ML18099A263
| ML18099A263 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes, Office of Nuclear Material Safety and Safeguards |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18099A263 (2) | |
Text
2010 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS Dr. Thomadsen created a subcommittee to evaluate patient release issues; to objectively review and analyze available data, which may include state regulations and guidance and international recommendations; to provide a statement on the issue; and to provide recommendations for improvements to existing NRC rules Closed 1 and guidance, if necessary, which should include the issue of patient release to 5/24/10 ACMUI Action 12/13/10 hotels. Subcommitte members include: Dr. Darrell Fisher, Ms. Debbie Gilley, Dr.
Susan Langhorst (chair), Mr. Steve Mattmuller, Dr. Orhan Suleiman, Dr. Bruce Thomadsen, Dr. James Welsh, Dr. Pat Zanzonico. The subcommitte should report to the full ACMUI at the fall meeting.
The Permanent Implant Brachytherapy subcommittee will revise the draft 2 subcommittee report and resubmit it to the full ACMUI for an email vote. The 5/24/10 ACMUI Action Closed ACMUI will submit a final subcommittee report to the NRC.
NRC staff should provide information that describes safety culture problems as Closed 3 5/25/10 NRC action contributing factors to violations. 9/29/10 NRC staff should revise the Y-90 microsphere brachytherapy guidance to delete Partially Closed 4 "but before the patient or human research subject leaves the post-prodecural 5/25/10 accepted 1/26/11 recovery area" under item 2 of the written directive section.
NRC staff should revise the Y-90 microsphere brachytherapy guidance to read (under 1 for written directives) "and, if the procedure was not performed in Partially Closed 5 5/25/10 accordance with the pre-adminstration written directive", then 2) "after accepted 1/26/11 administration and within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the procedure, the signature of an AU."
NRC staff should consider the necessity and evaluate options to collect or obtain Closed 6 data for the denominator for medical events to improve the overall value of the 5/25/10 Accepted 3/1/11 medical events subcommitte report.
The ACMUI fully supports Dr. Darrell Fisher as Patients' Rights Advocate. The 7 5/25/10 No NRC action Closed Committee expressed their appeciation and honor to serve with him.
NRC staff should provide optimal staff and support to facilitate the licensing 8 5/25/10 Acknowledged Closed process for new domestic producers of the medical isotope, molybdenum 99.
ACMUI endorses the permanent implant brachytehrapy subcommittee report with Closed 9 the caveat that this is an interim report that may be revised in the future to consider 10/20/10 Accepted 12/22/10 additional input such as that received from stakeholders at public workshops.
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2010 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS ACMUI endorses the draft version of FSME Policy and Procedures 2-5, Revision 0 Closed 10 10/21/10 Accepted presented at the meeting. 1/21/11 Dr. Thomadsen created a subcommittee to prepare a document to guide the Closed 11 December discussion on 10 CFR Part 37. Debbie Gilley (chair), Susan Langhorst, 10/21/10 ACMUI Action 1/5/11 Darrell Fisher.
ACMUI will incorporate the comments made during the meeting to revise the Closed 12 patient release subcommittee report. The committee will vote to finalize the report 10/21/10 ACMUI Action 12/13/10 via email and will resubmit it to NRC in the near future.
Steve Mattmuller, Bruce Thomadsen, and Susan Langhorst offered to provide Closed 13 support to respond to the letter dated October 20, 2010, to Chairman Jaczko from 10/21/10 ACMUI Action 10/21/10 Congressman Markey regarding patient release.
ACMUI planned a teleconference to discuss 10 CFR Part 37 rulemaking and safety culture on Monday, December 13, 2010, from 1:00 pm to 3:00 pm Eastern. The Closed 14 10/21/10 ACMUI Action backup time/date is Wednesday, December 15, 2010 from 11:00 am to 1:00 pm 12/13/10 Eastern.
15 ACMUI endorsed draft Policy and Procedure 2-5 with comments, as reflected in the Partially Closed 12/13/10 meeting handout. accepted 1/12/11 16 ACMUI approved the Patient Release Subcommittee Report, as reflected in the Closed 12/13/10 Accepted meeting handout. 12/13/10 17 ACMUI will provide a list of action items for NRC staff based on the Closed 12/13/10 ACMUI Action recommendations provided in the Patient Release Subcommittee Report. 9/22/11 2