ML23298A027
| ML23298A027 | |
| Person / Time | |
|---|---|
| Issue date: | 10/23/2023 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
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| References | |
| Download: ML23298A027 (1) | |
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ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES FALL 2023 MEETING OCTOBER 23-24, 2023 Meeting Handout
MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES October 23 - 24 2023 Two White Flint North Building (Meeting Room T2D30), Rockville, Maryland NOTE: Sessions of the meeting may be closed pursuant to 5 U.S.C. 552b 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.
Monday, October 23, 2023 CLOSED SESSION 9:00 - 10:00
- 1. Badging and Enrollment ACMUI OPEN SESSION 10:00 - 10:15
- 2. Opening Remarks Mr. Einberg will formally open the meeting and Mr. Williams will provide opening comments.
C. Einberg, NRC K. Williams, NRC 10:15 - 10:30
- 3. Old Business Ms. Armstead will review past ACMUI recommendations and provide NRC responses.
L. Armstead, NRC 10:30 - 10:45
- 4. Open Forum The ACMUI will identify medical topics of interest for further discussion.
ACMUI, NRC 10:45 - 11:30
- 5. Medical Events Subcommittee Report Dr. Harvey will provide an analysis of FY21 and FY22 medical events.
R. Harvey, ACMUI 11:30 - 12:15
- 6. Overview of NRC Requirements for Veterinary Release Dr. Tapp will provide an overview of the NRC requirements and guidance for the release of animals administered radioactive material.
K. Tapp, NRC 12:15 - 1:30 LUNCH 1:30 - 2:15
- 7. ICRP Publication 153 Mr. Davila will provide an overview of ICRP Publication 153, Radiological Protection in Veterinary Practice.
A. Davila, Tulane University 2:15 - 2:35
- 8. Financial Assurance for Disposition of Category 1 and 2 Byproduct Material Radioactive Sealed Sources Mr. Whited will provide an overview of the rulemaking effort to revise the financial assurance requirements in 10 CFR 30.35 for the disposition of Category 1 and 2 byproduct material radioactive sealed sources.
R. Whited, NRC 2:35 - 3:20
- 9. Recent Radiopharmaceutical Medical Events Dr. Tapp will provide an overview of medical events related to the use of Lu-177 radiopharmaceuticals.
K. Tapp, NRC 3:20 - 3:35 BREAK 3:35 - 3:50
- 10. Special Recognition for Dr. Metter Commissioner Wright will make a special presentation to Dr.
Metter.
Cmsr. Wright, NRC 3:50 - 4:05
- 11. Thoughts on Leaving the ACMUI Dr. Metter will provide her farewell remarks to the Committee D. Metter, ACMUI
ML072670110 and to staff.
4:05 - 4:20
- 12. Open Forum The ACMUI will identify medical topics of interest for further discussion.
ACMUI, NRC 4:20 - 4:35
- 13. Administrative Closing Ms. Armstead will provide a meeting summary and propose dates for the spring 2024 meeting L. Armstead, NRC BREAK Tuesday, October 24, 2023 CLOSED SESSION 8:30 - 9:30
- 14. Credit Card Training M. Ricker, NRC 9:30 - 10:30
- 15. Ethics Training J. Scro, NRC 10:30 - 11:00
- 16. Allegations Training S. Hawkins, NRC 11:00 - 11:30
- 17. INFOSEC Training B. Stapleton, NRC 11:30 - 11:35
- 18. Group Photo ACMUI ADJOURN
2020 ACMUI Recommendations and Action Items 2021 ACMUI Recommendations and Action Items ITEM DATE STATUS Target Completion Date for NRC Action 11 As part of the Non-Medical Events report, the ACMUI recommended to the NRC staff and/or NMP to evaluate the issue of detection of short-lived medical isotopes in municipal waste (waste from nuclear medicine patients that might be triggering the landfill alarms) and provide some level of guidance, best practices, or additional instructions.
9/21/2020 Accepted Open Spring 2024 ITEM DATE STATUS Target Completion Date for NRC Action 7
The ACMUI formed a new subcommittee on the Liberty Vision Y-90 Manual Brachytherapy source. The subcommittee is expected to provide a draft report and any recommendations at the spring 2022 ACMUI meeting.
10/04/2021 Accepted Open Spring 2024 10 The ACMUI endorsed the Radionuclide Generator Knowledge and Practice Requirements Subcommittee Report and the recommendations provided therein.
10/04/2021 Accepted Open March 2026
2022 ACMUI Recommendations and Action Items ITEM DATE STATUS Target Completion Date for NRC Action 15 The ACMUI endorsed the ACMUI RG. 8.39 Subcommittee report on CivaDerm and the recommendations therein.
12/15/2021 Accepted Propose to close Summer 2023 ITEM DATE STATUS Target Completion Date for NRC Action 4
The ACMUI endorsed the Y-90 microsphere ME Subcommittee report and the recommendations therein.
12/5/2022 Accepted Open Fall 2024 6
The ACMUI established two subcommittees: one to create generic process checklists to be used during medical administrations and one to review the DFA draft proposed rule.
The ACMUI also reestablished the Nursing Mothers guidelines to update the 2019 guidelines.
12/5/2022 Accepted Open Fall 2023
2023 ACMUI Recommendations and Action Items ITEM DATE STATUS Target Completion Date for NRC Action 8
During the ACMUI Spring 2023 meeting, the ACMUI requested additional tentative dates from the staff for its Fall 2023 meeting.
5/15/2023 Accepted Propose to close Fall 2023
OPEN FORUM (No Handout)
1 Medical Events Subcommittee Report Richard P. Harvey, DrPH Advisory Committee on the Medical Uses of Isotopes October 23, 2023
- Richard Harvey, DrPH (Chair)
- Michael Folkert, M.D.
- Richard Green, B.S.
- Darlene Metter, M.D.
- Zoubir Ouhib, M.S.
- Harvey Wolkov, M.D.
- Consultant: John Angle, M.D.
- NRC Staff Resource: Daniel DiMarco, M.S.
2 Subcommittee Members
- Review Medical Events (MEs) to advise the Advisory Committee on the Medical Use of Isotopes (ACMUI) and United States Nuclear Regulatory Commission (NRC) about emerging trends that may need regulatory attention.
3 Subcommittee Charge
- The NRC and ACMUI review MEs that occur throughout the country on a regular basis.
- MEs occur when radioactive material use in healthcare results in unexpected radiation dose to patients.
