ML24176A082

Draft Transcript of Meeting of the Advisory Committee on the Uses of Isotopes June 17 2024, Pages 1 - 93

ML24176A082
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Issue date:	06/17/2024
From:	Advisory Committee on the Medical Uses of Isotopes
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NRC-2869
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Official Transcript of Proceedings

NUCLEAR REGULATORY COMMISSION

Title:

Meeting of the Advisory Committee on the Medical Uses of Isotopes

Docket Number: (n/a)

Location: teleconference

Date: Monday, June 17, 2024

Work Order No.: NRC-2869 Pages 1-76

NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1716 14th Street, N.W.

Washington, D.C. 20009 (202) 234-4433 1

UNITED STATES OF AMERICA

NUCLEAR REGULATORY COMMISSION

+ + + + +

ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES

+ + + + +

TELECONFERENCE

+ + + + +

MONDAY,

JUNE 17, 2024

+ + + + +

The meeting was convened via

Teleconference, at 2:00 p.m. EDT, Hossein Jadvar, ACMUI

Chairman, presiding.

MEMBERS PRESENT:

HOSSEIN JADVAR, M.D., Ph.D., Chairman

RICHARD L. GREEN, Vice Chairman

REBECCA ALLEN, Member

ANDREW EINSTEIN, M.D., Member

MICHAEL R. FOLKERT, M.D., Ph.D., Member

JOANNA R. FAIR, M.D., Ph.D., Member

RICHARD HARVEY, Dr.Ph., Member

JOSH MAILMAN, Member

MELISSA C. MARTIN, Member

MICHAEL D. O'HARA, Ph.D., Member

ZOUBIR OUHIB, Member

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MEGAN L. SHOBER, Member

HARVEY B. WOLKOV, M.D., Member

NRC STAFF PRESENT:

LILLIAN ARMSTEAD, ACMUI Coordinator

DANIEL DIMARCO, NMSS/MSST/MSEB

SARAH LOPAS, NMSS/REFS

KATHERINE TAPP, NMSS/MSST/MSEB

ALSO PRESENT:

DAVID BUSHNELL, M.D.

KYLE UNDERWOOD

PAUL WALLNER, M.D., ACR

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AGENDA

Opening Remarks....................................4

Report on Nuclear Medicine Injection

Extravasations as Medical Events..................11

Closing and Adjournment..........................75

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P R O C E E D I N G S

2:01 p.m.

MR. EINBERG: Okay, if everybody else is

ready, I= m going to go ahead deal with the opening

remarks, and then turn it over to Dr. Jadvar.

So good afternoon. As the Designated

Federal Officer for this meeting, I= m pleased to welcome

you to this public meeting of the Advisory Committee

on the Medical Uses of Isotopes. My name is Chris

Einberg, I= m the Chief of the Medical Safety and Events

Assessment Branch, and I= ve been designated as the

Federal Officer for this advisory committee in

accordance with 10 CFR Part 7.11.

This is an announced meeting of the

committee. It is being held in accordance with the

rules and regulations of the Federal Advisory Committee

Act and the Nuclear Regulatory Commission. This

meeting is being transcribed by the NRC, and it may

also be transcribed or recorded by others.

The meeting was announced in the June 4,

2024, edition of the Federal Register, Volume 89, page

48001.

The function of the ACMUI is to advise the

staff on issues and questions that arise on the medical

use of byproduct material. The committee provides

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counsel for the staff but does not determine or direct

the actual decisions of the staff or the Commission.

The NRC solicits the views of the committee and values

their opinions.

I request that whenever possible, we try

to reach a consensus on the various issues that we will

discuss today, but also recognize there may also be

minority or dissenting opinions. If you have such

opinions, please allow them to be read into the record.

At this point, I would like to perform a

roll call of the ACMUI members participating today.

Dr. Hossein Jadvar, nuclear medicine

physician and chair of the committee?

CHAIRMAN JADVAR: Present.

MR. EINBERG: Mr. Richard Green, vice

chair, nuclear pharmacist?

VICE CHAIRMAN GREEN: Present.

MR. EINBERG: Michael Folkert, radiation

oncologist?

DR. FOLKERT: Present.

MR. EINBERG: Mr. Josh Mailman, patients=

rights advocate?

MR. MAILMAN: Present.

MR. EINBERG: Ms. Melissa Martin, nuclear

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medicine physicist? Melissa, I= m not sure if you had

your mic on or off, but Melissa is present.

MS. MARTIN: I am present. As far as I

know, everything= s on. Melissa is present.

MR. EINBERG: Very good, thank you.

Dr. Michael O= Hara, FDA representative?

I didn= t see him on earlier.

Okay, Mr. Zoubir Ouhib, radiation therapy

physicist?

MR. OUHIB: Present.

MR. EINBERG: Ms. Megan Shober, state

government representative?

MS. SHOBER: Present.

MR. EINBERG: Dr. Harvey Wolkov,

radiation oncologist?

DR. HARVEY: Present.

MR. EINBERG: Dr. Richard Harvey,

radiation safety officer?

DR. EINSTEIN: Present.

MR. EINBERG: Dr. Andrew Einstein,

nuclear cardiologist?

DR. EINSTEIN: Present.

MR. EINBERG: Dr. Joanna Fair, diagnostic

radiologist? Okay, I didn= t see her on earlier.

And Ms. Rebecca Allen --

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DR. FAIR: Present.

MR. EINBERG: Healthcare administrator?

MS. ALLEN: Present.

MR. EINBERG: We have a quorum, so we can

proceed.

So Dr. Joanna Fair recently was selected

as a diagnostic radiologist representative. And she= s

pending for a security clearance and will not have

voting rights for any of the actions requiring a vote,

but may participate in the discussions during today= s

meeting, if she joins us.

DR. FAIR: I am here. This is Joanna

Fair, I am here.

MR. EINBERG: Oh, okay, well thank you.

DR. FAIR: I= m not sure that you heard me

when I said present.

MR. EINBERG: I did not, yeah, thank you

for confirming that, I appreciate that.

Dr. John Engle, interventional

radiologist, consultant to the ACMUI, may participate

in today= s discussion, but does not have voting rights

for any of the actions requiring a vote.

All members of the ACMUI are subject to

federal ethics laws and regulations and receive annual

training on these requirements. If a member believes

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that they may have a conflict of interest as they --

that term if broadly used within 5 CFR Part 2635 with

regard to the agenda item to be addressed by the ACMUI,

this member should divulge it to the chair and the DFO

as soon as possible before the ACMUI discusses it as

an agenda item.

ACMUI members must recuse themselves for

participating in any agenda item for which they may

have a conflict of interest unless they receive a waive

or prior authorization from the appropriate NRC

official.

I would like to add that we are also using

Microsoft Teams so that members of the public and other

individuals can watch online or join via phone. The

phone number for the meeting is 301-576-2978. The

phone conference ID is 558-124-30#.

The handouts and agenda for this meeting

are available on the NRC= s ACMUI public website.

We have several NRC staff members on the

call today. Among them are Lillian Armstead, who is

our ACMUI coordinator; Dr. Katy Tapp; Daniel DiMarco;

and Sarah Lopas.

Members of the public who notified Ms.

Armstead that they would be participating via Microsoft

Teams will be captured as participants in the

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transcript.

Those of you who did not provide prior

notification, please contact Ms. Armstead by email at

LXA5@nrc.gov.Once again, that= s LXA5@NRC.gov at the

conclusion of this meeting.

Today= s meeting is being transcribed by

a court reporter. We are utilizing Microsoft Teams

for the audio of today= s meeting and to view

presentation material in real time. The meeting

material and agenda for this meeting can be accessed

from the NRC= s public meeting schedule.

For the purpose of this meeting, the chat

feature in Microsoft Teams has been disabled. Dr.

Jadvar, at his discretion, may entertain comments or

questions from members of the public who are

participating today.

Individuals who would like to ask a

question or make a comment regarding the specific topic

the committee has discussed and are in the room can

come up to the, well, can raise their hand and indicate

to the Ms. Lopas that they= d like to make a comment.

For those individuals on Microsoft Teams,

please raise your hand. And Ms. Armstead, if you wish

to speak, if you have called into Microsoft Teams using

the phone, please ensure that you have unmuted your

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phone.

When you begin your comment, please

clearly state your first and last name for the record.

Comments and questions are typically addressed by the

committee near the end of the presentation, after the

committee has fully discussed the topic.

We will announce when we are ready for the

public comment period portion of the meeting. And Ms.

Armstead now will assist in the facilitating of the

public comments.

For those who submitted comments prior to

the meeting, those comments will be included with the

meeting transcript.

At this time, I ask that everyone who is

not speaking to please mute your Teams microphones or

phone. And for those in the room, please mute your

phones.

And so I= m going to turn this on over to

Dr. Jadvar. Dr. Jadvar?

CHAIRMAN JADVAR: Thank you very much, Mr.

Einberg. Good morning, or good afternoon as the case

may be, to all. And I hope you all had a great day

yesterday at Father= s Day.

Today in this ACMUI public meeting, we are

going to hear the ACMUI subcommittee= s report on the

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NRC= s staff draft proposed rule and associated draft

implementation guidance for reporting nuclear medicine

injection extravasations as medical events.

With that, I will turn this now to Ms.

Melissa Martin, who served as the chair of the

subcommittee. Ms. Martin?

MS. MARTIN: Thank you, Dr. Jadvar.

It was my privilege to serve as chair of

this committee. This is the report of our subcommittee

on extravasations. Next slide, please.

Our subcommittee members included Dr.

Andrew Einstein, Mr. Richard Green, Dr. Richard Harvey,

myself, and Ms. Megan Shober. And Daniel DiMarco

served as our NRC staff resource. Thank you very much.

Next slide.

We received this -- our subcommittee

received this expanded charge from the U.S. Nuclear

Regulatory Commission staff that the -- we received

the charge to review the NRC Commission staff= s draft

proposed rule and associated draft implementation

guidance for reporting nuclear medicine injection

extravasations as medical events and provide feedback

and recommendations. That was our official expanded

charge. Next. Next slide, please.

This report incorporates several years of

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prior discussions on this topic. In 2019, the ACMUI

revisited the NRC decision to exclude extravasations

from medical event reporting. Was recommended that

extravasations be considered a type of passive patient

intervention.

In 2020, the ACMUI reiterated that

extravasations be considered a time of passive patient

intervention, and that an extravasation that leads to

unintended permanent functional damage be reported as

a medical event under 10 CFR 35.3045(b).

In 2021, the ACMUI supported the reporting

as medical events of extravasations that require

medical attention due to a suspected radiation injury

as determined by an authorized user physician of the

licensee. Next slide.

As background for this report, the NRC

staff has drafted a proposed rule and draft

implementation guidance in response to the Commission=s

direction on the staff= s proposal to codify

requirements of certain nuclear medicine injection

extravasations as medical events. Again, this has

been prepared at the request of the Commission.

The Commission directed staff to codify

requirements for the medical event reporting of

extravasations that require medical attention for a

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suspected radiation injury.

The Commission tasked the staff to explore

approaches that would reduce the reliance on patient

reporting. Next slide, please.

