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MRI Safety

By Matt Skoufalos

For all the benefits associated with magnetic resonance imaging (MRI) technology, the modality is largely safe and effective, albeit not entirely risk-free. Although it’s been 20 years since a litany of institutional failures led to the death of six-year-old Michael Columbini while he was undergoing an MRI at Westchester Medical Center in Valhalla, New York, procedure volumes continue to increase annually as MR systems likewise grow in complexity. As both patient volumes and the underlying technology that supports them advance, some observers within the medical imaging space argue that the safety measures associated with MRI should be tightened up at the same time.

In exploring the depth of this need for increased safety metrics around MRI, Tobias Gilk, founding principal of Gilk Radiology Consultants of Overland Park, Kansas, posits that observers should consider the framework within which MRI technology has evolved in the past two decades or so since Columbini’s death.

At the turn of the century, Gilk noted, an MR device with a 3-Tesla magnet would have been available in “ivory-tower research [settings] only,” whereas today, 3T scanners represent the fastest-growing segment of the clinical market for MR. There are also systems built around magnets more than twice the strength – in 2020, researchers in the UK worked to harmonize neuroimaging sequences and protocols across five sites using 7T scanners – in dozens of clinical settings around the world.

“I think we easily overlook the technological, operational and clinical changes that have taken place in MRI, the overwhelming majority of which increase the risks [related to the modality],” Gilk said. “We’re emphasizing faster acquisitions and greater signal-to-noise ratios, which all mean greater radiofrequency (RF) energy. We keep pushing not only what is minimal but what is feasible in a current hardware system.”

The increased power and intensity of the MR systems of today also brings with it increased risks of adverse effects as compared with the market-available systems of 20 years ago. More intense time-varying gradient energy yields greater potential for peripheral nerve stimulation, and increasing use of RF energy for scans corresponds with FDA reports of patients encountering tissue burns. Other patients have reported concerns ranging from tinnitus, which can occur due to the volume of mechanical noise produced during an MRI study, or physical discomfort from pinching or compression of the patient during positioning in the unit.

The power of an MR magnet can also generate energy fields that can produce additional complications for patients, be they related to implanted medical devices, foreign bodies embedded within the skin or other metallic objects drawn into the magnet. Dr. Emanuel Kanal of the University of Pittsburgh Medical Center, who’s studied extensively patient safety vis-à-vis MRI studies, noted in a 2014 American Medical Association commentary on MR interactions with cochlear implants that “what may be considered safe by some may well be unsafe or unacceptable to others” — a reminder that patient cohorting across a variety of categories is a necessary pretext to any imaging study.

“Not only are the magnets and the system hardware producing additional risk, if we’re doing the same study we did 20 years ago, the likelihood the patient has complications based on what’s in their body has increased,” Gilk said. “Today we’re seeing MR used as a stroke assessment tool for cord compressions, for emergent and urgent scans, for post-surgical patients. The patient cohort for MR has shifted quite rapidly.”

Gilk also notes that, concurrently with that shift, reimbursement rates are plummeting, leading to an increase in less-experienced MRI technologists – or simply fewer techs – on the job. He fears that a reduction in the patient-care supervisory capacity or knowledge of the people who comprise “the boots on the ground in charge of implementing MR safety” is another cause for concern about patient safety.

“The accumulation of all of these minor risk factors, and the compounding of risks; when we begin multiplying these small incremental risks together, things can change in terms of a risk profile fairly significantly,” Gilk said. “The idea that MRI is today what it was 20 years ago is a mythology that we need to shatter, and we need to look at MRI in 2022 with a very different set of perspectives than we did 20 years ago.”

To Gilk’s thinking, health care professionals have embraced their own narratives about the relative safety of MRI technologies over other forms of medical imaging (largely on the basis of its lack of exposure to non-ionizing radiation) so much so that raising questions about improving MR safety can become questioned as a waste of time and effort. But without dedicating a comprehensive, professional-driven response to specific responsibilities around the use of MR, he fears the problem will continue to be compounded.

