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Manufacturer
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What This Guide Helps With
Addresses failed leak-related or process challenge verification caused by setup, loading, utilities, accessories, test materials, or washer performance problems.
Step-by-Step Troubleshooting
1. Protect Processing Integrity
Do not return the washer to routine processing based on an unsuccessful required verification or challenge result.
Hold affected loads according to facility policy and use another verified processing pathway.
Expected outcome: The washer remains unavailable for routine use until the required verification is successfully completed.
2. Confirm the Exact Test That Failed
Identify the specific facility, manufacturer, or quality-system test being performed and document the result exactly as observed.
Do not substitute a different test or reinterpret a failed result as acceptable.
Expected outcome: The failed verification and its acceptance criteria source are clearly identified.
3. Verify Test Setup
Confirm that the test materials, indicators, challenge device, rack, or accessories were prepared and positioned according to the applicable approved procedure.
Check for obvious setup errors before assuming machine failure.
Expected outcome: The test setup is valid. If an obvious setup error is corrected, repeat only as permitted by the applicable procedure.
4. Check Expiration and Condition of Test Materials
Verify that any consumable test material is within its usable period and has been stored and handled appropriately.
Do not use damaged, contaminated, or questionable challenge materials.
Expected outcome: Test materials are suitable for use.
5. Verify Washer Loading and Rack Configuration
Confirm that the rack, cart, or challenge load is positioned correctly and does not obstruct spray patterns, drainage, or other required process paths.
Expected outcome: The test configuration allows the washer to perform as intended.
6. Verify Utilities and Chemistry
Confirm required water, steam, drainage, power, and chemistry supplies are available and normal.
A marginal infrastructure condition can cause a process test to fail without an obvious mechanical breakdown.
Expected outcome: External utilities and supplies are normal.
7. Inspect Accessible Chamber Components
When safe, inspect accessible spray arms, nozzles, screens, and chamber areas for obvious debris or obstruction.
Do not disassemble internal systems beyond routine approved access.
Expected outcome: Accessible process-delivery components are free of obvious obstruction.
8. Repeat the Verification Using the Approved Procedure
If an identifiable external or setup cause was corrected, repeat the required test exactly according to the applicable facility or manufacturer procedure.
Do not repeatedly test a failing machine without investigating the cause.
Expected outcome: The washer passes the required test. If it does, document the result and stop troubleshooting.
9. Escalate a Repeated Valid Test Failure
If the test is set up correctly, materials are valid, utilities are normal, and the washer still fails, remove it from service.
Expected outcome: A possible internal process-performance issue is referred for qualified evaluation.
If the Problem Persists
Common external and test-setup causes have been ruled out. Remaining possibilities may involve circulation, spray performance, temperature control, chemistry delivery, sensing, valves, controls, or other process-level functions.
The washer should be:
- Removed from service.
- Labeled Out of Service.
- Sent for repair or service evaluation.
- Evaluated using applicable STERIS documentation and approved test equipment.
- Repaired, calibrated, or configured only by qualified personnel.
Before return to service, the washer should pass the applicable required process verification and functional testing.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
A failed quality or process challenge test should be treated as evidence that washer performance has not yet been demonstrated.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Sterile Processing reported the Reliance Vision failed the department's required process challenge verification."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the challenge load had been positioned incorrectly and was obstructing normal spray exposure."
Resolution
What action was taken.
Example:
"Clinical Engineering corrected the load position, repeated the approved verification with staff, and confirmed a passing result before returning the washer to service."
Helpful Details to Include (If Known)
- Exact test performed
- Test result
- Applicable procedure used
- Test material condition
- Expiration information
- Load and rack configuration
- Utility status
- Chemistry status
- Accessible spray-path condition
- Results of repeat testing
- Final device status
Final Thought
A failed process verification is not resolved until the cause is identified and the approved test passes. Check setup and external conditions first, preserve process integrity, and escalate repeatable valid failures.
That is successful troubleshooting.