The Commission directed the staff to

evaluate whether the NRC should require licensees to

develop, implement, and maintain written procedures

to provide high confidence that radiation-significant

extravasations will be detected and reported, and to

create guidance to comprehensively explain and

illustrate the medical event reporting criteria for

evaluating and reporting all medical events, not only

extravasation events. Next slide.

So in this preliminary proposed rule

package, the documents include, one, a draft proposed

rule as published in the Federal Register; the draft

implementation guidance, which includes a draft

regulatory guide for the evaluating and reporting of

medical events including extravasation medical events.

Third, it includes a draft model procedures for

detecting and report extravasation medical events.

Next slide, please.

The ACMUI Subcommittee on Extravasations

has a couple of general comments. Number one, the

subcommittee supports the publication of this draft

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regulation and the draft regulatory guide. They are

well-written, and the draft regulatory guide contains

useful information for licensees. So in general, the

subcommittee is very much in support of publishing

these documents. Next slide, please.

For the topics of extravasation and

patient education, the background to this is that the

U.S. Nuclear Regulatory Commission has drafted a model

procedure for management of patients that may have an

extravasation of a radiopharmaceutical.

The current document that covers this is

the draft model procedures for evaluating and reporting

extravasation medical events. It is recognized that

extravasations of radiopharmaceuticals may occur, but

occurrences that may result in a radioactive medical

event are infrequent. Next slide.

Identification of events involving

radiopharmaceutical extravasations are included in

this document, with indications of radiopharmaceutical

extravasations. There is discussion of management of

events involving radiopharmaceutical extravasations,

including discontinuation and resumption of

administration, appropriate notifications, mitigation

strategies, and dose assessments. Next slide, please.

There is document -- there is

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recommendations for event documentation and follow-up

care, including documentation in the patient= s records,

follow-up care for ongoing care and referrals to other

specialties as needed.

There= s recommendations for patient

education, consisting of policies and procedures

consistent with available information from

professional societies. There is patient information

and discharge instructions. Next slide, please.

For specific comments on the proposed

rule. The definition of extravasation: as proposed

in this rule, the NRC defines extravasation to mean

the unintentional presence of a radiopharmaceutical

in the tissues surrounding the blood vessel following

an injection.

The subcommittee believes that this is

overly specific and excludes other possible injection

errors that may occur, such as during intra-arterial

injections, intrathecal injections, as well as

injections intended for a specific body cavity or

space. So the subcommittee= s recommendation is to

broaden the definition of extravasation. Next slide,

please.

Our specific comments on the proposed

rule. If you are reading it or if you read it in the

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future, page 1, we would say this proposed rule would

affect all medical licensees that administer

radiopharmaceuticals for diagnostic and therapeutic

purposes.

On page 5 and page 10, we would like to

expand the definition of extravasation to include

spinal or body cavity into which it was intended

following an injection. On page 11, again, this

proposed rule would affect all NRC and agreement state

medical licensees who administer radiopharmaceuticals

for diagnostic and therapeutic purposes. Next slide,

please.

On page 13, we would like to remove A IV@

from before the work A injection.@ This imposing a

dose-based criterion would require monitoring millions

of administrations per year, which would result in

significant regulatory burden for medical licensees

for only a marginal increase in radiation safety.

The subcommittee agrees with the comment

that in light of the above information on the potential

risk posed by extravasations of radiopharmaceuticals,

the NRC believes such a dose-based requirement would

be inappropriate. Next slide, please.

On page 14, we would insert the word A may@

in the phrase Anormal biological processes may

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transport the dose to the intended target.@

On page 17, we would suggest the following

sentence be removed: A Both radiopharmaceuticals

mentioned are not currently commercially available in

the United States, for example, extravasations from

I-131 iodocholesterol, resulting in erythematous

plaque and Thallium-201.@ That= s the sentence we

would like to have removed because those items are not

used in the U.S. Next page please -- I mean next slide,

please.

On page 20, upon consideration of this

feedback in this proposed rule, the NRC defines the

term Aextravasation@ in Section 35.2 as the

unintentional presence of a radiopharmaceutical in the

tissue around a blood vessel, spinal cord, or body

cavity into which it was intended following an

injection. Next slide, please.

On page 26, we -- the subcommittee agrees

with the comment AThe conclusion from the analysis is

that this proposed rule and associated guidance would

result in a cost to the industry, meaning NRC and

agreement state medical licensees that administer

radiopharmaceuticals for both diagnostic and

therapeutic purposes.@

On page 30, we have the --we agree with

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the question A Who will be required or asked to respond,@

and this is answered by A NRC and Agreement State

licensees who administer radiopharmaceuticals for

diagnostic and therapeutic purposes.@ Next slide,

please.

So we are reiterating extravasation means

the unintentional presence of a radiopharmaceutical

in the tissue surrounding a blood vessel, spinal cord,

or body cavity into which it was intended following

an injection. Next slide, please.

The next document we were asked to comment

on is the draft regulatory guide. And in Section

1.1.1, the subcommittee recommends that a statement

about whether it is reportable if an unintended dosage

was administered and the licensee did not fill out a

written directive when they should have. In other

words, there was no prescribed dosage to be added.

This would address situations where the

administered dose was greater than 20% different from

the intended dose that the physician failed to complete

the written directive. So it our recommendation that

we add a statement about that possibility. Next slide,

please.

In Section 4, instead of referencing the

best practices via -- available through the medical

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library number, we recommend that listing the best

practices explicitly in the regulatory guide as there

are only five short best practices.

Appendix B, add an example of a microsphere

medical event. Next slide, please.

In Appendix B right now, two of the

examples use Lutathera. The subcommittee recommends

limiting that to one example per radiopharmaceutical,

or describing the radiopharmaceuticals generically,

such as a beta-emitting radiopharmaceutical. We don= t

want to imply that all accidents happen -- that happened

use Lutathera. Next slide, please.

The other document we were asked to comment

on is the draft model procedures. Page 1, informed

consent should not be required for either diagnostic

or therapeutic nuclear medicine procedures. That is

the subcommittee= s recommendation.

Patient education, whether done verbally

and/or in printed format, is the appropriate method

of communication between the patient and physician or

healthcare professional. Next slide, please.

Guidelines for observation of unexpected

sensations by the patient or other developments

observed by the medical staff or the patient should

be developed by each facility in accordance with

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recommendations from the professional medical

societies, such as the Society of Nuclear Medicine and

Molecular Imaging, the American College of Radiology,

the American Society for Radiation Oncology, and the

American Association of Physicist and Medicine. Next

slide.

Thank you for your attention, and now we

have time for questions, first from the ACMUI

subcommittee members. I= ll turn this over to Dr.

Jadvar, who will handle the questions.

CHAIRMAN JADVAR: Thank you very much,

Melissa, for that report.

So as Melissa mentioned, this is now open

to the subcommittee members for any comments or

questions regarding this report. I hear none --

MR. OUHIB: This is Zoubir Ouhib.

CHAIRMAN JADVAR: Okay, go ahead.

MR. OUHIB: This is Zoubir Ouhib. I have

a --

CHAIRMAN JADVAR: Are you one of the

subcommittee members?

MR. OUHIB: Yes, this is Zoubir Ouhib.

CHAIRMAN JADVAR: Okay, very good. Go

ahead.

MR. OUHIB: I have questions,

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suggestions, et cetera, for the subcommittee. On page

6, the third sentence, it says, A In that extravasations

are virtually impossible to avoid.@ I was wondering

if perhaps we could say A In that extravasation are not

always predictable and virtually impossible to avoid,@

which is in my opinion is the fact. I mean, we can= t

really predict these.

The last sentence on page 6, it says A Under

Section A, none of these update address extravasation.@

I= m wondering if we can provide a short explanation

for that justification. Why was that not addressed

at all? Perhaps there= s a reason for, you know, the

reader to understand that.

On page 8 under Section 4, the second

paragraph, it says A The Commission directed the staff

to explore approaches to reduced reliance on patient

reporting, etc., etc.@

I am not really sure if that= s a good idea

in my opinion. Because for the majority of the time,

when there are issues on or with any procedures,

including extravasations, it= s the patient that

actually report the unusual item that they=re

experiencing.

You know, we see that in radiation

oncology, whether it= s brachytherapy or radiation beam

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or whatnot. And when there is a mishap, usually the

patient is the first one that actually detect that.

So I would -- I= m sure if that= s a good idea to reduce

the reliance on patient reporting.

On page 10, the first bullet point, it says

ARevising the definition for extravasation to mean the

unintentional presence of radiopharmaceutical, et

cetera, et cetera@ And I was wondering if it= s just

we say the unintentional resulting presence. Because

that basically this is something that happens

afterwards. It= s not already present there.

On page 19, the last sentence under Section

G, it says A All healthcare professional--A oh, my

apologies. I would say to add perhaps, because the

key item there is to really focus on the providing

physician there, whether it= s a nuclear medicine

physician or rad onc, whatnot.

But I think we should add something is that

all healthcare professionals however involved in

patient care are encouraged to communicate with their

staff physician should they identify any unexpected

observation or findings related to extravasation or

anything else, for that matter. So in other words,

not to exclude the rest of the staff completely, because

what I understood, they= re really not sort of per se

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qualifying and leave it to the providing physician.

Page 22, I would -- well, let me skip that

since I= ve got a few. Page 23, the use of the term

Ahigh confidence.@ I= m not sure if it= s needed as it

might lead the reader believe that the rest of the

recommendation are sublevel of confidence.

The slide No. 13, I would suggest changing

patient information to patient education. I= m not sure

what was meant about patient information.

The consent form. I feel very strong

about this, as the informed consent is one of the ninth

core principles of the American Medical Association= s

Code of Medical Ethics.

And if you look at the -- for instance,

just as an example, the APEx, which is the

accreditation, you know, for a radiation oncology

department, the consent form is required. And it= s

a document that the institution is to provide,

basically. If it= s not available, then that= s a

strike.

So I think that= s really very, very

critical, because in that, in the consent form, there

is a discussion regarding the diagnosis. The proposed

treatment plan, the risk and benefit of the plan, which

is there can be discussed at something like this can

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happen or this can happen, etc.

But also provide alternative options in

the consent form. In other words, the patient doesn= t

necessarily have to go through that procedure, and they

can perhaps look into other things.

And then finally of course it= s what happen

if you do nothing. And all that is included in the

informed consent form. And that= s usually signed by

the radiation oncologist.

I can tell you in our practice, we used

to have not only the rad onc, but also the patient,

because you could always have a patient saying nobody

discussed anything with me, I don= t know what you= re

talking about, should there be a problem. But then

if you have a signature, you have a documentation that

these discussion actually took place.

MR. EINBERG: Mr. Ouhib, this is Chris

Einberg from the NRC.

MR. OUHIB: Yeah.

MR. EINBERG: I= m just going to suggest

to you and Dr. Jadvar and to yourself that you= ve

provided a lot of comments all at once. And I= m not

sure that the subcommittee can, you know, remember all

the comments.

MR. OUHIB: Sure.

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MR. EINBERG: Maybe it= d be better to

address them one by one. And so I= ll leave that to

Dr. Jadvar to decide how to proceed.

MR. OUHIB: Yeah.

