Improving MRI Safety for Patients and Staff: Tobias Gilk

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My guest for Episode #497 of the Lean Blog Interviews Podcast is Tobias Gilk, the founder of Gilk Radiology Consulting (GRC). He is an architect by training, but has spent 20+ years focusing on MRI safety… initially through the architecture and planning of MRI facilities, but quickly growing into the technology, clinical practice, regulation, and economics of MRI safety.

He is recognized by both state and federal courts as an expert in MRI safety issues. Tobias has published dozens of papers and articles on MRI safety. He is also twice a member of the American College of Radiology's MRI Safety Committee (twice named co-author of ACR MRI safety standard guidance).

In this episode, we dive deep into the complexities of MRI technology, acknowledging its transformative role in health care but equally highlighting the overlooked dangers that require meticulous handling. Delving into safety protocols, process failures, and the risks associated with projectiles and thermal injuries, our discussion underscores the need for stricter adherence to safety protocols.

We not only discuss the intrinsic risks associated with MRI but also explore the regulatory landscape, identifying key gaps that permit inconsistency in safety practices. The narrative is a pointed reminder that safety is of paramount importance, and mitigating risks requires thorough screening, careful positioning, and a collective commitment to safety-first processes.

Questions, Notes, and Highlights:

  • Give us a quick MRI technology overview… 
  • “The safe modality”
  • What causes danger to staff and patients??
  • Machine malfunctions are very rare — possible burns?
  • A typical safety story?
  • Clinically safe but with inherent process-related dangers?
  • Why aren't there better access controls and checks about what and who comes near the magnet?
  • Couldn't we cheaply brute force this by posting an educated “MRI Guard” outside the danger zone? Is patient safety really the top priority??
  • Staffing cost vs. risks of harm or machine damage…
  • How common / frequent are incidents that harm or kill?
  • “If you've been told that MRI safety only comes at the expense of throughput, you've been lied to.”
  • “Absolutely, Lean is essential to MRI safety…”

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Episode Summary

MRI Safety: The Magic of Technology and Its Hidden Dangers

The Enigma of MRI Technology

Magnetic Resonance Imaging (MRI) has revolutionized medical imaging by allowing healthcare professionals to peer into the human body's intricate systems without the invasive risks of certain other methodologies. MRI machines are indeed fascinating pieces of technology. They make use of a powerful and constant magnetic field, along with time-varying magnetic pulses, to produce detailed images through complex computing processes. Unlike X-ray or CT scans, which depend on ionizing radiation, MRIs utilize magnetism–considered non-ionizing radiation that doesn't have the same damaging potential.

This distinction marked MRI as the “safe modality,” a blessing for health care at a time when the emphasis on reducing ionizing radiation was growing. The technology's real thrill comes from its ability to distinguish different tissues based on their molecular signals, providing valuable information that goes beyond structure to the chemical composition, thus being particularly effective with soft tissue differentiation.

The Overlooked Risks of MRI

Despite MRI's reputation for safety, there are intrinsic risks that have risen to prominence with greater use. One notorious hazard within the MRI suite is the potential for projectile accidents caused by the powerful magnetic fields, which can pull in metal objects at high speeds. Patients and staff could be exposed to danger if objects like firearms, poles, or even medical beds are accidentally brought into proximity with an active MRI scanner.

Moreover, the magnetic fields in MRI can interfere with medical implants like pacemakers or insulin pumps, potentially leading to malfunctions that can cause significant harm. Thermal injuries are another risk factor, where the energy from the magnet could result in burns if not properly managed during the scanning procedure. Although machine malfunctions are rare, the overwhelming majority of MRI-related incidents result from process failures, such as insufficient screening or improper patient positioning.

Process and Practice: Ensuring MRI Safety

Ensuring safety in MRI procedures relies heavily on established best practices like rigorous metal screening, careful positioning, and padding patients to avoid the concentration of RF energy. While these best practices are well understood within the professional community to mitigate risks, the question remains–why are they not regulated as mandatory requirements?

Interestingly, MRI was welcomed with open arms and minimal regulatory oversight due to its non-ionizing technology. This lack of regulation persists, with the FDA only having authority over mammography safety and relying on an act of Congress to extend its scope. Accrediting organizations have broadly deferred to the discretion of healthcare providers when it comes to enforcing safety protocols during MRI procedures. Consequently, safety practices across various facilities may be inconsistent, potentially leading to preventable accidents.

Conclusion

MRI technology brings with it spells of clinical magic, providing invaluable diagnostic insights without ionizing radiation. Yet the overlooked risks that come along with this magic call for a collective commitment to safety-first processes. Scenarios such as projectile accidents and thermal injuries serve as cautionary tales, emphasizing the need for strict adherence to safety protocols. Ultimately, patient and staff safety in MRI suites hinge on the conscientious application of best practices and perhaps a push toward stronger regulatory oversight to ensure these protocols are uniformly enforced.

Expanding the Role of Safety Protocols in MRI Suites

Importance of Access Control and Feedback Tools

A pivotal aspect of MRI safety is access control. This concept extends beyond simply restricting access to the MRI suite; it involves ensuring that all persons and objects entering the vicinity have been meticulously screened to prevent any magnetic interactions with the scanner. A ferromagnetic detector is an exemplary feedback tool that should be utilized in this setting to alert staff to the presence of magnetic metals. These sophisticated devices are paramount for the preemptive detection of potentially hazardous items such as cell phones or metal on the garments.

However, introducing and integrating these ferromagnetic detectors into everyday practice can raise challenges. Staff may experience what is known as “alarm fatigue,” becoming desensitized to the detector's alerts, typically leading to a disregard for its warnings or even disabling it entirely. This situation underscores the demand for comprehensive training and the importance of understanding the gravity of every beep, which indicates a failure in the preliminary safety protocols.

Economic Pressures and Staffing Implications

As MRI reimbursements have dwindled over the years, economic pressures have constricted hospitals' operational budgets. It is often the case that in the quest for cost reduction, MRI suites may be staffed with fewer or less experienced personnel, and these technologists are pushed to increase patient throughput to maximize revenue. This environment exacerbates the risk of process failures–the main culprits in MRI-related incidents.

Technologists are tasked not only with scanning but also with patient management and coordinating care, all the while adhering to complex safety procedures. The high acceleration of throughput and understaffing are detrimental to establishing a thorough safety culture, where every step is considered, and prevention measures are diligently applied.

Patient and Implant Variability

The evolving complexity of the patient demographic serves as another layer to the MRI safety challenge. With an increasingly high number of scans involving patients with a variety of implants and embedded devices, the need for individualized screening and preparation has never been more critical. Historic blanket prohibitions against scanning patients with any metal in their bodies are no longer practical as the FDA has cleared specific implants for MRI compatibility under certain conditions.

