ML22333B030

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M221206: Slides - Meeting with the Advisory Committee on the Medical Uses of Isotopes
ML22333B030
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Issue date: 12/06/2022
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Overview of ACMUI Activities Darlene Metter, M.D.

ACMUI Chair/Diagnostic Radiologist December 6, 2022

Todays Agenda

  • Darlene Metter, MD (ACMUI Chair, Diagnostic Radiologist)

- Overview of ACMUI Activities

  • Michael OHara, PhD (FDA Representative)

- ACMUIs Review of Yttrium-90 Medical Events 2

Todays Agenda (contd)

  • Hossein Jadvar, MD PhD (ACMUI Nuclear Medicine Physician)

- Emerging Radiopharmaceuticals in an Expanding Nuclear Arena

- Impacts of the American Board of Radiologys Request to Terminate NRC Recognition of the American Board of Radiologys Board Certification Processes 3

Todays Agenda (contd)

  • Megan Shober (Agreement State Representative)

- ACMUIs Comments on the NRC Staffs Regulatory Basis for the Rulemaking on Emerging Medical Technologies and Rubidium-82 Generators 4

Overview of the ACMUI

  • Membership
  • 2022 Topics
  • Current Subcommittees
  • Future 5

Role of the ACMUI

  • Advise the U.S. Nuclear Regulatory Commission (NRC) staff on policy & technical issues that arise in the regulation of the medical use of radioactive material in diagnosis & therapy.
  • Comment on changes to NRC regulations &

guidance.

  • Evaluate certain non-routine uses of radioactive material.

6

Role of the ACMUI (contd)

  • Provide technical assistance in licensing, inspection &

enforcement cases.

  • Bring key issues to the attention of the Commission for appropriate action.

7

ACMUI Membership (13 members)

  • Nuclear Medicine Physician (Dr. Hossein Jadvar)
  • 2 Radiation Oncologists (Drs. Ronald Ennis & Harvey Wolkov)
  • Nuclear Cardiologist (Vacant position)
  • Diagnostic Radiologist (Dr. Darlene Metter)
  • Nuclear Pharmacist (Mr. Richard Green)
  • FDA Representative (Dr. Michael OHara) 8 8

ACMUI Membership (13 members) (contd)

  • 2 Medical Physicists: Nuclear Medicine (Ms. Melissa Martin) & Radiation Therapy (Mr. Zoubir Ouhib)
  • Patients Rights Advocate (Mr. Josh Mailman)
  • Agreement State Representative (Ms. Megan Shober)
  • Healthcare Administrator (Ms. Rebecca Allen)
  • Radiation Safety Officer (Dr. Richard Harvey) 9 9

ACMUI Consultant

  • Interventional Radiologist (Dr. John Angle) 1 1 0 0

ACMUI Topics Dec 2021-Oct 2022

  • Alpha Dart Licensing Guidance
  • CivaDerm
  • EMT/Rb-82 Generator Rulemaking
  • Training and Experience for All Modalities
  • Impacts of ABRs termination of NRC recognition of ABRs Board Certification Processes 1

11 1

ACMUI Topics Dec 2021-Oct 2022 (contd)

  • Non-Medical Events
  • Minimizing Risk of Medical Events (Y-90 therapies) 1 12 2

ACMUI Topics in 2022 by Non-NRC Entities

  • SIR-Spheres Y-90 Resin Microspheres by Sirtex Medical
  • CORAR Comments on the NIST Radioisotope Measurement Assurance Program (RMAP) by CORAR

13 3

Staff Presentations to the ACMUI (2022)

  • Review of the Lu-177-PSMA Radiopharmaceutical
  • Decommissioning Financial Assurance for Sealed and Unsealed Radioactive Materials
  • Radioactive Source Security and Accountability
  • Medical Related Events
  • ACMUI Reporting Structure
  • Medical Team Updates
  • INFOSEC, Ethics and Allegations Training 1

14 4

Current ACMUI Subcommittees

  • T&E for All Modalities
  • Medical Events
  • Infiltrations/Extravasations and ME Reporting
  • Liberty Vision
  • Emerging Radiopharmaceutical Therapy Knowledge Requirements in Theranostics 1

