CMS Issues Revised Surveyor Guidance at F441

Hayden Parker

CMS has issued revised surveyor guidance at F441. It is posted on the CMS website at:


According to the S&C Memo Summary:


Advance Copy: The guidance under Tag F441, Infection Control, Preventing Spread of Infection/Indirect Transmission has been revised.

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.


Per the memorandum this guidance is “advance” guidance and is effective immediately.