CHAIRMAN JADVAR: Sure. Well, I want to

thank Zoubir for all the comments. And I= m sure this

is being transcribed, so hopefully this will be taken

into account by the subcommittee. And again, thank

you.

Now, I see Dr. Michael Folkert= s hand is

up. Dr. Folkert?

DR. FOLKERT: Hi, Mike Folkert, ACMUI

member. I wanted to echo what Mr. Ouhib had said, in

particular about the informed consent.

I definitely think that an informed

consent should be absolutely required, especially for

the high-dose therapeutic procedures. And so, and it

should just be a required part of the procedure. We= ve

been discussing in the medical events committee how

important it is to include a timeout.

And one key part of the timeout is, you

know, making sure that everyone knows what the

procedure is that you= re doing and that they=re

understand why they= re doing it. And I think this is

a critical way to improve patient safety and to reduce

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the risks of a misadministration or other medical

event. So I do think that informed consent should be

required.

The patient education is critical to us

being able to deliver treatment safely. I mean, we,

once patients have been administered a

radiopharmaceutical, they have to understand the

patient safety concerns in order to keep their friends

and family safe when they return home.

So I mean, this is all part and parcel for

the whole part of the procedure. Informed consent

should be required. Patient involvement, patient

education is required and is key to the safe delivery

of radiopharmaceutical therapy.

CHAIRMAN JADVAR: Thank you, Dr. Folkert.

I see that Mr. Richard Green has his hand up too.

VICE CHAIRMAN GREEN: Thank you, Dr.

Jadvar.

Mr. Ouhib, he had lots of good comments.

I want to -- I can=t remember them all, as Chris Einberg

mentioned, there was quite a few. I just want to

address a few that came to mind.

I believe in the context of the charge from

the commissioners, there was a direct quote from the

historical record that Melissa Martin described, the

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various years where the NRC has approached the ACMUI

for comments. And that= s where the direct quote was,

that extravasations are almost impossible to avoid.

And that= s not a current comment or a

current thought, that= s an historical record. And that

should be in there. Same with the, I= m not sure if

it was the commissioners or it was the NRC staff that

said with high level of precision, you know. So

again, that should be a direct quote.

One, I= ll let others embellish upon this.

I think there are many professional societies and

accreditation organizations that require a written --

require an informed consent, signed informed consent.

And I think they will still continue to do so, and

I think that= s appropriate.

I think what the subcommittee was

stressing, not that the NRC be a requirer of written,

of informed consent, but highly recommend that the

licensees conduct patient education with materials to

alert the patients so that they without a great deal

of technical background, should know if something went

awry and be able to inform their caregivers if they

suspect something is amiss.

So informed consent plays a role but we

don= t think as a subcommittee that it was a required

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as part of the NRC regulation. And hopefully others,

I know Dr. Einstein was also very well spoken on this

point.

Thank you.

CHAIRMAN JADVAR: Thank you, Richard. I

see Melissa has her hand up. Melissa?

MS. MARTIN: Yes, I was wondering if Dr.

Folkert would differentiate the requirement for

informed consent versus patient education based on

whether the administration was going to be diagnostic

or therapeutic.

Are you saying that you want -- your

recommendation is to require the informed consent for

all 12 million injections that happen per year? Or

do you -- are you comfortable with requiring it for

the therapeutic administrations?

DR. FOLKERT: Yeah, this is Mike Folkert.

I said specifically for the therapeutic

administrations.

MS. MARTIN: Thank you. I did not hear

that, thank you very much.

CHAIRMAN JADVAR: Okay, moving on, I have

Dr. Richard Harvey.

DR. HARVEY: Thank you, Dr. Jadvar. It= s

Dr. Richard Harvey, the radiation safety officer

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Representative.

So I think the items that Dr. Folkert had

mentioned, those things are already, already being

done. It= s not like they= re not being done. We don= t

need informed consent to do all the things that he

mentioned. They= re all already being done. And doing

informed consent for every injection is just really

superfluous. It= s just not necessary.

It= s not going to improve radiation safety,

it= s not going to improve the quality of what= s being

done. There are already -- there= s already education,

there= s already discharge instructions.

Patients sign off on those discharge

instructions. Patients have consults prior to the

procedure where everything is discussed. There are

alternatives. Everything that they, you know, could

do or don= t have to do or might be able to do.

So the addition of informed consent really

offers no additional benefit. And everything that you

mentioned is already being done. So I think that= s

important to recognize with this. Thank you.

CHAIRMAN JADVAR: Thank you, Dr. Harvey.

Mr. Green, do you still have a question? I see your

hand still up. Is that from before or new?

VICE CHAIRMAN GREEN: My apologies, I

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failed to lower my hand.

CHAIRMAN JADVAR: All right, very good.

So we go to Dr. Einstein.

DR. EINSTEIN: Yeah, I would second what,

the points which Dr. Harvey and Green have mentioned.

This came up and it was the subject of numerous

discussions among the extravasations subcommittee.

Certainly for diagnostic

radiopharmaceutical administration, it would cripple

the system for 15 million patients and maybe 20 million

injections per year in the United States to require

written informed consent.

But the thought of the subcommittee was

even for therapeutic administrations of

radiopharmaceuticals, to add specifically in the

context of extravasations a requirement for formal

written informed consent as distinguished from patient

education, which is really what= s central. We want

to inform patients.

We don= t necessarily want to institute

onerous requirements of more paperwork that are not

going to improve the quality of patient care and patient

outcomes here. And that= s why the subcommittee after

numerous discussions came to this conclusion.

CHAIRMAN JADVAR: Thank you, Dr.

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Einstein. Any other comments by the ACMUI members?

I have one minor comment on slide No. 14.

The sentence regarding surrounding the blood vessel.

I mean, this was really focused initially, as you

mentioned, on intravenous injections in the vein. But

as you know, arteries also are blood vessels.

So I would kind of spell it out,

intravenous, intra-arterial. And then as you added also

intrathecal and any body cavity or space, which I agree

with. Because they= re both vessels.

Any comments from the ACMUI members?

Okay, thank you.

Now with that--

MR. MAILMAN: So I do actually. This is

Josh, I do have my hand up.

CHAIRMAN JADVAR: Yes.

MR. MAILMAN: So there are a couple

things, you know, sorry about that. I= m traveling in

the car and I apologize for some of our connectivity

issues I have here.

But I will want to add a few things here.

So first of all, adding this to informed consent

becomes challenging when we don=t have what we=re

informing the patient on.

If we say that extravasations happen but

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don= t have the frequency to which medical event happens,

we= re, you know, to some of the earlier comments, we= re

adding information but not giving them a likelihood

of what it is that they= re consenting to, right.

They= re -- we need to say it happens in

two percent of the times in this procedure. And I

think, or whatever that number is. And I think that= s

one of the challenges that I have here as a patient,

is that we want to do patient education, which is like

their team, and yet --and maybe informed consent or

adding it to whatever standard checklist that we= re

talking about in addition to what we already go through

with patients.

But we need to be able to give the numbers

that matter to a patient. Just saying here is the risk,

we don= t really know what the risk is is actually

inappropriate. And we need to actually quantify the

risk if we= re going to talk about the risk. We can

talk about how to tell, you know, what it is

informationally so that they can report it.

But if they= re consenting to something,

it= s nearly impossible to consent to an unknown. And

that= s what -- certainly these are -- these are drugs

and things that are not in trials, where we might have

an unknown. These are things that we should have a

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known about.

Can you turn it back to slide 13 by chance?

Yeah, thank you. And slide 13 talks about, you know,

medical societies giving patient education if I --

remembering talks about patient education. And I do

think that we need to make it part of a standard

checklist of what we talk to the patients, whether it= s

the discharge information or however it is, and that= s

part of the guidelines.

But I also think that we need to use

standard language across the medical societies, and

that we should --we really do need to have specific

information again. Giving patient education on an

unknown is really challenging for patients to absorb.

So, and I know there was some comment about

the initial charge that the subcommittee had about

lessening the reliance on patient-reported

information.

I will say it doesn= t preclude the

reporting of patients in that it means to me that we= re

not solely relying on patients and that everyone= s in

the game of all -- everyone should be looking at that

checklist. And everyone is a partner in this and we= re

not just solely relying.

So I don= t mind if the language took the

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onus off the patient. You= re absolutely right, Zoubir,

that patients will notice these things a lot. And (audio

interference) in many conditions, but that doesn= t take

the onus off everyone else in the chain to make sure

that part of the reporting structure and part of the

observation structure.

So I think the charge to the subcommittee

was correct in saying you just can= t fall on the patient

because that= s I think inappropriate. But we have to

give patients good information of which they can help,

work and be a partner in their healthcare.

With that I= ll turn it back and try to lower

my hand on my phone.

CHAIRMAN JADVAR: Thank you, Josh.

So I have two hands up again. Dr. Folkert?

DR. FOLKERT: I apologize, we have power

failures. I= m reconnecting my phone.

You know, my concern particularly for that

consent comment, so I apologize, I= m going back to that,

is that on that page 24, it says A Informed consent should

not be required of the procedures.@

It doesn= t say anything about any -- about

extravasations, it doesn= t say anything like that.

It says A should not be required.@ And that is really

not in keeping with what we= ve been thinking about in

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other discussions for medical events.

I= m not saying that it needs to happen at

the time of the therapeutic procedure, but it is an

important part of it, of the overall treatment plan

for a patient. And for the NRC to make a statement

that informed consent should not be required, I think

that= s overstepping. I think that= s overreach.

CHAIRMAN JADVAR: Good point. Dr.

Richard Harvey. Dr. Harvey, did you have your hand

up?

DR. HARVEY: Apologize, I hit mute and

didn= t come off of mute and I started talking, and I

apologize. So again, it= s Dr. Richard Harvey,

radiation safety officer representative.

So much to comment on there. Let me start

with Dr. Folkert= s because it= s the most recent. I

kind of agree, we don= t want to -- we= re not -- the

intent is not to say that you can= t have informed

consent. Anybody could implement informed consent at

their own organization. I think the intent there is

that it= s not required.

Thinking about some of Mr. Mailman= s

comments, which are important, very important as well,

is this is certainly a team-based approach for the

procedures in nuclear medicine. So when the IVs are

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placed or the injections are done, whoever= s doing it,

the nuclear medicine technologist, a nurse, someone

else, they= re going to be monitoring, they= re going

to be looking for, they= re going to identify

extravasations.

You= re going to talk to your patient. Do

you feel any unusual sensations, do you feel any

burning? They= re going to be looking for swelling.

They= re going to be looking for anything out of the

ordinary.

And you know, you=re going to see this on,

you know, possibly when you= re doing imaging. You

might see some of the dose at the site of extravasation.

There= s definitely a team-based approach to make sure

that, you know, this burden is not all on the patient.

That I don= t think was anyone= s intent. Everyone here

is for the patient, making sure the patient gets the

best possible care that they can.

And you know, anyone in nuclear medicine

wants to put out high quality studies to benefit their

patients. So I think that= s really important to

recognize that, you know, this is a team-based approach

and it always has been.

