While they released a Sentinel Event Alert on MRI safety in 2008, and while they’ve interpreted MRI-specific applications of a couple of hospital-wide standards (mainly, non-magnetic portable fire extinguishers), it was this past December (2013) when they announced their first explicit MRI Safety Standards, which become effective in July of 2014.
There are a few highly-specific criteria that don’t leave much to interpretation (collect data on your failed screenings in which a ferromagnetic object was allowed to enter the MRI scanner room), and there are more somewhat ambiguously-worded standards (manage MRI safety risks). Any facility that has undergone more than one Joint Commission survey knows that there is often different emphasis from one survey to the next, even if the standards haven’t changed. What follows is my own, personal, compliance checklist of the new MRI standards. While not reviewed / approved / sanctioned / blessed by the Joint Commission, I would contend that anyone who can check all of these boxes should sail through any survey that uses the new MRI safety standards… Continue reading →
I apologize for my unusually long hiatus from posting. I’d love to tell you that I haven’t written because I’ve been so extraordinarily busy putting the final touches on a set of meaningful standards which will effectively protect the 30,000,000 (that’s million) annual MRI patients in the U.S. from the most frequent preventable MRI injuries. I’d love to tell you that, but it’d be a lie… Continue reading →
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.
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…
Unlike most of my posts, this one does not offer a position, much less a ‘call to action.’ Instead, I pose a question. You can read it as rhetorical, and allow me to stew in my own juices, or offer your thoughts. The essence of my question is what obligation do I have when I see horrible MRI suite design?
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?
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.