Not that I haven’t been working on MRI safety issues, but I don’t have nearly as much to show for this effort as I’d like. I think that’s part of the reason why I stopped writing here for a while. I was dispirited at my inability to land a killing blow on any one of my target windmills, and cataloging your failures in print isn’t always cathartic. So it took something to grab me by the figurative lapels and shake me, and that something came the other day in the form of a phone call from a dear friend. My friend went for an MRI and something that happened during that exam spurred him to call me afterwards.

As the ‘MRI guy’, I am used to getting calls or emails from friends who have been prescribed MRIs – or their loved ones have – and they’re looking for assurances that everything will be OK. I’ve also been on the receiving end of calls of friends who’ve just had an MRI, wanting to know if ‘it was supposed to be that loud?’ or ‘what did it mean that they said I was moving too much?’ This time, however, the call was a long distance admission of guilt.

My friend went for his MRI straight from work. He’s a normally fit and healthy adult and the MRI exam was scheduled at a pretty prestigious teaching hospital in his area. He walked in, gave the perfunctory ‘yeses’ to all of the screening questions. He emptied his pockets, went into the magnet room, hopped on the MRI scanner patient table, and was slid, head first, into the scanner. A moment later, he felt something moving at his thigh.

Turns out he hadn’t emptied all of his pockets. He had one of those folding multi-tools tucked in a pocket that he hadn’t checked, and he could feel it being pulled towards the magnet. Next thing he knew, it slid from his pocket and struck him on the elbow, right on the funny bone. Fortunately, he wasn’t injured, but he said that it hurt like hell for a while after. He knew what was happening, as it was happening, and instantly chastised himself (as he thought I would), for not checking and double-checking before his MRI.

Example of a multi-tool, opened up.

His call to me to recount his story shook me out of my hiatus.

We think of MRI accidents as being that which happens to ‘someone else’. We like to think that these accidents happen to patients who don’t understand why MRI screening is important, not good friends of MRI safety experts. We like to think that these accidents happen at disreputable MRI providers, not major academic medical centers. We like to think that these accidents only happen with under-qualified techs at the helm, and not well educated and credentialed technologists.

In the past 12 months I’ve had two friends tell me stories of their own MRI personal MRI mishaps. One was a failed screening which (by dumb luck and not because of anyone’s intentional actions) turned out to be a minor threat, and this past week’s story which could easily have resulted in a very serious injury. I have no expectation that I will ever see either of these events in a public reports of MRI accidents. They won’t be part of the quantified record of MRI accidents, and yet they occurred, as do thousands of others every year.

These preventable accidents are endemic to MRI in the U.S., and that’s inexcusable. We know what the root-causes are of nearly every MRI burn, projectile, and hearing injury. We know what the preventative steps are. And I won’t rest until it is an explicit part of the mission of every MRI provider to implement the protections that will prevent these types of accidents and injuries.

I hope I’m not too late.

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Email to Me From ACR

My Faustian bargain was this, I will throw my support enthusiastically behind HR 3269 if the ACR will simply identify a concrete timeline and performance objectives for MRI safety for their MR Accreditation program.

This should be very simple for the organization that has published the industry standard MRI safety document three (soon to be four) times over the last 10 years…

This should be simple for an organization that publicly stated that they would be doing exactly this three years ago at the AHRA annual meeting…

This should be simple for an imaging accrediting organization whose self-professed reason for being is “quality and safety”…

This should be simple for an organization that went before Congress stating that the country needed more radiology device accreditation requirements to protect the safety of patients…

It should be simple… but apparently it’s not.

While the ACR MR Accreditation program makes reference to the organization’s industry best-practice MR safety documents, it doesn’t actually require any of the performance criteria be met for accreditation. The ‘safety’ part of ‘quality and safety’ apparently isn’t applicable to the ACR’s MR Accreditation program.

Representatives of the ACR with whom I’ve spoken object, strenuously, to this characterization, insisting that the reason for image quality is to improve the read and patient outcomes, and isn’t that synonymous with safety?

In a word, no.

Yes, image quality holds out the promise of better reads and interpretations, and that is important. But one needs to look no further than the public records of how people are getting injured in the MRI environment. The overwhelming majority of injuries in MRI come down to burns, projectiles, and hearing damage.

