Monitoring of Sterilizers

  1. Use mechanical, chemical, and biologic monitors to ensure the effectiveness of the sterilization process. Category IB. 811-815, 819, 846, 847, 975-977
  2. Monitor each load with mechanical (e.g., time, temperature, pressure) and chemical (internal and external) indicators. If the internal chemical indicator is visible, an external indicator is not needed. Category II. 811-815, 819, 846, 847, 975-977, 980 
  3. Do not use processed items if the mechanical (e.g., time, temperature, pressure) or chemical (internal and/or external) indicators suggest inadequate processing. Category IB 811-814, 819. 
  4. Use biologic indicators to monitor the effectiveness of sterilizers at least weekly with an FDAcleared commercial preparation of spores (e.g., Geobacillus tearothermophilus for steam) intended specifically for the type and cycle parameters of the sterilizer. Category IB. 1, 811, 813-815, 819, 846, 847, 976, 977
  5. After a single positive biologic indicator used with a method other than steam sterilization, treat as nonsterile all items that have been processed in that sterilizer, dating from the sterilization cycle having the last negative biologic indicator to the next cycle showing satisfactory biologic indicator results. These nonsterile items should be retrieved if possible and reprocessed. Category II. 1
  6. After a positive biologic indicator with steam sterilization, objects other than implantable objects do not need to be recalled because of a single positive spore test unless the sterilizer or the sterilization procedure is defective as determined by maintenance personnel or inappropriate cycle settings. If additional spore tests remain positive, consider the items nonsterile and recall and reprocess the items from the implicated load(s). Category II. 1
  7. Use biologic indicators for every load containing implantable items and quarantine items, whenever possible, until the biologic indicator is negative. Category IB. 811-814, 819
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