Well, hopefully accidents didn’t jump a full 30%, but the number of reports to the FDA of MRI accidents did! This makes four consecutive years in which the numbers of MRI accident reports have climbed, increasing a whopping 270% above the 2004 rates!
To view the FDA’s own sloppy data, click here to go to the MAUDE database and type in product code ‘LNH’ (minus the quotes) to review the numbers of accidents and specific incidents.
Now, for the entirety of 2008, there are only 148 reports. But if expert opinions are to be trusted (and I think they are) these 148 reports probably represent around 14,800 real-world accidents (40 accidents every calendar day of the year, or roughly 57 per day if you take weekends off).
Some point, justifiably, at the abyssmal reporting rates (as exemplified by my correction of two orders of magnitude, above) and suggest that these radical increases in the rates of accidents are really only an indication of marginal improvement in accident reporting (after all, if you’re only reporting 1/2 of 1% of all the accidents, and you increase reporting by a meager 1/2 of 1%, you’ve doubled the reporting rate). But I don’t support this contention.
First, technical, clinical, operational, and financial risk factors have all compounded over the last several years. Each risk ‘domain’ has increased on its own, but when taken together these incremental increases are multiplied. These ratcheting-up risk factors have not been attenuated by any safety-supportive changes in regulation, accreditation, or payor credentialling.
At the same time that the risk factors have been growing, there have been no initiatives from the states, accrediting bodies, or federal regulatory authorities to increase end-user reporting of adverse events.
In short, I see many reasons why MRI accident rates would be going up, but not a single reason why the proportion of accidents that get reported would also increase.
So I’m left with this gnawing feeling in the pit of my stomach. I look at the data and the crystal clear trend that it’s describing and I know full well what is at the end of this parabolic curve… Obituaries of more MRI accident victims.
Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com
