ML23165A284
| ML23165A284 | |
| Person / Time | |
|---|---|
| Issue date: | 05/24/2023 |
| From: | NRC/NMSS/DREFS/MRPB |
| To: | |
| Shared Package | |
| ML23165A253 | List: |
| References | |
| Download: ML23165A284 (10) | |
Text
U.S. Nuclear Regulatory Commission Public Meeting Summary
Title:
Information Request Federal Register Notice Related to the Rulemaking on Reporting Nuclear Medicine Injection Extravasations as Medical Events Meeting Identifier: 20230589 Date of Meeting: May 24, 2023 Location: Webinar Type of Meeting: Information meeting with a question-and-answer session Purpose of Meeting: To provide information to facilitate stakeholder feedback on the preliminary proposed rule language and questions included in the information request Federal Register notice (88 FR 24130) related to the rulemaking on reporting nuclear medicine injection extravasations as medical events.
General Details: The NRC staff published the official public meeting notice on May 3, 2023, providing the agenda and webinar log-in instructions for attendees (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23128A025). The meeting was conducted remotely via webinar and began at 1:00 p.m. Eastern Time (ET). Dan Frumkin, the meeting facilitator, started the meeting by welcoming all attendees and discussing the meeting logistics. Kevin Williams from the Office of Nuclear Material Safety and Safeguards (NMSS) provided opening remarks, welcomed all attendees, and provided the purpose and agenda for the meeting. Irene Wu from NMSS presented background information on radiopharmaceutical extravasations, medical event reporting requirements, the NRC staffs evaluation of whether extravasations should be reported as medical events, the petition for rulemaking, and the rulemaking plan. Daniel DiMarco from NMSS presented the preliminary proposed rule language and the basis for the questions in the information request. After each group of questions (definitions, procedures, and healthcare inequities), the NRC staff provided an opportunity for members of the public to ask questions and provide feedback. Ms. Wu presented on how to prepare and submit comments and the next steps for the rulemaking. The NRC staff then provided another opportunity for members of the public to ask questions and provide feedback.
Ms. Wu then presented on the contact information and resources for this rulemaking and how to provide meeting feedback. Mr. Williams provided closing remarks and then Mr. Frumkin adjourned the meeting. The staffs slide presentation is available in ADAMS at Accession No. ML23132A116. The meeting had over 200 participants from the NRC, medical community, patient advocates, Agreement States, and the public. A list of NRC and external meeting participants is enclosed. The meeting concluded at 3:21 p.m. ET. The staff has summarized the questions and feedback received and a transcript of the meeting is available in ADAMS at Accession No. ML23159A193.
Summary of Questions and Feedback:
Definitions Regarding the proposed definition of extravasation, one commenter stated that the term leakage is inconsistent with the use or characterization of an extravasation as a medical event and incompatible with this rulemaking. Another commenter asked if the NRC has considered substituting the word leakage for infiltration since infiltration is a more active process and
2 leakage is more passive. Another commenter asked about how extravasation and infiltration would apply to radioembolizations with microspheres.
Regarding the proposed definition of medical attention, one commenter was looking for clarity in the definition and that it includes any techniques used to reduce the chance of suspected radiation injury.
Regarding the proposed definition of suspected radiation injury, one commenter asked if it would be the patient or a medical professional that would be making the determination of suspected radiation injury. NRC staff responded that the determination would be made by a medical professional, such as an authorized user, who has the training and experience to identify a radiation injury.
One commenter asked what criteria the NRC will use to define suspected radiation injury and if a numerical value will be used. Another commenter indicated that using a dose threshold for suspected radiation injury is the most practical and that injection site dosimetry is the obvious way to determine that. Another commenter responded that calculating dose from extravasation is difficult and requires patient-specific biological data and they question the accuracy of the dosimetry with Versant and Lucerno Dynamics technology.
One commenter asked what a deterministic health effect is from a suspected radiation injury and noted that erythema of skin is likely not a deterministic effect that could be attributed to radiation from injection. Another commenter responded that the vast majority of nuclear medicine injections that might lead to extravasations will not cause injury or deterministic effects.
Several commenters stated that diagnostic procedures are not likely to cause radiation injury and that reporting diagnostic infiltrations would be onerous, and therefore, they are mostly concerned with theranostic therapeutic procedures. Several commenters supported the idea for theranostics extravasations to be reported because of the written directive requirement. One commenter countered that diagnostic injections including positron emitters can actually result in a dose of multiple Gray.
One commenter said that there can be late effects considerably down the line, which is why they would advocate for all extravasations to be reported regardless of suspected radiation injury. Another commenter countered in saying that reporting every extravasation would be extremely cumbersome and that the NRCs rulemaking makes more sense as a middle-of-the-road approach.
Procedures One commenter described an endoline catheter with positive blood return and multiple successful flushes as an example of a technique used. Another commenter asked if there is data about injection techniques in relation to extravasations. Another commenter provided information on sensing technologies for extravasation detection. Another commenter indicated that the cost and practical availability of these technologies need to be considered.
