Tag Archives: FDA

No Vacation For MRI Safety (Recent Death)

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…

Click To Read More About The Recent MRI Death…

“The Magnetic Elephant In The Room (Or Congressional Hearing Chamber)”

Here we sit, on the cusp of mandatory accreditation for ‘Advanced Imaging’ modalities at outpatient providers (these are CT, MRI and PET), and a series of articles on medical radiation exposure splashes across the New York Times.

In nearly concurrent moves, the Joint Commission (JC) unveils their just-developed Advanced Imaging (AI) accreditation program, the FDA is clamoring for new authority to regulate medical device safety (or gearing-up to use authority that it’s been hiding for safe-keeping, that isn’t exactly clear to me), the US Congress whips together a set of hearings on the issue, and, at those hearings,  the American College of Radiology (ACR) recommends that the Feds expand the scope of the AI accreditation requirement to include radiation therapy and to apply the expanded accreditation requirements to hospitals, too.

Whew, that’s a lot of ground covered for radiology in just the last few weeks! Wait a minute… who is that sitting in the backseat? Who has been drug through all of the hullabaloo about radiation exposure and patient safety without once having been considered, individually? MRI, that’s who.

Click To Read About How MRI Should Be Considered…

30% Of Contraindicated Implant Patients Get MRIs Anyway!

And what’s even more alarming is that 20% of those implant patients that get MRIs experience some sort of device malfunction afterward! And yet, the dangers of imaging these patients are not well known by the doctors who prescribe these imaging studies.

Click To Learn Just How Many Doctors and Patients Are Ill-Informed Of These Risks…

MRI Projectile Accidents – One Exemplar

How to pick just one when there are a number of alarming, tragic, and needless MRI accidents to choose from? Let’s look at one that we can help the reader better imagine, the case of a pair of flying scissors that had to be surgically removed from a technologist’s forehead…

Click For The Rest Of This Story…

Building An MRI, GE Accidentally Invents Time-Travel

OK, I’ve been reading too many headlines in supermarket check-out aisles, but what else is a guy with an overactive imagination supposed to come up with?

You see, back in 1983 when GE was going through their pre-market approvals with the FDA for their first commercial clinical MRI system, they indicated that MRI suite safety minimally required ferromagnetic detection pre-screening. The only problem was, it hadn’t been invented yet!

Click Here For The Rest Of The Time-Traveling Story…

Colombini, Codes, Metal Detectors And MRI Safety

Go grab yourself a cup of coffee before you continue… this is going to be a long (for me, anyway) rant.

Ready? OK…

Let’s start at the very beginning (“what a very good place to start”). Click To Read The Whole Story…

Gurney Crashes MRI, Patient Injured, Hospital Fined $50K

It is the stuff of fabled oral-histories, often dismissed as MRI urban-legend. The patient is wheeled into the MRI room on a gurney that goes flying toward the scanner. “How on Earth could these accidents happen when we know about these risks,” the skeptics question? Almost never does more than a single fragment of information surface about these sorts of accidents and, without verification, nearly all accounts can be erroneously written-off as fiction. Or, that was until enough pieces fell into place to conclusively document a recent episode… Click Here To Read More About MRI Gurney Accidents…

2009 – The MRI Safety Year That Wasn’t

But 2010 holds the promise of reversing course.

Throughout 2009, we saw tantalizing glimpses of potential MRI safety improvements, which repeatedly escaped becoming real. Here are my ‘Top 3’ near-miss opportunities of 2009 to substantially reshape MR safety…

Can We Still Call Them ‘Never Events’ When Accidents Happen So Frequently In MRI?

This post attempts to draw-together two recent threads from here on the MRI Metal Detector blog. First, there was a long-running question about the FDA and their online-accessible database of medical device accidents which, for months, appeared to be malfunctioning, and recently was repaired. Second, there was my post in which I identified 5 MRI ‘Never Events’ which, if industry standard procedures are followed, should never occur.

Click For Several Recent Examples Of MRI Never Events…

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. So Click Here If You’re Curious…