ML18360A626
| ML18360A626 | |
| Person / Time | |
|---|---|
| Issue date: | 09/20/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| L Dimmick | |
| Shared Package | |
| ML18360A622 | List: |
| References | |
| NRC-3912 | |
| Download: ML18360A626 (193) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Meeting of the Advisory Committee on the Medical Uses of Isotopes Docket Number: (n/a)
Location: Rockville, Maryland Date: Thursday, September 20, 2018 Work Order No.: NRC-3912 Pages 1-188 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
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FALL 2018 MEETING
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THURSDAY, SEPTEMBER 20, 2018
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The meeting was convened in the Commissioner's Hearing Room, One White Flint North, 11545 Rockville Pike, Rockville, Maryland, at 11:00 a.m., Christopher J. Palestro, M.D., ACMUI Chairman, presiding.
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2 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 JOHN H. SUH, M.D., Member LAURA M. WEIL, Member NRC STAFF PRESENT:
DOUGLAS BOLLOCK, NMSS/MSST/MSEB, Designated Federal Official SABRINA ATACK, NMSS/MSST/SMPB MARYANN AYOADE, NMSS/MSST/MSEB/MRST LISA DIMMICK, NMSS/MSST/MSEB/MRST SOPHIE HOLIDAY, OE/EB KATIE TAPP, NMSS/MSST/MSEB DONNA-BETH HOWE, NMSS/MSST/MSEB/MRST NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 AGENDA Opening Remarks....................................4 Old Business......................................13 Open Forum........................................34 Medical Events Subcommittee Report................48 Non-Medical Events................................74 ABS Medical Event Case Study Program..............84 T&E for All Modalities Subcommittee Update .......98 T&E Stakeholder Outreach Plan....................133 ACMUI-SNMMI Session at the 2018 SNMMI Annual Meeting ...................................141 Nursing Mother Guidelines Subcommittee Report....145 ACMUI Comments on the Draft Revision of the Leksell Gamma Knife7 PerfexionJ and Leksell Gamma Knife7 IconJ Licensing Guidance..................160 Adjourn..........................................188 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 1 P-R-O-C-E-E-D-I-N-G-S 2 (11:01 a.m.)
3 CHAIRMAN PALESTRO: Good morning, this is 4 Dr. Palestro. I'm going to open this ACMUI meeting 5 and I'm going to turn it over to Mr. Bollock for 6 opening remarks.
7 MR. BOLLOCK: Thank you, Dr. Palestro.
8 Good morning everyone. As a designated federal 9 officer for this meeting I'm pleased to welcome you 10 to this public meeting of the Advisory Committee on 11 the Medical Uses of Isotopes.
12 My name is Doug Bollock, I'm the Branch 13 Chief of the Medical Safety and Events Assessment 14 Branch and I have been designated as the federal 15 officer for this Advisory Committee in accordance 16 with 10 CFR Part 7.11.
17 Present today as the alternate designated 18 federal officer, is Lisa Dimmick, the team leader of 19 the Medical Radiation Safety Team. This is an 20 announced meeting of the Committee, is being held in 21 accordance with the rules and regulations of the 22 Federal Advisory Committee Act and the Nuclear 23 Regulatory Commission (NRC).
24 This meeting is being transcribed by the 25 NRC, and it will also be transcribed and recorded by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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5 1 others.
2 This meeting was announced in the July 3 25th, 2018 addition of the Federal Register, Line 83, 4 Page 35287.
5 The function of the Committee is to advise 6 the NRC Staff on issues and questions that arise in 7 the medical use of byproduct material. The Committee 8 provides counsel to the Staff but does not determine 9 or direct the actual decisions of the Staff to the 10 Commission.
11 The NRC solicits the views of the Committee 12 and values their opinions. I request that whenever 13 possible we try to reach a consensus on the various 14 issues that we'll discuss today, but I recognize there 15 may be minority or dissenting opinions. If you have 16 such opinions, please allow them to be read into the 17 record.
18 At this point I'd like to perform roll call 19 of the ACMUI members participating today. Dr.
20 Christopher Palestro, our Chairman?
21 CHAIRMAN PALESTRO: Here.
22 MR. BOLLOCK: Thank you. Dr. Darlene 23 Metter, our Vice Chairman?
24 VICE CHAIRMAN METTER: Here.
25 MR. BOLLOCK: Thank you. Dr. Vasken NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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6 1 Dilsizian?
2 MEMBER DILSIZIAN: Here.
3 MR. BOLLOCK: Thank you. Dr. Ronald Ennis?
4 MEMBER ENNIS: Here.
5 MR. BOLLOCK: Thank you. Mr. Richard 6 Green?
7 MEMBER GREEN: Here.
8 MR. BOLLOCK: Thank you. Dr. Melissa 9 Martin?
10 MEMBER MARTIN: Here.
11 MR. BOLLOCK: Thank you. Dr. Michael 12 O'Hara?
13 MEMBER O'HARA: Here.
14 MR. BOLLOCK: Thank you. Mr. Zoubir Ouhib?
15 MEMBER OUHIB: Here.
16 MR. BOLLOCK: Thank you. Dr. Robert 17 Schleipman?
18 MEMBER SCHLEIPMAN: Here.
19 MR. BOLLOCK: Thank you. Mr. Michael 20 Sheetz?
21 MEMBER SHEETZ: Here.
22 MR. BOLLOCK: Thank you. Ms. Megan Shober?
23 MEMBER SHOBER: Here.
24 MR. BOLLOCK: Thank you. D. John Suh?
25 MEMBER SUH: Here.
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7 1 MR. BOLLOCK: Thank you. And Ms. Laura 2 Weil?
3 MEMBER WEIL: Here.
4 MR. BOLLOCK: Thank you. I confirm we have 5 a quorum and for the first time, I think in about two 6 years, we have a full 13 Member Committee.
7 I'd like to add that this meeting is being 8 webcast, so other individuals may be watching online.
9 We have a bridge line available and the phone number 10 is 888-677-2595. The pass code to access the bridge 11 line is 95756#.
12 Individuals who would like to ask a 13 question or make a comment regarding the specific 14 issue the Committee has discussed, should request 15 permission to be recognized by the ACMUI Chairperson, 16 Dr. Christopher Palestro.
17 Dr. Palestro, at his option, may entertain 18 comments or questions from members of the public who 19 are participating with us today. Comments and 20 questions are usually addressed by the Committee near 21 the end of the presentation, after the Committee has 22 fully discussed the topic.
23 We ask that one person speak at a time.
24 And this meeting is also closed captioned. I would 25 also like to add that handouts and agenda for this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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8 1 meeting are available at the NRC's public website.
2 At this time, I ask that everyone on the 3 call who is not speaking to place their phones on 4 mute. If you do not have the capability to mute your 5 phone, please press *6 to utilize the conference line 6 mute and un-mute functions.
7 At this point I'd like to turn the meeting 8 over to Ms. Sabrina Atack, the Acting Deputy Director 9 of Division of Material Safety, Security, State and 10 Tribal Programs, for some opening remarks.
11 MS. ATACK: Thank you, Doug. I'd like to 12 open the meeting by welcoming everyone to the Fall 13 2018 meeting and echo Doug's remarks regarding 14 congratulating the Committee for having a full 13 15 members at this time. It should be a great meeting.
16 Again, my name is Sabrina Atack, I'm the 17 Acting Deputy Director of the Division of Material 18 Safety, Security, State and Tribal Programs. And our 19 current Deputy Director, Kevin Williams, who you may 20 know, is on rotation in the Office of the Executive 21 Director for Operations, so he's unable to join us 22 today.
23 Our current division director, Dan Collins, 24 is also on annual leave so I apologize. But you have 25 me today.
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9 1 I'd like to highlight a few areas that may 2 be of interest to the Committee and to the meeting 3 participants in my opening remarks. As you're aware, 4 the Commission approved rule changes for the medical 5 use of byproduct material, a little more than a year 6 ago last August.
7 The final rule, 10 CFR Part 35, was 8 published on July 16th, 2018 and will be effective 9 this January. Again, thank you to the Committee for 10 working with the Staff on this major initiative, this 11 is a great accomplishment.
12 When the rule was voted on, the Commission 13 did direct the Staff to evaluate whether it makes 14 sense to establish tailored training and experience 15 requirements, for different categories of 16 radiopharmaceuticals.
17 Staff completed its initial evaluation and 18 provided the status and next steps to the Commission 19 in a recent SECY paper. That's SECY 18-0084.
20 We do anticipate further work in this 21 regard in the next year and we look forward to active 22 engagement with the Committee on this activity.
23 I'd like to take a couple of moments to 24 report out on some NRC organizational changes. Most 25 of them you may be aware of, and there are some that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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10 1 are coming up, so I'd like to take a moment to share 2 those with the Committee.
3 and foremost, the Commission also is at 4 full First staffing so we're excited about that. In 5 May of 2018 we were honored to have both Annie Caputo 6 and David Wright join the Commission as new 7 Commissioners.
8 And in July of 2018, Margaret Doane, or 9 Margie, became the NRCs executive director for 10 operations. She follows Vic McCree's position in 11 that regard.
12 At the more programmatic level, we do have 13 some changes that are coming up with respect to the 14 materials function in NMSS. First, Dan Collins, who 15 is not at this meeting today, has accepted a position 16 in NRCs Region I and will be leaving the division of 17 material safety, security, state and tribal programs 18 sometime this winter.
19 We are working to actively backfill for 20 Dan. Our office director and deputy, conducting 21 interviews in the next few weeks to identify Dan's 22 backfill, but we do anticipate having a period of 23 turnover such that the incoming division director 24 will be able to get up to speed on the activities of 25 the division during the November, December time NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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11 1 frame.
2 You may be aware that Doug Bollock has 3 accepted a position in our Office of Nuclear Reactor 4 Regulation and will be leaving the division as well.
5 Coming behind Doug will be Chris Einberg 6 who previously served in the medical branch many years 7 back. So, Chris Einberg will become the chief of the 8 medical safety and advance assessment branch in the 9 October time frame.
10 That's all we know of at the moment, and 11 hopefully we won't have many more organizational 12 changes to report, but we appreciate your patience as 13 we conduct transition activities in the organization.
14 With respect to ACMUI membership changes, 15 we'd like to recognize that this is Dr. Suh's last 16 meeting. His term on ACMUI ends in October.
17 Many thanks for the tremendous 18 contributions over the past eight years. And we 19 anticipate selecting his replacement and being able 20 to announce that within the next few weeks so that 21 ACMUI will retain its full membership status.
22 I would also like to recognize that this is 23 Dr. Schleipmans first meeting, so welcome.
24 With respect to the meeting items of 25 interest there are several. I know this will be a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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12 1 very engaging and active meeting. I'm excited to be 2 here with you today and tomorrow.
3 I acknowledge the Committees has been 4 working hard on a number of subcommittee reports and 5 the subcommittees will discuss those with the ACMUI 6 today.
7 First, Dr. Ennis will present the medical 8 event Subcommittee analysis of medical events for 9 Fiscal Year 2017.
10 Dr. Metter will provide an update of the 11 actions of the training and experience for all 12 modality subcommittee and the plan path forward. Dr.
13 Metter will also discuss the Subcommittee's final 14 report on the nursing mother guidelines for exposure 15 from diagnostic and therapeutic radiopharmaceuticals.
16 In addition, Dr. Suh will discuss the 17 Subcommittee's comments on the draft revision of the 18 Leksell Gamma Knife Perfection and Icon licensing 19 guidance.
20 This afternoon, Mr. Sheetz will discuss 21 non-medical events reported by medical use facilities 22 and commercial pharmacies.
23 And Mr. Ouhib will discuss the American 24 Brachytherapy Society's Medical Event case study 25 program.
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13 1 We will also hear a presentation on the 2 Staff's outreach plan for the continued evaluation of 3 training and experience for administering 4 radiopharmaceuticals.
5 Tomorrow morning, Marc Dapas, the Office 6 Director of the Office of Nuclear Material Safety and 7 Safeguards, will make special presentations to Dr.
8 Alderson and Dr. Suh to thank them for their service 9 on the Committee.
10 This will be followed by a staff 11 presentation on Yttrium-90 revised licensing guidance 12 and information provided by Mr. Green on the 13 compounding of radiopharmaceuticals. That concludes 14 my remarks, and thank you again to everyone for their 15 participation in the meeting.
16 MR. BOLLOCK: Okay, thanks for that. We'll 17 turn it back to Dr. Palestro.
18 CHAIRMAN PALESTRO: All right, thank you 19 for your presentations. Next item on the agenda is 20 old business, and Ms. Dimmick will review the past 21 ACMUI recommendations and provide NRC responses. And 22 also, will explain to us the meaning of open.
23 MS. DIMMICK: Okay. So, I'll work to 24 enlarge the screen a little bit, but we'll go ahead 25 and get started because you do have the handouts.
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14 1 So, I'd like to offer that we, in the last 2 meeting, were able to close pages and pages of open 3 items from the charts going back to 2007. So this 4 should be a much shorter presentation of the old 5 business than maybe some past meetings.
6 But, so our first open items are from 2007.
7 So, there are two open items that remain, and these 8 are under our delayed opening.
9 So, an open item is one that the ACMUI, we 10 made a recommendation or an action item that the Full 11 Committee agreed on, and/or it could be a 12 recommendation, it was basically a recommendation 13 that the Committee agreed upon, so it's an open item.
14 So, there is an expectation that there will 15 be some action to that open item at some point in the 16 future. And along the way we will work to close 17 these open items. So, that's what I know about open 18 items.
19 So, from 2007 there are two open items that 20 remain that did not get captured in the expanded 21 rulemaking for Part 35. So these items would remain 22 open until a future rule where they could be 23 reconsidered or if the Committee wanted to discuss 24 these at another time in the future we could do that 25 as well.
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15 1 But, so there is still two open items.
2 Items Number 33 and 34. And both of these do concern 3 optometric treatments under 35.490 and 35.491. Okay, 4 so they'll stay on as open.
5 Next chart. So the next chart is from 6 2008, and we only have two open items remaining from 7 2008 as the majority of the open items from 2008 did 8 get closed with the expanded rulemaking.
9 So here are, these are the two ones.
10 Again, they were not picked up specifically in the 11 Part 35 expanded rule but could be reconsidered in a 12 future rule. So they'll stay open.