Multiple commenters indicated that suspected infiltrations should be imaged to determine the extent of an extravasation. One commenter asked about pure beta emitters and how to image them if there is an extravasation since that cannot be done with conventional imaging devices.
One commenter indicated that it is becoming more common that these radiopharmaceuticals will be administered in urology clinics and radiation oncology therapy centers where there is no
3 imaging and they are concerned that licensees will be required to somehow investigate every administration for extravasations.
One commenter stated that allowing facilities to develop their own action plan as far has how they are going to address and protect their patients is a good position to take and that adding extra steps and requiring reporting would slow down the workflow and adversely impact patient care. Another commenter agreed with that position and indicated that extravasations are an important quality assurance issue that need to be handled at each licensee site and that adding extravasations as a medical event is not going to improve the process. Another commenter raised their concern about adding burden to the patient to identify suspected radiation injury.
Healthcare Inequities One commenter recommended having cautionary screening after a potential extravasation event so patients do not leave the facility and are put back in an environment in which they may not feel comfortable speaking with their doctor or have difficulty accessing transportation back to the facility. Several commenters stated that patient self-reporting is unacceptable as patients may not realize that they have experienced an extravasation and the symptoms may not be immediately apparent, which is particularly worrisome for patients with limited literacy. Another commenter asked the NRC to immediately issue interim guidance while the rulemaking progresses.
One commenter stated that whatever the presumed benefits are of screening for extravasations, there is a potential downside in terms of cost, patient throughput, and availability of tests and there may be the unintended consequence of lesser availability of high-tech imaging modalities in underserved communities. Several commenters followed up by asking if a financial impact statement or analysis will be done as part of this rulemaking.
Two commenters indicated that there are other classes of patients where extravasations tend to be more common, such as with obese patients, patients who have previously had chemotherapy, patients with extensive tattoos, small children, and infants.
One commenter indicated that improvement of monitoring and training and the use of technology will reduce extravasations and improve equity.
Additional Feedback Several commenters expressed that the rulemaking plan, which the Commissions decision was based on, was somewhat flawed, incomplete, and biased. One commenter applauded NRC staff for the questions raised in and the structure of the information request.
Several commenters stated that several of the questions in the information request were beyond the scope of NRCs regulatory oversight and intruded into medical practice. One commenter disagreed and stated that it is NRCs job to get involved.
Several commenters asked for the source of the questions included in the information request and the preliminary proposed rule language, specifically if they were generated by NRC staff or if they were from the Commissioners staff requirements memorandum. NRC staff responded that they were developed from both sources. Several commenters asked if the NRC had any plans to review and use existing national standards for this rulemaking and if staff had any plans to consult with drug manufacturers, the U.S. Food and Drug Administration, standards organizations, creditors, payers, and public health agencies. NRC staff responded that they will
4 be getting information from as many sources as possible, which includes Federal partners and other stakeholders.
One commenter stated that over-regulation is detrimental to patient safety and that technologists may not do procedures because they do not want to ruin their record of having no medical events and facilities may decide not to do procedures to avoid receiving violations from the NRC.
Several commenters asked about the availability of the dosimetry model. NRC staff responded that the dosimetry model is being developed and will be made available as part of the draft guidance along with the proposed rule.
One commenter asked if there was the potential for something other than a medical event reporting methodology for extravasations as there are better avenues to go about addressing this issue and improving patient care and safety without medical event reporting. NRC staff responded that there is the potential for staffs recommendation to change as the comments from this information request are considered. NRC staff also indicated that when the proposed rule is provided to the Commission, the Commission will decide which direction they would like NRC staff to proceed with.
Next Steps: The NRC staff will consider the comments received on the information request as it develops the proposed rule. The proposed rule is currently scheduled to be delivered to the Commission in August 2024. If approved by the Commission, the NRC staff will publish the proposed rule in the Federal Register for public comment.
