The Intersection of Technology and Patient Safety: Exploring Clinical Forensics Engineering
Jul 20, 2023
Tue, Jul 18, 2023 11:06AM • 30:05
htm, risk management, medical device, engineering, called, vancouver coastal health, disposables, infusion, device, process, occurred, incident, clinical, biomed, care, find, talk, organization, information, objective
Matt Baretich, Chyrill Sandrini
Chyrill Sandrini 00:15
Welcome back to HTM Insider, we’ve got a great episode lined up for you today. I’m Chyrill, your host with MultiMedical Systems. And today we’re going to talk about a topic that I find completely interesting. I want to learn more. Once I found this gentleman on the internet and started having some conversations and diving into it. I am super intrigued. And I think you’re gonna learn a lot today too. So I’d like to introduce you to my friend, Matt. Matt, can you introduce yourself to our listeners?
Matt Baretich 00:46
Yeah, sure. Nice to be back with you Chyrill. Looking forward to our conversation. I count the beginning of my career as a clinical engineer back to when I got my master’s degree in Biomedical Engineering way back in 1977. And since then, I have early on in my career, particularly I’ve worked for hospitals as a clinical engineer. And then in 97, I started a company called Berra to to engineering that does consulting in two areas in clinical engineering and forensic engineering, which we’ll talk mostly about today, I think. And I continue to work through bereted engineering. And as many years I’ve been doing it, I think it feels like I’m just getting started. So I’m hoping to keep doing it for a long time. But one thing I had in the last two years is that my wife and I moved to Canada. And I now work for Vancouver Coastal Health, and for an HTM group called the Lower Mainland Biomedical Engineering. And my role there is really, I would just describe it as I’m kind of an in current internal consultant, I get to find things that I think are opportunities for improvement and take them on and also have the time over over a long period of time to see those things come into fruition. So it’s it’s an ideal complement to the independent consulting that I do.
Chyrill Sandrini 02:30
It sounds fascinating. I mean, I’ve really liked the way this field and the healthcare technology field, it changes all the time. Don’t say it’s like something new. There’s a lot of changes. I mean, think about the changes you’ve seen in the last 10 years. It’s incredible, in the medical field, right?
Matt Baretich 02:50
It’s amazing. And you know, every time I think, well, let’s see, maybe I’ve got enough to coast through the rest of my career, I have enough knowledge. And then, you know, the next day, I realized, that ain’t happening. So everyday, you got to learn something new.
Chyrill Sandrini 03:06
Yep, continual educational learning stream.
Matt Baretich 03:11
I think podcasts like yours are, are part of that it’s so easy to access new information in all kinds of forums. But I particularly liked the podcast, audio and video, both because you can learn some things that you can’t learn by reading a book, for example. So and I’ve always been impressed by the the approach that you’ve taken in these interviews that you, you engage with the speaker, and we have a conversation back and forth. I’m happy you asked me to come on your show.
Chyrill Sandrini 03:51
Well, thank you for all the kind words and being a guest. So now for the question of the day. Because I don’t know that everyone really understands this. Let’s just ask it. What is Clinical Forensics Engineering?
Matt Baretich 04:05
Yeah, yeah, that’s it’s a good question. And I think once we talk about it, I think many of the people who listen are listening will recognize that they do some things very closely related to that. I like to start out by describing how I think of medical device related incident that needs some sort of investigation, some sort of forensic engineering attention. And so I’m thinking of a scenario where I have some patient care provider, a nurse or a physician surgeon who’s trying to achieve some clinical objective and that just means doing diagnosis or treatment or therapy or monitoring or something that that professional is trying to accomplish in the patient care area. So the provider has this objective needs a medical device to achieve the objective. And if you think about it, that’s almost every interaction these days. I mean, somewhere in that picture, there’s probably a medical device. And so the medical device is an essential part of achieving the objective. But for some reason, the provider can’t achieve the objective. And so I say that in really broad terms, because it’s it’s not pointing a finger at the provider, or the device, or environment or anything else, it’s just saying something didn’t go the way we would like it to go. But what makes it an incident that involves some investigation is as a result of not being able to achieve that objective, somebody gets hurt. There’s some kind of some kind of harm. And so the, when you look at that scenario, you’re thinking, how can we avoid having that happen again, because of course, we don’t want someone to be hurt. So when I was mentioning before that, I think a lot of us, in the HTM world have some involvement in that. And there many times we learned that something, say a medical device that we’ve been taking care of was part of some adverse event. And so even if it’s, if it’s a simple thing, like, why did this thing not function the way I wanted it to do? We’re involved in that, but medical device incidents go over a range of, you know, just this, this device, this pump didn’t work the way I expect it to work, all the way up to legal cases that could go on for for years. And so I work in my consulting more at longer term end of that spectrum. So, often my professional jobs are somewhat in risk management in the hospital, or an attorney, for one of the parties in a lawsuit, contacts me to help sort the situation out and try to discover what went wrong.
