ML19095B774

M190404: Transcript - Meeting with the Advisory Committee on the Medical Uses of Isotopes (Public)

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Issue date:	04/04/2019
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1 UNITED STATES NUCLEAR REGULATORY COMMISSION

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MEETING WITH THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES

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THURSDAY, APRIL 4, 2019

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ROCKVILLE, MARYLAND

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The Commission met in the Commissioners= Hearing Room at the Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, at 10:00 a.m., Kristine L. Svinicki, Chairman, presiding.

COMMISSION MEMBERS:

KRISTINE L. SVINICKI, Chairman JEFF BARAN, Commissioner STEPHEN G. BURNS, Commissioner ANNIE CAPUTO, Commissioner DAVID A. WRIGHT, Commissioner ALSO PRESENT:

ANNETTE VIETTI-COOK, Secretary of the Commission MARIAN ZOBLER, General Counsel

2 ACMUI MEMBERS PRESENT:

CHRISTOPHER J. PALESTRO, M.D., Chairman DARLENE F. METTER, M.D., Vice Chairman VASKEN DILSIZIAN, M.D., Member RONALD D. ENNIS, M.D., Member RICHARD L. GREEN, Member MELISSA MARTIN, Member MICHAEL D. O'HARA, Ph.D., Member ZOUBIR OUHIB, Member ARTHUR SCHLEIPMAN, Ph.D., Member MICHAEL SHEETZ, Member MEGAN L. SHOBER, Member LAURA M. WEIL, Member ACMUI NON-VOTING MEMBER PRESENT:

HARVEY B. WOLKOV, M.D.

3 1 PROCEEDINGS 2 9:59 a.m.

3 CHAIRMAN SVINICKI: Good morning, everyone, I call the 4 Commission's meeting to order. This morning we have one of our periodic 5 meetings with Members of the Advisory Committee on the Medical Uses of 6 Isotopes.

7 We'll hear about a number of topics this morning.

8 Before we begin, however, I would note that two Members of 9 the Committee, and especially the two sitting at the table before us today, 10 including the Chairman of the Committee, this will, unless something 11 unexpected happens, be their last appearance before the Commission in a 12 public engagement such as this meeting.

13 I think both have a few homework assignments and things 14 and continued engagements with the agency but I wanted to pause for a 15 moment just to particularly thank Dr. Christopher Palestro and Ms. Laura Weil 16 for their contributions to the Committee. Both have been on the 17 Committee since 2011 I believe, and so for eight years. Since that overlaps 18 with my time here I have been the beneficiary of your insights and perspectives 19 on important and, without exception, complicated issues in the medical area 20 that come before our Commission.

21 And I want to express on behalf of the Commission and 22 myself that these perspectives and insights, they provide a unique role for us 23 because we are not principally a medically-oriented regulatory agency.

24 And so I find and have found such special and particular 25 value in the service of the Members of this particular Advisory Committee, and 26 to you both, again, my personal gratitude and the Commission's gratitude for

4 1 your service, but my personal gratitude. I know that your insights and 2 perspectives have benefitted me as I have considered matters over the course 3 of your long service on the Committee. So, we certainly wish you well and 4 thank you both.

5 And I didn't know if any other Member of the Committee or the 6 Commission wanted to just join in? Everyone joins in, okay, there we go.

7 All right, well, again, thank you and it isn't like you're 8 disappearing today but this is a chance for me to publicly recognize your 9 contribution, so thank you very much.

10 COMMISSIONER BARAN: Chairman, since we're doing 11 public recognitions, we wanted to do this last Thursday but you were not here, 12 you were not able to attend. Last Thursday, I don't know how many of you 13 know this, was a big day.

14 11 years ago to that day on March 28, 2008 the Chairman 15 was sworn in as a Commissioner. Over the course of its 44-year history, 37 16 individuals have served on the Nuclear Regulatory Commission and you are the 17 first to serve 11 years.

18 In fact, you broke the NRC record for longest-serving 19 Commissioner on December 8, 2018. You are also the only NRC 20 Commissioner to have been nominated to serve on the Commission by three 21 different presidents.

22 During your -- this is going to sound like a lot of days -- 4,035 23 days on the Commission, you served alongside a total of 11 Commissioners.

24 That's almost a third of all the individuals who have ever 25 served on the Commission, and before being designated as NRC Chairman 26 yourself, you served with four prior Chairmen.

5 1 Of course you're not going anywhere anytime soon, so every 2 day you serve on the Commission you will be setting a new record. But last 3 week was special because it was your anniversary.

4 To mark the occasion, your current colleagues want to 5 present you with a little something, and it has magically appeared.

6 This engraved vase reads: Christine L. Svinicki in recognition 7 of your performance and extraordinary leadership as the longest-serving 8 Commissioner in the history of the NRC. Congratulations.

9 (Applause.)

10 CHAIRMAN SVINICKI: Okay, yes, that's true. If we put it on 11 the table it would be an irregularity in the webcast so we wouldn't want that.

12 Thank you very much and I think United Airlines owes you all an apology for -- I 13 had some difficulties in my return which is why I was not here on the 14 anniversary date. But that's certainly very touching, thank you all.

15 Longevity is always a thing to feel good about I guess but I 16 think like all of you and the Members and Chairmen that I've served with, what 17 keeps you going is colleagues, is the wonderful staff here at the NRC, and 18 coming here every day and seeing how as a Commission and as individual 19 contributors and as Members of team NRC we can make a difference here.

20 So, the people are what make the years go by so fast and somewhat 21 unnoticeably, and yes, 4000-something sounds like a whole lot. I will take that 22 on board but thank you very much for that really gracious recognition. It's a 23 please to serve with all of you.

24 And now that all these salutations and commendations have 25 been dispositioned, let us begin with, again, the very important topics that will 26 be presented today by Members of the Advisory Committee on the Medical

6 1 Uses of Isotopes.

2 And I think if you would prefer, Chairman Palestro, I will 3 probably turn over to you and then allow you to maybe recognize the Members 4 of the Committee and the topics in the order in which you've agreed amongst 5 yourselves to present. So, the floor is yours.

6 DR. PALESTRO: Thank you, may I have the slides, please?

7 Madam Chair, Members of the Commission, I=d like to 8 express gratitude on behalf of the ACMUI for once again having an opportunity 9 to appear before you and share with you some of our activities over the past 10 year.

11 And for that we are most grateful.

12 I'm going to begin with an overview of the ACMUI. Next slide, 13 please. And I'm going to review for you our role, our membership, some of the 14 topics that we have covered and are covering, as well as our future directions.

15 Next slide, please.

16 The ACMUI's role is to provide advice on policy and technical 17 issues that arise in regulating the medical use of radioactive material for 18 diagnosis and therapy, to comment on changes to NRC regulations and 19 guidance, to evaluate certain non-routine uses of radioactive material, to 20 provide technical assistance when and if requested, and to bring key issues to 21 the attention of the Commission for appropriate action.

22 Next slide, please. There are 13 Members on the ACMUI with 23 very diverse backgrounds and that is designed to encompass the diversity of 24 topics and issues with which we are faced. All of these individuals have 25 expertise in their various areas. They include a healthcare administrator, Dr.

26 Arthur Schleipman, a nuclear medicine physician, myself, two radiation

7 1 oncologists, Dr. Ronald Ennis and Dr. Harvey Wolkov.

2 Dr. Wolkov is undergoing clearance currently. A nuclear 3 cardiologist, Dr. Vasken Dilsizian, a diagnostic radiologist, Dr. Darlene Metter.

4 Next slide.

5 Two medical physicists, one nuclear medicine, Ms. Melissa 6 Martin, one radiation therapy, Mr. Zoubir Ouhub, a nuclear pharmacist, Mr.

7 Richard Green, a radiation safety officer, Mr. Michael Sheetz, patient rights 8 advocate, Ms. Laura Weil, an FDA representative, Dr. Michael O'Hara, and 9 Agreement States Representative, Ms. Megan Shober.

10 Next slide, please. Some of the topics that we have 11 addressed and are addressing at the moment include an analysis of medical 12 events, and you're going to hear more about this from Dr. Ennis a bit later.

13 I think this is a significant addition to our program because 14 while we reviewed medical events on a yearly basis in the past, this is the first 15 time that we're starting to take both a look back and forward at these events, 16 looking for trends in their causes with the ultimate goal of being able to reduce 17 the likelihood of these events occurring in the future.

18 So you're going to see some of the initial data today and I 19 think it holds great promise for the future.

20 Another topic was the American Brachytherapy Society's 21 Medical Event Case Study Program, a program designed to help individuals 22 reduce the likelihood of medical events in their practice. A review of non-23 medical events, an ongoing review of Training and Experience for All 24 Modalities, which you're going to hear from Dr. Metter in a little while, a draft 25 revised of the Leksell Gamma Knife Perfexion and Icon, compounding of sterile 26 and non-sterile radiopharmaceuticals.

8 1 Next slide, please. Nursing mother's guidelines, which Dr.

2 Metter also will go over with us, a review and an update of the ACMUI bylaws, 3 the appropriateness of medical event reporting, Yttrium-90 microspheres 4 brachytherapy licensing, and ACMUI external communications.

5 The ACMUI External Communications Program was started a 6 few years ago by my predecessor, Chair of the ACMUI, Dr. Philip Alderson.

7 And the goal of this venture, if you will, was to enhance communications 8 between the ACMUI and professional organizations.

9 And I'm pleased to report to you that in June, for the third 10 consecutive year, the ACMUI will have a full session at the annual meeting of 11 the Society of Nuclear Medicine and Molecular Imaging.