The Importance of a Cultivated Safety-First Approach

To combat the challenges stemming from understaffed environments and high patient acuity, a cultivated safety-first approach is paramount. This would entail not only adhering to best practices but also embedding a safety culture that recognizes the indispensability of each safety protocol and the role of every individual in the MRI suite.

MRI safety extends beyond the bounds of technology and tools–it is an orchestration of well-designed processes, continual education, and unwavering commitment to patient welfare. Only when all healthcare personnel, from technologists to administrators, embrace this ethos can MRI suites transform into sanctuaries that mitigate risks and safeguard against the unintended consequences of this otherwise magnificent technology.

Continuous Improvement in MRI Safety Protocols

Enhancing Reporting Systems for MRI Incidents

It is clear that there is an urgent need to improve the reporting systems for MRI incidents. The development of MRI-specific adverse event reporting systems like Caire Reporting is a positive step towards a more effective tracking of MRI safety incidents. By focusing solely on MRI-related events and gathering detailed information, a more accurate understanding of MRI safety failures can be achieved. This approach mimics the successful models found in other industries, such as aviation, where detailed reporting and analysis have resulted in significant safety improvements.

The Role of Process Redesign and Lean Principles

The integration of lean principles into MRI safety protocols cannot be overstated. By analyzing workflow and safety procedures through a lean lens, it is possible to identify improvements that not only enhance safety but also increase throughput. MRI suite operators should strive to:

  • Recognize inefficiencies and potential sources of error within their processes.
  • Apply lean methodologies to streamline workflow without compromising safety.
  • Foster a culture where safety and efficiency are viewed as complementary rather than conflicting outcomes.

Training and Education as Cornerstones of Safety

Continuous education and training are paramount for staff operating within MRI environments. Empowering staff with detailed knowledge and proactive problem-solving skills helps to mitigate risks. A comprehensive training program should include:

  • Understanding the MR safety framework and the potential risks associated with the technology.
  • Recognizing the importance of proper scanning acuity when dealing with a diverse patient population.
  • Ensuring staff is updated on the latest research and best practices in MRI safety.

Customizing Safety Protocols for Patient Diversity

As patient demographics continue to diversify and the range of implants and devices present in the patient population expands, it is vital to have dynamic safety protocols in place. This means:

  • Developing individualized screening protocols based on specific patient needs.
  • Discarding one-size-fits-all prohibitions in favor of nuanced, informed strategies.
  • Refining safety guidelines to accommodate the latest FDA-approved implants and their specific MRI compatibility stipulations.

Accountability and the Redistribution of Responsibility

In addressing MRI safety, it's crucial to create a structured accountability framework. Providers must assume the primary responsibility:

  • Understand the weight of responsibility that rests with the imaging center and its staff.
  • Reinforce the need for collective vigilance among all healthcare workers involved in MRI procedures.
  • Establish clear protocols and responsibilities to prevent the delegation of safety obligations to patients or less informed parties.

Beyond Compliance: Aspiring for a Model of Excellence

Ultimately, moving past a mere compliance model towards an excellence model in MRI safety is desirable. This transition requires:

  • Proactive measures for anticipating and countering any potential risks.
  • A system where near misses are reported and learned from, creating an environment of continuous safety improvement.
  • A genuine commitment from healthcare institutions and professionals to ensure the MRI suite is as safe as possible for every patient.

In conclusion, MRI safety is a multidimensional issue that requires attention to processes, patient diversity, reporting systems, and continuous education. By taking into account these varied aspects and integrating comprehensive strategies such as lean principles, the goal of creating a safe and efficient MRI suite is well within reach.

Achieving Balance Between Efficiency and Risk Management

The dialogue between Tobias Gilk and Mark Graban emphasizes the delicate yet crucial balance that must be struck between maintaining efficient patient throughput and adhering to effective risk management practices in MRI safety protocols. To ensure that balance is achieved, MRI centers should consider:

  • Implementing safety measures that align with the overall goal of patient welfare.
  • Focusing on eliminating unnecessary steps that do not contribute to safety or patient care.
  • Analyzing each change to protocols for its impact on both speed and safety, ensuring that improvements are beneficial on both fronts.

Addressing Pre-Scan Processes to Enhance Patient Experience

The frustration expressed by patients who miss work or personal commitments only to have their MRIs canceled due to incomplete pre-screening information is indicative of flawed pre-scan processes. Improving these processes can involve:

  • Ensuring complete and accurate pre-screening information to reduce last-minute cancellations.
  • Streamlining communication channels between MRI staff, patients, and referring physicians.
  • Implementing a robust information verification system to preemptively identify and resolve potential issues that could lead to procedure delays or cancellations.

The Impact of Efficient Safety Protocols on Stakeholder Satisfaction

Both patient satisfaction and the efficiency of healthcare delivery are deeply intertwined with MRI safety protocols. By refining safety procedures to reduce inefficiencies, the benefits can extend to all stakeholders:

  • Patients experience fewer delays and a more seamless care journey, leading to higher satisfaction.
  • Referring physicians gain confidence in the MRI service, knowing that their patients are being managed promptly and safely.
  • Personnel and capital equipment usage are optimized, making the process more cost-effective and improving overall productivity.

Engaging with Thought Leaders like Tobias Gilk

To implement a comprehensive approach towards MRI safety, it is valuable for practitioners and hospital administrators to stay abreast of the latest developments by engaging with thought leaders and experts. Ways to engage include:

  • Following experts like Tobias Gilk on professional networks such as LinkedIn to receive regular updates and insights.
  • Reviewing expert websites and resources to stay informed about new safety initiatives and research findings.
  • Attending webinars, workshops, or conferences that focus on MRI safety and process improvement.

Continuous Improvement as a Journey, Not a Destination

Mr. Gilk's insights remind us that MRI safety is an ongoing journey of improvement and learning. Continuous improvement in MRI safety protocols requires:

  • Viewing every incident, near miss, or inefficiency as an opportunity to learn and refine the existing protocols.
  • Seeking feedback from patients, staff, and referring physicians to identify areas in need of change.
  • Treating safety as a dynamic process that must evolve with advances in technology and changes within the patient population.

By focusing on the continuous refinement of MRI safety protocols, healthcare institutions can create an environment that prioritizes patient care, reduces risk, and maximizes operational efficiency.


Automated Transcript (Not Guaranteed to be Defect Free):

Mark Graban:
Welcome back to the podcast. I'm Mark Graban. Our guest today is Tobias Gilk, the founder of Gilk Radiology Consulting. He is, and we're going to learn a lot more about him and his work here. But he is an architect by training.

Mark Graban:
We spent more than 20 years focusing on MRI safety in healthcare, of course, initially through the architecture and planning of MRI facilities, but then quickly growing into the technology, clinical practice, regulation, and economics of MRI safety. He's recognized by state and federal courts as an expert in MRI safety issues. He's published dozens of papers and articles on MRI safety. He's also twice a member of the American College of Radiology's MRI safety committee and twice named co-author of the ACR MCI Safety Standard guidance. So, Toby, welcome to the podcast.