Chyrill Sandrini 07:28
Yeah. And I think that there’s never really the, there’s never that intent for something to go wrong. It just happens. Because I think the number one objective always for everyone in the HTM field and the end users is patient care first, patient safety.
Matt Baretich 07:45
Absolutely. You know, one of the things I’ve observed over my years in the profession is that everybody in the HTM world that I talked to, says the same thing, I’m here to take care have equipment that might be used on my family, or my friends, and or me, and I can use my technical skills to make that situation better. And I really believe people are sincere when when they say that. And so this is, so we do a lot of things, we make sure that the device is well maintained, and we help teach people how to use them. But the other thing we can do is when that’s how we make things go right, when things go wrong, then our role is to be one of the many professions represented at the table, if you will, whether it’s in a court room, or just around a meeting hall, meeting room in, in the hospital, that we’re one of the voices there, because the bottom line objective of the forensic engineering, and the incident investigation is just to make it less likely to happen again. And so in that way, we make healthcare safer, because we head off some of those some of those potential harms that could occur.
Chyrill Sandrini 09:19
So what I like to do, Matt, is let’s just take a scenario. Let’s say something happens in the OR, and I’m the biomed that’s on call. I’m the one that’s working the late shift, or maybe the only biomed and there’s no other like leadership or lead, supervisory biomed that might have more experienced and myself. Something happens. Can you run us down the steps that what can I do as a biomed to secure and maintain and preserve? Is there a checklist so you could run down?
Matt Baretich 09:55
Yeah, well, sure. There is. And it’s interesting, you would choose the OR for the scenario because I would say, of all the environments where things go wrong, the surgical environment is one of the top ones. I mean, any area like surgery or intensive care where there’s a high use of very sophisticated medical devices are, are the kinds of things that we ended up getting called in for. So the way I would start is, if I got called in I have been, and I imagine many of the people listening to our conversation have been, as well is to is, is to try to figure out what happened and be supportive of the care providers who are, are appropriately are focused on taking care of the patient. So some of us in technical areas wished that nurses, for example, took better care of the equipment. So we could, we could understand what happened more readily. But the right answer for the clinician is don’t worry about the equipment, kick it out of the way if you have to take care of the patient. And of course, when we’re if we get called up there, then we want to make sure we don’t get in the way or we can be helpful in some way. Actually, sort of a prior issue is, a lot of times we don’t get called up right away. We find out about it, hours later, or even days later that there was a problem. And so we’re already behind the curve. But suppose we do get called up and close to when the incident occurred. So if this is something that somebody seriously got hurt in, it’s important to sequester the device. And which means to put it aside somewhere eventually, particularly if it’s going to be involved in a lawsuit locked up somewhere, ideally…
Chyrill Sandrini 12:12
Do you tag it special? Do you put a… What do you put on the device? Well, everyone knows, doesn’t just need a PM?
Matt Baretich 12:20
Yeah, that’s a good point. Because as a number of people are probably thinking stuff shows up on my bench, and it just says broke. And I don’t know if it was involved in an incident. So, I’m going to start working on it, I’m going to check it out, I’m going to repair it if it’s if it’s broken. And that’s not what you want to do if it’s actually been involved in an adverse incident. But so, however you want to tag it, it’s fine. It’s mainly just get it out of the way, your hospital may have a place to secure it. Maybe in the shop, maybe in the risk manager’s office, it really depends on a lot of things, but what resources are available. But the idea is not to have it in service, get it out of service, and not have people make adjustments. And so that we know how it was set up at the time that the event occurred. We also want to preserve any of the disposables. For example, it’s relatively rare for an infusion pump to fail itself. But it’s more common for, say, there’s something wrong with the infusion set. So, to understand the problem, you really have to have that infusion set. So, anything you can collect along with it. It’s also important to if you can with those disposables to get the packaging, because could be a problem that’s related to a particular lot number. And so, gathering everything you can think of, and you would have to look around and ask people for it and look into wastebaskets and whatever you need to do to find that. And one thing that sometimes people don’t think about, it’s good to plug it in wherever you sequester it, plug the device in. And the reason is almost all sophisticated medical devices these days have some type of internal log that keeps track of events and alarms and when they happened and all of the steps leading up to it. And more and more, those logs are in some kind of a nonvolatile memory but there are still lots of pieces of equipment around that if you don’t keep the power on and the battery runs down someday all that information disappears. So putting it away and plugging it in for particularly as I said I tend to work on the situations where it could take years to resolve a lawsuit. And so there have certainly been cases where, you know, the information that once upon a time was in that device is is long gone, which makes it a lot harder to go back and understand what, what occurred.
