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…
“Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention”
‘Wait a minute… that may border on interesting (and I’m being very generous there), but that’s hardly a ‘jolt.’ What gives?’
Well, two weeks ago that exact same incident report described an accident in which an MR technologist had to be rushed to surgery to extract the pair of scissors from their forehead! Turns out that the tech was between the magnet and another staff person who had brought a pair of ferromagnetic scissors into the magnet room. The magnet ‘grabbed’ the scissors and started drawing them into the bore, but for the fact that the technologist’s head was in the way!
My longstanding complaint with the FDA and their MAUDE data has been that they seem completely disinterested in actually collecting it with regard to MRI accidents. The overwhelming majority of MRI accidents are a product of the inherent risks, and not a result of equipment malfunction and it seems to me as if the very existence of the MAUDE database is NOT as a patient safety tool, but as a CYA tool to validate that the approval of a medical device was warranted.
Now the hobbled MAUDE data (built on the FDA’s Medwatch program) has gone mute and the actual substance of an accident report is no longer there. Today there’s more information about the postal address of the company that manufactured the MRI than there is about the accident that is being reported, at least that’s the contemporary reality via the online database.
So I implore the FDA to please restore the narratives associated with MRI accidents. Removing this information does a grave disservice to patients and those who advocate for MRI patient safety.Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com