It took a while, but slowly I realized that tellin‘ and getting in trouble were two, very different things. This is a lesson that we in the MRI community would do well to learn regarding accidents.

MRI accidents – in which materials, devices and implants which have no business in the MRI scanner room – occur all the time. Mostly, these are caught in advance, before anyone is injured or anything is damaged. Fairly frequently though, the MRI’s magnet ‘finds’ cell phones, money clips, pocket-knives, unsafe wheelchairs, etc…. And fairly frequently large ‘black hole’ artifacts on initial scans expose ferromagnetic devices or implants that the patient disavowed in their clinical pre-screen. (A veritable photo album of projectile accidents is available in one of my recent posts, which you can access here.)

Because these sorts of events are often rationalized to be statistical inevitabilities, brushed-off as events that occur at all MR facilities (and, therefore, are certainly not news to anyone), little – if anything – changes as a result.

Now, because these accidents and ‘near-events’ are typically accepted as unavoidable, they are very, very rarely reported outside of mandatory reporting structures, such as the State of Pennsylvania’s Patient Safety Authority. And even within mandatory structures such as Pennsylvania’s, many projectile events never get a 2nd thought, much less an event report. The upshot is that others, who might have learned from these surrogate mistakes, are more likely to have the same mishap because neither the nature or the frequency are shared with the community at large.

‘But wait, Mr. MRI-safety man. There is a national MRI accident database kept by the FDA and reporting to the FDA’s database is mandatory.’

Yes, there is a FDA accident database. And yes, technically, reporting is mandatory. The accident reporting system is called MDR (Medical Device Reporting) and the data is published in the FDA’s MAUDE database (which anyone with an internet connection can access and search). The three criteria for mandatory accident reporting are:

• Death (pretty unequivocal)
• Serious Injury
• Unreasonable Risk of Death or Serious Injury

What constitutes serious injury? Well, if you’re a healthcare provider, you get to make that call as there is no standard that the FDA uses. Want to call a traumatic amputation a ‘slightly-less-than-serious’ injury? OK. Want to not report it because you’ve determined that it isn’t a ‘serious’ injury? The FDA says that’s OK, too.

We don’t even need to touch on unreasonable risk unless, of course, we’re talking about the risk of death, but then we open the question of what makes something ‘unreasonable.’ I suspect that the FDA leaves that determination up to the individual as well.

So given the two indisputable truths above (1) MRI accidents are reported only a mere fraction of the time and (2) even the reporting requirements have loopholes that you could drive a truck through, what is the point of this article?

Ignore precedent. Ignore lawyerly readings of the reporting language. Report every MRI accident and near-event that occurs.

‘What? OK, Mr. MRI-safety man, you’ve really gone off the deep end on this one!’

Hear me out. Remember my intro to this article… the difference between being ‘told on’ and getting in trouble? That wasn’t just a cute story to draw you into an unrelated article, it’s an analogy for what happens when MRI providers report accidents and near misses to the FDA.

First, accident reports go through your MRI manufacturer and do not need to go directly from you to the FDA (except in cases of death). Second, accident data is anonymized. There is nothing that needs to identify you, your facility, your location, anything other than the scanner involved in the accident.

But the most important reason to have your MRI manufacturer report these events is that, by sharing the information about the types and frequencies of accidents, our entire industry will be able to better respond, as a whole, to the [wink, wink] events that are too often taken for granted.

With a more accurate picture of what goes wrong and, even more importantly, what steps we can all take to make things right, we can each do our small part in helping to improve the safety and effectiveness of the entire MRI industry.

There is no 7-foot tall troll waiting for you at the other end of your accident report to the FDA. There is no enhanced regulatory scrutiny that follows. Heck, nobody external to your organization will even ask you if you’ve done anything to increase your chances of catching that same mistake again. In short, there is no real downside, though the information you provide may ultimately help another MR provider prevent a costly or dangerous accident.

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