ML20143A238
| ML20143A238 | |
| Person / Time | |
|---|---|
| Issue date: | 05/11/2020 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Jamerson, Kellee NMSS/MSST | |
| References | |
| Download: ML20143A238 (7) | |
Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES March 30, 2020 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 and Related Documents webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2020.html.
RECOMMENDATIONS AND ACTIONS The ACMUI endorsed the following subcommittee reports. These reports and their recommendations 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/.
The ACMUI endorsed the Patient Intervention Subcommittee report and its recommendations, as presented.
The ACMUI endorsed the Bylaws Subcommittee report and its recommendations, as presented.
The ACMUI endorsed the Interventional Radiology Subcommittee report and its recommendations, as presented.
The following actions resulted from discussions that took place during the meeting:
Dr. Metter formed a subcommittee to evaluate the impacts of COVID-19 on the medical community and provide recommendations for potential regulatory relief measures during the COVID-19 pandemic. Due to the urgency of the topic, the subcommittee is expected to provide its recommendations to the Committee at an upcoming public teleconference.
Subcommittee membership includes Dr. Dilsizian, Mr. Green, Dr. Jadvar (chair), Ms.
Martin, Ms. Shober, and Dr. Wolkov. Mr. Bloom and Mr. Ouhib will serve on the subcommittee as non-voting consulting members. The NRC staff resource is Ms. Lisa Dimmick.
Dr. Metter amended the membership of the Training and Experience Requirements for All Modalities Subcommittee to add Dr. Jadvar and remove Mr. Bloom. Subcommittee membership now consists of Dr. Ennis, Dr. Jadvar, Dr. Metter, Dr. Schleipman (chair),
Mr. Sheetz, and Ms. Shober. Mr. Bloom will serve on the subcommittee as a non-voting consulting member. Ms. Maryann Ayoade remains the NRC staff resource.
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.
The NRC staff requested that the ACMUI provide some clarity on the working definition of the practice of medicine and how it should inform NRCs decision making as it relates to the regulation of the medical use of radioactive material. The ACMUI stated that the practice of medicine is a very broad topic to define but will assess issues on the topic on a case-by-case basis.
Dr. Metter formed an Abnormal Occurrence (AO) Subcommittee to (1) define patient harm in AO; (2) reassess the current AO criteria; (3) define goals of AO criteria and reporting; and (4) determine if current AO criteria is adequate regarding public health and safety. Subcommittee membership includes Mr. Bloom, Dr. Ennis, Dr. Jadvar, Mr.
Ouhib, Mr. Sheetz (chair) and Ms. Shober. The NRC staff resource is Dr. Katie Tapp.
This subcommittee is currently placed on hold until further notice from NRC staff.
The ACMUI tentatively scheduled its fall 2020 meeting for September 21-22, 2020. The alternate meeting date is September 14-15, 2020.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
MEETING PARTICIPANTS ACMUI Darlene F. Metter, M.D. Chairman A. Robert Schleipman, Ph.D. Vice Chairman Gary Bloom Member Vasken Dilsizian, M.D. Member Ronald D. Ennis, M.D. Member Richard Green Member Hossein Jadvar, M.D. Member Melissa Martin Member Michael D. OHara, Ph.D. Member Zoubir Ouhib Member Michael A. Sheetz Member Megan Shober Member Harvey B. Wolkov, M.D. Member NRC STAFF Kevin Williams Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST)
Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Kellee Jamerson Designated Federal Officer and ACMUI Coordinator, MSEB Maryann Ayoade NMSS/MSST/MSEB Said Daibes, Ph.D. NMSS/MSST/MSEB Daniel Dimarco NMSS/MSST/MSEB Lisa Dimmick Medical Radiation Safety Team Leader, MSS/MSST/MSEB Jason Draper R-III/DNMS/MIB Robin Elliott R-I/DNMS/MLAB Jennifer Fisher NMSS/MSST/MSEB Sara Forster R-III/DNMS/MLB Robert Gallaghar R-I/DNMS/MLAB Anita Gray, Ph.D. NMSS/MSST/SMPB Vincent Holahan, Ph.D. NMSS/MSST Esther Houseman OGC/GCLR/RMR Donna-Beth Howe, Ph.D. NMSS/MSST/MSEB Ian Irvin OGC/GCLR/RMR Janelle Jessie COMM/OCMJB Penny Lanzisera R-I/DNMS/MLAB Sarah Lopas NMSS/MSST/MSEB Kathy Modes NMSS/MSST/SLPB Janice Nguyen R-I/DNMS/MLAB Dennis ODowd R-III/DNMS/MIB Shawn Seeley R-I/DNMS/MLAB Vered Shaffer RES/DSA/RPB Zahid Sulaiman R-III/DNMS/MIB Robert Sun NMSS/MSST/MSEB Katherine Tapp, Ph.D. NMSS/MSST/MSEB Irene Wu NMSS/MSST/MSEB Enclosure 1
