2021 Volume 11 Issue 3 Pages 195-204
The reprocessing of single-use devices (SUDs) is that the manufacturers responsibility collects the SUDs which have been used at medical facilities, disassemble, clean, replace the parts, reassemble, and sterilize, and then made commercially available after confirming to be as safe and effective as the original SUDs. The Japanese Ministry of Health, Labor and Welfare (MHLW) announced the establishment of a new system for the reprocessing of SUDs on July 31, 2017, and issued a notice on the Pharmaceutical Affairs Law. The cleanliness for reprocessing SUDs is required to be equivalent to that of the relevant original medical devices. However, since international standards for cleanliness assessment of reprocessing SUDs had not been developed, existing guidelines for reusable medical devices are to be considered as a reference. This section describes the trends in Japan and international standards for the cleanliness assessment of reusable medical devices, as well as the evaluation methods for residual protein and residual endotoxin, which are major markers for cleanliness evaluation.
