CMS SOM App. H, Tag V239

5.5.4 Bicarbonate concentrate distribution systems: weekly disinfection/dwell times/conc

[B]icarbonate concentrate delivery systems should be disinfected on a regular basis to

ensure that the dialysate routinely achieves the level of bacteriological purity [required by

these standards].

For piped distribution systems, the entire system, including patient station ports, should be

purged of bicarbonate concentrate before disinfection. Each patient station port should be

opened and flushed with disinfectant and then rinsed; otherwise, it would be a “dead leg”

in the system.

Appropriate dwell times and concentrations should be used as recommended by the

manufacturer of the concentrate system. If this information is not available, bleach may be

used at a dilution of 1:100 and proprietary disinfectants at the concentration recommended

by the manufacturer for disinfecting piping systems.

6.5 Concentrate distribution:

It is recommended that the interval between disinfections not exceed 1 week. If the

manufacturer does not supply disinfection procedures, the user must develop and validate

a disinfection protocol.

Interpretive Guidance § 494.40(a)

ANSI/AAMI RD52:2004

5.5.4 Bicarbonate concentrate distribution systems

Bicarbonate concentrates provide excellent media for bacterial proliferation. The

manufacturer’s instructions can provide an initial disinfection schedule. However, this schedule

may need to be adjusted on the basis of the user’s bacteriological monitoring.

All chemical disinfectants (e.g., bleach and peracetic acid products) that are compatible with

dialysis machines can be used to disinfect bicarbonate concentrate delivery systems. However,

some disinfectants attack biofilm better than others.

In the event that precipitation or salt build-up impedes flow through a piping system, cleaning

with a 1:34 solution of 5% acetic acid (e.g., distilled white vinegar) is recommended. Some

manufacturers supply bicarbonate concentrate systems with UV irradiation or ozone systems for

bacterial control.

Additional Guidance:

Alternatively, a 5% citric acid solution may be used instead of acetic acid if the manufacturer

allows. It is not expected that concentrates would be cultured or tested for endotoxin levels.

Bicarbonate concentrates are monitored via dialysate cultures.

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