ML22122A061

ACMUI Spring April 5, 2022 Meeting Summary

ML22122A061
Person / Time
Issue date:	04/05/2022
From:	Advisory Committee on the Medical Uses of Isotopes
To:
Don Lowman, NMSS/MSST
References
Download: ML22122A061 (7)

Text

MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 5, 2022 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 Mr. Don Lowman discussed the ACMUI Open Recommendations and Actions Report in which staff proposed closure of 11 open items. The ACMUI endorsed the report and closure of the 11 items.

Other topics discussed and/or presented during the meeting included:

Mr. Daniel DiMarco provided a detailed analysis of the fiscal year 2021 medical events.

Mr. Kevin Williams gave a special presentation to Dr. Vasken Dilsizian, who will retire as a full member of the ACMUI, thanking him for his service to the ACMUI. Dr. Dilsizian will receive a United States flag that was flown over the U.S Capitol, a certificate of appreciation from Chairman Hanson, and a lapel pin from the NRC.

Representatives of two manufacturers of Y-90 microspheres discussed their products and procedures for their use.

Dr. John F. Angle delivered a presentation on reducing misadministrations and other medical events during Y-90 radioembolization procedures.

Two presentations were given on the restart of the NIST Radioisotope Measurement Assurance Program.

The following actions resulted from discussion that took place during the meeting:

Isotopes used in medical applications are found in 10 CFR 30.71, Schedule B. The Medical Team will engage with an existing NRC working group that is tasked with drafting a rulemaking plan for the NRCs revision of Schedule B. The NRC working group is developing the rulemaking plan to request Commission approval to initiate a rulemaking to revise 10 CFR 30.71, Schedule B, to include additional radionuclides that are currently not listed in the table. This table is used along with 10 CFR 30.18, Exempt Quantities, in determining the need for a specific license. The staff also plans to revise certain sections in 10 CFR Part 30, Rules of General applicability to Domestic Licensing of Byproduct Material, related to exemptions to clarify when a license is required. Anticipated completion date is May 2023.

Due to the increased number of medical events in 2021, a suggestion was made that generic process checklists should be developed as a tool for authorized users. The ACMUI discussed whether the Committee or the professional licensing boards should take the lead on developing, communicating, and standardizing these checklists.

The ACMUI tentatively scheduled its Fall 2022 meeting for September 19-20, 2022. The alternate meeting date is December 5-6, 2022. An in-person meeting is expected for these dates.

Enclosures:

1. Meeting Attendees

2. Meeting Agenda

MEETING ATTENDEES April 5, 2022 ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Darlene F. Metter, M.D.

Chairman Vasken Dilsizian, M.D.

Vice Chairman Rebecca Allen Member John F. Angle Consultant to ACMUI Ronald D. Ennis, M.D.

Member Richard L. Green Member Hossein Jadvar, M.D.

Member Josh Mailman Member Melissa Martin Member Michael D. OHara, Ph.D.

Member Zoubir Ouhib Member Michael Sheetz Consultant to ACMUI Megan Shober Member Harvey B. Wolkov, M.D.

Member NRC STAFF John Lubinski Director, Office of Nuclear Material Safety and Safeguards Kevin Williams Director, Division of Materials Safety, Security, State and Tribal Programs Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Maryann Ayoade NMSS/MSST/MSEB Hiba Ahmed R-I/DRSS/MLAB Kristen Bonds R-I/DRSS/CIRDA Andrew Carrera NMSS/MSST/MSEB Angela Coggins OGC/LHE/MFW Said Daibes Figueroa NMSS/MSST/MSEB Anne DeFrancisco R-I/DRSS/MLAB Lisa Dimmick COMM/OCM Daniel Dimarco NMSS/MSST/MSEB Robin Elliott R-I/DRSS/MLAB Christina England OGC/LHE/MFW Cindy Flannery NMSS/MSST/MSEB Monica Ford R-I/DRSS Cassandra Frazier R-III/DNMS/MLB Robert Gallaghar R-I/DRSS/MLAB Farrah Gaskins R-I/DRSS Vincent Holahan NMSS/MSST Ian Irvin OGC/LHE/MFW Richard Jervey NMSS/DFM/FFLB Keith Lassman R-III/DNMS/MLB

2 Sarah Lopas NMSS/MSST/MSEB Don Lowman NMSS/MSST/MSEB Ed Miller NRR/DORL/LPL2-1 Kathy Modes NMSS/MSST/SLPB Janice Nguyen R-I/DRSS/MLAB Netra Patel R-I/DRSS/MLAB Gretchen Rivera-Capella NMSS/MSST/MSEB Kevin Roach OGC/LHE/MFW Shawn Seeley R-I/DRSS/MLAB Valerie Stowell OCHCO/ADHRTD/NRANB Katherine Tapp NMSS/MSST/MSEB Celimar Valentin-Rodriguez NMSS/MSST/MSEB PUBLIC PARTICIPANTS James M. Adams Scott Bruce Dubick Donna-Beth Howe Dave Adler Kelsey Everett Thomas E. Huston Joaquin Altamirano Lynne Fairobent Jeremy Iman Jose Antony Ching Mei Feng Alan Jackson Xander Arena Roger Fenner Janelle E. Jesikiewicz Jinsy Babu Scott M. Finch Paula Jeter Jaime Barnes Sandy Gabriel Brian M. Kelley Matt Barrett Wendy K. Galbraith Jessica Kendrick Deborah M. Barrickman Charlotte Gallagher Josh Knowland Kendall Berry William Gibbons Paul J. Kovach Erin R. Bertelsen Robert Golduber Kevin Kunder David Bierman Marjorie Gonzalez Georgia Lawrence Bette Blankenship John Gough Olusegun Akano Larinde Mary Burkhart Carl Granlund Christopher Lease Paul Burns Colt L. Greer Bryan P. Lemieux Olwen F. Burton Uli Graf Collin Ma David L. Bushnell Stephen A. Graves Vente Maarten Katherine R. Boyd Matthew Greenwood Archie Manoharan Peter F. Caracappa Serena Groff A. Marks Carrie R. Carson Sebastien Gros Jeffrey S. Mason Jeffrey T. Cessna Yu Guangfeng Richard Martin Sean Chapel Michael Guastella (Presenter)

