ML19081A145

Advisory Committee on the Medical Uses of Isotopes (ACMUI) April 3-4, 2019 Meeting Ebinder

ML19081A145
Person / Time
Issue date:	03/22/2019
From:	Office of Nuclear Material Safety and Safeguards
To:
Jamerson, Kellee
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Download: ML19081A145 (78)

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MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 3-4, 201 9 Three White Flint North Building, 11601 Landsdown Street, Room 1-C03/1-C05, North Bethesda, Maryland 20852 NOTE: Sessions of the meeting may be closed pursuant to 5 U.S.C.

552(b) to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACMUI; information the release of which would constitute a clearly unwarranted invasion of personal privacy; information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action; and disclosure of information which would risk circumvention of an agency regulation or statute.

Wednesday, April 3, 2019 OPEN SESSION

1. Opening Remarks Mr. Einberg will formally open the meeting and Ms. Kock will provide opening remarks. C. Einberg, NRC A. Kock, NRC

2. Old Business Ms. Holiday will review past ACMUI recommendations and provide NRC responses.

S. Holiday, NRC 8:30 - 10:30 3. Open Forum The ACMUI will identify medical topics of interest for further discussion.

ACMUI 4. Yttrium-90 Microspheres Brachytherapy Licensing Guidance Subcommittee Report Dr. O'Hara will discuss the subcommittee's recommendations on the NRC's draft Revision 10 to the Yttrium

-90 Microspheres Brachytherapy Licensing Guidance. M. O'Hara, ACMUI 5. Lucerno Dynamic's LARA Infiltration Detection Mr. Lattanze will provide an overview about a product that can assist with detecting nuclear medicine injection infiltrations.

R. Lattanze, Lucerno Dynamics 10:30 - 10: 45 BREAK 10:45 - 12:00 6. Summary of Changes to 10 CFR Part 35 Ms. Dimmick will discuss the changes to the final rule 10 CFR Part 35 that went into effect January 201

9. L. Dimmick, NRC

7. Germanium-68/Gallium-68 Subcommittee Report Ms. Shober will discuss the subcommittee's recommendations on the NRC's draft revision to the Germanium

-68/Gallium

-68 Pharmacy Grade Generator Licensing Guidance. M. Shober, ACMUI 1 2: 00 - 1:00 LUNCH 8. Medical Related Events Dr. Howe will provide an update on recent medical events.

DB. Howe, NRC 1:00 - 2:45 9. Appropriateness of Medical Event Reporting Subcommittee Report Dr. Ennis will discuss the subcommittee's recommendations on the appropriateness of the required medical event reporting in accordance with 10 CFR 35.3045.

R. Ennis, ACMUI

2:45 - 3:15 BREAK (public portion ends)

WEDNESDAY, APRIL 3, 2019 CLOSED SESSION 3:15 - 5:00 10. ACMUI Working Session: Biennial Evaluations and Commission Meeting Presentation Development ACMUI THURSDAY, APRIL 4, 2019 OPEN SESSION

11. ACMUI Reporting Structure Members will discuss the reporting structure of the Committee and provide feedback to the NRC staff.

K. Jamerson, NRC 8: 3 0 - 9: 30 12. Special Presentation to Ms. Weil Mr. Moore will make a special presentation to Ms. Laura Weil S. Moore, NRC

13. Thoughts on Leaving the ACMUI Ms. Weil will share her thoughts on leaving the ACMUI, after serving two full terms (8 years).

L. Weil, ACMUI 9:30 - 10:00 BREAK 10:00 - 12:15 14. Commission Meeting with the ACMUI The ACMUI will brief the Commission on various topics in a public meeting.

ACMUI 15. Group Photo The ACMUI will take a group photo with and without the Commission.

ACMUI 12:15 - 1:15 LUNCH 16. ACMUI Bylaws Subcommittee Report Ms. Weil will discuss the subcommittee's recommendations for changes to the ACMUI's Bylaws

- with particular focus on the ACMUI Chair's role with respect to subcommittees.

L. Weil, ACMUI 1:15 - 2:45 17. Open Forum The ACMUI will discuss medical topics of interest previously identified.

ACMUI 18. Administrative Closing Ms. Jamerson will provide a meeting summary and propose dates for the fall 2019 meeting.

K. Jamerson, NRC 2:45 ADJOURN Opening Remarks NO HANDOUT

2007 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 33 NRC staff should modify 10 CFR 35.491(b)(2) to specify 'superficial' ophthalmic treatments. Additionally, NRC staff should change the title of 10

CFR 35.491 to specify 'superficial' ophthalmic treatments.10/22/07Accepted Open Delayed 34 NRC staff should not revise 10 CFR 35.491 (intended for ophthalmologists) to include training and experience for the new intraocular device. Instead, NRC staff should regulate the new intraocular device under 10 CFR 35.490.

10/22/07 Partially Accepted Open Delayed STATUS 1 2008 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 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

Directive (WD) is required, administrations without a prior WD are to

be reported as regulatory violations and may or may not constitute

an ME."10/27/08Pending Open Delayed 26 NRC staff should revise 10 CFR 35.40 to clarify that the AU should sign and date both the pre-implantation and post-implantation

portions of the WD for all modalities with two part WDs10/28/08Accepted Open Delayed 27NRC 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.

[Note this allows for one AU to sign the pre-implantation portion of

the WD and another AU to sign the post-implantation portion of the

WD]10/28/08Accepted Open Delayed STATUS 1 2011 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 6 ACMUI created an action item to reevaluate its satisfaction with the reporting structure annually.

1/12/11 ACMUI Action Open indefinitely STATUS 1 2016 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 16Dr. 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.

Langhorst, Dr. Metter, Dr. Palestro (chair), Dr. Suh and Ms. Weil. NRC staff resource: Maryann

Abogunde.2/25/2016ACMUI Action Open Indefinitely 24The ACMUI will contact their respective professional organizations to request and encourage interactions between the NRC and ACMUI with their organization. 3/18/2016ACMUI Action Open Indefinitely 39The Committee recommended that staff issue a generic communication (information notice) regarding tubing issues (kinking, connection, hub etc.) during the administration of Y-90 microspheres brachytherapy. 10/6/16NRC Action Open 42The Committee recommended that the Pathway 2 remain for the Y-90 Microsphere Brachytherapy Licensing Guidance. The NRC/OAS working group should determine what the requirements should be for the proctoring of cases by the manufacturer(s). 10/7/16NRC Action Open 43The Committee recommended to support the update to the waste disposal section and the review of the Y-90 radiation safety issues in autopsy and cremation in the draft revision of the Y-90 Microsphere Brachytherapy Licensing Guidance. 10/7/16NRC Action Open 44For the NorthStar Guidance Subcommittee: The Committee recommended that NorthStar provide a video clip of how the system operates in the training module.10/7/16NRC Action Open 45For the NorthStar Guidance Subcommittee: Given the unique design and operation of the NorthStar system, the Committee agreed that NorthStar should have sole responsibility for the content of the training course and certification. 10/7/16NRC Action Open 46For 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 defined educational or training background. Given the unique role of the System Administrator, perhaps that individual should be named on the license. 10/7/16NRC Action Open STATUS 1 2016 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE STATUS 47For the NorthStar Guidance Subcommittee:The Committee recommended an explicit statement regarding the System Administrator Designee, although it may not have been intended, one could infer from the description of the system administrator designee that there can be only one designee. Presumably, there can, and should, be multiple System Administrator designees. 10/7/16NRC Action Open 48For the NorthStar Guidance Subcommittee:The Committee recommended that the appropriate time period allotted for training on the "changes" and the responsibility of the vendor/manufacturer to inform and train the applicants on changes in a timely manner be specified.10/7/16NRC Action Open 49For the NorthStar Guidance Subcommittee: The Committee recommended that the guidance clarify whether the generator will be "non-operational" until ALL individuals handling the generator are trained in the changes, including the AU, RSO, system administrator, etc. or does it require 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. 10/7/16NRC Action Open 50For the NorthStar Guidance Subcommittee: The Committee recommended using the term, "individual tasks" throughout the document for consistency and to clarify that there is only one protocol and software program with this system. 10/7/16NRC Action Open 51For the NorthStar Guidance Subcommittee: The Committee recommended that the manufacturer's procedures be reviewed and incorporated into the Licensing Guidance itself. 10/7/16NRC Action Open 52For the NorthStar Guidance Subcommittee: The Committee recommended that the term "higher than expected" be defined in terms of a maximum specific exposure or exposure-rate limit which a survey meter should be capable of measuring.10/7/16NRC Action Open 53The Committee endorsed the NorthStar Mo-99/Tc-99m Generator (RadioGenix) Subcommittee Report. 10/7/16ACMUI Action Open 2 2017 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 1 The Committee requested that the recommendations and actions pertaining to the Part 35 rulemaking be reviewed during the fall 2017 ACMUI meeting and that additional time

be provided to review each item.4/26/2017NRC ActionOpen 13 The ACMUI recommended that the NRC establish a program allowing a medical use licensee to evaluate MEs as described in 10 CFR 35.3045, in NRC 10 CFR 35.1000

licensing guidance, and in 10 CFR 35.3047 with an approved patient safety program.9/11/2017NRC ActionOpen 14 The ACMUI recommended that NRC licensees with an NRC-approved patient safety program will continue to report medical events as required with the following conditions:

(1) The NRC will not include this event notification in the Event Notification Report posted

on its website. If this is not possible, the ME notification posted on the website will leave

the licensee information and location anonymous. (2) The NRC will not conduct a

reactive inspection of the ME unless the event results or will result in death, unintended

permanent harm, or unintended significant temporary harm for which medical

intervention was or will be required to alleviate the harm or reduce radiation effects. (3)

The medical use licensee will write a report available for the next NRC inspection

describing the event cause and corrective action taken. (4) NRC will develop, with

