Frank G Shellock - Comment

RE: 28. If you believe that additional information should be required to assure the adequate identification of a medical device, please identify the information you believe is necessary and provide an explanation of your views. Some additional attributes that have been suggested are:
b. Magnetic Resonance Imaging (MRI) Compatibility Type (safe, unsafe, conditional); if conditional, the description of the conditions;
COMMENT: I strongly recommend that all implant and device manufacturers should be compelled to include concise and easy to understand MRI labeling that should be presented in a standardized manner. To date, this has not been done because there are apparently are no internal standards for MRI labeling of implants that are followed by the FDA. This needs to be corrected immediately!
Furthermore, please do not use the outdated term "compatibility". We stopped using that term in 2005 and the FDA and others continue to use it, causing confusion by members of the MRI community.
Please see this article for clarification on this matter (authored by Dr. Terry Woods, a member of the FDA):
Shellock FG, Woods TO, Crues JV. MRI Labeling Information for Implants and Devices: Explanation of Terminology. Radiology 253:26-30, 2009.
Please be advised that my comments are based on my 25+ years of experience having tested more than 4,500 implants and devices for MRI issues and publication of more than 220 articles in the peer reviewed literature as well as more than 10 medical textbooks, including the following:
Shellock FG. REFERENCE MANUAL FOR MAGNETIC RESONANCE SAFETY, IMPLANTS, AND DEVICES: 2012 EDITION. Biomedical Research Publishing Group, Los
Angeles, CA.
Respectfully,
Frank G. Shellock, Ph.D., FISMRM, FACC, FACSM
Adjunct Clinical Professor of Radiology and Medicine
Keck School of Medicine, University of Southern California
Director for MRI Studies of Biomimetic MicroElectronic Systems National Science Foundation, Engineering Research