attention, monitoring, added to the stress and the workload of the bedside staff. I never blame our bedside staff for the CLABSI challenge. They have 50 different things to do besides taking care of the IV line. And that's even aside from the patient, their family, their physicians, the -- outside dealing with discharging and case managers and social workers and feeding and swallowing it, all the different things these nurses are stressed with that they can't provide the one-to-one kind of care that we do at insertion. I can say, yes, I take the time to do a beautiful insertion. I clean, I let it dry. I do a very slow and sterile procedure. I have one patient at a time that I'm taking care of. These nurses have so many. And now you add COVID into it where we lost nurses, where nurses have been retiring or quitting and leaving the profession at a daunting rate. It's all over the news. And so you have the diehards that are staying on. Those of us that are probably on this webinar that are nurses, you're still here. But we're getting an influx of new nurses, but not enough. So the bed-to-nurse ratio is just too much. It could be 5:1. It could be 10:1. I see posts on LinkedIn with like 9:1 nurse-to-patient ratio. They can't watch. They can't make sure everything is perfect that way. So what we need to do is do 1 of 2 things. Can we increase the workforce? Can we give nurses more nurses, more techs, more physicians, more eyes on our central line catheters? If that's the answer, then that's fantastic. If we can't, how can we help them? How can we protect our lines? We protect it from the insertion site, to the dressing, to the end of the catheter hubs. What about all these extension tubing and the bags and all of these challenges that are on a day-to-day, hour-to-hour when the patient just disconnects himself and goes to the bathroom? And the challenges that these nurses are up against for a responsibility are just enormous. So there are a lot of consequences to CLABSI. Who is at risk? I mean every patient with a vascular access device is at risk, and we see that now. They are looking to do hospital-acquired infections. That means peripheral or central. So it's not enough to focus just on our central access. We have to focus on our peripherals, our midlines, our PICC lines. Every patient that has a device is at risk for a CLABSI. And it's our most vulnerable, right? It's the pediatric patient population who, at baseline, have the same risk factors as adults. But we have to factor in their behavior. First of all, adults are burdened by these things, and they don't like them. Kids just don't care. They're still going to play. They're still going to go to the bathroom. They're still going to eat their food like my 4 kids do at home, like a mess all over the place. Their developmental stage, their physiology, there's so many factors, especially for pediatrics that goes for contamination of their lines or even if we go to other issues like dislodgement. There's just so much in that pediatric phase. And again, they have 0 concern for this. They're not going to say, "Oh, you know what, by the way, I got my dressing dirty, or my tubing fell in the toilet when I was going to flush it because it was -- my IV, my PICC line was here, and I went to reach for the flushing thing and it dipped down." They're not going to tell you these things. And these are the things that we need to help the nurses with, help the families with and protect our patients. Here we are, another survey.

Katherine Evely

executive
#8

Another poll? Perfect. Thank you, Matt. So another one, another simple one. Three options this time and another 20 seconds to answer, and it should be starting now. [Voting]

Katherine Evely

executive
#9

Thank you, everyone, for your engagement. We've got 100% yes right now, 13 seconds left on the clock, 10 seconds and it remains at 100% of you saying always. So a, sorry, not yes, but always. Perfect. Thank you very much, and we'll move on now. Back to Matt.

