Bill Klaproth (host): Welcome to the Ashram podcast. Made possible by the American Society for Healthcare Risk Management to support efforts to advance, safe and trusted healthcare through enterprise risk management. You can visit ashram.org/membership to learn more and to become an ashram member. I'm Bill Klaproth, and with me is Toby Gil, founder of Gil Radiology Consultants.

As we talk about MRI, safety risk management, and the structures that. Don't exist. Toby, welcome.

Toby Gilk: Thank you, bill. So glad to be here with you.

Bill Klaproth (host): Yeah, good to talk with you. This is certainly an interesting topic, so let's jump in right here. MRI markets itself as the safe imaging option. But in the summer of 2025, a man died in an MRI accident in New York, and that accident appears to either contradict the safety slogan or with some sort of an unanticipated freak accident.

So Toby, what is the truth about MRI safety?

Toby Gilk: well first off, the accident that I think probably a lot of people are familiar with is not a freak accident, not in the sense that, you know, it was unanticipated or it wasn't preventable. Neither of those two things are true. There are risks that are associated with M-R-I-M-R. I kind of came into its own when we were hyper concerned about ionizing radiation exposure.

And of course, MRI doesn't have any ionizing radiation exposure, so we were like, oh. Well, this is a gift from heaven. This doesn't have the thing that we're worried about. The problem, I think, is that the follow on question to that was never asked. So if it doesn't have the ionizing radiation risks, does it have any risks that are peculiar to this?

Modality. and because those questions were never asked, they were never answered, and the fact of the matter is, yes, there, are some particular risks that are unique to MRI that we need to be actively managing and we tend not to be doing a great job of that.

Bill Klaproth (host): Okay, so what, are the risks then involved with MRI?

Toby Gilk: I think most people are familiar with the fact that MRIs are giant superconducting electromagnets that are immensely powerful. Anytime you see a newscast about the strength of an MRI, they talk about how it's more powerful than one of those junk yard magnets that picks up scrap cars. and that's true.

There are risks associated with that. In fact, you can go online and look for pictures of MRI accidents and you can see wheelchairs in crash carts and transport beds and ventilators. And essentially just about any piece of hospital equipment you can imagine stuck up against MRI scanners. And so that attractive force, and projectile risks, that's.

a real risk in the MRI environment, and that's a risk to anybody who's inside the room with the giant magnet. But in addition to that, there are risks to specific to patients and the exams that we perform. the MRIs not only generate that super high strength magnetic field, they also generate some pulsed or oscillating magnetic fields that are only present during imaging.

And those have risks of producing heating within the patient who's inside the tube of the MRI and or interfering with implants and devices and modifying the function of, say, a pacemaker. In ways we probably don't want it to be modified. So we have these projectile risks. We have interference with medical device risks, we have heating and burn related risks.

anybody who's ever had an MRI, knows that they're also incredibly loud. We have potential auditory injury, hearing damage related risks associated with these as well. They're not ionizing radiation, they're not the same risks, but there are MRI related risks, and as I say, we tend not to do a great job managing those.

Bill Klaproth (host): So that's interesting. So there are several incidents that can happen at MRI facilities. How well known are the associated preventions and what are those.

Toby Gilk: So the preventions are actually incredibly well known. so the a CR, the American College of Radiology has been publishing. Since 2002, an MRI safety standards document, essentially, these are the best practices for protecting patients, for protecting healthcare workers, for protecting visitors who come to this environment and the a CR.

As I say, the originally, the first document, which was called the White Paper on Mr. Safety, was published in 2002. That was updated in 2004, updated and renamed in 2007, 2013. changed the name again to the manual on Mr. Safety in 2020, and it was updated as the manual on Mr. Safety again in 2024.

So the a CR has poured a great deal of time and energy and expertise into this document that is, in my opinion, hands down the world's best safety standard of practice document that exists. So in terms of the availability of information of how do we protect people That domain of knowledge is actually really well developed.

There're always new things, and yes, it will continue to change and iterate and grow. But, in terms of our meat and potatoes, 99% of MR Studies, we have a document that very clearly defines what the safety standards are. The challenge is that that document, Is not really endorsed, accepted, codified, standardized in the form of state licensure requirements or accreditation requirements.