12 In July, the ACMUI will also have a session, Mr. Sheetz and 13 Ms. Holiday will be attending at the meeting of the Health Physics Society in 14 Orlando, Florida.

15 Next slide, please.

16 While it may seem that what I've presented, or while it may 17 seem from what I have presented that it's the ACMUI doing all of the 18 presentations, in point of fact there's always an ongoing dialog and an intimate 19 close-working relationship between the Members of the Committee and the 20 staff.

21 And I think that the staff presentations also should be 22 highlighted, and they include the Training and Experience Stakeholder 23 Outreach Plan, a review of the ACMUI's reporting structure, a summary of the 24 medical-related events for the past year, a summary of changes to 10 CFR Part 25 35, the Yttrium-90 microspheres brachytherpay licensing guidance, the medical 26 team highlights, and how the ACMUI and its Subcommittees work together with

9 1 the NRC staff and management under the Federal Advisory Committee Act.

2 Next slide, please. In the future, the ACMUI will continue to 3 provide advice and technical assistance, to comment on NRC regulations and 4 guidance, to evaluate the uses of radioactive material, and to bring key issues 5 to the attention of the Commission.

6 Next slide. The rest of today's agenda, Dr. Darlene Metter, 7 the ACMUI Vice Chair and Diagnostic Radiology Representative, will offer 8 comments on the guidelines to nursing mothers for exposure from the Medical 9 Administration of Radioactive Materials.

10 She will also offer comments on the Training and Experience 11 Requirements for All Modalities. Dr. Ronald Ennis, the ACMUI Radiation 12 Oncologist of Brachytherapy will provide a review and analysis of the reported 13 medical events for fiscal years 2014 to 2017.

14 Next slide.

15 And finally, Ms. Laura Weil, the ACMUI's Patients' Rights 16 Advocate will present her perspectives on the Nursing Mothers' Guidelines, the 17 Training and Experience Requirements for All Modalities, and medical event 18 reporting.

19 Next slide, please. And now I will turn it over to Dr. Metter.

20 Thank you.

21 DR. METTER: Thank you, Dr. Palestro, and thank you for 22 inviting us here to speak with you today. May I have my slides?

23 So today I'm going to be talking about the guidelines to 24 nursing mothers in regard to radiation exposure from the Medical Administration 25 of Radioactive Materials.

26 Next slide, please. Our Subcommittee Members are Dr.

10 1 Vasken Dilsizian, myself, Dr. Christopher Palestro, and Dr. Pat Zanzonico. And 2 our Resource Staff is Maryann Ayoade.

3 Next slide. So the charge of this Committee was to review 4 the radiation exposure from diagnostic and therapeutic radiopharmaceuticals, 5 including brachytherapy, to the nursing mother and child.

6 Next slide. Now, radiation therapy, radionuclide therapy, is 7 targeted to destroy disease tissue and, therefore, it's very important that we be 8 very careful in what we do.

9 Breastfeeding is not regulated, however, at times it is 10 necessary to administer radiopharmaceuticals to the nursing mother. And 11 many times, many of these agents appear in breast milk. So, with that, in 12 regards to -- may I have my slides, please? -- 10 CFR 35.75 and in regards to 13 the patient, and in this case the nursing mother, patient can be released if the 14 total effective dose equivalent to the nursing child is less than 5 millisieverts.

15 If the exposure could exceed 1 millisievert to the nursing 16 child, written instructions of adverse consequences must be given if nursing is 17 not stopped and guidance to the mother on the discontinuation of 18 breastfeeding.

19 Next slide. Now, most mothers who are administered 20 radiopharmaceuticals require temporary cessation of breastfeeding. However, 21 a few nursing mothers administered radiopharmaceuticals may require a 22 complete cessation of breastfeeding.

23 Next slide. A major exception, however, is I-131 sodium 24 iodide mainly this is to decrease the breast dose to the mother. And what 25 happens is when the mother who is nursing receives 1-131, it gives a significant 26 dose to the maternal breast as opposed to the non-lactating breast.

11 1 For example, if you look here, if a nursing mother is 2 administered 150 millicuries of I-131, that delivers 200 rads, a huge amount, to 3 the maternal lactating breast. So, to decrease the breast dose lactation must 4 cease and that takes about six weeks.

5 Therefore, breastfeeding must stop six weeks prior to 6 radiopharmaceutical administration of I-131 to cease lactation and then also 7 permanently for that child. In the future, however, the mother may breastfeed 8 for her future children.

9 Next slide.

10 Now, when you actually look at the radio exposure during 11 nursing to the mother and to the child, to the mother it's internal administration, 12 it's an internal source as far as regarding the administration of the 13 radiopharmaceutical.

14 To the child, the child actually has two sources, an external 15 source and an internal source.

16 Next slide, please. The external source is the mother. She's 17 a significant radiation source especially during routine childcare which entails 18 close prolonged contact with the child.

19 And as you know, our ALARA principle, which is our basis for 20 radiation protection, as low as reasonably achievable, the time spent in 21 childcare is prolonged which increases the dose to the child.

22 And as our ALARA principle, we like to decrease that time 23 period. And the distance is very close proximity in childcare so that clearly 24 increases the dose to the child.

25 And as you know, radiation, the further away you get, the less 26 radiation gets. So really, childcare has a significant radiation exposure to the

12 1 nursing child. Next slide. So, the internal source is going to be to the child the 2 ingested radioactive milk. Well, you say how much radiation does that make?

3 Well, it depends on the radiopharmaceuticals. Generally, less than 4 ten percent of pharmaceuticals administered to a nursing mother enters the 5 breastmilk and on average it's about 0.3 to 5 percent. The major exception is I-6 131 sodium iodide and as I mentioned, causes a significant increase in dose to 7 the lactating breast.

8 And in some cases this is a very high accumulation, 25 9 percent of the administered dose. So it's really best to cease breastfeeding six 10 weeks before administration of I-131, and again, permanently for that child, 11 however, the mother may nurse other children in the future.

12 Next slide. So the Subcommittee made this table in regards 13 to individuals who decide to administer radiopharmaceuticals to the nursing 14 mother because it's necessary.

15 And this gives a table about nursing interruption and the 16 radiopharmaceutical to help our healthcare providers in giving the best care in 17 regards to safety for their patients.

18 Nursing must stop for I-131 sodium iodide and, again, six 19 weeks prior to the therapy. Nursing must stop for I-124 sodium iodide, all alpha 20 agents, and for 177-lutetium.

21 No interruption is needed for the very short-lived 22 radiopharmaceuticals of oxygen-15, rubidium-82, and germanium-68, one hour 23 for carbon-11 and nitrogen-13, and four hours for fluorine-18.

24 Next slide, please. 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for 99-technetium agents, 3 days 25 for 1-123 sodium iodide, 4 days for 201 thalium, 6 days for indium-111 white 26 cells and octreotide, and 28 days or about a month for gallium-67 and

13 1 zirconium-89.

2 Next slide. For Y-90 microspheres, no interruption is needed 3 and for breast and sentinel lymph node sources once they're removed, no 4 interruption, as long as the sources are not in the nursing mother.

5 Next slide. So it's also very important that the Nuclear 6 Medicine Department has signage and this is to inform the nursing mothers or 7 mothers planning to nurse in the near future who are scheduled for a nuclear 8 medicine procedure.

9 And this is important that they are informed that certain 10 radiopharmaceuticals may require certain radiation safety precautions. And 11 such patients are advised to notify the nuclear medicine staff and physician 12 prior to the nuclear medicine procedure.

13 Next slide. On February 1, 2018 the ACMUI had a public 14 teleconference call. During this call, the ACMUI unanimously approved the 15 submitted report with some caveats and these are just regarding calculations 16 and certain modifications on the tables. During our fall meeting on September 17 20, 2018 the ACMUI unanimously approved the revised report with additional 18 language regarding FDA-approved radiopharmaceuticals and the need to 19 evaluate radiopharmaceuticals not encompassed in the report.

20 Next slide. And these are my acronyms. The next topic that 21 I'll be commenting on is the Training and Experience Requirements for All 22 Modalities, 35.300 Uses.

23 Next slide. My Subcommittee Members are Dr. Ronald Ennis, 24 myself, Dr. Robert Schleipman, Mr. Michael Sheetz, Ms. Megan Shober, and 25 Ms. Laura Weil and are NRC staff Resource was Maryann Ayoade.

26 Next slide. So in March 2018, the Training and Experience

14 1 Subcommittee came with the following two recommendations. The first was at 2 that time there was no objective data for current AU shortage.

3 The second recommendation, however, was to reconsider an 4 alternate AU pathway under 10 CFR 35.390 because the Committee wanted to 5 proactive rather than reactive with a recent turn of events which they observed 6 during that time.

7 And this was number one, in January of 2018 the FDA 8 approved 177-lutetium dotatate, which has the potential for greater clinical use 9 and more therapies.

10 And second, there was a decrease in the number of first-time 11 candidates sitting for the American Board of Nuclear Medicine certification 12 exam. So again, being proactive, they were concerned that maybe there may 13 be a potential shortage of AUs in the future.

14 Next slide. So let's look at that. Next slide. The current 15 pathways to become an authorized user, there are two as far as regarding 10 16 CFR 35.390. Pathway 1 is considered the Board certification pathway and this 17 is where the NRC deems status Boards and these are the American Boards of 18 Nuclear Medicine, Radiology, and Osteopathic Radiology.

19 When you pass these certification exams, you then are 20 qualified to become an authorized user under 10 CFR 35.390. And currently, 21 there are two programs that fall under this category.