13 So moving on, our next open item chart is 14 from 2016. So if we could talk about, we'll take a 15 look at these.
16 So, for Item 16, this was the, in the last 17 meeting the ACMUI wanted to leave this open because 18 this particular Subcommittee is still performing the 19 reviews. This is the T&E expanded for all modalities 20 Subcommittee. So this one would continue to stay 21 open as the work is ongoing and reviews are ongoing.
22 Item Number 24, this is one where the ACMUI 23 made the recommendation that they would contact their 24 respective professional organizations to encourage 25 interactions between NRC and the ACMUI. And this one NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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16 1 we have open as, the action item is, it's open 2 indefinitely. So this would be an ongoing activity.
3 Let's see. So, items, finding my notes, 4 Items 39, 42, and 43. So 39 through 43 concern 5 Yttrium-90 microspheres and the licensing guidance.
6 So these are open items, and they'll stay 7 open. You'll hear tomorrow from Dr. Tapp on the 8 current status of the Yttrium-90 licensing guidance.
9 So, basically, these items will stay open as that 10 licensing guidance is still in process and has not 11 yet been finalized by the working group.
12 Items 49 through, 49, 50, 51 and 52, these 13 items concern the Northstar Moly Tech generator.
14 This guidance was issued back in February, but what 15 has not yet been provided to the Committee, is the 16 dispositioning of the ACMUIs recommendations for this 17 guidance document.
18 So NRC will be providing that documentation 19 to the Committee. So, until we've provided you that 20 documentation to show the dispositioning of comments 21 that you had on that generator guidance document, 22 these will remain open as well.
23 Okay. And then that will take us to the 24 2017 chart. There are three open items for the 2017 25 chart.
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17 1 The first one is where the Committee had 2 requested that all of the Committees recommendations 3 concerning the Part 35 rule, going back from 2007 4 going forward, including reports that were done in 5 2013 and 2016, that the Staff present a detailed 6 description of showing where those recommendations 7 were correlated to the new rule.
8 So we don't have that presentation at this 9 point. The rule will become effective in January, 10 so what I would propose is that the status be changed 11 from pending to an open item and that the NRC Staff 12 would provide that information at the next meeting.
13 So, is there a motion to change the status 14 from pending to open?
15 VICE CHAIRMAN METTER: This is Darlene 16 Metter. I propose to change the status from pending 17 to open.
18 MS. DIMMICK: Somebody needs to second it.
19 MEMBER WEIL: Second.
20 MS. DIMMICK: Any discussion? I think I 21 heard a second from Laura Weil. Any discussion?
22 I will add that to further support this we 23 will also be doing training on the new rule for NRC 24 Staff, agreement state staff, NRC licensees, 25 agreement state licensees and the master material NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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18 1 licensees between October and March.
2 So there will be opportunities to see how 3 the changes of the new rule, which definitely 4 incorporate recommendations that were made by ACMUI.
5 Okay, the next open item is Number 12, Item 6 12. And this was, in reviewing the past transcripts, 7 here it says the NRC Staff will engage discussions 8 with the OAS Staff to find ways to centralize event 9 reporting from the agreement states.
10 The basis for this recommendation was, came 11 from, I believe the 2016 or the 2017 report of medical 12 events where that Subcommittee identified a lot of 13 variation and inconsistencies in the type of data 14 that was retrieved from NMED. So, the recommendation 15 was made to engage discussions with the agreement 16 states on improving the quality of that information.
17 So, NRC Staff did engage the agreement 18 states in a monthly OAS CRCPD call and talked about 19 what the ACMUI had noted. And also, to remind them 20 of timeliness and the quality of the type of 21 information and reviewed the procedural requirements 22 under the NMED reporting procedure, SA-300.
23 So we did have those discussions with the 24 agreement states. So, at this point, this is an open 25 item. Other than engaging the Staff, I mean, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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19 1 Staff did engage the agreement states, is there a 2 motion to close this particular recommendation based 3 on the actions taken so far?
4 MEMBER ENNIS: A Comment.
5 MS. DIMMICK: Sure.
6 MEMBER ENNIS: I think we were looking for 7 really a communication of setting up common items 8 that would have to be reported always, like a little 9 bit more structured substance to what the agreement 10 states would have to submit to match what we get at 11 NRC. So I'm not sure what was described is exactly 12 the way I recall what our Committee was looking for.
13 MR. BOLLOCK: Okay, so we do have 14 procedures that the agreement states use, SA, I think 15 it's SA-300 that gives the guidance for the agreement 16 states for what to report, what to put in NMED and 17 that information sharing.
18 So it is, there is commonality in what's 19 required and what's reported, it's just sometimes, 20 and I think we discussed this about a year and a half 21 ago in 2017, sometimes you just get disparity and 22 what information is in there. So we brought this up 23 at least once, I think actually more than one, OAS 24 call, we have monthly calls with OAS and CRCPD, we 25 brought this topic up as a reminder, to put in all NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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20 1 the information you have. The better the information 2 is, the better we can all use it.
3 There was also discussion. It was a very 4 small portion of discussion, but during the last CRCPD 5 meeting in May, we talked a little bit about this 6 with some of the states. So, it's been communicated.
7 There are the structures in the SA 8 procedures, and it's just a matter of keeping the 9 encouragement, keeping people to, the states in NRC 10 regions and updating the events as they come in with 11 the information they have.
12 There are some other mechanisms, informal 13 mechanisms. Our contractors have run the NMED 14 program, they will reach out to the states to update 15 information if they see that it's not, doesn't have 16 everything that's in the SA or required by NMED. They 17 will reach out to the states as well.
18 So there are multiple, there's a procedure, 19 there is us discussing with OAS, just reminders. And 20 then the NMED Staff also reaching out to the states 21 to remind them to keep that.
22 So those are kind of the mechanisms in place 23 to do that. But I think a year and a half ago we're 24 recognizing that we got to keep on it.
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21 1 communicate again, make sure to update it with the 2 best information. The more information we have the 3 more helpful it is for us and then for the other 4 licensees to, if the information is shared, to be 5 able to learn from the operational experience from 6 the events.
7 MEMBER ENNIS: So, if we need to stay on 8 it, does that speak to, we should keep this as an 9 open item?
10 MS. DIMMICK: Yes. If the Committee wants 11 to keep it open so that it's, that we're aware of it 12 and we continue to work towards improving the quality 13 of information, sure, we can keep it open.
14 MR. BOLLOCK: Yes, we can continue to work 15 towards it.
16 MEMBER ENNIS: Yes. I think if it's going 17 to be an ongoing phase it will help just remind us.
18 Now, in terms of the items that are 19 required, has there been a recent review of those 20 elements and what would be the mechanism for reviewing 21 and/or changing those?
22 MR. BOLLOCK: I don't know for sure when 23 the last SA update was. It was two years ago maybe.
24 Lisa, do you know --
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22 1 more background. So, for the agreement states, one 2 area or one way that they're evaluated for, their 3 reporting of events into NMED is through the 4 integrated materials performance evaluation program 5 (IMPEP)review of the agreement states as well as the 6 NRC materials programs in each region.
7 So, one of the responsibilities of the 8 IMPEP team is to evaluate incidents and allegations.
9 And they review the data from NMED.
10 So, one thing that they're looking for is, 11 do they have open or closed events in NMED and if 12 they've been closed timely. So there is another set 13 of eyes on the NMED data that is reported by each 14 agreement state in their log and how it's handled.
15 So, that would be if there were things that 16 were not aligned with the procedure, it would be 17 identified in the IMPEP reviews with regard to the 18 NMED reporting.
19 MEMBER ENNIS: I've never seen any of those 20 reports, is that something that would be valuable to 21 ACMUI to see, and if we think we're trying to improve, 22 would we expect to see a decrease in a number of 23 deficiencies in certain states over the next few 24 years?
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23 1 every three years.
2 MS. DIMMICK: Three years.
3 MR. BOLLOCK: Typically --
4 MS. DIMMICK: Four years.
5 MR. BOLLOCK: -- four, four to five years 6 in IMPEP reviews. And if there are deficiencies, 7 it's expected that they work on those, and that's 8 reviewed in the next IMPEP work as part of their, the 9 frequency increase or shorten the time frame that 10 they're reviewed.
11 So, it is expected that there is, in those 12 areas, that there is a deficiency that they are 13 improved or rectified. I don't know, I've got some 14 staff that may have a little bit more information.
15 DR. TAPP: Just a quick backtrack. The 16 information that's required to be reported is --
17 MS. DIMMICK: Excuse me, Katie, could you 18 announce your name for the court reporter?
19 DR. TAPP: Oh, this is Dr. Tapp. The 20 information that is required to be reported to be 21 reported into NMED goes back to our rule, so it would 22 take rulemaking to add additional items to the NMED 23 reporting.
24 MEMBER SHOBER: This is Megan Shober. I 25 thought that the required elements are specified in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 SA-300?
2 Are you talking about what the licensees 3 would be required to report to NRC?
4 There's more, for event evaluation, the 5 elements that are in SA-300 are what the agreement 6 states are expected to follow.
7 MR. BOLLOCK: Yes. So the structures, the 8 minimum requirements are in the NRC regulations and 9 that's what the states have to report to us. But if 10 SA-300 expands, as Megan said, SA-300 expands on that, 11 what more is expected from the states to share with 12 us. So that's kind of the documentation.
13 And then through the process is IMPEP 14 process, I failed to mention, thank you for reminding 15 me, that's the major review, formal process of 16 reviewing the states programs. But then the other 17 informal things in the time phase in-between.
18 MEMBER SHOBER: And this is Megan Shober 19 again. Just to speak to your question about the 20 records, all of the IMPEP reports are available on 21 NRC's website.
22 And there's a nice page, you can just click 23 through any state you want and those are all 24 available. And there is a section in there that's 25 about the incident reporting.
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25 1 MR. BOLLOCK: And Dr. Howe from my Staff 2 has something else to add.
3 DR. HOWE: One of the other points is that 4 medical event reporting is a health and safety 5 criteria between the agreement states and NRC, so 6 it's not at the level of a Compatibility B, where the 7 agreement states have to provide exactly what's in 8 our regulations. So that may cause some differences.
9 MS. DIMMICK: So, I guess I would ask at 10 this time, because of earlier comments about keeping 11 this open for a period of time, would there be a 12 motion to change this from open to open indefinitely?
13 MEMBER ENNIS: I guess I don't really know 14 what the distinction is. I'm not certain we're going 15 to need to review this forever, but I do have a 16 feeling right now that we need to review it more. So 17 you can advise me about whether you think that it 18 needs open indefinitely or open.
19 MR. BOLLOCK: Yes, I think the distinction 20 for us is when we look at the chart we say, this is 21 something we want to continually look at, similar to 22 some of the previous ones where they were ACMUI and 23 NRC reaching out to the professional societies to 24 continue dialogue.
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26 1 couple of years but we'd like to continue, so we just 2 put indefinitely to continue on. So that would just, 3 it's just to help us with recognizing when we look 4 through the chart that, yes, this is something we 5 want to keep doing and remind us to interact and 6 engage OAS and informally along with the formal 7 processes we have in place.
8 MEMBER SHOBER: And this is Megan Shober 9 again. From what I'm hearing in this discussion, the 10 item, what you want isn't really defined a way to 11 centralize reporting because reporting is already 12 centralized through the Ops center.
13 What you're looking for is consistent, 14 information that's consistent between like different 15 states. So I'm not sure if that bears mention here.
16 MEMBER WEIL: So if I might add, so what 17 you could consider is looking, based on the outreach 18 that was done closing the recommendation and then 19 discussing a new option in the open forum that we'll 20 be getting to in a moment if you want to consider a 21 different way to describe what was really, what is 22 intended or what the current need might be.
23 CHAIRMAN PALESTRO: Any comments on that?
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27 1 about, if we, as a committee, want to investigate 2 this further and how we want to articulate that.
3 CHAIRMAN PALESTRO: Can we have a motion 4 to that effect please?
5 MEMBER ENNIS: I move that we close this 6 item.
7 CHAIRMAN PALESTRO: Second?
8 MEMBER SUH: John Suh, second.
9 CHAIRMAN PALESTRO: All in favor?
10 (Chorus of ayes) 11 CHAIRMAN PALESTRO: Any opposed?
12 MS. DIMMICK: Okay, great, thank you.
13 Okay, the Items 13, 19 and 20 are related to the 14 recommendations that came out of the medical event 15 reporting and its impacts on medical licensee patient 16 safety culture, the NRC did speak about this at the 17 last ACMUI meeting, and also, this is one of the 18 topics in the commission brief last spring as well.
19 These items currently are shown as open and 20 the NRC will need to close them, provide our response 21 to those recommendations to you in a memo and we need 22 to do that. So, they should stay open until we 23 provide that memo to the NRC. I mean, to the ACMUI 24 members.
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28 1 2018 recommendations. So Recommendation 1 and 2 are 2 open items. And we will be hearing from Dr. Metter 3 on the nursing mother's guideline final report, I 4 think it's later today.
5 And so that will provide additional 6 information in these areas. So these would stay open 7 until after the Committee has approved that final 8 report.
9 And the first one is an NRC action because 10 it will be based on the final report, what NRC Staff 11 might do with that information with regard to 12 regulatory guide 8.39. Okay, Dr. Metter, you have a 13 --
14 VICE CHAIRMAN METTER: Yes, this is Darlene 15 Metter. I do see that some of the recommendations 16 here are listed, have been revised with different 17 calculations. So, after my final report if you could 18 update this action item.
19 MS. DIMMICK: Which number?
20 VICE CHAIRMAN METTER: Number 1.
21 MS. DIMMICK: Okay. Okay, so Items 3 to 22 5, these concern the physical presence requirements 23 for the Leksell Gamma Knife Icon updated licensing 24 guidance.
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29 1 Committee's draft report. Or I'm sorry, that 2 Committee's report on the licensing guidance so these 3 could stay open until after the Committee has an 4 opportunity to deliberate that report.
5 Okay. So, Item 6 was a recommendation from 6 the Committee for NRC to update the ACMUI, or to post 7 the recommendations that showed all of the 8 recommendations and their status on the web page.
9 And NRC did take action on that and did post a 10 recommendations on the ACMUI web page.
11 So, instead of it saying open indefinitely, 12 is there a motion that, to close this recommendation?
13 Or any discussion.
14 CHAIRMAN PALESTRO: Question?
15 MR. BOLLOCK: This is Doug Bollock. This 16 is one of those things that we're going to have to 17 continually update, so we can keep that as open 18 indefinitely as the, right, so we carry on.