ACMUI advice, new temporary inspection procedures for NRC review of licensee patient

safety event reports, and will evaluate, with ACMUI advice, need to change enforcement

manual procedures regarding MEs to support a test of this program. 9/11/2017NRC ActionOpen STATUS 1 2017 ACMUI RECOMMENDATIONS AND ACTION ITEMS 15 The ACMUI recommended that NRC should test out this program with two large medical centers, two community hospitals, two rural hospitals, and two patient clinics for a year, evaluating the ME reports with the ACMUI. During this test period, the NRC, with advice

from the ACMUI, should do the following: (1) Develop the minimum criteria for patient

safety program reviews; (2) Assess how this change in ME reporting impacts the NRC's

ability to protect patient health and to minimize danger to the patient's life; and (3)

Evaluate the different types of patient safety programs in how lessons learned from their

patient safety incident reviews are shared with the medical community. 9/11/2017NRC ActionOpen 16 The ACMUI recommended that after completion of the test year, the NRC should consider opening the program to all NRC medical use licensees who request approval of

their patient safety program, and to Agreement States who request to implement the

program with their medical licensees.9/11/2017NRC ActionOpen 17 The ACMUI recommended that the NRC redefine its perspective of patient safety to be different from occupational safety and from public safety. 9/11/2017NRC ActionOpen 18 The ACMUI recommended that NRC partner with the Department of Health and Human Services (HHS), specially the Agency for Healthcare and Research and Quality (AHRQ) ,

and ACMUI to develop a national database taxonomy specific for reporting patient events

involving medical use of byproduct material.9/11/2017NRC ActionOpen 19 The ACMUI recommended that the NRC Update its Medical Use Policy Statement and 10 CFR 35 event reporting regulations for patient safety programs to verify the active

involvement of the licensee's patient safety program review of medical errors and

reporting of reviews to the national patient safety database.9/11/2017NRC ActionOpen 20 The ACMUI endorsed the Medical Event Reporting and Impact on Medical Licensee Patient Safety Culture Draft Report, as amended to support the concept of the pilot

program with the total number of sites and duration to be determined at a later date and

to include the Patient Intervention Subcommittee recommendations as an addendum .

9/11/2017 ACMUI Action Open 2 2018 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 1 The ACMUI recommended that there be no breast feeding cessation for 11 C, 13 N, 15 O, and 82 Rb; a 12-hours cessation for 18 F-labeled and 68Ga-labeled; a 24-hours cessation for 99m Tc-labeled; 7-days cessation for 123 I-NaI and 111 In-leukocytes; 14 days cessation for 201-Tl-chloride; 28 days cessation for 67 Ga and 89 Zr; 35 days for 177 Lu, diagnostic; and total stop of breastfeeding for 131 I-NaI, 177 Lu, therapeutic, 223 Ra and all alpha emitters.2/15/2018NRC ActionOpen 2 The ACMUI endorsed the Nursing Mother Guidelines for the Medical Administration of Radioactive Materials Subcommittee

Report, as amended to: (1) include recommended cessation

periods for both 100 and 500 mrem limits; (2) acknowledge

benefits of breastfeeding; (3) incorporate corrections as needed

for gamma ray constants; (4) convert the units from

conventional to SI units; and (5) correct references.

2/15/2018 ACMUI Action Open 3 The ACMUI recommended that the AU be physically present during the initiation of all Leksell Gamma Knife Icon treatments.

However, the AU could be present in the department (defined

as a two minute walk to the console area) during treatment but

is immediately available to come to the treatment room. If there

is an interruption of treatment secondary to medical or

mechanical issues, the AU must return to the console prior to

reinitiation.2/15/2018NRC Action Closed STATUS 1 2018 ACMUI RECOMMENDATIONS AND ACTION ITEMS 4 The ACMUI recommended as a best practice that appropriately trained nursing or auxiliary staff be present at the console to

respond to any immediate medical needs.

2/15/2018 ACMUI Action Closed 5 The ACMUI unanimously endorsed the Physical Presence Requirements for the Leksell Gamma Knife Icon Subcommittee

Report. 2/15/2018 ACMUI Action Closed 6 The NRC staff will create an ACMUI Recommendations Web page and post the full ACMUI Recommendations and Actions

charts on the ACMUI Web page from 2007 - present3/7/2018NRC Action Open Indefinitely 7 The NRC staff will send out a medical list server announcement to inform subscribers of the availability of ACMUI and NRC ME

slides each time that they are posted on the Medical Toolkit. 3/7/2018NRC Action Open Indefinitely 9 Dr. Palestro appointed Ms. Megan Shober and Mr. Zoubir Ouhib to the Physical Presence Requirements for the Leksell

Gamma Knife Icon Subcommittee. Subcommittee membership

includes: Dr. Ennis, Mr. Ouhib, Ms. Shober, Dr. Suh (Chair),

and Ms. Weil. NRC POC: Sophie Holiday 7/16/2018 ACMUI Action Closed 11 The ACMUI endorsed the report of the Subcommittee on the Nursing Mother Guidelines for the Medical Administration of

Radioactive Materials with added language that this document

reflects the FDA approved radiopharmaceuticals on the market

at this time and that licensees are obligated to carefully

evaluate radiopharmaceuticals that are not encompassed in this

report to keep exposures ALARA to patients, staff, and

members of the public. The recommendation passed

unanimously.

9/20/2018 ACMUI Action Open 2 2018 ACMUI RECOMMENDATIONS AND ACTION ITEMS 12 The ACMUI endorsed the Leksell Gamma Knife PerfexionTM and Leksell Gamma Knife IconTM Licensing Guidance

Subcommittee Report. The recommendation passed

unanimously.

9/20/2018 ACMUI Action Closed 13 The NRC staff will provide the Committee with a copy of the Briefing on Results of the Agency Action Review Meeting

presentation slides on Yttrium-90 microspheres; SECY 0048, "Annual Report to the Commission on Licensee

Performance in the Nuclear Materials and Waste Safety

Program Fiscal Year 2017," which includes a discussion on

medical events involving Yttrium-90 microsphere brachytherapy;

and the Strategic Programmatic Overview of the Fuel Facilities

and Nuclear Materials Users Business Lines Commission

meeting slides related to Yttrium-90.9/21/2018NRC Action Closed 14 Dr. Palestro amended the membership of the Training and Experience for All Modalities Subcommittee. Subcommittee

membership now includes Dr. Metter (chair), Dr. Ennis, Dr.

Schleipman, Ms. Weil, Ms. Shober, and Mr. Sheetz. The NRC

staff resource continues to be Ms. Maryann Ayoade.

9/20/2018 ACMUI Action Open 3 2018 ACMUI RECOMMENDATIONS AND ACTION ITEMS 15 Dr. Palestro formed a subcommittee to review the Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance.

Subcommittee membership includes Ms. Shober (chair), Dr.

Metter, Mr. Sheetz, and Ms. Martin. The NRC staff resource is

Dr. Said Daibes.

9/21/2018 ACMUI Action Open 16 Dr. Palestro formed a subcommittee to review the revisions to Regulatory Guide 8.39, "Release of Patients Administered

Radioactive Material." Subcommittee membership includes Mr.

Sheetz (chair), Ms. Shober, Dr. Dilsizian, Dr. Schleipman, Ms.

Martin, and Ms. Weil. The NRC staff resource is Dr. Said

Daibes.9/21/2018 ACMUI Action Open 17 Dr. Palestro formed a subcommittee to review the Yttrium-90 Microspheres Brachytherapy Sources and Devices

TheraSphere and SIR_Spheres Licensing Guidance.

Subcommittee membership includes Dr. O'Hara (chair), Dr.

Dilsizian, Mr. Ouhib, Ms. Marin, Dr. Metter, and Dr. Schleipman.

The NRC staff resource is Dr. Katie Tapp.

9/21/2018 ACMUI Action Open 18 Dr. Palestro formed a subcommittee to review and update the ACMUI Bylaws as needed, including a review of the role of the

ACMUI Chair and his or her participation on subcommittees.

Subcommittee membership includes Ms. Weil (chair), Dr.

Schleipman, Ms. Shober, and Mr. Sheetz. The NRC staff

resource is Ms. Sophie Holiday.

9/21/2018 ACMUI Action Open 4 2018 ACMUI RECOMMENDATIONS AND ACTION ITEMS 19 Dr. Palestro formed a subcommittee to review the appropriateness of the required elements of medical event

reporting, the adherence to these requirements, and

recommend actions to improve reporting. Subcommittee

membership includes Dr. Ennis (chair), Ms. Weil, Ms. Martin, Mr. Ouhib, Dr. Dilsizian, and Ms. Shober. The NRC staff

resource is Ms. Lisa Dimmick 9/20/2018 ACMUI Action Open 20 The Committee recommended for the NRC to draft an Information Notice on the best practices that could help prevent

medical events.9/21/2018NRC ActionOpen 21 The Committee requested a list of all the current ACMUI members, their contact information, information regarding each

member's term, and the subcommittee(s) they serve on. The

Committee also requested that the NRC staff create a web

page that lists the active subcommittees and subcommittees

that have been sunset, their members with term expiration, NRC staff resource, and the specific charge of the

subcommittee.9/21/18NRC Action Closed 22 The Committee tentatively scheduled the spring 2019 meeting for April 15-16, 2019. The alternate meeting dates are April 3-4, 2019, subject to Commission availability.

9/21/18 ACMUI Action Closed 5 2019 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE 1The ACMUI recommended adding language into the draft Training and Experience Requirements for All Modalities Subcommittee report regarding the Committee's desire to work with the NRC staff to develop a curriculum for limited-scope authorized user pathway.

2/26/2019ACMUI Action Open 2The ACMUI endorsed the Training and Experience Requirements for All Modalities Subcommittee Report, and the recommendations included therein.

2/26/2019ACMUI Action Open STATUS 1 Open Forum NO HANDOUT

1ACMUI Sub-committee on the Draft Y-90 Microspheres Brachytherapy Licensing Guidance, Rev. 10Michael O'Hara, Ph.D.ACMUI FDA RepresentativeApril 3, 2019 Sub-Committee Members*VaskenDilsizian, M.D.*Melissa Martin, M.S.*Darlene Metter, M.D.*Michael O'Hara, Ph.D. (Chair)

• Zoubir Ouhib, M.S.*Robert Schleipman, Ph.D.NRC Resource: Katie Tapp, Ph.D.

