June 27, 2014
ALTSA: NH #2014-004
S&C 14-25-NH: REVISED GUIDANCE AT F441 – INFECTION CONTROL
SINGLE-USE DEVICE (SUD) REPROCESSING
Dear Nursing Home Administrator and Interested Parties:
The Centers for Medicare and Medicaid Services (CMS) recently issued survey & certification memo (S&C) 14-25 providing an advance copy of the revisions to Interpretive Guidance under Tag F441 – Single Use Device Reprocessing (Infection Control). The revised guidance is effective immediately revised to be consistent with current Food and Drug Administration (FDA) regulation and allows for the reprocessing and marketing of single use devices (SUDs) under specific conditions [21 CFR §807.92(a)(3)]
Nursing homes are allowed to purchase reprocessed single-use devices if the devices are reprocessed by an entity or third party processor that is registered with the FDA. Nursing homes that purchase reprocessed single-use devices must maintain documentation on file from the third party processor that indicates that it has been cleared by the FDA to reprocess the specific device in question.
The latest information contained in CMS S&C 14-25-NH dated May 9, 2014:
- Is current policy and is in effect for all nursing homes; and
- Provides the actual revised language at Appendix PP/F-441
- Provides more details about regulatory requirements for establishments engaged in reprocessing SUDs; and
If you have questions about this guidance, please contact your RCS Field Manager.
Sincerely,
Carl I. Walters II, Director
Residential Care Services