19 After this meeting when we've updated the 20 recommendations we'll put the new, we can put the new 21 one with any new recommendations coming out of this 22 meeting on the website. So I, NRC, I feel we should 23 leave that on there.
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30 1 reflected. Unless, right.
2 Okay. So, Item 7. This concerns sending 3 out a medical Listserv announcement after the ACMUI 4 has met and then issue and provide in those Listserv 5 announcements the recommendations or actions of the 6 ACMUI.
7 We did that after the last meeting. And, 8 again, this is another one reflected as being open 9 indefinitely. Since this is something new we're 10 doing, we would continue to keep it open indefinitely, 11 till it becomes part of our process.
12 Okay, so I'll move on to Item Number 8.
13 This one basically indicates the date for the fall 14 meeting. So I would propose, is there a motion to 15 close this item since we are in fact convening this 16 meeting?
17 MEMBER SCHLEIPMAN: Robert Schleipman, I 18 move that we close.
19 (Laughter) 20 PARTICIPANT: Second.
21 MS. DIMMICK: Second, okay. Okay. And 22 all those in favor?
23 (Chorus of ayes) 24 MS. DIMMICK: Okay. Just going through 25 formalities.
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31 1 Okay, so the next item, Number 9, is where 2 Dr. Palestro had appointed Megan and Zoubir to serve 3 on the physical presence requirements for the Gamma 4 Knife Subcommittee meeting.
5 This is currently open and it does link to 6 two, three other recommendations in 2018.
7 Recommendations 3, 4 and 5, which are the physical 8 presences ones.
9 So we could either, this is just showing as 10 that it's open because it's a current committee. So 11 we could keep it open until we address the physical 12 presence report.
13 CHAIRMAN PALESTRO: Any discussion or 14 comments on that?
15 MS. DIMMICK: Dr. Suh will talk about the 16 report and so I don't, unless you have discussion, 17 you want to talk about this.
18 CHAIRMAN PALESTRO: No, I meant about the, 19 whether or not we should keep it open, that's what 20 I'm referring to.
21 MS. DIMMICK: Oh, it could be closed 22 because the Committee is formed and reviewing it or 23 it could stay open until the Committee has presented 24 its report. I've seen it done both ways.
25 (Off microphone comments)
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32 1 MR. BOLLOCK: -- there may be other items 2 to close. So there is no right or wrong there.
3 CHAIRMAN PALESTRO: Okay.
4 MS. DIMMICK: Yes.
5 CHAIRMAN PALESTRO: So, is there a 6 consensus among the Committee? Leave it open until 7 such time?
8 MR. BOLLOCK: Yes.
9 CHAIRMAN PALESTRO: All right. Okay, 10 fine.
11 MS. DIMMICK: Okay. And the last one for 12 2018 is the ACMUI endorsed T&E SECY Subcommittee 13 report. The T&E SECY paper, this was the 14 Subcommittee report.
15 So, the T&E SECY paper, SECY 18-0084, was 16 sent to the commission. It is currently publicly 17 available under, in ADAMS, under Session Number 18 ML18135A276.
19 The ACMUI's final report and comments on 20 that draft, on the draft SECY report, are appended to 21 that commission paper. So you're feedback on that 22 report are part of the record for that SECY paper.
23 And you're also going to hear about NRCs 24 outreach plan by Maryann Ayoade later in this meeting.
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33 1 recommendation based on the publication of the SECY 2 paper and NRCs planned outreach? Continued outreach.
3 CHAIRMAN PALESTRO: Do we have a motion to 4 that effect?
5 VICE CHAIRMAN METTER: This is Darlene 6 Metter. I move to close the item.
7 CHAIRMAN PALESTRO: Second?
8 MEMBER SCHLEIPMAN: I'll second that.
9 Robert Schleipman.
10 CHAIRMAN PALESTRO: Any discussion? All 11 in favor?
12 (Chorus of ayes) 13 CHAIRMAN PALESTRO: Any opposed?
14 MS. DIMMICK: Okay, so that item is closed.
15 And that was the last old business item for this 16 meeting.
17 So now Dr. Palestro, I'll turn it back to 18 you for any open forum discussion. There are no 19 handouts for the open forum so this is where the 20 Committee can bring up any topics.
21 CHAIRMAN PALESTRO: All right, so we'll 22 move on to the next item which as Lisa said is the 23 open forum. Any topics for discussion?
24 MEMBER ENNIS: I guess we already had a 25 lead in to whether or not we want to look in more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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34 1 depth at what gets reported in NMED and the 2 differences between agreement states and not and 3 possibly also this report that I guess is available, 4 but ACMUI has never, as Committee, like looked at it 5 and see what kind of information is there about 6 individual states and their performance.
7 So, I guess it's an open question whether 8 we want to have a Subcommittee to look at that. I 9 think I would be in favor of it.
10 I feel like it's an open, it's a loose 11 thread that I don't have a good handle on and I guess 12 with being the medical events subcommittee chair and 13 having seen NMED and raised some of the issues, it 14 feels like this might be part of that loop that we 15 ought to investigate. But, I only want to do that 16 if other people do.
17 CHAIRMAN PALESTRO: This is Dr. Palestro.
18 Dr. Ennis, could you state what exactly would be the 19 charge of the Subcommittee?
20 MEMBER ENNIS: I'll try. The Subcommittee 21 will review the requirements, NRC requirements, in, 22 that are a part of the regulation it's in as well as 23 in the SA-300 document for, to evaluate the -- well, 24 I'm having a little trouble articulating it.
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35 1 relative to the charge of medical event analysis. It 2 probably could be articulated better, so feel free to 3 chime in.
4 CHAIRMAN PALESTRO: Any other comments or 5 suggestions? Mr. Ouhib.
6 MEMBER OUHIB: Yes, I think this item was 7 discussed multiple times if I recall correctly. And 8 the issues were there were some inconsistencies in 9 reporting medical event.
10 And that means details were not sufficient 11 to actually improve or provide corrective action and 12 all that. That sometimes even the event simply does 13 not make any sense when you read it. And there are 14 some corrections that come up later and so on and so 15 forth.
16 I know for a fact that, I think Bruce 17 Thomadsen, when he was the chair, we discussed this 18 and there is a task group within the AAPM, actually 19 was looking at this also at the same time. I can't 20 remember the task group number, it might have been 21 188, I can't remember.
22 But any rate, I think there's a great need, 23 in my opinion, to have some consistency, what should 24 be reported and what format should be reported sort 25 of becomes fairly easy to understand for everybody.
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36 1 But it also, you force the user to provide you that 2 information that we think it's really critical in 3 evaluating the event and perhaps providing some 4 corrective actions and so on.
5 MEMBER WEIL: This is Laura Weil. If I can 6 try to perhaps interpret some of the sub-text of 7 what's going on. We, in the item, agenda item that 8 we just closed, we closed it because we felt the 9 language did not reflect the ACMUI's interest in 10 getting, assuring that more complete information was 11 being received for all medical events, correct?
12 Okay.
13 So, perhaps what, because the stuff that 14 gets collected is determined by rule, it's not 15 something that we can change easily, it's rulemaking, 16 maybe what we need to do is simply have a sub-charge 17 to the Committee that looks at medical events to 18 monitor whether there is increasing compliance based 19 on NRC Staff's activities to engage with OAS and other 20 entities that are reporting.
21 Is that what we're after, just seeing if 22 things are improving whether we're getting more 23 complete information?
24 MEMBER ENNIS: I don't know, I think, at 25 least in my mind we're actually after two things.
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37 1 One is that, but two is, since there is, beyond 2 rulemaking, a possible mechanism for modifying. At 3 least what's strongly recommended.
4 I think it would be of value to the ACMUI 5 to look at that document, see what's required, see if 6 that makes sense to us, if it ought to be modified 7 and then make some recommendations about that 8 document. And maybe some rulemaking recommendations 9 too, although we understand the challenges in doing 10 that.
11 So I think it's both we need the elements 12 that are being asked of people and also how well that 13 is being done.
14 CHAIRMAN PALESTRO: So, this is Dr.
15 Palestro again. Dr. Ennis, then would you favor the 16 creation of a separate and distinct subcommittee to 17 do that?
18 MEMBER ENNIS: I'm really open to either 19 way. The NRC Subcommittee Members here could speak 20 to whether they want to do it as part of our medical 21 event Subcommittee or if there's interest for people 22 not on the Committee, maybe we form a separate 23 Subcommittee. I think either mechanism would be 24 fine.
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38 1 discussion. Any comments from the Subcommittee 2 Members in particular? Mr. Green.
3 MEMBER GREEN: I thought I heard Mr.
4 Bollock say that there was a subcontractor who 5 monitors the input of data into this database and can 6 go back to a state, an agreement state, and say, hey, 7 you're a little shy on the data here can you fill in 8 these fields? I'm not sure it's the ACMUI's role to 9 be the monitor of completeness, I think that 10 contractor will do that though.
11 I think we could look at the list of data 12 we request on the form that the agreement states work 13 with, to see if that has all the data elements that 14 we would like to see.
15 MEMBER ENNIS: I guess I'm feeling, just 16 having seen the data for a while, that maybe the 17 monitor needs a monitor. Or at least notice that 18 someone else is looking from time-to-time.
19 MEMBER SHEETZ: This is Mike Sheetz. Does 20 the NRC have a template on what information they are 21 requesting to report a medical event or some other 22 event on the other parts in the regulations?
23 MEMBER ENNIS: Yes.
24 MEMBER SHOBER: This is Megan Shober. It's 25 called a state agreements procedure. It's SA-300.
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39 1 Which, again, it's, I don't know which branch is 2 responsible for it but that has a list of all the 3 elements that are required for a complete NMED record.
4 And so if a state submits information to 5 NMED and it doesn't include all those elements, then 6 the NMED contractor sends an email to the state and 7 says, please provide this information within the next 8 60 days.
9 So, they're pretty on top of that. And the 10 state doesn't necessarily respond I guess, but NMED 11 is cross-checking the NMED report against the SA-300 12 elements and requesting more information when it's 13 not initially provided.
14 MEMBER SHEETZ: And this is Mike Sheetz 15 again, is there a mechanism to monitor whether the 16 state ever responds back with a request of additional 17 information?
18 MEMBER SHOBER: This is Megan again. NMED 19 doesn't follow-up after that initial round, but the 20 place where it would be noticed, again, is through 21 the integrated materials performance evaluation 22 program.
23 They do look at records that are open and 24 closed in making sure that records are getting closed.
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40 1 level of detail to look at those elements, but if 2 there is a problem with reporting of course, more 3 attention is paid in that area.
4 But as far as a routine basis, probably 5 not. Not that detailed.
6 MR. BOLLOCK: Right. So the IMPEP process 7 they may, if they see a programmatic issue, states 8 are lacking in information on every report they have, 9 it will probably be noticed.
10 Here, there missing information may not be 11 just based on, it's all sampling and looking at it 12 for, you know, a coder could not be identified. So, 13 I mean, there are, like I said, there are mechanisms 14 but we recognize the concern the Committee has brought 15 is that we want to make sure the information is as 16 best as possible, consistent as possible, can be as 17 useful as possible.
18 So, yes, the only other way I think it would 19 be identified is if the event was an AO, and then we 20 get all the information on it. So that's the only 21 other way, if the event is significant. And that's, 22 a structure is looking at what's most significant.
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41 1 supposed to be reporting on their SA-300 and it's 2 consistent to get the best information.
3 And then also, consideration for a 4 Subcommittee to review the SAs and seeing what is out 5 there. So I just want to, I think that's what I'm 6 hearing, I just want to make sure that we understand 7 so we can capture that, that's what it is.
8 CHAIRMAN PALESTRO: So I'd like to bring 9 that back to my original question. As Dr. Ennis 10 discussed, there are one or two options.
11 One is to incorporate this into the current 12 Subcommittee on medical events work or to establish 13 a separate subcommittee to carry out this task. And 14 so I'd like to get some discussion on that. Dr. Suh.
15 MEMBER SUH: Yes. So, I've had a chance 16 to review the medical event reporting for, I guess 17 it's now seven years.
18 And one thing that I have noticed is that 19 there are, the reports are not consistent and/or 20 sometimes not fully accurate. So I do believe there 21 is a need, as Dr. Ennis has pointed out, to have a 22 subcommittee or to really look at what can be done 23 differently so that there is greater consistency and 24 accuracy of these medical events.
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42 1 hopefully you'll get more information, which will 2 help drive changes, which will help patients and 3 healthcare providers as well.
4 So, whether or not it's part of the current, 5 what I say for, is because the current medical events 6 committee, subcommittee is familiar with how to 7 interoperate these NMED reports, that it should be, 8 that should be the charge of that particular 9 subcommittee rather than forming another 10 subcommittee. I'd still have to replace the 11 radiation oncology and that's whoever my replacement 12 will be.
13 CHAIRMAN PALESTRO: Other opinions?
14 MEMBER ENNIS: Well, I guess I have a 15 little opinion because both Megan and Zoubir have 16 seem to be interested in this topic and they're not 17 currently on the Committee, so I'm wondering, for 18 that reason, maybe, maybe we should have a different 19 Committee. But maybe they want to speak to that.
20 MEMBER OUHIB: This is Zoubir. Just a 21 comment. I guess my question would be is, when was 22 the last time that list, that required list that needs 23 to be submitted, was actually looked at to revise?
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43 1 possible that there is information that's lacking in 2 that list that is really critical or perhaps important 3 in reporting a medical event.
4 And there might be others that perhaps are 5 not really needed and is there time to look at that 6 and see, how can we best make that more efficient and 7 useful.
8 CHAIRMAN PALESTRO: I understand what 9 you're saying, this is Dr. Palestro, but I want to 10 come back to the question that really needs to be 11 answered, I think. And that's, do we incorporate 12 this new charge into the responsibilities of the 13 existing Subcommittee or do we want to create a 14 separate subcommittee? And that's what I would 15 really like to focus on at the moment.
16 MEMBER ENNIS: All right, so our current 17 members of the NRC Medical Event Subcommittee are --
18 sorry guys, I know you worked hard on our Committee 19 report that we're about to see, but I don't want to 20 miss anyone.
