CMS Revises Guidance at F-441 for Single Use Devices


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.


One thought on “CMS Revises Guidance at F-441 for Single Use Devices

  1. I may be misinterpreting the fourth deficient practice but it indicates that each resident must have their individual fingerstick device. If this is true we need to take fast and swift actions thanks Mary

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