US · guidance
CMS SOM App. H, Tag V357
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
13.3 Dialyzer failures (blood leaks)
Dialyzer blood leaks should be recorded in a log kept in the complaint investigation record
file (see [AAMI] 4.5). If there is excessive deviation from the expected performance, testing
methods should be evaluated (see [AAMI] 11.3.1) and appropriate adjustments made in the
reprocessing procedure.
Interpretive Guidance § 494.50(b)(1)
The complaint investigation records should include reports of any blood leaks.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
debc278b3d9f12bbfa3d4526c0004fc478aac165b74823fbc292ce074e99d607
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