ML20091P553

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

ML20091P553
Person / Time
Issue date:	03/31/2020
From:	Office of Nuclear Material Safety and Safeguards
To:
Jamerson, Kellee NMSS/MSST
References
Download: ML20091P553 (5)

Text

TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES March 11, 2020 MEETING

SUMMARY

PURPOSE To discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Regulatory Guide 8.39 Subcommittees draft report on the final recommendations for the draft final Phase 1 revision to Regulatory Guide 8.39, 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 include: Mr. Gary Bloom, Dr. Vasken Dilsizian, Ms.

Melissa Martin, Dr. A. Robert Schleipman, Mr. Michael Sheetz (Chair), and Ms. Megan Shober.

The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the ACMUIs comments while finalizing Phase 1 of the draft proposed Regulatory Guide 8.39, which will be issued in April 2020. A full transcript and handout for the ACMUI teleconference meeting can be found on the NRCs public web site at:

https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2020.html.

The ACMUI Regulatory Guide 8.39 Subcommittee report is available on the NRCs public web site under ACMUI Subcommittee Reports: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.

AGENDA TOPIC Draft Final Phase 1 revisions to Regulatory Guide 8.39, Release of Patients Administered Radioactive Material.

SUMMARY

The ACMUI Regulatory Guide 8.39 Subcommittee presented its draft report (Agencywide Documents and Access Management System (ADAMS) Accession No. ML20056D823), which focused on final recommendations that only pertained to the final draft Phase 1 revision to Regulatory Guide 8.39. In its report, the Subcommittee provided for consideration, several specific comments and recommendations which directed changes pertaining to wording, items of emphasis, and formatting. The draft subcommittee report was endorsed by the full Committee.

RECOMMENDATIONS AND ACTIONS The Regulatory Guide 8.39 Subcommittee discussed the following recommendations from the Subcommittee report.

1. In the Patient Precautions and Instructions Sections, it should be emphasized that the major source of radiation dose to other individuals will be from external exposure from

the patient. Therefore, the most important precautions to take are measures to reduce or avoid the external radiation exposure from the patient, especially in the early time period after administration of the radionuclide therapy.

2. The patient instructions should be simple, clear, and concise.

3. Discussions on the radionuclide therapy procedure and release instructions should also include a caregiver or family member, if possible.

4. Instructions should also be provided on how long the precautions should be followed.

As a guideline, the licensee may consider using several (3-5) effective half-lives of the radionuclide therapy.

5. The Regulatory Guide should not include instructions that are excessive, likely to cause patient anxiety, and not likely to reduce public exposures.

6. Table 1, 2, and A1 should be updated to include the new and potential radionuclides used in medicine.

7. In Table 3, Activities of Radiopharmaceuticals That Require Instructions and Records When Administered to Patients Who Are Breastfeeding an Infant or Child, the subcommittee supports the guidance for a standardized interruption time period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for all Tc-99m radionuclides, and the recommended interruption period to limit the dose to the nursing infant to 1 millisievert (mSv), and not the regulatory limit of 5 mSv.

The ACMUI unanimously approved the draft Regulatory Guide 8.39 Subcommittee Report, as presented, during its public teleconference meeting on March 11, 2020. The recommendations above can be viewed, in their entirety, in the final Regulatory Guide 8.39 Subcommittee Report (ADAMS Accession No. ML20085H267) on the NRCs ACMUI Subcommittee Reports webpage.

Enclosures:

1. Meeting Attendees

2. Teleconference Agenda

MEETING PARTICIPANTS ACMUI Darlene F. Metter, M.D. Chairman A. Robert Schleipman, PhD Vice Chairman Gary Bloom Member Vasken Dilsizian, M.D. Member Richard Green Member Melissa Martin Member Michael D. OHara, M.D. Member Zoubir Ouhib Member Michael Sheetz Member Megan Shober Member Harvey B. Wolkov, M.D. Member NRC STAFF Christian Einberg Chief, Medical Safety and Events Assessment Branch (MSEB)/Designated Federal Officer Lisa Dimmick Medical Radiation Safety Team Leader, NMSS/MSST/MSEB Kellee Jamerson Designated Federal Officer/ACMUI Coordinator Said Daibes Figueroa, Ph.D. NMSS/MSST/MSEB Daniel Dimarco NMSS/MSST/MSEB Jennifer Fisher NMSS/MSST/MSEB 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 Penny Lanzisera R-I/DNMS/MLAB Sarah Lopas NMSS/MSST/MSEB Jeffery Lynch NMSS/MSST/SLPB Minh-Thuy Nguyen RES/DSA/RPB Vered Shaffer RES/DSA/RPB Katherine Tapp, Ph.D. NMSS/MSST/MSEB John Tomon RES/DSA/RPB Irene Wu NMSS/MSST/MSEB MEMBERS OF THE PUBLIC Jaime Barnes Cook Childrens Medical Center Roland Benke Renaissance Code Development, LLC Lisa Bruedigan Texas Department of State Health Services Tina Buehner Unaffiliated David Crowley North Carolina Department of Health and Human Services, Radiation Protection Section Elizabeth Franklin Atrium Health Noelle Geier Froedtert & The Medical College of Wisconsin Jennifer Gersman Northwestern Medicine Enclosure 1

Phil Goble Utah Division of Waste Management and Radiation Control Miguel de la Guardia Cook Childrens Medical Center Stanley Hampton Eli Lilly Curtis Hicks, Jr. Scripps Health Bill Hinchcliffe Yale New Haven Health Mary Ellen Jafari Gundersen Health Tyler Kruse Minnesota Radioactive Materials Unit Ralph Lieto St. Joseph Mercy Health System Carol Marcus, Ph.D., M.D. University of California at Los Angeles Steven Marsh Baystate Health Richard Martin American Association of Physicists in Medicine Jeffrey Mason Department of Veterans Affairs Candi McDowell University of Pennsylvania Mary Moore CMC Veterans Affairs Medical Center Lora Moyle North Carolina State University Michael Peters American College of Radiology Carmine Plott Novant Health Daniel Samson New York State Department of Health Jeffry Siegel, Ph.D. Nuclear Physics Enterprises Eric Skotak Texas Department of State Health Services Cindy Tomlinson American Society for Radiation Oncology Brian Vamvakias Texas Department of State Health Services Karen Wheeler Bio-Med Associates William White Rush University Matthew Williamson Memorial Sloan Kettering Cancer Center Melonie Wissing Department of Veterans Affairs 2

Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Wednesday, March 11, 2020 2:00 PM - 4:00 PM (ET)

OPEN SESSION 2:00 pm - 4:00 pm Discuss the Draft ACMUI Subcommittee Report for the Final Draft of Regulatory Guide 8.39, Release of Patients Administered Radioactive Material Phase 1 Revisions Enclosure 2