(Please refer to 10 CFR 35 Subpart M - Reports and more specifically 10 CFR 35.3045 - Report and Notification of a Medical Event for more information.)
- The Medical Events Subcommittee of the ACMUI reviews the data to analyze the nature of medical events, identify emerging trends and provide recommendations to the ACMUI and NRC.
4 Background
- FY21 - October 1, 2020 to September 30, 2021
- FY22 - October 1, 2021 to September 30, 2022 5
Medical Event Review
Summary Two overarching themes remain
- Human Error
- Communication/feedback
- Failure to work in teams
- Inexperience
- Rapidly evolving use of radiopharmaceuticals
- Dissemination of use to smaller institutions with lower frequency of procedures performed 6
Specific Issues
- Increasing MEs: new and increasing use of current therapeutic radiopharmaceuticals 90Y microspheres remain the most common MEs.
- ACMUI Action: Added 2 specialty-specific subcommittee members
- ACMUI recommendation: AU adhere to manufacturer recommendations (i.e. avoid aggregation: use recommended catheter size and needle gauge) 7
35.200 Use of Unsealed Byproduct Material for Imaging and Localization 8
4/4 (100%) possibly preventable by time out in 2021 (Wrong Drug, Wrong Dosage & Wrong Patient)
Medical Events Summary 2017 2018 2019 2020 2021 2022 Total Cause Wrong Drug 0
0 0
0 1
0 1
Wrong Dosage 2
0 0
0 1
0 3
Wrong Patient 1
0 0
0 2
0 3
Extravasation 1
0 0
0 0
0 1
Human Error 0
0 1 (8 patients) 0 0
0 1 (8 patients)
Total 4
0 1
0 4
0 9
9 35.300 Use of Unsealed Byproduct Material, Written Directive Required Medical Event Summary 2017 2018 2019 2020 2021 2022 Total WD not done or incorrectly 2
1 2
0 0
1 6
Error in delivery
(# capsules) 1 0
1 0
0 1
3 Wrong Dose 0
0 0
0 4
3 7
Equipment 0
1 4
0 2
1 8
Human Error 0
0 1
2 3
4 10 Wrong Patient 1
0 1
0 0
0 2
Wrong Drug 0
0 0
0 1
0 1
Total 4
2 9
2 10 10 37 For 2021 & 2022: Time out 5/10 (50%), 3/10 (30%)
(Wrong Drug, Wrong Dosage & Wrong Patient)
35.400 Manual Brachytherapy Medical Event Summary
- Still using dose-based criteria 2017 2018 2019 2020 2021 2022 Total Applicator issue (e.g.
jam, eye plaque dislodged) 0 0
0 2
0 1
3 Wrong site implanted (e.g. penile bulb, bladder) 1 1
1 2
2 0
7 Activity/prescription error (e.g. air kerma vs mCi, enter wrong activity in planning software) 1 0
1 0
1 0
3 Prostate Dose 5
11 3
0 0
0 19 New Device 0
1 0
0 0
0 1
11 35.400 Manual Brachytherapy Medical Event Summary 2017 2018 2019 2020 2021 2022 Total Wrong Source 0
0 0
1 0
0 1
Patient Health
(?patient intervention) 0 0
0 1
0 0
1 Wrong Patient 0
0 0
0 1
0 1
Total 7
13 5
6 4
1 36 "Time Out" may have prevented 1
0 5
1 2
0 9
Lack of experienced/
inattention may have played a role 1
0 1
1 0
0 3
After 2019, many MEs were recategorized (dose to activity-based)
Potential ME issues:
- Lack of attention
- Inexperience 12 35.400 Manual Brachytherapy
Potentially ~25% (9/36) of ME from 2017 to 2022 may be prevented with the use of a Time Out (wrong site, wrong source and wrong patient):
- Time Out or checklist for 2021: 3/4 (75%)
- Retraining of an infrequently performed procedure (not a factor in MEs observed in 2021 or 2022)
- Increased attention during procedure (not a factor in MEs observed in 2021 or 2022) 13 35.400 Manual Brachytherapy
14 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Event Summary 2017 2018 2019 2020 2021 2022 Total Wrong position 2
3 4
7 0
1 17 Wrong reference length 2
1 4
2 2
2 13 Wrong plan 0
2 0
0 0
0 2
Wrong dose/source strength 0
1 0
0 0
0 1
Machine/applicator malfunction 2
3 1
1 1
2 10 Software/hardware failure 2 (9 patients) 0 1
1 0
0 4 (9 patients)
Treatment planning 0
0 0
2 1
2 5
Human Error 0
0 0
0 1
4 5
Total 8 (14 patients) 10 10 13 5
11 57 (14 patients)
15 GYN tumors most common site of ME 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Medical Event Summary 2017 2018 2019 2020 2021 2022 Total Location Breast 0
1 0
1 0
0 2
Gynecological 7 (14 patients) 7 8
10 4
2 38 Skin/neck 0
1 0
2 1
5 9
Bronchus 0
0 0
0 0
0 0
Prostate 0
0 0
0 0
0 0
Brain 1
1 2
0 0
0 4
Unknown 0
0 0
0 0
4 (7 patients) 4 (7 patients)
Total 8 (14 patients) 10 10 13 5
11 (7 patients) 57
MEs that may have been prevented by timeout (wrong plan or dose)
- 2017 0/8 events
- 2018 3/10 events
- 2019 0/10 events
- 2020 0/13 events
- 2021 0/5 events
- 2022 0/11 events Total 3/5 (%)
16 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit
MEs caused by infrequent user/inattention This is difficult to determine based on information in NMED. For this assessment, assumed wrong position is a surrogate for infrequent user/inattention 2017 2/8 events 2018 1/10 events 2019 1/10 events 2020 9/13 events 2021 0/5 events 2022 1/11 events 17 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic unit Total 14/57 (25%)
35.1000 Radioactive Seed Localization Medical Events Summary (No additional events) 2018 2019 2020 2021 Total Medical Events 0
1 0
1 Cause:
Delayed seed removal (patient intervention) 0 1
0 0
Lost seed 0
0 0
0 Wrong implant site 0
0 0
0 Seed migration 0
0 0
1
35.1000 Intravenous Cardiac Brachytherapy
- Medical Events Summary (no additional events) 2017 2018 2019 2020 Total Did not follow proper procedure 0
0 1
0 1
Tortuous vessel anatomy 0
1 1*
0 2
Catheter issue 0
1 0
1 2
Total 0
2 2
1 5
19
- AU felt this is patient intervention No time out issues Difficult to assess the unfamiliarity issue, but possibly played a role in some
35.1000 Gamma Knife Perfexion' Icon' and Esprit' Medical Events Summary 2017 2018 2019 2020 2021 2022 Total Total Medical Events 0
1 2
2 0
2 7
Cause:
Back-up battery power source failure 0
1 0
0 0
0 1
Patient set-up error 0
0 0
1 0
0 1
