Description:
Twenty-five years ago, the death of six-year-old Michael Colombini in a tragic MRI accident shocked the radiology world and forever changed how healthcare professionals think about MRI safety. The accident inspired the American College of Radiology’s first MRI safety guidance, launched the modern MRI safety movement, and transformed best practices around the world.
But here’s the question nobody seems willing to answer:
If we now know how to prevent most MRI accidents, why aren’t those safety practices required?
In this MRI Safety Week special, The Invisible Force Podcast concludes its three-part investigation into the 2001 Michael Colombini MRI accident by examining the extraordinary legacy it left behind. We trace the creation of the ACR White Paper on MR Safety, the evolution of the ACR Manual on MR Safety, and how one devastating event became the foundation of modern MRI safety practice.
But the story doesn’t end there.
Through an investigation of CMS requirements, Joint Commission standards, MRI accreditation programs, and state oversight, we uncover a troubling reality: despite decades of progress in MRI safety knowledge, many of the most important MRI safety practices remain recommendations rather than enforceable requirements.
In this episode:
• The Michael Colombini MRI accident and its lasting impact
• The origin of MRI Safety Week
• How the ACR White Paper on MR Safety was created
• The evolution of the ACR Manual on MR Safety
• MRI accreditation and Joint Commission standards
• CMS requirements for MRI patient safety
• Why MRI safety regulations remain surprisingly weak
• The gap between MRI safety best practices and enforceable rules
• What hospitals, imaging centers, regulators, and patients need to understand
Twenty-five years after the most influential MRI accidents in history, the MRI community possesses an extraordinary body of safety knowledge. The question is whether anyone is willing to require it.
Whether you’re an MRI technologist, radiologist, healthcare leader, patient-safety advocate, policymaker, or patient, this episode explores one of the most important unanswered questions in modern medical imaging.
Topics: Michael Colombini, MRI Safety Week, MRI safety standards, MRI regulations, MRI accreditation, ACR Manual on MR Safety, CMS Conditions of Participation, Joint Commission MRI standards, MRI accidents, patient safety, healthcare regulation, medical imaging safety, MRI technologists, radiology policy, and MRI risk management.
Show Notes:
Westchester County Clerk’s Office (Case Index No. 11101/2002)
CMS Hospital Radiology Conditions of Participation
CMS’s 2015 Interpretive Guidelines for Radiology Conditions of Participation
2008 MIPPA Law
Joint Commission Retiring Sentinel Events in Favor of NQF Serious Reportable Events List
2026 ACR Manual on MR Safety
NY State Dept of Health 2013 Memo Including Acknowledgement of Missing MRI Safety Standards
Rethink Imaging Podcast (Apple Podcasts)
Transcript:
“Hello, US Medicare and Medicaid Services. How can I help you?”
“Hello. I’m calling about your radiology conditions of participation. In there, it says that hospitals, quote, must meet professionally approved standards for safety. If it’s a CMS requirement that hospitals must meet a standard, there has to be somewhere where those standards are identified, right? Where can I find which professionally approved standard CMS says hospitals must meet for MRI safety?”
“I’m going to put you on a brief hold. [Hold Music] Okay, so I’ve been told that because investigations of compliance with the conditions of participation are performed at the state level, you have to ask the state’s Department of Health.”
“Wait, so the states each decide what professionally approved standards are required for federal CMS participation?”
“That’s what I’ve been told. You’ll have to ask the state.”
“State Department of Health.”
“Hello. I’m calling about the radiology conditions of participation. In there it says that hospitals must meet professionally approved standards for safety. I just spoke with CMS and they said that you, the state, define which standards providers quote must meet.”
“[LAUGHING] Oh, you were serious. Why on earth would a federal agency defer to 50 different state agencies to define what is a federal standard?”
“That’s what I thought too, but they told me to call you.”
“When we investigate providers for them, we follow federal standards. We don’t make them. If CMS says providers must meet some professionally approved standard, we need CMS to identify what that was. If you want to know what the CMS standard is, you’ll need to ask them.”
“Hello, US Center for Medicare and Medicaid Services. How can I help you?”
Hello, and welcome back to the second series of The Invisible Force Podcast. Invisible Force is an investigative documentary podcast all about MRI accidents, patient safety failures, healthcare mysteries, and some of the hidden risks in modern medicine.
