ML23159A193
| ML23159A193 | |
| Person / Time | |
|---|---|
| Issue date: | 05/24/2023 |
| From: | NRC/NMSS/DREFS/MRPB |
| To: | |
| References | |
| NRC-2378 | |
| Download: ML23159A193 (102) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Public Meeting on the Information Request Federal Register Notice (FRN) Related to the Rulemaking on Reporting Nuclear Medicine Injection Extravasations as Medical Events Docket Number:
N/A Location:
Videoconference Date:
05-24-2023 Work Order No.:
NRC-2378 Pages 1-101 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1716 14th Street, N.W.
Washington, D.C. 20009 (202) 234-4433
1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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PUBLIC MEETING ON THE INFORMATION REQUEST FEDERAL REGISTER NOTICE (FRN) RELATED TO THE RULEMAKING ON REPORTING NUCLEAR MEDICINE INJECTION EXTRAVASATIONS AS MEDICAL EVENTS
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WEDNESDAY MAY 24, 2023
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The Public Meeting convened via Videoconference, at 1:00 p.m. EDT, Dan Frumkin, Facilitator, presiding.
2 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com PRESENT DAN FRUMKIN, Facilitator DANIEL DIMARCO, NMSS/MSST/MSEB KEVIN WILLIAMS, NMSS/MSST IRENE WU, NMSS/REFS/MRPB ALSO PRESENT MARY AJANGO, Young Survivors Coalition XANDER ARENA GEORGE CHACKO CATHY CUTLER, Brookhaven National Laboratory SIMON DAVIES, Team Cancer America MICHELE EDWARDS DANIEL GOMEZ-CARDONA, Gundersen Health System RICHARD HARVEY, Roswell Park Comprehensive Cancer Center WILLIAM HINCHCLIFFE, Yale New Haven Hospital RAMSEY KILANI, Global Security Innovative Strategies TRACY KING, Medical Physics Consultants BRYAN LEMIEUX RALPH LIETO HELEN NADEL, Lucile Packard Children's Hospital Stanford CARMINE PLOTT, Forsyth Medical Center JIM SLINEY JR., Patients Rising
3 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com GINA KELL SPEHN, New Day Foundation for Families PAT ZANZONICO, Memorial Sloan Kettering Cancer Center
4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com T-A-B-L-E O-F C-O-N-T-E-N-T-S PAGE Welcome and Logistics 5
Opening Remarks 8
Background
11 Information Request and Preliminary Proposed Language 16 How to Prepare and Submit Comments 76 Next Steps 78 Public Feedback and Questions 80 Adjourn 101
5 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com P-R-O-C-E-E-D-I-N-G-S 1
1:00 p.m.
2 MR. FRUMKIN: Good afternoon, everyone, 3
and welcome. My name is Dan Frumkin. I'm going to be 4
your facilitator for today's meeting. Good afternoon 5
for those on the East Coast, Central Time. And 6
Mountain, I guess it's still morning, maybe.
7 As facilitator, I want to welcome you all 8
to this meeting regarding the information request in 9
the Federal Register notice that was published on 10 April 19, 2023 on the rulemaking on reporting nuclear 11 medicine injection extravasations as medical events.
12 During this meeting, we intend to provide 13 clarifications to the information in the April 19 FRN 14 and also explain the process of providing feedback to 15 the NRC.
16 This meeting is not intended to collect 17 comments. And although it will be transcribed, 18 statements made during this meeting are not 19 automatically included in the rulemaking docket. The 20 purpose is to encourage attendees and stakeholders to 21 provide feedback using the means discussed in the FRN.
22 That's feedback on the rulemaking.
23 We have allocated time during this meeting 24 at several points in the staff presentations and also 25
6 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com at the end of the meeting to allow stakeholders and 1
public to ask questions.
2 The slides for today's meetings are in our 3
ADAMS document library under Accession No.
4 ML23132A116. I'll drop that link in the chat.
5 My role is to help ensure the meeting is 6
informative, productive, on topic, and on time. Of 7
those four tasks, the most important is keeping the 8
meeting on topic. We have a lot to do and a short 9
time to do it. If you plan on speaking on something 10 other than the topic of the public meeting, please 11 hold those comments for a more appropriate venue.
12 If you are listening through a telephone 13 line, you will be muted, and you will press *5 to 14 raise your hand and *6 to unmute your mic. Phone 15 attendees should email Irene Wu at Irene.Wu@nrc.gov if 16 you would like your attendance recorded in the meeting 17 summary.
18 Teams has a chat function. We would like 19 to reserve the chat for technical questions about the 20 Teams platform and for clarifications about the 21 meeting features.
22 Please provide feedback orally through 23 Teams after unmuting or via phone. The meeting is 24 being transcribed. Therefore, we ask that your 25
7 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com feedback be provided during the audio portion of the 1
meeting.
2 When speaking today, be sure to speak 3
slowly, clearly, and directly into your microphone.
4 And please start with your name and affiliation even 5
if you have spoken before. So if you raise your hand 6
and then you raise your hand again, please provide 7
your name and affiliation a second time. And as much 8
as possible, please minimize any background noises 9
such as pets while you are speaking.
10 We want everyone who speaks to get the 11 chance, so we would like to limit the comment time for 12 comment to no more than two to three minutes. Let's 13 stay on topic. And please, one speaker at a time.
14 Finally, our opinions may differ but we 15 are all colleagues here. So let's maintain the quorum 16 in our forum.
17 There may be opportunities where you raise 18 your hand and you ask for some clarifications. We 19 might cut you off to let other people have a chance.
20 And you can just raise your hand again and get back 21 into the queue. This has worked successfully in other 22 forums.
23 Lastly, if there are any questions about 24 the process for managing this meeting at this time, 25
8 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com let me know. If so, you will see there's a Raise Hand 1
feature at the top of your screen or in the middle of 2
your screen where you can raise your hand. I just 3
activated it for myself and deactivated it.
4 When we get to points of questions, you 5
can raise your hands. Then we will introduce you by 6
name and you can unmute yourself to speak.
7 If you raise your hand as a caller, we'll 8
recognize you by number. You press *5 to raise your 9
hand and *6 to unmute. And with that, I will lower my 10 hand.
11 We will start with Kevin Williams, who 12 will give opening remarks. Kevin is the Director of 13 the Division of Materials Safety, Security, State, and 14 Tribal Programs in the NRC's Office of Nuclear 15 Material Safety and Safeguards.
16 With that, Kevin?
17 MR. WILLIAMS: Thanks, Dan.
18 Good afternoon and good morning to all.
19 Welcome to the public meeting on the information 20 request FRN for the rulemaking on extravasations. We 21 recognize there is a lot of energy and interest on 22 this topic, so we appreciate everyone taking the time 23 to attend this meeting.
24 Next slide, please.
25
9 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com As previously stated, the purpose of this 1
public meeting is to provide information to 2
stakeholders to help prepare their comments on this 3
information request.
4 By way of background, on December 12th of 5
- 2022, the Commission approved the staff's 6
recommendation to amend 10 CFR 35 to include certain 7
nuclear medicine extravasations as medical events.
8 The staff developed an information 9
request, which made available the preliminary proposed 10 rule language, and included a number of questions for 11 stakeholders to provide input on to help inform the 12 staff's development of the proposed rule.
13 The NRC, as Dan had talked about, is not 14 seeking comments at this meeting. Any comments should 15 be formally submitted using the instructions we 16 provide later in our presentation.
17 Although the NRC is not seeking comments 18 at this meeting, as part of the feedback you give to 19 us today at this meeting and any comments you submit 20 in response to this information request, we welcome 21 your thoughts on any questions that we may have missed 22 or any new information that we should consider that 23 wasn't part of the information request.
24 The comments we receive in response to 25
10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com this information request will be considered in our 1
development of the proposed rule.
2 Next slide.
3 Irene Wu will take us through the 4
background on the topic of today, of the meeting.
5 Daniel DiMarco will go over the information request 6
and preliminary proposed rule language. We will 7
provide information on how to submit comments and our 8
next steps. And we will have some time for public 9
feedback and questions.
10 I'd like to thank everyone again for 11 attending this meeting. We look forward to your 12 feedback.
13 I now turn the meting over to Irene Wu.
14 MS. WU: Hi. Thanks so much, Kevin.
15 I'm Irene Wu. I'm the Project Manager for 16 this rulemaking. I'm in the Division of --
17 MR. WILLIAMS: Irene, you're on mute. We 18 can't hear you.
19 MR. FRUMKIN: We can hear you, Irene. I 20 don't know why Kevin can't hear you.
21 MS. WU: Can you hear me now, Kevin?
22 MR. WILLIAMS: I still can't hear you.
23 MR. FRUMKIN: Can you hear me?
24 MR. WILLIAMS: Dan, can you hear?
25
11 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. FRUMKIN: Yes. I'll put it in the 1
chat.
2 Go ahead, Irene.
3 MS. WU: Okay. I'll keep going. Let me 4
know if you can't hear me.
5 Again, I'm in the Division of Rulemaking, 6
Environmental, and Financial Support in the Office of 7
Nuclear Material Safety and Safeguards here at the 8
NRC.
9 For this next section of our presentation, 10 as Kevin said, I'll give you some background on this 11 rulemaking and the steps leading up to the information 12 request that we published last month in the Federal 13 Register.
14 I do want to add that we have several NRC 15 staff in attendance at this public meeting, including 16 quite a few members of the working group, myself and 17 Daniel, who you will hear from shortly.
18 We also have Maxwell Smith, Ian Irvin, and 19 Jen Scro from our Office of the General Counsel. We 20 also have quite a few members from our NRC Medical 21 Radiation Safety Team, as well as the Rulemaking 22 Center of Expertise here at the NRC, who are 23 supporting this meeting and may pop on camera if need 24 be to help answer some questions.
25
12 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Next slide, please.
1 I'll start off with the 1980 final rule.
2 So back in 1980, the Commission amended part 35, which 3
is our regulation on the medical use of byproduct 4
material, to require quarterly reporting of diagnostic 5
administrations and prompt reporting of therapeutic 6
misadministrations.
7 And in that 1980 final
- rule, the 8
Commission excluded radiopharmaceutical extravasations 9
from the reporting requirements, stating in part that 10 extravasation frequently occurs in otherwise normal 11 intravenous or intra-arterial injections and it is 12 virtually impossible to avoid. Therefore, the 13 Commission does not consider extravasation to be a 14 misadministration.
15 So just to remind folks what we mean by an 16 extravasation, an extravasation is an unintentional 17 leakage of injected material into the tissue 18 surrounding a vein or artery.
19 And as included in our rulemaking plan, 20 which I'll talk about in a little bit, studies 21 indicate that overall radiopharmaceutical 22 extravasation rates range from, I think, about three 23 to 23 percent of injections.
24 And the probability of an extravasation 25
13 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com can be affected by several things: patient anatomy, 1
condition, movement of the patient. There's also 2
taking into consideration the training, experience, 3
and technique of the clinician or medical personnel 4
who is administering the injection. And then also the 5
catheter size plays a role.
6 Next slide, please.
7 Since then, the NRC staff over the years 8
has requested the Advisory Committee on the Medical 9
Uses of Isotopes to evaluate whether extravasations 10 should continue to be excluded from medical event 11 reporting.
12 Most recently, in January of 2020, staff 13 took a look at this and began an independent 14 evaluation of whether extravasations should be 15 reported as medical events. As part of that 16 independent evaluation, we wanted to hear from the 17 medical community and other stakeholders.
18 So in December of 2020, we held a public 19 meeting to provide information on the staff's 20 evaluation. And the ADAMS Accession number for the 21 public meeting summary is ML21005A436.
22 Staff then provided its preliminary 23 evaluation of reporting extravasations as medical 24 events to the Advisory Committee on the Medical Uses 25
14 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com of Isotopes. And at a high level that evaluation 1
contained six options, which were a mix of rulemaking 2
and non-rulemaking options, and then there was the no-3 action option.
4 The recommendation was that extravasations 5
events that require medical attention be reported as 6
medical events. All of the non-rulemaking options 7
were dismissed since staff determined that 8
extravasations don't fit into the current medical 9
event reporting criteria.
10 And then ACMUI after their review agreed 11 with the staff's recommendation during their September 12 2021 public meeting. The Adams Accession number for 13 that public meeting by ACMUI is ML21267A021.
14 Next slide, please.
15 Okay. So while the NRC staff evaluation 16 was progressing in the 2020 time frame, we received a 17 petition for rulemaking from Lucerno Dynamics in May 18 of 2020, requesting that NRC revise its regulations to 19 require medical event reporting of extravasations that 20 result in a localized dose equivalent exceeding 50 21 rem.
