ML23318A248
| ML23318A248 | |
| Person / Time | |
|---|---|
| Issue date: | 10/23/2023 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| NRC-2569 | |
| Download: ML23318A248 (1) | |
Text
2IILFLDO7UDQVFULSWRI3URFHHGLQJV 18&/($55(*8/$725<&200,66,21 7LWOH 0HHWLQJRIWKH$GYLVRU\&RPPLWWHH RQWKH0HGLFDO8VHVRI,VRWRSHV
'RFNHW1XPEHU QD
/RFDWLRQ WHOHFRQIHUHQFH
'DWH 0RQGD\2FWREHU
- RUN2UGHU1R 15& 3DJHV
1($/5*5266$1'&2,1&
&RXUW5HSRUWHUVDQG7UDQVFULEHUV
WK6WUHHW1:
- DVKLQJWRQ'&
1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 + + + + +
4 ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 5 + + + + +
6 MEETING 7 + + + + +
8 MONDAY, 9 OCTOBER 23, 2023 10 + + + + +
11 The meeting was convened via hybrid in-12 person and video-teleconference, at 10:00 a.m. EDT, 13 Darlene F. Metter, ACMUI Chair, presiding.
14 15 MEMBERS PRESENT:
16 DARLENE F. METTER, M.D., Chair 17 HOSSEIN JADVAR, M.D., Ph.D., Vice Chair 18 REBECCA ALLEN, Member 19 JOHN F. ANGLE, M.D., ACMUI Consultant 20 ANDREW EINSTEIN, M.D., Member 21 MICHAEL R. FOLKERT, M.D., Ph.D., Member 22 RICHARD L. GREEN, Member 23 RICHARD HARVEY, Ph.D., Member 24 JOSH MAILMAN, Member 25 MELISSA C. MARTIN, Member 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
2 1 MICHAEL D. O'HARA, Ph.D., Member 2 ZOUBIR OUHIB, Member 3 MEGAN L. SHOBER, Member 4 HARVEY B. WOLKOV, M.D., Member 5
6 NRC COMMISSIONERS PRESENT:
7 DAVID A. WRIGHT, Commissioner 8
9 NRC STAFF PRESENT:
10 CHRISTIAN EINBERG, Designated 11 Federal Official, NMSS 12 KEVIN WILLIAMS, NMSS 13 CYNTHIA FLANNERY, NMSS 14 KATHERINE TAPP, NMSS 15 LILLIAN ARMSTEAD, NMSS 16 CHRISTINE PINEDA, NMSS 17 KEVIN WILLIAMS, NMSS 18 SARAH SPENCE, NMSS 19 DANIEL DIMARCO, NMSS 20 MARYANN AYOADE, NMSS 21 DANIEL SHAW, NMSS 22 KEN BRENNEMAN, NMSS 23 24 25 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
3 1 C-O-N-T-E-N-T-S 2 Opening Remarks 3 Christian Einberg . . . . . . . . . . . . . . . 4 4 Kevin Williams . . . . . . . . . . . . . . . . . 14 5 Old Business . . . . . . . . . . . . . . . . . . 19 6 Open Forum . . . . . . . . . . . . . . . . . . . 24 7 Medical Events Subcommittee Report . . . . . . . 29 8 Overview of NRC Requirements for Veterinary 9 Release ICRP Publication 153 . . . . . . . . . . 71 10 Financial Assurance for Disposition 11 of Category 1 and 2 Byproduct Material 12 Radioactive Sealed Sources . . . . . . . . . . 124 13 Recent Radiopharmaceutical Medical Events . . . 136 14 Special Recognition of Dr. Metter . . . . . . . 171 15 Thoughts on Leaving the ACMUI . . . . . . . . . 174 16 Open Forum . . . . . . . . . . . . . . . . . . 181 17 Administrative Closing . . . . . . . . . . . . 182 18 19 20 21 22 23 24 25 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
4 1 P-R-O-C-E-E-D-I-N-G-S 2 10:00 a.m.
3 MR. EINBERG: Good morning, everybody.
4 It's great to see everybody here today. So I think 5 we'll go ahead and get started.
6 So good morning. As the designated 7 federal officer for this meeting I am pleased to 8 welcome you to the public meeting of the Advisory 9 Committee on the Medical Uses of Isotopes. My name is 10 Chris Einberg. I am the Chief of the Medical Safety 11 and Events Assessment Branch and I've been designated 12 as the federal officer for this advisory committee in 13 accordance with 10 CFR Part 7.11.
14 This is an announced meeting of the 15 Committee. It is being held in accordance with the 16 rules and regulations of the Federal Advisory 17 Committee Act and the Nuclear Regulatory Commission.
18 This meeting is being transcribed by the 19 NRC and it may also be transcribed or recorded by 20 others.
21 The meeting was announced in the October 22 17th, 2023 edition of the Federal Register, Volume 88, 23 page 71611.
24 The function of the ACMUI is to advise the 25 staff on issues and questions that arise on the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
5 1 medical use of byproduct material. The Committee 2 provides counsel to the staff but does not determine 3 or direct the actual decisions of the staff or the 4 Commission. The NRC solicits the views of the 5 Committee and values their opinions.
6 I request that whenever possible we try to 7 reach a consensus on the various issues that we will 8 discuss today, but I also recognize that there may be 9 a minority of dissenting opinions. If you have such 10 opinions, please allow them to be read into the 11 record.
12 At this point I would like to perform a 13 roll call of the ACMUI members participating today.
14 Dr. Darlene Metter, Chair, diagnostic radiologist.
15 CHAIR METTER: Present.
16 MR. EINBERG: Dr. Hossein Jadvar, Vice 17 Chair, nuclear medicine physician.
18 VICE CHAIR JADVAR: Present.
19 MR. EINBERG: Dr. Michael Folkert, 20 radiation oncologist.
21 MEMBER FOLKERT: Present.
22 MR. EINBERG: Mr. Richard Green, nuclear 23 pharmacist.
24 MEMBER GREEN: Present.
25 MR. EINBERG: Mr. Josh Mailman, patients' 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
6 1 rights advocate.
2 MEMBER MAILMAN: Present.
3 MR. EINBERG: Ms. Melissa Martin, nuclear 4 medicine physicist.
5 MEMBER MARTIN: Present.
6 MR. EINBERG: Dr. Michael O'Hara, FDA 7 representative.
8 MEMBER O'HARA: Present.
9 MR. EINBERG: Mr. Zoubir Ouhib, radiation 10 therapy physicist.
11 MEMBER OUHIB: Present.
12 MR. EINBERG: Ms. Megan Shober, state 13 government representative.
14 MEMBER SHOBER: Present.
15 MR. EINBERG: Dr. Harvey Wolkov, radiation 16 oncologist.
17 MEMBER WOLKOV: Present.
18 MR. EINBERG: Ms. Rebecca Allen, healthcare 19 administrator.
20 MEMBER ALLEN: Present 21 22 Dr. Richard Harvey radiation safety officer.
23 MEMBER HARVEY: Present.
24 MR. EINBERG: And Dr. Andrew Einstein, 25 nuclear cardiologist.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
7 1 MEMBER EINSTEIN: Present.
2 MR. EINBERG: I confirm that we do have a 3 quorum here of at least six members. Mr. Zoubir Ouhib 4 is joining us via Microsoft Teams as he was unable to 5 join us in-person.
6 I would like to welcome Dr. Folkert as 7 this is his first in-person meeting as a member of the 8 ACMUI. We presented him as the new brachytherapy 9 radiation oncologist representative during the spring 10 meeting.
11 All members of the ACMUI are subject to 12 the federal ethics laws and regulations and receive 13 annual training on these requirements. If a member 14 believes that they may have a conflict of interest as 15 the term is broadly used within 5 CFR Part 2635 with 16 regards to the agenda to be addressed by the ACMUI, 17 this member should divulge it to the Chair and the 18 designated federal official as soon as possible before 19 the ACMUI discusses it as an agenda item.
20 ACMUI members must recuse themselves from 21 participating in any agenda item for which they may 22 believe that they have a conflict of interest unless 23 they receive a waiver or prior authorization from the 24 appropriate NRC official.
25 I would like to add that this is a hybrid 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
8 1 meeting of the ACMUI. We are in person, but we also 2 using Microsoft Teams so that members of the public 3 and other individuals can watch online or join via 4 phone. The phone number for this meeting is 301-576-5 2978. The phone conference ID number is 353440864#.
6 Once again, 353440864#.
7 The handouts and agenda for this meeting 8 are available on the NRC's ACMUI public website.
9 Today's meeting is being transcribed by a 10 court reporter. We are utilizing Microsoft Teams for 11 the audio of today's meeting and to view presentation 12 material in real time. The meeting material and 13 agenda for this meeting can be accessed from the NRC's 14 public meeting schedule.
15 For the purpose of this meeting the chat 16 feature in Microsoft Teams has been disabled. Dr.
17 Metter, at her discretion, may entertain comments or 18 questions from members of the public who are 19 participating today.
20 Individuals who would like to ask a 21 question or make a comment regarding the specific 22 topic the Committee has discussed and are in the room 23 can come up to either the microphone set or up to the 24 -- right left to the table. For those individuals in 25 the Microsoft Teams, please use the raise hand 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
9 1 function to signal our Microsoft Teams host Lillian 2 Armstead that you wish to speak. If you have called 3 into the Microsoft Teams using your phone, please 4 ensure you have un-muted your phone.
5 When you begin your comment please clearly 6 state your first and last name for the record.
7 Comments and questions are typically addressed by the 8 Committee near the end of their presentation. After 9 the Committee has fully discussed the topic we will 10 announce when we are ready for the public comment 11 portion of the meeting.
12 At this time I ask that everyone who's not 13 speaking to please mute your Teams microphones or 14 phone. And for those in the room, please mute your 15 phones.
16 Dr. Kevin Williams will be joining us a 17 little bit later and providing some opening remarks as 18 well, but at this time I'd like to introduce the 19 Medical Team. Many of you are new and may not know 20 all of the Medical Team and who support this meeting 21 and all the great work that we do as a Medical Team.
22 So I'm going to start with Lillian 23 Armstead. Lillian Armstead is our new ACMUI 24 coordinator. And so she joined us from the Department 25 of Veteran Affairs a few months back and so now we 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
10 1 have a full-time person supporting the Committee. So 2 you'll be seeing emails from Lillian. And so please 3 welcome her.
4 Then we have Daniel DiMarco. Daniel's 5 been with us for a few years now. He's a health 6 physicist.
7 And then we have Dr. Katie Tapp, and Dr.
8 Tapp is a medical physicist and she's been with us 15 9 years.
10 (Audio interference) 11 MR. EINBERG: Awesome.
12 (Laughter.)
13 DR. TAPP: Eight years.
14 MR. EINBERG: Eight years? Okay. Sorry.
15 She has experience like she has 15 years.
16 Then we have Dr. Kenneth Brennerman. Dr.
17 Brennerman joined us about a year ago, or a little 18 over a year ago. He comes to us from the University 19 of Maryland. He was the radiation safety officer at 20 the University of Maryland Hospital there.
21 Then we have Cindy Flannery who's our 22 senior health physicist on the Medical Team. And 23 Cindy, many may remember her, but Cindy was the 24 Medical Team leader many years ago and then she went 25 and did other things within the agency. But she loved 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
11 1 medical so much she came back.
2 And we have Sarah Spence. Sarah joined us 3 recently, a few months back from Rutgers University.
4 She's a health physicist.
5 And you were the assistant RSO there, I 6 believe?
7 MS. SPENCE: Health physicist.
8 MR. EINBERG: Health physicist? Okay.
9 And she just passed her CHP, certified 10 health physicist, a few months back. And so we 11 welcome here.
12 And then last we have Dan Shaw. Dan Shaw 13 was the -- he joined us less than a year ago and Dan 14 was the radiation safety officer at Walter Reed. And 15 so we've -- we're grateful that we have such a strong 16 team supporting us and that these wonderful people 17 have agreed to join us.
18 And last but not least, we have Maryann 19 Ayoade. She's also on the Medical Team. And many of 20 you know Maryann from the subcommittee work, but 21 Maryann works remotely. She's in Texas and she's a 22 medical physicist. And there's Maryann. She came on 23 the screen.
24 So thank you, Maryann.
25 So Mr. Williams has joined us.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
12 1 I'm not sure if you're ready for your 2 opening remarks or you want to do that a little bit 3 later?
4 MR. WILLIAMS: How about a later?
5 MR. EINBERG: Okay. Very good.
6 MR. WILLIAMS: I will diverge and tell you 7 that I just came in from -- oh, sorry. I will take 8 this opportunity to tell you where I was. It was my 9 mother's 82nd birthday. And so my whole family came 10 down to -- she lives in Atlanta and we came down to 11 surprise her over the weekend several times. She just 12 thought it was going to be me and my wife. And so we 13 videotaped it and she saw my son and my daughter and 14 she was more excited. And then a friend of hers said 15 hey yesterday let's have a nice -- for those who 16 couldn't make the celebration she had on the 14th, 17 let's do it tomorrow. And so she was surprised as 18 well. My sister came down. So she got to --
19 surprised all around. So that's where I'm actually 20 coming from. I just got off a plane and drove here, 21 but I really did want to be at this meeting. And I 22 will share my remarks later, but thanks, Chris.
23 MR. EINBERG: Okay. Thank you, Kevin.
24 And so at this point I'd like to turn the 25 meeting over to Dr. Metter. Thank you.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
13 1 CHAIR METTER: Well, thank you, Mr.
2 Einberg.
3 And good morning. Welcome to the fall 4 2023 meeting of the ACMUI. I'm Darlene Metter, the 5 ACMUI Chair and diagnostic radiologist. I'd also like 6 to welcome our consultant Dr. John Angle for this 7 Committee. He's greatly contributed to the meeting's 8 agendas during these past few years.
9 Thank you very much.
10 So today the ACMUI meeting has several 11 interesting topics to include a two-year analysis of 12 the 2021 and 2022 medical events. A specific session 13 on lutetium-177 medical events, a section focusing on 14 veterinary regulatory protective practices, and a 15 presentation on current rulemaking efforts in revising 16 financial assurance of the disposition of Category 1 17 and Category 2 sealed sources.
18 Now if Mr. Williams is ready? You have 19 some opening remarks?
20 (No audible response.)
21 CHAIR METTER: And by the way, happy 22 birthday to your mother.
23 MR. WILLIAMS: Yes, see, she had this 24 surprised face the entire time. We really did 25 actually surprise her. She doesn't get to see my kids 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
14 1 that often, so I think it was really a good 2 opportunity for us to come down.
3 Where am I, Chris? I apologize.
4 All right. So I'll give a status update 5 of the NRC activities. I always -- I'm going to off 6 script, but I'm really extremely proud of the Medical 7 Team. And in that, I say all of Chris' brains, but 8 this particular meeting does focus on the medical use 9 of isotopes and there's a lot of work that we have 10 going on and a lot of hard work that goes on by --
11 behind the scenes and a lot of hard work by you all 12 that really actually puts this all together. We get 13 a lot of inputs from a variety of people and we all 14 come together and be able to distill it into -- take 15 the complex things and make them relatively simple in 16 plain language. And I think that's a testament to all 17 involved in this activity.
18 So I'm very much appreciative of it 19 because one, this is appraisal time. I get to take 20 credit for that. But what I'm most proud of are the 21 people, I mean the hard work, the dedication, the 22 collaboration, coordination, communication. That's 23 just demonstrated not only by Chris' team, but the 24 ACMUI as a whole. So I'm extremely appreciative of 25 that and I want to thank you. And thanks for allowing 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
15 1 me to go off script.
2 But I look at these things such as the 3 infiltration extravasation rulemaking. Since the 4 spring we've -- the comment period for the 5 information we closed on September of 2023. We 6 received over 200 comments from stakeholders on a 7 number of issues. The staff plans to begin the 8 concurrence of the proposed rule and associated 9 draft implementation guidance in January of 2024.
10 The staff expects to transmit these to the Committee 11 for review and comment in the spring of 2024. We 12 should have the proposed rule to the Commission by 13 August of 2024.
14 We also have the emerging medical 15 technologies rulemaking. We recently issued a 16 regulatory basis document for this rulemaking in early 17 July of this year. The 120-day comment period closes 18 on October 31st of 2023.
19 The training and experience for 20 unsealed byproduct material. The staff continues to 21 develop the implementation guidance for training and 22 experience requirements. The draft implementation 23 guidance will be issued in August of 2024 as interim 24 staff guidance and will address how persons seeking 25 authorized individual status under Part 35 can fulfill those training and experience requirements as well as
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
1($/5*5266
- $6+,1*721'& ZZZQHDOUJURVVFRP
16 1 clarify the roles and responsibilities of those 2 persons involved in and subject to training and 3 experience requirements. I know you will recall that 4 the training and experience was a big issue for us 5 before the Commission for a while and we continue 6 to implement the Commission's direction.
7 Another one of the topical areas is Reg 8 Guide -- Phase 2 for Reg Guide 8.39. The comment 9 period for the proposed revision closed in August of 10 2023. We received over 60 comments. We will review 11 and incorporate the comments into the draft guidance 12 as appropriate. The ACMUI will receive the final 13 draft review and comments prior to the final issuance 14 of the Reg Guide 8.39.
15 I will tell you in between there there 16 could be some different conversations that we have 17 internally and if anything changes there, we will 18 reach out and share that information as 19 appropriate.
20 (Audio interference)?
21 MR. EINBERG: Introduce (audio 22 interference)?
23 MR. WILLIAMS: Yes, so I said I get a 24 second chance to do it. But some of the 25 organizational changes. Ms. Lillian Armstead is the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
17 1 ACMUI coordinator. I'm sure a number of you have 2 spoken to her in some fashion.
3 Thank you, Lillian, and welcome to the 4 team.
5 Theresa Clark, who normally is my deputy 6 and would be attending these meetings, is in our 7 Region IV Office on a rotation. And Ken Erwin, who 8 comes from our Division of Rulemaking Environmental 9 and Financial Systems. He's the acting deputy. He'll 10 do that until Theresa comes back.
11 As Chris mentioned, Dr. Folkert's first 12 meeting as ACMUI brachytherapy radiation oncologist.
13 And since the fall meeting Dr. Ronald Ennis completed 14 his second term in ACMUI and his departure left a 15 vacancy for the ACMUI brachytherapy radiation 16 oncologist. And as Chris had talked about, we are 17 pleased to announce that Dr. Michael Folkert has been 18 appointed to serve as the brachytherapy radiation 19 oncologist. He is currently the Vice Chair and Chief 20 of the Brachytherapy for Northwell Health Cancer 21 Institute Radiation Medicine at the Center of Advanced 22 Medicine in Lake Success, New York. I would have to 23 get a little more information on that place. I'd like 24 to go there maybe.
25 For our meetings an item of interest; and 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
18 1 Dr. Metter kind of mentioned this, Dr. Harvey will 2 provide the Medical Events Subcommittee report for 3 Medical Events for fiscal year '21 and '22. Dr. Tapp 4 will discuss recent medical events related to the use 5 of radiopharmaceuticals. I'm going to mess up this 6 thing. Mr. Davila will provide an overview of our ICRP 7 Publication 153, Radiation Protection in Veterinary 8 Practice. That has a lot of interest around here as 9 well. And Dr. Tapp will provide an overview of the 10 NRC's regulatory framework for the release of animals 11 following an administration of radioactive material.
12 And finally we have a special presentation for Dr.
13 Metter, as this will be Dr. Metter's last in-person 14 meeting for ACMUI.
15 We definitely appreciate all your 16 accomplishments. I know we'll get to that part of it, 17 but I personally have appreciated your leadership and 18 how you continue to move ACMUI forward as well as 19 sharing information with the staff. I'm very 20 appreciative and definitely will miss you.
21 CHAIR METTER: Thank you.
22 MR. WILLIAMS: Thanks for this opportunity 23 for me to provide some opening remarks. I do wish you 24 a productive session today and I will say I myself 25 will be in and out because it is appraisal season and 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
19 1 I have four appraisals to give today. I know that.
2 And that will be later this afternoon. But I really 3 appreciate you meeting, meeting in person, taking of 4 your time and giving of yourselves because it does 5 make us better, makes us -- and I'll say smarter and 6 better and focused. So thank you for all of your time 7 and attention. And at this time I'm turn it back over 8 to Lillian Armstead.
9 MS. ARMSTEAD: Good morning, ACMUI 10 members, attendees, both virtual and in person. This 11 morning I will be providing and old business report 12 and giving a status update on some of the items in the 13 ACMUI's recommendations and action items beginning 14 with the year 2020.
15 Item 11, from 9/21/20. As part of the 16 non-medical events report the ACMUI recommended to the 17 NRC staff and/or NNP to evaluate the issue of 18 detection of short-lived medical isotopes in municipal 19 waste, and that is waste from nuclear medicine 20 patients that might be triggering the landfill alarm.
21 CHAIR METTER: Excuse me, Lillian. Can you 22 bring the microphone a little bit closer? (Audio 23 interference) 24 MS. ARMSTEAD: Can you hear me now?
25 CHAIR METTER: That's better, yes.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
20 1 MS. ARMSTEAD: Okay. Start over?
2 CHAIR METTER: You want her to start 3 over? Yes, why don't you start over?
4 MS. ARMSTEAD: Okay. Good morning, ACMUI 5 members, attendees, both virtual and in person. This 6 morning I will be providing an old business report 7 and giving a status update on some of the items from 8 the ACMUI's recommendations and action items beginning 9 with the year 2020.
10 Item 11 from 9/21/20. As part of the non-11 medical events report the ACMUI recommended to the NRC 12 staff and/or NNP to evaluate the issue of detection of 13 short-lived medical isotopes in municipal waste, and 14 that is waste from nuclear medicine patients that 15 might be triggering the landfill alarms and provide 16 some level of guidance, best practices, or additional 17 instructions. We recommend this remain open.
18 The NRC staff shared a voluntary survey 19 with Agreement States via CRCPD letter. The staff 20 is analyzing the responses from Agreement 21 State respondents. The staff will also review 22 current NRC regulations and any pertinent regulatory 23 analysis to make a recommendation to the Committee in 24 spring 2024.
25 Item No. 8 from 10/4/2021. The ACMUI formed a new subcommittee on the Liberty Vision Y-90
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
1($/5*5266
- $6+,1*721'& ZZZQHDOUJURVVFRP
21 1 Manual Brachytherapy Source. The subcommittee is 2 expected to provide a draft report and any 3 recommendations at the spring 2022 ACMUI meeting. We 4 recommend this remain open. The subcommittee will 5 receive the guidance for review and comment in the 6 fall of 2023. The NRC staff will plan for a public 7 teleconference in the spring of 2024.
8 Item 11 from October 4th, 2021. The ACMUI 9 endorsed the Radionuclide Generator Knowledge and 10 Practice Requirements Subcommittee report and 11 recommendations provided therein. We recommend this 12 remain open. The NRC staff kicked off the Rulemaking 13 Working Group on February 23rd, 2022. The NRC issued 14 a regulatory basis for the rubidium-82 emerging 15 technologies, other medical use of byproduct material 16 in July 2023. The NRC is accepting comments on this 17 document for 120 days until October 31st, 2023, but 18 may extend the comment period if requested by 19 i n t e r e s t e d s t a k e h o l d e r s .
20 The proposed and final rule are due by August 21 2024 and March 2026, respectively.
22 Item 15 from 12/15/2021. The ACMUI 23 endorsed the ACMUI Reg Guide 8.39 Subcommittee report 24 on CivaDerm and the recommendations therein. We 25 propose to close this. The NRC staff considered the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
22 1 subcommittee's comments. The staff issued the 2 CivaDerm memo on July 28th, 2023 and posted the memo 3 to the NRC's medical tool kit.