Matthew Ostroff

attendee
#10

And I'll stay on this slide because it's my most exciting probably part of this presentation. Are you looking for new ways to prevent your CLABSIs? This is what I tell my students, and it's ironic for me to say my students because I still am a student. I'm still following my mentors in the industry very closely. But I tell my students this, the greatest and most scary part of vascular access at this time is that innovations are being developed still to this day from the Broviac and Hickman catheter to our quads and our pediatric lines. And we're having supply chain issues. Things are changing. CLABSI is not just a problem. Again, it's a never event. And every day, I'm searching for more solutions to prevent it from ever happening to our patients. We may have -- we don't. But we may have a 0 infection rate at our hospital. But how do you keep that up? When you're the best athlete in the country, you're the fastest runner, don't you still look for new ways to train, new ways to stay the best? And I think that's really what's important with infections because they can come out of nowhere. We all know about the clusters that develop. We need to stay on top of, are we doing everything. Even if we're doing the best, are we doing everything and what more could help us. It's not a complication that I want to wait to treat. Meaning, even without a problem at this time, I just don't want it to become a problem, right? That's the difference between infection prevention and infection response is what I call it. So we will now move on to that next slide. So our basic CLABSI prevention bundles, right? Hand hygiene. It sounds so basic. And you're like, "Matt, okay, okay, I've heard enough about it." But how many of you and hopefully, everybody, I wish this was a poll. How many of you do that alcohol-based hand prep before you walk in every single patient room? It's become a religious thing, just something that I just instinctively do before I walk in a room anywhere. I use that alcohol-based hand sanitizer. And we know this. We know that hand hygiene is the single most important factor that you can do in a hospital to reduce infections. The use of CHG as our antiseptic. It's effective against gram-positive, gram-negative and fungal. So the important thing is to know how to apply it, to know how long to let it dry. These are important things that it's not enough just to slap it on. You've got to allow it to work. You've got to scrub the skin. You've got to allow it to dry. That's how chlorhexidine becomes effective. Our central line insertion checklist, it can become tedious. It can be -- is there really someone that really needs to look at this? But yes, there really is because if you miss one of those steps in the short 20- to 30-minute procedure, sometimes shorter of insertion, it's going to affect down the road for that patient and, of course, for the development of infection. Our central line insertion kits, not only are we focusing on central line insertion kits now, but our peripheral insertion kits, our midline catheter insertion kits, our PICC line insertion kits. These kits are so important because they come with all the tools necessary to do a sterile insertion and to protect your catheters. So if you have all the supplies bundled, then you will always have all the supplies bundled. But I remember back when I started doing all this, oh, I need that, I don't have this one. I need this thing. The insertion kits, honestly, I think, have changed so much. And you know as well as I do, when you see emergencies, you're never going to pull what you need or open individually what you need in that emergency. Those kits are what save our patients. Maximal sterile barriers. This is key. This is key. We have to protect everything. I love to use sterile towels. That's my big thing for my max barriers because I found that all the central line drapes, even the PICC drapes, they're either too big, too small. If we're using a pediatric or an adult, that circle doesn't go in the right place. With sterile towels, you can make your perfect site, your perfect work area and then use the other drapes to drape the rest of the body. I've just found that it eases my mind, takes the stress off because you can create your own beautiful thing, especially with jugulars and axillary access and even femoral to just drape that bed and get everything out of the way. And then finally, the daily review of the line necessity, right? That's key. That's what everybody is doing. Is this line necessary? But the key is all of the components of necessity, necessity because of poor vasculature, necessity because of an irritant drug or vesicant medication. And of course, necessity, what if they don't even have an infusion going? We take that risk away. If you have a vascular team at your hospital and they're available, then those patients that are not on infusions don't necessarily need to have a line because you can call that vascular team right away to establish access. You can call that rapid response and have an IO placed if, god forbid, there's that bad of an emergency that happens or you can do preparation, do venous mapping. If you have a young patient with great vasculature, you write in your note, has an antecube on the right arm, has a cephalic vein in the right forearm, whatever it is that