US · guidance
CMS SOM App. H, Tag V335
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR §
494.50(b)(1)
11.2 Rinsing/cleaning: chemicals used/rinse after each
11.2.4
Diluted solutions of hydrogen peroxide, sodium hypochlorite, peracetic acid, or other
chemicals may be used as cleaning agents for the blood compartment, provided that the
cleaning agent has been shown to be reduced to safe levels by subsequent flushing and has
no significant adverse effects on the structural integrity and performance of the dialyzer.
Each chemical shall be rinsed from the dialyzer before the next chemical is added, unless
mixing is known to be safe and effective for reprocessing.
Interpretive Guidance § 494.50(b)(1)
ANSI/AAMI RD47:2002/A1:2003
11.2 Rinsing/cleaning
11.2.4
A cleaning agent, such as sodium hypochlorite, shall be rinsed from the dialyzer before adding
formaldehyde, in order to avoid noxious fumes and degradation of disinfectant. Combining
sodium hypochlorite and peracetic acid may produce hydrochloric acid vapors, which are
harmful if inhaled.
Additional Guidance:
While one chemical may be used as a cleaning agent and a second chemical used as a germicide,
the first chemical must be rinsed from the dialyzer before the next chemical is added, unless it
has been demonstrated that mixing of the two chemicals is safe and effective. Allowing chemicals
to mix may risk unexpected reactions that could lead to staff injury or damage to the structural
integrity and performance of the dialyzer. If bleach is used as a cleaning agent, a procedure
must be in effect to limit the time the dialyzer may be exposed to bleach, as prolonged exposure
may damage the dialyzer membrane.
Page 142 of 420
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
09036dbca7a9f3567baa942dae32780dcd47355d386ed70563cdf775bb1442c8
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