64E-5.632. Use of Sources for Manual Brachytherapy  


Effective on Thursday, December 26, 2013
  • 1The licensee is allowed to use the brachytherapy sources listed below, provided they are approved by and used as specified in, the Sealed Source and Device Registry for medical uses, or in research in accordance with an active IDE application accepted by the FDA and the requirements of Rule 5064E-5.612, 51F.A.C., are met.

    54(1) Cobalt 60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;

    74(2) Strontium 90 as a sealed source in an applicator for treatment of superficial eye conditions;

    90(3) Palladium 103 as a sealed source in seeds for interstitial treatment of cancer;

    104(4) Iodine 125 as a sealed source in seeds for interstitial treatment of cancer;

    118(5) Cesium 137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;

    138(6) Iridium 192 as seeds encased in nylon ribbon for interstitial treatment of cancer;

    152(7) Gold 198 as a sealed source in seeds for interstitial treatment of cancer;

    166(8) Radon 222 as seeds for interstitial treatment of cancer;

    176(9) Radium 226 as a sealed source in needles or applicator cells for topical, interstitial, and intracavitary treatment of cancer;

    196(10) Cesium 131 as a sealed source in seeds for interstitial treatment of cancer; or

    211(11) For isotopes or uses not listed in subsections 22064E-5.632(1) 221through (10), F.A.C., above, the licensee must amend their radioactive materials license.

    233In order to use isotopes in accordance with Rule 24264E-5.632, 243F.A.C., an 245authorized user must satisfy the training and experience requirements specified in Rule 25764E-5.652 258or 25964E-5.657, 260F.A.C. 261An authorized user of only Strontium 90 as a sealed source in an applicator for treatment of superficial eye conditions listed in subsection 28464E-5.632(2), 285F.A.C., above 287must satisfy the training and experience specified in Rule 29664E-5.652, 29764E-5.653 298or 29964E-5.657, 300F.A.C.

    301Rulemaking Authority 303404.051, 304404.061, 305404.071, 306404.081, 307404.141 FS. 309Law Implemented 311404.022, 312404.051(1), 313(4), (5), (6), (8), (9), (10), (11), 320404.061(2), 321(3), 322404.071(1), 323404.081, 324404.141 FS. 326History–New 8-25-91, Formerly 10D-91.745, Amended 2-11-10, 12-26-13.

     

Rulemaking Events:

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