15 5

Future

- Provide advice and technical assistance

- Comment on NRC regulations and guidance

- Evaluate uses of radioactive material

- Bring key issues to the attention of the Commission 1

6

Acronyms

  • CORAR - Council on Radionuclides and Radiopharmaceuticals
  • EMT - Emerging Medical Technologies
  • FDA - U.S. Food & Drug Administration
  • INFOSEC - Information Security
  • ME - Medical Event 1

7

Acronyms

  • NIST - National Institute of Standards and Technology
  • NRC - U.S. Nuclear Regulatory Commission
  • PSMA - Prostate-Specific Membrane Antigen
  • RMAP - Radioisotope Measurement Assurance Program
  • T&E - Training and Experience 1

8

Y-90 Microsphere Medical Events Subcommittee Report Michael OHara, PhD Advisory Committee on the Medical Uses of Isotopes December 6, 2022 December 6, 2022 1

Agenda ACMUI Subcommittee Membership ACMUI Subcommittee Charge Key Messages

Background

Vendor Consultation Vender Consultation - Sirtex Medical Vendor Consultation - Boston Scientific Further discussion with both vendors 2

Subcommittee Members John Angle Vasken Dilsizian Josh Mailman Melissa Martin Michael OHara (Chair)

Megan Shober NRC Staff Resource: Katie Tapp 3

ACMUI Subcommittee Charge To evaluate the issue of Y-90 microspheres medical events in more depth and, in consultation with the vendors, propose methods to decrease the number of Y-90 microsphere medical events 4

Key Message

  • The reported number of medical events involving Y-90 microspheres is low compared to the number of treatments performed
  • However, it is important to evaluate causes of events to find ways to minimize the chance of similar types of events from happening again 5

Background

  • Hepatic radioembolization uses Y-90 microspheres for the treatment of primary and metastatic liver malignancies
  • Currently 2 vendors: Boston Scientific and Sirtex Medical
  • During the past few years, both vendors have increased their hepatic radioembolization business by approximately twenty percent.
  • The MEs reported during 2020 were low compared to the number of treatments performed 6

Background (cont.)

  • MEs involving Y-90 microsphere administration continues to be the most common MEs
  • Types of MEs for Y-90 microspheres included:

o >20% residual activity remaining in the delivery device, o delivery device setup error, o wrong dose given (treatment plan calculation error),

o wrong site treated (catheter placement error, wrong dose vial selected and wrong site listed on WD) 7

Background (cont.)

  • A past ACMUI MEs Subcommittee noted that performance of a time out and the use of a checklist immediately before administration of byproduct material could have prevented some MEs

Vendor Consultation

  • The ACMUI subcommittee contacted both Y-90 microsphere vendors, Sirtex Medical and Boston Scientific, to discuss possible methods to reduce MEs
  • Both vendors voluntarily met and greatly supported the subcommittee in this effort 9

Vendor Consultation (cont.)

  • Vendors were given
  • The ACMUI MEs Subcommittee Committee report presented on October 4, 2021,
  • general questions to start the conversation, and
  • ACMUI proposed recommendations to prevent 35.1000 Y-90 microsphere MEs
  • The vendors were asked if these 3 actions are appropriate and if they had any further recommendations 10

Proposed Actions to Prevent Future MEs The subcommittee proposed the following actions to the vendors as possible licensee actions to prevent future MEs:

  • Review mechanics of Y-90 microsphere delivery device and setup procedures
  • Confirm all data and calculations in the treatment plan
  • Perform time out at the beginning of each procedure (name, date of birth, activity etc.)

11

Consultation - Sirtex Medical

  • Sirtex evaluated the MEs reported by licensees in the 2021 ME Subcommittee report. They Identified 4 causes:
  • Greater than 20% residual activity remaining in the delivery device not due to vascular stasis
  • The wrong dose given (treatment plan calculation error)
  • The wrong site treated (catheter placement error)
  • The wrong site (written directive error)
  • Sirtex agreed that greater use of the ACMUI recommendations by licensees may prevent MEs due to device set-up and procedural errors. 12

Consultation - Sirtex Medical (cont.)