So we have this amazing body of knowledge, but nobody actually requires that it get used. So it largely is a choose your own adventure. at the point of the individual providers, the hospitals, the imaging centers.

Bill Klaproth (host): So the information is out there, but as you say, the individual MRI facility may not choose to use it or, follow those safety precautions.

Toby Gilk: Right, and which kind of gets us towards the title of today's podcast, the safety Standards that Don't Exist. So we have a body of knowledge, but. How, how do best practices typically get deployed at, hospitals and imaging centers? Well, we turn them into standards. We turn them into licensure requirements.

We turn them into accreditation standards. and then we simply follow. The licensure requirements or the accreditation standards that are handed to us, as conditions of being a healthcare provider. And if we compare and contrast the ionizing side of radiology, so x-rays and cts and fluoroscopy, if we look at that, the difference between the legal standard of care.

What state licensure and accreditation standards are. There's almost no daylight between what the standard of care is and what you are legally required to do to maintain your license. But if we look on the MRI side, the. there is a Grand Canyon sized gulf between what the minimum licensure or accreditation requirements are and what the standard of care is, and so the challenge for providers who are unaware of just how big this gap is.

Many of them operate under the assumption of, well, if I'm just complying with my state licensure laws, or if I'm just complying with the accreditation organization's minimums, that somehow is supposed to be demonstration that we are meeting the standard of care. And while that's generally true on the ionizing radiation side of radiology, it really couldn't be further from the truth on the MRI side of things.

Bill Klaproth (host): Wow, this is really interesting. So if there aren't any existing minimum compliance structures, regulation or accreditation, if you will, to help assure safety. do risk managers then assess and manage these risks?

Toby Gilk: However they choose to unfortunately, which leads to enormous variability in care and, individual practices. the thing that I recommend is, uh. If, God forbid, something goes badly in MRI, you will not be held to your state licensure standards. In fact, as I am discovering, many states don't actually have state licensure standards with respect to MRI.

there was an egregious accident that occurred a couple years ago where a an ICU nurse got trapped between a patient bed and an MRI scanner. She was the unfortunate filling in an Oreo cookie being squeezed between these two, a giant magnet and a giant magnetic object. And that accident happened in the state of California.

California Department of Public Health, took no licensure investigation or administrative action, relative to that accident. And it turns out that the reason that they took no action is because legally. State of California never gave California department a public health jurisdiction over MRI. So if we think that complying with our licensure laws is somehow an indication that we are practicing safely, that we are meeting the safety standard of care in states like California and states like New York where the man died.

In July of 2025 in that horrible MRI accident, those states actually sort of throw up their hands and abdicates all state responsibility for making sure that we're delivering safe healthcare Similarly. Not quite as bad. but on the accreditation side, again, all of the accreditation organizations, whether we're talking enterprise level accreditation, like Joint Commission or DNV, or if we're talking about modality level accreditation in radiology, such as the A's accreditation program or IAC or RAD site, those accreditation organizations similarly don't reference the standard of care, the legal standard of care for MRI safety, and it's worth noting.

That the a CR, which wrote the document that really has become recognized as the legal standard of care for MRI safety, the a CR on their professional society side of the organization writes this document. But on the other side of the organization that does modality level accreditation? The A-C-R-M-R-I accreditation program doesn't require the criteria of the A-C-R-M-R-I safety best practices document.

so there are people who make the presumption that simply because we are accredited by the a CR that therefore, we have demonstrated the fact that we are complying with the standard of care when in fact that's not even true. If you get your accreditation from the organization of the same name that produce the document that defines the safety standard of care.

Bill Klaproth (host): Right. So the accreditation organizations for hospitals and radiology, sounds like you're saying they promise all this quality and safety. However, it sounds like they're not picking up any slack, that it doesn't exist in the regulation, so they're not kind of covering the lack of regulation, even though they say that they promise quality and safety.

Is that right?

Toby Gilk: With respect to MRI and my area of expertise is very narrow, so I'm not gonna pretend to make some general statement that covers accreditation across the entire healthcare enterprise. But yes, with respect to MRI. They are not picking up the slack. I had a really interesting conversation several months ago, with folks from one of the large hospital accreditation organizations, and I asked them what I thought was a really simple and straightforward question to answer.

and the question was, your accreditation promises safety, so Do you QAQC, that claim with respect to MRI? Do you look at how are MRI injury accidents happening? What are the root causes? What would be effective preventions? And in this QAQC exercise? Are you measuring your own accreditation standards against the ability to prevent known forms of MRI accidents?