Patient movement 0
0 2
0 0
0 2
Wrong site (treatment plan) 0 0
0 0
0 0
0 Wrong site (human error-shifting of co-registration images) 0 0
0 1
0 1
2 Patient motion management system failure 0
0 0
0 0
1 1
35.1000 90Y Theraspheres Medical Events Summary For 2021 & 2022: Time out 4/23 (17%), 2/23 (9%) - Wrong Dose*
Infrequent/inattention 10/23 (43%), 2/23 (9%) - > 20% Residual 2017 2018 2019 2020 2021 2022 Total Total Medical Events 15 14 15 15 23 23 105 Cause:
> 20% residual activity remaining in delivery device/leakage 7
11 9
12 10 2
51 Delivery device set-up error 2
2 1
1 1
0 7
Wrong dose (treatment plan calculation error) 4 0
1 0
0 3
8 Wrong site (catheter placement error & size) 2 0
0 2
1 7
12 Wrong dose vial selected*
0 1
4 0
1 1
7 Wrong dose (calibration error)*
0 0
0 0
3 1
4 Aggregation of microspheres 0
0 0
0 7
9 16
35.1000 90Y SirSpheres Medical Events Summary 2021 & 2022: Time out: 1/18(6%), 1/9(11%) - Wrong Site (WD)
Infrequent/inattention: 2/18(11%), 1/9(11%) - >20% Residual 2017 2018 2019 2020 2021 2022 Total Total Medical Events 8
7 11 8
18 9
0 Cause:
> 20% residual activity remaining in delivery device/leakage 7
2 8
8 2
1 0
Wrong dose (treatment plan calculation error) 0 2
0 0
2 1
0 Wrong site (catheter placement error & defective catheter) 1 2
2 0
4 0
0 Wrong site (WD error) 0 1
1 0
1 1
0 Aggregation of microspheres 0
0 0
0 9
6 0
- Ensure familiarity with the mechanics of 90Y microsphere delivery device and setup procedures
- Confirm all data and calculations in treatment plan
- Perform Time Out to assure all elements of treatment are in accordance with Written Directive Actions to Prevent 35.1000 90Y Microsphere Medical Events
Identity of patient via two identifiers (e.g. name and DOB)
Procedure to be performed Radiopharmaceutical Activity Dosage -second check of dosage calculation and that the WD and dosage to be delivered are identical Others as applicable
- units of activity (LDR prostate)
- anatomic location
- patient name on treatment plan
- treatment plan independent second check has been performed
- reference length (HDR)
- Implant site location (RSL) 24 Possible Elements of a Time Out
- 10 CFR - Title 10 of the Code of Federal Regulations
- AUs - authorized users
- FY - fiscal year
- GYN - gynecological
- HDR - high dose-rate
- LDR - low dose rate
- mCi - milliCurie
- ME - medical event
- RSL - radioactive seed localization
- WD - written directive
1 U.S. Nuclear Regulatory Commission Advisory Committee on the Medical Uses of Isotopes Subcommittee on Medical Events Draft Report Submitted on September 21, 2023 Subcommittee Members:
Michael Folkert, MD, PhD (Brachytherapy Radiation Oncologist)
Richard Green, BS (Nuclear Pharmacist)
Richard Harvey, DrPH (Radiation Safety Officer; Chair)
Darlene Metter, MD (Diagnostic Radiologist)
Zoubir Ouhib, MS (Therapy Medical Physicist)
Harvey Wolkov, MD (Radiation Oncologist)
Consultant: John Angle, MD (Interventional Radiologist)
NRC Staff Resource: Daniel DiMarco, MS Subcommittee Charge: Review medical events (MEs) to advise the Advisory Committee on the Medical Uses of Isotopes (ACMUI) and U.S. Nuclear Regulatory Commission (NRC) about emerging trends that may need regulatory attention.
Background:
The subcommittee reviewed medical events from Fiscal Years 2021 and 2022 as part of its ongoing biannual review.
Findings: Medical events in Fiscal Years 2021 and 2022 were relatively low but there appears to be an increase in medical events related to 10 CFR 35.300 and 10 CFR 35.1000 uses. The volume of procedures involving 177Lu radiopharmaceuticals has increased during this period and this has resulted in an increased number of medical events in the category of 10 CFR 35.300.
Medical events related to 10 CFR 35.1000 uses have increased for treatments involving 90Y microspheres (for both TheraSpheres and SIR-Spheres). Reducing the number of medical events involving 90Y microspheres may be accomplished through improved education with emphasis on appropriate administration of the microspheres and proper set-up of the delivery device. In addition, a time-out may be a tool that can be implemented to reduce the number of medical events for procedures using 90Y microspheres.
The committee recognizes past effort and continues to discuss medical events that may benefit from a time-out or those that may be the result of infrequent/inexperience use. Improved education and use of a time-out may be beneficial in preventing medical events.
The subcommittee will continue to examine medical events involving radiopharmaceuticals approved for use under 10 CFR 35.300 as well as treatments performed with 90Y microsphere procedures (10 CFR 35.1000). Furthermore, the subcommittee will monitor trends that may continue and appear to be significant during the biannual review periods.
2 Concluding Remarks: The ACMUI Subcommittee on Medical Events appreciates the opportunity to continue reviewing these events. Emphasis will be placed on radiopharmaceuticals in 10 CFR 35.300 and 10 CFR 35.1000, specifically 90Y microsphere procedures, to discern if there are emerging trends in medical events involving these treatments. The subcommittee welcomes any comments and/or recommendations.
Respectfully submitted, September 21, 2023 Subcommittee on Medical Events Advisory Committee on the Medical Uses of Isotopes (ACMUI)
U.S. Nuclear Regulatory Commission (NRC)
Veterinary Release Katie Tapp, PhD Medical Radiation Safety Team Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards October 23, 2023
Regulations for Release of Patients
- 10 CFR Part 35 is specifically for medical use of byproduct material.