Tobias Gilk:
How are you? Thank you very much. I'm doing great. How are you?

Mark Graban:
I am doing really well. I'm excited that we can talk here today. I know your name. I've seen and followed your LinkedIn posts for a long time through a mutual friend, Dave deBronkart, e-patient Dave. So I'll give him credit for sharing and liking and commenting on all the things you've shared.

Mark Graban:
How do you know e-patient Dave?

Tobias Gilk:
Well, the patient advocate domain of folks who are interested in patient safety and more than just interested in, no influential, in patient safety. That's a very small list and e-patient Dave is a force of nature. Dave is amazing, and ever since I became aware of him, oh goodness, what would that be? Maybe ten years ago or so, I've just tried to follow him because I'm always impressed with his positive approach to identifying and then addressing problems in the healthcare arena. And I've taken that a little bit as an inspiration for my own work.

Tobias Gilk:
I know that, generally speaking, what he focuses on and what I focus on, the Venn diagrams of those two things don't really overlap other than they're both in healthcare. But I'm so appreciative of, number one, a patient voice and number know, his let's work the problem approach to. Yeah, yeah.

Mark Graban:
And I met Dave through he was invited to sit in on some lean training that I was doing for a hospital at Boston, and we realized the Venn diagram of things we care about. There's a lot of overlap. And for the episode here today, for those listening, I mean, this is the lean blog interviews podcast. I don't know if the word lean is going to come up again the rest of the discussion, and as far as I'm concerned, that's fine. But I think part of the overlap of the work that you do, Toby, and what I'm interested in talking about today and sharing with the listener is themes of patient safety, talking about process, talking about prevention.

Mark Graban:
How do we learn and help ensure the safest possible environment for patients and staff should make sure it's also about staff safety, and it's a great chance to pick your brain on all of that, Toby. But I'm curious before, and maybe this is part of the story of how you got in to this work. I want to hear about that and the issues that you've learned about and help people address. But for those that aren't really familiar or those of us who barely know what MRI stands for, could you give us kind of a quick technology over the overview of the technology and what about it creates risk to staff and patients.

Tobias Gilk:
So I became enamored of MRI technology because I think it's the closest thing to magic that human beings have ever built. MRI machines are just phenomenally interesting. So the basics of MRI is we put you in a high strength magnetic field, and then we thump you with additional applied, time varying magnetic fields that we sort of send these pulses of magnetism at you. And the combination of the high strength always on magnetic field, plus these magnetic field pulses that we send allows us to collect signal from whatever's in the middle of the MRI scanner. Right.

Tobias Gilk:
And through very sophisticated computers, we can take the cacophony of signal that comes out of your tissues, and we can slice it and dice it and wind up producing pictures. That's great. We can come up with pictures if we're doing x rays. Right. So why is MRI different from doing an x-ray or a CT, which is essentially just a whole bunch of x-rays stitched together by a computer?

Tobias Gilk:
What makes MRI really interesting is that it's looking at the emitted signal of each molecule and each molecule. Like spectroscopy. Right. We can filter the light from a distant star through a spectroscope, and we can identify what the chemical composition of that star is. Right.

Tobias Gilk:
MRI is very similar in that because we are looking at signal that originates from each and every molecule, we can essentially chemically fingerprint the materials that are giving off signal. Which means if you have a brain tumor, for example, in many cases, the brain tumor is essentially just sort of the brain's own tissue that has gone haywire in reproduction. Right. So if you took an x-ray of it, how is the x-ray or the CT going to differentiate between brain tissue and crazy reproducing brain tissue? Because they're the same thing.

Tobias Gilk:
Right. Except crazy. Reproducing brain tissue has a slightly different chemical signature. And so if we can image based on the chemical fingerprint of individual molecules, we can begin to differentiate. Wait a second.

Tobias Gilk:
No, that's the unhealthy tissue. That's the healthy tissue. And so we can make differentiations, primarily where some of the greatest benefit of MRI comes from is in soft tissue differentiation. So we see MRI used an awful lot for brain imaging, soft tissue differentiation, but it also has uses everywhere else. It's amazing for inflammation and cartilage and other non-bony tissues being able to be identified.

Tobias Gilk:
So we're finding applications for MRI all throughout the body, all different anatomical regions and disease processes and that sort of thing. It's absolutely fascinating. And if you want to geek out, like I do, on sort of the physics behind all of this, it's mind-blowing science. Like I say, closest thing to magic I think human beings have ever built.

Mark Graban:
And so it's a technology that doesn't expose the patient or the operator of the MRI to the same type of radiation that we would be exposed to by x-ray. Is that correct?

Tobias Gilk:
Right. So x, x-ray radiation. And again, x-rays are used in CTE scanners, and then there's nuclear medicine where we're using radioactive isotopes. That whole grouping of imaging technologies utilize what's called ionizing radiation. Ionizing radiation is what can cause damage to cellular reproduction.

Tobias Gilk:
Right. MRI uses magnetism. Magnetism is non ionizing radiation still electromagnetic radiation, just as x rays are electromagnetic radiation, but based on where it falls in the electromagnetic spectrum, magnetism doesn't have enough energy to cause the chromosomal damage that can lead to crazy reproduction, cancers, that sort of thing. So when MRI first came about clinically 40 years ago, plus or minus, we were very concerned with ionizing radiation. We were really beginning to kind of wrap our arms around what the effects of medical levels of radiation exposure were, and we had concerns about that.

Tobias Gilk:
And at that time, MRI comes upon the scene and MRI says, hey, guys, I know you're worried about this ionizing radiation thing. Guess what? We invented an entirely new imaging modality that doesn't use ionizing radiation. So the thing that you're worried about, this doesn't have at all. And everybody was like, that's fantastic.

Tobias Gilk:
Let's use MRI. The problem is that in the moment, I don't think anybody asked the follow on question, which to my mind is, well, if you don't have the risks that we've been historically worried about, do you have any new or different risks that we should be aware of, that we should prospectively respond to that part of the question was never really asked, has to date, never been asked in a regulatory or licensure framework. MRI came into the world with the marketing or PR slogan of the safe modality and has really sort of ridden that PR campaign all the way up into the future. Now, generally speaking, MRIs can be extraordinarily safe, right? We have professionally identified what the risks are and what the best practices are to mitigate those risks.

Tobias Gilk:
MRIs generate extremely powerful magnetic fields, and anybody who spends 15 minutes on Google can find all kinds of amazing and laugh and point and giggle kind of questions, photos of things that have gone flying at MRI scanners.

Mark Graban:
Those photos beg a lot of questions then, and we'll get into all of that.

