Menlo Park, California
Medical devices may be vulnerable to malfunction when used within or near a magnetic resonance imaging (MRI) environment. Device-related safety risks to the patient may include excessive heating or displacement, unintended stimulation, and failure to deliver intended therapy. If labeling claims are to be made, MRI testing is required for device clearance/approval.
The established methods through which to evaluate the magnetically induced displacement force and torque, heating, and artifacts for passive medical devices in an MR environment are detailed in ASTM standards. These include benchtop testing using clinical MR scanners, computer modeling of electromagnetic fields and specific absorption rate (SAR) distribution of passive devices. Further, active implantable medical devices, such as pacemakers/defibrillators and neurostimulators, present additional challenges to safety in the MR environment. ISO standards describe a tiered approach to the assessment of hazards stemming from gradient-induced vibration, radio frequency (RF) induced voltages/heating, and gradient-induced voltages/heating. The methodology for the evaluation and testing of active devices continues to evolve.
This seminar will cover the following:
- Product development and risk management of passive and active medical devices from the clinical, industrial, and regulatory viewpoints.
- Explore the intersection of the varying perspectives and examine different roles in the evaluation and communication (e.g. labeling) of MRI safety information.
- The development of a structured methodology which evaluates, prioritizes, and mitigates MRI-related device risks, highlighting differences between the evaluation frameworks for active or passive medical devices.
The seminar panel will include clinicians and academics from Stanford University, as well as engineers from the Biomedical Engineering Practice at Exponent.
Robert Herfkens, MDProfessor, Associate Chair for Clinical Technology and Director of MRI Stanford University
Ross Venook, Ph.D.Lecturer in Bioengineering Stanford University
Min-Sun Son, Ph.D.Manager, Biomedical Engineering Exponent, Inc
To register, please email Eileen Cheng.