22 So in September of 2020, we published a 23 Federal Register notice announcing the docketing of 24 that petition. And we had a 75-day public comment 25
15 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com period, which resulted in us receiving more than 480 1
comment submissions during that comment period.
2 Then in May of 2022, staff provided a 3
rulemaking plan -- that being SECY-22-0043 -- to the 4
Commission that presented options for amending part 5
- 35. And in that rulemaking plan, staff recommended 6
including as reportable medical events nuclear 7
medicine injection extravasations that require medical 8
attention for suspected radiation injury.
9 Staff also committed in that rulemaking 10 plan to develop regulatory guidance for the reporting 11 of extravasations, including developing a dosimetry 12 model that the medical community could use to 13 characterize extravasations and assess expected 14 radiation injury.
15 In December of 2022, the Commission issued 16 its Staff Requirements Memorandum, SRM-SECY-22-0043, 17 which directed staff to begin a rulemaking amending 18 NRC's regulations to mandate medical event reporting 19 of extravasations that require medical attention for a 20 suspected radiation injury.
21 In that SRM, the Commission also directed 22 staff to explore approaches to reduce reliance on 23 patient reporting, develop regulatory guidance for all 24 medical events, and also look for opportunities to 25
16 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com accelerate the rulemaking schedule without shortening 1
the public comment periods.
2 So that brings us to present day and the 3
information request that we recently published. I'll 4
turn it over to Daniel DiMarco to go through that and 5
the preliminary proposed rule language.
6 MR. DIMARCO: Hi, everyone.
7 Thanks, Irene.
8 I'm Daniel DiMarco. I'm a health 9
physicist here on the medical team for the NRC. I'm 10 going to bring you all through explaining some of the 11 things that were asking for in our information 12 request, as well as an overview of some of our 13 preliminary proposed rule language.
14 Next slide, please.
15 So this information request that we're 16 talking about right now was published in the Federal 17 Register on April 19, 2023. You can see the Federal 18 Register number is there.
19 The deadline for comments on it is July 20 18, 2023. So please be sure to go in and get your 21 comments in through the ways we'll show you later on 22 in the presentation.
23 This notice made the preliminary proposed 24 rule language for the rulemaking available, as well as 25
17 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com posing a few questions for us to obtain input from 1
stakeholders.
2 Next slide, please.
3 I just want to say beforehand the 4
preliminary proposed rule language here does not 5
represent a final NRC staff position, nor has it been 6
reviewed by the Commission. Therefore, this proposed 7
rule language may undergo revision and almost 8
certainly will undergo revision during this rulemaking 9
process.
10 Specifically, this preliminary proposed 11 rule language includes updates to two sections, 10 CFR 12 35.2 and 35.3045, as well as the addition of two 13 sections, 10 CFR 35.42 and 35.2042.
14 Next slide, please.
15 And that's all in 10 CFR 35. Just to get 16 into it, this is our preliminary proposed rule 17 language, the addition into the 35.2 Definitions 18 section of 10 CFR 35. First, we would like to add 19 these three definitions in there:
20 Extravasation, which means the leakage of 21 a radiopharmaceutical from the blood vessel into the 22 surrounding tissue; 23 Medical attention, which means any 24 techniques used to reduce the chance, severity, or 25
18 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com symptoms of a suspected radiation injury; 1
And suspected radiation injury, which 2
means a potential or observable deterministic health 3
effect to the area around an injection site that can 4
be attributed to radiation.
5 Next slide, please.
6 And so for this information request, we 7
decided to group these questions into three separate 8
topics: one on definitions, one on procedures, and 9
another on healthcare inequalities.
10 For the next several slides I'll show you 11 our preliminary proposed rule language, as well as any 12 of the questions related to that. And so for this, we 13 have our information request questions related to the 14 definitions. Specifically, we've got these questions 15 here.
16 Which term should the NRC use -- for 17 example, extravasation or infiltration -- when 18 describing the leakage of radiopharmaceuticals from a 19 blood vessel or artery into the surrounding tissue?
20 First of all, I would like to thank the 21 ACMUI. They were here. We presented these questions 22 to them last week at their public meeting, and they 23 gave us a lot of good feedback on we should have used 24 vein instead of blood vessel or artery. That was a 25
19 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com little bit redundant there.
1 But I do want to say for this question, we 2
wanted to start out basically as simple as we could 3
with this because, at least when I was doing my 4
research for this, extravasation in a medical sense 5
typically involves vesicants, of which there are no 6
radiopharmaceutical vesicants that I know of.
7 And so when we wanted to ask these 8
questions, we wanted to start with the very baseline 9
of -- we use all of these words very frequently. And 10 so we want to all know exactly what we're talking 11 about regulatorily, but especially for these public 12 meetings and things like that. We all need to know 13 exactly what we're talking about to really have any 14 sort of consensus on what we're getting at.
15 And so after that we've got, what criteria 16 should the NRC use to define suspected radiation 17 injury? This is kind of the crux of the issue here.
18 How do we make these extravasations reportable? What 19 level should we make them at?
20 And then afterwards we've got, what 21 techniques or methods should be included in the 22 definition of medical attention? This is very broad 23 intentionally because there are a lot of different 24 techniques that can be used to help mitigate the 25
20 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com chance of severity of these extravasations. And there 1
are ways that these medical techniques interact that 2
we definitely need more input from the stakeholders 3
on.
4 Next slide, please.
5 Now that we've gone through the definition 6
questions, I just want to open this up to take 7
questions from the public on this. I want to say 8
specifically we're asking for clarifying questions on 9
these questions.
10 If there's anything in these questions you 11 don't understand or you want me to clarify a bit more 12 just to help get your comments in more accurately, 13 process your views more accurately, then that's what 14 this time is for.
15 And I believe, Dan, you've got some 16 process stuff.
17 MR. FRUMKIN: Yes. Please raise your hand 18 using the hand-raising system. You have the ability 19 to unmute yourself so when we call on you, you will 20 need to unmute yourself.
21 Please provide your name, affiliation, and 22 your question for the staff regarding the information 23 regarding the April 19th FRN. And at this point, we 24 just want questions for the staff regarding the 25
21 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com definitions.
1 We have Pat -- I'm sorry -- Zanzonico?
2 DR. ZANZONICO: That's okay. Yes. This 3
is Pat Zanzonico, Memorial Sloan Kettering Cancer 4
Center in New York City.
5 It strikes me that the use of the term 6
leakage, which implies basically a passive process, is 7
entirely inconsistent with the use or characterization 8
of an extravasation as a medical event.
9 Leakage is not something that's caused by 10 a user, meaning the person performing the injection.
11 It's a passive process whereby material within blood 12 vessels is finding its way out of the blood vessels.
13 It really has nothing to do with what one 14 normally understands to be a medical event. So to my 15 way of thinking, it undermines the entire premise of 16 characterizing extravasations as medical events.
17 MR. FRUMKIN: Pat, is there a question in 18 there?
19 DR. ZANZONICO: No, other than that if 20 this is the language that's ultimately used, it's 21 inconsistent with the whole concept of a medical 22 event.
23 So I don't know if you want to qualify 24 this more specifically to match, I think, the 25
22 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com intention of this change in rulemaking. I think 1
simply the use of the word leakage is incompatible 2
with this rulemaking in general.
3 MR. FRUMKIN: Okay. Daniel, do you have 4
any comments or clarifications to provide?
5 MR. DIMARCO: I will say that once we get 6
into the next section, we'll go into some of the 7
actual proposed rule language for where these 8
reportable events will come from.
9 Just as a quick preview on that, we are 10 not looking for all extravasations to be reportable 11 events, just certain extravasations. But thank you 12 for that comment.
13 Like we've said before, please put that 14 into the Regulations.gov or a formal comment period to 15 be heard on the rulemaking because these are the good 16 perspectives that we're looking for on this. So thank 17 you.
18 MR. FRUMKIN: Thank you.
19 Now we move to Ralph Lieto. Please state 20 your name -- hopefully, I got it right -- affiliation 21 and your question for the staff regarding 22 clarification on the information from the April 19th 23 FRN in the definitions portion.
24 MR. LIETO: Thank you. My name is Ralph 25
23 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Lieto. I'm a medical physicist from Michigan.
1 Regarding the definitions, you may not 2
have the answer to this right now, but it would be 3
helpful to understand the source of these definitions 4
that you're applying to these terms. Did this come 5
out of some national standard from, say, nursing 6
administrations or something from an oncology in terms 7
of chemotherapy administration procedures?
8 It would have maybe some understanding of 9
-- I think it goes a little bit to the question that 10 Dr. Zanzonico had before, but also maybe trying to 11 understand where you're trying to define in these 12 terms because they seem to have a lot of questions in 13 terms of their clarity.
14 MR. DIMARCO: Yes. Thank you for that.
15 That was one of the troubles that we've had, 16 especially when determining some of these information 17 request questions. The preliminary proposed rule 18 language in particular was -- we don't want to step on 19 any toes of already-established medical terminology.
20 But of course, there's always issues with 21 that when we're trying to be as specific as we are 22 with the medical event reporting criteria that we've 23 got. So yes, we will definitely take that into 24 account going forward.
25
24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. FRUMKIN: The next question is from 1
Daniel Gomez-Cardona. Please unmute yourself, state 2
your affiliation and your question regarding the April 3
19th FRN, the definition section.
4 DR. GOMEZ-CARDONA: Thank you. I am a 5
diagnostic physicist, Gundersen Health System in 6
7 My question comes more about what 8
encompasses extravasation and infiltration, which is 9
by basic definition a fluid, and how that would 10 encompass a scenario such as radioembolizations with 11 microspheres, for example. Those are very high doses 12 as well.
13 Would those be included in this type of 14 proposal as potential issues that would affect the 15 patient? I don't know if you're thinking about 16 considering that.
17 MR. DIMARCO: That was a topic that was 18 actually brought up by ACMUI recently where the 19 nuclear pharmacist ended up including a bunch of 20 different radiopharmaceuticals that are not 21 administered through a vein or an artery.
22 And so that's something that we're also 23 thinking about now going forward as to how to 24 encompass the definition for all of those 25
25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com radiopharmaceuticals that we would like these events 1
to be reported as. So thank you.
2 MR. FRUMKIN: Thank you for your question.
3 It looks like we're getting close to the 4
end of the questions here. There's going to be plenty 5
of time to ask questions on the additional topics, 6
procedures, and so forth. If questions do come up on 7
this topic of definitions, those are welcome later in 8
the meeting as well.
9 So with that, Simon Davies, you can unmute 10 yourself. State your affiliation and clarifying 11 question about the April 19th FRN, definitions.
12 MR. DAVIES: Yes. My name is Simon 13 Davies. I'm the Executive Director of Team Cancer 14 America, which works to develop programs and services 15 for adolescents and young adults with cancer 16 throughout America. I'm also part of a coalition or 17 federation of efficacy organizations for Patients for 18 Safer Nuclear Medicine.
19 I just wanted to talk about the use of the 20 term suspected radiation injury and the work that 21 you're going to do on defining that. I think one of 22 the challenges in this is that the late effects of 23 this can be considerably down the line.
24 And so our advocacy would be for all 25
26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com incidents to be reported because it can be not clear 1
at the point of the leakage or whatever term ends up 2
being used for that. Injury is inevitable, but there 3
are often cases of people who have radiation late 4
effects, toxic effects some months afterwards.
5 And so we would advocate for a total 6
reporting of all incidents regardless of a suspected 7
radiation injury for the safety of patients. Thank 8
you.
9 MR. FRUMKIN: Thank you for your comment.
10 Okay.
11 Richard Harvey, you can unmute yourself.
12 Please state your affiliation and your questions about 13 clarifications on the definitions.
14 DR. HARVEY: Hi. Richard Harvey from 15 Roswell Park Comprehensive Cancer Center in Buffalo, 16 New York. I'm also the RSO on the ACMUI.
17 I'm in a dissenting view on this, but my 18 concern is the last speaker. Reporting every 19 extravasation would be extremely cumbersome and 20 probably would not provide a lot of bang for the buck, 21 so to speak.
22 Every time we penetrate a vein with an IV 23 injection, you're essentially having some potential 24 leakage of radioactive material. I think that the 25
27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com NRC's proposed rulemaking where we're looking at those 1
extravasations that could cause injury or potential 2
injury makes more sense, to take a more middle-of-the-3 road approach.
4 The actual number of extravasations that 5
you're going to have based on the number of procedures 6
performed would be astronomical or at least very 7
significant. I think suspected radiation injury, like 8
others say, has to be defined clearly.
