ML18355A696
| ML18355A696 | |
| Person / Time | |
|---|---|
| Issue date: | 01/10/2019 |
| From: | Andrea Kock NRC/NMSS/DMSST |
| To: | Troy Pruett, Shuabi M, James Trapp Division of Nuclear Materials Safety I, Division of Nuclear Materials Safety III, Division of Nuclear Materials Safety IV |
| Holiday, Sophie | |
| References | |
| Download: ML18355A696 (3) | |
Text
J. Trapp, UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 10, 2019 MEMORANDUM TO:
James M. Trapp, Director Division of Nuclear Materials Safety Region I Mohammed A. Shuaibi, Acting Director Division of Nuclear Materials Safety Region III Troy W. Pruett, Director Division of Nuclear Materials Safety Region IV FROM:
Andrea L. Kock, Director Division of Materials Safety, Security, State, and Tribal Programs
/RA Kevin Williams for/
Office of Nuclear Material Safety and Safeguards
SUBJECT:
ISSUANCE OF LEKSELL GAMMA KNIFE PERFEXION' AND LEKSELL GAMMA KNIFE ICON' LICENSING GUIDANCE, REVISION 1 This memorandum is to inform you that on January XX, 2019, the U.S. Nuclear Regulatory Commission (NRC), in conjunction with the Agreement States through a joint working group (WG), issued the enclosed revised licensing guidance entitled, Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon' Licensing Guidance, Revision 1.
The initial Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon' initial licensing guidance, hereafter referred to as Perfexion' and Icon' licensing guidance, was published in May 2016 and can be found in the NRCs Agencywide Documents Access Management System (ADAMS) Accession No. ML16109A208). The U.S. NRC issued this licensing guidance under Title 10 Code of Federal Regulations (CFR) 35.1000 due to the engineering changes, which makes the components and operation significantly different from the gamma stereotactic radiosurgery units currently regulated in 10 CFR Part 35, Subpart H, Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units.
CONTACT:
Sophie J. Holiday, NMSS/MSEB 301-415-7865
J. Trapp, et al.
2 In April 2017, Elekta, Inc. gave a presentation to the Advisory Committee on the Medical Uses of Isotopes (ACMUI) requesting that the ACMUI review possible amendments to the physical presence requirements for authorized users (AUs) for the Icon'. The ACMUI provided its recommendations (ADAMS Accession No. ML18071A413) to the NRC staff in February 2018.
The WG reviewed and evaluated both Elektas proposed amendments and the ACMUIs recommendations. Unlike previous Gamma Knife models, the Perfexion' and the Icon' units have additional safety functions and utilize a completely automated treatment system to deliver dose to the patient. Internal collimation alleviates the need to change collimator helmets and patients are positioned as required by the treatment plan by moving the patient couch. In the Icon unit, use of the cone beam computed tomography and high definition motion management systems for frame procedures ensures the patient is properly positioned prior to treatment and any movement during the treatment causes the sources to move to the blocked position. If movement ceases within 30 seconds, treatment resumes with no operator intervention needed.
However, if movement does not cease within 30 seconds, the treatment is terminated and operator intervention is required to initiate further treatment. As such, the physical presence of the AU throughout all patient treatments as required by 10 CFR 35.615(f)(3) for other types of gamma stereotactic radiosurgery units is unnecessary for the Perfexion' and Icon' units, provided that an authorized medical physicist and a physician, under the supervision of the AU, are present throughout the duration of all treatments.
This revised licensing guidance (published January 2019) supersedes the initial Perfexion' and Icon' licensing guidance. Therefore, it shall be considered Revision 1. The primary update to this revision incorporates the changes to the physical presence requirements for AUs (see Section 5.3 of the licensing guidance).
This licensing guidance may also be found on the NRC Medical Uses Licensee Toolkit at:
http://www.nrc.gov/materials/miau/med-use-toolkit.html.
Enclosure:
As stated
J. Trapp, et al 3
SUBJECT:
ISSUANCE OF LEKSELL GAMMA KNIFE PERFEXION' AND LEKSELL GAMMA KNIFE ICON' LICENSING GUIDANCE, REVISION 1. DATE: January xx, 2019 DISTRIBUTION Kevin Williams, NMSS Donna Janda, RI Jeff Griffis, TTC Joseph Nick, RI Patty Pelke, RIII Christian Einberg, NMSS Christine Lipa, RIII Michael Hay, RIV Lisa Dimmick, NMSS Linda Howell, RIV Henry Lynn, TTC Sophie Holiday, NMSS ML18355A696 *via email OFC NMSS/MSST NMSS/MSST NMSS/MSST NAME S. Holiday*
C. Einberg
/LDimmick for/
A. Kock KWilliams for:
DATE 12/20/2018 12/21/2018 01/ 10/2019 OFFICIAL RECORD COPY