For Rule 64B5-25.002, F.A.C., the Board proposes the rule amendment to further define sterilization and to incorporate the CDC Guidelines and OSHA Bloodborne Pathogen Standards. For Rule 64B5-25.003, F.A.C., the Board proposes the rule amendment to ...

 

DEPARTMENT OF HEALTH

Board of Dentistry

RULE NOS.:RULE TITLES:

64B5-25.002Definitions

64B5-25.003Required Sterilization and Disinfection Procedures

PURPOSE AND EFFECT: For Rule 64B5-25.002, F.A.C., the Board proposes the rule amendment to further define sterilization and to incorporate the CDC Guidelines and OSHA Bloodborne Pathogen Standards. For Rule 64B5-25.003, F.A.C., the Board proposes the rule amendment to update required sterilization and disinfection procedures.

SUMMARY: For Rule 64B5-25.002, F.A.C., sterilization will be further defined, and CDC Guidelines and OSHA Bloodborne Pathogen Standards will be incorporated in the rule. For Rule 64B5-25.003, F.A.C., required sterilization and disinfection procedures will be updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 456.032, 466.004(4) FS.

LAW IMPLEMENTED: 456.032, 466.028(1)(u), (x), 466.041 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jennifer Wenhold, Executive Director, Board of Dentistry, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B5-25.002 Definitions.

(1) “Sterilization” is defined to mean the process by which all forms of microbial life within an environment are totally destroyed.

(2) through (3) No change.

(4) “CDC Guidelines” are the Center for Disease Control’s Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, adopted and incorporated by reference and available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf and from http://www.flrules.org/Gateway/reference.asp?No=Ref-           .

(5) “OSHA’s Bloodborne Pathogen Standards” are the Occupational Safety and Health Standards, 29 CFR §1910 1030 (2012), adopted and incorporated by reference and available at https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS and from http://www.flrules.org/Gateway/reference.asp?No=Ref-           .

Rulemaking Authority 466.004(4) FS. Law Implemented 466.028(1)(u), (x), 466.041 FS. History–New 2-24-87, Amended 1-7-92, 2-1-93, Formerly 21G-25.002, 61F5-25.002, 59Q-25.002, Amended 5-20-01,                               .

 

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) through (d) No change.

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

(f)(e) 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 recommendation 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 Rule 64B5-25.002(4), F.A.C. the recommendations of the Centers for Disease Control (CDC).

(d) through (e) No change.

(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 a an FDA approved mechanical device, such as an ultrasonic cleaner or an FDA-approved instrument washer following the manufacturer’s instructions for use recommendations. 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) No change.

(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 Rule 64B5-25.002(4), F.A.C. using a procedure recommended by the Centers for Disease Control (CDC).

(6) through (7) No change. 

(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 Rule 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. It is recommended that Protective eyewear protection 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 Rule 64B5-25.002(5), F.A.C., and the CDC Guidelines as defined and incorporated by reference in Rule 64B5-25.002(4), F.A.C. recommendations

(9) through (10) No change.

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,                                 .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Dentistry

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Dentistry

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 23, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 24, 2019