ML24117A274
| ML24117A274 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/2024 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| Download: ML24117A274 (1) | |
Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 8, 2024 MEETING
SUMMARY
PURPOSE To discuss issues related to the implementation of the medical regulations in Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material.
OUTCOME The Advisory Committee on the Medical Uses of Isotopes (ACMUI) made recommendations, and the U.S Nuclear Regulatory Commission (NRC) staff gained a better understanding of the views and opinions of the ACMUI, as well as other stakeholders views and opinions. The NRC staff will consider these views in its continuing effort to make 10 CFR Part 35 more useful, practical, and not overly burdensome on licensees, while maintaining public health and safety.
Full transcripts and handouts from the ACMUI meeting can be found on the NRCs ACMUI Meetings webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/.
The meeting attendees are listed in Enclosure 1.
RECOMMENDATIONS AND ACTIONS The following provides a summary of the discussions that took place on the topics on the ACMUI meeting agenda (Enclosure 2).
The ACMUI endorsed the following subcommittee report. This report and its recommendations can be viewed, in their entirety, on the NRCs ACMUI Subcommittee Reports webpage, located at the following link: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/index.html.
The ACMUI unanimously endorsed the report from the Subcommittee on Medical Events Report, as presented.
The ACMUI unanimously endorsed the report from the Subcommittee on Akesis Galaxy RTi Draft Licensing Guidance, as presented.
The ACMUI unanimously endorsed the report from the Subcommittee on Yttrium-90 Microsphere Brachytherapy Sources and Devices Eye90 Microspheres Licensing Guidance, as presented.
The ACMUI unanimously endorsed the report from the Subcommittee on LV Liberty Vision Corporation Yttrium-90 Disc and Iwand Ophthalmic System Draft Licensing Guidance, as presented.
The following actions resulted from discussion that took place during the meeting.
The ACMUI recommended that the staff provide more information on root causes and corrective actions during their annual review of medical events and presentation to the Committee.
The ACMUI agreed that the current structure of reporting to the Office of Nuclear Material Safety and Safeguards continues to function effectively, and the meeting frequency is well-suited for the workload of the Committee.
Dr. Jadvar formed a subcommittee to review the Committees bylaws regarding disclosures related to conflicts of interest. The subcommittees membership includes Harvey Wolkov as chair, Rebecca Allen, Michael O'Hara, and Richard Green.
Dr. Jadvar formed a subcommittee to update the regulations in 10 CFR 30.35 that deal with financial assurance for Category 1 and Category 2 material. The subcommittees membership includes Richard Green as chair, Richard Harvey, Harvey Wolkov, and Zoubir Ouhib.
Dr. Jadvar formed a subcommittee to reassess including an interventional radiologist in ACMUI membership. The subcommittees membership includes Andrew Einstein as chair, Hossein Jadvar, Michael Folkert, Dr. Angle, and Rebecca Allen.
The ACMUI tentatively scheduled the fall 2024 meeting for October 7 - 8, 2024. After the meeting was adjourned the Committee decided to meet on November 4 - 5, 2024.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
MEETING ATTENDEES April 8, 2024 ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Hossein Jadvar, MD, PhD Chair Richard Green Vice Chair Richard Harvey, DrPh Member Josh Mailman Member Melissa Martin Member Michael D. OHara, PhD Member Zoubir Ouhib Member Megan Shober Member Harvey B. Wolkov, MD Member Andrew Einstein, MD Member Michael R. Folkert, MD, PhD Member Joanna R. Fair, MD, PhD Member John F. Angle, MD Consultant to the Committee NRC STAFF Kevin Williams Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST)
Christian Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Lillian Armstead NMSS/MSST/MSEB and Designated Federal Officer Celimar Valentin-Rodriguez NMSS/MSST/MSEB Aaron Thomlinson NMSS/MSST/MSEB Maryann Ayoade NMSS/MSST/MSEB Kenneth Brenneman NMSS/MSST/MSEB Daniel Dimarco NMSS/MSST/MSEB Cindy Flannery NMSS/MSST/MSEB