If these are the top sources of MRI injury (together comprising more than 90% of FDA-reported incidents from 2009 and 2010 which I evaluated with Dr. Kanal), wouldn’t it seem appropriate that any meaningful MR safety standards would require preventions for at least one of these? The fact is that ACR MR accreditation has no explicit standards that would mitigate any of these types of injuries.

So, despite my thinking that the overwhelming sources of injury in MRI would be at the top of the list of a ‘quality and safety’ MRI accreditation organization’s to-do list, I’ve found myself bargaining, unsuccessfully, with the ACR to support the MRI safety initiatives that they’ve previously promised to implement.

So, Dr. John Patti, Chair of the ACR Board of Chancellors, if you are reading this, please know that my offer still stands. I am willing to call my elected officials and support HR 3269, and all I need in return is an official statement from the ACR that outlines when and how you will honor prior promised to incorporate safety requirements in the MR Accreditation standards.

In the meantime, I’ll be sitting by my computer, waiting for your email.

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Yes, I’m talking about the ACR…

Before I launch into what they do that makes me crazy, it is only fair that I acknowledge what they do for which I am tremendously proud. The ACR has released the industry standard set of safety practices to address virtually every element of MRI safety. These practice standards could virtually eliminate all MR and MR-related adverse events, they’re that comprehensive and well developed. Three editions of these safe practice guidelines have already been published, and a fourth is in the final pre-publication steps as I write this. For one of these, the ACR deserves the industry’s thanks. For an ongoing effort that is about to produce the fourth iteration of this document, the ACR deserves praise and accolades. I wish that’s where this story stopped, but it isn’t.

While the ACR has gone to significant lengths to develop and keep current their MR safe practice guidelines, they don’t actually require them for their own accreditation clients (this despite an explicit request to do so from their MR safety committee, and even public promises that they would do so in 2009). That fact, however, hasn’t stopped the organization from promoting itself as the standard-bearer for MRI safety. Below is a screen capture of the press release that comes in the ACR’s ‘congratulations, you’ve been awarded MR accreditation’ package for all newly (re-)accredited sites.

Standard ACR Press Release For MRI Accreditation

For those who can’t read ‘microscopic’, you can click on the image to see it larger. The key phrase is in the lead sentence of the 2nd paragraph, which reads:

“The ACR gold seal of accreditation represents the highest level of image quality and patient safety.”

Click here to download the Word document template that the ACR provides on its website (which, as of December, 2011, reads exactly as the image above). Click here to see a Google search for items with exactly that sentence (will only show a couple of months of news items).

Grouping an assurance of image quality (for which the ACR does have some of the most exacting standards in the industry) with MR safety is erroneous, at best, if not outright deceit.

In order to obtain ACR accreditation for MRI, a site needs to go through rigorous image quality testing and validation. Highly specific imaging sequences must be recorded, both on quality-control phantoms (special test objects which, when scanned, can reveal several quality measures of images) and patients. A long series of images must be submitted for review, and regular followup must be done to assure that the MRI system sustains high levels of image quality.

In order to obtain ACR accreditation for the MRI physical safety criteria… well… just promise to do a safe job. That’s it!

• No requirement to have or use table pads / positioning aids (to prevent burns).
• No requirement to screen patients for clinical or physical contraindications.
• No requirement to provide patients with hearing protection.
• No requirement to label unsafe items kept in the controlled access areas of the suite.
• Heck, there’s not even a requirement to have a controlled access area of the suite!

It dumbfounds me that the ACR can put image quality and safety in the same sentence that extolls the value of their MRI accreditation program. Is it just their PR people running amok?

The ACR has been remarkably busy in the last couple of years. I mean they’ve been busy lobbying congress to require their accreditation services of all advanced imaging modalities (see the ACR’s own press release here). They might not be aware of the MRI safety situation and the constructive role that their own optional accreditation standard could have… except that it was presented to them at their Quality and Safety forum over a year ago (see the video recording here).

Personally, I find it unfathomable (and morally indefensible) to promote ACR accreditation as a safety advantage when the accreditation criteria don’t actually respond to the systemic (and preventable) accidents and injuries.

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Guess what? Today is one of my somedays! Or, I should say, today promises to be one of my somedays (there’s the cautious vein running through my optimism).

