The effectiveness of biological indicator and e-tracking system in sterilization failure event

Abstract

Purpose: Steam sterilization is the most popular method used in hospital, but the failure rate varies from 1% to 65 %. Use biological and chemical indicators are the gold standard for sterilization monitoring in the healthcare facilities. We wish to have a chance to verify the accuracy of these indicators. Methods: At 10:10am Sep 5 by 2014, the hospital CSR (Central Service Room) encountered a florescent positive biological indicator after incubated 160 minutes. Then the head nurse prompt click the button in the e-tracking system to alarm the recall process hospital-wide at 10:13am. Although the sterilizer record and Bowie-Dick test, class 4 chemical indicator were passed, the class 5 chemistry indicator is fail. CSR also contacted infection control department, service engineer, supervisor of CSR and operating room (OR) for this emergency event. Results: The e-tracking system show immediately 47 instrument sets processed in that questionable load, 5 of 47 already sent to operative room and children hospital operative room. With this system, CSR successfully recall 4 packs, only 1 pack was used at 10:18am of the day due to pediatric OR nurse misunderstood the risk of sterilization failure. The questionable sterilizer was removed from service, and all the relative loads were reprocessed and also started to investigate the root causes. Finally, we found this rare event was due to CSR operator error finally. Conclusions: We also found we need to educate the OR nurses, correct the CSR operation procedures, well trained the new employee, and audit the sterilizer record and monitoring products. The valued rapid readout biological indicator alarm in a short period and did do a great job to alarm the sterilization failure and prevent from pose the patient in infection risk.