A failed biological indicator means one thing above all: do not release the load. Hold the affected load, quarantine the instruments, and work the failure as a process problem rather than an inconvenience. The steps below are the sequence we walk clinics through, and the order matters because releasing a load before the cause is known is the error that turns a monitoring failure into a patient-safety event.
Step 1: What Should You Do First When a BI Fails?
As soon as a biological indicator result reads positive, mark the load as held and remove it from circulation. Do not open pouches to inspect them; that only adds contamination. Record the failed result in the log immediately, with the time, so the record shows the hold decision began when the result was read.
Step 2: How Do You Check the Air Removal Test and the Machine?
Before touching the indicators, look at the machine record. Did the air removal test pass that morning? Was the cycle completed without an interruption or a pressure drop? A failed air removal test, a door gasket leak, or a short cycle explains most failures, and each points to a specific fix.
Also check the basics that are easy to overlook: was the chamber loaded correctly with space between packs, was the steam supply normal, and was the water quality within the manufacturer's range. Those three factors account for a large share of first-time failures.
Step 3: How Do You Retest and Compare Results?
Retest with a new indicator from the same lot and, where possible, a second indicator from a different lot. If a fresh indicator passes on a clean, correctly loaded cycle, the problem is likely procedural and is now corrected. If the retest fails as well, treat the machine as faulty and escalate to service before returning it to routine use.
Log the retest beside the original result, not in a separate book. The whole point of the sequence is that someone reviewing the record can see the failure, the cause check and the retest in one place, and can confirm the unit was not used for routine loads in between.
Step 4: How Do You Investigate Loads Already Released?
Look back at the loads processed since the last passing result. If the failure is machine-related, any load run since the last good test may be suspect, and the clinic's recall policy decides what happens to it. This is why the daily record must be complete: without it, there is no way to bound the affected loads.
Give the reviewer a clear stop point. If the previous day's test passed and only that day's later loads are in question, say so in the log. If the machine has been drifting for days, the record should make that visible, and the correction becomes a servicing and reprocessing exercise, not a single retest.
Step 5: How Do You Close the Loop in Writing?
Record the cause, the corrective action, the retest result and the date the unit returned to service. Then review whether the same cause has appeared before; a repeated gasket or water-quality failure is a maintenance question, not a monitoring question. Closing the loop in writing is what turns one failure into a fixed process.
| Step | Action | Record it as |
|---|---|---|
| 1 | Hold and quarantine the load | Failed result, time of hold |
| 2 | Check air removal and machine basics | Cause-check note |
| 3 | Retest with a fresh indicator | Retest result beside original |
| 4 | Review loads since last pass | Affected-load range |
| 5 | Record cause and return to service | Corrective action, date |
Related reading
Sterilization compliance hub; daily air removal and Bowie-Dick requirements; how one clinic managed a 72-hour outage.
Download the printable sterilization log sheet and use the autoclave log generator. Ask a Sterilization Compliance Specialist at the compliance desk. Ordering for a clinic, lab or care home? Wholesale and multi-site ordering and the B2B wholesale collection cover case pricing and account setup. Clinics can also request a BI sample. Reselling? become a distributor.
Frequently Asked Questions
What is the first thing to do after a failed biological indicator test?
Hold and quarantine the load immediately and record the failed result, then check the air removal test and machine basics before releasing or reprocessing anything.
How do you retest after a failed biological indicator?
Retest with a new indicator from the same lot and, if possible, a different lot, and log the retest beside the original result so one reviewer can see the failure and the retest together.
Do you need to review earlier loads after a failed spore test?
Yes. Review the loads processed since the last passing result, because if the failure is machine-related those loads may be suspect, and the record is what bounds how far back the review goes.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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