US · guidance
CMS SOM App. H, Tag V342
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
11.4.2 Exterior: low-level disinfection
The outside of the dialyzer should be soaked or wiped clean of visible blood and other
foreign material. For chemically disinfected dialyzers, a low-level germicide that is
compatible with the dialyzer’s materials of construction should be used for this purpose.
Interpretive Guidance 494.50(b)(1)
AAMI Rationale for the Development and Provisions of this Recommended Practice
A.11.4.2 Exterior
Sodium hypochlorite at a concentration of 0.05% is usually suitable [for external cleaning].
Certain commercial low-level disinfectants may cause some plastics used for dialyzers to crack
after repeated or prolonged exposure.
Low-level germicides satisfactorily clean the exterior of the device to a degree comparable with
what a new dialyzer receives. For example, 1:100 dilution of household bleach will achieve the
concentration of sodium hypochlorite specified [here].
Page 149 of 420
Additional Guidance:
The exterior of each dialyzer must be cleaned after reprocessing steps are complete. Spraying
the dialyzer with germicide is generally unsatisfactory, unless all the surfaces of the dialyzer are
covered with the spray. Dialyzers may be dipped or allowed to soak in a germicide solution, or
wiped with a disposable cloth saturated with a germicide solution.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
9c245a586cc055988c669726a1a549e80909fab15c3a6679c5338a60eb9bae5d
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