Tables and Figure: Table 12

Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)

Format Change [February 2017]

Update or clarification r17The format of this section was changed to improve readability and accessibility. The content is unchanged.


Suggested protocol for management of positive biological indicator in a steam sterilizer

  1. Take the sterilizer out of service. Notify area supervisor and infection control department.
  2. 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 soon as possible, repeat biological indicator test in three consecutive sterilizer cycles. If additional spore tests remain positive, the items should be considered nonsterile, and supplies processed since the last acceptable (negative) biological indicator should be recalled. The items from the suspect load(s) should be recalled and reprocessed.
  3. Check to ensure the sterilizer was used correctly (e.g., verify correct time and temperature setting). If not, repeat using appropriate settings and recall and reprocess all inadequately processed items.
  4. Check with hospital maintenance for irregularities (e.g., electrical) or changes in the hospital steam supply (i.e., from standard ≥97% steam, <3% moisture). Any abnormalities should be reported to the person who performs sterilizer maintenance (e.g., medical engineering, sterilizer manufacturer).
  5. Check to ensure the correct biological indicator was used and appropriately interpreted. If not, repeat using appropriate settings.
  6. If steps 1 through 5 resolve the problem
    If all three repeat biological indicators from three consecutive sterilizer cycles (step 2 above) are negative, put the sterilizer back in service.
  7. If one or both biological indicators are positive, do one or more of the following until problem is resolved.
    1. Request an inspection of the equipment by sterilizer maintenance personnel.
    2. Have hospital maintenance inspect the steam supply lines.
    3. Discuss the abnormalities with the sterilizer manufacturer.
    4. Repeat the biological indicator using a different manufacturer’s indicator.

If step 7 does not resolve the problem
Close sterilizer down until the manufacturer can assure that it is operating properly. Retest at that time with biological indicators in three consecutive sterilizer cycles.

Modified from Bryce. 839

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