CMS SOM App. H, Tag V329

494.50(b)(1)

10.2 Label composition

Markings should be resistant to normal reprocessing and dialysis procedures. The dialyzer

labeling should not obscure the manufacturer’s model number, lot number, or indicators of

the direction of blood or dialysate flow or other pertinent information unless provision is

made for recording this information on the label. The label on hemodialyzers with

transparent casings should permit the blood path to be readily inspected.

Interpretive Guidance § 494.50(b)(1)

Page 136 of 420

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.10.2 Label composition

The AAMI RDD Committee initially recommended using indelible ink to label the dialyzer but

changed the recommendation to any method resistant to normal reprocessing and use

procedures; other satisfactory materials exist, and requiring indelible ink might preclude some

techniques, such as bar coding.

Additional Guidance:

Facility-applied labels must not obscure the pertinent information on the manufacturer’s label

and must leave at least a portion of the blood path uncovered to allow visualization of a section

of the fibers from header to header.