you find and say, in an emergency, this is what you go to. And then you have a plan for that patient without the IV. It's like central lines. When we remove the central lines -- I'm sorry, when we place the central line and I tell them, take out the peripherals and they go, "No, no, no. We're going to want to take out the central line one day," and I go, "That's fine." We're going to take out the old lines. And when you're ready to have that new peripheral placed, we're going to come back and we're going to put it in for you. But right now, we want to minimize, minimize that risk. Added evidence-based measures. So technology is what really helps us, right? Antimicrobial dressings. When we started putting on antimicrobial protection at the insertion site, those sponges, or now the cyanoacrylate that people are using or silver disks, you name it, impregnated dressings, you name it, whatever it is, it stopped that 24-hour dressing change. That was a big deal for central line access. So antimicrobial dressings, we're using these on our peripherals. I think it's important. The chlorhexidine bathing has been proven and especially around the sites of those central accesses. The passive disinfection caps, that has been huge. And it's exactly the same problem that we're having with nurse staffing. We had nurses that were overwhelmed. We had emergencies. We had so much happen that they weren't scrubbing the hub. And I kept saying to myself, can we blame them? Can we blame them? And in a perfect world where nurse staff ratios are perfect, no, no. That's not an excuse. They should scrub the hub and do what they need to do. In today's environment, where they're running around doing all these different things, if we can protect the end caps of those catheters with an impregnated disinfection cap, then why not help the nurses do that? Why not help the nurses and help the patient because it protects the patient. But the key is robust education programs. Your technology is only as good as the people behind the technology that understand it. If your clinicians putting on the cap and doesn't know whether they need to scrub with an alcohol pad or not or if they can replace it, without education on these products, it's not fair the nurses that are using it. They should know everything that they're doing. But it also doesn't help that staff maintain competency. It doesn't help them grow. It doesn't help them question. And it doesn't give them a resource to go to learn. And education, really as complex as it is because people don't have time, we thank you guys for coming here for a little education. It is the key. And when you get educated, you're refreshed. Even if you already know it, you're refreshed. And then compliance monitoring. Are we using it right? Are we using these evidence-based maneuver measures? Are we doing them right? Are we implementing the technology the right way? Because if we're going to spend money -- if hospitals are going to spend money, it has to be worth it. We have to measure the outcomes. We have to measure the compliance, and those are key for hospitals to acquire technology. But we're still having CLABSI. It's still a conversation. It's going to be a conversation today. And it's going to be a conversation until nothing is going into patients. So the question then is why? Why are CLABSIs still occurring? And I think what's really happening now is post COVID, we made so much progress. We made so much progress before COVID happened with surveillance, with infection control programs, with the pharmacy stewardships, with the dressings and the care and maintenance and having IV things expand to care and maintenance teams and then COVID happened. And it turned health care over on its head. While the clinicians were desperately trying to find ways to care for these patients and save the lives of hundreds of thousands of patients, central line care and infection reporting was placed on hold. Hospitals no longer had to report it. And we all know when you don't have to report -- and I don't want to say it this way, but follow the rules, things get -- things break down. And that high level of -- it gets lowered because you're focused on something else. We were focused on that airway. We were focused on keeping these patients alive. So infection control in our hospital, they didn't round on the COVID patients due to exposure. I mean at one point in my hospital, our entire infectious disease department was out with COVID. Many hospitals who ended up short on supplies, we were short staffed. These situations after years of good infection practice, these techniques fell apart. The nurses that we're teaching, the nurses that knew the proper things, the senior nurses were no longer working at the hospital. They were either out sick. They retired. And unfortunately, a lot of our workforce. When I say our, I mean, health care in the United States, died or were severely hurt. So COVID was a lesson in so many different ways. If we're just going to play a video in just 1 second because I just want to set you up for it. We started dealing with patients where we couldn't be with the patient. We had IV tubing running out of rooms. We had central lines in patients that we couldn't see when they were prone. All these connections, which is in there, in these rooms. And this video is just a little...