4 Item No. 4 from December 5th, 2022. The 5 ACMUI endorsed the Y-90 Microsphere ME Subcommittee 6 report and the recommendations therein. We recommend 7 this remain open. The staff is addressing the 8 recommendations including outreach to the Society of 9 Interventional Radiology to increase engagement and 10 communications. This will include a webinar in June 11 to discuss the current Y-90 microsphere guidance in 12 medical events. The staff is also looking more 13 closely at Y-90 microsphere medical events for the 14 next two years to evaluate if and how the use of 15 vendor tools play a role in medical events.
16 Item No. 6, December 5th, 2022. The ACMUI 17 established two subcommittees, one to create generic 18 process checklists to be used during medical 19 administrations and want to review the DFA draft 20 proposed guide. The ACMUI also reestablished the 21 Nursing Mothers Guidelines to update the 2019 22 guidelines. We recommend this remain open.
23 A subcommittee was established to review and 24 comment on the proposed rule. The other two 25 subcommittees are in the process of being established.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
23 1 Item No. 1, May 15, 2023. During the 2 ACMUI's spring 2023 meeting the ACMUI requested 3 additional tentative dates from the staff for its fall 4 2023 meeting. We propose to close this action.
5 Following the ACMUI's spring 2023 meeting the ACMUI 6 tentatively scheduled its fall 2023 meeting for 7 October 23rd through 24th, 2023.
8 And I should add; I should have mentioned 9 this earlier, but what you're seeing in your handouts 10 is different than what I'm reading. There were some 11 last minute edits that I will get to you guys and 12 girls before the session ends. I do apologize for 13 that.
14 ACMUI and staff this completes the old 15 business report and review of ACMUI 16 recommendations and action items. I have proposed to 17 close two items: No. 1 and 15. Is there a motion to 18 accept the report?
19 PARTICIPANT: So moved.
20 CHAIR METTER: Do I have a second?
21 PARTICIPANT: Second.
22 CHAIR METTER: All in favor of approving 23 the report as stated?
24 (Chorus of aye.)
25 CHAIR METTER: Any opposition or 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
24 1 abstention?
2 (No audible response.)
3 CHAIR METTER: Do we have any discussion?
4 (No audible response.)
5 CHAIR METTER: Seeing none, Ms. Armstead, 6 the report has been unanimously approved by the ACMUI.
7 MS. ARMSTEAD: Thank you.
8 CHAIR METTER: Thank you very much for 9 your complete report.
10 MS. ARMSTEAD: Thank you.
11 CHAIR METTER: So now we'll go onto the 12 next agenda item, which is the open forum. Do I have 13 any comments or suggestions for the open forum?
14 Yes, Mr. Green?
15 MEMBER GREEN: Thank you, Dr. Metter. I 16 wish to -- for the benefit of the members of the ACMUI 17 and the NRC Medical --
18 CHAIR METTER: Can you speak a little 19 closer to the -- and yes, the mics -- I think if 20 everybody speaks closer to the mic, we all can hear a 21 little better.
22 MEMBER GREEN: All right.
23 CHAIR METTER: Okay. Thank you.
24 MEMBER GREEN: For the benefit of members 25 of the ACMUI and the NRC Medical Radiation Safety Team 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
25 1 I wanted to give a short update on 2 radiopharmaceuticals that have or will soon cease 3 production and one that was just recently approved by 4 the FDA. And these are all excerpted from public 5 sources. There's no proprietary information here.
6 They're all from news reports.
7 NorthStar Medical Radioisotopes announced 8 October 5th that they will shut down their moly-99 9 production facilities in Deloitte, Wisconsin by the 10 end of 2023 citing increasing costs and competition.
11 This facility produced the RadioGenix System, the 12 technetium-99 generator, for production of Sodium 13 Pertechnetate Tc 99m US -- injection USP. This item 14 was licensed under 10 CFR 35 Part 1000 -- for the 15 court reporter that was a typo. That should have been 16 1000 -- and has a separate licensing guide and 17 training requirements. As a authorized -- trained 18 authorized user of the RadioGenix System I have used 19 it and it is a very extensive training program and 20 licensing guidance. So acknowledging the work of the 21 Medical Team, but that product is being removed from 22 the market.
23 There are currently two other FDA-approved 24 manufacturers of moly-99 generators that utilize 25 fission, Non-HEU derived tech moly-99 and a third 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
26 1 manufacturer has an NDA under review with the FDA for 2 a generator using neutron capture-produced moly-99.
3 ESNMI has reached out and evaluated the impact and it 4 does not appear that there will be any shortage of 5 material.
6 Regenics Pharmaceuticals, a subsidiary of 7 Lantheus Holdings, announced on August 24th that they 8 will no longer be producing AZEDRA iobenguane 1-131 9 injection indicated for the treatment of 10 pheochromocytoma and paraganglioma due to the lack of 11 commercial demand. Manufacturing of AZEDRA will 12 continue into the first quarter of 2024 in order to 13 provide doses to current patients. This 14 radiopharmaceutical was licensed under 10 CFR 35 Part 15 300.
16 And then a new addition to the marketplace 17 on September 29th, Cyclomedica received FDA approval 18 for the imaging agent tech-99M Technegas for use in 19 ventilation perfusion studies to diagnose pulmonary 20 embolism and other respiratory pathologies.
21 Technegas, for the preparation of technetium labeled 22 carbon inhalation aerosol, is an oval-shaped graphite 23 carbon crucible upon addition of Sodium Pertechnetate 24 injection USP to the crucible. The Technegas system 25 produces Technegas aerosol for oral inhalation, and 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
27 1 this radiopharmaceutical is licensed under 10 CFR 35 2 Part 200.
3 It's always dynamic. Some in, some out.
4 So I want to make sure the Radiation Safety Medical 5 Events Committees are aware of departures and 6 additions to the marketplace. We may see them come up 7 in events and perhaps MEs.
8 CHAIR METTER: Thank you very much, Mr.
9 Green, for that very good update and pertinent to our 10 patients and public and to this Committee.
11 Do I have any questions for Mr. Green 12 regarding these new items that have come up?
13 Yes, Dr. Tapp?
14 DR. TAPP: Not a question, but just wanted 15 to let everyone know that the Technegas that Mr. Green 16 just mentioned -- the NRC was aware of it. We did do 17 an evaluation of the Technegas to determine to make 18 sure we agreed with the licensing pathway that he 19 mentioned, the 35.200. And we did propose to the 20 Standing Committee of Emerging Medical Technologies; 21 it's an Agreement State Standing Committee, and the 22 NRC Standing Committee that it should be licensed 23 under 35.200. We are working on a licensing memo then 24 for -- to hand out to the regions and the states to 25 let them know that recommendation, assuming they 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
28 1 agree, and just following up with that process. So I 2 want to let everyone know that we did evaluate it.
3 CHAIR METTER: Well, thank you very much.
4 Any questions for Dr. Tapp?
5 (No audible response.)
6 CHAIR METTER: Any other questions for Mr.
7 Green's report or update?
8 MR. EINBERG: This is Chris Einberg. Yes, 9 thank you, Mr. Green, for that update. And we do 10 appreciate when the medical community does reach out 11 to us and to let us know what's upcoming and what's 12 planned on being discontinued. We're aware of the 13 RadioGenix System being shut down. We're going to 14 terminate our licensing guidance at the appropriate 15 time.
16 CHAIR METTER: Yes, thank you. And it 17 will be interesting what the nuclear medicine 18 community will be doing regarding that and regarding 19 interpretation for -- on their pulmonary embolism 20 criteria. They'll probably have to make new guidance.
21 Okay. If there are no other questions for 22 Mr. Green or for anything -- any other items that wish 23 -- people wish to bring up in the open forum?
24 (No audible response.)
25 CHAIR METTER: Okay. Seeing none, it's a 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
29 1 pleasure for me to introduce our next topic for this 2 meeting. It's the Medical Events Subcommittee report 3 by Dr. Richard Harvey, who's going to be giving 4 an analysis of the 2021 and 2022 medical events.
5 Dr. Harvey?
6 Dr. HARVEY: Thank you, Dr. Metter.
7 Good morning to everyone. It's a pleasure 8 to be here.
9 So I am the Chair of the Medical Events 10 Subcommittee, so we'll be talking about that. I'm the 11 Chair. Dr. Folkert has joined us. Mr. Green is on 12 the Committee, Dr. Metter, Mr. Ouhib, and Dr. Wolkov.
13 And special thanks to our consultant, Dr. Angle, and 14 our NRC staff resource Mr. DiMarco. Everyone has been 15 wonderful to work with and have contributed greatly to 16 this. So thank you to all of them.
17 So the Subcommittee's charge is to review 18 the medical events to advise the Advisory Committee on 19 the Medical Uses of Isotopes and the United States 20 Nuclear Regulatory Commission about emerging trends 21 that may need regulatory attention. So the NRC and 22 the ACMUI are regularly reviewing these medical events 23 and we're doing our review and bringing this report 24 forward.
25 Medical events that occur when radioactive 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
30 1 materials used in health care result in unexpected 2 radiation dose to patients, and certainly the 3 regulations there are cited. The Medical Events 4 Subcommittee of the ACMUI reviews the data to analyze 5 the nature of the medical events, identify those 6 emerging trends, and then provide recommendations to 7 the Committee, the ACMUI Committee, as well as the 8 Nuclear Regulatory Commission.
9 The period under review is FY '21 and FY 10 '22, so October 1st, 2020 to September 30th, 2021 and 11 October 1st, 2021 to September 30th, 2022. So we'll 12 be focusing on that. We will see in the tables some 13 of the earlier data and trends, but we haven't --
14 we're not including anything beyond September 30th, 15 2022.
16 We have kept with what I call the Dr.
17 Ennis methodology. So Dr. Ennis did a wonderful job 18 with the medical events. I have been elected to try 19 to fill those big shoes. And we have remained 20 consistent with his methodology going forward.
21 So there were two overarching themes:
22 human error and inexperience. Human error seems to be 23 influenced by communication and feedback between 24 individuals and healthcare as well as the failure to 25 work in teams.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
31 1 Inexperience has occurred when new 2 radiopharmaceuticals have come to market at a very 3 quick pace and people haven't developed the experience 4 with these radiopharmaceuticals.
5 Also, the dissemination of use of these 6 radiopharmaceuticals to smaller institutions that 7 perform these procedures at a lower frequency. There 8 seems to be more of a problem with individuals or 9 licensees that are not always, but in some cases --
10 where licensees are doing infrequent use and have 11 limited experience.
12 Increasing medical events. So again, due 13 to new radiopharmaceutical therapies coming to market, 14 theranostic treatments, and increasing use of current 15 therapeutic radiopharmaceuticals. We're seeing 16 increase of lutetium agents, yttrium-90 microspheres.
17 We're definitely seeing an increase in the volume of 18 the number of procedures being done.
19 With regards to yttrium-90 microspheres, 20 there are two common medical events. An ACMUI action 21 that I wanted to mention was that we added two 22 committee members. One is our consultant, Dr. Angle; 23 the other is Dr. Folkert.
24 ACMUI recommendation is that the 25 authorized users adhere to manufacturer 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
32 1 recommendations. One thing that's been identified is 2 that there's anatomy that needs smaller catheter, 3 smaller needle gauge sizes. Interventional 4 radiologists have moved to using needle gauge sizes 5 and catheter sizes that are smaller than what the 6 manufacturer recommends. We believe this has 7 contributed to some of the medical events with 8 yttrium-90 microspheres.
9 The other issue is aggregation of the 10 microspheres. So proper delivery, proper set up of 11 the delivery box, and agitation of the microspheres is 12 very important for our licensee so that they can 13 deliver the microspheres without aggregation, 14 clumping, and all of the radiopharmaceutical or the 15 microspheres can get to the patient.
16 Looking first at 35.200, you can see some 17 of the work done by Dr. Ennis and the Committee prior 18 to my involvement. And then you can see added 2021 19 and 2022. The number of medical events in 35.200 is 20 relatively small. And keeping with the Ennis 21 methodology, items that could be or medical events 22 that could be prevented by a time-out are wrong drug, 23 wrong dosage, and wrong patients by the Ennis 24 methodology. So the four medical events that occurred 25 in 2021 could have been prevented -- at least the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
33 1 Committee surmised that this could have been prevented 2 by the use of a time-out.
3 Next moving to 35.300 where a written 4 directive is required, we see a breakdown of the 5 different types of medical events by year. We see 6 that it's relatively constant, though there has been 7 -- I would say -- I'll keep it this way. Let me say 8 it that way. It's relatively constant. You see some 9 areas where there may be some uptick. So from 2021 10 and 2022 a time-out may have been useful in 50 percent 11 of the medical events that occurred in 2021. In 2022 12 about 30 percent of the medical events may have been 13 prevented by the use of a time-out. Again, these are 14 wrong drug, wrong dose, wrong patient.
15 Our next area is 10 CFR 35.400, Manual 16 Brachytherapy. So we see a relatively low number of 17 events in manual brachytherapy, which is great. We've 18 seen in the past some significant with prostate doses 19 being higher than expected, but that seems to have 20 tailed off as you look at 2019 and beyond. So most of 21 what happened in 2021 and 2022, the occurrences were 22 relatively low.
23 Let's move to the next slide, which is a 24 continuation of that slide. And you can see the 25 totals. They are 7, 13, 5, 6, 4, 1. So relatively 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
34 1 stable, relatively low. The other issue is will a 2 time-out have helped in these situations to prevent 3 the medical events? And the other area that we looked 4 at was was there a lack of experience or inattention 5 and how did that play a role in medical events?
6 Let's move to the next slide. This is a 7 note from previous work. After 2019 many of the 8 medical events were re-categorized from dose to 9 activity-based. So the potential medical event issues 10 that we mentioned were lack of attention and 11 inexperience.
12 Moving to the next slide. Summary. So 13 potentially 9 out of 36, or 25 percent, of the medical 14 events from the period of 2017 to 2022 may have been 15 prevented by the use of a time-out, which is defined 16 for this using the Ennis methodology as wrong site, 17 wrong source, wrong patient. So using a time-out or 18 a checklist in 2021 could have prevented three-19 quarters or 75 percent of the medical events that 20 occurred. Three out of four.
21 The training of infrequently performed 22 procedures did not seem to be a factor in the medical 23 events that occurred in 2021 and 2022, although that 24 was cited in previous years.
25 Increased attention during the procedure is not 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
35 1 a factor in the medical events observed in 2021 or 2 2022.
3 Next area to look at is 10 CFR 35.600.
4 You can see that medical events have been relatively 5 stable with a slight drop in 2021 and sort of back in 6 that area of around 10 to 13 medical events. These 7 events have occurred from a number of different 8 reasons, and I think some of the ones that stick out 9 were wrong position treated or the wrong reference 10 length from the transfer tubes in HDR brachytherapy.
11 Moving to the next slide, what we see here 12 is a breakdown by site treated. So GYN, or 13 gynecological treatments still seem to be the most 14 prevalent, the most -- had the largest number of 15 medical events occurring at that treatment site. As 16 you can see there are 38 as compared to the others, so 17 38 out of 57, certainly a large percentage.
18 Moving to the next slide, in summary, if 19 you look at the medical events that may have been 20 prevented by a time-out, which is defined in the Ennis 21 methodology as wrong plan, wrong dose, in 2017, time-22 out, there was no benefit. In 2018, 30 percent, 3 out 23 of 10 may have benefitted from a time-out. And from 24 2019 on no events were going -- would -- no events 25 would have benefit from the use of a time-out. And so 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
36 1 that total -- this is three out of five and --
2 confused as to what that is, so I'll have to get back 3 to you on that. So let me move forward because 4 certainly the denominator is not five.
5 So I think there's a mistake there. That's on 6 me. I apologize.
7 All right. The other issue is medical 8 events caused by infrequent users or inattention while 9 performing the procedure. Again, this is very 10 difficult to determine based on the information in the 11 nuclear medical events database. So what's been used 12 in the past for this assessment is that wrong position 13 is a surrogate for infrequent users and inattention.
14 So the wrong position was treated. And you can see 15 the breakdown. 2017, two out of eight; 2018, one out 16 of ten, and so on. And that total was 25 percent, or 17 14 in 57, of these events were caused by or at least 18 surmised to be caused by wrong position analogous from 19 infrequent user or inattention and inappropriate 20 levels of attention to detail.
21 The next area that we looked at as a 22 committee was 35.1000. 35.1000, there were not --
23 there was only one additional event, none in 2022, for 24 radioactive seed localizations. So radioactive seed 25 localizations seem to be a relatively low occurrence 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
37 1 of medical events, and the one that did occur was due 2 to seed migration in 2021.
3 Moving to the next slide is intravenous 4 cardiac brachytherapy. There were no new events in 5 this category in 2021 or 2022. So the summary from 6 Dr. Ennis' work and the Committee's prior work is 7 listed here. There's nothing new to present.
8 35.1000, specifically looking at Gamma 9 Knife Perfexion, Icon, Esprit. Total medical events 10 has been relatively stable; one or two, zero to two.
11 And you can see the different causes here. In 2021 12 there were no medical events involving Gamma Knife of 13 these three models. There was one due to wrong site, 14 which was due to human error and shifting of co-15 registration images, and there was one where the 16 patient motion management system failed. So two 17 events in 2022.
18 We spoke briefly about yttrium-90 19 microspheres earlier. There are TheraSpheres and SIR-20 Spheres. So we're going to talk about TheraSpheres 21 first. And we can see that it looks like there is an 22 uptick in the number of medical events involving 23 yttrium-90 TheraSpheres, up to 23 in 2021 and 2022.
24 So this does seem to be fairly significant. In 2021 25 there were 10 cases where there was 20 percent 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
38 1 residual activity remaining in the delivery box, the 2 delivery device due to the remaining radioactive 3 material there or possibly due to leakage within that 4 delivery set system.
5 Another area again was mentioned 6 previously was wrong site and -- actually it wasn't 7 mentioned earlier, excuse me, wrong site, where 8 catheter placement -- there was -- well, the wrong 9 placement size was mentioned, but placement location 10 was not. So let me clarify that. So there were seven 11 cases in 2022 where there was the wrong site either 12 due to catheter placement error or the size of the 13 catheter. And again size of the catheter, we should 14 stay with manufacturer recommendations. At least 15 that's our recommendation. And if you look down to 16 the bottom, a time-out may have been useful in some of 17 these situations. Time-out is those that were in the 18 category of wrong dose. So for 2021 4 out of 23, or 19 17 percent of these medical events could have 20 benefitted from a time-out. Two out of twenty-three, 21 or nine percent could have benefitted from a time-out 22 in 2022.
23 Infrequent or inattention. Ten out of 24 twenty-three, or forty-three percent could have 25 benefitted here. And this is for the residual doses 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
39 1 of 20 percent left in the delivery set box. So either 2 improper set up, problems with pressure, problems with 3 aggregation, problems with delivering the radioactive 4 microspheres properly. And then there were 2 out of 5 23, or 9 percent that might have benefitted from a 6 time-out in 2022.
7 Looking at SIR-Spheres, you can see that 8 the number is relatively constant. There was an 9 uptick in 2021 where there were 18 medical events.
10 2022 came back into the more normal realm of somewhere 11 between 7 to 11. And again, you can see a breakdown.
12 And it looked like the most prevalent situation in 13 2021 and 2022 with the SIR-Spheres was aggregation of 14 the microspheres within the delivery set. So it's 15 very important. And Mr. Green has pointed this out in 16 the past how important it is to agitate the spheres to 17 make sure that the spheres are delivered properly. If 18 the spheres sit, they can settle, they can clump and 19 aggregate and they don't get infused through the 20 delivery set properly.
21 So you can see that there were quite a 22 few: nine in 2021, six in 2022, due to aggregation of 23 microspheres. So a time-out may have benefitted in 24 one of the cases out of 18, or 6 percent in 2021. In 25 2022 one out of nine, or 11 percent may have 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
40 1 benefitted from a time-out. And this is defined as 2 wrong site.
3 Infrequent, inattention. Two out of 4 eighteen, or eleven percent for 2021. One out of 5 nine, or eleven percent -- or twenty percent of the 6 residual activity remaining in the delivery set and 7 wasn't infused to the patient leading to another 8 (audio interference).
9 In sort of some summary slides here, we 10 want to make sure that we're recommending that people 11 ensure their familiarity with the mechanics of the 12 yttrium-90 microsphere delivery device and their set 13 up procedures. They know their device well and they 14 set it up properly and have good procedures hoping 15 that medical events will be reduced.
16 Very important to confirm that all the 17 data and the calculations in the treatment plan are 18 correct. I think that goes without saying, but that 19 has been something that has been an issue in the past.
20 Performing a time-out is something that 21 may be beneficial to ensure that all elements of the 22 treatment are in accordance with the written 23 directive.
24 And possible elements of a time-out. And 25 these are directly stolen/plagiarized from Dr. Ennis.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
41 1 Again, obviously identifying the patient via two 2 methods to make sure that you have the correct patient 3 identified, identifying the proper procedure at the 4 time of time-out, the radiopharmaceutical, the proper 5 activity being administered, performing a second check 6 of the dosage calculation, and that the written 7 directive and the dosage are identical, because there 8 have been cases where there have been errors in this 9 area.
10 Other things that are applicable are the 11 units of activity for low-dose rate prostate, 12 identifying the anatomic location so the right site, 13 the correct site is treated, making sure the patient 14 and the treatment plan is accurate. Treatment plan 15 independent second check has to be performed. You 16 have to do a second check of the primary. Reference 17 length was seen as an issue for the transfer tubes.
18 If the reference length and the transfer tube is not 19 the proper length, then we're not going to be treating 20 the correct site. And the implant site location for 21 radioactive seed localization is something that was 22 identified in the past.
23 So these are the acronyms used on the next 24 slide. All right? I think we're mostly familiar with 25 these. And at this point that concludes the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
42 1 presentation that I would like to give. Again, I 2 appreciate the opportunity to participate on this 3 Committee and it was very valuable and I think 4 personally I learned quite a bit. I really commend 5 all of the Committee members, Subcommittee members for 6 all their effort.
7 There was some talk of potentially 8 defining maybe some of the medical events in a 9 slightly different way, but that's something that 10 we're going to be looking at before our next review, 11 so we kept with what I call the Ennis methodology, Dr.
12 Ennis' methodology going forward.
13 So thank you very much for the opportunity 14 to present and for all the help that everyone gave.
15 If I went too quickly, I apologize. I know there was 16 a lot to cover. And I'd be open to any questions that 17 you may have.
18 CHAIR METTER: Thank you, Dr. Harvey, for 19 a very comprehensive analysis of the unsealed and 20 sealed source medical events for 2021 and 2022.
21 Do I have a motion first of all to approve 22 the report by the Subcommittee?
23 (No audible response.)
24 CHAIR METTER: Okay. We can go ahead and 25 ask questions.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
43 1 VICE CHAIR JADVAR: Thank you, Richard, 2 and I want to thank you and the Subcommittee members 3 for that wonderful report.
4 Just a couple of observations and 5 comments. On page 8 there is -- so there was only one 6 extravasation over five years? I just want to --
7 because that has been an issue of interest and I just 8 want to highlight that we are reporting that there's 9 only one extravasation over five years. Is that 10 correct?
11 DR. HARVEY: I don't have the raw data in 12 front of me, so I hate to say I can't answer that 100 13 percent. I'm sure that your analysis is probably 14 correct, but I don't have the raw data in front me to 15 make that comment. I don't know if Mr. DiMarco could 16 add anything just because he's done so much work as 17 the NRC staff resource on this.
18 CHAIR METTER: Let me just -- before I 19 make that, thank you very much. Yes, either Mr.
20 DiMarco or Dr. Tapp, please make a comment. Thank 21 you.
22 MR. DiMARCO: Hi, Daniel DiMarco, NRC. I 23 would like to say that although that may have been 24 listed as an extravasation in the NMED database, the 25 NRC still and has not for this entire time recognized 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
44 1 any extravasation as a medical event as per the 2 current medical event reporting criteria. So while 3 that may be in NMED listed as extravasation, that is 4 not a medical event for that.
