 This is Donna Prosser, Chief Clinical Officer at the Patient Safety MIMMA Foundation. Today we're going to talk about radiation safety with Tobias Gil. Tobias is the founder of Gilc Radiology Consultants in Kansas City, Missouri. Welcome Tobias, thanks for joining us today. Thank you, it's my pleasure. I wonder if you'd tell us just a little bit about your background. Yeah, so I wound up becoming involved in patient safety, radiology safety, and in particular MRI safety, actually through a long series of strange left-hand career turns. I'm an architect by training and I became involved in design of radiology facilities with an eye towards protecting patient safety, enhancing the physical environment safety. In particular in MRI environments that becomes really important because we have pervasive physical hazards that we want to make sure that we don't allow people close to. And that interest in sort of the physical environment piece of it really metastasized. And I became much more involved in holistic safety in radiology, not only from the physical environment, but from clinical and operational standpoint as well. Great, well thanks so much for joining us. I wonder if we could start real quick with, you know, what is radiation safety? Why is it that we should be concerned about it? So radiation essentially just means electromagnetic waves or high-energy particles that travel from here to there. And those waves or those particles can be benign. Sunlight is radiation. The heat that comes off of the heating pad is radiation. So radiation sort of writ large is not something that we necessarily need to fear, but there is a subset of radiation that receives a great deal of attention and that's ionizing radiation. And what distinguishes ionizing radiation from its counterpart, non-ionizing radiation, is that ionizing radiation can do cellular damage. It can damage chromosomes that in reproduction somewhere down the line, the cell may go haywire and may produce cancerous growth. And so the concern with ionizing radiation is cancer, development of cancers. And we frequently compare and contrast the safety or known risks of ionizing radiation with non-ionizing radiation. And that's one of the reasons that we tend to try and oftentimes in a clinical setting move patients when it's a viable imaging option to move them from ionizing modalities like X-ray or CT or nuclear medicine to non-ionizing modalities such as ultrasound or MRI. Great. So tell us a little bit about MRI safety. And why is it preferred when we're looking at reducing radiation exposure and what are the specific safety concerns with MRI? So if the concern is ionizing radiation exposure, MRI has none of that. So in terms of managing that particular risk far and away, MRI as compared to X-ray or CT is the preferred way to go. All other things being equal if the exams produce the same relevant clinical information. In fact, we sort of market MRI as quote unquote the safe modality or the safe choice. But by virtue of this fact, by virtue of the fact that MRI as a non-ionizing modality does not carry with it the cancer risk. Now what that fails to explain is that MRIs have their own unique risks. And while it's true that cancer risk is completely absent, it's incredibly small on the X-ray side to begin with. So let's not mischaracterize this as, oh my God, we're going to die versus, you know, we're going to be perfectly fine. You're going to be perfectly fine if you have to go get an X-ray. The concern is lifetime accumulated dose or short period accumulated dose on the ionizing radiation side. On the MRI side, in order to produce the picture from an MRI machine, we actually use three different non-ionizing electromagnetic fields. And each one of them has a different physical size that the electromagnetic field occupies. Each one of them, each one of the energies are active at different times during the imaging process. And each one of the energies carries with them different physical risks. Very quickly, there's the always on static magnetic field. This is the one that they measure the magnetic field strength of the MRI. You may be familiar with a 1.5 Tesla or three Tesla MRIs. That's a measurement of the strength of the magnetic field, the static magnetic field at the center where they're taking the picture. But that magnetic field reaches significant distance away from the scanner itself. And it may actually extend into adjacent rooms. Or if the MRI is on an outside wall, it may actually protrude outside the building. And so we have physical risks that occupy a volume of space. Static magnetic fields, the risks of that are things might go flying at the magnet. These magnets are so incredibly powerful that if we walk into the room with a conventional wheelchair or a steel oxygen cylinder, it's not going to take very far into that room before the magnet grabs whatever that object is and rips it out of your hand and flies it at the MRI scanner. In addition to that, just the action of the electromagnetic field acting on implants or devices, say an implanted medication pump, it may cause that physical device to malfunction and inadvertently deliver an inappropriate dose of medication as a result of it. So for the static magnetic field, we're concerned, we're always concerned with patient safety, but we're also very much concerned about staff and healthcare workers safety because of the volume of space where this may be a problem. Additionally, because it's always on, it's not just in the exam room during the exam like an x-ray. It's only when that red light comes on when we're actually taking the x-ray that there's the ionizing radiation risk. Here, it's omnipresent. It's on at 4 a.m. in the morning when the department is closed. So we need to be very careful at that. The other two electromagnetic fields that we use for making the MRI picture are, there's a time-varying gradient magnetic field that induces neuromuscular activity. We can actually cause peripheral nerve stimulation, tingly twitches, whatever. If the patient has an implanted device that monitors physiologic activity through electrical signals, which pretty much describes a pacemaker, for example, that induced energy that comes from the time-varying gradients can send false feedback. It can send signal to the