CMS SOM App. H, Tag V314

494.50(b)(1)

7.1 Water systems

The system providing water for reprocessing shall meet all of the requirements for

pressure and flow rate for operating the reprocessing equipment under minimal and peak

load conditions. Product water used for rinsing, cleaning, filling, and diluting the germicide

shall be shown to comply with the chemical and microbiological quality requirements

[specified in these regulations].

Water bacteriology monitoring shall be carried out where the dialyzer is connected to the

reuse system or as close as possible to that point.

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11.4 Germicide

11.4.1.5 Water quality monitoring

The water used to rinse and clean dialyzers and dilute the germicide should be tested for

bacterial contamination and pyrogens according to the requirements [of these regulations]

before a reprocessing program is undertaken. Once dialysis with the reprocessed

hemodialyzers has begun, testing for bacterial contamination should be frequent (e.g.,

weekly). Less frequent testing, but not less than monthly, may be appropriate if there is a

documented history of at least 3 months of results consistently below the required levels.

Interpretive Guidance § 494.50(b)(1)

The product water chemical and microbiological requirements outlined in this section are the

same as those in ANSI/AAMI RD52:2004, incorporated by reference in these regulations under

the Condition for water and dialysate quality.

Water samples for microbial and endotoxin testing must be routinely taken each month from the

water supplying each reprocessing system, as close as possible to the point where the dialyzer

would be connected to the system. If more than one automated reprocessing system is in use, the

water supply to each system must be monitored monthly.

New facilities or facilities which add dialyzer reprocessing should validate the safety of the

water supply to the reprocessing system by testing for bacteria (microbial content) and pyrogens

(endotoxins) weekly for at least 3 months, and at least monthly thereafter. The sites to be tested

include the water supply to the sinks used for rinsing dialyzers, to outlets used for mixing

germicide, and to each reprocessing system.

Note: If water quality samples do not consistently meet AAMI standards, i.e., at least 3

consecutive months of testing results that meet required levels, the water quality testing is

expected to be performed more frequent than monthly.