5 CHAIR METTER: I do have a question for 6 the NRC staff. As far as medical event reporting, is 7 it primarily -- I know it's supposed to be when you 8 have a medical event, you should report it to the NRC 9 to look for trends, common trends that can help 10 protect our patients if common trends occur such as a 11 catheter issue with y-90 in the past. Are the primary 12 -- people that's into medical events, are they 13 primarily NRC or they're just also Agreement States?
14 I mean, I know they should be, but I'm just asking 15 what percent. Is it proportional to the percentage of 16 NRC versus Agreement States? Because there's only --
17 there's a small percentage of NRC states. And I just 18 want to ask that question.
19 DR. HARVEY: I would say that your 20 assumption there is correct. The medical events that 21 we get are primarily from Agreement States just 22 because, like you said, most of our licensees are in 23 Agreement States.
24 CHAIR METTER: Thank you.
25 Dr. Jadvar?
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
45 1 VICE CHAIR JADVAR: And I just want to 2 highlight that under 35.300 on page 9 there are no 3 extravasations. That's where Lutathera and Pluvicto 4 goes for treatment. I just want to highlight that.
5 The other comment I have is on page --
6 regarding SIR-Spheres and TheraSpheres, on page --
7 well, there's no page number here, but under SIR-8 Spheres the total is all zeroes. Those should be 9 changed. I count 61 total medical events for SIR-10 Spheres and you have 105 for TheraSpheres. So I'm 11 just wondering if this difference between these two 12 type of sphere is -- as far as the total medical 13 events is it because of the -- a reflection of the 14 type of -- or the prevalence of use of these 15 methodology? There may be more people using 16 TheraSpheres as opposed to SIR-Spheres? Or is it 17 really something dependent upon the technique itself 18 using either on one of these?
19 Perhaps you, Richard, or Dr. Angle can 20 address that.
21 DR. HARVEY: So first of all, you kind of 22 lost me. So which slide are you referring to first?
23 We could go back and take a look at that.
24 VICE CHAIR JADVAR: Okay. There is no 25 page number, so unfortunately I don't have it. So 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
46 1 it's under 35.1000.
2 MR. HARVEY: Yes.
3 VICE CHAIR JADVAR: Y-90 TheraSpheres, the 4 total medical events were 105.
5 Is that correct?
6 DR. HARVEY: That is correct, from 2017 7 through 2022.
8 VICE CHAIR JADVAR: Exactly. And then next 9 page, SIR-Spheres, the total medical events it says 10 zero, but it really should be 61.
11 The last column is all zeros. That's 12 incorrect. I added it myself.
13 DR. HARVEY: I apologize for that, and I 14 did not catch that. I will get that corrected and 15 get that resubmitted to the, to the NRC.
16 VICE CHAIR JADVAR: But what I'm saying is 17 that if I added correctly, it's 61 versus 105.
18 Is that just because people use more TheraSpheres as opposed to SIR-Spheres, or is it 19 something related that that difference in the medical 20 21 events numbers?
22 Is that something related to the technique 23 itself?
24 DR. HARVEY: So, I, Dr. Angle can speak 25 to that, too. I don't know if there is a higher 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
47 1 volume of usage of TheraSpheres versus SIR-Spheres.
2 I cannot answer that question.
3 Maybe Dr. Angle can, or maybe Mr. Green 4 can maybe put some light on that. I'm not sure. I 5 know they're both used very prevalently, but I don't 6 know if one's used more than the other.
7 CHAIR METTER: Let me have Mr. Green, and 8 then we'll have Dr. Angle speak.
9 Mr. GREEN: Thank you, Dr. Metter.
10 Unfortunately, Dr. Jadvar, we can't 11 answer, I'm sorry. Unfortunately, we can't answer it 12 directly what may be the proportionality concern here.
13 Couple things come to mind. One could be 14 market share. Second could be the actual sphere 15 composition. One's resin, one's glass. One's got a 16 greater density, that could be physics.
17 The other could be the delivery apparatus.
18 And the last one that comes to my mind is the 19 container.
20 They go from a simple V-vial to a more 21 complicated interconnected delivery apparatus where 22 the incoming saline actually flushes and causes a 23 vortex, to more adequately distribute them into 24 suspension, or distribution, so they could actually 25 leave and go out to the catheter and into the patient.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
48 1 So, there's I'm sure Dr. Angle can think 2 of more, but it's not as simple as to market share, or 3 other factors.
4 CHAIR METTER: Dr. Angle?
5 Dr. Angle Yes, I just want to elaborate little bit on 6 a comment Dr. Harvey made. Is it, the Y-90 delivery 7 I think, is very unique among almost anything we 8 talk about.
9 This is as you know, microspheres that are 10 injected into a very small caliber catheter. And 11 there's a bit of a rapid evolving market.
12 So not only do we not know the 13 number of procedures being done, but also the way 14 they're being administered is rapidly changing.
15 And what I mean by that is, is that up until maybe five years ago, most administrations would 16 lobar And now I would say most administrations are 17 18 segmental, or even less.
And so, operators are finding great 19 results with this. The clinical outcomes are very 20 encouraging in the literature, but it is going to 21 change, I think, our medical event reporting.
22 We're going to see more occlusions of 23 catheters, because smaller catheters being put in more 24 peripherally.
25 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
49 1 We of course in this committee, lump all 2 those medical events together. We've talked about 3 this many times.
4 Maybe in terms of patient harm, that isn't 5 as great as some other medical events, and may need a 6 repeat procedure.
7 But my point being is that, the practice 8 is changing rapidly. The administration is being done 9 in a different manner, which is going to lead to more 10 I think, medical events.
11 But their clinical impact needs to be looked at not only in terms of the whole number of 12 patients being done, but the relative good to the 13 14 relative adverse events.
CHAIR METTER: Thank you, Dr. Angle.
15 We may have to just re-look at this Y-90 medical 16 17 event and the current systems of going suubsegmental, I mean, you know, very, below 18 the recommendation.
19 20 And maybe we'll, we might have to re-speak 21 with industry again.
22 Yes, Dr. Einstein.
23 MEMBER EINSTEIN: Thanks. Two points, a 24 comment and a question.
25 In the possible elements of a time out, I 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
50 1 certainly support identity of patient via two 2 identifiers.
3 Some institutions specifically exclude 4 date of birth, as I understand it, as an identifier.
5 And, the Joint Commissions Accreditation Manual 6 defines a patient identifier as information directly 7 associated with an individual, that reliably 8 identifies the individual as the person for whom the 9 service or treatment is intended.
10 Acceptable identifiers may be the 11 individual's name and assigned identification number, 12 telephone number, date of birth, or other patient 13 specific identifier.
14 I think my recommendation would be not to 15 sort of single out name and date of birth as the two 16 identifiers to be used.
17 It's going to depend upon institutional 18 policies. We do say EG here, for example, but maybe 19 it would be worthwhile to consider those other 20 identifiers.
21 CHAIR METTER: Thank you, thank you for the 22 comment.
23 Any other comments?
24 MEMBER EINSTEIN: Question. I'm curious 25 why in the 35.600, the preponderance of medical events 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
51 1 occurred in gynecologic oncology patients.
2 And, it's sort of a similar question. Is 3 that simply due to the volume of studies performed in 4 that patient population, or is there something 5 intrinsic, something else going on?
6 CHAIR METTER: Very interesting question, 7 yes. Do I have one of the radiation oncologists?
8 Yes, Dr. Wolkov.
9 MEMBER WOLKOV: What was the question you 10 were specifically asking?
11 (No audible response.)
12 MEMBER WOLKOV: The number of GYN cases, 13 correct?
14 MEMBER EINSTEIN: About 600 of medical 15 event summary --
16 (Simultaneous speaking.)
17 MEMBER WOLKOV: Okay.
18 MEMBER EINSTEIN: -- to the table.
19 Thirty-eight of the 57 events occurred in patients 20 with GYN tumors.
21 MEMBER WOLKOV: Okay.
22 So, the, sorry, yes, Harvey Wolkov, 23 radiation oncology.
24 The reason for that largely was location.
25 The catheter placement. The device placement. So, 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
52 1 that was the majority of issues.
2 What we discussed as a committee, was 3 perhaps on page 16 by the way, including one other 4 factor, which partially addresses your concern, and 5 that looks at location.
6 So, location of the radioactive sources.
7 So if you look at the number of patients, actually it 8 was fairly high in the setting of GYN tumors, because 9 of that particular issue.
10 The other thing we discussed as a 11 committee, was whether or not we should change the 12 methodology specifically for 35.600, to include not 13 only wrong plan, wrong dose, but also location, wrong 14 location.
15 Because that then changes the statistics 16 quite a bit.
17 MEMBER HARVEY: And, we agreed to look at 18 that further going forward as a committee. And, we 19 may make that change that Dr. Wolkov is talking about, 20 going forward.
21 But we did remain consistent with Dr.
22 Ennis' methodology for this meeting. And, I very, 23 very much appreciate your support and the comment.
24 MEMBER OUHIB: This is the --
25 (Simultaneous speaking.)
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
53 1 CHAIR METTER: Thank you Dr. Wolkov --
2 MEMBER OUHIB: If I may interject here?
3 Regarding the GYN, there are a few things that 4 actually can happen.
5 And that is sometimes the, on the first 6 application there is imaging. But then assuming that 7 the applicator, GYN applicator, cylinder let's just 8 say, can fit just fine but there is no repeated 9 imaging.
10 And therefore, because of lack of re-11 imaging, that would lead to that.
12 The other thing it has to do with the 13 prescription. There is a misunderstanding prescribing 14 to the surface of the applicator, or 3 mm., or 2 mm.
15 or what not. And that actually also lead to quite a 16 few errors.
17 I just want to add one general comment.
18 And, that is related to the time out and the 19 checklist.
20 Unfortunately, we don't have access to the 21 user's time out, what was actually used, or the 22 checklist for that matter.
23 But I think the problem is even bigger.
24 This is a paradigm shift. It is not whether the 25 institution has a checklist or a time out, because I 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
54 1 can tell you the majority do have it.
2 Some is very detailed, others is a very 3 quick okay, yes, this is this, this is this. Okay, 4 let's move on.
5 But I think the big issue is really lack 6 of focus every aspect of that procedure. And that is 7 starting from patient verification, to actually end of 8 treatment.
9 And there are distractions, and so on and 10 so forth, and it's not like the people are not 11 focusing, but they might not be focusing on the right 12 thing.
13 And I think that's something that we probably should look into. And, I'll be happy to 14 15 answer to any question on that item.
16 CHAIR METTER: Thank you, Mr. Ouhib.
17 But we have to remember what our, the NRC is. We are not actually in the practice of medicine, 18 but we're on the regulatory prevention of overexposure 19 to the public, a patient in the public in regarding 20 the medical uses of radioisotopes.
21 So we have to be careful because there's 22 a fine line between that, and the practice of 23 medicine.
24 25 So I think you know, human error I think 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
55 1 as Mr. Harvey said, is actually a good term. And you 2 know, as far as being very specific, I don't think 3 it's in our purview to be that.
4 Is that correct, Mr. Einberg?
5 MR. EINBERG: Yes, that is correct, Dr.
6 Metter.
7 We want to limit or prevent over exposures 8 as much as possible, but we do not get into the 9 practice of medicine.
10 And if I may take this opportunity also, 11 I was just looking that we have a information notice 12 that we published in 2019 on the methods to prevent 13 medical events.
14 And I'm not sure if the committee, 15 subcommittee had a chance to review that. But one of 16 those aspects was to look at time outs. And, time 17 outs are discussed in that information notice.
18 And if you know, from the staff 19 perspective here, you know, if there is 20 recommendations that we need to go out and update our 21 guidance, our information notice, or generic 22 communications if it's not being effective, then you 23 know, would be interested in learning more about that.
24 Dr. Tapp is the author to that information 25 notice. And so, I'll, I see she wanted to say 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
56 1 something as well, so I'll give her the opportunity, 2 if that's all right.
3 CHAIR METTER: Yes, Dr. Tapp?
4 DR. TAPP: Yes. That information notice 5 came out of an ACMUI meeting from Dr. Ennis, and his 6 recommendations.
7 I do want to circle back though, on the 8 practice of medicine. On ensuring that the treatment 9 goes as directed by the authorized user, that is 10 something that we do continue to look at.
11 And, one of the things for HDR is we do have requirements of minimum calibration, and quality 12 13 assurance before the treatments, that are expected.
And, one of the places there is it is to 14 make sure the source applicators are going to the 15 location that they expect.
16 And, the calibration requirements kind of 17 tie back into professional standards. So, we do go 18 back to Zoubir, Mr. Ouhib is coming from with the 19 AAPM.
20 So, there is kind of like a loop. We do 21 make, in the role, we are making sure that the 22 administration is in accordance with the direction 23 of the authorized user.
24 25 So, there is a little bit of close call 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
57 1 there, but we do have a little role --
2 CHAIR METTER: Well, thank you, Dr. Tapp.
3 Yes, Dr. Harvey?
4 DR. HARVEY: Yes, I just want to beg the 5 pardon of the NRC and the committee, for the mistakes 6 on slides 22 and 16. They will be corrected, and they 7 will be resubmitted. And so, I apologize for that.
8 Thank you.
9 MEMBER MAILMAN: No worries. I think I 10 have three comments actually.
11 Following up to Dr. Jadvar's comment, not 12 only in the spheres realm but in all realms, and I 13 know it's hard to get this number, but it would be 14 interesting to know as a percentage of the procedures 15 done, rather than the absolute.
16 The absolute numbers are great, but you 17 know, we're going to have an increasing number of 18 certain therapies, and a declining of certain others.
19 And, it would be nice to know whether we're getting better or worse, as the percentage of 20 21 procedures going, go forward.
22 Richard, do you want?
Dr. HARVEY: So, the problem I think there is the 23 denominator and us now knowing the total number of 24 25 procedures.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
58 1 So, I don't know if we'd ever be able to 2 answer that question for you.
3 MEMBER MAILMAN: So, I hope one day we 4 figure out how to get the denominator in the future.
5 The second thing I would say is, one of your points on 6 where medical errors are more likely to occur, were in 7 centers that did things infrequently.
8 But do we have a definition of what 9 infrequently is for this? And, do we have specific 10 recommendations for infrequently?
11 Because I see a general set of recommendations, but if this is happening more in 12 places that infrequent, it would be nice to know what 13 14 that, what that definition is.
15 We have our acronyms, but we don't have a 16 definition and I don't know what infrequent is.
DR. HARVEY: I don't think that we have a 17 specific definition of the number of procedures that 18 would be used, that would be called frequent or 19 infrequent.
20 I think we're looking at it just very 21 qualitatively as in overarching you know, the 22 sentiment --
23 MEMBER MAILMAN: We're using it to define 24 that we have a delineation point. So, either we have 25 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
59 1 a delineation point that's infrequent or frequent, or 2 we need to come up with it to be specific so we can 3 make specific recommendations to that point.
4 DR. HARVEY: We can certainly address 5 that going forward, or we can not speak of it that way 6 if we can't do that.
7 I mean, it's very difficult for us to say 8 that we you know, somebody that wants to do the 9 treatment. Somebody doing a low volume, they may do 10 it very, very well.
11 And so we, we're not trying to say that somebody is an infrequent user shouldn't do it, or 12 13 anything of that nature.
So, I think we'll take a look at that as 14 a committee, and try to get that better defined for 15 you going forward, yes.
16 MEMBER MAILMAN: Right, because you're 17 using it as a point. You want to add to that, or not?
18 19 CHAIR METTER: If Dr. Einstein has a 20 comment.
21 MEMBER MAILMAN: The last, the last 22 comment.
23 CHAIR METTER: Since it's going to be on 24 this comment, Dr. Einstein?
25 MEMBER EINSTEIN: Yes.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
60 1 In terms of your question about the 2 denominator. So, such data are available. CMS has 3 some publicly available data.
4 Unfortunately, CMS's publicly available 5 data excludes studies performed by providers who 6 perform the test less than 10 times in a year.
7 I think most people performing these tests 8 do it more than 10 times per year. But even beyond 9 that, one can purchase data from CMS for $500.00 per 10 year, which may be doable for the NRC.
11 And, I don't know if CMS would charge the 12 NRC for it. So, that covers Medicare data. I've 13 purchased that for research studies and insofar as my 14 research agreement with CMS, you know, allows, I'm 15 happy to share that with, with the NRC.
16 But I'd have to check the verbiage of the 17 agreement which I have.
18 Not every patient obviously is covered by 19 CMS. There are private payers. It's also services 20 which aggregate private payer data, it's more 21 expensive than CMS data.
22 But the data's out there if you're willing 23 to pay for it if you want to get that denominator to 24 know what the, the rate of these events are.
25 CHAIR METTER: Thank you, Dr. Einstein.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
61 1 Mr. Einberg?
2 MR. EINBERG: Yes, thank you Dr. Einstein, 3 for that.
4 And just numerous years back, we did new 5 work with the manufacturers of microspheres. And, we 6 were able to get some data. Of course, that data is 7 proprietary and we have to be very careful when we 8 share that.
9 But we can take that as an action item, to 10 try to work with the manufacturers to try to get some 11 data. And Dr. Einstein, any pointers where we can 12 look for that data would be appreciated, as well.
13 CHAIR METTER: Thank you.
14 MEMBER MAILMAN: My last point I said I'd 15 have three, and I will keep it right to three.
16 You know, you do have a list of new or 17 suggested items to reduce medical events, which is 18 great.
19 Is there any concept or any idea of what 20 a patient could do to, to help reduce medical events?
21 Should they be proactive in this, or discussion of 22 pro-activity to make sure that their provider has 23 checked their data twice?
24 Or something that we can do in the patient 25 community across the board to say, when having the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
62 1 procedure, these are the following things to help 2 prevent a medical event.
3 You know, they happen rarely. I want to 4 be clear the numbers you're doing are, you look, 5 there's millions of procedures going on, or tens of 6 thousands depending on what the particular thing is.
7 So, these numbers on the absolute levels 8 are low. But if there's anything that we as the 9 recipients of these medical procedures can do to help 10 reduce this number as well, I think taking that into 11 account would be, would benefit us as well.
12 That was my three points.
13 DR. HARVEY: Richard Harvey, responding to Mr.
14 Mailman's comments. And, I think those are, all 15 your comments have been fantastic. I really like this 16 one quite a bit.
17 I can't really, I don't want to speak for the NRC, but I don't think that we can tell the 18 19 patients what to do.
But I do strongly believe that patients 20 should be a very strong advocate in their own care.
21 And they should be asking questions, and challenging 22 their health care providers to make sure that they're 23 given, you know, the proper treatments, and things are 24 done properly.
25 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
63 1 But I think I would leave it to the NRC to 2 comment on whether or not there could be guidance or 3 recommendations, given to patients.
4 MEMBER MAILMAN: Yes, I'm not asking to 5 put the onus on the patients to reduce medical events.
6 I'm just trying to be saying that we can be part of 7 the solution, and how, how we figure that out without 8 putting the onus on the patient.
9 But to keep that number at this low level, 10 or even reduce it.
11 MEMBER OUHIB: This is Zoubir Ouhib. If I 12 may? There are certainly things that a patient can do 13 to actually prevent certain medical error. And that 14 is be an active participant.
15 At a working group, we are actually 16 looking at that and say, and see what are the things 17 that a patient can actually do. Ask, or verify, and 18 so on and so forth.
19 To go back to the frequent and infrequent 20 term per se, I'm not really sure if the ACMUI should 21 be taking the lead on that.
22 I would say probably organizations such as 23 ASTRO can probably better define what's infrequent, 24 what's, and so on and so forth.
25 CHAIR METTER: Thank you, Mr. Zoubir.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
64 1 Yes, Mr. Green?
2 MR. GREEN: We don't know the term 3 frequent or infrequent. Can the contractor that runs 4 NMED be asked to make modifications so if there is an 5 event regarding microspheres, to inquire of the 6 reporter of the number of procedures they do annually?
7 I mean, could we get data through NMED 8 that might give us clarity?
9 MR. EINBERG: Chris Einberg. The NMED 10 contractor would be restricting you know, reaching out 11 to the manufacturers.
12 Now, they can work with the licensees to 13 ask clarifying questions, but it has to be within the 14 constructs of our regulations.
15 Now, we, for medical events, we require the certain details for that report. We can't go 16 17 beyond that.
And so, again, but we've tried to put out 18 guidance in the med annual report, what constitutes a 19 good medical event report, and tips for reporting with 20 provider training in that regard.
21 22 But we are limited in exactly what we can 23 ask.
24 Dr. Tapp had a question, if that's all 25 right.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
65 1 CHAIR METTER: Yes, Dr. Tapp?
2 DR. TAPP: Yes, going back to what could we 3 do with recommending for patients to advocate for 4 themselves.
5 I do think the NRC would be limited in 6 that role. We license the licensees, and not the 7 patients.
8 So, I think like Mr. Ouhib had said, 9 that's something that I think professional societies 10 are usually more involved with its recommendations 11 that way.
12 It would be hard for the NRC to put out 13 anything for the patients.
14 CHAIR METTER: Thank you.
15 One thing that I was thinking of as far as 16 regarding the question of the frequency of medical 17 events, let's say for the Y-90 microspheres perhaps.
18 And it's not going to be in, I don't think 19 it's going to be in the practice of medicine. But you 20 could also add to your medical event data, has this 21 been, has there been a medical event of this nature in 22 the last month, and then you say last three months.
23 And you can kind of gauge. I mean, and 24 you're looking at protecting the public. Because if 25 it's been in the last month, you might, they might 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
66 1 have to explain it if it.
2 But if there hasn't been any in the last 3 three, you know, that sort of thing. Just might ask 4 for a short time frame.
5 Because if they're going to have more than 6 you know, an x-number, they'll have it in the next 7 three months, or one month, or something like that.
8 I don't know if that's going to be a 9 doable thing.
10 MR. EINBERG: I'm not sure I completely 11 understand what the question was, but let me kind of 12 give a little bit of background that might help.
13 When a medical event is reported, it comes 14 into our headquarters operations office. And those 15 events actually come into my branch after, or medical 16 events come into my branch.
17 And we do an evaluation, the medical team 18 does an evaluation of those events immediately. And 19 if there's any trending or trends that they see, then 20 you know, we reach out for additional information.
21 We decide whether guidance is necessary, 22 rulemaking is required, follow up inspections are 23 required.
24 So, that's what we do on the medical side.
25 The other events also come into the branch there, and 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
67 1 they're sent to analysis and trending groups.
2 And so, we do trending for different types 3 of events, including medical events.
4 I'm not sure if that helps with where you 5 were going with that.
6 CHAIR METTER: No, that does. That 7 explains. You are tracking.
8 I think Dr. Angle has a question, or a 9 comment.
10 DR. ANGLE: I was just going to get us 11 grounded you know, back to the basics, which is there 12 are some things that you just have to call absolute 13 straight.
14 Even though the number of flights has gone 15 up, our tolerance for planes falling out of the air is 16 zero. And that applies to wrong site, and things.
17 And the comment I'd make is you know, the Joint Commission is very involved in patient advocacy 18 for time out, and talking about we have an opportunity 19 I suppose, to remind operators that time outs should 20 be very detailed, and the patient should be involved 21 22 in that time out.
23 CHAIR METTER: Thank you very much.
24 And just to remind you, the number of 25 procedures that we do for therapy is a large amount, 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
68 1 compared to the number of medical events.
2 I think in my opinion, they're still 3 small.
4 Are there any other questions or comments?
5 Yes, Mr. Green.
6 MEMBER OUHIB: This is Zoubir Ouhib.
7 CHAIR METTER: Oh, I'm sorry.
8 MEMBER OUHIB: We did entertain actually, 9 within this working group with the APM, that how can 10 we approach the manufacturers for institution that 11 they are not doing enough cases say, throughout the 12 year.
13 And, to provide some sort of a plan where 14 if they're not doing as many, to have some sort of a 15 training whether it's six months or whatever that is, 16 to sort of refresh you know, the users with how to 17 proceed safely.
