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What This Guide Helps With
Use this guide when the sterilizer cannot achieve or maintain the temperature or pressure required for normal cycle progression.
Step-by-Step Troubleshooting
1. Protect Patient Care and Process Integrity
Do not release loads from a cycle that failed to achieve required process conditions. Quarantine affected loads according to facility policy and provide another validated sterilizer.
Expected outcome: Potentially inadequately processed instruments are controlled and the affected sterilizer is not relied upon.
2. Confirm the Exact Failure
Identify whether temperature, pressure, or both fail to rise, rise too slowly, fluctuate, or drop during the cycle.
Document the cycle type, phase, displayed message, and cycle record.
Expected outcome: The thermal or pressure problem is clearly characterized.
3. Verify Facility Steam and Utility Availability
Confirm the sterilizer has the required facility steam and other supporting utilities available. Check whether nearby steam-fed equipment shows similar symptoms.
Coordinate suspected building-system issues with Facilities.
Expected outcome: External steam and utilities are available and stable. If correcting a facility supply issue restores normal conditions, complete process verification and stop troubleshooting.
4. Check Accessible Steam Supply Conditions
Inspect accessible steam piping interfaces and approved external controls for obvious closed valves, leakage, damage, or abnormal conditions.
Do not adjust pressure regulators or internal steam components without approved service documentation.
Expected outcome: The external steam path appears normal. If an external supply restriction is corrected and the cycle reaches expected conditions, verify performance and stop troubleshooting.
5. Inspect Door Sealing
Check for debris, visible gasket problems, or incomplete door closure that could prevent the chamber from maintaining pressure.
Expected outcome: The chamber door closes and seals normally. If correcting an external sealing condition restores normal pressure and temperature behavior, verify with an approved test cycle and stop troubleshooting.
6. Check Chamber and Drain Conditions
Inspect accessible drains for debris and verify no obvious condition is allowing abnormal condensate retention or interfering with normal steam conditioning.
Expected outcome: Chamber and accessible drainage areas are clear.
7. Confirm Normal Cycle Selection
Verify an approved cycle appropriate for the test is selected and no unauthorized setting has been changed.
Do not alter validated temperature, exposure, or pressure parameters to compensate for a fault.
Expected outcome: The unit is operating under its intended configuration.
8. Observe a Test Cycle
Run an appropriate test cycle and observe whether temperature and pressure progress normally through the affected phase.
Use approved test instrumentation when required by facility procedure.
Expected outcome: Temperature and pressure behave consistently through the complete cycle. If required verification passes, troubleshooting can stop.
9. Escalate if Conditions Remain Unstable
If external utilities, door sealing, chamber condition, and cycle selection are normal but the sterilizer still cannot achieve or maintain process conditions, remove it from service.
Expected outcome: An unreliable sterilizer is prevented from processing clinical loads pending qualified service.
If the Problem Persists
External utility, sealing, drainage, loading, and selection causes have been ruled out. Remaining possibilities may involve steam-control components, temperature or pressure sensing, internal piping, valves, vacuum functions, or control-system faults.
The sterilizer should be:
- Removed from service.
- Labeled Out of Service.
- Sent for qualified service evaluation.
- Evaluated using Getinge documentation and approved calibrated test equipment.
- Repaired or calibrated only by qualified personnel.
- Required to pass applicable process and performance verification before return to service.
Recognizing that a sterilizer unable to reach validated process conditions must remain out of service is proper troubleshooting.
Clinical Use Tip
A completed-looking cycle is not acceptable if required sterilization conditions were not achieved and documented.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Sterile Processing reported the Getinge GSS67H was aborting because chamber pressure and temperature were not increasing normally."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the facility steam supply to the sterilizer had been isolated."
Resolution
What action was taken.
Example:
"After Facilities restored the steam supply, Clinical Engineering completed an approved test cycle and verified normal temperature and pressure progression."
Helpful Details to Include (If Known)
- Whether temperature, pressure, or both were affected
- Cycle and phase involved
- Exact displayed message
- Cycle-record observations
- Facility steam availability
- Door sealing condition
- Drain condition
- Nearby equipment symptoms
- Test-cycle results
- Final device status
Final Thought
Verify facility steam, utilities, door sealing, drainage, and approved settings before assuming an internal control failure. A sterilizer that cannot reliably achieve required process conditions must remain out of service until fully verified.
That is successful troubleshooting.