Additional Actions Sirtex has taken that may reduce MEs

  • Developed a Microsphere Activity Calculator
  • Second check against the activity identified in WD 13

Consultation - Sirtex Medical (cont.)

Actions Sirtex has taken that may reduce MEs

  • Enhance Training Evaluation Certification Program
  • All necessary nuclear medical / radiation safety support is present
  • Includes in-service site visits and proctor assessments
  • Minimum frequency of use to continue treatments
  • More vendor staff in close contact with licensees 14

Consultation - Boston Scientific (cont.)

Vendor identified issues and currently available potential solutions:

  • >20% volume Y-90 spheres left in delivery device -

may need improved quality systems

  • Events related to the delivery device - enhancements to the WD and /or increased familiarization with the device
  • Wrong dose due to calculation errors, catheter placement errors or wrong dose vial - software tools 15

Consultation - Boston Scientific (cont.)

Resources provided to aid in the planning and facilitation of Y-90 treatments:

  • Software tools to assist licensees in treatment planning and ordering Y-90 microspheres

spreadsheet ordering tool

Consultation - Boston Scientific (cont.)

Resources provided to aid in the planning and facilitation of Y-90 treatments:

  • IFU supported by training at new sites for physician authorized users, RSOs and support staff
  • TheraSphere Administration Checklist instructs users to confirm patient identity, instructions for administration set priming, dose vial preparation, administration set assembly final assembly before administration and disassembly and cleanup 17

ACMUI Recommendations There should be further discussion with vendors to:

  • Understand fully how these programs can reduce MEs
  • How the vendor judges the effectiveness of these programs
  • How the vendor tests the accuracy of spreadsheet or software tools
  • What steps are being taken to minimize the chance of clogged microcatheters which causes residual activity to remain in delivery device 18

ACMUI Recommendations (cont.)

  • Investigate the utility of software programs and checklists provided by the microsphere vendors with licensees.
  • Issue information notice and speak at conferences to alert licensees of past MEs and share the ACMUI subcommittee recommended actions to reduce Y-90 microsphere MEs.

19

Acronyms

  • ACMUI - Advisory Committee on the Medical Use of Isotopes
  • MEs - Medical Events
  • WD -Written Directive
  • IFU - Instructions for Use 2

0

Emerging Radiopharmaceuticals in an Expanding Nuclear Medicine Arena Hossein Jadvar, MD, PhD, MPH, MBA Advisory Committee on the Medical Uses of Isotopes December 6, 2022

Agenda

  • Recent approvals
  • PSMA Theranostics
  • Imaging trials
  • Therapeutic trials
  • Summary

Trends in Radiopharmaceuticals Recent Approvals YEAR Neuropsychiatric Oncologic 2012 18F-florbetapir (AmyvidR) 11C-choline 2013 18F-futemetamol (VizamylR) 223Ra dichloride (XofigoR) 2014 18F-florbetaben (NeuraCeqR) 2016 18F-fluciclovine (AxuminR) 68Ga-DOTATATE (NetspotR) 2018 177Lu-DOTATATE (LutatheraR) 131I-Iobenguane (AzedraR) 2019 18F-fluorodopa 68Ga-DOTATOC 2020 18F-flortaucipir (TauvidR) 64Cu-DOTATATE (DetectnetR) 18F-fluoroestradiol (CeriannaR) 68Ga-PSMA-11 (UCSF, UCLA) 2021 18F-DCFPyL (PylarifyR) 2022 177Lu-vipivotide tetraxetan (PluvictoR) 3

THERANOSTICS Targeted Molecular Imaging and Therapy The Key-Lock Principle Schematic Representation of an Agent for Imaging and Targeted Therapy Courtesy Helmut Mcke (modified) pharmacokinetics/biodistribution modifier Target Ligand Linker Chelator Lock Key Radioisotope Biological Targets Molecular Ligands Reporting Unit

  • antigens
  • antibodies,
  • 99mTc, 111In, 67Ga (e.g., CD20, HER2) minibodies, affibodies,
  • 64Cu, 18F, 68Ga aptamers
  • Gd3+
  • GPCR (e.g. SSTR)
  • peptides (agonists & Cytotoxic Unit
  • enzymes & inhibitors antagonists)

