We are a manufacturer of orthopedic devices with a line of titanium implants. Over the last several years, the FDA’s and EU’s stance on MR compatibility has been evolving and we are getting increased pressure to address this issue in our labeling. We are planning on doing some testing to establish the MR Conditional parameters, but my question is whether 1.5 Tesla or 3 Tesla should be evaluated. What is the industry standard for this?
Thanks a lot for any insight that you can provide.
FDA’s rules for magnetic field safety are terribly constructed and managed.
My view is that you must test at the greatest field strength that is commercially available.
If your implants are provided with patient-communication cards, my further recommendation would be that that card should have further information on MR safety, particularly so that patients and later clinicians will be informed of the field strength used in testing. Stronger fields are used in some research facilities now, and may become available for commercial systems in the foreseeable future.