So, here is the justification my new nPSG, using the Joint Commission’s own words…

PPS (a Joint Commission publication) Feb, 2007 – “Safety in the MRI suite is both vitally important and unusually challenging to implement because of the invisibility of of the threats coupled with the increasingly common presence of objects that MRI can act upon with disastrous results.”

SEA #38, Preventing Accidents and Injuries in the MRI Suite, Feb, 2008 – “The Joint Commission offers the following recommendations and strategies to health care organizations for reducing  MRI accidents and injuries:” [Ten explicit objectives follow]

EoC News (a Joint Commission publication) May, 2009 – “In January 2009, the Joint Commission issued Standard EC.02.02.01, Element of Performance (EP) 1, which lists Sentinel Event Alert among the sources of information to assist in proactively identifying safety and security risks associated with the environment of care.”

EC.02.01.01 – “The organization identifies safety and security risks associated with the environment of care. Note: Risks are identified from internal sources… …and from credible external sources such as Sentinel Event Alerts.”

EoC News (a Joint Commission publication) May, 2009 – “…[W]e do ask each organization to look at the literature — any credible external sources, such as Sentinel Event Alerts — and put into place those things that can help prevent a safety incident involving their patients.” — John Fishbeck, R. A., Associate Director, Department of Standards, The Joint Commission.

SEA #38, Preventing Accidents and Injuries in the MRI Suite, Feb, 2008 – “Implement systems to support safe MRI practice such as written protocols and checklists and periodically review, and assess compliance with your organization’s MRI policies, procedures and protocols.” — paraphrasing Dr. Emanuel Kanal, FACR, FISMRM

Admittedly, a good editor could take my own words and re-purpose them to say something that I would find antithetical, but that’s not what I’ve done here. While I suspect that voices within the Joint Commission might be quick to come up with qualifications / rationalizations as to the un-enforceability of MRI safety, I can’t imagine that they would actually disagree with words that they themselves have spoken, written or published on the subject.

What follows are the 2011 nPSG’s which follow, fairly directly, from the hazard description above:

• nPSG.11.01.01 – Accredited Health Care Organizations that provide MR services must perform a risk / hazard analysis for those services in accordance with EC.02.01.01.
• nPSG.11.01.02 – Provide access restrictions, and both clinical and physical screening, for all persons prior to being granted access to the controlled access areas of the MRI suite, in accordance with the ACR Guidance Document for Safe MR Practices: 2007 and the ACR 4-Zone model described therein.
• nPSG.11.01.03 – Appoint a dedicated MR safety officer with responsibility and authority for implementing and enforcing MR safety procedures.
• nPSG.11.01.04 – Provide and document MR safety training for all MR staff at least annually.
• nPSG.11.01.05 – Use only portable equipment tested and approved as ‘MR Safe’ or ‘MR Conditional’ as appropriate to the MR environment.
• nPSG.11.01.06 – Provide ferromagnetic (only) detection screening for persons and objects prior to admission to controlled access areas within the MRI suite as stipulated in nPSG.11.01.02.
• nPSG.11.01.o7 – Provide padding in accordance with MR equipment manufacturer recommendations to isolate patients from RF coil elements or from conductive materials in proximity to the patient (including the skin-to-skin contact of the patient’s own tissues) during the MR exam.
• nPSG.11.01.08 – Provide hearing protection for all persons in the MR examination room during the MR exam, verifying proper fit before initiation of the exam.

These 8 nPSG’s, if enforced, could actually slash the number of MR accidents dramatically! A retrospective analysis of MRI accident reports to the FDA indicated that more than 92% of MRI clinical adverse events are burns, projectiles and hearing damage. Adherence to these 8 steps could nearly eliminate MRI accidents and injuries!

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Also, make no mistake that I find the highly publicized flock of radiation exposure accidents abhorrent oversights. Whether it was equipment calibration, record errors, or simple human foul-ups, each of these violates the simple truth of the special obligation to patient safety that imaging has. But I think we have to look at these accidents squarely, and assess what went wrong, what the adverse outcomes were, and the appropriate preventative and mitigating steps are before we promote knee-jerk responses.

