ML19171A423

Summary of Teleconference Meeting with the Advisory Committee on the Medical Uses of Isotopes (ACMUI)

ML19171A423
Person / Time
Issue date:	06/10/2019
From:	Office of Nuclear Material Safety and Safeguards
To:
Jamerson K
References
Download: ML19171A423 (5)

Text

TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES June 10, 2019 MEETING

SUMMARY

PURPOSE To discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) proposed amended Bylaws and the Regulatory Guide 8.39 Subcommittees draft report on the recommendations for Phase 1 of the draft proposed revision to Regulatory Guide 8.39, Revision 1, Release of Patients Administered Radioactive Material.

OUTCOME The ACMUI Regulatory Guide 8.39 Subcommittee provided a draft report for discussion with the full Committee. Subcommittee members included: Dr. Vasken Dilsizian, Ms. Melissa Martin, Dr. A. Robert Schleipman, Mr. Michael Sheetz (Chair), Ms. Megan Shober, and Ms. Laura Weil.

The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the Committees comments in its development of Phase 1 of the draft proposed Regulatory Guide 8.39, which will be published for public comment in the near future.

A full transcript and handout for the ACMUI teleconference meeting can be found on the NRCs public web site at: http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/.

The ACMUI Subcommittee final report is also available on the NRCs public web site at:

http://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.

AGENDA TOPICS Discuss the proposed amendments to the ACMUI Bylaws, as discussed and approved at the April 3-4, 2019, ACMUI meeting.

Discuss the ACMUI Regulatory Guide 8.39 Draft Subcommittee Report on the recommendations for Phase 1 of the preliminary draft proposed Regulatory Guide 8.39, Revision 1.

SUMMARY

The ACMUI discussed the proposed amendments to the 2019 Bylaws, with specific changes to Sections 1.3.6 and 4.1, regarding the ACMUI Chairs involvement in subcommittees and conflicts of interest, respectively.

The ACMUI Regulatory Guide 8.39 Subcommittee discussed its draft report, which focused on recommendations on Phase 1 of the draft proposed revision to Regulatory Guide 8.39. In its report, the Subcommittee provided several directed changes pertaining to wording, items of emphasis, and formatting. Other recommendations presented by the Subcommittee include the addition of a Table of Contents; updates to Table 1 and Table 2 to include the new and potential radionuclides used in medicine; update to Table 3 to reflect the radionuclides, activities, and recommended duration of interruption of breastfeeding as contained in the ACMUI

Subcommittee report on Nursing Mother Guidelines for the Medical Administration of Radioactive Materials, Final Report, January 31, 2019; and the addition of instructions for evaluation of holding trash to allow for radioactive decay at the landfill.

RECOMMENDATIONS AND ACTIONS The Regulatory Guide 8.39 Subcommittee provided the following recommendations in its draft subcommittee report:

1. The Subcommittee recommends emphasizing in the Patient Precautions and Instructions Sections that the major source of radiation dose to other individuals will be from external exposure from the patient.

2. While there is adequate guidance on the precautions to take to minimize radiation exposure for post mortem activities of a patient who dies after being administered a therapeutic quantity of radioactive material, there is little or no consistent guidance on what retained activity or time period when the precautions should be followed. The Subcommittee recommends that a dose-based model be developed to provide guidance on when precautions or restrictions would be appropriate following the death of a patient administered a therapeutic quantity of radioactive material.

The draft Regulatory Guide 8.39 Subcommittee Report (ML19143A367), and all its recommendations provided therein, was unanimously approved by the ACMUI during its public teleconference meeting on June 10, 2019. The final report (ML19171A222) will be posted on the ACMUI Subcommittee Reports webpage.

Additionally, the proposed amendments to the ACMUI Bylaws were approved by the ACMUI, with one abstention, during its public teleconference meeting on June 10, 2019. The revised ACMUI Bylaws (ML19184A622) will be posted on the ACMUI webpage.

