ML18099A266
| ML18099A266 | |
| 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: ML18099A266 (7) | |
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2008 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 2
NRC staff should pursue rulemaking to allow more than one RSO Closed on a medical use license with the indication of one RSO as the 4/28/08 Accepted 3/7/18 individual in charge.
3 NRC staff should promptly notify ACMUI members in a separate 4/28/08 Accepted Ongoing memo when an ACMUI recommendation is not accepted.
4 ACMUI form a subcommittee, which includes*: Dr. Darrell Fisher, Mr. Ralph Lieto, Dr. Bruce Thomadsen (Chair), and Dr. Richard Vetter. The subcommittees charge is to evaluate the efficacy and cost of cesium chloride versus current and proposed x-ray No NRC Closed 4/28/08 technologies and cobalt. The subcommittee will also evaluate action 10/13/08 security issues. *Dr. Malmud added the following members to the subcommittee on April 29, 2008: Ms. Debbie Gilley, Dr. Orhan Suleiman, and Dr. James Welsh.
5 NRC staff should incorporate the subcommittees recommendations Closed for the Leksell Gamma Knife Elekta Perfexion' in future 4/28/08 Accepted 3/7/18 rulemaking.
6 Dr. Subir Nag suggested ACMUI form a subcommittee to discuss the permanent implant brachytherapy rulemaking. The Motion did subcommittee would include : Dr. Nag, Dr. Bruce Thomadsen, and 4/28/08 Closed not pass Dr. James Welsh. The subcommittee could consult with other knowledgeable individuals, as necessary.
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2008 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 7 Dr. Leon Malmud, ACMUI Chairman, requested NRC staff email Dr.
Closed Nag separately once the permanent implant brachytherapy 4/28/08 Accepted 8/7/08 proposed rule is published.
8 NRC staff should arrange a public full Committee teleconferenced Closed meeting in July to discuss the permanent implant brachytherapy 4/28/08 Accepted 7/21/08 rulemaking.
9 NRC staff should revise the AO criteria to read, A medical event that results in: 1) death; or 2) a significant impact on patient health that would result in permanent functional damage or a significant 4/28/08 Accepted Closed adverse health effect that would not have been expected from the treatment regimen, as determined by an NRC or Agreement State designated consultant physician.
10 NRC staff should incorporate the three hands-on, in-vitro, simulated cases approach as proposed during the meeting. Additionally, NRC staff should indicate when it is appropriate for a licensee to submit a Closed license amendment to add the AU or Y-90 microspheres to the 4/29/08 Accepted 8/21/08 license. Lastly, NRC staff should add a statement to the guidance to require the manufacturer to proctor the first three cases performed by an AU.
11 NRC staff should make all of the changes as proposed, except on Closed page 2 the word post-operative should be replaced with post- 4/29/08 Accepted 9/10/08 procedural.
12 NRC staff should send an EDO daily note indicating the ACMUI Closed discussed the Part 35 Implant Brachytherapy Rulemaking at the 7/21/08 Accepted 7/24/08 7/21/08 ACMUI teleconference. 2
2008 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 13 NRC staff should proceed with SECY-08-0080 and publish the proposed rule in the Federal Register, as directed by the Closed 7/21/08 Accepted Commission. (ACMUI will submit comments during the 75-day 8/6/08 comment period.)
14 ACMUI should form a subcommittee for the permanent implant brachytherapy rulemaking. The subcommittee's charge is to meet No NRC Closed within the next two weeks to prepare ACMUI's comments on the 7/21/08 action 11/5/08 proposed rulemaking. The subcommittee includes: Dr. Nag (chair),
Mr. Lieto, Dr. Thomadsen, Dr. Vetter, and Dr. Welsh.
15 NRC staff should provide a status update on the technical basis for Closed 7/21/08 Accepted the Ritenour/AAPM petition at the October 2008 ACMUI meeting 10/28/08 16 NRC staff should distribute request letters for information on the Closed individuals impacted by the Ritenour/AAPM petition to the certifying 7/21/08 Accepted 10/08 boards as well as professional societies.
