So I get to start out with motivations for an MR safety program. So MR imaging has been available imaging tool for more than 35 years. Today, MR is used for both diagnostic and interventional purposes. And while MR is perceived as a safe imaging modality because of its use of non-ionizing radiation, it has very serious and unique environmental risks. These hazards are serious enough to kill a patient simply by walking in the room carrying the wrong thing. If you do a Google search or literature search, result in reports of MR accidents, including the death of six-year-old Michael Columbini in 2001, when an oxygen tank was carried into an MR room and became a projectile. His unfortunate death was the first of its kind, but we use this event and others to learn from and not repeat. MR imaging safety guidelines and regulations vary by country. In the US, the FDA governs patient exposure limits and contrast agent regulation. We'll talk about some of the exposure limits later in this talk. But there's also program accreditations from the American College of Radiology and the Joint Commission that are required for Medicare reimbursement. So meeting these accreditation requirements are also very important for an MR safety program. So since I'm the first talk, we get to talk about what are the risks. So we'll start off first with the main magnetic field, most commonly 1.5 or 3 Tesla, but we're starting to see clinical systems much higher than that. And the 7 and 8 Tesla range. And these magnets, like any other magnet, will attract various objects. And because of their strength, it attracts with great force and turns ordinary objects into dangerous projectiles. It's also important to mention fringe fields. When you're planning your MR suites, the fringe fields are the spatial gradients around the magnet. FDA guidelines refer to a magnetic field of five gauss, which limits, it's the field strength where no potential concern, there's no potential risk for patients even with implanted electronic devices. And although this audience probably already knows and does not need a reminder that the magnet is always on, so these dangers never really go away. So unlike the magnet, RF fields are only turned on for a very short period of time. We use our RF energy to excite hydrogen protons to create the image. Radiofrequency coil energy is deposited into soft tissue and is quantified in terms of specific absorption rate. SAR is expressed as watts per kilogram. And the FDA maintains limits on the maximum SAR and the maximum temperature increases in tissue. FDA guidelines limit SAR whole body exposure in patients with normal thermoregulation to four watts per kilogram in the body and 1.5 watts per kilogram in other cases. Most MR imaging systems will give you an SAR estimation and every vendor does it a little bit differently, so it's a little bit hard to track. Oh, I think I skipped the, and RF fields will also interact with implants. And I'll let Dr. Panda talk a little bit more about implants in the next session. Gradient fields are also rapidly changing magnetic fields and are only turned on for a short period of time. But this rapid change can cause peripheral nerve stimulation. The FDA does not have specific limits for how fast that gradient can be, so there's no specific millitesel per second limit, but it does say that it shouldn't be painful stimulation. Gradient fields can also interact with implants, and again, I'll leave that to Dr. Panda in a later session. And gradients will also contribute to the acoustic noise in the MRI machine. While the gradient coils are not really mobile, eddy currents do cause quite a bit of noise in your MR scanner when the gradients are turned on. The FDA does give limits for acoustic noise for an MR system at 140 dB, with hearing protection that's 99 dB. So earplugs and headphones are necessary to mitigate the risk of causing tinnitus or hearing loss in your patients. So I mentioned cryogen safety here. It's not very common injury because our cryogen is contained within your magnet, so your superconducting magnet is cooled by liquid helium. In the unusual event of an unplanned quench, cryogen, that liquid helium turns into a gas and is usually vented to the outside. In the case of venting failure, this can lead to a risk of asphyxiation, frostbite, and positive pressure entrapment. So if I know the dangers, then I should be able to design barriers to prevent harm from reaching my patients. But we must be vigilant as holes or gaps in these protective systems or Swiss cheese effect can lead to error or harm reaching the patient. So the first barrier I'll talk about is a physical barrier. This includes the zone planning, the ACR guidelines layout, the zones one through four. Controlled access to zones three and four is very important. Doorway protection, whether it's a strap, a gate, or someone guarding the door, closing the door, these are all very important things to keep your zone four safe. We also use a tethering system. Anything that's left in zone three that should not be going into zone four, anything large like this gurney for an inpatient setting, we use this as a tether to the wall. Also having a robust MR safety education program is another barrier. And we know that having knowledgeable staff is priceless. The