US · guidance
CMS SOM App. H, Tag V344
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
11.6 Disposition of rejected dialyzers
Reprocessed dialyzers that have been rejected for failure to meet performance, inspection,
or other release criteria should either be immediately discarded or further reprocessed and
subjected to the performance requirements of [AAMI] 11.3, 11.4, and 11.5. If the dialyzer is
to be further reprocessed, rather than discarded, it shall be labeled as rejected and stored
in a quarantine area to preclude use until requirements are met.
Interpretive Guidance § 494.50(b)(1)
The status of all dialyzers being reprocessed must be clear. If facility policy allows dialyzers
which initially fail criteria to be repeatedly reprocessed, or if dialyzers which have failed are not
immediately discarded, the status of those “failed” dialyzers must be clearly indicated.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
b4d397d5ee7d3d9bb5cf8c3491f3c4b5f23a179f34ca1701e15a9ad605f7c369
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