Japanese Regulations for Reprocessing Single-Use Medical Devices

Abstract

Reprocessed single-use medical devices (R-SUDs) are single-use medical devices collected from hospitals by the manufacturer for reuse after cleaning, sterilization, and performance testing. Regulations for R-SUDs have been implemented in Japan and some foreign countries. The characteristics of R-SUDs include collection form medical institutions, quality-assured transportation, and disassembly, cleaning, and reassembly in registered manufacturing facilities. In addition, manufacture of R-SUDs have to monitor the changes in the original medical devices that were used as the materials for remanufacturing of the R-SUDs. And manufacture also have to monitor the occurrence of malfunctions or adverse events that occur during the use of the R-SUDs and the original medical devices. Based on these features of R-SUDs, regulations has been implemented in Japan. For the further promotion of R-SUDs in the future, it is necessary to discuss how to effectively/rationally utilize and operate R-SUDs while ensuring the quality and safety of medical care for patients.