speaker's after me and we'll discuss the roles of MR, so MRMD and MRMSE further. But I'll point out that education should extend beyond these experts to your residents, your fellows, your physicians, your support staff, your nurses, anesthesia, pharmacy, possibly your cleaning staff. And the other one that I mentioned is really involving your EMS. So this is your local fireman who may be responding to fires in the MR suite as well. Patient preparation is also important. This includes screening. Here I've shown an example of the ACR's suggested screening form. You can find it on their website with an easy Google search. But changing clothes. Again, changing patients out of their standard street clothes really protects that patient from burns from unknown fibers in their seemingly harmless clothes. But also FMDs and their roles in the screening process is very important. And I mentioned patient positioning here as well as a risk of mitigating RF burns. So not allowing patients to touch the boar and avoiding any loops that could cause circuits. I do also mention standardized workflows. So here it's important to have standardized workflows. So when something unexpected is encountered, the technologist knows what to do, right? So that we're not making up steps, we're avoiding confusion and creating a safe space for our patients. So now we kind of generally know what we need, but where does it fit into the cost and value to our institution? Calculating the value in healthcare is often attributed to the following equation where outcomes are often dependent on quality and safety procedures. Budget line items that can be included in this section of personnel. So these are salaries and benefits of quality managers and safety specialists. Perhaps a percentage of a physician's time as a safety chair. And then also certifications. So that's ACR certifications, ABR certifications for physicians, and then technologist certifications as well. Another way to organize this is a cost model, cost of control model, where your prevention costs are here. So all the barriers that I talked about fit into this section. So it's all your prevention costs. Also appraisal costs. And I didn't mention this yet, but inspections, tests, auditing your barriers and systems that you have in place. Now the cost of failure is a little bit more difficult to describe, but internally we can just split them up into internal failure costs. And these are when you find a defect, what does it cost you to repair it or find it? These could be near miss events or maybe something that you found in your audit. External costs is when that harm actually reaches the patient and what happens. And so this results in patient dissatisfaction, perhaps loss of referrals or malpractice costs. So we know that a robust MR safety program is incredibly valuable. And I've described really four barriers to kind of help with that prevention step. But really we know that a whole lot more goes into that. So what I've described is that unique, but potentially dangerous MR environment and multiple barriers to keep your patients safe, knowing that a team of experts is absolutely invaluable and a quality and safety procedures increase your value to your patients and institution. So I'm gonna switch gears a little bit and talk about how to structure the MR safety program. And so there are key MR safety personnel which was introduced before. The MR medical director, the MR safety officer and the MR safety expert have been adopted in the ACR manual and MR safety. These roles were well described in the JMRI article from 2016, the recommended responsibilities for management of MR safety. But there are also, as Candice mentioned, a lot, many people within the department that need to be trained on MR safety. And so ACR goes on to define a level one MR personnel that are, those people that are safety educated to avoid danger to themselves and others in the MR environment. So they know enough to keep themselves safe and avoid injuring others. And so they are allowed unaccompanied, to be unaccompanied and controlled access areas near MR scanners. And then there are level two MR personnel that have more extensive training on MR safety including the RF exposure and the gradient exposure. And so they are trained well enough to supervise non-MR personnel in those controlled access areas near MR scanners. These are specific to the American College of Radiology. There are other, you need to be aware of whatever your local, in other countries, definitions might be, like in the UK with the MHRA definitions, it might be an MR authorized person would be equivalent to a level one MR personnel or an MR authorized with training and MR safety screening would be equivalent to a level two MR personnel. Now the non-MR personnel is basically everybody else, your patients, your visitors, and your facility staff who do not have that training to meet the criteria of level one or level two MR personnel. So it's important to understand that you need that level two MR personnel to be handling your patients as they go into zone three and zone four. And who's responsible to ensure that the MR safety policies and procedures are established and maintained? The ACR manual on that is pretty clear that each MR facility will name a physician MR MD