ML20034E997

From kanterella
Jump to navigation Jump to search
M170427: Scheduling Note and Slides - Meeting with the Advisory Committee on the Medical Uses of Isotopes (Public Meeting)
ML20034E997
Person / Time
Issue date: 11/02/2016
From:
NRC/SECY
To:
References
M170427
Download: ML20034E997 (63)


Text

FINAL: 11/2/16 SCHEDULING NOTE

Title:

MEETING WITH THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES (Public Meeting)

Purpose:

Provide the Commission an opportunity to hear views from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on medical-related topics of regulatory interest.

Scheduled: April 27, 201 7 10:00 am Duration: Approx. 1.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> Location: Commissioners' Conference Room, 1st fl OWFN

Participants:

Presentation ACMUI Panel 50 mins.*

Philip Alderson, M.D. , ACMUI Chair Topic:

  • Overview of ACMUI Activities Christopher Palestro, M.D. , ACMU I Nuclear Medicine Physician Topic:
  • ACMUl's Comments on the Training and Experience Requirements for All Modalities Laura Weil, ACMUI Patients' Rights Advocate Topic:
  • Patients' Rights Advocate's Comments on the Training and Experience Requirements Susan Langhorst, Ph.D. , ACMUI Radiation Safety Officer Topic:
  • Source Tracking for Category 3 Sources and its Impact on Medical Use John Suh, M.D. , ACMU I Radiation Oncologist Topic:
  • ACM Ul's Comments on Medical Event Reporting for All Modalities Excluding Permanent Implant Brachytherapy

Commission Q & A 30 mins.

Discussion - Wrap-up 5 mins.

  • For presentation only and does not include time for Commission Q & A's Documents:

Staff background material distributed: 4/17/17 Slides distributed: 4/20/17

I.

U.S.NRC United States N uclear Regulatory Commission Protecting People and the Environment Overview of ACMUI Activities Philip 0. Alderson, M.D., ACMUI Chairman ACMUI Commission Meeting April 27, 2017

Agenda

  • Overview of ACMUI Activities

- ACMUI Purpose

- Membership

- ACMUI Topics

- Present and Future

ACMUI Purpose

  • The ACMUI exists to advise the NRC staff, and thus you, the Commission, on policy on medicaJ uses of radionuclides.
  • Also, to provid e technical assistance and serve as consultants.

Membership Positions

  • Health Care
  • Nuclear Pharmacist*

Administrator

  • Radiation Safety
  • Nuclear Medicine Officer Physician
  • Patients' Right
  • 2 Radiation Advocate Oncologists
  • Agreement State
  • Nuclear Cardiologist RepresentativeA
  • Diagnostic Radiologist
  • U.S. FDA
  • 2 Medical Physicists* Representative
  • Pending security clearance A Vacant

ACMUI Topics Addressed in Last Year

  • T & E requirements for alpha and beta emitters and for all modalities,
  • Impact of medical event reporting on safety culture,

I

  • ACMUI Topics (Continued) '

~: .'

  • Clarification of patient intervention,
  • Licensing for radioactive seed localization,
  • Ge-68/Ga-68 generator licensing guidance,
  • Impact of Category 3 sources in medical practice,
  • Progress in improving ACMUI internal and external communications.

Current ACMUI Topics

  • Continuing discussions:

- T&E for AUs of all modalities,

- Medical event reporting for all modalities,

- Review of medical events,

- Patient release,

Current ACMUI Topics (Continued)

- Radioactive Seed Localization Licensing Guidance,

- Addressing the decommissioning funding plan requirements for the medical use of Ge-68/Ga-68 generators,

- Leksell Gamma Knife Icon Licensing Guidance,

Current ACMUI Topics (Continued)

- Ways to enhance communications between the NRC staff, the ACMUI, and the medical community.

Present and Future The ACMUI currently has a number of issues under discussion. As new issues arise, including emerging technologies, we will address and provide advice on aspects relevant to safe handling of radioactive sources.

Acronyms

  • AUs - Authorized Users
  • FDA - The Food and Drug Administration
  • LNT- Linear-No-Threshold
  • NRC - U.S. Nuclear Regulatory Commission
  • T&E - Training and Experience

U.S.NRC United States N uclear Regulatory Commission Protecting People and the Environment Comments on Training and Experience Requirements for All Modalities Christopher J. Palestro, M.D.

ACMUI Nuclear Medicine Physician ACMUI Commission Meeting April 27, 2017

I .

