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…
I was invited to present a paper at the American College of Radiology’s meeting on quality and safety held October 22 – 23 in Phoenix, Arizona. Actually, the invitation came in response to an abstract of a paper that hadn’t been written yet [not to self, don't promise papers you've not yet written again].
While the FDA’s adverse event data was clearly never intended to be useful to the outside world (we eliminated over 50% of the events from consideration, primarily because of too little narrative), it did provide a great snapshot of the diversity of accidents. We wound up with 104 useful event reports from an 18 month period of reporting.
We then compared each of these 104 events against the criteria in both the ACR Guidance Document and the Joint Commission Sentinel Event Alert #38. What we found gave us tremendous encouragement… encouragement tempered with some very unpleasant contemporary realities.
Stunning: Our review found that the ACR Guidance Document for Safe MR Practices: 2007 had explicit, actionable criteria that could have interdicted 80% of the 104 tested adverse events! And that doesn’t even include the general provisions for safety such as technologist training, or situational awareness.
The TJC Sentinel Event Alert (SEA) #38 fared somewhat less well, with a 49% effectiveness, though preventing half of the MRI adverse events that are occurring is certainly nothing to scoff at!
Frustrating: Neither the ACR nor the Joint Commission currently have any… ANY… explicit standards for MRI safety, despite the fact that each organization has published best-practice standards that promise to be 80% and 49% effective (respectively) in mitigating MR specific hazards in the MRI suite!
So the conclusion of the presentation offers a challenge to the ACR, the Joint Commission, DNV, and the IAC, to adopt explicit MRI safety standards as a requisite element of accreditation.
If you would like to view the presentation, please see the video (below).
Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com