ML22019A068
| ML22019A068 | |
| Person / Time | |
|---|---|
| Issue date: | 01/21/2022 |
| From: | Don Lowman NRC/NMSS/DMSST/MSEB |
| To: | |
| D. Lowman, NMSS/MSST/MSEB | |
| References | |
| Download: ML22019A068 (4) | |
Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES December 15, 2021 MEETING
SUMMARY
PURPOSE To discuss (1) the Subcommittee on Alpha Dart s review and comment on the U.S Nuclear Regulatory Commission (NRC) staffs draft Alpha Tau Alpha DaRT' Manual Brachytherapy licensing guidance; (2) the Subcommittee on CivaDerms review and comment on the NRC staffs memorandum, Draft Licensing Guidance for Superficial Manual Brachytherapy CivaDerm Device; and (3) the Subcommittee on Regulatory Guide 8.39s review and comment on the NRC staffs proposed revision 2 of Regulatory Guide 8.39, Release of Patients Administered Radioactive Material.
OUTCOME The Advisory Committee on the Medical Uses of Isotopes (ACMUI) subcommittees provided feedback and recommendations on the three documents developed by the NRC staff: draft Alpha Tau Alpha DaRT' Manual Brachytherapy licensing guidance; NRC staffs memorandum, Draft Licensing Guidance for Superficial Manual Brachytherapy CivaDerm Device; and the proposed revision 2 of Regulatory Guide 8.39, Release of Patients Administered Radioactive Material. The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the ACMUIs comments and recommendations prior to finalizing the three documents.
Full transcripts and handouts from the ACMUI meeting can be found on the NRCs ACMUI Meetings and Related Documents webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2021.html
SUMMARY
AND RECOMMENDATIONS Subcommittee on Alpha Dart Members: Dr. Ronald Ennis (chair), Dr. Hossein Jadvar, Dr. Michael OHara, Ms. Megan Shober, Ms. Becky Allen, Mr. Zoubir Ouhib, Dr. Katherine Tapp (NRC Staff Resource)
The Alpha Dart Subcommittee provided an overview and recommendations on the NRC staffs Alpha Tau Alpha DaRT' Manual Brachytherapy licensing guidance. The Subcommittee discussed licensing of Alpha DaRT' under 10 CFR 35.1000, roles of the authorized medical physicist and nuclear pharmacist, source leakage and integrity, contamination of procedure room, patient release, definition of medical event, and documentation of patient location.
The subcommittee report was unanimously approved by the ACMUI. The final report can be accessed at the ADAMS Accession No. ML22021B298.
Subcommittee on Regulatory Guide 8.39, Revision 2 (CivaDerm)
Members: Megan Shober (Chair), Dr. Vasken Dilsizian, Dr. Hossein Jadvar, Josh Mailman, Melissa Martin, Michael Sheetz (Consultant), Dr. Katherine Tapp (NRC Staff Resource)
The Subcommittee provided an overview and its recommendations on the NRC staffs memorandum, Draft Licensing Guidance for Superficial Manual Brachytherapy CivaDerm Device. The Subcommittee recommended that CivaDerm should be licensed under 10 CFR 35.400 and recommended that the NRC staff develop a shorter guidance document that focuses on the consequences of loose or dislodged sources. Additionally, the Subcommittee believes it is unlikely that public dose limits will be exceeded if the Palladium-103 source is dislodged.
The subcommittee report was unanimously approved by the ACMUI. The final report can be accessed at the ADAMS Accession No. ML22021B299.
Subcommittee on Regulatory Guide 8.39, Revision 2 Members: Megan Shober (Chair), Dr. Vasken Dilsizian, Dr. Hossein Jadvar, Josh Mailman, Melissa Martin, Michael Sheetz (Consultant), Dr. Katherine Tapp (NRC Staff Resource)
The Subcommittee provided an overview and its recommendations on the NRC staffs proposed revision 2 to RG 8.39, Release of Patients Administered Radioactive Materials. In Revision 2, the staff updated the dosimetric equations/methodologies used to calculate public dose from the released patient. Additionally, the staff made changes to the patient instructions and recommends analysis of public exposures from patient body cremation. The Subcommittee made six recommendations and provided specific comments on the NRC staffs draft RG 8.39.
The recommendations were related to the patient instructions, occupancy factors, hold times, and calculation methodologies.
The subcommittee report was unanimously approved by the ACMUI. The final report can be accessed at the ADAMS Accession No. ML22021B300.
The final reports can be viewed, in their entirety, on the NRCs ACMUI Subcommittee Reports webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
MEETING PARTICIPANTS ACMUI Darlene F. Metter, M.D. Chairman Vasken Dilsizian, M.D. Vice Chairman Rebecca Allen Member Ronald D. Ennis, M.D. Member Richard Green Member Hossein Jadvar, M.D. Member Josh Mailman Member Melissa Martin Member Michael D. OHara, Ph.D. Member Megan Shober Member Harvey B. Wolkov, M.D. Member NRC STAFF Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Maryann Ayoade NMSS/MSST/MSEB Angela Coggins OGC/LHE/MFW Daniel Dimarco NMSS/MSST/MSEB Robin Elliott RI/DRSS/MLB Cindy Flannery NMSS/MSST/MSEB Vincent Holahan NMSS/MSST Donna-Beth Howe, Ph.D. NMSS/MSST/MSEB Ian Irvin OGC/GCRPS/RMR Harriet Karagiannis RES/DE/RGPMB Erin Kennedy RIII/DNMS/MLB Penny Lanzisera RI/DRSS/MLAB Sarah Lopas NMSS/MSST/MSEB Don Lowman NMSS/MSST/MSEB Joan Olmstead OGC/LRAA/RASFP Vered Shaffer RES/DSA/RPB Michael Sheetz ACMUI Consultant Katherine Tapp, Ph.D. NMSS/MSST/MSEB Elizabeth Tindle-Engelman RIII/DNMS/MIB John Tomon RES/DSA/RPB Celimar Valentin-Rodriguez, Ph.D. NMSS/MSST Kevin Williams NMSS/MSST MEMBERS OF THE PUBLIC Matthew Williamson Ralph Lieto Peter Crane Dr. Michael Schuster Jeffrey Brunette Steven Frank - MD Anderson Cancer Center, Houston Dr. Lisa Aldape - Seattle Childrens Hospital Dr. Firas Mourtada - Christian Care, Newark, DE Mike Welling - University of Virginia Enclosure 1
TELECONFERENCE MEETING AGENDA Advisory Committee on The Medical Uses Of Isotopes December 15, 2021 2:00 PM - 4:00 PM EST OPEN SESSION
- 1. Opening Statements Mr. Chris Einberg will formally open the meeting. C. Einberg, NRC
- 2. Alpha Dart Licensing Guidance R. Ennis, M.D.,
Dr. Ronald Ennis will present the ACMUI Subcommittee on Alpha ACMUI Dart draft report on the NRC staffs draft licensing guidance.
- 3. CivaDerm M. Shober, ACMUI Ms. Megan Shober will present the ACMUI Subcommittee on Civaderm draft report on the NRC staffs additional considerations memo for CivaDerm.
- 4. Revision to Regulatory Guide 8.39 M. Shober, ACMUI Ms. Megan Shober will present the ACMUI Subcommittee on Regulatory Guide 8.39, Release of Patients Administered Radioactive Material draft report on the NRC staffs draft revision of the regulatory guide.
- 5. Closing and Adjournment D. Metter, M.D.,
Dr. Darlene Metter will close the meeting. ACMUI Enclosure 2