9 My understanding is unless we reach 50 10 rem, we don't have to report that. Is that correct?
11 MR. DIMARCO: I am not at liberty to 12 discuss any of the specifics right now of what we're 13 looking at for suspected radiation injury. We'll get 14 into that in a little bit more in the next section.
15 As I said before, this is an information 16 request notice. So nothing is set in stone yet.
17 We're still getting comments from the stakeholders.
18 That's all I can say right now on that.
19 MR. FRUMKIN: Thank you for your feedback.
20 We do want to remind folks that -- there 21 was a question there -- we are looking for questions 22 about what was in the FRN. So we can provide some 23 clarity on the FRN.
24 We don't want to lose this input. That 25
28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com would be something that we're trying to get as part of 1
the Regulations.gov submittal of comments by the July 2
date.
3 So these are very important, as Daniel 4
said. And we do want to get that information, but 5
this is a venue now to ask questions of the NRC staff 6
on what was the intent of the language in this FRN.
7 William Hinchcliffe, you can unmute 8
yourself and ask your question.
9 MR.
HINCHCLIFFE:
Hi.
William 10 Hinchcliffe. I'm the Radiation Safety Officer for 11 Yale New Haven Hospital.
12 I'm looking for a little bit of clarity in 13 the definition for medical attention and that it 14 includes any techniques used to reduce the chance of a 15 suspected radiation injury.
16 Really the question being that anytime you 17 have any suspected extravasation with a
18 radiopharmaceutical, it would be likely you have 19 procedures in line with other pharmaceutical 20 administrations in order to deal with the 21 extravasation. So even if you are not seeing a 22 potential or suspected radiation injury, you would 23 still go through techniques to reduce the impact of 24 that extravasation.
25
29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com And I don't see how the definition as it 1
exists now wouldn't end up requiring the reporting of 2
all extravasations as long as you did any technique 3
after the extravasation occurred, which you likely 4
would.
5 MR. DIMARCO: Yes. So that is something 6
that -- we left the medical attention definition 7
intentionally broad to encompass all of those 8
different techniques, either before or immediately 9
after the extravasation for this.
10 Just to clarify as I probably should have 11 put it in beforehand, in the next section we'll go 12 into the specific reporting requirements themselves 13 that we're looking at, the intention for these 14 reporting requirements. Specifically, that it's not 15 the application of any of these techniques that would 16 be a reportable threshold there.
17 The reportable threshold itself would have 18 to be determined either by the physician, if they were 19 able to identify that an extravasation had occurred 20 and had a good idea of the characterization of that 21 extravasation, or in a worst case scenario where a 22 patient would have to come back for the treatment of a 23 radiation injury due to an extravasation.
24 So the level is not specifically at 25
30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com medical attention. It is not specifically at an 1
injury itself being observed. It would be a level of 2
an extravasation occurring where a radiation injury 3
could in all likelihood occur.
4 So that's obviously a very ephemeral idea.
5 But that's why we included this information request, 6
so we could nail down that reporting level as best as 7
we could based on stakeholder input.
8 MR. FRUMKIN: Thank you for that question.
9 We have two more hands raised. After 10 these two hands, we're going to try to push forward 11 with the procedures section.
12 Ramsey Kilani, you can unmute yourself and 13 ask your question. State your affiliation as well, 14 please.
15 DR. KILANI: Hi. Dr. Ramsey Kilani, 16 board-certified radiologist, Chief Medical Officer at 17 Global Security Innovative Strategies in DC.
18 My question regarding number two is 19 suspected radiation injury by whom? There's been 20 discussion of the medical professionals identifying 21 the possibility of an extravasation and a possible 22 injury, and there's a dose threshold there that's 23 implicit in that.
24 But I also heard and read in some of the 25
31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com past commentary that there was a suggestion that a 1
patient should somehow be able to know whether they 2
should suspect a radiation injury. I think that needs 3
to be clear.
4 MR. DIMARCO: Yes.
5 DR. KILANI: The latter seems kind of 6
ridiculous.
7 MR. DIMARCO: Yes. That's part of our 8
procedures section afterwards, but the intention for 9
that is that the actual suspected radiation injury 10 will only be able to be identified by some sort of 11 professional who has the schooling, training, and 12 experience to identify a radiation injury, whether 13 that be an AU or a medical professional.
14 I've seen in different studies that 15 sometimes dermatologists are called in to deal with 16 these specific radiation injuries. But determining 17 whether or not an injury is induced by radiation is 18 not something that the patient would need to do.
19 The patient would just need to realize 20 that an injury has occurred. Of course, this is in 21 the worst case scenario that a medical professional or 22 a medical team was completely unaware that an 23 extravasation has occurred.
24 DR. KILANI: Sure. The point of this is 25
32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com this is exactly why there's a 50 rem threshold in the 1
rest of the NRC's reporting criteria. As we all know, 2
radiation is insidious.
3 Often
- times, the acute effects of 4
extravasation are just based on fluid volume and other 5
things. And the likelihood of a true radiation-6 induced injury is going to be obscured to even 7
professionals. We don't 100 percent know.
8 That's why the NRC's job has always been 9
to create thresholds with safety factors built in, so 10 that there's a mechanism to keep people as safe as 11 possible. With that, I'll hold the rest of my 12 comments for later.
13 MR. DIMARCO: Thank you for that comment.
14 Please do send a comment through the Regulations.gov 15 or other channels because we need to hear that 16 commentary. Thank you.
17 MR. FRUMKIN: Thanks for your comment and 18 your question.
19 Before we move on to the procedures 20 section and that rulemaking language, Kathleen 21 Hintenlang, please unmute yourself, ask your question, 22 and state your affiliation.
23 DR. HINTENLANG: Thank you. I'm Kate 24 Hintenlang. I'm a medical physicist querying on 25
33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com behalf of the ACR.
1 And we'd like to know, are there any plans 2
to use existing federal standards for this such as the 3
National Cancer Institute's Common Terminology for 4
Clinical Adverse Events, commonly referred to as 5
CTCAE, which grades adverse event severity based on 6
deterministic
- effects, if it required medical 7
intervention levels? Thank you.
8 MR. DIMARCO: In short terms, yes. We 9
have been looking into different medical communities 10 as well as international guidelines on radiation 11 effects to help, I guess, guide our thoughts on these 12 classifications.
13 MR. FRUMKIN: Thanks for that question.
14 I'm going to pull back everyone to the 15 same slide. We can move to the next section if that's 16 okay with you, Daniel.
17 MR. DIMARCO: That's fine by me. Thanks, 18 Dan.
19 MR. FRUMKIN: All right.
20 MR. DIMARCO: Okay. So this next section, 21 starting off with some of the preliminary proposed 22 rule language in 35.42. This is an entirely new 23 section of 10 CFR 35, but it's very similar to 35.41, 24 procedures for evaluating and reporting medical 25
34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com events.
1 So for this, you can see here that for any 2
administration in which an extravasation can occur, 3
the licensee must develop, implement, and maintain 4
written procedures to provide high confidence that an 5
extravasation that requires medical attention for a 6
suspected radiation injury will be detected and 7
reported in a timely manner and in accordance with 8
35.3045.
9 These written procedures required by 10 paragraph (a) must address how the licensee determines 11 that an extravasation meets the criteria for a medical 12 event. And the licensee must retain a copy of the 13 procedures written under paragraph (a) in accordance 14 with 35.2042.
15 My next slide is 35.2042, which is 16 basically completely in line with the 35.2041, where a 17 licensee must retain a copy of the procedures required 18 by 35.42 for the duration of the license. And so this 19 is just to be in line with the rest of our 20 regulations.
21 Next slide, please.
22 So here's, I guess, the meat and potatoes 23 of it, the reporting and notification of a medical 24 event where we're adding just one under 35.3045(a)(3),
25
35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com the administration of byproduct material that results 1
in an extravasation that requires medical attention 2
for a suspected radiation injury. That's where these 3
medical events will be reported under.
4 Next slide, please.
5 Going on to some of the questions for 6
that, we've got a couple of slides for questions on 7
this. I will go through all of the questions for 8
these procedures ones, and then at the end open it up 9
again for questions on these questions. Dan will open 10 up these slides so you can move back and forth between 11 them to refresh yourself for a question.
12 Question 4, what steps could the licensee 13 take to minimize the chance of a radiopharmaceutical 14 extravasation occurring? This is something that was 15 not specifically asked by the Commission in the SRM, 16 but something that we wanted to get more input on from 17 the stakeholders.
18 What steps should the licensee take when 19 an extravasation is suspected or discovered?
20 What techniques, technologies, or 21 procedures -- for example, post-treatment imaging, 22 visual observation of the patient, or getting more 23 patient feedback during the injection -- should be 24 used to help identify an extravasation during or 25
36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com immediately after a radiopharmaceutical injection?
1 Next slide, please.
2 Question 7,
which techniques, 3
technologies, or procedures -- post-treatment imaging 4
or survey measurement, for example -- should be used 5
to better characterize an extravasation immediately 6
after radiopharmaceutical treatment?
7 What information should licensees provide 8
to nuclear medicine patients on how to identify an 9
extravasation and how to follow up with their 10 physician if they suspect a radiation injury?
11 This is something that could be done 12 before or during the treatment to help prime the 13 patient for if there is any feelings that are going 14 wrong during the treatment to help identify these 15 extravasations as soon as possible.
16 The next
- question, when should a
17 reportable extravasation be counted as discovered for 18 the purposes of notification; for example, when 19 medical attention is administered, when the physician 20 identifies that the injury is from radiation?
21 In our regs we have very strict guidelines 22 on identification of medical events and specifically 23 when those notifications need to come out. So we 24 would like more information on that specifically for 25
37 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com extravasations.
1 Next slide, please.
2 Like in this question where the NRC 3
requires that the licensees notify the referring 4
physician and the individual who is the subject of a 5
medical event no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the 6
discovery of said medical event.
7 So when should licensees be required to 8
provide notification of an extravasation medical event 9
to the referring physician and the individual who had 10 been extravasated?
11 This next question harkens back to a 12 previous question. Who -- for example, the patient's 13 primary care physician, any authorized user, a nuclear 14 medicine technician -- which, as a side note, thank 15 you again to the ACMUI for correcting us on this.
16 That should be nuclear medicine technologist, not 17 technician. Who should be able to identify an 18 extravasation that could result in a suspected 19 radiation injury?
20 And then finally, what topics should the 21 NRC include in guidance to assist licensees to 22 accurately identify, characterize, and report these 23 extravasation events in a timely manner?
24 Guidance is something that we are 25
38 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com currently writing for this. And so with this proposed 1
rule, there will be guidance on how to report all of 2
these extravasations depending on where we come down 3
on that reporting criteria.
4 And so I believe this is the last question 5
in the procedures section of it. I'll send it back 6
over to Dan to field questions from the public.
7 MR. FRUMKIN: Yes. Please raise your hand 8
and we can call on you. The slides are free. If you 9
have a question about a specific question, let us 10 know. We can bring people who are following me back 11 to that slide.
12 With that, Pat?
13 DR. ZANZONICO: Yes. Pat Zanzonico, 14 Memorial Sloan Kettering Cancer Center in New York 15 City.
16 My perception about most of these 17 questions, but in particular 4 through 6, is that 18 they're well beyond the scope of regulatory oversight.
19 This really is intruding, in my opinion, into medical 20 practice, into how patients are managed and so forth, 21 which obviously is an issue between the patient and 22 the patient care team.
23 This is more of a question than a comment, 24 but perhaps it could help in recasting these 25
39 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com questions. They just seem to delve far more into 1
medical practice than regulatory issues typically do.
2 I will just leave it at that.
3 MR. DIMARCO: Thank you for that comment.
4 The answers to these questions specifically in this 5
section of the FRN will likely be used to beef up any 6
of the guidance, as well as any suggestions for 7
procedural parts of that for specifically the guidance 8
section of that.
9 A lot of these will not be going into 10 rulemaking language themselves, but thank you again 11 for your comment. Yes, thank you.
12 MR. FRUMKIN: Please use the Raise Hand 13 feature on your screen. If you're unable to raise 14 your hand, you can use the chat.
15 Jim from Patients Rising, you can unmute 16 yourself -- I believe that's your affiliation; you can 17 correct me -- and ask your question for the staff 18 regarding clarifications of information on the FRN on 19 the procedures section.
20 MR. SLINEY: Thank you very much. I see 21 some language here that's encouraging as far as 22 keeping the burden of identifying the problem and 23 reporting the problem on providers and clinicians.
