CMS SOM App. H, Tag V181

4.3.2.2 Bacteriology of ultrapure dialysate: Ultrapure dialysate should contain a total viable

microbial count lower than 0.1 CFU/mL and an endotoxin concentration lower than 0.03

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EU/mL. If those limits are exceeded in ultrapure dialysate, corrective measures should be

taken to reduce the levels to an acceptable range. The user is responsible for monitoring the

dialysate bacteriology of the system following installation. It is the user's responsibility to

establish a regular monitoring routine.

Interpretive Guidance § 494.40(a)

AAMI Rationale for the Development and Provision of This Recommended Practice

A.4.3.2.2 Bacteriology of ultrapure dialysate

Ultrapure dialysate is defined as one having a bacterial content of less than 0.1 CFU/mL and an

endotoxin content of less than 0.03 EU/mL. This definition is now widely accepted, particularly

in Europe, and the use of ultrapure dialysate is considered a requirement for on-line convective

therapies (see AAMI A.4.3.2.3).

Ultrapure dialysate is prepared by sequential ultrafiltration of dialysate prepared from purified

water meeting the requirements of AAMI 4.1 and concentrates. Dry powder cartridges are

frequently used for the online preparation of bicarbonate concentrate to minimize the potential

for the concentrate to contribute high levels of bacteria and endotoxin to the dialysate.

Additional Guidance:

The sensitivity and specificity of the test assay significantly impact the accuracy and subsequent

interpretation of test results. Users should select assays that are sensitive to the test being

performed.

At the time of publication of these regulations (April 15, 2008, 73 FR 20369), most dialysis

facilities in the U.S. were using conventional dialysate, rather than ultrapure dialysate. The use

of conventional or ultrapure dialysate is a clinical decision made by the ordering physician.

There is no Federal requirement to use ultrapure dialysate.