This episode, which we’re releasing during MRI safety week, wraps up our second series. This series has been dedicated to an MRI accident that really launched contemporary MRI safety 25 years and one day from the day we’re dropping this episode. This accident, the tragedy that took the life of 6-year-old Michael Colombini, occurred at Westchester Medical Center, just outside of New York City. Through this series, we’ve been describing this accident for you and really how it became a watershed moment for MRI safety.
But before we round out this second series of The Invisible Force and the story of Michael Colombini, let’s reintroduce our hosts.
I’m John Posh, an MRI technologist, MRI safety educator, and longtime advocate for MRI safety practices. I’m also faculty at two universities and teach MRI safety multiple times per year.
And I’m Toby Gilk. I’m a certified MRI safety officer, certified MRI safety expert, MRI facility architect, and site consultant and co-author of a new MRI safety textbook, The Technologist’s MRI Safety Handbook.
For those of you that don’t know, the week that contains July 27th, the anniversary date of the accident that wound up taking Michael Colombini’s life, well, that week is now always MRI Safety Week. This episode is being released on July 28th, 25 years plus one day from that accident that completely reframed our industry’s perspective on MRI safety and right smack dab in the middle of MRI Safety Week. Before this accident happened, there were no licensure minimums or accreditation requirements or even really clear best practice standards to find the point of care safety associated with MRI. In the 25 years after this accident happened, however, what exactly has changed? That’s what this episode is all about.
The Colombini accident and more specifically, the media attention it got. You’ll remember that we said that there were other MRI deaths before Colombini. His was the first to get real press attention. Well, this accident was like an explosion that occurred in the MRI professional community. It captured everyone’s attention. In our last episode, we shared with you that the ACR, the American College of Radiology, announced their blue ribbon panel on MRI safety at the 2001 RSNA annual meeting, just four months after the Colombini accident. That committee, headed by the godfather of MRI safety, Dr. Emanuel Kanal, was assembled in direct response to the Colombini accident, with the expressed mission of developing an MRI safety practice guide.
Seven months after that blue ribbon panel was formed in June of 2002, their MRI safety practice guide entitled, ACR White Paper on MRI Safety, was published in the American Journal of Radiology. For those of you unfamiliar with either professional society committees or academic journal publishing, seven months to coalesce a committee, prepare a manuscript, every recommendation of which requires unanimous support of all panelists, and get through journal review, well, that’s a superhuman pace. That’s a four-minute mile. That’s fast.
For those of you who know a thing or two about me, you may know that my background is that I’m an architect. I was actually designing an MRI suite in the summer of 2002, when that original white paper on MR safety got published. The lead MR tech at that hospital, he handed me the 14-page document and told me, whatever this says we should do in the buildout for our new MRI suite, do it. Turns out that this same hospital had previously had an accident scarily similar to the Colombini accident, with an oxygen tank flying into the MRI scanner with a patient right there. At this hospital, however, they were as lucky as could be. The tank flew into the MRI tube, but it narrowly missed the patient and immediately stuck against the bore wall. I think it was that personal story of how important MRI safety was to my friend, the lead tech, that began hooking me on MRI safety.
As an MRI tech, I was already very well attuned to the risks of MRI by 2002, when the original white paper came out. They say that one of the definitions of an expert is someone who’s made every mistake there is to make in the profession. I’m glad to say that while I haven’t personally made every MRI safety mistake, there is though some that I’ve made. I’ve made several. I think I’ve probably seen every type of mistake, either at places I’ve worked or in the safety reviewing or consulting work I’ve done for other hospitals or attorneys. Even so, it’s hard to overstate the importance of the original white paper when it came out. There had been publications with a helpful word of advice on MRI safety here and there, but this was the first publication in the US at least that was all about MRI safety practices. Not only that, but it was published under the name of the American College of Radiology.