(e.g., PSMA)

  • 90Y, 177Lu, 213Bi, 225Ac
  • amino acids 4
  • transporters
  • 105Rh, 67Cu, 186,188Re

Prostate-Specific Membrane Antigen (PSMA)

  • Type II transmembrane enzyme (FOLH1; carboxypeptidase)
  • Release of glutamate from folates, activation of glutaminergic system, redirecting cell survival signaling from MAPK pathway to PI3K/Akt oncogenic pathway
  • LOW: secretory cells of prostate epithelium, brain
  • MOD/HIGH: small bowel, proximal renal tubule, salivary glands, tumor neovasculature
  • Undergoes internalization constitutively
  • Over-expressed in aggressive PrCa, met/rec dz.

(1000x nl./benign, ~2M/cell)

  • 5-10% CAP no PSMA expression
  • Intra- and inter-tumor heterogenous PSMA expression 5

PSMA PET Approved 12/1/20 Approved 5//27/21 68Ga-PSMA-11 18F-DCFPyL 18F-rhPSMA-7.3 18F-PSMA-1007 (Illuccix; Locametz) (Pylarify)

Prostate Cancer Natural History Induced Oligomets MDT Dx & Initial Staging Synchronous Metachronous Oligomets Oligomets MDT MDT Metastatic Disease Biochemical Recurrence Omlin, 2016 7

proPSMA Lancet 2020 AUC Sp. Sn.

vs. CI HiRsk: either of PSA>20, ISUP 3-5, Clin Stage>T3 PSMA PET-CT has better accuracy, with Impact consequent management change, fewer equivocal results, and lower radiation exposure compared mSv with CI CAN REPLACE CI 8

OSPREY 2021

  • Cohort A (n=252) high-risk ca undergoing RP+PLND (SOT:+histo)
  • Pelvic LN (sn 40.3%, sp 97.9%, ppv 86.7%, npv 83.2%); sn endpoint met w/ LN size > 5 mm
  • M0 to M1 12.3%
  • Cohort B (n=93) suspected rec/met on CI Jadvar 9

2021 CONDOR

  • 208 men with BCR per AUA/ASTRO-Phoenix criteria &

uninformative CI

  • Median PSA 0.8 ng/mL (0.2-98.4 ng/mL)
  • 1o endpoint: CLR defined as PPV with anatomic colocalization &

composite SOT with lower bound 95% CI for CLR>20% for 2/3 readers

  • CLR 84.8%-87.0%
  • 63.9% management change 1 0

Trends in Radiopharmaceuticals Oncologic & Theranostics Prostate-Specific Membrane Antigen (PSMA)

JNM 2018 49% pts +PSMA 19% pts with at least 1+ lesion not covered by RTOG guidelines CTVs 1

1

PSMA-SRT Trial Post-RP BCR, PSA>0.1 ng/ml Outcome: >20% decline in SRT failure at 5y 1

2

Jadvar H. et al. J Nucl Med January 2022 Hope & Jadvar. J Nucl Med May 2022 1

SNMMI, ACNM, ASCO, AUA, EANM, ACP, ANZSNM 3

Trends in Radiopharmaceuticals Oncologic & Theranostics 177Lu-PSMA-617 JNM 2018 1

4

LuPSMA Lancet Oncol 2018 PSA response after 12wks

  • 30 men mCRPC
  • Prior Rx: 87% chemo, 83% ADT
  • PSMA+ / FDG-
  • RLT: 7.5 GBq/cycle x 4 cycles q6w Best PSA
  • 1 (100%), 2 (93%), 3 (80%), 4 (47%) response
  • PSA50 -- 57% of patients
  • 82% objective response
  • 37% improvement in global health 1

5

TheraP Lancet 2021

-N: CBZ (85), Lu (98)

-No FDG+/PSMA - (28%)

-PSA50:

(CBZ 44% < Lu 66% )

-Gr. 3/4 AE (no xerostomia)