Vincent Holahan NMSS/MSST Daniel Shaw NMSS/MSST/MSEB Sarah Spence NMSS/MSST/MSEB Katherine Tapp NMSS/MSST/MSEB Janice Nguyen R-I/DRSS/MLAB Travis Jones OGC/LHE/MFW Brian Allen RES/DSA/RPB Latischa Hanson R-IV/DRSS/MLB Jason VonEhr R-I/DRSS/MLAB PUBLIC PARTICIPANTS Bill Erwin Patrick Turner Ralph Lieto Kaci Studer Clair Drozd Ian Irvin Stanley D. Hampton Todd Senglaub Sandy Gabriel David Pellicciarini David Crowley Sean O. Wilson Matt Hendrickson Sean Chapel Carol Wen Cindy Tomlinson Brenna Kettlewell
Daisy Coffman Mary Burkhart Michael A. Welling Ariel Doucet Kim C. Wiebeck Melonie Paige Olusegun A. Larinde Richard Peros Karen Flanigan Dave Adler Ron Parsons Adam Ekstedt Ashley Cockerham Matthew Greenwood Jonathan J. Otten Mary Ann Spiker Gabriel J. Munoz Billie Harvey Cindi L. Gilbert B. Harvey Brian M. Kelley Tara Medich Andrew Zimnoch Sandra M. Ramirez Michelle D. DeLeon Mike N. Stephens Georgia Lawrence Christopher Lease
Jennifer Gersman Diana Thompson Cami Still Arthur R. Schleipman Manuel Diaz Daniel Januseski Emily C. Rostel Alec Donahue Andrea Armstrong Wendy K. Galbraith David Schlesinger Michael Peters Kaci Studer Stanley D. Hampton David Crowley Sandy Gabriel Sean O. Wilson Michael A. Welling Melonie Paige Dave Adler Brandi Woods Michael Peters Chris Eastlee
MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 8 - 9 2024 One White Flint North Building, 11555 Rockville Pike, Commissioners Hearing Room North Bethesda, Maryland 20852 NOTE: Sessions of the meeting may be closed pursuant to 5 U.S.C. 552(b) to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACMUI; information the release of which would constitute a clearly unwarranted invasion of personal privacy; information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action; and disclosure of information which would risk circumvention of an agency regulation or statute.
Monday, April 8, 2024 OPEN SESSION 8:30 - 8:45
- 1. Opening Remarks Mr. Einberg will formally open the meeting and Mr. Williams will provide opening remarks.
C. Einberg, NRC K. Williams, NRC 8:45 - 9:00
- 2.
Old Business Ms. Armstead will review past ACMUI recommendations and provide NRC responses.
L. Armstead, NRC 9:00 - 9:15
- 3.
Open Forum The ACMUI will identify medical topics of interest for further discussion.
ACMUI 9:15 - 10:45 4.
Medical Related Events Mr. Dimarco will provide an update on recent medical events.
D. Dimarco, NRC 10:45 - 11:15 5.
Akesis Galaxy RTi Unit Subcommittee Report Dr. Wolkov will discuss the subcommittees comments and recommendations on the NRCs draft licensing guidance for the Akesis Galaxy RTi unit.
H. Wolkov, ACMUI 11:15 - 11:45
- 6.
A Review of Prescription Error Reduction Methods Mr. Green will review seven published articles on error reduction methodologies and their relative success and value.
R. Green, ACMUI 11:45 - 1:00 LUNCH 1:00 - 1:45
- 7.
Eye90 Microsphere Device Subcommittee Report Dr. Folkert will discuss the subcommittees comments and recommendations on the NRCs draft licensing guidance for the Eye90 microsphere device.
M. Folkert, ACMUI 1:45 - 2:30
- 8.
Medical Events Subcommittee Report Dr. Harvey will review medical events reported to the NRC from fiscal years 2021-2023.
R. Harvey, ACMUI 2:30 - 3:15
- 9.
Medical Team Updates Dr. Valentin-Rodriguez will provide an update on the Medical Radiation Safety Teams activities.
C.Valentin-Rodriguez, NRC 3:15 - 3:30 BREAK
3:30 - 4:00
- 10. Liberty Vision Y-90 Episcleral Brachytherapy Source Subcommittee Report Mr. Ouhib will discuss the subcommittees comments and recommendations on the NRCs draft licensing guidance for the LV Liberty Vision Y-90 Episcleral Brachytherapy Source.
Z. Ouhib, ACMUI 4:00- 4:15
- 11. ACMUI Reporting Structure Ms. Armstead will provide an overview of the current reporting structure.
Members will discuss the reporting structure of the Committee and provide feedback to the NRC.
L. Armstead, NRC 4:15 - 4:30
- 12. Open Forum The ACMUI will discuss medical topics of interest previously identified.
ACMUI 4:30 - 4:45
- 13. Administrative Closing Ms. Armstead will provide a meeting summary and propose dates for the fall 2024 meeting.
L. Armstead, NRC 4:45 BREAK (public portion ends)
Tuesday, April 9, 2024 Open Session 10:00 - 12:00
- 14. Commission Meeting with the ACMUI The ACMUI will brief the Commission on various topics in a public meeting.
- 15. Group Photo The ACMUI will take a group photo with and without the Commission.
ACMUI 12:00 ADJOURN