Tag Archives: FDA

Looooooong Overdue…

Those who know me know that I’m an upbeat person. Not the spring-out-of-be-fifteen-minutes-before-the-alarm-“so-happy-to-greet-the-morning” type of upbeat, but more of an indefatigable cautious-optimism. Yes, there are bad days… days when I’d just prefer to pull the covers over my head to wait to see if next week Thursday offers enough to coax me out of bed. But I’m of the firm belief that – on those days – you have to drag your sorry butt out of bed and put one foot in front of the other, if for no other reason than you might forget how if you skip a day. Someday, no matter how distant or unlikely, you will meet your goal.

Guess what? Today is one of my somedays! Continue reading

MRI Safety, Per ACR Accreditation Standards

“Peachy Keen!”

One can only presume that this is the commentary that US States and radiology accreditation agencies have to offer on the contemporary state of MRI safety. After all, there’s been nothing more than navel-gazing when it comes to measurable changes in standards for MRI providers. Let’s break it down…

Click to Read About the ACR and MRI Safety Standards…

PLEASE Don’t Call It The “MRI Safe” Pacemaker…

It’s almost enough to bring my high school English teacher back from the dead… me, railing on someone else’s vocabulary skills. What I’m talking about here is the new Revo pacemaker (formerly known as Enrhythm) by Medtronic, designed to allow pacemaker patients to receive MRI scans.

Revo MRI Sure Scan Pacemaker

Revo MRI Sure Scan Pacemaker by Medtronic

Continue reading

MRI Safety Resolution

I’m not big on New Years’ resolutions. In fact, I’ve previously resolved to not resolve… but today I’m breaking that vow (or would that be a ‘disavow’?). This year there are just too many things precariously poised — that could fall our way or not — that I can’t help but to resolve to rededicate myself to making substantive changes to industry standards and practices for MR safety, and here’s how I’m going to do it…

Click To Learn How…

Radiation Therapy Accidents vs. MRI Accidents

I stumbled across a paper abstract from the International Journal of Medical Physics Research and Practice. The abstract described a meeting on radiation oncology safety which, “attracted 400 attendees, including medical physicists, radiation oncologists, medical dosimetrists, radiation therapists, hospital administrators, regulators, and representatives of equipment manufacturers. The meeting was cohosted by 14 organizations in the United States and Canada.”

Damn! I’m impressed, particularly since the abstract also states that this meeting was hastily called in response to articles appearing, starting in January of this year, in the New York Times on radiology and radiation therapy accidents. Such a coordinated response by the professional societies. Such representation from the professional community at a time when conference and professional development budgets are being slashed. How does this compare with MRI?

Click To Read How The Two Compare…

Calling Out Radiology Accreditation For MRI Safety (video)

This past weekend I was invited to present the findings of a study I did with my friend and colleague, Emanuel Kanal. Among his many accolades and credentials, Manny Kanal is the Chair of the ACR MR Safety Committee, a fellow of the ACR and ISMRM, and a neuroradiologist at the University of Pittsburgh Medical Center. The study had a two-part mission, first to review and categorize 18 months of the FDA’s MRI accident data, and second to compare each of these adverse events against existing best-practice standards for MRI safety. The results of the analysis were both stunning, and disheartening…

Click To Read More About The Meeting And The Results…

‘Learn The Things You Don’t Know That You Don’t Know.’

This, in essence, is the entirety of point-of-care safety standards for MRI.

Hey, you, MR technologist! Make sure you know what you’re supposed to know to keep people safe around MRI.

Make no mistake, as someone who spent a decade in college (which included a Masters degree and about half of a 2nd Bachelors), I’m a huge fan of education. What I’m adamantly opposed to – when it comes to MRI safety – is education without any standards or benchmarks, which is precisely where we find ourselves today.

Click To Read What Tobias Thinks Is Wrong With MRI Safety Training…

NOT Magnet Safe Scissors!

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…

CMS Asked To Review MRI For Pacemaker Patient Exclusion

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

Click To Read More And Link To The CMS Info…

MRI Accident Rates: It’s Not As Bad As Previously Reported…

IT’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…