Episode 35

July 01, 2020

00:22:52

Elimination of False Positives in Blood Cultures

Hosted by

Richard Miles James Di Virgilio
Elimination of False Positives in Blood Cultures
The Inventivity Pod
Elimination of False Positives in Blood Cultures

Jul 01 2020 | 00:22:52

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Show Notes

Dr. Rich Patton, MD, grew up in the small town of Wahoo, Nebraska where the town doctor clearly had a better life than he did as a child farm hand. That inspired Rich to eventually go to medical school and to become a pathologist. From there he saw how many patients got treated unnecessarily for sepsis – blood infection – and he was pretty sure he knew why. So, he invented the SteriPath, a device that virtually eliminates false positive diagnoses in blood cultures. *This episode was originally released on April 26, 2019.*

 

TRANSCRIPT:

 

Intro: 0:01
Inventors and their inventions. Welcome to Radio Cade a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We'll introduce you to inventors and the things that motivate them, we'll learn about their personal stories, how their inventions work, and how their ideas get from the laboratory to the marketplace.

Randy Scott: 0:38
Hello, for those of you expecting the velvet voice of Richard Miles, I'm sorry to disappoint you, but this is Randy Scott, your guest host today for Radio Cade. I'm here today with Dr. Rich Patton , MD out in Seattle. And he's the inventor of the SteriPath blood collection device. Hi, Rich, are you doing today?

Dr. Rich Patton: 0:59
As pleased to say, life has been very good to me and continues to do so.

Randy Scott: 1:06
I appreciate you making some time here. So just to start things off, why don't we take a minute or two for our listeners if you can explain the SteriPath, you know, pretty basic terms, what the SteriPath does and how it benefits patients.

Dr. Rich Patton: 1:21
The SteriPath, instrument essentially replaces and does away with false-positive blood cultures. How does it do this? The process is to use on needle, which goes into a vein and a vein then are a conduit for putting blood into a culture vial, and that's the way it has been for 50 years. You know what goes into, in most cases, a vein which then directs blood into a bottle with medium, and that process passes a skin biopsy into the culture bottle and that is where our large portion of the contamination occurs. What SteriPath does is divert very first portion of blood from a vein and sequesters it, and that being done, the blood is directed past that sequester and into the bile of medium. So it's a very simple process and simple to understand, and that's, what's the beauty of it is. It's something that is very doable, should be done worldwide. A lot of expenses and patient success and the patient safety is, has moved greatly ahead was this type of blood culture procedure.

Randy Scott: 2:45
So Rich, that's interesting. So you're trying to avoid these false positives in blood cultures, maybe a little bit more background for me and the listeners on what are the medical uses for a blood culture? Why would a blood culture be taken in the first place?

Dr. Rich Patton: 3:00
Blood cultures are taken when people have high fevers or maybe become systemic and ill with not only a high fevers, but increased heart rate, and no symptoms are present than a blood culture is ordered and it takes about 24 to 48 hours to get result. And that result is something that hides the therapy, antibiotic treatment, part of this. So that's the way it begins. And that's taking it to the point where our culture, our shows and our organism that is a pathogen and it needs to be taken care of.

Randy Scott: 3:37
A false positive means that they've detected what they think is an infection and there's not really an infection there, I guess. And so then they're going to administer antibiotics when the antibiotics aren't actually needed. Is that kind of how it goes?

Dr. Rich Patton: 3:50
Yes, that's right prior to the use of the SteriPath, about half of the blood cultures that show positive are false positives and that results in unnecessary antibiotics and increase in blood tests increase in images. And all of this is not good for the patients who are put in the health care system. Unnecessary antibiotics are ended up being a different issue and America and the world.

Randy Scott: 4:18
And so how does a false positive come to happen and take place? I mean, why, why would that occur? It seems like it shouldn't be too hard to figure out if, you know, worked in a hospital lab or something, but obviously it happens a lot. So how does that actually occur?

