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Sterilization Procedures <br />When a body art facility is equipped with a decontamination and sterilization room and will be <br />sterilizing reusable instruments and body art jewelry, the following sterilization procedures <br />must be followed: <br />Clean instruments to be sterilized shall first be sealed in peel -packs that contain either a <br />sterilizer indicator or internal temperature indicator. The outside of the pack shall be <br />labeled <br />2. Sterilizers shall be loaded, operated, decontaminated and maintained according to <br />manufacturer' directions, and shall meet all of the following standards: <br />• Only equipment manufactured for the sterilization of medical instruments shall be <br />used. <br />• Sterilization equipment shall be tested using a commercial biological indicator <br />monitoring system after the initial installation, after any major repair, and at least once <br />per month. The expiration date of the monitor shall be checked prior to each use. <br />• Each sterilization load shall be monitored with mechanical indicators for time, <br />temperature, pressure, and at a minimum, class V integrators. The Class V integrator <br />gives an immediate response on whether the sterilization has been achieved. Each <br />individual sterilization pack shall have an indicator. <br />• Biological indicator monitoring test results shall be recorded in a log that shall be kept <br />on site for two years after the date of the results. <br />• A written log of each sterilization cycle shall be retained on site for two years and shall <br />include all of the following information: <br />- The date of the load. <br />- A list of the contents of the load. <br />- The exposure time and temperature. <br />- The results of the Class V integrator. <br />- For cycles where the results of the biological indicator monitoring test are positive, <br />indicate how the items were cleaned, and proof of a negative test before reuse. <br />3. Clean instruments and sterilized instrument packs shall be placed in clean, dry, labeled <br />containers, or stored in a labeled cabinet that is protected from dust and moisture. Use <br />clean gloves to handle sterilized packages to prevent cross contamination of the sterilized <br />item when the package is opened for use. <br />4. Sterilized instruments shall be store in the intact peel -packs or in the sterilization <br />equipment cartridge until time of use. <br />5. Sterile instrument packs shall be evaluated at the time of storage and before use. If the <br />integrity of a pack is compromised, including, but not limited to, cases where the pack is <br />torn, punctured, wet or displaying any evidence of moisture contamination, the pack shall <br />be discarded or reprocessed before use. <br />Page 9 of 11 <br />