ML19297E949
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| ML19297E949 | |
| Person / Time | |
|---|---|
| Issue date: | 10/23/2019 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Jamerson K | |
| References | |
| Download: ML19297E949 (1) | |
Similar Documents from Advisory Committee on the Medical Uses of Isotopes | |
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Category:Report
MONTHYEARML24040A1292023-10-23023 October 2023
[Table view]Some use of "" in your query was not closed by a matching "".ACMUI Fall 2023 Medical Events Subcommittee Report Final October 23, 2023 ML24040A1032023-09-21021 September 2023 ACMUI Fall 2023 Medical Events Subcommittee Report Draft September 21, 2023 ML23136A4582023-05-17017 May 2023 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on the Decommissioning Financial Assurance for Sealed and Unsealed Radioactive Materials, Final Report, May 17, 2023 ML23136A4592023-05-17017 May 2023 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Training and Experience for All Modalities, Final Report, May 17, 2023 ML22353A0542022-12-19019 December 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Y-90 Medical Events, Final Report, December 19, 2022 ML22322A1832022-11-18018 November 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Y-90 Medical Events, Draft Report, November 18, 2022 ML22322A1572022-11-18018 November 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Emerging Medical Technologies/Rubidium-82 Generator Rulemaking Draft Regulatory Basis, Draft Report, November 18, 2022 ML22021B2982022-01-21021 January 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Alpha Dart, Review and Comment on Draft Licensing Guidance Alpha Tau Alpha Dart Manual Brachytherapy, Final Report ML22021B2992022-01-21021 January 2022 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on RG 8.39, Release of Patients Administered Radioactive Materials, Review and Comment on the Draft Civaderm Device Licensing Guidance, Final Report, January 21, 2022 ML22021B3002022-01-21021 January 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on RG 8.39, Release of Patients Administered Radioactive Material, Review and Comment on Draft Proposed Revision 2 to Regulatory Guide 8.39, Final Report, January 21, ML21288A1272021-10-14014 October 2021 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommitee on Medical Events, Final Report, October 14, 2021 ML21287A6312021-10-14014 October 2021 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Emerging Radiopharmaceutical Therapy Knowledge Requirements in Theranostics Subcommittee, Final Report, October 14, 2021 ML21288A1262021-10-14014 October 2021 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Radionuclide Generator Knowledge and Practice Requirements, Final Report, October 14, 2021 ML21264A0772021-10-0404 October 2021 Me Subcommittee Report 10-4-21 Final ML21288A1252021-09-16016 September 2021 Advisory Committee on the Medical Uses of Isotopes (Acmui), Final Report, Subcommittee Review and Comments on NRC Staff Preliminary Evaluation of Radiopharmaceutical Extravasation and Medical Event Reporting ML21287A0742021-07-30030 July 2021 Advisory Committee on the Medical 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Subcommittee, Final Report, May 4, 2020 ML20118D0142020-04-30030 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) April 30, 2020 Teleconference Meeting Ebinder ML20125A1452020-04-27027 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) COVID-19 Subcommittee, Draft Report, April 27, 2020 ML20097F4762020-04-0606 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Patient Intervention, Final Report, April 6, 2020 ML20097F5322020-04-0606 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Bylaws Subcommittee, Final Report, April 6, 2020 ML20097F6252020-04-0606 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Interventional Radiology Subcommittee, Final Report, April 6, 2020 ML20085H2672020-03-25025 March 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Regulatory Guide 8.39, Release of Patients Administered Radioactive Material, Draft Final, Revision 1 (Phase 1), Final Report, March 25, 2020 ML20075A0282020-03-0505 March 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Patient Intervention, Draft Report, March 5, 2020 ML20075A0302020-02-25025 February 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Interventional Radiology Subcommittee, Draft Report, February 25, 2020 ML19325E6712019-11-18018 November 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Annual Report FY2019 ML19316E0672019-10-23023 October 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Extravasation, Final Report, October 23, 2019 ML19296D1462019-10-23023 