Tobias Gilk:
And projectile accidents are indeed one of the most significant risks in the MRI environment. Now, obviously, if we just screen things and people before they go into the room or we make things out of metals for the MRI suite that don't go flying, we can effectively manage those risks. But projectile risks are not the only ones. The magnetism, whether it's the always on magnetic field or the extra applied magnetic fields that happen during imaging, they can interfere with implants and medical devices, right? So we might cause your pacemaker or your implanted insulin pump to malfunction, and that malfunctioning pacemaker or insulin pump or other device might cause you harm as a result of the fact that it had this negative interaction with the MRI scanner.

Tobias Gilk:
The energies that we superimpose on the always on magnetic field, also, all of that stuff winds up getting converted into heat inside your body. If you've ever had an MRI, a lot of times you'll start out feeling like the room that they put the MRI in is a meat locker, right? It's just so cold. When you walk in there, they throw.

Mark Graban:
A blanket on you.

Tobias Gilk:
MRI scanner, you swear to God that somebody just sort of dialed the thermostat up 20 degrees. The room temperature is exactly the same. The thing is that the MRI procedure inputs energy into your body, and that energy gets converted into heat. Now, generally speaking, it's diffused, right? You come out feeling warm or maybe even sweaty, uncomfortably hot, but not harmed.

Tobias Gilk:
But there are certain mechanisms by which the thermal energy that gets put into your body winds up getting focused or concentrated into small areas instead of broadly sprinkled over your body. And then we can actually produce burns.

Mark Graban:
Would that be a machine malfunction or a mistake in how it's set up to cause burn?

Tobias Gilk:
There are MRI machine malfunctions, but they are so vanishingly rare that in any big picture conversation of MRI safety, they're almost not even worth raising. Right? Sure. In 99% of the MRI accidents, it involves the failure to identify a potential contraindication. Right.

Tobias Gilk:
The patient had something with them, in them, on them, that made this potential risk come into being. Right. Or we failed to effectively position the patient or pad the patient, just as one example. And there are a few different ways that we can actually wind up producing a burn in an MRI. But one of the more common ways is the transmitters of some of that radio frequency electromagnetic energy actually are behind the walls of the tube.

Tobias Gilk:
And when you are really close to the transmitter, it actually behaves something like a microwave oven. There's what's called a dipole. Dipole interaction. It excites water molecules and the water molecules can heat up. In most MRI scanners, the manufacturer, the Siemens, the GES, the Phillips, the cannons of the world, they say, you know what, when you slide the patient in, just make sure that they're not right next to the walls of the tube.

Tobias Gilk:
Right. If it's a skinny person, great. Just have them keep their arms close to their torso, if it's a bigger person. Right. Put some padding in there and just make sure they don't get too close.

Tobias Gilk:
Because if. If your shoulders or your elbows or whatever get too close to the walls of the tube, those might get a disproportionate amount of the energy, the electromagnetic energy, and it may be in, you know, maybe close enough where it's acting like a microwave. Right. And it cooks some of the water under your skin. So we understand the overwhelming majority of how these accidents occur.

Tobias Gilk:
We understand the mechanics of how injury is produced. Right. And as a result, we can look to existing best practices and say this best practice interrupts this pathway of causation. Right. This blocks off one of the swiss cheese layers.

Tobias Gilk:
If we do this, the problem is that those best practices are not mandatory, they're not requirements. So the US FDA, they only regulate point of care for one radiology device, mammography. In the United States, it literally takes an act of Congress to get the FDA to regulate point of care safety. And through mammography Quality and Standards act, the US government essentially gave the FDA power to regulate point of care for mammography. They have not received authority to regulate point of care for any other radiologic imaging device.

Tobias Gilk:
So the FDA doesn't regulate it nationally. States largely have bought into the MRI is the safe modality, and therefore we don't need to regulate it. Mindset and the regulator, excuse me, the accrediting organizations, by and large, have kind of been hands off laissez faire about the whole thing. So it comes down to the individual provider for the overwhelming majority of the preventions as to whether they want to do it or not.

Mark Graban:
So what I hear you saying is the equipment in and of itself could be generally considered safe, but there could be process problems. I mean, I think of times when I've had a lower back MRI, I was asked questions. There was a checklist that would seem to be one of the procedural things to make sure that I didn't have any metallic implants or didn't have any heavy metal objects with me in Texas. I don't carry a gun, but it seems like they need to very strictly screen and make sure that somebody realizes they can't bring their gun near the MRI. Right.

Mark Graban:
There are process problems that could lead to harm, and I'm thinking most. I've learned something here about that heat impact. I was thinking mostly of these dramatic photos of items being sucked into. And I know it's not suction, but pulled, drawn into the magnet, which could be. I mean, I think there have been cases of guns, like maybe a security guard or police officer has a gun, metallic poles, beds, other items like that.

Mark Graban:
Could you share some of those examples, or at least kind of like a typical case study of the danger of metallic object being pulled into the magnet?

Tobias Gilk:
Sure. Just a few weeks ago, there was a case made public, I think it happened last year, of a woman who went into an MRI scanner with a concealed firearm, and the magnet pulled the pistol from her. And there really isn't enough detail to understand. The magnetism can act on the inner workings, the mechanics of the firing of a pistol. And so the magnetism can actually force the pistol to fire, or it can go flying, and it can hit the face of the MRI scanner, and that impact or shock can cause it to discharge around.

Tobias Gilk:
So we don't know exactly what the mechanisms were of it discharging around, but it actually shoots the woman in the butt, shoots her through the buttock, which I laugh because the only other alternative is to cry that we have these process breakdowns that allow these kinds of accidents to occur. Several months prior, another pistol, not in the United States this time, but this was in Brazil. A man who I believe was accompanying his mother or his mother in law into the MRI room, fills out the screening form. No, I don't have any metal, walks in, has a concealed pistol goes flying, shoots him in the back, and he winds up dying of the injuries. But pistols are far and away not the only thing that goes flying.

Tobias Gilk:
There was a case last year of a hospital in California where an ICU nurse brought the ICU bed with the patient on top, into the MRI scanner. And then the MRI scanner is sitting at one end of the room, and the nurse is coming in with the bed. And when you cross the magic threshold, the magnet is going to grab the bed and it slams the bed against the MRI. The only thing was, the nurse was in between. The nurse winds up getting pinned between the bed and the magnet, and she suffered some pretty extensive injuries as a result of that.

Tobias Gilk:
So each of these incidents are ones where there is an inherent risk created by the machine and the electromagnetic fields that the machine generates. Right. Not because the machine is malfunctioning, quite the opposite. Because the machine is functioning exactly the way it's designed to. Right.

Tobias Gilk:
It's generating these electromagnetic fields. Right. As you pointed out, if we do the process, the prospective risk management process, before we bring the people or the equipment material into the room, we know what the risks are, we know how to manage these risks. We just don't do them uniformly. The two pistol accidents, both of those purportedly, were ones where the site gave instructions to the patient or the visitor saying, no metal is allowed in that room, but relied on patient disclosure.

