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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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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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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Damn! I’m impressed, particularly since the abstract also states that this meeting was hastily called in response to articles appearing, starting in January of this year, in the New York Times on radiology and radiation therapy accidents. Such a coordinated response by the professional societies. Such representation from the professional community at a time when conference and professional development budgets are being slashed. How does this compare with MRI?

Well, MRI accidents haven’t been the focus of a string of national news articles, and I certainly wouldn’t begrudge safety-minded professionals within radiation oncology from seizing upon the public attention to address longstanding safety issues… but how do the raw numbers compare? Fortunately, we have an excellent resource for raw numbers and we don’t have to idly wonder.

The FDA’s medical device adverse event database, MAUDE, is much maligned (much of the maligning is by me), but its one redeeming value is that it gives us a snapshot, over time, of medical-device related adverse events.

I searched MAUDE, and from 1999 – 2009, three ‘radiation therapy’ product codes (JAI, LHN, IWB) accounted for 165 total adverse event reports. Some of those included things like pinched fingers while the couch was moving, but some were also the more serious adverse events, such as incorrect dose administration.

During the same 10 year period, the MAUDE database revealed that MRI (product code LNH) has 838 adverse event reports! That’s 5 times as many as radiation therapy! Similar to the radiation therapy reports, there were also adverse event accounts that were spurious, at best, but mixed in were accounts of broken bones, penetrating wounds, and even death, related to MRI hazards.

At the risk of being repetitive, I do not begrudge or belittle the current efforts at making radiation therapy safer for all who administer and receive it. Everywhere there is error in healthcare delivery, we have a duty to work to squeeze it out of existence, and nowhere is that mission more important than in the highly technical arenas of radiology, nuclear medicine and radiation therapy. My frustration, however, lies in the fact that larger safety issues, and safety issues that clearly have a dangerous trajectory, are being ignored.

I would love to see a collaborative forum of 14 organizations, MR manufacturers, and regulatory agencies from multiple countries gather to speak to the alarming growth of MR accidents. I’d love to see 400 professionals convene for a conference dedicated to practical, actionable and direct solutions to our contemporary MR safety needs. Unfortunately, many organizations that have similar duties to the MR community are ‘just too busy’ to look at MR safety right now.

I’ve said it before (and will say it again despite the fact that I hope I am completely and utterly wrong), it may take another high-profile MRI fatality to shake-off the professional indifference to MR safety issues.

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I was invited to present a paper at the American College of Radiology’s meeting on quality and safety held October 22 – 23 in Phoenix, Arizona. Actually, the invitation came in response to an abstract of a paper that hadn’t been written yet [not to self, don't promise papers you've not yet written again].

While the FDA’s adverse event data was clearly never intended to be useful to the outside world (we eliminated over 50% of the events from consideration, primarily because of too little narrative), it did provide a great snapshot of the diversity of accidents. We wound up with 104 useful event reports from an 18 month period of reporting.

We then compared each of these 104 events against the criteria in both the ACR Guidance Document and the Joint Commission Sentinel Event Alert #38. What we found gave us tremendous encouragement… encouragement tempered with some very unpleasant contemporary realities.

Stunning: Our review found that the ACR Guidance Document for Safe MR Practices: 2007 had explicit, actionable criteria that could have interdicted 80% of the 104 tested adverse events! And that doesn’t even include the general provisions for safety such as technologist training, or situational awareness.

The TJC Sentinel Event Alert (SEA) #38 fared somewhat less well, with a 49% effectiveness, though preventing half of the MRI adverse events that are occurring is certainly nothing to scoff at!

Frustrating: Neither the ACR nor the Joint Commission currently have any… ANY… explicit standards for MRI safety, despite the fact that each organization has published best-practice standards that promise to be 80% and 49% effective (respectively) in mitigating MR specific hazards in the MRI suite!

So the conclusion of the presentation offers a challenge to the ACR, the Joint Commission, DNV, and the IAC, to adopt explicit MRI safety standards as a requisite element of accreditation.

If you would like to view the presentation, please see the video (below).

http://www.youtube.com/watch?v=O4zsQ1Yh15A

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“Hey, you, MR technologist! Make sure you know what you’re supposed to know to keep people safe around MRI.“

Make no mistake, as someone who spent a decade in college (which included a Masters degree and about half of a 2nd Bachelors), I’m a huge fan of education. What I’m adamantly opposed to – when it comes to MRI safety – is education without any standards or benchmarks, which is precisely where we find ourselves today.

The title of this post really isn’t far off the mark of what the current expectations of safety are. Regulatory, licensing and accreditation bodies seem to be unanimous in their concern that explicit MRI safety standards (even for education) would be ‘burdensome’ to the provider. As a result, many MRI providers find themselves in a position where they aren’t provided support tools to enhance safety, with the rationale that a ‘good tech is all you need.’ But at the same time, nobody has defined what MRI safety knowledge makes the ‘good tech’, well… good.

In a few weeks I’m going to be at the ACR ‘Maximizing Value in Radiology through Quality and Safety Improvements‘ meeting. At that meeting, I’ll be presenting information from a paper written by Dr. Emanuel Kanal and me; a retrospective analysis of FDA adverse event reports on MRI. The data is pretty grim.

