Regardless of how many new regulations, recommendations, suggestions, policies and procedures, and common-sense knowledge we implement, MRI safety accidents continue to increase. Some are startling. How is this happening? Are we so overworked, short staffed, and burned out that we have let our defenses down?
FDA regulations for reporting MRI accidents do not require reporting unless a patient or others are harmed.
In accordance with 21 CFR 803.30 (a), user facilities must submit an adverse event report to FDA and the manufacturer within 10 working days of becoming aware that:
- A device has or may have caused or contributed to the death of a patient at the facility
- A device has or may have caused or contributed to a serious injury to a patient at the facility.
Many interpret this further as a patient must be hospitalized for the accident to be reported. This has led to most of the reporting being anecdotal and never officially recorded – except on social media.
The most astonishing accident happened in January 2023 in Brazil, where a Brazilian lawyer died of injuries he sustained after he was shot by his own 9 mm handgun which he carried into the room. He was accompanying his mother during her MRI scan when his gun was pulled into the magnet and discharged. Both he and his mother signed forms acknowledging they understood the magnetic dangers and had removed any metallic objects.
Visitors to the MRI department pose a significant threat as they have not received any safety training. And first responders, like firefighters, security guards, and prison guards, in addition to family members, are another concern. We must defend against our own healthcare professionals and facility employees. Even our safety and technical engineers can be fooled, as was demonstrated recently when one engineer was working with equipment deemed MRI safe and the bolts/screws in the equipment detached themselves from the equipment – striking him in the face and shattering facial bones.
Recommendations have been made for two MRI technologists to be assigned to each unit, assuring an MRI safety trained technologist will be at the equipment to prevent entry by unauthorized or unknowing individuals. This was recently demonstrated at the Arizona Department of Corrections when the only MRI technologist on duty was called away to assist the CT technologist, and an armed prison guard entered the area with his shackled prisoner. Both were injured and pinned to the magnet.
Many of the accidents reported on social media involve hospital personnel who should have known the rules for magnetic safety. Many of these accidents can be attributed to a phenomenon called “perceptual blindness.” It is a reality that when an individual is surrounded by a normal situation, he sees what he expects to see. It is a documented problem with lifeguards who must be trained to see the body at the bottom of the pool. It is a problem with soldiers who are trained to look for the “bad guy” and miss seeing the bomb in the room. Misinformation, lack of information, and perceptual blindness can lead a healthcare worker to miss the obvious.
Evidently licensing and accreditation are not insurance against safety issues. It requires a commitment to safety and training. The elements of responsibility for safety cannot rest on the shoulders of a single MRI technologist. There must be structure, supervision, management policy, regulation, and diligence. I have included a few anecdotal pictures from social media chronicling the most recent events.
Since We Were Gone – April MRI Safety Events Update Reported to the FDA
In the April FDA reports there are reports of burns, the butt plug projectile, the service engineer injured trying to pry a walker off the magnet, hearing damage to a patient not shown how to properly place foam ear plugs, a patient death associated with a defib patient who died during MRI, a service engineer injured when a magnetic part of a table assembly came loose during servicing, and magnetic displacement of a cochlear implant.
In case you missed it on Twitter, the story of the butt plug in the MRI field has been reported to the FDA as an injury to the patient. This, obviously, will generate another question on the MRI screening form about unusual artifacts in your body. The realities grow grimmer every day.