Dental sterilizer monitoring · United States
How often must a dental office spore test its sterilizer?
At least weekly for every sterilizer, using a biological indicator and a control from the same lot (CDC, 2003 dental infection-control guidelines).
Florida offices test more often: steam and chemical vapor sterilizers every 40 hours of use or every 30 days, whichever comes first (Florida rule 64B5-25.003).
The schedule at a glance
- Every sterilizer: a spore test at least weekly (CDC, 2003 dental infection-control guidelines).
- Every implant load: a spore test rides in that load (CDC, 2003 dental infection-control guidelines).
- Florida, steam and chemical vapor: at the earliest of 2,400 use-minutes since the last test or 30 days (Florida rule 64B5-25.003).
- After a positive test: repeat immediately, on the same cycle (CDC, 2003 dental infection-control guidelines).
The weekly baseline
The CDC guidelines for dental health-care settings ask offices 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).
The control is not run through the sterilizer; it is incubated together with the test indicator (CDC, 2003 dental infection-control guidelines).
CDC's short summary for dental settings says the same: a spore test should be used at least weekly to monitor sterilizers (CDC, 2016 summary of infection prevention practices).
Weekly is the whole of the routine schedule; CDC gives no separate recommendation for sterilizers that are used on a part-time basis (CDC, 2024 sterilization-monitoring page for dental settings).
Monitoring can happen in the office, or through a mail-in service from a private company or a dental school that tests both the indicator and the control (CDC, 2003 dental infection-control guidelines).
Every implant load gets its own spore test
A biological indicator is used for every sterilizer load that contains an implantable device, and the items are quarantined until the results are known, whenever that is possible (CDC, 2003 dental infection-control guidelines).
Ideally, implantable items are not used until they test negative (CDC, 2024 sterilization-monitoring page for dental settings).
What your state requires
Florida writes its own interval (Florida rule 64B5-25.003). Each row below gives its source.
| Jurisdiction | What the rules say |
|---|---|
| All states (CDC baseline) | Monitor each sterilizer at least weekly with a biological indicator and a control from the same lot number (CDC, 2003 dental infection-control guidelines). |
| Florida |
Steam under pressure and chemical vapor: biological monitoring 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: every 120 hours of operation 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). |
| New York | No state rule sets a spore test frequency; the rules require scientifically accepted infection prevention techniques for cleaning and sterilizing instruments (New York rule 29.2(a)(13)). |
| New Jersey | When providing dental services, licensees and registrants must comply with CDC infection-control guidance for dental practices, as amended and supplemented (New Jersey rule 13:30-8.5). |
| Pennsylvania | Failing to follow current infection-control recommendations issued by the CDC is unprofessional conduct for dentists (Pennsylvania rule 33.211(a)(7)). |
| Georgia | Current CDC recommendations are considered by the board to be minimum standards of acceptable and prevailing dental practice (Georgia rule 150-8-.01(a)). |
When a spore test comes back positive
Take the sterilizer out of service and review the sterilization procedures, including work practices and the use of mechanical and chemical indicators, to determine whether operator error could be responsible (CDC, 2003 dental infection-control guidelines).
Repeat the spore test immediately, loading the sterilizer correctly and using the same cycle that produced the failure, and review all records of chemical and mechanical monitoring since the last negative test (CDC, 2003 dental infection-control guidelines).
If the repeat spore test is negative, and the mechanical and chemical indicators are within normal limits, the sterilizer goes back in service (CDC, 2003 dental infection-control guidelines).
If the repeat test is positive, do not use the sterilizer until it has been inspected or repaired, or the exact reason for the positive test has been determined (CDC, 2003 dental infection-control guidelines).
Recall and reprocess, to the extent possible, all items processed since the last negative spore test (CDC, 2003 dental infection-control guidelines).
Implantable items from that period are recalled and quarantined, and are not used until they are shown to be sterile (CDC, 2024 sterilization-monitoring page for dental settings).
Before the sterilizer is used again, it is rechallenged with biological indicator tests in three consecutive cycles after the cause of the failure has been determined and corrected (CDC, 2003 dental infection-control guidelines). CDC's 2003 and 2008 guidelines describe those as empty-chamber cycles, while CDC's 2024 dental page calls for three consecutive fully loaded cycles (CDC, 2008 disinfection and sterilization guideline; CDC, 2024 sterilization-monitoring page for dental settings).
For sterilization methods other than steam, a single positive biological indicator means treating as nonsterile everything processed since the last negative test (CDC, 2008 disinfection and sterilization guideline), and the sterilization process with liquid chemical sterilants cannot be verified with biological indicators (CDC, 2003 dental infection-control guidelines).
Sterilizers are tested with biological and chemical indicators on installation, when a unit is relocated or redesigned, after major repair and after a sterilization failure (CDC, 2008 disinfection and sterilization guideline).
Finding a lapse like this may warrant immediate consultation with the state or local health department, and appropriate notification and testing of potentially affected patients (CDC infection prevention checklist for dental settings).
What to record
For each sterilization cycle, record the type of sterilizer and cycle used, the load identification number, the load contents, the exposure parameters such as time and temperature, the operator's name or initials, and the results of mechanical, chemical and biological monitoring (CDC, 2008 disinfection and sterilization guideline).
The results of biological monitoring are recorded, and sterilization monitoring records, mechanical, chemical and biological, are retained long enough to comply with state and local regulations (CDC, 2003 dental infection-control guidelines).
Packages are labeled to show the sterilizer used, the cycle or load number, the date of sterilization, and the expiration date if there is one (CDC, 2016 summary of infection prevention practices).
This guide is not legal advice; check your state board's current rules.
Records for these tests, without the binder
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