pacemaker that the pacemaker may misinterpret as an arrhythmia. And it may deliver therapy to the patient thinking this patient has a weird arrhythmia. Let me try and correct that when, in fact, it's not detecting an abnormal heart rhythm. It's detecting signals coming from the MRI scanner. Then there's also radiofrequency fields that are used, and the radiofrequency fields, once they enter the patient's body, they get converted into heat, into thermal energy. This could be, should be, like sunbathing, laying out in the sun where you get this nice warm diffuse heat applied over a large part of your body. But like sunlight, if we take a magnifying glass, and we put it in the sunlight, we can actually take the amount of energy that's deposited over a large area, and with a lens, we can essentially focus it down to a little tiny spot. And that concentration of energy can turn what is normally a very pleasant warming experience into a quantity of energy, a focused beam of energy that can produce a burn. And we can do similar things in an MRI environment. We can concentrate and focus the radiofrequency energies in such a way that we can wind up burning patients. So static magnetic field affects everybody in that MRI environment, the time varying gradients and the radiofrequencies, because they're only on during imaging. And the physical space that they occupy is, depending on a few different variables, it may be as small as, you know, a cantaloupe, and it may be as large as a yoga ball. But that's really sort of the generalized volumes of space that we're looking at. And again, only during active imaging for those two. The good news is that the harms that can be produced by any of these are fairly well understood. And what's more important is the best practices to keep them from happening, keep the harms from happening, are out there for all of us to use. Excellent. So I'd like to go back to the ionizing radiation discussion that you were talking about. How do you determine, when you talk about lifetime accumulation of radiation, how do you determine that a patient has had too much radiation exposure and it's time to consider reduction through MRI? So because ionizing radiation causes chromosomal damage, right? So it may potentially disrupt the part of a cell that governs replication. So over the life of a cell at some point, depending on the cell type, it's going to replicate, it's going to divide and create, you know, an offspring cell. And that cell, if it inherits the chromosomal damage, its offspring, you know, may inherit the chromosomal damage. And at some point, something may go haywire enough that, you know, all of a sudden it starts replicating like crazy, it becomes cancerous. Now, we don't really know from, you know, the chest x-ray you get or the head CT you get. We don't really know if that exposure is really going to trigger somewhere down the line, the development of a cancer in any individual patient as a result of any individual diagnostic level exposure. What we're concerned about is that if a patient starts to rack up too many of these too much exposure over the period of months or years, that we may actually begin to push into that realm. Now, there are lots of different competing theories about how dangerous small doses of radiation are. Some people actually believe that like, you know, small exposure to viruses and bacteria, it strengthens our immune system. That's pretty well established. There are some people who believe that modest exposure to ionizing radiation has a similar beneficial effect to us. The most conservative models essentially say, okay, we know that at some point in terms of exposure, there's a measurable increased lifetime risk of cancer. And so what we're going to assume is if that's 100 millisieverts, a unit of radiation exposure, and that's the point at which we think that there is a 1% increased lifetime risk of developing cancer as a result of those exposures. Is that 100 millisieverts? So we just treat it as if every one millisievert is a, you know, 1% of 100 millisieverts in terms of exposure. So we're looking at maintaining annual exposures as modestly as possible. But it's that 100 millisievert level is the point at which we believe a person has incurred a 1% greater likelihood of developing some cancer as a result of those exposures. In terms of what that would take, if you were getting chest X-rays, it would take you about 80 chest X-rays a week, plus the natural ambient exposure that we're all exposed to. If you eat a banana, you get a little bit of radiation. You live in a house with brick or stone in the construction, you're probably getting little bits of radiation from that. We're getting little tiny bits of exposure to radiation all the time. You take those that are sort of naturally occurring, which depending on where you live is on average around four millisieverts per year. In order to get that additional 96 millisieverts of exposure, that's the 80 chest X-rays a week for the duration of the year. Interesting. And so how does that affect health worker safety? Because maybe a patient doesn't have 80 chest X-rays, but it's possible that a health worker could be exposed to 80 chest X-rays a week. Right. So imagine for a moment sort of a bare exposed light bulb, right? And you set it in the middle of the room and you flip the switch and you turn on the light bulb, that light goes every direction inside the room. You know, if you're on the east side of the room, you get hit by the light. If you're on the west side of the room, you get hit by the light. But if we take some sort of shade, right, and we block the light from going to the east side or to the west side or to the top or to the bottom or whatever, we can essentially reduce the light exposure in any one direction. This is shielding in effect. The exposure that you or I get to this exposed light bulb can also be reduced if we just spend less time in the room, right? Or the light bulb is on shorter durations of time, right? Now, obviously, if we're an X-ray tech and the light bulb turns on, you know, 50 times a day, we need to be concerned about that cumulative effective dose. The three mitigating factors given a light bulb are time distance and shielding, right? So time exposure, if I never turn that light bulb on, if