Enclosures:

1. Meeting Attendees

2. Teleconference Agenda

MEETING ATTENDEES ACMUI Christopher J. Palestro, M.D. Chairman Darlene F. Metter, M.D. Vice Chairman Vasken Dilsizian, M.D. Member Richard Green Member Melissa Martin Member Michael D. OHara, M.D. Member Zoubir Ouhib Member A. Robert Schleipman, PhD Member Michael Sheetz Member Megan Shober Member Laura Weil Member Harvey B. Wolkov, M.D. Member NRC Robert Lewis Deputy Director, Office of Nuclear Material Safety and Safeguards (NMSS)

Christian Einberg Chief, Medical Safety and Events Assessment Branch (MSEB)/Designated Federal Officer Kellee Jamerson Designated Federal Officer/ACMUI Coordinator/MSEB Maryann Ayoade NMSS/MSST/MSEB Stephanie Bush-Goddard RES/DSA/RPB Colleen Casey R-III/DNMS/MLB Samantha Crane OCM/DAW Said Daibes, Ph.D. NMSS/MSST/MSEB Lisa Dimmick Medical Radiation Safety Team Leader, NMSS/MSST/MSEB Julie Ezell OGC/GCHA/AGCNRP Cassandra Frazier R-III/DNMS/MLB Robert Gallaghar R-I/DNMS/MLAB Sophie Holiday NMSS/MSST/MSEB Esther Houseman OGC/GCLR/RMR Donna-Beth Howe, Ph.D. NMSS/MSST/MSEB Cynthia Jones OCM/AXC Harriet Karagiannis RES/DE/RGGIB Sarah Lopas NMSS/MSST/MSEB Minh-Thuy Nguyen RES/DSA/RPB Patty Pelke R-III/DNMS/MLB Halfon Schlom RES Vered Shaffer RES/DSA/RPB Daniel Strohmeyer R-III/DNMS/MLB Katherine Tapp, Ph.D. NMSS/MSST/MSEB Alexus Willis RES/DE/CMB Irene Wu NMSS/MSST/MSEB Enclosure 1

MEMBERS OF THE PUBLIC Jaime Barnes Cook Childrens Medical Center Roland Benke Renaissance Code Development, LLC Kendall Berry Fox Chase Cancer Center Janice Campbell Beaumont Health Peter Crane Unaffiliated David Crowley North Carolina Department of Health and Human Services, Radiation Protection Section Brian Erasmus British Technology Group Sandy Gabriel Unaffiliated Bennett Greenspan, M.D. Society of Nuclear Medicine and Molecular Imaging (SNMMI)

Miguel de la Guardia Cook Childrens Medical Center David Hamby Renaissance Code Development, LLC Alan Jackson Henry Ford Health System Brandon Juran Minnesota Radioactive Materials Unit Linda Kroger University of California at Davis Tyler Kruse Minnesota Radioactive Materials Unit Alexis LaViolette Boston Childrens Hospital, Harvard Medical School Ralph Lieto St. Joseph Mercy Health System Terry Lindley University of Cincinnati Cindi Luckett-Gilbert Unaffiliated Carol Marcus, Ph.D, M.D. University of California at Los Angeles (UCLA)

Richard Martin American Association of Physicists in Medicine (AAPM)

Candi McDowell University of Pennsylvania Chris Mitchell Kettering Health Jose Morales, M.D. Unaffiliated Michael Peters American College of Radiology (ACR)

Carmine Plott Novant Health Aria Razmaria, M.D. UCLA Medical Center Samuel Rhoades, IV Mercy Health Gloria Romanelli ACR Jeffry Siegel, Ph.D Nuclear Physics Enterprises Eugene Silvestrini Northwell Health Andres Sinisterra UConn Health Joe Steiner Henry Ford Health System Cindy Tomlinson American Society of Radiation Oncology (ASTRO)

Joseph Wissing St. Joseph Mercy Health System Miyuki Yoshida-Hay Northwell Health Andrew Zimnoch Environmental Health and Radiation Safety, University of Pennsylvania

Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Monday, June 10, 2019 2:00 PM - 4:00 PM (ET)

OPEN SESSION 2:00 pm - 4:00 pm Discuss the proposed amendments to the Advisory Committee on the Medical Uses of Isotopes Bylaws Discuss the ACMUI Regulatory Guide 8.39 Draft Subcommittee Report regarding the review and comments on Phase 1 of the preliminary draft proposed Regulatory Guide 8.39, Release of Patients Administered Radioactive Material.

Enclosure 2