ML18099A350

Advisory Committee on the Medical Uses of Isotopes (ACMUI) 2016 Recommendations and Actions Chart - April 2018

ML18099A350
Person / Time
Issue date:	04/09/2018
From:	Office of Nuclear Material Safety and Safeguards
To:
Holiday, Sophie
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Download: ML18099A350 (14)

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The Committee endorsed that component of the current proposed rule re-defining medical events Closed 1 in permanent implant brachytherapy in terms of activity (i.e. source strength) rather than radiation 1/6/2016 Accepted 3/7/18 dose).

The Committee endorsed, with reservation, designating the current proposed rule re-defining Closed 2 medical events in permanent implant brachytherapy as Compatibility Category C, with activity- 1/6/2016 Accepted 3/7/18 based medical event metrics defined as an essential program element.

The Committee recommended changing the language for a wrong-location medical event in permanent implant brachytherapy from the current proposed language, Closed 3 Sealed source(s) implanted directly into a location where the radiation from the source(s) will not 1/6/2016 Accepted 3/7/18 contribute dose to the treatment site, as defined in the written directive, to Sealed source(s) implanted directly into a location discontiguous from the treatment site, as defined in the written directive.

The Committee recommended revising the passage in lines 4182-4186 on page 167 in the Draft Final Rule as follows, thereby eliminating the dose-based criteria for a leaking source medical event:

Not Closed 4 3) An administration that includes the wrong radionuclide; the wrong individual or 1/6/2016 Accepted 3/7/18 human research subject; a leaking sealed source; or a sealed source or sources implanted into a location discontiguous from the treatment site, as defined in the written directive.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The Committee endorsed the elimination of the preceptor-statement requirement for Board-Closed 5 certified individuals for an individual seeking regulatory authorization as an authorized user, 1/6/2016 Accepted 3/7/18 authorized medical physicist, Radiation Safety Officer, or authorized nuclear pharmacist.

With respect to the amended requirements for preceptor attestation for an individual seeking regulatory authorization as an authorized user, authorized medical physicist, Radiation Safety Officer, or authorized nuclear pharmacist through the alternate pathway, the Committee Closed 6 endorsed changing the language for the preceptor attestation from the individual has achieved 1/6/2016 Accepted 3/7/18 a level of competency to function independently for the authorization to the individual can independently fulfill the radiation safety-related duties associated with the authorization being requested.

The Sub-Committee recommended that the date of recognition by the NRC of a certifying board should not impact individuals seeking to be named as an authorized user, authorized medical physicist, Radiation Safety Officer, or authorized nuclear pharmacist through the certification Closed 7 pathway. During the discussion, this recommendation was modified in the final report as follows: 1/6/2016 Accepted 3/7/18 The Sub-Committee recommends that NRC Staff consider providing guidance in the NUREG-1556, Volume 9 update to licensees on the ways individuals with board certifications prior to NRCs board recognition date may seek authorization.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The Committee recommended that the NRC adopt the parent-breakthrough limits for radioisotope generators specified in the relevant Food and Drug Administration (FDA)-approved package inserts. During the discussion, the Committee ACMUI Closed 8 1/6/2016 recommended to eliminate this recommendation and instead, revise the general comments Action 3/7/18 section of the report to suggest that NRC consider, in future rulemaking, establishing conformity with the FDA breakthrough-limit regulations.

The Committee did not endorse the new requirement in the Draft Final Rule that licensees report to the NRC as well as to the manufacturer/vendor generator elutions with out-of-tolerance parent- Not Closed 9 1/6/2016 breakthrough but, instead, recommends a single reporting requirement to the Accepted 3/7/18 manufacturer/vendor.

The Committee endorsed allowing Associate Radiation Safety Officers (ARSO) to be named on a Closed 10 1/6/2016 Accepted medical license. 3/7/18 The Committee recommended that the designation of a board-certified authorized user, Not Closed 11 authorized medical physicist, or authorized nuclear pharmacist as the Radiation Safety Officer 1/6/2016 Accepted 3/7/18 (RSO) or as an ARSO requires their board certification to include the designation, RSO Eligible.

