A positive biological indicator means the monitored cycle did not reach the lethality the test expects. The load the indicator accompanied is not released, the sterilizer is not returned to routine use, and the cause is investigated before anything else is sterilized on that unit.
What is the first thing to do?
Quarantine the load. Identify every instrument in the load the indicator monitored and keep those items out of circulation. This is not optional and not a judgement call: until the cause is understood, the instruments cannot be treated as sterile. Recall any items from the same load that have already been used, and notify the clinical lead.
What do you investigate?
Work through the physical causes in order: was the correct cycle selected, was the chamber loaded correctly, was there a vacuum or drainage fault, was the indicator handled and incubated as intended, and was the unit serviced recently. Check the run parameters against the cycle specification, because a unit that never reached temperature or pressure will show it there.
How do you return the sterilizer to service?
Fix or rule out the cause, then retest with a fresh indicator from a current lot before releasing any new load. Do not use the failed indicator for the retest, and do not count a passing air-removal test as a substitute, because it answers a different question. Document the failure, the investigation and the retest result.
| Step | Action | Do not |
|---|---|---|
| 1 | Quarantine the load, notify the lead | Do not release the instruments |
| 2 | Recall used items from the same load | Do not assume partial use is safe |
| 3 | Check cycle, load, vacuum, incubation | Do not retest before checking |
| 4 | Retest with a fresh indicator | Do not reuse the failed unit |
| 5 | Log the event and the outcome | Do not leave it undocumented |
What should the record of a failure contain?
Record the date, sterilizer, cycle, indicator lot, the failed result and what was found during the investigation. A record that names only the word fail gives the next reviewer nothing to work with. Where a failure repeats, the log is what makes the pattern visible.
What equipment keeps the response quick?
A fixed incubation routine makes results available at a predictable time, so a failure is caught early rather than discovered days later. Clinics typically pair the 24-hour rapid readout biological indicator, 50-pack with a 15-well precision dry-block incubator, and keep a BI 5-pack trial (CA $12.99, shipping included) for training staff on the response before they face a real failure.
Ordering for a clinic, lab or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers. Reselling? become a distributor.
Take the printable version with you: the compliance log centre holds a sterilization log generator you can print and post at the sterilizer. Questions about your own cycles? Ask a Sterilization Compliance Specialist.
Where to Buy Sterilization Monitoring Supplies in Canada
CliniEco Medical supplies these from Ontario with published CAD pricing (MDEL #35334) — no quote required, and each pack ships with the lot number printed on it so your monitoring record stays traceable.
| Format | Pack size | Price (CAD) | |
|---|---|---|---|
| 24-hour self-contained BI | 25-pack | $84.99 | Order |
| 24-hour self-contained BI | 100-pack | $299.00 | Order |
Round Out Your Sterilization Setup
A biological indicator is one link in the chain — these are the pieces it works with:
- Sterilization pouches — Class 4 dual-indicator, 200-pack — the packaging the indicator rides inside
- Autoclave indicator tape — 3-roll set — the external chemical indicator on every pack
- Class 5 chemical integrators — 100-pack — the in-pack check that pairs with your biological indicator
- Sterilization roll — 50 m pre-cut sheets for larger instruments
- Constant-heat pouch sealer — 200 °C, 12 mm seal — for consistent pouch closures
Which format does your sterilizer actually need?
Match the readout time to how fast you need the result: a 24-hour self-contained indicator works in any gravity or pre-vacuum cycle with a standard incubator, while a 3-hour fluorescence tube needs the matching reader. Running one cycle type per day, the 25-pack covers a month; busier clinics move to the 100-pack and cut the per-test cost.
How much do spore tests cost in Canada?
Published pricing runs $3.40 per test on the 25-pack down to $2.99 on the 100-pack — no distributor quote, no account needed.
Not sure which format your sterilizer needs? Generate a free sterilization log sheet first — it maps your cycles and tells you the pack size that fits. Questions about your setup? Ask a Compliance Specialist.
Related Reading
- Autoclave spore test FAQ: incubation and failed results
- Biological indicators after sterilizer repair: how many?
- Autoclave error codes and pressure drops: troubleshooting Q&A
Frequently Asked Questions
What does a positive spore test mean for the load?
The load is not released. Quarantine every instrument the indicator monitored and recall any that were already used, until the cause is understood and the unit is retested.
Can I reuse the failed indicator for the retest?
No. Retest with a fresh indicator from a current lot, after checking the cycle, load configuration, air removal and incubation conditions.
Does a passing Bowie-Dick test clear a failed spore test?
No. A Bowie-Dick test checks air removal, not lethality. A passing air-removal result does not substitute for a valid biological indicator result.
What should the log record after a failure?
The date, sterilizer, cycle, indicator lot, the failed result, the investigation findings and the retest outcome, so a repeat failure is traceable.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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