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Abstract #4658

Interpreting Spatial Field Gradient MR Conditional Device Labeling & the IEC 60601-2-33 3rd Edition Fringe-Field Compatibility Technical Specification Sheet Requirements

Michael C. Steckner1, Georg Frese2, Johan van Den Brink3, Daniel J. Schaefer4

1TMRU, Mayfield Village, OH, United States; 2Siemens Medical Solutions, Erlangen, Germany; 3Philips Medical Systems, Best, Netherlands; 4General Electric Healthcare, Waukesha, WI, United States

While MRI manufacturers generally contra-indicate scanning patients with implants, the implants frequently carry the MR Conditional label. Implant labels imply safety under certain specific conditions. MRI users compare implant vendor labeling with the MRI Compatibility Technical Specification. Terminology can be confusing (Spatial Gradient Fields are not the switched spatial encoding imaging gradients) and there is misunderstanding of the intent and use of information provided by MR vendors. The result is requests to MR vendors for additional information. Members of the IEC 60601-2-33 committee who assisted in writing the Compatibility Technical Specification requirements, clarify the technical aspects of this issue here.