What are the process monitors used for low temperature sterilization and why are they important?
Association for the Advancement of Medical Instrumentation (AAMI) ST58(R)2018 states:
- Physical: Displays, digital printouts, gauges
- “Physical monitoring provides real-time assessment of the sterilization cycle conditions and provides permanent records by means of chart recordings or digital printouts. Physical monitors are needed to detect malfunctions as soon as possible, so that appropriate corrective actions can be taken in the event of failures” (p. 51).
- Physical: Displays, digital printouts, gauges
- “Chemical indicators should be used in conjunction with physical monitors and Bis to demonstrate the efficacy of the sterilization process” (p. 51)
- Biological indicators spores: BIs, PCDs
- Biological indicators are intended to demonstrate whether or not the conditions were adequate to achieve sterilization. A negative BI does not prove that all items in the load are sterile or that all were exposed to adequate sterilization” (p. 3).
- “PCDs are challenge test packs containing a BI or BI and a CI. A PCD is used to assess the effective performance of a sterilization process by providing a challenge to the process that is equal to or greater than the challenge posed by the most difficult item routinely processed” (p. 53).
How often should a PCD be used for low temperature sterilization?
Two professional organizations that provide guidelines for sterilization of medical devices provide recommendations for how often a PCD should be used in low temperature sterilization.
- AAMI states in ST58 that “a PCD with the appropriate BI should be used at least daily, but preferably in every sterilization cycle.”
- AORN in their Guidelines for Perioperative Practice states -“Routine sterilizer efficacy monitoring should be performed every day for each sterilization cycle used (e.g. standard, advanced, lumen, non-lumen), preferably with each load.”
WHY should a PCD for Low Temperature Sterilization be used in every cycle?
- PCDs are constructed to test worst case sterilization load. (ANSI/AAMI ST58:2013 (R) 2018)
- PCDs can be used for periodic testing of the sterilizer. (ANSI/AAMI ST58:2013 (R) 2018)
- Using a PCD in every load meets AAMI guidelines and AORN recommendations.
- Quick readout PCDs allow the sterilized load to be quarantined prior to reading the BI results.
- There are three process monitors for low temperature sterilization: Physical, chemical and biological. Confirming results of all three for every cycle provides the greatest assurance of sterility. (ANSI/AAMI ST58:2013 (R) 2018)