By Matt Skoufalos
The conventional wisdom associated with magnetic resonance imaging (MRI) is that it’s a safer imaging modality than computed tomography (CT) or X-ray because it doesn’t rely on exposing human tissue to ionizing radiation. However, that doesn’t mean that MRI is a completely benign modality, or that there aren’t safety concerns and contraindications for patients prescribed an MR study.
Kimberly Love, vice president of the Nashville, Tennessee-based radiology consultancy Regents Health Resources, spoke about the variety of practical considerations associated with safely providing MR services. The principal resource for guidance managing those risks is provided by the American College of Radiologists (ACR) Manual on MR Safety.
The 2024 edition of the ACR Manual on MR Safety recommends establishing a well-defined organizational structure for MR safety, designating key positions within an imaging facility. Those include a Medical Director for MR Safety (MRMD), MR Safety Officers (MRSOs), which ACR notes “are often highly trained technologists,” MR Safety Experts (MRSEs), “who are typically highly trained medical physicists,” according to ACR. These roles ensure compliance with safety protocols, training, and risk mitigation strategies.
“If I were the MRI Safety Officer, my responsibilities would include ensuring that departmental policies and procedures align with ACR and FDA recommendations and guidelines,” Love said. “This would involve developing site-specific protocols and screening procedures and keeping them consistently updated.”
Those procedures encompass onsite safety and training mechanisms, personnel education, including that of non-clinical staff as well as architects and engineers who design imaging facilities. More specifically, they also include the four ACR-designated safety zones in an imaging facility, their classification, meaning, and how to educate patients and visitors about their significance in context.
Maintaining rigorous screening protocols for patients, staff, and visitors with ferromagnetic safety screenings and access restrictions involves creating proper signage, barriers and checkpoints, as well as maintaining MRI accessories so that they preserve their MRI safety performance characteristics.
“You need to ensure compliance with these protocols and establish a reporting mechanism for safety incidents. Additionally, an action plan must be in place to address and document these incidents effectively,” Love said.
“You need to coordinate an emergency protocol and what that would look like, and then you would have to have detailed records for the absolute and relative contraindications of patients for anything on or inside their body,” she continued. “If you set your information responsibly and correctly, I do believe you will cover all the protocols and safety procedures, adhering to those zones as they’re supposed to be.”
These precautions are established to mitigate risk of unnecessary exposure to radiofrequency (RF) fields and magnetic time-varying gradients, which are created during an MRI study, and can affect the body in different ways. Objects containing even small amounts of metal can be attracted by the magnetic fields, have induced electrical currents from the time-varying gradients, and radiofrequencies can heat them up to the point of damaging tissue.
Part of the challenge in conducting a rigorous screening process for mitigating patient risk lies in the number of unknown contraindications from materials that could have a negative interaction with the RF fields and magnetic gradients. Some of those items are more easily identifiable – removing piercings or body modification elements, keeping metallic items out of the magnetic field – and some are not.
“To me, there’s two types of contraindications,” Love said: “the absolute ones that can’t be removed, like implantable medical devices, and the relative ones that people do to themselves – foreign bodies, tattoos, fingernail polish. Beyond that, you have [gadolinium-based] contrast injury.”
“The time spent screening a patient before an MRI is appropriately emphasized in these new safety codes,” she said. “Since the magnetic field can alter blood flow, it’s important to inform patients about potential side effects like dizziness, nausea, or rashes. Additionally, those sensitive to noise may require earplugs or noise-reducing headphones to prevent discomfort or adverse reactions.”
Francisco Rodríguez-Campos, Principal Project Officer I for Medical Imaging and Device Safety at the nonprofit ECRI of Plymouth Meeting, Pennsylvania, said that current best practices in MRI safety involve assessment tools to determine whether certain implantable medical devices can be scanned safely. Some manufacturers publicized this information in an organized fashion, but not all, Rodríguez-Campos said. Presently, however, most vendors have built in solutions in their scanning software to check for such elements.