With regards to extravasations, they do

occur. They= re relatively uncommon. That can be

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argued a bit. But I= ve been doing this for 33 years,

and I= ve never seen an extravasation cause a radiation

injury. And I think it= s very important to segregate

or distinguish between the fact that you can have a

small amount of the radiopharmaceutical extravasating

and it= s going to have no impact on the patient.

I am aware of one extravasation in my

career that happened somewhere else, and yes, I= ve seen

pictures and they do happen. But we don= t want to,

at least in my opinion, make a mountain out of a molehill

when we don= t have very many extravasations causing

radiation injuries.

So I think we really have to recognize

that. And our thoughts are if you identify an

extravasation, you provide the patient with education

and what to do going forward, and you work with them.

If you up front tell everyone that, you

know, there can be an extravasation, it might cause

this, it might cause that, you= re probably

unnecessarily causing fear and anxiety in patients,

you know, for no, really no helpful reason.

You know, if an extravasation occurs, it= s

most likely going to be identified by the team,

including the patient. And then it can be addressed

and it can be dealt with going forward.

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So that= s sort of at least where I= m coming

from on this, and I= m just going to stop there and give

somebody else a change. Thanks.

CHAIRMAN JADVAR: Thank you, Richard.

Let= s see -

MR. MAILMAN: I= d like to --

CHAIRMAN JADVAR: Josh, yeah.

MR. MAILMAN: Re-comment on that really

quick. When we have words like, you know, A very rare@

or you know, A infrequent,@ these are what needs to be

quantified. And I= m, you know, unfortunately I haven= t

been doing this for 30 years, and I= ve been poking my

head around for several and with this topic, for at

least the last year. And unfortunately, I have seen

these things, not to myself.

And I do agree that they happen relatively

rarely. And we can discuss what that is, whether it= s

one in 700, one in 1000, one in whatever that number

is. But we have a set of, you know, we certainly get

a set of comments that say this happens one in every

17 or one in every 30. And the other journal articles

will say it happens one in every, you know, 30,000.

So I think we need to figure out how we

get to a definitive number so that we can give people

the relative risk. I completely agree with you that

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it is, you know, giving the information about what may

happen so you can identify it and saying it happens

very infrequently and here= s what we know is much better

than saying, you know, here it is, we think it doesn= t

happen very much but that doesn= t -- that doesn= t happen

>til we can quantify it.

And I= ll turn off my mic now.

CHAIRMAN JADVAR: Okay, thank you, Josh.

Dr. Harvey again.

DR. HARVEY: Yes, thank you very much, Dr.

Jadvar. Dr. Richard Harvey again, the Radiation

Safety Officer Representative.

I think what, please correct me somebody

if I= m wrong, but I think what the NRC is proposing

is that if we have an extravasation that causes a

radiation injury, it is reported as medical event.

And I think then we get -- and we quantify those numbers,

and those are useful for Mr. Mailman, for patients to

understand.

But to try to quantify every extravasation

that occurs that doesn= t cause radiation injury, at

least in my opinion, it doesn= t have any value. So

you can have --

MR. MAILMAN: Don= t disagree.

DR. HARVEY: A little bit -- that= s fine.

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And we can agree to disagree. And again --

MR. MAILMAN: No, I actually said I don= t

disagree with you at all. I mean, that= s a challenge,

is that if we study this enough or if we actually ran

a trial that we could look at this so that we could

really quantify it, it would be good.

And I= m -- I believe I= m closer to where

you are in the occurrences, but I think we need to get

that data, right. And just -- and that= s what I=m --

that= s not what I= m harping on, but what I believe is

important.

But I don= t disagree in your -- in what

you= re saying at all. We= re not actually disagreeing

at all.

It= s more of I think we have the ability

with the number of phase III trials that are happening

in therapy to really actually quantify these in a

clinical study, in a clinical trial study that can help

inform patients and clinicians in a relatively short

time.

And that that would be a very useful

exercise so that we= re, you know, not waiting for years

and years of collected data but we have something where

we already have things that are ongoing where people

are doing, where people -- where centers are doing,

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you know, three hours post-therapeutic scans. And we

can really quantify and see, one, what= s happening,

and two, at what level do they cause injury so that

we can -- we can really put some numbers behind it.

And that= s all I= m saying, is that I think

we have the means to do better, but I actually think

that ultimately what you= re seeing is that it is a

relatively rare, and we can define what rare is, but

that= s it. We need to define what that is, because

rare to me and rare to you was different until we put

numbers on what that means.

DR. HARVEY: Thank you, Mr. Mailman. I

serious, sincerely respect your comments and your

opinions. I= ll just reiterate I feel that

extravasations that result in radiation injury should

be quantified and that others do not need to be.

And you know, maybe we= ll just differ on

that. And that= s certainly okay. And thank you very

much, and I certainly respect everything that you have

said and you bring to the committee. Thanks.

CHAIRMAN JADVAR: I= ll just add that

talking about data, you see, you may have noticed that,

you know, relatively recently you see some reports in

some cases case reports of extravasations of

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radiopharmaceutical agents. The most recent one I

want to draw your attention to is a case report from

the Netherlands Cancer Institute that was published

in clinical nuclear medicine just this past month.

And in that, this patient was undergoing

a peptide receptor radionuclide therapy, PRRT, with

a lutetium-177 dotatate, and a third of dose was

extravasated in that case. They had an image of that

in the case report, and they did the usual thing with

the lifting the arm above the level of the heart and

warm pads and the usual interventions.

And in this particular case, actually

after treating the patient at 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, there was really

very little left at the site of extravasation, of

injection of the agent. And the agent slowly cleared

to the target -- to the targets, the somatostatic and

receptor expression tumors.

And they followed this patient for 11

months, and there was no radiation injury whatsoever.

Although as I said, a third of the dose of therapeutic

dose was extravasated.

So things of this sort are being published,

and it would be good to keep track of these publications

as they come out.

I see Melissa has her hand up. Melissa?

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MS. MARTIN: Actually what I want to do

is have Dr. Einstein speak, because he was very active

in this subcommittee and has lots of information as

a practicing nuclear medicine physician. I think his

input would be very valuable.

CHAIRMAN JADVAR: Dr. Einstein, you= re

muted. Please unmute yourself.

MS. MARTIN: Take yourself off of mute,

Dr. Einstein. No.

CHAIRMAN JADVAR: We still cannot hear

you.

DR. EINSTEIN: Can you hear me now?

MS. MARTIN: Yes.

DR. EINSTEIN: Okay, fantastic. Yeah,

you know, so I mean, I= m a practicing nuclear

cardiologist, not a general nuclear medicine

physician, so the doses of the radiopharmaceuticals

which I administer to patients are lower and the

consequences of an extravasations lower as well.

But you know, I= ve researched this subject

and spoken to nuclear medicine and interventional

radiology colleagues as part of being on this committee

just to understand things better.

And you know, my impression, having served

on this committee, you know, based on what my colleagues

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think, it is really to share the opinion, again, that

patient education, shared decision-making is

important. But formal written informed consent goes

beyond what would be required, given the statistically

very rare occurrence. So I share the perspective taken

by the subcommittee.

CHAIRMAN JADVAR: Thank you, Dr.

Einstein. Any other comments by the ACMUI members?

We had a very robust discussion, that= s wonderful.

Thank you.

Any other comments?

MR. OUHIB: Yes, this is Zoubir Ouhib.

CHAIRMAN JADVAR: Okay, just go ahead.

MR. OUHIB: I= d just like to go back to

the consent form item. First of all, I don= t think

NRC should be involved or make any statement saying

that the informed consent form is not needed. That= s

not the role of NRC. That= s medical practice, in my

opinion.

And then there seemed to confusion between

an informed consent form and patient education, patient

instruction, and so on and so forth. The informed

consent form is a legal document, especially for

therapeutic dose, basically. And that= s a

requirement.

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As far as patient instruction and patient

education, that= s -- that= s part of the chart patient

that it was provided that do this, don= t do this, do

this, do this, call us and so on and so forth.

So I want to clarify that. Thank you.

CHAIRMAN JADVAR: Thank you, Zoubir. Any

other comments by the ACMUI members? All right --

MS. ALLEN: Hi, it= s --

CHAIRMAN JADVAR: Okay, yeah, Ms. Allen,

please.

MS. ALLEN: Yes, it= s Rebecca Allen,

healthcare administrator. You know, we talk about the

informed consent and the NRC= s role. However, just

keep in mind is that the -- most informed consents in

the hospital are dictated more from a joint commission

regulatory guidelines, not about the radiation piece.

So regardless of NRC, if anyone recommends

informed consent or not, this is by hospital about the

requirements of who will need an informed consent or

who does not. Thank you.

CHAIRMAN JADVAR: Thank you, Ms. Allen.

I can just tell you that we do use informed consents

for all the therapeutics injections.

Any other comments by the ACMUI members?

MR. DIMARCO: Hi, Dr. Jadvar?

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CHAIRMAN JADVAR: Yes.

MR. DIMARCO: Hi, this is Daniel DiMarco

from the NRC. I just wanted to come in and make a quick

clarification about this entire discussion that we= ve

been having.

In the proposed model procedures bit of

the package that you all reviewed, there= s a bit in

there about patient information. And we= ve heard Dr.

Harvey and Richard as well talk about the patient

intervention part on that.

I want to be very clear about this. I very

specifically did not say anything about a formal

informed consent procedure. I agree with the other

members of the ACMUI, but that it= s not something that

the NRC is -- that= s not in the NRC= s jurisdiction,

it= s likely not. It= s likely very much a part of

medical practice.

The intention with that was never to be

in a -- whether a recommendation on informed consent,

merely just a recommendation that patient education

could help in being part of the team response to a

potential extravasation. Yes, so that was -- that was

all the intention there. It was never to be a specific

informed consent bit there.

I very specifically did not use the term

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Ainformed consent@ for that reason. So yes, just to

-- just to clarify for everyone that that was the

intention there.

CHAIRMAN JADVAR: Thank you very much, Mr.

DiMarco.

Now that you are -- any other comments by

the NRC staff? Oh, I see Dr. Andrew Einstein again.

Please, go ahead.

DR. EINSTEIN: Yeah, thank you. Daniel,

I think the concern which the subcommittee had is that

there was some verbiage originally proposed which used

the word A informed@ in there, and it= s difficult to

-- for readers to tease out about informed versus

informed consent.

So once the original verbiage was going

down that road, maybe not completely but leaning in

that direction, it was felt that there was a need to

opine and weigh in there.

CHAIRMAN JADVAR: Okay. Any other

comments by the NRC staff?

DR. TAPP: Yes. This is Katy Tapp with

the NRC staff. One of the things is I asked Sarah to

pull up the comment from the subcommittee= s report.

Because you guys had a lot of good discussion on this.

And I just want to make sure that these is just a

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discussion right now, and that we= re not recommending

changes here to either of these recommendations.

I didn= t hear anything, but I want to make

sure I= m capturing your thoughts correctly. So I asked

her to pull up the comment specifically on informed

consent and making sure we= re -- there wasn= t any

changes that we= re missing here.

CHAIRMAN JADVAR: Melissa?

MS. MARTIN: I would agree with that.