Chyrill Sandrini 15:19
Let me ask you this, Matt, is it a good idea? And I’m kind of speaking from a prior law enforcement career, Is it good idea to maybe start jotting down, you know, times locations, when I was called to the room? What I saw and I sequestered to the device, specific time where I put it, is that kind of data use maybe in your investigation?
Matt Baretich 15:44
Absolutely. I think that anything you can, you can write down, anything you can take note of take pictures, take videos, take whatever, not only at the immediate side of the problem, but any work that you do subsequently. If you think it might be involved in a lawsuit, real soon after you secure the equipment, you’re going to talk to risk management and make sure they kind of lead you through what the likely trajectory is for investigating the incident. But the more you can collect on site, the better. Keeping again in mind that you know, you’ve got patient confidentiality issues, you’ve got a variety of things that you have to balance. But the more information you can collect, the better it can be. One of the things that I get asked quite a bit that kind of connects to your question is, if I’m a tech that gets called into the or what’s my liability in this situation? I don’t want to do something that gets me in trouble as well. And my experience is, number one, you’re typically protected by the organization because you’re acting on behalf of the organization. And I have yet to encounter a case myself or with any of my colleagues who do this work as well, where the tech was put in some kind of legal jeopardy because of what they did, I think they just need to be, write it down. Keep hold of it. And again, if it’s going to turn into a lawsuit work with risk management and let risk release any information to anybody and not, not go sharing that information widely outside yourself and risk management and leadership within the organization.
Chyrill Sandrini 17:58
So, after you documented what occurred, you gather all the evidence possible that you can think of, you sequestered the device, whether it’s in your shop, tagged, bagged in risk management, you let your supervisor your htm leader know about it. Then what do you do?
Matt Baretich 18:18
Well, at that point, you can even wait and see what they want you to do. Ideally, someone in a HTM program is going to be called in to be part of the review and investigation and root cause analysis and what the hospital does in response to that that case. And so that’s the real opportunity I see in hospitals where I consult so separate from forensic engineering, one of the things I do fairly often is evaluation and assessment of an HTM program. So one of the things I will always ask about is, if there’s an incident, do you that involves a medical device, do you HTM leader always get called in to be part of the review process? And the answer varies a lot. In some cases, it’s of course, we are always it’s by policy. We’re part we’re at the table. There are other places that we’re saying “Sometimes they call us and sometimes they don’t. And that’s all we know.” And so, it’s really, I would say it’s a real opportunity for HTM leaders to start building liaisons with risk management and with the patient safety and quality office to make sure we get involved early on. So, it’s not just sporadically asking us for information. We’re actually part of the decision making process. One of the really nice things about the job I have here at Vancouver Coastal Health is my boss is head is the Executive Director for Patient Safety and Quality and Risk Management and a couple other things. And so she’s always interested in, in breaking down silos between the different groups. And so if you’ve got a, if you’ve got someone in your organization that will champion that, that’s great. If you don’t, you’re going to have to be the one to, you know, get yourself at the table. I’ve always said it when people say, “How do you get at the table?” I say, well, you know, if you do good work, and you win, you’re called on to provide valuable information, then people will value it, and they’ll invite you. But I’ve been chastised by some of my friends and colleagues, particularly Carol Davis Smith, who would be a real good person to put on your show is don’t wait for him to ask, you know, show up, come to the meeting, sit at the table, and make yourself part of the process. And I think I think she’s right. And so, however you can do it, the more you can, I call it think outside the basement, the more you can go beyond the kinds of things we do routinely. We have a terrific amount of knowledge that’s relevant to the deliberations that are going on. So, we should be there, we should routinely be part of the response process.
Chyrill Sandrini 21:32
I agree 100%. After let’s think about next step. So we’ve done all the have-to’s, and we’re taking it taking all the necessary steps to preserve the patient data, everything that occurred. And what happens next that device does the FDA or does any other organization getting involved at some point? Or is there a reporting process that needs to go out to some of their regulatory oversight?