18 And, the manufacturers were sort of like 19 open to that idea. But nothing has been sort of 20 tackled yet.
21 CHAIR METTER: Thank you for that comment.
22 Any comment on that, Mr. Einberg?
23 (No audible response.)
24 CHAIR METTER: Okay, Dr. Tapp?
25 DR. TAPP: (Audio interference) -- working 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
69 1 group that he's on AAPMs.
2 CHAIR METTER: Well, thank you.
3 So to keep on time, do I have any other --
4 yes, Mr. Williams?
5 MR. WILLIAMS: I have two questions. Mr.
6 Einberg had mentioned that you know, based on the 7 assessment and what you looked at over the events, is 8 there a need for us to you know, re-look at our 9 generic communications?
10 I don't think I heard an answer to that, 11 that piece. But I would be interested in knowing do 12 we think that's something we should look at.
13 And my second statement was, maybe you 14 want to put a finer point on what Daniel had said is, 15 because we have not made any determination that people 16 need to report extravasations, I wouldn't infer 17 anything from the report that you know, there are not 18 extravasations happening because we've not required 19 anyone to request, to report them.
20 I'm just trying to make sure that we don't 21 infer anything from that because we, we haven't 22 finished the rulemaking. We haven't made a 23 determination.
24 So, I think it would be a little premature 25 to make that statement.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
70 1 CHAIR METTER: Thank you very much. Yes, 2 those are very important comments to make, and I 3 appreciate your comments on that. And Mr. Harvey will 4 be taking those into consideration.
5 Any other comments or questions?
6 (No audible response.)
7 CHAIR METTER: So, we have comments and 8 questions taken from our ACMUI subcommittee, our 9 committee on the NRC staff.
10 Do I have any questions from the public?
11 (Pause.)
12 (No audible response.)
13 CHAIR METTER: Okay, seeing none, do I have 14 a motion to approve the subcommittee -- yes, Dr.
15 Wolkov?
16 MEMBER WOLKOV: Move approval of the 17 committee report.
18 CHAIR METTER: Approval of the report with 19 the suggestions, and addendums.
20 Okay, thank you. Do I have a second for 21 that?
22 MEMBER MARTIN: Second.
23 CHAIR METTER: Thank you, Ms. Martin.
24 All in favor of the report and the 25 additions, and the comments to be amended say aye.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
71 1 (Chorus of aye.)
2 CHAIR METTER: Any opposition or 3 abstentions?
4 (No audible response.)
5 CHAIR METTER: Well, thank you very much, 6 Mr. Harvey for a very comprehensive, and thank you for 7 the committee and NRC staff for a very comprehensive 8 discussion.
9 So, just to be on time, we'll go ahead and 10 go to our next topic, which is by Dr. Tapp, of the 11 NRC.
12 She'll give an overview of the NRC 13 requirements for veterinary release.
14 Dr. Tapp?
15 DR. TAPP: I promise I won't take up the 16 entire time so if you need a little break, stand up, 17 you know.
18 Thank you guys, stuck -- good. Thank you 19 guys for letting me speak. I'm going to move over 20 here for the presentation, and not get distracted by 21 the screen.
22 At this presentation, I'm going to talk 23 about veterinary release. So, we're going to be 24 switching it up a little bit to talk about animals, 25 and the veterinary practice, and how do we release 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
72 1 the, how do licensees release animals from the 2 veterinary clinics.
3 Next slide, please.
4 Before I do that, I'm going to talk first 5 about reminder of how do we release patients. As we 6 all know, 10 CFR, Part 35 is specifically for medical 7 use of byproduct material.
8 10 CFR Part 35.75 allows medical licensees 9 the ability to authorize release of patients, if the 10 dose to another individual from the exposure to that 11 patient, is not likely to exceed 5 millisieverts.
12 This is a per release limit. 10 CFR Part 13 35 is specifically for medical use. So, it's not for 14 veterinary use.
15 Therefore, veterinarians and veterinary 16 clinics cannot use 35.75 to release animals from their 17 clinics.
18 Next slide, please.
19 So, the veterinary release regulations are 20 contained in Part 20. Part 20 public dose limits then 21 apply for the release.
22 Because the licensees and vets do not have 23 the ability to use 35.75 and that regulation that 24 allows the release, the licensees must have the 25 release procedures approved on their license condition 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
73 1 prior to use.
2 So, there's no regulation that is stands 3 for everyone. They have to have it approved prior to 4 use.
5 The dose limits in Part 20 are 1 6 millisieverts per year from all licensed operations.
7 So, no longer per release limit. This is from 8 everything they're going to be exposed to from that 9 licensee's operations.
10 In addition, it's .02 millisieverts in any 11 one hour from external sources. So, the exposure from 12 the animal to a human, they have to meet that 13 requirement of 2 millirem in any one hour from the 14 sources.
15 This is a little different from 2 millirem 16 per hour. This limit is 2 millirem in any one hour.
17 So, it can be slightly higher if it's going to be a 18 shorter duration of dose rate.
19 Sorry, it can be a slightly higher dose 20 rate if the animal is not around a person for that 21 hour2.430556e-4 days <br />0.00583 hours <br />3.472222e-5 weeks <br />7.9905e-6 months <br />. So it's 2 millirem in any one hour.
22 So say if they, it's 4 millirem but 23 they're there less than 30 minutes, that would be okay 24 because they're getting less than 2 millirem in that 25 one hour.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
74 1 To use these dose limits for release, the 2 licensees are required to demonstrate by measurement 3 or calculation, that the dose to the individual who is 4 likely to receive the highest dose, does not exceed 5 the annual dose limits.
6 Or, that the individual cannot exceed the 7 limits if they're continuously present near the 8 source. Or the animal in this case.
9 Most veterinary license users are going to 10 use that first one. They're going to show by 11 measurement or calculation, that the dose to the 12 individual is not likely to exceed the highest, the 13 annual dose limit.
14 Next slide, please.
15 The veterinary release guidance is 16 contained in Appendix D of NUREG 1556, Volume 7, which 17 is to consolidate guidance for material licensees 18 specific to academic, research and development, and 19 other licenses of limited scope.
20 This is different than Volume 9 that's 21 used in medical.
22 This guidance states that licensees should 23 provide owners with written instructions to reduce 24 dose to members of the public.
25 These instructions should be used as a 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
75 1 margin for dose reduction, but should not be relied 2 upon as the primary way of keeping members of the 3 public below the annual dose limits.
4 It also informs licensees and applicants, 5 that the criteria for release must be submitted in the 6 application for review and approval by a licensed 7 viewer before implementation.
8 Next slide, please.
9 The current guidance that's in this NUREG 10 is specific for cats treated with Iodine-131. This is 11 the most common veterinary use, and it's very, 12 provided in the guidance.
13 The guidance criteria that's approved in 14 the guidance, is that cats are to be held not less 15 than four days after administration.
16 The dose rate is less than .01 17 millisievert per hour at six inches. Written 18 instructions are provided to owners.
19 And, licensees can demonstrate that 20 members of the public would not receive a dose from 21 the cat, to exceed that .02 millisieverts in any one 22 hour2.546296e-4 days <br />0.00611 hours <br />3.637566e-5 weeks <br />8.371e-6 months <br />, or 1 millisievert in any year.
23 This guidance is like I said, is very 24 specific to the cats and the iodine, because this is 25 what was used most frequently in the past, and what 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
76 1 was available.
2 But the guidance does state that other 3 release criteria may be accepted on a case-by-case 4 basis.
5 In addition, not just for other animals or 6 other treatments, cats can also have different types 7 of release criteria, but it has to be reviewed on a 8 case-by-case basis. This is what's just approved in 9 the guidance as like the starting point.
10 Next slide, please.
11 The NUREG does have recommendations for 12 what should be included in the instructions to the 13 owners.
14 These include that the regulatory limits, 15 and the need to keep doses as low as reasonably 16 achievable.
17 The potential radiation field surrounding 18 the animal, and the potential dose rate, the potential 19 dose with time at various distances.
20 Maintaining distance from people and 21 public places, and in the home. Minimize time in 22 public places.
23 Precautions to spread, to reduce the 24 spread of radioactive contamination. The handling and 25 storing of animal excretia, and the duration for 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
77 1 storage if it is going to be held in for the decay.
2 This is to avoid landfill picking up the 3 excretia, the waste.
4 The permitted extent and duration of 5 contact by individuals with the animals and handling.
6 Talks about contaminated bedding or other objects 7 which the animal may come into contact with, and give 8 instructions on that.
9 And then, the length and time each of 10 these precautions should be in effect.
11 Next slide, please.
12 So as I said, the guidance is very 13 specific to cats with iodine. In 2019 the NRC 14 received an application for release of dogs being 15 treated with Synovetin OA.
16 Synovetin OA is a tin-117m colloid that's 17 used to treat osteoarthritis in dogs' joints. What 18 happened was Exubrion provided a template procedure to 19 release these dogs so veterinarians in the future 20 could use their, their procedure, and then use that 21 for proposals so they could get a license to release 22 animals after following treatment with their product.
23 Their specific proposal that the NRC 24 reviewed was for treating both dog's elbows with a 25 maximum of 111 megabecquerels per elbow, or 222 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
78 1 megabecquerels total.
2 For consistency and efficiency, the NRC 3 evaluated this template provided by the manufacturer, 4 for future licensees' use.
5 As described in the licensing guidance, 6 licensees still have to provide this procedure as part 7 of their applications if they wish to use it, even 8 though the NRC conducted their review and had 9 conducted our evaluation, and determined it was 10 appropriate.
11 Next slide, please.
12 So, the procedure proposal was to allow 13 release of the dogs with a measured dose rate of less 14 than .45 mR per hour at 1 meter.
15 To provide competence that the dose limits 16 would not be exceeded, the procedure included a multi-17 layer approach.
18 As I said, these, that dose rate there is much higher than you see in the guidance, so they 19 provided a lot more assurance that the dose limits 20 21 would not be exceeded.
They first did a technical assessment to 22 evaluate common dog/human interactions that could 23 potentially exceed the dose limits that are in Part 24 20.
25 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
79 1 They then created a release procedure, 2 which included pre-screening questionnaire to 3 determine if the dog had these type of behaviors.
4 And if they needed to stop or modify these 5 behaviors, which could exceed the dose limit. Or 6 potentially, if they could not stop or modify these 7 excedures, exclude the release of the animal following 8 treatment to ensure the dose limit is not exceeded.
9 The release procedure states the licensee 10 would only provide the treatment if they're confident 11 the owner understands the need to comply with these 12 instructions, to ensure the dose limits wouldn't be 13 exceeded.
14 And, they could comply with the behavior 15 modifications as necessary. And the patient specific 16 instructions are signed by the owner.
17 The NRC found Exubrion's proposed 18 procedure provides adequate assurance that public dose 19 limits would not be exceeded, when licensees perform 20 adequate pre-screening and the instructions are 21 followed.
22 Next slide, please.
23 A little bit about this pre-screening 24 questionnaire. It is more --
25 (Audio interference.)
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
80 1 VICE CHAIR JADVAR: Hossein Jadvar. Very 2 interesting report, thank you.
3 So, I-131 for cats and tin-117m colloid 4 for dogs. I just wonder as a curiosity. What is the 5 range of radionuclides that are used in veterinary 6 medicine?
7 DR. TAPP: They are increasing. We have a 8 report in our Office of Research, that has looked at 9 some recent uses.
10 They are increasing. Most is Iodine-131 and tin to my knowledge, in clinical sense at this 11 12 point.
But, do you have something to add?
13 MR. GREEN: You're correct, feline 14 hyperthyroidism I think, is the leading veterinary 15 16 use. I personally have never had any exposure with 17 t-117m.
But we must not forget the equine use, the 18 bone scan. There are certain parts of the country 19 that is very, very large 200 millicurie bone scan for 20 a horse.
21 DR. TAPP: There is a Yttrium-90 gel also 22 being used in animals, but they are increasing.
23 24 CHAIR METTER: And, what is the Y-90 gel 25 used for?
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
81 1 DR. TAPP: I believe it's sarcomas in dogs.
2 But it's relatively new.
3 MEMBER OUHIB: This is Zoubir Ouhib. Are 4 there any guidance as far as cremations for these 5 animals, in the event of death?
6 DR. TAPP: Yes.
7 In the tin-117 proposal, it is a 8 recommendation that you would tell the owner they have 9 to, if something were to happen, to contact the RSO.
10 And then, they would be determined what 11 could be done with the animal's body at that time. It 12 would probably be a decay situation.
13 But there's no specific hard set guidance, 14 but it is recommended that they contact the RSO if 15 something were to happen.
16 CHAIR METTER: Yes, Dr. Einstein, and then 17 Dr. Harvey.
18 MEMBER EINSTEIN: I assume because you 19 didn't specify otherwise, that this, these dose limits 20 would be the same for service animals and non-service 21 animals.
22 So, that could lead to delay of the 23 release of a service animal back to their, the 24 individual for whom they are caring, because that 25 individual would receive more than 1 millisievert over 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
82 1 the course of the year.
2 Is there any discussion about whether 3 exemptions should be made for essential service 4 animals?
5 DR. TAPP: That is a good question. I 6 believe from the manufacturer for this one product, 7 they did state that service animals likely would not 8 have osteoarthritis, because they wouldn't be able to 9 perform the activity.
10 So they didn't request that. So we have 11 not done any type of valuation on that yet.
12 CHAIR METTER: Dr. Harvey?
13 DR. HARVEY: Hi, Richard Harvey.
14 Yes, I just wanted to clarify. I mean, I 15 think the health medical physicists are so, should you 16 know, be available in a consolatory role to help with 17 this.
18 What I was kind of referring to before was 19 where this practitioner wanted me to be their RSO, and 20 accept all the responsibility as more of a third 21 party, which is why I wasn't comfortable with it.
22 So, I just think that's something to watch 23 out for. I'm sure you already know that, but I just 24 wanted to clarify that comment from before.
25 Thank you, Dr. Tapp.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
83 1 DR. TAPP: Thank you for the clarification.
2 CHAIR METTER: I do have a question.
3 What are the criteria for a veterinarian 4 to become an authorized user? And for example, I 5 think you said it's on a case-by-case basis, but who 6 determines it?
7 Is there a veterinary state board? Is it 8 the local licensee, or who determines who gets put on 9 the license, or how they become an authorized user?
10 Because I guess there wouldn't be a 11 license on, you know, in their own clinic.
12 DR. TAPP: And, I do believe this varies by 13 state to state, but veterinary authorized users I do 14 not believe are listed on a license.
15 16 17 I'm looking for a license reviewer.
18 MEMBER SHOBER: So, this is Megan Shober.
19 We would, you know, typical limited scope 20 license that would cover veterinary uses, would have 21 authorized users listed on it.
22 Those would typically be the 23 veterinarians, but not the vet techs that would be 24 handling, caring for the animals during the time they 25 were boarded.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
84 1 So, yes, absolutely the veterinarians 2 would be listed on the license.
3 CHAIR METTER: And you mentioned as far as 4 veterinarian training and experience, it's not 5 standardized.
6 So, was I correct?
7 MEMBER SHOBER: The NUREG 1757 -- 1556, 8 line 7, does include criteria for authorized users in 9 general. And then the veterinary use is a subset of 10 the whole, that whole document.
11 So, we would be looking for specific 12 training and experience that did involve radioactive 13 material, with the feline therapies.
14 The people that have come to us seeking 15 approval, AU status for the I-131 therapies, I mean, 16 that is around in clinics.
17 And so, those veterinarians come in 18 usually with experience, because they would have 19 gotten that somewhere else before they're setting up 20 their own vet clinic.
21 But yes, we would be reviewing their 22 hours2.546296e-4 days <br />0.00611 hours <br />3.637566e-5 weeks <br />8.371e-6 months <br />, and their experience with radioactive material 23 before we put them on the license.
24 CHAIR METTER: The other thing is that you 25 know, as far as when they get their authorized use, it 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
85 1 is going, is it going to be like our 35.390, or is it 2 going to be individual just for I-131, and then when 3 the tin comes in and all these other ones, they need 4 to get separate authorized users?
5 MEMBER SHOBER: So, to speak to that, we 6 haven't seen clinics that have more than one use. So, 7 it's either you have a vet clinic that is doing the I-8 131 therapy.
9 The clinic we have in Wisconsin that is 10 licensed for the Exubrion, doesn't do I-131. So, we 11 would, if there were a clinic that were having more 12 than one type of use, yes, we would want to see 13 experience with both products.
14 I would, personally. Not going to speak for all the states, or the NRC. But for certain, 15 16 that's, I think that would be pretty common tactic.
DR. TAPP: Yes, to follow on with that, 17 there is not regulatory training and experience 18 requirements for veterinary use.
19 It's contained in the guidance, which 20 gives it a little bit more flexibility for license 21 reviewers.
22 But they are listed individually like, 23 what they are approved for. And as I said, if they're 24 going to use a release procedure, that has to be 25 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
86 1 reviewed and tied down in a license.
2 So it's going to be reviewed by a license 3 reviewer, and they're going to ensure that the 4 training's there, that there's an RSO capabilities.
5 And that's the tie ins. There's not in 6 the regulations, but it's a license reviewer.
7 CHAIR METTER: And who would be the license 8 reviewer? Is there a specific one let's say for OSA?
9 MEMBER SHOBER: So, each state, you know, 10 would be doing that.
11 CHAIR METTER: Okay, thank you.
12 Do I have any other questions? It's a 13 very, very interesting topic and I'm glad you brought 14 it up because it's another scope that we're, I just 15 personally, I knew about hyperthyroid catd I-131, but 16 I didn't know about these other entities, and 17 treatments.
18 Yes?
19 DR. TAPP: I see Maryann has her hand 20 raised.
21 CHAIR METTER: Oh, I'm sorry. Yes, go 22 ahead.
23 MS. AYOADE: Hi, not a question, just a 24 comment for the record and for the court reporter 25 because we did lose signal, Katie, for the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
87 1 presentation.
2 I believe it was on your slide for the 3 pre-screening questionnaire. The slides are available 4 to the members of the public, and so they can look at 5 those there.
6 But I didn't know if you all were fully 7 aware that we missed about maybe 4-5 minutes of the 8 last, towards the end of your presentation.
9 But just for the record, just so that it's 10 on there and they can review the slides.
11 CHAIR METTER: Thank you very much Ms.
12 Ayoade. I didn't realize that, but thank you for that 13 very, that comment for our public members -- viewers.
14 Any other last comments or questions from 15 the committee, or the NRC staff?
16 (No audible response.)
17 CHAIR METTER: Any public members in the 18 room?
19 (No audible response.)
20 CHAIR METTER: Any public members on the 21 call?
22 (No audible response.)
23 CHAIR METTER: Okay, thank you very much 24 for a very interesting, and very comprehensive report.
25 And appreciate your looking into that.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
88 1 So at this point, that is our last 2 presentation for the morning and we're a little bit 3 early, so you have a little more time to, for lunch.
4 And, we will conclude the morning session 5 of the ACMUI and we will re-adjourn at 1:30.
6 Thank you.
7 (Whereupon, the above-entitled matter went 8 off the record at 11:52 a.m. and resumed at 1:31 p.m.)
9 CHAIR METTER: Good afternoon, and welcome 10 back to the 2023 fall meeting of the ACMUI. I'm 11 Darlene Metter, ACMUI chair and diagnostic 12 radiologist.
13 Before we start our afternoon 14 presentation, the committee needs to revote on the 15 open items that Ms. Armstead had presented today. So 16 may I have a motion regarding the open items for 17 approval by the committee?
18 MEMBER EINSTEIN: So moved.
19 CHAIR METTER: Dr. Einstein moves to 20 approve those open items. Do I have a second?
21 DR. HARVEY: I'll second.
22 CHAIR METTER: Dr. Harvey has seconded.
23 Do I have any -- all in favor, say aye.
24 (Chorus of aye.)
25 CHAIR METTER: All opposed or abstain?
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
89 1 Ms. Armstead, we have unanimous approval of the open 2 items.
3 Okay, for the first presentation for this 4 afternoon will be Mr. Davila, NRC staff, on ICRP 5 Publication 153.
6 Mr. Davila.
7 MR. EINBERG: He's going to be presenting 8 remotely.
9 MR. DAVILA: Good afternoon. I think I 10 need to be made a presenter so I can share my screen.
11 MS. ARMSTEAD: You should be able to do it 12 now. And we can see the screen and we can see you.
13 Thank you.
14 MR. DAVILA: Okay, perfect awesome.
15 Thank you so much for the introduction.
16 Good afternoon, everybody, or good morning for those 17 of you on the West Coast. As they mentioned, my name 18 is Tony Davila. I am currently the Radiation Safety 19 Officer for Tulane University.
20 However, I was fortunate enough to serve 21 on the ICRP Task Group 110, Radiological Protection in 22 Veterinary Practice under Dr. Nicole Martinez. And 23 today I'll be giving an overview of the task group's 24 publication.
25 I have no conflict of interest to declare.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
90 1 However, I do have seven pets, so do what you will 2 with that information.
3 I'd like to start by just kind of showing 4 you task group members. I'm not going to, list 5 everybody out by name. However, I do want to mention 6 Debbie Gilley, who is not pictured here but made 7 significant contributions.
8 Like I said, I'm not going to list 9 everybody. But I do just want to point out the 10 diverse background of the task group. We had health 11 physicists, medical physicists, nuclear physicist, 12 veterinary radiologists, veterinary radiation 13 oncologists, regulators, researchers, radiation 14 ecologists. So a wide range of disciplines were 15 covered on the task group.
16 So here I have the contents of both the 17 publication and of my presentation today. I'm 18 essentially going to be giving everybody a guided tour 19 through the document, highlighting some of the most 20 important ideas.
21 So first even before the introduction, we 22 have a section called why this publication. And 23 essentially the purpose was to provide a summary of 24 the motivation for the explicit considerations of 25 radiological protection in veterinary practice.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
91 1 Veterinary practice has changed 2 considerably over the years, and along with it the 3 types and number of applications of ionizing radiation 4 have increased. And because of this evolution, the 5 radiological risks have also increased as a result.
6 And these risks can affect both the animal 7 being examined or treated, as well as the humans 8 involved in the procedures, whether they're veterinary 9 professionals, or laypersons, owners who may be 10 helping out.
11 The objective of this publication is not 12 to discourage veterinarians or animal user from using 13 radiation. However, we just want to be sure that it's 14 done safely.
15 Also, why now? Well, veterinarians were some of the first people to understand the importance 16 of ionizing radiation. Pictured here is a dog who was 17 being operated upon back in 1918 with the use of 18 19 radiology.
And in fact, the chair of the first and 20 second congress, a radiological congress, was a 21 veterinarian. He was a close friend of William 22 Roentgen, and he's actually the only veterinarian 23 to have ever held the honor of chair.
24 25 And early on, most applications it was 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
92 1 pretty much strictly plain film radiography. So by 2 just applying a few simple rules, it was easy to 3 sufficiently limit the risk to staff, the animals, and 4 even the owners and handlers. And so it was believed 5 that, you know, the animal's not really any real risk 6 from just plain film radiography.
7 However, over the past several years, 8 applications and the availability of those 9 applications has grown and diversified considerably.
10 Factors such as digitalization, the increase in 11 veterinary-specific equipment and also second-hand 12 equipment, and even social factors have all played a 13 role in this growth.
14 Kind of honing in on the social factor 15 here, nowadays a lot of animals are considered part of 16 the family. You know, we recognize the human-animal 17 bond and the human -- the different benefits we get 18 from the human-animal interactions. Just to name a 19 few, things like, you know, stress relief, joy, 20 empathy. You know, there's lots of benefits we derive 21 from our relationship with animals.
22 And so we want to give them the best care 23 possible. And if they're not necessarily a pet, you 24 know, it could be a working animal and that would mean 25 that they're part of a family's livelihood. Or maybe 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
93 1 it's an endangered animal or an exotic species, and 2 it's important for conservation effort.
3 In all of these cases, the animals deserve 4 the best care and their owners want the best care for 5 them. And so that often entails some sort of 6 radiological procedure.
