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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About fifteen years ago, there was a fire at a medical office building in Stockton. The smoke was so thick that the firefighters searching the building didn’t see the MRI warning signs on the door they went through. Once inside the room, one firefighter felt his pike (a long stick with a hook at the end used to pull apart loose materials to look for fire) pulled to the MRI scanner.

Immediately recognizing the hazard, the firefighter went and told the incident commander of the risk. But before a warning could be broadcast to the other firefighters, a different fireman, this one with an axe on his belt, approached the MRI scanner and was pulled, bodily, to the scanner by the attractive forces acting on the axe-head.

Fortunately, no serious injuries resulted. (click here for an article on this incident)

Fast-forward to March of 2010, when Stockton MRI goes up in flames.

Stockton, California, MRI Center on Fire.

This time, the firefighters’ hoses, axes and pikes are supplemented with their acute awareness of the hazards of MRI. No firefighter will enter the MRI scanner room without confirming that the magnet is not at field, first. The fire, which didn’t originate in the scanner room, will be fought from all locations except the magnet room.

Apparently, however, one of the MRI’s at the center was in cahoots with the MRI from the fire 15 years earlier, and desperately wanted its very own firefighter souvenir. According to the newspaper report, the magnetic field from the MRI within the building pulled an axe out of the hands of a firefighter who was working on the roof of the imaging center!

As before, the accident did not result in any injuries. Unlike the prior incident, this MRI was denied its own firefighter souvenir .

The moral of this story is that if you’re a firefighter, be very cautious of the MRI’s in Stockton, California. In fact, since we don’t know how far this MRI conspiracy goes, it might be wise for geared-up firefighters to be extraordinarily cautious near all MRI’s!

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This past weekend I had the privilege of participating in OSU MRI conference. I was able to sit-in on a number of the presenters, plus I presented, and was asked to sit-in on a panel discussion on safety with Bill Faulkner and Candi Roth. The conference provided me the opportunity to hear from a number techs regarding their most recent Joint Commission surveys, and I was encouraged by what they had to say.

My (longstanding) prior criticism of the Joint Commission and their MRI patient safety survey efforts have centered around one simple fact… they didn’t do anything with respect to MRI safety. JCAHO hasn’t ever had MRI-specific standards or survey criteria, but I was certain that the 2008 release of Sentinel Event Alert #38 on MRI accidents and injuries would change that, instantaneously (a SEA being the Joint Commission’s ultimate patient safety warning). It didn’t.

I was certain that the change to the Joint Commission’s 2009 changes to their Environment of Care (EC) standard which specifically invoked Sentinel Event Alerts would immediately change their survey methods. Reports I received from JCAHO accredited providers who were surveyed in the first half of 2009 indicated that I was to be disappointed again. But at the OSU conference, the clouds parted and glorious beams of hope shot down from the sky and landed on me.

Yes, I did hear several of the expected ‘their shadow never crossed our doorway’ stories of JCAHO surveyors ignoring MRI. There were also the accounts of ‘checked fire extinguisher and walked out.’ As little as one year ago, I would have expected that to be the end of the list, but several people came up to me and recounted recent surveys in which Joint Commission surveyors asked about…

• Screening forms
• ACR four-zone separations
• MR Conditional equipment
• Infection control procedures
• Emergent / code procedures, and,
• Ferromagnetic screening

One person told me of how the surveyor spent more than 30 minutes in their department, tracing the entire sequence of the screening and care of an MRI patient.

These heartening stories of surveyor attention to MRI were the minority, but given that JCAHO surveys occur on a 3-year interval, that there was any change in the status quo in the past year is likely an indicator of a significant prioritization of MRI safety at the Joint Commission.

The hazards of MRI come from the fact that – as soon as you step into that room – the fundamental laws of physics change, without any outward indication. Non-ferromagnetic objects still fall down, but ‘gravity’ works in a different direction for magnetic materials. This simple, invisible truth requires a host of MRI-specific safety protocols. Application of generalized hospital-wide patient safety standards to MRI hasn’t worked terribly well (as in, not at all) in the past, so I can’t tell you how encouraged I am by this recent news.

