What is the only approved method to confirm whether sterilization has occurred?

The only approved method to confirm whether sterilization has occurred is through biologic monitoring, commonly referred to as spore testing. This process involves using highly resistant bacterial spores that are introduced into the sterilization process. After the cycle is complete, these spores are cultured to see if they survive the sterilization process. If the spores are killed, it confirms that the sterilization conditions were effective.

This method provides the most reliable evidence of the sterilization process because it specifically tests the effectiveness against biological organisms, not just the physical conditions.

Other methods, while useful, do not confirm the actual destruction of microorganisms. Visual inspection can show whether instruments appear clean or assembled properly but does not confirm sterilization. Chemical indicators can indicate that the instrument has been processed through the sterilizer, but they do not prove that the microbes have been eradicated. Time and temperature logging provides data about the conditions during the sterilization cycle but does not guarantee that the items were sterilized effectively. Hence, biologic monitoring stands as the gold standard for ensuring that sterilization has been achieved.