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Title
Advance Copy – Single Use Device Reprocessing under Tag F441, Revisions to Interpretive Guidance in Appendix PP, State Operations Manual (SOM) on Infection Control
Memo #
14-25-NH
Posting Date
2014-05-16
Fiscal Year
2014
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.