ACMUI Standing Subcommittee on Training & Experience (T&E)

  • Established in 2016
  • Charge

- Periodically review T&E requirements currently in effect for a ll modalities

- Make recommendations for changes as needed

ACMUI Standing Subcommittee on *rraining & Experience

.* Review T&E requirements currently in effect for uses of

- Unsealed byproduct materia.ls

( 10 CFR 35.100, 35.200, 35.300, & 35.1000)

- Sealed byproduct materials

( 10 CFR 35.400, 35.500, 35.600, & 35.1000)

Issues to be Addressed by the Subcommittee

  • Periodic review

- T & E requirements

- Competency

- Patient access

Periodic Review

  • What is a reasonable time interval between reviews?

- 15 years: Too long

- 1 year: Impractical

- 5 years: Reasonable/practical

  • More frequently if needed New procedure Increase in ME's or RSE's Other

Review Template for T&E Requirements T & E Requirements for .....

- Classification

  • Appropriate
  • Inappropriate
  • Obsolete

- Evaluation

  • Medical Events
  • Radiation Safety Events
  • Patient access

T & E Requirements Evaluation:

Medical & Radiation Safety Events

  • Number & Trends

- Explanation

  • Procedure
  • Competency

Competency

  • General Definition:

- Ability to do something, especially measured against a standard

  • Medical Definition

- Principle of professional practice, identifying th e ability of a provider to consistently administer safe, reliab le care

Determining Competency

  • Majority of individuals

- Deemed status of various certifying boards (ABNM, ABR, etc.)

  • Potential Alternative Pathways

- Didactics (with examination) and "hands-on" experience with preceptor certification

- Practical examination (independent examining committee)

Patient Access

  • Do current/proposed regulations limit patient access .to procedures?
  • Do current/proposed regulations provide adequate protection from unintended radiation exposure?
  • Accessible/reasonable pathways for obtaining AU status

Review Template Example 10 CFR 35.190 Training for uptake, dilution, and excretion studies.

Evaluation ME's: None re ported over 10 yrs.

RSE's: Not available Patient access: No known issues Classification Appropriate

Stakeholder Input

  • Informal

- Faster

- Potential for bias

  • Formal

- Slower

- Broader respondent base

Acronyms

  • ABNM - American Board of Nuclear Medicine
  • ABR - American Board of Radiology
  • AU - Authorized User
  • T&E - Training and Experience

U.S.NRC U n ited States N ucl ear Reg ul atory Commission Protecting People and the Environment Patients' Rights Advocate's Comments on the Training and Experience Requirements Laura Weil ACMUI Commission Meeting April 27, 2017

Ethical Framework for Evaluating

. Impact of T&E Regulations

  • Beneficence
  • Justice
  • Autonomy

The Safety Test

  • Does existing or proposed T&E regulation adequately protect clinicians, patients, and the public from harm?
  • Is existing or proposed T&E regulation unnecessarily restrictive such that it inhibits patients' access to necessary care?

"700 Hours" Safety Test

  • Effectively limits designation as authorized user to a narrow subset of clinical specialties. Physicians cover those 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in residency training:

comprehensive knowledge

  • Is the depth of knowledge acquired in residency training for these clinical specialties necessary for safe use of all radiopharmaceuticals?

Acronyms

  • T&E - training and experience

U.S.NRC United States N uclear Regulatory Commission Protecting People and the Environment Source Tracking for Category 3 Sources Impact on Medical Use Susan M. Langhorst, Ph.D.

ACMUI Radiation Safety Officer ACMUI Commission Meeting April 27, 2017

I

  • Category 3 Sources Used in Medicine
  • lr-192; 74 day half-life; 10-11 Ci receipt r Ir 192 line source diameter: 0.34 mm Length: 5 mm

- Wire diameter:

0.59 mm Wire material: Nill superelastlc alloy

HDR Medical Uses

  • Internal radiation therapy
  • Delivers radiation from HDR source placed close to, or inside, the tumor
  • Types of cancer treatments include breast, esophagus, gynecologic, head and neck, lung, prostate, rectum, and _

skin (-33,000 in 2010)

HDR lr-192 Source Replacement

  • 74 day half-life
  • Source re p lace m e nt due to:

- Decay of source activity

-Number of source cable runs

  • Replaceme nt about every 1 to 3 months

HDR lr-192 Shipments

  • HDR vendor ships re placement source to their customer licensee
  • HDR vendor arranges for service engineer to perform sourc.e exchange and return shipment of old source

Impact of NSTS Tracking on HDR lr-19.2 Use

  • HDR licensee new reporting responsibilities

- Estimated 1,100 HDR licensees

-Estimated 75% of HDR licensees have no Category 1 or 2 sources

  • Increased costs from HDR vendor to cover new reporting responsibilities

Need to Track HDR lr-192 Sources?

