“You Can't Solve a Problem You Can't See”: LIV Process and the Battle Against C Difficile

In an interview with Pharmacy Times, Michael McIntyre, co-inventor, founder, and CEO of LIV Process, highlights the urgent threat posed by Clostridioides difficile—the longest-living surface pathogen in the world—and the devastating human and financial toll it takes on patients, families, and health care facilities. He emphasizes the limitations of existing kill-based cleaning protocols, which have long relied on guesswork in the absence of any visual verification tool.

McIntyre introduces the patented LIV Process water-based solution, which, for the first time, enables hospitals and long-term care facilities to visualize viable C difficile spores on surfaces in approximately 2 minutes, enabling targeted cleaning and confirmed eradication. He calls for a shift from reactive to preventive action and urges the health care community to humanize the C difficile crisis to drive broader awareness and adoption of solutions that can save lives now.

Pharmacy Times: How would you describe the current scale of C difficile as a public health threat, and why do you think it remains underappreciated by the general public?

Michael McIntyre: Yes, it’s quite fascinating because C difficile is arguably the most prominent, the most disruptive, and clearly the longest-living surface pathogen in the world, surviving for weeks, months, and even over a year on surfaces. The impacts of C difficile are devastating. Those who go through C difficile infections are in a life-threatening state. There are some fascinating data points that I just learned as recently as 6 months ago: One in 11 patients aged 65 and older who get a C difficile infection will die within a month. It’s quite startling to hear that C difficile infections occur every 45 seconds in the United States, which equated to around 645,000 cases…last year in just US hospitals and long-term care facilities alone.

And the most important thing is the humanistic side, which is really something that I respect so much about the Peggy Lillis Foundation and Christian [John Lillis]’s leadership on behalf of and in memory of his mom—the humanistic view of C difficile. It is devastating for those who suffer from it and their family members. Not only the pain that you experience and discomfort, but if you get dehydrated, it’s embarrassing. It’s highly contagious. And the impact of it to the care providers is enormous as well. Not only the risk it [poses] to the health care providers who treat those with C difficile, but also the tremendous financial pain that it causes for hospitals and long-term care facilities as well.

But, you know, our approach as a company and my approach as a human being is to do good for others by saving lives now. That is our mantra. How can we make C difficile visible and equate it to saving lives now and providing greater awareness to [humanize] this life-threatening problem—doing good by amplifying awareness, doing good by making this more accessible to anyone who suffers from it or who has family members suffering from it? And hence, again, we’re honored to be a big champion and advocate of the Peggy Lillis Foundation.

Pharmacy Times: Before LIV Process existed, how were hospitals actually determining whether a room was free of C difficile contamination after cleaning, and what was the fundamental problem with that approach?

McIntyre: It’s a great question on so many levels. There’s a lot of great technology and great solutions that will kill C difficile. But up until the LIV Process—and LIV stands for Light, Identify, Verify, Eradicate—became available last March in the United States, there was no way to verify it was gone. The idea happened 9 years ago when I said: How can you solve a problem you can’t see? With C difficile being the longest-living pathogen, the concept was that the effort it takes to get rid of C difficile is going to get rid of everything around it. But how hospitals and nursing homes treat the problem now—they use kill methodologies, kill cleaning products for C difficile—[is different from before, as] they could never verify that C difficile was not in the environment. There was no visual way. There’s no visual proof, visual evidence, or visual verification tools to do so.

And we are the first of our kind to give specific quantification, sensitivity, and almost instant visualization. In a matter of about 100 to 120 seconds, we can cost-effectively, quickly, and accurately give you visualization of C difficile post disinfectant cleaning. So now you can spot the target and do a little touch-up cleaning to make sure you completely eradicate the problem. It’s like anything in life that we have to deal with—the challenges we deal with are much more achievable to deal with and eradicate when we can see where the problem is, or even recognize it. And visual recognition of where C difficile is is a breakthrough at the highest level. Up until this point, it’s a guessing game—that’s the real layperson’s term answer. No matter what technology you’re using, it’s a complete guessing game to get visual verification prior to the process being available.

So we’re really proud of it. We’re obviously a technology company and a team of people with great purpose, and it’s such an important question that I think magnifies our great purpose. Doing something collectively and amplifying awareness about how important it is to save lives by educating the public [about] the solution.

Pharmacy Times: Walk us through how the LIV Process visualization system works. When a hospital uses it after their standard cleaning protocols, what are they actually seeing that they couldn’t see before?

McIntyre: It’s a completely safe, water-based solution that comes in a 10-oz bottle. Ninety-eight percent of the formula is water; 2% is a proprietary, patented biomolecule. When the solution is applied on surfaces, there’s a solution applicator that releases a fine mist of the water-based formula that dries in about 2 minutes, almost to the second. Once the water evaporates, all that’s left is the patented biomolecule that binds to proteins on the outer layers of a viable C difficile spore on the surface. Then there’s a chemical reaction that quenches… that biomolecule—that’s the microbiology piece. Two minutes. That’s all that happens.

