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.
Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams
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!
This week the settlement documents were released — closing the chapter on the lawsuit that arose from the seminal event in MRI safety, the 2001 oxygen tank fatality of then-six-year-old Michael Colombini.
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…
Near the end of last year I posted an article from an RSNA ‘tip of the day’ regarding external fixation, halo, hardware and ferromagnetic risks. Now, in the first few weeks of 2010 we learn of new MRI safety risks from orthopedic hardware that may be more common than halo systems, scoliosis body braces.
External fixation and braces are typically very carefully screened for contraindication for MRI examination, but what may not be as frequently screened is the clothing underneath. Click Here For The Rest Of The Story…
Yesterday I was provided a copy of an anonymized MRI accident / incident report which described how an MRI patient wearing a ThermaCare HeatWrap (something of a self-warming patch for muscle aches) had the wrap pulled off of them by the magnetic attraction of the MRI.
ThermaCare HeatWrap Products Contain Iron And May Be Drawn Into MRI Scanners
Every year the ECRI Institute publishes their Top 10 health technology hazards, identifying the 10 most serious (and unintended) risks posed by our ever-increasing use of sophisticated medical devices to diagnose and treat patients. In November, the Institute released their 2010 watch list, which dedicated a Top 10 slot, and an entire page, to ferromagnetic projectiles in MRI.
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…
“Tweet, tweet” is usually all I hear from little birdies… but one little bird that flew past my office recently had a surprisingly large vocabulary and told me of new requirements that will be introduced in the forthcoming 2010 update to the ‘Guidelines for Design and Construction of Health Care Facilities’ (commonly referred to as ‘Guidelines’).
For those of you who aren’t familiar with the Guidelines, they are the design requirements that are cited by the Joint Commission and, at last count, 42 of the 50 U.S. State Departments of Health. Technically, they aren’t a building code, but the function in almost the exact same way. For the first time, the Guidelines are going to have specific MRI suite design requirements for patient safety.
That’s right. Yesterday, October 26th, the Colombini family formally accepted a settlement offer for the MRI vs. oxygen tank accident which killed their 6-year-old son in 2001. The settlement puts to rest 8 years of litigation resulting from the single largest MRI safety incident in the industry’s consciousness. And though precedent-setting verdicts won’t result, the dollar-value of the settlement will likely cause many MRI providers to sit up and take notice.
External fixation and braces are typically very carefully screened for contraindication for MRI examination, but what may not be as frequently screened is the clothing underneath. Click Here For The Rest Of The Story…
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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