“I am happy that almost all of them, if not all of them, have some sort of application that we’ve seen included as standard,” he said. “Since 2011, implant and device manufacturers should provide some information to you about what conditions made it an MR-conditional device; what are the magnetic field limits. That’s great because it’s an extra level of safety for the technician. It’s giving them more information that they can scan this patient safely.”
Rodríguez-Campos said that the safest point from which to begin contemplating MRI compatibility is to consider “anything that you put in your body” to be an implant, while noting that some are removable, and others are not. The list continues to grow beyond medical devices to cosmetics, augmented clothing fabrics, and even body art.”
“Something that nobody has thought about is fake eyelashes,” Rodríguez-Campos said. “I didn’t realize that some of those have magnets, or maybe some metal. There was one or two cases where they flew out.
“It’s a lot of stuff that you don’t think about,” he said.” “A bra underwire, you have to take it out. In the last couple years, many people are wearing leggings with copper in them, or silver. The metal won’t pull out, but it could warm up, and that’s why the recommendation is that if you have no idea about your clothing, the best thing to wear is a gown that you know is safe.”
Rodríguez-Campos also described less-common incidents that nonetheless have resulted in tragedy. In January 2023, a Brazilian lawyer and pro-gun advocate failed to disclose that he was carrying a concealed weapon into the MRI room. The magnetic field ripped the gun from his waistband, and it discharged into his midsection, fatally wounding him, The Independent reported. Something similar happened in June 2023, when a 57-year-old woman did not disclose that she had a concealed firearm on her person during an imaging study. According to a report filed with the U.S. Food and Drug Administration, the gun was pulled into the MRI magnet and fired a single round into her backside. In October 2023, a botched police raid on the Noho Diagnostic Center in Los Angeles, California led to a damaged MRI scanner when an officer ignored postage signage and took his rifle into an MRI suite, where it was pulled to the equipment, and damaged it, The Merced Sun-Star reported.
To safeguard against events like these, Rodríguez-Campos said, facilities are investing in door locks that won’t open if an embedded metal detector is triggered. Others are employing handheld wand detectors to make final checks of patients entering the study suite.
Still other guidance changes reflect the increasing strength of static MRI magnetic fields and their effect on implantable medical devices, namely, inadvertently activating them. Revised standards from the International Electrotechnical Commission (IEC) have changed the safe distance from an MRI magnet from a 5 to a 9-gauss standard, which means that patients can be closer to the magnet without fear of their devices malfunctioning.
“Magnet fabrication is better; shielding is better,” Rodríguez-Campos said. “Magnets are more homogenous; their fringe field is more stable. It may make an impact in new facilities.”
Rodríguez-Campos said there’s less information available about how implantable medical devices are affected by 7-Tesla magnets, which heretofore have been used mostly in research environments, but which slowly are gaining broader clinical application. Likewise, he foresees the increasing application of remote scanning environments as coming to the fore of future safety conversations.
“That’s another important thing, because remote scanning requires a lot of other considerations, not just about the capability of technicians, but you also have to have a very reliable connection onsite,” he said. “I’m glad a lot of places are adopting an MRSO onsite, and of course there are training requirements for personnel, which are very high. This changes from state to state, too.”
Anticipating the future of MRI safety challenges involves more inclusive contemplation of patients and the accessibility of MRI, said MRI Safety Consultant Tobias Gilk, founder of Gilk Radiology Consultants of Overland Park, Kansas, and senior vice-president at Radiology Planning.
As of January 1, 2025, six new Current Procedural Terminology (CPT) codes for MRI safety services – 76014 through 76019 – offer enhanced reimbursement for providers who are taking extra MRI safety precautions for their patients. To certify that a patient with a pacemaker who is registered for an MRI study can undergo a scan safely, imaging teams might need to track down medical records from out-of-state or out-of-network institutions. They might need to contact the manufacturer of a specific device, or work with a radiologist to develop a patient-specific risk assessment or risk mitigation plan.