That= s why we labeled them A specific comments.@ But

this is not -- these were not specific motions to make

changes at this time. They were items we thought

should be considered.

CHAIRMAN JADVAR: Dr. Folkert.

DR. FOLKERT: Okay, it= s me, Folkert.

Yeah, I mean, this is, this particular comment, though,

this is the concern. As a policymaking body, the

statement is being made that informed consent should

not be required for either diagnostic or therapeutic.

And that -- I mean, to say that informed consent should

not be required, I do not think that that= s an

appropriate statement to be made.

CHAIRMAN JADVAR: Okay. Any other

comments? I have Mr. Green.

VICE CHAIRMAN GREEN: Yes, this is Richard

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Green, the nuclear pharmacist representative. Dr.

Folkert, I think we could take that item 17, page 1,

and take that further where informed consent should

not be required by the U.S. NRC or licensing agency.

So it= s this agency is not requiring it as part of

this regulation.

If other agencies, other CMS and

accreditation organizations, that= s their prerogative.

And that more likely is the case, that= s a fact of

life today. We just wanted to make sure that folks

who read this guidance document didn= t see, you know,

inform your patient is basically what it said. I go,

well, that= s confusing. That= s --it= s ambiguous.

So yes, patients should be informed, they

should be educated, they should be on the lookout.

But we= re not saying they have to have written informed

consent. So I think if we modify that to informed

consent should not be required by regulators of the

U.S. NRC, we can modify that. But that= s what we were

striving toward.

Thank you.

DR. FOLKERT: And that makes more -- that

makes sense. And so it= s just this statement is just

far too global.

CHAIRMAN JADVAR: Okay, thank you. Dr.

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Wolkov, I think you had your hand up. Are you planning

to speak?

DR. WOLKOV: I did have my hand up, but

I think that was reasonable compromise language by Mr.

Green. And I had an alternative language, but I

actually prefer his to mine.

CHAIRMAN JADVAR: Okay. Dr. Harvey?

DR. HARVEY: I would second Mr. Green= s

motion. And I think we should vote on that. NRC staff

can correct me if that= s wrong, but I think I would

second his motion. Thank you.

CHAIRMAN JADVAR: Very good. Let me see,

I think we were going to wait a vote on the

subcommittee= s report at the end of the public comments,

if that= s okay.

But any other comments by the NRC staff

before we move on?

MR. OUHIB: Yeah, this is Zoubir Ouhib.

CHAIRMAN JADVAR: Okay.

MR. OUHIB: I= m just curious whether there

is a need to have that first sentence at all. Why do

-- why shouldn= t -- what is the purpose of having that

sentence AInformed consent should not be required for

either diagnostic or therapeutic nuclear medicine

procedure.@ What is the purpose of that?

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Why don= t we just strike and just simply

put patient education, whether done verbally, et

cetera, et cetera, et cetera?

CHAIRMAN JADVAR: Okay, Dr. Harvey.

DR. HARVEY: The only intent of that

section -- that sentence, was to clarify. Because when

some people read the document, they thought that it

might be asking for written informed consent. So the

point of that sentence was to clarify that the NRC and

Agreement States, regulatory bodies are not asking for

informed consent.

CHAIRMAN JADVAR: Very good. Okay, any

other comments from NRC staff or other --

MR. MAILMAN: Would that be a separate

informed consent? Because I think to, Dr. Jadvar, your

comment as well, you require an informed consent at

USC, which is fine. It= s just, we=re not recommending

a separate informed consent on board the subcommittee,

which I think would be more appropriate than just

throwing it out there.

CHAIRMAN JADVAR: Well, let= s ask folks

on this call that do you require informed consent for

therapeutic injections at least?

DR. FOLKERT: Definitely. Mike Folkert,

definitely. Required by JAYCO, required in --

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CHAIRMAN JADVAR: Yeah.

DR. FOLKERT: By our professional

societies across the board.

MR. OUHIB: Absolutely, it= s a must.

CHAIRMAN JADVAR: Yeah, yeah.

MS. MARTIN: But I think to clarify, it

wasn= t a separate consent. I think that= s the

question. It= s the one that you= re required to have

for joint commission and all the other accrediting

bodies.

CHAIRMAN JADVAR: Yeah.

MR. OUHIB: But also required by, you

know, ASTRO, by ACR, by there= s a whole document --

MS. MARTIN: Right, which are accrediting

bodies, right.

MR. OUHIB: There= s a whole document

written by ACR ASTRO regarding that.

DR. FOLKERT: Yeah. Now, I= m not saying

anything about a separate consent. I= m very concerned

that there= s a statement here saying A informed consent

should not be required.@ It doesn= t say anything about

an additional consent, it doesn= t say anything about

a form.

It is a policymaking body, the NRC is

stating that informed consent should not be required.

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And I don= t think we should be saying that.

MS. MARTIN: Yeah. I like the

modification that was made to the statement earlier,

required by the NRC. With the idea that I think we

could develop that statement further. It= s developed,

the informed consent should be developed in accordance

with the professional societies.

CHAIRMAN JADVAR: Okay. All right, I

think I= m going to turn this over to Ms. Sarah Lopas

to navigate us through the hearing public comments on

this subcommittee= s report.

Sarah?

MS. LOPAS: First I wanted to just double

check that we didn= t need to go through any of Zoubir= s

earlier comments when he first started and he had kind

of a list of comments. I just wanted to double check

that we didn= t need to go back through the report, now

that I= m sharing the report.

MS. MARTIN: I think we= ve covered most

of them.

MS. LOPAS: Okay. All right, well, with

that, I am going to --we are going to open it up to

the public to make comments. So I want to make a couple

notes before we get started.

So those of you that have submitted

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comments ahead of time, written comments, those will

be upended directly to this transcript. So those= ll

be publicly available, attached directly to this

transcript. So that= s one note.

I also want to note that we= re looking for

your comments today on what the ACMUI just discussed,

on their recommendation report, which is available on

the ACMUI website. If you have general comments on

the extravasation proposed rulemaking, you know,

generally, at some point in the future this rule may

get published as a proposed rule and there will be a

public comment period.

You know, there= s several steps to get to

that point. We have to finalize this document, we have

to submit it to the Commission for their consideration

and review. If they were to approve it for

publication, there= s a couple more administrative

processes.

And then it would finally get published

and we would have -- we= d give everybody ample notice

of when that proposed rule comment period is coming,

and we would have probably several public meetings to

help clarify the package for everybody.

So I just wanted to just let everybody know

this isn= t -- this isn= t a one-and -done deal, right.

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This is one step of many in a public meeting process.

So with that, we= re going to use the

raise-hand function for those of you that are in the

Teams app. For those of you on your cellphones, I

believe you press star-5 to raise your hand. So that

will let me know.

So we can kind of get right into it. And

we do have to leave about 15 minutes at the end to allow

the ACMUI to just finalize their thoughts based on what

they= ve heard from the public and take their vote.

So we will be kind of folding up comments at 3:45, just

to give everybody a warning.

Okay, and I see David, I know you= ve had

your hand raised for a long time, so go ahead, you can

go ahead and unmute yourself. And please begin by

introducing yourself and stating your affiliation if

you have one. That= s helpful for the transcript as

well and to give us all some context.

So thank you, go ahead, David Bushnell.

DR. BUSHNELL: Sure, thank you very much.

David Bushnell, the National Program Director Nuclear

Medicine in the Veteran= s Health Administration.

A very interesting discussion, a very

interesting process that= s been going on here for a

while. I thought I saw, and maybe I misread it, I

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thought I saw in one of the slides that NRC was

potentially going to propose mitigation procedures.

And maybe I= m misunderstanding, but

perhaps you could clarify whether they mean medical

mitigation procedures. If that= s the case, that would

-- that would certainly not, I think we= d all agree,

that would certainly not be appropriate.

MS. LOPAS: Dr. Harvey, do you have your

hand raised?

DR. HARVEY: I do, thank you.

MS. LOPAS: Yeah.

DR. HARVEY: I think, so what I would

recommend and what we talked about is individual

licensees should have their own policy and procedures

for identification, management, mitigation, patient

education.

Those things should all be handled with

-- at the -- by the licensee. And I don= t think there= s

any push from the subcommittee anyway to say that there

should be specific procedures written by the NRC that

licensees would have to follow.

Thank you.

DR. BUSHNELL: Thanks very much. Perhaps

I misunderstood, and thank you for clarifying that.

And I thought the -- by the way, the discussion on

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the informed consent was very good.

Obviously we all agree that there has to

be informed -- from a medical standpoint. And

certainly even though rare, we would include the

potential radiation complications from extravasation

for therapeutic procedures within the informed

consent.

I mean, there= s a lot of risks, right,

there= s a lot of risks that we deal with for

radiopharmaceutical or radio-likened therapies. And

this would be one, although rare that we would include

as well. Thank you.

MS. LOPAS: All right thank you. Okay,

and I see Dr. Wallner. Dr. Wallner, you can go -- oh,

unless is somebody else going to jump in? I thought

I heard somebody. No?

Okay, Dr. Wallner, go ahead. You can

introduce yourself and state your affiliation.

DR. WALLNER: Thank you very much. Dr.

Paul Wallner representing the American College of

Radiology. I= m a radiation oncologist.

We think there should be some

clarification of some of the language regarding medical

radiation injury. We think that the language should

be clarified that it should be radiation injury

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requiring medical intervention.

I don= t think we are interested in any

potential radiation injury, just something that

requires intervention. And I think that was the intent

of the commissioners.

Secondly, again, regarding radiation

injury, there is very speculative verbiage suggesting

that it can be attributed to radiation. We would

suggest that that be changed to A has been attributed

to radiation@ or Ais most likely attributable to

radiation.@ A Can be attributed to radiation@ is

highly speculative and could be judged by many people

incorrectly.

The other issue regarding medical events

reporting, we would recommend deleting, and this is

in quotes A or has the potential to result in radiation

injury.@ Again, that= s highly speculative.

There was some comment, and I will provide

these comments in writing to Ms. Armstead so they can

be added to the record. There was also some comment

about clinical trials and the reporting of adverse

events.

Any clinical trial in the United States

certainly that is approved by an IRB, and that=s

effectively all clinical trials, requires adverse

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event reporting, regardless of the intervention or

regardless of the adverse event. So that= s readily

available in those reports, and I wouldn= t suggest any

additional reporting mechanism in that regard.

Thank you very much.

MS. LOPAS: Okay, thank you, Dr. Wallner.

Okay, so a reminder that raise your hand,

that= s the little raise-hand icon. You can just tap

that once on Teams. If you= re on the phone, you press

star-5. And we will give everybody a couple of minutes

before we send it back to the ACMUI.

And just as a reminder, we= re taking the

public comments on the subcommittee= s recommendations

here today as they presented them today and in their

report. And you can find that, their report and what

they reviewed for us on the ACMUI website.

I just pulled it up, right in time for this

meeting. I pulled up, I Googled A ACMUI@ and

Arecommendations and extravasations,@ and it came

right up for me. So, very easy to find online if you

do need to review that.

I think, Dr. Jadvar, seeing as I=m not

seeing other, any other hands raised, I think I= m going

to send it back to you all. And I don= t know if Chris

jumps in as well to help kind of close you out and maybe

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Dr. Tapp as well, so.