Now, what you do is put on these goggles to block out ambient light—they’re orange goggles. You have a lens clip you can put on your phone to take pictures. And we have a customized forensic light that has patented filters that give you visualization in various shades of green. It could be yellowish green, brighter green—but anything that’s green is representative of somewhere between 200 to 2000 viable spores on the surface. So, you’re catching early-stage levels of C difficile that may have been there for a while—like months on surfaces—but you could never see them before. And you’re getting this visualization literally in approximately 2 minutes, and you have the ability to take a picture of those images to share with teammates who are responsible for infection prevention in facilities, as well as environmental services and housekeeping teams.

So not only does it make the patient safer, but all of those who are the care providers—we call them the invisible heroes who are attacking this invisible problem—they’re right on top of this potentially deadly problem themselves. And we give them a tool that makes them safer, their family members safer, their team safer, and ultimately elevates patient safety to an exponentially…higher level.

Pharmacy Times: In your pilot study at a large hospital, nearly half of surfaces per room still showed contamination after routine cleaning LIV Process. What does that finding tell us about how C difficile has been spreading undetected, and what changed for that facility once they had a tool to actually see the problem?

McIntyre: I love that question because it’s a behavior change that’s pretty simple. It simply involves being able to see the target, where the trouble spots are. A real granular, specific example would be the handrails on beds in hospitals. Both the right and left sides of a handrail are touched about 200 to 300 times per day, documented in all kinds of articles, periodicals, and studies. I’ve done maybe 1200 to 1300 demonstrations of the product. I’ve gone into the cleanest rooms and facilities, and every time we apply our solution on a handrail, there are going to be blotches and clusters of green on those handrails. Trash can lids in hospital rooms—most of us are right-handed, so when we apply a solution on the top of the trash can, the right-hand side always lights up. You track C difficile on your feet—the foot pedals light up. What’s happening is a movement to create greater awareness [of] the process on all devices. Your portable infusion pumps, monitors, and the IV [intravenous] poles that are wheeled around the facility can be overlooked in the disinfection and cleaning process. They light up, too. And by having awareness of where those trouble spots are on those high-touch areas, it [has] exponentially improved outcomes.

We have one hospital that’s releasing data very soon—I cannot say the name of the hospital yet, but in probably 2 to 3 weeks, the whole world will know about this. They tracked 6 environmental service techs for a period of 5 months, and they all had different levels of experience. They deployed the process on 2000 discharge cleanings. At the beginning of that study, there was a baseline of C difficile removed on about 60% to 80% of surfaces from this team, who knew exactly what their purpose was—they went to the high-touch areas, they were trying to remove it, eradicate it—but they couldn't see it. Deploying the process, that number went up to 98.5% to 99.3% of surfaces. No more C difficile on every discharge cleaning in the last 2 to 3 months of that study. That’s a breakthrough improvement in operational execution and performance metrics of the infection prevention and cleaning teams working together.

We also have 2 facilities. One is a VA hospital—again, waiting to get clearance to release the data—but they are taking calls from every VA hospital in the country. In the 4 months after deploying the process, they had zero C difficile infections. Another hospital, University Health in San Antonio: 9 months after using the LIV Process, [they had] 120 fewer C difficile infections. Now, I will preface it: The process isn’t the only reason there are fewer C difficile infections. It requires being integrated into a high-level cleaning protocol. But being able to see in a matter of minutes, for literally $3 per discharge cleaning per room and 2 minutes of your time, that there‘s no more C difficile on those high-touch areas—you have made a quantum leap in making that environment safer for everyone in it. We're really proud of that, and we’re seeing more and more of these data coming out.

[This] aligns with 3 really important things I want to share in this opportunity with all of you today. Similar to Christian and the Peggy Lillis Foundation, we’re all about saving lives now. We’re all about standing up and being assertive with amplifying awareness and accessibility to solutions and technologies like ours. But our really big goal is to make everyone aware that there are solutions—to take preventive action instead of reactive responses to when someone gets C difficile.

And right now, the challenge—as you guys know from the great conversations and meetings we’ve had with Chris and his team—[is that] around 2015, only about 25% of people knew what C difficile was. Today, it’s maybe 50%. How can we get that to 100%? Isn’t it fascinating that the largest, most significant, biggest problem in infection prevention—it’s clear to us what it is, yet half the population doesn’t know that? How much of a leap would that be if we could create awareness at that level? How much of a leap would that be if we could provide the process to every hospital in the world to provide visualization to this problem and ultimately save lives? That alone would be our ultimate vision.

