US · guidance
CMS SOM App. H, Tag V378
§ 494.50(b)(2) - Reprocess hemodialyzers and bloodlines – (i) By following manufacturer’s
recommendations; or (ii) Using an alternate method and maintaining documented evidence
that the method is safe and effective.
Interpretive Guidance § 494.50(b)(2)
Each manufacturer of dialyzers for multiple use is required by FDA to provide at least one
acceptable reprocessing method with at least one germicide. The facility may use that
method/germicide or choose an alternate method. If the facility has chosen an alternate method,
there must be documentation that the chosen method has been validated as safe and effective.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
6ee0c121ccd07dfb389ca4a07263e4b1bda4a443d054cac636402b9bbc80a4b3
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