Dr. Rich Patton: 4:33
What we have discovered is that a false positive results from small scan piece being dislodged from the skin, the blood drawn is obtained. And if using the SteriPath, that scan piece is diverted into a sequester area. I'm just not going to enter the bloodstream. That is a very simple approach. And that's a simple solution to the problem. And I have been told by a lot of people that, you know , why didn't I think of that? It simply gets rid of the piece of tissue, which has defending a skin residing organisms. That's once the sterile pads in place, the antibiotics therapy is started right after the blood culture has been drawn . And physicians can be positive about being treating aggressively on the case. Without this diversion technique, about half of the blood cultures that are, could grow some organisms, those are getting residing organisms that are normal and need, no , no treatment, but it takes a while beyond that to make a, to make a , a , uh , a blood culture result known takes off in 48 hours. Before the true nature of that infection is understood.

Randy Scott: 6:05
Okay. So I think I can kind of picture this in my mind. So normally they go, they take the blood sample, the needle goes in, and of course the needle is a circle of metal that kind of cat captures the, like the little tiny miniature pipe. And it captures a little chunk of skin before it gets to the blood and that skin then has the bacteria on it. So that makes sense. So the SteriPath then it sounds like is taking that little plug of skin and it's setting it off to the side and only the blood then flows instead of the blood plus that little piece of skin is that right?

Dr. Rich Patton: 6:40
That's right on.

Randy Scott: 6:42
Great. So yeah , you are practicing doctor and you came up with this idea about maybe let's step back in time, a little bit curious, just how you came, be a doctor, you know , where did you grow up and what led you down the path of being a physician?

Dr. Rich Patton: 6:58
Oh , that's , that's a good one. I grew up in a small town in Eastern Nebraska about 3,500 people from the best farm plan in the world. And one person that got my pension , which was a physician there. His name was Dr. French. And I found him to be someone who was articulate, who was calm, who was well dressed and was very, very kind person. And I'd have to admit that appeared to be prosperous. So it was a combination of all those things that made me look at medicine as a good career for me. So I would say yes, he was the biggest influence on me. And I had a lot of experience with being a farm hand and a ranch hand. And I certainly didn't want to do that for the rest of my life. So I ended up going to undergraduate school and eventually medical school.

Randy Scott: 8:00
Okay. So is this Dr. French? Was he like your family doctor?

Dr. Rich Patton: 8:04
Yes, he was, yeah .

Randy Scott: 8:06
Okay. Nebraska probably didn't have very many doctors I'm guessing.

Dr. Rich Patton: 8:10
There were two doctors there that were physicians . I think you mentioned that one of the things that you thought I should let you know about is what other people influenced me in that town . And I have to tell you this, that person that I looked up who beyond this position was my mother. And she was born in a sod house in Nebraska. Became to first of a large family to go to college and she was just a super professional with grade school kids. With first grade. Um, she was somebody who I was pleased with students that did well, and she had great empathy for those that struggled . And my mother died and there was a funeral and an older man than me came up to me and said, gee, I was in shock when your mother died. I knew her as a beautiful woman. And indeed she was, and then recently, maybe a year ago, a woman about 45 years old introduces me , she was living in Omaha at that time. And she asked me, are you in relationship to mrs. Patton ? And I told her that I'm her son. And she told me of families , that she knew that my mother was teahcing and she told me that she was a beloved person in a small town. So I think of her often. And I'm trying to think about how she handled her life.

Randy Scott: 9:29
Oh yeah . So from a sod house to a prosperous doctor in one generation, that's pretty good. That's great. So you obviously went to medical school, but you're now a pathologist, right? So I know what a pathologist is, but I'm not sure if our listeners will . So why don't you describe for us what a pathologist is and why a pathologist would be the type of doctor that would invent a device like the SteriPath?

Dr. Rich Patton: 9:54
Well , first of all, pathologists are in general, considered a doctors , doctor. Doctors see patients and to treat them, they know they have to get tests done from blood tests to sometimes obtaining small pieces of tissue for analysis. For example, if someone has a lump in the breast, a needle might be put into that lump and then given to a pathologist to make a diagnosis of benign or malignant. And the pathologist handle all that type of work pending receiving, not just biopsies from breasts, but also many biopsies of the GI tract and so on. And then additionally, the clinical side of the pathology work is to make sure that laboratory work is accurate and up to date. So that is the relationship that it was always just have with clinical areas when they need this kind of help. Also, the relationship becomes one that now there are pathologists who are experts with liver disease, somewhat gastrointestinal disease, somewhat skin disease, skin , tumors, and so on. All those have been , become the system, whereas handling systems becoming more and more specialized. In other words, doctors, as I just mentioned, concentrate in these various areas. Again, liver, lung, brain, GI tract, on and on , there are specialists in pathologists that are confined their practices, those specialized areas.

