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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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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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

Some insurance payers are beginning to refuse reimbursement for care that is necessitated by certain ‘never events’, and that list is likely to grow. And while they may not always result in patient injury, I’d like to propose my own list of 5 MRI ‘never events’ which should at least trigger an investigation…

#5 Unauthorized Access: If any person, patient, visitor or staff member, gains access to the restricted areas of the MRI suite (Zones III and IV) without having been appropriately screened and supervised, this should raise red-flags and be the impetus for a review of the physical protections and operational protocols. Too often, because these safety-symptoms don’t immediately result in injury, they are disregarded as harmless, which couldn’t be further from the truth. If unscreened people or equipment are making it into the controlled access areas of the MRI suite, it’s only a matter of time before one of them is involved in a real accident.

#4 NSF / Renal Function Screening: A year ago, this may have appeared as the #1 item on this list, but the fact is that, today, many facilities are doing a great job of this. Essentially, we need to provide, at a minimum, a renal function risk-factor screening for every patient prior to being administered Gadolinium-based contrast agents. And, minimally, for patients identified as falling within one of the higher-risk profiles, a calculated eGFR should be taken for verification of patient risk and to inform the treatment of that patient. As with the #5 never event above, the failure to provide effective screening, even if it doesn’t result in an adverse outcome, is enough to warrant a review of operational protocols.

#3 Contraindicated Implants: There are times when, as a concurrent result of poor patient history / records, and inconspicuous (or absent) indicators for medical devices, patients (or visitors) enter the MRI scanner room with contraindicated devices. Nobody expects MR Technologists to be omniscient about what is on or inside their patients, but it is critical that we provide an appropriately thorough screening for the circumstances to try and ascertain whether the patient has any of the potpourri of shunts, pacers, stimulators, clips, pins, plates, etc… that may be dangerous to them. Any failure to use the appropriate means available to identify contraindications should, minimally, spur an evaluation of policies & procedures.

#2 RF Burns: This one factor may be the fastest-growing source of patient injury in MRI. By verifying that unneeded coils and leads are removed, that remaining leads are appropriately positioned and insulated from the patient, that the patient’s body is not positioned to form large-caliber loops, and that there is appropriate distance / insulation between the patient and any transmitting RF coils are all integral, requisite elements to minimizing the risks of MR burns. A failure to follow the appropriate steps to protect the patient, even if the shortcut doesn’t result in a visible burn, should (as with the proceeding never events) trigger a review of operational procedures.

#1 Projectiles / Missiles: Screening protocols should do everything to make sure that ferromagnetic materials are not brought into the MRI scanner room. Any discovered ferromagnetic material inside the MRI room indicates a breakdown in screening and presents all of the ingredients for injury or equipment damage. Particularly for MRI providers that don’t gown all of their patients, the use of a ferromagnetic detector is more than just recommended, it is codified in the ACR Guidance Document for Safe MR Practices as a part of the MR safety best practice. And as with all of the MRI never events before #1, any discovery of a ferromagnetic threat inside the magnet room should trigger a review of existing protections, operations and protocols.

While these 5 don’t encompass all of MRI safety, they do clearly represent 5 of the most common (and most avoidable) hazards in the MRI environment. MRI providers should have rigorous protocols and protections to minimize these risks to patients, staff, visitors and, in the case of projectile accidents, millions of dollars of MRI equipment.

It suggests that, legally, you’re out on your own.

Let’s contrast this with two situations, starting with an adverse Gadolinium contrast reaction.

If a site were to inject a patient with impaired renal function with Gadolinium contrast and that patient developed NSF (God forbid), and the damages were determined to be $10 million, that patient could conceivably sue the pharmaceutical manufacturer for failing to make the NSF warning sufficiently bold on the packaging (by the way, watch for news reports of lawsuits mimicking this hypothetical model following this decision). Yes, the provider would likely have a piece of the $10 million pie, but the liability would move up and down the ‘food chain’.

If, on the other hand, a catastrophic SAR accident in MRI facility were to critically injure a patient, and the damages for that accident were similarly determined to be $10 million, the Supreme Court decision suggests that the device manufacturer can not be held liable in a state suit. This reasoning concludes that the sum-total of any liability, malfunction, or negligence is laid at the feet of the MRI provider.

Personally, I think that these two decisions bracket the area where the law should be on this issue, but they are both so far from the rational middle-ground that it will require at least one more case before we can begin to make sense of this.

In the meantime, what this suggests to me is that MRI providers are out in the legal forest with no ‘Hansel and Gretel’ breadcrumb trail back to others who share their responsibility to patient safety.

