FDA’s MAUDE Database Appears To Be Restored

For a couple of months, at least, the FDA’s MAUDE database wasn’t displaying all of the accident narratives online… This appears to have been fixed!

A number of the MRI accident reports, when the narratives weren’t appearing, were little more than the name and mailing address of the MRI manufacturer. Today, if you want to read about the MR Technologist who had a pair of scissors magnetically-impelled into his forehead, you can do so.

MAUDE report of MRI + scissors vs. Tech.

Though I must admit to indulging sinister fantasies that the FDA was trying to ‘cover up’ some of these accidents, so I requested the information that wasn’t being displayed through the online MAUDE database through a good-old-fashioned Freedom of Information request. The result is that I have PDF copies of many stunning, alarming, and disconcerting accidents. And if you’re so inclined, you can download PDF copies of them, too…

And the above accidents only represent a proportion of the collected number of accidents for little more than half of 2009!

The above list should not scare anyone out of getting an MRI exam. It is meant to illustrate just how far we have yet to go to eliminate the ‘pilot error’ types of accidents which continue to jeopardize patients, staff, and millions of dollars of MRI equipment.

Sometime in February or March, we should have access to the complete 2009 MAUDE data. Early indications already suggest that we’re on track for a dismal year-end report, with a 20% (or more) growth in accident numbers.

Continue to stay tuned for the latest information on MRI accidents and – more importantly – the tools and protocols that can help reduce the risks.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com
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3 thoughts on “FDA’s MAUDE Database Appears To Be Restored

  1. Pingback: Can We Still Call Them ‘Never Events’ When Accidents Happen So Frequently In MRI? « MRI Metal Detector Blog

  2. rick

    Do you have any information about metal implants affecting the image? I’m being pressured to have an MRI, but I wonder if there’s any point. How far from the metal (in my lumbar spine) will the image be clouded? I can’t find any information online. I’d appreciate a link if you know of anything about this.

  3. Tobias Gilk Post author

    Rick, almost all surgically implanted metals (plates, screws, pins, etc…) will have some distortion effects on an MRI image, but the area that is obscured will depend mostly on what kind of metal these are made of. The more magnetic the metal, the bigger the volume where imaging would be useless. There are special techniques, available on some MRI scanners, that can be used to greatly minimize the artifacts created by scanning metal.

    Often the ‘black hole’ artifact surrounding a metal implant is limited to a couple of centimeters, but this is dependent upon the material in the screws.

    I would recommend that you get as much information as you can about the screws (how many, who made them, model or serial numbers, when they were implanted, precisely where they’re implanted) and what it is that your doctor wants to diagnose with the MRI scan, and ask to talk with the radiologist at the hospital or imaging center you would go to.

    With this information, the radiologist should be able to figure out if there’s a good chance of getting useful information from your scan or not… or even whether it would be safe for you to have such an exam.

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