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US · guidance

CMS SOM App. H, Tag V379

§ 494.50(b)(3) - Not expose hemodialyzers to more than one chemical germicide, other than

activein force · 2026-07-22 – presentas-observed

bleach (used as cleaner in this application), during the life of the dialyzer. All

hemodialyzers must be discarded before a different chemical germicide is used in the

facility.

No Tag

(Rev. )

§ 494.50(c) - Monitoring, evaluation, and reporting requirements for the reuse of

hemodialyzers and bloodlines. In addition to the requirements for hemodialyzer and

bloodline reuse specified in paragraphs (a) and (b) of this section, the dialysis facility must

adhere to the following: (1) Monitor patient reactions during and following dialysis.

Interpretive Guidance § 494.50(c)(1)

Page 168 of 420

This tag is informational, as this requirement is addressed in the ANSI/AAMI RD:47, section 13,

at tags V354 and V355.

History

Rev.

Provenance

Source
cms.gov
Retrieved
2026-07-22
Edition
som-2026-07-22
Content hash
ef16fd3f244c429476a10574a53bd241d3010bcd1264af235f9e5843bbb9448c
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