The evolution of MRI safety compatibility testing, coupled with the European MDR requirements to evaluate devices for safety with respect to external electric and magnetic fields, has necessitated the evaluation and in some instances re-evaluation of medical devices for MRI safety. Testing for MRI safety is based on standards published by ASTM International and ISO, as well as based on FDA guidance; however, those tests may not be sufficient to address all safety concerns and additional evaluations may be required to fully label for MRI safety and compatibility.
In this webinar, you will learn:
Joshua White, Ph.D. expertise includes identifying risks associated with medical devices in and around MRI scanners. He frequently assists clients to develop custom protocols for performing MRI compatibility testing according to the relevant ASTM and ISO standards based on the risk profile of the device. His experience in MRI compatibility testing includes performing both multiphysics modeling in COMSOL and experimental testing. While at Exponent, Dr. White has assisted clients with responses to inquiries from both US FDA and international notified bodies related to their MRI compatibility assessments.
Dr. White is knowledgeable in particle analysis of orthopedic and cardiovascular medical devices. He is experienced in the generation of particles using benchtop methods including pin on disc testing, simulator testing, and tortuous track models. For particles embedded in tissue or wear fluid, he is also well-versed in isolation techniques that rely on both chemical- and enzyme-based approaches. Dr. White is also skilled with particle characterization techniques including scanning electron microscopy, energy-dispersive X-ray spectroscopy (EDS), dynamic light scattering and light obscuration, and inductively-coupled plasma mass spectroscopy (ICP-MS).
Dr. White is also experienced with the execution of medical device retrieval programs that incorporate his knowledge of biomaterials, tissue assays, and surface characterization techniques to evaluate devices and associated animal, cadaveric, and human tissues. He has helped clients establish international device and tissue retrieval programs in accordance with ASTM, ISO, and IATA standards. As such, he has evaluated device performance and performed failure analysis of devices at the preclinical, clinical, and post-market surveillance phases of the total product lifecycle.