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Florida Administrative Code (Last Updated: November 11, 2024) |
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64. Department of Health |
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64E. Division of Environmental Health |
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64E-5. Control Of Radiation Hazards |
1(1) Registration and Notification.
5(a) No electronic brachytherapy device may be used on a human without a current certificate of registration from the department.
25(b) An electronic brachytherapy device that is not operational and that is under the control of a registered vendor prior to final installation is exempt from the registration and fee requirements of this section.
59(c) A separate registration and radiation protection program are required for facilities for which one or more of the following applies:
801. The facilities are not at the same physical address;
902. The facilities are not under the same radiation safety program; or
1023. The facilities are not under the same management.
111(d) Each person who acquires an electronic brachytherapy device shall apply for registration of the radiation device with the Department within 30 days after acquisition. Application for registration shall be on DH Form 1107, 10/15, “Radiation Machine Facility Registration,” as incorporated in subparagraph 15564E-5.511(2)(a)1., 156F.A.C. The application must include the following documents:
1641. A list identifying the radiation safety officer and all authorized medical physicists, authorized operators, and authorized users except visiting authorized users, together with documentation of their training and education as described in Rule 19864E-5.1603, 199F.A.C.;
2002. A copy of the most current record of surveys, calculations and quality assurance checks on each device;
2183. A current copy of the quality management program as described in subsection 23164E-5.1604(3), 232F.A.C.;
2334. A current copy of the quality assurance program as described in subsection 24664E-5.1604(4), 247F.A.C.; and
2495. A copy of the device manufacturer’s U.S. Food and Drug Administration certification; and
2636. Facility design information, which at a minimum must include:
273a. A diagram of the physical facility showing the location of the electronic brachytherapy treatment rooms;
289b. Whether the facility is a new structure or a modification to an existing structure; and
305c. The type and thickness of the portable shielding used for compliance and a procedure demonstrating the use of the shielding prior to treatment.
329(e) The registrant shall update the registration on file with the department within 30 days of any change to any information reported in paragraph 35364E-5.1602(1)(d), 354F.A.C.
355(2) Installation, Maintenance or Repair.
360(a) Only a manufacturer’s representative registered as a vendor under subsection 37164E-5.511(3), 372F.A.C., shall install an electronic brachytherapy device.
379(b) Only a manufacturer’s representative registered as a vendor under subsection 39064E-5.511(3), 391F.A.C., or an authorized medical physicist shall adjust, repair, maintain, or service an electronic brachytherapy device in accordance with the manufacturer’s guidelines.
413(c) A registrant shall retain a record of the installation, maintenance, adjustment, service and repair of an electronic brachytherapy device for 5 years.
436(3) Fees. The registrant of an electronic brachytherapy device shall comply with the requirements of paragraph 45264E-5.511(2)(b), 453F.A.C., and pay the fees for a medical accelerator unit.
463Rulemaking Authority 465404.051(4), 466404.22 FS. 468Law Implemented 470404.051, 471404.081(1), 472404.22 FS. 474History–New 3-12-09, Amended 6-3-15, 3-21-16.
