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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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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Also, make no mistake that I find the highly publicized flock of radiation exposure accidents abhorrent oversights. Whether it was equipment calibration, record errors, or simple human foul-ups, each of these violates the simple truth of the special obligation to patient safety that imaging has. But I think we have to look at these accidents squarely, and assess what went wrong, what the adverse outcomes were, and the appropriate preventative and mitigating steps are before we promote knee-jerk responses.

I am enthralled by MRI. And while my life and livelihood are by no means tied exclusively to this one modality, I am certainly doing myself no worldly favor by suggesting that the ‘simple fix’ of moving more patients to the safe solution, MRI, is neither simple nor necessarily safe (or safer, which is really the object). Hear me out…

Medical radiation accidents, in most of the reported cases, involve over-exposure of the individual. While there are extreme examples of this that result in clear, severe and sometimes fatal outcomes, most these over-exposures are similar in incremental lifetime risk to that of having spent your teenage years sun-worshiping, instead of worshiping bottles SPF 30. The best estimations for many of these accidents are that they involve modest increases to lifetime risks of developing cancer… outcomes that will manifest themselves often 20 years or more after the exposure.

It should not be forgotten that MRI is not without its risks. While they aren’t insidious, clandestine biological risks like lifetime cancer probabilities, they are equally serious. Recent examples include burns (up to a severity requiring amputation) magnetically-induced projectiles breaking bones or crushing body parts, and earlier this year a woman who was struck, killed, and her corpse magnetically-pinned to the MRI scanner!

Because the negative effects of medical ionizing radiation exposure (from X-ray based modalities, radiopharmecuticals or beam therapies) often won’t be realized for decades, particular consideration should be paid to treating the young, those under 30. Whenever feasible and clinically appropriate, these patients should be considered for non-ionizing exams and therapies, such as MRI or ultrasound, in lieu of CT. But we shouldn’t simply redirect everyone who can name all three Jonas Brothers to MRI, certainly not with how well we’ve been managing those risks.

While it hasn’t made Walt Bogdanich’s New York Times series on radiology accidents, the last several years of MRI accident data show accidents and adverse events quadrupling over four years! MRI is currently still an extraordinarily safe imaging option, but the meteoric growth in accidents, and the continued acceleration of that growth, are each frightening.

I have a ten-year-old daughter, and we have (reluctantly) acceded to her having a fluoroscopic exam, and I would choose an MRI, hands-down, for anything for which it was equally diagnostic. But each year that I watch the accident-trend data, the calculus gets a little bit more difficult. The MRI grows less appealing, and this is egregious because it should be the irrefutably safe option.

You see, we know what causes MRI accidents, and we know how to prevent them. The fact of quadrupled MRI accidents isn’t because of sunspots, or statistical clusters, or global warming, or MRI voodoo dolls, or anything else similarly beyond our understanding or control. The fact of quadrupled MRI accidents is because we, individually and collectively, fail to act. We fail to follow industry best practices. We fail to even expect best practices of our providers!

We should directly confront the issues of radiology safety, and not just those that land on the pages of the NY Times. In imaging we have a particular obligation to protect our patients, including those going for MRI.

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PS: They’re Nick, Joe and Kevin (the Jonas Brothers). You could either think I’m under 30 (‘Ha’), or realize that I have a pre-teen daughter… Take your pick.

“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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Wired UK Illustration by Lee Hasler. Click for Wired UK source.

The UK edition of Wired magazine just ran one of their ‘featurettes’ on this blog and picked their favorite (though, that’s a slightly squint word-choice for potentially deadly accidents) types of projectile accidents. Quote’s from — and a direct link to — the article follow.

Often when I renew my subscription to Wired (the US edition) I get the complimentary tote, or whatever other trinket they’re giving away. This time, however, apparently my renewed subscription coincided with a small feature in the UK edition for this blog! [Perhaps I should start subscriptions to Forbes or Yachting to see if there's content-related good fortune that rubs off from either of those!!]

Below are quotes from the article (the original version of which is just a click away on the article title, below) and some of my added links to related content that aren’t in the online edition of the article. Please do visit the Wired UK site (click on the quoted headline, below) because they have embedded links to other, very interesting related Wired articles.

MRI’s fatal attraction

By Vaughan Bell|06 August 2010

Look out! It’s the dark side of the magnetic force

“It’s like Russian roulette, except that many don’t know that they’re even playing,” says Tobias Gilk, a California-based MRI safety consultant. MRI scanners have electromagnets so powerful that they can dislodge pacemakers, suck in beds from across the room and turn small metal objects into dangerous “ferromagnetic projectiles”. Gilk now collects data and reports of incidents at mrimetaldetector.com/blog.

[Well, maybe not dislodge pacemakers, but certainly disrupt them... sometimes with fatal results.]

Here are six of Wired’s favourite MRI metal menaces.

Floor polisher
This is so common that the internet has whole galleries of trapped cleaning machines. Floor polishers end up stuck in scanners when cleaners stroll into MRI facilities out of hours and only realise they’re in trouble when their equipment starts to gravitate towards the magnet.