24 I think it really needs to be clear -- I 25
40 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com noticed in item 8 and item 10, there seems to be a 1
little bit more burden put on the patient to make 2
these identifications. I feel like the rulemaking, 3
which was based on the petition for rulemaking and 4
rulemaking plan on reporting nuclear medicine, was not 5
-- it's somewhat flawed and incomplete, perhaps 6
biased.
7 I think that any decisions that put an 8
inappropriate burden on patients to identify that they 9
have a problem or what to do about it if they think 10 they may have a problem, which any of us who have been 11 a patient before -- they're likely not to do anything 12 about.
13 Oh, I have a bruise on my arm. No big 14 deal, but that could be a big deal. How is the 15 patient supposed to know that? So I think that the 16 burden needs to put more on the professionals who know 17 the difference. I think that the NRC should really 18 think about that.
19 It's unacceptable to place that burden on 20 patients. What is an extravasation and what do I do 21 about it? That's my point. Thank you.
22 MR. DIMARCO: Thank you for that.
23 MR. FRUMKIN: I guess if I don't hear a 24 question I'll just assume it's a comment. And please, 25
41 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com we are looking for all of these things as part of our 1
outreach. We're going to talk about that at the end 2
of the presentation, how to provide the input.
3 Daniel, if there's a question there that I 4
missed, please cut me off.
5 Ramsey
- Kilani, please state your 6
affiliation and your question about the clarification 7
about the FRN.
8 DR. KILANI: Yes. Dr. Ramsey Kilani, GSIS 9
in DC. I have a dissenting opinion from my esteemed 10 colleague from New York regarding the validity of 11 these questions.
12 With respect to radiopharmaceuticals and 13 frankly, radiation that the public encounters in 14 general, it is the job of the NRC to get involved.
15 And so I don't think saying that this is the NRC 16 regulating medical practice really holds a lot of 17 water when you're talking about radiopharmaceuticals.
18 That's a special case. And there's a 19 reason there's a separate regulatory body. So that's 20 my only comment on that.
21 MR. FRUMKIN: Thank you for your comment.
22 With no hands raised, folks, please raise 23 your hand or you can unmute yourself. There are some 24 comments coming through the chat from Ron Parsons and 25
42 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Xander Arena.
1 Please, we would like you to go on audio 2
and ask those comments. If you can't, I can read 3
them, but please ask me to read them in the chat so 4
that we know that's what your intent is. Otherwise 5
they won't be in the record.
6 Dr. Helen Nadel, you can unmute yourself 7
and ask your question about the FRN's section on 8
procedures. And state your affiliation, please.
9 DR. NADEL: Yes. Dr. Helen Nadel, Lucile 10 Packard Children's Hospital at Stanford. You just 11 asked us to unmute to ask a question.
12 My question is about -- I'd like to see 13 the first slide. And I may have a question after 14 that. It's the Information Request Questions. My 15 question is -- actually, could I see 1 to 3, please?
16 Okay.
17 For question 2, what criteria should the 18 NRC use to define suspected radiation injury, will 19 there be a numerical value put to that? There were 20 some numerical values in the past rules that were 21 there. And I just wonder if that could be clarified, 22 please.
23 MR. DIMARCO: As of right now, we are not 24 putting a numerical value on that. That may change 25
43 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com depending on the comments received from stakeholders.
1 So if you have an opinion one way or 2
another whether or not there should be a numerical 3
value on that, please comment on this information 4
request. That would be very helpful.
5 DR. NADEL: Thank you. We will. Thank 6
you.
7 MR. FRUMKIN: This is a question from the 8
chat from Xander Arena. Using an Endoline catheter 9
with positive blood return and multiple successful 10 flushes is typically adequate.
Suspected 11 infiltrations should be imaged to determine the extent 12 of extravasation.
13 That appears to be a comment, but now it's 14 on the record.
15 MR. DIMARCO: Thank you for that. I'll 16 take that as that's an example of a technology or 17 technique that we would like to know about. That 18 would answer some of these questions. So thank you.
19 MR. FRUMKIN: Attendees, please raise your 20 hand and unmute yourself. If you have a comment in 21 the chat you want us to read, let us know that as 22 well. We have a few more sections, but I believe this 23 is intended to be the largest section of the meeting.
24 If I get a head nod from Daniel on that, that would 25
44 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com be -- okay, good.
1 Richard Harvey, please unmute yourself.
2 And please share your question about the FRN.
3 DR. HARVEY: Yes, just a comment to go 4
along with the previous comment. Dr. Richard Harvey, 5
Roswell Park Comprehensive Cancer Center.
6 We image all of our patients after they 7
have treatments with Pluvicto or Lutathera. So I 8
think if you miss an extravasation upon 9
administration, that's a useful way of maybe detecting 10 that extravasation or infiltration of the radiation 11 dose.
12 So just a comment to build on a comment 13 from before. Thanks.
14 MR. FRUMKIN: I'm not seeing additional 15 comments. Why don't we just go to the next session?
16 One question here. Has there been data 17 gathered about injection techniques in relation to 18 extravasation? In my career, I have noticed many 19 facilities still do straight needle sticks. This is 20 from Ebony M. Bush.
21 MR. DIMARCO: Yes. There certainly are 22 studies out there, whether or not they're specific to 23 radiopharmaceuticals.
There are more on the 24 chemotherapy and contrast CT side of things. As for 25
45 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com just injection quality in
- general, I'm not 1
particularly well versed in the studies on that.
2 MR. FRUMKIN: If there are studies that 3
you're aware of, please provide them as part of the 4
comment period.
5 Next question, Simon Davies. Please state 6
your affiliation and your question on the April 19th 7
FRN procedures section. You can unmute yourself at 8
any time.
9 MR. DAVIES: Simon Davies, Team Cancer 10 America and also the Patients for Nuclear Safety. On 11 that last point really, and I'm not sure whether it's 12 covered because we can't see all the questions at 13 once.
14 I think that actually a question from the 15 NRC about what training and technology should be used 16
-- training the staff in preparation for injecting 17 radioactive fluid and also technology that's used 18 because there is some technology, I understand, that 19 can make the procedure safer, vein finding technology, 20 et cetera.
21 So I wonder whether that should be one of 22 your questions, if it's not already embraced in one of 23 the questions you already asked.
24 MR. DIMARCO: I believe it is.
25
46 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Dan, if you want to go back one slide, I 1
believe that would -- I guess another slide back.
2 That would be encompassed in question 6, 3
techniques, technologies, and procedures to help 4
identify extravasations.
5 MR. DAVIES: Thank you for that. I just 6
wasn't sure. Thank you.
7 MR. DIMARCO: Yes. Thank you.
8 MR. FRUMKIN: Before we get to William, 9
Jim from Patients Rising, did we get your full name?
10 If you can unmute and let us know.
11 MR. SLINEY: Sure. My full name is Jim 12 Sliney, Jr., Executive Director of Patients Rising.
13 MR. FRUMKIN: Thank you.
14 William
- Janes, please state your 15 affiliation and your question about the FRN after you 16 unmute yourself.
17 DR. CHACKO: I'm sitting here at --
18 William Janes actually is my colleague and I'm sitting 19 by him. My name is George Chacko. I'm an MD board-20 certified in nuclear medicine. I practiced nuclear 21 medicine in Oklahoma for many decades. I've been 22 administering radioisotopes to patients.
23 The thing is that if you have a pure beta-24 emitting isotope, how would you image it is my 25
47 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com question if there's an extravasation. You can't image 1
it with conventional imaging devices. So I think I 2
just wanted to bring that to the attention of the NRC.
3 That's a question of -- you would have to 4
just look at what happens post-extravasation. Is 5
there sloughing of the skin, some damage there? You 6
really can't image it if it's a pure beta-emitting 7
isotope that's been used. That's my comment.
8 MR. DIMARCO: Thank you for that. I may 9
take some time on that. That's part of the reason why 10 we're trying to be more agnostic on some of these 11 questions, especially because we've seen a lot of 12 public interest in pure alpha emitters for 13 radiopharmaceutical therapy.
14 Like you said, pure beta emitters, things 15 that don't have any gammas, as well as the increase in 16 theranostics.
There are a
wide variety of 17 radiopharmaceuticals out there on the market and more 18 are coming every day.
19 So we would like to have as wide a range 20 of technologies to deal with these extravasations 21 because it's obvious that there's not a one-size-fits-22 all Band-Aid for this. That's why we're trying to 23 cast as wide a net as we can, to see all of the 24 different technologies that should be available to 25
48 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com help deal with these extravasations.
1 So thank you. And if you have any more 2
comments on that and any technologies that could help 3
with that, please put it in a response for this 4
information request FRN.
5 MR. FRUMKIN: You can raise your hand, 6
unmute yourself, or ask for a comment in the chat to 7
be read. If we don't get something, we can move on to 8
the next section. Maybe that will encourage new 9
ideas. We can take questions from any of the three 10 parts after that section as well.
11 Daniel, if you're ready, we will advance 12 to the third section.
13 Ralph, hand up or hand down? You'll have 14 an opportunity to ask questions at the end of this 15 section. So thank you.
16 MR. DIMARCO: Yes. Okay. So on to the 17 last two questions for our information request 18 questions.
19 Just a little bit of background on why 20 we're asking about these healthcare inequities. We've 21 heard from patient safety groups some concerns about 22 inequities in the healthcare community, and so we 23 would like to ask for input from everybody on how this 24 rulemaking specifically can help effectively address 25
49 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com these concerns.
1 So our 13th question, which regulatory 2
actions could help ensure that the extravasations in 3
patients affected by healthcare inequities are 4
accurately assessed and reported?
5 And are vascular access tools and other 6
technologies, such as ultrasound-guided vein finders, 7
likely to reduce the potential for an extravasation in 8
all patients, however particularly patients of color?
9 This is an import topic. We believe that 10 the NRC could get some good information to help 11 address these in this rulemaking. So we would like to 12 take the opportunity to get more information from 13 stakeholders on these questions.
14 I believe that's all I've got. I'll kick 15 it back over to Dan to take questions.
16 MR. FRUMKIN: There's a citation from Jim 17 of Patients Rising for Sensing Technologies for 18 Extravasation Detection: A Review, which was published 19 March 13, 2023. So that's also now on the docket.
20 And Josh Knowland is
- asking, what 21 pharmaceuticals are pure beta emitters? I think that 22 gets into the question of the tools.
23 MR. DIMARCO: Yes. None that I know of, 24 but I don't have a comprehensive list of all 25
50 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com radiopharmaceuticals that are being used or produced.
1 Like I said, there are more coming online 2
every day.
There are constant new 3
radiopharmaceuticals being produced and used. So we 4
want to be a little bit more forward-thinking with our 5
regulations here.
6 I see a few hands up. I'll send it back 7
to you.
8 MR. FRUMKIN: Dr. Helen Nadel, please 9
state your affiliation and your question regarding any 10 part of this FRN.
11 DR. NADEL: Hello. Dr. Helen Nadel, 12 Lucile Packard Children's Hospital at Stanford.
13 I'm not sure that it was in any of what 14 you presented today, but can you define suspected 15 radiation injury for me? What is suspected radiation 16 injury? I'm asking a question about one of your 17 questions.
18 MR. DIMARCO: If you could go back, Dan, 19 to the proposed rule language?
20 MR. FRUMKIN: This one?
21 MR. DIMARCO: Yes. So suspected radiation 22 injury, at least in this preliminary proposed rule 23 language -- like I said before, this may change 24 depending on public comment and has not gone up to the 25
51 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Commission for any sort of review. Currently, 1
suspected radiation injury is defined as a potential 2
or observable deterministic health effect to the area 3
around an injection site that can be attributed to 4
radiation.
5 DR. NADEL: Daniel, I'm sorry I don't know 6
your last name. It only comes up as Daniel D. In 7
your first comment, as you started to speak you 8
mentioned that by definition no radiopharmaceutical 9
was a vesicant.
10 Assuming that this would be a
11 deterministic health effect, would you say that this 12 would be a deterministic health effect that you would 13 be looking for as a sign of radiation injury?
14 MR. DIMARCO: I'm sorry. I don't think I 15 understood the question.
16 DR.
NADEL:
It says you want a
17 deterministic health effect.
18 MR. DIMARCO: Yes.
19 DR. NADEL: So my question to you would 20 be, what is a deterministic health effect that would 21 be from a suspected radiation injury? And you had 22 already mentioned just as you began your discussion 23 back in the beginning that radiopharmaceuticals are --
24 I believe it was you that said radiopharmaceuticals 25
52 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com are not vesicants.
1 MR. DIMARCO: So I'll go from the first 2
question to the last one on that. My intention with 3
the comment that radiopharmaceuticals are not 4
vesicants -- if I'm misinformed, I apologize.