The Committee did not endorse establishing a separate category of Authorized Users for parenteral administration of alpha-emitting radiopharmaceuticals but, instead, recommends Partially Closed 12 deleting § 35.390(b)(1)(ii)(G)(4) in the current Draft Final Rule and revising the pertinent passage 1/6/2016 Accepted 3/7/18 in § 35.390(b)(1)(ii)(G)(3) as follows, Parenteral administration of any radioactive drug for which a written directive is required.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The Committee endorsed the elimination of the requirement to submit copies of NRC Form 313, Closed 13 Application for Material License, or a letter containing information required by NRC Form 313 1/6/2016 Accepted 3/7/18 when applying for a license, an amendment, or renewal.

The Sub-Committee recommended changing the medical-events language in lines 5531-5532 (page 232) of the Draft Final Rule from, A licensee shall report as a medical event, any administration requiring a written directive, except for an event that results from patient intervention, back to the language in the current Draft Final Rule, A licensee shall report any event, except for an event that results from patient intervention During the discussion, the recommendation was modified in the final report as follows: Not Closed 14 1/6/2016 The Sub-Committee recommends changing the medical-events language in lines 5531- Accepted 3/7/18 5532 (page 232) of the current version of the Draft Final Rule from, A licensee shall report any event, except for an event that results from patient intervention back to the language published in the Proposed Rule as presented for public comment, A licensee shall report as a medical event, any administration requiring a written directive, except for an event that results from patient intervention, The Committee endorsed the 2016 Rulemaking Subcommittee Report with modifications as Closed 15 1/6/2016 NRC Action listed above. 3/7/18 Dr. Alderson formed a subcommittee to review and evaluate the training and experience requirements for all modalities in 10 CFR Part 35. Subcommittee members include: Dr. ACMUI Open 16 2/25/2016 Langhorst, Dr. Metter, Dr. Palestro (chair), Dr. Suh and Ms. Weil. NRC staff resource: Maryann Action Indefinitely Abogunde.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The ACMUI recommended maintaining the current 700 training and experience hours under 10 17 3/10/2016 NRC Action Closed CFR 35.390.

The ACMUI recommended establishing a standing subcommittee to review the training and ACMUI 18 3/10/2016 Closed experience requirements for all modalities under 10 CFR Part 35. Action The ACMUI unanimously endorsed the training and experience for authorized users of alpha, ACMUI 19 3/10/2016 Closed beta, and gamma emitters under 10 CFR 35.390 subcommittee report. Action The NRC staff will provide data to the ACMUI for medical events reported over a five-year span 20 3/17/2016 NRC Action Closed for trending purposes.

Dr. Alderson formed a subcommittee to 1) explore the impact of ME reporting and its impact on self-reporting (safety culture); 2) identify potential ways to improve effectiveness of self-reporting in support of a culture of safety; and 3) suggest ways to share ME reports and lessons-learned ACMUI 21 3/18/2016 Closed with the medical community to promote safety. Subcommittee members include: Mr. Costello, Dr. Action Dilsizian, Dr. Ennis, Dr. Langhorst (chair), and Ms. Weil. Mr. Ouhib will serve as a consultant to the subcommittee. NRC staff resource: Dr. Katie Tapp The NRC staff will provide the ACMUI with the draft final 35.1000 licensing guidance for the 22 Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon. Interested members will be 3/18/2016 NRC Action Closed encouraged to provide comments to the Working Group.

Dr. Langhorst requested that NRC staff provide the ACMUI with the total number of medical use 23 3/18/2016 NRC Action Closed licensees within the United States (NRC and Agreement States).

