Last year I highlighted an FDA MRI accident report in which a technologist had to have a pair of scissors surgically removed from his forehead after they’d caught him between the magnet-homing missile that they became, and the isocenter of the MRI. You may remember that I fauxtoshopped a hypothesis as to what that accident would have looked like on plain film: perhaps something like this… Click For More On What This Accident Was Like…
Posts Tagged ‘FDA’
NOT Magnet Safe Scissors!
Tuesday, July 6th, 2010MRI Accident Rates: It’s Not As Bad As Previously Reported…
Monday, June 28th, 2010IT’S WORSE!
That’s right, the FDA has updated it’s MRI accident figures available online through the MAUDE database. We were alarmed and astonished when we thought that the rate of increases in MRI accidents was only 270% (from 2004 to 2008). Turns out that the FDA must have found additional accident reports that were in a stack of junk-mail, or got lost between the sofa cushions, which means that the rate if adverse events went up, significantly, in 2008 from the prior calculation.
Click Here To Learn How Much Worse MRI Accident Rates Really Are…
No Vacation For MRI Safety (Recent Death)
Tuesday, June 15th, 2010Yes, 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…
“The Magnetic Elephant In The Room (Or Congressional Hearing Chamber)”
Sunday, February 28th, 2010Here 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.
30% Of Contraindicated Implant Patients Get MRIs Anyway!
Tuesday, February 23rd, 2010And 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
Friday, February 19th, 2010How 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…
Gurney Crashes MRI, Patient Injured, Hospital Fined $50K
Sunday, January 24th, 2010It 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…
CMS Asked To Review MRI For Pacemaker Patient Exclusion
Friday, July 2nd, 2010The Centers for Medicare & Medicaid Services (CMS) has opened a brief public comment period on a request to lift reimbursement restrictions on imaging pacemaker patients with pacemakers.
Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams
Click To Read More And Link To The CMS Info…
Tags: cardiac, CMS, comment, death, defibrillator, device, FDA, hazard, ICD, imaging, implant, injury, magnetic, Medicaid, Medicare, MRI, National Coverage Determination, NCD, pacemaker, public, radiology, resonance, risk, Russo, safety, Scripps
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