- 10 CFR 35.75, in part, allows medical licensees the ability to authorize release of patients if the dose to another individual from exposure to the patient is not likely to exceed 5 mSv (0.5 rem).
- This is a per release limit.
- 10 CFR Part 35 is specifically for medical use of byproduct material, not veterinary use.
- Therefore, 10 CFR 35.75 does not apply to release of animals administered radioactive material.
Veterinary Release Regulations
- 10 CFR Part 20 public dose limits apply to animal release.
- Licensees must have release procedures approved in a license condition prior to use.
- These dose limits are:
- 1 mSv (0.1 rem) per year from all licensed operations.
- 0.02 mSv (2 mrem) in any one hour from external sources.
- Licensees are required to demonstrate:
- by measurement or calculation that the dose to the individual who is likely to receive the highest dose does not exceed the annual public dose limit,
- or that an individual cannot exceed these limits if they are continuously present near the source (i.e., animal).
Veterinary Release Guidance
- Appendix D of NUREG-1556, Volume 7, Revision 1, Consolidated Guidance about Materials Licenses, Program-Specific Guidance about Academic, Research and Development, and Other Licenses of Limited Scope.
- Licensee should provide owner with written instructions to reduce dose to members of the public. The instructions should provide a margin for dose reduction but should NOT be relied upon as the primary way of keeping members of the public below the annual dose limit.
- Informs licensees / applicants that criteria for release must be submitted in an application for review and approval, before implementation.
Veterinary Release Guidance (cont.)
- Provides specific guidance only for release of cats treated with iodine-131:
- Cats are held not less than 4 complete days after administration
- The dose rate is less than 0.01 mSv/hour at 6 inches (or 0.0025 mSv/hr at a foot)
- Written instructions are provided to owners, AND
- Licensee can demonstrate that a member of the public would not receive a dose from a cat that would exceed 0.02 mSv (2 mrem) in any one hour and 1 mSv in a year.
- Guidance states other release criteria may be accepted on a case-by-case basis.
Instruction Guidance
- The NUREG recommends including the following items in instructions:
- the regulatory limits and the need to keep doses as low as reasonably achievable
- the potential radiation fields surrounding the animal and potential dose with time at various distances
- maintaining distance from people in public places and the home
- minimizing time in public places (e.g., walks on public sidewalks, parks, beaches, grooming salons)
- precautions to reduce the spread of radioactive contamination
- the handling and storage of animal excreta, and the duration of storage if held for decay
- the permitted extent and duration of contact by individuals with the animal, and handling
- of contaminated bedding and other objects with which the animal comes into contact
- the length of time each of these precautions should be in effect
Exubrion Template Procedure
- In October 2020, the NRC staff completed an evaluation of Exubrions proposed release criteria and procedure for future licensees to use to release dogs treated with their product, Synovetin OA.
- Synovetin OA is a tin-117m colloid used to treat osteoarthritis in dogs joints.
- The specific proposal NRC reviewed was for treating both dogs elbows with a maximum of 111 MBq (3 mCi) per elbow or 222 MBq (6 mCi) total.
- For consistency and efficiency, the NRC evaluated a template procedure developed by the manufacturer for future licensees use. As described in the licensing guidance, licensees still have to provide the procedure as part of their application for use if they wished to use it.
Exubrion Template Procedure
- Exubrions proposal was to allow release of a dog with a measured dose rate of less than 0.45 mR/hr at 1 m.
- To provide confidence than dose limits will not be exceeded, the proposal included a multilayer approach, which included
- A technical assessment to evaluate common dog-human interactions that could exceed the dose limit.
- Release procedure which includes a prescreening questionnaire to determine if the dog would need to stop or modify behaviors which were determined could exceed the dose limit, or potentially exclude release if the behavior could not be modified.
- Release procedure which states the license will only provide the treatment if they are confident the owner understands the need to comply with dose limits, behaviors would be modified as necessary, and patient specific instructions that are signed by the owner.
- The NRC found Exubrions proposed procedure provides adequate assurance that public dose limits will not be exceeded when licensees perform adequate prescreening and instructions are followed.
Prescreening Questionnaire
- Includes open-ended question about typical human-dog contact and how long it lasts
- Includes yes/no questions to common behaviors which might need to be modified to ensure dose limits are not exceeded, including
- Sleeping in the same bed
- Lap sitting or coach sitting
- Interactions with children
- Yes/No questions if behaviors which cause close contact could be modified were identified
- The questionnaire is used to bin animals into certain groups based on the typical dog-human behavior pattern to determine instruction duration is necessary to ensure compliance
NRC Conclusions and on-going work
- The NRC found Exubrions proposed procedure provides adequate assurance that public dose limits will not be exceeded when licensees perform adequate prescreening and instructions are followed.
- This evaluation was specific to the procedure provided. Modifications need to be reviewed on a case-by-case basis to ensure same conclusions apply before licensing and use.
- NRC determined need to develop compressive animal release guidance and rulemaking to provide clarity.
- NRC and OAS established a working group to develop a rulemaking plan to codify release of animals administered radioactive material.
- Deferred to work on higher priority rulemakings.
- hr - hour
- MBq - Megabequarel
- mCi - millicurie
- mR - milliroentgen
- mSv - millisievert
- NRC - Nuclear Regulatory Commission
- OAS - Organization of Agreement States
Overview of ICRP Publication 153 Presented by Anthony DAVILA Tulane University NRC ACMUI October 2023
Lodewijk VAN BLADEL (Co-chair, C3)
Nicole MARTINEZ (Co-chair, C4)
Jérme BENOIT Sarah DORLING Jennifer GAMBINO Lajos BALOGH R. Jan PENTREATH Masahiro NATSUHORI Kathelijne PEREMANS Elissa RANDALL Catherine ROY
Åste SØVIK (Co-chair, C3)
Ignacia TANAKA Anthony DAVILA Task Group 110 Members
Radiological Protection in Veterinary Practice 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Anne x A. Ro le s a nd re sp o nsib ilitie s Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt
Summary of the motivation for explicit consideration of radiological protection in veterinary practice 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Anne x A. Ro le s a nd re sp o nsib ilitie s Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt
Why now?