7 And we can see this in the fact that, you 8 know, a lot of states have some sort of law against, 9 you know, animal cruelty. And we can even see this in 10 our research ethos, right. We want to protect lab 11 animals. In fact, any place that uses animals for 12 research must have a institutional animal care and use 13 committee, right.
14 And there's the three r's of animal 15 research, you know, replacement, reduction, and 16 refinement. And so, you know, it's evident throughout 17 society that animals are important. And you know, 18 monetary value can further stimulate this interest in 19 an animal's welfare.
20 Again, you know, an animal research 21 subject is -- can be very important. But also going 22 back to the pet side of things or the family life, pet 23 insurance has become more commonplace. And so these 24 procedures are becoming increasingly affordable, and 25 some pet insurances even require it as part of the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
94 1 kind of eligibility screening process.
2 But going even beyond just the animals, 3 you know, there's an increasing awareness of the 4 interconnectedness of the health between human health, 5 animal health, and environmental health and welfare.
6 You may have heard of this as the CDC's One Health 7 approach. Sometimes it also goes by the One Welfare 8 approach.
9 And basically by optimizing, you know, the 10 environment and animal health, we can also better 11 human health as well. It's important to recognize, 12 you know, the interrelationship between the human, 13 animal, and environment.
14 So getting into the introduction, 15 basically we provide our objective and the scope of 16 the publication, along with elaborating on some of the 17 historical background and modern motivation. As I 18 mentioned with the advances in technology and the 19 availability of said technology, there's a need to 20 fully describe the radiological protection challenges 21 in veterinary practice and how we can manage them by 22 applying the ICRP's framework.
23 And the objective of the publication isn't 24 to provide direct practice-oriented advice, but rather 25 just kind of give an initial set of recommendations 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
95 1 and observations.
2 You know, the priority of radiological 3 protection in veterinary medicine is still of the 4 humans involved, however, the animal patient's 5 protection is now also explicitly being considered.
6 As well as protection of the environment from any 7 veterinary nuclear medicine applications.
8 And this publication is intended for a 9 wide-ranging audience. So radiological protection 10 professionals, veterinary staff, students and anybody 11 who would be providing education and training to those 12 individuals. And as well as interested members of the 13 public.
14 And you know, we aren't the only ones who 15 have noticed this need. Several authorities have 16 either updated or released some sort of guidance in 17 regards to radiation safety in veterinary medicine.
18 Probably the two most impactful to us or meaningful 19 here in the States would be the NCRP's Report 148, 20 Radiation Protection Veterinary Medicine.
21 And they came to a similar conclusion.
22 The reasons for using radiation in veterinary medicine 23 are to either obtain optimum diagnostic information, 24 or to achieve a specific therapeutic effect while 25 maintaining the radiation dose to the radiological 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
96 1 personnel and the general public as low as reasonably 2 achievable. In other words, the ALARA principle.
3 Similarly, it is also important to avoid all 4 unnecessary irradiation of the animal patient.
5 And so in the next section, kind of 6 getting into the meat of the publication, it is basic 7 concepts of radiological protection. As I mentioned, 8 this is intended for a wide-ranging audience, so we do 9 review dosimetric quantities, such as absorbed dose, 10 equivalent dose, effective dose, activity. We 11 discussed the deterministic and stochastic effects.
12 And it also covers the ICRP's framework 13 for radiological protection, including things like the 14 different exposure of situations and different 15 exposure categories, along with the principles of 16 protection.
17 So I want to talk a little bit about the, 18 you know, biological basis for radiological protection 19 in veterinary medicine. And we know it's really the 20 same in, as in human medicine, right. The things that 21 we expect to see are, you know, deterministic effects 22 and stochastic effects.
23 In veterinary medicine, there tends to be 24 this misconception with regards to the deterministic 25 effects that radiation doses in veterinary medicine 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
97 1 are not high enough to produce deterministic effects.
2 Now, this generally comes from people who I guess are 3 still operating under the assumption that most -- that 4 you know, it's mainly plain film radiography.
5 However, as I've mentioned, you know, 6 things have changed. High dose radiological 7 procedures are being increasingly adopted. Here I 8 have pictured a dog that exhibited leukotrichia three 9 months after receiving IMRT for a sino-nasal 10 neoplasia.
11 Now you know, this is a trivial 12 deterministic effect, the change in the fur color, you 13 know, doesn't affect the dog's health. However, the 14 effects aren't always so trivial, you know. They do, 15 they can receive things like skin burns and you know, 16 deterministic effects that you would expect in human 17 medicine.
18 And then when it comes to stochastic 19 effects, there's a wide-held misconception that 20 animals don't live long enough to get radiation-21 induced cancer. However, we've known as early as the 22 1970s that this is not true. Cancer patterns in 23 mammals are similar and relative to lifespan. So 24 animals with shorter lifespans have shorter latency 25 periods for cancer onset.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
98 1 And there have been a large number of 2 studies showing this. And in fact there has been a 3 study that showed dogs who have osteosarcoma five 4 years post-treatment of a mast cell tumor following 5 radiotherapy.
6 And it is important to note that radiation 7 sensitivity is known to differ among species. And of 8 interest in veterinary practice is that dogs as a 9 species are particularly cancer-prone. And in fact 10 canine cancer prevention literature explicitly states 11 that, you know, only to expose dogs to radiation when 12 the benefits clearly outweighed the risks. And so you 13 know, justification is important here.
14 The next section, Ethics and Values, 15 reviews the ethical basis of the system of 16 radiological protections with connections to 17 veterinary and environmental ethics.
18 The system of radiological protection is 19 rooted and informed by the three pillars, science, 20 ethics, and experience. And you know, ethics kind of 21 focuses on being able to distinguish right from wrong.
22 And so I'll discuss briefly some of the 23 ethical theories that kind of underpin the ICRP's 24 system of radiological protection. And those are 25 utilitarianism, the ontology, and virtue ethics.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
99 1 Basically, you know, utilitarianism seeks 2 to maximize good for the greatest number of people.
3 It's the furthering of the collective interest.
4 Actions are preferable, based on, you know, their 5 outcomes. And this falls in line with optimization.
6 On the ontology, generally that's a 7 respect for individuals and their rights. There's 8 like a set of obligations or rules that decides what 9 moral or just. And this can kind of be seen in 10 application of dose limits.
11 And then lastly we have virtue ethics, 12 which is the promotion of integrity, discernment, and 13 wisdom. And basically a moral or virtuous life is 14 based upon some concept of human nature. And this can 15 be seen in justification, right. Do good, do no harm.
16 This all builds off of the framework that 17 ICRP kind of laid down in Publication 138. But from 18 these ethical theories, the ICRP identified five core 19 values, along with a few procedural values to kind of 20 aid in the implementation of them. And that's 21 beneficence, non-malfeasance, prudence, justice, and 22 dignity, those are the core ones.
23 And then accountability, transparency, and 24 inclusiveness. And these aren't the only values, but 25 these are just some of the main ones here.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
100 1 And so it's important to note that ethics 2 not only encompasses what should be done, but also how 3 it should be done. And so ethical risk evaluation and 4 management, you know, goes, considers factors that go 5 beyond just the magnitude of the radiation exposure 6 and the cost associated with reducing that exposure.
7 And so one of the aims of this section was 8 to make ethical ties between the values of 9 radiological protection and ethical values in 10 veterinary practice. And so here I've kind of 11 outlined a few, such as animal welfare, solidarity, 12 sustainable development, reverence for life, 13 stewardship, respect for autonomy, and empathy.
14 And they all correlate well with one of 15 the core or procedural values. And now this shouldn't 16 be taken as either the only, you know, this is a 17 single one-to-one relationship. These are all 18 interrelated.
19 So the next section is unique aspects of 20 veterinary practice where we discuss the similarities 21 and differences between human medicine and veterinary 22 medicine, kind of highlighting some of the unique 23 veterinary challenges.
24 Veterinary applications of ionizing 25 radiation and their protection challenges are to a 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
101 1 large extent similar to situations in human medicine.
2 So we don't necessarily need to reinvent the wheel.
3 Justification, optimization, and application of dose 4 limits are still our friends.
5 However, radiological protection 6 challenges specific to veterinary medicine typically 7 arise from unique operational environments that are 8 required when dealing with animals, and also a 9 different combination of personnel and members of the 10 public who could be involved.
11 And some of the issues I'm about to 12 discuss is not meant to be seen as exhaustive, merely 13 illustrative. Right, so as I kind of just touched 14 upon, one of the unique aspects in veterinary medicine 15 is the environment that they sometimes have to work 16 in. They're not always specifically designed for a 17 radiological procedure.
18 Sometimes veterinarians have to go out 19 into the field, do a rad out on the farm. Or maybe if 20 it's a, you know, if you're on a conservation and 21 working with exotic animals.
22 The next one is equipment, right. So 23 there's a prevalence of second-hand equipment from 24 human medicine, and there's also dedicated veterinary 25 equipment that typically falls under industrial 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
102 1 standards because it's not recognized as a human 2 medical device.
3 And while you know, we welcome dedicated-4 for-purpose equipment, it's important that it meets 5 the appropriate radiation standards. And if it's 6 regulated as industrial equipment rather than medical, 7 it may not always comply with the imaging quality or 8 radiation protection standards.
9 And then what I have here is competence.
10 Because there is a lot of difference worldwide, but 11 even just within the country on the basics and 12 specific education and training requirements that are 13 needed. Right, radiological protection isn't 14 necessarily covered in the veterinary curriculum. If 15 they're lucky, they'll maybe get some of it in their 16 radiology class.
17 A lot of times these procedures can have 18 a lack of specialized staff involved, right. A 19 veterinarian doesn't have to be a veterinary 20 radiologist to perform or even interpret a radiograph.
21 And similarly, the people involved in the 22 procedure may not be a veterinary x-ray tech, they may 23 simply be a veterinary nurse. And there's not always 24 the involvement of a medical or a health physicist as 25 well.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
103 1 And another thing is the uniqueness of the 2 regulations and guidelines. There's lack of things 3 like appropriateness criteria or diagnostic reference 4 levels to aid the practitioners. Very little 5 regulatory harmonization, not only worldwide, but I 6 mean even just here within our states, right. You 7 pick any two states and they could have very different 8 ways of handling this.
9 In fact I -- there's only a few states off 10 the top of my head that come to mind that have 11 explicit veterinary regulations.
12 Additionally, in veterinary medicine there 13 are no guards against self-referral or self-14 presentation. What I mean by self-referral is that 15 the same veterinarian basically refers the dog for a 16 radiograph and then he can perform that same 17 radiograph and even interpret it himself.
18 Self-presentation in a veterinary medicine 19 case would be a client, the owner coming to a vet and 20 saying I want my dog to have a radiograph. And 21 there's not a lot of methods or controls in place to 22 prevent those.
23 And of course in veterinary medicine the 24 patients come in all shapes and sizes. You could have 25 a leopard gecko that needs to get a radiograph done.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
104 1 Or maybe you work at a zoo and the elephant needs a 2 rad of its tusk.
3 And as I've mentioned, the applications 4 are becoming increasingly high dose. Pictured here in 5 the center is a cat receiving strontium-90 6 brachytherapy. And of course we have pictures of dogs 7 here that are receiving external beam therapy and 8 other types of applications.
9 So how do we apply the system of 10 radiological protection in veterinary practice?
11 That's kind of the main theme behind Section 6, where 12 we kind of discuss justification, optimization, and 13 application of dose limits in the context of 14 veterinary medicine.
15 So when it comes to justification, you 16 know, obviously we want proper justification of 17 radiological procedures. It's necessary in order to 18 avoid the unnecessary exposure of people, animals, and 19 the environment.
20 And like I said, we don't need to reinvent 21 the wheel. The three levels of justification that we 22 have for human medicine can be adopted. And so we 23 have a recommendation for that here. So at level one, 24 proper use of radiation in medicine is accepted. You 25 would just have to change that to proper use of 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
105 1 radiation in veterinary medicine is accepted.
2 Now, generally for medicine, level one 3 justification is taken as a given. Level two, you 4 know, specific procedures achieves a specific 5 objective. Again, just a slight change in the 6 language from exposed individual to exposed animals.
7 And then level three, the justification of 8 a particular procedure. Again, instead of --
9 (Off-record comments.)
10 MR. DAVILA: Instead of doing more good 11 than harm to the individual patients it's to the 12 individual animal patient.
13 Talking about justification a little bit 14 more specifically, for medical procedures it is 15 important that the veterinary practitioner has 16 received appropriate training and education so they 17 can make that justification.
18 And one thing that we think is warranted 19 would be the development of decision support tools to 20 help the clinicians with justifying procedures. And 21 of course it's important that equipment is properly 22 assessed for radiological protection.
23 And so when it comes to medical 24 procedures, level three justification is really 25 important, that that specific procedure should be 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
106 1 answering a specific clinical question.
2 But one thing that is unique in veterinary 3 medicine is that we have non-medically indicated 4 investigations. So they do perform imaging of 5 asymptomatic animals in veterinary medicine, usually 6 as part of screening programs. So hip or elbow 7 dysplasia screening in dogs, but also radiographic 8 exams of horses are another example.
9 And so for non-medically indicated 10 investigations, it needs to be consistent with current 11 clinical evidence. And so in this sense, level two 12 justification is really important. There needs to be 13 thorough clinical evidence and a demonstrable 14 relationship between the imaging findings and this 15 goal of -- and the goal of the screening.
16 So for example, talking about pre-sale 17 radiographic exams of horses, there should be a 18 demonstrable relationship between the findings of that 19 imaging and their performance later on.
20 When it comes to optimization, 21 optimization is always aimed at achieving the best 22 levels of protection under the prevailing 23 circumstances through an ongoing iterative process.
24 And so, and this is usually done in two steps. You 25 know, you want the appropriate design and construction 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
107 1 of the installation, along with the careful selection 2 of the equipment.
3 But also in the day-to-day strategies.
4 And so that includes things like adequate education 5 and training of staff. Clarity of roles and 6 positions, routine performance tests of equipment.
7 And it all comes down to the safety culture at the 8 organizational level.
9 As I've mentioned, the priority is always 10 going to be the safety of the humans involved. But as 11 human medicine, it's important to not confuse 12 optimization with dose minimization.
13 If you focus too much on dose reduction, 14 you could impede the diagnostic or therapeutic quality 15 of the procedure. And then you, you know, you're 16 providing suboptimal care or you may even have to 17 repeat a procedure, which would not be ALARA.
18 And so factors to consider are going to be 19 other occupational hazards. Radiation is just one 20 hazard that veterinarians have to deal with. Right, 21 as I'm sure you can imagine, if you need to do a 22 radiograph of a live horse, just being around a live 23 horse itself is an occupational hazard. They could 24 very easily injure somebody.
25 And then of course the animal's clinical 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
108 1 condition needs to be considered. The use of sedation 2 and anesthesia is something that's generally 3 recommended in veterinary practice. However, 4 depending on the condition of the animal, that may not 5 be the best course of action.
6 When it comes to application of dose 7 limits, I want to talk about a topic that's of 8 interest to a lot of licensees. And that's this carer 9 concept. And so in human medicine a carer is an 10 individual who may be exposed to radiation as a 11 volunteer helper providing support or care for a 12 patient.
13 And this is, you know, this is something 14 that's outside of their job. It's not their 15 occupation to help this patient. So it's typically a 16 loved one, a family member, a friend.
17 But as far as the law goes, veterinary 18 medicine animal patients are not legally recognized as 19 patients. So the carer designation is not applicable 20 to them. In fact, as Ms. Tapp mentioned in her 21 presentation earlier, all of 10 CFR 35 does not apply 22 to veterinary medicine.
23 However, we believe that the concepts of 24 patients and carer ideally should be tailored to be 25 applicable within reason in the veterinary practice.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
109 1 And obviously the issues it kind of most impacts would 2 be things like hospital stays and release criteria.
3 And we believe that further studies are warranted, 4 looking specifically at doses to owners and handlers 5 from veterinary nuclear medicine procedures.
6 And if an owner or a handler is deemed, 7 you know, if the exposure of an owner is deemed 8 justified based on the prevailing circumstances, then 9 dose constraints should be used, potentially set above 10 the public dose limit, like the -- like in the case of 11 a carer to guide the optimization in a practical and 12 proportionate way.
13 So recall that we have a few different 14 exposure categories and exposure situations. On the 15 exposure category side, an exposure could either be 16 occupational, something you get in the line of your 17 work. It could be medical. Or if it's not either of 18 those, it could be public.
19 And an exposure situation could either be 20 planned, meaning that you have the ability to prepare 21 for the exposure. Or it can be existing, meaning it's 22 already there and a decision needs to be made on how 23 to control it. Or an emergency situation where it's 24 unexpected.
25 But so where would animals fall into this?
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
110 1 Animal patients don't really fit neatly into any of 2 these categories, because as I've already mentioned, 3 they -- it's not considered medical exposure. But 4 veterinary applications are to a large extent 5 comparable to the human medical applications. The 6 only difference is that in one the subject is a human, 7 and the other the subject is an animal.
8 In both cases, you have occupational and 9 public exposures occurring, but there's only medical 10 exposure in one of those situations. And so this 11 could lead to a bit of conflict because from a 12 regulatory perspective, essentially veterinary 13 practices can -- is considered comparable to an 14 industrial application.
15 And this can lead to an approach where the 16 animal is considered an object without consideration 17 that it is indeed a sentient living creature. Or you 18 know, neglecting unique, the necessary aspects, such 19 as the safety of patients under anesthesia.
20 And so the Commission does now specify 21 that the system include protection of the individual 22 animal in special circumstances. And so animal 23 patients undergoing a veterinary procedure is one such 24 case. Others include things like animal research 25 subjects and pets and domestic animals in a 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
111 1 radiological or nuclear emergency situation.
2 Then Section 7 is a summary of the 3 recommendations and considerations. Basically we just 4 kind of list the key takeaways. And this, as I've 5 mentioned, you know, the objective of this publication 6 was to provide an initial set of relevant 7 observations, considerations, and general 8 recommendations to a wide-ranging audience.
9 The radiological protection challenges 10 specific to veterinary medicine come from a 11 combination of different personnel involved, both 12 professionals and members of the public. And also the 13 different operational environments that may be 14 necessary when dealing with animals.
15 And as I've mentioned, the priority is 16 always of the people involved. However, the exposure 17 of the animal does deserve explicit attention. And in 18 general, you know, if you're able to reduce the 19 exposure to the animal patient, that will in turn 20 reduce exposure to staff as well, generally speaking.
21 And then veterinary practice, the core 22 and procedural ethical values of the system of 23 radiological protection are elaborated on. And we 24 kind of take the values further and connect them to 25 veterinary values.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
112 1 And as I've mentioned a few times, 2 veterinary applications are comparable to the human 3 applications. And so it could benefit from similar 4 approaches, right. We could still use justification, 5 optimization, and dose limits, of course always taking 6 into account all the different factors, such as 7 economics, societal and environmental.
8 Then we did have a couple of annex 9 sections. We have the roles and responsibilities 10 section where we discuss the individual and 11 organizational functions and the anticipated 12 obligations.
13 As you all know, radiological protection 14 requires commitment from all parties involved, right.
15 It can't just be the RSO or even just the doctor.
16 Everybody involved has to commit.
17 Just kind of quickly -- is kind of 18 responsible for like evaluating and assessing the 19 radiological and epidemiological studies. ICRP then 20 kind of takes that scientific data, kind of applies 21 ethics and values judgments to kind of issue initial 22 recommendations, and then like the IAEA. We will take 23 those recommendations to set -- to set regulations 24 that then individual countries can adopt.
25 But more specifically in terms of the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
113 1 veterinary practice, there are a few rules and 2 responsibilities that we do highlight. A rule is the 3 individual or organization's position or function and 4 the responsibility is the anticipated obligation, 5 duty, or commitment associated with that rule.
6 And so the first role is that of the 7 hospital or practice. And so some of the things that 8 they're responsible for is making sure that their 9 installation is appropriate and that the location is 10 fit, the location and all the equipment is fit for 11 purpose. And of course they're responsible for 12 maintaining the quality assurance program.
13 We have the role of radiological 14 practitioner, who will generally be a veterinarian.
15 They're responsible for the appropriateness of the 16 procedure and how the procedure is performed. And so 17 they must be responsible for informing and instructing 18 any non-staff members who may be helping out.
19 And then we have training programs whose 20 responsibility is to provide the adequate education 21 and training. And they should be explicitly 22 addressing radiological protection in those training 23 programs.
24 And then the last section we have is 25 ethical issues associated with the protection of 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
114 1 animals and the environment, where we elaborate on 2 humanity's relationship with and responsibility to 3 animals and the environment. Because you know, 4 humans, we share our environment with many other life 5 forms. We don't live in a vacuum.
6 And animals can serve a lot of different 7 purposes, whether a companion, providing comfort or 8 entertainment. They could be livestock providing 9 labor or food, other commodities, or even workers from 10 non-food service operations like therapy or military 11 operations. And even research subjects.
12 So some of the specific ethical issues in 13 veterinary practice are animal ethics, or what's also 14 known as the animal problem, a discussion going back 15 to the days of Aristotle, basically. What is the 16 difference morally speaking between humans and 17 animals?
18 I don't have the answer to that. But if 19 there is no difference, how do we justify treating 20 animals the way that we do? And if there is a 21 difference, what is it about that difference that 22 allows us to treat animals the way that we do?
23 And then of course animal welfare is 24 always a big topic, how an individual animal's life 25 could be improved or impoverished through our actions 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
115 1 or inactions and what does that mean for what we're 2 responsible for.
3 And then lastly I want to touch on what I 4 call the three-party problem in veterinary medicine.
5 In human medicine you have the patient and the doctor, 6 and generally they both agree pretty well on the best 7 course of action for the patient. However, in 8 veterinary medicine you have the veterinarian, the 9 animal patient, and the animal's owner or guardian.
10 And so a lot of things -- or one of the 11 main ethical dilemmas of the veterinarian is who 12 should their primary responsibility be to? Is it to 13 the animal patient, or is it to the animal owner?
14 Again, I don't have an answer for this, 15 but it's just something to consider, right, because in 16 many places the owner has property rights over the 17 animals. And so the owner is free to do essentially 18 what they want with their pet.
19 And, right, an ethical vet could maybe 20 very well refuse to perform a certain procedure if 21 they don't think it's in the animal's best interest.
22 However, that owner and guardian could then just go to 23 a practice that would be willing to accept their money 24 for such a procedure.
25 But the bottom line is this, that the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
116 1 Commission hopes that highlighting radiological 2 protection concerns and related knowledge gaps will 3 inspire additional research and development related to 4 the evidence-based use of ionizing radiation in 5 veterinary practice in support of the justification 6 process.
7 Dedicated facilities and equipment, 8 improved understanding of the radiosensitivity of 9 different types of animals, and practice guidelines in 10 support of exposure management and other relevant 11 areas to promote health and safety of personnel, the 12 general public, and the environment, while further 13 improving the quality of care for the patients and 14 healthy animals submitted to radiological procedures.
15 And I'll leave you with some future 16 considerations. So that would be things like how to 17 decontaminate livestock following an emergency. What 18 if instead of the animal being radioactive after a 19 procedure, what if the animal is an emotional support 20 or a service animal and their owner received some sort 21 of nuclear medicine procedure? What's the appropriate 22 course of action then?
23 And of course there's a wide range of 24 working animals, right, search and rescue or military 25 or police. And of course research animals are another 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
117 1 group of animals that deserve special consideration.
2 And of course for all of this, we need more dosimetric 3 data in order to be able to make the best decision 4 possible.
5 And so I thank all you guys for your 6 attention. I do have a QR code here that you can scan 7 to access Publication 153. And I also have my contact 8 here as well if you ever want to reach out with any 9 questions. And I believe we have some time for Q&A?
10 CHAIR METTER: Well, thank you, Mr.
11 Davila, for that very interesting and complete and 12 quite unique presentation on the aspects of radiologic 13 protection in veterinary medicine.
