2020 Volume 11 Issue 1 Pages 3-8
A team of industry, government, and academic experts worked to change the shape of the plasma port of the plasma separator from a slip-in system (ISO8637) to a luer-lock system (ISO80369-7) as a measure to prevent a recurrence of a 2011 fatal mix-up of the blood purification column. For this conversion, the limited use of intermediate connector to link the old plasma separator and the new blood circuit was approved until the end of August 2020 by the Ministry of Health, Labour and Welfare of Japan. The new plasma separator was launched in September 2019, and the old plasma separator and blood circuit were discontinued in February 2020. This conversion project was promoted by the related academic societies and the MTJAPAN Blood Purification Subcommittee under the guidance of the government. In January 2020, the Central Social Insurance Medical Council reviewed the reimbursement price for plasma separators from a safety supply perspective, and on March, the government announced a revised price. This project provides an important perspective for future product development as an evaluation of safety measures taken collectively by industry, government, and academia.