October 2019 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on ACMUI Institutional Memory, Final Report, October 23, 2019 ML19297E9492019-10-23023 October 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Medical Event Reporting, Review of FY2018, Final Report, October 23, 2019 ML19309D4022019-10-23023 October 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Xcision Gammapod Licensing Guidance, Final Report, October 23, 2019 ML19297E8332019-08-19019 August 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Xcision Gammapod Licensing Guidance, Draft Report, August 19, 2019 ML19297H3162019-08-15015 August 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Extravasation, Draft Report, August 15, 2019 ML19184A6222019-07-10010 July 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Bylaws July 2019 ML19171A2222019-06-19019 June 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Draft Proposed Regulatory Guide 8.39, Release of Patients Administered Radioactive Material, Revision 1 (Phase 1), Final Report, June 19, 2019 ML19143A3672019-05-23023 May 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Draft Proposed Regulatory Guide 8.39, Release of Patients Administered Radioactive Materials, Revision 1 (Phase 1), Draft Report. May 23, 2019 ML19130A1032019-05-0909 May 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Yttrium-90 Microsphere Brachytherapy Sources and Devices Licensing Guidance, Revision 10, Final Report, May 9, 2019 ML19126A2962019-05-0606 May 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Germanium-68/Gallium-68 Generator Licensing Guidance, Revision 1, Final Report, May 6, 2019 ML19126A2972019-04-10010 April 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the ACMUI Bylaws, Final Report, April 10, 2019 ML19091A2422019-03-25025 March 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Appropriateness of Medical Event Reporting, Interim Report, March 25, 2019 ML19091A2402019-03-11011 March 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Draft Revision 10 of the Yttrium-90 Microspheres Brachytherapy Sources and Devices Therasphere and SIR-Spheres Licensing Guidance, Draft Report, March 11, 2019 ML19091A2382019-03-0707 March 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the ACMUI Bylaws, Draft Report, March 7, 2019 ML19058A5982019-02-27027 February 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee Report on Training and Experience (T&E) Requirements for All Modalities, Final Report, February 27, 2019 ML19039A1132019-02-0707 February 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee Report on Training and Experience (T&E) for All Modalities, Draft Report, February 7, 2019 ML19091A2562018-11-30030 November 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Germanium-68/Gallium-68 Generator Licensing Guidance, Revision 1, Draft Report, November 30, 2018 ML18253A1242018-08-31031 August 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Draft Revision to the Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon Licensing Guidance, Draft Report, August 31, 2018 ML18201A4172018-07-16016 July 2018 ACMUI Final Report - Comments on the Draft NRC Secy Paper Entitled Staff Evaluation of Training and Experience Requirements for Administering Radiopharmaceuticals. 2023-09-21 Category:Technical MONTHYEARML23136A4592023-05-17017 May 2023
[Table view]Some use of "" in your query was not closed by a matching "".Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Training and Experience for All Modalities, Final Report, May 17, 2023 ML22353A0542022-12-19019 December 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Y-90 Medical Events, Final Report, December 19, 2022 ML22322A1832022-11-18018 November 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Y-90 Medical Events, Draft Report, November 18, 2022 ML22322A1572022-11-18018 November 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Emerging Medical Technologies/Rubidium-82 Generator Rulemaking Draft Regulatory Basis, Draft Report, November 18, 2022 ML22021B2992022-01-21021 January 2022 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on RG 8.39, Release of Patients Administered Radioactive Materials, Review and Comment on the Draft Civaderm Device Licensing Guidance, Final Report, January 21, 2022 ML22021B3002022-01-21021 January 2022 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on RG 8.39, Release of Patients Administered Radioactive Material, Review and Comment on Draft Proposed Revision 2 to Regulatory Guide 8.39, Final Report, January 21, ML21287A6312021-10-14014 October 2021 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Emerging Radiopharmaceutical Therapy Knowledge Requirements in Theranostics Subcommittee, Final