14 I do have a question regarding human 15 exposure. And I believe you had mentioned that the 16 priority of radiologic protection in veterinary 17 practice is that of the humans involved. And so I was 18 wondering are the -- is the veterinarian and the 19 veterinary technologist badged, and who checks their 20 badges?
21 MR. DAVILA: So this will be up to each 22 licensee. But generally you do see badging in place.
23 CHAIR METTER: Okay, thank you. Dr.
24 Harvey has a question.
25 DR. HARVEY: Mr. Davila, I might have 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
118 1 missed it, but is there a recommended dose limit for 2 carers, like 5 millisieverts, or something along that 3 lines? Or is it just up to the licensee to determine?
4 MR. DAVILA: Well, so again, in veterinary 5 medicine the concept of carer does not apply. So as 6 Ms. Tapp mentioned earlier, they have to follow the 7 public dose limit. However, our recommendation is 8 that the concept of carer be tailored to veterinary 9 medicine with a dose limit that is higher than the 10 public dose limit.
11 MEMBER HARVEY: Maybe I misunderstood. I 12 thought that the carers could have a higher dose limit 13 than members of the public. Maybe I misunderstood.
14 CHAIR METTER: I think Dr. Tapp -- Oh, I'm 15 sorry, Dr. Tapp does have something to say. I'm 16 sorry, I keep interrupting you.
17 MR. DAVILA: No, that's okay. I was just 18 going to say yeah, the concept of carer does not apply 19 in veterinary medicine.
20 DR. TAPP: Does not apply right now.
21 CHAIR METTER: Sorry, thank you again.
22 Are there -- yes? Mr. Green and then Ms. Martin.
23 MEMBER GREEN: Mr. Davila, personally I'm 24 more familiar with human use of radiopharmaceuticals.
25 Do you have any idea as to the number of nuclear 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
119 1 medicine licensed veterinary practices in the United 2 States?
3 MR. DAVILA: I don't have that number off 4 the top of my head. However, I do know that there is 5 going to be upcoming paper in the HBJ that kind of has 6 some of that information. A colleague of mine 7 performed a survey of several licensees, and so she is 8 working on publishing that information.
9 MEMBER GREEN: Thank you.
10 CHAIR METTER: Ms. Martin?
11 MEMBER MARTIN: So I'm still confused. I 12 heard a couple of things, that you cannot declare a 13 workers as -- a carer as an occupational dose limit, 14 and yet I'm hearing that you're not requiring badges 15 to be worn by these people.
16 So how -- what is the recommendation as 17 far as tracking and knowing what dose the carers are 18 receiving? If you don't require badges on them, how 19 do you know if they're getting more than the public 20 limit?
21 MR. DAVILA: So again, right now the 22 concept of carer doesn't apply in veterinary medicine.
23 So there is no tracking of their doses because 24 licensees are limiting their dose to the public dose 25 limit.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
120 1 In terms of badging staff, you know, that 2 just follows the, you know, you're required to badge 3 staff if they're likely to get 10% of the annual 4 occupational limit.
5 MEMBER MARTIN: But do you know if you 6 have documentation that that's being done? Do you 7 have enough data to show that that's being done in 8 these facilities?
9 MR. DAVILA: Yes, there is -- there are 10 publications out there about the occupational doses 11 that veterinary staff receive.
12 CHAIR METTER: I believe Ms. Shober has a 13 comment as an OAS representative.
14 MEMBER SHOBER: So all of these sites that 15 would be doing nuclear medicine would have a 16 radioactive materials license. When they apply for a 17 radioactive materials license, dosimetry is one of the 18 items on the application form. And they -- the ones 19 that I've seen all commit to badge their 20 occupationally exposed workers.
21 So and those sites would be inspected at 22 a regular inspection frequency. So there is 23 regulatory oversight for the dose monitoring aspects 24 of that work.
25 CHAIR METTER: Thank you. I'm sorry, who 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
121 1 has a comment? Oh, Zoubir, sorry I didn't see you.
2 (Simultaneous speaking.)
3 CHAIR METTER: -- comment or question?
4 MEMBER OUHIB: Thank you. I'm just 5 curious, how are mishaps and medical errors or medical 6 events, whatever we want to call them, handled at the 7 level of the veterinarian society?
8 MR. DAVILA: So that's actually a great 9 question. There is actually a greater need to make 10 veterinary licensees aware of how and where to report 11 medical events and accidents. We do believe that 12 those are probably -- actually not probably, those are 13 being under-reported.
14 MEMBER OUHIB: Yeah, if nothing else it 15 will be lesson learned for others.
16 MR. DAVILA: Correct.
17 MEMBER OUHIB: Thank you.
18 CHAIR METTER: Thank you. Are there any 19 other questions from the committee? Any questions 20 from the NRC staff? Any questions from the public 21 members in the room?
22 MS. PICCONE: Will the slides be made 23 available?
24 CHAIR METTER: Mr. Davila, did you hear 25 that, will the slides be made available?
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
122 1 MR. DAVILA: Yeah, I can make them 2 available.
3 CHAIR METTER: Could you put it, I guess 4 on the ACMUI website?
5 MR. DAVILA: Of course.
6 CHAIR METTER: Okay, I'm sorry. Ms.
7 Armstead, what did you say?
8 MS. ARMSTEAD: I will do that.
9 CHAIR METTER: Thank you. Okay, are there 10 any -- yes, Dr. Tapp?
11 DR. TAPP: Just for the attendees on the 12 line, the slides will be made available for all 13 presentations at the end of the meeting online.
14 CHAIR METTER: Thank you. Are there any 15 questions from the public? Is that a question from 16 the public? I can't tell. Go ahead --
17 MR. EINBERG: If there's any questions 18 from the public, please raise your hand. I don't see 19 any.
20 CHAIR METTER: Okay, looks like there are 21 no questions from the public.
22 Well, Mr. Davila, thank you for, again, 23 for a very interesting, comprehensive, and quite 24 unique presentation. It makes us more aware and 25 appreciate our pets and animals. And congratulations 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
123 1 to -- you said you had seven pets?
2 MR. DAVILA: Yes, I do.
3 CHAIR METTER: Great, wonderful, I have 4 four. But anyway, it's -- plus our cows. But anyway, 5 I appreciate it.
6 MR. DAVILA: Yeah, thank you so much.
7 Thank you all for having me and giving me this 8 opportunity to speak to you guys. Greatly appreciate 9 it.
10 CHAIR METTER: Thank you very much. A 11 very unique perspective and actually an eye-opener for 12 sure.
13 Okay, our next presenter is going to be 14 Mr. Whited, who'll be NRC staff talking about the 15 financial assurance for disposition of Category I and 16 II byproduct material in radioactive sealed sources.
17 Mr. Whited.
18 MR. WHITED: Thank you very much, can you 19 hear me?
20 CHAIR METTER: Yes, we can.
21 MR. WHITED: Okay. I will share my screen 22 hopefully and pull some slides up. And can you see 23 the slides now?
24 CHAIR METTER: Yes, we can.
25 MR. WHITED: Great.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
124 1 CHAIR METTER: Yes, we can.
2 MR. WHITED: Okay, wonderful.
3 Good afternoon, everyone. My name is Ryan 4 Whited, I am a Senior Project Manager in the Low-Level 5 Waste and Projects Branch of the Office of Nuclear 6 Material Safety and Safeguards.
7 I'm going to provide a brief presentation 8 today on a rulemaking effort that's currently under 9 way regarding financial assurance for the disposition 10 of Category I, II, and III sealed radioactive sources.
11 A little background first. NRC's 12 requirements for byproduct material financial 13 assurance are contained in 10 CFR 30.35, which is 14 entitled Financial Assurance and Recordkeeping for 15 Decommissioning.
16 However, the threshold for providing 17 financial assurance does not currently apply to a 18 majority of radioactive sealed sources, including many 19 Category I and II sources. And so for many licensees 20 that had resources, there is no requirement for 21 decommissioning or end-of-life financial planning.
22 However, licensees are still responsible 23 for providing safe and secure end-of-life management 24 for these sources. And the associated financial 25 burden may be significant if it's not properly 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
125 1 considered in advance.
2 And this can include costs related to its 3 kind of storage when the sources become disused, to 4 packaging, transportation, and ultimately the 5 selective disposition option, which could be disposal 6 in a low-level waste site. It could be returned to a 7 supplier for reuse or recycling.
8 So this effort started back in the 2015-16 9 timeframe. In 2016 the NRC staff conducted a scoping 10 study to determine if additional financial assurance 11 requirements were needed for some radioactive 12 byproduct material, in particular sealed sources.
13 That scoping study is documented in a SECY paper, 14 SECY-16-0046.
15 And because that study led us to think 16 about rulemaking, we then followed that with a 17 rulemaking plan, which is SECY-16-0115, which was 18 submitted in October of 2016. And both of those 19 papers are publicly available on the NRC website.
20 And so based on the information that was 21 collected and analyzed in these two SECY papers, the 22 staff recommended rulemaking to expand the financial 23 assurance requirements in 10 CFR 30.35 to include all 24 byproduct material Category I and II sealed sources 25 that are tracked in the national source tracking 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
126 1 system.
2 We focused on Category I and II sources 3 because they have the highest risk significance and 4 they're generally the most likely sealed sources to 5 pose disposition challenges.
6 So in 2021, we did get Commission 7 direction through an SRM. And in that SRM the 8 Commission directed the staff to proceed in expanding 9 requirements in 30.35 to require financial assurance 10 for Category I and II byproduct material sources.
11 They provided some additional direction in 12 terms of how we go about doing that and directing us 13 to carefully explore the options to mitigate potential 14 adverse impacts on existing and future licensees, 15 particularly with medical users and others that 16 benefit from the use of these radioactive materials.
17 They directed us to also look at Category 18 III sources to see if financial assurance needs to be 19 extended to those as well. And to make sure that we 20 use a risk-informed basis for doing this that 21 considers factors such as overall risk and the total 22 cost of disposal.
23 I wanted to talk a little bit about the 24 types of sources this rulemaking's intended to 25 address. So the chart you see shows the distribution 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
127 1 of radionuclides in the National Source Tracking 2 System. And you can see that more than 91% of the 3 tracked Category I and II sources are cobalt-60.
4 And this is because cobalt-60 is used in 5 devices that contain a lot of individual sources, such 6 as large panoramic irradiators and Gamma Knives.
7 About 4% of the sources are irridium-192, and another 8 almost 4% are cesium-137.
9 However, NRC's financial assurance 10 requirements don't apply to radionuclides with half-11 lives below 120 days. And that includes irridium-192.
12 We don't plan to change that in this rulemaking. And 13 so because of that our focus is really on cobalt-60, 14 cesium-137, and americium-241.
15 However, it's important to understand that 16 the NSTS tracks sources and not devices. And so if, 17 you know, if it's -- with a panoramic irradiator with 18 500 sources, each one of those sources is going to be 19 listed individually in the NSTS.
20 And what we found in looking at this issue 21 is you really have to make the jump from what sources 22 a licensees has to what devices they have. Because 23 the kind of device is really going to drive the 24 disposition options that are available and the 25 associated cost.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
128 1 And so where we're at right now on this 2 effort, we're in the first stage of rulemaking, and 3 that is the development of the regulatory basis. We 4 established a working group that includes 5 representatives from the NRC regions and the 6 organization of agreement states.
7 That working group has been coordinating 8 quite a bit with the Department of Energy's National 9 Nuclear Security Administration, and also the 10 Conference of Radiation Control Program Directors to 11 understand costs that are associated with NNSA source 12 recovery efforts.
13 NNSA operates what's called the Offsite 14 Source Recovery Program, which deals with the higher 15 activity, Category I and some Category II sources.
16 And they also fund CRCPD's source collection and 17 threat reduction program, or SCATR Program, which 18 deals with the slightly lower activity sources that 19 generally have a commercial disposal pathway.
20 We've also conducted outreach to certain 21 stakeholders, including low-level waste disposal 22 facilities that can accept some of these sources, low-23 level waste brokers, some sealed source device 24 manufacturers and distributors. And the purpose of 25 these meetings has been to help the working group 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
129 1 understand and assess various categories of devices to 2 understand the disposition pathways and the associated 3 costs.
4 The group's currently focused on 5 identifying and analyzing potential regulatory options 6 for the rulemaking, such as financial assurance based 7 on what type of device that a licensee has, and 8 possible changes to requirements for developing 9 decommissioning funding plans.
10 Typically a decommissioning funding plan 11 is a case-by-case assessment. Given the licensee and 12 the facility they have and all of the devices they 13 have, what is their plan when decommissioning comes 14 around and what are they going to do with each of 15 those sources in terms of their disposition.
16 And so we are looking at who's currently 17 required to do a DFP and do we need to change some of 18 those requirements to encompass more types of 19 licensees.
20 I just want to talk a little bit about 21 some of the issues and challenges that the working 22 group's grappling with. This is an issue that several 23 groups have looked at over the past 20 years, 24 including the Interagency Radiation Source Protection 25 and Security Task Force that NRC leads.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
130 1 There was another interagency working 2 group led by NRC that put a report out in 2010 on this 3 issue. And those groups have generally recommended 4 NRC do rulemaking, but the action has been deferred 5 over the years until now. And some of the reasons for 6 that are listed on this slide.
7 There's not a lot of cost data to support 8 financial assurance requirements because in general 9 these devices have either been picked up by NNSA and 10 dealt with through that government-funded offsite 11 source recovery program, or they're in storage. There 12 have been very few disposals at commercial low-level 13 waste facilities.
14 The second issue, there are many different 15 types of devices that use these sources, Category I, 16 II, and III sources, from small radiography devices, 17 gauges, and calibrators, to very, very large panoramic 18 irradiators. And so looking at the possible 19 disposition pathways and the associated costs for all 20 of these different kinds of devices is a complex task.
21 And adding to that complexity is the low-22 level waste disposal landscape in the United States.
23 Disposal costs vary significantly, depending on what 24 disposal site a licensee has access to. There 25 typically are two places that these sources can go, 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
131 1 and that's the waste control specialist facility in 2 Texas or the U.S. Ecology Facility in Washington 3 State.
4 Costs can vary quite a bit between those 5 two facilities. But only certain waste generators 6 have access to the U.S. Ecology Facility.
7 And even for the Texas facility, it makes 8 a big difference whether you're in the Texas low-level 9 waste compact, which is the state of Texas and state 10 of Vermont, or if you're outside of the compact.
11 There are additional costs if you're an out-of-compact 12 generator.
13 The fourth issues, and for some sources, 14 such as those that are classified as greater than 15 Class C low-level waste, there may be no commercial 16 disposal pathway. For example, some of the cesium-137 17 blood irradiators have very high activity sources.
18 The only place those can go right now is through NNSA.
19 NNSA can pick them up through their offsite source 20 recovery program.
21 And last thing is the range of licensees 22 that use these sources is very broad, from very small 23 businesses to large hospitals, universities, 24 industrial facilities. And so looking at how this 25 rule could impact the very diverse licensee base is a 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
132 1 complicated task.
2 And so the working group's grappling with 3 all of these issues as we work through and develop 4 options for this regulatory basis.
5 So just in summary, where we're at right 6 now, the staff is preparing a regulatory basis to 7 expand financial assurance requirements as we were 8 directed to do by the Commission for Category I and II 9 and possibly Category III byproduct material sealed 10 sources.
11 We're looking at several potential 12 regulatory options and analyzing that and doing cost-13 benefit analyses. And you know, we will step through 14 those options in the regulatory basis. And we 15 anticipate providing that draft regulatory basis for 16 ACMUI's review next spring, in the spring of 2024.
17 And that is all I had for this afternoon.
18 And I'm happy to take any questions you may have.
19 CHAIR METTER: Thank you, Mr. Whited, for 20 that very interesting topic on the current status of 21 the financial assurance disposition of Category 1 and 22 Category 2 sealed sources. Do I have any questions or 23 comments from the ACMUI Committee? Mr. Green?
24 MEMBER GREEN: Always an education.
25 You're always going to find something you don't know 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
133 1 anything about. I have more experience with financial 2 assurances for germanium generators.
3 And this is outside the scope of this 4 presentation. This is Category 1, 2, and 3 sealed 5 sources. Has the NRC teed up a review of financial 6 assurance warranties that are currently in place and 7 required for germanium generators?
8 MR. WHITED: So there's another rulemaking 9 on that exact issue. And sometimes it is confusing to 10 folks because there's an ongoing rulemaking on 10 CFR 11 30.35. And it's my -- I'm not directly involved in 12 that rulemaking.
13 But it's my understanding that the 14 germanium/gallium generator issue was one of the key 15 things that prompted that rulemaking. And what that 16 one is doing is it's expanding. There's a table in 17 30.35 of isotopes.
18 And depending on what kind of device you 19 have, you go to that table and that table tells you 20 how much financial assurance you need. Well, 21 germanium and gallium were unlisted in that table.
22 And so there was a petition for rulemaking to add 23 those and other unlisted isotopes.
24 And that rulemaking is ahead of the one I 25 just talked about. It's going on right now to address 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
134 1 some issues. And basically for those kinds of 2 devices, licensees felt the current requirements were 3 too burdensome, and it really was because those 4 isotopes weren't listed in the table.
5 And so there's an effort ongoing to update 6 that table and unlisted isotopes and address that 7 issue. I'm not sure if that's exactly your question.
8 But I just wanted to make that point that there's a 9 separate rulemaking dealing with that issue that is 10 believe with the Commission now for their review.
11 MEMBER GREEN: Thank you, Ryan. That's 12 great. I think Mr. Einberg also has a comment.
13 MR. EINBERG: Actually, Cindy Flannery has 14 some additional information on that.
15 MS. FLANNERY: Yeah. I mean, I guess I 16 don't really have anything else to add to what Ryan 17 said. He covered everything. That rulemaking, yeah, 18 is up with the Commission, and it does address the 19 germanium issue.
20 But that table that Ryan was talking about 21 isn't going to include a lot of isotopes that aren't 22 currently listed and updating them. It's only going 23 to apply to -- right now, the list has many different 24 isotopes. But it's only going to list the ones with 25 a half-life of greater than 120 days. So several 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
135 1 updates to that table. And that's really the focus of 2 that.
3 MEMBER GREEN: From a practical and 4 operational standpoint, every facility, pharmacy, or 5 medical institution that possess a germanium generator 6 has an established contract with the germanium 7 generator provider. But they'll accept a full return.
8 All that is, is a less than 100-dollar FedEx fee to 9 make it go away to an authorized place. So financial 10 assurances warranty is an extreme.
11 CHAIR METTER: Thank you for that comment.
12 Are there any comments from the public? Zoubir, I'm 13 sorry. I can't see you. But if you'll let me know.
14 Thank you. Go ahead, Mr. Zoubir.
15 MEMBER OUHIB: Okay. Thank you. I think 16 this is a great initiative. I recall several years 17 ago being in the state of Florida where there was a 18 similar initiative to unload some sources. Those were 19 cesium-137.
20 And you have no idea what a relief that 21 was that we did not have to deal with anything. I 22 mean, that was a very smooth operation unloaded. And 23 they took on and that was fantastic because we were 24 wondering what the heck are we going to be doing with 25 these sources that we no longer use basically. Thank 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
136 1 you, Ryan, for that.
2 MR. WHITED: Thank you. Thank you for 3 that comment.
4 CHAIR METTER: Thank you. Any other 5 comments? Are there any comments from the public or 6 questions?
7 (No audible response.)
8 CHAIR METTER: Okay. Seeing none, thank 9 you again for that very updated report on this very 10 important topic.
11 (Simultaneous speaking.)
12 MR. WHITED: We'll see you in the spring.
13 CHAIR METTER: Okay. Our next topic is by 14 Dr. Katie Tapp of the NRC staff. She'll be speaking 15 on lutetium-177, radiopharmaceutical medical events.
16 Dr. Tapp?
17 DR. TAPP: Okay. Lillian is going to 18 bring up the slides. But Ryan, you have to stop 19 sharing your screen first. There you go.
20 MR. WHITED: Yes, I will do that now.
21 DR. TAPP: Great. I can switch. Okay.
22 I'm going to talk about radiopharmaceutical medical 23 events. Next slide, please. So before I talk about 24 the events, I want to do a reminder on the written 25 directive and then a reminder on what is a medical 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
137 1 event that's the rules for radiopharmaceutical 2 therapies.
3 So a written directive must be dated and 4 signed by an authorized user before the administration 5 of iodine-131, sodium iodide greater than 1.11 6 megabecquarels or any therapeutic dosage of unsealed 7 byproduct material. So basically, all therapeutic 8 radiopharmaceuticals except for anything under 1.11 9 megabecquarels of iodine must include a written 10 directive. Per administration of therapeutic dosages 11 of unsealed byproduct material other than sodium 12 iodide-131, the written directive must include the 13 radioactive drug, the dosage, and the route of 14 administration.
15 And then licensees must have and follow 16 procedures to ensure high confidence that each 17 administration is in accordance with what is in the 18 written directive. Next slide, please. So next will 19 be the medical event criteria that are associated with 20 radiopharmaceutical therapies. Next slide. So the 21 first one I like to call is deviation medical event 22 criteria.
23 This has two parts to it. First, the 24 event must meet a dose threshold. And the dose 25 thresholds are listed on the one side which is 5 rem 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
138 1 effective dose equivalent, 50 rem to an organ or 2 tissue, or 50 rem shallow dose equivalent to the skin.
3 In addition, there must be a deviation.
4 So the deviations are plus or minus 20 percent the 5 prescribed dosage or the dosage falls outside the 6 prescribed dose range. So for radiopharmaceuticals, 7 you're allowed to have that directive provide either 8 a set dosage or a range of dosages.
9 If they use a range, if it falls outside 10 that range, that would be a deviation. And then 11 there's also the plus or minus 50 percent, a single 12 fractionated dose. Historically, that wasn't used as 13 much in radiopharmaceutical therapy. But that could 14 become an issue going forward now that we have some 15 fractionated therapies.
16 And then the corner as you see, patient 17 intervention is excluded from this event criteria as 18 well as all the medical event criteria. So if the 19 event was caused by a patient intervention, it would 20 not meet these. Can you go back one slide, Lily? I'm 21 sorry. There you go.
22 The next medical event is -- I called it 23 the error medical event criteria. And again, we still 24 have the dose thresholds. But this one has a cause to 25 the medical event.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
139 1 So this could be, like, a wrong patient, 2 the drug was delivered to the wrong patient, the wrong 3 drug, the wrong route, or the wrong mode. Not as 4 important with the radiopharmaceutical therapy for the 5 wrong mode. But those are the cause of these type of 6 medical events.
7 Again, patient intervention, it would be 8 excluded. Next slide, please. And finally, we have 9 the wrong site medical event criteria. Again, we have 10 a dose threshold.
11 But this dose threshold is a little bit 12 different. This one is 50 rem or more is expected to 13 that site if the administration had been given in 14 accordance with the written directive. So this is a 15 medical event where the site is moved.
16 And you have to look at what was expected 17 to that site. So if the site was expected to get, 18 say, one gray but then it received two gray, that 19 would be a medical event. But if the site was 20 expected to get 50 rem and it only got 75 rem, it 21 would not meet that dose threshold. I'm sorry to 22 switch units on you there.
23 In addition to that dose threshold, there 24 is the deviation. So it's, like, this medical event 25 in addition to the dose threshold has to have a 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
140 1 deviation of 50 percent or more than the expected dose 2 to that site if the administration had occurred with 3 the way the written directive was prepared. So again, 4 we're looking at the event and looking at what was 5 expected to have been received on that site and then 6 what was actually received.
7 I'm looking at what was the deviation.
8 Again, this is a medical event criteria where patient 9 intervention would not be included in reporting. So 10 if it was involved, patient intervention that would 11 not be reported to the NRC. Next slide, please.
12 For a patient intervention report, you see 13 I cross off the dose threshold. In patient 14 intervention reports, there is no dose threshold 15 included. These events are reported if there's any 16 event resulting from intervention of a patient which 17 administration results in unintended permanent 18 functional damage to an organ or physiological system 19 as determined by a physician.
