The Joint Commission (TJC or, to those of us schooled in their acronym more than 3 years ago, JCAHO): TJC has just referenced the 2010 edition of the Guidelines for Design and Construction of Health Care Facilities as the new design and construction standard (effective today). The 2010 Guidelines codifies a number of the MR safety recommendations that have passed from the Joint Commission’s own lips and makes them standards for new construction. In 2011 I will apply whatever cajoling, leveraging, sweet-talking, or shaming that will help the Joint Commission to apply it’s own standards to the thousands of existing MRIs at TJC accredited providers. This began last year with training provided to TJC’s ambulatory care surveyors, forestalled and rebuffed offers of the same for their hospital surveyors.

Centers for Medicare / Medicaid (CMS): At least somewhat in response to the public attention that was focused on the issues of radiology / nuclear medicine safety through the ongoing series of articles by Walt Bogdanich of the New York Times, in 2010 CMS began development of a set of radiology / nuclear medicine patient safety standards that they intend to roll-out as a condition of reimbursement. It is anticipated that these will be unveiled in the spring for public comment before being enacted some time later. I know that, last year, MR safety proposals were presented to CMS, and at the anticipated public meeting I will seek to make sure that the single largest healthcare benefits provider in the US includes substantive MR safety standards.

Food and Drug Administration (FDA): Quick as they were to arrange public hearings on radiology safety (after the first couple Bogdanich articles saw print), the FDA has been ‘in the planning and coordination’ stages of a similar meeting on MRI safety for well over six months. Originally proposed for last year September, the prospective date has been nudged enough times that, as of my last inquiry, they’ve stopped even suggesting months, or even seasons, and I was last left with the promise of ‘sometime in 2011… hopefully the first half…’ I will endeavor to see that this meeting takes place (perhaps in concert with the CMS meeting), because I know that smart, capable people within the FDA have done analyses of MRI accidents and have developed an MR safety ‘short list’ of preventions which the FDA has yet to release, to say nothing of promulgate or endorse. Sitting on effective safety solutions when the accident rate is quadrupling is… well… inconceivable.

American College of Radiology (ACR): At the ACR’s presentation at the 2009 annual meeting of the American Healthcare Radiology Administrators (AHRA), the ACR representatives announced that the organization was going to incorporate MR safety standards from it’s own ACR Guidance Document for Safe MR Practices: 2007 in the ACR’s MR accreditation program. In 2010 I was privately told by a very well-placed person within the ACR that the new CMS oversight of the MIPPA accreditation process made it ‘logistically onerous’ to change the existing MR accreditation program (this despite the fact that the ACR was pleased to submit to CMS — and receive prompt approval for — an entirely new breast MR accreditation program). In 2011 we expect to see a new edition of the Guidance Document, which will make the fourth publication appearing under the ACR’s name that speaks to effective solutions for the reduction of MR accidents… and the fourth one that the ACR will have not included as an element of their own MR accreditation program. Whether it’s through meaningful standards passed down from CMS, or by reversing the apparent hypocrisy of the ACR, itself, I will spend 2011 working to see that substantive MR safety standards are incorporated as a part of the ACR’s MR accreditation program.

So what is the monster-list of standards that would be necessary to mitigate the vast majority of MRI accidents and injuries? Well, it turns out that it isn’t long at all, and all of these are already promulgated as best practice recommendations…

1. Provide annual MR safety training for all MR personnel (and MR irregulars)
2. Restrict access to controlled areas of the MR suite for unscreened / unsupervised persons and untested equipment per the ACR 4-zone model
3. Provide uniform and documented screening for all persons entering controlled areas of the MR suite
4. Screen persons and objects with a ferromagnetic-only detector before allowing access to controlled areas of MR suite
5. Provide hearing protection (and ensure proper usage) for all persons remaining in the magnet room during the MR exam
6. Use positioning aids and insulating pads as recommended to separate the MR patient from RF elements and conductive materials (including their own tissues)

These six items would likely cut the rates of MR accidents by more than 90%! These items have also been recommended (or very similar elements) by the Joint Commission, ACR, and others. If they were enforced, however, we could very nearly eliminate MR accidents in governed facilities!

Getting us to enforcement, that is my 2011 New Year’s Resolution, but I won’t make it there alone. Can I count on you to work on this with me?

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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.

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

The review has been requested by Robert Russo, MD, with Scripps Research Institute. A copy of Dr. Russo’s request can be viewed here.

The public comment period is open through July 28, 2010, and I strongly encourage anyone with questions or concerns about the safety of MR imaging for patients with implanted cardiac devices (Dr. Russo correctly points out that CMS’ restriction fails to speak directly to implanted cardio-defibrillators, or ICD’s) to offer their comments to CMS.

The full explanation of the current restrictions on MR imaging of pacemaker patients (also aneurysm clip patients, and pregnant patients), as well as the instructions for reviewing other public comments or submitting your own, can be found here.

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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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External fixation and braces are typically very carefully screened for contraindication for MRI examination, but what may not be as frequently screened is the clothing underneath. We’ve received a report of a patient who received a burn from the specialty T-shirt, worn under their brace! The T-shirt, which included electrically-conductive silver fibers, purportedly acted as an RF antennae and produced focal heating.

This incident, like so many others, goes to show how so many risks in the MRI environment, such as concealed ferromagnetic threats, can be difficult to find if you don’t have the proper tools and knowledge with which to look for them.

Every MRI provider should avail themselves of the latest MRI safety information, standards, recommendations and peer accounts of accidents and near-misses in order to deploy the greatest protections, both for their patients and for their own risk management. For burn risks, this means diligent screening of everything that accompanies the patient into the bore. For ferromagnetic (projectile) risks, this includes the use of ferromagnetic detection systems.

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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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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.

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.

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For those of you who aren’t familiar with the Guidelines, they are the design requirements that are cited by the Joint Commission and, at last count, 42 of the 50 U.S. State Departments of Health. Technically, they aren’t a building code, but the function in almost the exact same way. For the first time, the Guidelines are going to have specific MRI suite design requirements for patient safety.

2010 Guidelines

The 2010 edition of the Guidelines are purported to codify the single most often cited MRI suite safety design criteria, the 5-gauss line (or three-dimensional bubble, more accurately). The design must necessarily control access to locations where the static magnetic field is present at strengths of 5-gauss or more.

the 2010 Guidelines will also define situational-awareness requirements for suite layouts. These will include a requirement that the patient can be seen inside the scanner from the operators’ console location, and that the operator has direct visual control of the entrance to the MR scanner room.

The unique challenges of infection control and handwashing in the MRI environment are also explicitly addressed, for the first time, in the new Guidelines.

And one of my favorite provisions is the new requirement that MRI suites be designed to follow the ACR 4-Zone model for screening and access controls, including ferromagnetic detection systems!

The Guidelines publication is undergoing a significant organizational overhaul along with the regular content update, so I don’t have specific section citations to where the new MRI safety design requirements will be (though MRI probably won’t have the same section numbers as the current, 2006, edition has). My understanding, however, is that the publication will be released on schedule in January, so it is only a very short time until we can verify the specific contents and section numbers.

It is particularly encouraging that these new requirements validate what the some of the best MRI providers have been doing for years. Clearly MRI site-safety, including ferromagnetic detection, can no longer be regarded as simply “a good idea.” With the 2010 edition of Guidelines, we will have one more codified example of how these elements are truly part of the contemporary standard of care.

If you would like more information about the Guidelines, including information on how to order a copy of the document, please click here.

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