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Manufacturer
Model
What This Guide Helps With
Addresses failed leak or sterilization-process challenge testing caused by test setup, sealing, loading, chamber condition, utilities, or service-level performance problems.
Step-by-Step Troubleshooting
1. Remove the Sterilizer From Routine Load Processing
A failed required test means the sterilizer's process performance has not been demonstrated. Follow facility policy for loads processed since the last acceptable test and stop routine clinical use when required.
Expected outcome: Potentially affected loads are controlled and the sterilizer is not used beyond facility policy.
2. Confirm Which Test Failed
Identify whether the failure involved a leak test, chemical indicator, biological indicator, air-removal challenge, or another facility-required process challenge.
Record the exact test result without interpreting every failed indicator as the same type of equipment failure.
Expected outcome: The specific test and failure mode are known.
3. Verify Test Materials and Setup
Confirm the correct approved test pack, indicator, holder, or challenge device was used and was within its usable condition. Check that it was positioned according to facility and manufacturer instructions.
Do not repeat tests using expired, damaged, improperly stored, or incorrectly prepared materials.
Expected outcome: The test method itself is valid.
4. Verify the Correct Cycle Was Selected
Confirm the cycle used is appropriate for the test being performed. Do not modify cycle parameters simply to obtain a passing result.
Expected outcome: The failed test was performed against the correct validated process.
5. Inspect the Chamber and Door Seal
When safe and cool, inspect the door gasket, sealing surface, chamber, and accessible drain area for debris, residue, damage, or obstruction.
Expected outcome: No obvious external sealing or chamber condition explains the failed test.
6. Verify Water and Load Conditions
Confirm required water is available and that the chamber configuration matches the specified test setup. Remove unrelated materials if the test requires an otherwise empty chamber or specific challenge arrangement.
Expected outcome: Test conditions are appropriate and reproducible.
7. Repeat the Test Only After a Correctable External Cause Is Found
If a definite setup problem, obstruction, or external condition is corrected, repeat the required test according to approved procedure.
Do not repeatedly rerun a failing test without identifying why another attempt is justified.
Expected outcome: The repeated test passes after a documented external cause is corrected. If it passes and policy requirements are satisfied, troubleshooting can stop.
8. Compare With Other Process Evidence
Review available cycle records, physical parameter data, and indicator results for consistency. A single abnormal result should be investigated in context, but required test failures cannot simply be dismissed.
Expected outcome: Available process evidence either supports restored operation or confirms a continuing problem.
9. Complete Required Return-to-Service Testing
Before returning the sterilizer to clinical use, complete all required challenge testing and process qualification required by facility policy and manufacturer instructions.
Expected outcome: All required tests pass and the sterilizer is formally cleared for use.
10. Escalate Repeated Test Failure
If an appropriately performed leak or challenge test continues to fail after external setup, sealing, water, and chamber conditions are checked, remove the sterilizer from service.
Expected outcome: Internal vacuum, sealing, heating, sensing, plumbing, or control problems are evaluated at the appropriate service level.
If the Problem Persists
Test setup, consumables, cycle selection, visible door sealing, chamber condition, and basic water conditions have been verified. Persistent failure may involve internal leakage, valves, pumps, pressure or temperature measurement, air removal, heating, or other process-control functions.
Remove the sterilizer from service, label it Out of Service, and arrange qualified evaluation using appropriate Tuttnauer documentation and approved test equipment.
Do not return the sterilizer to use until required post-repair challenge and process tests have passed. Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
A failed required sterilization test is a process-control issue, not just an equipment alarm; affected loads may require review under facility policy.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Sterile Processing reported that the Tuttnauer T-Edge 10 failed a required process challenge test."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the challenge device had been positioned incorrectly for the approved test procedure."
Resolution
What action was taken.
Example:
"The test setup was corrected and repeated according to approved procedure, with acceptable results confirmed before the sterilizer returned to service."
Helpful Details to Include (If Known)
- Exact test performed
- Indicator or challenge device used
- Test material expiration or condition
- Test position
- Cycle selected
- Door and gasket condition
- Chamber and drain condition
- Water availability
- Previous acceptable test result
- Repeat-test result
- Final return-to-service status
Final Thought
Treat failed process testing as meaningful evidence until the cause is identified. Verify the test method before assuming equipment failure, but do not return the sterilizer to service until all required challenge and process checks are acceptable.
That is successful troubleshooting.