chipmoore
10-19-2008, 08:04 AM
I have heard and read that some people think that when selecting extended cycle times as recommended by a device Mfg, that the use of the sterilizer (a Class II Med Device) would be “off label” because it is beyond the sterilizer Mfg exposure time instructions for use.
I disagree and here’s my logic. Sterilizers are validated by the Mfg, using challenge loads defined in AAMI/ANSI ST8 for density and metal weight. Those loads do not resemble the typical mixed loads processed everyday in CS departments throughout the US and Canada. Thus, the sterilizer provides conditions to achieve sterilization for mixed loads when prepared and loaded per recommended practices. Yes, the sterilizer Mfg provides time at temperature in their manuals for generic hospital cycles but at the same time, the extended cycle requirement has also been validated in a sterilizer. Users need to follow device Mfg intended use instructions and the sterilizer is designed to provide a steady state temperature control inside the chamber for any time selected.
Other opinions?
Chip Moore
Rochester, NY
Retired but involved
I disagree and here’s my logic. Sterilizers are validated by the Mfg, using challenge loads defined in AAMI/ANSI ST8 for density and metal weight. Those loads do not resemble the typical mixed loads processed everyday in CS departments throughout the US and Canada. Thus, the sterilizer provides conditions to achieve sterilization for mixed loads when prepared and loaded per recommended practices. Yes, the sterilizer Mfg provides time at temperature in their manuals for generic hospital cycles but at the same time, the extended cycle requirement has also been validated in a sterilizer. Users need to follow device Mfg intended use instructions and the sterilizer is designed to provide a steady state temperature control inside the chamber for any time selected.
Other opinions?
Chip Moore
Rochester, NY
Retired but involved