AAMI ST79:2017

Key changes for AAMI ST79:2017

1. A major change in AAMI ST79:2017 is anew recommendation for daily testing of the equipment and the results documented(Section 13.2, Monitoring of mechanical cleaning equipment)
   • This will require organizations to review their policy and procedures related to testing, look at the financial impact of this new recommendation and possibly look at other options for meeting this recommendation
2. The reference tables on the Sterilization Parameters (Section 10.2) have been removed and organizations are now instructed to follow the manufacturer’s instructions.The revised guideline now states:
   • “The sterilizer manufacturer’s written IFU should be followed for operation of the sterilizer and indications for use” (Section 10.2.2)
   • “The sterilization cycles used by the health care facility should be FDA cleared and should incorporate sterilization monitoring accessories (e.g., CIs, BIs, process challenge devices [PCDs]) and sterilization packaging labeled and cleared for that sterilization cycle” (Section 10.2.2.1)
   • A new definition and clearer guidance on immediate-use steam sterilization has also been added (Section 10.2.3)
3. AAMI ST79:2017 stillrecommends that implant loads be monitored with a PCD containing a biological indicator and a Type 5 integrating indicator
   • Biological indicators are intended to validate whether the sterilization conditions were adequate to kill a large number of highly resistant bacterial spores and are the only sterilization process monitoring instrument that measures the lethality of the sterilization process
4. The section onChemical indicators (CI) (Section 13.5) did not changein ST79:2017, but
   • The ‘type’ definition, rather than ‘class’ of CI, now lines up with the labeling on the CIs you should be seeing on your prep and pack stations
   • Internal chemical indicators (Section 13.5.2.2.2) has been slightly modifiedto read, “One or more internal chemical indicators should be placed within each package, tray, or rigid container. These indicators can be any type (Type 3, 4, 5, or 6) but preferably a Type 5 or Type 6 indicator as these types of CIs provide the user with more information on the critical steam sterilization parameters. All indicators should be used for the cycle(s) for which they are labeled and used in accordance with the manufacturer’s written IFU.”
   • The guidelines go on to state:“Internal CIs should be placed so that:
     • one CI is visible to the person opening the package;
     • CIs are in the area or areas considered least accessible to steam penetration; and
     • all applicable written IFU are followed.”