US · guidance
CMS SOM App. H, Tag V359
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
11 Reprocessing
11.3.2 Ultrafiltration
If the patient’s expected weight loss is not achieved with the reprocessed dialyzer, the
reprocessing method and all other weight removal variables should be reevaluated.
Interpretive Guidance § 494.50(b)(1)
ANSI/AAMI RD47:2002/A1:2003
11.3.2 Ultrafiltration
In vitro ultrafiltration coefficients should not be used to predict in vivo results.
AAMI Rationale for the Development and Provisions of this Recommended Practice
A.11.3.2 Ultrafiltration
Ultrafiltration rate (UFR) is the flow rate of fluid that passes through the membrane under a
given pressure gradient at a given temperature. It is the product of the ultrafiltration coefficient
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of the hemodialyzer (KUF) and the transmembrane pressure. The KUF, and thus the UFR at a
given transmembrane pressure, may be affected by changes in the intrinsic permeability of the
membrane, the surface area of the membrane, and the presence of hydraulically resistive
deposits on the membrane. Cleaning agents, such as sodium hypochlorite, may affect the
intrinsic water permeability of many types of dialysis membranes.
In vitro KUF is not recommended to predict in vivo ultrafiltration performance because the
former overestimates the latter in hollow-fiber hemodialyzers. This difference occurs in part
because of the additional hydraulic resistance of the formed elements and proteins in blood.
Additional Guidance:
Assessment for compliance with this requirement should find patients are weighed before and
after each treatment. Missed weights should be rare and include an explanation for the weight
not being obtained. Repeated entries of “unable to stand” should result in a change in the plan
of care to allow determination of pre- and post-treatment weights.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
44d913ec8f86fecb19dbb0d5001438dc601121882c2557b4e0d0dde7f01de84b
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