How to make routine efficacy testing for Hydrogen Peroxide Plasma Sterilizers.



In typical facilities, VH2O2 sterilizers are used many times each day and instruments are quickly returned to patient use. A robust quality assurance program includes routine efficacy testing using the monitoring tools.



<Physical Monitors>

: Section 9.5.1 of AAMI ST58 discusses the use of physical monitors for monitoring gaseous chemical

sterilization processes. Two key quotes are: “At the end of the cycle and before items are removed from the processing

equipment, the operator should examine and interpret the printout to verify that cycle parameters were met and should

initial it to allow later identification of the operator.” (Section 9.4.2) and, “If the interpretation of the physical monitors

suggests inadequate processing, the items should not be dispensed or used.” (Section 9.5.1).



< External Chemical Indicator Tape or Label>

:“A CI should be used on the outside of each package unless the internal indicator is

visible. The CI is examined after sterilization and also before use of the item to verify that the item has been exposed to

the sterilization process.” (AAMI ST58:2013, Section 9.5.3.2).



<Internal Chemical Indicator Strip>

:An internal CI should be used inside each package, tray and containment device to be sterilized. (AAMI ST58:2013, Section 9.5.3.2).



<Biological Indicators>

:AAMI ST58 states: “A PCD with the appropriate BI should also be used at least daily, but preferably in every sterilization cycle” (Section 9.5.4.3). AAMI ST58 goes on to state in Section 9.5.4.5.2 that the PCD should be labeled before use and then positioned in the load according to the sterilizer manufacturer’s written IFU.

AORN’s Guideline for Sterilization is slightly more specific and states, “Routine sterilizer efficacy monitoring should be

performed at least daily on each cycle type, preferably with each load” (Recommendations XX.h.4 and XX.h.5). In

hospitals, end-users typically place a BI and an internal CI in a peel-pouch indicated for use in VH2O2 sterilizers and then

position the pouched BI in the sterilizer chamber as recommended by the sterilizer manufacturer. As a best practice and

to provide optimal patient safety, we recommends that every sterilization load be monitored with a biological indicator.



< How to take actions if BI Results is positive>

A positive result for a test BI indicates a sterilization process failure. AAMI ST58 provides guidance on handling

positive BI results in Section 9.5.4.6. This section states: “Because a sterilization failure has occurred, items processed

in that sterilizer since the sterilization cycle having the last negative BI should be considered non-sterile. They should be

retrieved, if possible, and reprocessed. The sterilizer in question should be taken out of service.”



References

1. ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities.

2. 2016 Edition AORN Guidelines for Perioperative Practice. Guideline for Sterilization.