Background*Manual intra-arterial brachytherapy implants with unique properties for 1?;and 2?;hepatic malignancies*Regulated under 10 CFR 35.1000 "Other Medical Uses of Byproduct Material or Radiation from Byproduct Material" Background*The licensing guidance was published in 2002 and revised in 2004, 2007, 2008, 2011 and 2016. *In Oct. 2016, the ACMUI provided comments on the initial draft Rev. 10 of the licensing guidance. Specific topics addressed included:1.Consider the elimination of Pathway 2 (manufacturer AU training)2.Update the waste and disposal section3.Review Y-90 radiation safety issues in autopsy and cremation 2 Background*In Nov. 2017, the NRC published the draft Rev. 10 of the licensing guidance in the FRfor public comment. The comment period ended in Jan.

2018.*In July 2018, the final Part 35 rule, "Medical Use of Byproduct Materials-Medical Event Definitions, Training and Experience, and Clarifying Amendments," was issued. The rule went into effect Jan. 14, 2019 for NRC licensees.

Background*The NRC/Agreement State WG updated the draft Revision 10 licensing guidance to include the criteria for T&E and medical event reporting, inventory requirement specifications, and waste disposal issues and aligned the guidance with the Part 35 rule. *After addressing public comments, the 2016 ACMUI comments, and the rule changes, the WG provided the Subcommittee with a revised draft guidance for its review and comment.

Subcommittee ChargeTo review the staff's draft Revision 10 of the Yttrium-90 Micros phere Brachytherapy Sources and Devices TheraSpheresand Sir-Spheres Licensing Guidanceand provide any comments or recommendations for change/acceptance of the guidance.

Comments on the Licensing Guidance*The Subcommittee believes this is a well written and documented licensing guidance document. *Subcommittee endorses the draft Revision 10 of the licensing guidance, subject to the following specific changes 3Specific Comments on the Licensing Guidance*Defining manufacturer's representative*Keeping three hands-on cases for each type of microsphere delivery device. The Y-90 spheres are slightly different (glass or polymeric) and the delivery systems of the two devices have different characteristics*RSO familiarity required with all devices used at the facility *Evaluation of a possible ME for unexpected dose or activity to an organ or tissue other than the treatment site that is caused by catheter placementSpecific Comments on the Licensing Guidance*Delineating the site to be treated more specifically (left hepatic lobe, right hepatic lobe)*Adding activity, date of administration and route of administration*Question whether intervention should be defined in the licensing guidance document*Explicit labeling to include patient name, dose, date and treatment site, if feasible Acronyms 11ACMUI Advisory Committee on the Medical Uses of Isotopes AU Authorized user CFR Code of Federal Regulations FR Federal Register MEMedical Event NRCU.S. Nuclear Regulatory CommissionRSORadiation Safety Officer T&ETraining and experience WG Working GroupY-90Yttrium-90 U.S. Nuclear Regulatory Commission (NRC)

Advisory Committee on the Medical Use of Isotopes (ACMUI)

Subcommittee on Yttrium

-90 Microsphere Brachytherapy Sources and Devices TheraSphere and Sir-Spheres Licensing Guidance, Revision 10 Draft Report Submitted on: March 11, 2019 Subcommittee Charge The Subcommittee's charge was to review the staff's draft Revision 10 of the Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and Sir-Spheres Licensing Guidance and provide any comments or recommendations for change/acceptance of the guidance. Subcommittee Members Dr. Vasken Dilsizan Mr. Zoubir Ouhib Ms. Melissa Martin Dr. Robert Schleipman Dr. Darlene Metter Dr. Michael O'Hara (Chair)

NRC Staff Resource: Dr. Katie Tapp Introduction Yttrium-90, a pure beta emitter, decays to stable zirconium

-90 with a physical half

-life of 64.1 hours1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> (2.67 days). The average energy of the beta emissions from yttrium

-90 is 0.9367 MeV with an average penetration range of 2.5 mm and a maximum range of 11 mm in tissue. Following delivery of the yttrium

-90 microspheres in tumorous liver tissue, the microspheres provide an embolic effect and the beta radiation emitted provides a therapeutic effect. The microspheres are delivered into the liver tumor through a catheter placed into the hepatic artery that supplies blood to the tumor. The microspheres, being unable to pass through the vasculature of the liver due to arteriolar capillary blockade, are trapped in the tumor and exert a local radiotherapeutic effect with some concurrent damage to surrounding normal liver tissue.

There are currently two Y

-90 based microsphere devices that have been reviewed by the FDA. They differ slightly in composition of the spheres and in the patient population for which they are approved.

TheraSphere consists of insoluble glass microspheres where yttrium

-90 is an integral constituent of the glass.

A preassembled single use TheraSphere Administration Set is provided for each dose. Also provided are re-usable accessories including an acrylic box base, top shield, removable side shield, bag hook and a RADOS RAD

-60R radiation dosimeter (or equivalent). TheraSphere is an approved HDE device indicated for use in radiation treatment or as neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters.

SIR-Spheres microspheres consist of biocompatible resin microspheres containing yttrium

-90 with a size between 20 and 60 microns in diameter. The administration set includes a delivery box (an acrylic box base), delivery set (including all the catheters and connectors), and a V

-vial (including the shielding). Sir

-sphere are an approved PMA device for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intrahepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

Background

The "Yttrium

-90 Microsphere Brachytherapy Sources and Devices TheraSphere and Sir-Sphere s Licensing Guidance" was published in 2002 and revised in 2004, 2007, 2008, 2011 and 2016. NRC staff, stakeholders and the ACMUI identified numerous issues that needed to be addressed. NRC staff and Agreement State Representatives formed a working group to address the issues and make any necessary revisions.

Revision 10 updated the criteria for training and medical event reporting, inventory requirement specifications, and waste disposal issues and aligned the guidance with the Part 35 rule entitled "Medical Use of Byproduct Materials

-Medical Event Definitions, Training and Experience, and Clarifying Amendments" which went into effect on January 14, 2019 for NRC licensees.

Overall, the Subcommittee believes this is a well written and documented licensing guidance document. The Subcommittee endorses the draft Revision 10 of the licensing guidance, subject to the specific changes outlined below.

Specific Changes to the Guidance Considered by the Subcommittee and its Recommendations Page 8, section iii, line 3: The current section reads-to support training provided by a Y

-90 microsphere manufacture r representative involving: We suggest defining what manufacturer's representative means. This will help to ensure the manufacturer's trainer has the proper experience.

Page 9, section B, paragraph 2, line 2: This section currently reads- unsupervised use should include at least 3 hands

-on patient cases for each type of Y

-90 microsphere requested.

We suggest keeping three hands on cases for each type of microsphere delivery device. The Y-90 spheres are slightly different (glass or polymeric) and the delivery systems of the two devices have different characteristics. This will ensure that the user has documented experience with both device types.

Page 11, section 4.2, line 4: The current sentence reads

, "-An RSO already listed on a license that includes one type of microsphere device does not require additional approval for the other type of microsphere device

-" We suggest adding to the end of the sentence

, "but should be familiar with all devices used at the facility

."

Page 13, section 5.1, paragraph 1, last sentence: The current sentence reads, "- Unexpected dose or activity to an organ or tissue other than the treatment site that is caused by catheter placement during delivery of the y

-90 microspheres is not considered shunting.

" We suggest adding "and should be evaluated as a possible medical event" to the end of the sentence.

Page 14, section 5.2, paragraph 3, line 2:

The current sentence reads, "-the treatment site, the radionuclide (including the physical form (Y

-90 microspheres)); the model of spheres e.g. TheraSpheres or Sir-Spheres) or manufacturer, the prescribed dose or activity, and if appropriate for the type of microsphere used, the statement 'or dose or activity delivered at stasis". We suggest describing the site to be treated more specifically (left lobe, right lobe) Page 14, section 5.2, paragraph 3, line 4: The current sentence reads, "-the treatment site, the radionuclide (including the physical form (Y

-90 microspheres)); the model of spheres e.g. Thera Spheres or Sir-Spheres) or manufacturer, the prescribed dose or activity, and if appropriate for the type of microsphere used, the statement 'or dose or activity delivered at stasis". We suggest adding activity, date of administration and route of administration Page 14, section 5.2, paragraph 4, line 6:

The sentence currently reads, "-anatomical description of the tissue intended to receive a radiation dose-

" We suggest changing tissue to tissue(s).

Segmented doses may be delivered to various anatomic locations.

Page 15, section 5.3, paragraph 1, line 3: The current sentence reads, "-as a result from patient intervention, as defined in 10 CFR 35.2..." We question if the term "intervention" should be defined in the guidance document.

Page 16, section 5.3, paragraph 1, line 1:

The sentence currently reads

"-organ or tissue other than the treatment site-

" We suggest that treatment site should be intended treatment

. Page 16, section 5.6, paragraph 2, line 2: The current sentence reads "label syringes and syringe radiation shields with the radioactive drug.

" We believe the label should be explicit and include patient name, dose and date , and treatment site

, if feasible

. Other Recommendations There are no other recommendations from the subcommittee.

