Jan. 10, 2007 — A report is now available summarizing the findings from a workshop last October sponsored by Biophan Technologies Inc. and the FDA for the purpose of addressing safety issues surrounding MR and implantable medical devices.
Authored by Howard Bassen, Ph.D. of the FDA, Jeffrey Helfer, Biophan VP Engineering, and Andreas Melzer, M.D., CEO of Biophan Europe, the paper — "Biophan Technologies CRADA Workshop on the Safe Use of Implantable Medical Devices in Magnetic Resonance Imaging (MRI) Systems - Summary from Initial Workshop” — is accessible at http://www.biophan.com/crada_workshop0107.
The CRADA titled "Measurements and Computer Modeling to Evaluate the Safety of Medical Implants by Examining Leads of Cardiac Rhythm Management and Neurostimulation Devices in the Presence of Electromagnetic Fields from Magnetic Resonance Imaging," began with a workshop attended by leading device manufacturers and medical, scientific and industry experts from around the world. Participants discussed cardiac rhythm management and neurostimulation devices and their behavior in an MRI environment. The group focused on factors perceived as most relevant to device safety, including lead heating and induced voltages, and how to properly measure these effects.
The report summarizes the many safety-related factors identified by workshop participants, including device design, MRI scanner, and patient parameters.
The next phase of the CRADA will involve experiments to identify worst-case conditions for testing MRI safety, to establish device safety guidelines, and to define measurement methods.