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Sterilization Procedures When a body art facility is equipped with a decontamination and sterilization room and will be sterilizing reusable instruments and body art jewelry, the following sterilization procedures must be followed: 1. Clean instruments to be sterilized shall first be sealed in peel-packs that contain either a sterilizer indicator or internal temperature indicator. The outside of the pack shall be labeled with the name of the instrument, the date sterilized, and the initials of the person operating the sterilizing equipment. 2. Sterilizers shall be loaded, operated, decontaminated and maintained according to manufacturer's directions, and shall meet all of the following standards: • Only equipment manufactured for the sterilization of medical instruments shall be used. • Sterilization equipment shall be tested using a commercial biological indicator monitoring system after the initial installation, after any major repair, and at least once per month. The expiration date of the monitor shall be checked prior to each use. • Each sterilization load shall be monitored with mechanical indicators for time, temperature, pressure, and, at a minimum, Class V integrators. The Class V integrator gives an immediate response on whether the sterilization has been achieved. Each individual sterilization pack shall have an indicator. • Biological indicator monitoring test results shall be recorded in a log that shall be kept on site for two years after the date of the results. • A written log of each sterilization cycle shall be retained on site for two years and shall include all of the following information: (a) The date of the load. (b) A list of the contents of the load. (c) The exposure time and temperature. (d) The results of the Class V integrator. (e) For cycles where the results of the biological indicator monitoring test are positive, how the items were cleaned, and proof of a negative test before reuse. 3. Clean instruments and sterilized instrument packs shall be placed in clean, dry, labeled containers, or stored in a labeled cabinet that is protected from dust and moisture. Use clean gloves to handle sterilized packages to prevent cross contamination of the sterilized item when the package is opened for use. 4. Sterilized instruments shall be stored in the intact peel-packs or in the sterilization equipment cartridge until time of use. 5. Sterile instrument packs shall be evaluated at the time of storage and before use. If the integrity of a pack is compromised, including, but not limited to, cases where the pack is torn, punctured, wet, or displaying any evidence of moisture contamination, the pack shall be discarded or reprocessed before use. Page 7 of 9