The most likely reason for the recall of a steam-sterilized load is thefailure of the biological indicator (BI), specificallyGeobacillus stearothermophilus, which is used to monitor high-temperature steam (moist heat) sterilization processes. This organism is the biological indicator of choice because it has high resistance to moist heat and thus serves as a reliable marker for sterilization efficacy.
The APIC Text and AAMI ST79 guidelines confirm thatGeobacillus stearothermophilusis used for steam sterilization and that a failed BI indicates a failure in the sterilization process, which requires immediate action, including recalling all items sterilized since the last negative BI and reprocessing them. This is a crucial aspect of ensuring patient safety and preventing the use of potentially non-sterile surgical instruments.
"BIs are the only process indicators that directly monitor the lethality of a given sterilization process. [...]Geobacillus stearothermophilusspores are used to monitor steam sterilization..."
"Evidence of sterilization failures (e.g., positive biological indicators) is the most common reason for a recall."
Additionally, it is noted:
“With steam sterilization, the instrument load does not need to be recalled for a single positive biological indicator test, with the exception of implantable objects.”
However,multiple positive BIs or BI failure confirmation does require a recall.
The incorrect options explained:
A. Bacillus subtilis– This is not used in steam sterilization but rather in dry heat or EO processes.
C. Placement of the biological indicator on the bottom shelf over the drain– While incorrect placement can lead to test failure, the recall is prompted by BI failure, not just placement.
D. Incorrect placement of instruments– This can cause sterilization failure but is not the direct trigger for a recall unless it leads to a failed BI.
[References:, CIC Study Guide, 6th Edition, Chapter 10 – Cleaning, Sterilization, Disinfection, Asepsis, Pages 211, 236, APIC Text, 4th Edition, Chapter 106 – Sterile Processing, ANSI/AAMI ST79:2017, cited throughout APIC Text and APIC 4 for sterilization monitoring protocols., , ]