Efforts Toward the Practical Use of Reprocessed Single-use Devices

Abstract

In July 2017, the legal regime for remanufactured single-use devices (SUDs) was established in Japan, allowing manufacturers to collect used SUDs from medical institutions, disassemble, clean, replace parts as necessary, reassemble, and sterilize, and make them commercially available as remanufactured SUDs (R-SUDs) after performance testing. In order to actually commercialize R-SUDs, approval is required for each product, and at present, four items have been approved by two companies. Used SUDs need to be collected and transported separately from infectious wastes. In this paper, we describe the knowledge gained through the collection of used SUDs, consultations with the Ministry of Health, Labor and Welfare and the Ministry of the Environment, and the activities of Japan R-SUD Association (JRSA), during we have been conducting to commercialize R-SUDs.