Katherine Evely

executive
#11

Sorry, Matt, cut you off there. You were saying this video, and then it played, but...

Matthew Ostroff

attendee
#12

Yes, no, that's great. This video is just a reminder for everybody out there. I was talking to my colleague yesterday, and it's good. That's not in the news anymore, but we forget that millions and millions and millions of people died. And those of us that are on the webinar, you're a survivor. If you're a frontline worker, you're a survivor of what is our greatest pandemic of our generation. So how do we target the source when we're talking about external contamination, right? We have the patient's skin flora. That, in itself, is huge depending on where the patient is coming from. They're being transferred all over the hospital. Families coming in and visiting and hugging and touching again. During COVID, we didn't have visitors. I don't even know it would be a really interesting study just to see the difference in skin flora during that time. But I don't know what changed. But now that we have visitors coming back in, whether they're adults and children and family, we're dealing with that. The exogenous flora from the surfaces, god, this is the worst. From pediatrics, forget about it. They live on the floor, which is awful. But the bed rails. If you've ever watched patients get changed and they slide out the bedding, feces ends up on the side rails, blood ends up, you name it, food. There's just contamination everywhere. I watched patients who can feed themselves and half their food is in their shirt, and their jugular line is in their neck and their tubing is in their shirt. So they're getting contaminated from food. The flora that's transferred from the health care professionals during transferring of patients, how many connections and disconnections or reconnections are done in the hospital just to go down for a CT, just to have your MRI done, to go to the OR? You're transferred and then anesthesia is accessing. There's just so many opportunities for these connections. And when you leave the room and they've disconnected you and that tubing is sitting there, is it just sitting there? Does it fall on the floor? Like what really happens to all of these things? Gross contamination events such as emesis and gastrointestinal secretions, oral and tracheal secretions. When you have those stomas and those colostomy bags and the open wounds and the surgical sites, the urine, the stool on the femoral catheters, this can get into the catheter threads, the Luer connections to the lines or the caps. So we look at literature on hub contamination. And [indiscernible] makes a direct reference to the concern of gross contamination at catheter hubs describing it as contamination from emesis, gastric, urine and oral secretions, involving the dressing and parts of the catheter hub, the cap or the catheter threads. So in our practice today, we focus a lot on the insertion site as a potential entry source for pathogens. But for how many years have we given less attention to the catheter connections in the hubs? And it's well known and documented in the literature that these points are vulnerable to pathogen entry causing subsequent infection. And as we really examine in the literature, Morrow and Flynn, they published on disinfection of needleless connector hubs, clinical evidence, systemic review in the Journal of Nursing Research and Practice in 2015. They stated clearly, hub contamination is a causative element in catheter-related infections. Salzman and Rubin, in 1993, published in the Journal of Clinical Microbiology that 71%, 20 out of the 28 catheter studied of catheter-related infections, originated in the catheter hub presumably from contamination. [indiscernible] published in the American Journal of Infection Control that contamination of the catheter hub is one of the most important and prevalent sources of CLABSI, along with microbial invasion of the skin at the insertion site. And then finally, Kaler publishes the article titled Making it easy for nurses to reduce the risk of CLABSIs in patient safety and quality health care in 2014. And they called out that unprotected IV access points can touch the floors, the armpits, the bed linens and other unsterile surfaces adding to their bio burden. The infusion therapy guidelines recognizes this, primary and secondary continuous infusions, and it says to replace the primary or secondary continuous administration sets used to administer solutions other than lipids, bloods or blood products no more frequently than 96 hours, but at least every 7 days. So these connections, these tubings are staying connected for days, sometimes up to 7. And if we're not looking at all of the connections along that pathway to the infusate, we're actually missing something. They say that it should be changed. The vascular access devices change, or if the integrity of the product or system has been compromised, that whole system, if that's compromised, will introduce infection. It's not just, we always say, is it a contaminated infusate? It might not be the infusate. It might be somewhere else down that pathway to the catheter. And then, of course, b, it says, plan to change the primary administration set to coincide with the vascular access change. So we need to stay on top of these tubing changes. And that, in some hospitals, is the primary bedside nurse's responsibility, not the infusion teams. So it does become more challenging. We need to teach the nonclinical staff patients and caregivers not to connect and disconnect administration sets to prevent these, one, misconnections; but two, the reintroduction of bacteria into those lines. And in some home care setting situations, it's the caregivers that may connect and disconnect these devices. So they need to be trained. They need to have a competency. As we've learned over the decades of infection prevention, it all begins with a discussion from the handwashing to max barrier to protection of the insertion site, the antimicrobial catheter, the antimicrobial discs, the silver to CHG, close system IVs, antimicrobial locking solutions to protect Luer connectors. We mentioned when to change extension sets and IV tubing, but not really how to protect those Luer connections. So gross contamination. I hate to say that gross contamination is a passion of mine. But because my passion, especially in the NICU, is in the lower extremity, gross contamination of stool is one thing that I am very on top of and concerned about. The catheter hubs and the connections are one of the most critical areas for infection prevention in my neonatal population. And as I just said, the primary line, and this is one of the articles that we published from the NICU, is in the mid-thigh region. And we do this for many reasons. One, because of the large caliber, the vessel of the femoral vein, allowing us to place a larger caliber catheter to that site. Also, we can establish mid-thigh location, whether it's the greater saphenous that some people would place the line in, in the same exit site, but accessing a larger vein to the common femoral. So we're essentially placing a greater saphenous line, but we're accessing the common femoral vein from an exit site perspective. But the risk is stool, stool and urine, when you're putting any kind of device to the lower extremities. So in the past, we've protected these lines with wrapping the catheter in gauze or putting padding around the area. Unfortunately, the only time that I've ever had issues with these lines is when it's exposed to gross contamination. And that is probably the only challenge that we have with these lower extremity lines. But when you look at PICC lines in these neonates, when their arms' down, the tubing is down by their leg. So their bodies are so small, and there's just not a lot of real estate that gross contamination really is a risk for these patients in many different places. And here you go, you can see, those of you that practice know, but you can see how small they are. Even the little IV in that neonate there in the patient's hand is down by the diaper area. So that baby's IV tubing and dressing is still at risk for contamination. And on that picture to the right, you see a patient with a tracheostomy and a PICC line. But you see how the trach tubing drapes down over the axillary region or the armpit area, secretions can run down the arm and contamination happens. And it's just one of those things that we really, really need to look at. Tunneling can help with this stuff. That's another talk that I will do one day. So here we are to another poll.

