US · guidance
CMS SOM App. H, Tag V345
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
11.7 Storage
Reprocessed dialyzers that meet the performance and inspection criteria for multiple use
should be stored according to the provisions of [AAMI] 8.2. Prolonged storage (greater
than 1 month) should be documented to be safe and effective.
Dialyzers that have exceeded the facility’s maximum storage time shall be reprocessed or
discarded. The dialyzer and disinfectant labeling should be consulted regarding proper
storage conditions.
Page 151 of 420
Interpretive Guidance § 494.50(b)(1)
Additional Guidance:
The AAMI RDD Committee were, unaware of any adverse effects of storage for up to 1 month.
Dialysis facilities that store its multiple use dialyzers for more than one month should have
documented evidence that such a time period does not pose a risk to patient safety..
There might be occasions when reprocessed dialyzers are stored for extended periods of time,
such as when patients are absent (e.g. hospitalized, vacation). There must be a system for
ensuring dialyzers are not stored longer (without reprocessing) than the maximum time limit
specified by the germicide manufacturer and facility policy.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
29dd3788836f1ca4737ba43cc9b2322bc29981b9a38a02c41295541d3ff36b95
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