21 Richard Green, Dr. Metter, Dr. O'Hara, Dr.
22 Suh and Mr. Sheetz. Did you guys want to work on 23 this or should we have a separate Committee?
24 CHAIRMAN PALESTRO: How many members do you 25 have, six?
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44 1 MEMBER ENNIS: Six.
2 CHAIRMAN PALESTRO: Okay. At this point 3 you can't add any more members.
4 (Off microphone comment) 5 MEMBER ENNIS: Well, Dr. Suh is leaving but 6 does he have to be replaced by another --
7 CHAIRMAN PALESTRO: That would be replaced, 8 but you can have a maximum of six members on the 9 Committee.
10 MEMBER ENNIS: Okay.
11 CHAIRMAN PALESTRO: So the Committee can 12 choose --
13 MEMBER ENNIS: So I'd like to suggest we 14 have a separate Committee because I see some valuable 15 members around the table that are not able to be on 16 this Committee.
17 CHAIRMAN PALESTRO: All right. Well, as 18 Chair I believe I have the prerogative to establish 19 a separate, or to establish a subcommittee, which I 20 will now do. But I will rely on Dr. Ennis to create 21 the specific charge for that subcommittee.
22 MEMBER ENNIS: I'm going to ask Ms. Weil 23 to articulate it for me.
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45 1 at this minute. I'd like to have it before the close 2 of business today so that we can formalize it.
3 MEMBER WEIL: Yes, that's fine.
4 MR. BOLLOCK: Yes, that's fine, as long as 5 you close --
6 CHAIRMAN PALESTRO: Rather than being vague 7 and trying to knock it out in five minutes before 8 lunch. So, Dr. Ennis, and again, while the Chair 9 appoints the Subcommittee Members, I think it makes 10 sense to ask for your input, who you feel should be 11 on the Committee. Subcommittee.
12 MEMBER ENNIS: Okay. Dr. Ouhib, would you 13 be willing to serve?
14 MEMBER OUHIB: I'd be happy to.
15 MEMBER ENNIS: Megan?
16 MEMBER SHOBER: Yes.
17 MEMBER ENNIS: Okay. Laura, are you going 18 to be around on the Committee for long enough to --
19 MEMBER WEIL: Only about a year though.
20 MEMBER ENNIS: Oh, a year is good enough.
21 Will you be willing to serve?
22 (Laughter) 23 MEMBER WEIL: Yes.
24 MEMBER ENNIS: All right. One more 25 volunteer. Oh, sorry.
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46 1 DR. HOWE: I just wanted to make a point, 2 Dr. Suh, this is his last day so he will be coming 3 off of the medical event committee, so you may want, 4 if you have more than him, you might keep it in the 5 same committee or you might come in with a new 6 subcommittee.
7 MEMBER ENNIS: Great. No, I think we felt 8 there was an interest in people who could not be, 9 because of size requirements that subcommittees fit, 10 so we're going to do a separate committee.
11 We probably would want to ask the new 12 radiation oncologist to join this Subcommittee but we 13 don't know who it is or when it's going to be, so for 14 now I think we've got a good Committee, but maybe 15 there be one more person to volunteer?
16 MEMBER MARTIN: I'll volunteer.
17 MEMBER ENNIS: Excellent.
18 MEMBER OUHIB: Yes. This is Zoubir. I 19 think that would be perfect because we definitely 20 need a variety of therapy, diagnostic and so on and 21 so forth.
22 MEMBER ENNIS: Do we have enough nuclear 23 medicine expertise though? There are nuclear 24 medicine events and I think actually we need some 25 nuclear medical expertise, sorry, but --
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47 1 MEMBER DILSIZIAN: I'll volunteer.
2 MEMBER ENNIS: Okay. Dr. Dilsizian has 3 volunteered, thank you.
4 CHAIRMAN PALESTRO: All right, so then just 5 to review very quickly. Dr. Ennis is the Chair of 6 the Subcommittee and the Members are Dr. Dilsizian, 7 Mr. Ouhib, Ms. Shober and Mr. Sheetz, is that correct?
8 I'm sorry, and Ms. Weil.
9 PARTICIPANT: That would be six.
10 (Off microphone comment) 11 PARTICIPANT: That's six, we don't need, 12 okay.
13 (Off microphone comment) 14 CHAIRMAN PALESTRO: All right, so that's 15 the Subcommittee. But again, I would ask that before 16 the close of business, at some point, you come back 17 with the specific formal charge.
18 And now that we have this Subcommittee I 19 would also ask that Staff appoint a liaison.
20 MR. BOLLOCK: Yes, I'll work on that. Lisa 21 and I have to discuss and we'll absolutely supply a 22 staff liaison.
23 CHAIRMAN PALESTRO: Any other matters for 24 the open forum? All right then, we will adjourn and 25 we resume at 12:45.
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48 1 (Whereupon, the above-entitled matter went 2 off the record at 11:58 a.m. and resumed at 12:45 3 p.m.)
4 CHAIRMAN PALESTRO: I call the afternoon 5 session to order. First presentation this afternoon 6 is the Medical Events Subcommittee and it will be 7 presented by Dr. Ennis.
8 MEMBER ENNIS: Thank you Dr. Palestro, good 9 afternoon, everyone, I'm happy to report the Medical 10 Events Subcommittee report for this meeting. The 11 report is the work of all members of the subcommittee, 12 it is very much a joint effort with each of us pretty 13 much owning one part of the report and I invite all 14 the subcommittee members to speak to their point at 15 the end if I haven't touched on all key elements.
16 Next slide, please.
17 MR. BOLLOCK: This is Doug Bollock with NRC.
18 I apologize, we're having some technical difficulties 19 so it seems like we're getting them resolved quickly.
20 MEMBER ENNIS: Okay, back one slide please.
21 So our subcommittee members in addition to myself, 22 Mr. Green, Dr. Metter, Dr. O'Hara, Dr. Suh and Mr.
23 Sheetz. Thank you.
24 The subcommittee decided to change the way 25 it had been reporting for the last several years, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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49 1 with encouragement from NRC staff, particularly Dr.
2 Howe with the support of Dr. Palestro, that rather 3 than go through NMED ourselves for the last fiscal 4 year and review all the events and report on them in 5 a way similar to what Dr. Howe had done in the spring, 6 instead we decided to review the last three-year 7 reports of this committee plus Dr. Howe's spring 8 report, so this is covering three and a half fiscal 9 years to take a wider angle or high level looking for 10 themes that might be recurring within Part 35 or 11 perhaps even across different parts and see if we can 12 come up with some recommendations for improvements.
13 So in the end as you'll see is the data but 14 just to give you a summary now, we saw two overarching 15 themes. One, there's good examples to suggest that a 16 performance of a time-out type procedure 17 immediately prior to the administration of 18 radioactive byproduct material has been done in 19 surgery and other settings in medicine, currently 20 with great success, could have prevented some others.
21 And there seems to be a second theme, that 22 lack of a recent or frequent performance of a specific 23 administration appears to be a contributing factor in 24 a number of cases. Next slide.
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50 1 and a half years by section. In Part 200, Unsealed 2 Byproduct Material for Imaging and Localization not 3 meeting written directives, these are the types of 4 events that have occurred over the last four years, 5 21 events in total, wrong drug, wrong dosage, wrong 6 patient. Next slide.
7 Time out likely would have been able to 8 deal with several of these, confirm the order compared 9 to the prescription, wrong patient also a time out 10 ought to have been an effective mechanism for 11 minimizing that. A rough estimate is about half of 12 the cases might have been prevented if a time out 13 had been used.
14 The wrong dosage is a little trickier in 15 that dose calibrators are not necessarily required 16 and not everyone has them, so that those errors may 17 be a little bit more difficult to overcome and 18 probably not effectively changed by implementing a 19 time out. Next slide.
20 In 300, Unsealed Byproduct Material 21 Requirement Directive, these are the issues and 22 again, a few every year, pretty consistent, you know, 23 a handful, half dozen or so different types of things 24 cover the vast majority of events, and again at least 25 half to three-quarters may have been able to be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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51 1 prevented by a time out.
2 Written directive not done or incorrectly 3 done would be likely, error in the number of capsules 4 is a common theme, and again something about time 5 out, how many capsules as a check, dose, equipment 6 things obviously are different, unauthorized clinic 7 is obviously a totally separate issue. Again, wrong 8 patient ought to be able to be caught by a time 9 out. Thank you. Next slide.
10 Manual brachytherapy, both prostate and 11 non-prostate, these are obviously a little bit more 12 technical in nature. Applicator issues, the 13 applicator moved during the implant, wrong site 14 implanted and activity, being prescribed, 15 prescription error and air kerma versus millicuries.
16 Then in the prostate there's dose group, which has 17 been a large group. Next slide.
18 Looking at these, let's go back actually if 19 you don't mind, just to be able to talk about it. The 20 applicator issue sort of had a time out issue 21 potentially for some not familiar, not doing the 22 procedure often issue, although most of the ones 23 actually described here did not appear to be that 24 either, but you could imagine sometimes that might be 25 a role.
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52 1 Wrong site implanted, in this setting we're 2 talking penile bulb implantation which is a 3 significant number of those. It is certainly an 4 infrequency of the procedure that is playing a 5 significant role. And activity prescription error is 6 a time out, potentially caught by time out.
7 The prostate dose, of course, with the new definition 8 of medical events, this is going to change 9 dramatically. Many of these events are by the new 10 definition not events, so it will be very interesting 11 to see what emerges afterwards.
12 But some of the prostate dose events are 13 the type that could be caught by a time out, 14 because there were errors in prescription for, just 15 one example, someone getting external beam and a seed 16 implant ought to get a certain dose and there was at 17 least one or two events where they prescribed the 18 wrong dose, confusing that the patient also got 19 external beam. So a time out could have caught 20 that. Next slide.
21 So in summary, sense is about ten percent 22 of these types of events might be affected by a time 23 out, and another maybe 15 are impacted by a lack of 24 experience. Next slide. Let's see, I think we've 25 covered this here. Next slide.
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53 1 In 600, HDR and the gamma knife are 2 regulated under 600. These are the types of events.
3 Wrong position, reference Linux plans, software 4 failure. 37 events over four years and again, if 5 there's a half a dozen things that pretty much cover 6 all of them. Next slide.
7 This is just broken down by disease site.
8 Again, all related to wherever brachytherapy or gamma 9 knife played a role in the diseases. Next slide.
10 Again, looking in review, time outs 11 likely impact, could have an impact in about 15 12 percent. Next slide.
13 The infrequent user phenomena may be 14 playing a role in about 30 percent. So it seems like 15 so far at least the technical anatomic procedures, 16 it's a little bit more about frequency of the 17 procedure and the comfort or experience of the person, 18 and that plays a lesser role in the radioactive 19 intravenous administrations for diagnostic or 20 therapeutic purposes. Next slide.
21 Okay, and radioactive seed localization, we 22 have a few obviously different parts to 1,000, so 23 just a few events but potentially could be an impact 24 of a time out, at least the wrong site implant.
25 Next slide.
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54 1 For Perfexion, Gamma Knife Perfexion, these 2 are the number of events and the causes, the most 3 common being positioning alignment, but that was a 4 very specific vendor and site. Other ones pretty 5 uncommon but a few events, some of them potentially 6 addressed by time out, wrong site for example.
7 Perhaps patients had maybe some experience playing a 8 role there as well. Next slide.
9 Then Y-90, so as we have seen before, more 10 events in this category. We have talked about this 11 before. Complicated procedure, tubings, etc., so 12 here's a nice summary of events over time, and a lot 13 of it has to do with activity remaining in the device 14 or problems with the catheter, the shunting issue, 15 setting up properly, but some of the more kind of 16 dose calculation issues as well. Next slide.
17 This is for SirSpheres, the prior slide was 18 for Theraspheres, not demonstrably different, pretty 19 similar patterns of what's common and what are the 20 issues. Next slide.
Formatted: Font: Bold 21 So again, nice way to review this is in a 22 pie chart. A big one is residual activity, but then 23 we have the other problems as well. Next slide.
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55 1 the mechanics of delivery device and setup procedure, 2 again speaking particularly, I think, to the setting 3 of infrequent users or not having used it in a while Formatted: Font: Bold 4 or just getting started, time out type thing to 5 report all the, reveal review the elements that are 6 in the written directive would be helpful as well, as 7 we have mentioned. Next slide.
8 Just trying to categorize, ball park if you 9 will, what kind of impact the time out might be 10 able to have on the three different areas within 1000 11 that we just talked about so for the RSL, maybe one 12 of them, so maybe 25 percent. Obviously it's a small 13 number. Within the gamma knife sphere, 14 Perfexion/Icon, maybe also about 25 percent could 15 have been prevented if a time out had been done 16 and the Microspheres, about 12 percent. So again, 17 kind of consistent with the idea when doing technical 18 procedures, anatomic ones, the time out has a 19 modest impact, potentially ten to 20 percent. Next 20 slide.
21 In terms of just infrequent user type 22 problems, none of the RSLs seem to be that. Maybe 15 23 to 20 percent of the Perfexion/Icon events that may 24 have played a role and Microspheres best guess is a 25 small percentage as well. Next slide.
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56 1 So if we were to try and distill this idea 2 of a time out across all parts of Part 35, what 3 could we think about as being something that might be 4 suggested as elements of a time out for all of 5 them? A pretty basic stuff of what's a time out 6 in surgery and in other settings that it's already 7 being used, identifying the patient with two 8 identifiers is a generally accepted element of a 9 time out, reviewing the exact procedure that's 10 going to be performed, the isotope, its activity, the 11 dosage, then there may be consideration for adding 12 additional elements depending on the acuity of the 13 procedure, the whole treatment being done.
14 For example, an LDR prostate would be wise 15 to include a recalculating based on air kerma or 16 millicuries, anatomical location for the anatomic 17 type procedures would make sense, is the patient's 18 name on a treatment plan if there is such a thing, so 19 like in brachytherapy is there a treatment plan, or 20 in Y-90, is that this patient's plan, independent 21 second check, has that been performed in a way that's 22 required in many quality programs but you are 23 verifying that it's actually been done prior to 24 proceeding.
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57 1 about HDR related to catheter lengths, that is a 2 consistent source of occasional error. Almost every 3 year there's one of those, and --- like for a cell 4 implant site location. Next slide.
