MRI safety standards have been comprehensively developed over 25 years, but they remain largely voluntary in the U.S. This podcast series wrap-up explores the most pressing problems in MRI safety today.
Key points
- It is unclear whether federal agencies such as CMS and HHS have reviewed MRI safety standards.
- Regulatory buck-passing between federal agencies, state health departments, and accreditation organizations creates the potential for gaps at the provider level.
- Emerging MRI risks continue to increase.
Point-of-care safety met MRI 25 years ago this week, but MRI safety standards still have no teeth today, according to MRI safety experts and educators Tobias "Toby" Gilk and John Posh.
In a special MRI Safety Week release, Gilk and Posh close out their second series of The Invisible Force podcast on the AuntMinnie Podcast Network, on both a soft and strong note. Series 2, Episode 3 wraps up the case study of the death of 6-year-old Michael Colombini, casting the spotlight on the most pressing MRI safety problems today.
MRI licensure minimums, accreditation requirements, and clear practice standards did not exist when Colombini died, Gilk and Posh explain. Today, they are asking the hard question: after 25 years of building thorough MRI safety guidance, why is almost none of it mandatory in the U.S.?
According to Gilk, it's unclear if MRI safety has ever been reviewed in the U.S. Department of Health and Human Services (HHS) or Centers for Medicare and Medicaid Services (CMS).
The guidance is there and it's had a global influence. The American College of Radiology (ACR)'s "Manual on MR Safety" has expanded into a 156-page document compared to its 14-page first edition in the months following the Colombini accident.
Despite the ACR MR safety manual's breadth and depth, regulatory buck-passing between state health departments and CMS, and lagging accreditation policies point to an overall approach that Gilk and Posh believe has been too soft.
Furthermore, the ACR manual exists in a "weird purgatory space," and hospital accreditors generally capture less than 10% of the MRI safety criteria, Gilk explains during the episode.
"While it's definitely the MRI safety standard of care-defining document in the United States, ACR's protestations to this fact notwithstanding, it's also unclear when, or if, its performance criteria are actually required, and this is true even under the ACR's own MRI accreditation program," Gilk said.
There have been massive leaps in professional practice guidance around MR safety, but the bottom line is that federal standards are lacking, according to Gilk and Posh, who add that different approaches to accreditation also create a "race to the bottom" market incentive.
According to Gilk, one accreditation official said they'd like stricter MRI safety rules but couldn't move first without losing business -- they were waiting on CMS to raise the floor for everyone.
States have been no more willing, Gilk and Posh also note. However, New York, the setting of both of the podcast's first two accident series, has acknowledged gaps in its MRI oversight. It hasn't acted yet to close those gaps, however.
"The ugly truth appears to be that it's taking a whole lot more than killing people to get states to care or take action about MRI safety," Posh notes during the show. "Of the states we've looked at, their laws either fail to acknowledge that MRI exists at all, or they acknowledge that it does exist, but there's absolutely zero minimum safety standards or enforcement mechanisms in place."
If today's MRI safety standard of care were followed, would MRI accidents would be impossible, or nearly impossible? Gilk and Posh test the hypothesis throughout the show, exploring hospital radiology conditions of participation, outpatient conditions for coverage, and modality-level accreditation organizations. Listen now.
"In radiology, we like to think that accreditation is a good representation of the legal standard of care, and that’s largely true on the ionizing-side of things. But for MRI safety, licensure and accreditation minimums are far below the standard of care," Gilk said via LinkedIn.
"MRI Safety Week is only a means to an end. Yes, I'm overjoyed to see so many formally acknowledging this designated week, but the aim is to meaningfully strengthen MRI safety faster than the risk factors are growing ... to gain ground to the MRI risks that have been moving faster than us for decades." -- Toby Gilk
Plus, stay tuned for the next series of The Invisible Force: a 2023 accident in California in which an ICU nurse was crushed between a hospital bed and an MRI scanner.
Host
Tobias "Toby" Gilk is the founder of Gilk Radiology Consulting. An architect by training, he has spent over 20 years focusing on MRI safety, initially through the architecture and planning of MRI facilities, but growing into the technology, clinical practice, regulation, and economics of MRI safety. Gilk holds both MR Safety Officer (MRSO) and MR Safety Expert (MRSE) certifications from the American Board of Magnetic Resonance Safety (ABMRS). An evaluator of serious reportable events (SRE), he is also a volunteer member of the Technical Expert Panel (TEP) of the National Quality Forum, and co-author of "The Technologist MRI Safety Handbook."
Co-host
John Posh is an MRI educator, safety consultant, and safety auditor with over 35 years of experience in the field of MRI safety and education, working with outpatient facilities, hospitals, and universities. He owns Posh Education in Bethlehem, PA, and currently serves as global director of education and training for Aspect Imaging, chief academic officer-MRI at John Patrick University, and adjunct professor of medical imaging at Rush University.
This episode of "The Invisible Force" is brought to you by AuntMinnie and the AuntMinnie Podcast Network. You can also find it on Apple Podcasts and Spotify. Check out AuntMinnie's full podcast library, including extras, on Apple Podcasts and Spotify.