Package ML23165A253; Meeting Summary ML23165A284; Slide Presentation ML23132A116; Meeting Notice ML23128A025; Meeting Transcript ML23159A193
- via email OFFICE NMSS/REFS/MRPB/
PM NMSS/REFS/MRPB/
RS NMSS/REFS/MRPB/
BC NMSS/MSST/MSEB/
BC NAME IWu DBearde JShepherd CEinberg DATE 06/14/2023 06/14/2023 06/16/2023 06/22/2023
Enclosure ENCLOSURE MEETING ATTENDEES Public Meeting on the Information Request Federal Register Notice Related to the Rulemaking on Reporting Nuclear Medicine Injection Extravasations as Medical Events May 24, 2023 Webinar 1:00 - 4:00 PM (Eastern Time)
U.S. Nuclear Regulatory Commission Hiba Ahmed Tricia Lizama Brian Allen Fajr Majeed Maryann Ayoade Marianne Narick Jessica Bielecki Janice Nguyen Cindy Bladey Christine Pineda Andrew Carrera Ronald Raunikar Sara Cody Katie Rouse David Cullison Dan Ruby Anne DeFrancisco Kevin Salcedo Diana Diaz-Toro Jen Scro Daniel DiMarco Daniel Shaw Lisa Dimmick Sahej Sharma Christian Einberg Jill Shepherd Robin Elliott Maxwell Smith Cindy Flannery Sarah Spence Mark Franke Candace Spore Dan Frumkin John Tomon Nick Hefferle Celimar Valentin-Rodriguez Ian Irvin Kevin Williams Janelle Jessie Susanne Woods William Johnson Irene Wu Public Name Affiliation (if provided)
Mary Ajango Young Survivors Coalition James Albright Lauren Allaire Holi Allen Rich Anderson Xander Arena Lillian Armstead Amy Barocsi Joseph M. Beckman Julia Bellinger Kendall E Berry David Bierman Willam Bilotta
2 Public Name Affiliation (if provided)
Jerry Bingaman Nicholas Borges Louis Brayboy Jeffrey J. Brunette Janet Bryant Sue Bunning Ebony M. Bush David Carlson Carrie R Carson Rosinda Castanon George Chacko Allegra Chilstrom Neal R. Gross & Co., Inc.
Jessica Clements Chris Comfort Caitlynn Couch Logan A. Cowart David P Crowley Ron Crihfield Cathy Cutler Brookhaven National Laboratory Simon Davies Teen Cancer America Leland Davis National Institutes of Health Sussie DeMello Matt Dennis Ann Marie Derby Newbegin Devaraj Michele Edwards Chinwe Ekwuribe Diane M Elmer Laura M. Evans U.S. Department of Veterans Affairs Brain S. Fairchild Harry Truman Memorial Veterans Hospital Janet Franco Elizabeth Franklin Jennifer Freeman Scott Fuller James A Futch Andrew Garner Stravroula Giannouli William Gibbons Daniel Gomez-Cardona Gundersen Health System Matthew Greenwood Kendall Greer Allen Grewe Stanley D Hampton Ashley A. Hanson Becki Harisis Anna Harrison Kathleen Harrison
3 Public Name Affiliation (if provided)
Billie Harvey Richard Harvey Lyndsi Hay Meredith Henderson Abdulla Hidayat William Hinchcliffe Yale New Haven Hospital Kathleen Hintenlang American College of Radiology Buffy M. Hofschild Jennifer R. House William Janes Paul E Kanabrocki Olivia Karoly Ramsey Kilani Global Security Innovative Strategies Tracy King Medical Physics Consultants Paul Knapp Josh Knowland Lucerno Dynamics Laura M. Knox Arda Konik Karl G. Korneffel Catalina E. Kovats Angela Kwon Sathish Kumar Lageshetty Olusegun Akano Larinde Ronald Lattanze Lucerno Dynamics Bryan P. Lemieux Ralph Lieto Roger Macklin Josh Mailman Anna Manfredo Matthew J. Marzano Lynes Matos Josh McIlvain Mahta Mirzaei McKee Amy McKenna Tara Medich Douglas L. Miller Angela Minden Chris Mitchell Jonathan D Moore Mary E. Moore Helen Nadel Lucile Packard Childrens Hospital Stanford Najmun Naher Sheung Chee T. Ng Thai Q. Nguyen Rachel Nichols Jordan Nofzinger Jaclyn ODonnell
4 Public Name Affiliation (if provided)
Akin Ogretici Jonathan J. Otten Zoubir Ouhib Michele Panichi-Egberts Tina Papagiannopoulos Virginia Pappas Jade M. Parisey Luke Park Ron Parsons Michael Peters Christopher A. Peterson Phillip Peterson Colorado Department of Public Health and Environment Rachael Picchi Carmine M Plott Forsyth Medical Center Kimyli Recca Robert Reiman Jr.
Grace Roemer Gloria Romanelli Casey Schmitz Brian Serencsits Michael A Sheetz Beth Shelton Tina Shoemaker Justin D. Silkwood Albert Sinusas Roger C Sit Jim Sliney Jr.
Patients Rising Dr. Smith Defense Health Agency Gina Kell Spehn New Day Foundation for Families Gabriela Spilberg Mary Ann Spilker Gregory Stackenwalt Mike N Stephens Kristen E Stryker Jason Timm Mike Timmerman Cindy Tomlinson Matthew Torrico Brittany Varney Arianna Vinales Karl Von Ahn Texas Department of State Health Services Paul Wallner Chu Wang Hayley Weaver Mike Welling John C. White
5 Public Name Affiliation (if provided)
William White Christopher Whitener Kim C. Wiebeck Matthew Williamson Sean Odell Wilson Melonie Wissing Harvey Wolkov Pat Zanzonico Memorial Sloan Kettering Cancer Center Michael Zgaljardic Note: The attendance list is based on the Microsoft Teams attendance report and transcript. This list does not include individuals who called in and individuals who did not provide their last name when signing into the meeting.