Tobias Gilk:
Yes, I do.

Mark Graban:
No, I don't. Sorry to interrupt. I can't go into a sporting event without walking through a magnetometer to check to see if I have a gun or a weapon.

Tobias Gilk:
Exactly. And there are specially designed. They call them ferromagnetic detectors. They are specifically designed to screen for the types of metal that go flying into MRI scanners. Right.

Tobias Gilk:
Which is great, because we don't want alerts or alarms on titanium or aluminum or things that aren't going to be attracted to the MRI. Things from which we make a bunch of the stuff that lives in MRI suites. Right. But we do want to catch the ICU beds and the pistols and cell phones and God knows what else. So they do have these ferromagnetic detectors at the hospital where the ICU bed went in.

Tobias Gilk:
They actually had them. And after the accident occurred, the hospital biomedical engineering department went in and tested them to make sure that they were working as they were supposed to, and they found, sure enough, thumbs up, they're working. Which means either the MRI department staff turned them off or they just were so inured to the alarms that they didn't use them as a feedback tool to tell them you're about to make the worst professional decision you've ever made in your life.

Mark Graban:
Is there a scenario, I mean, alarm fatigue is discussed a lot in healthcare and probably in other workplaces where people turn off the alarm and they get away with it for a while until something bad happens. Are there times when something verging on a false alarm of, let's say, a small piece of metal sets off the alarm? People get frustrated and like, oh, you know what? They just get kind of laxed. Do you think until then, sadly, the big piece of metal that you would have wanted to catch does get through?

Tobias Gilk:
Yes, that does happen. And that, in my mind, that's symptomatic of a less than ideal approach to a feedback tool. Right. Right. Lots of sites that have had ferromagnetic detection for MRI prescreening, somebody essentially shows up, attorneys or the risk management department, or somebody shows up on Monday and says, we bought this new thing, we're putting it up here.

Tobias Gilk:
It'll go beep when something with magnetic metal walks through it. Right. And that's kind of the whole story that the staff winds up getting. Right. And sure enough, you walk through, or you approach the thing, you walk through the detector and it goes beep.

Tobias Gilk:
Right. Well, if that was the beginning, middle and end of the. Here's the tool and here's how to use it. Explanation. Absolutely.

Tobias Gilk:
That's going to lead to alarm fatigue.

Mark Graban:
I think there's also a lesson to be learned around change management if that's how the new tool is being introduced instead of more fully engaging people and understanding the problem and how this is a countermeasure, to me, there's adjacent to process problems or often training or communication issues.

Tobias Gilk:
Right. So the sites that take that exact same tool in the exact same position and look at it as this is a feedback tool, this is a device to tell us whether all of the things that we think that we're doing effectively and efficiently upstream. Right. That we're divorcing our patients and our personnel from the things that can go fly. That's why you have changing rooms.

Tobias Gilk:
Right. That's why we go through this prescreening process. All of that is essentially geared towards getting to the doorway into the MRI room and being perfectly ready to go in there. Right. So if the thing at the doorway alarms, if it goes beep, what that should be telling you is not that the thing went beep, what that should be telling you is, hey, wait a second.

Tobias Gilk:
All of the two or three or ten or 20 processes that we set to make sure this thing doesn't go beep when the patient arrives. Somewhere in that list of precursor steps, we didn't do something the way we thought we were going to do. Right. And as soon as you start using the machine that goes beep as a feedback tool for your preparation process, now all of a sudden it becomes an extraordinarily valuable safety tool. So it's not the tool as much as it is your willingness to integrate the tool into the.

Mark Graban:
And I'll point people in the show notes to your LinkedIn page, Toby, and videos and things that you post. It's been very know education for me and it seems like one of the key risk factors that we need to have good countermeasures for, as you've already touched on, is access control. Varying spaces nearest different zones. Is that the right way to say it? Nearest to the MRI and kind of further back where you might have access control.

Mark Graban:
And we're recording this almost a week after the Runway incursion. This is going to sound like I'm totally changing topics, but I think there's parallels here. The Runway incursion at the Tokyo Hanada airport. Japanese coast guard plane was told to taxi and hold. Don't enter the Runway, you're not cleared for takeoff.

Mark Graban:
For reasons yet unknown here on January eigth, that plane ended up on the Runway and was hit by a landing Jal Airbus. And so I've talked to a pilot friend of mine and reading the news reports around just access control and the access controls aren't as strict as they maybe could be, right? Physical barriers, lights that were stoplights that weren't operational at the moment, whether it's this question of like, well, who isn't keeping their eyeballs? Paying someone to keep their eyeballs on every single plane versus a hospital, like kind of brute forcing it without technology, of paying someone who's trained well enough to screen the people and items and materials, it seems like even without an elegant technology solution, why couldn't you just brute force that to prevent, and I'm not saying using force against people, but using the clumsy, even just costly, labor intensive solution. If patient safety is always our top priority, as hospitals like to say.

Mark Graban:
I think I'm finally getting around to a question I got up on my soapbox. Why aren't best practices followed yet alone made mandatory? If it's a choice, why is that choice not made?

Tobias Gilk:
That's the $64,000 question right there. So one of the challenges is if we look over the last 2030 years, what a hospital gets paid for performing one MRI today is probably a fifth, a 10th of what it was 2025 years ago. Right. 25 years ago, MRI was this ivory tower kind of medical procedure. And I guess the negotiating power that hospitals had with the insurance companies was far greater because there was a limited supply of them.

Tobias Gilk:
And so they were making bank off of MRI services. Then huge proliferation of outpatient imaging centers. Essentially, the market gets saturated, and insurance companies now have the negotiating power. And like I say, rates today, just in terms of straight dollars, not adjusted for inflation or anything like that, are probably one fifth to one 10th of what they were 25 years ago. So there has been this massive squeeze in terms of cost control of MRI services and staffing.

Tobias Gilk:
Once you take your million and a half dollars cost of the MRI scanner and your half million dollar cost for the specialty construction of an MRI suite, right, you've got all of this fixed cost. Your number one variable cost is staffing. And so two things simultaneously happened. One, we wanted to reduce staffing costs, which meant either fewer bodies or less experienced, lower on the wage scale, individuals, or some combination of those two things. Plus, we want to try and accelerate the number of patients that we put through the machine.

Tobias Gilk:
Right. If we get paid on a per patient, per exam basis, we do more exams, we're going to make more money. Right? So simultaneously, we see a reduction in workforce, both experience and just the numbers of individuals sort of put to task for this. And we have much greater throughput demands.

