Florida Board of Dentistry, Rule 59Q-25.003 (9).
The procedures and equipment used for sterilization must have their efficacy tested periodically. 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 30 days, which ever comes first. 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 30 days, whichever comes first. (Use time is determined by multiplying the number of cycles by the individual cycle time.) Disinfectant/sterilants as set forth in subsection (e) of paragraph (1) above, when used instead of heat-sterilization procedures, must be used according to the manufacturer’s recommended dilution and exposure time and must be changed according to the manufacturer’s recommendations.
Proper functioning of sterilization cycles should be verified by the periodic use (at least weekly) of biologic indicators (i.e., spore tests).
Proper Laboratory Procedures
- Use spore tests that are registered with the FDA.
- Follow written standard protocols for handling and analysis of test strips.
- Provide clear instructions on processing, storage, handling and mailing of tests.
- Train personnel to analyze problems that can arise and have an understanding about aseptic technique and standardized procedures.
- Identification system to assure test results to proper client.
- Standardized growth medium identified by lot numbers and tested for growth promotion, sterility, and standard volume.
- Routinely monitor and record incubator temperatures and maintain uniformity in incubation temperature.
- Control BI (strips) with each test BI test provided. These controls are to have the same lot number and are to be handled exactly the same way as the test BI.
- Confirmation of quality on each lot number of BI used.
Maintain Good Records
- Keep a record of results.
- Maintain confidentiality of test results.
- Keep a “device history record.” Must be able to account for every BI purchased and be able to recall all if necessary (e.g., to comply with an FDA recall of BI By the manufacturer, if found to be defective or misbranded.)
Help with Sterilization Failures
- Daily observation of incubating BI.
- Confirm Positive.
- Call office as soon as a positive test is identified.
- Offer assistance to identify and solve the problem (determining if there were possible errors in procedures or sterilizer malfunction.)
- Provide a clear understanding of what the office should do when a failure does occur.
- review all packaging, loading, operating procedures
- make necessary changes if operational errors detected
- remove sterilizer from service
- re-test with BI and chemical indicator and observe cycle
- put sterilizer back in service or repair it
- if repaired, re-test before returning back to service
Additional tests should be run whenever:
- there has been a failed BI spore test
- the unit appears to be malfunctioning (e.g., parameters not attained)
- the unit is serviced
- start up of a loaner unit
- the unit is moved for cleaning