US · guidance
CMS SOM App. H, Tag V313
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR §
494.50(b)(1)
7 Equipment
Each piece of equipment used for reprocessing shall be appropriately designed,
constructed, and tested to perform its intended task. Satisfactory operation of manual and
automated systems shall be ensured by appropriate functional tests. Strict QC and QA
shall be maintained for any type of dialyzer reprocessing equipment. Additionally,
complete documentation of system function, operating procedures, potential system
failures, and dialyzer-reuse criteria shall be included in the dialyzer reprocessing manual,
known to the operator, and available for review.
Interpretive Guidance § 494.50(b)(1)
AAMI Rationale for the Development and Provisions of this Recommended Practice
A.7 Equipment
Types of reprocessing systems vary from sophisticated microprocessor-controlled systems to
hand-operated valving systems.
It is particularly important that appropriate equipment is used properly to ensure all water that
comes into contact with the fluid pathways for blood or dialysate is of AAMI quality, because the
blood side of the dialyzer might take up endotoxins that could be released into the circulation
system during the subsequent dialysis.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
bb27eb6501d0f4fd1b44f3d5c69cb852da2ea0ae4d3a1cac2faf3e27432ad292
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