Tobias Gilk:
And the role of the MRI technologist is not just simply to sit back there and place a doku and hit the go button every four minutes. They're also doing lookups for the next patient and juggling schedules because this patient didn't show. Or if they're in the hospital, somebody from neurology wants a stat exam on it. So the in between times between. Mark, we're about to start your next pulse sequence.

Tobias Gilk:
It's going to last four and a half minutes. They're not twiddling their thumbs for the four and a half minutes that that part of the exam is going on. They're attending to ten or 20 other things that are sort of competing for their time and attention. Right. As we increase throughput, we increase the number of things that are competing for their time and attention.

Tobias Gilk:
Also, simultaneously, we have seen a marked increase in the levels of both patient acuity and implants, devices and contraindications or complications, at minimum, that come with the patient to MRI. 25 years ago, all of the MRI manufacturers had these big, bold print legal statements in the operator's manual that essentially said, look, under no circumstances do you put any patient who has anything metal with them in them, on them. You do not put that person inside this magnet, or if you do, we are out. We take zero responsibility. Everything is on you.

Tobias Gilk:
Right. Then they came up with labeling or designation for implants and devices that have been tested and demonstrated to be safe in MRI environment, oftentimes with specific, limiting sets of conditions. Right. But the FDA said, you guys can't keep putting this disclaimer saying you do not allow any of these patients to be scanned when they have devices that we, the FDA, have said, yes, under that set of circumstances, it's okay to scan this patient. So the manufacturers took those prohibitions out.

Tobias Gilk:
Good friend of mine, Dr. Kanal, who is a neuroradiologist at the University of Pittsburgh Medical center, he did a study of the UPMC MRI patients across all of their mris. So hospitals and outpatient imaging centers, and he found, I think the numbers were somewhere between 35 and 40% of all the MRI patients that get imaged in the UPMC system have implants, devices, shrapnel, foreign bodies, dermal piercings, tattoos, or other things that might represent meaningful complications from the safety perspective for the MRI patients. So we have radically changed who our patient cohort is in MRI. So we have the economics that have not worked in the favor of MRI.

Tobias Gilk:
In response to the economics, we have reduced workforce and increased throughput, and we also concurrently have this change in the makeup of our patient population. And the significant portion of the MRI patient population have these risks and complications and contraindications that didn't exist in the MRI patient population 25, 30 years ago. So all of these factors are sort of coming together as sort of perfect storm kind of set of circumstances to make the MRI safety environment more challenging today than it ever has been. Yeah.

Mark Graban:
So I've done consulting with hospitals, but I'm going to wear the outsider to healthcare hat because I guess I can choose. Last time I was doing consulting work regularly with a hospital, I walked through a magnetometer every day. It was in a large city. There are, sadly shootings that occur, people bringing weapons into the emergency room or into the hospital, and whether someone installing security, whether that's reactive or proactive, I don't think they're doing an ROI statement. They're probably just saying, well, this is a sad but necessary cost of doing business.

Mark Graban:
And I would still just wonder that parallel of the staffing costs versus the risk of harm to staff, the risk of damage to the equipment. Some of these incidents maybe, at best, throw the machine offline for a period of time, if not damage it. It's an interesting set of trade offs, even if someone were only strictly looking at financial trade offs. I know it's human nature. We don't do a good job of gauging risk known costs versus potential costs.

Mark Graban:
I got more philosophical, but it is surprising that it seems so easy for people to get metal close to the MRI. I can let you react to that, but how many incidents are there a year in the US that cause harm or death? MRI mishaps.

Tobias Gilk:
Death is very few. Death is a very small number, probably single digits in any given year. And keep in mind that in the US, historically, we've done around 30 million MRI studies per year. So a handful of deaths, while almost all of them, tend to be preventable through existing best practices and therefore are in some ways kind of inexcusable. But in terms of gross numbers, we're not dealing with a particularly large number.

Tobias Gilk:
I was joking the other day and said to somebody, if my goal was to save more lives, I would probably better spend my time keeping people from tipping vending machines over on themselves to get the chip bag that didn't come out of the corkscrew dispenser or whatever, get angry, and they wiggle the machine trying to get it out, and it falls over on them and crushes them. More people die in the United States from vending machines tipping over on themselves than in MRI. So if you don't have a fear about going and getting candy bar out of the vending machine, you probably shouldn't have a fear of going into MRI. Right.

Mark Graban:
But if I can just interject for a minute. When I lived in California, you get all kinds of warnings about attaching your furniture to the wall if it's tall and it could tip over, it seemed like vending machine makers or installers. I mean, I know they would say, well, you shouldn't be rattling the machine.

Tobias Gilk:
Right?

Mark Graban:
But it seems like that could be prevented. Human nature is, people are going to rock the machine.

Tobias Gilk:
Right? To some degree. Right. One of the important distinctions for me in terms of people who die by tipping the vending machines over on themselves and people who are injured or die in an MRI environment is we all understand how gravity works, right? We are assuming some degree of autonomy and responsibility if we're going and shaking the vending machine.

Tobias Gilk:
Right.

Mark Graban:
And that's really more solely the result of one person's action.

Tobias Gilk:
Exactly. Right. So in the MRI environment, the thing that makes me so enamored of MRI, the thing that makes me describe it as the closest thing to magic is what makes it so difficult to understand from the patient's perspective. Right. We don't expect the patient to understand.

Tobias Gilk:
You have ABC implant of this particular variety implanted in this part of your body, and we're going to be imaging this other part of your body. And so, therefore, it is a risk or it isn't a risk, or modify the study in the following ways to manage those risks. It would be grossly unfair to put a layperson in that position where they have to have responsibility over the decisions to keep them safe. Sure. Whereas the vending machine example, it's one person who's responsible, beginning to end, for the whole event in an MRI environment, that is not the case.

Tobias Gilk:
And the person who is most likely to be injured is the person who has the least knowledge and control over that situation, which, in my mind, transfers all of that responsibility onto the provider of the service of the care. Right. That it's the hospital, the imaging center, the physician's office that needs to assume the responsibility for the whole enchilada. Right. They are responsible for soup to nuts, everything associated with this episode of patient care, right?

Tobias Gilk:
Yes. We turn to the patient, we have them fill out the screening form, and so we ask for information from the patient to inform that process. But the execution of that process and the responsibility for keeping the patient safe falls with the institution and the individuals who are delivering care. Right. One of the things that grinds my gears when we see accidents, like if you go and you google the woman who shot herself in the butt because she brought her pistol into the MRI, you will see language used over and over again in depictions of that accident and other accidents where they talk about it was a freak event, right.

Tobias Gilk:
As if God came down and pointed his finger at this particular patient care episode and created this. They are not freak events. They are not some sort of inescapable, stochastic risk of dealing with patient care. Right. Do I believe that if you make something idiot proof, they'll come up with better idiots?