5 It was my understanding that vesicants 6
typically operate under a chemical reaction for those 7
types of injuries. Things such as chemotherapy drugs 8
are typically more vesicants than radiopharmaceuticals 9
where the method of injury is different there.
10 And so for your second question, or I 11 suppose your first question on the deterministic 12 health
- effect, one of the lower levels of 13 deterministic health effect that we're looking at as a 14 possible limit for this reportable event would be 15 erythema of the skin specifically due to radiation.
16 There's obviously complications there 17 where -- before I've said vesicants and other physical 18 processes can result in erythema of the skin, but 19 whether or not that would be radiation induced is 20 where we're thinking that the limit for this reporting 21 would be.
22 Did that answer your questions?
23 DR. NADEL: I think you answered your own 24 question to say that erythema of the skin is likely 25
53 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com not a deterministic effect that could be attributed to 1
specifically radiation from a radiopharmaceutical 2
injection, as just any intravenous cannula insertion 3
without anything injected could cause erythema of the 4
skin.
5 MR. DIMARCO: Yes. Thank you. That is 6
where the complications from this arise and that is 7
why we're asking for more information from 8
stakeholders on this. So thank you.
9 MR. FRUMKIN: All right. Let me jump back 10 to the section we're in. We are getting some comments 11 here.
12 Let me read this one from the chat from 13 Josh Knowland. Based on emitted energies, skin injury 14 may not be likely even though significantly higher 15 dose affects the underlying tissue. I think that gets 16 to the previous comment.
17 MR. DIMARCO: Yes. And that's why we 18 didn't say specifically to the skin in any of our 19 definitions. It was just the area around the 20 injection site.
21 MR. FRUMKIN: Richard Harvey, you may 22 unmute yourself and ask your question about any part 23 of the FRN questions.
24 DR. HARVEY: Thank you very much. Dr.
25
54 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Richard Harvey from Roswell Park Comprehensive Cancer 1
Center.
2 Just to reiterate and point out, the vast 3
majority of these nuclear medicine injections that 4
might lead to extravasations are not going to cause 5
injury. We're not going to have deterministic effects 6
from those. The concern really is for some of the 7
theranostic therapeutic procedures that are becoming 8
much more commonplace now.
9 I think it's important to point out that 10 diagnostic injections of radiopharmaceuticals are not 11 likely to cause these injuries. You have to have a 12 cutoff, I think, somewhere on what you want to include 13 as a medical event in the regulations and in the 14 rulemaking. So thank you.
15 MR. FRUMKIN: Jim Sliney, Patients Rising, 16 you can unmute yourself.
17 MR. SLINEY: Yes. Jim Sliney, Jr., from 18 Patients Rising once again. I'm commenting on the 19 healthcare inequities section, items 13 and 14.
20 I feel like the best way to ensure that 21 people are not treated equitably is to let them leave 22 the site without being screened afterwards because 23 this puts them back into the environment in which they 24 may not feel comfortable speaking with their doctor, 25
55 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com may have difficulty accessing transportation to get 1
reevaluated, and so forth.
2 So it seems to me that the fairest way to 3
do this to make sure that no patients are overlooked 4
is to have some kind of cautionary screening at the 5
end of a potential extravasation event. Thank you.
6 MR. FRUMKIN: Ralph Lieto, please unmute 7
- yourself, state your affiliation, correct my 8
pronunciation, and ask your question about the FRN.
9 MR. LIETO: Thank you. My name is Ralph 10 Lieto. I'm a medical physicist from Michigan.
11 I have a couple of questions going back to 12 your procedures questions and a clarification. Did 13 you state that these questions were generated from 14 staff, or were any of these questions generated from 15 the Commissioners' SRM, or both?
16 And could you kind of maybe clarify which 17 were specifically Commissioner-generated questions 18 about procedures?
19 MR. DIMARCO: Was there another question 20 there? I don't want to cut you off.
21 MR. LIETO: Yes. I've got a couple of 22 other ones, but different areas.
23 MR. DIMARCO: Okay. I can answer that one 24 quickly then. These questions were all developed by 25
56 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com staff based on the Commission SRM. So I guess the 1
answer is a bit of both for all of them.
2 MR. LIETO: Okay. And again under the 3
procedures, you're asking about techniques, 4
technologies, and so forth that are available to 5
address extravasations or prevention and so forth, but 6
nowhere do I see any concern or question raised about 7
the cost or the practical availability of these 8
technologies being a consideration.
9 Just the fact that something's available 10 does not necessarily mean that in a community hospital 11 setting it's going to be able to be purchased or even 12 widely implemented across the area of injections.
13 So I think that needs to be a very 14 important consideration going forward in questions 15 that are answered because just because you think 16 something's available doesn't necessarily mean it is, 17 especially with the cost of healthcare and 18 technologies being what they are.
19 When you're talking about you're going to 20 have to implement something just to address some 21 potential, I think you're going to find that medical 22 facilities are going to start to consider, is this 23 something that we even want to do. And that is 24 definitely going to be harmful to the patient and to 25
57 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com healthcare.
1 So that's a statement. You don't need to 2
respond to that, but that is definitely something I 3
want to ask that NRC staff look at going forward in 4
addressing these questions under procedures.
5 My last point is under healthcare 6
inequities. I think this is a big overreach by the 7
NRC. The NRC is not a healthcare agency and nowhere 8
in their charge or scope inequities of health care 9
part of their charge.
10 That's the practice of medicine. Whether 11 something is appropriate to be administered or whether 12 something is appropriate to be followed up as a result 13 of clinical indication, that's the practice of 14 medicine.
15 Nowhere, especially number 13 in terms of 16 regulatory actions, should there be anything there 17 that would be addressing the, quote, inequalities or 18 inequities of administering this type of healthcare.
19 That's my last statement. Thank you.
20 MR. DIMARCO: Thanks for those comments.
21 I know you didn't say to respond to it, but I do want 22 to respond to your second one.
23 To help alleviate that, one of the things 24 that we're developing for this rulemaking is a 25
58 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com dosimetry model to help with the characterization of 1
the extravasations. That will be part of the appendix 2
of the guidance documents that we will eventually 3
produce for this rulemaking. So thank you.
4 MR. LIETO: Quick follow-up question to 5
that?
6 MR. DIMARCO: Yes.
7 MR. LIETO: So in looking at this, are you 8
looking at also the cost and practicality of 9
implementing this at just a technologist level?
10 MR. DIMARCO: I believe those discussions 11 will come in with the --
12 MR. LIETO: A lot of what's being done out 13 there and presented -- that's great if you have 14 medical physicists on staff to either reference or 15 consult with. But where most of this nuclear medicine 16 is done at the community hospital, it's basically 17 authorized user technologist level.
18 I think that gets lost a lot in what is 19 done in terms of NRC putting forth not only guidance 20 but regulations. Thank you.
21 MR. DIMARCO: Thank you for that comment.
22 MR. FRUMKIN: Thank you for that comment.
23 And please provide your feedback through the 24 Regulations.gov information we're going to provide.
25
59 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com I would like to read this question from 1
Josh Knowland. Josh, if you could also provide your 2
affiliation in the chat.
3 To the comment about diagnostics not being 4
able to cause injury, what is that based on? Is it 5
deterministic injury based on dose? Diagnostics 6
including positron emitters can actually result in a 7
dose of multiple gray.
8 That was in the chat. Josh, if you could 9
provide your affiliation, that would be appreciated as 10 well. He's from UT Knoxville.
11 Mary, I'm going to not pronounce your name 12 properly. Mary, could you please unmute yourself, 13 provide your name and affiliation, and a question 14 about any part of the FRN?
15 MS. AJANGO: Yes. Mary Ajango, Young 16 Survival Coalition and Patients for Safer Nuclear 17 Medicine. I have a comment about the patient 18 reporting and reportable extravasations.
19 The NRC is responsible for ensuring the 20 protection of public health and safety regarding the 21 handling of nuclear medicine materials in healthcare 22 settings. The agency provides reasonable assurance of 23 adequate protection by establishing regulations and 24 enforcing compliance with those regulations.
25
60 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com According to a recent admission by the 1
NRC, at least 28,000 patients are extravasated every 2
year, which would exceed the agency's current medical 3
event reporting requirements. But the proposed 4
rulemaking to address this lack of protection 5
regarding extravasations doesn't help.
6 According to the NRC's own estimates, the 7
new patient injury reporting criterion is expected to 8
result in approximately 80 medical events reported 9
annually, which is about 0.28 percent of the estimated 10 28,000 occurrences of large extravasations.
11 So one of the main issues with self-12 reporting is that many patients may not even realize 13 they have experienced it. And if centers are not 14 actively monitoring, they won't be able to tell 15 patients when one has happened.
16 Symptoms may not be immediately apparent 17 and patients may not know what to look for. This is 18 particularly worrisome for low-literacy educated 19 patients.
20 And then even if the patient is informed 21 of symptoms and recognizes signs, they may not report 22 it to their healthcare provider or know what to do 23 next. Thank you.
24 MR. FRUMKIN: Thank you for your comments.
25
61 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Pat Zanzonico, please state your 1
affiliation and provide your comments or questions.
2 DR. ZANZONICO: Yes. This is Pat 3
Zanzonico again, Memorial Sloan Kettering Cancer 4
Center in New York City. I just wanted to follow up 5
on the comment by Ralph Lieto.
6 I think an additional question that I know 7
you're asking specifically about is what, if any, 8
unintended adverse consequences of universal screening 9
for extravasations may that entail?
10 And by that I mean, I think it would 11 inevitably reduce patient throughput in a busy 12 clinical setting, as well as require additional 13 equipment and staff costs, and so forth and so on.
14 So whatever the presumed benefits of 15 screening for extravasations may be, I think it is 16 important to recognize that there is at least a 17 potential downside in terms of
- cost, patient 18 throughput, availability of tests, and so forth and so 19 on.
20 And if anything, those may have an 21 unintended consequence of lesser availability of, for 22 lack of a better term, high-tech imaging modalities in 23 under-served communities. So I think it would be 24 worth including a question to that effect explicitly 25
62 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com among the questions that are being proposed.
1 MR. FRUMKIN: I think the intention at 2
this point would be we're asking you to provide that 3
feedback in response to one or more of the questions 4
that are here. Then we can consider that in the 5
proposed rulemaking. And if I'm wrong, somebody 6
correct me.
7 With that, Carmine Plott, you can unmute 8
- yourself, state your affiliation, correct my 9
pronunciation, and ask your question about the FRN.
10 DR. PLOTT: Hi there. This is Carmine 11 Plott. I work for Forsyth Medical Center in Winston-12 Salem, North Carolina. I am the Radiation Safety 13 Officer for multiple nuclear medicine facilities in 14 our community.
15 As an agreement state, I know I rule 16 making process, but I don't understand with regard to 17 NRC. And this to piggyback on the gentleman who just 18 spoke and Ralph Lieto.
19 Are you required to actually do a 20 financial impact statement or analysis as part of this 21 rulemaking?
22 Because in addition to the technologies 23 that are available with regard to proactively assess 24 potential extravasations, while I agree that some of 25
63 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com the suggestions for follow-up are excellent 1
suggestions such as imaging to actually consider the 2
extent of the extravasation, you do need to include 3
the financial impact of delayed imaging and whether or 4
not you have a patient who cooperates and is willing 5
to return to the department to actually characterize 6
the half-life or the movement of that radioactivity 7
from the site of injection.
8 You also have to consider -- for example, 9
you mentioned technologist training. Granted, if you 10 want to require them to undergo annual training, 11 phlebotomy training, or whatever, there's going to be 12 costs associated with that.
13 And like those gentlemen, I'm concerned 14 that particularly in under-served communities that 15 nuclear medicine -- unfortunately, because of the 16 potential costs associated with it, I just hope that 17 they're willing to continue to offer services.
18 Again, I fully support the idea for the 19 theranostics, the therapeutics, simply because they 20 require a written directive. And if you deviate from 21 a written directive from the authorized user, of 22 course follow-up is required. But to have a proactive 23 approach to this, I'm just curious about the financial 24 impact to licensees.
25
64 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com So my question is, are you required to 1
actually do such an impact statement or analysis for 2
such rulemaking?
3 MS. WU: Hi, Carmine. This is Irene Wu 4
with the NRC. I'll jump in. I was going to touch 5
upon this in some of the ending slides with the next 6
steps.
7 Yes, our rulemaking package which we are 8
working on for the proposed rule will include a draft 9
regulatory analysis. So that includes the cost and 10 benefit piece that you were talking about.
11 MR. FRUMKIN: And we have a lot of 12 resources about our rulemaking process on the public 13 website.
14 With that, Kathleen Hintenlang, you can 15 unmute yourself. State your affiliation and we will 16 hear your question about the FRN.