“These are not your meat-and-potatoes, everyday patients,” Gilk said. “These are patients who typically require more time, energy, and effort to be able to effectively scan. Previously, people were paid the same amount no matter what; now, if you’re doing extra work to be able to image this patient, there are extra dollars for you.”
Gilk also pushes back against the “bumper-sticker slogan” that MRI safety is a collective responsibility on the objection that it, perhaps counterintuitively, allows for the work to fall through the cracks.
“When we democratize safety to the point of saying it’s everybody’s responsibility, it becomes the world’s largest group project,” he said. “If you’re having a bad day, you can kind of check out because everybody else is going to cover you.”
“One of the critical elements of MR safety is that we name individuals who have specific responsibility and authority for patient care,” Gilk said. “We don’t do that to say ‘only these people need to worry about it,’ it’s a structural recognition that if we don’t have somebody specific in charge, we have nobody in charge.”
Related to that argument is Gilk’s critique that point-of-care-related MRI safety aspects are still fairly gently regulated. As important as the work of standards accreditation groups and credentialing organizations has been, those bodies either lack the authoritative capability for meaningful corrective action, or the nuance of appropriate responses to safety concerns.
“CMS (the Center for Medicare and Medicaid Services) has the power to do a bunch, but one of the problems is they have one ginormous stick to kick people out of reimbursements,” Gilk said.
“That is so impactful and disruptive to people’s ability to access healthcare that nobody wants to do that. You have these polite suggestions, and the nuclear option, and nothing in between, and it allows the cowboy providers to keep being cowboys.”
Moreover, the depth and complexity of potential patient contraindications for MRI has only broadened over time. Industry-wide, a rough calculation holds that between 30 and 50 percent of all MRI patients have a device, piercing, or tattoo that would be contraindicative of imaging or would complicate an imaging study.
“That has shifted the burden to technologists,” Gilk said. “Throughput has to be accelerated, and they have to identify and verify any of the things that is related to the workload of safely scanning MRI patients. Even if we hadn’t ramped up throughput and safety expectations, the safety-related workload has increased enormously for MRI technologists primarily, and it’s a blessing and a curse.”
“The blessing is there are all of these patients who for years were turned away from getting MRIs who can actually do this; the curse is, especially in a time of declining reimbursement, this is a case of do more with less,” he said. “It has been this Sisyphean task of rolling the boulder up the hill, and it just keeps getting harder each and every day based on the proliferation of implants and devices.”
Patients with complex medical needs who present for imaging studies would also benefit from greater coordination of their cases with other practitioners, Gilk said, but those “are difficult conversations to get started.
“The perfect metaphor for MRI safety is the frog in the boiling pot,” he said. “It has been a very slow warm under the pot that the frog is in.”
“Everything that leads up to the act of putting the patient on the table and hitting the scan button has been changing around us,” Gilk continued: “image-guided biopsies, more pediatric patients, which means greater sedations; post-op checks for neurologists within six hours of a procedure. No one of these things is unreasonable, but you take these little things and start adding them together, and what we have done is create a more complicated risk environment.
“How do we broach this subject about the need for an interdisciplinary approach that goes against the model that has been forever?” he asked. “There is an inherent resistance to building the collaborative structures that are really necessary to managing patients’ needs of today. It can be a real uphill battle, and it takes establishing buy-in.”
Beyond making small, immediate, tactical choices to resolve ongoing collaborative issues, Gilk said that imaging departments must partner with other specialty practitioners to find common solutions that affect the overall operation of a healthcare facility. Unless sites that deal with more complex patient-care setups are willing to rethink their processes holistically, those challenges will persist.
“If all you ever make are tactical, putting-out-the-fire decisions, you will never have a system that is as safe as it could be in terms of delivering care,” Gilk said. “Because we’ve developed MRI organically, there’s never been an external thing that has happened that has really caused hospitals and imaging providers to completely reimagine how they provide service.”
“We’ve done it incrementally, but when you think systemically about MRI services and patient access and safety and those sorts of things, you can begin to build some remarkable systems.”