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The ACMUI will contact their respective professional organizations to request and encourage ACMUI Open 24 3/18/2016 interactions between the NRC and ACMUI with their organization. Action Indefinitely The ACMUI have planned to hold the fall 2016 ACMUI meeting at NRC Headquarters on October ACMUI 25 3/18/2016 Closed 6-7, 2016. The back-up date is September 1-2, 2016. Action The Committee endorsed the elimination of the written directive with the understanding that there 26 will be documentation in the medical record pre-procedure and post-procedure that would allow 6/24/2016 Accepted Closed regulators to determine whether a medical event occurred.

The Committee endorsed the third pathway in which a radiologist could become an authorized user with the listed 80-hours of training and experience. However, the Committee did not support 27 surgeons or others without a significant background in radiation (from a residency or other 6/24/2016 Accepted Closed similarly intense education and practical experience) becoming Authorized Users for RSL with only 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of training.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The Committee endorsed the modified definition of medical events (MEs) with the caveat that such an outcome would not be an ME if the physician makes the determination not to explant the seed for various patient conditions (e.g. doing so would jeopardize the patients wellbeing).

The Committee endorsed this change and supports exclusion from an ME under circumstances in which the physician deems removal would not be in the best interest of the patient.

28 6/24/2016 Accepted Closed Additionally, the Committee endorsed the position that an ME has not occurred if the patient fails to return for the surgical removal procedure, considering this to be an instance of patient intervention, provided the patient has been properly counseled about the importance of returning for the procedure and the risk of radiation exposure if the sources are not removed.

Documentation of this counseling should be made in the patients medical record.

The Committee recommended inclusion of the following in the Draft Guidance:

Patient should be advised not to breast feed from a breast into which one or more radioactive seeds been implanted and not yet removed. Breastfeeding is, of course, permissible once the seed(s) has(ve) been removed. In the event of seed rupture within the breast, the subcommittee recommends the patient be advised to never breast feed from the effected breast for this child. Not 29 6/24/2016 Closed During the discussion, this recommendation was modified as follows: Accepted Patient should be advised not to breast feed from a breast into which one or more radioactive seeds been implanted and not yet removed. Breast feeding is, of course, permissible once the seed(s) has(ve) been removed. In the event of seed rupture within the breast, the subcommittee recommends the patient be advised to never breast feed from either breast for this child.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS ACMUI 30 The Committee endorsed the RSL Subcommittee report with the modifications above. 6/24/2016 Closed Action The Committee recommended that the section entitled, Licensing Guidance, be re-named, Purpose, and re-located to the beginning of the Guidance (i.e., immediately following the Table of Contents). An explicit statement such as the following should be included, This Guidance 31 8/10/2016 NRC Action Closed provides applicants with an acceptable means of satisfying the requirements for a license for the use of a column based Ge-68/Ga-68 generator for producing Ga-68 to be used in the preparation of Ga-68 radiopharmaceuticals.

The Committee recommended to provide clarification of what is regulated under 10 CFR 35.200 and 10 CFR 35.1000. The guidance should state that the regulation of Ga-68 radiopharmaceuticals under 10 CFR 35.200 applies to patient dosages obtained from appropriately trained authorized users or authorized nuclear pharmacists within a medical facility as well as from commercial nuclear pharmacies. Accordingly, the Committee recommended revisions of the passage in lines 73-84 on page 2 of the Licensing Guidance, including the section entitled, Commercial Nuclear Pharmacy User under 10 CFR 30.33, as follows:

Use of Ga-68 Radiopharmaceuticals 32 Please note that licensees that use unit dosages of Ga-68 radiopharmaceuticals for medical 8/10/2016 NRC Action Closed imaging and localization studies will be regulated under 10 CFR 35.200 and authorized users (AUs) must comply with the requirements of 10 CFR 35.290. The licensee may use a Ga-68 radiopharmaceutical that is prepared from the elution of a Ge-68/Ga-68 generator for medical use for imaging and localization studies that is either:

1) Obtained in a manner described in 10 CFR 35.200 (c) or (d);

2) Obtained from a manufacturer or preparer licensed under 10 CFR 32.72 or equivalent Agreement State requirements and has made commitments as described in this guidance; or, 8

2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS

3) Prepared by an authorized nuclear pharmacist (ANP); a physician who is an AU who meets the requirements of this license guidance and the requirements specified in 10 CFR 35.290, or 10 CFR 35.390 and 10 CFR 35.290(c)(1)(ii)(G); or an individual under the supervision, as specified in 10 CFR 35.27, of the ANP or the physician who is an AU and have made commitments as described in this guidance.

