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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The ECRI report references a publication from the Pennsylvania Patient Safety Authority that identified 148 reported cases of inadequate screening for ferromagnetic materials in 2008 in that state alone. Based on what we know about ferromagnetic material risks, my suspicion is that this 148 number is only a drop in the bucket of the actual rate.

Though, if we simply accept the 148 incidents, and multiply times 50 to get a rough approximation for the whole US, that indicates that we have 7,400 annual failed screenings for ferromagnetic material, each of which has the potential to injure patients, staff, or incapacitate a million-dollar MRI scanner.

What to do about this silent safety epidemic that is almost wholly avoidable? Well, it wouldn’t hurt to follow the recommendations of the ECRI Institute, number one of which is:

“Consider installing ferromagnetic detectors to screen patients and equipment. These are handheld wands and walk-through/wheel-through or walkby/ wheel-by detector systems positioned before the entrance to the MR environment.”

–’2010 TOP 10 TECHNOLOGY HAZARDS,’ ECRI Institute

So, we can add the ECRI Institute to the chorus of voices that includes the ACR, VA, JCAHO, and MR safety experts that all call for ferromagnetic detection as a part of pre-MRI screening.

If you would like your own copy of the ECRI publication, they are graciously making it available as a free download from their website.

If you would like information on the Mednovus SAFESCAN® ferromagnetic detection products, these are available on the company’s website.

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

Just how much is the settlement? Well that’s (temporarily) subject to a little ‘good news – bad news’ dichotomy.

The good news is that the settlement is not confidential and will be part of the public record. The bad news is that we will have to wait a month or so until all of the formal paperwork is filed with the court to become part of the public record. The parties to the suit (and now the settlement) have agreed to keep everything on the down-low and not seek any publicity associated with the resolution. In short, they’re not talking.

My understanding is that Westchester Medical Center’s parent organization settled on behalf of itself, and the director of radiology / owner of the MRI management company, and the technologists who had been named. This settlement may, ironically, have been both enabled and motivated by the fact that GE had been dismissed as a defendant to the suit in a pre-trial motion.

I can’t begin to fathom the difficulty for the family, reliving their greatest loss through nearly a decade of incessant litigation. In that context, I can fully appreciate the desire to resolve the suit and avoid a trial. I have made no secret, however, of the fact that I wanted a public trial, replete with special reports from Sanjay Gupta televised on CNN.

Why would I want to shine such a glaringly bright light on our industry? Not out of any lack of sympathy for the family. Not to feed an irrational panic about what is one of the safest medical services available. But to focus attention on how we can eliminate at least 90% of all the MRI accidents through changes to operations and protocols. I even had a ‘dream team’ list of non-monetary concessions I wanted to see from the various parties.

From Westchester Medical Center: I wanted the hospital to honor the original promise of transparency made by then-hospital President and CEO, Edward Stolzenberger. I wanted articles, presentations, papers, that explained what went wrong, and what interventions they’ve developed (or that others have developed that they support). I’d like to see a real failure mode effects analysis (FMEA) for this accident.

From GE Healthcare: I wanted to see a new corporate policy that every MRI projectile accident for magnets under GE’s care of which they’re notified (as in “please come and pull out this wheelchair,” or, “we got the wheelchair out, but we need to have this busted coil replaced,” or, “did we ever tell you about what happened here last week?”) to be recorded. Three things should happen. The event should be recorded in the magnet’s service history. A letter should be sent to the client site, notifying them that the record of this accident (and the grave safety risk that it presented) has been entered in the service history. And an incident report should be filed with the FDA for their Medwatch database.

The Colombini family: I do know that one of the principal motivations for the family was to try and make sure that similar accidents don’t happen to other families. I would like to see them lend their name to the development of a fund dedicated to the promotion of MRI safety. In fact, it could be something like an endowed faculty position, but with an ad hoc expert paid to provide presentations or develop materials free from institutional bias. I can even think of someone I’d nominate for the ‘Colombini MR Safety Chair’… the name (absurdly) rhymes with “banal.”

Do I think that these things can still happen without their having been a trial and jury verdict? Yes, they can. My fear, however, is that each of the parties involved would like nothing more than for this entire event to ‘slip quietly into the night’ and fade from everyone’s memory. And while I understand that motivation, I’m afraid that this will rob us of the ability to leverage meaningful change from the MRI industry that would make the next fatality less likely.

UPDATE: Details of the lawsuit settlement are available here.

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.