CMS SOM App. H, Tag V276

When using a

preconfigured, FDA-approved hemodialysis system designed, tested and validated to yield

AAMI quality (which includes standards for chemical and chlorine/chloramine testing)

water and dialysate, the system’s FDA-approved labeling must be adhered to for machine

use and monitoring of the water and dialysate quality…

Interpretive Guidance § 494.40(e)

At the time of publishing these regulations (April 15, 2008, 73FR20369), several different

preconfigured hemodialysis systems were available. These included conventional water

treatment components and single-pass (conventional) dialysis machines; integrated systems

which incorporated water treatment and dialysate preparation and delivery into one system; and

sorbent-based systems which utilized columns (cartridges) of chemicals to regenerate the used

dialysate for recirculation through the dialyzer. Although primarily used for home therapies, a

preconfigured hemodialysis system may be used in-center. Such use might be for training a home

patient, for back-up treatment of home patients, or for routine in-center treatment. In all cases,

the system’s FDA-approved labeling must be followed for machine use and monitoring of the

water and dialysate quality.

Following the rationale established in AAMI 4.1: Water and 6.2.7 for achieving product water

quality, if the preconfigured hemodialysis system incorporates a water treatment system,

analysis of the water quality must be performed to ensure contaminants do not exceed maximum

level of chemical contaminants listed at AAMI 4.1.1 (Table 1). A chemical analysis of the

product water must be done at least annually near the end of the usability of any disposable

component, or when any modifications are made to the treatment components (other than the

replacement of disposable components). When any repairs are made to water treatment

equipment, the impact on water quality should be evaluated and a chemical analysis performed

if the repairs resulted in any modifications to the treatment components.

Chlorine/chloramine levels must be tested prior to the start of each treatment (or before use of

each new batch of dialysate) in accordance with AAMI guidance and the manufacturer’s

recommendations/instructions for that test method. An appropriate volume of water for the

testing method in use should be tested for the presence of chlorine/chloramine. The minimum

volume of water required for testing is typically specified by the manufacturer or laboratory

conducting the test. For batch systems (integrated systems which prepare enough dialysate for

multiple treatments), the chlorine/chloramine testing must be performed at the worst case

scenario, i.e., after the preparation of each batch of dialysate, but before use of that batch. If the

test results exceed AAMI’s maximum allowable level, the user must discard the batch, replace

any applicable components, prepare a new batch of dialysate, and retest.

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Systems that use sorbent technology do not produce water; the product of the sorbent cartridge

is dialysate, thus, the requirements for the chemical, bacteriological and endotoxin testing of

water do not apply. With sorbent technology, due to the low volume of exposure of patients to

water (i.e., 6 liters per treatment) and the capacity of the single use sorbent cartridge to remove

chlorine and chloramine, testing for chlorines and chloramine is not required. Sorbent system

users are expected to perform bacteriological and endotoxin testing on dialysate.

Monitoring of the system must be in accordance with the FDA-approved labeling, which includes

the manufacturers' directions for use (DFU). The facility should have the manufacturers' DFUs

on file, and facility procedures should reflect those DFUs.