And the organization I was talking to couldn't or wouldn't, respond to that question, which left me with the sense that the standards that exist are there because they're the standards that existed when. The person who's in the job now assumed that job and the assumption has always been, well, somebody must have come up with this for a reason and it must be doing something, otherwise it wouldn't be here.

And. Simply asking the question about, you know, do you QAQC, your standards with respect to safety and how safety incidents happen and your standards ability to prevent those safety incidents. yeah, I, got a deer in the headlights kind of look. Now this becomes incredibly important to the risk manager because I think every risk manager is looking for indications out in the world, licensure, standard accreditation standards, as a litmus test for.

Am I doing enough? Am I doing the right things to effectively assure safety at my institution? And what I'm finding in my own personal opinion is that none of those external validators, none of those external yardsticks of performance really tell us anything about the safety of our sites and our patient care.

Bill Klaproth (host): Seems like there's a loophole in MRI regulation. Would that be correct?

Toby Gilk: Yeah, I think it's a loophole big enough to drive a truck

Bill Klaproth (host): So radiology and radiation, as you know, are intensely regulated at both the federal and state levels. It sounds like that regulatory. Oversight or strictness certainly doesn't extend to MRI Then.

Toby Gilk: It doesn't. And in fact, there's circular logic in many instances of the state and federal regulations. radiology and radiation is dangerous. We regulate radiation and the exposure of both workers and the general public to radiation. MRI doesn't have that same type of radiation. Ergo. MRI is free from the regulatory structures.

And again, it's sort of this easy circular line of reasoning and nobody in a regulatory stance, and to a large extent, the accreditation organizations, nobody is stopping and saying, but are there unique risks? Are there. Distinct risks to this modality and this type of patient care that we're delivering.

I personally, I think it's a horrible mistake. If we imagine that states licensed hospitals from. The helipad on the roof of the building to, the pathology lab in the basement of the building. And they, regulate the safety and efficacy of the delivery of healthcare, from the rooftop to the basement.

Except we're gonna carve out this one spot inside the hospital, the spot that we call MRI, and we are going to essentially see no evil, hear no evil, speak no evil. With respect to this one piece of the hospital institution. We are going to say what? That it doesn't need it, that the people who are being injured or killed, that those injuries or deaths were somehow, we couldn't anticipate them.

or maybe they happen in small enough numbers that they just don't deserve the time, energy, effort. I don't know what the argument is for the status quo. other than it's the status quo and we don't actually have to do any work to maintain it. It is what it is,

Bill Klaproth (host): This is really interesting. So we have all these regulations for radiation and radiology, but if you leave a metal cart and you're an MRI machine, oh well.

Toby Gilk: pretty much. Yeah. Yeah.

Bill Klaproth (host): Alright. A couple more questions then. So, in your opinion, how do we go about fixing this?

Toby Gilk: I think that that's a two step process. in the short term, I think what it means for risk managers and radiology directors and anybody who has responsibility over, you know, sort of the radiology part of hospitals or healthcare enterprises. The first thing for the people boots on the ground is to take a very careful look at your MRI safety practices, recognizing that the yardstick that we measure performance against in other parts of the hospital, in other parts of radiology, those yard sticks are not gonna tell us anything meaningful about MRI safety.

So it's, I hate to be the bearer of bad news, but the tools we most often use elsewhere throughout the hospital are not the tools that we need to be using in MRI. You need to be taking a look at the standard of care related documents. You need to take a look at the a CR 2024 manual on Mr. Safety because.

Like I say, God forbid something bad happens, that is the standard that your performance will be evaluated against, both civilly if somebody files a lawsuit, but also if you are a Medicare, Medicaid participating provider. If CMS comes in and they have a finding of immediate jeopardy, CMS is actually going to more than likely use this a CR document as the yardstick against which your compliance and performance relative to participation in Medicare Medicaid reimbursement.

