CMS Issues Revision to F441 Infection Control Guidance

On May 9th, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum (S&C: 14-25-NH) to State Survey Agency Directors as an Advance Copy of revisions to  Interpretive Guidance for F441 on Infection Control for preventing the spread of Infection.  The guidance is effective immediately.

In the section, “Preventing Spread of Infection, Indirect Transmission,” current guidance states that “Single use disposable equipment is an alternative to sterilizing reusable medical instruments.  Devices labeled by the manufacturer for single use are never to be reused, even if they are reprocessed.”  The revised guidance is issued to be consistent with current Food and Drug Administration (FDA) regulation that allows for the reprocessing and marketing of single use devices (SUDs) under specific conditions.

In summary the guidance focuses on the following:

  • Single-Use Device Guidance: Nursing homes may purchase reprocessed single-use devices when these devices are reprocessed by an entity or a third party re-processor 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.

An advance copy of the updated SOM Appendix PP, 42 C.F.R. §483.65(b), Infection Control, Preventing Spread of Infection is included with the memo.