A failed Bowie-Dick test tells you that air was not removed from the chamber in that cycle. It does not tell you that your instruments are unsterile, but it does mean the load cannot be released and the sterilizer should not be used on patients until the fault is resolved. Canada and the United States both run a daily air-removal check on pre-vacuum sterilizers, yet the retest and recall steps that follow a failure are written into different documents in each country — and that difference is where most clinics get caught.
The practical gap is not the test itself. It is what the office does in the 60 minutes after a dark or uneven indicator card: who is allowed to release the load, how many repeat cycles are required, and which log entries a reviewer will ask to see.
Is a failed Bowie-Dick test a sterility failure?
No. An air-removal failure is an equipment finding, not a sterility finding. The Bowie-Dick test is a Type 2 indicator under ISO 11140-5, and it is designed to detect residual air that prevents steam from contacting the load uniformly. When the card fails, the cycle it ran in cannot be trusted — but earlier cycles that passed are unaffected, and nothing about the instruments themselves has changed.
That distinction matters for how you document the event. Writing "sterilization failure" in the log invites a much larger investigation than the facts support, while writing nothing at all leaves the next reviewer with no evidence that the fault was found and corrected.
How often is a Bowie-Dick test required in Canada vs the US?
Both countries expect the test at the start of each day the sterilizer is used, before the first load. The Canadian expectation comes from CSA Z314 series practice and provincial college IPAC standards, both of which expect a documented daily air-removal check on pre-vacuum units. The US baseline is set by CDC guidance and AAMI ST79, which use the same daily cadence for pre-vacuum and dynamic air-removal sterilizers.
| Item | Canada | United States |
|---|---|---|
| Air-removal check frequency | Each day the sterilizer is used, before the first load | Each day the sterilizer is used, before the first load |
| Governing documents | CSA Z314 series; provincial college IPAC standard; PIDAC guidance | CDC sterilization guidance; AAMI ST79 |
| After a repair or major fault | Repeat air-removal check plus biological monitoring before returning to service | Repeat air-removal check plus biological monitoring per facility policy |
| Who signs the release | Named reprocessing lead or delegate, per written office policy | Facility-defined, often the sterile processing supervisor |
| Record format | Cycle log with date, operator, result and corrective action | Cycle log with the same core fields |
What must a Canadian office do after a failed Bowie-Dick test?
Three steps, in order. First, quarantine anything from the failed cycle and repeat the air-removal test once the cause has been addressed — a loose door gasket, a blocked drain, a wet steam supply or an overloaded chamber are the usual culprits. Second, if the repeat test passes, run the sterilizer empty or with a light load and continue only after a passing biological indicator result. Third, record the failure, the cause, the corrective action and the passing result in the cycle log.
Provincial colleges describe this as part of the office's reprocessing quality assurance program rather than as a fixed number of repeat cycles, so the defensible position is the one written down before the event. A clinic that has never documented what happens when the card fails is a clinic that will improvise at 8:40 a.m. with a full day of patients waiting.
What do US facilities typically do after an air-removal failure?
US practice follows AAMI ST79 more closely than provincial college standards do. The common sequence is to review the cycle parameters, check the chamber and door, repeat the air-removal test, and hold the load until the repeat passes. Recall of previously released loads is tied to whether the failure is traced to a component that would also have affected earlier cycles; if it is, the facility's policy determines how far back to look.
This is the point where Canadian and US documents diverge most: Canadian provincial standards tend to push the recall decision into the office's written policy, while US guidance gives a framework that the facility adapts. Neither approach is stricter in principle — but only one of them gives you a document to show an inspector.
Which record entries prove the retest was done?
Four fields do the work in an audit: the date and time of the failed test, the operator who identified it, the corrective action taken, and the result of the repeat test. A log that shows a failure followed by a passing result on the same day, in the same hand or the same printout, answers the question before it is asked.
Clinics that download cycle data from the sterilizer have an advantage here, but a printed chart alone is not a log. The air-removal result, the operator and the corrective action are still entered by a person, and those are the entries reviewers actually read. Keep the printable record as an attachment to the log, not as a replacement for it. Our guide to daily Bowie-Dick requirements for pre-vacuum autoclaves covers the timing side of this in more detail, and the common causes of air-removal failures is worth reading before you write your corrective-action list. If your office is rebuilding a defect log after a College practice visit, the worked review of a failed Bowie-Dick record set shows what the reconstructed log looked like.
Keeping a bowie-dick test pack in stock on the shelf is what makes the retest possible inside the same hour: ISO 11140-5 Type 2 bowie-dick test packs are a single-use consumable, and the sterilization monitoring collection groups them with indicators and spore tests so a clinic can reorder the whole line at once.
Not sure which monitoring consumable fits your cycles? Start with the BI 5-pack trial (CA $12.99) or request a volume quote through the wholesale and multi-site ordering page. The sterilization compliance hub collects the rest of the office-facing guides.
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.
Related reading
- Air Removal Testing on Pre-Vacuum Autoclaves: Daily Bowie-Dick Requirements
- Why Do Autoclave Cycles Fail the Bowie-Dick Test?
- Case Review: Rebuilding Sterilization Records After a Failed Bowie-Dick Test
Frequently Asked Questions
Does a failed Bowie-Dick test mean the instruments must be recalled?
Only the load from the failed cycle is affected. Check whether the cause would also have affected earlier cycles — a slow door leak or a wet steam line can reach back further than one load, so the recall range depends on the cause, not on the test.
Can the sterilizer be used again the same day after a passing retest?
Yes, provided the cause was corrected, the repeat air-removal test passes, and the monitoring required by your provincial standard also passes. Return the unit to service with a passing biological indicator result recorded, not with a verbal all-clear.
Who should sign the sterilization log in a Canadian clinic?
The person who ran the cycle signs the cycle record, and the named reprocessing lead signs off on the corrective action after a failure. Initials are acceptable where the office has a signature list that maps initials to full names.
What is the difference between a Bowie-Dick test and a biological indicator?
A Bowie-Dick test answers a mechanical question about air removal inside the chamber. A biological indicator answers a biological question about whether the cycle actually killed a known resistant organism. They are complementary, and one cannot substitute for the other.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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