Respectfully Submitted

, Subcommittee on Yttrium

-90 Microsphere Brachytherapy Sources and Devices TheraSphere and Sir-Sphere s Licensing Guidance, Revision 10 Advisory Committee on the Medical Use of Isotopes Nuclear Regulatory Commission

1 NuclearMedicineInjectionInfiltrationsRonLattanze,LucernoDynamicsACMUIMeeting April3,2019InfiltrationAgenda*Presentation-RonLattanze-Overview-Incidence-Patientimplication/impact

-Solution-RequestNRCandACMUIreconsidera1980decisionregardinginfiltrations

• Q&A-RonLattanze,Dr.DavidTownsend,andDr.DanielSullivanOverview*Bolusinjectionqualitycritical*Infiltrationdefinitionandeffects*QualityControl(QC)for"injected"dose,butnotthedose"delivered"intocirculationOverview-NRCandACMUIInfiltrationPosition*1980-MisadministrationReportingRequirementsFinalRule*2008-BostonVAreportsaninfiltrationasaMedicalEvent*2002-"Misadministration"replacedby"MedicalEvent"-"infiltrationsarevirtuallyimpossibletoavoid" 2 NuclearMedicineInfiltrationRatesAreHigh*2017AlbertaQI,9centers:-15.0%(0%28%)-20.0%(8%44%)RoutineImagingFieldofView*2006 17Publisheddata:-15.2%(3%23%)*2018LaraQI,7centers:-6.2%(2%16%)Lesionquantificationisunderstated,butnooneknowswheninfiltrationisoutsidetheimagingFOVInfiltrationsCanMatter 50+referencessupporthowdiagnosticradiopharmaceuticalinfiltrationscanharmorhaveharmedpatientsDay1Day3 MissedMetastaticLesionSUVDay1Day5Understated Lesion15.2710.4950%

Lesion23.975.9433%

Lesion37.1711.4637%

Lesion42.625.7354%AdverselyAffectsAssessmentScanConclusionsPatient11490SUVChangeAdverselyAffectsTreatmentPlanningMTVDay1Day5Understated Lesion17.4311.3434%

Lesion25.5710.6648%

Lesion327.7741.0732%

Lesion40.882.9370%Patient11490MTVChange6~50%ofinjectionsitesareoutsideimageFOVInfiltrationsCanExceedReportingLimits*ReportingLimit-0.5Sievert(Sv)effectivedoseequivalenttothetissueTimebetweeninjectionandimagingEstimatedinfiltrationactivityattimeofimagingEstimatedeffectivedoseequivalenttothetissuefrominjectiontoreabsorptiontimeA57mins4.55mCi11.5Sv(~23xlimit)TimebetweeninjectionandimagingEstimatedinfiltrationactivityattimeofimagingEstimatedeffectivedoseequivalenttothetissuefrominjectiontoreabsorptiontimeA57mins4.55mCi11.5Sv(~23xlimit)B107mins0.11mCi2.26Sv(~4.5xlimit)InfiltrationsAreAvoidable*2017Chemotherapyrates-0.18%Timeactivitycurveisindicativeofanidealinjection,beforeimaging.Boluspassesinjectionarmsensorandcountsdroptoreferencearmlevelswithin30seconds.TACisindicativeofalargeinfiltration.Injectionsensorcountsremainhighduringuptakeperiod.*Monitoringnuclearmedicineinjectionqualitycanleadtosignificantandquickimprovement*2016ContrastCTrates-0.24%SiteMeasurePhaseRateStandardErrorImprovePhaseRateStandardErrorChange A 13.3%2.1%2.9%1.0% 78%B 15.7%4.0%6.0%2.6% 62%C 12.8%1.5%8.7%1.3% 32%D 2.1%0.6%1.9%0.6% 10%

3Identifying,Reporting,andReducingInfiltrationsConsistentwiththegoalsof:-NRC-NuclearMedicineSocieties-Technologists

-Physicians-PatientsRequest*Nuclearmedicineinfiltrationsareavoidable*Someinfiltrationscannegativelyaffectpatients*SomeinfiltrationsexceedreportinglimitsRequestingtheNRCandACMUItoreconsiderthe1980infiltrationdecisionand,movingforward,requirereportingofinfiltrationsthatmeetSubpartMcriteria.DiscussionandQ&AAcronyms*QI-QualityImprovement

• SUV-StandardizedUptakeValue*MTV-MetabolicTumorValue*FOV-FieldofView*mCi-Millicurie

• CT-ComputedTomography

• TAC-Time activityCurve 110 CFR Parts 30, 32, and 35FINAL RULE CHANGESLisa Dimmick, Team LeaderMedical Radiation Safety TeamApril 3, 2019 Objective*Present a summary of rule changes that became effective January 14, 2019 Major Changes

• Permanent implant brachytherapy medical event reporting & notification

• Name Associate Radiation Safety Officers on a medical license

• Training & Experience (T&E) generic changes for all individuals

• Molybdenum (Mo) breakthrough measurement frequency and reporting of failed generators General Topics

• Diagnostic Medical Uses

• 10 CFR 35.300 Radiopharma-ceuticals*Sealed Source & Device Registry

• Vendor Training

• Gamma Knife Source Exchange

• Generators

• Associate RSO & Ophthalmic Physicist*Emerging Technologies

• Notification

• Manual Brachytherapy

• Training & Experience 2Generators: 35.204 & 35.3204

• Breakthrough has to be measured for each elution of Mo-99/Tc-99m generator*Breakthrough in excess of regulatory limits need to be reported to NRC and the generator distributor

• Information that has to be reported and reporting timeframe is providedAssociate RSO (ARSO) and Ophthalmic Physicist: 35.2 & 35.24

• Associate Radiation Safety Officer Ophthalmic physicist -defined

• Revised the Preceptor definition -add ARSO*Introduced provisions to appoint an ARSO*Clarified requirements for licensee, RSO, and ARSOAssociate RSO: 35.50

• Added ARSO

• Permit ARSO to provide written attestation

• Permit new AU to be RSO on new license

• Permit authorized individuals (AU, AMP, ANP) to use authorized status be RSO on a different license for same uses for which the individual is authorizedOphthalmic Physicist: 35.433

• Added ophthalmic physicist to individuals who are required to perform certain task

• Clarified the training needed to be an ophthalmic physicist

• Clarified expected duties of AMP and ophthalmic physicist for Strontium-90 sources used for ophthalmic 3Emerging Technologies: 35.12

• Clarified information required for 10 CFR 35.1000 medical uses application

• Additional aspects needed for radiation safety not in or different from requirements in the regulations

• Identification and commitment to meet appropriate existing requirements

.Notification: 35.13, 35.14, & 35.15

• Added notification/termination provision for the ophthalmic physicist

• Added amendment requirement before an individual works as an ARSO or before the RSO can assign duties and tasks to an ARSO beyond the current authorizationNotification: 35.13, 35.14, & 35.15

• Added notification provision for certain manual brachytherapy sources

• Removed notification attestation statement*Exempted Type A broad scope licensees from needing to notify NRC when permitting an ophthalmic physicist to working as an ophthalmic physicist;Manual Brachytherapy: 35.40

• Clarified permanent implant brachytherapy written directive (WD) components:

-Still includes AU signature and dating before administration

-Requiring the total source strength in the pre-implantation portion of the WD

-recovery 4Manual Brachytherapy: 35.40 cont.

• Deleting the total dose from the post-implantation portion of the WD added total number of sources and date

• Deleting the requirement to include dose*Requiring completion of the post-implantation portion of the WD before the patient leaves post treatment recovery area Manual Brachytherapy: 35.40 The term post-treatment recovery area means the area or place where a patient recovers immediately following the brachytherapy procedure before being released to a hospital intensive care unit or patient room, or in the case of an outpatient treatment, released from the licensee's facility.Manual Brachytherapy: 35.40

• Revises the definition of an ME for permanent implant brachytherapy:

-The total source strength for inside and outside the treatment site compared with post-implantation written directive

-The wrong radionuclideManual Brachytherapy: 35.40 cont.

-The wrong individual or human research subject

-Sealed source(s) directly delivered to the wrong treatment site

-A leaking sealed source resulting in a dose that exceeds 0.5 Sv(50 rem) to an organ or tissue 5Manual Brachytherapy: 35.40What does discontiguous mean?*As it relates to the ME criteria in 10 CFR 35.3045 for PIB, discontiguousmeans a location that is not physically adjacent to or touching the treatment site.

-facilityManual Brachytherapy: 35.41

• All licensees must have procedures to determine if a medical event occurred

• Permanent implant brachytherapy licensees must have procedures to determine within 60 daysManual Brachytherapy: 35.41 cont.

-The total source strength outside treatment site compared to total source strength in post implant written directive.

-That if a patient was not available within the 60 days, the licensee must document the reason for the unavailability.

-facility Training and Experience (T&E)

• Removed written attestation from board certification pathway requirements

• Revised written attestation statement

-"-is able to independently fulfill the radiation safety-related duties as -"

• Permits residency program directors to provide written attestation under certain conditions 6T&E: 35.51

• Require AMP to be board certified by board recognized under 10 CFR 35.51T&E: 35.57

• Grandfathered RSO's and AMP's must meet requirements in 10 CFR 35.50(d) or 35.51(c), for materials or uses not authorized earlier

• Grandfathered individuals board certified on or before October 24, 2005 by boards listed in regulation for materials and uses performed before this dateDiagnostic medical uses: 35.65

• Clarified medical use does not include calibration, transmission, and reference sources except as authorized under 10 CFR 35.500

• Bundled or aggregated sources with activities greater than maximum single source activities in 35.65 is not permitted under 10 CFR 35.65Diagnostic medical uses: 35.65 cont.

• Clarified when sources do not have to be listed on license 7Diagnostic medical uses: 35.590

• Authorizes an AU for imaging uses for medical use of sealed sources and medical devices for diagnosis Radiopharmaceuticals: 35.300, 35.390, & 35.396

• Clarified that 10 CFR 35.300 only applied to materials listed in 10 CFR 35.390

• Revised listing of materials in 10 CFR 35.390 for parenteral uses by the primary emission needed for the particular medical use (i.e., is primarily used for -

emission)Radiopharmaceuticals: 35.300, 35.390, & 35.396

• Current Rule reads:-A licensee may use any unsealed byproduct material prepared for medical use and for which a written directive is required that is-Radiopharmaceuticals: 35.300, 35.390, & 35.396 cont.