whose responsibilities will include ensuring that MR safe practice guidelines are established and maintained. And in the appendix, it goes on and when it describes the roles that the MR MD assumes overall and ultimate responsibility for MR facility operational safety. Now that said, safety requires a team and a good team at that. So they do go on to recognize that consistent with the consensus document. The ongoing management should be shared between the MR MD, MR safety officer and the MR safety expert in an advisory role. But as you're thinking about who to bring together to develop your policies and procedures, it's very important to look at other stakeholders and involve them at an early stage. And so those are the people in the desk operations, your nursing staff, your anesthesia staff that may be working in the area. The people who will be servicing your equipment and your facility, all of the HVAC and other things that you need to keep your building working well. And people from employee safety and administration are important so that they understand the importance and the costs of everything that you're implementing. And it's also good to have that broad perspective. Sometimes we become so focused on MR safety that we lose sight of the bigger picture. And so how will that change in process that you're implementing for MR safety impact other aspects of patient care? Are we missing the people who are gonna be taking care of that? And to be aware of the unintended consequences of proposed MR safety solutions, will those ultimately introduce potential other hazards that are important for infection control or interventions? And so having the correct group of stakeholders is really helpful. So when you're establishing policies, where should you get started? First, national and international standards and recommendations exist, and also location-specific regulations are there. Good places to look are the CMS conditions of participation. If your facility is participating in Medicare and Medicaid, they need to have these conditions implemented. And those recognize professionally approved standards such as the ACR standards. And so they, you'll notice that many of these, many of these issues span across all three of the groups. The ACR manual on safety then has the requirement to maintain MR safety policies and procedures and name those MRMD and MRSO people that are specifically creating the MR safety program. And joint commission also has speckled throughout their different elements of performance requirements for MR safety. There's also a federal law, the 21 CFR part 803, that if a user facility has a device-related death, that that needs to be reported to the FDA, and any serious injury in that needs to be reported to the manufacturer. So the joint commission standards are really interesting. You'll hear anecdotal stories about being cited for one thing or another. It's really important to go back to the original source and read the standards there specifically. The standards are organized into chapters. So there's a chapter on the environment of care that has a couple of elements of performance that are specific to MR safety. For instance, the institution manages MRI safety risk associated with the patient care, various objects and acoustic noise. And another one that says it manages the MR safety risks by doing the following, restricting access of everyone not trained in MR safety or screened by trained staff, and restricted access to make sure that it's directly supervised by staff trained in MR safety, and posting signage at the entrance to the MR scanner that conveys the potential dangerous magnetic fields that are present in the room. And it doesn't say anything about going through and posting a zone sign all over your facility. It just says that you need to post a sign at the entrance to the room. And so there's nothing there about fire extinguishers and the Ferris pin either. And so it's important to go back and read that. What they do say is that you need to develop policies and you need to follow your own policies. So many of the anecdotal stories you may hear may be that an institution implemented a policy and then didn't follow it. So it's important to write policies that you can follow. And then finally, they also have a nice mention of the culture of safety in their leadership chapter that the leaders create and maintain a culture of safety and quality. And that focuses on teamwork, open discussions of concerns about safety and quality, and the encouragement and the reward of internal and external reporting of safety and quality issues. To have that open dialogue within your committee members and your staff helps to constantly improve the safety environment. And then a quick mention then to designing those patient workflows to know how your patients are gonna move through the department or other departments that you may have to collaborate with to get the exam done. So to do that device investigation, to identify the contact people within all the other departments that may handle the device programming or interrogation, to get any pre-exam imaging and to identify who is responsible for that post-exam care to make sure that after the exam, the patient gets back to a safe state with their device and to do the risk benefit