Metrology at the service of diagnostics
To protect the safety of patients with implants, by testing and certifying the compatibility of prostheses with exposure to magnetic fields is the aim of the research project MIMAS - "Procedures allowing medical-implant manufacturers to demonstrate compliance with MRI safety regulations", funded under EURAMET, the association that brings together and coordinates European institutes of metrological research.
Along with the National Institute of Metrological Research-INRIM, the 3-year project, started in June 2018, also involves the Istituto Ortopedico Rizzoli in Bologna (IOR), international reference centre for advanced orthopedics.
The project stems from the observation that more than fifty million people in Europe have implants needed to make their bodies work, which include orthopedic prostheses, metal plates, pacemakers and other medical devices.
But what happens when they undergo a magnetic resonance? What are the risks of being exposed to the intense magnetic fields of last-generation devices?
Even if the current prostheses are made of compatible materials, the use of last-generation machines has opened new safety issues: in some conditions, the interactions between metallic materials can cause an increase in temperature.
However, in order to evaluate these risks, expensive instruments are needed which cannot be afforded by radiology units nor by prosthetic system manufacturers.
“The idea is to identify updated manufacturing criteria, procedures and protocols which allow manufacturers to develop safe products, the compatibility of which with modern MRI is documented and certified”, said Luca Zilberti, from INRIM.
“With MIMAS, we aim at developing and using a wide range of instruments for the prediction of possible increases in temperature in passive prosthetic systems, such as hip and knee implants in patients undergoing MRI”, said Fabio Baruffaldi, from IOR.