CHAIRMAN JADVAR: Okay, thank you, Sarah,

for your help.

So let= s go back to, we need to vote on

the subcommittee= s report. But before we do that, I

want to make sure that if there is any alterations or

other additions or changes that you want to make to

the report based on all the discussions that the

subcommittee heard.

MS. MARTIN: Hello, this is Melissa. I

do think we need to take the comments that Richard

Harvey made. I just remember Richard making them, I= m

not sure who made them initially, but there was a couple

of things that we agreed on to make it as --

modifications to this report.

CHAIRMAN JADVAR: Okay. Would you please

repeat those items one more time for clarity?

VICE CHAIRMAN GREEN: This is Richard

Green. I believe it was Item 17. We want to specify

it= s the informed consent is not required by the U.S.

NRC.

MS. MARTIN: Correct.

VICE CHAIRMAN GREEN: I do know that= s a

very open statement that it= s not required. So that

should be modified. So I= m suggesting that informed

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consent should not be required by the U.S. NRC for

either diagnostic or therapeutic nuclear medicine

procedures. Just a small inclusion.

CHAIRMAN JADVAR: Anything else?

DR. HARVEY: I would second that.

Richard Harvey.

CHAIRMAN JADVAR: Okay, thank you. Any

other items? All right, so with that, do I have a

motion for approval of the subcommittee= s report with

that stipulation that was recited?

DR. WOLKOV: So moved, Harvey Wolkov.

CHAIRMAN JADVAR: Any seconds?

DR. HARVEY: Second.

DR. FOLKERT: Second.

CHAIRMAN JADVAR: All in favor, say aye.

(Chorus of aye.)

CHAIRMAN JADVAR: Any opposed? None,

none heard. Any abstentions?

DR. EINSTEIN: Aye.

MS. ALLEN: Aye. This is Rebecca Allen.

MR. MAILMAN: I don= t know if you can hear

me or not.

MR. OUHIB: This is Zoubir Ouhib.

CHAIRMAN JADVAR: Okay, I was talking

about any abstentions.

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MR. MAILMAN: Well, I don= t know if --

DR. FOLKERT: Is the audio not going

through? Sorry.

MS. MARTIN: No, we can hear you, Dr.

Folkert, go ahead.

DR. FOLKERT: Yeah. No, so I mean, you

had asked if there were other --if there were other

questions about the report?

CHAIRMAN JADVAR: Oh, yes, okay.

DR. FOLKERT: So that, you know, so I mean,

so we mentioned this one. I mean, the other thing which

I do think Dr. Wallner= s point actually was quite good

about removing A or has the potential.@ And so yeah.

So that was --

MS. MARTIN: What line was that, do you

know which line?

DR. FOLKERT: Yeah, so let= s see. If we

go, let= s see, it=s in the -- so in the reporting nuclear

medicine --

CHAIRMAN JADVAR: Page 10.

DR. FOLKERT: Page 10 and 11.

CHAIRMAN JADVAR: Yup.

DR. FOLKERT: And so like let= s see, so

on page 10, second paragraph from the bottom, A or has

the potential to result in radiation injury.@

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MS. MARTIN: Yes.

DR. FOLKERT: And then also page 11, where

it also says A or has the potential to--@ Where was

the? I was trying to do a search for that specific

phrase, but there are, I know that there was more than

location where it was said.

MR. OUHIB: You are correct, it was on 11

also.

DR. FOLKERT: Yeah. And then also, I

mean, in the index also on point F, why does the report

of threshold require reporting for extravasation of

results or has the potential to result in a radiation

injury from an extravasation.

So, I mean, I agree that removing Aor has

the potential@ because I mean that= s incredibly vague

and speculative. So removing that A or has the

potential for causing injury@ I think would make sense

to remove.

MS. MARTIN: I agree.

MR. OUHIB: Yes.

DR. FOLKERT: I have those items on my

list.

CHAIRMAN JADVAR: Okay, so we have to vote

again. Any other items?

So I heard three stipulations or changes,

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alterations. Is that correct?

MS. MARTIN: Correct.

CHAIRMAN JADVAR: All right, so with that

DR. TAPP: This is Dr. Tapp with the NRC.

Can I?

CHAIRMAN JADVAR: Sure.

DR. TAPP: Just make sure that I= m

following here. This is actually not on the report

itself, but this is actually an additional

recommendation to the proposed rulemaking, am

capturing this correctly. So this is actually on the

rulemaking text.

And we= re talking about an extravasation

that results or has the potential result in radiation

injury. So I just wanted to capture that that was to

the text.

And just to give a little bit of history

on staff= s, so everyone= s aware here that the thought

on this text language was for when there is an

extravasation that is maybe on a therapeutic, that is

a large dose. And that you have a physician who

believes and determines that it has a potential to

result in radiation injury. So, a large does that has

that potential.

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And you know up front you want to do this

quick reporting so we can have maybe something that

is something that could reoccur in other locations,

getting this quick reporting to the NRC, that was the

purpose of adding this A or has the potential.@

So, just want to make sure that background

was given to the ACMUI for this.

MR. EINBERG: And this is Chris Einberg.

Yeah, sorry to interject. This is a huge shift in

fundamentally what our approach would be if we removed

this language. And so if you make that recommendation,

please make it fully informed that you know, this is

a big shift in our approach.

CHAIRMAN JADVAR: Okay, thank you for that

explanation.

Dr. Harvey?

DR. HARVEY: Rather than say A has the

potential,@ can we say A expects@ ? I think the idea

here is if the authorized user or the physician expects

it to resolve in a radiation injury, that we report

it, and take out the vagueness of A has the potential.@

It= s just a thought.

PARTICIPANT: Results could be expected

to result -- yeah, I like that phrasing, A that results

or could be expected@ or Awould be expected to result.@

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MS. MARTIN: Could be expected results or

would be expected to result.

CHAIRMAN JADVAR: Is then A would be

expected,@ isn= t that a little firmer than A has the

potential@ ?

MS. MARTIN: Yes. It= s harder.

CHAIRMAN JADVAR: It= s harder. Is that

-- is that what you want? You know, in other words

you already have surmised that this is expected, it=s

going to happen. But A has the potential@ is still is,

I think is less firm. You know, you think it may

happen, it may not happen.

DR. FOLKERT: Yeah, because when you= re

looking at doses --

CHAIRMAN JADVAR: So I think the A has the

potential@ is -- I think A has the potential@ is, I= m

okay with that, but you know, I leave it up to you.

DR. EINSTEIN: How about A is likely to@

as an intermediate language? AHas the potential to@

could have a very tiny probability of it occurring.

DR. FOLKERT: I like that better.

DR. EINSTEIN: A Is expected to@ has an

extremely high probability.

DR. FOLKERT: Yup.

CHAIRMAN JADVAR: Okay, well.

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DR. FOLKERT: ALikely@ seems like a

reasonable compromise.

PARTICIPANT: That= s reasonable.

CHAIRMAN JADVAR: so Chris, going back to

what you mentioned, Mr. Einberg. If this A has the

potential@ wording is changed to something else, is

that a --is that an issue, major issue? What --is

that okay?

MS. MARTIN: If it= s changed to A is likely

to,@ I think that= s been the suggested changing --

changed wording.

MR. EINBERG: So I will ask members of the

medical team to opine, either Dr. Tapp or Daniel

DiMarco, to weigh in on this. Because I know that they

extensive discussions in the working group when they

were developing this language, and I think Daniel is

ready to discuss that.

MR. DIMARCO: Hi, Chris, hi, members of

the ACMUI. Daniel DiMarco here for the NRC. The major

change here with the addition or I guess the deletion

of this wording, like Dr. Tapp said before, was that

this specifically went to the timing of the

extravasation, where we know that radiation effects

typically have some sort of lag time or delay time.

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And so the wording of this, like Dr. Tapp

said before, as well as the wording that, from what

I= m hearing, you guys are thinking about changing it

to with A expected@ or A is likely to,@ it was -- the

wording was in there specifically to capture these

events before any symptoms appear.

Where there= s, you know, some amount of

potential based on, well, where we have it as determined

by a physician determination, there= s some sort of

potential for radiation injury, and therefore it could

be reported before any symptoms appear so we can get

the information quickly and help the patient as soon

as we can.

So, from what I was hearing with some of

the potential changes you were having with the wording

here, if you= re changing it from A has the potential

to@ to maybe something like A is expected to@ or Ais

likely to,@ then that wouldn= t be a major change in

the reporting requirements that we= ve set out.

But if you did away with the language

altogether, that would be a major change to the

reporting requirements as we> ve set them out. I hope

that clarifies things.

CHAIRMAN JADVAR: Yeah, very much. Thank

you.

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MR. OUHIB: This is Zoubir, if I may.

CHAIRMAN JADVAR: Please.

MR. OUHIB: This is for DiMarco. What do

you think if we say, you know, like, and notification

of a medical event that result or based on certain

indications, clinical indication, or whatever that is,

has the potential to result in a radiation injury?

We just add something that= s convincing

that the potential is not vague, there= s some -- there= s

something behind the justification for that matter.

MS. MARTIN: Well, I think that= s what kind

of we covered -- oh, go ahead -- by the Ais likely to.@

MR. DIMARCO: Oh, no, I think you were,

well, that= s, for the NRC, when I put that in there

or when we put that in there, the A as determined by

a physician@ bit at the very end of that, that was the

key factor there, where the NRC is not interested in

getting into these determinations of whether or not

something like this has the potential for radiation

injury.

We recognize that the physicians as well

as their teams have the -- have the required experience

and expertise as well as the tools necessary to make

that determination themselves. And so we didn= t want

to step into the clinic, as it were, to make these

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determinations themselves.

And so we were putting the determination

in the hands of those who have the best experience and

the best tools to make that determination themselves,

the physicians and their teams.

MR. OUHIB: Thank you.

CHAIRMAN JADVAR: Thank you. Yeah, I

just give my opinion. I don= t see any specific problem

with this as it is. It says at the end is determined

by a physician. Yes, there may be a potential based

on judgment, clinical judgment, that it could be

something like that. And you follow it, if that= s what

the physician decides.

I= m not sure, when you put A likelihood@

or Aexpected,@ you know, you= re adding one level of

certainty to it, and I don= t know if that= s necessary.

A Potential@ is open, you know, it could be may happen,

may not happen. Anyway.

DR. FOLKERT: Well, I think the concern

would be if just say A potential,@ that could be 1%,

2%, 3%, whereas if you say A likely,@ then that= s at

least probably more that 50% chance that there= s a

possibility.

CHAIRMAN JADVAR: Anywhere from say

20-80% would be the intermediate DQs (phonetic)-- yes.

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DR. FOLKERT: But I mean, we= re talking

about therapeutics. I mean, even like half of a cc

could have the potential of causing some issues. So

it= s like, yeah, just saying A potential@ is, I agree,

it just seems to be too vague, with the public comment.

So I would say at least go with A likely@

or A expected.@

CHAIRMAN JADVAR: Okay. Okay, so is

everybody agreeing? And I think Dr. Einstein

suggested A likely.@ Is that acceptable?