Since 2004, reported MRI adverse event reports are up to a number more than 4-times what they were. Of the MR-specific reports, just over 92% of them fall into 3 categories, each of which could be significantly attenuated if existing ‘best practice’ guidance was simply adopted as required standards. Our analysis found that 80% of these adverse events had an explicit, measurable best practices that would have stopped them, and that doesn’t even include benefits to be gained from ill-defined standards for ‘provide MR safety training.’ Presumably enhanced training would both reinforce the explicit performance measures (enhancing the effectiveness of mitigating those 80% of events), and would likely diminish the 20% remainder that weren’t directly combated by the explicit measures.

So while the trend data is very disconcerting, the good news is that we already have the tools to reverse the alarming growth in MRI accidents. This patient safety initiative is so extremely ‘shovel ready’ that it could be deployed with little more than a few words amending existing accreditation and license standards.

In the meantime, imaging providers are slashing staffing ratios, cutting out travel allowances for conferences and training, seeking out less-experienced MR personnel (who will work for a lower salary). So while we admonish MR techs to ‘learn what you don’t know that you don’t know,’ we’re simultaneously taking away the tools that they might actually need to accomplish this near-impossible task.

In the weeks ahead I’ll be able to share more of Dr. Kanal’s and my research, but the take-away is already apparent…

We will continue to injure our MR patients, visitors and techs at increasing rates unless the accrediting bodies (ACR, TJC, and IAC), the regulatory authorities (FDA and individual State departments of health) and 800-pound gorilla payors (CMS) pick up and codify the practice standards that have been laid at their feet.

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Well, in case your imaginations have only wrapped around the aftermath, and not the incident, I’ve just recently come across another visual aid that might just help you with the complete picture. Imagine a pair of scissors, an MRI, and a pumpkin…

MRI + scissors + pumkin = Do Not Try This!

Now, the screen shot, above, taken from the video doesn’t do the moving picture justice. I encourage you to take a look at it for yourself. But before you do it is vital to remember that this isn’t just a hypothetical. This accident and many, many other MRI projectile accidents – with, thankfully, less catastrophic outcomes -  occur all the time.

This isn’t simply a gee whiz scientific demonstration. This represents the real nature of projectile threats. It is at our (and our patients’) own peril that we relegate these to intellectual curiosities instead of cautionary tales.

So, with that prelude, you can find the video here.

I hope that every single MRI is adequately protected against similar sorts of accidents. This protection should include, in nearly every instance, ferromagnetic detection screening of patients, visitors, and equipment.

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Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams

The review has been requested by Robert Russo, MD, with Scripps Research Institute. A copy of Dr. Russo’s request can be viewed here.

The public comment period is open through July 28, 2010, and I strongly encourage anyone with questions or concerns about the safety of MR imaging for patients with implanted cardiac devices (Dr. Russo correctly points out that CMS’ restriction fails to speak directly to implanted cardio-defibrillators, or ICD’s) to offer their comments to CMS.

The full explanation of the current restrictions on MR imaging of pacemaker patients (also aneurysm clip patients, and pregnant patients), as well as the instructions for reviewing other public comments or submitting your own, can be found here.

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That’s right, the FDA has updated it’s MRI accident figures available online through the MAUDE database. We were alarmed and astonished when we thought that the rate of increases in MRI accidents was only 270% (from 2004 to 2008). Turns out that the FDA must have found additional accident reports that were in a stack of junk-mail, or got lost between the sofa cushions, which means that the rate if adverse events went up, significantly, in 2008 from the prior calculation.

Somehow, when I did the analysis last year (in 2009) of the 2008 numbers, it was apparently 11% shy of the final total. When we add the (previously uncounted) adverse events, the actual rate of accident growth is 310%!!!

Between 2004 and 2008, MRI Accident Rates Increased 310%

That’s right, in 2008 we were more than 4 times as likely to injure someone during an MR exam than we were just four years earlier!

What would happen in your town if:

• Traffic accidents quadrupled in 4 years?
• Rates of violence in schools quadrupled?
• Divorce rates increased 4x in 4 years?

Alarm bells, that’s what! People for certain would not be complacent.

There would be efforts to figure out why, and fix whatever was going wrong. Reduced speed limits or more traffic enforcement? You bet! Counselors in the schools and demands for greater teacher and parent involvement? Darn right! Lay and religious leaders reassessing the very nature of the marital institution in our society? Abso-friggin-lutely!

So, with an exploding rate of MRI injuries and adverse events, what is being done to identify and curb the source of these incidents? [cue cricket sounds]

NOTHING!

Apart from the continuous efforts of a small cadre of MR safety advocates, whose cries have (apparently) fallen on deaf ears, there are no substantive accreditation, licensure, or regulatory actions that have reversed the trend of the last several years.

The silver-lining may be that the increase from 2008 to 2009 was very modest. Perhaps we’re leveling-off, or perhaps, like 2004, this is just a momentary pause before we skyrocket upwards again. And given the FDA’s marked upward adjustment of the 2008 numbers, it may wind up being another year before we can feel confident about the 2009 accident report numbers.

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