Fatal accident calls MRI safety standards into question—are more regulations needed?

A man in Brazil recently passed away of the injuries he sustained in an MRI suite when the magnet’s powerful pull caused his gun to involuntarily discharge and shoot him in the abdomen. After news of the event began to circulate, many questioned how such an accident could occur in an MRI suite in the first place.

Between screenings with MRI techs prior to exams, contraindication questionnaires and multiple warning signs prohibiting the presence of metal near the scanner, how did a loaded gun make its way into an MRI suite?

It is important to note that man involved in the accident was not a patient, but was instead assisting his mother, who was the patient. It also merits noting that the facility where the accident occurred followed safety precautions and screened both the man and his mother for the presence of metal, receiving signatures from both assuring that they understood the dangers of having metal within the magnet’s reach.

The incident could easily be described as a “freak accident,” but it is hardly the first serious safety event to occur within an MRI suite. It has, however, prompted renewed interest in MRI safety.

Health Imaging spoke with an expert in the field to get a better understanding of the overall state of MRI risks and safety, as well as how it can be improved to prevent future accidents. Tobias Gilk, MRSO, MRSE, senior VP of RAD-Planning and founder of Gilk Radiology Consultants, told HI that although there have been many advances in healthcare technology intended to promote safer patient environments, he feels like MRI safety risks are even greater today than they were decades ago.

What are the MRI safety risks?

There are numerous medical devices that are subject to malfunction when in the presence of a strong magnetic field, such as pacemakers, aneurysm clips, neurostimulators, certain medication pumps and other medical implants. For decades, patients with these sorts of devices rarely made appearances in MRI suites without prior approval and physician clearance, as a scanner’s magnet can interfere with their devices’ function and cause bodily harm or even death.

Until recently, this was a firm rule, but advances in medicine and technology have resulted in numerous exceptions to the “no implants or metallic foreign bodies inside the suite” rule.

In fact, some of these devices are now considered completely safe, depending on their vendor and manufacture date. The same goes for pacemakers—many newer models are now classified as MRI-safe due to recording zero adverse events during clinical trials. Although such updates are positive, they require techs, providers and patients to do a double-take on device compatibility during screening processes.

"The complexity of our patient population has grown enormously in the past couple decades, and the consequences of MRI interactions with old aneurysm clips, or newer wearable insulin pumps, couldn’t be more serious," Gilk said.

There is also the issue of metal objects turning into projectiles in the suite. There have been several incidents throughout the years in which these projectiles have resulted in serious injury and even death. This is why facilities have restrictions on medical equipment like oxygen tanks, stretchers and wheelchairs in the exam room. MRI magnets are powerful enough to velocitize a steel oxygen tank and send it through a cinderblock wall.

But what about less intimidating things like athletic shorts and yoga pants? At first glance, these items seem MRI-friendly, but some could contain metallic threading, which could heat up and burn patients during their scans.

Burns actually are the most common injury that occurs during MR imaging. According to the U.S. Food and Drug Administration, between 2008 and 2017, such burns accounted for 59% of MRI safety events.

And then there are things like hair extensions, permanent makeup, false eyelashes, permanent jewelry, etc. The list of items that could pose risks when in the presence of a strong magnetic field is a long one for techs and patients to keep track of, and it is subject to constant updates.

Safety inconsistency a concern among MRI experts

While it may seem simple enough, the “no metal in the MRI suite” rule does not account for a general lack of awareness pertaining to the material makeup of objects coming within close range of the magnet. This is why patients are asked to remove all clothing, jewelry and applicable medical devices prior to their exam. Most (but not all) facilities require their patients to wear nothing but a hospital gown during their scan. However, these practices are not consistent across the board, which is another big concern among experts.

Gilk suggests that this general lack of consistency could be due, in part, to a lack of minimum safety standards.

“There really is a great body of existing best practice knowledge which, if we followed it, could make MRI much safer,” Gilk said. “But the organizations who set the minimum standards at the point of care (state licensure, accreditation organizations, CMS ‘conditions of participation’) have repeatedly failed to make these minimum standards.”

MRI operator requirements to improve safety

For MRI exams to be conducted safely, a number of things must fall into place—equipment needs to be properly maintained and operated, techs need to be thoroughly trained and knowledgeable of MRI safety and risks. Providers need to be well versed in contraindications and patients need to be briefed and screened for anything that might put them or the imaging staff at risk. These aspects are critical, yet their consistency varies.

For example, take the education and training of MRI operators (the technologists) into consideration. Their qualification and training requirements vary across the U.S. In some states, the only requirement an individual must meet to conduct MRI examinations is that they be a registered radiologic technologist—RT(R). However, this title does not necessarily include MRI-specific training, but rather an introduction and exposure to MRI environments, scans and safety. This title also does not require techs to have completed MRI-specific clinical experience rotations or to comp different exams (lumbar, extremity, abdomen, etc.), nor does it require techs to pass MRI boards.

Although the American Registry of Radiologic Technologists does have such education, clinical experience and ethics requirements included in its pathway to MRI board eligibility, many states do not require RT(MR) credentials to operate MRI equipment. As a result, relevant education and training among MRI operators varies widely across the country.

Facility-level requirements to improve MRI safety

Then there are facility-level safety precautions. While facilities are given a lengthy list of best practice recommendations to guide their site's policies, the list containing actual concrete requirements relative to MRI safety is a short one.

MRI scanners are subject to the FDA’s Federal Food, Drug, and Cosmetic Act and the general requirements of their Electronic Product Radiation Control provisions. But the first of the aforementioned does not regulate safety at the point of care, and the second has little to do with MRI given that MR scanners do not emit ionizing radiation. The agency recognizes voluntary consensus standards, such as the risks of magnetically induced displacement on medical devices, radiofrequency-induced heating near implants and safety assessments for patients with medical implants, etc. But these are simply an acknowledgement of standards, rather than a mandate requiring facilities to implement actions to prevent such events from occurring.

Though the American College of Radiology has ample data and best practice guidelines on MRI safety—more than 140 detailed performance statements on the topic—its input also stops short of specific MR accreditation program requirements intended to prevent injury.

The Joint Commission has what is perhaps the most specific accreditation criteria. In 2015, The Joint Commission released its Revised Requirements for Diagnostic Imaging Services, which contains a list of patient safety risks and minimum requirements relative to access to the MR scanner room. The document also requires that safety zones accessible to patients contain signage that designates restricted areas and conveys the dangers of strong magnetic fields.

The Joint Commission also requires that facilities have their MRI techs complete an annual MRI safety training course, but the contents of the course are largely left to facilities' discretion.

Both the Joint Commission and the ACR have policies in place pertaining to MR techs training on the dangers of burns, but neither specify preventative actions, such as providing padding between patients and the bore wall during studies, which is recommended by most MRI manufacturers.

MRI safety recommendations are not the same as safety standards

Gilk notes that although there are a number of well-intended recommendations that could prevent injuries, stopping short of mandating standards fails to address patient safety concerns in a serious manner.

“The existing best practices that we know would prevent MRI injury accidents, such as requiring padding of patients, or requiring the use of ferromagnetic detectors, or suites that provide 4-zone access controls, aren’t minimum performance requirements under existing hospital or radiology accreditation programs,” Gilk said.

The good news is that the majority of MRI exams are event-free and the safety events that do occur are largely preventable. But Gilk suggests that if best practice recommendations were to become requirements for accreditation, there is even greater potential for accident reduction.

Hannah murhphy headshot

In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.

Trimed Popup
Trimed Popup