17 DR. HINTENLANG: This is Kate Hintenlang, 18 a medical physicist querying on behalf of ACR.
19 So a follow-up to Carmine, Pat, and Ralph, 20 if NRC is asking which steps may be clinically 21 justifiable for each individual radiopharmaceutical 22 product, are there any plans to consult with drug 23 manufacturers,
- FDA, standards organizations, 24 creditors, payers, and public health agencies? Thank 25
65 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com you.
1 MR. DIMARCO: I guess I can answer that 2
one. At least on the technical side, yes. We're 3
definitely getting information from as many sources as 4
possible, which includes the FDA and our other federal 5
partners as well as other stakeholders for that.
6 MR. FRUMKIN: Richard Harvey, you can 7
unmute yourself, state your affiliation, and ask your 8
question about the FRN.
9 DR. HARVEY: Thank you. Dr. Richard 10 Harvey, Roswell Park Comprehensive Cancer Center. I 11 have a few things.
12 The first is regarding our imaging. We 13 image the same day that the patient has the dose 14 administration. It's part of the procedure so we 15 don't have to have somebody come back later.
16 If you miss an extravasation, you may be 17 able to find it on imaging that day, which is part of 18 the procedure. So you don't have to inconvenience the 19 patient to have them come back.
20 The comment regarding my comment about 21 diagnostic extravasations, if you look at the 22 activities of diagnostic radiopharmaceuticals, their 23 half-lives, those characteristics, where tissue 24 reactions or radiation dose health effects or 25
66 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com biological effects occur, you're not likely if at all 1
to see any tissue reactions from diagnostic injections 2
of radiopharmaceuticals.
3 As Dan pointed out, there are always new 4
things that are coming down the pipe. So could there 5
be something like that in the future?
6 In 32 years, I've never seen diagnostic 7
administration of a radiopharmaceutical ever cause a 8
radiation injury or tissue reaction. So I just wanted 9
to comment on that for -- I think it was Josh 10 Knowland.
11 And I
do strongly believe that 12 extravasations are a very important quality assurance 13 issue that need to be handled at each site, each 14 facility, where it's incumbent upon us to get the 15 radiopharmaceutical into the vessel so it can be used 16 for its intended purpose. I just don't think that 17 adding this as a medical event is really going to make 18 that process any better.
19 It's incumbent upon us to make sure that 20 we deliver this radiopharmaceutical
- properly, 21 adequately, and mitigate any steps that occur. If we 22 don't, we're not doing our job as a provider and we're 23 not helping our patients.
24 I respect the NRC's position and everyone 25
67 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com else. Again, as I've stated before, I think where 1
this could become an issue is when you get those 2
theranostic type of therapeutic radiopharmaceuticals 3
that may result in tissue reactions. But to include 4
this for all radiopharmaceuticals injected is just not 5
really going to improve anything in any way.
6 So I'll stop there. Thanks.
7 MR. FRUMKIN: Thank you for your comment.
8 Ramsey Kilani, you can unmute yourself, 9
provide your affiliation, and ask your question on the 10 FRN.
11 DR. KILANI: Ramsey Kilani, GSIS. I think 12
-- and I've forgotten the name of the person now. If 13 you can go back to the proposed terminology, the slide 14 with the red writing? That there.
15 The challenge here is that as this is 16 currently written here, suspected radiation injury, 17 the only criteria you can really use to suspect a 18 radiation injury particularly right after an 19 injection, which is when you have a chance to do 20 something about that, would be to use a dose 21 threshold.
22 There is no other practical way to suspect 23 a radiation injury immediately after an injection. So 24 I think injection site dosimetry is an obvious way to 25
68 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com determine that.
1 I would respectfully say to my colleagues, 2
I think that there are probably
- many, many 3
extravasations in nuclear medicine that go undetected 4
period because we're not looking. And there is the 5
downstream thing, which has not been brought up here.
6 We're focused on the local effect of the 7
extravasation.
8 The other problem with dumping, say, 90 9
percent of your dose into the arm instead of into the 10 vessels is that when the computers auto-level -- I'm 11 speaking in layman's terms -- when the computers auto-12 level the image data for interpretation, if you don't 13 know there was an extravasation, that can be done in a 14 way that can actually alter your diagnostic 15 interpretation. There are a lot of papers out there 16 that show this.
17 So to act like it's not an important 18 issue, I think number one, is a little bit 19 disingenuous. And number two, to act like there's a 20 way other than a dose threshold to assess this, I 21 think, is also not well thought out.
22 And then thirdly, where else in radiology 23 or in any other part of a hospital where IVs and other 24 sticks are happening all the time would they accept an 25
69 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com extravasation or bad IV rate of up to 23 percent, as 1
Ms. Wu reported earlier in the literature? That isn't 2
even close to the standard.
3 So I suspect that if we had mechanisms to 4
track this and report it, what will happen over time, 5
as has happened in the rest of medicine, once we start 6
tracking something and having to report it, we get a 7
lot better at it.
8 And so the idea that training 9
technologists is too expensive is laughable, frankly.
10 It's too expensive to protect patients with something 11 that's as simple as just training people how to be 12 better at IVs? I don't feel like I can get behind 13 that.
14 MR. DIMARCO: Thank you for that comment.
15 I know we've been talking a lot about the questions 16 on this one and getting comments on the questions, but 17 I do want to remind people that we've put all of this 18 preliminary proposed rule language in the FRN.
19 And please feel free to comment on the 20 proposed rule language in your specific comments 21 through the Regulations.gov, the mail-in, or anything 22 like that. We're taking all comments, not just the 23 ones that comment specifically on the questions of the 24 preliminary proposed rule language. So thank you.
25
70 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. FRUMKIN: Tracy King, please unmute 1
yourself, and provide your affiliation and your 2
question on the FRN.
3 MS. KING: My name is Tracy King. I'm a 4
medical physicist in the Midwest with Medical Physics 5
Consultants, with 36 years of experience consulting to 6
community-based hospitals in nuclear medicine, X-ray, 7
and radiation oncology.
8 I do have a question, but first I'd like 9
to say I do agree strongly with Carmine about the 10 issues she raised.
11 Secondly, my question is on question 12 number 14. You identified a class of patients as 13 being particularly vulnerable, I guess, or likely, but 14 you failed to address several other classes of 15 patients where extravasations tend to be more common.
16 Those are the obese patients, patients who have had 17 chemotherapy, and also small children, infants.
18 My last comment would be -- well, not my 19 last. My second to last comment would be an example 20 of how over-regulation is detrimental to patient 21 safety. This is a great example.
22 You can have situations where you have two 23 or three technologists working. And you have a 24 patient come in who looks to be a difficult injection.
25
71 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com A senior technologist says, I'm not going to ruin my 1
record of having no medical events or no NRC reports.
2 You go do it. The newest person gets shifted.
3 That maybe isn't something you like to 4
think about, but in reality that is a possibility.
5 And also, as Carmine said, facilities may decide not 6
to do procedures in order to avoid NRC violations.
7 And we have seen that in nuclear medicine over the 8
past 30 years.
9 My last comment is dose threshold on paper 10 sounds very good but calculating that dose from an 11 extravasation, or as we more commonly call it a sub-Q 12 in nuclear medicine, is very difficult and requires 13 patient-specific biological data to look at the 14 clearance of that material, the volume of tissue 15 involved.
16 Even with Versant and Lucerne's technology 17 that they have available, I still question the 18 accuracy of that dosimetry. Thank you very much.
19 MR. DIMARCO: Thank you for those 20 comments. Just to regard your second comment there, 21 it was not our intention to not include anyone else in 22 these healthcare inequities.
23 Another that I've seen in studies are 24 patients that are dealing with chemotherapy treatments 25
72 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com as well as radiopharmaceutical treatments. Typically 1
the chemotherapy has a measured impact on vascular 2
access. And so the intention there was not to leave 3
out anyone there.
4 If you have any comments on any of these 5
patients, on any of these different classes of 6
healthcare inequities, please put that in your 7
comments for the information request.
8 MR. FRUMKIN: Xander Arena, you can unmute 9
yourself and provide your affiliation, please, and ask 10 your question on the FRN.
11 MR. ARENA: Hello, everybody. Nuclear 12 medicine technologist and an associate radiation 13 safety officer at a large medical facility. These 14 comments and my question are not reflective of my 15 organization's position on the matter.
16 The question to the NRC, has the NRC 17 considered substituting the word leakage for 18 infiltration since infiltration is a more active 19 process and leakage more passive? Potentially you 20 could use both
- words, extravasation and then 21 infiltration as the event that might be worth paying 22 closer attention to?
23 MR. DIMARCO: Yes. The intention of our 24 first question was to get information from 25
73 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com stakeholders, people who are more familiar with the 1
actual processes themselves, for a more accurate 2
definition of what we're looking at.
3 If you have a comment on that, please put 4
it in our Regulations.gov or any of the other ways to 5
comment on this rulemaking.
6 MR. ARENA: I'll put it in there. Just to 7
add a few comments, I think reporting diagnostic 8
infiltrations frankly, as others have opined, would be 9
onerous.
10 Our radiologists, for example, in PET/CT 11 can read through an infiltration of FDG. They look at 12 the target SUVs, the background SUVs on liver. It's 13 relative. It's a relative update.
14 So even if there is a fraction in the arm, 15 they can still get diagnostic information from the 16 exam. When we don't observe ill effects from those 17 sorts of tracers, theranostics, I think it's a wise 18 approach to consider a package like this.
19 Allowing facilities to come up with their 20 own action plan as far as how they're going to address 21 and protect their patients -- we all want to protect 22 our patients. That should be implicit. But to leave 23 it up to the facilities to determine that, I think, is 24 a good position to take.
25
74 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com The other thing is that I read the 1
proposal that initiated this rulemaking. Some of the 2
proposed mechanisms, like the device that monitors 3
flow from one arm to the other, that doesn't stop an 4
infiltration. It can't stop it.
5 The infiltration is done by the time the 6
device picks it up. So you're really not preventing 7
anything by making this device be strapped to 8
somebody's arm for every exam.
9 I think that the process of adding those 10 extra steps and other sorts of things, and reporting 11 and other things, as others have mentioned, would 12 cause such a slog in the work flow of busy clinical 13 settings and impact patient care adversely.
14 Those are my comments on the proposed 15 rulemaking with respect to theranostics. It makes 16 sense. You have a written directive. You have a 17 target tissue. You want to get a certain amount in 18 there. And if you didn't achieve that target, then 19 it's probably a worthwhile medical event. That is all 20 I have to add for the session. Thank you.
21 MR. DIMARCO: Thank you for that comment.
22 MR. FRUMKIN: Thank you for the comment.
23 There's a couple of comments in the chat.
24 If we don't get any more hands raised, we'll move on 25
75 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com to the next section.
1 Josh Knowland, who provided that he's 2
affiliated with Lucerno Dynamics, talked about 15 3
microcuries of a positron emitter in 5 ccs of tissue 4
would be a significant dose and you're not likely to 5
see it on the skin. I think we talked about that as 6
well.
7 Brian Fairchild of Harry Truman Memorial 8
Veterans' Hospital in Columbia, Missouri. I know my 9
states. Other patients of concern for extravasation 10 due to difficulty finding veins are patients with 11 extensive tattoos at common IV injection sites. That 12 was similar to what Daniel was referring to with 13 cancer patients, obese patients, children, and the 14 other commenter.
15 MR. DIMARCO: Yes. These are -- sorry. I 16 just want to say these are all great comments. And 17 even though it may seem a little redundant, please 18 reiterate these through the comment period on this 19 because I want these to be in the Register for us to 20 look at for going forward with this comment period.
21 MR. FRUMKIN: And with that, I was using 22 the comments in the chat to try to encourage that.
23 But I really want people to be raising their hands and 24 asking questions.
25
76 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com I think we can move on to the next 1
section. Irene, if you would provide your insights on 2
the preparing comments. We'll have more opportunity 3
for questions and comments about everything that 4
preceded.
5 So with that, Irene?
6 MS. WU: Yes. Okay, thanks. Thanks, Dan.
7 This next section is to really drive that 8
point home about how you can prepare and submit the 9
comments. We've heard a lot of great feedback in the 10 meeting so far. We want to make sure that that's all 11 on the record.
12 Even though we're transcribing this 13 meeting for our public meeting summary, the formal way 14 of getting those comments on the record, as has been 15 said multiple times already, is to get those submitted 16 in the different ways that are outlined in the FRN.