(CBZ 53% > Lu 33% ) 1 6

  • 40% decline in risk of death
  • 60% decline in radiographic progression
  • 4-m OS benefit; 5.3-m rPFS benefit NEJM 2021
  • More side effects but low grade and manageable Standard of Care:

NOT ALLOWED - chemo, Ra, immunoRx, investigational drugs Enocyte/Novartis ALLOWED: ADT, bone-directed Rx, NCT03511664 1 palliative XRT 7

iPFS 5.3 m benefit OS 4.0 m benefit Time 1st SRE 4.3 m benefit VISION: NEJM 2021 1

8

Trends in Radiopharmaceuticals Oncologic & Theranostics 225AC-PSMA-617 213Bi-PSMA-617 Kratochwil, JNM 2016 Sathekge, EJNMMI 2018 1

9

177Lu-PSMA I&T SPLASH NCT04647526 POINT Biopharma 2

0

2 1

2 2

2 3

2 4

TACTIST 225Ac-PSMA I&T

Summary

  • Theranostics is aligned with the concept of precision oncology
  • Theranostics is growing rapidly with anticipated imaging-radiopharmaceutical therapy pairs targeted to new biological targets
  • Theranostics will extend to other non-oncologic diseases
  • Focus areas will be on education, physician/technologist/scientist/physicist pipeline, radioisotope supply, and potential regulatory ramifications 2 8

Acronyms

  • CTV: clinical target volume
  • FDG: fluorodeoxyglucose
  • I&T: imaging and therapy
  • PET: positron emission tomography
  • PSMA: prostate-specific membrane antigen
  • RT: radiation therapy
  • RTOG: radiation therapy oncology group
  • SPECT: single-photon emission computed tomography 2

9

Impacts of the American Board of Radiologys Request to Terminate NRC Recognition of the American Board of Radiologys Board Certification Processes Hossein Jadvar, MD, PhD, MPH, MBA Advisory Committee on the Medical Uses of Isotopes (ACMUI)

December 6, 2022

Subcommittee Members

  • Hossein Jadvar, MD, PhD (Nuclear Medicine Physician; Chair)
  • Ronald D. Ennis, MD (Radiation Oncologist)
  • Richard Harvey, DrPH (Radiation Safety Officer)
  • Darlene F. Metter, MD (Diagnostic Radiologist)
  • Megan L. Shober (Agreement State Representative)
  • Melissa C. Martin (Medical Physicist, Nuclear Medicine)

Subcommittee Charge

  • To identify any potential impacts of ABRs request to terminate NRC recognition and other inactive boards identified during the NRCs evaluation of specialty boards and provide recommendations to mitigate any potential impacts
  • To review and evaluate the NRCs current board recognition criteria and provide any recommendations for action 3

NRC Recognized Boards (certificate holder can request to NRC for granting AU status)

  • American Board of Healthy Physics (ABHP)
  • American Board of Science in Nuclear Medicine (ABSNM)
  • American Board of Radiology (ABR)
  • American Board of Medical Physics (ABMP)
  • Canadian College of Physicists in Medicine (CCPM)
  • Board of Pharmacy Specialties (BPS) [Formerly Board of Pharmaceutical Specialties]
  • The American Board of Nuclear Medicine (ABNM)
  • Certification Board of Nuclear Cardiology, Part of the Alliance for Physician Certification and Advancement' Medical Specialty Boards and Certification Programs (CBNC)
  • The American Osteopathic Board of Radiology (AOBR)
  • The American Osteopathic Board of Nuclear Medicine (AOBNM) --- INACTIVE since March 5, 2019recognition status under review
  • Certification Board of Nuclear Endocrinology (CBNE) --- INACTIVE, no longer recognized 4

American Board of Radiology (ABR)

Background

  • Founded in 1934 as a non-for-profit organization and a member of the American Board of Medical Specialties (ABMS), one of 24 specialty certifying boards
  • Certifying board for Diagnostic Radiology (DR), Interventional Radiology (IR), Medical Physics (Diagnostic, Nuclear, Therapeutic), Radiation Oncology (RO), and subspecialties (Nuclear Radiology, Neuroradiology, Pediatric Radiology)
  • Mission

- To certify that our diplomates demonstrate the requisite knowledge, skill, and understanding of their disciplines to the benefit of patients.