Licensees that use cyclotron-produced Ga-68 radiopharmaceuticals for medical imaging and localization studies will be regulated under 10 CFR 35.200 and AUs must meet 10 CFR 35.290.

33 The Committee recommended to modify the language in the Use of Ge-68/Ga-68 Generators Section to the following language:

Use of Ge-68/Ga-68 Generators Recently, the FDA approved a gallium-68 (Ga-68) radiopharmaceutical for diagnostic imaging of somatostatin receptor (SSR)-positive neuroendocrine tumors. Ga-68 is a positron emitter which allows Ga-68 radiopharmaceuticals to be imaged using positron emission tomography (PET) in a 8/10/2016 NRC Action Closed manner similar to fluorine-18 (F-18) radiopharmaceuticals. Ga-68 produced in a cyclotron, like F-18, may be used to produce Ga-68 radiopharmaceuticals for use under 10 CFR 35.200.

However, unlike F-18, Ga-68 can also be produced from the elution of a Ge-68/Ga-68 generator to prepare Ga-68 radiopharmaceuticals. As such, the Ge-68/Ga-68 generator eluate generally cannot be used directly in patients for imaging, but only as a precursor for the preparation of Ga-68-labeled radiopharmaceuticals.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS 34 The Committee agreed with the recommendation to modify the language in the Authorized Individuals Section to the following language:

4) Meets the criteria under 10 CFR 35.290, Training for imaging and localization studies;

5) Has completed the following training in the use of a Ge-68/Ga-68 generator for producing Ga-68 radiopharmaceuticals for 35.200 use:

8/10/2016 NRC Action Closed

a. elution and quality control procedures needed to determine Ga-68 activity and Ge-68 breakthrough levels appropriate for the preparation of radiopharmaceuticals for imaging and localization studies;

b. measuring and testing the eluate for radionuclidic purity; and

c. safety procedures for the use of the Ge-68/Ga-68 generator.

The Committee agreed with the recommendation to modify the language in the Training for individuals other than AUs and ANPs Section to the following language:

Training for individuals others than AUs and ANPs 35 8/10/2016 NRC Action Closed The applicant shall commit to provide training in the licensees procedures to all individuals involved in Ge-68/Ga-68 generator use for the production of Ga-68 radiopharmaceuticals for 35.200 use, commensurate with the individuals duties to be performed. This training must be provided to all individuals eluting the generator or preparing, or measuring the Ga-68 unit dose.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The Committee agreed with the recommendation to modify the language in the Radiation Protection Program Changes Section to the following language:

This guidance may be revised as additional experience is gained regarding the use of a Ge-68/Ga-68 generator for preparation of Ga-68 radiopharmaceuticals for 35.200 use. An applicant 36 8/10/2016 NRC Action Closed initially applying for authorization for use of Ge-68/Ga-68 generator under this 35.1000 use may request to incorporate into its license a change process similar to 10 CFR 35.26. Such a change process can allow some future changes without the need to amend the license to radiation safety programs provided that the change process requires the following conditions to be met for revisions to the radiation safety program:

ACMUI 37 The Committee endorsed the Ge-68/Ga-68 Subcommittee report. 8/10/2016 Closed Action Dr. Alderson requested that the ACMUI discuss the nursing mothers guidelines during the Spring ACMUI 38 10/6/16 Closed 2017 ACMUI Meeting. Action The Committee recommended that staff issue a generic communication (information notice) 39 regarding tubing issues (kinking, connection, hub etc.) during the administration of Y-90 10/6/16 NRC Action Open microspheres brachytherapy.