17 I'll go through that shortly.
18 Next slide, please.
19 I just wanted to provide some quick tips 20 on preparing your comments. Regulations.gov has a 21 great document on their website that includes tips for 22 submitting effective comments. You should be able to 23 click on that link there. The link is also available 24 in the slides. You can also access that document when 25
77 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com you're going in and submitting your comments through 1
Regulations.gov.
2 I really urge you all, as you have been 3
giving us feedback during this public meeting, to 4
really go through the questions that we asked in the 5
information request, look to answer those questions in 6
the FRN, and comment on the preliminary proposed rule 7
language. That will really help us as we move forward 8
in developing the proposed rule package.
9 Next slide, please.
10 All right. You've heard this already but 11 I'll reiterate it again. We've got these three 12 methods for submitting comments. The information 13 request Federal Register notice that was published 14 back on April 19, 2023, again, has a 90-day comment 15 period.
16 The three methods are to either submit 17 your comments through Regulations.gov and go to our 18 specific docket, which is on the screen, Docket ID 19 NRC-2022-0218. You can submit a comment that way.
20 You can also email us with your comments 21 via Rulemaking.Comments@nrc.gov. And lastly, if you 22 prefer, you can always mail us your comments to the 23 address on the slide and also listed in the Federal 24 Register notice.
25
78 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Again, I'll just try to drive the point 1
home one more time. We really appreciate hearing all 2
of your feedback during this meeting. But again, 3
since this meeting isn't the venue for collecting 4
comments to get on the record, please formally submit 5
those comments using the methods that are on this 6
slide and in the FRN.
7 All right. Next slide, please.
8 Okay, next steps. The public comment 9
period for the information request ends on July 18, 10 2023. We will be considering all of the comments we 11 receive from you all on the information request in our 12 development of the proposed rule.
13 What comes next is the proposed rule is 14 currently estimated to go to the Commission in the 15 August 2024 time frame. Before it goes to the 16 Commission, staff's going to be working on putting 17 that rulemaking package together, getting it ready, 18 and going through our internal review.
19 That rulemaking package not only has a 20 Federal Register notice but it'll also include that 21 draft regulatory analysis that I mentioned a little 22 earlier with the cost and benefits in it, the draft 23 environmental analysis, and a Commission paper.
24 And then after the proposed rule goes to 25
79 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com the Commission, the Commission will still have to vote 1
and provide direction to the staff in a staff 2
requirements memorandum, or SRM, before we can 3
actually publish the proposed rule for notice and 4
comment in the Federal Register.
5 When we do publish that proposed rule, it 6
will also include getting comments on the draft 7
regulatory analysis and the draft environmental 8
analysis. And we'll also be making available for 9
comment the implementation guidance as well. That is 10 currently estimated for December of 2024.
11 Next slide, please.
12 Okay. That's the end of my presentation 13 and talking about the next steps. I think at this 14 time we wanted to give the public one more opportunity 15 to ask any questions and provide us with your feedback 16 on everything that's been discussed so far, not just 17 the last bit on how you can submit comments on the 18 rulemaking process.
19 If you thought more about the background 20 of the rulemaking, any of the preliminary proposed 21 rule language, or questions that were part of the 22 information request, this is your last opportunity 23 during the public meeting to ask your clarifying 24 questions.
25
80 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com I will turn it over to Dan, our 1
facilitator, to help facilitate this portion of the 2
meeting.
3 MR. FRUMKIN: Thank you. And I have been 4
watching the chat for questions.
5 If you have questions that you can't 6
unmute yourself for, please let us know. This meeting 7
is intended to get questions for the staff about the 8
FRN.
9 Simon Davies, you can unmute yourself.
10 Please state your affiliation and ask your question.
11 MR. DAVIES: Thanks again for the time.
12 Simon Davies, Executive Director at Team Cancer 13 America and a member of the Patients for Safer Nuclear 14 Medicine.
15 I just wanted to say a point that we felt 16 very strongly about in terms of feedback for you. We 17 felt the Commission decision which led to the 18 rulemaking was actually based on a flawed document 19 with inaccurate, incomplete, and biased information.
20 So we thought your starting point wasn't great.
21 Having said that, I applaud you for many 22 of the questions that you've raised. The way in which 23 you've structured this, I think, is very helpful.
24 I do want to just reiterate a point that I 25
81 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com think has been largely accepted. I've heard it come 1
up a couple of times. The idea of patients self-2 reporting being the standard, I think, is quite 3
unacceptable and ridiculous, especially when patients 4
don't know what some of the effects might be when they 5
might come up later. So we think that's really 6
important to us.
7 In our view, the improvement of the 8
monitoring, the training, and the technology will 9
actually massively reduce extravasations. And we 10 think that it will also improve equity because 11 particularly, as has been stated, there are financial 12 challenges for organizations.
13 If you reduce extravasations then you 14 would reduce the late effects. And actually, that's 15 going to be cheaper, not more expensive. We think 16 that this is a useful investment.
17 We do want to just raise the point that if 18 you have another type of nuclear accident and you have 19 to report it, it could be less harmful than an 20 extravasation. And yet here we are saying that 21 something intravenous might not be reported.
22 That just seems an absurd inequity when 23 you think about the other type of reporting for 24 spills, et cetera, that the NRC has made it their 25
82 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com business to monitor and report on. Thank you.
1 MR. FRUMKIN: Thank you for your feedback.
2 Please raise your hands, unmute yourself, 3
and ask your questions. The slides are free for 4
navigation, so you can also see the contact 5
information and acronyms at the end or navigate 6
throughout the slide deck.
7 Gina Kell Spehn, you can unmute yourself, 8
state your affiliation, and ask your question. You're 9
unmuted on our side.
10 If anybody else has a question, raise your 11 hand or unmute yourself and ask your question.
12 DR. CUTLER: Hi. This is Cathy Cutler.
13 I'm from Brookhaven National Laboratory. I also have 14 a leadership role in the Society of Nuclear Medicine.
15 I was curious because you had indicated 16 that you have developed a dose model. Has that been 17 put out and looked at by people outside of the NRC to 18 comment on?
19 MR. DIMARCO: I can answer that. Not yet.
20 It will be though. It's still currently in 21 development.
22 This is something that we'll have with the 23 guidance document that will be going out. So it's 24 currently in development, but there will be a time for 25
83 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com people to see what it is.
1 MR. FRUMKIN: You may raise your hand or 2
unmute yourself.
3 There's a question in the chat from 4
Kathleen Hintenlang. Is the NRC planning to review 5
national standards at the institutional level, Q&A 6
practices to ensure that any regulation or guidance on 7
these topics does not impose upon existing IV 8
practices?
9 MR. DIMARCO: I can answer that. The NRC 10 is not regulating IV access or any of that, vascular 11 access. The intention of those questions is just for 12 other sorts of procedures of best practices for things 13 that we can wrap into our guidance.
14 And so I would hope that we would get 15 information that would be harmonious with current IV 16 practices or better to help with these vascular access 17 problems. On the strictly regulatory side, we're not 18 interested in regulating vascular access at this time.
19 MR. FRUMKIN: Ralph Lieto, please provide 20 your affiliation and ask your question.
21 MR. LIETO: Thank you. Ralph Lieto, a 22 medical physicist from Michigan.
23 A question for -- probably this is for 24 Irene and the other NRC staff. Is this proposed 25
84 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com rulemaking an absolute, shall I say, going to happen 1
type of a thing?
2 Or based on responses to these questions 3
and procedures, is there the potential for something 4
other than a medical event reporting methodology being 5
possible to be implemented for licensees? And a 6
follow-up question on that also.
7 MS. WU: Yes. Thanks for the question.
8 We're going to be taking all of the feedback that we 9
get.
10 We're going to take all of the comments 11 that we receive from this information request to help 12 inform our development of the proposed rule. We'll 13 also take into consideration the direction that we got 14 from the Commission.
15 What we put up to the Commission as part 16 of the proposed rule package, the Commission will look 17 at what the staff recommends as well as alternatives.
18 And it'll be up to them to decide which direction 19 they would like us to proceed with.
20 So I think there's still definitely some 21 room for this to change as we are informed by 22 stakeholder comments.
23 MR. LIETO: Okay, just a last statement.
24 Having been involved with medical event reports and 25
85 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com their analysis over many years, medical event 1
reporting is not a process of proven mechanism. I 2
think that there are definitely better avenues to go 3
about addressing this issue and improving patient care 4
and safety without medical event reporting.
5 So again, thank you. I appreciate all you 6
guys have done, and taking comments and responding to 7
everybody today.
8 MS. WU: Thank you.
9 MR. FRUMKIN: Thank you for your feedback.
10 William Hinchcliffe, please give us your 11 affiliation and ask your question.
12 MR. HINCHCLIFFE: Thank you. William 13 Hinchcliffe, Radiation Safety Officer at Bridgeport 14 and Yale New Haven Hospital.
15 I just wanted to reiterate a little bit.
16 I know the concerns already brought up initially by 17 Pat Zanzonico and reiterated more recently by Kathleen 18 on behalf of ACR, but I do share the concern of the 19 questions, especially 4 through 8, in terms of the 20 practice of medicine in the NRC.
21 I know, Daniel, you have already discussed 22 not incorporating into regulation but rather 23 soliciting information to include in guidance. Again, 24 I caution that guidance can often be incorporated 25
86 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com during the licensing process into licensees' 1
commitments, and therefore sort of translating that 2
guidance into requirement.
3 So just stating that and adding to it.
4 Thank you for clarifying that you're soliciting it for 5
guidance, but it does not really diminish my concern.
6 MR. FRUMKIN: I come from the reactor 7
side, but generally the guidance is to support a 8
regulation. The guidance doesn't stand alone without 9
something attached to it.
10 Is that accurate, Daniel?
11 MR. DIMARCO: I would say that that's 12 accurate. That's actually something that's been 13 brought up in the working group, not having the 14 guidance set too far into being regulations. Guidance 15 in name only; regulations in spirit.
16 And so that's something that we're well 17 aware of and we're trying to stay in the forefront of.
18 The answers to these questions will definitely help 19 us with that. So thank you.
20 MR. FRUMKIN: Bryan Lemieux, I believe.
21 Please unmute yourself and provide your affiliation.
22 MR. LEMIEUX: Bryan Lemieux. I'm a 23 medical health physicist from Kentucky commenting on 24 my own behalf.
25
87 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com I wanted to echo the comments of one of my 1
physics colleagues earlier on regarding the accuracy 2
of the dosimetry models. In an ideal world, good 3
dosimetry would be indicative of biological end-point 4
and biological harm.
5 We know, however, even when we know the 6
dose fairly accurately for cutaneous skin injury from 7
fluoroscopic X-rays and other cases that the 8
biological responses that are actually seen is widely 9
variable, even at very large doses at 15 gray, 20 10 gray, 10 gray. So just a grain of salt in terms of 11 how accurate is the dosimetry.
12 I have looked at the Knoxville tool. It's 13 model-based dosimetry, right? If we're evaluating 14 patients in-clinic for clearance, we're looking at 15 clearance from site. That's the early clearance. Is 16 there a pharmaceutical sticking there?
17 We know that there's differences in 18 clearance from the site in different pharmaceuticals.
19 We don't necessarily know unless we're doing very 20 specific imaging what the 3D distribution is doing in 21 that tissue over time.
22 And so really, to get truly accurate 23 dosimetry is a non-trivial challenge. We can get some 24 idea. I think that's what Dr. Harvey kind of was 25
88 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com alluding to on some level. Where do we focus our 1
efforts for the greatest avoidance of patient harm and 2
where do we focus our efforts for protecting the most 3
people?
4 That's why a lot of times our attention is 5
the theranostics, the therapies, the written 6
directives. These are the things that are most likely 7
-- not that it isn't theoretically possible to cause 8
injuries from a diagnostic injection. I think there's 9
one or two cases, maybe three reported in the 10 literature over the last ten or 15 years. There's 11 certainly a paucity of them, but it's possible.
12 That's why we think that.
13 I wanted to segue that into another issue.
14 The theranostics stuff is really taking off.
15 Unfortunately, I logged in a little late so I didn't 16 know -- while NRC is considering how to regulate this 17 and how to look at how licensees manage this for the 18 safety of patients, and particularly as we're looking 19 at higher risk procedures, one of the things to 20 consider is the growing volume and the growing numbers 21 of sites and organizations that we'll be looking at 22 doing these sort of theranostics procedures.
23 Things like Pluvicto, there's a lot of 24 different places that want to start doing them outside 25
89 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com the major academic medical centers that have that 1
infrastructure, that physics support, and things like 2
that.
