Dental sterilizer monitoring · United States
Spore tests for dry heat and chemical vapor sterilizers
Every sterilizer, dry heat and chemical vapor included, gets a spore test at least weekly with a biological indicator and a control from the same lot number (CDC, 2003 dental infection-control guidelines).
Florida counts use instead of days: chemical vapor every 40 hours of use, dry heat and ethylene oxide every 120 hours, and all of them at least every 30 days (Florida rule 64B5-25.003).
The weekly test covers every sterilizer
Spore testing is not an autoclave-only job. The CDC guidelines for dental offices say to monitor sterilizers at least weekly by using a biological indicator with a matching control, meaning a biological indicator and a control from the same lot number (CDC, 2003 dental infection-control guidelines). That covers your dry heat cabinet and your chemical vapor unit the same way it covers a steam sterilizer (CDC, 2003 dental infection-control guidelines).
The indicator must fit the machine. The 2008 disinfection and sterilization guideline asks for an FDA-cleared commercial preparation of spores intended specifically for the type and cycle parameters of the sterilizer, and its one named example is for steam (e.g., Geobacillus stearothermophilus for steam) (CDC, 2008 disinfection and sterilization guideline). These rows name no spore species for dry heat or chemical vapor units, so this page does not invent one.
How the test is run, and what each way asks of your staff, is its own topic: In-office or mail-in spore testing.
Florida counts hours of use
Florida's dental rules set their own clock on top of the weekly baseline. The two are not the same measurement: one counts days, the other counts hours of use. This page shows both and does not pick one for you (Florida rule 64B5-25.003; CDC, 2003 dental infection-control guidelines).
At least weekly, every sterilizer
Monitor sterilizers at least weekly with a biological indicator and a control from the same lot number (CDC, 2003 dental infection-control guidelines).
Hours of use, with a 30-day cap
Chemical vapor, like steam under pressure: verified at least every 40 hours (2,400 minutes) of use or at least every 30 days, whichever comes first (Florida rule 64B5-25.003).
Dry heat and ethylene oxide: verified every 120 hours of operation at sterilization parameters or every 30 days, whichever comes first (Florida rule 64B5-25.003).
Use time is the number of cycles multiplied by the individual cycle time (Florida rule 64B5-25.003).
| Sterilizer | Florida rule 64B5-25.003 |
|---|---|
| Chemical vapor | At least every 40 hours (2,400 minutes) of use or at least every 30 days, whichever comes first (Florida rule 64B5-25.003) |
| Dry heat | Every 120 hours of operation at sterilization parameters or every 30 days, whichever comes first (Florida rule 64B5-25.003) |
| Steam under pressure (e.g., autoclave) | At least every 40 hours (2,400 minutes) of use or at least every 30 days, whichever comes first (Florida rule 64B5-25.003) |
| Ethylene oxide | Every 120 hours of operation at sterilization parameters or every 30 days, whichever comes first (Florida rule 64B5-25.003) |
Every row above also sits under CDC's baseline: at least weekly for every sterilizer (CDC, 2003 dental infection-control guidelines).
Florida's rule names the four methods in the table: steam under pressure (e.g., autoclave), dry-heat, chemical vapor and ethylene oxide. Devices used to achieve sterilization must be approved by the U.S. Food and Drug Administration (FDA) for sterilization (Florida rule 64B5-25.003).
Dental Logbook will count use-minutes as the total of the full logged cycles since the last test, and will tell you which clock comes due first.
One positive test in a non-steam unit
For sterilization methods other than steam, the more conservative approach should always be used (CDC, 2003 dental infection-control guidelines).
After a single positive biological indicator in a dry heat, chemical vapor or ethylene oxide unit, treat as nonsterile everything the sterilizer processed, from the cycle that had the last negative spore test up to the next cycle that shows satisfactory spore test results (CDC, 2008 disinfection and sterilization guideline).
One positive is the whole trigger. These rows give no single-retest shortcut for a non-steam unit. What they give instead is a window: from the last negative test to the next cycle with satisfactory results, everything is treated as nonsterile (CDC, 2008 disinfection and sterilization guideline).
