Japan Association for Medical Informatics

[3-D-4] Utilization of GS1 Standards for the Identification of Medical Devices and Materials, in Collaboration with Industry, Medical Societies and Government

*Kengo Miyo1,2, Koichi Uemura3, Takuya Ohata4, Futoshi Ohashi5, Masao Kondo6, Mitsuru Yuba7 (1. National Center for Global Health and Medicine, 2. Graduate School of Medicine, The University of Tokyo, 3. GS1 Japan, 4. The Japan Federation of Medical Devices Associations, 5. SHIP HEALTHCARE HOLDINGS, INC, 6. Graduate School of Pharmaceutical Sciences, Osaka University , 7. Pharmaceuticals and Medical Devices Agency)

Medical Device Traceability, GS1, Hospital Logistics, Regulatory Science, Barcode

Pharmaceutical and Medical Device Act in Japan was amended in 2019, making barcode labeling mandatory to improve traceability of medicines. In addition, the package inserts have been digitized to ensure that the information is always up-to-date, and the GS1 barcodes and GTINs (Global Trade Item Number) are now used to access this digitized information. However, at present, GS1 barcodes are not widely used to improve patient safety and operational efficiency in hospitals, with the exception of some advanced medical institutions. To put this situation in the right direction, a grand design is needed that includes all stakeholders involved in medical materials, rather than local optimization. In Japan, medical products have been already coded and barcode labeled according to international standards. Discussing the data utilization accumulated through the use of these barcodes from various angles and positions and reviewing the current issues and problems is extremely important as a compass for advancing medical DX beyond the identification of objects. In this session, we will discuss the challenges and prospects regarding the effective and efficient use of standard codes from various standpoints, including the manufacture, utilization and regulation of medical materials.