ML24101A408

Medical Events Subcommittee Report ACMUI 2024 Spring

ML24101A408
Person / Time
Issue date:	03/14/2024
From:	Advisory Committee on the Medical Uses of Isotopes
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Download: ML24101A408 (2)

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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 (MEs) to advise the Advisory Committee on the Medical Use of Isotopes (ACMUI) and United States Nuclear R egulatory Commission (NRC) about emerging trends that may need regulatory attention.

Background:

The subcommittee reviewed medical events from the Fiscal Year 2 021 and 2022 as part of its ongoing biannual review. In addition, the subco mmittee reviewed medical events from the Fiscal Year 2023.

Findings: Medical Events in Fiscal Years 2021, 2022 and 2023 were relativ ely low but there appears to be an increase in Medical Events in 10 CFR 35.300 an d 10 CFR 35.1000. The volume of procedures involving 177Lu radiopharmaceuticals has increased during this period and this has resulted in an increased number of Medical Events in t he category of 10 CFR 35.300.

Medical Events in 10 CFR 35.1000 have increased for treatments involving 90Y microspheres (for both Theraspheres and SirSpheres). Reducing the number of Medical Events involving 90Y microspheres may be accomplished through improved education wit h emphasis on appropriate administration of the microspheres and proper set-up of the del ivery device. In addition, a Time-Out may be a tool that can be implemented to reduce the n umber of Medical Events for procedures using 90Y microspheres.

The committee recognizes past effort and continues to discuss M edical 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 preventi ng Medical Events.

The Subcommittee will continue to examine Medical Events involv ing radiopharmaceuticals approved for use under 10 CFR 35.300 as well as treatments perf ormed with 90Y microsphere procedures (10 CFR 35.1000). Furthermore, the subcommittee wil l monitor trends that may continue and appear to be significant during the biannual revie w period (Fiscal Year 2021 and 2022) as well as Fiscal Year 2023.

1 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, speci fically 90Y microsphere procedures, to discern if there are emerging trends in Medical Events involving these treatments. The subcommittee welcomes any comments and/or reco mmendations.

Respectfully submitted, March 14, 2024 Subcommittee on Medical Events Advisory Committee on the Medical Uses of Isotopes (ACMUI)

U.S. Nuclear Regulatory Commission (NRC)

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