In about 4 years, NSF was identified (originally called Nephrogenic Fibrosing Dermopathy), the culprit identified, the population-specific susceptibility deduced, and effective screening protocols developed and deployed. Yes, it is still possible to develop NSF today, but we also have the tools requisite to interdict the agents that trigger the disease, and an industry-wide awareness of the preventative steps which are effective in doing so.

This is a testament to an international confederation of radiologists, nephrologists, pharmacologists and pathologists who collaborated on the challenge of this disease. It is worthy of a self-congratulatory pat on the back for radiology that we were able to sleuth-out the cause, and disciplined enough to execute effective prevention, in such a short time. But lest we spend too much time singing our own accolades, we should remember that more than 92% of MR accidents studied (selected based on the availability of information on causation), were made up burns, projectiles and hearing damage. These aren’t clinical problems, per se, rather they’re operational in nature.

Perhaps that accounts for the disparity in response. MR is a clinical instrument, and NSF was in the clinical wheelhouse. Yes, it extended well beyond radiology, but it was (and still is) essentially a clinical issue.

More often than not you will never find a radiologist actually in an MRI suite, so they are unfamiliar with – and often uncomfortable with – operational concerns. There are, of course, exceptions to this but those are… well… exceptional.

If NSF can be identified, studied, researched, and ultimately almost universally prevented in the course of a handful of years, how is it that we continue to see alarming year-over-year growth in combined burns, projectiles and hearing damage? If we can study a brand new disease and prevent it with nearly 100% effectiveness, why can’t we make sure insulating pads are used, or that ferromagnetic detectors are part of every MRI center, or that we make sure that hearing protection is used (and used properly)?

For these injuries there is no direct-causation mystery. We don’t need expensive animal trials, or chemical analysis of different contrast agents. We don’t need an international interdisciplinary clinical team. We need pads, ferromagnetic detectors, and earmuffs.

So my appeal, made plain in the headline, is for us to let NSF go. Let us not dwell in an anachronistic state of fear, nor linger any longer in self-congratulation. We have other tasks to help make MRI as safe as we know it can be, and we need to redirect our attention to that job ahead of us.

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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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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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The article describes how the boy was wrapped in a metallic ‘space blanket’ during the exam, and yet the 3rd degree burn was attributed (by the hospital administration) to ‘trapped heat’ in the cotton blanket that came from a blanket warmer.

Example of Space Blanket

Though it may have taken a little ‘nudging’ to get a formal commitment on the part of the hospital to cover the costs of all treatment associated with the burn, it is the least that should be done to offset the injury that was caused by a failure to follow industry standard screening protocols.

Hopefully this incident will also trigger a review of MRI protocols and procedures at this facility, too. Often the ‘it’ll never happen here’ attitude persists even after an incident (morphing, ever so smoothly, into ‘it’ll never happen here again‘), with little effectively done to reduce the risks of recurrence.

And as I am a firm believer in the gold-plated opportunity that is presented every time we learn of any mistake (our own or others’), I hope that MRI providers around the world look at this incident as one more validating event that periodic reviews of our safety policies is not just a good idea, it’s absolutely necessary in such a dynamic area as MRI.

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.

Def.  Hyperbolic:  Rhetorical exaggeration or diminishing beyond the fact; exceeding the truth; as, an hyperbolical expression.

I have this sense that some feel that virtually all talk of MRI accidents is hyperbolic, or exaggeration. To those who believe this, I say there is a truth buried in this thought, but it’s not what they may think…

Flash back to high school when I simultaneously learned the alternate definitions for hyperbole. Mrs. Mayer, my English composition teacher taught that it was taking a truth and exaggerating it to just this side of the breaking point. Ms. Bohne, my geometry teacher, taught that the same word was used to describe mathematical curves which, as an example, were revealed in the cross-section of conical structures.

To those who feel that talk of the risks and costs of accidents in the MRI suite are exaggerated, I offer you Ms. Bohne’s hyperbola in response, as provided by the FDA’s accident data.

MRI Accident Rates As Reported To The FDA

The trend in these reports of accidents is both a marked increase over the last 4 years, as well as a marked acceleration in the growth rate.

It would be worrisome enough if this were just a straight-line function, exceeding as it does any rational explanation for ‘natural’ growth in accidents resulting from increased MRI utilization, but the fact that the year-over-year rate of accidents is accelerating should have the radiology and patient safety realms in an uproar.

The above graph may look familiar to you, as I’ve published prior versions of it before the 2008 data was available. The acceleration pattern was strongly suggested in last year’s numbers, but appears confirmed in the full 2008 figures.

What do these numbers mean? They mean that we’re unnecessarily injuring a significantly greater proportion of MRI patients today than we were just a few years ago.

I say ‘unnecessarily’ because we know the causes of the most prevalent MRI accidents (projectiles, device interference, burns, tinnitus) and we know how to dramatically attenuate the risks (ferromagnetic detectors, thorough screenings, effective patient positioning, hearing protection).