analysis of performing the exam. So lots of different workflows that need to be in place. So I thank you very much for your commitment to MR safety. Good morning and thank you to the organizers for inviting me to speak on behalf of the MR technologist, radiographer, manager, and MR safety officer. It's an incredibly important role for the hospital. My disclaimer, I work for the US government so these are my private opinions. And the objectives you can read online. The previous two speakers have already talked about having a safety program and how important it is to have that team out there. It is absolutely critical to do that. Your MR safety officer works under the authority of the MR medical director. It's really important to have a good conversational rapport with one another because the MRSO is the one handling all those day-to-day activities. And it's really important that if something pops up, they can go and talk to the MR safety director on that. There's also very important that you have a good working relationship with the MRSC. So the MRSC is there as that expert that helps you out with what you have to do if there's a problem that you don't understand. For the general technologist and radiographer, the annual training is absolutely crucial. If something unusual pops up in the MR safety world, it's important to get that conveyed more than once a year. The MR technologists are the ones screening the patients at the very last end. Screening happens right from the very start, but at the very end, if there's something that's been missed throughout the screening, it's really important for the MR technologist to be able to have that interview with the patient and catch those little things. Most of them aren't trained on how to follow the MR conditional implants. Sometimes there's one that pops up and they need some help from the MRSO, which is why the MRSO needs to be available. Do be aware that all of these practices, what they're called as well, technologist, radiographer, vary from state to state and country to country. So your MRSO in most places is like usually your supervising technologist, lead radiographer, MR manager, a lot of names around the world for this. If you're in a facility that has a lot of scanners and is complicated, you're gonna want a designated MRSO position because their workload is really heavy. There's lots of research they have to do. They have to be talking with their staff. They have to make sure they're trained. So there's a lot of different components going into the MRSO role, excuse me, and it's really important that the MRSO has advanced education and training and they have to constantly keep up with this education and training. Now safety starts at screening. So the MRSO really needs to make sure that the schedulers are trained on what questions to ask and to know when those patients need to be referred on to the MRSO for advanced or special care. There needs to be really good rapport throughout the entire staff because we need to make sure that at the screening position that those patients that need special care or have a device are flagged and taken care of because if they show up the day of the exam, it throws everything off and you can have an upset patient. We also have to schedule a lot of other people, anesthesiologists, nurses, sometimes visit support, cardiologists, there's a lot of different things that have to be coordinated by the MRSO. But most importantly, there needs to be a written standard operating procedure for your facility. This is gonna be the guide that allows the MRSO to practice well and this guide needs to be written with all three components of the MR safety team working together to make sure it's a solid plan, because this is the plan that's going to help guide you throughout your practice. The MRSO also needs to get educated well on how to figure out the labels that are put on devices. Some of the labeling over the years has been pretty awful, as the next seminar coming up after us is going to get into a little bit, but the MRSO really needs to have advanced training on how to figure out how to read these labels so that they're handling the patients safely. There are new ASTM guidelines coming out soon that will increase the label readability that's put out there by the FDA. Then your scanners. It's also critical that the MRSO works with the technologists to make sure that they know what mode they're in, what the different modes are, how to change them, and also how to look at the SAR and the B1 plus RMS and manipulate the sequences or the scanner in order to meet the MR safety conditions for that particular device. Some scanners have special device modes. Some have LOSAR modes, and there's a brand new MR Equipment Output Conditioning, or MROC, mode that's new this year for 1.5 and 3 Tesla scanners. There are a lot of places we can go to get additional information. I call vendors a lot. I keep them bookmarked on my computer. I can create a library, but you have to update it regularly. There's also websites and books. One of the things that we do in our facility is we post posters in our area, and inside our patient dressing rooms, we actually have it posted that they are required to change, and there is a free... All these are free on websites. We post the MR safety