Damn! I’m impressed, particularly since the abstract also states that this meeting was hastily called in response to articles appearing, starting in January of this year, in the New York Times on radiology and radiation therapy accidents. Such a coordinated response by the professional societies. Such representation from the professional community at a time when conference and professional development budgets are being slashed. How does this compare with MRI?

Well, MRI accidents haven’t been the focus of a string of national news articles, and I certainly wouldn’t begrudge safety-minded professionals within radiation oncology from seizing upon the public attention to address longstanding safety issues… but how do the raw numbers compare? Fortunately, we have an excellent resource for raw numbers and we don’t have to idly wonder.

The FDA’s medical device adverse event database, MAUDE, is much maligned (much of the maligning is by me), but its one redeeming value is that it gives us a snapshot, over time, of medical-device related adverse events.

I searched MAUDE, and from 1999 – 2009, three ‘radiation therapy’ product codes (JAI, LHN, IWB) accounted for 165 total adverse event reports. Some of those included things like pinched fingers while the couch was moving, but some were also the more serious adverse events, such as incorrect dose administration.

During the same 10 year period, the MAUDE database revealed that MRI (product code LNH) has 838 adverse event reports! That’s 5 times as many as radiation therapy! Similar to the radiation therapy reports, there were also adverse event accounts that were spurious, at best, but mixed in were accounts of broken bones, penetrating wounds, and even death, related to MRI hazards.

At the risk of being repetitive, I do not begrudge or belittle the current efforts at making radiation therapy safer for all who administer and receive it. Everywhere there is error in healthcare delivery, we have a duty to work to squeeze it out of existence, and nowhere is that mission more important than in the highly technical arenas of radiology, nuclear medicine and radiation therapy. My frustration, however, lies in the fact that larger safety issues, and safety issues that clearly have a dangerous trajectory, are being ignored.

I would love to see a collaborative forum of 14 organizations, MR manufacturers, and regulatory agencies from multiple countries gather to speak to the alarming growth of MR accidents. I’d love to see 400 professionals convene for a conference dedicated to practical, actionable and direct solutions to our contemporary MR safety needs. Unfortunately, many organizations that have similar duties to the MR community are ‘just too busy’ to look at MR safety right now.

I’ve said it before (and will say it again despite the fact that I hope I am completely and utterly wrong), it may take another high-profile MRI fatality to shake-off the professional indifference to MR safety issues.

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“Hey, you, MR technologist! Make sure you know what you’re supposed to know to keep people safe around MRI.“

Make no mistake, as someone who spent a decade in college (which included a Masters degree and about half of a 2nd Bachelors), I’m a huge fan of education. What I’m adamantly opposed to – when it comes to MRI safety – is education without any standards or benchmarks, which is precisely where we find ourselves today.

The title of this post really isn’t far off the mark of what the current expectations of safety are. Regulatory, licensing and accreditation bodies seem to be unanimous in their concern that explicit MRI safety standards (even for education) would be ‘burdensome’ to the provider. As a result, many MRI providers find themselves in a position where they aren’t provided support tools to enhance safety, with the rationale that a ‘good tech is all you need.’ But at the same time, nobody has defined what MRI safety knowledge makes the ‘good tech’, well… good.

In a few weeks I’m going to be at the ACR ‘Maximizing Value in Radiology through Quality and Safety Improvements‘ meeting. At that meeting, I’ll be presenting information from a paper written by Dr. Emanuel Kanal and me; a retrospective analysis of FDA adverse event reports on MRI. The data is pretty grim.

Since 2004, reported MRI adverse event reports are up to a number more than 4-times what they were. Of the MR-specific reports, just over 92% of them fall into 3 categories, each of which could be significantly attenuated if existing ‘best practice’ guidance was simply adopted as required standards. Our analysis found that 80% of these adverse events had an explicit, measurable best practices that would have stopped them, and that doesn’t even include benefits to be gained from ill-defined standards for ‘provide MR safety training.’ Presumably enhanced training would both reinforce the explicit performance measures (enhancing the effectiveness of mitigating those 80% of events), and would likely diminish the 20% remainder that weren’t directly combated by the explicit measures.

