US · guidance
CMS SOM App. H, Tag V366
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
14.7 Hemodialyzer labeling (audit frequency)
Page 166 of 420
Designated staff members should audit for compliance with the provisions of [AAMI]
section 10 at least quarterly.
Interpretive Guidance § 494.50(b)(1)
AAMI Section 10 includes the following: Hemodialyzer labeling, Time of labeling, Label
composition, and Information recorded. These audits should be recorded quarterly.
Centralized reprocessing requires that this audit be done at the reprocessing site as well as at
the user facility.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
80969dd8f2498ed70805787309208b94ade0914cbab163c894ad3fe20eaa8d3e
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