If one is truly interested in patient safety, and has been critical of others for a lack of attention to these issues, there is no sweeter sound than to hear that you are wrong. When weighed against the benefits to be realized by MRI patients, staff and providers from enhanced safety (fewer accidents), any swelling of my personal ego is of zero importance. I hope that the degree of my wrongitude only grows from here going forward.

‘On the Joint Commission,’ I should add. I do have my weekly PowerBall lottery ticket, and I would very much love to be right on that.

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This is just one example of a laundry-list of serious projectile accidents that occurred in 2009.

I should note that the above isn’t a real X-ray of this injury, but hopefully it was ‘real enough’ to at least get you to swallow hard at the thought.

In this incident occurred when a technologist was positioning the patient on the table for the MRI exam. At that moment, the person who brought the patient to the MRI department entered the room with a pair of ferromagnetic scissors. The rest, as they say, is history.

But what about this one event makes it worth holding out as an example?

It, like the many other serious projectile injuries of last year, was completely avoidable. And the same is true for the burn injuries, and those that occurred as a result of incomplete clinical screening. These three causes are responsible for over 90% of the serious injuries in MRI.

Often these occur because the only accident protection in place is the vigilance of the technologist on duty (which, increasingly often, is only a single individual). When everything depends on that one, fallible, individual, the process will break down.

Effective clinical screening depends, in part, on the appropriate prescription of MR studies by primary care clinicians (more than half of which, according to a recent study, were unaware that medical implants were a contraindication for MRI exams). A review of the patient’s accurate medical records, effective pre-screening by scheduling staff, careful review of the patient’s screening form, all of which should be done to reduce the burden on the Technologist.

For burns, patients should be transported to MR without any extraneous monitors, equipment or devices. Upon arriving, they should be switched to MR Conditional monitoring equipment, as needed. The site should provide ample insulating and positioning pads to properly situate the patient for the exam. As with the preliminary screening steps, these will also reduce the burden on the Tech’s unblinking vigilance to prevent these types of accidents.

For projectiles, it isn’t realistic to keep a metal-free MRI suite. This means that the objects which can hurt patients or staff, and damage million-dollar scanners, are littered, like time-bombs, throughout our day. Changing patients, educating key support staff, implementing rigorous access controls, and using ferromagnetic detection can dramatically cut the risks associated with projectile accidents.

These preventative steps, above, have two things in common. First, their almost universally accepted as industry best practice. Second, they are universally omitted from any patient safety requirements! That’s right, no regulatory or accreditation body has objective standard requirements for screening, positioning, or projectile protection!

As long as these instances of head-piercing scissors, or leg-crushing gurney rides, or brain-damaging flying carts, or face-whalloping monitor panels, or any of the others, are viewed as just text descriptions of statistical aberrations, instead of easily-preventable human tragedies, we’ll stay stuck with ineffectual recommendations and scores of stupid, stupid injuries.

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Nearly nine years after the accident, the lawsuit was settled for $2.9 million, a settlement that was likely both diminished by, and made possible by, a pre-trial motion which excused GE Healthcare as a defendant to the suit.

The county-owned hospital, which almost immediately asserted its responsibility for the accident, ultimately settled the case on behalf of all of the remaining defendants, which included the head of radiology and the technologist who administered the boy’s scan.

Perhaps now, with the lawsuit resolved, we can actually learn something about the events that precipitated this tragedy, beyond the fragmentary slivers of information gleaned from court documents and news accounts.

That’s right, despite the fact that this one event has become the touchstone for MRI safety, there has not been a single root-cause analysis to inform MRI suite design, departmental operations, regulatory and accreditation frameworks… at least not one that has been shared with the public.

Hopefully, with the lawsuit resolved and jeopardy attached for all defendants, we can have an open conversation about what contributed to the accident and what can be done, at the thousands of MRI suites across the country, to help see that this sort of accident never recurs. Based on recent news accounts and last year’s shocking collection of ferromagnetic projectile accidents, the lessons from the Colombini tragedy are still profoundly needed.

If we are willing to explore this darkest chapter in the brief history of MRI, we may learn lessons that will help protect the 30 million Americans who will receive MRI’s this year, and next year, and the year after that.

