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MRI Safety: 10 Years Later
By: Tobias Gilk
MRI safety has a lot to trumpet from the last ten years. There have been three MRI safety documents from the ACR (2001, and 2004 ‘White Papers on MR Safety’, and the 2007 sequel, renamed the ‘Guidance Document for Safe MR Practices’), a 2008 Joint Commission Sentinel Event Alert on reducing MRI accidents and injuries, US Department of Veteran Affairs MRI Design Guide, and the 2010 Guidelines for Design and Construction of Health Care Facilities. Measured in pounds of paper, we should immensely proud of our accomplishments in the ten years since an MRI accident which killed a six-year old boy was splashed across the press.
Too bad these measures are insignificant, though. If they were meaningful, we wouldn’t be injuring our MRI patients and caregivers at a rate of almost five-times what it was just a few years ago!
That’s the alarming thing… despite a confederated ‘brain trust’ of radiology, patient safety, and operations experts all working on best-practices to prevent avoidable accidents, the 2009 rates of reported MRI adverse events shot up 4.7-times the rate of just five years earlier!
Here’s the ‘other shoe’ of that alarming statistic, in an analysis of 18-months of FDA-reported MRI adverse events, the ACR’s Guidance Document was shown to have explicit safety criteria that would interdict at least 80% of clinical adverse events! If we already have the tool that could reverse a 5-fold increase in MRI adverse events, why are these accidents not only continuing, but growing?
We’ve failed, that’s why.
Not that we’ve failed to find solutions to the causes to MRI accidents. Not that there aren’t tools, standards, and best-practices that could make MRI adverse events endangered, if not extinct. We’ve found solutions and developed the tools. The problem is that these new tools are often different than ‘the way we’ve always done things,’ and we’re resistant to change. Add to that the fact that some changes, particularly when retroactively applied, have associated costs and radiology also feels as though the reimbursement-rug has been pulled out from under it. As a result, the voluntary nature of MRI safety best-practices is on the cusp of becoming a whole lot less voluntary than it has been.
2010 saw a gatling gun-like barrage of articles and investigations into the safety of ionizing radiology (primarily CT) and beam therapies. As a consequence CMS, the agency that administers Medicare and Medicaid for the US Government, has been working with the FDA’s Center for Devices and Radiological Health (CDRH) on the development of a set of safety standards for imaging and radiation therapy. While the spark for this initiative was generated by X-ray devices, it grew to include MRI.
It is unclear just what steps that the FDA and CMS will be taking with regard to MRI safety, but each is uncomfortably aware of both the current absence of any meaningful MRI safety requirements and the unmistakable trend of accelerating rates of MRI adverse events. The FDA and CMS each influence very different parts of the safety equation. FDA, with the exception of mammography, has no authority over point of care quality and safety for a radiological device. CMS has no other sphere of influence other than point of care. If these two agencies collaborate, there could be no stronger partnership for MRI safety.
While we may have to wait several months to see exactly how these issues shake out, rest assured that we will be seeing MRI safety coming from the federal government’s bowl of acronym soup before the year is out.
The million-dollar question, though, is will the product be measurable in substantive improvements to MRI safety, or simply more pounds of paper.
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802 Broadway 5th Floor
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