Randy Scott: 11:32
So I guess if you're used to dealing with needle biopsies than you're used to the idea of pieces of tissue stuck in a needle. So I guess this idea made sense to you that way, too, that you were perhaps sensitized to think in that direction?

Dr. Rich Patton: 11:45
The fact that when needle biopsies go through skin or sampling tissue, for example, liver or thyroid. What happens with that needle is that when the skin is punctured , the needle actually cuts off a small portion of skin, which ends up in the specimen that is submitted for examination. So a common thing that would happen is just say that someone was doing needle procedure and the thyroid gland, what I might see or another pathologist is not only a piece of your thyroid, but also a small piece of skin that would have been dislodged by any needle, puncture and thyroid .

Randy Scott: 12:26
Okay. So anyway going back, I guess the way this kind of played out. So you kind of recognize this issue about the little piece of skin that gets caught in there. It causes these false positives and therefore the unnecessary use of antibiotics. So you'd identified the problem and the source of the problem, I guess I'd say. And then the actual product itself, how far along did you take that on your own? And at some point, obviously you've partnered up with someone to help commercialize the products, or how did that part of the story play out?

Dr. Rich Patton: 12:58
Well, what happened initially was not as I'm serving these fragments and checking to see if these pieces of tissue that , uh , contained in. And that was something that initiated in my laboratory and showing the test of getting rid of the skin piece , decreased our contamination rate by 50%, which was astonishing because over time, small increments, terminated tests improving, and nobody had come on anything at all in that range. So what I did initially after that was to encourage another pathologist in Seattle area to run the same test that I had done in his result was the same contamination rate decreased by 50%. So at that point, we knew that we had a new procedure that was going to affect blood culture globally. And at that point I started up a business with our CEO and other people, to build advice that would capture these skin pieces and not them get into the vessels that have culture medium in them. And that took a lot of engineering, a lot of testing. And that's where we are now is we've shown that using that approach is revolutionary for the blood culture test and is something that we're working on beyond the stage , but also kind of a lot of intellectual property to cover our device. Not only to use all around the world, Canada, Europe, Japan, on and on and on.

Randy Scott: 14:37
Great. So products actually being used in hospitals right now and basically saving lives today, right?

Dr. Rich Patton: 14:44
That's right. And saving a lot of money for hospitals and the healthcare system. Hospitals save money by fewer tests. It's very good for patients since cultures that are contaminated often result in unnecessary antibiotics and increased stays in the hospital and puts them at risk for developing hospital acquired infection .

Randy Scott: 15:09
Tell me some more about that. So I would, it's just a layman. I would think that obviously, if I run a blood culture, I get a false negative. In other words, I, blood culture says there's no infection, but there really is. So I don't treat the patient. Obviously I understand how that's bad for the patient. It seems to me like a , just a layman that a false positive wouldn't be a big deal. So maybe somebody gets antibiotics and there's probably some expense associated with the antibiotic, but how does inappropriate antibiotic use actually harm patients?

Dr. Rich Patton: 15:42
What happens is patients end up with unnecessary antibiotics, unnecessary blood and fluid tests, fewer imaging procedures, both positive can increase hospital stays, and there's potential there for acquiring the hospital infections. Overall expenses go up just because of the involvement of medical staff and so on. It's a big issue to let this go on. I feel like it's not going hard as , as fast as it is growing because it's sloppy medicine to let this blood culture contamination go on in our country and worldwide.

Randy Scott: 16:20
So basically the idea is that they're getting the antibiotic treatment, they're going to spend an extra couple of days in the hospital and other bad things might happen to them during that time. Great. So obviously you're a physician. You come up with this idea for this new product. You're not a marketer or whatever, but you've, I think remained involved with the company as it's gone to market with the product some . So what's been maybe the most surprising thing to you as a physician inventor . And what's been the most surprising thing to you about the business and commercial side of things.

