How does Exponent approach MRI safety and risk management using a multidisciplinary approach?
Magnetic resonance imaging (MRI) is a non-invasive and often lifesaving procedure that can also pose serious risks to patients with implanted medical devices. Many implanted devices contain metallic components that can interact with the magnetic fields of an MRI machine. These interactions can damage the device, create image artifacts, and harm the patient through device malfunction, unintended stimulation, heating, or magnetically induced force or torque.
Exponent helps medical device manufacturers identify MRI compatibility hazards and optimize device designs for use in an MRI environment. Applying advanced computational modeling techniques for medical device testing, our MRI laboratory team evaluates worst-case scenarios that may occur while scanning a patient with an implantable device, and we assist clients in the feasibility and verification stages of product development through careful analysis of the collected data.
We also help medical device manufacturers meet regulatory labeling requirements through physical testing of the worst-case matrix for products. By leveraging our in-house benchtop radiofrequency and gradient coils, accredited by the American Association for Laboratory Accreditation, we provide analyses and labeling guidelines to help clients prepare regulatory submissions and formulate strategies for marketing devices evaluated for MRI safety.
We have the in-house capability, accredited to ISO 17025, to test in 1.5 T and 3 T MRI scanners in accordance with all applicable FDA guidance and ASTM International and ISO standards. We also have arrangements with regional research institutions to conduct studies at higher and lower field strengths, as needed. Our biomedical engineering experts are active members in standards committees related to MRI compatibility testing and routinely assist our clients in applying the standard methods to their specific products and indications.