CMS Memorandum S&C 14-25-NH: Advance Copy – Single Use Device Reprocessing under Tag F441, Revisions to Interpretive Guidance in Appendix PP, State Operations Manual (SOM) on Infection Control
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.
View the memo here: S&C 14-25-NH or visit www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-25.html?DLPage=1&DLSort=2&DLSortDir=descending.