3 So that's something that the regulatory 4
community, if you are making these things, you have to 5
think about that as well, in addition to how this 6
pushes out to those community hospitals, how this 7
pushes out to those smaller licensees that do not have 8
the physics infrastructure and that may not have 3D 9
imaging to be able to take a spec scan on a patient 10 after they do a Pluvicto injection.
11 They might only have a planar camera. Or 12 it may be an oncologist's office that wants to do 13 Pluvicto and they want to do a license, but they don't 14 even have a camera. They're just going to do a 15 parenteral administration. Or they want to do Xofigo 16 at an oncologist's office and there's no imaging 17 equipment there. You can't image.
18 So there's a lot of complexity there that 19 I would hope the NRC would consider in the dosimetry 20 guidance, in how you roll out this regulation, and in 21 how you consider licensees' ability to adapt their 22 programs to protect patient safety and also come up 23 with some sort of meaningful solution to this. Thank 24 you.
25
90 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. FRUMKIN: Thank you for your feedback.
1 It does look like we have a queue of 2
questions, but I would like to take a five-minute 3
break now. Let's see if I get a nod from some folks 4
and take five minutes. We've been going at this for 5
two hours. We will go all the way to 4:00 if need be, 6
if that's where the questions take us.
7 So let's just take a break now. You can 8
leave your hands raised and we will get to them in 9
order. We'll see you all at 3:07, by the time on my 10 computer.
11 (Whereupon, the above-entitled matter went 12 off the record at 3:02 p.m. and resumed at 3:07 p.m.)
13 MR. FRUMKIN: Thank you for returning to 14 our public meeting.
15 Tracy King, if you are there, you can 16 unmute yourself, provide us your affiliation, and ask 17 your question on the upper end.
18 MS. KING: Thank you. My name is Tracy 19 King. I'm with Medical Physics Consultants.
20 My question is when will the dosimetry 21 model that you've referred to be available?
22 MR. DIMARCO: So not the actual coding 23 itself, but the model will be there -- I believe by 24 the end of the summer is what the schedule is for 25
91 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com that. The dosimetry model itself in its full form 1
will be released with the guidance document that we'll 2
be releasing with the proposed rule.
3 MS. KING: Okay, next question then. Have 4
you considered that dosimetry model may likely show 5
that only therapeutic agents need to be considered?
6 And if so, that will drastically affect the comments.
7 So should we maybe extend this comment 8
period until that dosimetry model that the licensees 9
could use is actually available for peer review?
10 MR. DIMARCO: The dosimetry model itself 11 will just be the tool. We're not intending for it to 12 be part of the regulation itself. And so the 13 licensees themselves and the stakeholders affected by 14 this are free to use it if they want to, but it will 15 not be a requirement to use that.
16 MS. KING: However, it's likely the only 17 tool that many community hospital licensees have at 18 their disposal. So much like in the other NRC 19 regulatory guides for patient release, they give us 20 the models to use, the calculation, the equation to 21 use.
22 I think we need that before we can 23 accurately assess the affect of this proposed 24 regulation on the practice of nuclear medicine. Thank 25
92 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com you very much.
1 MR. FRUMKIN: Thank you for your comment.
2 Michele Egberts, you can unmute yourself -
3
- you've done that already -- and state your 4
affiliation.
5 MS. PANICHI-EGBERTS: Hi. My name is 6
Michele Panichi-Egberts. I am the radiation safety 7
officer for several outpatient theranostic facilities, 8
as well as a couple of imaging facilities.
9 My concern is will we be required to 10 somehow investigate every administration for 11 extravasation or only those that we suspect there is 12 leakage? Like the gentleman two speakers ago said, 13 there is no way that we can image anything.
14 Let me just tell you. It's more common 15 than not these are going to be administered in urology 16 clinics as well as radiation oncology therapy centers, 17 which there is no imaging involved. So just saying, 18 that's who these manufacturers are targeting at this 19 point in time, not hospitals.
20 MR. DIMARCO: I believe the question in 21 there was on the requirements.
22 MS. PANICHI-EGBERTS: Will we have to 23 investigate every one?
24 MR. DIMARCO: Yes. The requirements for 25
93 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com those -- our medical event reporting regulations do 1
not require monitoring of any procedures.
2 MS. PANICHI-EGBERTS: So only when we 3
suspect that there is an extravasation do we look into 4
it?
5 MR. DIMARCO: I can't say what the 6
procedures would be for any specific medical facility.
7 Hopefully, our guidance documents will help the 8
medical facilities comply with our regulations. But 9
at least at this stage of the game, we're still in the 10 pre-proposed rule stage. So I can't comment on what 11 any medical facility will do.
12 MS. PANICHI-EGBERTS: I'm not saying what 13 we would do, but what we would be required to do.
14 MR. DIMARCO: I can't comment on what that 15 requirement would be at this stage.
16 MS. PANICHI-EGBERTS: Okay. Thank you.
17 MR. FRUMKIN: Thank you for your comment.
18 Gina Kell Spehn, thank you for coming back 19 and giving us another chance. You can unmute yourself 20 and ask your question. And state your affiliation 21 too, please.
22 MS. KELL SPEHN: Hi. Thank you. Sorry 23 about that earlier. I'm not sure what happened. I'm 24 not sure how far I got in my comments. I'm with New 25
94 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com Day Foundation for Families and I'm with Patients for 1
Safer Nuclear Medicine.
2 My comment today, first of all, I want to 3
reiterate what one of the callers mentioned earlier, 4
which is that the Commissioners' decision which led to 5
this rulemaking is based on a flawed document with 6
inaccurate, incomplete, and biased information. And 7
so I just want to preface my comments with that.
8 While acknowledging that the reporting 9
exemption for extravasations is no longer supportable, 10 you're initiating a rulemaking that would place 11 responsibility for identifying a radiation safety-12 significant extravasation on the patient. And that's 13 not an improvement.
14 So we want to make sure to mention that.
15 We're asking patients to detect radiation injury when 16 clinicians themselves often disagree on how injury 17 should be identified.
18 And we're asking patients to monitor 19 themselves for months or even years while they're 20 waiting for an injury to present itself rather than 21 proactively emphasizing the need for providers to 22 identify and mitigate extravasations when they occur.
23 There is only one way to interpret this staff 24 requirement, and that is that the patient's voice 25
95 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com matters less to you than the industry voice.
1 So not only is the decision to put the 2
burden on the patients wrong, but now that you know 3
that many patients are being exposed to high tissue 4
doses when they receive extravasations, nothing has 5
changed for today's nuclear medicine patients.
6 Technologists are going on LinkedIn.
7 They're complaining that patients are asking about 8
extravasations.
9 Leaders in nuclear medicine are no 10 different.
The radiation safety officer 11 representative on the ACMUI thinks that facilities who 12 accidentally inject large amounts of radiation into a 13 patient's tissue instead of the vein shouldn't have to 14 report this as a medical event.
15 And I thought that medical event reporting 16 was designed to ensure that accidents that result from 17 human error, lack of quality procedures, or lack of 18 training that then expose patients to high doses of 19 radiation are supposed to be investigated, shared with 20 the patient and their physician and with the NRC.
21 My question is, is an accidental injection 22 of a large dose of radiation into a patient's tissue 23 not the exact situation of some combination of these 24 things that are human error, lack of training, or lack 25
96 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com of quality procedures?
1 So instead of relying on subjective 2
assessments of the patients and instead of delaying a 3
correction for a couple more years now in the 4
rulemaking process, we're asking the NRC to simply 5
reaffirm the objective criteria that is used to 6
identify as in any other medical event.
7 To help patients right now, we're asking 8
NRC to immediately issue interim guidance on just 9
three points. One is that the patient must be 10 informed when they've experienced a radiation safety 11 and procedure-significant extravasation. We think 12 this is a basic patient right to have this 13 information.
14 They need to know as soon as it happens to 15 mitigate tissue damage and do what needs to be done to 16 hopefully help them. They must be informed of how 17 much radiation has entered their tissue so that they 18 can better understand the impact to their procedure 19 and care as well.
20 Number two, patients must be provided with 21 simple written information to help identify symptoms 22 of extravasation injuries. And they must know when 23 these symptoms might appear because often times there 24 are no immediate visible symptoms of underlying tissue 25
97 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com injury.
1 Finally, we would ask that patients 2
receive written instructions from their providers 3
explaining where to go and who to talk to if they 4
experience symptoms. This is necessary to ensure that 5
their suspected radiation injury is in fact reported 6
to the NRC.
7 This is something, like I said, that we're 8
hoping to have immediate interim guidance while we're 9
waiting for these rulemaking decisions to come 10 through. Thank you for your time.
11 MR. FRUMKIN: Thank you for your comments.
12 Irene provided all the information for submitting 13 this in the Regulations.gov or other means.
14 The next question is Richard Harvey. You 15 can unmute yourself, state your affiliation, and ask 16 your question.
17 DR. HARVEY: Yes. Hi again. Dr. Richard 18 Harvey from Roswell Park Comprehensive Cancer Center.
19 I don't think I'm representing ACMUI on this, so I'm 20 speaking as an individual.
21 Just to clarify the last comment, yes. I 22 don't believe that these extravasations need to be 23 classified as medical events. I believe that they 24 should handled at the institution level because it's a 25
98 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com very serious concern.
1 I just don't want anyone to think that I 2
don't think this is a serious issue. I think it's a 3
very important quality assurance issue that needs to 4
be resolved at that level. People need to identify 5
extravasations when they occur, at the time of 6
administration, or I would recommend when they perform 7
imaging afterwards. I understand not everyone does 8
perform imaging.
9 So I think it's very important to identify 10 this, mitigate it, and then provide the patient with 11 everything that they need. And again, it should be 12 identified at that time, not put on the patient. I 13 don't think the intent here is for anyone to put this 14 on the patient.
15 I
think this should be these 16 extravasations need to be identified on the day of 17 administration. So I just wanted to clarify my 18 position on that. Thank you.
19 MR. FRUMKIN: Thank you for your comments.
20 If people have more questions for the 21 staff on the FRN, please raise your hand or unmute 22 yourself and speak up. It looks like we're winding 23 down. If I don't see anything in a couple of moments, 24 we will open it up for Irene to provide some closing 25
99 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com remarks.
1 Irene?
2 MS. WU: Okay. If you can go to the next 3
slide, I can provide some contact information and 4
resources.
5 Again, here are the main contacts for this 6
rulemaking. I've also included a link to our 7
extravasations rulemaking public website, as well as 8
the overall NRC rulemaking process website to help you 9
stay connected with us on this rulemaking.
10 And then lastly, if you'd like to provide 11 us some specific feedback on this public meeting, we 12 used to provide forms. Now you just have to go and 13 click back to the public meeting notice where you got 14 the information to click into this meeting.
15 There should be a new link there that was 16 added where you can click on it and provide feedback 17 to us. That's separate. That's more feedback on the 18 public meeting itself versus providing us comments on 19 the questions and the preliminary proposed rule 20 language in the FRN.
21 I will see if Kevin is still on the line.
22 Maybe he can do some closing remarks as we bring this 23 meeting to a close.
24 Kevin, are you still on?
25
100 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com MR. WILLIAMS: I am still on. Thank you.
1 I'd like to thank everybody for their 2
contributions. I'll start with -- I'll get his name 3
right this time -- Daniel, thank you for facilitating.
4 Both Daniels, actually.
5 Daniel, thank you for addressing the 6
questions and walking us through this.
7 And Irene, thank you for setting this up 8
and being able to take us through the process of what 9
we're going to be doing here.
10 As we have stated, the importance of 11 providing good feedback is going to help make the 12 process better. So we thank all of you who engaged us 13 in meaningful conversation here. It will help to 14 inform our process as we navigate through the next 15 steps.
16 We appreciate everyone's comments. And as 17 stated, please make sure that you do submit your 18 comments as has been outlined in this process. I know 19 there will be another opportunity as we go through 20 here to comment on the rule itself. We will engage 21 appropriately.
22 I really want to appreciate all of the 23 energy that's around this and the high level of 24 engagement that was demonstrated by you all. So thank 25
101 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com you for your participation. Thank you for all who had 1
a hand in bringing this meeting together.
2 We really appreciate the feedback that we 3
get, and really appreciate the staff for the 4
opportunity to come in and meet with everyone to 5
ensure that we have a well-informed product. So 6
thanks to everyone.
7 I'll turn it back to Daniel.
8 MR. FRUMKIN: Not hearing any more 9
comments and having heard some closing remarks, the 10 slides are available online. The feedback form and 11 rulemaking interfaces are all available.
12 With that, we will close the meeting.
13 Thank you all for your participation.
14 (Whereupon, the above-entitled matter went 15 off the record at 3:21 p.m.)
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