20 And patient intervention means actions by 21 the patient or human research subject, whether 22 intentional or unintentional, such as dislodging or 23 removing treatment devices or permanently terminating 24 the administration. Next slide, please. And I think 25 we talked about this a little bit earlier about 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
141 1 reporting or what's required. And in the regulations, 2 we do have the specifics of what is required for a 3 report.
4 A report comes in. We are looking for 5 what is the dose, what happened, what's the root 6 cause, and what are the corrective actions. And the 7 regulations are very specific about what we can ask 8 for in these reports.
9 But we do have some guidance out about 10 some best practices because we do use these medical 11 event reports to look for trends and generic issues.
12 And there is a bare minimum that's in the regulations 13 that licensees can meet. But it is helpful when we 14 get reports that have a little bit more information to 15 help us look for trends and generic issues.
16 The report should allow an uninvolved 17 individual to have full understanding of the event.
18 As a reminder, a lot of people assume when they send 19 in these reports that you guys are looking at it 20 immediately or other doctors are looking at it 21 immediately. But it's NRC staff looking at it 22 immediately, and we are not doctors.
23 And there's a lot of new treatments out.
24 We may not have been exposed to this. So we're really 25 asking that when reports come in especially with a new 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
142 1 radiopharmaceutical or a device, there's a little bit 2 more information so we can have a full understanding 3 of the event. Takes much longer for us to go out, 4 reach out, and play the telephone game.
5 In addition, there is helpful details to 6 include so we can catch trends quickly. And these 7 include the manufacturer, the model, and any specifics 8 about the supporting equipment associated with the 9 event such as the IV pump or gauge size. A lot of 10 times we'll hear of the incorrect gauge size was used, 11 but we don't know what was the gauge size.
12 In addition, relevant information that 13 proceeded the event. Sometimes we'll see that there 14 wasn't enough staff. But maybe if you provide how 15 many staff were on site would be helpful.
16 What staff was present, how the event was 17 identified, including short and long-term corrective 18 actions, and how they're actually linked to the event 19 is helpful. And then clearly highlight if the event 20 or corrective actions involve common industry-wide 21 practice or procedures. This last one I think is very 22 important.
23 If the event is something that's commonly 24 used and especially, like, a software or a procedure.
25 And it's important to let us know this is a common 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
143 1 practice or procedure that's done and it caused this 2 event. So it really clearly highlights something that 3 could impact other licensees.
4 So we can make immediate notification if 5 necessary. Next slide, please. So now I'm going to 6 cover some examples of recent radiopharmaceutical 7 medical events. Next slide. As I think everyone here 8 knows, there's an increasing use of 9 radiopharmaceuticals.
10 In January 2018, Lutathera was approved by 11 the FDA for treatment of some gastroenteropancreatic 12 neuroendocrine tumors. And in March 2022, Pluvicto 13 was approved by the FDA for treatment of some prostate 14 cancers. In addition, there's numerous ongoing 15 clinical trials with current and new therapeutic 16 radiopharmaceuticals.
17 We have had one report of a patient 18 receiving the wrong radiopharmaceutical. This is an 19 event where one patient came in to receive Pluvicto 20 and they received Lutathera. And the other patient 21 received Lutathera when they were meant to receive 22 Pluvicto.
23 That type of event we found to be a 24 serious event. And we're hoping as there's 25 increasingly uses and a lot more therapeutics coming 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
144 1 out, we really want to make sure those events are 2 avoided. In addition, both lutetium-177 3 radiopharmaceuticals have a recommended standard 4 dosage of 200 millicuries for multiple fractions 5 unless the patient conditions warrant a reduction in 6 dosage.
7 And the reduction can occur between the 8 fractions. So they could have 200 millicuries to 9 start and then it could be a reduction later on. In 10 the last two years, we've had five events where an 11 authorized user prescribed a smaller dosage based on 12 patient lab results, but the patient still 13 administered the full standard dose of 200 14 millicuries. Next slide, please.
15 I'll just give one example of that 16 reduction of dose. There was a Lutathera standard 17 dose protocol of 200 millicuries every eight weeks for 18 a total of four doses. That's the standard protocol.
19 A patient was prescribed 100 millicuries 20 by the authorized user on a later fraction due to 21 kidney disease but received the standard dose of about 22 206 millicuries. The administer technologist did not 23 review the written directive and just drew the 24 standard dose. The root cause in this event was 25 failure to follow established protocols and lack of 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
145 1 communication in the department.
2 This licensee had a corrective action to 3 include a daily huddle to communication key 4 information and secondary verification requiring 5 physician signature on the written directive. Next 6 slide, please. Next I want to cover types of events 7 with the verification of activity was shown to be very 8 important. 10 CFR 35.63 requires licensees to 9 determine and record the activity of each dosage 10 before medical use.
11 During this check, it is important that 12 the activity be checked against the written directive 13 immediately prior to administration because failure to 14 do so has caused several events recently. Next slide, 15 please. One type of event was the patient was 16 rescheduled to receive 3.47 megabecquarels of radium-17 223 Xofigo. On the day of the treatment, the 18 patient's procedure was canceled due to low blood 19 pressure.
20 The licensee then kept the dosage in the 21 hot lab for decay. One month later, the patient came 22 back for their treatment. They received the dosage 23 from the original vial which resulted in 24 administration of 0.63 megabecquarels.
25 This demonstrates the need to verify the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
146 1 dosage on a written directive immediately prior to 2 treatment. Next slide, please. Next I'll talk about 3 protocol and scheduling. The protocols are becoming 4 more complex and sometimes include multiple steps and 5 other treatments in addition to the 6 radiopharmaceuticals.
7 These new products coming out have a 8 little bit more complex protocols I think, and they're 9 becoming more complex from one of those societies I 10 think even than they are today. In addition, certain 11 drugs may interfere with the distribution of the drug 12 in the body. It is important to note that the way 13 medical event criteria is written is not all incidents 14 involving incorrect protocol scheduling or drug 15 interference are reportable to the NRC per 16 regulations.
17 These events can be medically important 18 and sometimes do qualify as medical events. The NRC 19 has been notified of several of these events.
20 Sometimes they are medical events and sometimes we 21 find that they aren't.
22 For example, if the chemo drug was given 23 the day before versus the day after, that may not be 24 a medical event for us because we're looking at the 25 radiopharmaceutical and the dosing. So it doesn't 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
147 1 actually change the dose, but it's changing the 2 protocol. It's medically important. Next slide, 3 please.
4 The one protocol example that I wanted to 5 highlight was during a typical -- or the standard is 6 during a typical Lutathera treatment, an amino acid 7 infusion begins 30 minutes prior to the radioactive 8 drug administration to protect the kidneys by lowering 9 the dose. In one event, a patient's Lutathera 10 treatment began without the amino acid infusion as the 11 amino acid line was still clamped. The technologist 12 realized this approximately 20 minutes after the 13 Lutathera treatment began and started an amino acid 14 infusion.
15 The licensee calculated the kidneys 16 received an estimated dose of 740 centisieverts 17 instead of the intended 490 centisieverts and reported 18 this event. The corrective actions include moving the 19 amino acid solution to a separate primary IV line 20 which would alarm if it was still clamped, training 21 the nursing staff, and adding a pause to ensure the 22 amino acid infusion has begun before starting the 23 Lutathera. Next slide, please. There's also 24 scheduling examples, and I provide this one.
25 It's while a patient was undergoing 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
148 1 lutetium-177 Lutathera infusion, they were informed by 2 the AU that they received the chemotherapy the day 3 before. They said the normal protocol for Lutathera 4 treatment is for the chemotherapy to be done after the 5 radioactive lutetium infusion. So the AU immediately 6 stopped the infusion, and this led to an underdose and 7 a medical event.
8 If they wouldn't have stopped the dosage 9 there, it might not have been reported to the NRC 10 because it might not have been a medical event. But 11 I would still imagine this is medically important.
12 You'd want the schedule correct.
13 So this event demonstrates that the 14 authorized users and staff should check the status of 15 the patient's entire protocol, especially if multiple 16 departments are involved prior to each administration.
17 As we're finding with these new radiopharmaceuticals, 18 there's more staff involved, new departments that may 19 not be used to working with nuclear medicine. And so 20 when someone is bringing off a treatment, making sure 21 that the entire medical departments and everyone 22 involved is aware has been important to avoid medical 23 events. Next slide, please.
24 And finally, we'll talk about set up and 25 administration incidents. In the last two years, 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
149 1 we've had six events reported due to unexpected set up 2 issues associated with the newer procedures. Everyone 3 should be trained on a new administration and the 4 equipment they may handle during the procedures.
5 With a lot of places starting up, we found 6 that we got to make sure we're training the support 7 staff and staff who may not have been used to handling 8 radiopharmaceuticals. And then we can't forget about 9 those who handle the equipment or perform set up even 10 before the administration begins. As I mentioned, the 11 amino acid with the clamp, that occurred before the 12 administration even began.
13 That was before the nuclear medicine 14 technologist was there and with the nursing staff. So 15 that shows that we have to make sure the training is 16 throughout the whole procedure. One thing we've heard 17 from societies was cold -- administrations, including 18 set up with the entire team, could significantly 19 reduce the chance of an event. Next slide, please.
20 One of these examples was a nurse removed 21 the clamp and opened the roller clamp on a flush bag 22 line at the beginning of an iodine-131 IV treatment.
23 This led to a leaking tube in an infusion system and 24 resulted in a patient only using 53 percent of the 25 prescribed dose. Luckily, there was no contamination.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
150 1 Again, the root cause was failure to train 2 staff on this specific procedure and the support 3 staff. And the corrective actions in this event was 4 to ensure nuclear medicine and radiopharmacists were 5 trained on the infusion pump and would solely be in 6 charge of that pump for future patients. So for this 7 licensee, they decided to move the pump control to the 8 nuclear medicine and radiopharmacy staff. Next slide, 9 please.
10 Another one is a Xofigo administration.
11 There's a three-way stopcock was used to allow the 12 administration of saline in radium dichloride. An 13 incorrect cap was used on the unused port of the 14 three-way stopcock. The cap that was used was 15 designed to maintain sterility of the port connection 16 but did not prevent flow which led to a leak.
17 And the root cause again was failure to 18 train staff on the equipment of this administration 19 prior to the administration. Next slide, please. And 20 this is the last type of events which is the leaks.
21 In the past two years, we've had seven events 22 associated with leaks and spills.
23 Some of the ones I just mentioned were 24 included in these type of events, but I broke it down 25 a little farther to look into what was causing these.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
151 1 And four events were expected to be associated with 2 the incorrect setup that I was just mentioning. But 3 there are three more events associated with infusion 4 tubing, but not setup issues were noted.
5 Leaks occurred with Xofigo, Lutathera, 6 Pluvicto administrations. So they didn't seem like 7 they were located to just one. But they occurred with 8 different types. And one licensee reported to us that 9 they did test the additional tubing from the same lot 10 and identified more tubing leaked.
11 So they removed the entire tubing lot. So 12 this licensee went further and testified all the 13 tubing and found there's more leaking from their 14 administration and IV sets. Next slide, please. So 15 in summary, the NRC has seen an increased number of 16 medical events associated with radiopharmaceuticals as 17 new drugs come into the market.
18 I will say, I want to point out that Dr.
19 Harvey's group, you guys might not have seen these 20 because a lot of these events occurred in 2023. I'm 21 reporting the events that occurred. Some of them 22 occurred within the last month. But we're definitely 23 seeing more events happen and different types of 24 events happen and different types of events as these 25 radiopharmaceuticals are coming onto the market.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
152 1 Many of these events associated with the 2 increased complexity and lack of training of staff on 3 the new protocols before they start using them in 4 their clinics. Many types of these events are new to 5 the NRC such as leaks and set up issues associated 6 with the delivery. NRC expects to see -- continue to 7 see new types of medical events as new protocols enter 8 the clinic. And the NRC is in the process of 9 developing an information notice to inform licensees 10 of these events that have been reported and then the 11 industry recommended corrective actions. Next slide, 12 please. I think this is the acronyms.
13 CHAIR METTER: Well, thank you, Dr. Tapp.
14 That was a very, very nice and very excellent report.
15 And it's very clear and concise. And really your 16 examples were very helpful and help for us to 17 understand what happened and the site's corrective 18 actions regarding this.
19 And I hope that not only the people on the 20 committee here but also the public on this call will 21 learn from that. And I do like the idea of the 22 information notice coming out. Do you have a time 23 frame when that will be?
24 DR. TAPP: In the next couple months. We 25 are actively working on it.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
153 1 CHAIR METTER: That's very interesting 2 because I think, like I said, the new 3 radiopharmaceuticals and the more complexities of 4 these therapies, I think every little step will cause 5 -- has the potential for another issue to come up.
6 Now are there any questions from the committee? I see 7 a lot of questions. Okay. Let me go ahead and have 8 Dr. Jadvar. He hasn't asked any questions recently.
9 VICE CHAIR JADVAR: Thank you so much for 10 that presentation. Just one quick question. So 11 Pluvicto package insert says that if you want to give 12 -- if there is adverse events, you're allowed to 13 decrease the dose by 20 percent from 200.
14 So let's say the patient gets 160. But 15 then for the next fractionation -- and also it says --
16 the package insert says that you should not re-17 escalate. So it should be 160 and then 160 from then 18 on. But suppose let's say number 3, it's 200 by 19 mistake.
20 The patient is given 200. Does that 21 constitute a medical event or not? It is not what the 22 package insert says, but still it's 200.
23 DR. TAPP: If that's what the authorized 24 user wants to give, that would not be a medical event 25 in the written directive, right, in the written 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
154 1 directive.
2 VICE CHAIR JADVAR: Thank you.
3 CHAIR METTER: Dr. Harvey?
4 DR. HARVEY: Thank you. One comment 5 and one question. Yeah, I did take a sneak peek just 6 on my own to look for some of the medical events that 7 you talked about today just for my own edification.
8 And then the second thing was a question. And so if 9 licensees in agreement states have stricter 10 interpretations of the regulations, say 10 percent 11 instead of 20 percent of prescribed activity. And if 12 we report those because we're required to because 13 either our license conditions or our state regulations 14 and those come to the NRC, would they be excluded from 15 the NMED database them?
16 DR. TAPP: That's a good question. The 17 work between agreement states and the NRC, sometimes 18 we do get events that don't meet the NRC's criteria.
19 We do not then -- we'll work with the agreement states 20 to see if they would like to pull it out of the NMED 21 and see if they think it meets our criteria.
22 Because in NMED, we do want to keep it to 23 NRC criteria. So we do generally probably exclude it.
24 But there is collaboration with agreement states.
25 MEMBER SHOBER: Yeah, this is Megan 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
155 1 Shober. So once an event gets reported through the 2 operations center, it automatically goes in NMED even 3 if it's subsequently retracted. So once something 4 goes in NMED, it doesn't come out.
5 But that being said, if we get an event 6 report for something that's not reportable for NRC's 7 regulations, we won't forward that report. So I think 8 that's pretty standard practice. But of course, 9 there's some things that's, like, you're not sure the 10 time of the event comes in. And so those things may 11 get reported even if they're later determined not to 12 be reportable.
13 DR. HARVEY: Thank you both.
14 CHAIR METTER: And thank you, Megan, for 15 that addition. Dr. Einstein?
16 MEMBER EINSTEIN: Andrew Einstein. Thanks 17 for a great presentation. In the remediation plan 18 which you cited there was a daily huddle rather than 19 a patient-specific time out, why is that?
20 DR. TAPP: The corrective actions were 21 specific to the licensees. The inspectors ensure that 22 they believe the corrective actions are adequate. But 23 we don't really have a say.
24 We just report what they report to us as 25 what they want to do for their corrective actions.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
156 1 Maybe that would be a good one for an information 2 notice or a recommendation. But we don't know why 3 they did what they did.
4 MEMBER EINSTEIN: Particularly for an 5 institution which has already failed for one patient.
6 DR. TAPP: Yeah.
7 CHAIR METTER: I think Ms. Allen has a 8 comment or question.
9 MEMBER ALLEN: Yes, first, thank you for 10 the presentation. As an administrator looking at it, 11 a lot of this goes back on education, training, 12 retraining. We also know that retraining and 13 education is a level of reliability of a one.
14 So it's not very reliable when you go and 15 say part of the action plan is retraining. And so I'm 16 looking forward to seeing the recommended corrective 17 actions and some examples or some lead way because I 18 think it's very important that it's easy to say we're 19 going to retrain. And that's a part of it. But it's 20 not going to give us the level of reliability to 21 reduce the medical event.
22 CHAIR METTER: Thank you.
23 MEMBER ALLEN: Thank you.
24 CHAIR METTER: Mr. Ouhib has a question.
25 MEMBER OUHIB: Yeah. Thank you, Dr. Tapp.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
157 1 That was a great presentation. I think in quite a few 2 slides you talked about providing training and so on.
3 But I think along that line, there should 4 be a statement that says people who have not gone 5 through proper training or official training or 6 manufacturer training should not be part of the 7 procedure, period. And I think because providing 8 training someone could still be participating until 9 they get their training next year or in six months 10 from now. But I think eliminating any person without 11 any training from the procedure I think is a wise 12 move.
13 DR. TAPP: I would say that one thing is 14 for the information notice. I won't be able to add 15 something. That would be a new regulation. I can 16 only provide what we're seeing from the industry, 17 corrective actions, or if you guys have 18 recommendations into an information notice.
19 But I wouldn't be able to do far reaching 20 into that. I would think if there's actions to take 21 based on therapeutic radiopharmaceuticals that require 22 a regulation change which I'm not sure if that would.
23 But if something did, that would have to go into a 24 rulemaking.
25 MEMBER OUHIB: When you think in the case 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
158 1 of our procedures or whatever, the only requirement is 2 that someone has to be trained and know what they're 3 doing as far as medical physicist and all of that.
4 It's very, very clear. And if you don't have that 5 education and that training and knowledge and all 6 that, you can't participate in that, period.
7 CHAIR METTER: I do have a comment on 8 that. Usually at sites when any new entity or any 9 procedure, particularly therapy comes in, it's a 10 credentialing issue. So I think it's a local issue 11 and really like Dr. Tapp said as far as that is 12 probably more at that level. Okay. Any other -- oh, 13 yes, Mr. Green.
14 MR. GREEN: Thank you, Dr. Tapp. A 15 great presentation. Really intrigued by the 16 categorization of how events can occur and the error 17 medical event where there's the wrong patient or the 18 wrong drug or the wrong route and the importance of 19 verification of activity, assay it.
20 And Ms. Allen, I appreciate your 21 evaluation of the poor return on investment. I'll 22 train. Doesn't last very long.
23 There is an industry standard throughout 24 the hospital that is used. Needs to make its way 25 further into radiology. That's Barcode Medication 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
159 1 Administration, BCMA.
2 And if that occurred, people are 3 wonderful. But barcodes can do things that people 4 should do but don't. Is it the right drug? Is it the 5 right patient? Is it the right amount? Is it the 6 right route?
7 Check the computer system. BCMA made its 8 nuclear recommendation you might put in your advisory 9 document. BCMA, you can impose. It should be an --
10 it is an industry standard in the hospital. It's not 11 made it to nuclear yet and it should.
12 CHAIR METTER: Thank you, Mr. Green, for 13 that addition, additional comment in safety issue.
14 Mr. Mailman?
15 MR. MAILMAN: Thank you for an 16 excellent presentation as well. Just for your report, 17 though, Dr. Harvey's report later, I would assume that 18 a patient getting Pluvicto when they should've gotten 19 Lutathera is a medical event. I would assume when a 20 patient getting Lutathera when they should've been 21 getting Pluvicto is a medical event as well.
22 I don't consider them one medical event.
23 I consider them two medical events because there were 24 two patients. It was listed as a single medical 25 event, and it may be a single screw up. But to me, 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
160 1 it's two patients both getting the wrong dose. And I 2 would say for the future accounting that I would hope 3 that it listed twice.
4 MR. DIMARCO: Daniel DiMarco. I remember 5 this event specifically. This was caught when only 6 one of the patients was given the wrong drug and the 7 other patient had not been given the wrong drug. So 8 they caught it at the first part of a patient. And 9 then that second injection was canceled when they 10 realized that they had given the wrong --
11 MR. MAILMAN: So this is the event from 12 December of last year. I have to go back to it 13 because I read it differently. But that's okay. So 14 it was only in one patient. That's fine. And it's a 15 single event.
16 MR. DIMARCO: To the best of my 17 remembrance, that was --
18 MR. MAILMAN: But that's not how it was 19 written here. So I'm just double checking.
20 CHAIR METTER: Okay. Thank you. Any 21 other questions from the ACMUI? NRC staff? Any 22 members in the public? Yes, I do have Lantheus. Do 23 you want to come to the microphone here?
24 MS. THOMPSON: Hi, can you hear me? Hi, 25 my name is Diana Thompson. I'm the director of 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
161 1 Radiopharmaceutical Health Physics at Lantheus. And 2 I had two questions.
3 Also, first, thank you very much for your 4 wonderful presentation, Dr. Tapp. So the first 5 question that I wanted to ask is that because there 6 are four doses, are the doses considered fractionated?
7 Or is it one written directive for one administration?
8 DR. TAPP: That is dependent on how the 9 authorized user writes the written directive. Across 10 right now, I mostly see individual written directives 11 per each treatment. And I think that's because you're 12 drawing blood, taking labs, checking the status. So 13 I think they're writing written directives each time 14 right now.
15 MS. THOMPSON: The second question that I 16 had was in the beginning of your presentation, you 17 noted that you could write a dose range on a 18 therapeutic administration. And I think I've only 19 seen that for diagnostics. And I wanted to confirm if 20 that is an acceptable way to document a dose on a 21 written directive for therapeutics.
22 DR. TAPP: I do not have the regulations 23 in front of me. In something that tight, I'd have to 24 double check. I'd have to look at 35.40.
25 35.40 pulls up exactly what the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
162 1 requirement is. And it could be different amongst 2 agreement states. So I think everyone should double 3 check what is required for 35.40. You're probably 4 correct. Chris is pulling it up right now.
5 MS. THOMPSON: I believe 35.40 says dose.
6 But that could be a range if that's what the clinical 7 trial approves. And I just wanted to -- if there's 8 examples out there that has been seen on inspection or 9 with other products. I just wanted to clarify since 10 it was in the slides.
11 DR. TAPP: Yeah, the slides could be --
12 because it is possible to have a medical event with a 13 diagnostic. And diagnostics are allowed to have 14 ranges.
15 MS. THOMPSON: That does clarify. Thank 16 you very much.
17 MR. GREEN: I don't know the 18 regulation. I agree you should look it up. But when 19 you're doing a sodium iodine capsule, it all goes down 20 the gullet. Here you have an infusion where you can 21 have residual activity in the vial or the syringe and 22 infusion apparatus.
23 So even though it measured 200, you're not 24 getting 200 in. There's always going to be something.
25 So I think the range makes sense. We should check the 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
163 1 regs.
2 CHAIR METTER: I do see Mr. Zoubir. Do 3 you have a question? I do see --
4 (Simultaneous speaking.)
5 MR. OUHIB: No, I don't. My hands are 6 down.
7 CHAIR METTER: Okay. I see a public 8 member. Could you read that?
9 (Simultaneous speaking.)
10 DR. TAPP: Just one second to the virtual 11 caller. It does say in 35.40 it's dosage. Dosage is 12 defined in 35.2. And it is dose or dosage range.
13 CHAIR METTER: I have -- I can't read the 14 -- yeah, could you pull it up? We have Nicole. Are 15 you able to unmute, Nicole?
16 MS. NARDECCHIA: Hi, sure. Thank you.
17 Thanks for the presentation. My name is Nicole 18 Nardecchia. I work as a quality improvement and 19 patient safety manager for radiology at Yale-New Haven 20 Hospital.
21 And I just wanted to go back quick to the 22 root cause analysis and corrective action plans that 23 were mentioned. I don't remember who mentioned it.