Veterinarians have long employed ionizing radiation; the chair of the First (1905) and Second (1906) Radiological Congresses was a veterinarian Early on, applying a few simple rules could sufficiently limit the risks to staff, owners/handlers, etc., and animal patients not believed to be exposed to any real risk Over the past several years though, applications and availability have grown and diversified considerably Operating upon a dog for instruction, Central Medical Department Laboratory Dijon, France (1918)
Courtesy of Otis Historical Archives, National Museum of Health and Medicine Schnelle (1968) Veterinary Radiology 9:5 Kealy (2002) Vet Radiol Ultrasound 43:213
The same may be true for w o rking a nim a ls, e nd a ng e re d sp e cie s, e xo tic a nd sp o rts a nim a ls Bouma et al. (2021) Int J Environ Res Public Health 29:193; Shir-Vertesh (2012) Am Anthropol 114:420; Walsh (2009) Fam Process 48:462 Ma ny co m p a nio n a nim a ls a re co nsid e re d part of the family a nd e ntitle d to the b e st ca re a va ila b le.
Monetary value m a y furthe r stim ula te inte re st in a n a nim a ls w e lfa re
The same may be true for w o rking a nim a ls, e nd a ng e re d sp e cie s, e xo tic a nd sp o rts a nim a ls Bouma et al. (2021) Int J Environ Res Public Health 29:193; Shir-Vertesh (2012) Am Anthropol 114:420; Walsh (2009) Fam Process 48:462 Ma ny co m p a nio n a nim a ls a re co nsid e re d part of the family a nd e ntitle d to the b e st ca re a va ila b le.
Monetary value m a y furthe r stim ula te inte re st in a n a nim a ls w e lfa re The re is a lso incre a sing a w a re ne ss o f the inter -
connectedness o f hum a n, a nim a l, a nd e nviro nm e nta l he a lth a nd w e lfa re https://www.cdc.gov/
Objective and scope of the publication with elaboration on historical background and modern motivation 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Anne x A. Ro le s a nd re sp o nsib ilitie s Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt
Relevant Guidance The reasons for using radiation in veterinary medicine are to either obtain optimum diagnostic information or to achieve a specific therapeutic effect while maintaining the radiation dose to the radiological personnel and the general public as low as reasonably achievable (the ALARA principle).
Similarly, it is also important to avoid all unnecessary irradiation of the animal patient
[emphasis added].
img src: ncrponline.org img src: iaea.org
1.
W hy this p ub lica tio n?
2. Intro d uctio n 3.
Basic concepts of radiological protection 4. Ethics a nd va lue s 5. Uniq ue a sp e cts o f ve te rina ry p ra ctice 6. Ap p lica tio n o f the syste m o f ra d io lo g ica l p ro te ctio n to ve te rina ry p ra ctice 7.
Sum m a ry o f re co m m e nd a tio ns a nd co nsid e ra tio ns Anne x A. Ro le s a nd re sp o nsib ilitie s Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt Brief review of dosimetric quantities, the biological basis of RP, the system of RP, and practical protection strategies; intended for a wide - ranging audience
Biological Basis for RP Tissue Reactions (Deterministic effects)
Misconception: Radiation doses in veterinary medicine are not high enough to produce deterministic effects.
High dose radiological procedures are being increasingly adopted.
Stochastic Effects Misconception:
Animals dont live long enough to get radiation induced cancer.
Shorter latency periods for short lifespans Leukotrichia 3 months after IMRT for sinonasal neoplasia. ICRP 153 Osteosarcoma in a dog 5 years after treatment for mast cell tumour. Pentreath et al. 2020
Review the ethical basis of the system of RP with connections to veterinary and environmental ethics 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Anne x A. Ro le s a nd re sp o nsib ilitie s Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt
Ethical Theories Building off the framework of ICRP Publication 138 Core Values:
Beneficence/non
- maleficence, Prudence, Justice, Dignity Procedural Values:
Accountability, Transparency, Inclusiveness Utilitarianism Deontology Virtue Ethics Furthering of the collective interest Preferability of certain actions based on their outcomes Optimisation Respect for individuals and their rights A set of obligations or rules for human society Dose limits Promotion of integrity, discernment, and wisdom Virtuous life based on a certain concept of human nature Justification
Animal w e lfa re Re ve re nce fo r life Em p a thy So lid a rity Susta ina b le d e ve lo p m e nt Re sp e ct fo r Auto no m y Ste w a rd ship Beneficence/
Non - maleficence Prudence Dignity Accountability Transparency Inclusiveness Justice Ethical Values Core ethical and procedural values with additional interpretation The e xte nsio n o f the co re a nd p ro ce d ura l va lue s is to he lp cla rify the se va lue s fo r the sp e cific RP a p p lica tio n Re fle cts the d e sire fo r a co nsiste nt a p p ro a ch a m o ng hum a n, e nviro nm e nta l, a nd ve te rina ry a sp e cts o f RP No te tha t the re a re a va rie ty o f inte rre la tio nship s b e tw e e n va lue s; this is no t a ha rd o ne - to - o ne link
Similarities and differences between human medicine and veterinary practice highlighting unique veterinary challenges 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Anne x A. Ro le s a nd re sp o nsib ilitie s Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt
Unique Aspects Environmental Not specifically designed for radiological procedures Animal enclosures, farms, in the field Equipment Prevalence of second
- hand from human medicine Dedicated veterinary equipment that falls under industrial standards Competence Lack of RP training in veterinary curriculum Lack of specialized staff Lack of medical/health physicist involvement Regulations/Guidelines Lack of appropriateness criteria, DRLs Lack of regulatory harmonization Lack of guards against self
- referral and self
- presentation
Photos courtesy of Dr. Elissa Randall, Colorado State University Veterinary patients come in all shapes and sizes and available technologies are consistent with human medicine Photo by Gail Tabone src: https://senecaparkzoo.org/tusk-x-rays-on-an-elephant/
Discussion of justification, optimisation
, and application of dose limits (in the context of animal patients as well as workers and the public) 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Anne x A. Ro le s a nd re sp o nsib ilitie s Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt
Justification (1)
Level Human medicine Recommended for veterinary practice Level 1 (General use)
Proper use of radiation in medicine is accepted as doing more good than harm to society. Now taken as a given.
Proper use of radiation in veterinary medicine is accepted as doing more good than harm to society. Now taken as a given.