Matt Baretich 22:02
Yeah, so there there, aside from the internal reporting, which already talked about, you know, notifying your supervisor notifying risk management, there are requirements to notify certain events to the FDA in the US, and that’s a matter of so at some point, there’s a decision, is this a reportable event or not? And typically, what I advise is, we should be part of advising risk management, whether it’s reportable risk management is likely to be the part of our organizations that do the reporting. So there’s a report. Every state I believe in the US also has reporting requirements, and they vary. So another reason to get to know your risk manager and understand that process. So our role there is really advisory. It’s very similar process in Canada, not through the FDA within a federal agency called Health Canada, there has very similar requirements to the FDA where there’s a requirement, but again, we tend to work through risk management and getting that information, ultimately reported up to Health Canada. So that’s important, but again, work with work with risk management to follow through the bureaucratic details about how to do that.
Chyrill Sandrini 23:34
Is there any requirement for you as the biomed? If you find it, we were talking about that for a second there. I thought about the lots like you’re talking about disposables, or a device in particular that you find that there’s an issue with right away? Is there any responsibility or liability to the biomed? To make sure we remove that lot of disposables that may, right or that device, realizing that all the devices could be affected the same way? Is there any any suggestions or
Matt Baretich 24:04
Yeah, so there’s there’s a process. I’m thinking of FDA and joint commission requirements where there’s some kind of process in place for handling recalls and safety alerts, and whether they’re related to an incident or just something that we’ve become aware of. So each organization I talked to has a little bit different process for how that works. I think, sort of the most common process is that if it’s a medical device, particular, recall or alert, then htm is responsible for making those changes. If it’s a supply typically, or an accessory, typically that’s supply chain does it but it needs to be but it needs to be coordinated at at some point. give you a quick example of a major incident response that occurred here at Vancouver coastal health. A couple of years before I started here, there was a case where we were having repeated over infusions with with our infusion pumps, which, of course can be have serious consequences for patients, depending on what medication is being infused. And the difficulty was finding exactly what was at the heart of it, we would get in for testing equipment, and it would work fine. And we would test some of the infusion sets and they would work fine. And we big collaboration with clinical care, to see that all of the procedures were followed, and programming was done correctly. And still, there were problems. And finally, to people here, I say keep saying we It wasn’t me yet, but the people who are here in this multidisciplinary process got hold of a and infusion set that clearly was problematic it, the problem followed the infusion set as it was put into different devices. So good standard trip, troubleshooting, when you’ve got the stuff in hand, you can do good troubleshooting turned out, I get to the end of the story, it turned out that some of the tubing sets were manufactured in a way that they were not round, and the tubing was not of uniform thickness. And so depending on how it got manufactured, and how it randomly got put into the infusion pump, some time, sometimes it worked fine. And sometimes it didn’t. And there were CT images that confirm that. And as a result, it was at the end that literally 10s of millions of infusion sets were recalled pulled off the shelves in Canada and the US and about a dozen countries around the world as a result of work that was was done here. So in some respects, that’s the ideal outcome, which is sometimes it’s hard to know exactly what caused a problem. And it’s hard to know exactly how to fix it. But here, the people here nailed it, they knew exactly what the problem was, and they killed it. So it’s a wonderful success story. Actually, in 2020, the the organization’s won an equity award for for excellence, I forget the exact title excellence in clinical engineering.
Chyrill Sandrini 27:47
I love that story. Well, man, I think I could talk to you for hours. This is also intriguing. I love the investigation portion of it, finding the facts, and to avoid the reoccurrence finding that solution. So you’ve been a joy to have on today. And again, I’d like to invite you back and dig into some more, you know, cases and maybe some case studies on on what you’ve been through, because I think you have a vast experience. And I’d love to do it. Thank you. So what we like to do here at HTM insider is in with your Wow word, your word of wisdom are your words, would you like to leave our listeners? Well,
Matt Baretich 28:25
so I it took me a while because I’m kind of an expert on clinical engineering. I’m not an expert on wisdom by any stretch of the imagination. So what I came up with is my favorite definition of of wisdom. I’m not sure who came up with it, but it’s, it’s defined as the ability to take your own advice. And I think that we’re all really good at knowing what somebody else ought to do. And if you would just do what I tell you to do, everything would be fine. You know, we all do that. I do that. But I try to remind myself that just turn that around and say to myself, what’s the what should I be doing? And goodness knows, I don’t always do I know what to do. And I don’t do it sometimes. And so I think that’s my current attempt to move toward wisdom is to start taking my own advice.
Chyrill Sandrini 29:30
Thanks again, Matt for coming on. htm insider, it’s been a joy to have you as a guest. Please follow us anywhere you listen to your podcast. You’ll find it htm insider, you can Google it on YouTube, and also find it on our website at MultiMedicalSystems.com. But enjoy having you listen and join us today and we look forward to seeing you on the next episode. Thanks, Matt.
Matt Baretich 29:53