That original blue ribbon commission got ultimately turned into the ACR’s MRI Safety Committee, and that group has, over the years, made multiple revisions to that original white paper document. They updated it in 2004, renamed and expanded it in 2007, revised it in 2013. In 2019, they published a coming attractions teaser for a major revision. And then in 2020, they released that major revision, retitling the document again with its now current name, the ACR Manual on MR Safety. There was another major revision published in 2024, and a subsequent minor revision published earlier this year in 2026. That original 14-page white paper, today, the 2026 manual is 156 pages. I was very fortunate to have been on the committee and co-author for the 2007 and 2019 and 2020 publications.
And while the document is published by the American College of Radiology, its influence is truly global. The Royal Australian slash New Zealand College of Radiology, or RANZCR, has published their own MRI safety guidance document that’s essentially a stripped down version of the ACRs. The UK’s MHRA, which is somewhat similar to the US. FDA, although they chaff at that comparison, who’s actually had the MRI safety guideline published before the ACR did, is harmonizing their MRI safety guidance with things like the ACR’s zoning. To be fair, the ACR is reciprocating by including some of the MHRA’s design space designations. And Toby showed me an MRI safety survey document from the Saudi Arabian Ministry of Health that extensively referenced the ACR’s safety performance criteria.
However, the ACR Manual on MRI Safety, today, in 2026, largely continues to exist in this weird purgatory space. While it’s definitely the MRI Safety Standard of Care Defining Document in the United States, ACR’s protestations to this fact notwithstanding, but 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. But that’s a subject we’re going to cover more in the second half of this program.
In the past 25 years since the Colombini accident, we’ve seen massive leaps in professionally approved best practice guidance. But in 2001, Westchester Medical Center was accredited by the Joint Commission. 25 years ago, the Joint Commission or TJC or JCAHO, as they’re often referred to, despite being far and away the largest hospital accreditation organization, didn’t have a single MRI specific standard. While the ACR came out with the MRI Safety Guidance within a year of the accident, JCAHO didn’t release any MRI specific guidance for their accredited hospitals until 2008. Despite being an accreditation organization that makes minimum rules for hospitals, JCAHO’s 2008 information was a Sentinel Event Alert number 38. Sentinel Event Alerts have a particular position of simultaneously saying, hey, this is something that can be exceptionally dangerous, along with we don’t actually require that you do anything about it. We just wanted to let you know.
The 10 specific performance criteria in that Joint Commission Sentinel Event Alert number 38 about MRI safety, they were all essentially borrowed from the ACR’s publication with an additional three criteria recommended personally by Dr. Emanuel Kanal. At some point, JCAHO withdrew Sentinel Event number 38, pointing people instead to the ACR’s MRI safety publications. But despite pointing to the more comprehensive MRI safety standard document, it still remained a, we think you should think this is a good idea, and that you should do it, but we’re not telling you to actually do it, kind of recommendation from JCAHO. As a side note, starting in 2027, JCAHO is ditching the Sentinel Event Alerts altogether in favor of the National Quality Forum’s Serious Reportable Events, or SRE, list. While the name and the content are changing, SREs are similarly not enforceable, and despite reportable being in the name, JCAHO will not be requiring that these events get reported to them. Now, seven years after that 2008 Sentinel Event Alert, in 2015, Joint Commission released their Diagnostic Imaging, or DI, standards. JCAHO had, for the very first time, a handful of MRI-specific safety standards. Interestingly, a year or two after the DI standards started being enforced, a Joint Commission bigwig made a presentation at a conference I was attending, and they expressed real shock that half of all of the problems they found on surveys using these new standard criteria, which covered CT and MRI and nuclear medicine, that half of them were MRI problems.
But surely if Westchester Medical Center was following the contemporary 2026 Joint Commission standards, there’s no way that the Colombini accident could occur today, right? Well, let’s test that hypothesis. Joint Commission’s minimum standard for MRI suite layout is that there’s a secured area between the public and the MRI scanner room. If the door from the waiting room to the back hallway of the Westchester MRI edition had a lock on it, then presumably it would meet the contemporary design requirement. Today, JCAHO only requires that MRI techs have any MRI safety training. Remember that the MRI techs went into the equipment room and it was the anesthesiologist and nurse who were acting on their own. In 2001, Westchester Medical Center was storing portable steel oxygen tanks right next to the MRI scanner room. And in 2026, the current JCAHO standards would also permit this practice. There is some language about supervision from the MRI safety trained personnel that may have made a difference. But really, there’s little, if anything, MRI safety specific in the current Joint Commission standards that would interrupt the series of events that led to the Colombini accident.