Our goal as a company is to be maniacally focused on saving lives now, and to look for other voices to help us amplify awareness—experts in the field, but also the patients and the family members—and just create this whole movement. Again, I couldn’t be [prouder] of Christian and his team [for] honoring the legacy of his mom to do something like this. We’re just glad to be here, part of it, and truly honored and blessed to meet people like all of you who get it.

But I think our job is to never underestimate the power of each of our voices to make a difference, and to live it every day. Never let the noise and the distractors—those who might be slow to adopt—distract you. We just keep our heads down and every day focus on elevating awareness to this big problem, with the solution that, up until this point, you couldn’t see. Well, now, as of a year ago this March, we can make it visible, which is certainly going to enhance all of our ability to accelerate solutions to eradicate this problem and prevent it before it spreads.

Pharmacy Times: What infection prevention measures have proved most effective in hospital and long-term care settings, and where do facilities still fall short?

McIntyre: This is a great question. I’m going to give an unfiltered response, and I will preface it by saying it's the response of a person who has dedicated the last 10 years to this purpose. One of the problems we have—and this is a US problem as much as anywhere—is that we hear a lot about the importance of room turnover. We’ll get pushback: “This is going to add 2 minutes to our discharge cleaning.” And we say, “Well, what’s the amount of time it takes when you actually get a [patient with] C difficile in your facility?”

But let’s go beyond that. Let’s go to the humanistic side—something that Christian really emphasizes and that has resonated with our whole company and whole team. C difficile infections are horrific in every way. They smell, they’re embarrassing, [and] there’s enormous gastrointestinal pain. More people are now dying from it almost every hour. Since I woke up today—I’ve been up since 5 am; I’m in Chicago — you’re looking at like 35 to 40 people who have died just today. And you can keep doing all these numbers and analytics, but when I hear that, I go: Really?

And then people will compare this to technologies that don’t provide microbial visualization—a wide range of solutions where they’ll say, “Oh, it’s killing C difficile.” And we know if it’s used right, it will kill C difficile. We still don’t have verification that you actually did it. So we get a little frustrated and want to shake people and say, come on. And here’s the other thing—we have that one hospital in Texas. How much time have they saved by having 120 fewer C difficile infections over 9 months? They have saved hours. How much money have they saved exactly? A minimum of around $40,000 per patient to the hospital—well over $4 million. And their head of environmental services said, “We can fund the environmental service team payroll for the next 3 to 4 years by this. We could buy product for the next 2 decades by this."

And again, that’s not a commercial to buy more product—it’s a message, an initiative to say: We’ve got to wake up here. The CDC protocols, which are frankly upside down right now, are being used as an excuse for people not to adopt new technologies. We intend to do everything possible to become a recommended, required protocol by the CDC, the Joint Commission, and all of those bodies. And we do believe that will happen, because again, how can you solve a problem you can't see, no matter who you are, [with] what[ever] level of expertise or lack thereof? When you can see the problem, you can solve it. Our process is additive and makes all the kill products—whether UV technology, sporicidal disinfectant wipes, whatever methodologies there are—smarter, faster, and more cost-effective by simply being able to see where the problem is.

But it’s a big challenge. It’s a political challenge, a business challenge, an implementation challenge. It’s a change movement, and it’s human nature to resist change. But how do we support the early adopters and partner with them to see this vision forward? And again, it goes back to the H word: Humanize it. We’ve got to humanize it together.

I always open my presentations with: “How can you solve a problem you can’t see?” And I'll ask, ”Have any of you had a family member, friend, or loved one who had a C difficile infection?” When you ask people that, half don't know about it—so educate them. But one particular client said, “Michael, how fast can you get out here? Three of my 4 grandparents in the last 4 years have died from C difficile infections, and 2 of them I couldn’t see for the last 6 to 8 months of their lives. We’re all in. You don't even need to present it. I’ve got the research, I‘ve got the data, I've talked to 2 of your testimonial customers. Get out here as fast as you can.” And what happened? Their cleaning protocols improved tremendously. Their turnover time in the rooms improved tremendously. They reduced incidents. Is it all because of the process? No. But we’re certainly making an impact.

And I tell our team: This is what saving lives looks like. If we’re really serious about saving lives, we stay focused on the humanistic aspect of our great purpose. And all the other stuff will fall into place. There’s a great book called The Go-Giver, and it’s all about the rewards of being selfless and helping others; the exponential return and joy and gratitude you get from that, you can’t even put a price on it. But ironically, all that stuff falls into place. It gives us the perspective we all need to do good in the world, one day at a time.

Not to get on a soapbox about it, but that really is what we’re all about—in the process and in my capacity leading our team.

Pharmacy Times: If there’s one message you want health care providers, policy makers, and the public to walk away with today, what is it?

McIntyre: Take the time to look at where the problem is, and you’ll be amazed at how fast you can improve the situation and solve the problem. And most importantly, take the time—all of us together—to humanize this problem. Together, we will make a big impact.