We are having a second steam sterilizer installed in our Surgical Center, what tests need to be run before we can start using it?
To verify that your new sterilizer is working properly you need to run three consecutive Biological process challenge devices (a Biological pack containing a class 5 integrating indicator) in a “normal” sterilization cycle, the minimum exposure time, temperature and pressure recommended by the steam sterilizer manufacturer. These need to be run in an empty chamber placed on the sterilization rack over the drain. If this is a dynamic air removal sterilizer (prevac) these need to be followed by three consecutive Bowie-Dick tests.
This is the same test that AAMI recommends you perform on your steam sterilizer after a major repair (ANSI/AAMI ST-79 10.6.4). Normal service of your autoclave that occurs during preventive maintenance, like the replacement of gaskets or the rebuild of a solenoid valve is not a major repair, replacing the whole sterilizer door, vacuum pump, steam generator or weld repairs in the pressure vessel IS, so is rebuilds or upgrades of controls, any major piping assembly work or moving the sterilizer. If you were in a large institution where your steam was supplied by a free standing boiler and that was replaced by a new boiler or new piping was installed from boiler to sterilizer it would also be considered a “major repair”.
If your steam sterilizer is designed to be used for multiple cycles, dynamic-air removal (prevac), gravity displacement, and immediate use (flash) sterilization, then each of these modalities must be run 3 consecutive times each with a Bi PDC test on their minimum cycle followed by 3 Bowie/Dick tests. When all BI’s have been incubated for their given time and there are no positive cultures and the Bowie/Dick Tests have all passed, your sterilizer can be put in service. So free up some time and incubator space because you have your work cut out for you….and please remember to document everything. GOOD LUCK!