CMS SOM App. H, Tag V220

7 Strategies for bacterial control

7.1 General (disinfection of machine supply line)

Users should establish a procedure for regular disinfection of [the line between the outlet

from the water distribution system and the back of the dialysis machine].

Interpretive Guidance § 494.40(a)

ANSI/AAMI RD52:2004

7 Strategies for bacterial control

7.1 General

For most dialysis machines, routine disinfection with hot water or with a chemical germicide

connected to a disinfection port on the machine does not disinfect the line between the outlet

from the water distribution system and the back of the dialysis machine. One approach is to rinse

the dialysis machines with water containing germicide or hot water when the water distribution

loop is disinfected. If this procedure is used with a chemical germicide, each dialysis machine

should be rinsed and tested for the absence of residual germicide following disinfection.

Additional Guidance:

The line between the outlet from the water distribution system and the back of the dialysis

machine is commonly referred to as the machine supply line. It is a hose that connects the

dialysis machine to the treated water outlet. This hose should be disinfected at the same

frequency as the water distribution loop is disinfected, i.e., monthly.

No Tag

(Rev. )

ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)

5.4 Concentrate preparation

5.4.1 General

Page 84 of 420

Dialysate is customarily prepared from two concentrates: the bicarbonate concentrate,

which contains sodium bicarbonate (and sometimes additional sodium chloride), and the

acid concentrate, which contains all remaining ions, acetic acid, and sometimes glucose.

Acid concentrate can be supplied by the manufacturer in bulk (usually 55 gallon

containers) or in gallon containers.

Systems have recently been introduced that allow a user at a dialysis facility to prepare

acid concentrate from packaged powder and purified water using a mixer. Acid

concentrate prepared at the dialysis facility from powder and water is also the

responsibility of the user.

Bicarbonate concentrate can be supplied by the manufacturer in one of three ways:

• in gallon containers,

• as packaged powder that is mixed with purified water at the dialysis facility, and

• in powder cartridges that are used to prepare concentrate on-line at the time of

dialysis.

Interpretive Guidance § 494.40(a)

This is an informational tag outlining the methods used for bicarbonate and acid concentrate

delivery.