So while the trend data is very disconcerting, the good news is that we already have the tools to reverse the alarming growth in MRI accidents. This patient safety initiative is so extremely ‘shovel ready’ that it could be deployed with little more than a few words amending existing accreditation and license standards.

In the meantime, imaging providers are slashing staffing ratios, cutting out travel allowances for conferences and training, seeking out less-experienced MR personnel (who will work for a lower salary). So while we admonish MR techs to ‘learn what you don’t know that you don’t know,’ we’re simultaneously taking away the tools that they might actually need to accomplish this near-impossible task.

In the weeks ahead I’ll be able to share more of Dr. Kanal’s and my research, but the take-away is already apparent…

We will continue to injure our MR patients, visitors and techs at increasing rates unless the accrediting bodies (ACR, TJC, and IAC), the regulatory authorities (FDA and individual State departments of health) and 800-pound gorilla payors (CMS) pick up and codify the practice standards that have been laid at their feet.

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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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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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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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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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As I mentioned in the article on the restoration of the full MAUDE narratives, I filed a Freedom of Information Act (FOI) request for the data, motivated by a concern that the problem with the online database would not be resolved in a timely fashion. Below are a handful of PDF files from my FOI request, enumerating just MRI projectile accidents (one of the five types of MRI ‘never events’) from part of the 2009 data…

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

• 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)

The length and scariness of this list says two things to me… 1. Even without correcting for the presumed 1% reporting rate, this list is already too long suggesting that we have a long way to go, and 2. Why aren’t we taking a more proactive role in preventing these sorts of accidents when there are tools and techniques readily available?

Is it that crushing facial injuries, brain trauma and scissors embedded in someone’s forehead are collectively ‘minor exceptions’ even when these events (and many others) occur within weeks of one another?

To answer the rhetorical question posed by the title of this post, absolutely we continue to call them ‘never events’ because they should never happen. The fact that we have a long way to go to get close to that frequency is not an indictment of the validity of the goal, but it is a reason to call for professional / regulatory change if the industry can’t close the gap on its own.

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

Every so often there is an MRI accident description that is so stunning that it sends a jolt through me, reminding me why I do what I do. This is the entry that I came across just two weeks ago…

“Event Type Injury   Patient Outcome Life Threatening; Hospitalization Required Intervention”

‘Wait a minute… that may border on interesting (and I’m being very generous there), but that’s hardly a ‘jolt.’ What gives?’

Well, two weeks ago that exact same incident report described an accident in which an MR technologist had to be rushed to surgery to extract the pair of scissors from their forehead! Turns out that the tech was between the magnet and another staff person who had brought a pair of ferromagnetic scissors into the magnet room. The magnet ‘grabbed’ the scissors and started drawing them into the bore, but for the fact that the technologist’s head was in the way!

My longstanding complaint with the FDA and their MAUDE data has been that they seem completely disinterested in actually collecting it with regard to MRI accidents. The overwhelming majority of MRI accidents are a product of the inherent risks, and not a result of equipment malfunction and it seems to me as if the very existence of the MAUDE database is NOT as a patient safety tool, but as a CYA tool to validate that the approval of a medical device was warranted.

Now the hobbled MAUDE data (built on the FDA’s Medwatch program) has gone mute and the actual substance of an accident report is no longer there. Today there’s more information about the postal address of the company that manufactured the MRI than there is about the accident that is being reported, at least that’s the contemporary reality via the online database.

So I implore the FDA to please restore the narratives associated with MRI accidents. Removing this information does a grave disservice to patients and those who advocate for MRI patient safety.

If you’d like to read the article, “Risky Business: MRI accidents increase fourfold in as many years,” pick up your copy of RT-Image that looks like this (below):

RT-Image | August 3, 2009

Or you can simply click on the cover image (above) or right here to be taken to the online version of the article.

Thank you for your ongoing attention to improving MRI safety!