CER Endoscope Sterilization Methods Questions and Answers 4 — Questions and Answers
Question 1: Which biological indicator (BI) organism is used to monitor ethylene oxide (ETO) sterilization cycles?
- Geobacillus stearothermophilus spores
- Bacillus atrophaeus spores (Correct answer)
- Clostridium sporogenes spores
- Mycobacterium terrae
Correct answer: Bacillus atrophaeus spores
Bacillus atrophaeus (formerly B. subtilis var. niger) spores are the standard biological indicator for ETO sterilization due to their high resistance to the ETO sterilant.
Question 2: According to AAMI standards, biological indicators must be used with every sterilization load containing which type of items?
- Flexible endoscopes
- Implantable devices (Correct answer)
- Powered surgical instruments
- Rigid bronchoscopes
Correct answer: Implantable devices
AAMI ST79 requires that implantable devices be monitored with a biological indicator in every load, and the load should be quarantined until the BI result is confirmed negative.
Question 3: Which class of chemical indicator is considered the most comprehensive, responding to all critical sterilization parameters for a specific cycle type?
- Class 1 — process indicators (exposure indicators)
- Class 3 — single-variable indicators
- Class 5 — integrating indicators
- Class 6 — emulating indicators (Correct answer)
Correct answer: Class 6 — emulating indicators
Class 6 emulating indicators are cycle-specific and react to all critical parameters (time, temperature, sterilant concentration) calibrated to a specific sterilization cycle.
Question 4: When a positive biological indicator result is confirmed after a sterilization cycle, what is the required immediate action?
- Discard the BI strip and repeat the test on the next load
- Release items from the load since chemical indicators passed
- Quarantine all items from the load and initiate a recall investigation (Correct answer)
- Document the anomaly and continue normal operations
Correct answer: Quarantine all items from the load and initiate a recall investigation
A positive BI indicates sterilization failure; all items from the affected load must be quarantined, a recall initiated, and the sterilizer taken out of service pending investigation.
Question 5: Before each use of a liquid peracetic acid sterilization system, what quality control step is REQUIRED?
- Measure the temperature of the sterilant solution
- Test the sterilant concentration with a manufacturer-approved test strip (Correct answer)
- Verify the pH level of the sterilant
- Confirm the volume of sterilant in the chamber
Correct answer: Test the sterilant concentration with a manufacturer-approved test strip
The concentration of peracetic acid must be confirmed with an approved test strip before each cycle to ensure the sterilant meets the minimum effective concentration.
Question 6: What minimum records must be documented for each sterilization cycle per regulatory and accreditation standards?
- Biological indicator result only
- Cycle number, date, load contents, operator identification, and monitoring results (Correct answer)
- Patient name and procedure type associated with sterilized items
- Chemical indicator result and sterilizer model number only
Correct answer: Cycle number, date, load contents, operator identification, and monitoring results
Complete cycle documentation enables traceability for recalls and must include cycle number, date and time, load contents, operator ID, and results of all monitoring (chemical and biological).
Question 7: What corrective action is required when a sterilization cycle experiences a confirmed parameter deviation, such as an unplanned temperature drop during the cycle?
- Release the load if the biological indicator incubation result is negative
- Quarantine the entire load and investigate before any items are released (Correct answer)
- Re-run the sterilizer and release items from both the original and repeat cycles
- Document the deviation but release items since chemical indicators show passage
Correct answer: Quarantine the entire load and investigate before any items are released
Any cycle parameter deviation requires quarantine of the affected load until a thorough investigation is completed, because compromised parameters may result in inadequate sterilization.
CER Endoscope Sterilization Methods Questions and Answers 4
Which biological indicator (BI) organism is used to monitor ethylene oxide (ETO) sterilization cycles?