“The PR campaign that MRI is ‘the safe modality’ has been so effective historically that it runs the risk of making MRI dangerous,” Gilk said. “People can’t get past the branding of MRI as ‘the safe modality’ to recognize the ways in which it is distinctly different [from other forms of imaging].”

“Our organizations as much as, if not more than, anybody else have bought the PR campaign hook, line and sinker,” he said. “Today it boils down to the individual MRI provider to follow best practices or not. It’s entirely possible for a facility to be accredited, and follow each of the explicit criteria [for MRI safety], and be an environment where dangerous and deadly accidents can happen. Despite the fact that we know how they occur and what would prevent them, those preventions aren’t actually explicit criteria in accreditation standards.”

Gilk argues that although “ionizing radiation in the clinical setting has been dropping like a rock for the last 25 years,” MR technologies have seen steady increases in adverse patient effects over the last two decades at about two to three times the rate of growth of MRI procedure volume. To him, that suggests that, in the past 20 years, more patients are experiencing adverse effects as a proportion of total patient volume just in terms of raw numbers. According to his analysis of FDA adverse event reports, 100 to 200 such events are catalogued as MRI-related; however, those reports may be limited or confused by the classification process that could attribute such an event to an implantable medical device, for example, rather than to the imaging system.

“It’s anathema to think that the more experience we get, the more knowledge we have, the more published papers and accounts of accidents and events, the worse we do,” Gilk said.

Gilk posits that “the notion that everybody is responsible for MRI safety” has created a broad culture implying that “someone else will pick up the slack.” In the absence of clearly designated roles and responsibilities – having a certified MR Safety Officer (MRSO); enacting clinical policies, procedures and practices around MRI safety – can give individuals “both the responsibility and authority to make choices in furtherance of MRI safety,” and thereby drive improvements that create a safer environment. Including that as a requirement in other accreditation surveys is another way to certify those considerations are being made.

“If I could write a dozen performative rules for MRI safety that everybody, whether they bought into them or not, could understand and perform on a case-by-case basis, I would do that in the snap of a finger,” Gilk said. “I think we put too much hope and expectation in a culture change alone in terms of what it can do, or that it’s the only legitimate way to go about making these changes, when there are these rather straightforward implementable steps that could be taken that could pretty significantly reduce the most preventable types of harm.”

“We keep kicking the can down the road on things that could be, should be, effective preventions,” he said. “Let’s not fail to act on the simple-to-resolve questions because there are complex questions lurking out there.”

Angelic Bush, radiologic director at the University of Texas Medical Branch (UTMB) in Galveston, Texas, said that as MR utilization continues to increase considerably, so too do the operational challenges around its safe management. To Bush, policies by themselves aren’t sufficient to intercept potential problems. Instead, she said, effective MRI safety requires “hard stops” in the clinical setting, including holding patients to strict boundaries “even if it’s a dissatisfier.”

“I see the most near-misses at the external-to-the-patient clearance,” Bush said. “It’s the devices that go in, the clothes they’re wearing, the lead the nurses didn’t remove attached to their original gowns. We’ve got an uneducated patient base, and we need to hold the line.”

To Bush, one of the most significant needs prior to an MR study is for patients to don dressing gowns. Even if patients remember their pacemakers, or the shrapnel in their knee, if they don’t strip down completely, they could be at risk from the very fibers in their clothing, which have become more complex as 21st century textiles have evolved, and may include elements that can interfere with the operation of the magnet.

“One-hundred percent removal of all garments is absolutely critical,” Bush said. “There’s so many materials now that patients have no idea about. Your jogging pants may have metallic fibers woven in.”

Bush said that further complications can arise from extra-departmental staff entering the imaging suite to retrieve a piece of equipment, or to leave something behind. She described striping the devices with tape in a candy-cane fashion and tethering it to the wall with clear plastic loops to create visual cues that it must remain where it is. Nonetheless, she’s encountered the occasional confusion with staff who may be following their own protocols for equipment management.