Dr. Pat Zanzonico stepped down from the subcommittee. Dr. Alderson appointed Mr. Frank Costello to the Medical Event Reporting for All Modalities Excluding Permanent Implant ACMUI 40 Brachytherapy Subcommittee. Subcommittee membership includes: Mr. Costello, Dr. Dilsizian, 10/6/16 Closed Action Dr. Ennis, Dr. Palestro, and Dr. Suh (Chair). Mr. Ouhib will be added to the subcommittee once he receives full voting rights. Dr. Katie Tapp is the NRC resource.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS Dr. Alderson re-established the Patient Intervention Subcommittee. The subcommittee's new charge is to make a recommendation on what the definition of "patient intervention" should be. ACMUI 41 10/6/16 Open Subcommittee membership include: Mr. Costello, Dr. Dilsizian (Chair), Dr. Ennis, Dr. Suh, and Action Ms. Weil. Ms. Maryann Abogunde is the NRC resource.

The Committee recommended that the Pathway 2 remain for the Y-90 Microsphere 42 Brachytherapy Licensing Guidance. The NRC/OAS working group should determine what the 10/7/16 NRC Action Open requirements should be for the proctoring of cases by the manufacturer(s).

The Committee recommended to support the update to the waste disposal section and the 43 review of the Y-90 radiation safety issues in autopsy and cremation in the draft revision of the Y- 10/7/16 NRC Action Open 90 Microsphere Brachytherapy Licensing Guidance.

For the NorthStar Guidance Subcommittee: The Committee recommended that NorthStar 44 10/7/16 NRC Action Closed provide a video clip of how the system operates in the training module.

For the NorthStar Guidance Subcommittee: Given the unique design and operation of the 45 NorthStar system, the Committee agreed that NorthStar should have sole responsibility for the 10/7/16 NRC Action Closed content of the training course and certification.

For the NorthStar Guidance Subcommittee: The Committee stated that it is important to clarify that a System Administrator can be any individual assigned by the AU without a specifically 46 10/7/16 NRC Action Closed defined educational or training background. Given the unique role of the System Administrator, perhaps that individual should be named on the license.

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2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS For the NorthStar Guidance Subcommittee:The Committee recommended an explicit statement regarding the System Administrator Designee, although it may not have been intended, one 47 could infer from the description of the system administrator designee that there can be only one 10/7/16 NRC Action Closed designee. Presumably, there can, and should, be multiple System Administrator designees.

For the NorthStar Guidance Subcommittee:The Committee recommended that the appropriate time period allotted for training on the changes and the responsibility of the 48 10/7/16 NRC Action Closed vendor/manufacturer to inform and train the applicants on changes in a timely manner be specified.

For the NorthStar Guidance Subcommittee: The Committee recommended that the guidance clarify whether the generator will be non-operational until ALL individuals handling the generator 49 are trained in the changes, including the AU, RSO, system administrator, etc. or does it require 10/7/16 NRC Action Closed only the AU to be trained on the changes. If the latter, once the AU is trained on the changes, is the AU then solely responsible for training all others on these changes? This should be stated.

For the NorthStar Guidance Subcommittee: The Committee recommended using the term, 50 individual tasks throughout the document for consistency and to clarify that there is only one 10/7/16 NRC Action Closed protocol and software program with this system.

For the NorthStar Guidance Subcommittee: The Committee recommended that the 51 10/7/16 NRC Action Closed manufacturers procedures be reviewed and incorporated into the Licensing Guidance itself.

For the NorthStar Guidance Subcommittee: The Committee recommended that the term higher 52 than expected be defined in terms of a maximum specific exposure or exposure-rate limit which 10/7/16 NRC Action Closed a survey meter should be capable of measuring.

The Committee endorsed the NorthStar Mo-99/Tc-99m Generator (RadioGenix) Subcommittee ACMUI 53 10/7/16 Closed Report. Action 13

2016 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The Committee tentatively scheduled the Spring 2017 Meeting for March 20-21, 2017. The back- ACMUI 54 10/7/16 Closed up dates are April 25-28, subject to Commission availability. Action 14