Tobias Gilk:
Yes, I do. I think human beings will continuously try and find new and inventive ways to short circuit circumvent processes, right. And we cannot anticipate all of the potential downstream responses to a risk mitigation step. Does that mean that we shouldn't take the risk mitigation step because we can't foresee all of the circumventions that somebody might take? Absolutely not.

Tobias Gilk:
Right. So this idea that this fatalistic stuff's going to happen is just that. It's a freak event that nobody could have anticipated. No, we anticipate things all the time. Both of those.

Tobias Gilk:
The fatalistic and hand of God sort of explanations for this just absolutely make me crazy. Right? But if you go back and you look at depictions in the popular and trade press about MRI accidents, and you remove any kind of framing or contextualization of hand of God or fatalistic, well, this is just going to happen. You remove all of those references and you're really left with no choice but to scratch your head and go, well, if we know this can happen, why don't we prevent it from happening?

Mark Graban:
And before coming back to that, real quick, the numbers around harm, are there dozens of incidents a year? Roughly speaking, hundreds. And I'm sure there's under reporting, especially of near misses.

Tobias Gilk:
Right? So the US FDA has what's called the MDR medical device reporting database. You and I, we can actually go online and we can view it, we can search it. It's called the MoD database. M-A-U-D-E.

Tobias Gilk:
If you google Maud FDA, it'll send you right to it. MoD is some horribly tortured acronym. So the way that medical device reporting works in the United States is an accident happens at a point of care, right? And if we don't kill the person at the point of care, then what's supposed to happen is the hospital or physician practice or imaging center is supposed to let the manufacturer of the MRI device know, and then the manufacturer of the device is supposed to report this to the FDA. So if the site or the hospital sort of sweeps it under the rug, if it's not something that we need to call in a service call, or even if it is something that we need to call in a service call to repair, because we wrote something important on the MRI.

Tobias Gilk:
As long as we don't tell the service engineers that somebody was injured in that accident, then this vital link in the chain to share the information about the event doesn't happen. And the whole process is essentially short circuited from at the very beginning. Right? So a little over ten years ago, Dr. Canal, who I mentioned earlier, he and I did a research paper on how do MRI accidents occur?

Tobias Gilk:
How do we prevent them? How comfortable are we in quantifying to your specific question, are we dealing with tens or hundreds or whatever in the FDA database? There are today probably on average, between 152 hundred MRI classified adverse events per year in the FDA database. So Dr. Canal and I did an evaluation.

Tobias Gilk:
State of Pennsylvania has mandatory adverse event reporting only for hospitals, but they collect the data from hospitals, then they don't make it all public, but episodically, they pick a special issue, a specific topic, and they will publish a year and a half worth of reporting data on that topic. And so Pennsylvania had published, I think, 18 months of MRI adverse event reports that came into Pennsylvania patient safety Authority. We were like, this is a golden opportunity. We're going to compare adverse event reporting to the state of Pennsylvania, which is mandatory against national reporting over the same time period. And the numbers in the state of Pennsylvania were 90% of the FDA's number for the entire year.

Tobias Gilk:
For the entire country. Right. So the Pennsylvania numbers only came from hospitals with mandatory reporting. And at that time, almost exactly 50% of MRI imaging was done in an outpatient setting. So we're like, okay, so if we take this number and double it, we're probably somewhere close to the actual number for the entire state of Pennsylvania, across all providers.

Tobias Gilk:
State of Pennsylvania was, at the time, roughly 5% of the US population. So if we population correct for that, so we multiply times 20. So we double it based on provider type multiply times 20 for population correction to begin to get an estimate across the entire United States. When we did that, the US FDA number represents 2% of what the Pennsylvania data modeled out to a national level reflects, which would suggest that we're actually looking at somewhere between seven and 8000 MRI adverse events in the United States in any given year. And over time, that number appears to be increasing.

Tobias Gilk:
And not only is it increasing, but it also appears to be increasing at a substantially faster rate than we're growing MRI procedure volume. Right? So if MRI procedure volume is growing at 10% per annum, the accident rate is actually growing somewhere between 25 and 30% per annum. So we are headed in the wrong direction. Right.

Mark Graban:
There's a lot of connections to general, broader patient safety themes around underreporting of near misses and harms. That seems to circumvent the opportunity to learn aviation while it's become very safe. I think because of, I'm generalizing, doing a better job of learning from past incidents very broadly, not repeating this incident in Japan will be learned from in ways that lead to system improvements, communication improvements. I'm much more confident about that than I am of the learning that might come from a widely reported healthcare safety incident. There's some we advocate for broader mandatory, non punitive reporting, and that part, there's a non punitive part seems to be key.

Mark Graban:
And then there's the discussion around the numbers and what grinds my gears is when you go off of estimates, sort of like you were walking us through here with MRI safety incidents. Healthcare doesn't report the real numbers. And then when clinicians and researchers do their best to estimate it, well, people poo poo the estimates, like, well, if you'd give us real numbers, but either way, whether it's 44,000 deaths a year or 440,000 deaths a year, when so many of these are preventable, any of those numbers are too high. And I don't want to be fatalistic of, well, what can we do about it? We got to keep answering that question.

Mark Graban:
Sorry, end of speech.

Tobias Gilk:
Well, to your point, the reporting mechanism that exists through the US FDA is not a patient safety reporting system. It is a regulatory compliance. It is has this device that the FDA has approved, is the device causing more problems than we thought it was going to cause? Right. It's a device centric regulatory compliance mechanism.

Tobias Gilk:
It is not a patient safety mechanism.

Mark Graban:
And the problem is not the device.

Tobias Gilk:
Right, exactly.

Mark Graban:
Overlap of. We have these process problems to report.

Tobias Gilk:
Exactly where there may in fact be know medical devices about which the FDA legitimately has know this device is a bad device. Right. And we've all seen stories of things along those lines that historically has not been the case with MRI. It is about the process. It is about point of care decision making and patient safety.

Tobias Gilk:
So this reporting mechanism that we have, while it may be perfectly appropriate to sort of a regulatory compliance regime, it is, number one, not patient safety focused. And number two, even if it was, the information that it collects is so generified that it has no relevance, really, to MRI safety specifically. Some colleagues and I actually, we just launched this a handful of weeks ago. We developed an MRI specific adverse event reporting system. It's called care reporting, Caire reporting.org.

Tobias Gilk:
And it is an MRI specific adverse event reporting structure. The idea being, if we do exactly what you described, what you were talking about with the japanese coast Guard crash plane collision on the Runway, if we act like the MRI safety, NTSB, and we collect the information, we digest it, we identify what the points of failure were, and then we share that information out in an anonymized fashion. Right. This is not name and shame. This is not about pointing fingers and laughing at individuals or organizations.

