CMS SOM App. H, Tag V346

494.50(b)(1)

12 Preparation for dialysis and testing for chemical germicides and potentially toxic

residues

A written procedure that has been shown to be effective shall be followed.

12.5 Written procedure for tests for germicide or other residues

There shall be a written procedure for all tests employed in preparing the dialyzer for use,

including mention of each test’s sensitivity. The germicide manufacturer’s instructions for

use should be consulted in determining the maximum residual level. The physician in

charge of the reuse program shall approve any alterations in the procedures.

Interpretive Guidance § 494.50(b)(1)

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.12 Preparation for dialysis and testing for chemical germicides and potentially toxic

residues

When the [AAMI RDD] Committee revised RD47 in 2002, it decided that sufficient information

was available to indicate that the residual level of formaldehyde should be reduced to less than 3

ppm. The testing technology for residual formaldehyde had also improved, and it was feasible to

easily test to less than 3 ppm.

The [AAMI RDD] Committee considered establishing maximum residual levels for germicides

other than formaldehyde. Because these newer germicides are all cleared by the FDA and could

have different allowable levels of residuals even for the same generic type of germicide, [they]

determined that it is best to recommend that the manufacturer’s instructions for use be followed.

The [AAMI RDD] Committee noted that toxicology studies are favorable for some of these

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agents, and the FDA reviews labeling information for them, which includes the maximum

residual level.

When checking for the presence or concentration of the germicide in the hemodialyzer, [do not

place anything] into the blood or dialysate ports of the device (e.g., test strip or syringe) to

withdraw the sample. Doing so may damage the fibers of the dialyzer and lead to blood leaks

during dialysis. . , If a germicide test strip or kit is being used, the instructions provided by the

manufacturer should be followed.

Additional Guidance:

The reagents used for the germicide tests must be sensitive to the levels specified by the

germicide manufacturer (i.e. high level for presence test, low level for residual test).