Katherine Evely

executive
#13

Perfect. Thank you so much for that insightful overview of the literature. Rather than using the polling function this time, we invite you to share in the chat. And just weigh in on which patient population you feel are most at risk or the greatest concern for when it comes to gross contamination. And I want to thank everyone who is using the chat and interacting with one another in there. I think it's fantastic, and I'm monitoring it. In the interest of time, I also want to keep us moving forward because Matt's got a lot of other great content to share. And I do want to keep us within the hour and be respectful of your time.

Matthew Ostroff

attendee
#14

If you look at this picture here, though, on the slide, we have a contracted patient with, if you can see, has a femoral line. And then you can see the tubing runs up the patient's bedside rail, but it stops right by the patient's mouth. Again, so you would think, well, I'm worried about gross contamination from feces and urine. Now I'm worried about oral contamination from this patient. So honestly, with IV tubing and all the connections, the risk, whether you're placing it from a thoracic approach or an inferior vena caval approach, the risk really does remain the same, depending on where these extension tubings are being placed. Here we do. We do have a survey or a poll as you call it.

Katherine Evely

executive
#15

Yes. Just a quick poll, and it is starting now. For 20 seconds, yes or no, just surveying whether you are currently using a barrier. And this -- it really varies. There's a bunch of different things out there that are being used. We've run into tape. We've run into the laboratory product Parafilm. We've run into even kitchen products, [indiscernible] being used in this way. And while they act as a physical barrier, there might be some drawbacks, which Matt will review with us now. [Voting]

Katherine Evely

executive
#16

So this was split actually more no than yes. So we are around 60% no. I'll pass it back to Matt.

