CMS SOM App. H, Tag V340

494.50(b)(1)

11.4.1.4 Chemical germicidal procedure

If applicable, the hemodialyzer shall be filled with the germicide solution until the

concentration in the hemodialyzer is at least 90% of the prescribed concentration.

The ports of chemically disinfected dialyzers shall be disinfected and then capped with new

or disinfected caps. The caps may be disinfected with dilute bleach, with the chemical used

for disinfecting the hemodialyzer, or with any other germicide approved by the FDA as a

disinfectant that does not adversely affect the materials of the dialyzer.

Interpretive Guidance § 494.50(b)(1)

If a manual reprocessing system is in use, the blood and dialysate compartments must be filled

with a volume of germicide equal to three times the total volume of the blood and dialysate

compartments of the dialyzer (to equal three compartment volumes) in order to reach at least

90% of the prescribed germicide concentration. Reuse logs must include documentation of

verification of the desired (prescribed) concentration of germicide.

Used and new port caps must be disinfected prior to use. The reuse technician should be

knowledgeable about the minimum contact time required for germicide disinfection of port caps.