If we fail, next year we’ll be able to look back at this moment, wistfully, and imagine young Michael getting his drivers’ license, or attending his junior prom, on the verge of adulthood. But he is forever trapped in 2001… a victim of circumstances he had no control over.

Let’s see what we can do, together, to help make sure that this never happens again.

My heartfelt thoughts and prayers are extended to the Colombini family.

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Many people in the medical industry, even within radiology, are quick to dismiss stories of accidents in the MRI suite as ‘fish stories’ which, though they may be based on a kernel of truth from the original telling, grow and grow as the story gets passed along the line. What may have begun as a pager getting drawn into the MRI scanner, winds up becoming a telephone repairman… or so goes the rationalization. And some seem to think that most MRI accident stories aren’t even really exaggerations, but rather pure fiction, akin to what you would see on some nighttime television medical drama. To these people, any account of a patient bed hitting the MRI could only have come from an episode of ER (as opposed to a real accident having become the basis of the TV show’s fictionalized version)…

Not that there haven’t been cases of gurneys drawn to MRI scanners before, because the MRI professional communities are awash in stories of all manners of ferromagnetic materials inadvertently becoming MRI-homing magnet missiles. Everything from personal computers, iPods, pagers, cell phones, anesthesia machines, ‘sand’ bags, medical gas (oxygen) cylinders, welding tanks, rolling carts, wheelchairs, hand-tools, canes & walkers, furniture, filing cabinets, hand-trucks, and the list goes on, and on, and on (to see pictures of a number of items, please check out this prior post). And yes, even hospital gurneys…

MRI Scanner Eats an ICU Patient Bed

Much to my chagrin, I’ve heard people dismiss the above as somebody’s Photoshop fantasy. Those sorts of statements, sadly, work to diminish all efforts toward MRI safety. But a recent account should, permanently, put to rest any question of whether this sort of thing can really happen. Late last year I posted a story that included links to a number of FDA MRI accident reports. One of the reports to the FDA’s MAUDE database described an incident in which a patient had their foot-ankle-leg injured when they were transported into the MRI scanner room on a conventional gurney (click here to download the PDF file from the FDA’s data). The date in the FDA’s anonymized report coincides very nicely with this somewhat-less-than-anonymous newspaper article that just came out…

Hoag Hospital has been fined $50,000 by the state Department of Public Health after an MRI patient on a metal gurney was magnetically pulled into the imaging machine, the hospital said Friday.

[Dr. Richard] Afable, [chief executive officer of Hoag Memorial Hospital Presbyterian], said that last January a woman was taken into an MRI room on a metal gurney that was not compatible with the machine. The powerful magnet in the MRI pulled the gurney into the machine and the patient’s leg was trapped for about three minutes. She was taken to the emergency room and spent three days in the hospital for treatment of fractures in her lower leg and foot.

The above quote is taken from the January 22nd, 2009 article appearing on the Orange County Register’s website (click here to go straight to the article). Based on the dates, the description of the accident, and the patient injuries, it sounds as if the FDA account is the same incident as what is described in this newspaper article. The $50,000 fine may sound like steep punishment, but considering the cost to restore the magnet after the quench (described in the FDA account), the cost of downtime and lost revenue between the accident and the time the MRI was returned to service, the cost of care to treat the patient, the cost of internal safety / quality / regulatory investigations, the legal costs for the hospital, and any lawsuit settlement costs, the state’s penalty is likely to just be icing on the cake. The cost to the hospital for this transgression could very easily be into 7-figures! All of this simply demonstrates two critical points about MRI safety.

1. MRI accidents do happen, and at greater frequency and cost than many are led to believe.
2. The costs of the safety provisions to help prevent these accidents are peanuts when compared to the costs of accidents.

My soap-box pontificating on this point will likely become moot over the next many months. In a ‘perfect storm’ of regulatory and accreditation attention to MRI safety, we’re very likely to see requirements for MRI safety provisions, such as ferromagnetic detectors (which could have been instrumental in helping to avoid this gurney accident). I will share more about each of these efforts, as I’m able. In the meantime, MRI providers should put a great deal more stock in the validity of MRI accidents accounts and ask themselves, “Do I have adequate physical protections in place, beyond what’s written in my policy manual, to help prevent this sort of accident?” The likely answer is “No.”

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