US · guidance
CMS SOM App. H, Tag V382
§ 494.50(c)(2) – When clinically indicated (for example, after adverse patient reactions), the
facility must – (ii) Undertake evaluation of its dialyzer reprocessing and water purification
system. When this evaluation suggests a cluster of adverse patient reactions is associated
with hemodialyzer reuse, the facility must suspend reuse of hemodialyzers until it is
satisfied the problem has been corrected.
Interpretive Guidance § 494.50(c)(2)(ii)
In this context, “cluster” refers to a group of hemodialysis patients suspected of having adverse
reactions that could be clinically related to dialyzer reprocessing and/or reuse practices.
Responsible staff (e.g., chief technician, area technical manager, medical director) must be able
to describe actions to be taken if a group of patients experiences adverse reactions potentially
related to reprocessing/reuse. If a cluster of adverse patient reactions associated with
reprocessing/reuse was identified, dialyzer reprocessing/reuse should be suspended, pending
investigation.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
5e38b7e1a636d12a2fcb252ee0e77a6cc6bf6f34005da460fe0041dbb3fe2d07
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