If the MRI industry were to follow the best-practice standards outlined in the ACR Guidance Document for Safe MR Practices, I would expect that the rates of MRI accidents would take a dramatic nose-dive. Nearly every accident in the FDA’s 2008 record might have been avoided through the proper use of the four interventions listed above.

Concern about MRI accidents can not possibly be hyperbole when the growth in accidents appears hyperbolic.

No, that’s not what the FDA just said, but the news in the FDA’s most recent alert is almost as dated as my hyperbolic example. What the FDA did in their March 5th alert on the MRI safety of transdermal medication patches was essentially recapture what had been stated in the 2007 ACR Guidance Document, which was very similar to what the ACR said in the 2004 edition of the White Paper on MR Safety, which was expanded from what was said in the 2002 White Paper.

But what the FDA wrote, and what their representatives said, were contradictory (not a first for the FDA). The carefully considered release states that some transdermal patches may contain concealed metal foils that would be subject to heating under certain MR conditions and that patients should consult with their physicians and the MRI provider about the appropriate course of action (the removal of some drug-delivery patches may alter therapies – and replacements, particularly for pain medications – can be extraordinarily difficult to get).

However, in an interview with the Wall Street Journal, Sandra Kweder, Deputy Director of the FDA’s Office of  New Drugs, was quoted as saying that if there was any doubt, patches should be removed. In fact, Ms. Kweder aluded to a pending requirement for manufacturers of foil-backed transdermal patches to place “remove before MRI” directly on the patch.

Fortunately, it seems that the medication side of the FDA and the device side of the FDA are combining their respective knowledge domains and that, if these patches are to be marked, it may be with the FDA / ASTM approved ‘MR-Conditional’ designation.

While it would be great to have a ‘one-size-fits-all’ response to the risk of medication patches in MR, I’ve yet to find a ‘one-size-fits-all’ response for any aspect of MR safety. The ACR Guidance Document and the printed FDA release got it right… make sure Technologists are aware of patches (where and what type they are) that an informed decision can be made as to the best way to minimize all risks to the patient (including the risk of an altered medication therapy).

So while the latest FDA information hardly classifies as ‘breaking news,’ it certainly doesn’t hurt us to be reminded of the multivalent hazards that are present in MR.

ECRI Institute is a not-for-profit organization that provides evaluations of medical equipment and safety information for its members. They have a long history of following equipment safety issues, including MRI. They were the first (and only, as far as I’ve learned) organization that received a breakdown of the Pennsylvania Patient Safety Authority’s MRI incident reports, which they shared on a conference call in September of 2005. They also conducted a survey of their members to obtain a breakdown of the type and frequency of MRI accidents.

60% of those ECRI members that participated in the survey indicated that they had experienced a MRI projectile incident, about 16% indicated that they had a patient burn event, 11% indicated that they had an episode in which the MRI interfered with another device and roughly 13% indicated that they had other types of MRI safety incidents that weren’t appropriately categorized in the other classifications.

[By the way, information from MR safety experts who are often consulted in MRI injury cases suggests that the ECRI data is correct in defining the comparative order of frequency of MRI incidents.]

So, the ECRI Institute’s member data suggests that projectile incidents occur at nearly a 4:1 rate over burns, 6:1 over device interference and 5:1 over all other unclassified accidents, combined. So which MRI hazard made the Institute’s Top-10 list? Burns.

I do not fault ECRI for bringing attention to the issues surrounding RF burns and their prevention. As with projectiles, we conclusively know the causes of RF burns and the effective means to prevent them. A bright light should be shone on the issues of RF burn prevention to prompt providers to take the necessary steps to prevent what should be a ‘never event.’ But if we’re creating Top-10 lists, shouldn’t we pick the top items for the list?

Previously, Dr. Emanuel Kanal has characterized projectile threats in the MRI environment as ‘public enemy #1′ with regard to the safety of patients and caregivers. If we want to make the largest positive impact on MR safety, shouldn’t we tackle the greatest problems first (or at least concurrent with other hazards)?

“Number one injury in the MR environment today, thermal. Now I agree that that’s the number one reported adverse event, I’m not convinced that it’s the number one source of injury in MR environments. I believe that there may be many, many more projectile events still occurring that, if it’s serious enough, they try to settle without going to report and without going to trial.“

– Emanuel Kanal, MD, FACR, FISMRM, AANG (click here for the recording)

I applaud the ECRI Institute for its diligent and persistent attention to MRI safety issues. They have championed this focus at times when other organizations were largely silent. I agree that RF burns are a serious safety issue within MR, an issue that deserves immediate attention by MR providers. However, if the interest in publishing the Top-10 hazard list is to effect the greatest positive outcome in patient safety, shouldn’t we tackle the largest threat, ferromagnetic materials in the MRI suite, first?