Today the FDA announced that they are hosting a public workshop on MRI Safety! Faced with staggering growth in MRI accidents and a diaspora of state, accreditation, professional and regulation organizations (who either can’t or won’t acknowledge the role that they each could have played in preventing the dramatic increase in accidents), the FDA is assembling a public workshop not unlike the one that fostered unprecedented cooperation among industry, providers and regulatory bodies to address ionizing radiation exposure concerns in ionizing medical imaging.

Like the ionizing predecessor, the challenge for the MRI safety workshop will be twofold… first, getting stakeholders (who disavow being stakeholders with a responsibility) to work together will be like herding cats. Fortunately, there are a few of us crazies [ahem] zealots, er enthusiasts who won’t forsake this opportunity and will help marshal the kitten rodeo. Second, and more critical, will be the commitment to actually doing something!

“Try harder” or “Improve tech education” or “Develop a policy” have all been tried to death! The ‘we promise we’ll do better in the future’ line, without specific, measurable criteria, has been the staple of MRI safety improvement efforts over the course of time in which we’ve seen the rates of MRI accidents grow to five times what they were just a few years ago. The promise to ‘do better’ is wholly inadequate. The promise to ‘measure up’ to an explicit standard is what we need.

Alarming Growth In MRI Accidents

This planned meeting – or more specifically, the progress that it represents – is long overdue, as is this contribution to this forum.

If you would like to participate in this upcoming FDA meeting, scheduled for October 25th – 26th, 2011, please sign up soon on the FDA’s registration website, here.

I hope to see you in DC, herding cats and agitating for standards for the safety of MRI patients and staff!

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First, a little background. I am neither beholden to, or have an axe to grind against, any of the prominent (potential) players in MRI safety. They’ve each provided me opportunities to advance the cause, and rebuffed me. In the interest of transparency, here are my relationships with both the American College of Radiology (ACR) and the Joint Commission (TJC).

Dr. Emanuel Kanal, MRI safety guru extraordinaire, has been the ACR’s MRI Safety Committee chairperson since the group was formed in 2001. He invited me to serve on that committee in 2006, and an ACR executive group, which holds veto power over committee appointments, approved me. I participated on that committee and am one of the authors of what became the 2007 ACR Guidance Document for Safe MR Practices. When Dr. Kanal successfully lobbied the ACR to support an update to the Guidance Document last year, the prior committee was disbanded and each individual was subject to re-appointment. I was renominated by Dr. Kanal, but my reappointment was blocked by the ACR executive group. I do not serve on the current incarnation of that committee (which is working on an update to the ACR Guidance Document due out later this year).

Through the ACR, I got one superb opportunity to influence MRI safety. I thought I would get more than one… but it was just one. I have no engrained personal interest in lifting up the ACR, so when I recommend the Guidance Document, it’s because I believe that this product is worth my support. Similarly, when I criticize the ACR with respect to MRI safety (as I did, pretty unabashedly, here), it is because I believe that they can do better, and not some petty personal resentment. I did, after all, get that superb opportunity through them.

Switching gears, my relationship with the Joint Commission is strikingly similar to my relationship with the ACR. Over the years, Joint Commission Resources (their educational arm) has asked me to write several pieces for them on MRI safety for various publications. They’ve also interviewed me for another publication (a piece that almost didn’t see print because of a disagreement between me and TJC’s Standards and Survey Methods division about what SEA #38 meant to an accredited provider’s internal risk assessment). I also had the opportunity to provide an introduction to MRI safety as surveyor training to TJC’s ambulatory accreditation surveyor corps after TJC was selected as an approved radiology accrediting body under the MIPPA law. That’s the good (or, at least ‘mostly good’).

TJC is a large organization, and while I’ve gotten along successfully with their education group, spoken at one of their conferences, and provided services to their ambulatory group, the ‘mother ship’ of TJC is their hospital accreditation organization. I’ve butted heads, usually privately… though sometimes not, with the hospital side of the organization. Most recently I’ve been informed that TJC can not accept any of my services, paid or volunteered, because of a potential appearance of a conflict of interest. Effectively, I’ve been ‘blackballed’ from the Joint Commission. While there is much more that I would like to accomplish with and through TJC, I’ve already managed to do a fair amount with them. As with the ACR, I think I’m on even terms with TJC… no debt… no malice.

I lay this groundwork to get around to the main gist of this post. A few weeks ago I posted, and then, within a week, took down the TJC companion piece to the ACR critique.

“Why would you give preferential treatment to the Joint Commission… or did you go off the deep-end and say something you regretted?”

