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What This Guide Helps With
Addresses inadequate temperature or pressure caused by door sealing, loading, water availability, utility conditions, settings, or service-level heating and sensing problems.
Step-by-Step Troubleshooting
1. Protect the Load and Stop Clinical Processing
Do not release a load from a cycle that failed to achieve or maintain required sterilization conditions. Quarantine the affected load and use another validated sterilizer for continued processing.
Expected outcome: No inadequately processed load reaches patient care.
2. Confirm the Reported Condition
Determine whether the cycle fails during heat-up, pressure rise, sterilization exposure, or another phase. Record any displayed message and whether the cycle aborts automatically or simply stalls.
Expected outcome: The timing and repeatability of the temperature or pressure problem are known.
3. Verify the Door Is Fully Sealed
Inspect the accessible door gasket and mating surface for debris, residue, visible damage, or improper seating. Confirm the door closes and locks normally.
Expected outcome: There is no obvious external sealing problem. If cleaning an accessible sealing surface restores normal cycle performance, continue to complete verification.
4. Check Water Availability and Chamber Condition
Confirm the sterilizer has its required water source available and that the chamber and accessible drain area are clean and unobstructed.
Expected outcome: Water-related operating conditions are normal.
5. Verify the Selected Cycle
Confirm the intended cycle was selected and that normal user-accessible settings are appropriate for the load. Do not alter validated temperature, pressure, or exposure parameters to compensate for a malfunction.
Expected outcome: The sterilizer is being asked to run an appropriate validated program.
6. Evaluate Loading and Chamber Arrangement
Check for excessive loading, tightly packed items, incorrect tray placement, or objects interfering with the door or normal chamber operation.
When allowed, compare performance with an approved reduced or test load.
Expected outcome: Loading is not preventing normal heat and steam conditions.
7. Observe for Evidence of Leakage
During an approved controlled test, inspect for visible steam or water leakage from accessible areas. Stop testing if leakage is significant or creates a burn or electrical hazard.
Expected outcome: The sterilizer remains externally leak-free during pressure development.
8. Run an Approved Test Cycle
Operate the sterilizer under approved test conditions and observe whether it reaches the required cycle phases without abnormal delay or abort.
Do not rely on an apparently normal display alone if the sterilization process has previously failed.
Expected outcome: The cycle progresses normally through heat-up, exposure, exhaust, and completion as applicable.
9. Perform Required Process Verification
Use facility-approved physical, chemical, biological, or other required process verification appropriate to the sterilizer and load before clinical return.
Expected outcome: Required sterilization conditions and process indicators are satisfactory. Troubleshooting can stop when all required checks pass.
10. Escalate Failure to Achieve Sterilization Conditions
If sealing, water, load, and normal settings are correct but temperature or pressure still fails to develop or remain stable, remove the unit from service.
Expected outcome: Potential heating, sensing, valve, plumbing, control, or pressure-related faults are addressed by qualified service.
If the Problem Persists
External causes involving the door seal, load, water source, cycle selection, and visible leakage have been ruled out. Remaining causes may involve heaters, temperature sensing, pressure sensing, internal valves, plumbing, control logic, or another service-level component.
Remove the sterilizer from service, label it Out of Service, and arrange qualified evaluation using appropriate Tuttnauer documentation and approved test equipment. Do not recalibrate or change validated process parameters without proper authorization and procedure.
Complete all required post-repair calibration, functional checks, and sterilization-process verification before return to service. Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
A cycle that finishes but does not meet validated sterilization conditions is still a failed cycle; process verification matters more than apparent completion.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Staff reported that the Tuttnauer T-Edge 10 aborted because it was not reaching normal sterilization conditions."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found residue on the accessible door sealing surface preventing a consistent seal."
Resolution
What action was taken.
Example:
"The sealing surface was cleaned, normal door sealing was restored, and the sterilizer completed the required verification cycle successfully."
Helpful Details to Include (If Known)
- Cycle and phase affected
- Temperature or pressure symptom as displayed
- Door gasket condition
- Visible leakage
- Water availability
- Load size and arrangement
- Cycle selected
- Test-load result
- Process indicator results
- Final device status
Final Thought
Failure to develop sterilization temperature or pressure must be treated as a process failure. Rule out sealing, loading, water, and selection issues first, then escalate rather than altering validated parameters or assuming a specific internal component has failed.
That is successful troubleshooting.