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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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