[We could establish a very long gallery of floor polisher accident photos. In fact, in the 'Flying Objects' image collection of my friend Moriel Ness Aiver on his website, SimplyPhysics.com, there are quite a number of them to see! And while they don't show you the actual accident, here's a link to a Seattle news story on a floor-polisher meets MRI accident that occurred there.]

Metal gurney
A patient and a metal gurney were both lifted off the ground and pulled towards the magnet as they were accidentally wheeled into the MRI room. The scanner had to be shut down in order to free the bed, and the unlucky patient suffered from foot, ankle and leg fractures.

[Here's a link to the FDA accident report for this specific accident (the news account having been linked above). And here's a link to a popular image showing an ICU bed magnetically adhered to the face of an MRI scanner.]

Pistol
An MRI machine disarmed an off-duty US police officer. She forgot she was carrying her Glock pistol as she accompanied her mother, who was being scanned. The gun was pulled by the magnetic force, jamming her hand between the pistol and the machine and trapping the officer.

[Here's a link to my summary of the news story from that specific incident. There is also a peer-reviewed journal piece on a different, but similar, incident in which the handgun actually fired, despite the presence of two engaged safeties.]

Flat-screen
A member of the public who was inside the scanner solely for research purposes got badly injured when hospital staff walked a flat-screen monitor through the room. The magnetic field tried to put the screen and the participant in the same place; the next stop was casualty.

[Here's the link to the FDA accident report PDF for this one, too.]

Scissors
An MRI technician ended up with a pair of scissors embedded in his forehead as he prepared a patient. Someone entered the scanner room with the scissors in their pocket — they were pulled out by the magnet and collided arrowstyle with the technician’s head.

[There have been multiple accidents involving flying scissors in the MRI room. This one is among the most severe.]

Wheelchair
A wheelchair brought into the danger area shot across the room and pinned a radiographer to the scanner. The staff member was unharmed but a patient waiting for her scan was so frightened she fell off the bed and broke her leg.

[As with floor polishers, there have been many, many incidents of not-safe-for-MRI wheelchairs being brought to the MRI room. You can see a couple of these, as well as a sampling of other projectile objects here.]

Wired UK, September 2010

I am very flattered that the editorial staff at Wired UK included information on our humble little blog in their September, 2010 issue. I hope that this sort of attention raising opportunity is not lost on the audiences in the US and elsewhere.

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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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If you’d like to watch it, it’s in 3 parts. The first of 3 is available here (requires QuickTime viewer).

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Just a few months ago a service engineer was replacing a fan-blower assembly in an MRI unit (a part that is notoriously ferromagnetic). Working alone in the suite in the evening, after the regular staff had left, the engineer had finished early… or that’s what the security guard thought when he called to her and got no reply.

Turns out that she had been struck and pinned to the MR scanner by the blower assembly, and was unconscious, if not already dead, when the guard checked to see if she was still there.

This tragic story is something of a departure from my typical mantra of patient and staff safety. Yes, this was a trained individual who knew about the risks of the MR environment and materials she was working with. And yes, this was a vendor, and not a hospital worker or patient. But this is a repeatable condition, and an accident which, because there have been MRI accidents involving such a tremendous variety of ferromagnetic materials, deserves a little analysis for a ‘lessons-learned’ output.

One of the (theorized) main contributing factors to this accident is the design of the magnet room. Since the advent of active shielding, we’ve seen MRI rooms go from the size of racquetball courts to office cubicles. In this case, the clearances around the magnet were uncomfortably tight, and what space there was between the magnet and the walls of the suite was purportedly infringed by shelves, storage and clutter.

By failing to provide an appropriately-sized room to accommodate not only the MRI unit itself, but also the service and storage needs, the layout may have substantially increased the likelihood of an accident.

And while conventional screening methodologies wouldn’t have helped in this particular scenario (the object already in the MRI room), it’s not like this is the only strange thing that has been brought into a MRI room to be ‘sucked’ into the scanner. Yes, we all know about oxygen tanks (well, apparently we don’t, as there was another one reported recently, here), but they aren’t all!

Personal computers, iPods, filing cabinets, desk chairs, anesthesia machines, cribs, gurneys, wheelchairs, dollies, staplers, power tools, axes, roller skates, ‘sand’ bags, hampers, mop-buckets, and the list goes on, and on, and on… All of these, and many, many more objects have found their way into MRI scanner rooms. Sometimes the people involved, like in the circumstances surrounding the recent fatality, know that they’re taking a risk. But at least as often the accident occurs because the person is unaware of what they’re doing.

The magnets don’t take vacations. They’re not on just when ‘taking the picture’. They’re not turned off for the night when the last patient is done for the day. The risks are omnipresent, which demands that we are equally vigilant about providing the appropriate protections for everyone and everything that approaches the MRI room.

In the weeks ahead, I hope to have information for you about some of the efforts in the works that may help codify some of these expectations at the point of care. Suffice it to say that right now, for the first time in the U.S., substantive consideration is being given to explicit MRI safety requirements at the point of care. This is still all in the formative stages, and lots of work remains to be done. But perhaps when it is, there’s an umbrella drink and sandy beach with my name on them.

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