one on why you have to change so you don't get burned, because a lot of people come in with all this fancy athletic wear that's anti-stink, and they think they're okay. Those actually have metal. Flow sheets, check sheets. These are the MRSO and the technologist's best friends. It makes sure that you're going through the checklist with these different devices to make sure you're not making a mistake and missing an important part in these complex patients, complex devices. Have a written plan for all of this, and then also ensure that your radiographer, if they have a device or a patient that needs monitoring, that they are not alone. The MR technologist needs to focus on the scanning, and the person who needs monitoring needs to have a person dedicated with the right level of education and certification in order to monitor them properly. If you're doing any of these procedures where you need monitoring, you really should be doing a timeout prior to these getting started, and do it in conjunction with all your hospital policies. Off-label scanning is the decision of your MR medical director. Not the MRSO, the medical director. They're the ones in charge of your facility. They're the ones making the case, and they're going to be the ones helping guide you through how to scan certain types of off-label devices. Have written policies for these, and if it's an unusual case, make sure you're documenting everything as you go along. Make sure you're documenting how you screened, the informed consent. Any checklists with programming and checks afterwards that may be needed. And again, the MR technologist needs to focus on the scanning. Someone else is going to focus on the patient care part. Appropriate patient care and attention to detail is going to make the patient very happy. And one other thing, if you're doing these off-label devices, they really need to be in a hospital or medical center that has immediate emergency personnel available. Okay, summary, it's a team. So please work on building your team, having good rapport with all levels of your safety team, and with the technologists in general. Advanced training is required for your MRSO, and follow written policies and practices. Thank you. So I will be talking about probably the most variable role when it comes to MR safety, and that's the MRSE role, which is typically filled, but not always, by a physicist. So our focus here really is not about exactly how we're going to go about doing things. Again, right now, that will be in our sister section, which will be coming up in about an hour or so. So right now, I want to really focus on what we do. So as a physicist, yes, if you have a physicist in there, they can, of course, do research. And research is great, but we're talking about clinical right now, so let's talk about what clinical safety and what the MRSE's role is. So for instance, as you're putting in a magnet, it might be something like sighting and hazard walkthroughs. So for instance, we had where the hardware in the cabinets was metal, and we were considering that to be a danger, because if one of those little shelf holders came off, it could get into the magnet, and that would be not necessarily so good for the magnet. And so that was identified during a walkthrough by our MRSE. At the Mayo Clinic in Arizona, where I am, the MRSE's are very involved in the MR safety program. We have several of them on site. Some places might not have any at all, so the things I'm going to talk about today may be filled by other roles, such as the MRMD or the MRSO, more likely, in other institutions. So you could also have an image quality walkthrough or review. So an example of that might be, I'm sorry, I take that back, that would be the, I'm sorry. So you might also have a review where they were walking through, and for instance, looking at the sighting, what we found out was that there was a 480-volt line going underneath the magnet. Well, the problem with the 480-volt line going underneath the magnet was, it was going to cause a major problem with image quality every time it decided to really ramp up. And so that was identified by a physicist, and that 480-volt line was moved from underneath the floor of the magnet that was about to be put in, that way we didn't have to rip it out and then do it and put it back in again. You also have a deep dive into policy. So it's not just about compliance, but also blanket policies, and it might be done by the MRSO, but MRSEs will do a deep dive as well and try to get in there and say, okay, what are things that we can scan very safely and very easily that we see a lot within our institution? Okay, what are the special cases that we really have to do a deep dive in, make sure that we have special review on? And then there's workflow optimization. So in our hospital, we have interventional MR procedures, and the physicists were very, very involved in terms of making sure that there was a safe way to get through to move the patient between where the floral room is and where the MR room was, and making sure that all the pieces came together to be safe and effective for the patient. And you can see here, for instance, another role is doing something as simple as mapping those fringe field lines and making sure that those fringe field lines are indeed