64B1-8.002: Monitoring Sterilization and Infection Control
PURPOSE AND EFFECT: The Board proposes to review the rule to delete unnecessary language and to add new language to clarify procedures for sterilization of acupuncture needles and other equipment.
SUMMARY: The rule amendment will delete unnecessary language and to add new language for clarification of the procedures for sterilization.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board has determined that the proposed rule amendments will not have an adverse impact on small business, nor will the proposed rule amendments be likely to directly or indirectly increase regulatory costs in excess of $200,000 in the aggregate in this state within 1 year after the implementation of the rule.
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: 457.104, 457.1085 FS.
LAW IMPLEMENTED: 457.1085 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Anthony Jusevitch, Executive Director, Board of Acupuncture/MQA, 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256
THE FULL TEXT OF THE PROPOSED RULE IS:
64B1-8.002 Monitoring Sterilization and Infection Control.
(1) Sterilization of acupuncture needles and other equipment other than acupuncture needles, when the equipment has penetrated tissue or has been exposed to blood, shall be accomplished by proper autoclaving according to the instructions of the manufacturer of the autoclave.
(2)(a) A sterilization indicator shall be used with each autoclaving to monitor the sterilization procedure.
(b) Strips must indicate both exposure to steam and 250º F.
(3) Non-presterilized acupuncture needles shall be sterilized prior to use:
(3)(4) All sterilized items must be stored and handled in a manner which maintains sterility.
(4)(5) Each acupuncture office utilizing autoclave sterilization techniques shall post the sterilization procedures and shall maintain documentation of all autoclave service.
(5)(6) It shall be the responsibility of the Acupuncturist to insure that personnel responsible for performing sterilization procedures pursuant to this rule shall be adequately trained.
(6)(7) The procedures and equipment used for sterilization must have their efficacy tested periodically. Adequacy of steam under pressure (e.g., autoclave) must have its 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.
Rulemaking Specific Authority 457.104, 457.1085 FS. Law Implemented 457.1085 FS. History–New 5-6-87, Amended 12-23-87, 6-7-89, 11-13-89, Formerly 21AA-8.002, 61F1-8.002, Amended 2-22-96, Formerly 59M-8.002, Amended 2-26-01,_________.