On May 9, 2014, CMS issued advance copy of a change to interpretive guidance in the SOM regarding the requirements for single use devices. The S&C letter, “Advance Copy – Single Use Device Reprocessing under Tag F-441, Revisions to Interpretive Guidance in Appendix PP, State Operations Manual (SOM) on Infection Control” (Ref: S&C: 14-25-NH) states the following:
- Nursing homes may purchase reprocessed single-use devices when the devices are reprocessed by an entity or 3rd party reprocessor that is registered with the FDA
- Nursing homes must have documentation from the reprocessor that shows it has been cleared by the FDA for processing that particular device
Read the full S&C letter.