within compliance and safe for the patient. Now in device scanning in our institution, the MRSE is very, very involved, and so really it's about the complex cases. So they're gonna oversee general cases, but it's really the low SAR, very low SAR cases, the cases that have a very short amount of time in order to scan them, and that's where they're gonna get involved, making sure we're optimizing protocols and things of that nature. So you can see here on the bottom, this is a general workflow. The MRSOs are recording information. They're taking care of a lot of the day-to-day stuff. They're doing the passive implants and things like that that are a little bit easier to deal with and that we don't wanna interrupt the throughput of patients. The physicists get involved when you really need to start doing a deep dive into changing protocols and in terms of liaisoning with the radiologist to make sure things are working the way that they should for this particular patient. The other thing is that they will also get involved in off-label scanning, essentially advising on risks, not necessarily making decisions, as that is the role of the MRMD that will be talked about later. In terms of assessment, physicists in these complex sort of active implants, they have a big role in our institution. We actually developed an entire workflow manager that's internal to our hospital that allows us to get about 230 pieces of data as we're going through these different things. We start mapping it out, and you can see some things here, like, for instance, what is the typical SARS that we're seeing in our devices? And so you can see here, for instance, that once we get that, we can start developing protocols that hone in on what we need. So what are the SAR levels they have to be able to hit? Finally, I'm going to throw it over to my colleague, but we're going to do this with a question. So what do you think the average MRSE time is to assess, optimize, and oversee scanning of an on-label complex active implant? So something with a low SAR, low time. Thank you, Dr. Sensakovic. I'm Sam Fahrenholtz, one of the four MR safety experts at Mayo Clinic Arizona, and according to the data we've collected on these on-label, not off-label, it takes us, on average, about 70 minutes of MR expert time to assess. So a median of 20 minutes to assess, and about 60 minutes median to scan, average is about 70. And critically, all this work is unreimbursed, or at least unreimbursed beyond the charge you get for whatever CPT code of that exam. So the role I'm going to talk about for the expert is, when I am on-site, or in our case we also have some remote coverage, when I'm covering a case, what are the things I care about? So I care about if there's a cardiac implanted device, there's anesthesia, passive implants and shrapnel, and these sort of similar things. None of those things will necessarily trigger me to, in our practice, involve me being there in person or remotely. However, if I am working in the, sometimes it's zone two, very, pretty much the whole time it's zone three, occasionally it's zone four. When I'm in those spaces, those are the things I'm aware of. What mostly in our practice triggers my involvement at the console is monitoring active implanted medical devices. So deep brain stimulators, spinal cord stimulators, things that have reduced SAR, heating. And before the exam, I am reviewing the instructions for use, and especially if it's off-label, I'm reviewing the plan we have for that exam. The point of all that is, quite obviously, so that way I'm aware of what's going on when I'm at the console, but if you can imagine, as an MRR physicist at zone three, lots of people are interested, in my opinion, on a protocol. There's lots of opportunity for distractions. So if I have those reviewed, I'm very focused on what that exam is. During that exam, or the moments before, I'm verifying with the MRSO that the devices in whatever correct mode, whether it's off, all these devices are idiosyncratic. They each have their MR setting and so on. So I'm verifying that's set. I am verifying that the patient state, whether it's their mental state, fever, if there's anesthesia involved, that our plan is, that we're going into that, is the case when I'm there at the exam. And then also the equipment of the MRI. Is it the right magnet? Is it the right transmit-receive coil, and that kind of thing. And at our practice, you can see, sorry, the pointer's gone, but the yellow labels there are transmit-receive stickers, so that everyone can easily tell this is a transmit-receive coil, so that we're using the correct coil. Another thing, I'm verifying, I'm not doing this myself. These are our expert MR technologists doing this, but this is an example of an active device that there's an exclusion zone of where you can localize. For anesthesia and cardiac devices, I'm just one more set of eyes verifying that those policies are followed, but all that stuff is kind of figured out beforehand. I'm not there bossing anyone around. And when it comes to anesthesia, it can make things off-label if, say, there's a requirement for that device to be responsive. You also, with anesthesia, might consider taking breaks to check the skin, especially if the patient's a larger size. When it comes to the