• New Rule reads:-A licensee may use any unsealed byproduct material identified in §35.390(b)(1)(ii)(G) prepared for medical use and for which a WD is required that is-

--

8 Radiopharmaceuticals: 35.300, 35.390, & 35.39610 CFR 35.390(1)(ii)(G) categories for 3 casesCurrent Rule reads:1.Oral 1.22 GBq(33 mCi) of NaII-131 WD;2.Oral > 1.22 GBq(33 mCi) of NaII-131 WD;Radiopharmaceuticals: 35.300, 35.390, & 35.396 cont.3.Parenteral of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a WD is required; and/or4.Parenteral administration of any other radionuclide, for which a WD is required;Radiopharmaceuticals: 35.300, 35.390, & 35.39610 CFR 35.390(1)(ii)(G) categories for 3 casesNew Rule reads:-A licensee may use any unsealed byproduct material identified in §35.390(b)(1)(ii)(G) prepared for medical use and for which a WD is required that is -1)the same as current rule.

Radiopharmaceuticals: 35.300, 35.390, & 35.396 cont. 2)the same as current rule3)Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required 9SS&D: 35.400, 35.500, & 35.600

• Clarifies that use includes uses under the appropriate medical use that is not explicitly listed in the Sealed Source and Device Registry (SSDR)

• Requires the use to be in accordance with radiation safety conditions and limitations in SSDR

• Differentiated between use requirements for sources and devices containing sourcesVendor Training: 35.610

• Requires vendor training of 10 CFR 35.600 medical use devices when there are upgrades that affect the operational and safety of the unit

• Vendor training must be by the vendor or someone certified by the vendorGamma Knife: 35.655

• Clarifies in the title that the section is addressing full-inspection servicing

• Retains 5 year frequency for teletherapyunits*Changes frequency for gamma stereotactic units to 7 years Acronyms*ANP -Authorized Nuclear Pharmacist

• AMP -Authorized Medical Physicist

• ARSO -Associate Radiation Safety Officer

• AU -Authorized User

• Ga -Gallium

• Ge -Germanium

• GBq-Gigabecquerel 10 Acronyms*I-131 -Iodide-131

• keV-kiloelectronvolts

• mCi-millicurie

• ME -Medical Event

• Mo-99 -Molybdenum-99

• NaI-Sodium Iodide

• PIB -Permanent Implant Brachytherapy

• PRM -Petition for Rulemaking Acronyms*Rb-Rubidium

• RSO -Radiation Safety Officer

• Sr-Strontium

• SS&D -Sealed Source and Device

• SSDR -Sealed Source and Device Registry

• T&E -Training and Experience

• Tc-99 -Technetium-99

• WD -written directive 1 1 Subcommittee on Germanium-68/Gallium-68 Generator Licensing Guidance Megan ShoberAdvisory Committee on the Medical Uses of IsotopesApril 3, 2019*Melissa Martin *Darlene Metter, M.D.

• Michael Sheetz*Megan Shober(Chair) 2 Subcommittee MembersCurrent Ge-68/Ga-68 Generator Licensing Guidance (2017)*Expressly names Eckert and Ziegler brand of generator*Includes specific breakthrough limit*Describes steps to take if generator has not been eluted within 48 hour5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />s*Requires notification to the NRC Operations Center if an eluate exceeds breakthrough levels*Requires wipe tests each day of use 3*Brand neutral

• Removed reconditioning requirements for generators not eluted within 48 hour5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />s*Revised breakthrough reporting requirements ("multiple" failures) 4Proposed Revision to Ge-68/Ga-68 Generator Licensing Guidance 2Recommendations*Subcommittee recommends endorsing the draft guidance with changes as noted:1.Add alternate pathway training option for ANP user.2.Remove brand-specif ic breakthrough limit. 3.Reject proposed breakthrough failure reporting requirement and recommend conformance with 10 CFR 35.3204.

5Recommendations cont'd.4.Due to the long time period required for breakthrough testing, add guidance on when breakthrough failure is "effective." 5.Revise survey requirements to allow increased flexibility in performance.

6ANP -Authorized Nuclear PharmacistCFR -Code of Federal Regulations Ga-68 -Gallium 68Ge-68 -Germanium 68NRC -Nuclear Regulatory Commission 7Acronyms 1 of 3 Nuclear Regulatory Commission (NRC)

Advisory Committee on the Medical Use of Isotopes (ACMUI)

Subcommittee Review and Comments on Germanium-68/Gallium-68 Generator Licensing Guidance

, Revision 1 Submitted on: November 30 , 2018 Subcommittee Members:

Ms. Melissa Martin Dr. Darlene Metter Mr. Michael Sheetz Ms. Megan Shober (Chair) NRC Staff Resource: Said Daibes

-Figueroa, Ph.D.

Background

The subcommittee and its Chair were appointed by ACMUI Chairman, Christopher Palestro, at the ACMUI meeting on September 21 , 2018. The purpose of the subcommittee was to review the NRC staff's draft proposed revision to the licensing guidance for Germanium-68 (Ge-68)/Gallium-68 (Ga-68) generators. The NRC's current licensing guidance for Ge

-68/Ga-68 generators (Revision 1) was issued on July 13, 2017.

At that time, the only Ge

-68/Ga-68 generator approved by the U.S. Food and Drug Administration (FDA) and available on the market was the Eckert and Ziegler GalliaPharm generator. As such, the NRC tailored its licensing guidance to this specific product. Now that additional Ge

-68/Ga-68 generators (IREs [Institute of Radio Elements] Galli EoŽ generator and others

) are becoming commercially available, the Ge

-68/Ga-68 generator licensing guidance is being revised to eliminate reference to any specific generator manufacturer or product. This document represents the Subcommittee's report on the draft propos ed revision of this licensing guidance issued by NRC staff in July 2018. Changes to Guidance Considered by the Subcommittee and its Recommendation s General Comment

Throughout the document, ensure that font sizing and bullet size and shape are uniform. Specific Comments Title: The Subcommittee supports the change to the title of the proposed guidance.

Pg 1 , 1 st paragraph:

Delete the sentence "Future Ge-68/Ga-68 radionuclide generators will be addressed in revisions to the licensing guidance

."

2 of 3 Pg 2, Section 4.1, 2nd paragraph: Replace the word s "FDA approved" with "if utilizing an FDA

- approved kit for radiolabeling

." Pg 3 , Authorized Use for commercial nuclear pharmacies: Add "(Form 313 Item 5)" under "Radionuclides

," "Chemical/Physical Form

," and "Maximum Possession Limit

." Pg 4 Section 4.4, 1 st paragraph: Replace "to develop/create Ga

-68" with "to elute Ga-68". Pg 4, Section 4.4: The training for authorized individuals has omitted an "alternate pathway" option for ANPs, similar to 10 CFR 35.55(b), and written attestation signed by a preceptor ANP.

Pg 5 Written attestation requirement: Replace "35.1000 Ge

-68 generator use" with "35.1000 Ge

-68/Ga-68 generator use."

Pg 5, Section 4.4, last sentence: Replace "Physicians or nuclear pharmacists" with "Other individuals."

Pg 6 , 1 st bullet: Delete the word "to." Pg 6 , 3 rd bullet: Begin the sentence with "Eluting-"

Pg 6 , 7 th bullet: Remove the value of 0.001 percent, as this is specific to a particular manufacturer. Replace with a generic reference to "the manufacturer's recommended breakthrough limit."

Pg 6, 7 th bullet: Delete the sentence "Not knowingly distributing or administering to a patient or human research subject any material containing Ga

-68 which is determined to exceed the manufacturer's 0.001 percent breakthrough limit

." This topic is covered by the revised 8 th bullet, below.

Pg 6 , 8 th bullet: Revise to read "During the course of breakthrough testing, if the eluate exceeds the manufacturer's breakthrough limits, the eluate will not be distributed or administered to a patient or human research subject;" Pg 6 , 10 th bullet: Move this bullet to be the last bullet in the series.

Pg 6, 11 th bullet: The criteria for "multiple" and "unusable" are vague. Delete "on multiple occasions rendering the generator unusable in human patients and research subjects." Adopt the language from the new 10 CFR 35.3204 for telephone reports to the NRC Operations Center within 7 days.

Pg 6 , 12 th bullet: "Center" should be capitalized.

Pg 7, general: Due to the extended time necessary for completing a breakthrough test, the guidance should specify when a generator failure is "effective." The Subcommittee recommends specifying that a generator has "failed" on the date when the breakthrough calculation is 3 of 3 performed. This should be no more than 7 days from the date of the previous breakthrough calculation.

Pg 7, 1 st bullet: Remove this bullet. There is no reasonable scenario where a breakthrough failure could cause a reportable medical event due to Ge-68, based on 5 rem effective dose to the whole body or 50 rem dose to an organ.

Pg 7, 2nd bullet: In the first sentence, replace "manufacture's" with "manufacturer's."

Pg 7 , 3 rd bullet: Revise the sentence to read "Conduct surveys of all areas of licensed material use, including the generator storage and kit preparation areas, for contamination each day of use; and

" Pg 7 , 4 th bullet: Remove the bullet. This bullet appears to be less stringent than the guidance in NUREG-1556, Vol. 13, Appendix R, which says that areas where licensed material is stored must be surveyed for contamination weekly. What additional survey should be performed every three months that would not be captured in the required weekly surveys? Pg 8, Section 7.3.2: Distributor (in 2 cases) should be spelled with an "o."

Pg 9, Section 7.4.1, 2nd paragraph: In the last sentence, delete the first "for" to read "-must provide financial assurance for decommissioning-"

Pg 10, Section 8 , 1 st paragraph: Add "Medical" at the beginning of the first sentence.

Pg 10, Section 8, 2nd paragraph: Delete "also."

Other recommendations The subcommittee agrees with the remainder of the licensing guidance document. Respectfully submitted, November 30 , 201 8 , Subcommittee on Germanium-68/Gallium-68 Generator Licensing Guidance

, Advisory Committee on the Medical Use of Isotopes (ACMUI), Nuclear Regulatory Commission (NRC)

1 1Status of Medical Events FY 2018Donna-Beth Howe, Ph.D.Medical Radiation Safety TeamApril 3, 2019Medical Events The dose threshold for diagnostic events precludes reportable events most years.Each year, there are approximately 150,000 therapeutic procedures performed utilizing radioactive materials.