24 But I completely agree about education and retraining 25 being a really weak form of a corrective action plan.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
164 1 And I just would challenge any of the root 2 cause analysis. I'm not sure how those are performed 3 or how the NRC documents those. But stating that 4 there was a failure to follow policy or protocol as a 5 root cause, that's actually kind of -- that's the 6 problem. That's not really the root cause. So I 7 would just challenge maybe some of the documentation 8 on how a root cause or corrective action plan is put 9 into place because I think there could be more strong 10 corrective action. Thank you.
11 CHAIR METTER: Thank you. Dr. Tapp, can 12 you read the next person?
13 DR. TAPP: Sure, Venkata Neti. I'm sorry.
14 MR. NETI: Yeah, can you hear me?
15 DR. TAPP: Yes.
16 MR. NETI: I'm Neti, radiation safety 17 officer at RBHS Newark. Particularly, I do want to go 18 into specific example, the one you mentioned as one of 19 the examples Lutathera administered to Pluvicto 20 patient and Pluvicto administered to Lutathera 21 patient, these are two medical events because two 22 patients are involved, but I have a question. In 23 Pluvicto, we don't have any infusion. Is that 24 correct?
25 Whereas for the Lutathera you have 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
165 1 infusion. So even the infusion is also done 2 incorrectly thereby changing the dosimetry for 3 Pluvicto because we are not protecting kidney by 4 infusion for Pluvicto. But -- to the Pluvicto 5 patient. That's the dosimetric change is the big 6 issue from the dosimetric point of view.
7 DR. TAPP: The medical consequence, I 8 would have to leave that up to the licensee and the 9 inspectors and look it up. But wrong drug in a 10 therapeutic would be a big concern, I think. If 11 anybody here you guys want to add?
12 MR. NETI: That's true in case of 13 Pluvicto. What about Lutathera where there was no 14 infusion. But as for the procedure, you have the 15 infusion. Without infusion you can't administer 16 Lutathera. Besides the medical event, is there any 17 consequences to the patient from the health point of 18 view?
19 DR. TAPP: I do not have the -- in front 20 of me the patient consequence in this type of view in 21 the individual events. But when we do have a medical 22 event, we do follow up with patient consequence.
23 Patient consequence is a required reporting item as 24 well as you know the states would follow up and find 25 out the medical consequence. So an individual event, 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
166 1 they would follow up on that and I would be concerned 2 in those type of events.
3 MR. NETI: Thank you.
4 CHAIR METTER: Thank you. I do not see 5 any other questions, do you, from the public?
6 DR. TAPP: Mr. Neti just put his hand back 7 up.
8 CHAIR METTER: Oh, but I do see one from 9 the committee. Zoubir, go ahead.
10 MR. OUHIB: Yeah, I just want to 11 comment briefly regarding the root cause that one of 12 the attendees just brought up. We did look at this 13 within the AAPM. And Bruce Thomadsen as probably most 14 of you know him was the chair of this task group.
15 And we looked at it and just sort of 16 thought about what would the verbiage should be. What 17 is really required? What is needed? What could 18 actually help understand the event itself also the 19 remedies that would be appropriate?
20 And I think maybe at some point it would 21 be worth looking into that, knowing it might not be 22 easy. But it's almost like a mandatory form that has 23 to be filled out by every user, per se, in the case of 24 a medical event. And any blank is not accepted, 25 period. Thank you.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
167 1 CHAIR METTER: Thank you. I do see other 2 individuals. I can't read their names.
3 DR. TAPP: Yeah, Venkata Neti.
4 MR. NETI: Hi, it's me again. So it's not 5 a concern at least for Lutathera and Pluvicto, because 6 Lutathera is for neuroendocrine and Pluvicto is for 7 MCRP patients. Maybe written directives should 8 include those checkmarks where it's a neuroendocrine 9 or MCRP patient. That way we may avoid in the 10 future some of the cases.
11 CHAIR METTER: I have a question for Mr.
12 Green. Are they in different colored -- do they get 13 distributed in different colors as far as the 14 radiopharmaceuticals so we can identify them as 15 different?
16 MR. GREEN: I don't know how many 17 colors there are in the world. But I know there's 26 18 English letters in the English alphabet. And the 19 English letters are different.
20 And BCMA can read letters through a 21 barcode and tell you it's the wrong drug. I looked it 22 up. There are 56 FDA approved drugs, 45 of which 23 currently are intravenously administered.
24 There are 16 tech drugs, 9 fluorinated 25 drugs, and 2 lutetium drugs. There's going to be a 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
168 1 lot more lutetium drugs coming. There's 257 lutetium 2 clinical studies underway at clincialtrials.gov.
3 We will see some of them hit the 4 marketplace. It's new, but we got to do better. And 5 that means read the label. Sorry.
6 CHAIR METTER: Thank you, Mr. Green. Are 7 there any other questions in the room here? I do not 8 see any questions in the public. Is that correct?
9 Oh, I'm sorry. There is. Dr. Einstein?
10 DR. EINSTEIN: Barcodes and labels are 11 great. But I do think colors serve as a second check.
12 I don't think the two of them are mutually exclusive.
13 It would be great if drugs which can get confused are 14 color coded appropriately as well.
15 CHAIR METTER: We just have to be sure not 16 to use green and red. But anyway, okay, I do see a 17 hand in the public. There's an individual. William?
18 MR. HINCHCLIFFE: Hi, yeah, William 19 Hinchcliffe, radiation safety officer at -- Hospital.
20 Just to sort of give a direct answer to this question, 21 the Lutathera and the Pluvicto come in identical 22 colored pigs, same size. They are indistinguishable 23 at first glance.
24 The vials are very similar sized and the 25 volumes are different in size but not so different to 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
169 1 be easily noticeable. They come from the same 2 companies. The labels do look very similar except 3 when you read them identically and typically do not 4 come with patient information on the outside of the 5 pig. So they're easy to confuse until you look at 6 them very closely.
7 CHAIR METTER: Thank you very much for 8 that confirmation of the idea of colors. Dr.
9 Einstein?
10 DR. EINSTEIN: Does the NRC have 11 regulatory capabilities of packaging materials? And 12 could they -- could you mandate different colors?
13 DR. TAPP: No, it wouldn't be in the 14 regulations today. That would fully require 15 rulemaking. And I'd see that being a difficult one.
16 I know we talked about it before and I 17 know we talked about it here. But barcoding and 18 recommendations with different colors could come from 19 the ACMUI. I'm just saying if there's a subcommittee 20 that did a formal recommendation because right now I'm 21 just taking it as a comment from Mr. Green. So I 22 didn't know if that's something for consideration for 23 the future.
24 CHAIR METTER: Since this is actually a 25 new therapeutic that's come up with a significant 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
170 1 number of medical events particularly in 2023, I think 2 we might need to form a subcommittee with maybe 3 looking at that and suggest recommendations. But 4 thank you. That's a very good suggestion.
5 DR. EINBERG: Yeah, Chris Einberg here.
6 I was going to say as alluded, Dr. Tapp is developing 7 the information on this right now on medical events.
8 And this information will come to the ACMUI for 9 review. At that time, if you want to make comments on 10 that information notice, that's another opportunity to 11 influence that information notice.
12 CHAIR METTER: Excellent. Thank you, Mr.
13 Einberg. Okay. Any other final comments before we go 14 to our break? Seeing none in the room or in the public 15 chat box, let's go ahead and conclude this portion of 16 the afternoon meeting. And we'll reconvene at 2:35.
17 Thank you, Dr. Tapp.
18 MR. EINBERG: 3:35.
19 CHAIR METTER: I'm sorry, 3:35.
20 (Whereupon, the above-entitled matter went 21 off the record at 3:22 p.m. and resumed at 3:35 p.m.)
22 MR. EINBERG: Yes, this is Chris Einberg.
23 We're reconvening the meeting right now. The next 24 agenda item is the special presentation to Dr. Metter.
25 As you all know, this is Dr. Metter's last official 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
171 1 meeting of the ACMUI.
2 And so it's with great regret that she's 3 going to be leaving us. She's still going to serve 4 until the March time frame. But this is her last 5 official meeting.
6 And so it's with a heavy heart that I am 7 saying goodbye to her. But we have a special 8 presentation from Commissioner Wright. Commissioner 9 Wright is going to have an award for you.
10 Commissioner Wright?
11 COMMISSIONER WRIGHT: Thank you so much.
12 MR. EINBERG: Okay. Well, are we there?
13 COMMISSIONER WRIGHT: All right. Well, 14 good afternoon, everyone. And I'm pleased to be with 15 you here today to recognize the contributions of Dr.
16 Darlene Metter to the ACMUI and actually to the NRC as 17 a whole. As many of you know, her term ends February 18 24th of next year, I believe.
19 So this, as you mentioned, is her last 20 meeting as ACMUI chair and as diagnostic radiologist 21 representative. And we want to take time, the time 22 that we have today to recognize you for your 23 contributions and to celebrate your service here. So 24 first before I bring you up here, let me take a moment 25 to recognize your expertise in the field of radiology 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
172 1 and to celebrate just everything that you've done, the 2 leadership that you've provided not just to this 3 committee but to the NRC and how we as Commissioners 4 and the agency as a whole have benefitted from things 5 that you have been involved in since you were 6 appointed as a representative back in 2016.
7 That was seven years ago. We've had the 8 good fortune to learn from you, from your expertise 9 and the experience that you have and you've garnered 10 throughout your life. You were appointed to the 11 position of vice chair in 2018.
12 That was just two years after you joined 13 the committee. And having done something like that 14 before, that's not an easy thing to do to come in. It 15 takes usually a couple years just to get up to speed.
16 And then you were appointed chair in 2019 17 -- in September of 2019. During your time here at the 18 ACMUI, you had kept me and the other Commissioners 19 well informed of this committee's views on different 20 medical topics including presenting to the Commission 21 and this committee's comments on things like the 22 guidelines to nursing mothers and training and 23 experience requirements for all modalities. And that 24 was back just in April of 2019, pre-COVID.
25 You've also provide overviews of this 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
173 1 committee's activities in 2021 -- in 2020, 2021, and 2 2022 at our annual Commission briefings. And I 3 remember these meetings, virtual and in person. And 4 I've always appreciated your professionalism, the way 5 you carry yourself, your clarity, and everything that 6 you do that just enhances your presentations to the 7 Commission.
8 During your tenure as well, you've 9 actively participated in committee meetings and 10 provided valuable advice to the NRC on very technical 11 relevant policy issues by serving as chair and member 12 of numerous subcommittees which by my count is almost 13 20 different subcommittees that you've been involved 14 in. And again by my count, that's almost every 15 subcommittee that you could possibly have been 16 involved in. So you're not just good, but you're a 17 workaholic.
18 I appreciate you for wanting to do that.
19 You've been involved in everything from medical events 20 to abnormal occurrences, from linear no-21 threshold petitions to Y-90 licensing guidance.
22 And not just the committee but the NRC is 23 better for your involvement and participation 24 here. And I want to thank you for that.
25 So if you would come up here, stand by me, 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
174 1 I want to present you with a few tokens of our 2 appreciation and gratitude for your eight years of 3 dedicated service to ACMUI and to the NRC. So first 4 is a flag of the United States that has been flown 5 over the Capitol. It's a certificate that's been 6 signed by Maryland U.S. Senator Chris Van Hollen which 7 is kind of cool, I have one of these for each of my 8 children.
9 A second thing is a certificate of 10 appreciation that's signed by our chair, Chris Hanson.
11 Okay? And then last but not least is an NRC pin, 12 right? Now it's just like this one, and I wear it 13 everywhere. It's very pretty. It's very nice.
14 And then last of the last but certainly 15 not least is a handshake from me on behalf of the 16 Commission thanking you for your eight years of 17 service and everything that you've done to make this 18 agency better and this committee better. The advice 19 that you've given to us has been seriously taken and 20 considered. And I just want to thank you for not just 21 myself but the members of the commission and the NRC.
22 Congratulations. Would you like to say something?
23 CHAIR METTER: Thank you, Commissioner 24 Wright. My fellow ACMUI members and NRC staff, thank 25 you for the privilege and honor of being a member of 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
175 1 the ACMUI since 2016, and as Commissioner Wright said, 2 your vice chair in 2018 and your chair since 2019. As 3 an ACMUI member, as you know, work can be quite 4 intense and challenging in advising the NRC in their 5 mission which includes protecting patients and the 6 public health and safety in the medical uses of 7 radioisotopes.
8 Despite these challenges, the ACMUI tasks 9 have been quite rewarding. And only in large part due 10 to the incredible expertise, support, and knowledge of 11 the NRC staff and my fellow ACMUI members. When I 12 attended my first meeting in 2015, Bruce Thomadsen was 13 the ACMUI chair.
14 It was really a true eye opener and to be 15 a part of this massive federal organization was 16 totally impressive. As today, we're in a conference 17 room with this horseshoe table. And the newest 18 member would start at one end of the table and 19 through their tenure rotate around the table to a 20 final position before rotating off.
21 And as you remember, one member actually 22 said, I'm falling off. But during these first 23 meetings, my first goal was really just to observe.
24 And I truly wanted to be a silent member.
25 I wanted to rotate around the room and 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
176 1 fall off. Unfortunately, the following year, Dr. Phil 2 Alderson, a fellow nuclear radiologist, became the 3 ACMUI chair. And Dr. Christopher Palestro, another 4 nuclear medicine colleague, became the next chair.
5 And I was soon tasked at being a chair of 6 subcommittees regarding Y-90 microsphere, nursing 7 guidelines, and training and experience.
8 And as you had heard with Commissioner 9 Wright, I was also on several other subcommittees.
10 The subcommittee topics and work were all really quite 11 challenging. And especially with a highly 12 engaged active national stakeholder audience, 13 video recording and legal transcripts of our 14 meetings.
15 However, I soon discovered that the 16 expertise, knowledge, and support of my fellow ACMUI 17 members and NRC staff whose teamwork contributed to 18 the success in producing well thought out and 19 comprehensive final subcommittee reports. During 20 these last few years, the ACMUI experience has been 21 very rewarding and not only in contributing to 22 the regulatory safety of our patients and the public 23 but in part being a part of the rich camaraderie of 24 this organization. Thank you for this great privilege 25 and honor to being a part of the ACMUI and NRC family.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
177 1 The ACMUI experience will be a true highlight in my 2 professional career and a very, very long lasting 3 treasured memory. In reminiscing the final words 4 of our recent past chair, Dr. Christopher Palestro, 5 and I truly agree with him, the hardest thing I 6 have had to do as an ACMUI member is leaving the 7 ACMUI. Thank you very much.
8 (Pause.)
9 MR. EINBERG: Some members requested that the ACMUI 10 members come up here along with the NRC staff for 11 a group photo. And so if we can do that, it'll be a 12 nice memory.(Pause.)
13 CHAIR METTER: Thank you very much, 14 everyone.
15 (Pause.)
16 MR. EINBERG: So Dr. Metter, remember 17 during these presentations after you give your closing 18 remarks or your farewell, we open it up to the ACMUI 19 staff to see if they have any thoughts that they'd 20 like to share. And so I'll open it up to the staff 21 right now -- to the ACMUI members. I see Dr. O'Hara 22 has something.
23 MEMBER O'HARA: Yeah, I want to thank you 24 for the example of leadership that you've shown since 25 I've been here. I've enjoyed learning from you and 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
178 1 from all of my colleagues and all of our colleagues 2 from the past. So I want to thank you and wish you 3 the best.
4 CHAIR METTER: Thank you, Dr. O'Hara.
5 MR. EINBERG: Dr. Jadvar.
6 VICE CHAIR JADVAR: Darlene, we have known 7 each other for many, many years. You have been a 8 great colleague and friend and I always cherished it.
9 And just want to say that I learned much from you.
10 Thank you for mentorship over the past few 11 years here in the ACMUI. And I know we're going to 12 see each other for many, many years to come. And 13 again, I'm very privileged to have you as a friend.
14 Thank you.
15 CHAIR METTER: Thank you, Dr. Jadvar. And 16 your leadership has been very helpful to me too and 17 your presentation as chair in all these subcommittees.
18 And I know you'll do a great job in leadership in the 19 ACMUI in the future. Thank you very much.
20 MR. EINBERG: Mr. Green?
21 MEMBER GREEN: How many years ago was it 22 when we were the new fish at that corner of the table?
23 I felt like a very small fish in a very big pond.
24 You're very kind to be welcoming and receptive.
25 And your leadership has been remarkable.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
179 1 I'm very impressed. I shouldn't be impressed, but you 2 have an impressive degree of concern for the patient.
3 And that's always forefront in your mind.
4 Even though we're not dealing with the 5 patients here, we're dealing with regulations. But 6 you always bring it back to the patient. I appreciate 7 that.
8 CHAIR METTER: Thank you, Mr. Green. I do 9 remember the time that you, myself, and Zoubir were 10 sitting at the end of the table and just kind of being 11 really quiet. But we weren't that quite. But it was 12 very good.
13 And we are here for our patients. And I 14 think we dedicate our lives to the safety and 15 protection and the best of health for our patients.
16 Thank you.
17 MEMBER OUHIB: And on behalf of -- sorry.
18 Zoubir.
19 MEMBER OUHIB: Yes. Speaking of quiet, I 20 just want to thank you, Dr. Metter, for all the hard 21 work you put together. And it showed over the past 22 years a lot of contributions to the ACMUI. Thank you 23 so much. And it was certainly a pleasure and an honor 24 to know and work with you. All the best.
25 CHAIR METTER: Thank you, Zoubir. And 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
180 1 I've always learned from your comments and your 2 questions. And they're always very unique and really 3 something that I wouldn't have thought of. But I 4 thank you too for your contributions to the ACMUI.
5 MR. EINBERG: Okay. So on behalf of the 6 NRC, I think the collaboration that we've had between 7 the ACMUI and the NRC staff is in large part due to 8 your leadership and your collaborative nature, your 9 friendly nature, your welcoming. I think we've had a 10 very good working relationship over the years. And 11 you've really fostered that.
12 And so that goes without saying we're very 13 appreciative of that, your expertise, your knowledge 14 that you bring to the table, and your care for the 15 patients. It's all in the interest of treating the 16 patients and for the good for the American public.
17 And so when Commissioner Wright went through all the 18 subcommittees that you've been on, you've been very 19 involved in all aspects of ACMUI.
20 And when you think of the reach of nuclear 21 medicine in this country, we touch about 20 million 22 individuals per year. You had the very influential --
23 you've had a very influential role in all of this. So 24 on behalf of the NRC, I want to say thank you.
25 CHAIR METTER: Thank you very much. And 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
181 1 you've got, like I said, a great team and a great 2 culture. And I was very honored to be -- I'm 3 privileged to be a part of that. Thank you very much.
4 For the open forum, any other items or comments from 5 the ACMUI? NRC staff? Dr. Tapp?
6 DR. TAPP: Yes. For the open forum, I 7 just wanted to let the ACMUI know that we have two 8 35.1000 documents coming to you guys for review coming 9 up. We have the EYE90 which is a Y90 microsphere 10 product for manual brachytherapy for HCC. And that 11 will be coming your way.
12 It's similar to the TheraSphere and the 13 SIR-Spheres and the licensing guidance document as 14 well as we have the Akesis Galaxy which is a new gamma 15 stereotactic radiosurgery unit used for treatment of 16 the head and neck. And that will also be coming your 17 way for review. We're hoping that there could be 18 subcommittees formed to review these. And hopefully 19 you'll have a teleconference before the next meeting 20 in this spring so we can issue these guidance 21 documents with your recommendations and your review 22 for them.
23 CHAIR METTER: Thank you, Dr. Tapp, for 24 that update on our upcoming subcommittees. Any other 25 items for the open forum? Seeing none, we're on our 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
182 1 last portion of our meeting with our administrative 2 closing with Ms. Armstead.
3 MS. ARMSTEAD: Prospective dates for the 4 spring 2024 conference. As you can see on the 5 calendar for the month of March, it's the 18th and the 6 19th of March. And for the month of May, it's the 8th 7 and the 9th of May -- I'm sorry, April 2024. I did 8 receive greater response from the ACMUI for the April 9 8th and 9th dates. Is there any further discussion 10 for these dates?
11 (No audible response.)
12 MS. ARMSTEAD: So other than finalizing 13 the potential spring 2024 meeting, I do not have 14 anything else to add. Dr. Metter?
15 MR. EINBERG: And Dr. Metter, Chris 16 Einberg. So can we -- assuming the tentative dates 17 are the April 8th and 9th because that was the first 18 priority, that's acceptable to all. Thank you.
19 CHAIR METTER: Do we need to vote on that?
20 Yes, Ms. Shober.
21 MS. SHOBER: Yes, thanks. Are we doing a 22 Commission briefing at the spring meeting, or are 23 those dates -- will they take that into account?
24 MR. EINBERG: Dr. Tapp?
25 DR. TAPP: Yes, the plan at this time 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
183 1 would be to do a commission briefing in the spring.
2 So the tentative dates that we would aim for is the 3 8th and 9th. But you're right. We have to wait for 4 SECY to finalize dates. We're trying to get it 5 together.
6 CHAIR METTER: Okay. Thank you. Do we 7 have to vote on that?
8 DR. TAPP: I do believe -- I think we just 9 hold it tentatively at this point.
10 MS. ARMSTEAD: Dr. Metter, there was a 11 vote that went out last month and the team favored the 12 8th and the 9th.
13 MR. EINBERG: But what Dr. Metter was 14 asking whether right now in the public forum do they 15 need to vote on that. And so Dr. Tapp had something 16 to say.
17 DR. TAPP: Yes, we do vote on the 18 tentative dates to have it on those dates. So yes, 19 there should be a vote.
20 CHAIR METTER: Okay. Do I have a motion 21 to approve the tentative dates for the spring meeting 22 as April 8th and 9th pending the Commission's 23 scheduling and our meeting with them?
24 MEMBER GREEN: So moved.
25 MEMBER WOLKOV: Second.
1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
184 1 CHAIR METTER: Okay. All in favor, say 2 aye.
3 (Chorus of aye.)
4 CHAIR METTER: All opposed or abstain?
5 Thank you. The motion is unanimously approved by the 6 committee. Any other administrative closing items?
7 Ms. Armstead?
8 MS. ARMSTEAD: That's it, Dr. Metter.
9 CHAIR METTER: Thank you. So Mr. Einberg, 10 any other final comments before we close this meeting?
11 MR. EINBERG: I just wanted to thank the 12 ACMUI members for all their hard work they put in 13 throughout the year, their expertise that they bring 14 to the NRC and to the public. I want to thank the NRC 15 staff for putting together this meeting. And there's 16 a lot of preparation that goes into it.
17 But that's all I have for right now. And 18 I want to say goodbye to Dr. Metter. And so all the 19 best to you.
20 CHAIR METTER: Thank you very much. And 21 this concludes the 2023 fall meeting of the ACMUI.
22 And thank you for your attention and participation and 23 the timely updates and reports by the ACMUI members 24 and NRC staff.
25 I also would like to wish you all a happy 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
185 1 holiday, upcoming holiday and be safe and safe travels 2 to your home. Thank you very much. The meeting is 3 adjourned.
4 (Whereupon, the above-entitled matter went 5 off the record at 4:03 p.m.)
6 7
8 9
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1($/5*5266
&28575(3257(56$1'75$16&5,%(56
WK675((71:68,7(
:$6+,1*721'& ZZZQHDOUJURVVFRP
C E R T I F I C A T E This is to certify that the foregoing transcript In the matter of: Meeting of the Advisory Committee on the Medical Uses of Isotopes Before: US NRC Date: 10-23-23 Place: teleconference was duly recorded and accurately transcribed under my direction; further, that said transcript is a true and accurate DPNQMFUFrecord of the proceedings.
Court Reporter 1($/5*5266 COURT REPORTERS AND TRANSCRIBERS
7+671:67(
(202) 234-4433 :$6+,1*721'& www.nealrgross.com