passive implants and shrapnel and so on, again, this is me relying on the screening that's what's done before, that we found out as much information about those disparate items as possible before that exam is done, and how that might involve, how that might influence how the exam goes. And thank you for your involvement in MR safety. All right, perfect. Well, thanks very much for the kind invitation, and this is great to see such a packed room for this really important, sometimes not as exciting topic, but I actually think it is really quite interesting and important. And this is something that we think about a great deal in our practice. I have had several roles involved in safety at my own institution as the MR medical director and the chair of our safety committee. And so what I'd like to do is just go through a little bit about what we've talked about today, extend that to the MR medical director, and then give you a few thoughts on an approach that you might take for actually how you might make decisions that are considered to be off-label. I have no relevant disclosures. So a few highlights here, talk just briefly about some of the roles and responsibilities of the MR medical director, talk about the concept of risk versus benefit considerations, and then the decisions that we have to make sometimes in the real world. Implants of unknown origin is an approach that we use at our institution, and I'll try to get a few principles out of that that I think you might find interesting. Now we've already talked about this particular article. It's come up a couple of times, and I would highly recommend that you take a look at it. It's only about three pages. It goes through all of the detail and the definitions of the various roles and responsibilities, and it's something that all of you who have an MR safety program should have all of this documented as well. So this is sort of one of those must-have papers. It is actually the official position of a number of societies as well, and this is going to define institutional roles and all of the responsibilities. So just talking a little bit about those roles, we've already talked about this in detail. So I'm going to be talking about the MR medical director. I also want to point out as well that the terminology from the GMRI paper also talks about the MR research director. So if any of you are running a translational imaging research center where we're not actually doing clinical care, but these really are patient human subjects, we can use that terminology as well. But for the rest of the talk, the two of these are interchangeable, but I want to point out that these guidelines and safety approaches also apply in that environment as well. We've talked a lot about MR safety officer and MR safety expert, and I'm going to focus on this here as well. So quickly, I just want to summarize some of the various roles and responsibilities. Generally, the legal responsibility for MR safety does fall on the MR medical director. Credentialing may vary, but generally speaking, it's going to be a physician who's licensed to practice medicine and has appropriate training. Operational responsibility, however, on a day-to-day basis can be delegated, and this is a really important key, is that the lines of delegation have to be well-defined between the MR MD and the MR SO and safety expert as well. A couple of the gory details that you can look up in that GMRI paper, but just to go through this again, is to either directly or through delegation is to oversee the safe execution of MRI on all of the humans, and I say humans thinking about both clinical patients and research subjects. They need to be accessible to the MR operator, so the technologist or radiographer who's actually doing the scanning needs to be able to call to access either the MR MD or a delegate, and we need to ensure that there's at least one MR safety expert available and a safety officer that's actually available to all of the systems. You don't need a safety officer on every single system, but they have to be rapidly and easily available. Ensuring that policies and procedures are up to date, developing a safety and quality assurance program, making sure that there's good record keeping of any adverse events, as well as making sure where necessary that root cause analyses are performed, and then of course having ongoing risk assessment. This is a process. It's not something that you do once and you set up. It's just something that's a continuous process improvement. So I wanted to switch gears a little bit and talk about a real world scenario, and I bet almost all of you in the room have seen this. Patient presents for MRI for cancer staging prior to chemotherapy and curative surgery, but during the safety screening they said, well, doc, I had a coronary stent that was placed two years ago, and of course there's no other information available, there's nothing on record, we don't know what kind of stent it is, and what are you gonna do? And I think most of you would probably in this situation would say, well, we're just gonna scan him. But really that is considered to be an off-label decision. And so it really comes down to a risk versus benefit, and we need to think about the potential risk of MRI, but here we are talking about a patient