Level 2 (Specific procedure and objective)
A specified procedure with a specified objective is justified if it will improve the diagnosis or treatment or if it will provide necessary information about exposed individuals A specified procedure with a specified objective is justified if it will improve diagnosis or treatment of a defined group of animal patients or if it will provide necessary information about exposed animals Level 3 (Particular procedure for the patient)
The application of a radiological procedure is justified if it is judged, in advance, to do more good than harm to the individual patient The application of a radiological procedure is justified if it is judged, in advance, to do more good than harm to the individual animal patient
Justification (2)
Medical Procedures Appropriate training and education Suggestion
- develop decision support tools Equipment RP assessment Level 3 - procedure should answer clinical question Non - medically indicated investigations Imaging of asymptomatic animals Hip/elbow dysplasia screening in dogs Presale radiographic exams of horses Should be consistent with current clinical evidence Level 2 - clinical evidence, demonstrable relationship between the imaging findings and the goal of the screening
Optimization Optimization is always aimed at achieving the best level of protection under the prevailing circumstances through an ongoing, iterative process.
Appropriate design and construction of installations and careful selection of equipment Day - to - day strategies Priority is safety of humans Not to be confused with dose minimization Factors to consider:
Other occupational hazards Use of sedation/
anaesthesia
Application of dose limits Carer - an individual who may be exposed to radiation as a volunteer helper providing support or care for a patient in a context that is not associated with their occupation.
Veterinary medicine animals have not been legally recognized as patients so carer designation not applicable though in many circumstances there is a direct benefit to both animal and owner.
The concepts of patient and carer ideally should be tailored to be applicable within reason in veterinary practice.
Hospitals stays and release criteria Suggestion
- additional studies looking at doses to owners/handlers from veterinary nuclear medicine procedures.
Recall Planned : planned introduction and operation of sources Emergency
- unexpected situations requiring urgent attention Existing : already exist when a decision on control must be made Exposure situations Exposure categories Occupational
- exposure received as a direct consequence of ones job Public : exposure that is not occupational or medical Medical
- Patients, carers, research volunteers Protection of animals in the context of environmental protection addresses the collective impact
, e.g., preservation of species and maintaining biodiversity and, as currently written, the medical exposure category appears to apply solely to human medicine
Where do animal patients fit then?
Veterinary applications of ionizing radiation are comparable to human medical exposures
, but because this involves subjects other than humans, local governments and regulatory agencies manage exposures received in a veterinary setting in different ways.
However, if from a regulatory perspective veterinary practice is considered comparable to an industrial application, this may lead to an approach whereby the animal is considered an object, without consideration that it is a sentient living creature, or neglecting unique but necessary aspects (e.g., safety of patients under anesthesia)
The Commission now specifies that the system includes protection of the individual animal in special circumstances Animal patients undergoing radiological veterinary procedures comprise one case among others including animal research subjects and pets/domestic animals in a radiological emergency (e.g., Publication 146)
Review of key takeaways of the publication 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Anne x A. Ro le s a nd re sp o nsib ilitie s Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt
Main Points (1)
The objective of this publication is to provide an initial set of relevant observations, considerations, and general recommendations related to radiological protection in veterinary practice, intended for a wide - ranging audience Radiological protection challenges specific to veterinary practice arise from the different combinations of personnel and members of the public who may be involved, and from operational environments required when dealing with animals.
The priority of radiological protection in veterinary practice is that of the humans involved
, but the exposure of animals should also be the object of explicit attention because, like humans, animals are subject to potential tissue reactions or stochastic effects resulting from exposure to radiation.
Main Points (2)
In veterinary practice, the core and procedural ethical values of the system of radiological protection are elaborated on with discussion of additional interpretations of these values, including animal welfare, sustainable development, solidarity, reverence for life, stewardship, respect for autonomy
, and empathy Veterinary applications of ionizing radiation, and their ensuing protection challenges, are, to a large extent, comparable to situations in human medical applications
, and could benefit from similar approaches, such as the three levels of justification
, and optimization as a process to ensure that the likelihood and magnitude of exposures and the number of individuals exposed are reasonable and appropriate for the situation at hand, considering economic, societal, and environmental factors.
Discussion of individual and organizational functions and anticipated obligations relevant to RP in veterinary practice 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Annex A. Roles and responsibilities Anne x B. Ethica l issue s a sso cia te d w ith the p ro te ctio n o f a nim a ls a nd the e nviro nm e nt
Roles and Responsibilities (1)
United Nations Scientific Committee on the Effects of Atomic Radiation International Commission on Radiological Protection International Atomic Energy Agency
Roles and Responsibilities (2)
Role - an individuals or organisations position or function Responsibility
- the anticipated obligation, duty, or commitment associated with a particular role Hospital/Practice Radiological Practitioner Installation Location Fit - for - purpose Quality assurance program Appropriateness of the procedure How the procedure is performed Inform and instruct non - staff members Training Programs Provision of adequate education and training Explicitly address RP
Elaboration on humanitys relationship with and responsibility to animals and the environment 1.
Why this publication?
2.
Introduction 3.
Basic concepts of radiological protection 4.
Ethics and values 5.
Unique aspects of veterinary practice 6.
Application of the system of radiological protection to veterinary practice 7.
Summary of recommendations and considerations Anne x A. Ro le s a nd re sp o nsib ilitie s Annex B. Ethical issues associated with the protection of animals and the environment
Ethical Issues in Veterinary Practice Animal Ethics What is the difference, morally speaking, between humans and animals?
Animal Welfare How individual animals lives may be improved or impoverished through our actions/inactions 3 Party Problem Veterinarian, animal patient, animal owner/guardian To whom should the vet s primary responsibility be?
Bottom line The Commission hopes that highlighting radiological protection concerns and related knowledge gaps will inspire additional research and development related to the evidence
- based use of ionising radiation in veterinary practice in support of the justification process; dedicated facilities and equipment
- improved understanding of the radiosensitivity of different types of animals; and practice guidelines in support of exposure management and other relevant areas to promote health and safety of personnel, the general public, and the environment, while further improving the quality of care for the patients and healthy animals submitted to radiological procedures.
Future considerations?
Decontamination of livestock following an emergency T he animal as the comforter Other working animals (e.g.,
search and rescue)
Research animals More dosimetric data Toronto Police Service dog Split Creek Farms baby goats (N. Martinez)
Animal assisted therapy, Langley Air Force Base Split Creek Farms baby goats (N. Martinez)
Toronto Police Service dog
Thank you for your attention!