22 These are the nuclear medicine and radiation oncology 23 programs. So, again, graduates who complete these programs and pass the 24 certification Board of the respective Boards as listed become authorized users 25 under 35.390.

26 Next slide. The second pathway is called the alternate

15 1 pathway and this is where an individual in training completes 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of 2 training and experience including classroom and laboratory hours and basic 3 radionuclide handling techniques, the medical uses of unsealed byproduct 4 material requesting a directive.

5 And under this category, there are two current programs: the 6 diagnostic radiology, the redesigned pathway. And this was approved by the 7 American Board of Radiology in 2010 and it entails 16 months of nuclear 8 medicine during a 48-month diagnostic radiology residency.

9 The second is the Nuclear Radiology Fellowship and it's a 10 one-year program that is completed after four years of a radiology residency.

11 Next slide. So when you actually look at the number of 12 potential trainees in the pathway to have 35.390 and if you look at pathways 1 13 and 2, in training there are four, actually, residency programs that incorporate 14 these individuals.

15 In nuclear medicine, nuclear radiology, the redesign pathway 16 and radiation oncology the potential number of individuals who will be able to 17 become authorized users for 35.390 is 921.

18 If you extrapolate that, just an estimate as far as number of 19 graduates per year, the total is almost 270. So if you go further out, in four 20 years you have over 1000 new individuals who will be able to perform therapies 21 under 35.390.

22 Next slide. So, is there an AU shortage? Let's look at the 23 numbers. In the current academic year of 2018, the pipeline for 35.390 is over 24 900 graduates. For 2019, about 270.

25 And in 2018, the American Board of Nuclear Medicine looked 26 at the diplomats in the number and there are 3591, almost 3600, practicing

16 1 authorized users. So, in 2019 when we actually looked at the data, there was 2 no objective evidence for an authorized user shortage.

3 Next slide, limited scope pathway. As I mentioned, 4 radionuclide therapy's goal is to destroy disease tissue. Now, with that, 5 radionuclide therapy then poses the highest risk and highest impact of any of 6 our nuclear medicine procedures and, therefore, it has to be performed 7 properly.

8 If it's improperly performed, you can have severe 9 unintentional damage or destruction of organs or tissues. Therefore, to protect 10 the public and safety, anyone who does radionuclide therapy must have a basic 11 minimal level of competency to protect the patient and be safe.

12 In addition, not only the acknowledged topic and the Training 13 and Experience, the limited scope and a full authorized user must have an 14 equivalent level of competency for that radionuclide therapy.

15 Next slide. So when we actually sat down and looked at the 16 feasibility of a limited scope authorized user, we started with what do you need 17 to know to be safe?

18 What's the minimum level of knowledge and training you need 19 to be safe to deliver radionuclide therapy? And pretty much it's a total novice 20 topic in 35.390.

21 And then we looked at the individual radiopharmaceuticals for 22 therapy and each individual radiopharmaceutical has their own conflict radiation 23 safety issues.

24 And if you actually again look at it, it's so complex there's 25 multiple overlaps in topics that you have to learn. So any category would 26 clearly include the prior radiopharmaceutical knowledge base you need and be

17 1 a carbon copy of all the other pharmaceuticals.

2 So with that, rather than just repeat for this therapy one, you 3 need this knowledge topic or experience this second radionuclide, which is, oh, 4 by the way, the same thing as the previous one.

5 The Subcommittee concluded that it was not feasible to 6 recommend a limited scope authorized user pathway.

7 Next slide. So our final recommendations. The Committee 8 strongly supports the current AU pathways for 35.390 which protects the 9 public's health and safety. There is no objective data to support an authorized 10 user shortage.

11 Next slide. The Committee does not recommend a limited 12 scope AU pathway for the reasons I discussed for unsealed byproduct material, 13 for which a written directive is required.

14 Next slide.

15 The Committee agrees that if the NRC pursues a limited 16 scope AU pathway despite the ACMUI recommendations, the authorized user 17 candidate must attest to the acquisition of the basic knowledge topics of 35.390 18 and the skills to successfully complete a formal competency assessment with 19 continued formal periodic competency reassessment.

20 And this would be to maintain their limited scope AU status.

21 Next slide. On February 26, the ACMUI approved the report 22 and its recommendation with one revised to add the language below.

23 And this says the Subcommittee will work with the NRC if the 24 NRC decides to pursue a limited scope pathway, and again, against our 25 recommendation. But we're willing to work with the NRC staff to develop an AU 26 curriculum of knowledge topics. Next slide. And these are acronyms. And now

18 1 I turn it over to Dr. Ennis.

2 DR. ENNIS: Thank you, Dr. Metter, and good morning to the 3 Commission. Thank you so much for your attention and the opportunity to 4 speak with you today. Slides, please?

5 My topic is going to be a review of medical events to share 6 with you some insights that the ACMUI has gleaned from review of events over 7 the years 2014 to 2017.

8 As Chairman Palestro alluded to before, the ACMUI yearly 9 reviews all the medical events as does NRC staff. But this year we decided to 10 broaden the look and look at a group of years to start to looking for something 11 more meaningful.

12 Thankfully, there are relatively few medical events per year.

13 As you well know, there are approximately 150,000 uses of 14 radiopharmaceuticals and medical isotopes per year and a very small 15 proportion of medical events.

16 Nevertheless, we are committed to driving that as low as 17 possible but the only way to do that meaningfully is to look at a larger group of 18 events. So that's what I'm going to share with you.

19 Our Subcommittee was myself, Mr. Richard Green, Dr.

20 Metter, Dr. O'Hara, Dr. Suh, who just rotated off of ACMUI, and Mr. Sheetz, and 21 we were supported by Sophie Holiday.

22 Next slide, thank you.

23 So, the approach here was not to look anecdotally at single 24 events and understand exactly what happened with each one, but to look for 25 more common themes that might be within sections, within types of applications 26 or across applications as a way to then help spread that knowledge, share that

19 1 knowledge, and decrease the number of medical events. So we reviewed four 2 years' worth of reports that we had accrued over the last four years in the 3 presentations we had done before for this purpose.

4 Next slide. And we ended up determining that we could 5 articulate two themes that stood out, and I'll show you the data in the coming 6 slides.

7 But the themes are, number one, performance of a timeout 8 prior to an administration of radioactive byproduct material, as is done now very 9 commonly in the medical world and before surgeries in particular and other 10 procedures, could have prevented a significant minority of medical events.

11 Number two, there appears to be an issue regarding lack of 12 recent or frequent performance of specific administrations, and that seems to 13 be a contributing factor in a number of cases as well.

14 Next slide. So now we'll look at the data within each of the 15 various administration categories. So, for 35.200, unsealed byproduct material 16 for imaging and localization, these are the number of events over the four-year 17 period. And in total, 21 events over the four years.

18 And they were really broken up into three groups really, I 19 categorized all of them, either the wrong drug, the wrong dosage, or the wrong 20 patient. And many of the wrong drug and wrong dosage were overlapping 21 events.

22 Next slide. In thinking about these three categories, what 23 would help? So a timeout could certainly have an impact on wrong drug, the 24 effective moment of the timeout. One of the things that was reviewed is, is this 25 the drug for this patient? Similarly, the wrong patient would also be caught 26 potentially by a timeout and that timeout, the core to a timeout, is verified by two

20 1 means, patient identification, typically name and date of birth. Wrong dosage 2 would not necessarily be facilitated by a timeout.

3 So about half of the 35.200 medical events over the four-year 4 period could have potentially been prevented by the additional of a timeout to 5 the procedure. So, giving the administration.

6 Next slide. Within 35.400 manual brachytherapy events, so 7 we had 27 events -- I'm sorry 40 events over the four-year period. a number of 8 them are in their prostate dose.

9 Prostate dose, as you know, was part of the issue that led to 10 the revised of the Part 75 rule and many of those events would not be 11 categorized as events now. Some still would but many would not.

12 In terms of other sources of medical event within the manual 13 brachytherapy category, we have applicator issues, wrong site implantation, 14 and activity/prescription errors such as confusing air kerma and millicuries.

15 Next slide. So again, with this lens in terms of total medical 16 events, affording the timeout would have had the potential to prevent about ten 17 percent of these events, particularly the ones regarding prescription, air kerma, 18 millicurie, for example.

19 And this is a matter of judgment but our expertise looking at 20 the medical events, we felt there was a sense of a lack of experience playing a 21 role in approximately 15 of these medical events.

22 Next slide. So, this pretty much summarizes what we said 23 before. So about 25 percent of cases, a timeout or some type of enhanced 24 training or prior to be using common procedures, these two themes explain 25 about 25 percent or contribute about 25 percent of the medical events within 26 this category.

21 1 Next slide. Going to 35.600, which is seal sources in 2 afterloader uses, teletherapy units, and gamma knife, gamma stereotactic units.

3 4 So, again, over the four-year period, 37 events and they are 5 categorized here: wrong position, wrong reference length, which is a specific 6 thing having to do with high-dose-rate catheters, the wrong plan, the wrong 7 dose or source strength, and some machine or software malfunctions.

8 Again, looking for themes through the lens that we have 9 described.

10 Next slide.

11 Sorry, but this is just breaking it up by parts of the body so 12 gynecologic applications are the leading category for which that's HDR 13 application brain is typically what we were talking, about the Gamma Knife 14 applications.

15 Next slide. So, again, with this lens, the timeout overall would 16 have potentially caught about 15 percent of these events over the time period 17 that we analyzed.

18 And next slide. Again, infrequent user phenomenon, if you 19 will, again, this is hard, it's based on an assessment of the animate information 20 and with our expertise getting a sense of whether we thought that played a role.

