Current situation of endotoxin retentive filter

Most Japanese facilities use central dialysis fluid delivery systems (CDDS). In addition, since high-performance dialysis membranes are frequently used in Japan, the standard recommends that ultrapure dialysis fluid (UPD) should be used for all dialysis modalities at all dialysis facilities. RO produces and endotoxin retentive filters (ETRFs) occupy the most important position for UPD in this CDDS process. But ETRF is not accepted as medical equipment now in Japan. Since the logarithm reduction value (LRV) of ETRFs widely used today may be a desirable 3 for endotoxin (ET) and 7 for bacteria, UPD could be theoretically obtained through the use of ETRFs. However, we have no data of the LRV for ET and bacteria with a both new and used ETRF now. So we must study whether ETRF has this performance by doing an ET and bacterial challenge test in the near future. Also, ETRF will have to be accepted as medical equipment indicating the safety of CDDS.