Contact info:
Anthony Davila, MS adavila@tulane.edu SCAN ME TO ACCESS P153
Financial Assurance for Disposition of Category 1-3 Sealed Sources Ryan Whited, Sr. Project Manager Low-Level Waste and Projects Branch Division of Decommissioning, Uranium Recovery and Waste Programs Office of Nuclear Material Safety and Safeguards October 23, 2023
=
Background===
- NRCs regulations in 10 CFR 30.35 provide a threshold above which decommissioning financial assurance (FA) is required
- Most Category 1-3 radioactive sealed sources fall below the threshold, and there is no requirement for end-of-life financial planning
- This does not relieve the licensee from the responsibility of proper end-of-life management
- Financial burden associated with source disposition may be significant 2
- Objective was to determine if additional FA requirements for certain sealed sources were needed.
- Scoping study documented in SECY-16-0046 (April 7, 2016).
- Rulemaking plan provided in SECY-16-0115 (October 7, 2016). The NRC staff recommended that:
The Commission approve the initiation of rulemaking to expand the financial assurance requirements in 10 CFR 30.35 The scope of the rulemaking should be limited to Category 1 and 2 byproduct material sealed sources tracked in the National Source Tracking System (NSTS) 3 NRC Staff Activities - 2016
- On December 8, 2021, the Commission issued SRM-SECY-16-0115, directing the staff to:
Expand 10 CFR 30.35 to require FA for disposition of Category 1 and 2 byproduct material sources tracked in the NSTS
Carefully explore options to mitigate potential adverse impacts on existing and future licensees, particularly medical users, and those who benefit from using these radioactive materials
Consider and seek public comment on whether FA requirements should also be extended to Category 3 sources
Develop and seek public comment on a risk-informed basis for establishing FA requirements, considering factors such as the overall risk and total cost of disposal 4
Commission Direction - 2021
5 Category 1 & 2 Sources National Source Tracking System (~84,000 total sources)
Co-60 (91.2%)
Cs-137 (3.7%)
Ir-192 (4.0%)
Am-241 (0.1%)
Other - mostly DOE (~1%)
Other radionuclides (e.g., Sr-90, Pu-238) mostly owned by DOE To understand the number of licensees affected and the disposal costs, we need to understand devices as well as sources
- The NRC staff is preparing a regulatory basis for rulemaking to implement the Commissions direction Established working group including representatives from the NRC Regions and Organization of Agreement States Coordinating with the U.S. Department of Energys National Nuclear Security Administration and the Conference of Radiation Control Program Directors Met with low-level waste (LLW) disposal facility operators, LLW brokers, and sealed source/device manufacturers and distributors Identifying and analyzing potential regulatory options, such as FA based on device type and changes to decommissioning funding plan requirements 6
Rulemaking Status
- Availability of cost data to support FA requirements
- Assessing disposition pathways for many different source and device types
- Complexity of the U.S. LLW disposal landscape
- Limited disposal examples / lack of a disposal pathway for some high-activity sealed sources
- Evaluating impacts of additional requirements on many diverse licensees 7
Issues / Challenges
- NRC staff preparing a regulatory basis to expand FA requirements for Category 1 & 2 (and possibly Category
- 3) byproduct material sealed sources
- Developing and analyzing several potential regulatory options
- Anticipate providing the draft regulatory basis for ACMUI review in Spring 2024 8
Summary
Questions?
9
Radiopharmaceutical Medical Events Katie Tapp, PhD Medical Radiation Safety Team Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards October 23, 2023
RADIOPHARMACEUTICAL WRITTEN DIRECTIVE
- A written directive must be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 megabecquerels and any therapeutic dosage of unsealed byproduct material.
- For administration of therapeutic dosage of unsealed byproduct material other than sodium iodide I-131, the written directive must include:
- radioactive drug,
- dosage,
- and route of administration.
- Licensees must have and follow procedures to provide high confidence that each administration is in accordance with the written directive.
RADIOPHARMACEUTICAL MEDICAL EVENTS CRITERIA
DEVIATION MEDICAL EVENT CRITERIA 0.05 Sv (5 rem) effective dose equivalent 0.5 Sv (50 rem) to organ or tissue 0.5 (50 rem) shallow dose equivalent to skin Dose Threshold
+/- 20% prescribed dosage Outside prescribed dose range
+/- 50% prescribed single fraction dose Deviation Patient Intervention
ERROR MEDICAL EVENT CRITERIA 0.05 Sv (5 rem) effective dose equivalent 0.5 Sv (50 rem) to organ or tissue 0.5 (50 rem) shallow dose equivalent to skin Dose Threshold Wrong Patient Wrong Drug Wrong Route Wrong Mode Cause Patient Intervention
WRONG SITE MEDICAL EVENT CRITERIA 0.5 Sv (50 rem) or more than expected to that site if administration had been given in accordance with the written directive prepared or revised before administration Dose Threshold 50 percent or more than expected dose to that site if administration had been given in accordance with the written directive prepared or revised before administration Deviation Patient Intervention
PATIENT INTERVENTION REPORT Any event resulting from intervention of a patient in which administration results or will result in unintended permanent functional damage to an organ or physiological system, as determined by a physician.
Dose Threshold Patient intervention means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.
REPORTING BEST PRACTICES
- We use medical event reports to look for trends and generic issues.
- The report should allow an uninvolved individual to have a full understanding of the event.
- Helpful details include:
Manufacturer, model, or specifications of supporting equipment associated with the event such as IV pump or gauge size.
Relevant information that preceded the event.
What staff was present.
How the event was identified.
Include short and long-term corrective actions and how they are linked to the event.
Clearly highlight if the event or corrective actions involve a common industry-wide practice or procedure.
RADIOPHARMACEUTICAL MEDICAL EVENTS EXAMPLES
- There are increasing uses of radiopharmaceuticals.
- January 2018 - Lu-177 Lutathera was approved by the FDA for treatment of some gastroenteropancreatic neuroendocrine tumors.
- March 2022 - Lu-177 Pluvicto was approved by the FDA for treatment of some prostate cancers.
- Numerous ongoing clinical trials with current and new radiopharmaceuticals.
- The NRC has had 1 event reported where patients received the wrong radiopharmaceutical, with 1 patient receiving Lutathera and the other patient receiving Pluvicto.
- Both Lu-177 radiopharmaceuticals recommend a standard dosage of 200 mCi for multiple fractions unless patient conditions warrant a reduction in dosage.
- The NRC has had 5 events reported over the last 2 years when the AU prescribed smaller dosages based on patients lab results, but the patient was administered the full standard dose of 200 mCi.
VERIFICATION OF WRITTEN DIRECTIVE
- Lu-177 Lutathera standard dosage protocol is 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses.
