64B5-25.003. Required Sterilization and Disinfection Procedures

(1) At least one of the following procedures must be used in order to provide proper sterilization:

(a) Steam under pressure (e.g., autoclave);

(b) Dry-heat;

(c) Chemical vapor;

(d) Ethylene oxide;

(e) Devices used to achieve sterilization must be approved by the U.S. Food and Drug Administration (FDA) for sterilization.

(f) Disinfectant/sterilant. U.S. Environmental Protection Agency (EPA) approved disinfectant/sterilants or U.S. Food and Drug Administration (FDA) approved sterilant may be used but are only appropriate for sterilization when used in appropriate dilution and for the time periods set forth in the manufacturer’s instructions for use and only on non-heat tolerant instruments which do not penetrate soft tissue.

(2)(a) Surgical and other instruments that normally penetrate soft tissue or bone, including, but not limited to, forceps, scalpels, bone chisels, scalers, and surgical burs, must be sterilized after each use.

(b) Instruments that are not intended to penetrate oral soft tissue or bone, including, but not limited to, high speed dental handpieces, contra-angles, prophy angles, amalgam condensers, plastic instruments, and burs, but that may come into contact with oral tissues must be sterilized after each use according to the manufacturer’s instructions for use.

(c) However, if heat, steam under pressure, or chemical vapor sterilization of an instrument is not technically feasible, due to its size or composition, the instrument must undergo sterilization with a disinfectant/sterilant that destroys viruses and spores. Disinfectants must be registered by the U.S. Environmental Protection Agency (EPA) as a disinfectant/sterilant and must be used in accordance with the manufacturer’s recommendations and in accordance with CDC Guidelines as defined and incorporated by reference in subsection 64B5-25.002(4), F.A.C.

(d) High speed dental handpieces, slow speed dental sleeves and contra-angles and prophy angles must be sterilized after each use using a heat or heat with pressure or heat with chemical method. The method used must be capable of sterilization.

(e) Heat-sensitive instruments may require up to 10 hours of exposure in a liquid chemical agent registered by the U.S. Environmental Protection Agency (EPA) as a disinfectant/sterilant.

(3) Before sterilization, instruments must be cleaned to remove debris. Cleaning must be accomplished by a thorough scrubbing with soap or a detergent and water or by using an FDA approved mechanical device, such as an ultrasonic cleaner or an FDA-approved instrument washer following the manufacturer’s instructions for use. Metal or heat-stable dental instruments must be sterilized after each use by one of the procedures identified in paragraphs (a)-(d), of subsection (1), above.

(4) Oral prosthetic appliances received from a dental laboratory must be washed with soap or a detergent and water, rinsed well, appropriately disinfected and rinsed well again before the prosthetic appliance is placed in the patient’s mouth.

(5) At the completion of dental treatment, all surfaces that may have become contaminated with blood, saliva or other bodily fluids must be disinfected in accordance with CDC Guidelines as defined and incorporated by reference in subsection 64B5-25.002(4), F.A.C.

(6) Disinfectant/sterilants appropriate for use under paragraph (e) of subsection (1), above, are only those disinfectant/sterilants that are registered by the EPA. Those disinfectant/sterilants must be used in accordance with the manufacturer’s recommendations for correct use as a disinfectant/sterilant.

(7) The sterilization and disinfection procedures required by this rule must be followed unless appropriate disposable items are used. Disposable items may only be used on a one time basis and may never be used on more than one dental patient. The use of disposable items is encouraged.

(8) Surgical or examination gloves and surgical masks shall be worn by all dentists, dental hygienists, and dental assistants while performing or assisting in the performance of any intra-oral dental procedure on a patient in which contact with blood and/or saliva is imminent. Surgical or examination gloves must be changed between patients. Hands shall be washed with soap and water and dried immediately after removing and prior to replacing gloves. A healthcare grade alcohol-based hand rub may also be used according to the most current CDC Guidelines as defined and incorporated by reference in subsection 64B5-25.002(4), F.A.C. Gloves are never to be washed and reused. Surgical or examination gloves that are punctured or torn must be removed and replaced immediately with new gloves following rewashing of provider’s hands with soap and water. Protective eyewear must be worn by all dentists, dental hygienists, and dental assistants while performing or assisting in the performance of any dental procedure on a patient in accordance with OSHA’s Bloodborne Pathogen Standard, as defined and incorporated by reference in subsection 64B5-25.002(5), F.A.C., and the CDC Guidelines as defined and incorporated by reference in subsection 64B5-25.002(4), F.A.C.

(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 thirty days, whichever 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 thirty 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 paragraph (e) of subsection (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.

(10) All OSHA category 2 employees must be provided with and must use the barrier techniques required by this rule when they are in situations where they may be exposed to blood, saliva, or other bodily fluids from the patient during the treatment or examination process.

Rulemaking Authority 456.032, 466.004(4) FS. Law Implemented 456.032, 466.028(1)(u), (x), 466.041 FS. History–New 2-24-87, Amended 12-6-87, 10-24-88, 1-7-92, 4-5-93, Formerly 21G-25.003, Amended 11-22-93, Formerly 61F5-25.003, 59Q-25.003, Amended 10-31-01, 3-19-02, 12-11-19.