ML18099A267
| ML18099A267 | |
| 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: ML18099A267 (2) | |
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2009 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS NRC staff should allow IRs to become AUs for Y-90 microspheres with: 1) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> training in: a) radiation physics & instrumentation; b) radiation protection; c) mathematics pertaining to the use and measurement of radioactivity; d) chemistry of byproduct material for medical use; and e) radiation biology; and 2) work experience under the supervision of an Authorized User involving: a) ordering, receiving, & unpacking radioactive materials safely & performing the related radiation surveys; b) checking survey meters for proper operation; c) examination of each individual; d) calculating, measuring, & safely preparing patient or human research subject dosages; e) using Closed 1 5/7/09 Accepted administrative controls to prevent a medical event involving the use of byproduct 1/26/11 material; f) using procedures to control and to contain spilled byproduct material safely &
using proper decontamination procedures; g) follow up and review of each patient's or human research subject's case history; and h) the operation of and quality management for dose calibrators; and 3) board certification in diagnostic radiology with a subspeciality in interventional radiology or three years supervised clinical experience in diagnostic radiology with one year in interventional radiology NRC staff should revise 35.390(b)(1)(ii)(G)(3) to read "parenteral administration requiring a written directive for any radionuclide that is being used primarily because of its beta Closed 2 emission, or low energy photo-emission, or auger electron; and/or" and revise 5/7/09 Accepted 3/7/18 35.390(b)(1)(ii)(G)(4) to read "parenteral administration requiring a written directive for any radionuclide that is being used primarily because of its alpha particle emission" NRC staff should revise 10 CFR 35.490 & 690 as proposed with one exception. Delete "private practice." The regulation should read "500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience, under the Superseded 3 5/7/09 Closed supervision of an Authorized User who meets the requirements in [35.490 or 35.690] or by item 10 equivalent Agreement State requirements at a medical institution or clinic..."
To prevent reccurrence of events like those at the VA, ACMUI recommends: 1) Every brachytherapy quality assurance program include peer review as published by the No NRC 4 5/7/09 Tabled American Brachytherapy Society and 2) Authorized Users should perform post-implant action dosimetry 1
2009 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS ACMUI will create a subcommittee that includes three members to review ICRP Report 5 5/8/09 Accepted Closed 103 and get back to Dr. Don Cool a) ACMUI came to a consensus on NCRP report 160, which is believed to be scientifically sound and well-written b) ACMUI believes NRC and Agreement States should collect and maintain dose records and keep ACMUI aware of the issues but No NRC 6 should continue a policy of not intervening with medical practice c) ACMUI supports the 5/8/09 Closed action medical principle of "First do no harm" and expressed continued concern about exposure to children d) ACMUI's current belief is that the benefit of medical procedures involving radiation outweighs the risk ACMUI endorsed the subcommittee report for American Board of Radiology candidates No NRC 7 who may experience a delay between the completion of Training and Experience and 5/8/09 Closed action receipt of board certification NRC staff should not require licensees to report therapeutic infiltrations as Medical 8 5/8/09 Not Accepted Closed Events.
Dr. Malmud added three temporary members to the medical events subcommittee: Dr.
ACMUI 9 Welsh (chair), Dr. Langhorst, Mr. Mattmuller. Existing subcommittee members inlcude: 10/19/09 Closed Action Ms. Gilley, Dr. Suleiman, and Dr. Thomadsen.
ACMUI recommends NRC staff delete the phrase "at a medical institution" from 10 CFR Closed 10 10/19/09 Accepted 35.2, 35.490(b)(1)(ii), 35.491(b)(2) and 35.690(b)(1)(ii). 3/7/18 ACMUI recommends NRC staff revise 10 CFR 35.41(a) by adding "(3) If the Motion did 11 administration is not in accordance with the written directive, a determination of whether 10/19/09 Closed not pass it resulted in a reportable medical event will be made in a timely manner."
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