Report, October 14, 2021 ML21288A1262021-10-14014 October 2021 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Radionuclide Generator Knowledge and Practice Requirements, Final Report, October 14, 2021 ML21288A1272021-10-14014 October 2021 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommitee on Medical Events, Final Report, October 14, 2021 ML21288A1252021-09-16016 September 2021 Advisory Committee on the Medical Uses of Isotopes (Acmui), Final Report, Subcommittee Review and Comments on NRC Staff Preliminary Evaluation of Radiopharmaceutical Extravasation and Medical Event Reporting ML21287A0742021-07-30030 July 2021 Advisory Committee on the Medical Uses of Isotopes (Acmui), Final Report, Subcommittee Review and Comments on NRC Staff Preliminary Evaluation of Radiopharmaceutical Extravasation and Medical Event Reporting ML21223A0852021-07-30030 July 2021 U.S. Nuclear Regulatory Commission Staff Preliminary Evaluation of Radiopharmaceutical Extravasation and Medical Event Reporting for ACMUI Review ML21227A0012021-06-0101 June 2021 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Abnormal Occurrence Subcommittee, Proposed Revisions to Abnormal Occurrence Medical Event Criteria, Final Report, June 1, 2021 ML20279A8032020-09-24024 September 2020 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Medical Events, Final Report, September 24, 2020 ML20279A6792020-08-11011 August 2020 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Medical Events, Draft Report, August 11, 2020 ML20125A1482020-05-0404 May 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) COVID-19 Subcommittee, Final Report, May 4, 2020 ML20118D0142020-04-30030 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) April 30, 2020 Teleconference Meeting Ebinder ML20125A1452020-04-27027 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) COVID-19 Subcommittee, Draft Report, April 27, 2020 ML20097F4762020-04-0606 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Patient Intervention, Final Report, April 6, 2020 ML20097F5322020-04-0606 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Bylaws Subcommittee, Final Report, April 6, 2020 ML20097F6252020-04-0606 April 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Interventional Radiology Subcommittee, Final Report, April 6, 2020 ML20075A0282020-03-0505 March 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Patient Intervention, Draft Report, March 5, 2020 ML20075A0302020-02-25025 February 2020 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Interventional Radiology Subcommittee, Draft Report, February 25, 2020 ML19316E0672019-10-23023 October 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Extravasation, Final Report, October 23, 2019 ML19296D1462019-10-23023 October 2019 Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on ACMUI Institutional Memory, Final Report, October 23, 2019 ML19297E9492019-10-23023 October 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Medical Event Reporting, Review of FY2018, Final Report, October 23, 2019 ML19309D4022019-10-23023 October 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Xcision Gammapod Licensing Guidance, Final Report, October 23, 2019 ML19297E8332019-08-19019 August 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Xcision Gammapod Licensing Guidance, Draft Report, August 19, 2019 ML19171A2222019-06-19019 June 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Draft Proposed Regulatory Guide 8.39, Release of Patients Administered Radioactive Material, Revision 1 (Phase 1), Final Report, June 19, 2019 ML19143A3672019-05-23023 May 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Draft Proposed Regulatory Guide 8.39, Release of Patients Administered Radioactive Materials, Revision 1 (Phase 1), Draft Report. May 23, 2019 ML19130A1032019-05-0909 May 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Yttrium-90 Microsphere Brachytherapy Sources and Devices Licensing Guidance, Revision 10, Final Report, May 9, 2019 ML19126A2962019-05-0606 May 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Germanium-68/Gallium-68 Generator Licensing Guidance, Revision 1, Final Report, May 6, 2019 ML19126A2972019-04-10010 April 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the ACMUI Bylaws, Final Report, April 10, 2019 ML19091A2422019-03-25025 March 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Appropriateness of Medical Event Reporting, Interim Report, March 25, 2019 ML19091A2402019-03-11011 March 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Draft Revision 10 of the Yttrium-90 Microspheres Brachytherapy Sources and Devices Therasphere and SIR-Spheres Licensing Guidance, Draft Report, March 11, 2019 ML19091A2382019-03-0707 