If you’ve ever been on an email mailing list for the ACR, then you’ve probably received a few of these in the last few months… emails imploring you to contact your Senators and Representatives to urge them to support the Diagnostic Imaging Services Access Protection Act (HR 3269). So far I’ve received three or four of them, and for the ones I’d received previously, I replied, agreeing to contact my elected officials on their behalf, but on one condition…
Ambivalence is rampant with respect to MRI safety. “It hasn’t happened to us (so therefore the risk is just theoretical)”, or “MRI is the safe modality”, or “our last license or accreditation surveyor didn’t say anything, so we must be good.” In large part, I understand this let-sleeping-dogs-lie attitude (I don’t agree with it, but I can understand where it comes from). What I can’t abide, however, is hypocrisy with regard to MRI safety as typified by one entity’s ‘we’re the greatest thing for MRI safety since sliced bread’ PR.
Yes, I’m talking about the ACR…
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
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…
Make no mistake, Nephrogenic Systemic Fibrosis (NSF), a horrible (and thankfully very rare) disease which can afflict persons with significantly impaired kidney function who receive certain gadolinium based MRI contrast agents. Over the past few years, tremendous resources have been poured into the identification of patients, research on the specific mechanisms of disease, and effective means of prevention. NSF has run into a problem, however, which has dramatically curtailed further research… we’ve darn-near eliminated this disease!
First, let me say that this isn’t a ‘leak’ in the sense that none of the information I’m about to share is (any longer) confidential. This information is all public record as a result of court filings for the now-settled civil suit surrounding the 2001 MRI fatality of Michael Colombini. There are documents associated with that civil lawsuit which did not wind up as filings with the court and therefore are not a part of the public record. I have no difficulty not releasing those because (among other reasons) I don’t have any of them.
“Why — now — ten years later would you post these documents?”
Excellent question! Here’s why I didn’t publish these long ago…
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?
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…
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.
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.