What does this mean, in terms of how these facts should influence our behavior?

For a multitude of reasons (including the specter of legal liability), MRI providers should proactively look at their MRI safety protocols and provisions. All sites should follow the ACR and JCAHO recommendations and use ferromagnetic-only screening instruments. If you are Joint Commission accredited, take a look at the new EC Standards and Sentinel Event Alert #38. All MRI providers should also scrutinize the ACR Guidance Document as the basis for their own safety manuals.

A combination of these new 21st century MRI safety technologies, updated accreditation standards, and the industry-standard practices documents, should guide providers to help deploy the greatest protection for patients and staff (and liability protection for themselves).

Until this legal-liability disparity is resolved between pharmaceutical and device manufacturers, it seems to me that the most prudent course of action is to take the additional steps needed to provide the recommended safety solutions as indicated by the ACR and JCAHO. These would include careful adherence to established screening protocols and the use of recommended ferromagnetic detection systems.

PS: you might be interested in a similar article I wrote for The Health Care Blog

But then, typically after I’ve lost all hope of seeing anything that approaches reality, something plausible and even downright real is shown on one of these programs…

OK, so there are probably 100 unreal aspects to the above clip (like MD’s, even though they’re residents, bringing the patient to the MR to run the scan themselves). But the main message, the patient bed being drawn to the MR, is a concern. And the concern is not theoretical, but is in fact quite real.

Beyond the above photo, an anecdote was shared with me by a trusted source of an accident somewhat similar to the video clip above.

In the story, an end-stage AIDS patient in a hospital is brought down for an MRI and, like in the video, is transported into the MRI scanner room on a conventional hospital bed. As in the video, the magnet attracts the bed which rolls across the floor until it strikes face of the MRI machine. The impact of the front end of the bed (where the patient’s feet are) against the machine causes the back end of the bed (where the patient’s head is) to lift up off the ground momentarily. The magnetic field of the MRI is pulling on the back end of the bed, however, and essentially catapults the back end of the bed over the front end, smashing the patient’s face and upper-body against the outside of the MRI scanner.

According to my source, the patient died a couple days later and the official cause of death was identified as ‘complications from AIDS’ and there was no explanation offered for the severe facial contusions and fractures that were present at the time of death.

Now, I wouldn’t suggest that you take every fish-story you hear at face value, but the more I learn about the breadth and breathtaking frequency of MRI projectile accidents, the less skeptical I’ve become about the relative ‘impossibility’ of the anecdotes I’ve heard. Some of the most outlandish and improbable have proven to be true.

Per the aphorism, “as soon as you make something foolproof, they come out with a better fool,” there is no way to 100% prevent projectile accidents in the MRI suite. However, the fact that we can’t make a safety solution ‘foolproof’ is no reason to reject the healthy improvement that we can make with improvements to process and technology.

Appropriate staffing levels, regular MR staff training, access controls tied to screening protocols, and ferromagnetic detection systems all help to reduce the risks of projectile accidents in the MRI suite. The first three of these four options have been well known elements of MRI safety for years, and yet projectile accidents keep occurring and the overall rates of MRI accidents appears to be climbing… alarmingly.

Simply put, we have the ability to make these sorts of accidents largely fictional, left to ER and House, but we haven’t done so. And when prime-time television is more honest about MRI accidents than the industry is (even if their honesty is purely coincidental), we’ve all got a way to go.

So, it surprised me, more than a little, when I came across this gem…

“There must be metal detectors at the entrance to every room with a MRI device.”

Realizing that the speaker meant ferromagnetic detection, these words sound like ones that have passed my own lips, or those of noted MRI safety guru Dr. Emanuel Kanal. Imagine my surprise to learn that this statement was issued by none other than Walter Marzendorfer, CEO of Siemens’ MRI business unit.

The interview, which appears in the Israeli business publication ‘Globes’ [click here to go to the Globes interview], includes the statement about the magnetic field risks and the necessity of projectile detection to help mitigate the safety concerns.

“The main safety issue where MRI is involved is the fact that it is a magnet. Accidents happen when a doctor enters the MRI room with a scalpel in his pocket and bends over the patient. People forget. There must be metal detectors at the entrance to every room with a MRI device.”

–Walter Marzendorfer, CEO of Siemens’ MRI business unit

I believe that Siemens Medical worldwide views this statement with the same unequivocal eye with which I read it, and that ferromagnetic detection will be offered for Siemens MRI installations.

Stay tuned as the MRI vendor situation develops!