US · guidance
CMS SOM App. H, Tag V327
Page 135 of 420
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR §
494.50(b)(1)
10 Hemodialyzer labeling
Each reprocessed hemodialyzer shall be used for only one patient. The labeling shall
uniquely identify the patient who is using the dialyzer. The dialyzer should also be labeled
with other information essential to proper reuse procedure.
Interpretive Guidance § 494.50(b)(1)
Precautions must be in place to ensure that each dialyzer is used only for one patient. Each
reprocessed dialyzer must have a permanently affixed label uniquely identifying the patient using
that dialyzer. Each patient must always receive treatment on their own dialyzer, and dialyzers
must not be mismatched to patients.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
b6bd5f078ea90e18adba70acafd1a3a57b248745c17645a2828f02dea5347206
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