Year after year, the number of patients with implanted medical devices, such as cardiac pacemakers or vascular stents, has been steadily increasing. MRI machines use powerful magnetic fields, and implants cannot be readily removed. Depending upon the interaction between the implanted devices and the magnetic fields, there is the possibility of injury and/or heat generation by way of the magnetic fields.
To prevent accidents, health care professionals must determine beforehand the MR compatibility of implants to know whether or not a patient can safely receive an MRI examination.
However, in Japan, health care professionals had the difficult task of making this determination without the benefit of an integrated database. The MR Safety-Related Information System is a reference base of MR compatibility, which has been developed to assist health care professionals.
This MR Safety-Related Information System was developed from a joint study between Medie and Dr. Yasuhiro Fujiwara of the graduate school of Kumamoto University.
With regard to the MR compatibility of implanted medical devices (IMD’s), Medie chose and applied one of the above five MR compatibility status groups, (which conform to the language and terminology of the ASTM International "Standard Practice" F2503-13 and Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Guidance for Industry and Food and Drug Administration Staff. Document issued on December 11,2014.) for each IMD, based on medical packaging inserts.
Further, Medie has placed information regarding MR compatibility of MR conditional IMD’s into standardized categories. This allows health care professionals to easily verify information on MR compatibility.
Also, IMD’s, e.g., pacemakers, with conditional compatibility are not only complicated, but also varied, so to the extent feasible, Medie created a way to directly view medical packaging inserts regarding MR compatibility.