5

American Board of Radiology (ABR)

Background

  • Prior to 2005: ABR did not provide AU-E designation on board certificates
  • 2005-2023: AU-E, AMP-E, & RSO-E designations was an option for candidates
  • December 31, 2023: Last date for AU-E designation on certificates (DR, IR-DR, RO, Diagnostic MP (RSO-E), Nuclear MP (RSO-E), Therapeutic MP (AMP-E)
  • 2024 and beyond: No AU-E designation option; candidates provide relevant T&E documentation through their employers directly to NRC to add the employee to employers license

- not aligned with the core ABR mission; diverts limited resources

- ABR has never issued AU status; most radiologists are not (and do not need to be) AUs

- ABR merely passed along documentation of T&E and direct pathway to becoming AU exists

- AU requirement for 700h T&E in nuclear radiology is an ACGME (residency) requirement

- IR-DR(Forms A & B), RO (2-page verification form) need not be submitted to ABR

- RISE questions will not be scored separately

- Trainees and programs should continue to keep T&E documentation

- T&E docs needed for 16-m embedded NM/DR pathway and NR fellows to sit for NR CAQ exam 6

7 8

Ensure a sufficient # of professionals (physicians/scientists/technologists) qualified to practice all aspects of nuclear medicine/molecular imaging now and in the future.

  1. of Residents by Academic Year Nuclear Medicine Nuclear Radiology Linear (Nuclear Medicine) 180 161 166 160 149 155 NR is relatively minor across time 140 136 NM stable since 2015 & expected to rise 120 120 107 100 93 84 78 74 71 75 69 76 80 60 40 12 11 18 16 15 16 13 12 11 11 12 18 20 8 10 7 0

9

Ensure a sufficient # of professionals (physicians/scientists/technologists) qualified to practice all aspects of nuclear medicine/molecular imaging now and in the future.

  1. of Commission on Accreditation of Medical Physics Education Programs (CAMPEP) Accredited Program Graduates by Academic Year 1

0

Ramifications & Potential Issues

  • Potential confusion and challenges with burden on applicants and institutions for securing AU, AMP, or RSO status for new hires

- AU-E board certification is rapid for proof of AU eligibility; ABR may have underestimated the burden being placed on the applicants, preceptors, and program directors

- Deceased preceptors, unwilling preceptors to sign off if >7y window (per requirement in 10 CFR 35.59) or if preceptor was not involved with applicants T&E

- Potential increase in time reviewing T&E documentations (NRC & Agreement States); possible delays may impact practice of medicine (AU-E could function immediately)

  • California: 4h per license amendment; ~100 AUs added per year; no time difference between ABR certification v. alternate pathway
  • Wisconsin: no apparent adverse impact on regulatory agencies based on licensing databases for 2020/2021
  • SECY-20-0005: Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35), cost-benefit analysis, 15 hrs for 1

NRC, 11 hrs for Agreement States, and 5 hrs for licensees 1

Ramifications & Potential Issues (cont.)

  • ~80% of ABR certifications included AU-E; unknown what %

become AUs on RAM licenses

  • Alignment of ACGME / AAPM-CAMPEP and NRC T&E requirements for AU and AMP designations
  • No indications that other NRC recognized entities will follow ABRs decision

- CBNE (dissolved) and AOBNM (inactive and very small even when they were active)

  • Association of University Radiologists (AUR) meetings may be appropriate venues for discussions and potential publication of recommendations in the AUR flagship journal, Academic Radiology 1 2

American Board of Radiology (ABR)

Questions

  • Can ABR reveal time spent and/or expense for including AU-E designation vs.

eliminating it?

  • How do ABR members (applicants, preceptors and program directors) feel about the extra burden that will be placed on them by eliminating the AU-E designation on board certificates?
  • Are there other options rather than eliminating the AU-E designation on the board certification?
  • Did the AU-E to clinical AU conversion play into the ABR's decision, and if so, what was this estimate and how was this estimate obtained?
  • How many ABR Certified Physicists get the RSO-E designation on their certificates/year?
  • If there is a significant decrease in MPs approved to be RSOs, are they any plans to increase the number of radiologists who are prepared to become RSOs?