21 22 And our estimates were that it was a significant issue in 23 35.600 with approximately a third of the events appearing to have an infrequent 24 user issue as a contributing factor.

25 Next slide. In terms of the 35.1000 category, the first one 26 within that that we'll talk about is radioactive seed localization and there are

22 1 very few events in this category.

2 Next slide. Within the Leksell Gamma Knife Perfexion and 3 Icon, which are licensed under 35.1000, a relatively small number of events as 4 well, 12 events.

5 A large number of them were really a single issue, a patient 6 positioning system problem. Other than that, a couple of patient setup error 7 issues, patient movement, wrong site.

8 Next slide. And the last category within 35.1000 that we'll talk 9 about is microspheres and on this slide and the next slide are the summaries 10 for each of the two types of microspheres that are out there, the TheraSpheres 11 and SIR-Spheres.

12 And from our perspective, they were very similar in terms of 13 the kinds of events. There are more events, not necessarily staying 14 proportional to the -- because we don't have the denominator here but just 15 numerically there are more events of this type. In some of the other categories, 16 a large number of them seem to have to do with the residual activity remaining 17 within the delivery device, the tubing, the hub, et cetera.

18 But there are issues related to setup and wrong dose, wrong 19 site, shunting issues, catheter placement issues. So that's it for the 20 TheraSpheres and then the next slide will summarize for SIR-Spheres.

21 And again, we're not trying to compare the two or even 22 compare these to others, just to share that they, to our view, are fairly similar in 23 the themes and the issues that you see with slightly varying numbers but in the 24 same ballpark.

25 Next slide. So, a summary of this will tell us a little bit better 26 so about 60 percent of the medical events in this subgroup of Y-90

23 1 administration has to do with residual activity within the tubing, the hub, et 2 cetera.

3 Wrong dose is about 11 percent, wrong site is about 11 4 percent due to catheter placement. Shunting plays a similar role and setup 5 area is again about ten percent.

6 So, next slide. Okay, medical events that might have been 7 able to be prevented within this category based on the timeout concept. So, for 8 the seed localization, one of them may have been prevented by performing a 9 timeout prior to implantation of the seed.

10 Within the Perfexion Icon category, approximately 25 percent 11 we thought could have been prevented by a timeout. And in the microsphere 12 space, about 12 percent.

13 Next slide. And then again trying to parse out whether there 14 was a role of lack of experience or infrequent user phenomena if you will in 15 these categories.

16 It seemed as though this did not play a role in radioactive 17 seed localization. About 15 percent of Perfexion Icon and about 10 percent, 8 18 percent in the microspheres.

19 Next slide. So, if a timeout was done, what would that look 20 like? In this extrapolating, again, from the concept that's used in surgery and 21 kind of having in mind the problems that we saw in this review, a timeout could 22 include the following elements.

23 One, the identifying of a patient by two means. Number two, 24 confirming the procedure to be done. Number three, confirming the isotope.

25 Number four, confirming the activity. Number five, confirming the dosage.

26 And other features that would be applicable to certain

24 1 applications but not others, and therefore not necessarily part of a uniform 2 radioactive timeout, but for certain ones would be confirming the units of 3 activity.

4 In particular, not just the activity but the units because we've 5 seen that as an LDR prostate issue and atomic location for those that are 6 actually anatomically specific, which a fair number are.

7 A patient's name is on the treatment plan so not just 8 confirming who is in front of me but is the plan that I'm about to apply to that 9 patient actually this patient?

10 Making sure that the plan itself has had an independent 11 second check, that the reference length is proper, this is a very specific thing 12 having to do with HDR but is a common theme that we see.

13 So that could be added to a timeout as applied to an HDR.

14 Have we checked the length? And implant site location, which is similar to 15 anatomic location really.

16 Next slide. Now, what to do about the issue of infrequent 17 procedures or that concept?

18 So, again, suggesting to the medical community that for those 19 who are in such a situation or about to do a procedure they have not done 20 recently or are doing but not frequently, there are a number of review courses 21 available from professional societies that they can avail themselves of.

22 There are a plethora of review articles in the overwhelming 23 medical literature nowadays that are available. Obviously, reaching out to 24 colleagues to review the procedure, doing a dry run would be an excellent 25 recommendation that we might be able to make to the medical community with 26 your entire team prior to doing an actual procedure.

25 1 And reviewing your equipment, your device setup and 2 equipment again to be sure it's working properly and that you know very 3 specifically what to do.

4 Next slide. So, our Subcommittee then recommended to 5 NRC at the September 2018 meeting this report was accepted by the broader 6 ACMUI community and we recommended that the NRC issue an information 7 notice alerting authorized users to the themes identified herein.

8 The NRC staff has accepted this recommendation and 9 execution of this is pending resource availability.

10 And with that I'll turn the podium over to my colleague, Ms.

11 Weil.

12 MS. WEIL: Thank you, Dr. Ennis. Thank you. Over the last 13 nearly eight years of my tenure on the ACMUI, the subject of medical event 14 reporting has been raised repeatedly.

15 We've discussed the punitive nature of required reporting, the 16 perceived unfairness of public reporting of events that cause no patient harm, 17 and of the failure to make use of the collective event data in a way that can be 18 proactively beneficial as an educational tool and part of safety culture.

19 NMED is a regulatory database and I assume it works pretty 20 well for its stated purpose.

21 But aside from the purely regulatory purpose of required 22 reporting and NMED data entry, there's at least a theoretical hope that the 23 subsequent required investigation will foster honest self-assessment in the 24 reporting institution and the implementation of meaningful corrective action to 25 mitigate the likelihood of event recurrence.

26 That's useful for the involved institution certainly, but it

26 1 basically ends there. As a patient advocate, I feel strongly that there's a missed 2 opportunity here.

3 We'd like to see that the collected data is used more broadly 4 for all interested healthcare providers to learn from the mistakes of others and 5 hopefully prevent similar occurrences in their own workplaces. As 6 stated, NMED may work well from a regulatory perspective but it's willfully 7 inadequate for the broader educational purpose. There is simply not enough 8 detail captured in NMED or the detail is basically inaccessible for useful 9 learning.

10 NRC needs to decide if it's willing and able to engage in what 11 may be an ambitious endeavor to upgrade NMED into something proactively 12 supportive of safety culture.

13 The Nursing Mother Subcommittee provided a detailed and 14 comprehensive report on guidelines to reduce infant exposure and maternal 15 harm. The exposure of any nursing infant to radiation from mother's treatment 16 should be unacceptable.

17 If it occurs, it's solely attributable to a failure on the part of the 18 healthcare provider to appreciate the risks of radiopharmaceutical use.

19 Unlike an undisclosed or as yet un detectable pregnancy, the 20 healthcare provider is able to and has a responsibility to identify a nursing 21 mother.

22 The provider has an obligation to communicate the risks of 23 radiopharmaceuticals effectively and allow time for the nursing mother to plan 24 for whatever pre or post treatment precautions must be made, including 25 cessation or termination of lactation.

26 Providers need a comprehensive knowledge of radiation

27 1 biology and up to date awareness of the risks of new radiopharmaceuticals as 2 they become available, and commitment to good communication and safety. All 3 of this is dependent on comprehensive training and experience.

4 The last time I offered my observations about Training and 5 Experience requirements. I was on the fence about the benefit of finding 6 tailored T&E requirements for certain kinds of radiopharmaceuticals.

7 I cited concerns about healthcare providers being protective 8 of both professional and financial turf. I posed whether that was at least 9 partially driving physician/organization opposition to any changes in T&E 10 requirements, which are traditionally accomplished in medical residency 11 trainings.

12 And on the other side, one can argue that there are certainly 13 financial motivations to opening up the field with limited scope license 14 opportunities for non-residency-trained physicians.

15 Concerns have been expressed about a looming shortage of 16 authorized users. These concerns still feel relevant, however, the argument 17 that broad experience and training with the topics encompassed in the 18 traditional training pathways serves patients better, that's a compelling 19 argument.

20 Given the potential for proliferation of new 21 radiopharmaceuticals and the complexity of most of these administrations, 22 they're best delivered in the context of comprehensive knowledge and 23 expertise. And since the U.S. healthcare market is market-driven, we have to 24 assume that the market will drive more physicians into training programs to 25 become authorized users of a proliferating market segment. Will 26 some patients have to travel to access this expertise? Yes, they will. And will

28 1 that create insurmountable barriers for some of these patients? Yes, it will.

2 But it's not the role of regulation to create access. The role of 3 regulation is to create safety. And that delicate balance point is in making sure 4 that regulation does not create unnecessary barriers.

5 Healthcare providers who wish to offer radiopharmaceuticals 6 to their patients need to be a competent to do so.

7 The competence is dependent on a wide range of knowledge 8 and experience, and in addition, regulation regarding the measurement of such 9 competence and the maintenance of competence needs to be manageable and 10 enforceable.

11 Creating separate T&E thresholds for each existing and in-12 the-pipeline radiopharmaceutical could cause a regulatory nightmare that might 13 well compromise patient safety and public safety.

14 I=d like to offer some final thoughts. This is my last ACMUI 15 meeting and Commission briefing and I would love to express my gratitude for 16 your interest over the past years in hearing an advocacy perspective at these 17 briefings.

18 It's worth stating that I consider all my colleagues on the 19 ACMUI to be patient advocates, and very rarely have I felt that the 20 consideration of patients' rights or the ethical perspectives of advocacy have 21 been at odds with the opinions and positions of the Committee as a whole.