I am enthralled by MRI. And while my life and livelihood are by no means tied exclusively to this one modality, I am certainly doing myself no worldly favor by suggesting that the ‘simple fix’ of moving more patients to the safe solution, MRI, is neither simple nor necessarily safe (or safer, which is really the object). Hear me out…

Medical radiation accidents, in most of the reported cases, involve over-exposure of the individual. While there are extreme examples of this that result in clear, severe and sometimes fatal outcomes, most these over-exposures are similar in incremental lifetime risk to that of having spent your teenage years sun-worshiping, instead of worshiping bottles SPF 30. The best estimations for many of these accidents are that they involve modest increases to lifetime risks of developing cancer… outcomes that will manifest themselves often 20 years or more after the exposure.

It should not be forgotten that MRI is not without its risks. While they aren’t insidious, clandestine biological risks like lifetime cancer probabilities, they are equally serious. Recent examples include burns (up to a severity requiring amputation) magnetically-induced projectiles breaking bones or crushing body parts, and earlier this year a woman who was struck, killed, and her corpse magnetically-pinned to the MRI scanner!

Because the negative effects of medical ionizing radiation exposure (from X-ray based modalities, radiopharmecuticals or beam therapies) often won’t be realized for decades, particular consideration should be paid to treating the young, those under 30. Whenever feasible and clinically appropriate, these patients should be considered for non-ionizing exams and therapies, such as MRI or ultrasound, in lieu of CT. But we shouldn’t simply redirect everyone who can name all three Jonas Brothers to MRI, certainly not with how well we’ve been managing those risks.

While it hasn’t made Walt Bogdanich’s New York Times series on radiology accidents, the last several years of MRI accident data show accidents and adverse events quadrupling over four years! MRI is currently still an extraordinarily safe imaging option, but the meteoric growth in accidents, and the continued acceleration of that growth, are each frightening.

I have a ten-year-old daughter, and we have (reluctantly) acceded to her having a fluoroscopic exam, and I would choose an MRI, hands-down, for anything for which it was equally diagnostic. But each year that I watch the accident-trend data, the calculus gets a little bit more difficult. The MRI grows less appealing, and this is egregious because it should be the irrefutably safe option.

You see, we know what causes MRI accidents, and we know how to prevent them. The fact of quadrupled MRI accidents isn’t because of sunspots, or statistical clusters, or global warming, or MRI voodoo dolls, or anything else similarly beyond our understanding or control. The fact of quadrupled MRI accidents is because we, individually and collectively, fail to act. We fail to follow industry best practices. We fail to even expect best practices of our providers!

We should directly confront the issues of radiology safety, and not just those that land on the pages of the NY Times. In imaging we have a particular obligation to protect our patients, including those going for MRI.

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PS: They’re Nick, Joe and Kevin (the Jonas Brothers). You could either think I’m under 30 (‘Ha’), or realize that I have a pre-teen daughter… Take your pick.

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

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

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

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

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

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

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

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

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

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

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The National Council on Aging just released a study which details these alarming numbers. The matter-of-fact language of their release did nothing to diminish my welling fear as the study went on to detail chronic failures in our healthcare system to educate, alert, and prevent the dangers inherent in MR imaging of medical implant patients. Here are a few of the particulars:

• Medical implant patients over age 65 have between a 50% and 75% chance of requiring imaging during the useful life of their implant.
• While 90% of physicians knew of MRI risks for some pacemakers, over half of doctors say that they aren’t informed about imaging limitations when a patient is implanted.
• Nearly a third of patients who receive medical implants are not informed of MRI restrictions.
• After exposed to the MRI risks to their implant, nearly 20% of these device patients experience some sort of problem or malfunction with their implant.

Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams

The near universal opinion (98%) of healthcare providers is that they require additional information and training on these MRI safety risks.

Let’s hope that regulatory (FDA and States) and accreditation (JCAHO, ACR, and IC) bodies for MR imaging look at ways that they can take a more active role in promoting education and protecting these patients.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

MRI Scanner Eats an ICU Patient Bed

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

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

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

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

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

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

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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.