with cancer, and we can't do the curative surgery, we can't do the chemotherapy without staging, unless we have the information from the MRI. So it's pretty critical information. We need to remember the benefit side of this equation as well. So how do we make decisions with incomplete information? And this is really a common theme of medicine in general, but I do want to point out that a lot of times you do have some information as a coronary stent placed a couple of years ago. Those are two very important pieces of information. So there's several scenarios that are relatively common, and I think it's important to think about these scenarios. For a patient who might have some sort of implant, but we don't know what it is exactly. We might know what it is, but there's no safety data that's in the literature, but there might be good reason to think that it might be safe, but we just don't know. A patient who might be found down and unconscious. We need to screen that patient. Perhaps they need a stat brain MRI. What are you gonna do? How do you know that they don't have a pacemaker, for example? And also if the clinical need to obtain the diagnostic information outweighs the potential risk, and this is really what led to some of the guidelines, for example, for defibrillators and implanted pacemakers. One of the things I really would advocate for, I'm a very process-oriented person, is to develop a standardized approach, because what you don't want is radiologist shopping. Well, this radiologist said the patient can't go in the scanner, and then the surgeon keeps looking until they find a radiologist who says it's okay. That is something that you absolutely want to avoid, and even though it is ultimately up to the MD, we want to make sure that we're not getting into that very detrimental situation. So we've developed an algorithm that we refer to as metallic implants of unknown origins. A few principles to consider. First of all, you always need to do your very best to have a good faith attempt to find about the identity of the implant, and then follow the guidelines that are in the literature or in the package insert. But we all know that this fails sometimes. And so developing a standardized approach based on typical scenarios. So for example, a common class of implant. So with coronary artery stents, we've investigated this. All implants that are available in the last couple of years, generally speaking, are going to be safe, perhaps at 1.5 Tesla. And you can go through these various scenarios. If a patient is found down, how do we exclude metallic implants? Use radiography. It's a great approach. And I don't have time to go into all of these different things. I do want to just give one slide. These are the common classes of implants that we use at our institution. And there's a lot of literature and research that goes in behind these. I can't talk about all of these in detail, but IUDs are common, orthopedic hardware, coronary artery stents, other types of stents, cardiac valves, some of which are contraindicated, some of which are not. IVC filters is an interesting topic in itself. Non-neuroembolization coils, different stimulator devices that we've talked about, neuroembolization coils have special nuances as well. Shrapnel in foreign bodies, this might be important if you work at the VA, for example. Unresponsive patients, I have 13, so you can take your picture when you get to number 13. And then otolaryngological implants, like, for example, scleral buckles. And here's number 13, so here you can take your picture, is metallic implants. And so, for example, if it's jewelry, and it's a ring, and there's a high risk of this could cause a burn, it needs to come out. On the other hand, if it's a cardiac pacemaker, you're obviously not going to be removing that. And just a couple of other thoughts for you in the last few seconds here is that a previous MRI does not clear a patient for future MRI, just because they have a metallic implant. Oh, well, doc, I had an MRI two years ago, so I should be safe. That is not sufficient, because just because you walk blindfold across a freeway once does not mean you're going to make it again next time. Couple of other quick thoughts as well, caregivers with unknown implants probably should not be going into the scanner room. Research subjects, unless it's related to the research, we're generally not going to allow those subjects in. And you might want to consider other modalities as well. And in some cases, and here's one that I don't want you to forget, you can actually remove the implant sometimes. So jewelry is an easy example of that. Of course, you're going to remove the jewelry. But sometimes there are other implants that if they're not being used, for example, or if you have an IVC retrieval clinic, you might actually consider doing that before the patient gets their MRI. And so with that, thanks very much for your attention. We've talked a little bit about roles and responsibilities of the MRI medical director, some safety data, some concepts of implants of unknown origin. And thank you very much for your attention.

MRI safety program

non-ionizing radiation

MRI projectile incident

safety guidelines

magnetic field hazards

multidisciplinary safety team

patient screening

safety culture