Florida dental sterilization rules: what to test, record and keep

How CDC guidance fills the gaps in Florida's rules

Florida's rules do reach CDC material, but only for part of the rulebook.

• Florida's rules adopt and incorporate by reference the CDC 2008 disinfection and sterilization guideline (Florida rule 64B5-25.002(4)).
• The sterilization rule uses that guideline in its subsections on liquid sterilants, surfaces, and hand rub and eyewear, not in the subsection that sets the spore-test intervals (Florida rule 64B5-25.002(4)).
• Where a topic below is not addressed by Florida's rules, this page gives what CDC guidance says, and names the CDC document in the same sentence.

How often to spore test

This is the one topic where Florida's rules give their own numbers, and the numbers depend on the sterilizer.

• Steam under pressure (e.g. autoclave) or chemical vapor sterilization must have its efficacy verified by appropriate biological monitoring at least once every 40 hours (2,400 minutes) of use or at least once every thirty days, whichever comes first (Florida rule 64B5-25.003(9)).
• 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 (Florida rule 64B5-25.003(9)).
• Use time is determined by multiplying the number of cycles by the individual cycle time (Florida rule 64B5-25.003(9)).

What to do about implant loads

Florida's rules do not mention implantable devices or the loads that carry them (Florida rules 64B5-25.001 to 64B5-25.003).

• CDC's dental guidance says to use a biological indicator for every sterilizer load that contains an implantable device, and to verify results before using the implantable device, whenever possible (CDC, 2003 dental infection-control guidelines).
• The same guidance says the items are quarantined until BI results are known, and notes that in an emergency, placing implantable items in quarantine until spore tests are known to be negative might be impossible (CDC, 2003 dental infection-control guidelines).
• CDC's current dental page says implantable items should ideally not be used until they test negative (CDC, Best Practices for Sterilization Monitoring in Dental Settings).

What to check on every cycle

Florida's rules set no per-cycle checks (Florida rules 64B5-25.001 to 64B5-25.003).

• CDC's dental guidance says to monitor each load with mechanical (e.g., time, temperature, and pressure) and chemical indicators (CDC, 2003 dental infection-control guidelines).
• Place a chemical indicator on the inside of each package; if the internal indicator is not visible from the outside, also place an exterior chemical indicator on the package (CDC, 2003 dental infection-control guidelines).
• Do not use instrument packs if mechanical or chemical indicators indicate inadequate processing (CDC, 2003 dental infection-control guidelines).
• Use mechanical and chemical indicators for each unwrapped sterilization cycle, and do not sterilize implantable devices unwrapped (CDC, 2003 dental infection-control guidelines).

Air-removal tests on pre-vacuum sterilizers

Florida's rules set no air-removal test (Florida rules 64B5-25.001 to 64B5-25.003). The air-removal test is for pre-vacuum (dynamic-air-removal) steam sterilizers (CDC/HICPAC, 2008 disinfection and sterilization guideline).

• If a sterilizer fails the air removal test, it should not be used until inspected by sterilizer maintenance personnel and it passes the test (CDC, 2003 dental infection-control guidelines).

What to do after a failed spore test

Florida's rules give no failure procedure (Florida rules 64B5-25.001 to 64B5-25.003), but they do say what failing the rules means: failure to follow proper sterilization and disinfection procedures as set forth in rule 64B5-25.003 constitutes failure to provide reasonable sanitary facilities and conditions in violation of section 466.028(1)(u), F.S., and constitutes negligence in the practice of dentistry (Florida rule 64B5-25.001).

The steps below come from CDC guidance.

1. Remove the sterilizer from service and review sterilization procedures (e.g., work practices and use of mechanical and chemical indicators) to determine whether operator error could be responsible (CDC, 2003 dental infection-control guidelines).
2. Repeat the spore test immediately after correctly loading the sterilizer and using the same cycle that produced the failure, and review all records of chemical and mechanical monitoring since the last negative BI test (CDC, 2003 dental infection-control guidelines).
3. If the repeat spore test is negative, and mechanical and chemical indicators are within normal limits, put the sterilizer back in service (CDC, 2003 dental infection-control guidelines).
4. If the repeat spore 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).
5. Recall, to the extent possible, and reprocess all items processed since the last negative spore test (CDC, 2003 dental infection-control guidelines).
6. For sterilization methods other than steam, the conservative approach should always be used: treat as nonsterile all items that have been processed in that sterilizer, dating from the cycle with the last negative biological indicator to the next cycle showing satisfactory results (CDC, 2003 dental infection-control guidelines; CDC/HICPAC, 2008 disinfection and sterilization guideline).

• Identifying such a lapse 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 a log entry holds

Florida's rules say nothing about what a sterilizer record contains (Florida rules 64B5-25.001 to 64B5-25.003).

• CDC's 2008 guideline says that for each sterilization cycle, record the type of sterilizer and cycle used; the load identification number; the load contents; the exposure parameters (e.g., time and temperature); the operator's name or initials; and the results of mechanical, chemical, and biological monitoring (CDC/HICPAC, 2008 disinfection and sterilization guideline).
• Packages should be labeled to show the sterilizer used, the cycle or load number, the date of sterilization, and, if applicable, the expiration date (CDC, Summary of Infection Prevention Practices in Dental Settings).

How long to keep records

Florida's rules set no retention period for sterilizer records (Florida rules 64B5-25.001 to 64B5-25.003).

• CDC's dental guidance says sterilization monitoring records, mechanical, chemical and biological, should be retained long enough to comply with state and local regulations (CDC, 2003 dental infection-control guidelines).
• The 2008 guideline says to retain them for a time period that complies with standards (e.g., 3 years), statutes of limitations, and state and federal regulations (CDC/HICPAC, 2008 disinfection and sterilization guideline).
• The three-year figure is the example CDC gives, not a Florida requirement (CDC/HICPAC, 2008 disinfection and sterilization guideline; Florida rules 64B5-25.001 to 64B5-25.003).

Who can inspect a Florida dental office

• Duly authorized agents and employees of the department have the power to inspect, at all reasonable hours, any establishment at which the services of a licensee authorized to prescribe controlled substances specified in chapter 893 are offered (Florida Statutes 456.069).
• Failure to follow proper sterilization and disinfection procedures as set forth in rule 64B5-25.003, F.A.C., constitutes failure to provide reasonable sanitary facilities and conditions in violation of section 466.028(1)(u), F.S., and constitutes negligence in the practice of dentistry (Florida rule 64B5-25.001).
• The sterilization rule says it shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date (Florida rule 64B5-25.003(11)).

Florida's rules at a glance

One row per topic. Where a row says the rules are silent, they do not address that topic.

Scroll the table sideways to see all three columns.