Matthew Ostroff

attendee
#17

So the off-label solutions and their drawbacks. Well, first, why don't we talk about the positive because I always try to turn things around that. That's how all the femoral work that I've done got developed is, how do I look at something that's bad and make it better. And the way that we look at these off-label solutions is that industry takes what we're doing off-label and tries to make them on-label, and tries to make them safe and appropriate for patients. So it's important that we ask industry to help us with what we need so that we don't have to do these off-label solutions. Remember, doctors were using Super Glue at one point. Lack of standardization, no formal protocols. What happens with this? Lack of product education. I mean how do you educate on Glad Press'n Seal, unless you're a home patient that has been instructed and taught on this? But the complications that can happen from off-label are just too great. And when we're talking about CLABSI and sepsis and possible death, off-label becomes very dangerous. It impedes monitoring. It impedes quick access. Usually, when you're putting on these types of protective devices or covering things, they're hard to remove. So people are using scissors or razors or scalpels to get them off and you end up damaging catheters. So off-label solutions, although they're important at that moment, today, you have to figure out a solution. That solution needs to go to industry with you. Do an NDA, make some money. But that solution needs to go to industry so that we can solve it because if you are experiencing a challenge, we all are because we're all doing the same thing. So here we go. This is why I'm here today. The solution for a recognized clinical issue. It's a few years ago, Covalon, the company that's sponsoring this talk was working closely with hospitals on the shower protection for IV sites, the AquaGuard product. And in this work, the team noticed that the nurses were very often looking for ways to cover up the extension tubings and hubs to protect them from contamination. And one institution was experiencing CLABSI in their NICU caused by E. coli, and they believe that the diaper was the source. So they saw the AquaGuard product, and they were trying to fashion it to cover their lines so that they could cover the extension tubing with a cover. It was hard to apply. Obviously, it was too large and a safety hazard because it was off label. And then Covalon recognized this gap in practice, and they worked with the clinicians to design a product that would provide protection to these sites while also being friendly and safe to the user and patient. And that meant keeping the line visible at all times, which is the most important, and making sure the product can be quickly removed so that access to the lines was never impeded. So this is an actual product to protect the IBD connections and lumens from gross contamination from where the -- I'm pointing to this as if you can see what I'm doing -- from where the end cap connects to the catheter hub, from where the extension tubing connects to the end cap and any other primary or secondary sets that extend from there. It's protecting those threads from gross contamination of either touching things or being dipped into things and it creates a seal to protect them, but it also remains transparent so that you can see your connection and also see if there is any contamination. So sounds great. And of course, my question was, well, does it really work? Does it really come off easily? And I just -- I had to just put this one on one of my dialysis catheters trying to make it for the camera easy for you. So this is sealed with the seal. So it's completely protected. And it's so easy to take off that you find that blue strip, as you see in the middle here on the bottom of the slide. And literally, you peel off the strip and it slides right off. That's the beauty of it because it cannot be burdensome to either our techs or our nurses to remove. That's how simple it is to come off. What's interesting is that everybody has a different agenda with this. I brought it to the PICU, I showed it to our pediatric attending, to our nurses. Their immediate reaction was just wow, why haven't we thought of this? Why haven't we been using this. In fact, our pediatric attending said, yes, we use this for cables like with electricity. We have these covers. But it was our techs, our patient care associates that bathe our patients that said, "You don't know how stressful it is when we're bathing our patients that we're afraid of contaminating the IV extension tubing while we're giving our patients the baths or while we're changing their diapers." So everybody has a reason of purpose and a need for this, and it's a recognized clinical issue that has no other solution right now that's on label. And this is such a simple one. That's why I took the time out of the day to come here and just share this with you because it's completely revolutionized my thinking of how we can safely protect our patients at the bedside. So quickly, I'll go through these case studies. I see that it's 1:50. So we're in the home stretch. Tunnel jugular catheters on a 1-year old that I had to do in the emergency department. Well, great, Matt. Good job. But after that, how do we protect that catheter from gross contamination, from the trach, from the secretions, from the child and the family? It's sitting near the armpit, the axillary region. How do we protect it? We need to seal that end beyond the catheter. I was thinking today, one of my mentors is Dr. [ Madan ]. And he goes around the country speaking on the life of the catheter, the life cycle of the catheter. And it's wonderful about infection prevention and the setup to the care and maintenance. But I haven't heard people address beyond the end cap. We've talked about protected covers for the end cap. But we haven't talked about that connection. That connection between the end cap and the catheter hub and beyond when we have other Luer connections. And it's a great risk. I was actually -- had a crazy case this morning. Two-hour case, had to change lines, reposition arterial, peripheral to bridge to get the vasopressors to put in the central. And the nurse came in to change the end caps on the central line. And I went to go do it, and I was like, "Oh, don't forget, you do have to scrub the hub of that catheter before you put that new cap on." And it just was like "Oh, my god. And I told my go. And I'm presenting on contamination, gross contamination from these external components today." So anyway, that's really important. Case 2, here's a PICC line, a PICC line with an ostomy. Oh, avoid the lower extremity. They have an ostomy. Okay, I buy that, and I'm doing the PICC. But when that baby puts its arm down, it's