ML24117A048
| ML24117A048 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/2024 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| Download: ML24117A048 (8) | |
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 ACMU I 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-co llections/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 fr om 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 chai r, 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
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
- 1. Opening Remarks C. Ein Mr. Einberg will formally open the meeting and Mr. Williams will provide K. Will opening remarks.
- 2. Old Business L. Arms Ms. Armstead will review past ACMUI recommendations and provide NRC responses.
- 3. Open Forum The ACMUI will identify medical topics of interest for further discussion.
5 4. Medical Related Events D. Dim Mr. Dimarco will provide an update on recent medical events.
15 5. Akesis Galaxy RTi Unit Subcommittee Report H. Wolko Dr. Wolkov will discuss the subcommittees comments and recommendations on the NRCs draft licensing guidance for the Akesis Galaxy RTi unit.
45 6. A Review of Prescription Error Reduction Methods R. Gree Mr. Green will review seven published articles on error reduction methodologies and their relative success and value.
0 LUNCH
- 7. Eye90 Microsphere Device Subcommittee Report M. Folke Dr. Folkert will discuss the subcommittees comments and recommendations on the NRCs draft licensing guidance for the Eye90 microsphere device.
- 8. Medical Events Subcommittee Report R. Harve Dr. Harvey will review medical events reported to the NRC from fiscal years 2021-2023.
- 9. Medical Team Updates C Dr. Valentin-Rodriguez will provide an update on the Medical Radiation Safety Rodrig Teams activities.
BREAK
- 10. Liberty Vision Y-90 Episcleral Brachytherapy Source Subcommittee Z. Ouhib 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.
4:00- 4:15 11. ACMUI Reporting Structure L. Armstead, NRC 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.
4:15 - 4:30 12. Open Forum ACMUI The ACMUI will discuss medical topics of interest previously identified.
4:30 - 4:45 13. Administrative Closing L. Armstead, NRC Ms. Armstead will provide a meeting summary and propose dates for the fall 2024 meeting.
4:45 BREAK (public portion ends)
Tuesday, April 9, 2024 Open Session 10:00 - 12:00 14. Commission Meeting with the ACMUI ACMUI The ACMUI will brief the Commission on various topics in a public meeting.
12:00 ADJOURN