ML23136B251
| ML23136B251 | |
| Person / Time | |
|---|---|
| Issue date: | 05/18/2023 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Metter D Advisory Committee on the Medical Uses of Isotopes |
| References | |
| Download: ML23136B251 (3) | |
Text
May 18, 2023 MEMORANDUM TO: Darlene Metter, M.D., Chair Advisory Committee on the Medical Uses of Isotopes Signed by Einberg, Christian FROM: Christian Einberg, Branch Chief on 05/18/23 Medical Safety and Events Assessments Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
RESPONSES TO THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES RECOMMENDATIONS ON Y-90 MICROSPHERE MEDICAL EVENTS Below are the U.S. Nuclear Regulatory Commissions (NRC) staff responses to the recommendations and comments from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on yttrium-90 (Y-90) microsphere medical events. The ACMUI provided these recommendations to the NRC staff on December 19, 2022. The full report from the ACMUI can be found in Agencywide Documents Access and Management System (ADAMS) at Accession No. ML22353A054.
Recommendations
- 1. ACMUI recommendation: The NRC or the ACMUI should also consider publishing a journal article or give a presentation at a national meeting to reach licensees.
NRC Response: Accepted. The NRC staff has reached out to the Society of Interventional Radiology to establish a relationship and provide communication to its members regarding past medical events and common corrective actions.
- 2. ACMUI recommendation: The NRC should evaluate the utility of the software programs and checklists provided by the microsphere vendors. A regular review of these tools can improve the licensees understanding of these software devices, assist vendors with further development of these tools, and potentially catch inconsistencies between vendors and with NRC regulations and recommendations.
NRC Response: Accepted. The NRC will track Y-90 microsphere medical events for the next two years to see if vendor tools are associated with any of the events. If vendor tools are found to have been associated with medical events, the NRC may evaluate them further as part of medical event follow-up to determine if any inconsistencies exist between vendors and NRC regulations.
- 3. ACMUI recommendation: The NRC should issue information notices (IN) to alert licensees of MEs [medical events] and, where possible, make recommendations and
D. Metter 2 suggest measures licensees can take to prevent similar events in the future. These recommendations can be used by the NRC and the vendors to serve as additional learning tools to prevent MEs.
Response: Not accepted. In 2019, the NRC issued two INs to alert licensees to similar medical events and provided similar measures as recommendations to prevent events in the future. Therefore, the NRC staff does not plan to issue another IN at this time based on this recommendation. Instead, the NRC will continue to monitor medical events to determine if another information notice is necessary at a later date. At this time, the NRC will focus on other communications such as webinars and presentations at professional society meetings as described below to ensure more users of Y-90 microspheres learn about these recommendations to prevent medical events.
- 4. ACMUI Recommendation: NRC or the ACMUI should also consider publishing a journal article or give a presentation at a national meeting to reach licensees.
NRC Response: Accepted. The NRC has reached out to the Society of Interventional Radiology (SIR) to establish a relationship. The NRC plans to provide SIR with a webinar on Y-90 microsphere licensing, guidance, and these recommendations in June 2023.
ML23136B251 OFFICE NMSS/MSST/MSEB NMSS/MSST NMSS/MSST/MSEB CValentin-Rodriguez NAME KTapp KT CEinberg CE CV DATE May 17, 2023 May 18, 2023 May 18, 2023