Modification of the dialysate port of plasma separators as a measure to prevent recurrence of fatal mix-ups of blood purification columns

Efforts and challenges for medical professionals and industry groups

Abstract

A fatal mix-up of a hemofilter for continuous hemodiafiltration (CHDF) with a plasma separator for plasma exchange occurred at Kyoto University Hospital in 2011. The mix-up may have been associated with the close resemblance between the two devices, both of which followed the Japanese standard for blood purification columns. Because modifications of the connectors on medical gas containers or on tubing systems for enteral nutrition have been extremely effective in preventing misconnection, relevant academic societies have proposed a modification of the dialysate port of plasma separators to prevent another mix-up of a plasma separator with a blood circuit for CHDF. Medical professionals have been discussing this issue with an industry group, the Medical Technology Association of Japan. In September 2016, the International Organization for Standardization (ISO) introduced new standards for medical device connectors. Based on the new standards, the current dialysate port of plasma separators (slip-in type, ISO 8637) will be changed to the Lure lock type (ISO 80369-7). This new standard is being proposed for approval in 2018 under the guidance of the Ministry of Health, Labor and Welfare of Japan.