going to be in the diaper anyway. It's going to be right next to the ostomy because I'm on the right side. So being able to protect that tubing, those connections, in this type of case is very important. Case 3, here at my home again, right, the femoral area, venous and arterial femoral catheters. We talk about venous catheters. We talked about CLABSI. Same thing can happen with our arterial lines. So being able to protect that femoral venous line, that femoral arterial line from gross contamination from the diaper is just key for me and for my patients and is why we are bringing this product in to protect these kids in addition to adults. So how do we improve practice? Check it out. This is when I introduced it and when our PICU kind of went crazy over it. There is my original baby that you see at the top of the screen with no protection. And then I added the VALGuard product on to the extension, which basically, if you didn't know it was there since it's clear, it doesn't change anything. It just protects. So that's an improvement in practice for me on my side. Here's a great case. So the doctor said put in a fem line. They called me. They're like, can we replace the femoral line? Okay. So we have gross contamination from the femoral line that we're trying to avoid in that case. So now I'm going up to the axillary region in this child. But if you look, the secretions from the mouth, the nasogastric tube, he has an arterial line in his left forearm that I placed after the central catheter. I need to protect all of these tubing sites, not just at the insertion site with my chlorhexidine, not just stabilizing my catheter, not just my Tegaderm, not just my alcohol impregnated end cap, but the connections of the set and beyond. My favorite, right, is my back tunneling, and not favorite to do, but my favorite solution for patients that we didn't have a solution for. This was a pediatric 2-year-old with autism and attention deficit disorder with sell-through, removing all the lines, so I tunneled it to the back. Look, you can even see what I did. I protected the catheter, covering it with gauze to protect that site and also to prevent a pressure ulcer on the back if the baby was lying on his back. But I had nothing to protect that connection. And not only can I not see it, it's on his back. So I would go back in time and put a protector over there to protect that from any gross contamination of wherever he's laying and rolling and doing all this good kid stuff. Okay. Now I get excited. You know my passion is innovating at the bedside. And you know those of you that follow me, I'm doing tunneled dialysis catheter insertion at the bedside without floral. And that's when I said, oh my god, we wrap our dialysis catheters in gauze so that you won't use it. We wrap it in gauze so that the end caps won't come off. And we wrap it in gauze to protect it. What if, and look at this improving practice, what if we could cover it in something clear? What if we could observe our end of our dialysis catheters and not just wrap them in gauze and make it invisible? It just makes everything visible, able to assess again. And I know this is a pediatric and a central line type of product and in -- on the floors, but in the dialysis patient population that live with these catheters every day where they're eating and just doing all of these things, to protect that connection so that we don't have to replace a tunneled, cuffed catheter in these patients with such limited vasculature, to me, that's the flag that I would be carrying in the tunneled dialysis flag. And I'll give everybody else the neonatal flag and the adult flag, but this product would be a game changer in the dialysis population. Okay. Let's just summarize real quick. CLABSIs remain a serious clinical challenge across patient populations, particularly in our critically ill children. This catheter hub contamination is an important and prevalent source of CLABSI. And we're talking about the Luer connections, the hub connections. This is an unaddressed issue that's really been unaddressed for many years. But new technology can help strengthen infection prevention bundles. I believe that this product will become part of the bundle because it has to, because we cannot watch these lines 24 hours a day. We cannot follow these children 24 hours a day. We need to protect those connections so that they are not grossly contaminated when we have to put on new tubing or disconnect and reconnect for these patients. I'm a dad. When I was learning about this product and thinking about all the things that my daughter did when she was running around the hospital and in the playroom and doing whatever she had to do, the IV tubing just drags on these kids and just put everywhere. I would do anything I could to protect my child. And as a clinician, I would do anything I could to protect every patient in our hospital. So I just -- I really want to thank you all for allowing me to speak to you today. We do have one more slide that's going to come after this, but I really appreciate your attention to what I think is the next piece of our CLABSI bundles.

Katherine Evely

executive
#18

Thank you so much, Matt, for a wonderful presentation. Really insightful and so much sharing of really, I think, important information. And thank you, everyone, who is engaging in the chat. I just need you to stay with me for one more poll. And this was really just for feedback for us. We are -- we would like to just know if you are -- sorry -- yes, interested in learning more about after-hub protection, and it will be again just 20 seconds. [Voting]

Katherine Evely

executive
#19

And while those responses are coming in, I just want to thank each and every one of you who took the time out of your day to join and interact and engage and share. We are just at time. We have 2 minutes to spare right now. So unfortunately, we're not going to be able to get to any questions, but I see them in the chat, and the team will have those, and we will be able to reach out to you with any answers. I also encourage you to reach out to us at [email protected]. We want to hear your feedback on today's webinar. We want to hear about topics you're interested in hearing about moving forward. We're going to keep our webinar program going into the spring and beyond, hoping to do one each quarter. And the next one will be scheduled for late June. We'll be changing the focus over to dressings and maintaining skin integrity well, keeping vascular access sites protected. Okay. Thank you again, everyone. Please, again, reach out. And it looks like just for awareness from our last poll that 88% of you are interested in learning more, and that is fantastic to hear. Thank you again for your time and engagement today.

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