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SAN JOAQUIN GENERAL HOSPITAL Department of STERILE PROCESSING Page of 2 2 Policy/Procedure No. Effective Date Date Replaces 10.04 10/02 07/99 Title of Policy/Procedure BIOLOGICAL MONITORING OF THE STERILIZERS ampule and place in the incubator. Incubate immediately at 55°C to 60°C for 48 hours / 3 hours or 1 hour depending on the test pack. Examine the indicator at regular intervals for any color change (1, 2, 3, 12 and 24 hours). (While the recommended incubation time can be 3 or 48 hours, the BI test will exhibit inadequate sterilization conditions with a high confidence level within l; 2, 3, 12, or 24 hours.) As a positive growth control, place an activated non -sterilized BI test indicator in the incubator along with the sterilized BI. Label the control vial with a C and the date. 7. Remove the previous days BIs and visually inspect and compare the vials for color changes. a. When the BI is negative there is no growth --the load vial will remain purple and the control vial will be cloudy yellow. b. When the BI is positive there is growth and the load vial will turn cloudy yellow along with the control vial. 8. If the test results indicate a positive result, notify the SPD Manager / Department Manager immediately. 9. The SPD Manager / Department Manager will start supply recall procedures (see P&P on Recall Procedures). 10. Turn off the sterilizer and notify the Biomedical Engineering Department. 11. Document all test results in the proper Sterilizer Log. AUTHORS: Materials Management, Transition Planning, Sterile Processing. REF: RAMI, Association for the Advancement of Medical Instrumentation Standards and Recommended Practices, Manufacturer's Biological Indicators --Instructions for Use DEPARTMENTS COVERED IN THIS POLICY: Sterile Processing Department, Surgery Department, Family Maternity Center, Dental Clinic, Laboratory Department and Engineering Department.