That's what they're gonna be looking at. So that's what risk managers ought to be doing. That's the near term. what I'd really like to see in some intermediate or longer term is I would like to see a. The states and the accreditation organizations do the QA QC efforts in terms of, are we doing minimally what we can to prevent injury in these environments and what.

Rules or standards do we need to implement? I think that that's a much, much longer fight. and it will be a patchwork of successes and failures when we do start taking on that fight. So for the foreseeable future. The risk manager is gonna have a very active role in assuring the safety of their patients, their healthcare workers.

When it comes to MRI, they're gonna have a role that isn't going to be effectively shoring up by state licensure requirements that won't be shor up by the accreditation criteria.

Bill Klaproth (host): That's very good. Alright, so for our risk managers listening to this, and you just kind of said first of all, take a look at your MRI safety practices for a risk manager listening to this. What's your best advice for them? What should they do first, second, third, how should they look at this problem and try to adjust it?

Toby Gilk: so MRI is weird. MRI has a set of risks that, are environmental, just people walking into the space. They have risks that are clinical. Can we expose this person who has this particular type of implant to the. Specific MRI study that we want to do. they have operational related risk or safety criteria.

Are we training people correctly? do we give the right people, access and exclude the wrong people from having access to these potentially dangerous environments? So there are a bunch of different components to the risk manager, I would say. build a coalition. Build a team, because a risk manager who has responsibility for the entire enterprise.

unless if you're like me and you wanna just absolutely dive down the rabbit hole and begin to learn, everything there is to know about MRI safety, I applaud you. I think that that's brilliant. but I know. Risk managers tend to have responsibility for many, many areas within the enterprise, and that may not be feasible.

So reach out to, an MRI manager, a senior technologist. If your organization has a designated MR safety officer, an MRSO, reach out to that individual. On the clinical side of things, identify radiologists within the affiliated practice group, who have particular expertise in MRI. Again, there's a designation if the radiologists have an MRMD, an Mr. Medical director, somebody with that credential.

ahead of the game because you've got great members of the team. So the third credential that if you have access to, bring this onto your expert team, and that is the Mr. Safety expert, MRSE. Oftentimes that's a medical physicist. mostly but not always. and so surround yourself with people who have an immediate sort of frontline appreciation for what the safety concerns are based on.

Your MRI equipment and the patients you see, and the acuity of patients that you're willing to accept, and the level of aggressiveness or conservatism relative to, how willing are we to manage risks associated with patients with implants and devices and foreign bodies, because those. On the ground, in the trenches kinds of experiences married with the standard of care documents, the a CR manual.

that combination of inputs will allow you to assess, here's what we need here, where our weaknesses are, and here are where we need to protect our staff, our patients, and the institution of the organization.

Bill Klaproth (host): I think if it's. Very well said, very thorough, Toby, thank you for that. It's really a good step-by-step, practice for risk managers listening right now. Toby, this has been great, really informative. Is there anything else you want to add as we finish up talking about MRI, safety risk management structures that don't exist?

Toby Gilk: I guess the only thing that I really wanna add is, um. the simultaneous good news and bad news about MRI risk and MRI accidents and MRI injury is that they are almost entirely manageable. and that's good news because if we take the appropriate steps, we can make sure that we are providing a standard of care, level of protection for our patients and our caregivers.

The flip side of that coin, however, is because virtually every MRI injury is. Anticip and preventable. if something bad happens at your facility, there really is no question about, well, how did it happen? And who is to blame? because nearly every MRI accident is anticipated and preventable through existing standard of care and best practices if and when it happens.

There's no ambiguity about who the finger gets pointed at. and so taking the steps to make sure that we are doing the things that we know we can do, and prevent these accidents is really incumbent upon every institution that provides MRI Care.

Bill Klaproth (host): absolutely. Toby, this has been great. Thank you so much for your time today, and thank you for giving us all of this great information. We appreciate it.

Toby Gilk: Thank you, bill.

Bill Klaproth (host): Absolutely, and again, that is Toby Gil. For more information, you can go to ASHRM dot org slash join. ASHRM and the Ashram podcast was made possible by the American Society for Healthcare Risk Management to support efforts to advance, safe and trusted healthcare. Through Enterprise risk Management, you can visit ASHRM dot org slash membership to learn more and become a member.

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