Tobias Gilk:
This is the only way that we are collectively going to raise the floor is if we share information about how things go badly. And as long as there are all sorts of incentives to bury these things, the mechanisms that exist for reporting are poor fits for MRI. We don't actually ask for the types of information that illuminate the unique hazard properties of MRI. As long as all of those things continue to be true, then we're never going to get the information that helps us QAQC, our ability to act safely in and around these complicated, expensive, and clinically extraordinarily valuable pieces of. Right, right.

Mark Graban:
So, Toby, maybe one final question before we wrap up, and there's an endless list of other things I would love to ask you, but maybe I'll leave it just to one more question, or it's actually to ask for you to talk about something that's on your website that stands out to me. And I think there are strong parallels to lean thinking, especially when it comes what the late Paul O'Neill, who was CEO of Alcoa and a healthcare safety advocate, talked about, false trade offs. And as you say on the website here, if you've been told that MRI safety only comes at the expense of throughput, you've been lied to.

Tobias Gilk:
That we.

Mark Graban:
Can have both safety and throughput.

Tobias Gilk:
Right? Yes. I was so waiting for an opportunity to circle back around to your very opening where you said, we're probably not going to talk about Lean over the course of the conversation. This is the perfect book, Kent. Absolutely.

Tobias Gilk:
Lean is essential to MRI safety, whether you call it lean or not. But you need to recognize that integrating safety practices, risk management practices, this is not just sort of slapping layers on a process. Many sites do it that way. And I argue against that and suggest that you're not helping yourself by doing that, but by reengineering the process so that you take into account in consideration the financial realities of where we are in MRI and what is the reimbursement. And we really can't afford to be offering services at a significant loss for the majority of our patients.

Tobias Gilk:
Right. So we need to recognize the financial realities. We need to look at how do we maximize revenue, how do we effectively constrain costs while at the same time recognizing that there are risks? And risk management absolutely has to be a central part of designing or redesigning a process. It is so easy to essentially come in with some sort of checklist sticker that you slap on the wall and you always do these twelve things, right.

Tobias Gilk:
If those twelve things don't recognize who the patients are, what the equipment is, what the clinical needs are, who the referring physicians are, what the reimbursement structure is, if you don't understand and embrace the entire operational model and you just come in and superimpose these extra twelve things that folks are supposed to do. Absolutely. That goes against the normal operations and efficiencies or productivities that are built in. And that is sort of the worst example of risk assessment, risk management that is easy to implement, and yet the costs associated with implementing in that fashion are just astronomical when it comes to MRI. Apart from patients not showing up or not showing up on time, the single biggest delay in throughput and productivity is MRI safety related questions or concerns if we are smarter, if we have better processes for managing that 35% to 40% of the patient population that have some kind of complication or contraindication.

Tobias Gilk:
Right. One of those shows up at our doorstep and we don't have the training or the process to effectively manage it. Our entire process, our entire throughput productivity is going to grind to a screeching halt until we figure out how to deal with this atypical, unusual, unanticipated patient condition. Right? Which means all of the infrastructure, all of the capital investment is now just sort of sitting idle and costing us money.

Tobias Gilk:
Right? Whereas if you have effective processes, if you have effectively trained individuals at the point of care, managing patient care, and you look at that situation and you're like, I know exactly what to do in that situation right now, all of a sudden, there is no delay. If sites actually quantified how much delay, how much drag there is on their throughput and productivity strictly because of MRI safety questions, and then extrapolated out what the cost of that missing patient care time is over the course of a quarter a year, the ten year lifespan of an MRI scanner, those costs are exorbitant. I mean, the amount of money that sites lose on a given year simply because they don't have smart and effective integrated processes for safety sort of built into the way that they operate. The idea that we're only going to improve safety at the cost of productivity or throughput is so backwards to the average state of the average MRI provider in the United States.

Tobias Gilk:
Almost always I can go into a site, improve safety and improve their productivity and throughput. And when you look at what the economic implications of that are over a significant chunk of time, it's huge. Yes.

Mark Graban:
And I think if a team is still doing this work in a way where the safety steps are slowing down throughput, that just means we haven't figured out how to do it the better way. And, you know, I think whether it's Paul O'Neill or a quote unquote lean sensei, would challenge people to, well, don't, don't say it can't be done in a way that breaks the trade off. You just haven't figured it out yet. Not to be Pollyanna about things, but that's the challenge. You have to figure it out and be creative and redesign things instead of just adding triple checks on top of things and just kind of final thought that comes to mind.

Mark Graban:
John Grout, who's a professor who studied Toyota, and he's in particular an expert on mistake proofing. And he's published a great book, it's available free through AHRQ on mistaking healthcare. And he says quite definitively, good mistake proofing doesn't slow down the process.

Tobias Gilk:
Right.

Mark Graban:
And it's very possible to have good mistake proofing that doesn't slow you down. So I think hopefully that provides some inspiration to somebody to kind of get past that assumed it always has to be this way. Trade off.

Tobias Gilk:
Yes, because, yes, there probably are discrete things that should get introduced that might have sort of a slowing contribution to the overall process. But that's one thing that might add a little bit of a slow for an effective risk management result. But that one thing that slows things down is usually going to be coupled with five 6810 things that are going to cut steps out or cut delays out and allow for the care for more patients, the more effective and efficient way to get patients through. So many hospitals today are just absolutely hung up on their prescani patient satisfaction scores. How satisfied do you think the patient is when they take off from work and they show up for their exam and you tell them, oh, I'm sorry, we can't do it because we don't have the information that allows us to do the risk assessment.

Tobias Gilk:
Right. Right. So you're shooting yourself in the foot six different ways when you don't effectively manage these patients with the complications and contraindications. You're not making use of your personnel, you're not utilizing the capital equipment. You're aggravating the patients, you're aggravating the referring physicians.

Tobias Gilk:
All of these things. You improve the process, which should innately include the safety aspects of it, and you're going to improve all of those things because inefficiency in the way we handle safety is such a point of friction in patient care in MRI today.

Mark Graban:
Well, Toby, I want to thank you for the work that you're doing to shed light on the issue and to help people in MRI settings, hospitals and otherwise improve safety for all. And I want to thank you for being here today. I feel like this is a very rich topic. I feel like we just scratched the surf just a little bit, but I would encourage the listener to follow Toby on LinkedIn. Tobias Gilk, you can find him there.

Mark Graban:
Go check out his website. There'll be a link in the show. You. I just want to thank you for agreeing to do the conversation here today. This has really been enlightening.

Tobias Gilk:
Thank you. It's my pleasure.


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Mark Graban
Mark Graban is an internationally-recognized consultant, author, and professional speaker, and podcaster with experience in healthcare, manufacturing, and startups. Mark's new book is The Mistakes That Make Us: Cultivating a Culture of Learning and Innovation. He is also the author of Measures of Success: React Less, Lead Better, Improve More, the Shingo Award-winning books Lean Hospitals and Healthcare Kaizen, and the anthology Practicing Lean. Mark is also a Senior Advisor to the technology company KaiNexus.

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