The contemporary ACR manual on MR safety, however, if its performance criteria were followed, it would make it almost impossible for the Colombini accident to happen again. From strict access restrictions to minimum safety governance structures to the identification of MRI safety properties of equipment stored in the MRI suite, all the way down to requisite MRI safety training, there are many critical interrupters that we can find in the current ACR manual.
Which begs the question, if we develop this incredible body of MRI safety practice knowledge over the past 25 years, practices that would nearly make every MRI injury accident at least difficult to happen, if not outright impossible, if this is the legal standard of care to which healthcare providers will be held when accidents like this go to court, why aren’t there minimum rules to protect us when we get MRIs? We’re going to try and answer that in the second half of this program.
The sponsor of The Invisible Force Podcast is cairereporting.org. That’s care, spelled C-A-I-R-E. cairereporting.org is a confidential MRI adverse incident reporting system. Available to all of us, the public, as well as being an enterprise solution for hospitals and imaging centers, enabling secure, confidential reporting of MRI incidents, accidents, and near misses. If you have direct knowledge of an MRI incident that may have been swept under the rug, or if you want information on how CAIRE could be set up as a private internal error reporting tool for your hospital or imaging center, carereporting.org can help you with both of those. CAIRE has an assembled panel of international experts in MRI safety and accidents. Reports submitted either through the public website or through an enterprise system get reviewed by their experts who then deliver insights into the contributing causes of how accidents or near miss events happened, and more importantly, steps that could prevent similar accidents in the future. For more information, please visit cairereporting.org. Again, that’s CAIRE spelled C-A-I-R-E.
Before the break, we shared with you the immense progress that has been made largely attributable to the ACR’s MRI Safety Committee in developing rock-solid set of MRI safety practices over the last 25 years since the Colombini accident happened. And using the Joint Commission and their accreditation of Westchester Medical Center as an example, we pointed out how JCAHO has gone from having zero MRI safety standards to having a few, but those few probably wouldn’t have stopped this accident from happening either. In the second half of today’s program, we’re going to be asking you the $64,000 question. If we have such great MRI safety best practices, how come we don’t hardly have any MRI safety minimum requirements?
If you were here with us for episode 5 of our first series on the McAllister accident that happened a year ago, you heard us go through some of the organizations that might potentially regulate MRI safety. In that episode, we mentioned, but kind of glossed over CMS, the Centers for Medicare and Medicaid Services. If you want to talk about national standards for safety in any type of patient care, CMS is probably going to be your starting point. CMS has separate structures and rules for hospitals than it does for outpatient type providers. Since we’re looking at this through the lens of the Colombini accident which happened at a hospital, we’re going to start looking at CMS hospital standards.
So hospital providers who want to get paid by CMS for MRI care, delivered to Medicare or Medicaid patients, they have to meet a set of standards called the conditions of participation. As you heard in our audio play introduction, one of those conditions of participation is that the hospital must meet professionally approved standards for safety. In a 2015 document, CMS elaborated on what that meant. Beyond meeting federal government requirements and those of accredited organizations, that document says,
“Professionally approved standards also include the recommendations or guidelines promulgated by expert government agencies such as the US Food and Drug Administration, as well as those issued by nationally recognized professional organizations, such as the American Medical Association, the American College of Radiology, the Radiological Society of North America, the Alliance for Radiation Safety and Pediatric Imaging, American Society of Radiologic Technologists, the American College of Cardiology, the American College of Neurology, the American College of Physicians, etc.“
So, of all the agencies that they list, FDA, AMA, ACR, RSNA, RSPI, ASRT, ACC, ACN, and ACT, there’s only one that has published a professionally approved standard on MRI safety, and that is, today, the ACR’s Manual on Safety. So, in the universe in which there is one single professionally approved standard for MRI safety from the organizations recognized by CMS to produce such a standard, of course, it makes sense to acknowledge it, right? Except that they won’t. Despite the fact that CMS insists that hospital providers must meet a standard, even when there’s only one that fits with their defining criteria, CMS plays dumb and tries to get states to define federal standards.