time equals zero, then I'm not exposed to anything. Or if it's on all the time, but I'm only in the room, you know, a tiny fraction of the time, then my exposure is very low. So the light that may be uncomfortably bright in your eyes if I'm a foot away from you and shining flashlight in your eyes may not be so uncomfortable if I'm 10 feet away or 100 feet away. So the further we get from the source, the less energy we absorb. And then the last of the three sort of mitigating factors is shielding. Radiographers should all be protected in terms of either personal protective equipment if they have to be directly in the room or next to the patient during imaging. So we're talking, you know, aprons and, you know, leaded gloves and eye protection and thyroid guards and that sort of thing depending on the level of the energy and the frequency of exposure. Or more frequently in sort of a diagnostic setting, we're going to have a wall that has a leaded window and that wall will be shielded. And for the duration of the exposure that the tech is going to duck back behind the wall. So it's between them and the X-ray device that's emitting the radiation. And those combinations of factors dramatically reduce the exposure to our staff and workers. They depend on sort of the correct function of the device. So it's really important that we maintain QAQC regimens for, you know, X-ray devices, fluoroscopy, CT scanners, nuclear medicine equipment, to make sure that the device is emitting the proper amount of radiation and in the proper directions. Directionality is another part of it. But with those protections, properly functioning equipment, good policies and procedures in terms of protecting staff from occupational exposure, and then the infrastructure that provides us with personal protective equipment for radiation protection or shield walls and that sort of thing. Those combination of factors really make worker exposure very modest in terms of additional radiation they're exposed to besides the bananas and living in brick houses that they'll experience over the course of a year. Interesting. So are there any common organizational gaps that you see in hospitals these days with when it comes to either patient safety or health worker safety? So that's a really interesting question because I think that there are some pretty strong disparities between and among the different types of imaging equipment, right? So ionizing radiation, we are all conditioned to imagine, you know, Godzilla and Three Mile Island and, you know, horrific consequences of exposure. The result of that is that we have federal laws, we have state licensure requirements, we have accreditation verification of lots and lots of elements of ionizing radiation safety. On the flip side of that, you take a look at the non-ionizing radiation safety, and it's almost as if, you know, well, they don't have ionizing radiation. Ergo, they must be safe without ever really having delved into, well, what are the unique, you know, safety consequences of static magnetic fields, time-varying gradient magnetic fields, radio frequency energies. So if you look at just sort of the body of regulation accreditation licensure literature for ionizing and you contrast it with what there is for MRI, for example, most states in the Union don't require licensure of operators of MRI equipment. Now, they may be required under reimbursement requirements for payers or accreditation regimes, but contrast the level of training and demonstrated competency and licensure for beautician. I would venture dollars to donuts that your state has much more significant requirements for the person who's coloring your hair than the person who's administering your MRI. And that's, in my opinion, that's just wrong. Not that we shouldn't have, you know, licensure requirements or competency for people doing, you know, hair coloring, but we should have at least similar requirements for the person who's administering an MRI scanner. So there's a significant discrepancy in terms of the levels of oversight, the levels of regulation credentialing that go on in these different levels. And I guess what that means is from the MRI side, it's really up to us. It's up to individual providers, unless and until accreditation organization or state licensure organization step up. We are responsible for making sure that best practices are known and followed, that we have, I don't think that a hospital in this country could get licensed with a nuclear medicine program if they didn't have a radiation safety officer. How many hospitals have MRI safety officers associated with their operation? If they do have it, it's because they've taken it on themselves, not because anybody, you know, federal regulators, state licensure officials or accreditation organizations have told them they have to. We just, we have two very different standards in terms of oversight from the perspective of the safety of both healthcare workers and patients, depending on whether it's ionizing or non ionizing devices. So we're a global organization, we have a lot of hospitals and healthcare organizations in our network who are not here in the United States. I imagine those regulations are probably very significantly from country to country as well. Do you have any, I'm sorry, go ahead, please. Yes and no. So, ionizing radiation regulations do vary significantly between countries, but I think it's fairly consistent that throughout the world there are very few regulations with respect to MRI safety. Italy, however, is a notable example that are notable exemption from that, that they have passed some regulatory objectives in terms of MRI safety that still sort of being hammered out into the rulemaking process as to what specifically those expectations will look like at a provider level. But with the exception of what Italy has done, we're all pretty much on our own wherever we happen to be. Wow. And any final thoughts or recommendations for healthcare organizations, things they can put into place to better serve their patients and health workers? Yeah. So we have the RSO, the Radiation Safety Officer. So if you don't have parallel structures for your non ionizing modalities, do that. Identify an individual or individuals who have both responsibility and authority for safety