The full routine, out of service to return to service, is laid out in What to do when a dental sterilizer fails a spore test.
Liquid chemical sterilants have no spore test
A liquid chemical sterilant is not one of the machines above, and no spore test schedule applies to it: not weekly and not on any use-hour clock. The reason is in the source wording: the sterilization process with liquid chemical sterilants cannot be verified with biological indicators (CDC, 2003 dental infection-control guidelines).
Dental Logbook treats dry heat and chemical vapor as their own sterilizer types, and keeps liquid chemical sterilants out of the spore test schedule entirely.
What to record
A good log answers what the rows above ask for:
- Which sterilizer and which cycle the indicator rode in, because the indicator must be intended for the type and cycle parameters of that sterilizer (CDC, 2008 disinfection and sterilization guideline).
- The biological indicator and the control, from the same lot number (CDC, 2003 dental infection-control guidelines).
- The date of the test and the use time it covers, since use time is the number of cycles multiplied by the individual cycle time (Florida rule 64B5-25.003).
- The result and who entered it. Dental Logbook will store both, next to the load it belongs to.
How long to keep these records, who signs them and what else a record must contain are not set by the rows on this page. How long to keep sterilization records covers the retention side.
What these sources do not say
Where the source pack is silent, this page says so:
- Which spore species a dry heat or chemical vapor unit needs. The only named example in these rows is for steam (e.g., Geobacillus stearothermophilus for steam) (CDC, 2008 disinfection and sterilization guideline).
- Any air-removal test for these two kinds of unit. The rows quoted on this page set none.
- Record contents, signatures and retention periods for spore tests.
- Schedules for states other than Florida. This page quotes Florida's rule; other states write their own.
The sources, word for word
Every rule on this page comes from the lines below, with their source IDs, so you can check the wording yourself.
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“Monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e., biological indicator and control from same lot number)”
C03-1 · CDC, Guidelines for Infection Control in Dental Health-Care Settings — 2003 (MMWR 52/RR-17), recommendation VI.F.6 (strongly recommended), page 43
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“Use biologic indicators to monitor the effectiveness of sterilizers at least weekly with an FDA-cleared commercial preparation of spores (e.g., Geobacillus stearothermophilus for steam) intended specifically for the type and cycle parameters of the sterilizer.”
D08-1 · CDC/HICPAC, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, recommendation 16.d (strongly recommended)
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“Adequacy of steam under pressure (e.g. autoclave) or chemical vapor sterilization must have their efficacy verified by appropriate biological monitoring at least once every 40 hours (2400 minutes) of use or at least once every thirty days, whichever comes first.”
FL-1 · Florida rule 64B5-25.003(9)
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“Dry heat and ethylene oxide sterilizers must have their efficacy verified with appropriate biological monitoring every 120 hours of operation at sterilization parameters or every thirty days, whichever comes first. (Use time is determined by multiplying the number of cycles by the individual cycle time.)”
FL-2 · Florida rule 64B5-25.003(9)
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“After a single positive biologic indicator used with a method other than steam sterilization, treat as nonsterile all items that have been processed in that sterilizer, dating from the sterilization cycle having the last negative biologic indicator to the next cycle showing satisfactory biologic indicator results.”
D08-9 · CDC/HICPAC, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, recommendation 16.e (suggested)
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“This more conservative approach should always be used for sterilization methods other than steam” … “the sterilization process with liquid chemical sterilants cannot be verified with biological indicators”
C03-20 · CDC, Guidelines for Infection Control in Dental Health-Care Settings — 2003, pages 25 and 23
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“Steam under pressure (e.g., autoclave);” “Dry-heat;” “Chemical vapor;” “Ethylene oxide;” “Devices used to achieve sterilization must be approved by the U.S. Food and Drug Administration (FDA) for sterilization.”
FL-4 · Florida rule 64B5-25.003(1)
This page is not legal advice; check your state board's current rules.
Records for these tests, without the binder
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