22 It's been an honor to serve on the ACMUI and I thank you for 23 the opportunity to talk to you.

24 CHAIRMAN SVINICKI: Well, thank you again to each 25 presenter for the presentations and to each of the Subcommittees for their work 26 in the Committee as a whole.

29 1 It's the practice of our Commission to rotate the order of 2 questioning and today we begin with Commissioner Burns.

3 COMMISSIONER BURNS: Thank you, Chairman, and thank 4 you all for being here and the work that you do with the Committee. And Dr.

5 Palestro and Ms. Weil, thank you for your services as you rotate off the 6 Committee, I appreciate that.

7 You touched on a number of interesting topics this morning.

8 Maybe I can start on the question on the authorized users. I appreciate that 9 analysis, that data analysis.

10 One of the things I think we would get as Commissioners 11 when we've had drop-in visits or other letters or information on the question on 12 the authorized users was, and I think in a way Ms. Weil touched on it, is the 13 question of access.

14 While I think statistically what you're showing, Dr. Metter, is 15 that there is a pipeline or a refresh in the system, the question that some will 16 raise is that may look fine as a generic matter if you look at it overall, but you 17 may have regional issues with that or access in rural areas and things like that.

18 19 I don't know if you'd like to comment on that?

20 DR. METTER: The issue of rural areas and entities, they're 21 not in the urban areas where they have the medical specialty, I=d like to make 22 an analogy with chemotherapy.

23 So, as far as you have a specialist who can administer 24 chemotherapy or radiation, an oncologist, and they know what to look for and 25 right now the newer agents are getting more and more complicated in their 26 indications, their administrations, their toxicities.

30 1 And really as far as our current authorized users we have to 2 learn more. So the idea is not to decrease the level of knowledge, it's actually 3 you have to increase it. And actually, it's not only the knowledge base, but it's 4 the experience. And if you actually look at the rural areas, you have individuals 5 -- you can have, say, for chemotherapy, you have an oncologist and you have --

6 and I was in family practice so I'm not putting that down, but you have a family 7 practitioner who can go ahead and say, well, I'm going to push this, this is 8 number one, this is number two.

9 And the patient starts having problems. They don't know how 10 to deal with that and you know, you really need an expert. And radionuclide 11 therapy is really getting, like I said, more complicated. Another 12 issue in the rural areas is cost. The cost of these radionuclides are very 13 expensive. I mentioned 177-lutetium, the cost of that agent for one therapy is 14 analysis $50,000 just to order it by the pharmacy and that's not the cost that the 15 insurance has to pay.

16 And that individual is not just one dose, they need four 17 therapies, so you're looking at like $200,000 just to pay for the cost of the 18 radiopharmaceutical.

19 And then if that site does not have the facilities of safely 20 delivering it for the patient, the staff, and the public, I kind of made a general 21 look at what's the cost as you just said in an area, it's going to be over 22 $100,000.

23 And then you have to maintain it with the personnel and all 24 that. And so in the rural area, yes, there's nothing that's going to stop them, it's 25 going to be a financial issue.

26 And if you just have one or two insurance that doesn't pay for

31 1 it, it'll be not financially feasible for that community.

2 COMMISSIONER BURNS: Thank you. Dr. Ennis? Certainly.

3 4 DR. ENNIS: Just to add, the specialists who now have the 5 main pathway training are nuclear medicine and radiation oncology who do 6 things beyond radiopharmaceutical therapy, nuclear medicine, particularly 7 mostly imaging, radiation oncology using external radiation treatments.

8 And there is no evidence or call from any sector of society 9 that I know of a shortage of imaging availability in nuclear medicine or radiation 10 oncology and external radiation.

11 So, how could that be that we have adequate supply even in 12 the rural areas of radiation therapy, external treatments and nuclear medicine 13 imaging? These are the same people.

14 So, it doesn't seem a logical or reasonable argument to think 15 there really is an actual shortage of authorized users because these companies 16 are being served by the other practices that these physicians provide.

17 It doesn't seem likely that they're there.

18 COMMISSIONER BURNS: Thank you. In some ways I 19 guess it's related or it's a corollary area what I'm interested in.

20 I know this issue for example on training and either you have 21 the certifications or then the provisions that include the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> training. And 22 that's another one over my term here that that issue has been raised.

23 Are you also looking at the issue overall on the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> or 24 the content or things like that, or what the training mods are?

25 DR. PALESTRO: The answer is at the present time no.

26 We have the Subcommittee on Training and Experience

32 1 which tends to go through all of the various training experience for all modalities 2 and it was our plan to begin and work our way up for the 100, 200, 300 series 3 and so forth.

4 However, we were directed to focus on the 390 series for the 5 limited scope authorized user. So, the short answer to your question is it's not 6 being done at the moment. We will get there in the future to look at the 700 7 hours8.101852e-5 days <br />0.00194 hours <br />1.157407e-5 weeks <br />2.6635e-6 months <br />.

8 COMMISSIONER BURNS: Okay, thank you. Dr. Metter?

9 DR. METTER: Yes, and one other major important thing 10 regarding your question is that when you look at the overall spectrum of what 11 that entails, the bottom line is it's not safe.

12 It's not safe for the patient and the public for the limited scope 13 pathway.

14 COMMISSIONER BURNS: Okay, thank you. Dr. Ennis, I 15 thought it was a very interesting presentation on this analysis of the medical 16 events and the timeout or take a breath, it's sort of the same thing.

17 So I was very interested in the Committee's recommendation 18 that the staff go forward in the information notice. This is probably not so much 19 a question but I would hope the staff -- you all made the recommendation last 20 September.

21 I think I probably would be interested to know, which is not 22 something within your camp but from the staff as an outcome of this meeting, 23 what's the resource hold-up and where we can move forward?

24 Because it's very interesting when you look at the statistics. Again, as 25 you say, you're in a context of thousands and thousands of events with 26 relatively few, which speaks well to I think the practice.

33 1 But still, there are instances where the learning is have I got 2 the right person, have I got the right dose, have I got the right machine? Or 3 whatever type question it is. So I found that extraordinarily interesting.

4 I don't know whether you looked at all -- within the set of a 5 medical event, obviously some of those hit our Congressionally required targets 6 for abnormal occurrences and I don't know if there was any particular focus on 7 those within that set?

8 DR. ENNIS: Right, those are very rare and it was not a focus, 9 it was not a specific focus.

10 COMMISSIONER BURNS: Okay, thanks. And Ms. Weil, in a 11 sense related to your comments in terms of approving the NMED system, what 12 would you say a vision for that in terms of making it maybe more broadly 13 useful?

14 As you say, in many respects it helps the regulatory process 15 or it's focused on that. Elaborate on what you were trying to tell us?

16 MS. WEIL: Sure. So, the cases that are entered into NMED 17 are often incomplete and the information that would be useful for learning from 18 a medical event is simply not accessible.

19 Perhaps the corrective actions haven't been entered or the 20 description of the event is simply entered from a pick-list of menu items, which 21 isn't -- there needs to be a narrative feel to describe what happened.

22 And then an evaluation of why it happened, and then an 23 evaluation of what could one do to prevent it from happening again. Once 24 those cases are complete and useful, then it should be accessible to the 25 broader medical community.

26 It's not, you can't look into NMED unless you're authorized to

34 1 do so. And I don't know what the criteria are for getting into NMED, I know I 2 can, but I know that the local physician in the hospital down the road can't.

3 And that's crazy, it should be available so that medical 4 professionals can look at what happened to their colleagues and figure out 5 ways not to have that happen to them.

6 COMMISSIONER BURNS: Anybody else care to comment.

7 Dr. Ennis?

8 DR. ENNIS: Well, to that end, just to let you know, we do 9 have a Subcommittee in ACMUI looking at this very question and it was an 10 outgrowth of the first presentation I gave you.

11 So, we're not ready yet to make formal recommendations but 12 we will have some ideas coming forth.

13 COMMISSIONER BURNS: Okay, great. Well, thank you 14 again to all of you for your presentations and for your service on the Committee.

15 CHAIRMAN SVINICKI: Thank you very much. Next we will 16 recognize for questions Commissioner Caputo. Please? I'm sorry, you can tell 17 we had a Congressional Hearing this week. Commissioner Caputo, thank you.

18 COMMISSIONER CAPUTO: I've always got to stand up.

19 COMMISSIONER BARAN: We know who you are.

20 COMMISSIONER CAPUTO: I know who I am too. I'm 21 certainly very aware I'm not a Senator. So, I'm going to start with sort of a 22 broad forward-looking question for any of the panelists I think.

23 There was mention to increasing number of new therapies 24 being developed. Are there any technologies or therapies that are under 25 development that might require us to change our procedures or change our 26 requirements?

35 1 Are there advances that we need to think of and be preparing 2 in advance if they're going to require different means of regulation?

3 DR. PALESTRO: The answer is there are numerous new 4 technologies as well as radiopharmaceuticals under development that we need 5 to be aware of and when the time is appropriate, to focus on them and to make 6 a determination about what sorts of procedures or training and experience need 7 to be adjusted or modified.

8 And again, going back to the Training and Experience 9 Subcommittee, while the focus has been for the past couple of years, and 10 rightly so, on the limited authorized user status, that Committee was set up to 11 be an ongoing Subcommittee and to keep abreast of these sorts of changes, 12 review the various technologies, the various agents and so forth on a regular 13 periodic basis and make recommendations from changes in Training and 14 Experience.

15 COMMISSIONER CAPUTO: So, in general, in the past, have 16 our regulations been flexible enough to accommodate new therapies coming 17 into the market? Or in general, do we require tweaks?

18 DR. PALESTRO: I think that up until now, the regulations 19 have been broad enough and comprehensive enough that there have not been 20 issues with the introduction of new technologies.