Dr. Rich Patton: 16:54
What has struck me is that this product that we have works very well and as a level of improvement compared to the previous way of doing things is quite encouraging and pleased to see that this has done regularly now, but I have been very disappointed that it's not catching on sooner because of the reason, so we've already discussed. Everybody should have this done tests, not just locally or in United States, but it should be something done and this blood culture test worldwide.

Randy Scott: 17:26
So why wouldn't every hospital just adopt it immediately? It seems like it's much better for the patients. So is there some particular reason it's not obvious that this is a harder decision for a hospital.

Dr. Rich Patton: 17:40
There are a number of reasons why this has gone not as quickly as we hoped. You have to understand that the blood culture procedure has not in 50 years and not change in a significant way for five decades. And when we start talking about this, a lot of people think, Oh, we don't really have to deal with this in a hurry, but we'll probably take care of it, someday. There reason for that is part of this reason I should say is that the test change involves multiple individuals and on healthcare chain all the way from the chief executive officer to the person who investigates the tests and in a way that how it's going to cost them. And it turns out that any institution this has been successful has been one individual who's taken the leadership, getting it done and getting this right and changing procedures all the way from the emergency department to the critical care area. All of those individuals that are involved need to be trained. And it's just a big job to get that done. So those are some of the reasons why it's been slower to be adopted than we had hoped for.

Randy Scott: 18:56
There's a author you may be familiar with, Nicholas Taleb that written a couple of books, "Black Swan Antifragile." He actually makes a point that we hear echoed through the voices of inventors like you all the time, but he makes the point that the things that have been unchanged the longest are in fact, the hardest things to change. So an example, he gives us that if you tried to innovate around the fork and spoon, it would probably be very difficult to get people to change because the fork and spoon have been the same for generations and generations. On the other hand, to get people to accept innovation around their smartphone is really easy because they expect it to change all the time. And they're already kind of preprogrammed per change. That sounds like the dairy path, a little bit victim of that, but the way the blood cultures have been taken and process has been the same for so long. It's maybe not an area where the clinicians and hospitals are that interested in even considering change.

Dr. Rich Patton: 19:56
Yeah, absolutely. You hit that right on the nail. I think what is waiting for this to suddenly become an improvement that will be overwhelming in terms of the obviousness very significant primarily on a patient's safety level, more than anything else. We don't know how many patients end up being killed by a false positive . I'm sure it's probably in the hundreds and maybe even thousands annually in the U.S. and as I say, that part of that has never really been studied in a way, and it's very difficult to do that, but even if it's one person in the whole United States, everybody's saving money. And if you have a straight path, a pathway on taking care of patients, you're doing a good service, good patient safety that we all should, we all should be, acutely aware of it.

Randy Scott: 20:45
You didn't set out in life, it doesn't sound like to be an inventor, but you became one. Any thoughts for other folks, maybe like you, that don't think of themselves as inventors, but they have a great idea to make the world better. Any parting ideas or words of wisdom for somebody like that?

Dr. Rich Patton: 21:03
I was thinking about this and what would I do to describe someone who let's say that we're talking about physicians. The best physicians that I know were, and are truly interested in their jobs. As I mentioned earlier, life has been good to me and part of which was being a pathologist and these days there are great options of medicine that are mind -bending, a number of specialties, researchers, educators, executives , just unlimited possibilities for people to work in medicine. And I would tell anybody who is interested in medicine, that you should find your niche in medicine, where you belong and you'll do well.

Randy Scott: 21:52
Great. Okay. Well, thank you very much for your time here today. I appreciate it. And if people want to learn more about SteriPath, they can just go to www.SteriPath.com to learn more.

Outro: 22:06
Radio Cade would like to thank the following people for their help and support Liz Gist of the Cade Museum for coordinating and vendor interviews. Bob McPeak of Heartwood Soundstage in downtown Gainesville, Florida for recording, editing and production of the podcasts and music theme, Tracy Columns for the composition and performance of the Radio Cade theme song, featuring violinist Jacob Lawson and special thanks to the Cade Museum for Creativity and Invention located in Gainesville, Florida.

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