CMS SOM App. H, Tag V347

494.50(b)(1)

12.1 Visual inspection (dialyzer inspection prior to use)

The dialyzer should be inspected before it is prepared for use. Completion of this

inspection should be recorded in the reprocessing record (see [AAMI] 4.2), along with the

signature or other unique means of identifying the person completing the inspection. The

inspection should include the following:

• The reprocessed dialyzer shall be legibly labeled with the information

recommended in [AAMI] 10.3.

• There should be no indication of structural damage or tampering with the

dialyzer.

• The ports of the dialyzer should be properly capped.

• The presence of germicide in the dialysate and blood compartments, including

headers, should be confirmed, and there should be no evidence of leakage from

the ports or other portions of the dialyzer.

• The duration and conditions of storage should be appropriate for the agent or

method used to sterilize or disinfect the dialyzer; and

• The cosmetic appearance of the dialyzer should be aesthetically acceptable to the

staff and the patient.

Interpretive Guidance § 494.50(b)(1)

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.11.5 Inspection

The [AAMI RDD] Committee recognized that the patient should be included in the aesthetic

evaluation of the hemodialyzer.

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