- A patient was prescribed 3.7 GBq (100 mCi) by the AU due to kidney disease but received a 7.62 GBq (206 mCi).
- Administering technologist did not review the written directive and drew the standard dose.
- Root cause was failure to follow established protocols and lack of communication in department.
- Corrective actions include a daily huddle to communicate key information and secondary verification requiring a physician signature on written directive.
STANDARDIZED DOSES EXAMPLE
- 10 CFR 35.63 requires that a licensee determine and record the activity of each dosage before medical use.
- During this check, it is IMPORTANT that the activity be checked against the written directive immediately prior to administration because failure to do so has been the cause of several numerous events.
VERIFICATION OF ACTIVITY Vial Activity Written Directive Activity
- Patient was scheduled to receive 3.47 MBq of Ra-223 Xofigo.
- On the day of treatment, patients procedure was cancelled due to low blood pressure.
- Licensee kept dosage in hot lab for decay.
- One month later, the patient came back for treatment.
- Received the dosage from original vial, which resulted in an administration of 0.63 MBq.
- Demonstrates the need to verify dosage with the written directive immediately prior to treatment.
VERIFICATION OF ACTIVITY EXAMPLE
- Protocols are becoming more complex and sometimes include multiple steps or other treatments in addition to the radiopharmaceuticals.
- In addition, certain drugs may interfere with distribution of the drug in the body.
- Note - Not all incidents involving incorrect protocol scheduling or drug interference are reportable per NRC regulations. However, these events can be medically important and sometimes do qualify as medical events.
- The NRC has been notified of several of these types of events.
PROTOCOL AND SCHEDULING
- During a typical Lutathera treatment, an amino acid infusion begins 30 minutes prior to the radioactive drug administration protect the kidneys by lowering the dose.
- In one event, a patients Lutathera treatment began without the amino acid infusion as the amino acid line was still clamped.
- The technologist realized this approximately 20 minutes after the Lutathera treatment began and started the amino acid infusion.
- The licensee calculated the kidneys received an estimated dose of 740 cSv (rem) instead of intended 490 cSv (rem) and reported the event.
- Corrective actions included moving the amino acid solution to a separate primary IV line which would alarm if it is still clamped, training nursing staff, and adding a pause to ensure the amino acid infusion has begun before starting the Lutathera.
PROTOCOL EXAMPLE
- While a patient was undergoing a Lu-177 Lutathera infusion, they informed the AU they received chemotherapy the day before.
- The normal protocol for Lutathera treatment is for the chemotherapy to be done after the infusion so the AU immediately stopped the infusion leading to an underdose to the patient and a medical event.
- This event demonstrates that AUs should check the status of the patients entire protocol, especially if multiple departments are involved, prior to each administration.
SCHEDULING EXAMPLE
- In the last 2 years, 6 events have been reported due to expected set up issues associated with newer procedures.
- Everyone should be trained on new administrations and the equipment they may handle in the procedure.
- Do not forget about support staff.
- Do not forget about those who handle equipment or perform set up before administration even begins.
- Cold mock administrations (including set up) with entire team significantly reduce the chance of an event.
SET UP AND ADMINISTRATION INCIDENTS
- A nurse removed an occluding clamp and opened the roller clamp on a flush bag line at the beginning of an I-131 Iomab-B treatment.
- Led to leaking tube in the infusion system.
- Resulted in patient receiving only 53% of prescribed dose but no contamination.
- Root cause was failure to train staff on this specific procedure.
- Corrective action was to ensure nuclear medicine and radiopharmacist were trained in the infusion pump and would be solely in charge of the pump for future patients.
SET UP AND ADMINISTRATION EXAMPLE
- During a Xofigo administration, a three-way stopcock was used to allow for administration of saline and radium dichloride.
- An incorrect cap was used on the unused port of the three-way stopcock.
- The cap that was used was designed to maintain sterility of the port connection, but not prevent flow, which led to a leak.
- Root cause was failure to train the staff on the equipment prior to the administration.
SET UP AND ADMINISTRATION EXAMPLE
- In the last 2 years, 7 events have had an associated leak or spill.
- 4 events were expected to be associated with incorrect set up.
- 3 events were associated with infusion tubing but no set up issues were noted.
- Leaks occurred in Lutathera, Pluvicto, and Xofigo administrations.
- One licensee reported they tested additional tubing from the same lot and identified that more tubing leaked. They removed entire tubing lot.
LEAKS
- The NRC has seen an increase in medical events associated with radiopharmaceuticals as new drugs come into the market.
- Many events are associated with the increased complexity and lack of training of staff with new protocols.
- Many types of events are new to the NRC, such as leaks and set up issues associated with radiopharmaceutical delivery.
- NRC expects to continue to see new medical events as more protocols enter the clinic.
- The NRC is in the process of developing an information notice to inform licensees to events that have been reported and industry recommended corrective actions.
SUMMARY
- AU - Authorized User
- cSv - Centisievert
- GBq - Gigabecquerel
- Lu-177 - Lutecium 177
- mCi - Millicurie
- Sv - Sievert
- NRC - Nuclear Regulatory Commission
SPECIAL RECOGNITION For Dr. Metter by Cmsr. Wright (No Handout)
DR METTERS THOUGHTS ON LEAVING ACMUI (No Handout)
OPEN FORUM (No Handout)
March 2024 SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY 25 26 27 28 29 1
2 3
4 5
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10 11 12 13 14 15 16 17 18 19 20 21 22 23 TENTATIVE ACMUI DATE TENTATIVE ACMUI DATE RSS MEETING RSS MEETING
- 1. RSS MEETING
- 2. PURIM HOLIDAY 24 25 26 27 28 29 30 PURIM HOLIDAY 31 1
Notes
- 1. RSS MEETING, March 21 - 23
- 2. PURIM HOLIDAY
- 3. EASTER
- 3. EASTER
April 2024 SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY 31 1
2 3
4 5
6 7
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10 11 12 13 TENTATIVE ACMUI DATE TENTATIVE ACMUI DATE 14 15 16 17 18 19 20 AHA Annual Meeting AHA Annual Meeting AHA Annual Meeting 21 22 23 24 25 26 27 Passover Passover Passover Passover Passover Passover 28 29 30 1
2 3
4 Passover Passover Passover 5
6 Notes
- 1. American Hospital Association Annual Meeting, April 14 - 16, 2. Passover