Trenton L. Mays Jessica B. Clements Steven Griffith Franklin G. McCammon Ashley Cockerham (Presenter)

Joseph Grudzinski Tara Medich Tom Conley Kathi Haldeman Michael J. Merrick James Cook Matthew Hall John P. Metyko Whitney Cox Amin M. Hamideh Andy Miller Bruce Curran Glenn Hathaway Vivek Mishra Anthony R. Davila Pete J. Hernandez Jorge D. Munoz Michelle A. Delgado Bill Hinchcliffe Ashli L. Nieves Miguel de la Guardia George Hinkle Peter Oehlberg Dan J. Devries Kathleen Hintenlang Nick Dorrell Ariel Doucet Michaela Hollis Alyssa Oskin Bill Dowling Timothy Houston Lara Renz Paciello

3 Willie Regits Mary Ann Spilker Kendall A. Williams Ron Parsons Michael Lee Stanfield Matthew H. Williams Sally M. Pasell Mike N. Stephens Matthew Williamson Michael Peters Kim Steves Sean O. Wilson John Pfabe Diana Thompson (Presenter)

Charles Wilson Josie Piccone Wendy W. Terrenoire Melonie Wissing Sandra M. Ramirez Matthew Torrico Brandi Woods Kimyli Recca Brian Vamvakias Michael J. Wutkowski Manar K. Sakalla David Vassy Christin E. Young Mark Seddon Jason Vognetz Miyuki Yoshida-Hay Mr. Shaw Lora Weidner Brian E. Zimmerman (Presenter)

Dominic Siewko Wang Wei-Hsung Hernandez Eugenio Silvestrini Michael Welling Chad Smith Carol Wen Danielle Hjelm Akin Ogretici Jill Southerland Kim C. Wiebeck Justin Spence William White

MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 5, 2022 Virtual Meeting 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.

TUESDAY, APRIL 5, 2022 OPEN SESSION 10:00 a.m. to 12:15 p.m.

EST

1. Opening Remarks Mr. Einberg will formally open the meeting and Mr. Williams will provide opening remarks.

C. Einberg, NRC K. Williams, NRC

2. Old Business Mr. Lowman will review past ACMUI recommendations and provide NRC responses.

D. Lowman, NRC

3. Open Forum The ACMUI will identify medical topics of interest for further discussion.

ACMUI

4. Medical Related Events Mr. Dimarco will provide an overview of the NRC staffs assessment of FY21 medical events.

D. Dimarco, NRC 12:15 p.m.to 12:45 p.m

.EST LUNCH 12:45 p.m. to 3:15 p.m. EST

5. ACMUI Reporting Structure Mr. Lowman will provide an overview of the current reporting structure. Members will discuss the reporting structure of the Committee and provide feedback to the NRC.

D. Lowman, NRC

6. Special Presentation to Dr. Vasken Dilsizian J. Lubinski, NRC

7. TheraSphere' Y-90 Glass Microspheres A representative from Boston Scientific will provide an overview of the TheraSphere' Y-90 glass microspheres.

Ashley Cockerham, Boston Scientific

8. SIR-Spheres Y-90 Resin Microspheres A representative from Sirtex Medical will provide an overview of the SIR-Spheres Y-90 resin microspheres.

Diana Thompson, Sirtex Medical

2

9. Minimizing Risk of Medical Events Dr. Angle will provide an overview institutional processes and team approaches to reducing errors.

J. Angle, NRC

10. CORAR Comments on the NIST Radioisotope Measurement Assurance Program Mr. Guastella will discuss CORARs request that NIST facilitate the restart of NRMAP and provide sufficient resources to NRMAP and Radioactivity Measurement Group.

M. Guastella, CORAR

11. Update on NIST Radioisotope Measurement Assurance Program Dr. Zimmerman will provide an update on the NRMAP program and an overview of NISTs plan to reorganize the program.

B. Zimmerman, PhD, NIST 3:15pm to 3:30pm EST BREAK 3:30pm to 5:00pm EST

12. Non-Medical Events Mr. Sheetz will provide an analysis of FY20-FY21 non-medical events reported by medical use facility and commercial pharmacies.

M. Sheetz, NRC

13. Medical Team Updates Dr. Valentin-Rodriguez will provide an update on Medical Radiation Safety Team activities.

C. Valentin-Rodriguez, PhD, NRC

14. Open Forum The ACMUI will continue discussion on medical topics of interest.

ACMUI

15. Administrative Closing Mr. Lowman will provide a meeting summary and propose dates for the fall 2022 meeting.

D. Lowman, NRC 5:00pm EST ADJOURN