US · guidance
CMS SOM App. H, Tag V367
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
14.8 Reprocessing (audit frequency)
Initially, designated staff members should audit the written procedures for the various
steps in this process and verify implementation at least monthly. Subsequently, semiannual
audits may be sufficient if there is a documented history of favorable results. Trend
analysis should be performed.
Interpretive Guidance § 494.50(b)(1)
For a new reuse program, monthly audits of reprocessing steps must be done at a minimum. For
an established program, audits of the practice of reprocessing should be done semiannually,
unless problems are identified, which would require more frequent audits until a pattern of
compliance is established.
Centralized reprocessing requires that the reprocessing site perform these audits and report the
results to all user facilities.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
c184326e466a3a251de07cd07d5e2a92cbd93becb2d52d66a5afb157e35d1b6b
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