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…
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…
Make no mistake, I believe that healthcare has a special obligation to protect the well being of our patients, our beneficiaries, our charges. When it comes to radiology, nuclear medicine and radiation therapy (where treating the patient involves sticking them in an astoundingly complex machine and exercising advanced concepts in physics to have a computer reconstruct fragments of data into an intelligible picture)… well its just so damned complicated that we have to assume the full responsibility for patient safety because, under those circumstances, it is wholly unreasonable to expect the patient to be active participants in their own safety.
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.
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