Review Article
Trend of Re-Manufacturing Single-use Devices
2020 Volume 35 Issue 1 Pages 7-14
Details
2020 Volume 35 Issue 1 Pages 7-14
On July 31, 2017, the Ministry of Health, Labor and Welfare established a new system for remanufacturing single-use devices (SUDs). Along with this, the Standards for Re-Manufacturing Single-Use Devices were instituted based on a ministerial ordinance prescribing a partial amendment of the Pharmaceuticals and Medical Devices Law.
The aim is to build a system for re-manufacturing SUDs that have been used and disposed for redistribution as commonly used disposable SUDs, whose quality and effectiveness are the same as those of the original SUD. This process is the responsibility of the approved medical device manufacturers and involves collecting, disassembling, cleaning, and reassembling SUDs after effectively removing contaminants.
Re-manufacturing SUDs is drawing attention because it has the potential for effectively utilizing resources, reducing medical waste, lowering medical cost, and so on.