5 For the issue of the infrequent or user 6 hasn't used it for a while or program, rather than 7 not just a specific user, but it could be the 8 department, the program, things that might be 9 recommended at this point, just in terms of taking 10 advantage of what's out there, requiring or 11 recommending, requiring is probably too strong a 12 word, recommending a review course be done. There's, 13 also, all professional societies now have video or 14 slide review courses that can be taken on line, 15 there's review articles all over the place for all 16 these procedures for people to review.
17 There's obviously the opportunity but 18 encouragement to speak to a colleague with 19 experience, and I think particularly important might 20 be a recommendation that a dry run be done if you 21 haven't done this procedure or you're not feeling 22 totally comfortable or confident, go through all the 23 steps with your entire team. I think that could go a 24 long way.
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58 1 particular device, particularly a Y-90, and the 2 tubing, just perform a dry run essentially so you 3 know exactly how what to push when and when you flip 4 the catheters or the, you know, to make the flow go 5 in the right direction. Next slide.
6 So what could NRC do to affect this or 7 promulgate this? We thought that, and our 8 subcommittee recommends, that NRC consider issuing an 9 information notice alerting authorized users to these 10 things and to the recommendations of the subcommittee 11 about ways to prevent them in the future. Thank you.
12 Committee members, anyone want to add to, if I left 13 out any important things or just any other comments?
14 CHAIRMAN PALESTRO: Any comments from 15 members of the ACMUI? Dr. Martin?
16 MEMBER MARTIN: Learn how to do the buttons.
17 Just a question. We obviously have an idea that 18 everything would be perfect and we would never have 19 any of these medical events. I think it would be 20 interesting to know how many total procedures were 21 done that were done correctly. In other words, if 22 we've got 21 events, it's 21 out of how many thousand 23 did we do correctly? Just to put it into perspective 24 that this is not a hazardous, I mean, not that we 25 like to have 21 events, but it's 21 out of, I don't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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59 1 know, 2,000, 20,000, how many procedures were 2 actually done of those type of procedures? I think it 3 would just be interesting, maybe put it into 4 perspective as to, quote, really how big a hazard 5 this is.
6 MEMBER ENNIS: So yes, in prior reports that 7 kind of information has been shared, and it's a tiny 8 fraction of each one of these reports. Certainly one 9 perspective can be well, there's hardly any events, 10 but that being the case we don't need a subcommittee 11 to look at it, frankly. And I think we would all agree 12 that if there's relatively straightforward easy 13 things to do to do better, then why not do that.
14 MEMBER MARTIN: I completely agree. I was 15 just putting it into perspective so it didn't come 16 across that this was a real hazardous process that 17 we're doing.
18 CHAIRMAN PALESTRO: Other comments? Dr.
19 O'Hara?
20 MEMBER O'HARA: Yeah, Mike O'Hara. One 21 follow up on this is that a few years ago we started 22 having two review scientists from the FDA be able to 23 review the NMED data base, and that and Dr. Howe's 24 report has added a lot of strength to our review of 25 medical device failures.
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60 1 What I mean, there's a couple of examples 2 here. Machine malfunction could be a medical device 3 failure and software failures. Those are, software 4 failures are definitely something that we're 5 interested in. And just for everybody's knowledge, in 6 radiation oncology, right now 74 percent of all of 7 the recalls that involve radiation therapy devices 8 are due to software failures. So we actually are 9 putting a lot of effort into approve, or clearing, 10 new devices with new procedures, new ways of testing 11 for the software failures. And NRC has really helped 12 us to that, with better communication.
13 CHAIRMAN PALESTRO: Dr. Dilsizian?
14 DR. DILSIZIAN: Great presentation, Ron.
15 When I looked at your summary, you had two main 16 themes. One was the time out and the other one 17 was the lack of training or experience. Both of those, 18 unfortunately are not regulations. It's the practice 19 of medicine.
20 The reason this comes up every time is 21 because I'm the chairman of radiation safety 22 committee and our radiation oncology colleagues on 23 the committee want to have us as a safety committee 24 to decide what type of a period you would need of 25 lack of let's say doing Y-90s, where you should not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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61 1 either teach or do, which I thought was the order of 2 medicine, not radiation safety.
3 So what's interesting is that as a 4 committee we're trying to deal with these, which you 5 summarized beautifully, but it's really the practice 6 of medicine. You even mentioned that the Society 7 should be recommending this, not NRC. So what is then 8 our role? It's very interesting.
9 MEMBER ENNIS: That's a great comment and 10 something we struggle with here all the time. It's on 11 that line and I guess maybe in part we're not really 12 joined to any kind of regulatory work. This is just 13 more of informational, hey, as a body that reviews 14 medical events, so that's kind of working it into the 15 regulatory space. As regulators, if you will, we want 16 to help you minimize that and these are some things 17 we're recommending.
18 I agree I wouldn't want NRC to start to 19 stipulate the definition of what's frequent, what's 20 not frequent for this particular procedure. That's 21 definitely out of their purview, but I think it's 22 okay for NRC to say, hey, we're regulating you, we 23 see a pattern here, and we want to highlight that for 24 you and you guys now think about what's the 25 appropriate time, what's the appropriate things in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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62 1 the time out, I mean we're not really mandating 2 the specific things, just think about time, I'd like 3 to hear some suggestions.
4 I think that comes close to the practice of 5 medicine but is still as a practitioner I think that 6 would be okay for NRC to kind of let me know, here's 7 some advice.
8 CHAIRMAN PALESTRO: Other comments or 9 questions?
10 MEMBER OUHIB: Two minor items, probably.
11 One regarding the education and training, sort of 12 like get people -- you know, perhaps medical events 13 should be part of that training, to be aware of what 14 actually has happened using that device or doing that 15 procedure, and they need to know how things can go 16 wrong. Unless you know, you might very well make the 17 same mistake. I think that would be valuable.
18 The other one is on the time out.
19 Looking at other medical events that took place, 20 perhaps, is that asking a simple question as, is there 21 anything that is different that we're doing in this 22 procedure that we have done before? Modification of 23 the applicator, anything, a very recent upgrade of 24 the software was done last night, something regarding 25 the device itself. Something, there was a repair that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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63 1 was done, the engineer was, I don't think it would 2 affect you but just look at. Things like that I think 3 would be valuable to sort of, so anybody can speak up 4 and talk about it.
5 CHAIRMAN PALESTRO: Mr. Sheetz?
6 MEMBER SHEETZ: I would like to follow up on 7 Zoubir's comment about licensees understanding what 8 the occurrence was for other medical events, 9 especially with the Y-90 microspheres. If you look 10 at the main cause for the events, it's greater than 11 20 percent of the residual activity remaining in the 12 delivery apparatus, not due to stasis. So it was not 13 all an elective termination of the procedure.
14 These can be caused by trying to infuse too 15 many microspheres, kinking of a catheter, or 16 inadequate flushing of the device. If we looked at 17 the cause of lack of experience or infrequent use for 18 the Y-90 microspheres, we only attributed those for 19 the device setup errors, and it was around eight 20 percent, so it wasn't significant.
21 But if you add the residual activity, 22 greater than 20 percent, to the infrequent use because 23 they weren't quite sure how the device worked or they 24 weren't sure combinations of flushing and infusing 25 microspheres, that comes up to over 70 percent as the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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64 1 reason for the medical event.
2 So I'm not sure of the answer on how to 3 correct that but maybe licensees could reach out back 4 to the manufacturer for a refresher if it's been a 5 period of time for them using the device. The 6 manufacturers are very willing to come out and provide 7 additional instruction after they've already been 8 approved. Thank you.
9 MEMBER OUHIB: And just to follow up on this, 10 during that refresher I would love to see the 11 manufacturers actually creating events during the 12 training and showing them how the system can actually 13 go wrong. I'm going to do this, watch this and see 14 what's going to happen, and go over every single event 15 that is known, basically with the users so they are 16 prepared and they can avoid it.
17 MEMBER GREEN: This is Richard Green.
18 Playing off Dr. Martin's comments that there are very 19 few events for the millions that occur. Many 20 practitioners, knock on wood, will go through a career 21 and not have a medical event. But it's not until we 22 aggregate this data to the level that we have, this 23 30,000 foot view that we have of all the data for 24 multiple years, where we come up with this very 25 salient, you know, this time out. This review of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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65 1 a skillset that you may have had but that may have 2 gotten rusty because of unuse.
3 I think it's, this level of our viewpoint, 4 we can suggest, and that's all it is, a suggestion, 5 that the NRC puts out an informational notice that 6 says, this is good advice. It's not a regulation, 7 it's not all things are infringing on the practice of 8 medicine, but it's something that we can identify 9 that you may not see, may have gone a whole career 10 and not had a problem, but this could help prevent a 11 problem.
12 CHAIRMAN PALESTRO: Other comments or 13 questions from the committee?
14 MEMBER SCHLEIPMAN: One quick one. The 15 possible elements of a time out or use of a time 16 out, is there a possibility that could be put into 17 model procedures at the NRC post, and/or appendant to 18 the written directive 35.3 regulations to say, this 19 is strongly suggested or this is an element of safety 20 that could be incorporated into the written 21 directives?
22 MEMBER ENNIS: Well, I think that's a 23 question for NRC, whether they can and can't. Is there 24 a way of going into and changing the regulations 25 themselves, it's not a big enough problem to do that.
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66 1 I think the information notice was the mechanism we 2 thought, but again, I would open it up to Doug or 3 anyone else to say --
4 MR. BOLLOCK: Yes, from the NRC. So to answer 5 a direct question, we could but is it necessary, like 6 Dr. Ennis said, is it necessary with this low number 7 of cases, probably not. That would be getting another 8 step further. We would have to really evaluate if 9 it's a problem, and right now we don't see it as a 10 problem.
11 But that doesn't mean there are other 12 things that can be done, like the stuff in these 13 recommendations for information for us to share. You 14 know, here are, here's our personal experience for 15 seeing here the events, here are some of the causes, 16 here are some things that could prevent it. You know, 17 that is absolutely something that we can do very 18 easily.
19 CHAIRMAN PALESTRO: Mr. Green?
Formatted: Font: Courier 20 MEMBER GREEN: I think the information 21 notice that that does occur would then go to the 22 professional medical societies for them to 23 incorporate into their procedure guidelines and model 24 procedures for them to work with their peer group to 25 perfect and improve the processes within each NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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67 1 professional society.
2 CHAIRMAN PALESTRO: Mr. Ouhib?
3 MEMBER OUHIB: And I think just to answer 4 that one, I think that's already part of an accredited 5 program by ASTRO, for instance. That is a must. The 6 time out is a must. But let me just add one more 7 thing is, we talk about a time out button prior 8 to the procedure I'd like to suggest that perhaps a 9 time out at the end of the procedure to make sure 10 that the treatment was actually delivered according 11 to the written directives and there is nothing out 12 there that perhaps went incorrectly, and not wait for 13 the fifth fraction to discover that all these five 14 previous fractions were treated incorrectly.
15 And I think, and I hate to call it a time 16 out, but it probably will fit just fine, to have a 17 good review at the end of the procedure and say, okay, 18 let's take a look. Did we do anything incorrect here, 19 and can we confirm it, and how?
20 CHAIRMAN PALESTRO: Dr. Ennis?
21 MEMBER ENNIS: I'm not sure how I feel about 22 that. I guess the hesitation is I feel like if 23 anything did happen, that generally does get 24 discussed and the need to add a layer to every single 25 procedure of yet one more, I'm not sure the value NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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68 1 added. In theory, I get it but in practice I'm not 2 really sure.
3 MEMBER OUHIB: Well, there are certain 4 procedures that you're required to review your case 5 and make sure that nothing has happened and there 6 wasn't a medical event. Then you're supposed to 7 document that. I think what I'm saying is that perhaps 8 that should be applicable to all procedures to make 9 sure that there wasn't a medical event and not wait 10 for the fifth fraction, perhaps.
11 CHAIRMAN PALESTRO: Any other comments or 12 questions from the committee? Dr. Ennis, I have one 13 question for you. This indeed is a change in the focus 14 of the subcommittee, and I think a change for the 15 better. We've talked about this at the ACMUI meetings 16 for several years and I think you certainly have 17 provided useful information. However, you looked at 18 a time span of three and a half years.
19 My question is, and you and I have talked 20 about this via email, is this report, should this 21 report continue to be an annual report or should it 22 be less frequently, at some specified interval, so 23 that you look at new accrual of data?
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69 1 few events per year and there's going to be 2 significant overlap to next year this year. We'd be 3 looking at the same data.
4 I guess my gut feeling would be maybe every 5 two years would be appropriate. Whether this 6 committee should not really report anything except 7 every two years or it should do something else on the 8 intervening years, I'm open to thoughts. But in terms 9 of this task, at least, seems like it probably makes 10 more sense to do it every two years.
11 CHAIRMAN PALESTRO: Dr. Metter?
12 VICE CHAIRMAN METTER: This is Darlene 13 Metter, and I think that's a good idea but I think it 14 still should be monitored in case any event does come 15 up that I don't want to wait two years or three years 16 before we realize that two years ago these events 17 occurred. So perhaps the subcommittee can at least 18 monitor it and we can maybe report that there was 19 nothing unusual that occurred this year and not give 20 such a detailed report, but somebody needs to monitor 21 it on an annual basis.
22 CHAIRMAN PALESTRO: Any other comments or 23 questions from the committee? Dr. Suh?
24 MEMBER SUH: I commend the fact that we have 25 actually started to look at 30,000 foot views for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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70 1 medical events, and think one of the things that this 2 report really underscores is the importance of very 3 simple practices to make a difference in the quality 4 and safety of patient care.
5 So I would really encourage the 6 subcommittee and committee to continue to promote 7 things like universal time out. I mean, it's very 8 simple to do, it should be part of the universal 9 practice in terms of how we treat patients, and yet 10 it's not being done. And if you look at the 11 percentages, it ranges from the various reports from 12 between 15 percent to maybe as high as 85 percent, 13 medical events could have been prevented with a time 14 out.
15 Which to me, that's why even though it's a 16 very small number of patients the fact that the 35.300 17 upwards of 85 percent may have been prevented at the 18 time I think is a very powerful statement.
19 CHAIRMAN PALESTRO: I certainly agree with 20 you, Dr. Suh. Any other comments, questions from the 21 committee? Ms. Weil?
22 MEMBER WEIL: This is Laura Weill. Just a 23 question. You cite infrequency of use as a significant 24 factor. How did you determine that, and is it related 25 to the kind of facility or the location of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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71 1 facility?