2Medical Events FY 2013 -2015

• 43 Medical events reported -FY 2013

• 46 Medical events reported -FY 2014

• 57 Medical events reported -FY 2015FY13FY14FY1535.200 01335.300 2 3835.400 15 59 (10)35.600 10 1017 35.1000 16 2720 (30) 3Medical Events FY 2016 -2018

• 50 Medical events reported -FY 2016

• 43 Medical events reported -FY 2016

• 50 Medical events reported -FY 2018FY16FY17FY1835.2004 0 035.300 44 235.400 6 (18)7 13 (15) 35.600 68 (14) 10 35.1000 3024 25 (26) 4 2Medical Events 201835.300 Medical events 2Iodine-131 MIBG 1Radium-223 1 535.300 Medical EventsIodine-131 MIBG 1

• 50,000 to 12,000 cGyskin dose to 15 cm²-Patient was disconnected from infusion pump at Spiros connection to use restroom.-At end of procedure, high activity of I-131 on patient's clothing and bed linen.-Two days later, patient reported discomfort and reddening of skin on upper right thigh erythematous lesion to desquamation the next day.

6*35.300 Medical EventsIodine-131 MIBG (cont.)

• 50,000 to 120,000 cGyskin dose to 15 cm²-Did not decontaminate patient until signs of erythema. -Will only disconnect patient if medical emergency.

-Will use adsorbent pads under administration line.-Will develop patient spec ific decontamination procedures.

7 8Ra-223 dichloride 1

• Administered 176.1 µCi instead of 180 µCi-Signed written directive called for oral administration-Technologist administered intravenous-Will implement new written directive-Review current policy and procedures with staff35.300 Medical Events 3Medical Events 201835.400 Medical events 13 (15)Eye Plaque 1Unknown procedure 1 Prostate 11 (13)One licensee, 3 reports 3 (5)Human error 2Wrong site 1Larger than pre-plan or swelling 2 935.400 Medical Events Eye Plaque1

• Prescribed 8,600 cGy-received 6,500 cGy-Used new model of eye plaque that differed from old model-Isodosecurves differed from brachytherapy plan.

-Dose was deeper than expected 1035.400 Medical Events Unknown Procedure1

• 70% of the intended dose was delivered 1135.400 Medical Events Prostate9 (11)One licensee, 3 separate reports, 5 patients*Report 1 -First patient prescribed 14,000 cGy, but administered 8,990 cGy-62% of prescribed dose-No root cause, but attributed to human error-Some seeds may have migrated post-implant

-Performed historical review after inspection-Second Patient prescribed 14,500 cGy, but received19,200 cGy-132% of the prescribed dose-Third Patient prescribed 14,500 cGy, but received 18,900 cGy-130% of the prescribed dose 12 435.400 Medical Events One licensee, 3 separate reports, 5 patients (cont.)*Report 2 -Patient prescribed 14,500 cGy, but received 10,500 cGy-72.4% of the prescribed dose*Report 3 -Patient prescribed 14,500 cGy, but received 7,000 cGy-48% of the prescribed dose 1335.400 Medical Events

• Patient prescribed 11,000 cGy, but received 5,815 cGy-53% of dose-Partial seed strand implanted in the bladder -Removed errant seeds immediately with cystoscopy-Attributed to human error

-Corrective actions include:*New written procedure *Use of more needles, more seeds, and less aggressive sparing of the urethra *Stop using pre-loaded stranded seeds, so improperly implanted seeds can be individually 1435.400 Medical Events

• Patient intended 10,800 cGy, but 50% of prostate received no dose -Ultrasound volume of prostate was smaller on ultrasound pre-implant scan than CT post-implant

scan-Real-time implantation with ultrasound did not permit potential visualization errors -Attributed to human error -Corrective actions include:*Additional training to personnel and improved supervision*Terminate the seed implant program due to low patient volume 1535.400 Medical Events

• Patient prescribed 11,000 cGy, but received 6,215 cGy-56.5% of dose-Attributed to human error-Improve imaging techniques

• Patient prescribed 14,400 cGy, but received only73% of dose -Attributed to 18% increase in prostate size compared to pre-plan-Planned intentional cooler coverage near rectum-Additional training to personnel 16 535.400 Medical Events

• Patient intended 12,500 cGy, but received 1,000 cGy12.5% of dose (Pd-103 seeds) -Used Foley catheter but inflated balloon in prostate urethra instead of bladder -32 of 54 seeds placed outside prostate and 3 seeds could not be seen -Expect risk of radiation damage to rectum and surrounding tissue-Failed to locate Foley catheter compounded by using magnification factor of ultrasound device that did not give full view of relevant anatomy 17*35.400 Medical Events

• Patient intended 12,500 cGy, but received 1,000 cGy12.5% of dose (Pd-103 seeds) [cont.] -Physician and medical physicist will audibly concur on image quality before preceding -Manufacturer reset new default magnification value that will initial view of relevant prostate anatomy-Once first seed is implanted, fluoroscopic image will be used to verify relative location of seed and Foley catheter is where it is expected to be 1835.400 Medical Events

• Patient prescribed 12,500 cGy, but received 9,670 cGy-77% of dose (Pd-103 seeds)-Three seeds from one needle did not remain in place-Contributing factors:*AU's preference for peripheral loading*Potential rotation of the prostate during needle insertion

• Pressure effects from using hydrogel to separate prostate from rectum-Corrective actions:*No longer implant needle between urethra and rectum -will use two needles offset on axis*Use stabilized needles during surgery 19Medical Events 201835.600 Medical events 10 HDR*Skin1

• Breast2

• Gynecological 7Device malfunction 2Wrong site 3 Human mistake 2 20 635.600 HDR Events Skin 1

• Patient prescribed 8 fractions of 500 cGyeach to temple area, but received 350 cGyon first 2 fractions -First physicist used incorrect setup -forgot to use accuform-second physicist used correct setup-Wrong position -gap between treatment device and patient's skin 2135.600 HDR EventsSkin (cont.)-Lack of policy for custom immobilization devices for skin treatment-Therapist present at first treatment and any time there is a new physicist-Photograph set up with and without patient to show accuform-Barcode scanning to track custom set up devices 22*35.600 HDR EventsBreast 2

• Wrong site -1,200 cGyto lateral breast skin-Patient contacted oncologist because of skin reaction -Physicist used tip end instead of connector end in treatment plan-Corrective actions:*Additional training to personnel 2335.600 HDR EventsBreast 2

• Wrong site -1 cc volume of skin received 850 cGyinstead of intended 256 cGy-Savi applicator -struts 2 and 6 mislabeled -changed orientation of the applicator -direction of radiation-Corrective actions:*Second physicist to independently verify catheter struts in treatment plan.*HDR review checklist -verify digitization of struts in treatment plan*Add HDR plan review to monthly audit

• Additional training to personnel 24 735.600 HDR EventsGynecological 7

• Device malfunction-Patient to receive 1,500 cGyduring 3 fractions in 13 dwell points-HDR unit malfunctioned at dwell point 9-Treatment adjusted after repair of the HDR unit 2535.600 HDR Events

• Device malfunction-Device failed to fully retract at completion of treatment fraction -Dose of 100 cGYto patient thigh -source was 5 cm from cylinder guide tube connector-Source wire was bent near source

-Delay in removing source from vicinity of patient and reporting the event to RSO 2635.600 HDR Events

• Catheter movement -connector locking nut too loose, which allowed catheter to slide out -Event discovered by skin reaction progressed to moist desquamation-Dose to skin of 5,154 to 8,555 cGy-Corrective action:*Retrain medical staff and AU*AU will double check all connections and placement before and after each treatment*Purchased new cylinder with new design 2735.600 HDR Events

• Prescribed 6 fractions of 350 cGyeach -first fraction received 2,100 cGy-Total treatment time incorrectly entered into treatment planning system-Human error and poor decision making -started first treatment after hours -second physicist not available-Corrective actions:*Second physicist has to independently verify treatment plan*Physicist to check that plan was exported correctly to the treatment console 28 835.600 HDR Events

• Wrong Site -587 cGydose to small intestine and bowel instead of 220 cGy-Patient's pelvis had extensive damage from uterine cancel-Two dwell positions shifted to deliver dose to non-targeted small intestine/bowel in first of 3 fractions-Treatment plan modified for next 2 fractions-Licensee thought not reportable -10 CFR 35.3045(a)(1) and (3); NRC determined reportable -10 CFR 35.3045(a)(1)(iii) and (a)(3) 2935.600 HDR Events

• Wrong site -5.5 cm outside the treatment site received 500 cGyin 0.5 cm volume -Channel 12 digitized twice with no digitization of Channel 13 (Channel 13 digitization included in Channel 12 with no dwell positions for 13)-Treatment plan displayed expected dose distribution to critical organs and tumor and no dwell positions for Channel 13-Physician approved the plan 30*35.600 HDR Events

• Wrong site -5.5 cm outside the treatment site received 500 cGyin 0.5 cm volume (cont.) -Patient discomfort (full bladder)-Physicist rushed to complete the plan and export to treatment console -error overlooked-Corrective action:*Second check by physicist that did not prepare the plan*Each channel will be carefully reviewed

• Patient not brought to treatment area until plan has been checked and exported to console 3135.600 HDR Events

• Wrong site -100 cGyoutside treatment sitePrescribed 1,890 cGy, but received 1,675 cGy-In first of three fractions digitize the catheter as linear instead of as a single curved catheter-Physicist failed to recognize the incorrectly reconstructed catheter shape in planning software-Treatment length of 15.7 cm instead of 9 cm 32*

935.600 HDR Events (cont.)

• Wrong site -100 cGyoutside treatment site (cont.) -Discovered on second fraction-Treatment plan was not enlarged so physicist could not see the dwell points overlapping-Corrective actions:*Enlarge each treatment plan in which the physicist signs off*Use of a formalized check list 33Medical Events 201835.1000 Medical events 25 Perfexion 1Intervascular Brachytherapy 1Radioactive seed localization 1Y-90 Microspheres22Unidentified 2Therasphere 13 SirSphere 7 3435.1000 Medical EventsPerfexion1

• Device malfunctioned -Device recorded an error and backup power was low, so the sources were returned to the shielded position-One-third of prescribed dose delivered 35Intravascular Brachytherapy 1-First extra long delivery catheter -source could not get to treatment site and retracted safely to unit-Second extra long treatment catheter -source still could not get to treatment site but source could not be returned to IVB unit; all catheters removed-Hydraulic return mechanism failed to return source.

