Florida Regulations 64E-5.1602: Administrative Requirements
Current as of: 2024 | Check for updates
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(1) Registration and Notification.
(a) No electronic brachytherapy device may be used on a human without a current certificate of registration from the department.
(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.
(c) A separate registration and radiation protection program are required for facilities for which one or more of the following applies:
1. The facilities are not at the same physical address,
2. The facilities are not under the same radiation safety program, or
3. The facilities are not under the same management.
(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 subFl. Admin. Code R. 64E-5.511(2)(a)1. The application must include the following documents:
1. 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 Fl. Admin. Code R. 64E-5.1603,
2. A copy of the most current record of surveys, calculations and quality assurance checks on each device,
3. A current copy of the quality management program as described in subsection 64E-5.1604(3), F.A.C.,
4. A current copy of the quality assurance program as described in subsection 64E-5.1604(4), F.A.C.; and,
5. A copy of the device manufacturer’s U.S. Food and Drug Administration certification; and,
6. Facility design information, which at a minimum must include:
a. A diagram of the physical facility showing the location of the electronic brachytherapy treatment rooms,
b. Whether the facility is a new structure or a modification to an existing structure; and,
c. The type and thickness of the portable shielding used for compliance and a procedure demonstrating the use of the shielding prior to treatment.
(e) The registrant shall update the registration on file with the department within 30 days of any change to any information reported in Fl. Admin. Code R. 64E-5.1602(1)(d)
(2) Installation, Maintenance or Repair.
(a) Only a manufacturer’s representative registered as a vendor under subsection 64E-5.511(3), F.A.C., shall install an electronic brachytherapy device.
(b) Only a manufacturer’s representative registered as a vendor under subsection 64E-5.511(3), F.A.C., or an authorized medical physicist shall adjust, repair, maintain, or service an electronic brachytherapy device in accordance with the manufacturer’s guidelines.
(c) A registrant shall retain a record of the installation, maintenance, adjustment, service and repair of an electronic brachytherapy device for 5 years.
(3) Fees. The registrant of an electronic brachytherapy device shall comply with the requirements of Fl. Admin. Code R. 64E-5.511(2)(b), and pay the fees for a medical accelerator unit.
Rulemaking Authority 404.051(4), 404.22 FS. Law Implemented 404.051, 404.081(1), 404.22 FS. History-New 3-12-09, Amended 6-3-15, 3-21-16.
(a) No electronic brachytherapy device may be used on a human without a current certificate of registration from the department.
(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.
(c) A separate registration and radiation protection program are required for facilities for which one or more of the following applies:
1. The facilities are not at the same physical address,
2. The facilities are not under the same radiation safety program, or
3. The facilities are not under the same management.
(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 subFl. Admin. Code R. 64E-5.511(2)(a)1. The application must include the following documents:
1. 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 Fl. Admin. Code R. 64E-5.1603,
2. A copy of the most current record of surveys, calculations and quality assurance checks on each device,
3. A current copy of the quality management program as described in subsection 64E-5.1604(3), F.A.C.,
4. A current copy of the quality assurance program as described in subsection 64E-5.1604(4), F.A.C.; and,
5. A copy of the device manufacturer’s U.S. Food and Drug Administration certification; and,
6. Facility design information, which at a minimum must include:
a. A diagram of the physical facility showing the location of the electronic brachytherapy treatment rooms,
b. Whether the facility is a new structure or a modification to an existing structure; and,
c. The type and thickness of the portable shielding used for compliance and a procedure demonstrating the use of the shielding prior to treatment.
(e) The registrant shall update the registration on file with the department within 30 days of any change to any information reported in Fl. Admin. Code R. 64E-5.1602(1)(d)
(2) Installation, Maintenance or Repair.
(a) Only a manufacturer’s representative registered as a vendor under subsection 64E-5.511(3), F.A.C., shall install an electronic brachytherapy device.
(b) Only a manufacturer’s representative registered as a vendor under subsection 64E-5.511(3), F.A.C., or an authorized medical physicist shall adjust, repair, maintain, or service an electronic brachytherapy device in accordance with the manufacturer’s guidelines.
(c) A registrant shall retain a record of the installation, maintenance, adjustment, service and repair of an electronic brachytherapy device for 5 years.
(3) Fees. The registrant of an electronic brachytherapy device shall comply with the requirements of Fl. Admin. Code R. 64E-5.511(2)(b), and pay the fees for a medical accelerator unit.
Rulemaking Authority 404.051(4), 404.22 FS. Law Implemented 404.051, 404.081(1), 404.22 FS. History-New 3-12-09, Amended 6-3-15, 3-21-16.