What is the U.S. Food and Drug Administration Class II chemical indicator used in dynamic air removal sterilizers called?

The U.S. Food and Drug Administration Class II chemical indicator used in dynamic air removal sterilizers is known as the Bowie-Dick test. This test is specifically designed to evaluate the air removal capability of the sterilizer and to ensure that the steam can effectively penetrate the load. It involves placing a chemical indicator within the sterilization cycle that changes color when exposed to the appropriate conditions of heat and steam, indicating that the sterilizing process is functioning correctly.

The Bowie-Dick test is crucial for validating the performance of steam sterilizers, particularly those that use pre-vacuum technology. By confirming that air has been adequately removed and that the sterilizer can create the necessary conditions for effective sterilization, the test helps ensure patient safety and the efficacy of sterile processing.

Other choices, like external chemical indicators, biological indicators, and process challenge devices, serve different purposes in sterilization monitoring. External indicators are typically used on packaging to indicate exposure to sterilization, biological indicators use spores to test the effectiveness of sterilization by confirming that microorganisms are killed, and process challenge devices validate the performance of sterilization processes but are not specifically identified as the chemical indicator for dynamic air removal sterilizers.