Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64E - Division of Environmental Health
Chapter 64E-5 - CONTROL OF RADIATION HAZARDS
Section 64E-5.1602 - Administrative Requirements
Universal Citation: FL Admin Code R 64E-5.1602
Current through Reg. 50, No. 187; September 24, 2024
(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 subparagraph
64E-5.511(2)(a)
1., F.A.C. 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 Rule
64E-5.1603, F.A.C.,
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 paragraph
64E-5.1602(1)(d),
F.A.C.
(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 paragraph 64E-5.511(2)(b), F.A.C., 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.
New 3-12-09, Amended 6-3-15, 3-21-16.
Disclaimer: These regulations may not be the most recent version. Florida may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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