“We are religious about training our anesthesia and MRI team, but respiratory might not understand what the line on the floor means,” Bush said. “By tethering it to the wall, we keep them from moving it further than they should. Some of the carts aren’t MRI-safe; they’re MRI-conditional, and they can only come within so many feet of the magnet.”

Bush said she’s also “stopped a lot of near-misses that the patients themselves are not aware of” by ensuring that technologists consider the entirety of their patients’ medical imaging histories, as well as holding to an internal MRI safety document that recommends two staffers per scan to avoid problems related to fatigue or being overworked.

“The 2020 ACR MRI Safety Manual has finally put teeth behind safe staffing per scanner by changing the word recommended to MINIMUM! Without that every institution across the country continue to fight productivity standards of only one person per scanner. This is a huge step forward and we must fight to enforce this,” Bush said.

Along the same lines, UTMB has an MR safety officer (MRSO) for the entirety of the health system, which creates a shared resource for every technician who has a concern or question.

“Instead of every MRI tech doing their own research for every patient, they send the MRSO a message, and he can access the images and talk to the faculty immediately,” Bush said. “We standardize it through one filter so we have consistency in how patients are being screened because not every tech does it the same way.”

Despite the risks implicit in an MR study, radiologist Dr. Thomas Gilbert, MRSO and chief clinical officer at Rayus Radiology of Minneapolis, Minnesota, believes it remains “the best modality for numerous conditions,” and that the responsibility for safe utilization of MRI rests solely with the imaging center and radiologist performing the imaging study – “not on the referring doctor, and not even really on the patient.”

“It’s our responsibility to make sure the patient gets their imaging in a safe environment,” he said. “Patients are counting on us to ensure their safety.”

To provide that level of patient safety, Gilbert said Rayus follows MRI safety guidance that he authored two years ago, and policies that were updated even more recently. Its technicians complete MRI safety courses, an MRSO is appointed at every location, and each group includes a physician MR safety officer and an MR safety advisor, which adds depth to its safety protocols.

In addition to offering access to a variety of medical imaging modalities, Gilbert believes that imaging professionals must also command a fundamental understanding of physics in order to cultivate the highest standards of patient safety.

“You’ve got to know what are the dangers and how did the dangers come about,” he said. “Say you have a gunshot wound that left bullet fragments in the body. You’ve got to figure out, is that ferromagnetic? Is it near a vital organ? Is it smooth or sharp? A round BB in the middle of the muscle might be OK. A piece of jagged shrapnel sitting next to an artery or a nerve, that’s not OK.”

In addition to stringent in-house protocols and a solid understanding of medical physics, Gilbert said imaging staff must be trained to navigate the thorny process of gathering information from patients. Relying on patients’ memories or anecdotal experiences of prior MRI studies is insufficient, he said; moreover, those risks can be compounded in different imaging environments.

“The number of implanted devices, electronic and non-electronic, is proliferating,” Gilbert said. “We’re continually running into new devices that may not even be tested. We check and re-check with patients to make sure that they don’t have anything in their body that they were not born with.”

He described the “different flavors of mistakes” associated with different imaging environments, from outpatient medical histories to interdepartmental crossover concerns in inpatient settings.

“In the hospital, there’s another whole level of issues because when a patient comes down from a floor, they may have catheters, assisted ventilation devices, electronic monitors for their heart or oxygen levels,” Gilbert said. “Those all come down with cords and wires and monitors. You’ve got to make sure that you have an MR-safe way to scan those patients.”

In each of those settings, Gilbert said, the most important takeaway is a necessity for safety protocols and systems that rely neither on patient memory, nor on the referring physician’s understanding of medical imaging modalities, but upon a chain of professionals following proscribed guidelines.

“You can’t take the word of anybody that something is safe,” he said. “You have to have the documentation in there. You need a team of people.”

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