Now, there’s a similar conditions of participation language in the description for different medical specialty areas, not just radiology. CMS says that they have neither the desire nor the capability to be the professionally approved standards librarian, despite the fact that they’ve kind of put themselves in exactly the position by requiring compliance with an unnamed standard. And even when we say to them, hey, I don’t want all hospital professionally approved standards, I only want the MRI safety ones, CMS refuses to open that door, even the tiniest crack, presumably out of fear of being bombarded by other requests for other standards in every other part of the hospital in their delivery of patient care.
For outpatient-based medical providers instead of hospitals, there’s a parallel structure in CMS, except instead of conditions for participation, on the outpatient side it’s called conditions for coverage. There’s not much detail on the hospital side about safety, and there’s even less on the outpatient side. But fear not, because in 2008, Congress passed the Medicare Improvements for Patients and Providers Act, or MIPPA, which specifically regulated quality and safety at outpatient providers of the advanced diagnostic imaging modalities, CT scans, PET or nuclear medicine scans, and you guessed it, MRI scans.
Where the radiology conditions of participation put minimum safety standards directly on the hospital, MIPPA, for outpatient providers, MIPPA put the obligation for safety standards on the modality level accreditation organizations. In the first half of the program, we highlighted one of the hospital accreditation organizations, the Joint Commission, but there’s a parallel structure for outpatient-based radiology providers, where the individual scanners need to be accredited in order for the provider to get CMS reimbursement. The specific language of the MIPPA law that John introduced is that the Secretary of HHS, and HHS is organizationally the parent of CMS, the Secretary of HHS is required to make sure that there are accreditation requirements in order to quote, ensure the safety of both outpatient healthcare workers and patients. A few years ago, I did a Freedom of Information Act request to CMS, asking for all documentation of the HHS’s Secretary’s review or approval of the requirements as being sufficient to assure the safety of MRI patients. But it turns out that there was none. It’s unclear if MRI safety has ever been reviewed in HHS or CMS, either through the hospital conditions of participation or the outpatient conditions for coverage or the MIPPA laws.
The front line of ensuring MRI safety, both at hospitals and outpatient imaging centers, has reportedly been these accreditation organizations. On the hospital or conditions of participation side of things, Joint Commission has standards for MRI safety that have a passing resemblance to perhaps a third of the criteria in the ACR’s 2013 MRI safety document. The other hospital accreditation organizations, ACHC, CIHQ and DNV, have fewer than 10% of their own explicit performance standards that resemble anything in the ACR safety guidelines.
But, of course, when it comes to the organizations that explicitly accredit MRI machines, the MRI safety standards are going to be significantly tighter, right? Well, that was our expectation, too. But it turns out that’s not the case. On the modality level accreditation side of things, those organizations that have MRI accreditation programs, that would be the ACR, the IAC and RAD site, they too have explicit standards that touch on only around 10% of the ACR’s MRI Safety Standard of Care document. Let me say that again because it bears repeating. The ACR’s own MRI Accreditation Safety Minimums are a weakened version of around perhaps only 10% of the ACR’s own MRI Safety Guidance.
So if all of this MRI Safety Standard of Care information is out there, right under our noses or a couple of clicks away through our web browsers, just waiting to be incorporated into our minimum safety standards, why hasn’t it been? Because a hospital or imaging center can switch accreditation organizations in a manner like switching the vendor who provides the facility’s toilet paper, the accreditation organizations are pressed by the clientele to regulate less and charge less than their accreditation competitors. Facilities reimbursement is tied to having the accreditation box ticked, not to preventing preventable MRI accidents. This creates a race to the bottom market incentive.
A few years ago at RSNA, I actually had a sit down with someone from one of the accreditation organizations, who essentially told me that they wanted to implement more concrete MRI safety standards, but that doing so would be financial suicide, at least if they chose to do it unilaterally. The hope was that CMS would raise the minimum MRI safety standard expectations for all of the accreditation organizations, allowing the safety standards to improve without punishing the accreditation organizations who wanted to see more meaningful standard. This approach, of course, is contingent on CMS, who won’t presently tell you what standards you must meet, taking on a series of minimum standard improvements. Today, that doesn’t seem very likely.