21 Whether or not the current rules and regulations, training and 22 experience and so forth, are going to be sufficient for the future, I don't know. I 23 don't have an answer for that.

24 COMMISSIONER CAPUTO: All right, thank you. Dr. Metter, 25 on nursing mothers, you mentioned that you think there needs to be signage to 26 inform nursing mothers.

36 1 I've got to tell you, I think if I was in the position where I was a 2 nursing mother and needing treatment, I would probably be thinking about so 3 many things between worrying about my child and worrying about the threat to 4 my life that I'd be a little distracted I would expect.

5 Isn't there a requirement for the folks that are administering 6 the treatments to ask? Because there are any number of things that can be 7 done to women where they will ask you five times, are you sure you're not 8 pregnant? Yes, I'm sure.

9 Are you sure you're not pregnant? Yes, I'm sure. No, are you 10 sure you're not pregnant? I mean there's such a thorough focus on that, isn't 11 there a protocol for that?

12 DR. METTER: Well, for radionuclide therapy, in our institution 13 anyway, I can't speak for other institutions, we meet the patient first and 14 generally well in advance of the therapy.

15 And first of all, we go ahead and review the therapy to see if 16 it's appropriate and if it's not appropriate, we contact the healthcare provider.

17 And if we find out the time that -- let's say there is a nursing 18 mother when they come in, we then -- and I've done that before. I say I'm sorry.

19 And most of their treatments are elective so there's time that we can go ahead 20 and we educate the patient, and I had them come back in six weeks to be sure 21 they're not lactating, and then I went ahead and treated her.

22 But, no, we do meet the patient, we take a history, we 23 examine the patient, we discuss the procedure at length, and they come back 24 generally for the procedure.

25 COMMISSIONER CAPUTO: But you said this protocol exists 26 at your facility so it's not across the country? This isn't just standard protocol to

37 1 identify nursing mothers in advance of treatment?

2 DR. METTER: The practice of medicine is individually and is, 3 as far as individual practitioners -- let's say if I were and like I said, I was in 4 family practice, my way of treating of hypertension is very different than let's say 5 Dr. Palestro's would be.

6 So it's something that we have to get out there and I think I 7 actually make our clinicians know that.

8 COMMISSIONER CAPUTO: Okay, and that would be done 9 through the information notice?

10 DR. METTER: That would be very helpful. And I think part of 11 this is really your practitioners and we are in our own little world and we see our 12 own little world as far as nuclear medicine, radiology. And we 13 should actually, and this is a very good point, reach out to our primary care 14 physicians or OB-GYN doctors and all those other societies to let them know 15 this is available and this is an important issue regarding radiation to the nursing 16 mother and child.

17 COMMISSIONER CAPUTO: All right, thank you.

18 Dr. Ennis, with regards to Yttrium-90, you mentioned residual 19 activity remaining in the deliver device. What happens to it when it remains in 20 the device?

21 Are we just talking about an inadequate dose to the patient?

22 Does it end up located somewhere in other tissues that it was not intended? Or 23 are there other complicated --

24 DR. ENNIS: There are different kinds. The issue within the 25 treatment device just means it was not in the patient. And so it gets disposed of 26 properly. There was no evidence of disposal issues or anything like that.

38 1 Just as an example, one problem can be a kinking of the 2 tubing. The tubing is rather delicate and it may not be able to be unkinked so 3 then there's a decrease and that leads to the medical event, because of a 4 decreased dose compared to what was intended because of that.

5 COMMISSIONER CAPUTO: And of course, it's probably hard 6 to determine exactly how much or too small the dose was.

7 DR. ENNIS: No, generally you can figure out the volume and 8 therefore figure out what the dose was, and therefore you can determine 9 whether it's reportable or not. But that's the issue.

10 COMMISSIONER CAPUTO: Actually, I have no further 11 questions so I'll just turn back my time.

12 CHAIRMAN SVINICKI: Thank you very much. Next we'll 13 heard from Commissioner Wright. Please proceed.

14 COMMISSIONER WRIGHT: Thank you, Madam Chairman.

15 I'm so happy you're back here so we could have celebrated with you today.

16 We did miss you last week and congratulations to both of you, 17 we'll be missing you. And thank you for your service.

18 So, a couple of softball questions, Dr. Palestro. The 19 interaction with the NRC staff, are you getting what you need? And how are 20 things going I them?

21 DR. PALESTRO: The answer is I've been on the Committee 22 now for eight years and the interactions have always been cordial, prompt, 23 through, informative, and I think mutually beneficial.

24 And I think it should be pointed out that for nearly two years 25 we were without an ACMUI coordinator, and I don't think I realized how much 26 work that individual did until they were no longer there.

39 1 But in that individual's absence, that position was more than 2 competently and admirably filled by Ms. Sophie Holiday, Ms. Lisa Dimmick, and 3 Mr. Doug Bollock, as well as the remainder of the staff.

4 So the answer is that was an unfortunate incident but they 5 more than compensated for that vacancy over what was a fairly long time.

6 COMMISSIONER WRIGHT: Thank you for that and I'm glad 7 you recognized my name. That really is important so thank you.

8 So, I guess what do you foresee as a medical -- in the 9 community, what's going to rise up to the level that maybe the NRC needs to be 10 prepared for going forward with new emerging technologies or anything like 11 that?

12 Can you maybe give me a little insight?

13 DR. PALESTRO: I think certainly from the nuclear medicine 14 standpoint, which is my area of expertise, therapeutic agents, they have been 15 slow to develop over the years but there seems to be an increasing number of 16 them coming at a more rapid pace. For example, we've talked about lutetium-17 177 dotatate, which was approved I guess about two years ago. But there was 18 another agent, I-131 MIBG designed to treat certain neuroendocrine tumors 19 that was approved this past July.

20 There are other therapeutic agents still not approved for 21 prostate carcinoma and for some other malignancies that will undoubtedly be 22 available in the near future. Their administration is a bit more complex in many 23 cases than what we've had in the past. So the knowledge of the individuals 24 administering them will have to be more comprehensive than it was in the past.

25 26 I'm not an expert on radiation oncology and that technology

40 1 and with your presumably, sir, I would defer to Dr. Ennis who I think is in a 2 better position to answer that.

3 COMMISSIONER WRIGHT: Sure.

4 DR. ENNIS: So there are always to me a remarkable number 5 of creative people out there coming up with new ways to apply radioactive 6 materials and there are a number of devices that have been developed or are 7 under development.

8 I do not foresee them creating challenges for the NRC, the 9 structure that's in place. As best I understand, everything that's in development 10 would fit within the structure and be able to be handled appropriately there.

11 The challenge for them is a little bit outside of the regulatory 12 space but still within NRC's space if you will.

13 There are some forces at play trying to discourage radioactive 14 material usages and I do have a concern that that will decrease innovation over 15 time to the detriment of patients.

16 So, that's more of I guess a political issue than a regulatory 17 one, but still one that NRC plays a role in. And I hope we'll be able to continue 18 to develop these.

19 COMMISSIONER WRIGHT: Thank you. So I'm going to take 20 a little different track because having been the recipient as a colon cancer 21 patient, and my daughter as well, Stage 3C, so we've gone through that.

22 So I understand the importance of the people who are going 23 to be treating you having the knowledge and the skillset and the repetition of 24 have them doing it for the safety of myself as a patient and my daughter as a 25 patient and anybody else who is a patient. Because it's critical.

26 So, I recognize what you're saying and I believe I understand

41 1 you've already answered Commissioner Burns' question about what your 2 challenges were and why you have the position today that you did, which I 3 guess is a little different than last year a little bit.

4 You've come out in a little stronger position now, and I 5 understand it. I want to go to access a little bit because you brought up 6 insurance and with an patient advocate here too, I'm from South Carolina.

7 We are a very rural state, we're a very poor state, access is 8 an issue. We have many, many people who are uninsured or under-insured 9 and we're not unique in that as a state, probably more in the Southern states 10 than anywhere else around the country. So, to the point that there are also 11 poorer people if they don't have insurance so they can't go get screened, for 12 example. They can't take the time off if they have a job.

13 They have to take two days off and that's to them a lot of 14 money so we're trying to find ways to help them. How do you address that if we 15 have someone who is uninsured?

16 For example, I don't know, they're playing Russian roulette 17 with their life to go get screened or not. And then if they're found to have 18 cancer then they have to go into a situation where they have to receive 19 radiation or any other type of therapy, what if they're uninsured? How do you 20 handle that?

21 Is that something you can kind of give me something about?

22 Because I hear what you're talking about, but that's people who have 23 insurance. How do the other people -- and how do you handle that?

24 Because I know you're caring people. So just if you could give me a 25 little bit of background for that?

26 MS. WEIL: Well, healthcare is not a right in the United States

42 1 and access is based on your ability to pay. Most institutions do have charity 2 care and there are ways of receiving care if you can get to the institution but 3 that's not something that the NRC can fix.

4 COMMISSIONER WRIGHT: Right, I understand that. But 5 you say there's not a shortage and I agree with that. But if you're going to be 6 treated, you've got to go to a facility that may be out of your ability to get to.

7 And I know there's data that really supports where they're at 8 and I know it's a financial decision too, whether you're going to put that stuff in 9 the community or not.

10 So, I'm trying to understand and get a balance about that 11 myself for the access part of it.

12 MS. WEIL: If I can just take it a little further, Dr. Metter used 13 an analogy and I=d like to use a different analogy.

