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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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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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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You see, back in 1983 when GE was going through their pre-market approvals with the FDA for their first commercial clinical MRI system, they indicated that MRI suite safety minimally required ferromagnetic detection pre-screening. The only problem was, it hadn’t been invented yet!

During R&D the physicists at GE discovered that the MRI scanner could be tuned in such a way to create something of a ‘worm hole’ and permit time-travel. Anyone who has spent 2 or 3 hours in an MRI, only to have their wristwatch tell them they’d only been in it for 30 minutes, won’t have a hard time believing that there’s still some vestige of time-warp still left, even in contemporary MRI scanners.

What did the GE physicists see during their clandestine time-traveling jaunts into the 21st century? We suspect that they saw MRI’s everywhere – hospitals, imaging centers, strip malls – and each and every one of them was protected by ferromagnetic detection pre-screening devices. When they returned to 1983, it seemed such a natural thought, to protect patients, staff and these marvelous machines, that the requirement for ferromagnetic detectors actually made it into their safety submittals to the FDA.

Admittedly, I’m taking (more than a little) artistic license here. What GE actually stated in their November, 1983 ‘Hazard Analysis’ that accompanied their MRI device application to the FDA was that metal detection (for prevention of ferromagnetic projectile accidents) was a “minimum requirement” for safety in the MRI suite.

As described in my exhaustive summary of a couple weeks ago, conventional “airport” style metal detectors are actually horribly counterproductive to pre-MRI screening for most patients, particularly when screening for ferromagnetic materials. Operationally, this is a truth that simply couldn’t be known to GE at the time that they were preparing their recommendations for MRI safety, a concern that never really existed before they brought this product to market.

This metal detector “minimum requirement” soon became an unwelcome nuisance, and GE’s promotion of it as a safety tool withered to near-nothingness.

That’s not to say that the hazard that the metal detector was to help mitigate withered, too. In fact, as GE (and Siemens, and Philips, and Toshiba, and Hitachi…) made stronger and better MRI systems, the risks of ferromagnetic projectiles kept ratcheting upward, too.

Today we’re faced with sticky situation… The entire FDA approval of MRI can be traced back to this GE application, which recognized – and required – projectile protection. The only available tool (at the time) turned out to be far less effective than hoped, so its use was discontinued. After a tragic, headline-grabbing MRI projectile fatality in 2001, real ferromagnetic (only) MRI pre-screening instruments were developed, and have been available for a number of years. However, these new tools, which respond specifically to the needs identified by GE almost 30 years ago, haven’t been appointed by manufacturers and regulators to the safety role that they’re meant to play.

Perhaps it’s all a product of the ongoing effort on the part of the government to keep the secret of time-travel… well… secret, but nobody seems interested in revisiting patient protections called for in 1983.

And what became of those GE physicists who originally stumbled upon the secret of MRI time-travel? Well, after collecting data on the forthcoming 20 years worth of Superbowls, World Series’, and PowerBall jackpots, they each decided that working for a living was, simply, too much work.

But you can bet, whatever private island-paradise they own today, when their doctor proscribes them an MRI, they find one with ferromagnetic pre-screening.

; )

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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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ThermaCare HeatWrap Products Contain Iron And May Be Drawn Into MRI Scanners

According to the report, this patient was not injured and the MR staff was able to successfully remove the wrap from the MRI magnet. But any time you have ferromagnetic materials flying through the air near patients and staff, there is the very real risk of injury. Not only to people, but also to a million-dollar MRI scanner!

And assuming that it didn’t go flying, if there’s enough iron in this product that there’s that possibility, there’s likely enough iron to create some significant spatial distortions in the general vicinity of the wrap. And if the little iron ‘nuggets’ were to escape the wrap material and get under the covers to the bore of the magnet, you could wind up with shim problems that require a service call to correct.

According to the ThermaCare website:

“Protected inside ThermaCare^® HeatWraps are air-activated heat discs made of heat-generating materials (iron, charcoal, table salt and water).”

We’re in the process of testing the capabilities of the SAFESCAN® ferromagnetic detectors to detect these materials and I hope to have an update for you on this very soon.

In the meantime, whether you have the SAFESCAN® ferromagnetic screening products or not, please add these types of wraps to your ‘watch list’ of potentially dangerous materials to be kept out of your MRI suites.

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A number of the MRI accident reports, when the narratives weren’t appearing, were little more than the name and mailing address of the MRI manufacturer. Today, if you want to read about the MR Technologist who had a pair of scissors magnetically-impelled into his forehead, you can do so.

MAUDE report of MRI + scissors vs. Tech.

Though I must admit to indulging sinister fantasies that the FDA was trying to ‘cover up’ some of these accidents, so I requested the information that wasn’t being displayed through the online MAUDE database through a good-old-fashioned Freedom of Information request. The result is that I have PDF copies of many stunning, alarming, and disconcerting accidents. And if you’re so inclined, you can download PDF copies of them, too…

• Rolling cart seriously injures Siemens Apps Specialist (facial fractures & brain trauma)

• Flat-screen monitor hits research subject (facial fractures & surgery)

• Patient on gurney gets more of a ride than planned (foot, ankle, leg fractures)

• IV cart nearly strikes patient (near-miss)

• Knife slices patient (laceration requiring stitches)

• ‘Sand’ bag injures patient (brain hemorrhage, tongue laceration and facial injuries)

• Scissors seriously injures tech (embedded in forehead, surgical removal required)

• Bed tray-table (ambiguous injuries, including facial lacerations)

And the above accidents only represent a proportion of the collected number of accidents for little more than half of 2009!

The above list should not scare anyone out of getting an MRI exam. It is meant to illustrate just how far we have yet to go to eliminate the ‘pilot error’ types of accidents which continue to jeopardize patients, staff, and millions of dollars of MRI equipment.

Sometime in February or March, we should have access to the complete 2009 MAUDE data. Early indications already suggest that we’re on track for a dismal year-end report, with a 20% (or more) growth in accident numbers.

Continue to stay tuned for the latest information on MRI accidents and – more importantly – the tools and protocols that can help reduce the risks.

Link

Now, this time line actually fits nicely within the trial judge’s own disposition deadline of January 4th, 2010. At the moment, however, there still is one unresolved pre-trial motion, and there’s nothing to say that the parties to the trial won’t want to go and file more motions (which may wind up pushing the entire time line back, yet again).

Just over a month ago, I wrote about the resolution of three of the pre-trial motions in this case. I was startled by what appears to me to be a disconnect between the judge’s decisions on some of the questions put to the court in the pre-trial motions, and the real world practice of MRI.

It remains to be seen if, as has been done with an earlier pre-trial decision rendered by this same judge, the attorneys for the Colombini family seek to challenge the judge’s rulings on responsibility and authority of the defendants. If that happens, I imagine that it could easily result in another postponement of the actual start of the trial.

If you are interested in following developments on the trial (and other issues of MRI safety) more closely, you are invited to follow me on Twitter for periodic updates, as they become available.

This case (and the event that precipitated it) are likely to be the most important influences on MR safety (hopefully) for a long time. I invite and encourage you to follow these events as they unfold.

UPDATE: Details of the finalized lawsuit settlement are available here.