Advance Copy – Single Use Device Reprocessing under Tag F441, Revisions to Interpretive Guidance in Appendix PP, State Operations
Manual (SOM) on Infection Control
• Advance Copy: The guidance under Tag F441, Infection Control, Preventing Spread of Infection/Indirect Transmission has been
• Single-Use Device Guidance: Nursing homes may purchase reprocessed single-use devices when these devices are reprocessed
by an entity or a third party reprocessor that is registered with the Food and Drug Administration.
• Single-Use Device (SUD): A SUD is a device that is intended for one use on a single patient during a single procedure.
• Reprocessed SUD: A reprocessed SUD is an original device that has previously been used on a patient and has been subjected
to additional processing and manufacturing for the purpose of an additional single use on a patient.