ML21267A021

September 02 2021 - ACMUI Teleconference Meeting Summary

ML21267A021
Person / Time
Issue date:	09/02/2021
From:	Office of Nuclear Material Safety and Safeguards
To:
D DiMarco, NMSS/MSST
References
Download: ML21267A021 (4)

Text

MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 2, 2021 MEETING

SUMMARY

PURPOSE To discuss the ACMUI Subcommittee on Extravasations review and comment on the U.S.

Nuclear Regulatory Commission (NRC) staffs memorandum, Preliminary Evaluation of Radiopharmaceutical Extravasation and Medical Event Reporting.

OUTCOME The ACMUI Extravasation Subcommittee provided feedback and recommendations on the NRC staffs memorandum with the full ACMUI. Subcommittee members include: Dr. Vasken Dilsizian, Mr. Richard Green, Ms. Melissa Martin (chair), Mr. Michael Sheetz, and Ms. Megan Shober. The NRC staff resource is Lisa Dimmick. The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the ACMUIs comments and recommendations on the preliminary evaluation of radiopharmaceutical extravasation and medical event reporting in its development of a SECY paper to be provided for Commission consideration.

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/2021.html.

SUMMARY

AND RECOMMENDATIONS The U.S. NRC staffs memorandum was reviewed by the Extravasation Subcommittee and recommendations were presented to the full ACMUI. The Extravasation Subcommittee recommended changing the wording of option 4 of the Subcommittee report to read:

Option 4 would be a non-dose-based option for reporting extravasations that result in a radiation injury. If a patient requires medical attention for a suspected radiation injury due to extravasation which results in tissue damage at or near the administration site, and this radiation injury is confirmed by a physician authorized user of the licensee to be due to radiation from the extravasation, then this will require medical event reporting.

With this amendment, the Subcommittee report was accepted unanimously and endorsed option 4 as modified.

The final report can be viewed, in its entirety, on the NRCs ACMUI Subcommittee Reports webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.

MEETING ACTIONS The following actions resulted from discussions that took place during the meeting:

Dr. Metter formed a new subcommittee, as detailed below:

1. Subcommittee on the Diffusing Alpha-emitter Radiation Therapy (DaRT)

Manual Brachytherapy Source Subcommittee Charge:

To review and evaluate the staffs Alpha DaRT manual brachytherapy licensing guidance Provide considerations and recommendations to NRC staff Subcommittee Membership: Dr. Ronald Ennis (chair), Mr. Zoubir Ouhib, Ms. Megan Shober, Dr. Michael OHara, Dr. Hossein Jadvar, Ms. Rebecca Allen NRC Staff Resource: Dr. Katie Tapp The subcommittee is expected to provide a draft report and any recommendations at the spring 2021 ACMUI meeting.

Enclosures:

1. Meeting Attendees

2. Meeting Agenda

MEETING PARTICIPANTS ACMUI Darlene F. Metter, M.D.

Chairman A. Robert Schleipman, Ph.D.

Vice Chairman Vasken Dilsizian, M.D.

Member Ronald D. Ennis, M.D.

Member Richard Green Member Hossein Jadvar, M.D.

Member Josh Mailman 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 John F. Angle, M.D.

(Consultant)

NRC STAFF Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer 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 Sarah Lopas NMSS/MSST/MSEB Lynn Ronewicz NMSS/REFS/MRPB Donna-Beth Howe, Ph.D.

NMSS/MSST/MSEB Ian Irvin OGC/GCLR/RMR Katherine Tapp, Ph.D.

NMSS/MSST/MSEB MEMBERS OF THE PUBLIC Daniel Fass, M.D.,

Princeton Health Care Alliance Miguel De La Guardia, Cook Childrens Medical Center Ronald Lattanze, Lucerno Dynamics Ralph Lieto, Michigan Radiological Society, American College of Radiology Josh Knowland, Lucerno Dynamics David Townsend, Ph.D.,

Lucerno Dynamics Matt Wait, Kaiser Permanente Paul Wallner, D.O.,

American College of Radiation Oncology David Williams, M.D.,

Pediatrician

Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Thursday, September 2, 2021 1:00 PM - 3:00 PM EDT OPEN SESSION

1.

Opening Remarks Mr. Chris Einberg will formally open the meeting.

C. Einberg, NRC

2.

Extravasations and Medical Event Reporting Ms. Melissa Martin will present the ACMUI Subcommittee on Extravasations and Medical Event Reporting draft report on the NRC staffs preliminary evaluation on extravasations.

M. Martin, ACMUI

3.

Closing and Adjournment Dr. Metter will close the meeting.

D. Metter, M.D.,

ACMUI