ML20140A357
| ML20140A357 | |
| Person / Time | |
|---|---|
| Issue date: | 05/19/2020 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Jamerson, Kellee NMSS | |
| References | |
| Download: ML20140A357 (6) | |
Text
TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 30, 2020 MEETING
SUMMARY
PURPOSE To discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) COVID-19 Subcommittees draft recommendations for regulatory relief measures for medical licensees during the COVID-19 public health emergency.
OUTCOME The ACMUI COVID-19 Subcommittee provided a draft report for discussion with the full Committee. Subcommittee members include: Dr. Vasken Dilsizian, Mr. Richard Green, Dr.
Hossein Jadvar (chair), Ms. Melissa Martin, Ms. Megan Shober, and Dr. Harvey Wolkov. The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the ACMUIs recommendations when developing guidance for medical licensees that request temporary exemptions during the COVID-19 pandemic.
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.
The ACMUI COVID-19 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 Discuss the draft ACMUI COVID-19 Subcommittee recommendations for potential regulatory relief measures for medical use licensees during the COVID-19 pandemic.
SUMMARY
The ACMUI COVID-19 Subcommittee presented its draft report (Agencywide Documents and Access Management System (ADAMS) Accession No. ML20125A145), which focused on recommendations for potential regulatory relief options during the COVID-19 pandemic. In its report, the Subcommittee provided for the NRCs consideration, several recommendations in specific areas where licensees may be unable to meet specific regulatory requirements in a timely manner due to the public health emergency. The draft subcommittee report was endorsed by the full Committee.
RECOMMENDATIONS AND ACTIONS The COVID-19 Subcommittee discussed regulatory relief options for medical licensees during the COVID-19 pandemic in the following specific areas: 1) training and education; 2) regulatory reporting; 3) medical event reporting; 4) radiation protection activities; 5) physical presence; 6) inspections; and 7) regulatory fees.
Regarding regulatory relief options for physical presence, the ACMUI discussed some hypothetical scenarios in which a facilitys authorized user (AU) or authorized medical physicist (AMP) could not be physically present for treatment due to suspected or confirmed COVID-19 infection. The ACMUI concluded that there should be no change to the physical presence requirements for high dose rate brachytherapy or gamma knife stereotactic radiosurgery, as these are high-risk procedures that require the physical presence of the AU and AMP.
Additionally, the ACMUI discussed and considered concerns about the possibility of regulatory relief for patient release criteria for patients who receive radionuclide therapy during the COVID-19 pandemic. The ACMUI agreed that for exceptional situations related to patient release during COVID-19, medical licensees should contact the NRC or their regional regulatory office to seek a temporary exemption request on a case-by-case basis.
The ACMUI unanimously approved the draft COVID-19 Subcommittee Report and its recommendations, as presented, during its public teleconference meeting on April 30, 2020. The final report (ADAMS Accession No. ML20125A148) can be viewed, in its entirety, 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 Ronald Ennis, M.D.
Member Richard Green Member Hossein Jadvar, M.D.
Member Melissa Martin 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 Darrell Adams OCA Maryann Ayoade NMSS/MSST/MSEB David Brown COMM/OCM Colleen Casey R-III/DNMS/MLB Laura Cender R-III/DNMS/MLB Said Daibes Figueroa, Ph.D.
NMSS/MSST/MSEB Sara Forster R-III/DNMS/MLB Cassandra Frazier R-III/DNMS/MLB Vincent Holahan, Ph.D.
NMSS/MSST Sophie Holiday NSIR/DPR Esther Houseman OGC/GCLR/RMR Donna-Beth Howe, Ph.D.
NMSS/MSST/MSEB Ian Irvin OGC/GCLR/RMR Janelle Jessie COMM/OCMJB Cynthia Jones COMM/OCMAC Erin Kennedy R-III/DNMS/MLB Michael LaFranzo R-III/DNMS/MCID Penny Lanzisera R-I/DNMS/MLAB Olivier Lareynie NRR Samantha Lav COMM/OCMDW Christine Lipa R-III/DNMS Sarah Lopas NMSS/MSST/MSEB Kathy Modes NMSS/MSST/SLPB Dennis ODowd R-III/DNMS/MIB Robert Orlikowski R-III/DNMS/MLB Bryan Parker R-III/DNMS/MLB
2 Darren Piccirillo R-III/DNMS Vered Shaffer RES/DSA/RPB Katherine Tapp, Ph.D.
NMSS/MSST/MSEB Geoff Warren R-III/DNMS/MIB Duncan White NMSS/MSST/SLPB Irene Wu NMSS/MSST/MSEB MEMBERS OF THE PUBLIC Christina Arenas Society of Nuclear Medicine and Molecular Imaging Rex Ayers American Association of Physicists in Medicine Sukhjeet Ahuja Society of Nuclear Medicine and Molecular Imaging Roland Backhaus Morgan Lewis Jaime Barnes Cook Childrens Medical Center Janet Bukovcan Boston Scientific Mary Burkhart Illinois Emergency Management Agency Whitney Cox Illinois Emergency Management Agency Elaine Crescenzi Pennsylvania Department of Environmental Protection David Crowley North Carolina Department of Health and Human Services, Radiation Protection Section Lewis Csedrik Morgan Lewis Ariel Doucet Virtua Health Michele Egberts Nuclear Diagnostic Products Brian Erasmus Boston Scientific Sandy Gabriel Unaffiliated Ira Goldman Lantheus Medical Imaging Erin Grady, M.D.
Emory University School of Medicine Miguel de la Guardia Cook Childrens Medical Center Stanley Hampton Eli Lilly James Harvey NorthStar Medical Technologies Joseph Koshy Pennsylvania Department of Environmental Protection Tyler Kruse Minnesota Radioactive Materials Unit Ralph Lieto Unaffiliated William Lorenzen Boston Childrens Hospital Cindi Luckett-Gilbert Unaffiliated Carol Marcus, Ph.D., M.D.
University of California at Los Angeles Richard Martin American Association of Physicists in Medicine Candi McDowell University of Pennsylvania Mahta McKee Wake Forest Baptist Health Vanessa Mongeon Boston Scientific Niki Noll Pennsylvania Department of Environmental Protection Michael Peters American College of Radiology Gloria Romanelli American College of Radiology Katie Scott Pennsylvania Department of Environmental Protection Tracy Scherer Pennsylvania Department of Environmental Protection Tim Showalter University of Virginia Diana Thompson Sirtex Christopher Tighe University of Pennsylvania Cindy Tomlinson American Society for Radiation Oncology Jeff Wagner University of California at San Diego
3 Bradley Williams U.S. Senate Committee on Environment and Public Works John Witkowski United Pharmacy Partners Pat Zanzonico, Ph.D.
Memorial Sloan Kettering
Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Thursday, April 30, 2020 2:00 PM - 4:00 PM (ET)
OPEN SESSION 2:00 pm - 4:00 pm Discuss the Draft ACMUI COVID-19 Subcommittee recommendations for potential regulatory relief measures for medical use licensees during the COVID-19 pandemic.