14 In the rural community medical center or just in a rural 15 community in general, there may not be a pediatric neurosurgeon. And 16 surgeons are not suggesting that general surgeons in rural companies or 17 surgical PAs should be licensed to perform pediatric neurosurgery.

18 It's not a matter of access, it's a matter of expertise and 19 appropriateness, and some people don't live near what they need. But one 20 shouldn't compromise safety in order to provide access.

21 COMMISSIONER WRIGHT: Exactly. Thank you for that.

22 DR. METTER: And I=d like to actually expound on that. I did 23 mention safety in Dr. Ennis' report with medical events and these are 24 individuals who are highly trained.

25 One-third medical events was related to infrequent use so 26 that's one out of three. So I think the expertise is really important and if were

43 1 giving your family, your child, any procedure or anything, you'd want it to be 2 done by the best person you can do.

3 And so I know it's an unfortunate thing as far as Ms. Weil --

4 we did promote her by the way. I'm here today because I care about patients, 5 that's why I went into medicine and I want to do the best for my patients.

6 And I think safety is a very important issue and I think as 7 regulators, that's our goal.

8 COMMISSIONER WRIGHT: Great, well, thank you so much.

9 Thank you.

10 CHAIRMAN SVINICKI: I will maybe continue some themes 11 that my colleagues have begun. But I did have a point of clarification.

12 First, Dr. Metter, on your Slide 22 and continuing on 23, you 13 had nursing mother recommendations for those instances where a nursing 14 interruption would be sufficient and you didn't need to have total cessation.

15 I was just curious about the durations that were listed here.

16 How would you characterize the sense of medical certainty around the 17 sufficiency of these durations? Are they a minimum duration for interruption?

18 Would it depend on the biology of the individual lactating mother? Or is this 19 fairly settled in terms of these recommendations, like there's a lot of 20 concreteness around them?

21 DR. METTER: The individual who actually did the 22 calculations was Dr. Zanzonico. He's actually one of the leading experts on this 23 in the country and there's actually a very complicated formula and physics 24 involved.

25 And these are the requirements for the safety of the mother 26 and the lactation state, it doesn't matter. The only one that really matters is the

44 1 I-131.

2 CHAIRMAN SVINICKI: Okay. That's actually very helpful. I 3 was a little surprised not to see them maybe as a range or something like that 4 given the complexity of it as you've just acknowledged.

5 DR. METTER: And so the other thing we look at something 6 called half-life and that's actually very standard as far as the physical half-life.

7 But you're right, the biology is going to be different. So really, 8 these are the maximum so we actually went the most conservative so these 9 would be the maximum. So, you might fall within let's say it's seven days or 10 you may fall in the three days but we say seven days.

11 And so this is the maximum for the patient safety.

12 CHAIRMAN SVINICKI: Okay, I thought it was probably 13 something along those lines because you'd need to have a conservatism in 14 there. Dr. Palestro, did you want to --

15 DR. PALESTRO: Yes, Madam Chair. In addition, the 16 objective was to make the guidelines as uncomplicated for those of us who 17 have to issue them as well as for the patients.

18 If we were to say three to seven days you should refrain from 19 breastfeeding, it's a lot more of a decision placed on the patient than to say 20 seven days no breastfeeding.

21 So, we took a very conservative approach and tried to keep it 22 as simple as possible while maximizing safety.

23 CHAIRMAN SVINICKI: Thank you for that and I think there is 24 merit if you're going to go out with the guidelines to try to make it 25 straightforward.

26 And if you're going to do that then you would error on the side

45 1 probably of the more conservative and longer duration for the interruption.

2 Thank you. That was a helpful clarification.

3 And then on the issue of the potential recommendation for the 4 timeout, I appreciated the multi-year evaluation, Dr. Ennis, of the medical 5 events.

6 As you noted, there are so few per year, which is of course a 7 good news thing, but I think it's useful to try to look across years. I think in any 8 given year it would be really difficult to reside a lot of confidence across a 9 population of events so small.

10 And again, the denominator is so overwhelmingly massive in 11 comparison to the event. As I was listening to the timeout concept, I was 12 thinking about the nuclear industry as a whole which often before some sort of 13 modification of something in a nuclear plant is undertaken, they do what they 14 call a pre-job brief.

15 It's the team that will be conducting whatever they're about to 16 do. Of course, it's been trained, has read the procedure, but it is to say we're 17 gathered here to do this now and let's all agree that we understand what the 18 steps are.

19 And is this the right pump that we're about to open up and 20 modify? Things like that. So, you mentioned that something a kind to a timeout 21 is often found maybe in operating theaters or a surgical context or something 22 like that, so my question was is this kind of a current best practice?

23 And how much of a change in procedure would it be to 24 implement that more broadly in the radiation and radiopharmaceutical 25 techniques?

26 DR. ENNIS: So I think that it has been implemented in some

46 1 practices but it's clearly not in others, just from experience and clearly from 2 some of the events.

3 So, these kinds of concepts are infiltrating into medicine at 4 large.

5 CHAIRMAN SVINICKI: Okay, thank you. And then another 6 aspect of the categorization of events or causes was the infrequent user, and 7 that pointed out to me I have a lack of awareness.

8 My sense is that practitioners in this field of expertise 9 specialize a bit -- this is a really difficult question to phrase intelligently.

10 But is it somewhat uncommon for a practitioner to be asked to 11 do something to administer a technique of some kind that would be truly 12 infrequent, like once a year?

13 Is there kind of a specialization that occurs amongst the 14 practitioners?

15 DR. ENNIS: I think it's hard to really --

16 CHAIRMAN SVINICKI: Characterize --

17 (Simultaneous Speaking.)

18 DR. ENNIS: -- characterize this.

19 I would say that getting back to Commissioner Wright's 20 comments, it certainly could happen and does happen that if I'm in a relatively 21 small rural practice perhaps I'll have only one cervix patient a year who needs 22 an implant.

23 And even though I trained and did lots of them when I trained, 24 if I'm my age now and I've only been doing one a year, maybe I need a 25 refresher before I do each one, for example.

26 CHAIRMAN SVINICKI: Okay, that's helpful. Does any other

47 1 Member of the Committee have just a broad perspective on how frequently a 2 practitioner is confronted with doing something they do very, very rarely?

3 Is that a good broad characterization that Dr. Ennis has given, 4 that it can happen, it does happen depending on where you're practicing?

5 MS. WEIL: I think with the introduction of limited scope 6 licenses, it's more likely to happen more often because you wouldn't be serving 7 patients in Centers of Excellence where things happen all the time, but rather in 8 smaller practices.

9 CHAIRMAN SVINICKI: Okay, that's helpful. Dr. Metter, did 10 you want to add to that?

11 DR. METTER: Yes. So, when you actually look at 12 radionuclide therapy, and I mentioned before, there's a certain basic minimal 13 level of competency you must master.

14 So if you have those basic tools, if something comes up that 15 you've already been trained for like Dr. Ennis, you know what to do and you 16 know to look for flags and look for any adverse issues that occur or toxicities.

17 So, you have to still have the basic knowledge topic, and the 18 frequency issue is a problem but you're trained to look for that and take care of 19 it. And then also, continuing and refreshing up on reviewing the therapy before 20 you perform it.

21 CHAIRMAN SVINICKI: Okay, thank you, that's helpful. And 22 in your responses you kind of got to the kernel of why the question matters, 23 which is that is this something that isn't common and we don't need to worry 24 about?

25 Or with again potential new modalities and treatments coming 26 out, could this be actually a cause, a possible systemic cause, of medical

48 1 events that is actually growing in its incidence so that you would want to put 2 measures in place?

3 Dr. Palestro?

4 DR. PALESTRO: Yes, just adding to that, there's no doubt 5 that the more frequently an individual performs a task, excuse me, the more 6 proficient they are at it.

7 And we tend to focus on rural areas as potentially being 8 underserved or having less access. I think it's equally important to point out 9 that there are small or smaller community hospitals that are not in rural areas in 10 which these types of procedures are practiced only infrequently.

11 And you can say, well, you're only 50 miles from Manhattan 12 and you've got some of the greater hospitals in the world, why don't you go 13 there?

14 And the answer is patients I think inherently are more 15 comfortable with going locally, and so it's not something that's limited just to 16 rural or underserved areas.

17 CHAIRMAN SVINICKI: Well, thank you for that point.

18 And to build off that, it's not so much a question but some of 19 my colleagues have asked questions about access and I find, Ms. Weil, I 20 appreciated your acknowledgment of an evolving perspective on the 21 development of alternative pathways or other standards for the training and 22 qualification of practitioners who might administer things.

23 In the course of thinking about this over the years myself, 24 you're confronted with the developers of new modalities and things that come in 25 and say, well, it would just be in some sort of thing that is already prepared in 26 the dosage and it's so portable and injectable.

49 1 But what began to weigh heavily in my mind is something that 2 you all have commented on, which is the individual biology of any given patient 3 and how they might react to something, and the broad base of both knowledge 4 of that patient and medical background that's necessary should their individual 5 reaction to something not be exactly what was predicted.

6 Each patient falls somewhere on a continuum of how they 7 tolerate something or complications or other things going on. And while access 8 is something that certainly would bring cost down and would proliferate the 9 availability of techniques to patients who might benefit from it, there is this 10 overriding safety benefit, greater access if it comes at the expense of greater 11 risk to the ultimate patient care.

12 And again, as we were mentioning with the lactating mothers, 13 there's individual biology and what's happening and the individual health status 14 of each of the people receiving this.

15 And so while they want access, should they not also benefit 16 from having the kind of care provider that would know the totality of their 17 medical circumstance?