I think that the TJC piece was equivalent to the ACR piece. They’re both accurate and critical of certain actions within each organization. I don’t think that anything in either piece is inflammatory, or hurtful. I didn’t write anything that I regret having put down in bits. I know that several regular readers of this blog did see the TJC piece, and I invite any who did read it to post with any thoughts they had that it was / wasn’t appropriate and fair.

“So, why’d you take it down then?”

Those of you who know me know that I’m something of an MRI safety evangelist. I have said and done (foolishly and unrepentantly) things that were not in my own personal best interest when I felt that they advanced MRI safety. I have zero interest in having an “I told you so” moment, either in elevating myself or in denigrating healthcare / radiology institutions. I want improvement. I want results. And that’s why I took down the Joint Commission critique.

“Ummm, OK… But how did taking it down advance those improvements or results?”

For a long time, years in fact, TJC has been toying with the idea of substantive MRI safety programs, but there are both internal and external hurdles to overcome to allow this to happen. Every historical effort towards implementing MRI safety on the hospital side of the organization has atrophied and died.

Very shortly after I posted the Joint Commission MRI safety critique, I learned that my friend and colleague, Dr. Kanal, was arranging a meeting with TJC to re-spark the conversation about advancing MRI safety within TJC’s hospital accreditation program. While I have no direct involvement with TJC and Dr. Kanal in these conversations, Dr. Kanal and I did collaborate for the non-hospital MRI safety introduction for the Joint Commission, and I didn’t want the critique I wrote, coupled with any legacy of prior collaboration, to poison Dr. Kanal’s current efforts. So I took the post down.

If I felt that there were any parallel efforts underway at the ACR, and that taking down that post would advance those efforts, I’d pull it down in a heartbeat, too. To my knowledge, however, there aren’t, so until I see an advantage to taking it down, it stays and I invite everyone interested in this topic to read it, here.

And if the situation with the Joint Commission changes, and the current effort on MRI safety slips into the comfortable, well-worn precedent of failure, know that the post isn’t gone, it’s only disappeared, and will reappear if / when it’s absence isn’t more constructive.

Ultimately, it’s all about affecting change. We expect that we have thousands, perhaps tens-of-thousands, of MRI adverse events occurring every year in the US, and the vast, VAST majority of these are readily preventable, or would be if we had enforced standards. That’s what I’m after.

And this is me, being as transparent about the whole situation as I can be.

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One can only presume that this is the commentary that US States and radiology accreditation agencies have to offer on the contemporary state of MRI safety. After all, there’s been nothing more than navel-gazing when it comes to measurable changes in standards for MRI providers. Let’s break it down…

This first installment will look specifically at MRI safety standards as implemented by the American College of Radiology (ACR). By tackling them, first, I don’t mean to suggest that they’re the only concern with respect to MRI safety. In fact, in a weird, schizophrenic way, ACR has simultaneously advanced and held back MRI safety. More on that towards the end of this piece.

MRI Accident Rate Slide from ACR Quality & Safety Forum 2010

The American College of Radiology has distinguished itself with the premier industry best practice publication on MR safety, the Guidance Document for Safe MR Practices. Originally named the White Paper on MR Safety (published in 2002), its name switched to the Guidance Document with a 2004 update. I was fortunate enough to be a part of the ACR’s MR Safety Committee (the authoring body) for what became the 2007 edition.

When the Committee met at the ACR headquarters in the late summer of 2006, to review drafts and collectively decide on the final revisions, it was noted that the ACR’s contemporary MR accreditation program didn’t actually require any of the safety provisions found in the (then twice published) Guidance Document. In that meeting, five years ago, the MR Safety Committee unanimously voted to formally request that the ACR incorporate safety provisions found in the Guidance Document in the MR accreditation program (this was frightfully easy since the representatives of the College were there in the room with us).

Surrounding that Committee meeting in 2006, Nephrogenic Systemic Fibrosis (NSF) was the hot topic in MR safety. The radiology community and trade press were trading speculation, recrimination, and early analyses. The 2006 Guidance Document was held until it could be published with the collected best available information regarding NSF, which meant that it wasn’t released until early 2007.