17 NRC staff should allow the manufacturers to continue to use their current standards for proctoring the first three patient cases for new Authorized Users. For Sirtex, at least the first two cases will be 7/21/08 Accepted Closed proctored by a physician. For MDS Nordion, all three cases will be proctored by an MDS Nordion employee.
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2008 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 18 NRC staff agreed to consider incorporating the subcommittees recommendations from the August 1, 2008 Fingerprinting Subcommittee Report in NRCs Questions and Answers with 10/27/08 Pending Open Regards to Fingerprinting and Criminal History Records Checks or use another appropriate method of communication to transmit the information to licensees.
19 NRC staff should accept the six recommendations of the Permanent Implant Brachytherapy Subcommittee report with one modification.
Recommendation six should be modified to read, When a Written Open 10/27/08 Pending Directive (WD) is required, administrations without a prior WD are to Delayed be reported as regulatory violations and may or may not constitute an ME.
20 The ACMUI endorsed the permanent implant brachytherapy No NRC Closed 10/27/08 subcommittee report. action 10/27/08 21 The ACMUI formed a subcommittee to draft a set of proposed qualifications that IRs must satisfy to become AUs for Y-90 No NRC Closed microspheres. The subcommittee includes: Dr. Bruce Thomadsen 10/27/08 action 5/8/09 (chair), Dr. Douglas Eggli, Dr. Subir Nag, Dr. James Welsh, and Mr.
Steve Mattmuller.
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2008 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 22 ACMUI encouraged NRC staff to begin the rulemaking process to move the medical use of Y-90 microspheres from 10 CFR 35.1000 Partially Closed to another section of the regulations, so that the training and 10/27/08 accepted 3/7/18 experience requirements for AUs can be vetted though the public review process instead of residing in guidance space.
23 The ACMUI strongly encourages NRC to: (1) continue supporting the exportation of HEU material for Mo-99 targets used by Acknowle Closed 10/28/08 international producers; (2) provide all possible help towards the dged 4/23/09 development of US producers of Mo-99.
24 ACMUI formed a subcommittee to develop a solution that satisfies both the training needs of the residency program and the NRC requirements for achieving AU status using the board certification pathway. The subcommittee should create a recommendation to be No NRC Closed 10/28/08 discussed at a future teleconference prior to the spring 2008 ACMUI action 5/8/09 meeting. The subcommittee includes: Dr. Douglas Eggli (chair), Dr.
Subir Nag, Dr. William Van Decker, and Dr. Mickey Guiberteau (technical assistance).
25 NRC staff should revise 10 CFR 30.35(b) to allow licensees to Not Closed 10/28/08 exceed the limits short term (e.g. 60 days) during source exchange. Accepted 5/24/10 5
2008 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 26 NRC staff should revise 10 CFR 35.40 to clarify that the AU should Open sign and date both the pre-implantation and post-implantation 10/28/08 Accepted Delayed portions of the WD for all modalities with two part WDs 27 NRC staff should revise 10 CFR 35.40 to clarify that an AU, not the AU, should sign and date both the pre-implantation and post-implantation portions of the WD for all modalities with two part WDs. Open 10/28/08 Accepted
[Note this allows for one AU to sign the pre-implantation portion of Delayed the WD and another AU to sign the post-implantation portion of the WD]
28 NRC staff should revise 10 CFR 35.65 to clarify it does not apply to sources used for medical use; however, NRC should not require licensees to list the transmission sources as a line item on the Closed license. NRC staff should also revise 10 CFR 35.590 to permit the 10/28/08 Accepted 3/7/18 use of transmission sources under 10 CFR 35.500 by AUs meeting the training and experience requirements of 10 CFR 35.590 or 35.290.
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2008 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 29 NRC staff should revise 10 CFR 35.204(b) to require a licensee that uses Mo 99/Tc-99m generators for preparing a Tc-99m radiopharmaceutical to measure the Mo-99 concentration of each Closed 10/28/08 Accepted eluate after receipt of a generator to demonstrate compliance with 3/7/18 not administering to humans more than 0.15 microcurie Mo-99 per millicurie Tc-99m.
30 NRC staff should require licensees to report to the NRC events in Closed which licensees measure molybdenum breakthrough that exceeds 10/28/08 Accepted 3/7/18 the regulatory limits.
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