MS. MARTIN: I agree. I think, well this

is Melissa. I think the A is likely to@ is the best

one.

CHAIRMAN JADVAR: Okay, A as determined by

a physician,@ which is at the end of the sentence.

MS. MARTIN: Mm-hmm.

CHAIRMAN JADVAR: Okay. And I think that

would be a-- that would not be a major change as

described by Mr. DiMarco, right?

MS. MARTIN: Correct.

MR. EINBERG: Yeah, we agree. I see Dr.

Tapp came on. If she could have a moment.

DR. TAPP: Yeah, and I know you guys, if

I may, you do like specific language to provide in your

recommendation. However, terms like A potential,@

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Alikely,@ and Aexpected@ all do have a slightly

different meaning when we go into regulations. And

sometimes are, there are rulemaking trigger words that

we don= t like to add.

So if you prefer and you= re still debating

between Alikely@ or Aexpected,@ you could add both

to your report if they= re both okay to you, if you like

them better than A potential.@ And then we can work

through that back here with our administrative staff.

Because I= m not sure, A likely@ sometimes does have

some concerns with our regulatory administrative staff

that does look at this.

So if both are okay, maybe add, you could

add A likely or expected@ to your recommendation.

CHAIRMAN JADVAR: Yeah.

MS. MARTIN: That= s okay then.

CHAIRMAN JADVAR: Is that okay?

MS. MARTIN: That gives you guys a little

bit of leeway.

CHAIRMAN JADVAR: Okay.

DR. TAPP: Thank you.

CHAIRMAN JADVAR: Okay, thank you, Kate.

All right, sounds good.

So any other things before we vote again?

MR. UNDERWOOD: So I did have one

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question. And this may be obvious to me but I may have

missed something. But Aas determined by a physician@

is a very wide statement. Is it -- I mean, is that

meant to be A authorized user@ ? Or, so any physician

with any medical degree can determine if the radiation

injury is likely to occur and it= s a reportable event?

MS. LOPAS: And just to clarify, this is

Kyle Underwood. This is somebody, this is external.

I= m just clarifying for the transcript, Kyle

Underwood.

MR. UNDERWOOD: Sorry, thank you, I should

have said that.

MS. LOPAS: No worries.

MS. MARTIN: In the past, we= ve gotten lots

of comments from the public that it= s too restrictive

to restrict it to authorized users. So that= s why it

was left purposely at this point just by a physician.

CHAIRMAN JADVAR: Right. And I remember

that what Daniel showed at the end of this reports,

it says that the patient, when the patient received

the dose and all that. So any physicians in medical

degree should be able to determine that this may have

been caused by radiation.

Anyway, so are we good, or additional

comments before we do the vote?

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So, let= s have a motion again for this

subcommittee report, with the stipulations that were

recorded.

Do we have a vote --do I have a motion?

Anyone?

DR. EINSTEIN: So moved.

CHAIRMAN JADVAR: Okay, any seconds?

DR. FOLKERT: Second.

MR. EINBERG: Can you please -- can you

please identify who made the motion and who seconded

for the court reporter, please?

CHAIRMAN JADVAR: Oh yes.

DR. EINSTEIN: Andrew Einstein, so moved.

DR. WOLKOV: Harvey Wolkov, second.

CHAIRMAN JADVAR: Harvey Wolkov, second.

All in favor, say aye.

(Chorus of aye.)

CHAIRMAN JADVAR: Any opposed?

MR. OUHIB: Aye.

CHAIRMAN JADVAR: Any opposed? Any

abstention?

MS. ALLEN: Aye, Rebecca Allen.

CHAIRMAN JADVAR: Okay, thank you. So

the subcommittee report is passed with the stipulations

as recorded.

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And I think that= s the end of our business

today. So I want to turn it back to Mr. Einberg.

MR. EINBERG: Okay, yeah, thank you, Dr.

Jadvar. Thank you, subcommittee members who worked

diligently with NRC staff for the support on this.

Thank you for the ACMUI members as well. Thank you

to the insightful comments that we received from the

members of the public. This all helps us inform our

rulemaking process.

As Sarah Lopas pointed out, as we move

forward in finalizing our rulemaking and guidance

development, we will be providing this to the NRC

commission. After such, if they agree to publish this,

then there will be other opportunities for members of

the public to comment on this.

So this is a, you know, a process where,

you know, we value public input. And the members of

the public will have additional opportunities to

comment. As Sarah also pointed out, the comments that

we have received will be appended to the transcript.

And so that will be made part of the record as well.

And so with that, I thank you all on behalf

of the NRC, and we can adjourn the meeting.

CHAIRMAN JADVAR: Meeting is adjourned.

Thank you, everyone.

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(Whereupon, the above-entitled matter

went off the record at 3:40 p.m.)

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 Whom It May Concern:

Thank you for considering this public statement regarding the June 17 th meeting to discuss the ACMUIs subcommittee report on the NRC staffs proposed changes to NRCs requirements for medical use of byproduct material to address reporting of nuclear medicine injection extravasations as medical events.

I am Daniel G. Guerra Jr., founder and CEO of Altus, a technology services company that focuses on radiation technologists who work in clinics and hospitals to keep patients safe during medical imaging such as CT scans and radiation therapy. Altus offers a range of products including continuing education courses for radiation technologists, tools for clinics to organize their credentialing requirements, and webinars for scientific device manufacturers.

I have followed with great interest the actions of NRC, ACMUI, and Congress regarding medical event reporting of nuclear medicine extravasations. A couple of years ago, Altus hosted a panel discussion focusing on how radiopharmaceutical extravasation affe cts the quality and quantification of nuclear medicine imaging studies, and a series of interviews with subject matter experts on the topic.

From lobbying disclosure records and a recent critical report by NRCs Office of the Inspector General, I have become aware that professional societies that represent nuclear medicine physicians, whose members populate ACMUI, are engaged in lobbying against medical event reporting of large extravasations. This policy position is counter to the views of prominent individual physicians and subject matter experts, and counter to the view of a large coalition made up of dozens of patient advocacy organizations.

I think all parties involved would agree this is an important issue for patient safety and transparency. I also believe it is critical that policymakers and regulators benefit from honest, unbiased, and unconflicted advice as they decide this policy issue. NRC, Congress, and the public must hear an open exchange of views on this matter, in which statements not borne out by scientific and clinical evidence can be challenged and debunked. Policy must be based on the best scientific evidence for the benefi t of patients, not predetermined by well-placed insiders.

That is why I offer the services of Altus to host an online forum featuring proponents and opponents of medical event reporting of large extravasations can make their arguments and challenge statements that they believe to be false. I believe this would be illuminating and helpful for policymakers, regulators, and the public. I hope NRC and ACMUI consider this good -faith proposal and accept it in the spirit of supporting the best science for the benefit of patients.

I look forward to hearing from NRC and ACMUI about this possibility.

Daniel G. Guerra Jr., CEO

Altus l PO Box 910 l Madison, WI 53701 Direct: 608-212-2391 l Email: dguerrajr@altusinc.co Website: https://altusinc.co l https://thenhti.org

I am writing to express my concerns regarding the NRC rulemaking process and the proposed rule.

The public is being asked to provide comments and questions regarding the recently announced ACMUI subcommittee report on NRCs proposed rulemaking for the reporting of extravasations. I have no insight into the what the report says and was given an extremely short turnaround time to submit a comment. Additionally, the published Special Investigation report from the OIG would lead me to believe that the two individuals accused of violating federal ethics rule should recuse themselves from discussing this issue with NRC medical staff.

As such, I believe the proposed rule re"ects the improper in"uence of con"icted members of the ACMUI. The recommendation to use qualitative reporting criteria for patient injuries related to extravasation of radiopharmaceuticals is alarming. It disregards the longstanding reasons for dismissing such criteria, which were clearly outlined in the 1980 Federal Register.

The proposed rule by the NRC exacerbates the problem for patients. Most patients are unaware they are being injected with radiation during nuclear medicine scans. Many patients believe they are being injected with some kind of contrast or dye. Additionally, it is a well-known fact that patients are not given information about the symptoms of ionizing radiation damage. Without monitoring for extravasations and without crucial information of symptoms that may arise weeks, months, or even years later, patients will not know they are experiencing effects from an extravasation.

Additionally, I have come to understand that nuclear medicine physicians typically do not take patient appointments. Even if they did, the question arises: who would bear the cost of these extra office visits? This is another added burden that patients should not have to shoulder.

My concerns extend to the broader issue of healthcare inequities and systemic racism in healthcare facilities. Qualitative patient-reported injury criteria disproportionately impact minorities. Since your committee lacks diversity, ACMUI may not fully gras p how unlikely it is for patients of color to report, much less convince a physician, that an injury is related to radiation exposure when there is no documentation of extravasation and potentially no visible skin damage. This creates a signi"cant barrier for patients of color, further deepening the disparities in healthcare.

My stake in this issue is deeply personal. I started the New Day Foundation for Families in 2007 with my husband Michael. We both lost our "rst spouses to cancer, giving us an intimate understanding of the emotional and "nancial toll cancer takes. Both my sons receive yearly nuclear medicine scans due to their high risk of developing cancer. Without the monitoring of extravasations, I am not con"dent that the scans are 100 percent accurate.

Unfortunately, I cannot attend the June 17meeting due to previous commitments for my advocacy organization. I have two questions that I hope ACMUI will address during the meeting.

1. Have any of your members (on the subcommittee or the whole ACMUI) had any conversations with members of the professional societies regarding the subcommittee report before the June 17 meeting? If so, when did thes e conversations happen and what was communicated?

2. Will the NRC and ACMUI reconsider the implementation of qualitative reporting criteria for patient injuries related to radiopharmaceutical extravasation? It is imperative that we maintain objective, transparent, and accurate reporting standards to ensure patient safety and equity in healthcare. Large extravasations that exceed the existing NRC dose thresholds for a reasonable volume of healthy tissue indicate a potential problem in the handling of radioactive isotopes. These should be reported no differently than any other medical event. Not reporting these will continue to allow nuclear medicine centers to avoid improving their processes.

In summary, as a patient advocate, I do not feel that patients are being adequately represented in this process. I reiterate my concerns regarding the proposed rulemaking.

Existing objective medical event criteria should be followed.

Thank you for your attention to this critical matter.

Gina Kell Spehn New Day Foundation for Families FoundationForFamilies.org

1.What term should the NRC use (e.g., extravasation, infiltration) when describing the leakage of radiopharmaceuticals from a blood vessel or artery into the surrounding tissue?

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10 John Witkowski President United Pharmacy Partners 5400 Laurel Springs Parkway Suite 405 Suwanee, GA. 30024 Office: 770-205-2651 Paul E. Wallner, DO, a radiation oncologist, representing the American College of Radiology. Please include my name as participating in the subcommittee Teams call today, and as I indicated in my oral comments, these are the remarks that I would request be appended to the meeting transcript:

For your report of recommendations, the ACR asks ACMUI to consider making these 3 additional recommendations to NRC staff

1. Recommend that a radiation injury require medical intervention, such as surgery, to be reported as this proposed Medical Event type. The Commissioners decision explicitly directed NRC staff to focus on radiation injuries requiring medical attention, which indicates a higher level of safety concern than is evident in the draft proposed rule. Importantly, this rulemaking is about what patient data is collected in a federal database without a patients consentit should be of radiation safety significance and of actionable concern to NRC. In this regard, if a CTCAE grade is to be included in the recommendations, the minimum reporting grade should be grade 3.