of those modalities. If you as an organization suggest this and all of a sudden everybody takes two steps back, you need to ask yourself, what do they know about the safety of our facility that these individuals are unwilling to accept any kind of responsibility for safety, for patient care? So the fact that you don't have it is not proof that you don't need it. It may in fact be a bit of an indictment of how your facility has operated that nobody is really willing or eager to step forward and assume some responsibility for that. So that's sort of the first thing that I would say is facilities need to identify individuals who have both authority to make change and responsibility for outcomes and designate those individuals. If people involved in maintaining safe environments for patients or for other healthcare workers feel ill prepared for those responsibilities, and with the MRI examples, this is not unusual because as surprising as it sounds, the MRI safety is not a standard part of the training of either radiologic technologists or radiologists. It is not a formal part of the curriculum. If they learn it on the job or get hand-me-down knowledge from their trainer, fantastic, but that's as structured as it gets in most facilities. So the expectation that, oh, you are an MR tech or you're a radiologist and ergo you have in your head all of this knowledge and competency is not a safe assumption to make. So if those people who have responsibility for it shy away from those responsibilities seek out training for those people, get them advanced MR safety training and help them grow into the responsibilities of that position to protect patients and staff and the enterprise itself. And then the third thing that I'll say is policies and procedures. I visit a lot of hospitals and there are a lot of hospitals that I see where the policies and procedures are some dusty three ring binder on a shelf somewhere, right? We wrote them up because the state required us to or we have to do it for accreditation or what have you and nobody has looked at it since the last time there was a surveyor came through who demanded to see it. I think that policies and procedures should be the sounds pejorative and I don't mean it that way dummies guides that they should essentially coach the new employee, you know, through how do we do this? How do we handle these situations? It should be decision support tools for if presented with this situation then we do the following and it should really map out some of the more sticky and troublesome types of scenarios so that there is a uniform and consistent way to apply best practice knowledge to them. If you work at a facility where the policies and procedure manual is a dusty all three ring binder or the digital equivalent to that a folder on a shared drive that hasn't been opened in the last six years, update your policies and procedures. Make sure that they reflect what equipment do we have? What types of patients are we seeing? What clinically are we doing in radiology in each modality, not radiology in general to NCT, in X-ray, in fluoro, in MRI? What are we doing to these patients while they're there? What clinical support do these patients need? Do we ever do ICU patients who need ventilators? How do we handle ventilators and equipment that comes down from the floors? All of these are the sorts of things that policies and procedures should lay out and should make plain for the overwhelming majority of scans and patient conditions that present themselves. So if you don't have designated individuals, if the people who have responsibility don't have the knowledge, the skills, the competency and you don't have the roadmap to making these decisions in alignment with best practices, each of those three are steps that I would recommend taking. That is very well said Tobias and actually applies to pretty much everything in a hospital, doesn't it? Not in the radiation safety. There are unique details when we start looking at radiology and MRI safety. Yes, absolutely. And there are particular concerns and considerations, but the overarching structure of safety is the same as it is everywhere else. Yes. Yeah, here at the patient safety movement, you know, we advocate for making it really easy for the frontline to know what to do. That's one of the one of the biggest barriers to patient safety is that we have so many policies and procedures that are in dusty, throwing binders or these days, they are in a computer program someplace and still nobody can find it, but they need at the time that they need it. So, The overwhelming majority in radiology, the overwhelming majority of injury accidents that occurred from the modality are not because the device malfunctions. It's not like, you know, all of a sudden it's going to shock you or deliver a mega dose of radiation. The overwhelming majority of the reasons that patients get injured in the radiology setting is poor decision making at the point of care. So, we should be doing everything we can to facilitate better informed, better directed patient care decisions in again in alignment with best practices. And that comes from clear lines of authority and communication that comes from competency and training in the personnel who have responsibilities. And then it comes with decision support tools so that we have references to turn to if, you know, whoever, whoever the, the, you know, chief of radiology is or, you know, their designee is not available, you know, for a phone call that we have references and resources that we can pick up and we know these are endorsed by the chief of radiology, the administrative director of radiology, and we have essentially, you know, written direction on how to administer patient care. It's not going to work for every patient in every situation, but well written policies and procedures will resolve, you know, 95 plus percent of all of the questions and concerns about how do I take care of this situation. Well, Tobias, thank you so much for joining us today. This has been some great information. We really appreciate having you join us. Thank you very much. It's my pleasure. Well, have a wonderful rest of your day. And I hope that we can have you back again to talk about radiation safety and the future. It would be my pleasure. Thank you.