US · guidance
CMS SOM App. H, Tag V244
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
Page 98 of 420
5.5.4 Bicarbonate concentrate distribution systems (disinfection of bicarbonate jugs)
6.5 Concentrate distribution
7 Strategies for bacterial control
7.1 General
5.5.4 Bicarbonate concentrate distribution systems (disinfection of bicarbonate jugs)
When reusable concentrate jugs are used to distribute bicarbonate concentrate, they
should be rinsed free of residual concentrate before disinfection.
6.5 Concentrate distribution
When reusable concentrate jugs are used to distribute bicarbonate concentrate, they
should be disinfected at least weekly.
7 Strategies for bacterial control
7.1 General
Following disinfection, jugs should be drained, rinsed, and inverted to dry.
Interpretive Guidance § 494.40(a)
ANSI/AAMI RD52:2004
7 Strategies for bacterial control
7.1 General
Facilities that reuse concentrate jugs for bicarbonate concentrate should disinfect the jugs at
least weekly. Bicarbonate concentrate can support prolific growth of microorganisms. Jugs can
be disinfected with household bleach solutions (300 mg to 600 mg free chlorine, or 30 mL to 60
mL of 6.15% household bleach per gallon of water) with a contact time of about 30 minutes or
another EPA-registered disinfectant according to the manufacturer’s instructions.
Additional Guidance:
A 1:100 solution of household bleach: treated water may be used, which yields about 500-615
ppm available chloride. If the facility uses less contact time than 30 minutes, there must be
evidence of the use of dialysate culture results to determine the needed disinfectant contact time.
In all cases, the bicarbonate container disinfection process must result in compliance with the
allowable dialysate microbiological levels of <200 cfu and <2 EU.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
1be44ee3b9196dea678854149dce179e9ff1c35279a833a1b6f8738732fd1059
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