US · guidance
CMS SOM App. H, Tag V349
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
12.3 Verification of germicidal contact
The contact time of the germicide or disinfection procedure shall comply with the facility’s
protocol and the manufacturer’s recommendations.
The presence of chemical germicide in each hemodialyzer shall be ensured through either
direct testing or an on-line process and procedural control. If other disinfection procedures
(e.g., heat) are used, there shall be methods to ensure that each hemodialyzer has been
properly subjected to the disinfection process. A record shall be kept indicating that the
dialyzer has undergone the appropriate storage time, and the record shall be appropriately
verified.
Interpretive Guidance § 494.50(b)(1)
Page 154 of 420
Staff must be able to determine the date and time of each dialyzer’s last reprocessing.
Responsible staff (e.g., reuse technician, direct care staff) must ensure the dialyzers have been
exposed to the germicide for the required contact time before set up and use.
For systems using heat disinfection, staff must verify the dialyzer was exposed to the appropriate
temperature for the required time period to ensure disinfection.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
8045980a7480d6a34f5e2177f45369849b6228be163dc0eaea519b31090cf133
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