Table 3 Standard on the management of endotoxin retentive filter (ETRF), excerpt from reference [15]

Definition of ETRFs and required performance

• Endotoxin retentive filters generally refer to the filters used to remove ET and microorganisms from dialysis fluid for their purification. This ETRF Management Standard addresses the management of an ETRF installed immediately before the dialyzer in a bedside dialysis console.

• An ETRF should maintain LRVs of at least 2 for ET and at least 4 for bacteria to obtain ultrapure dialysis fluid, assuming that the dialysis fluid before the ETRF maintains its microbiological quality at values for standard dialysis fluid specified in the JSDT Standard.

Standard for handling ETRFs

• Manufacturers’ instructions for the ETRF installation shall be observed.

• To obtain ultrapure dialysis fluid sample, the dialysis fluid at the inlet of the ETRF should be maintained within the allowable level for standard dialysis fluid specified in the JSDT Standard.

Cleaning and disinfection of ETRFs

• Dialysis machines shall be cleaned and disinfected following the methods recommended by the manufacturer.

• The inside and outside of hollow fibers shall be cleaned and disinfected during the cleaning and disinfection of ETRFs.

• When cleaning and disinfection methods other than those recommended by the manufacturer are used, the durability of ETRFs shall be tested at each facility to confirm their safety.

Duration of ETRF use

• The duration of ETRF use recommended by the manufacturer shall be observed when the dialysis fluid flowing into the ETRF cannot be maintained within the allowable levels for standard dialysis fluids as specified in the JSDT Microbiological Quality Standard for Dialysis Fluids.

• The duration of ETRF use should be determined by the Dialysis Equipment Safety Management Committee when the standard dialysis fluid falls within allowable levels.

Monitoring and durability test of ETRFs

• When ETRFs are used under conditions other than those recommended by the manufacturer, their durability shall be tested at each facility to confirm their safety.