2 MEMBER ENNIS: So, it's a very soft 3 judgment. That's why we, part of why we divided it up 4 by expert. The expert was reviewing what was reported 5 and it's like, that sounds to me like someone who 6 probably hasn't had, but we didn't have like a nice 7 group of criteria and so it's just a rough estimate 8 based on expertise and we did not delve into type of 9 institution, so there's no doubt those things play a 10 role but we don't have enough data to really look at 11 it in that kind of a way.
12 CHAIRMAN PALESTRO: Any other comments, 13 questions, from the committee?
14 MEMBER ENNIS: So I just want to hear a 15 little bit more clearly what the charge for my 16 subcommittee should be for next year. Should we report 17 the way we did in the past, and go through all the 18 events and just say, you know, in that kind of 19 detailed kind of thing to make sure the numbers are 20 not high, like our old reporting similar to Dr. Howe, 21 or in what way do you want us to make sure, I just 22 kind of want to know what the greater committee would 23 like our subcommittee to do.
24 MR. BOLLOCK: This is Doug Bollock, NRC. I 25 don't know if you want some of our perspective eye NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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72 1 and say that your current, the report you just did is 2 more helpful than a rehash of the annual reports, and 3 then perhaps like Dr. Metter said, each year if 4 something came up that is noticeable, that is 5 identified that hey, this could be a problem, to bring 6 that, to review that.
7 MEMBER ENNIS: Okay, so we will just kind of 8 review them all and if we think there's a theme we 9 want to report on or otherwise say, basically, no 10 change, subcommittee's comfortable without a bit 11 report or anything.
12 MR. BOLLOCK: Right. I can see that we do 13 that, you know, if you feed us that. I can see the 14 value in that but your report looking back at the 15 last three and a half years, this is very helpful to 16 us. I mean, I'd like to thank the subcommittee. This 17 is good information, these are things we find useful.
18 We may not say, in information notes we may 19 not say exactly what you said but it, this, this is 20 right along the lines of what we would offer in 21 information notices. This is extremely helpful to us.
22 We do appreciate that. So that's our perspective, and 23 I've got some staff I think may have some other 24 perspectives. Dr. Howe?
25 DR. HOWE: My perspective is that your NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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73 1 presentation this year was exactly what we need to 2 hear, because we go through in the spring time and 3 give you the details of each medical event.
4 One of the things I did want to bring in is 5 the regulatory perspective. We do have NRC 6 requirements that get to some of your issues. They're 7 peripheral. One would be that the licensee is required 8 to provide training for the supervised individuals on 9 what is a medical event, and on the regulations which 10 would also be the written directives and in the 11 program to ensure that administrations are in 12 accordance with the written directive.
13 Probably one of the things that we are 14 missing is we don't have that same requirement for 15 periodic training of the supervising individual, 16 because as you come into the medical practice in your 17 30s and then you get into your 60s, things have 18 changed and so it's probably still important to know 19 what is a medical event for your specialty this year.
20 Another point is that we have in our new 21 rule which will be effective in January, there is a 22 requirement under 35.40 which is your written program 23 to assure that administrations are given in 24 accordance with the written directive, that you 25 determine if there's a medical event.
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74 1 We've assumed that would happen in the 2 past, but now every time there is an administration, 3 the licensee is supposed to determine if there was a 4 medical event. So there should be more focus now on 5 what is a medical event for each of the modalities 6 and did this particular treatment meet that standard.
7 So we do have certain parts of the 8 regulation, one on supervision, one on written 9 directive, one on your written program to assure 10 administrations are in accordance with the written 11 directive, and then the medical event reporting that 12 get to some of these issues. Not exactly the issues, 13 but they do get to some of them.
14 So we could probably write an information 15 notice from that regulatory perspective. Thank you.
16 CHAIRMAN PALESTRO: Any other comments or 17 questions from attendees in the room? Questions or 18 comments from anyone on the telephone lines? Hearing 19 none, I presume it's time for the committee to accept 20 the report, is that correct?
21 MR. BOLLOCK: Yes, that's correct.
22 CHAIRMAN PALESTRO: All right. And the 23 motion is the report itself, if I'm not mistaken. We 24 need a second. Do we have a second, on acceptance of 25 this report? Seconded by Dr. Schleipman. Any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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75 1 discussion? All in favor? Any opposed? Thank you.
2 All right, the next presentation is 3 entitled Non-Medical Events, and it will be presented 4 by Mr. Sheetz.
5 MEMBER SHEETZ: This presentation will cover 6 the non-medical-related events reported by medical 7 licensees for fiscal year '17. Next slide, please.
8 This data comes from the nuclear material 9 events database for non-medical events reported by 10 licensees in both NRC and agreement states. It does 11 not include the medical events reported under Section 12 35.3045 involving patient administration errors, 13 Section 35.3047 involving unintended exposures to a 14 embryo fetus or nursing infant or other events 15 involving patient safety or harm.
16 What is included are the events reported 17 under various sections of 10 CFR parts 20,30, 35 and 18 49 CFR 171 involving leaking sealed sources, lost or 19 stolen radioactive material, personnel overexposures, 20 contamination incidents and transportation incidents 21 involving radioactive material. Next slide, please.
22 If we look at the different categories and 23 number of non-medical events occurring in fiscal year 24 '17, there were eight leaking sources, seven lost, 25 abandoned or stolen sources, four personnel NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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76 1 overexposures, four incidents with the shipment of 2 radioactive material and three radioactive 3 contaminations incidents. There are no equipment 4 malfunctions. Next slide, please.
5 This chart shows the relative number of 6 non-medical events reported by medical licensees 7 compared to the total number of NMED events for all 8 categories. You can see that they are a relatively 9 small fraction of approximately five percent. Next 10 slide, please.
11 If we look a little closer at the 12 circumstances of the events in the different 13 categories, for lost sources there were three 14 involving I-125 seeds used for radioactive seed 15 localization of non-palpable breast lesions. Two were 16 lost in the process of trying to remove the seed from 17 the tissue specimen after it had been explanted from 18 the patient, and one involved transferring a specimen 19 not knowing that it contained a radioactive seed to 20 another hospital.
21 Two involved the loss of 200 microcuries 22 Cesium-137 sealed sources used for calibration of 23 dose calibrators in nuclear cardiology. One involved 24 the loss of a 400 microCurie I-125 calibration seed 25 that was shipped in a separate lead pig from the other NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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77 1 brachytherapy seeds and so was discarded with the 2 shipping box.
3 Then there was an incident with a return 4 shipment of a 4 Curie Iridium-192 source where the 5 common carrier tracking system could not account for 6 the location of the package but it was ultimately 7 delivered back to the manufacturer. Next slide, 8 please.
9 For leaking sources, five involved the 10 Cesium-137 dose calibrator sealed sources, found to 11 have removable contamination during the routine six-12 monthly test. An Iridium-192 source had removable 13 contamination discovered during source replacement, 14 and I-125 seed was cut during removal of the seed 15 from the tissue specimen, and a P-32 flex film used 16 for brachytherapy treatment of an eye tumor was found 17 to have removable contamination at the completion of 18 the treatment. None of these resulted in the spread 19 of significant contamination. Next slide, please.
20 For shipments of radioactive materials, 21 there were three incidents where the outer surface of 22 the package containing radiopharmaceuticals coming 23 from a commercial vendor had removable contamination.
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78 1 that the contamination occurred during packaging at 2 the vendor facility. There was no noted contamination 3 of the common carriers.
4 And there was one incident where the 5 container of an Iridium-192 source was cracked during 6 transit. However, there was no loss of contents, 7 contamination or exposure to personnel. Next slide, 8 please.
9 For radioactive contamination, one incident 10 involved contamination of a hospital room from a 11 patient who was admitted and had been administered 12 200 millicuries of I-131 sodium iodide two days 13 earlier, and they did not know the patient had been 14 administered this iodine.
15 There was extensive contamination of 16 several rooms in a nuclear medicine department from 17 a child who, after being administered a capsule 18 containing 30 millicuries of iodine 131 sodium 19 iodide, removed it and held it in their hand. There 20 was also extensive contamination on the child. What 21 a mess.
22 And there was an incident resulting in 23 contamination of an interventional radiology suite 24 from the improper setup of the Y-90 microsphere 25 delivery device. Next slide, please.
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79 1 For personnel overexposures, there were two 2 overexposures to personnel from PET isotope radio-3 pharmaceutical production. These were in commercial 4 radiopharmacies, one resulting in an extremity dose 5 of 510 millisieverts and the other with a whole-body 6 dose of 110 millisieverts.
7 There was an overexposure to an engineer 8 from cyclotron repair and maintenance activities with 9 an extremity dose of 941 millisieverts and there was 10 an exposure to three non-radiation workers from the 11 release of fluorine-18 from a V vial event at a 12 commercial radioactive pharmacy cyclotron, resulting 13 in a calculated whole-body dose of approximately 112 14 millisieverts. Next slide, please.
15 There are always a number of miscellaneous 16 events that get reported to NMED which do not fit 17 into one of their defining categories. One of these 18 related to medical licensees is the detection of 19 short-lived medical isotopes at municipal waste 20 landfills or transfer stations. The radioactivity 21 gets into the waste from the body fluids of patients 22 who have been administered radiopharmaceuticals, 23 treated diagnostic or therapeutic 24 radiopharmaceuticals procedures.
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80 1 for these events. The NRC does not require them to be 2 reported and so the requirement varies from state to 3 state. In the past there have been a relatively large 4 number of events, coming primarily from four 5 different states. Up until the past year, there have 6 been averaging around a hundred reported events 7 annually. I can't explain the reason for the small 8 number in fiscal year '17.
9 I'm sure many of these events are still 10 occurring across the country. The response to these 11 events often results in either the waste being held 12 in the garbage truck for a day or two until the 13 radioactivity has decayed away or the contents of the 14 truck are unloaded and an attempt is made to locate 15 the hot waste bag.
16 If the bag is located, there may be attempts 17 to identify the originator of the hot waste, which 18 can then result in a fine or request to retrieve the 19 waste.
20 I take the time to point this out as I feel 21 these reported events are only the tip of the iceberg 22 and that a significant response effort is being 23 undertaken for something that does not present a 24 public safety hazard or risk.
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81 1 monitoring program to address this problem, where it 2 requires all waste to be monitored for radioactive 3 sources. It allows waste identified to only contain 4 short-lived medical isotopes to immediately be 5 buried. This eliminates the response efforts for 6 something that does not pose any risk to the public.
7 Next slide, please.
8 So, in conclusion I think there are a 9 relatively small number of non-medical events 10 reported by medical licensees. Types of events 11 occurring have had minimal health and safety impact, 12 and standardization of landfill radiation alarm 13 response to allow for short-lived medical isotopes to 14 be immediately buried will reduce the burden on both 15 regulators, licensees and landfill operators. Thank 16 you.
17 CHAIRMAN PALESTRO: Thank you for a very 18 interesting presentation, Mr. Sheetz. Comments or 19 questions from the committee? Mr. Sheetz, I have a 20 question for you. You may have answered it and I 21 simply didn't hear it, or you may have already 22 mentioned it.
23 In terms of the decrease in the large, 24 relatively large number of events down by more than 25 a 100 in 2014 to fewer than 20 in 2017, explanation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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82 1 for that? Have the alarms been readjusted in terms of 2 sensitivity? Or have individuals received more 3 detailed instructions about storing radioactive waste 4 or potentially radioactive waste?
5 MEMBER SHEETZ: I do not know the answer to 6 that. I just have the data from the NMED.
7 CHAIRMAN PALESTRO: Any other questions or 8 comments from the committee? Comments or questions 9 from the attendees in the room? Comments or questions 10 from anybody on the phone lines? Thank you, Mr.
11 Sheetz. I do have a question for Mr. Bollock, 12 procedural. This is not a formal subcommittee report, 13 does it need to be formally approved by the committee?
14 MR. BOLLOCK: No, there's nothing that was 15 reviewed, nothing given to us other than the 16 presentation itself, so no further action.
17 CHAIRMAN PALESTRO: Thank you. All right, 18 next presentation is the American Brachytherapy 19 Society's effort to reach out to the brachytherapy 20 community for creative corrective actions regarding 21 events that have taken place, and it will be presented 22 by Mr. Ouhib.
23 MEMBER OUHIB: Thank you, Dr. Palestro. This 24 idea came about when Dr. Howe, actually we were 25 talking about medical events, and we said maybe we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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83 1 could do something with all these medical events and 2 improve patient safety. Next slide, please.
3 So in general, basically it's a lesson 4 learned from medical events. Understand how to use 5 medical events in improving patient safety, identify 6 possible corrective actions for a known medical 7 event. What I mean by known, known with a lot of good 8 and accurate details. Look for possible preventive 9 actions to avoid such medical events, and lastly, 10 engage the brachytherapy community in improving 11 patient safety. Next slide, please.
12 I have no disclosure. Next? So, facts on 13 medical event, they're here to stay and we know that 14 no one is immune. Similar events are occurring at 15 different facilities. New events will also eventually 16 replace the old ones. You have new technologies, some 17 upgrades and things like that, or even if you 18 implement something as a corrective action, you might 19 have just introduced another possibility of a medical 20 event. So the question is, how can we prevent some, 21 and hopefully reduce others? Next slide, please.
22 Importance of information when reporting 23 events. This is addressed to the users. Need of 24 accurate information and details about the event 25 define effective solutions. Without those, we can't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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84 1 do a whole lot.
2 Details on an event before, that means 3 preconditions, during the event and certainly after 4 the event are very, very essential. When reporting 5 events, provide facts only and not personal 6 interpretation because that could be misleading 7 information. Information on the software, which 8 version's being used, the hardware, the devices, 9 application, modality, etc.
10 And certainly involve all individuals with 11 knowledge about the event. You'd be surprised when a 12 therapist can provide you some valuable information 13 that nobody thought about. Next slide, please.
14 Again, report event to regulatory agency 15 but also notify the vendor as soon as possible. And 16 there's a reason for that as far as the vendor. The 17 vendor can help you really understand what actually 18 took place. But more important, if there is a need 19 for a recall or notifying FDA, so on and so forth, 20 they are prepared to.