18 And maybe have a better sense of how their individual system 19 is going to react to anything that is administered.

20 I know that falls in the category of unknown unknowns and 21 that can't by itself be a reason why there are significant obstacles to something, 22 but I think, Ms. Weil, as you mentioned in your statement, it is something that 23 needs to be given considerable weight here as we move forward.

24 And with that, I just wanted to close by stating that I have 25 been so impressed over the course of time with the thoughtfulness you've 26 brought to the balancing of factors, as I call it. It's kind of a term that

50 1 decision-makers use.

2 But often in complex issues where there are a lot of important 3 public goods or public health objectives to be met, we have to balance a lot of 4 different factors.

5 I have noticed I have no training in medical ethics or ethics 6 generally, I'm an engineer so we didn't have a lot of time for those types of 7 topics while interesting.

8 But as the Committee thinks about filling your big shoes 9 behind you, I do think that someone who had a formalized training, I've watched 10 you balance a lot of ethical factors and it is a complex art all in itself. And it is a 11 skill area and there are people who specialize in it.

12 And so I'm not saying that the patients' right advocate should 13 become a medical ethicist but I think there's merit to thinking about as we look 14 at candidates, if candidates come forward that have that. I've 15 benefitted from it as I've thought about these issues so I don't know. I'm over 16 my time but if you wanted to add anything to that?

17 MS. WEIL: I think it's a useful framework for looking at 18 advocacy issues, but then there are many useful frameworks. And I know that 19 my seat on the Committee is a hard thing to fill, but I agree with you it's useful.

20 CHAIRMAN SVINICKI: Okay, thank you very much. And with 21 that, we will turn to Commissioner Baran.

22 COMMISSIONER BARAN: Well, thank you for your 23 presentations and for all your work. I think the discussion on the Training and 24 Experience requirements has been good. I have a few additional questions 25 there.

26 It sounds like a significant factor in the Committee's

51 1 conclusion that we should stick with the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> requirement and not go 2 down the path of a limited scope authorized user for particular 3 radiopharmaceuticals or classes of radiopharmaceuticals.

4 It sounds like a key factor or a significant factor in that 5 analysis. It has to do with the toxicity of some of the emerging therapies and 6 risks associated with misadministering some of these radiopharmaceuticals.

7 Can you talk a little bit more about that? Has there been a 8 change? Is there a difference in the toxicity of the newer therapies than 9 previous therapies?

10 How does all that factor into your thinking?

11 DR. METTER: So one of our earlier therapies, as you know, 12 is I-131 for thyroid disease. And so that in itself is one organ and the goal of 13 the therapy generally is to destroy disease tissue. So, that was one item.

14 The next one is that that became more available, there was 15 Zevalin for a little time but that passed. And then now we have Xofigo, our 16 alpha agent for bone metastases.

17 Now, that's a little more complex. We don't want to destroy all 18 the bone, okay? We want to just destroy the disease but that in itself becomes 19 more complex although it's still one organ.

20 Lutetium-177 has come out and that's a neuroendocrine 21 tumor which you could have multiple types of tumors in multiple different 22 organs.

23 And then it's a very complex administration, it usually takes 24 half a day or longer because there's toxicity to the kidneys so we have to 25 protect and some special protection with that.

26 And then you have a lot of nursing staff and it's a really a

52 1 team of people, as opposed to the others before. You have your patient and 2 your technologist and it's a very limited group.

3 Now it's a bigger area, you have to have special rooms and 4 things like that. So, yes, it is becoming more complex and so that opens the 5 door with lutetium-177.

6 COMMISSIONER BARAN: And so with that complexity, if I 7 understand the presentation right, when you look at the training topics, a limited 8 scope authorized user should have a particular radiopharmaceutical or class of 9 radiopharmaceuticals. You end up with a list that's basically the same as what 10 you would have for the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> for a full-blown authorized user when you did 11 that analysis?

12 Is that the right way to think about it?

13 DR. METTER: Are you talking about lutetium?

14 DR. ENNIS: No, just in general, yes. Concluding 15 that when your Committee tried to look at what would be required for a limited 16 scope license it was practically the entire curriculum. And then when you 17 looked at another class of isotopes, you came to the same conclusion.

18 So you concluded there really wasn't room for a limited scope 19 license because the broad knowledge you need even to do one of these is 20 essentially the whole curriculum.

21 DR. METTER: Because each radiopharmaceutical has their 22 own complexity and once you look at it they all kind of overlap.

23 And when you look at it, it would just be the same training 24 requirements for radionuclide A and B, and so it doesn't seem feasible to 25 separate things out with the same training requirements and call them different 26 things.

53 1 And so that was the main basis of that.

2 COMMISSIONER BARAN: Ms. Weil, did you want to...?

3 MS. WEIL: When we looked at 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> we were actually 4 very uncomfortable with the concept of hours because we really wanted to 5 assure that there were certain competencies.

6 And if we had the time and the resources, we'd probably want 7 to come up with competencies rather than hours. But as a surrogate, hours 8 work but that's not what it's about.

9 It's knowing that a provider is competent in the areas that are 10 required.

11 DR. METTER: I believe I misunderstood your question, but 12 yes, our Committee is actually looking at the knowledge topics that you need to 13 know. And really the bottom line is everybody is a different learner, but at some 14 point in time you have to end up with hours because that's how you have to 15 adjust things.

16 But right now we're looking at what is the basis for the future 17 as far as other items that an individual needs to know? And then really the 18 bottom line is going to be the competency assessment.

19 You may know these knowledge topics but can you apply 20 them? Can you use them? Can you use them safely? And that's going to 21 generally be through a certification exam.

22 And again, in my topics I mentioned that it's not only a 23 certification which occurs one time. And in the past you understand we used to 24 have Board certification and you're forever and then they had recertification 25 every ten years.

26 And now they're going into ongoing longitudinal assessment

54 1 with recurring further questions reassessments.

2 And so I think that's going to be very important to maintain 3 your competency and that's going to be best for the patient. And especially like 4 we mentioned with emerging technologies and new radiopharmaceuticals.

5 COMMISSIONER BARAN: Okay, and so I guess in my mind 6 I was kind of having a close nexus between the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> and whether we 7 should pursue some type of limited scope authorized user.

8 It sounds like you all are still looking at the question about 9 whether 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> itself makes sense as the authorized user requirement. Is 10 that right?

11 Or whether it makes sense to move to something more 12 competency-based, whatever that would look like?

13 DR. METTER: We're working on that, yes.

14 COMMISSIONER BARAN: So that piece is still ongoing.

15 I saw that one member voted not to approve the final Training 16 and Experience report and I was just wondering whether someone's able to 17 discuss or represent whatever the area of disagreement was there?

18 DR. PALESTRO: I was the dissenting Member on that 19 Subcommittee and the former Chair of that Subcommittee. My concerns are as 20 follows.

21 Number one, we've seen a documentation of the number of 22 authorized users that are available and the conclusion was that this is a 23 sufficient number. The problem that I have is on what data is that conclusion 24 based?

25 I can't tell you that it's incorrect but I can't tell you that it's 26 correct. I didn't see any data that says there should be or it's estimated that

55 1 there should have been 1 AU per 100,000 people or per 1 million people and so 2 forth.

3 So, I'm not willing to accept that as fact, that there are 4 sufficient numbers of authorized users.

5 My concern, as I've expressed in the past, is that as these 6 new agents are developed and as there is presumably going to be an increased 7 demand for their use, will there be a sufficient benefit of authorized users?

8 And again, I don't have an answer for that. And rather than 9 being reactive in the future when we suddenly say, wow, we are short, we need 10 to develop more authorized users, I would rather be proactive and have an 11 alternative pathway established. And the reason why I want to be proactive is 12 because it takes a long time to be able to, at least as far as I know, get these 13 programs into place. So rather than waiting until such a time as a crisis is 14 developed and then saying, well, now it's going to take us five or six or seven 15 years to ramp up the manpower, be prepared ahead of time.

16 Do I think that's going to solve all of the problems in terms of 17 access? No, not in and of itself because the long and the short of it is that there 18 are areas, and they don't have to be rural, that people simply aren't interested in 19 going to for one reason or another and have never been interested in going to.

20 And those areas will always have manpower shortages, and 21 there are other ways around that but that's beyond the scope of what we do.

22 So, again, I haven't changed my philosophy and my opinion, I 23 still believe that we should be proactive rather than reactive and I would like to 24 see an alternative AU program in place.

25 I'm also not convinced that it has to be identical to the current 26 alternate pathway because much of that pathway pertains to diagnostic

56 1 procedures.

2 And I'm unwilling to put a number of hours on it because I've 3 been opposed to hours from the beginning, and it would be focused on 4 competency.

5 COMMISSIONER BARAN: Thank you for that. AndI 6 just have a little bit of time left but earlier this year, the final rule, the Part 35 7 rule, which made several changes to the regulations related to the medical use 8 of byproduct material took effect.

9 I'd just be interested in any brief thoughts you all had about 10 how the implementation of those changes has been going. Does anyone have 11 any early perspectives to share on that? If not, that's fine too.

12 Okay, that's fine. Thanks.

13 CHAIRMAN SVINICKI: All right, thank you very much. Again, 14 my thanks to the Committee and to my colleagues. Again, I think the 15 discussion made clear the wonderful benefit of having this Committee's 16 perspectives available to Members of our Commission. So, thank you for that 17 and I will adjourn us but I think that we are scheduled to do a photo so I would 18 ask that you Committee Members not dash out of the room super quick. We 19 can just get it over with really fast if we all stay in the room.

20 Thank you and we are adjourned.

21 (Whereupon, the above-entitled matter went off the record at 22 11:42 a.m.)