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What This Guide Helps With
Use this guide when an air-removal test fails because of test setup, chamber condition, steam quality, drainage, leakage, or vacuum-system performance.
Step-by-Step Troubleshooting
1. Protect Patient Safety and Stop Questionable Processing
A failed air-removal test can indicate inadequate removal of air or steam penetration for applicable sterilization cycles.
Follow facility policy regarding use of the sterilizer after a failed test, and divert loads to another verified unit when required.
Expected outcome: Production does not continue on a sterilizer whose required air-removal performance is unverified.
2. Confirm the Test and Failure
Verify that the reported failure came from the intended Bowie-Dick or approved air-removal test process.
Determine:
- Test type used.
- Test cycle selected.
- Chamber condition.
- Test-pack placement.
- Whether the result was interpreted according to the approved test manufacturer's instructions and facility policy.
- Whether this is a first or repeated failure.
Expected outcome: The failure is confirmed as a true air-removal test failure rather than a setup or interpretation problem.
3. Verify Correct Test Pack and Placement
Confirm the test pack or device was appropriate, within its usable condition, and placed as required by the approved procedure.
Do not substitute improvised materials or change the test configuration to obtain a passing result.
Expected outcome: The test setup is correct. If an incorrect setup caused the failure, repeat the approved test properly and stop troubleshooting if it passes.
4. Confirm the Correct Cycle Was Selected
Verify the sterilizer was operated using the cycle required for the facility's approved air-removal test procedure.
Do not modify exposure parameters or other validated cycle settings to force a pass.
Expected outcome: The correct test cycle is selected using normal controls.
5. Inspect Chamber and Door Condition
Check that the chamber is otherwise empty as required, the door closes properly, and accessible sealing surfaces are free of debris or damage.
Expected outcome: Chamber and door conditions do not provide an obvious source of air leakage. If debris is found and removed, repeat the test under approved conditions.
6. Inspect Drain Area and Residual Moisture
Look for visible drain obstruction, unusual standing water, or abnormal chamber moisture.
Poor drainage can affect conditioning and air removal.
Expected outcome: The drain area is clear and no abnormal water accumulation is present.
7. Review Recent Vacuum Leak Test Status
Check facility records for the most recent applicable vacuum leak test or similar required equipment-performance testing.
If the unit is also failing leak testing, treat that as a significant indication that additional service evaluation is required.
Expected outcome: Required supporting tests are current and satisfactory. A concurrent leak-test failure supports removal from service and escalation.
8. Check Facility Steam Conditions
Determine whether other steam sterilizers or steam-dependent equipment are experiencing unusual performance. Check for recent steam-system maintenance or reported utility problems.
Clinical Engineering should not assume sterilizer vacuum failure when the steam source may be abnormal.
Expected outcome: No facility-wide steam problem is identified. If infrastructure is the cause, coordinate correction before retesting the sterilizer.
9. Repeat the Approved Air-Removal Test
After any identified external condition is corrected, repeat the test exactly according to approved facility and manufacturer procedures.
Document the result rather than relying on memory or verbal confirmation.
Expected outcome: The test passes using the approved acceptance criteria. If successful and all related required tests are satisfactory, troubleshooting can stop.
10. Escalate Persistent Air-Removal Failure
If test setup, cycle selection, chamber condition, door seal, drainage, supporting leak testing, and steam supply have been evaluated and the test continues to fail, stop external troubleshooting.
Potential service-level causes include vacuum-system performance, internal leakage, steam admission, drainage, trapping, noncondensable gases, utility quality, sensing, or control issues.
Expected outcome: The sterilizer remains out of production pending qualified service evaluation.
If the Problem Persists
Common external and test-method causes have been ruled out. Remove the sterilizer from service, label it Out of Service, and arrange qualified repair or service evaluation.
Use current STERIS documentation and approved test equipment. Evaluation of the vacuum system, steam path, valves, traps, internal piping, and sensing should be performed only by qualified personnel.
After corrective work, complete all required vacuum, air-removal, operational, and sterilization-performance testing before return to service. Proper escalation after repeated test failure is part of successful troubleshooting.
Clinical Use Tip
A failed Bowie-Dick or approved air-removal test should be treated as a sterilization-process concern, not merely a test-pack problem, until proven otherwise.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Sterile Processing reported that the AMSCO 600 Series failed the daily Bowie-Dick air-removal test."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the test pack had been placed on a loading rack in a position inconsistent with the facility's approved test procedure."
Resolution
What action was taken.
Example:
"Corrected the test setup, repeated the approved air-removal test successfully, verified no sterilizer abnormalities, and returned the unit to service."
Helpful Details to Include (If Known)
- Test product used.
- Test placement.
- Cycle selected.
- Exact result observed.
- Number of failed attempts.
- Vacuum leak test status.
- Chamber and drain condition.
- Facility steam status.
- Corrective action.
- Final approved test result.
- Final device status.
Final Thought
Confirm the test method before condemning the sterilizer, then evaluate chamber sealing, drainage, steam, and supporting tests logically. Persistent air-removal failure requires qualified escalation and documented verification.
That is successful troubleshooting.