US · guidance
CMS SOM App. H, Tag V363
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
14.4 Equipment Manuals and Procedures
Designated staff members should audit written procedures and manuals for relevance at
least annually and whenever adverse findings could be attributed to equipment failure.
Designated staff should also audit maintenance and repair policies at least annually.
Interpretive Guidance § 494.50(b)(1)
Page 165 of 420
Centralized reprocessing requires that relevant procedures and manuals be audited at both the
reprocessing site and the user facility.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
a9832f84cfbba5482c160bc20691c6afacd4731ef9803e08146f16e8fd4d8120
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