  • HDR licensee will have only 1 to 2 sources per HDR unit at any given time
  • HDR vendor maintains tracking information for all its customer licensees

Questions about NSTS Tracking of HDR lr-192 Sources

  • Is the NSTS and staff capable of handling the significant increase in reporting?
  • Would the HDR ve ndor need to verify their customer's license and vice versa for each source exchange? ,

[.* *

  • Questions about NSTS Tracking of HDR lr-192 Sources [cont.)
  • Are the LVS and WBL ready to support this effort?
  • Are Agreement State programs ready to support this effort?

Incorporating Category 3 Sources in 10 CFR 37 Security Requirements

  • Existing control and reporting requirements in 10 CFR 20 provide robust security for Category 3 sources
  • Wou ld inc lusion of Category 3 sources overwhelm the Part 37 security program and potentially diminish Category 1 and 2 source security?

Acronyms

  • CFR - Code of Federal Regulations
  • Ci - curies
  • HDR - high dose remote afterloader
  • LVS - License Verification System

Acronyms [cont.]

  • NSTS - National Source Tracking System
  • WBL - We b-Based Licensing System

U.S.NRC U n ite d Sta tes N uclea r Regulatory Commission Protecting People and the Environment Medical Event Reporting for All Modalities Except Permanent Implant Brachytherapy John Suh, M.D., ACMUI Radiation Oncologist ACMU I Commission Meeting April 27, 2017

Subcommittee Members

  • Ronald Ennis, M.D.
  • Vasken Dilsizian, M.D.
  • Chris Palestro, M.D.
  • John Suh, M.D. (chair)
  • Frank Costello
  • Zoubir Ouhib, M.S.

Subcommittee Charge

  • To propose the appropriate criteria for ME Reporting for events other than permanent implant brachytherapy.*

Rationale

  • Medical event reporting has not change d significantly for many years.
  • Given advances in technologies, in particular radiation oncology, the current definition may not be sufficient for AU and regulators.

Number of Medical Events

  • The annual number of reports is extremely low considering the estimated 15,000,000 diagnostic and 150,000 therapeutic procedures performed annually.

Number of Medical Events FY 2013 FY 2015 35.200 4 35.300 7 35.400 16 5 7 35.600 9 11 14 35.1000 15 261 14 ME Events Reporting FY 2015. Oct 6, 2016

Number of Medical Events

  • Does this accurately reflect the true number of cases if the current definition may be ambiguous?
  • Does the curre nt process, which is perceived as being punitive by some, lead to the desired goal of transparency, education, and adoption of best practices?

Guiding Principles

  • Medical events reporting should allow identification of an ME and provide a forum to discuss how to avoid/reduce the likelihood of such an event.
  • The definitions of ME reporting need to be broad, simple, and consistent, so reports are easily applicable by AU, evaluable by regulators, and process-focused in order to eliminate any ambiguity.

Guiding Principles

  • The subcommittee believes that any proposed changes should not be overly prescriptive and must not encroach on the practice of medicine.
  • Focus of ME reporting should be on education and improvement rather than punitive action whenever possible.

ME criteria would need to cover a variety of treatment modalities

  • Gamma Knife'
  • LDR temporary implants
  • lntraoperative modalities

Current Definition of 35.3045

  • Clear ME: Wrong drug, route of administration, patient, and mode; or leaking sealed source
  • Ambiguous ME:

- Total dose delivered differs from prescribed dose by 20% or more;

- Single fraction dose delivered differs from prescribed dose by 50% or more

- Intervention of patient or human subject in which the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

1 .

35.2 Definition

  • "Treatment site means the anatomical definition of the tissue intended to receive a radiation dose, as described in the written directive."
  • Since the written directive gives the AU a great deal of flexibility, this can be a potential source of ambiguity as treatment site can have different meanings among AU.
  • Treatment site is often defined as a volume, which may be source of confusion.

Recommendations

  • Continue to use the current 10 CFR part 35.3045 definition for medical event reporting for all modalities except permanent implant brachytherapy.
  • ACMUI is discussing patient intervention at this time.

I. .

  • Recommendations
  • Encourage major societies to issue white paper(s) to develop consensus on what should be incorporated into a written directive for various diagnostic and therapeutic modalities.
  • Benefits of white paper

- Will help with inspections and regulations by promoting standardization for identifying ME.

- Will assist licensees determine if ME has occurred.

- Assist institutions to develop SOP to prevent future ME.

Acronyms

  • AU - Authorize d User
  • CFR - Code of Federal Regulations
  • FY - Fiscal Year
  • GYN - Gynecological
  • HDR - High Dose Rate
  • IMRT - Intensity modulated radiation therapy
  • LDR - Low Dose Rate

Acronyms (Cont.)

  • ME - Medical Event
  • SBRT - Stereotactic body radiation therapy
  • SOP - Standard Operating procedures
  • SRS - Stereotactic radiosurgery
  • SIRT - Selective internal radiation therapy
  • 2D - Two dimensional
  • 3D-CRT - Three dimensional conformal radiation therapy