MEMBERS OF THE PUBLIC Jenna Abbott Illinois Emergency Management Agency Sukhjeet Ahuja Society of Nuclear Medicine and Molecular Imaging Rex Ayers Northwest Medical Physics Center Jamie Barnes Cook Childrens Medical Center Amy Bolar Illinois Emergency Management Agency Keith Brown University of Pennsylvania Mary Burkhart Illinois Emergency Management Agency Ashley Cockerham Mercurie Consulting Susan Corey Cook Childrens Medical Center Elaine Crescenzi Pennsylvania Department of Environmental Protection David Crowley North Carolina Department of Health and Human Services, Radiation Protection Section Matt Dennis CRD Associates, LLC Terri Dodson Illinois Emergency Management Agency Ariel Doucet Virtua Health Adam Ekstedt Illinois Emergency Management Agency Brian Erasmus Boston Scientific Kelsey Everett University of Pennsylvania Lynn Fairobent Unaffiliated Lisa Forney Pennsylvania Department of Environmental Protection Jordan Frengut Unaffiliated Mike Fuller Virginia Department of Health Sandy Gabriel Unaffiliated Debbie Gilley International Atomic Energy Agency Miguel de la Guardia Cook Childrens Medical Center Gary Hall Fort Bragg Department of Public Health Matthew Hall Sirtex Stanley Hampton Eli Lilly Meg Harkins University of Pennsylvania James Harvey NorthStar Medical Radioisotopes Dan Hill Cardinal Health James Hirn Illinois Emergency Management Agency Mary Ellen Jafari Gundersen Health Janelle Jesikiewicz University of Pennsylvania Josh Knowland Lucerno Dynamics Todd Lafrenze Illinois Emergency Management Agency Ronald Lattanze Lucerno Dynamics Georgia Lawrence American Society of Nuclear Cardiology Ralph Lieto St. Joseph Mercy Health System William Lorenzen Boston Childrens Hospital, Harvard Medical School Carol Marcus University of California at Los Angeles Richard Martin American Association of Physicists in Medicine Jeffrey Mason Department of Veterans Affairs Trenton Mays Eli Lilly Candi McDowell University of Pennsylvania Thomas Mohaupt NorthStar Medical Radioisotopes Vanessa Mongeon Boston Scientific Tom Namsa BWX Technologies Jon Neuhoff U.S. Department of Energy, Isotope Program Enclosure 1
Richard Peros New Jersey Department of Environmental Protection Michael Peters American College of Radiology Deron Robbins Illinois Emergency Management Agency Grace Schoeniger Pennsylvania Department of Environmental Protection Katie Scott Pennsylvania Department of Environmental Protection Diana Thompson Sirtex Cindy Tomlinson American Society for Radiation Oncology Gibb Vinson Illinois Emergency Management Agency Karamdeep Virk Illinois Emergency Management Agency Joseph Wissing St. Joseph Mercy Health System Melonie Wissing Department of Veterans Affairs Enclosure 1
MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES March 30, 2020 Teleconference/WebEx 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, MARCH 30, 2020 OPEN SESSION
- 1. Opening Remarks C. Einberg, NRC Mr. Einberg will formally open the meeting and Mr. Layton will provide M. Layton, NRC opening remarks.
- 2. Old Business K. Jamerson, NRC 9:30 - 10:45 Ms. Jamerson will review past ACMUI recommendations and provide NRC responses.
- 4. Trends in Radiopharmaceuticals H. Jadvar, ACMUI Dr. Jadvar will provide a presentation on the status of emerging radiopharmaceuticals.
10:45 - 11:00 BREAK
- 5. Patient Intervention Subcommittee Report M. Sheetz, ACMUI Mr. Sheetz will discuss the subcommittees recommendations regarding the definition of patient intervention and other actions exclusive of medical 11:00 - 12:15 events.
- 6. NMED Overview R. Sun, NRC Mr. Sun will provide an overview of the NRCs Nuclear Material Events Database.
12:15 - 1:15 LUNCH
- 7. ACMUI Reporting Structure K. Jamerson, NRC Members will discuss the reporting structure of the Committee and provide 1:15 - 2:30 feedback to the NRC.
- 8. ACMUI Bylaws Subcommittee Report H. Wolkov, ACMUI Dr. Wolkov will discuss the subcommittees recommendations for changes to the bylaws, with focus on term limits for the ACMUI Chair and Vice Chair.
2:30 - 2:45 BREAK
- 9. Medical Related Events DB. Howe, NRC Dr. Howe will provide an update on recent medical events.
Enclosure 2
- 10. Interventional Radiologist Subcommittee Report M. Shober, ACMUI Ms. Shober will discuss the subcommittees recommendations on the need for 2:45 - 5:00 an Interventional Radiologist on the ACMUI.
- 12. Administrative Closing K. Jamerson, NRC Ms. Jamerson will provide a meeting summary and propose dates for the fall 2020 meeting.
5:00 ADJOURN Enclosure 2