MR ScanWise implant (MROC)

Treatment of many chronic conditions involves the placement of implants or use of body-worn treatment-delivery devices. Millions of patients benefit from passive implants, active implants or devices. For numerous medical conditions, MRI is the modality of choice^4-8 recommended by consensus guidelines for diagnosis and treatment monitoring. Current medical practice, however, excludes patients with an implant from access to MRI, based on serious and valid safety concerns. This “clash of technologies”⁹ results in unnecessary health inequalities for a rapidly growing group of patients.

Implants must be strong for MSK applications or flexible, for instance when used as stents, and biocompatible. Active implants must sense or stimulate electrophysiological signals from the heart or the central nervous system.¹⁰ Their microcontrollers and electronics must be protected against electromagnetic interferences in everyday life. All these requirements suggest the use of metallic structures, which can be problematic when brought near or inside an MRI system. The strong electromagnetic fields required for MRI far exceed the electromagnetic fields encountered in urban environments.

Scanning patients with implants requires having significant additional organizational measures in place at the hospital. Retrieval and interpretation of MR Conditional implant labeling must be organized in a multidisciplinary team. Cross-industry harmonization and standardization efforts by IEC and ISO14 and FDA guidance¹¹ have improved the availability of information to support the clinical decision to scan in compliance with MR Conditional labeling. Users should understand the possible interactions between implants and the MRI system and should be able to identify related safety concerns.