Current situation of endotoxin retentive filter

Area of Science:

• Nephrology
• Biomedical Engineering
• Infectious Disease Control

Background:

• Most Japanese dialysis facilities utilize central dialysis fluid delivery systems (CDDS).
• Ultrapure dialysis fluid (UPD) is recommended for all dialysis modalities due to the prevalence of high-performance dialysis membranes in Japan.
• Endotoxin retentive filters (ETRFs) are critical components in CDDS for achieving UPD, but are not currently recognized as medical equipment in Japan.

Purpose of the Study:

• To evaluate the efficacy of endotoxin retentive filters (ETRFs) in achieving ultrapure dialysis fluid (UPD).
• To determine if ETRFs meet the theoretical logarithmic reduction value (LRV) for endotoxin (ET) and bacteria.
• To advocate for the acceptance of ETRFs as medical equipment to ensure the safety of central dialysis fluid delivery systems (CDDS).

Main Methods:

• The study proposes conducting endotoxin (ET) and bacterial challenge tests on both new and used ETRFs.
• Theoretical performance assessment based on existing LRV data for ET (3) and bacteria (7).

Main Results:

• Currently, there is a lack of empirical data on the LRV for endotoxin and bacteria for both new and used ETRFs.
• The theoretical performance suggests ETRFs could achieve UPD, but this requires experimental validation.

Conclusions:

• Further research, including challenge testing, is essential to validate the performance of ETRFs for endotoxin and bacterial removal.
• Establishing the safety and efficacy of ETRFs through testing is necessary for their acceptance as medical equipment in Japan.
• Ensuring the effectiveness of ETRFs is critical for maintaining the safety and quality of ultrapure dialysis fluid in CDDS.