ML24085A017
| ML24085A017 | |
| Person / Time | |
|---|---|
| Issue date: | 03/14/2024 |
| From: | Dimarco D NRC/NMSS/DMSST/MSEB |
| To: | |
| Armstead, L | |
| References | |
| Download: ML24085A017 (2) | |
Text
1 U.S. Nuclear Regulatory Commission Advisory Committee on the Medical Uses of Isotopes Subcommittee on Medical Events Draft Report Submitted on March 14, 2024 Subcommittee Members:
Michael Folkert, MD, PhD (Brachytherapy Radiation Oncologist)
Richard Green, BS (Nuclear Pharmacist)
Richard Harvey, DrPH (Radiation Safety Officer; Chair)
Zoubir Ouhib, MS (Therapy Medical Physicist)
Harvey Wolkov, MD (Radiation Oncologist)
Consultant: John Angle, MD (Interventional Radiologist)
NRC Staff Resource: Daniel DiMarco, MS Subcommittee Charge: Review medical events to advise the Advisory Committee on the Medical Use of Isotopes (ACMUI) and United States Nuclear Regulatory Commission (NRC) about emerging trends that may need regulatory attention.
Background:
The subcommittee reviewed medical events from the Fiscal Year 2021 and 2022 as part of its ongoing biannual review. In addition, the subcommittee reviewed medical events from the Fiscal Year 2023.
Findings: Medical events in Fiscal Years 2021, 2022 and 2023 were relatively low but there appears to be an increase in medical events in 10 CFR 35.300 and 10 CFR 35.1000. The volume of procedures involving lutetium-177 (177Lu) radiopharmaceuticals has increased during this period and this has resulted in an increased number of medical events in the category of 10 CFR 35.300.
Medical events in 10 CFR 35.1000 have increased for treatments involving yttrium-90 (90Y) microspheres (for both TheraSphere and SIR-Spheres). Reducing the number of medical events involving 90Y microspheres may be accomplished through improved education with emphasis on appropriate administration of the microspheres and proper set-up of the delivery device. In addition, a Time-Out may be a tool that can be implemented to reduce the number of Medical Events for procedures using 90Y microspheres.
The committee recognizes past effort and continues to discuss medical events that may benefit from a Time-Out or those that may be the result of infrequent/inexperience use. Improved education and use of a Time-Out may be beneficial in preventing medical events.
The Subcommittee will continue to examine medical events involving radiopharmaceuticals approved for use under 10 CFR 35.300 as well as treatments performed with 90Y microsphere procedures (10 CFR 35.1000). Furthermore, the Subcommittee will monitor trends that may continue and appear to be significant during the biannual review period (Fiscal Year 2021 and 2022) as well as Fiscal Year 2023.
2 Concluding Remarks: The ACMUI Subcommittee on Medical Events appreciates the opportunity to continue reviewing these events. Emphasis will be placed on radiopharmaceuticals in 10 CFR 35.300 and 10 CFR 35.1000, specifically 90Y microsphere procedures, to discern if there are emerging trends in medical events involving these treatments. The subcommittee welcomes any comments and/or recommendations.
Respectfully submitted, March 14, 2024 Subcommittee on Medical Events Advisory Committee on the Medical Uses of Isotopes (ACMUI)
U.S. Nuclear Regulatory Commission (NRC)