1 3

Acronyms

  • AAPM - American Association of Physicists in Medicine
  • ABR - American Board of Radiology
  • ABNM - American Board of Nuclear Medicine
  • ACGME - Accreditation Council for Graduate Medical Education
  • AU-E - Authorized User-eligible
  • AMP-E - Authorized Medical Physicist-eligible
  • CAQ - Certificate of Added Qualification
  • CAMPEP - Commission on Accreditation of Medical Physics Education Programs
  • IR-DR - Interventional Radiology-Diagnostic Radiology
  • MP - Medical Physicist 1

4

Acronyms (cont.)

  • NM-DR - Nuclear Medicine - Diagnostic Radiology
  • NR - Nuclear Radiology
  • NRC - Nuclear Regulatory Commission
  • RO - Radiation Oncology
  • RISE - Radioisotope Safety Exam
  • RSO-E - Radiation Safety Officer-eligible
  • T&E - Training and Experience 1

5

ACMUIs Comments on the NRC Staff s Regulatory Basis for the Rulemaking on Emerging Medical Technologies and Rubidium-82 Generators Commission Briefing l December 6, 2022 l Megan Shober

BACKGROUND The last major structural revision to 10 CFR Part 35 was in 2002.

Energy Stereotactic Policy Act Devices Microsources Alpha- Theranostics emitters 2

BACKGROUND 10 CFR 35.1000 used when technologies dont fit.

  • Complex devices with new components
  • Tiny sealed sources that behave like a liquid
  • Need for device-specific training
  • Physical presence requirements
  • Atypical authorized users 3

RULEMAKING TIMELINE Rulemaking Plan Draft Regulatory Basis SECY-21-0013 (to ACMUI) 2/9/2021 9/27/2022 Commission Direction Regulatory Basis 1/13/2022 (public comment)

Spring 2023 4

RULEMAKING PROGRESS Option 1: Rubidium-82 generators only Option 2: Rubidium-82 generators, limited EMTs Option 3: Rubidium generators-82, broadly incorporate EMTs Staff developed draft regulatory basis.

5

REGULATORY ISSUES Consistency Specificity Compatibility Adaptability Efficiency Flexibility Rulemaking Guidance 6

PROPOSED CHANGES

  • Add EMTs into the best fit Subpart and then expand regulations to accommodate differences
  • New Subpart for microsources
  • Device-specific training
  • Conforming administrative updates 7

SUBCOMMITTEE EVALUATION Well-established technology

  • How widespread?
  • How mature?
  • How different?

8

SUBCOMMITTEE EMT EVALUATION Well-established Limited Not Available Ge-68 generators Alpha DaRT' ViewRay' Intravascular brachy GammaPod' Epi-Rad90' Seed localization *RadioGenix' GliaSite Gamma Knife **Liberty Vision Microspheres

  • NRC Staff chose to leave in 35.1000.
    • Licensing guidance not yet published. 9

SUBCOMMITTEE RECOMMENDATIONS New Subpart for microsources Incorporate well-established EMTs into existing 10 CFR Part 35 Subparts Changes to Radiation Safety Committee membership, written directives Device-specific training Performance-based changes to 35.600 1

0

SUBCOMMITTEE RECOMMENDATIONS Do not add product-specific requirements in regulation unless EMT is well-established Add general requirements to address simple issues with EMTs Re-evaluate ophthalmic sources Re-evaluate authorized medical physicists Broadly consider training for atypical AUs 1

1

SUBCOMMITTEE CONCLUSIONS

  • Many of the current EMTs are well-established and should be moved out of 35.1000.
  • Some EMTs should stay in 35.1000 due to limited operating experience.
  • NRC should periodically assess whether EMTs are still in use.
  • Thanks to Staff for their efforts on this project!

1 2

ACRONYMS

  • AUs: Authorized Users
  • CFR: Code of Federal Regulations
  • EMTs: Emerging Medical Technologies
  • Ge-68: Germanium-68
  • NRC: Nuclear Regulatory Commission 1 3
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