I apologize for my unusually long hiatus from posting. I’d love to tell you that I haven’t written because I’ve been so extraordinarily busy putting the final touches on a set of meaningful standards which will effectively protect the 30,000,000 (that’s million) annual MRI patients in the U.S. from the most frequent preventable MRI injuries. I’d love to tell you that, but it’d be a lie… Continue reading
First, let me say that this isn’t a ‘leak’ in the sense that none of the information I’m about to share is (any longer) confidential. This information is all public record as a result of court filings for the now-settled civil suit surrounding the 2001 MRI fatality of Michael Colombini. There are documents associated with that civil lawsuit which did not wind up as filings with the court and therefore are not a part of the public record. I have no difficulty not releasing those because (among other reasons) I don’t have any of them.
“Why — now — ten years later would you post these documents?”
Excellent question! Here’s why I didn’t publish these long ago…
That’s right, the FDA has updated it’s MRI accident figures available online through the MAUDE database. We were alarmed and astonished when we thought that the rate of increases in MRI accidents was only 270% (from 2004 to 2008). Turns out that the FDA must have found additional accident reports that were in a stack of junk-mail, or got lost between the sofa cushions, which means that the rate if adverse events went up, significantly, in 2008 from the prior calculation.
Yes, I’ve not kept up with my blog postings as I usually do. I’d like to tell you that it was because I’ve been spending the last month or so sipping umbrella-drinks on a sunny beach somewhere, but that’s about the furthest thing from the truth. The fact is that there have been torrents of activity, but they’re all happening below the glassy surface. For example, the radiology press has been strangely silent about the most recent MRI fatality…
I like to keep my finger on the pulse of MRI accidents and safety issues. One consequence of this is that I frequent the FDA’s MAUDE database (MAUDE is a tortured acronym for medical device user-reported mishaps). I have long criticized the FDA for their half-hearted efforts at collecting MRI accident data (which, in fairness, appears to be as much a product of congressional limitations on the FDA’s power as anything else), but MAUDE has been the only national database for these accidents that is publicly accessible.
Every so often there is an MRI accident description that is so stunning that it sends a jolt through me, reminding me why I do what I do. This is the entry that I came across just two weeks ago…
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.
Yes, though we’ve got more than a full month’s worth of reports yet due, it turns out that 2008 is a record year for MRI safety!
No, I’m not talking about the year of record sales of ferromagnetic detection systems or the publication of no less than three MRI safety best practice guidance papers… What I’m talking about is the numbers of MRI accident reports to the FDA.
There are a number of startling statistics related to MRI safety that I’ve been wanting to weave into a posting or two. In bits and bites, these data points are interesting, but it’s when they’re taken all together that they tell the greatest story. So, at the risk of writing my driest entry to date, here’s the picture painted by a slew of statistics…