21 Manufacturer to alert as soon as possible 22 other users. Once a year users confirm and provide 23 some clear guidance because the user might not be 24 able to provide that. Manufacturers should resist 25 user evaluating the possible source of event, try to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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85 1 sort of guide them. Corrective action to be shared 2 with others. Next slide, please.
3 Regulators. Written and very clear 4 statements should be provided. Preliminary reports 5 should perhaps be reviewed by the user before going 6 public for accuracy. And I should add, perhaps, should 7 be viewed by the manufacturer, because perhaps the 8 user did not provide full information. Next slide, 9 please.
10 So, for both solutions there have to be 11 reasonable specific, practical, proven and have been 12 evaluated to avoid new errors. Next slide, please.
13 The medical event project basically was to 14 simply select the medical event based on its impact 15 and frequency, share the event with users for input 16 on corrective and preventive actions, tabulate the 17 solutions and share them with the brachytherapy 18 community. Solutions are reviewed by an ABS select 19 team. Next slide, please.
20 To ensure the final recommendation is 21 shared among all users so the whole peer is to really 22 have the ABS and the ABS website and available to 23 AAPM, ASTRO, IAEA, manufacturers and so on, so forth.
24 But really, our hope is to bring in all these 25 organizations into this and then work like a team, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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86 1 track these specific errors and evaluate effect on 2 information sharing. Are we seeing this error again 3 or not, or was this institution aware of these 4 corrective actions?
5 Encourage users to share similar near-6 misses errors, very similar to what just took place.
7 Maybe they almost had the same error, but maybe with 8 the information they had they were able to avoid it.
9 Next slide, please.
10 So, here's the first case, Incorrect Source 11 Transfer Tube Length. This was actually selected by 12 two of our graduate students at Florida Atlantic 13 University, and you will see their names later on. We 14 provided them with a case description basically to 15 the users, specific feedback requested from the users 16 and provided them with an email where they can send 17 the feedback. Next slide, please.
18 The intent of the project, the number one 19 was to improve patient safety. Involve as many users 20 as possible for best possible solutions, involve the 21 manufacturer for better solution improvement and 22 share solution with the community. Next?
23 Here's how the question that was proposed 24 as far as for case number one. "When you are 25 considering corrective action, try answering the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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87 1 following questions. What safety barrier failed to 2 identify the incident? What possible safety barriers 3 identify the incident? What safety barriers might 4 have identified the incident? What possible factor 5 contributed to the incident? Next slide, please.
6 That basically will lead the users to look 7 at what preventive action could stop reoccurrence of 8 a similar event Next slide, please.
9 The users' feedback was to be sent at this 10 email address, which was very creative by these 11 graduate students, PreventMedEvent@gmail.com. And 12 that was by Sarah Price and Panagiota Galanakou.
13 Excellent work. Next slide, please.
14 There's always a motivation line in jumping 15 in on something, and I recall at the most recent ABS 16 meeting there was a keynote speaker, Tom Kelly, and 17 his statement was, "Noticing that something is broken 18 is an essential prerequisite for coming up with a 19 creative solution to fix." That never left my mind.
20 It was like, you know what, this is something that 21 maybe I should embark on and take a look because 22 there's something broken out there. Next slide, 23 please.
24 I'm not going to ask you to read all this 25 but this is the information that was sent to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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88 1 users, basically. What the project is all about, and 2 so on and so forth. Next slide, please.
3 Here's a summary of the case. This was for 4 11 patients. HDR unit was commissioned with a click-5 fit A. The institution received later Miami 6 applicator with a click-fit B for all three catheters, 7 tandem and ovoid. The click-fit B is ten centimeter 8 longer than a click-fit A. One of the click-fit A 9 broke, so new plan was generated using a click-fit B.
10 The therapists were instructed to use click-fit B for 11 tandem only. There was a miscommunication and that 12 led to the use of click-fit B for all three catheters, 13 not just the tandem.
14 What was the result of such action? Those 15 from ovoids were inferior then designed by ten 16 centimeters, less goes to target and more goes to 17 normal tissue. You can see a picture down below there.
18 You can see the click-fit A being shorter than the 19 click-fit B, which is with the green marker. Next 20 slide, please.
21 Summary of case number two. This is 22 additional 57 patients that were involved. While 23 investigating the previous event, additional was 24 discovered and it led me back to the time out on 25 the very first case. If that was done, perhaps these NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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89 1 77 patients would have not been affected by that.
2 The actual total meant for click-fit B was 3 133.5. For planning purpose, this is just detail, 4 length of tandem should be 133.5 minus 1.4, that's 5 132.1. What is that 1.4 cm? That accounts for the 6 quick-connect part for the HDR unit.
7 For planning, there's a default value of 8 130 cm that was used, versus 132 for one that has 9 been measured. So the result is that the previous, in 10 addition to the previous 11 patients, actually 11 received treatment at 2.1 cm further lower than the 12 previous ten centimeters, which is about 12.1 cm. So 13 that means the dose is even lower, lower in terms of 14 anatomy-wise. Next slide, please.
15 This is the case that was sent out to all 16 users to evaluate. Next slide, please.
17 And the information regarding the error 18 tube. Next slide, please.
19 So, the same thing here, basically. I'll 20 just read you the bottom here is that, "We are eager 21 to receive your reply on how you would have dealt 22 with this situation if it had occurred in your 23 institution and what you have in place that would 24 have prevented similar events." Next slide, please.
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90 1 user, oh, this is what was sent to the users. "As 2 promised in our case 001, posted on brachytherapy 3 Brachyblast on July 31, 2018, we are eager to present 4 the feedback corrective and preventive measures that 5 we have collected from several colleagues, medical 6 physicians and radiation oncologists. At the same 7 time, it was a reminder to reader this is a case of 8 a HDR procedure where the use on an incorrect length 9 has led to a medical event." Next slide, please.
10 This is the summary, more or less, and it's 11 unfortunate that we can't see it very clear from here.
12 The feedback from you said there was corrective action 13 and there was a preventive. This is for the immediate, 14 that means short term, independent manual measurement 15 check to verify treatment length matches planning 16 length. And you'll have to forgive me, I'll have to 17 get my hard copy here. I can't read that either.
18 Okay. Policy and procedures that required 19 the medical physicist to be directly involved with 20 the treatment setup when there are any alterations to 21 the plan, HDR equipment or treatment devices. So they 22 should be directly involved in service for the 23 brachytherapy team, regarding the use of click-fit 24 with all applicators and the clinical impact when 25 using the non-planned one. What could actually NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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91 1 happen?
2 The preventive was when a different click-3 fit than manufacturer recommended click-fit is to be 4 used as a substitute with any applicator, a 5 commissioning should be performed in advance using 6 manufacturer-recommended length, confirmed of course 7 with measurement by the users.
8 All members of the brachytherapy team 9 should be directly informed regarding any 10 modification to the use of device or treatment plan.
11 In addition, the verbal instructions, written ones 12 with photos of selected click-fit set used for 13 planning should be provided for treatment setup 14 verification and delivery. That means they will have 15 some sort of a hard copy to take for the setup.
16 The physicist involved in the modification 17 of any treatment plan should directly be involved in 18 the patient setup prior to treatment. The resulting 19 setup should be independently verified by a treatment 20 team.
21 When there's any doubt about proper setup 22 and use of brachytherapy device, time out should be 23 performed and a manufacturer should be contacted for 24 clarification and recommendation prior to treatment.
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92 1 click-fits, A and B, consider retiring one set to 2 eliminate the use of the wrong one. The resulting 3 total length when connected to the selected click-fit 4 set remains a variable, and one should consider a 5 cable of thorough length for all applicators as a 6 reference for treatment planning so they will have 7 the values in front of them by the treatment planning 8 and they will know which total length should actually 9 be used. Next slide, please.
10 Long terms. Manufacturers should consider 11 redesigning the afterloader to measure in a dummy 12 sequence each treatment length and stop treatment if 13 the measured value is not within one millimeter of 14 the planning length, and I know manufacturers are 15 actually currently working on that. It has not been 16 released yet.
17 Manufacturers should move the legacy magic 18 number, the 1.4 cm difference between the actual 19 measurement of the treatment length with a quick-20 connect for Varisource IX and the actual treatment 21 length.
22 Manufacturers should remove the default 23 treatment length from the BrachyVision TPS system.
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93 1 initial or password to proceed. This will ensure 2 measurements were actually performed.
3 Click-fit should be designed and sold such 4 that they have the same length for all applicators.
5 Manufacturers should provide illustration or 6 demonstration of the possible ramification of 7 improper use in various click-fit sets. For this 8 specific example, demonstrate how using an incorrect 9 click-fit set will result in a medical event.
10 During training. Emphasis should not only 11 be on how things will work well, but also things can 12 lead to medical events. Reported event should be part 13 of the education, with demonstration. Manufacturers 14 should provide detailed demonstration or 15 demonstration of the procedure the staff should 16 follow for proper treatment.
17 And last is treatment summary. Generated by 18 the plan that will include all critical parameters 19 for treatment setup and delivery will be very useful.
20 Parameters such as patient name, applicator model, 21 click-fit set, planning length, fraction and so on, 22 and perhaps even a diagram of the setup itself. That 23 could be taken for setting up the patient and 24 verifying what's in the treatment console to make 25 sure that everything is good. I think that would be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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94 1 very helpful. Next slide, please.
2 This is what was sent to the users. "We 3 encourage our readers to continue to submit their 4 ideas to this email address, as there might have been 5 other preventive and corrective actions that we did 6 not identify. Be sure to check out our next month's 7 Brachyblast where we will present case number two."
8 We already working on case number two as we speak.
9 Next slide, please.
10 These are the acronym, and last slide, 11 please. I would like to acknowledge Dr. Howe, IAEA, 12 Debbie Gilley was very helpful in providing us the 13 medical events, Sarah Price and Panagiota, the 14 graduate students, have done a wonderful job. These 15 are the names of the users that made a huge 16 contribution to this project. Thank you.
17 CHAIRMAN PALESTRO: Thank you for your 18 presentation, Mr. Ouhib. Comments or questions from 19 the committee? I have a question for you. How often 20 are these cases sent out? Is it on a monthly basis, 21 one case per month, or ---
22 MEMBER OUHIB: The intent right now is to 23 send it on a monthly basis and that the, by the second 24 month will provide the answers. We'd like to sort of 25 delay it. So we'll provide the solutions that we came NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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95 1 up with, and in the meantime we send out the second 2 case so that way people can start working on case 3 number two.
4 CHAIRMAN PALESTRO: My second question is, 5 do you have, I assume this is just starting up, but 6 do you have a way of determining or will you have a 7 way of determining how many individuals will be 8 participating in this?
9 MEMBER OUHIB: Yes. We're tracking that, 10 actually, because we asked them to write us their 11 names, their institution, their profession, medical 12 physicist, radiation oncologist. The institution name 13 is actually optional, they don't have to, they can 14 just simply, so we're keeping that information.
15 CHAIRMAN PALESTRO: Thank you. Any other 16 comments or questions from the committee? Comments or 17 questions from attendees in the room? Comments or 18 questions from anyone on the phone lines? Dr. Ennis 19 has a comment or question.
20 MEMBER ENNIS: I just think it's great. It 21 will be really interesting to see what the feedback 22 is. It looks quite valuable. I'd be interested to see 23 how it plays out and if it really has an impact. I 24 guess the next thing would be maybe other societies, 25 particularly ones involved with technical procedures, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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96 1 I'm thinking Y-90 maybe, might want to mimic this in 2 some way.
3 MEMBER OUHIB: Yes, we actually, I had 4 personally approached the AAPM and we've been talking 5 about this, and there is an interest in that. We're 6 hoping to sort of join forces and hopefully maybe 7 we'll get ASTRO and ISTRO, who knows? Because keep in 8 mind, this is not just going to the US, this is going 9 worldwide because the IAEA will put this on their 10 website also. So there are people who are going to be 11 seeing it in, you name it, so this information 12 hopefully will help a lot of people.
13 CHAIRMAN PALESTRO: Dr. Suh?
14 MEMBER SUH: Excellent presentation. How 15 receptive do you feel the vendors will be with your 16 short term and long term action plans? Obviously the 17 vendors can help out a lot. We had heard from Mike 18 O'Hara that software failure being reached in therapy 19 treatments.
20 MEMBER OUHIB: They have been very 21 receptive, let me just tell you this. They were 22 willing to assist us and provide us information that 23 we're looking for. I can tell for case number two, 24 for instance, the vendor has already done a 25 presentation for us on the case itself and said, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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97 1 here's actually what took place, and we intend to 2 talk to them some more.
3 I think, at least from my point of view, 4 this will only help the manufacturer, basically.
5 Because we're here to say okay, here's what's going 6 on, here's what we think happened, what do you think 7 you could do to prevent this or whatever? And they 8 might have some suggestion, recommendations or 9 whatnot, but this is helping everybody. Really, 10 everybody for one and only one cause, improving the 11 patient safety. Nothing more, nothing less.
12 It is not by making a manufacturer look 13 bad, it is not by making an institution look bad, or 14 a physicist or a radiation oncologist because we don't 15 even touch those names at all. We focus on the process 16 itself. How did it happen and can we prevent this?
17 What can we do to avoid such error, and how can we 18 inform somebody else from not doing it, and what's 19 the best way to do this?
20 So we're hoping that this information will 21 go to all website, hopefully, and then people, medical 22 organizations and people will learn from them. I don't 23 know how we're going to keep up with this, because 24 eventually these graduate students will move on with 25 their lives and we have to figure out a way.
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98 1 But let me just tell you another thing, is 2 that we also hoping to capture experts for different 3 manufacturers and identify them like the expert team, 4 and then that we we'll go to them and say okay, here 5 are all the solutions that we have gathered. What are 6 your thoughts? And they might say, well, yeah, this 7 is good but guess what? This isn't going to work and 8 here's why, and so on, so on.
9 So we don't just make a decision and put 10 that information there. We run it by all these experts 11 and see what they think, and then we finally tabulate 12 that and then provide it to users.
13 CHAIRMAN PALESTRO: Any other comments, 14 questions? Again, thank you, Mr. Ouhib. At this point 15 we are ready to go into break unless, Mr. Bullock, 16 are there any loose ends that need to be tied up 17 before we recess?
18 MR. BOLLOCK: No.
19 CHAIRMAN PALESTRO: All right then, we will 20 reconvene at 2:45. Thank you.
21 (Whereupon the above-entitled matter went 22 off the record at 2:03 p.m. and resumed at 23 2:45 p.m.)
