Tag Archives: regulation

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

2011 nPSG.11.01 (nuclear-Magnetic-Resonance Patient Safety Goal)

I hope my 2011 nPSG on MRI safety doesn’t cause any confusion with the Joint Commission’s new NPSG (National Patient Safety Goals). The fact is that this is distinct… it only uses the Joint Commission’s own wording to craft a patient safety goal specific to MRI in an effort to break through the paper-thin fallacy of ‘supporting MRI safety’ without providing (a) specific standards, (b) comparable scrutiny based on TJC published best-practices, (c) enforcement of requisite risk-management standards as they would apply to MRI, or (d) specific expert training on MRI safety issues for their on-site surveyor corps.

So, here is the justification my new nPSG, using the Joint Commission’s own words… Click Here To Read TJC’s Own Words On MRI Safety…

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…

MRI Safety Video Available Online

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

Click for Tobias Gilk's Twitter Profile Click here for Tobias’ Twitter Profile

“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…

MRI Design Requirements – Guidelines Dominoes

In stark contrast to the speed with which we expect to see medical technology advance, the more bureaucratic process of regulatory or accreditation tends to be more deliberative and… oh heck, I’ll just say it… glacial in its pace to keep up. Every once in a while, however, these efforts ‘sling-shot’ forward.

Much to my surprise (and delight), this is happening with the new Guidelines for Design and Construction of Health Care Facilities (or Guidelines, for short). Though the 2010 edition of Guidelines has only been published for about a month (and the publisher has been struggling to catch up on back-ordered copies), two states have already adopted the 2010 edition as their requirements for licensure.

Click To Learn If Your State Is Among The First…

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…

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…

$2.9 Million Settlement Closes Colombini MRI Death Case

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.

Click To Learn More About The Accident And Settlement…