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…

• Rolling cart seriously injures Siemens Apps Specialist (facial fractures & brain trauma)

• Flat-screen monitor hits research subject (facial fractures & surgery)

• Patient on gurney gets more of a ride than planned (foot, ankle, leg fractures)

• IV cart nearly strikes patient (near-miss)

• Knife slices patient (laceration requiring stitches)

• ‘Sand’ bag injures patient (brain hemorrhage, tongue laceration and facial injuries)

• Scissors seriously injures tech (embedded in forehead, surgical removal required)

• Bed tray-table (ambiguous injuries, including facial lacerations)

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.

Link

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.