March 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the ACMUI Bylaws, Draft Report, March 7, 2019 ML19058A5982019-02-27027 February 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee Report on Training and Experience (T&E) Requirements for All Modalities, Final Report, February 27, 2019 ML19039A1132019-02-0707 February 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee Report on Training and Experience (T&E) for All Modalities, Draft Report, February 7, 2019 ML19091A2562018-11-30030 November 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Germanium-68/Gallium-68 Generator Licensing Guidance, Revision 1, Draft Report, November 30, 2018 ML18253A1242018-08-31031 August 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Draft Revision to the Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon Licensing Guidance, Draft Report, August 31, 2018 ML18186A5172018-07-0505 July 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Draft T&E Secy Paper, Draft Report, July 5, 2018 ML18177A4512018-06-26026 June 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Nursing Mother Guidelines for Medical Administration of Radioactive Materials, Final Report, June 26, 2018 ML18071A4132018-02-27027 February 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Physical Presence Requirements for the Leksell Gamma Knife Icon, Final Report, February 27, 2018 ML18033B0332018-02-0101 February 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Physical Presence Requirements for the Leksell Gamma Knife Icon, Revised Draft Report, February 1, 2018 ML18033B0342018-02-0101 February 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Nursing Mother Guidelines for Medical Administration of Radioactive Materials, Revised Draft Report, February 1, 2018 ML17293A2482016-09-13013 September 2016 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Yttrium-90 Microsphere Brachytherapy Licensing Guidance, Draft Report, September 13, 2016 ML17293A2492016-09-0808 September 2016 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Comments on the Draft Northstar Molybdenum-99/Technetium-99m Generator (Radiogenixtm) Licensing Guidance, Draft Report, September 8, 2016 2023-05-17 |
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U.S. Nuclear Regulatory Commission Advisory Committee on the Medical Uses of Isotopes Subcommittee on Medical Events Final Report October 23, 2019 Subcommittee Members: Mr. Richard Green, Dr. Ronald D. Ennis (Chair), Dr. Darlene F. Metter, Mr. Michael Sheetz, and Dr. Harvey Wolkov NRC Staff Resource: Ms. Lisa Dimmick Charge The specific charge of this subcommittee is to annually review the medical events (MEs) with an eye to advising the ACMUI and NRC about emerging trends needing regulatory attention.
Background
At the Fall 2018 ACMUI meeting this subcommittee presented an in-depth trend analysis of MEs over a four-year period and made specific recommendations. Because there are relatively few MEs each year and trends in MEs tend to emerge slowly, it was decided that the subcommittee would perform an in depth tend analysis every two years. In the intervening year, the subcommittee would perform a review of MEs of the previous fiscal year looking for urgent issues that need to be addressed immediately and cannot wait for the in-depth review of the following year. The subcommittee herein provides such a report.
Findings The Subcommittee on Medical Events reviewed the Medical Events from FY 2018. Events from each section were reviewed in detail by a subcommittee member with expertise in the area. There were no new notable event types. There were no apparent marked increases in any of the event categories or types compared to prior years.
One area identified by the subcommittee that could emerge in coming years involves new radiopharmaceuticals which have a high activity and are given in a relatively large volume of fluid (i.e. more than a few milliliters). These characteristics increase the risk of MEs and of their potential for serious medical consequences. There are two newer agents that have these features: lutetium-177 dotatate (Lutethra) and iobenguane Iodine-131 (Azedra). The subcommittee will pay particular attention to these agents when it does its next review. The Subcommittee does not recommend any action regarding these agents at this time.
Concluding Remarks The subcommittee looks forward to performing an in depth trend analysis in 2020.
The subcommittee welcomes any comments and/or suggestions.
The ACMUI unanimously approved this report during its fall 2019 meeting on September 10, 2019.
Respectfully Submitted on October 23, 2019, The Medical Event Subcommittee
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