Perhaps the ACR was waiting for the new Guidance Document to be released, I thought, so they didn’t implement any of the safety requirements in their MR accreditation program prior to the new version’s publication. So the rest of 2006 came and went, as did all of 2007, without so much as a hint that the MR Accreditation program would include the Guidance Document‘s safety standards. Nearly all of 2008 passed the same way, with no indication that the ACR intended to include it’s own MRI safety standards in its accreditation requirements. But things showed promise of moving forward at the 2008 RSNA meeting.

I learned that the ACR’s MR accreditation committee was entertaining the notion of including some elements of the Guidance Document’s safety standards and that they had asked one of their physicists (not anyone from the MR Safety Committee) to draft a checklist set of safety standards. Purportedly, at that 2008 RSNA meeting, it was proposed that the 30+ page Guidance Document be distilled to about a half-dozen check-box question. One could argue that ‘something was better than nothing’, but the notion that these questions actually captured the essential safety elements of the Guidance Document was laughable. It didn’t fly. Back to square one.

Fast forward about a year, to summer 2009, when, at the AHRA annual meeting, representatives from ACR were giving a status update about accreditation standards. It was a packed meeting as the writing was on the wall about CMS requiring modality accreditation through the new MIPPA law. In that presentation, the ACR representatives stated that ACR would be incorporating elements of the Guidance Document‘s safety principles in the MR Accreditation program. Precisely how this was to happen was yet to be determined, but it would happen.

In early 2010 CMS announced that the ACR would be one of three approved accreditation bodies to accredit imaging providers’ CT, PET, and MRI scanners to qualify for reimbursement under the MIPPA law.

I was tremendously optimistic that this new requirement status would help to remove the concern within the ACR that implementing safety standards, unilaterally, would make other accreditation programs comparatively easier, and therefore more appealing to MRI providers. Now providers would be required to get accreditation, and ACR was clearly the front-runner in modality accreditation of the three named agencies. I called the ACR and spoke with a senior person within the organization about the safety standards. That person quickly burst my bubble…

Despite the public promise to incorporate elements of the Guidance Document from the prior year, in 2010 the ACR representative told me there would be no such plan going forward because they were now an approved accrediting body under the MIPPA law. According to this person, it was determined that it would be far too ‘bureaucratically burdensome’ to have to go through CMS (a step which would be required for any change to the accreditation structure, now that it was CMS sanctioned) to update it’s standards to include the safety elements in the Guidance Document. The irony of a federal law mandating quality and safety standards being the reason that an accrediting agency claimed it couldn’t enact safety standards wasn’t lost on me. Fortunately, I was just about to get the chance to talk with the principal radiology quality and safety person at CMS to let her know what I thought of their safety-inhibiting bureaucracy.

In the summer of 2010, I was a participant in a joint presentation on MRI safety between the FDA and CMS.  One of the CMS representatives in that presentation was Jeannie Miller, Deputy Director of the Clinical Standards Group. After that presentation, I followed up with Ms. Miller and asked her about the ACR contention that it was now too ‘burdensome’, because of their new role with CMS, to add safety standards to their existing MR Accreditation program. In a word, Ms. Miller was incredulous.

She told me that, just a few weeks prior to our conversation, the ACR had submitted their breast MR accreditation program to CMS for their approval. How long did the ‘burdensome’ CMS bureaucratic review take for this new and unprecedented MR accreditation program? Less than two weeks! Ms. Miller was dumbfounded at the suggestion that CMS would make it anything but easy for a quality and safety standard to enhance its safety components. So, if CMS ‘burdensome bureaucracy’ is just a smoke screen, what’s the real reason ACR is unwilling to heed the recommendation of their own MR Safety Committee, and honor the promise they made two years ago, to incorporate substantive safety requirements in their MR Accreditation program? Could it be money?

Though ACR is one of the accrediting bodies from which CMS mandates that outpatient participants must obtain accreditation, it’s still one of three. While ACR is seeking to ‘make the pie bigger’ by advocating for mandatory accreditation of more modalities than just CT, MRI, and PET and for accreditation of hospital-based imaging, nuclear medicine and radiation therapy, they’re also looking at their proportional slice of that pie. Were they to unilaterally decide on MR safety enhancements to their accreditation program, it might make providers looking for the lowest-threshold CMS accreditation steer clear of ACR. I suspect that the ACR’s thinking goes that, by enacting MR safety standards, they’re likely to lose prospective members and the revenue that their participation in the ACR’s accreditation program provides.

