Implants - K4Health


What is a non-steriled implant implant implant?

  • (a) Non-sterile non-biological implants contained in loaner instrument trays, not part of the VA medical facility’s inventory, are received in the VA medical facility at least 48 hours prior to use in order to provide adequate time for reprocessing (e.g., decontamination, sterilization and cooling of the instrument set(s). NOTE:Failure to

What happens to unopened implants?

  • unopened VA-owned and consigned implants (biological and non-biological) are promptly returned to the assigned storage location, if the return is permitted by the manufacturer. Implants unable to be returned to storage or that are expired should be

Why are non-biological implants sterilized in SPS quarantined?

  • Non-biological implants sterilized in SPS must be quarantined until the biological indicator is read as negative and the instrument set has sufficient time to cool down. NOTE:An early implant release waiver must be requested of and approved by

What are the requirements for human tissue implants?

  • for human tissue implants should include confirmation from the manufacturer that the product meets FDAs definition of HCT/Ps (e.g., minimally modified and for homologous use). (3) Ensuring Network Contracting Officers comply with this directive.
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