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.
* According to the APIC Text:
"BIs are the only process indicators that directly monitor the lethality of a given sterilization process. [...] Geobacillus stearothermophilusspores are used to monitor steam sterilization..."
* TheCIC Study Guide (6th ed.)also specifies that:
"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.