So we’re left with this profound contradiction presented by the ACR. One one hand, they have produced the industry’s best MRI safety best-practice document. On the other hand, they’re playing ‘see no evil, hear no evil, speak no evil’ when it comes to implementing the real-world safety benefits that their own Guidance Document.

And it’s not as if the ACR has any doubts about the value of the Guidance Document… as a safety tool. They have brought together many of the best minds on MR safety, four times now (the 4th release of the Guidance Document is likely to come out in the 2nd half of 2011). The MR Safety Committee lead the charge in disseminating best practice standards relative to NSF screening. And at the ACR’s own radiology quality and safety forum, last year, they were presented with a paper jointly authored by their own MR Safety Committee chair, Dr. Emanuel Kanal, and me, which showed that the explicit provisions in the Guidance Document could mitigate at least 80% of the clinical MRI accidents (see the video of that presentation, here).

So, ACR, you’ve been asked to implement the Guidance Document in your MR Accreditation standards. You’ve said that you would do so. Then you reneged on that promise with an excuse that’s been shown to be tissue-thin. At the same time, representatives have testified before Congress that in the interest of safety, there should be more accreditation of imaging and therapy devices in more healthcare settings.

Explain to me one more time why it is that you can’t honor your promise to include MRI safety standards in your MR Accreditation program?

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PS: Tune back in for the next installment, which will be taking a close look at the Joint Commission’s role in MRI safety.

Revo MRI Sure Scan Pacemaker by Medtronic

You see, up until the Revo, pacemakers were considered a very potent contraindication to MRI exams. Interference from the MRI acting on the pacemaker could turn the pacer off, turn it into a fairly benign ‘asynchronous mode’, start pacing your heart as if it were a hummingbird’s at 100′s of beats per minute, burn cardiac muscle, or drain the pacer’s battery precipitating an earlier-than-planned replacement.

Some pacemaker patients could still get MRI exams, but you had to be the right kind of pacemaker patient, with the right kind of pacing device, needing the right kind of MRI on the right kind of scanner. Even then, you ought to have had the cardiologist and a code team (to resuscitate you if the MRI and your pacer decided to not cooperate), plus someone to de-program and re-program your pacer. Even with those protections, some insurance companies simply forbid coverage of MRI exams for any pacemaker patient.

Along comes the Medtronic Revo pacemaker. This is the first FDA-approved biostimulation implant that has been specifically designed, from the ground up, to permit MR examinations (though it won’t be the last). It is not, however, carte blanche for MRI examinations. There are important limitations, or conditions, for its safe use.

There are three designations, each with very specific critera, that an object or medical device can obtain to describe its relative safety in the MR environment, ‘MR Safe’, ‘MR Conditional’, and ‘MR Unsafe’. Given the fact that I just described the Revo as having important limitations, or conditions for safe use, which of these three designations do you think the Revo has earned?

If an object receives the ‘MR Safe’ designation, it means that that object would be safe under any allowable MRI conditions. Field strength? Doesn’t matter. Magnetic spatial gradient? Who cares. Time-varying gradient? No worries, mate. RF deposition? Don’t worry your pretty little old head. In short, to receive the ‘MR Safe’ designation there can not be any restrictions on its use.

So here we are, with a pacemaker that isn’t ‘MR Safe’, but is being touted in nearly every medical media (or mass media with a health reporter) as the “MRI Safe pacemaker”.

[We'll ignore, for this entry, the fact that a company has already copyrighted the phrase "MRI Safe", as well as the fact that this company uses the copyrighted name to describe products that aren't classified as 'MR Safe'.]

For the lay person, my hair-splitting must seem awfully pedantic. The problem is that the technologist who will administer a patient’s MRI exam gets the bulk of the information about the patient’s medical history from the patient, himself. If the patient doesn’t remember the brand-name of the pacemaker (and so many of them seem to forget — or at least fail to disclose — that they even have the device, I think remembering the model and manufacturer is very unlikely), they’re probably likely to remember that this particular one was “MRI safe”. Now the technologist, charged with vetting the patient for MRI safety, is being given misleading information about the safety of scanning that patient.

So, my call to healthcare media and reporters is to please… PLEASE stop calling the Revo the “MRI Safe” pacemaker. Call it what it is, the first pacer designed to allow MRI scanning, or the first MR Conditional pacemaker, or even Medtronic’s towering achievement (which it is).

