Evaluation of the Japanese-English Mapping in the Adverse Event Terminology for Medical Devices.

The purpose of this study is to develop an automatic terminology mapping system for adverse events between Japanese (JFMDA) and English (IMDRF) terminologies. IMDRF terms were analyzed in four versions: untranslated (English), two machine-translated, and officially translated into Japanese. Conceptual similarity was evaluated using SentenceBERT, and mapping accuracy was assessed against a gold standard. Results showed that translating IMDRF terms into Japanese improved mapping accuracy, with official translations performing best. However, the accuracy was not significantly different from that of machine translations. Term names outperformed definitions, achieving approximately 50% accuracy for health effects. This method supports manual mapping and offers potential for further refinement.