US · guidance
CMS SOM App. H, Tag V343
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
11.5 Inspection: after reprocessing
The hemodialyzer shall be examined after reprocessing to ensure that the external surface
is clean, the dialyzer is not damaged, and the rinsing of blood has been satisfactorily
completed. The dialyzer should also be aesthetically acceptable in appearance to patients
and staff.
11.5.1
The dialyzer jacket should be free of visible blood or other foreign material.
11.5.2
There shall be no leaks or cracks in the dialyzer jacket or the blood or dialysate ports.
11.5.3
No more than a few dark, clotted fibers should be evident on inspection of the exterior of
the hollow fibers.
11.5.4
The headers of hollow-fiber dialyzers should be free of all but small peripheral clots or
other deposits.
11.5.5
Blood and dialysate ports shall be capped without evidence of leakage.
11.5.6
The label shall be properly filled out and legible.
Interpretive Guidance § 494.50(b)(1)
AAMI Rationale for the Development and Provisions of this Recommended Practice
A.11.5 Inspection
The [AAMI RDD] Committee considered a recommendation not to accept hemodialyzers with
visible clots because venous filters are not used for all hemodialyzer circuits, leading to the risk
of embolization to the patient if a clot were to break loose. The [AAMI RDD] Committee decided
Page 150 of 420
to reject this proposal because the allowable clots are required to be small and in stagnant areas
that are present during the first use of the hemodialyzer and because there is no evidence of
embolization from reprocessed hemodialyzers that meet this criterion.
A proposal that the number of dark, clotted fibers evident upon external inspection be limited to
five was not accepted because a considerably larger number may be clotted without significant
adverse effect on performance and because some authorities do not agree that this criterion is
essential to an aesthetically pleasing appearance. A recommendation that hemodialyzers with a
pink or brownish tint not be acceptable was also deleted because this condition is difficult to
define and because glutaraldehyde disinfection results in a slight tan color of the membranes
that has not been shown to impair the safety or performance of the hemodialyzer.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
ee7f530ee961a47c59042763bbf5c15d1d4f4f506f3985db2892e7bdd5248189
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