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If you accept the notion that an expert is defined as a person who has survived in their industry despite having made nearly every mistake there is to be made, then I’m an MRI suite design expert. I don’t stand in an ivory-tower of self-aggrandizement, rather I offer what I’ve learned, more often than not, the hard way.

So I stumble across designs for an MRI suite that are to be built soon. The building has sprinklers, fire-exits, and presumably conforms to all requisite codes, but the MRI suite… well…

[segue] My bedroom is quite large. It’s big enough that there should be a half-dozen different ways to lay it out with the furniture that I have… except for reading lamps. Despite the size of the room (which suggests a great deal of flexibility), there is only one possible configuration (which doesn’t involve extension cords) that provides an outlet at the bedside table on each side of the bed. This seemingly simple design element constrains the function of this room. [/segue]

If my bedroom and this MRI facility are each compliant with the applicable codes, does that mean that they’re well designed? No, in both cases.

A poorly-designed MRI facility can handicap patient safety (e.g. failure to provide lines of sight to patients in the scanner or entrances to the scanner room), can degrade image quality (e.g. ferromagnetic content in construction, including magnetic shielding, approaching shim tolerances), can impair clinical utilization (e.g. inadequate space or ineffectual layout for anesthesia or biopsy patients), and, when combined, can accelerate the replacement need for equipment ($$$) or facility renovations ($$).

So last week I came across such a design. There were no apparent code violations, but the design ran counter to a very large number of design best practices for MRI. The project manager (working on behalf of the client) and the project architect, who I contacted, were largely dismissive of these concerns. After all, no mandatory codes were violated…

Should I have even stuck my nose in a project that was outwardly none of my business? Rebuffed though I was, should I have taken my concerns further up the food-chain? Or did I strike an appropriate balance of bringing concerns to their attention without evangelizing?

I think that these questions are ‘blog-worthy’ in part because situations like this occur fairly regularly. Sometimes I’m asked, and sometimes I just stumble into situations where I see MRI suite designs that would benefit from a major rework. My firm belief is that these design changes will benefit patients and building owners, but may come at the expense of someone else’s ‘rightness’ or authority. In each instance I find myself coming back to the same questions of how should I best handle the situation.

Tonight, as I’m nodding off to sleep, I’ll try and imagine what it would be like with the bed on the opposite wall, instead of imagining this MRI suite with an efficient and functional layout.

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The Joint Commission (TJC or, to those of us schooled in their acronym more than 3 years ago, JCAHO): TJC has just referenced the 2010 edition of the Guidelines for Design and Construction of Health Care Facilities as the new design and construction standard (effective today). The 2010 Guidelines codifies a number of the MR safety recommendations that have passed from the Joint Commission’s own lips and makes them standards for new construction. In 2011 I will apply whatever cajoling, leveraging, sweet-talking, or shaming that will help the Joint Commission to apply it’s own standards to the thousands of existing MRIs at TJC accredited providers. This began last year with training provided to TJC’s ambulatory care surveyors, forestalled and rebuffed offers of the same for their hospital surveyors.

Centers for Medicare / Medicaid (CMS): At least somewhat in response to the public attention that was focused on the issues of radiology / nuclear medicine safety through the ongoing series of articles by Walt Bogdanich of the New York Times, in 2010 CMS began development of a set of radiology / nuclear medicine patient safety standards that they intend to roll-out as a condition of reimbursement. It is anticipated that these will be unveiled in the spring for public comment before being enacted some time later. I know that, last year, MR safety proposals were presented to CMS, and at the anticipated public meeting I will seek to make sure that the single largest healthcare benefits provider in the US includes substantive MR safety standards.

Food and Drug Administration (FDA): Quick as they were to arrange public hearings on radiology safety (after the first couple Bogdanich articles saw print), the FDA has been ‘in the planning and coordination’ stages of a similar meeting on MRI safety for well over six months. Originally proposed for last year September, the prospective date has been nudged enough times that, as of my last inquiry, they’ve stopped even suggesting months, or even seasons, and I was last left with the promise of ‘sometime in 2011… hopefully the first half…’ I will endeavor to see that this meeting takes place (perhaps in concert with the CMS meeting), because I know that smart, capable people within the FDA have done analyses of MRI accidents and have developed an MR safety ‘short list’ of preventions which the FDA has yet to release, to say nothing of promulgate or endorse. Sitting on effective safety solutions when the accident rate is quadrupling is… well… inconceivable.

