scope:

This technical information report (TIR) is intended to provide technical information that will assist health care facilities in the selection and use of process challenge devices (PCDs). It is to serve as a resource that health care personnel can use when directing questions to the PCD manufacturer about the suitability, effectiveness, and safety of a specific PCD. Currently, there are no standards that define the performance of these medical devices or provide methods to evaluate them.

This TIR describes user-assembled PCDs that originally used biological indicators (BIs) to evaluate the ability of a sterilization process to sterilize a known challenge. It also describes user-assembled PCDs that use chemical indicators (CIs) to conduct the Bowie-Dick test for air removal/steam penetration in dynamic-air-removal steam sterilization processes.

Preassembled commercial PCDs for sterilization processes that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) can be used as alternatives to the original user-assembled PCDs.

PCDs used in liquid chemical sterilization processes are excluded from the scope of this TIR.