Emanuel Kanal MD, Abstract Co-Author: Consultant, Medtronic, Inc Consultant, Guerbet SA Speakers Bureau, Bracco Group

Tobias Gilk, Presenter: Executive, Mednovus, Inc Stockholder, Mednovus, Inc Executive, JUNK Architects / RAD-Planning

Under-reporting of MRI accidents creates an environment where providers are unaware of the greatest risks, and undervalue programs to manage them. This research quantifies MRI adverse events, defines major types, and identifies steps that mitigate the associated hazards.

The authors queried FDA’s MAUDE database for adverse event reports (AEs) of the product code for Magnetic Resonance Imaging (product code “LNH”) for 2009 and 2010. Individual AE’s were not evaluated if they failed to identify a ‘testable’ adverse event or a non-clinical MR event. Remaining AEs were tested against explicit criteria from the ACR Guidance Document for Safe MR Practices: 2007, and TJC’s Sentinel Event, Alert Preventing Accidents and Injuries in the MRI Suite, measuring each standard’s effectiveness in mitigating MR risk.  

The explicit criteria of the ACR Guidance Document mitigated 129 (83.7%) of 154 AEs reviewed. This level of mitigation does not include preventions potentially achieved through general standards, such as safety training. The authors compared the FDA MRI AE reports independently from the state of Pennsylvania’s Patient Safety Authority published records. This data, projected nationally, suggests that the FDA database contains roughly only 1 out of 50 actual national MRI safety incidents. The analysis of adverse events helped the authors to identify ten explicit steps that could eliminate the overwhelming majority of MRI adverse events.  

Existing standards do not effectively address the most frequent (and growing) risks to the MRI patient and provider. This research quantifies and profiles MR risks and, critically, preventions that will effectively protect against accident and injury.

In the absence of societal defined standards, the MR community must manage risks of avoidable MRI accidents . The actionable findings of this research are immediately relevant to safe MR practices.

Kanal, E, Gilk, T, MRI Accidents & Adverse Events: Empirical Analysis of Frequency, Type, Severity, Trends and Preventions.  Radiological Society of North America 2012 Scientific Assembly and Annual Meeting, November 25 - November 30, 2012 ,Chicago IL. http://archive.rsna.org/2012/12023518.html