Standardisation for safe implant scanning in MRIShort Name: STASIS, Project Number: 21NRM05
Standardisation for safe implant scanning in MRI
Over 40 million Magnetic Resonance Imaging (MRI) scans are performed annually in the EU to diagnose medical conditions. However, scanning of patients with medical implants poses a health issue. Implants can interact with the MRI scanner’s strong electromagnetic fields – resulting in dangerous tissue heating by radio frequency (RF) fields or gradient-induced heating of an implant. Standards ISO 10974 and ASTM F2182 in this area currently do not provide guidance on personalized or in situ risk assessments suitable for RF and/or gradient heating of implants. Risk is based on in silico results or past knowledge and there is no quantified in vivo data establishing patient risk.
MRI equipment and implant manufacturers, as well as convenors of MRI safety standards, urgently need updated methodology related to implant safety in this area.
Based upon the project MIMAS, this project will evaluate and explore the uncertainty of an implant safety concept in MRI where ‘smart’ implants contain sensors that can interact with an MRI to direct magnetic fields around implants, reducing heating effects without loss of MRI data. To do this metrologically sound sensor-calibration procedures, open-source generic implants and a communication strategy between an implant and a scanner will be implemented.
Rigorous testing procedures to assess gradient-induced heating of an implant during a scan will be developed for MRI equipment and implant manufacturers, and an RF testbed established and published as open-source hardware.
This work will improve the safety and efficiency of MRI examinations, support the inclusion of implant MRI compatibility in future revisions of standards, and the EU Medical Device Regulation, enhancing the safety of about 50 million EU citizens carrying implants.