-No dose to treatment site and 39 cGyto surrounding tissue-Deformation of delivery ca theter confirmed root cause 3635.1000 Medical Events 10Radioactive seed localization 1-Expected dose 12 cGyto tissue, but patient received 99 cGyto tissue-Seed implanted and scheduled for removal 6 days later-Insurance company rescinded approval after seed was implanted and required 3 medical opinions-Surgery performed approximately 64 days after implant 3735.1000 Medical EventsY-90 Microspheres 25Unknown 2 3835.1000 Medical Events35.1000 Unknown Y-90 Events Unknown 2*Prescribed 13,400 cGyto a segment of the liver, but received 10,300 cGy-77% of intended dose*Patient received 60%

of prescribed dose 39Y-90 Microspheres 25 Therasphere 13 (14)-Overdose1-Catheter/Obstruction8-Bubbles 2-Backflow to contrast 1-Human mistake 1 4035.1000 Medical Events 11 35.1000 Y-90 Therasphere Events Overdose *Prescribed 13,600 cGy, but received 29,400 cGy-Picked up wrong dosage, measured and compared activity to shipping box information and not the written directive-Shipping box was for next week's patient -Post administration calculations identified the medical event-Will add a dose verification step in interventional radiology 41 35.1000 Y-90 Therasphere EventsDose in Waste Jar

• Prescribed 12,000 cGyadministered 1,770 cGy-liver volume -14% of intended dose-Licensee thought equipment did not function as designed-Most of the dosage was in the waste jar-Manufacturer could not determine root cause 42 35.1000 Y-90 Therasphere Events*Two patients received less dose than prescribed-First patient prescribed 72.6 mCi, but received 15 mCi.Inspector thought expansion tubing resulted in turbulent flow triggering suspension issues-Second patient prescribed 72 mCi, but received 36.75 mCi-Inspector thought lack of adequate agitation prior to administration or issues with quality/sizing of microspheres-Extension tubing no longer used-Manufacturer supported Inspector's findings 43 35.1000 Y-90 Therasphere Events*Prescribed activity 122 mCi-received 46 mCi-38% of intended activity -From device components sent to manufacturer no cause for the blockage was determined-Obstruction/blockage located in microcatheter-obstruction in the outlet tubing at the E junction -Manufacturer recommended handling microcatheterswith extra care and looking for kinks 44 12 35.1000 Y-90 Therasphere Events*Prescribed 12,000 cGy-received 2,000 cGy(rad) -Malfunction in the administrative set -significantly less pressure than usual to press syringe-Saline accumulating in overflow vial

-Only returned portion of administration set that infused dosage into patient to manufacturer-May have been a kink or obstruction in treatment catheter but not conclusive-Will send complete administrative set next time 45 35.1000 Y-90 Therasphere EventsOne licensee -2 reported medical events

• Report 1 -Prescribed 64.8 mCi, but received 41 mCi-65% of activity -Air bubbles noted in overflow tubing connected to the micro-catheter-Connected 3-way stopcock between overflow tubing and micro-catheter aspirated bubbles to syringe with stopcock close to patient-Resurvey of delivery kit showed residual activity 46*35.1000 Y-90 Therasphere Events*Report 2 -Prescribed 46 mCibut received 27 mCi-59% of activity -Used left radial artery with 5-French Sarah Radial catheter with coaxial micro-catheter-Nothing unusual was encountered

-No radioactive contamination of the suite-Dose was in catheter, gauze, dose vial and other waste 47 35.1000 Y-90 Therasphere Events*Prescribed 89,200 cGy, but received 57,500 cGy-64% of dose-Backflow of microspheres into contrast line and syringe -Significant contamination in contrast syringe, flushing syringe, contrast tubing, and associated y-adaptor-Thought contrasting syringe and tubing were made of materials that bind microspheres more than administration kit -will look for same materials-Will use clamp and one-way valve 48 13 35.1000 Y-90 Therasphere Events*Prescribed 23 mCi, but received 7.4 mCi-32% of the activity -Blockage occurred in the delivery apparatus -Imaged the administration set and saw most of the undelivered activity near where plunger connects to the dose vial-Will send administration set and procedure waste to contractor for manufacturer 49 35.1000 Y-90 Therasphere Events*Prescribed 35 mCi, but received 5.4 mCi-16% of activity -Microspheres were coagulated in the tubing

-Unexpected activity remained near the Touhy-Borst connector-Manufacturer thought caused by issues with the micro-catheter-Will flush micro-catheter immediately prior to connecting it to the administration kit 50 35.1000 Y-90 Therasphere Events*Prescribed 13,000 cGyto left lobe of liver, but received 8,490 cGy-65% of dose-First vial administered without incident-Second vial primed and prepped, but saw a train of bubbles in the line between the dose vial and patient-AU stopped the procedure; did not want the bubbles to cause the flow to reflux into gastric artery and cause permanent damage to the stomach -Could not pinpoint cause of bubbles -Limit number of staff trained to prime and do set-up and ensure enough are available on treatment days 51 35.1000 Y-90 Therasphere Events*Prescribed 24,500 cGy, but administered 13,083 cGy-53% of dose -CT scan verified dose was administered to correct location-Remainder of dose hung up in catheter despite flushing-Catheter tubing met manuf acturer's specifications-No root cause identified 52 14 35.1000 Y-90 Therasphere Events*Prescribed 1,300 cGyto specific part of liver, but received 931 cGy-71% of dose -Used 3 different written directives to fractionate the delivery-Thought the small activity prescribed contributed to under dose because of typical losses in the valve and

tubing-Order higher dosages for any administration below 10 mCi-Amend license to go to different manufacturer 53SirSphere7-Wrong site 2

-Measurement unit error 1-Written Directive error 1-High activity clogging 1-Low activity administration 1 5435.1000 Medical EventsWrong treatment site 2

• Prescribed 38.4 mCito liver but received about 13 mCito abdominal wall-Post-treatment scan appeared normal with small uptake in bowel-Pain in abdomen with erythema on abdomen -thought dose was above 55 cGybut less than 1,000 cGy-Thought one-third of dose migrated up a venous ligament and lodged in abdominal wall 55*35.1000 Y-90 SirSphereEventsWrong treatment site (cont.)-Difficult visualizing arterial access to the tumor-Micro-catheter was not advanced far enough into correct artery-Pre-existing kidney impairment precluded using more contrast-Add second monitor to refer to original arteriogram without switching tasks and improve confidence of correct location-Take prophylactic measures for future patients with impaired kidney function 5635.1000 Y-90 SirSphereEvents 15Wrong site

• Prescribed 4,874 cGyto right lobe of liver, but received 11,080 cGyto left lobe-Human error-Placed catheter in left hepatic artery instead of right hepatic artery 5735.1000 Y-90 SirSphereEventsMeasurement Unit Error

• Prescribed 0.91 GBq, but received 8.9 mCi-Ordered 0.91 mCi-marked wrong box in computer

-Did not multiply measured dose value by correction factor of 10 -Not identify until post-procedure check-Worksheet revised to be in SI units-Written directive sheet to be in SI units

-Dose preparation and post-procedure forms to be in SI units 5835.1000 Y-90 SirSphereEventsWritten Directive Error

• Prescribed 1,504 cGyto right lobe of liver, but received 1,498 cGyin left lobe -Written directive prepared incorrectly -AU wanted to treat left lobe-Identified after completion of the procedure-AU did not indicate correct treatment site on written directive; AU did not forward pre-treatment information to the RSO-Clinical staff failed to identify discrepancy during patient time-out just before the implantation 5935.1000 Y-90 SirSphereEventsHigh activity clogging 1

• Prescribed 4,320 cGy, but received 828 cGy-19%

of the dose-Micro-catheter clogging due to unusually large number of microspheres being used-Prescribed activity was at high end of the treatment range-Patient administration delayed 1 day -25% increase in number of microspheres were needed to deliver

the dose-Will use smaller aliquots and/or slower infusion rate 6035.1000 Y-90 SirSphereEvents 16Device malfunctioned 1

• Prescribed 32.5 mCibut received 8 mCi-25% of activity-Treatment device malfunctioned and ceased to deliver microspheres-Manufacturer's representative was present, but cause of malfunction is unknown-Will return delivery device to manufacturer for technical analysis and root cause determination 6135.1000 Y-90 SirSphereEvents

• Prescribed 19.6 mCito left lobe of liver, but received 10 mCi-51% of activity -Planned to deliver activity in two split dosages-Written directive not properly reviewed, so split one dosage in two instead of the total dosage in two-Radiation oncologist failed to check the drawn dosages prior to injecting them-Identified after injection when the remainder of the dosage was discovered 62*35.1000 Y-90 SirSphereEvents

• Prescribed 19.6 mCito left lobe of liver, but received 10 mCi-51% of activity (cont.)-Lack of comprehension of dose draw worksheet-Miscommunication and failure to review the written directive-Failure to perform a safety pause and properly review the dosage to be administered against the written directive prior to the administration 6335.1000 Y-90 SirSphereEvents Acronyms*AU -Authorized User*cGy-centiGray

• FY -Fiscal Year*GBq-Giga Becquerel*HDR -High Dose Rate Remote Afterloader

• I-131 -Iodine-131 *I-124 -Iodine-124*IVB -Intravascular Brachytherapy

• Ra-223 -Radium-223*MBq-Mega Becquerel 64 17 Acronyms*µCi -microcurie*mCi-millicurie*MIBG -Metaiodobenzylguanidine*Pd-103 -Palladium-103*RSO -radiation safety officer

• SI units -International System of Units *Y-90 -Yttrium-90 65 QUESTIONS?