If the feds won’t act, what would it take to get the individual states to do so? The first two series of The Invisible Force have been about fatal MRI accidents in the state of New York. After the MIPPA law came out and New York recognized that there was at least an implicit expectation that they regulate MRI safety, and they acknowledged that they hadn’t, and they had no plan to do it. And if you heard our last series on the Nassau Open MRI accident, there’s no outward indication that the state of New York is doing anything following the McAllister fatality either. 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. 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.
So here we find ourselves 25 years on from the Colombini accident. That accident prompted the development of a mountain of best practices, guidance that has circled the globe. We are rich with tried and true MRI safety practices that could dramatically slash the rates of MRI accidents and injuries if only they were required. Both the individual states and the feds are being ostriches. They’re plunging their heads in the sand. Even the accreditation organizations who are there ostensibly to assure us of the highest levels of patient safety, those that want to improve safety have their hands tied by the competitive systems that operate within.
To the Colombini family, we want to share our deepest condolences to you and we hope that you found some measure of peace even through this anniversary. If it matters, know that the two of us were deeply impacted by Michael’s death and are going to continue to push for standards to help prevent future MRI accidents.
“Hello, US Medicare and Medicaid Services. How can I help you?”
“Hello. I’m calling about your radiology conditions of participation. In there, it says that hospitals, quote, must meet professionally approved standards for safety. If it’s a CMS requirement that hospitals must meet a standard, there has to be somewhere where those standards are identified, right? Where can I find which professionally approved standard CMS says hospitals must meet for MRI safety?”
“I’m going to put you on a brief hold. [Hold Music] Okay, so I’ve been told that because investigations of compliance with the conditions of participation are performed at the state level, you have to ask the state’s Department of Health.”
“Wait, so the states each decide what professionally approved standards are required for federal CMS participation?”
“That’s what I’ve been told. You’ll have to ask the state.”
“State Department of Health.”
“Hello. I’m calling about the radiology conditions of participation. In there it says that hospitals must meet professionally approved standards for safety. I just spoke with CMS and they said that you, the state, define which standards providers quote must meet.”
“[LAUGHING] Oh, you were serious. Why on earth would a federal agency defer to 50 different state agencies to define what is a federal standard?”
“That’s what I thought too, but they told me to call you.”
“When we investigate providers for them, we follow federal standards. We don’t make them. If CMS says providers must meet some professionally approved standard, we need CMS to identify what that was. If you want to know what the CMS standard is, you’ll need to ask them.”
“Hello, US Center for Medicare and Medicaid Services. How can I help you?”
This wraps up our three-part series on the original MRI accident from 2001. For a next series, we’re taking you from New York to California, where a 2023 accident crushed an ICU nurse between the hospital bed and the MRI scanner. So make sure you’re subscribed to the Invisible Force Podcast to get each new episode in our upcoming series as soon as it drops.
For those of you recognizing MRI Safety Week this week, we encourage you and your team to take a minute of reflection on this accident that started it all. We’d also like to encourage you to check out the Rethink Imaging Podcast. Rethink Imaging has an amazing variety of recorded interviews with a huge cross-section of radiology professionals. And their next episode, also being released during this MRI Safety Week, is an interview with me, all about MRI Safety and about the podcast series you’re listening to right now. Like us, you can also find Rethink Imaging on Apple Podcasts and Spotify or your favorite podcast service. We encourage you to check them out.
For this week’s show, our resources were the court archives of the Colombini family’s lawsuit, as well as CMS requirements, their interpretive guidelines, and various accreditation standards. Our introductory radio play is a dramatization of calls that I’ve had with CMS and various state departments of health. Our voice actors for this episode’s dramatization, in addition to me, were Brandon Grugle and Amanda McLaughlin.
If you have any information about this accident or any MRI accidents, please reach out to us through our website, invisibleforcepodcast.com. Episodes, show notes, transcripts, and a tip line contact page are always there. Also, you can leave us a voicemail with information about any MRI accident at area code 631-MRI-tips. That number again is 631-MRI-tips or 631-674-8477.
We also ask you to like and share our podcast with your friends, colleagues, and coworkers. If you have a chance to rate the podcast or even better, leave your comments with Apple Podcast or Spotify. That will help others to find us. Together, with your help and with a little bit of luck, we can help make sure that accidents like this one don’t ever occur again.
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