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Reformatting Licenses. Adoption of 10 CFR 35. January 2011. RHB will amend all licenses to reflect Part 35 format beginning in January Licenses will have similar appearance to existing format Changes to groups and authorized use Some easier than others. Review of Part 35 Groups.

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Reformatting Licenses

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Reformatting Licenses

Adoption of 10 CFR 35


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January 2011

  • RHB will amend all licenses to reflect Part 35 format beginning in January

  • Licenses will have similar appearance to existing format

  • Changes to groups and authorized use

  • Some easier than others


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Review of Part 35 Groups

  • Group 1  35.100: uptake, dilution and excretion studies, no WD required

  • Groups 2 and 3  35.200: imaging and localization studies, no WD required

  • Groups 4 and 5  35.300: use of unsealed radioactive material, WD is required


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Review of Part 35 Groups

  • Group 6  35.400: use of sources for manual brachytherapy

  • Group 7  35.500: use of sealed sources for diagnosis

  • Groups 6 and 8  35.600: use of sealed source in remote HDR afterloader, Teletherapy or GSR

  • 35.1000: Other medical uses not specially addressed in 10 CFR 35 subparts D - H


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35.1000

  • “Other medical uses of byproduct material or radiation from byproduct material”

  • Also called “Emerging Technologies”

  • Procedure may not necessarily be new

    • Yttrium-90 TheraSpheres and/or SIRSpheres

    • Best Vascular, Inc. Beta-Cath IntravascularBrachytherapy System

    • NeoVista, Inc. Epi-Rad Ophthalmic

    • I-125 GliaSite Radiation Therapy System


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35.1000 (cont.)

  • Leksell Gamma Knife Perfexion

  • I-125 and Pd-103 LDR seeds used for localization of non-palpable lesions

  • Nucletron seed Selectron System, Isotron Brachytherapy Sources and Nucletron FIRST System


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Generators

  • Old Group 3: Reagent kits and generators for preparation of radiopharmaceuticals listed for Group 2

  • Group 2 and 3 combined in 35.200

  • 35.200: imaging and localization studies

  • Authorization found in 35.290, Training for imaging and localization studies:

    • Board certification (ABR, ABNM) or

    • Training and experience including eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and


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License Example

OLD FORMAT

NEW FORMAT

9. Authorized Use

Group 1Diagnostic studies involving measurement of uptake, dilution, or excretion, but not involving imaging.

Group 2Diagnostic studies involving imaging

  • Authorized Use

  • A.Any uptake, dilution and excretion study permitted by 10 CFR 35.100.

  • B. Any imaging and localization study permitted by 10 CFR 35.200.


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License Example

(Was Group 6)

Authorized Use

To be used for nuclear medicine procedures as specified below:

A. One source for medical use described in 10 CFR 35.600, in a Varian Medical Systems, Model GammaMed Plus HDR remote afterloading unit. The source activity may not exceed 12 curies at the time of medical use. One source in a shipping container as necessary for replacement of the above source in the remote afterloader unit.


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Administration of I-131

  • Physician authorization for 10 CFR 35.300 will be specified to make the transition from Groups 4 and 5.

  • If previously authorized for Group 4, then “10 CFR 35.300, quantities less than or equal to 33 mCi I-131 only.”

  • If previously authorized for Group 5, then “10 CFR 35.300, I-131 only.”

  • 35.300, Oral administration of I-131 in quantities less than or equal to 33 mCi for imaging and localization studies.


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Brachytherapy

  • Not a clear transition for Group 6

  • Manual Brachytherapy: 10 CFR 35.400

  • HDR Brachytherapy: 10 CFR 35.600

  • TheraSpheres, SIR Spheres, other newer modalities: 10 CFR 35.1000


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Physician Authorizations

  • 35.300

  • 35.400

  • 35.600

  • 35.1000

Will specify quantity of of I-131, allow all of 35.300, or list exclusions

All of 35.400, likely no exclusions

Will specify HDR, GSR or Teletherapy

Will specify other uses


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Grandfathering Provisions for Physician Authorized Use

  • Read the Information Notices!!

  • Harder to do after January 1 due to use of new forms and required preceptor signatures


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Other changes

  • No Alternate RSO for Medical Licenses

    • RSO can name qualified individual in writing

    • RSO still responsible for radiation safety program

    • ARSO does not exist in Part 35

  • No Custodian of Sealed Sources (due to repeal of Title 10 CCR 30321.) This responsibility belongs to the RSO.


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Summary

  • Reformatted licenses will include Part 35 structure

  • “Groups” going away

  • Authorizations for use not necessarily given for the entire category

  • Read your information notices and request any changes before January 1.


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