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What This Guide Helps With
Unexpected sterilization indicator failures caused by load conditions, cycle selection, packaging, monitoring materials, process performance, or equipment malfunction.
Step-by-Step Troubleshooting
1. Protect Patient Safety Immediately
Do not release the affected load for patient use.
Follow facility infection-prevention and sterilization-failure procedures for quarantining, recalling, or reprocessing affected items as applicable.
Expected outcome: Potentially nonsterile instruments are prevented from reaching patients.
2. Confirm the Indicator Failure
Identify:
- Indicator type
- Load and cycle involved
- Indicator placement
- Whether the failure was biological, chemical, or both
- Whether other indicators in the same load behaved normally
- Whether the sterilizer reported normal cycle completion
Expected outcome: The event is clearly characterized before equipment failure is assumed.
3. Verify Indicator Handling and Validity
Confirm the indicator:
- Was within its usable date
- Was stored correctly
- Was processed correctly
- Was incubated or interpreted according to its instructions when applicable
- Had an appropriate control when required
Expected outcome: A defective or mishandled indicator is either identified or ruled out.
4. Review Cycle Selection
Verify the selected cycle was appropriate for the load and packaging according to facility policy and manufacturer guidance.
Expected outcome: The sterilizer was operated using an appropriate cycle.
5. Review Load Configuration
Inspect the reported loading arrangement for:
- Overloading
- Dense packing
- Poor steam exposure
- Improper tray placement
- Containers or packs positioned incorrectly
Expected outcome: Load configuration is not the obvious cause of indicator failure.
6. Inspect Basic Sterilizer Conditions
Check:
- Water level and quality
- Door gasket and sealing surface
- Visible steam leakage
- Drainage
- Chamber cleanliness
- Cycle completion
Expected outcome: No basic external sterilizer condition explains the failed indicator.
7. Review the Cycle Record
Compare available cycle documentation with expected normal operation.
Look for:
- Incomplete cycle
- Abnormal interruption
- Unexpected display behavior
- Power loss
- Extended or shortened phase
- Missing record data
Do not interpret unverified displayed values as proof of successful sterilization.
Expected outcome: Cycle documentation is reviewed for evidence of process abnormality.
8. Perform an Approved Test Cycle
With the unit removed from clinical service, perform facility-approved performance testing using appropriate monitoring materials and test equipment.
Expected outcome: The sterilizer either demonstrates acceptable operation or reproduces the sterilization-process concern.
9. Repeat Only When Procedure Supports It
If infection-prevention policy and manufacturer procedures permit repeat testing, perform a controlled repeat after external causes have been corrected.
Do not use repeated testing to dismiss a confirmed biological failure without appropriate clinical and infection-prevention review.
Expected outcome: The sterilizer has clear, documented evidence supporting either successful function or continued failure.
10. Escalate Any Unresolved Sterilization Failure
If an unexplained indicator failure remains or test results are inconsistent, keep the sterilizer out of service.
Expected outcome: An uncertain sterilization process is not returned to patient-care use.
If the Problem Persists
Common external causes such as indicator handling, cycle choice, loading, water condition, door sealing, and documentation have been ruled out. Remaining causes may involve heating performance, steam generation, pressure or temperature sensing, valves, calibration, control systems, or other service-level issues.
The sterilizer should be:
- Removed from service
- Labeled Out of Service
- Sent for repair or bench evaluation
- Evaluated using appropriate Midmark documentation and approved test equipment
- Repaired or calibrated only by qualified personnel
Coordinate with Infection Prevention and Sterile Processing leadership as required before return to service. Appropriate performance monitoring must confirm acceptable sterilization function.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
A failed biological indicator should be treated as a sterilization-process event, not merely as an equipment alarm.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Sterile Processing reported a failed biological indicator from an M11 cycle that otherwise appeared to complete normally."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering ruled out obvious loading, water, sealing, and indicator-handling issues and reproduced abnormal sterilizer performance during controlled testing."
Resolution
What action was taken.
Example:
"The sterilizer was removed from service and referred for qualified evaluation, with return to service withheld pending successful sterilization-performance testing."
Helpful Details to Include (If Known)
- Indicator type
- Indicator lot and expiration status
- Cycle selected
- Load contents
- Indicator placement
- Control result
- Cycle record
- Water condition
- Door seal condition
- Test-cycle results
- Infection Prevention notification
- Final device status
- Indicator type
- Indicator lot and expiration status
- Cycle selected
- Load contents
- Indicator placement
- Control result
- Cycle record
- Water condition
- Door seal condition
- Test-cycle results
- Infection Prevention notification
- Final device status
Final Thought
Indicator failure requires a conservative response: protect the load, verify simple process causes first, test the sterilizer appropriately, and escalate whenever sterilization effectiveness remains uncertain.
That is successful troubleshooting.