2. Also, for the radiation injury regulatory definition, recommend changing the speculative verbiage can be attributed to radiation to the more explicit has been attributed to radiation or is most likely to be attributed to radiation. Radiation attribution is key. This ensures data is correctly scoped to NRCs authority over byproduct material, and that NRC is not collecting common reactions to sterilization, needle puncture, non-radioactive substances, adhesive, or bandaging.

3. In the regulatory language for the new Medical Event type, recommend deleting or has the potential to result in (a radiation injury). This is speculative and likely to result in downstream compliance burden and confusion by investigators or licensees.

Thank you.

Paul E. Wallner, DO

I am providing this written comment and question in response to a noti"cation I received regarding the Nuclear Regulatory Commission (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) meeting scheduled for June 17, 2024.

The notice suggested that persons wishing to provide a written statement should provide their comment by close of business on June 11 (today) and ensure their comment is related to the agenda topic. The topic for the June 17 meeting is the ACMUI subcommittee report o n the NRC stas draft proposed rule and associated draft implementation guidance for reporting nuclear medicine injection extravasations as medical events.

Unfortunately, the subcommittee report was not available on the website. So, as you can imagine, it is dicult for me to ensure my comment is addressing legitimate concerns with the subcommittee report when the public doesnt have access to this report.

So instead, my comment will be focused on the proposed rule and the fact that the NRC and ACMUI are making it extremely dicult for uncon"icted members of the public to eectively weigh in on the report and associated draft implementation guidance (since I dont think we have access to that info). But this approach appears to be consistent with the past processes used by the NRC to draft the proposed rule.

In January 2022, Ms. Mary Ajango and I wrote the NRC regarding the fact that the ACMUI appeared to be con"icted when it came to providing advice to the NRC medical sta regarding the radiopharmaceutical extravasation petition for rulemaking. While we have yet to hear back from the NRC on this issue, we were approached by the NRC Oce of Inspector General because someone within the NRC had a similar concern. We provided the special agents our opinion and provided them with others to approach. While we ar e pleased that the OIG report con"rmed that members of the ACMUI were con"icted and violated federal ethics rules, we are extremely disappointed that the NRC has not addressed these con"icts over the past two years.

For those of you who have not seen the March 2024 U.S. NRC Oce of the Inspector General (OIG) report you can see it here at this link: https://bit.ly/NRCOIG.

The OIG "ndings that two members of the subcommittee should have recused themselves from any discussion on the issue is the tip of the iceberg. Most ACMUI members who have commented on extravasations are also in"uential "gures within medical societies that are actively battling against the eort to raise awareness about extravasations. It is completely unacceptable that these members are providing any guidance whatsoever to the NRC on this topic. From my research of ACMUI members associated with this topic, nearly every member except for the FDA representative and Ms. Laura Weil, the former patient advocate, should have recused themselves. The others held positions or past positions in their respective professional societies that likely in"uenced the drafting of society activities meant to in"uence the NRC to continue to exempt extravasation reporting.

The lack of proactive steps by the NRC to address these con"icts reveals that NRC has little interest in taking the patients side on the issue of extravasation. And unfortunately, the OIG report does not obligate the NRC to take action. While one would hope this OIG report would be enough to convince NRC and the ACMUI to ensure con"icts of interest do not arise in the future, and to take concrete steps to better position itself as a guardian of the patients well-being. Unfortunately, we remain thoroughly disappointed in the NRC and ACMUI response. In an earlier NRC ACMUI meeting this Spring, Mr. Kevin Williams discounted the report and praised the ethics and performance of the ACMUI. It is obvious to patients that the only thing being guarded is the interests of the medical societies. Interests that are clearly at odds with the interests of patients.

Which takes me to my comments on the proposed rule. The proposed rule is inappropriate in so many ways. It is the only medical event or nuclear power safety event that relies on a qualitative reporting criterion. Even worse, NRC is suggesting patients, who have little to zero knowledge of radiation in general and the eects of ionizing radiation on tissue, report a medical event. This "ies in the face of radiation protection tenets. It is a clear example of a failure of NRC sta to protect patients.

Patients will not stand for this. In October 2023, the Patients for Safer Nuclear Medicine (PSNM)

Coalition "led a separate complaint with OIG. We provided OIG "ve speci"c, evidence-backed examples of how NRC has failed to appropriately protect patient safety by disregarding crucial clinical data, propagating factual errors in NRC documents, and more. We are actively working to ensure that the NRC OIG investigates these allegations with vigor. We have also shared these legitimate allegations with members of Congress.

Examples of bias and con"icts of interest clearly exist among those advising NRC. It is abundantly clear to anyone who reads the transcripts of the December 2008 and May 2009 NRC ACMUI meetings on extravasations, that the NRC has mismanaged its policy on nuclear medicine extravasations. NRC heard evidence that extravasations were not virtually impossible to avoid. They heard that patients were receiving high doses that greatly exceeded reporting thresholds. And they heard Dr. Nag say even if patients got a high dose from these preventable medical events, he did not want to be bothered with having to tell the patient, their physician and then have to do all the blah, blah, blah, associated with reporting. When patients see these past meeting transcripts, when we see the subsequent NRC/ACMUI eorts to keep the reporting exemption in place despite knowing the exemption was incorrect, when we see meeting noti"cation shenanigans intended to squelch the patient voice, we know that NRC has failed us. We know we must work with the Inspector General and Congress to hold the NRC accountable.

My "nal input on this meeting is for you all to realize that patients do not trust that you have their best interests in mind when making your decisions. You need to re-earn our trust. My advice is for you to study the evidence. The evidence is clear. If the nuclear medicine community addressed these accidental exposures, like they would if their wife, or child, or father was being extravasated during their important nuclear medicine procedure then they can start improving. Injections are a process like an y other if monitored and if focused on, the process can get better.

Thank you in anticipation of you making the right decisions today.

Best wishes

Simon Davies

Simon Davies Executive Director Teen Cancer America Tel: 310 208 0400 11845 Olympic Blvd. #775W Los Angeles, CA 90064 simon@teencanceramerica.org www.teencanceramerica.org

My name is Stephen Harris and I am a vascular access nurse and the Director of Research and Development for Vascular Wellness. Vascular Wellness is a multi -state vascular access company with a very high understanding of vascular access and the tools, training, and skills required to properly place and maintain vascular access. I have also previously been a clinical educator for Bard Access, a medical device company specializing in vascular access. Furthermore, I am also a co-author of a joint Vascular Access and Nuclear Medicine Te chnologist Expert peer-reviewed paper (https://www.frontiersin.org/articles/10.3389/fnume.2023.1244660/full) on the current nuclear medicine vascular access practices. I also presented these "ndings, before our manuscript was published, at the Annual SNMMI meeting a year ago in Chicago. I believe many members of the NRC medical staff may have been present. If you need to see my credentials, please reach out to me on our company website Since, my position involves an extensive amount of traveling to help hospitals across the Southeast gain access in the most difficult venous access patients, I appreciate the chance to provide a written comment regarding the ACMUI subcommittee report on the proposed NRC rule and guidance for the reporting of large extravasations. In fact, I am drafting this comment now from a hospital based in southern Virginia and I will be traveling on June 17.

I also appreciate the opportunity to comment for another important reason. I have reviewed the credentials of the incredibly august membership of the ACMUI but did not "nd any member who is an expert in vascular access. I have worked in this "eld for ov er 20 years and have extensive experience working with nuclear medicine technologists trying to gain access in nuclear medicine patients. As a result, I feel that I am uniquely quali"ed to provide a vascular access perspective on the extravasation discussion that I have not seen covered by the NRC medical staff, the ACMUI, nor from my review in any of the history of this issue. In fact, the only vascular access connection I have found is a public comment from one of the leading vascular access societies, the Association for Vascular Access (AVA). AVA made several important statements(emphasis added)that should be reconsidered here:

Many adverse outcomes related to vascular access are immediately recognized while others, like extravasation of radiopharmaceuticals, may go unrecognized for a prolonged period of time (sometimes years) and may be associated with negative outcomes including missed diagnosis or suboptimal treatment of nuclear therapy used to treat malignancies.

Clinician education is essential to avoid negative complications associated with venous access. Consistent, evidence-based education is lacking among clinicians who are expected to perform the procedure.

Monitoring a vascular access device for complications like extravasation is a critical responsibility of the healthcare provider. Prevention and reduction of device complications may be achieved through clinician education, evidence-based education, and avoiding blind-stick insertions. Finally, healthcare consumers must be educated about the risks associated with vascular access and enable them to become advocates for safe vascular access in all care settings.

I make these points because I do not have access to the ACMUI subcommittee report on the NRC proposed rule (for some reason I cannot "nd the report that NRC is asking for comments). Without having access to the report, I can only comment on the proposed rule as I know it. And my comments on the proposed rule are in agreement with the AVA - monitoring for a complication like extravasations is a critical responsibility of the healthcare provider. Our Best Practices manuscript clearly shows that nuclear medicine technologists are not using anything close to the current best practices in vascular access. Conversations with nuclear medicine technologists online also show they have not been taught best practices. These knowledge and training gaps indicate that the onus is on the provider to close them. It is not in any way the responsibility of patients. As a vascular access expert, I want to be perfectly clear in my comments.

Putting any responsibility on patients to monitor for or identify when they have been extravasated is entirely inappropriate. It is the responsibility of the nuclear medicine team to monitor for and identify extravasations when they happen. And then take the necessary steps to mitigate patient harm. Waiting to see if extravasated patients report injury has no place in vascular access management and especially when the purpose of vascular access is for the administration of radioactive drugs.

I would also like to make one other observation for the ACMUI and NRC to consider. Recently, a paper was published from the south of India. Nuclear medicine physicians found that without the use of vein "nding technology, their teams were extravasating pa tients with darker skin more frequently than those with lighter skin. Based on my experience, this does not surprise me. And since nuclear medicine technologists rarely use vein "nding technology in the United States, it is highly likely that patients of color are being extravasated at a higher rate than those with lighter color skin. A proposed rulemaking that puts the reporting requirements on patients will lead to an increase in health inequity. It is well known that patients of color are far less likel y to report errors in their care than Caucasian patients.

My view as a vascular access expert is simple. NRC should scrap any idea of having patients play a role in monitoring and reporting poor quality administrations. If the NRC wants to protect patients, I suggest they treat extravasations like any other medic al event. Centers that routinely have extravasations will then be forced to take the steps appropriate for their center to resolve their high rates of extravasation. While this recommendation is not in my best "nancial interest, since I bene"t from helpi ng nuclear medicine technologists gain access in difficult patients, it is absolutely the right recommendation for patients and healthcare.

I welcome any questions from any member of the NRC or ACMUI, and thank you for the opportunity to provide comment. You have my email address.

Stephen Harris CRNI, VA -BC Director, Research and Development Vascular Wellness 919-623- 0675