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 ITEMSITEMDATE 1 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
and guidance, if necessary, which should include the issue of patient release to
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.5/24/10ACMUI Action Closed 12/13/10 2 The Permanent Implant Brachytherapy subcommittee will revise the draft subcommittee report and resubmit it to the full ACMUI for an email vote. The
ACMUI will submit a final subcommittee report to the NRC.5/24/10ACMUI ActionClosed 3 NRC staff should provide information that describes safety culture problems as contributing factors to violations.5/25/10NRC action Closed 9/29/10 4 NRC staff should revise the Y-90 microsphere brachytherapy guidance to delete "but before the patient or human research subject leaves the post-prodecural
recovery area" under item 2 of the written directive section.
5/25/10 Partially accepted Closed 1/26/11 5 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
accordance with the pre-adminstration written directive", then 2) "after
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."
5/25/10 Partially accepted Closed 1/26/11 6 NRC staff should consider the necessity and evaluate options to collect or obtain data for the denominator for medical events to improve the overall value of the
medical events subcommitte report.5/25/10Accepted Closed 3/1/11 7 The ACMUI fully supports Dr. Darrell Fisher as Patients' Rights Advocate. The Committee expressed their appeciation and honor to serve with him.5/25/10No NRC actionClosed 8 NRC staff should provide optimal staff and support to facilitate the licensing process for new domestic producers of the medical isotope, molybdenum 99.5/25/10AcknowledgedClosed 9 ACMUI endorses the permanent implant brachytehrapy subcommittee report with the caveat that this is an interim report that may be revised in the future to consider
additional input such as that received from stakeholders at public workshops.10/20/10Accepted Closed 12/22/10 STATUS 1 2010 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE STATUS 10 ACMUI endorses the draft version of FSME Policy and Procedures 2-5, Revision 0 presented at the meeting.10/21/10Accepted Closed 1/21/11 11 Dr. Thomadsen created a subcommittee to prepare a document to guide the December discussion on 10 CFR Part 37. Debbie Gilley (chair), Susan Langhorst, Darrell Fisher.10/21/10ACMUI Action Closed 1/5/11 12 ACMUI will incorporate the comments made during the meeting to revise the patient release subcommittee report. The committee will vote to finalize the report
via email and will resubmit it to NRC in the near future.10/21/10ACMUI Action Closed 12/13/10 13 Steve Mattmuller, Bruce Thomadsen, and Susan Langhorst offered to provide support to respond to the letter dated October 20, 2010, to Chairman Jaczko from
Congressman Markey regarding patient release.10/21/10ACMUI Action Closed 10/21/10 14 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
backup time/date is Wednesday, December 15, 2010 from 11:00 am to 1:00 pm
Eastern.10/21/10ACMUI Action Closed 12/13/10 15 ACMUI endorsed draft Policy and Procedure 2-5 with comments, as reflected in the meeting handout.
12/13/10 Partially accepted Closed 1/12/11 16 ACMUI approved the Patient Release Subcommittee Report, as reflected in the meeting handout.12/13/10Accepted Closed 12/13/10 17 ACMUI will provide a list of action items for NRC staff based on the recommendations provided in the Patient Release Subcommittee Report.12/13/10ACMUI Action Closed 9/22/11 2