The 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.
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.
Just a very brief note to let you know that the video of my presentation from the April MRI Safety Workshop at Children’s Mercy Hospital in Kansas City is now available for online viewing.
If you’d like to watch it, it’s in 3 parts. The first of 3 is available here (requires QuickTime viewer).Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com
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…
I didn’t know that MRI scanners formed clubs, or gangs, but it appears that they’ve at least colluded in Stockton, California, and they’ve got it out for the municipal firefighters!
Alright, I don’t love the fact of being wrong, but my mission is to motivate improvements in MRI safety for patients, staff, and providers. I’m not the least bit interested in having the longest list of ‘I told you so’ moments, and I’m uncomfortable when someone applies the term ‘guru’ to me. I am openly, vocally, critical of organizations when I feel that they haven’t lived up to their obligation to reinforce MRI safety standards, so when one of them does well, I can’t tell you how happy I am to eat my prior words, and today is an example of that…
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.
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…
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!
News broke the other day of a nurse in England who was in agony for three months following a routine surgery during which her gall-bladder was removed. Fearing an infection, she was sent for an MRI. Unfortunately, the MRI could not be completed as the magnetic field began torquing the 7-inch pair of forceps that had been left inside her abdomen during the surgery, causing excruciating pain! Click Here For The Follow-Up X-ray And The Rest Of The Story…