When I was eight, these words struck fear in my heart. It didn’t matter how small the infraction I committed was (or if there even was an infraction to begin with), I would beg the other kid to not ‘tell’ whoever it was that they were planning to tell. It may have been their kindly grandmother that they planned on telling, but in my mind it was always some 7-foot troll who would have undoubtedly come outside and chewed me to bits.
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.Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com