American College of Radiology (ACR): At the ACR’s presentation at the 2009 annual meeting of the American Healthcare Radiology Administrators (AHRA), the ACR representatives announced that the organization was going to incorporate MR safety standards from it’s own ACR Guidance Document for Safe MR Practices: 2007 in the ACR’s MR accreditation program. In 2010 I was privately told by a very well-placed person within the ACR that the new CMS oversight of the MIPPA accreditation process made it ‘logistically onerous’ to change the existing MR accreditation program (this despite the fact that the ACR was pleased to submit to CMS — and receive prompt approval for — an entirely new breast MR accreditation program). In 2011 we expect to see a new edition of the Guidance Document, which will make the fourth publication appearing under the ACR’s name that speaks to effective solutions for the reduction of MR accidents… and the fourth one that the ACR will have not included as an element of their own MR accreditation program. Whether it’s through meaningful standards passed down from CMS, or by reversing the apparent hypocrisy of the ACR, itself, I will spend 2011 working to see that substantive MR safety standards are incorporated as a part of the ACR’s MR accreditation program.

So what is the monster-list of standards that would be necessary to mitigate the vast majority of MRI accidents and injuries? Well, it turns out that it isn’t long at all, and all of these are already promulgated as best practice recommendations…

1. Provide annual MR safety training for all MR personnel (and MR irregulars)
2. Restrict access to controlled areas of the MR suite for unscreened / unsupervised persons and untested equipment per the ACR 4-zone model
3. Provide uniform and documented screening for all persons entering controlled areas of the MR suite
4. Screen persons and objects with a ferromagnetic-only detector before allowing access to controlled areas of MR suite
5. Provide hearing protection (and ensure proper usage) for all persons remaining in the magnet room during the MR exam
6. Use positioning aids and insulating pads as recommended to separate the MR patient from RF elements and conductive materials (including their own tissues)

These six items would likely cut the rates of MR accidents by more than 90%! These items have also been recommended (or very similar elements) by the Joint Commission, ACR, and others. If they were enforced, however, we could very nearly eliminate MR accidents in governed facilities!

Getting us to enforcement, that is my 2011 New Year’s Resolution, but I won’t make it there alone. Can I count on you to work on this with me?

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In about 4 years, NSF was identified (originally called Nephrogenic Fibrosing Dermopathy), the culprit identified, the population-specific susceptibility deduced, and effective screening protocols developed and deployed. Yes, it is still possible to develop NSF today, but we also have the tools requisite to interdict the agents that trigger the disease, and an industry-wide awareness of the preventative steps which are effective in doing so.

This is a testament to an international confederation of radiologists, nephrologists, pharmacologists and pathologists who collaborated on the challenge of this disease. It is worthy of a self-congratulatory pat on the back for radiology that we were able to sleuth-out the cause, and disciplined enough to execute effective prevention, in such a short time. But lest we spend too much time singing our own accolades, we should remember that more than 92% of MR accidents studied (selected based on the availability of information on causation), were made up burns, projectiles and hearing damage. These aren’t clinical problems, per se, rather they’re operational in nature.

Perhaps that accounts for the disparity in response. MR is a clinical instrument, and NSF was in the clinical wheelhouse. Yes, it extended well beyond radiology, but it was (and still is) essentially a clinical issue.

More often than not you will never find a radiologist actually in an MRI suite, so they are unfamiliar with – and often uncomfortable with – operational concerns. There are, of course, exceptions to this but those are… well… exceptional.

If NSF can be identified, studied, researched, and ultimately almost universally prevented in the course of a handful of years, how is it that we continue to see alarming year-over-year growth in combined burns, projectiles and hearing damage? If we can study a brand new disease and prevent it with nearly 100% effectiveness, why can’t we make sure insulating pads are used, or that ferromagnetic detectors are part of every MRI center, or that we make sure that hearing protection is used (and used properly)?

For these injuries there is no direct-causation mystery. We don’t need expensive animal trials, or chemical analysis of different contrast agents. We don’t need an international interdisciplinary clinical team. We need pads, ferromagnetic detectors, and earmuffs.

So my appeal, made plain in the headline, is for us to let NSF go. Let us not dwell in an anachronistic state of fear, nor linger any longer in self-congratulation. We have other tasks to help make MRI as safe as we know it can be, and we need to redirect our attention to that job ahead of us.

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