ML25093A077
| ML25093A077 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/2025 |
| From: | NRC/OCM |
| To: | |
| Shared Package | |
| ML25064A503 | List: |
| References | |
| M250408B | |
| Download: ML25093A077 (1) | |
Text
Overview of ACMUI Activities Hossein Jadvar, MD, PhD ACMUI Chair/Nuclear Medicine Physician April 8, 2025
Todays Agenda
- Overview of ACMUI activities
- Richard Green, BS Pharm, ACMUI Vice Chair/Nuclear Pharmacist
- Growth in Radiopharmaceutical Therapy 2
Todays Agenda (contd)
- ACMUI Review of Training and Experience for Emerging Medical Technologies
- Statement from the ACMUI Patients' Rights Advocate.
3
Overview of the ACMUI
- ACMUI Role
- Membership
- 2024-2025 Topics
- Current Subcommittees
- Future 4
Role of the ACMUI
- Advise the U.S. Nuclear Regulatory Commission (NRC) staff on policy & technical issues that arise in the regulation of the medical use of radioactive material in diagnosis & therapy.
- Comment on changes to NRC regulations & guidance.
- Evaluate certain non-routine uses of radioactive material.
- Provide technical assistance in licensing, inspection &
enforcement cases.
- Bring key issues to the attention of the Commission for appropriate action.
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ACMUI Membership (13 members)
- Nuclear Medicine Physician, Chair (Hossein Jadvar, MD, PhD)
- Nuclear Pharmacist, Vice Chair (Mr. Richard Green)
- Nuclear Cardiologist (Andrew Einstein, MD, PhD)
- Brachytherapy Radiation Oncologist (Michael Folkert, MD, PhD)
- GSR Radiation Oncologist (Harvey Wolkov, MD)
- Diagnostic Radiologist (Joanna Fair, MD, PhD)
- FDA Representative (Michael OHara, PhD) 6 6
ACMUI Membership (13 members)
- Nuclear Medicine Medical Physicist (Ms. Melissa Martin)
- Radiation Therapy Medical Physicist (Mr. Zoubir Ouhib)
- Patients Rights Advocate (Mr. Josh Mailman)
- Agreement State Representative (Ms. Megan Shober)
- Healthcare Administrator (Ms. Rebecca Allen)
- Radiation Safety Officer (Richard Harvey, DrPH) 7 7
ACMUI Consultant
- Interventional Radiologist (John Angle, MD) 8 8
ACMUI Topics April 2025
- Y-90 Microsphere Gastrointestinal Deposition Medical Events
- Generic Process Checklist
- Training and Experience Requirements for Emerging Medical Technologies 9
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ACMUI Topics 2024
- Financial Assurance Requirements for Disposition of Category 1-3 Byproduct Material Radioactive Sealed Sources
- Report on Nuclear Medicine Injection Extravasations as Medical Events
- Interim Staff Guidance on Implementation of Training and Experience 10 1
0
ACMUI Topics 2024
- ACMUI Bylaws Recommendations
- Akesis Galaxy RTi Unit licensing guidance
- Eye90 Microsphere Device licensing guidance
- Liberty Vision Y-90 episcleral brachytherapy source licensing guidance 11 1
1
ACMUI Topics 2024
- A Review of Prescription Error Reduction Methods
- Review of Medical Events 12 1
2
Staff Presentations to the ACMUI (2024-2025) 13 1
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- Medical Radiation Safety Team Updates
- Medical events
- Y-90 Microsphere Medical Events
- Status of Patient Release Guidance
- Advanced Act
- Medical Team Updates
Staff Presentations to the ACMUI (2023-2025)
(contd)
- Patient Waste Guidance
- ACMUI Reporting Structure
- Required and Expanded Ethics Training 14 1
4
Current ACMUI Subcommittees 15 1
5
- NRC Mission and Medical Use Licensing and Oversight
- Patient Release Subcommittee
- Training and Experience for All Modalities Subcommittee
- Medical Event Reporting and Extravasation Subcommittees
- Y-90 Microsphere Gastrointestinal Deposition Medical Events
Current ACMUI Subcommittees (cont'd) 16 1
6
- Emerging Medical Technologies and Rubidium 82 Generator Subcommittee
- Membership of an Interventional Radiologist
Future
- ACMUI will continue to
-Provide advice and technical assistance
-Comment on NRC regulations and guidance
-Evaluate uses of radioactive material
-Bring key issues to the attention of the Commission 1
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- EMT - Emerging Medical Technologies
- FDA - U.S. Food & Drug Administration
- GSR - Gamma Stereotactic Radiosurgery
- NRC - U.S. Nuclear Regulatory Commission
- Y yttrium-90 1
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