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What This Guide Helps With
Use this guide when an approved leak test, process challenge, or other routine sterilizer performance verification does not pass.
Step-by-Step Troubleshooting
1. Protect Patient Care and Sterilization Quality
Do not use a failed process test as acceptable evidence of sterilizer performance. Follow facility policy for affected loads and transfer processing to another validated sterilizer if required.
Expected outcome: Sterilization quality is protected while the failure is investigated.
2. Confirm the Exact Test Failure
Identify the test performed, whether it was run correctly, the reported result, and whether the failure has occurred more than once.
Preserve any printout or electronic record.
Expected outcome: The failure is documented and separated from an operator setup or documentation issue.
3. Verify Correct Test Setup
Confirm the correct approved test method, cycle, load condition, test material, and placement were used.
Do not change the manufacturer's or facility's test method to obtain a passing result.
Expected outcome: The test setup matches the approved procedure. If an incorrect setup caused the failure, repeat the test correctly and stop troubleshooting if it passes.
4. Inspect Door and Sealing Surfaces
Visually inspect the door gasket and accessible sealing surfaces for debris, damage, or foreign material.
Expected outcome: The chamber has an unobstructed visible sealing surface. If cleaning approved accessible debris restores a passing test, complete required verification and stop troubleshooting.
5. Inspect Chamber Drain and Accessible Openings
Check accessible chamber drains and screens for debris that could affect evacuation, air removal, drainage, or process consistency.
Expected outcome: The chamber and accessible drain areas are clear.
6. Verify Facility Utilities
Confirm steam, water, electrical power, drainage, compressed air, and other required utilities are normal.
Expected outcome: External utilities are stable. If an infrastructure issue is identified and corrected, repeat the approved test.
7. Repeat the Test Once Conditions Are Correct
After obvious external causes are corrected, repeat the exact approved leak or process challenge test.
Avoid repeated testing without corrective action if failures continue.
Expected outcome: The test passes according to the approved procedure. If it does, complete any additional required verification and troubleshooting can stop.
8. Review Recent Changes
Determine whether the failure began after maintenance, utility work, prolonged shutdown, cleaning, loading changes, or another environmental event.
Expected outcome: A relevant external change may identify the direction for correction or escalation.
9. Remove the Unit From Service After Repeated Failure
If an approved test continues to fail after setup, door, chamber, and utility checks, stop troubleshooting and escalate.
Expected outcome: The sterilizer is prevented from clinical use until the cause is professionally evaluated and performance is demonstrated.
If the Problem Persists
Common test-setup and external causes have been ruled out. Remaining categories may include chamber leakage, vacuum-system problems, internal valves, door-seal mechanisms, sensors, control functions, or other service-level process issues.
The sterilizer should be:
- Removed from service.
- Labeled Out of Service.
- Sent for qualified service evaluation.
- Evaluated using applicable Getinge procedures and approved calibrated test equipment.
- Repaired or adjusted only by qualified personnel.
- Required to pass all applicable leak, process, and functional verification before return to service.
Knowing that repeated process-test failure is a valid stop point is proper troubleshooting.
Clinical Use Tip
Do not treat a failed process challenge as a nuisance alarm; it is evidence that sterilizer performance has not been demonstrated.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Sterile Processing reported the Getinge GSS67H failed its routine process challenge test."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found debris on the accessible door sealing surface that prevented consistent chamber sealing."
Resolution
What action was taken.
Example:
"Clinical Engineering cleaned the accessible sealing surface using the approved method, repeated the required test successfully, and documented the passing verification."
Helpful Details to Include (If Known)
- Test performed
- Test result
- Cycle selected
- Test setup and placement
- Door and gasket condition
- Chamber and drain condition
- Utility status
- Recent maintenance or utility changes
- Repeat-test result
- Final device status
Final Thought
A failed performance test deserves a methodical response: verify the test setup, chamber, door, and utilities before assuming an internal fault, then escalate repeated failures and document the passing verification required for return to service.
That is successful troubleshooting.