66 1Appropriateness of Medical Event Reporting Subcommittee ReportRonald D. Ennis, M.D.April 3, 2019 Subcommittee Charge

• Toreviewtheappropriatenessoftherequiredelementsofmedicaleventreporting;theadherencetotheserequirements;andrecommendactionstoimprovereporting.

Subcommittee Members

• Dr.Dilsizian*Dr.Ennis(Chair)*Ms.Martin*Mr.Ouhib*Ms.Shober*Ms.WeilPurpose of Reporting

• AnMEisreportedtoanAgreementStateorNRCper10CFR35.3045assummarizedin"EventReportingScheduleforAgreementStates7/29/12"andSA 300,"ReportingMaterialEvents"-"Theinformationcollectedon-medicalevents-isinvaluableinassessingtrendsorpatterns,identifyinggenericissuesorgenericconcerns,andrecognizinganyinadequaciesorunreliabilityofspecificequipmentorprocedures.

ThereportedinformationiscriticalforinitiatingatimelyandeffectiveresponsetosecurityrelatedeventsandwillsignificantlyaidinunderstandingwhytheeventoccurredandidentifyinganyactionsnecessarytoimprovetheeffectivenessofNRCandAgreementStateregulatoryprograms."

2 Documents Reviewed

• SA 300FSMEProcedureApprovalReportingMaterialEvents*SA 105ReviewingtheCommonPerformanceIndicator,TechnicalQualityofIncidentandAllegationActivities

• EventReportingforAgreementStatesofJuly29,2012*NMEDAnnualReportof2017*OASLetter7/2/14regardingproposalforapublicNMED*Rootcauseandcorrectiveactionpicklists*NMEDcontentNuclear Material Events Database

• NuclearMaterialEventsDatabase(NMED)*IncludesdatafrombothAgreementStatesandNRC*NMEDismanagedbyNRC'sOfficeofNuclearMaterialSafetyandSafeguards

• TheNMEDcontractorisresponsibleforcodingandqualitycontrolofinformationwithgeneraloversightfromtheNRCNMEDProjectManager*AccesstoNMEDislimited NMED Issues

• Frequently,narrativeisinadequateforanACMUIreviewertounderstandanevent,itscauseandcontributingfactorsandtheadequacyofthecorrectiveaction.*Attimes,thereappearstobeadisconnectbetweenthenarrativeandthechosencausefromthe"causepicklist."*Attimes,thereappearstobeadisconnectbetweenthenarrativeandthechosencorrectiveactionfromthe"correctiveactionpicklist."NMED Issues

• NMEDlacksinformationfromsomeinspectionsthathasbeenconductedbytheNRCregionorAgreementState.*In23%ofMEsfromFY2017 18,eithernocauseornocorrectiveactionwasindicatedinNMEDreport.*Ofall2017MEs,11%areincompleteandanadditional11%arependingadditionalinformation.

• Public,includingAUsandRSOs,onlyhaveaccesstoanNMEDannualreport.

3 Recommendations of the Subcommittee

• RootcauseandcorrectiveactionsectionsonNMED-Inadditiontothepicklists,anarrative,searchable,sectionshouldberequired.*RequirerootcauseandcorrectiveactionsectionsinNMED,bothpicklistandnarrativesectionsalwaysbecompleted.

• RequireinformationgatheredfromanyinvestigationbeaddedtoNMED.*RequirethatareportinNMEDbecompletedwithin12months.*RequireACMUIandNRCstafftopromulgatethefindingsofannualreportoftheACMUISubcommitteeonMedicalEventstothemedicalandmedicalphysicscommunities.

Recommendations under Consideration by this Subcommittee

• ModifyhowEventReportsarewritten:-Requirethereportuseadditionalguidelinestobedevelopedbythissubcommitteetoassuremorecompleteandusefulinformationisprovided.-RequirethereportbeinitiallywrittenbytheAUandclinicalphysicistsandsubsequentlyreviewedbytheinspector.-RequiretheinspectorinterviewallinvolvedintheME.-Requireareportfromthemanufacturerbeincludediftheeventinvolvedadevice.-Correctiveactionshouldincludemedicalaswellastechnical.

-RequirethefinalreportmustbesignedoffbytheAU,physicistandinspector.

Conclusion

• Significantopportunitiesexisttoenhancetheutilityofmedicaleventreporting,theNMEDdatabase,andthepromulgationoftheinformationtotheusercommunity.

• TheSubcommitteeasksthatitbeabletocontinueevaluatingtheseissuesinmoredetailwithagoalofcreatingasetofspecificrecommendations.

Acronyms*ACMUI-AdvisoryCommitteeontheMedicalUseofIsotopes*AU-Authorizeduser*FSMEOfficeofFederalandStateMaterialsandEnvironmentalManagementPrograms*FY-fiscalyear*ME-medicalevent*NMED-NuclearMaterialsEventDatabase*NRC-NuclearRegulatoryCommission

• OAS-OrganizationofAgreementStates*RSO-RadiationSafetyOfficer*SA-StateAgreement NO HANDOUT 1 Committee Reporting StructureKellee Jamerson, ACMUI CoordinatorMedical Radiation Safety TeamApril 4, 2019 Outline*Current Reporting Structure*Annual Review*Meetings*Discussion 2Current Reporting Structure 3The Commission EDO Director, NMSSDirector, MSST ACMUI MSEBAnnual Review *In September 2012, the ACMUI recommended to have an annual review of reporting structure.*This is the ninth annual review.

4 2 MeetingsTwo meetings at Headquarters each year *March/April*September/October Approximately 2-3 teleconferences (as needed) 5 Discussion 6Points of Contact*Andrea Kock -MSST Director -301-415-2368; Andrea.Kock@nrc.gov*Christian Einberg -Designated Federal Officer (DFO), Chief, MSEB-301-415-5422; Christian.Einberg@nrc.gov*Kellee Jamerson -DFO, ACMUI Coordinator-301-415-7408; Kellee.Jamerson@nrc.gov 7 Acronyms*EDO -Executive Director for Operations*MSST -Division of Materials Safety, Security, States, and Tribal Programs*MSEB -Medical Safety and Events Assessment Branch*NMSS -Office of Nuclear Material Safety and Safeguards 8

NO HANDOUT Thoughts on Leaving the ACMUI

NO HANDOUT

Commission Meeting with the ACMUI

NO HANDOUT

Group Photo

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1 ACMUIBylaws Subcommittee Laura WeilApril 4, 2019 Subcommittee Members*Robert Schleipman, M.D.*Michael Sheetz*Megan Shober*Laura Weil (chair)NRC Staff Resource: Sophie Holiday Subcommittee Charge*Review ACMUI Bylaws and recommend updates*Particular focus on the role of the ACMUI Chairman and his/her participation on subcommittees Existing Language in the BylawsSection 1.3.6 currently states:"The Chair may take part in the discussion of any subject before the ACMUI and may vote. The Chair should not use the power of the Chair to bias the discussion. Any dispute over the Chair's level of advocacy shall be resolved by a vote on the Chair's continued participation in the discussion of the subject."

2Suggested Additional Language The Subcommittee proposes to add the following language:In matters where the ACMUI Chair's unique experience and knowledge would be especially informative, the Chair may serve on relevant subcommittees. In these instances, the ACMUI Chair will not chair the subcommittee. Existing Language -Conduct of MembersSection 4.1 currently states: "If a member believes that he or she may have a conflict of interest with regard to an agenda item to be addressed by the ACMUI, this member should divulge it to the Chair and the DFO as soon as possible and before the ACMUI discusses it as an agenda item. ACMUI members must recuse themselves from discussion of any agenda item in which they have a conflict of interest."Suggested Language -Conduct of MembersThe Subcommittee proposes to add the following:Members cannot personally and substantially participate in the review of any particular matter (including general matters such as a rulemaking) that could directly and predictably affect their personal financial interest or the financial interest of: -Their spouse or minor child -Their general partner or organization in which they serve as an officer, director, trustee, general partner, or employee -An organization with which they are negotiating or have an arrangement for prospective employment Recommendations*ACMUI Chair should be permitted to serve as a subcommittee member (not chair) when his/her specific expertise is necessary. A specific statement to that effect should be included in the ACMUI Bylaws.*Explicit language defining financial Conflict of Interest (COI) should be inserted in bylaws.

3 AcronymsACMUI -Advisory Committee on the Medical Uses of IsotopesCOI -Conflict of InterestDFO-Designated Federal Officer U.S.NuclearRegulatoryCommission(NRC)AdvisoryCommitteeontheMedicalUseofIsotopes(ACMUI) Subcommittee on ACMUIBylaws DraftReportSubmittedOn:

SubcommitteeMembers:

NRCStaffResource: SubcommitteeCharge:Subcommitteeprocess:

Issuesconsidered: Discussion:

InmatterswheretheACMUIChair'suniqueexperienceandknowledgewouldbeespeciallyinformative,theChairmayserveonrelevantsubcommittees.Intheseinstances,theACMUIChairwillnotchairthesubcommittee. Summaryofrecommendations:

Open Forum

NO HANDOUT

Monday Tuesday Wednesday Thursday Friday 2 3 4 5 6 Labor Day X 9 10 11 12 13 16 17 18 19 20 ASTRO An nual Meeting ASTRO Annual Meeting ASTRO Annual Meeting X 23 24 25 26 27 30 Rosh Hash ana September 2019 Monday Tuesday Wednesday Thursday Friday 1 2 3 4 Rosh Hashana 7 8 9 10 11 X Yom Kippur 14 15 16 17 18 Columbus Day Sukkot Sukkot 21 22 23 24 25 Shmini Atzeret Simchat Torah 28 29 30 31 October 2019