24 CHAIRMAN PALESTRO: All right. It's 2:45, 25 and we're going to resume. The first presentation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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99 1 will be given by Dr. Metter, and it's entitled 2 "Training and Experience for All Modalities: The 3 Update of the Subcommittee." Dr. Metter?
4 VICE CHAIRMAN METTER: Thank you, Dr.
5 Palestro. I'm Darlene Metter, and I'm giving the 6 report on the Subcommittee on Training and Experience 7 for All Modalities. Now, I'd like to thank the 8 members of my subcommittee: Dr. Philip Alderson, Mr.
9 Michael Sheetz, Megan Shober, Dr. John Suh, and Ms.
10 Laura Weil.
11 Now, the Training and Experience 12 Subcommittee, or the T&E Subcommittee, created a 13 standardized approach and template for T&E review.
14 They completed the review of 10 CFR 35.100. However, 15 a concern was raised about patient access, so 10 CFR 16 35.300 and specifically 10 CFR 35.390 was expedited 17 for review.
18 During our March 2018 ACMUI conference, 19 public teleconference, there was a new concern that 20 was raised by the subcommittee and that was the 21 potential for future shortages of AU for therapy, and 22 this resulted in two recent developments at the time, 23 the first being the FDA approval for 177 Lutetium 24 dotatate which has a wide broad-spectrum of therapy 25 indications and, thus, may increase the therapeutic NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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100 1 procedures; and, number two, there was a concern for 2 decrease of the number of candidates sitting for the 3 initial American Board of Nuclear Medicine 4 certification exam.
5 So the T&E Subcommittee's concern with the 6 idea of potential increase in procedures with a 7 concurrent decrease in authorized user had a 8 potential future AU shortage. So their 9 recommendation at this time was to reconsider an 10 alternate authorized user pathway for therapy.
11 So what is the current status? Well, as 12 you know, in August of 2017, there was a revision of 13 10 CFR Part 35, and the Commission tasked the NRC 14 staff to investigate the feasibility of a limited 15 authorized user pathway specifically for 16 radiopharmaceutical therapy. The Commission 17 requested that there be an update every six months 18 with the first report to be given this past August in 19 2018.
20 So what were the tasks for a limited AU 21 pathway? Well, the first one was is it feasible 22 to have a limited AU pathway for certain 23 categories of radiopharmaceuticals? And if so, 24 how were we to develop these categories? And 25 with these categories, what would be the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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101 1 appropriate training and experience 2 requirements? And lastly and very importantly, 3 how could you assess competency that the 4 knowledge and skills obtained would be able to 5 be used in a competent fashion on patients and 6 would this be based on the number of training 7 and experience hours or by an objective measure 8 such as an examination?
9 So the NRC staff started to assess the 10 feasibility of a limited AU pathway with tailored 11 training and experience and documentation of 12 competency. And at this point in time, they are 13 continuing their broad stakeholder input.
14 Next slide. So the staff, NRC staff 15 developed a draft of the potential knowledge topics 16 needed for an authorized user for therapy, and they 17 started with 10 CFR 35.390 and there was subcommittee 18 input.
19 As I mentioned, the proposed curriculum 20 incorporated, it started off with the knowledge 21 topics of 10 CFR 35.390 as a starting point, and these 22 could potentially be tailored to the specific 23 radiopharmaceutical that was going to be looked at 24 for therapy with potential need for additional 25 knowledge topics, depending on what the agent was.
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102 1 Next slide. However, due to time 2 constraints, there was an initial stakeholder 3 outreach which was limited.
4 So what were the results? With the initial 5 stakeholder response, pretty much the majority agreed 6 that there needs to be a fundamental and specific 7 radiopharmaceutical knowledge in 10 CFR 390 to safely 8 administer radiopharmaceuticals. That was pretty 9 much the majority of stakeholder input.
10 How to obtain this knowledge? There were 11 many varied responses. How to evaluate the 12 independent application of this knowledge, and this 13 was also very varied in the responses obtained.
14 Next slide. There were many stakeholder 15 concerns, and some of these included how to categorize 16 a radiopharmaceutical. How were these training and 17 experience requirements going to be administered, and 18 how many hours would it take to have adequate training 19 and experience? And, lastly, how to assess 20 competency? Were they going to develop an exam, 21 perhaps by the medical community or medical specialty 22 boards, or was a preceptor attestation needed, and 23 perhaps maybe there may be new certification boards 24 that would need to be created.
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103 1 this initial stakeholder input came to the conclusion 2 that it may be feasible to develop a limited AU status 3 for certain radiopharmaceuticals with tailored 4 training and experience and a competency-based 5 assessment of the knowledge and skills obtained. So 6 the ACMUI subcommittee reviewed this, and we agreed 7 with the broadest stakeholder outreach was needed for 8 the potential limited AU status. And with this, they 9 needed to define the radiopharmaceutical categories.
10 What were going to be the limited training and 11 experience requirements? And the competency 12 assessment for knowledge and skills obtained would 13 need to be very carefully looked at.
14 The subcommittee review agreed that you 15 need collaboration with the medical community in 16 developing competency-based assessment tools and that 17 the subcommittee also warned that minimizing training 18 and experience may jeopardize patient, staff, and 19 public safety.
20 Next slide. The subcommittee also looked 21 at the issue of an AU shortage, and it looked at it 22 and said that the initial, there was initial 23 underestimation of available AUs for 10 CFR 35.390.
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104 1 training, and this included radiation oncology, 2 nuclear medicine, nuclear radiology and the 3 redesigned American Board of Radiology pathway. The 4 America Board of Osteopathic, for Osteopathic 5 Radiology has about 150 to 200 trainees at this point 6 in time with about 30 to 40 authorized users 7 graduating every year. So you're looking at over a 8 thousand authorized users in training.
9 Next slide. So the subcommittee reviewed 10 that the feasibility of an alternate pathway, despite 11 the number of authorized users that are currently in 12 training, should still be explored. There was a 13 concern about estimating the number of hours of 14 training and experience required, and the training 15 and experience requirements should be based on the 16 necessary knowledge and skills and not on hours and, 17 therefore, should be based on competency.
18 Next slide. So the subcommittee 19 recommended that we review the existing authorized 20 user pathways to maintain safety, maximize patient 21 access, and clearly define the authorized users' 22 scope of practice. The training and experience must 23 be inclusive. It must have a comprehensive coverage 24 of radiation physics, radiation biology, radiation 25 instrumentation and mathematics, radiation protection NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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105 1 and safety, patient release, and applicable 2 regulations at the federal and state level and 3 information on medical events. Authorized user 4 competency must be determined objectively for not 5 only initial assessment but ongoing maintenance of 6 competency, and we strongly agreed that a greater 7 stakeholder input is needed.
8 So what are the subcommittee 9 recommendations? Recommend the NRC staff should 10 monitor potential AU shortage for 10 CFR 35.300 to 11 include geographic data and perhaps practice patterns 12 as part of the monitoring process.
13 Next slide. So the current plans for the 14 subcommittee is to work with the NRC staff to expand 15 the stakeholder outreach and to explore the 16 feasibility of a limited AU pathway or pathways.
17 Next slide. The subcommittee's future 18 work. We plan to work with the NRC staff if the NRC 19 plans to propose changes to the current training and 20 experience requirements as a result of this broad 21 reassessment.
22 Next slide. Future work. We need to look 23 at the training and experience. What are the core 24 requirements? What is going to be the adequate 25 acquisition and application of the knowledge and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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106 1 skills obtained for the appropriate 2 radiopharmaceutical use and administration of the 3 radiopharmaceutical while ensuring patient, staff, 4 and public safety? The subcommittee plans to 5 continue to work with the NRC staff to determine how 6 best to assess competency.
7 And these are the acronyms we used. Thank 8 you.
9 CHAIRMAN PALESTRO: Thank you, Dr. Metter.
10 Members of the subcommittee have any comments, 11 questions? Members of the ACMUI, any comments or 12 questions? Dr. Dilsizian?
13 MEMBER DILSIZIAN: A very nice 14 presentation. So I'm thinking about this, and it 15 seems to me that you've all agreed, the subcommittee, 16 that an alternate pathway is a reasonable thing to 17 do. So, therefore, the whole training of whether 18 there's enough physicians out there, radiologists or 19 radiation oncologists, nuclear medicine physicians, 20 is really not the issue. You've kind of accepted the 21 philosophy in several slides that it's reasonable to 22 explore an alternate pathway. Is that a fair 23 beginning? Because then I would like to continue if 24 that's the --
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107 1 all, as far as the question of AU shortage, there is 2 not, I mean, that we'd foresee as a shortage now or 3 in the future. And as far as the feasibility, we 4 still thought that perhaps we should still look at 5 the feasibility of a limited authorized user 6 pathway, which is looking at the feasibility of it.
7 MEMBER DILSIZIAN: Exactly. So if that's 8 where we're going to start, the next question is that, 9 in several places, we're talking about hours and 10 competency to administer this safely, the words are 11 safely, and that we shouldn't be limited on hours 12 alone but plus some type of an examination. I think 13 the way I'm seeing this is that the oncologist or 14 whoever it's going to be going through this alternate 15 pathway, I don't think they've asked us to change the 16 requirements of the training. The whole radiation 17 biology, radiation physics, all of those things are 18 there.
19 I think the question that's always come up 20 is that do those educational pathways translate to 21 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> or less? And all that they're, I think, 22 asking us is to say please define is it 600, is it 23 500 or 400? I don't think they're asking us to kind 24 of give a crash course so that they be less safe to 25 patients. I think that we should be respectful that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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108 1 these are physicians that have had medical school 2 degrees, three years for medicine, three years of 3 oncology. I don't think they're going to be 4 irresponsible physicians, shall we say. They're 5 simply saying please define what is a reasonable 6 number of hours, and they're not even saying that it 7 should be 80. They're simply saying define the 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />.
9 So from my perspective, I'm simply looking 10 at this and saying why don't we just take the 11 curriculum because nobody has defined 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, how 12 we came to that number, but in a reasonable way come 13 up what is the number and simply provide that. Am I 14 missing something?
15 VICE CHAIRMAN METTER: The subcommittee is 16 looking at that, you know, as far as the core 17 knowledge, like you said, that has to be obtained.
18 And then we're looking at that other issue you spoke 19 about. But it's very difficult. Again, the bottom 20 line is going to be, with that basic knowledge and 21 skills that you need for therapy, how are you going 22 to assess competency? It's going to be based on 23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br />, which is very difficult, versus another type 24 of assessment.
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109 1 define anybody's competency is the number of years of 2 training as a cardiologist or as a surgeon or a 3 radiation oncologist and then you pass board 4 certification. Why don't we just simply apply what 5 we always do? Give certain number of minimum hours 6 for the trainees to be educated and then give them a 7 competency test like we always do? I don't think it 8 should be that complicated. I don't think it's one 9 or the other. I think it should be both.
10 CHAIRMAN PALESTRO: Dr. Dilsizian, just to 11 comment. In point of fact, the stakeholders who are 12 looking and seeking the so-called limited alternative 13 pathway were quite clear about the number of hours 14 and they suggested that 80 hours was more than 15 sufficient. So there was an hour issue.
16 Any other comments or questions? Mr.
17 Green?
18 MEMBER GREEN: I appreciate the very 19 thorough review of the proposal and it's just the 20 beginning of the process to, you know, figure it out.
21 I'm excited by drugs. I'm a drug dealer. I 22 shouldn't have said that, huh?
23 MEMBER ENNIS: Unusual to acknowledge it 24 in a federal facility.
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110 1 license to sell drugs. But Lutetium 177 was remarked 2 in your presentation. Since our last meeting in 3 April, the FDA has approved a new therapeutic I-131, 4 iobenguane. Azedra is the brand name. So we have 5 another therapeutic 35.300 drug. I don't know if 6 it's going to go crazy, but it's another drug in the 7 armamentarium of physicians to treat patients, and 8 there will be more following those footsteps.
9 CHAIRMAN PALESTRO: Mr. Ouhib?
10 MEMBER OUHIB: Yes. I think we need to be 11 careful about, you know, new procedures are coming 12 along the line to justify or to jeopardize the safety 13 of treatment, in my opinion. I think we need to 14 separate them completely.
15 I think when you go to training and 16 education, it's only getting, I would say, better. I 17 wouldn't say worse. It's getting better. I mean, I 18 look back, as a medical physicist looking back, that 19 I used to spend two years or whatever and I can get 20 my master's degree and I can jump and -- you can't 21 get that anymore. You get your degree and you have 22 to go and do a residency program. That's a two-year 23 program to actually be qualified and, of course, pass 24 the board to actually be a qualified medical physicist 25 out there in the field.
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111 1 So I think we need to be careful. I'm 2 almost like, you know, is 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> enough really?
3 Is it enough? You know, I'm thinking the other side.
4 I'm not looking on the lower side, I'm looking on the 5 higher side probably. So I think we need to pay 6 attention to that.
7 CHAIRMAN PALESTRO: Any other comments?
8 Dr. Ennis?
9 MEMBER ENNIS: Just echoing the things 10 here. I think thinking about competencies and 11 defining a curriculum, you know, is a very reasonable 12 response and way to move forward. I doubt that will 13 translate into something that's easily achievable, 14 but potentially a specialist who really wants to 15 genuinely do this and become their niche? Maybe.
16 But I do think we're being asked to kind of really 17 define a real curriculum.
18 But I want to echo what Zoubir said.
19 There's no doubt it's not enough to have book 20 knowledge, and any alternative pathway is going to 21 have to require some significant apprenticeship. You 22 know, three cases, let's say, which is kind of a 23 common kind of, like, thing in some of the regulations 24 to have a specific new authorization, is clearly not 25 enough. You're never going to see all the mistakes, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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112 1 all the errors, all the problems. So we're going to 2 have to think about that aspect, but I think that 3 that's going to be a crucial element to this, some 4 substantial apprenticeship.
5 CHAIRMAN PALESTRO: Other comments, 6 questions, from the committee? Dr. Suh?
7 MEMBER SUH: So first of all, thanks, Dr.
8 Metter, for that excellent presentation. So this is 9 a question of what's going to be considered safe, 10 also by quality, protecting the public, protecting 11 the patients, etcetera. And, obviously, the 12 stakeholders kind of have different interests in 13 terms of what qualifies for a sufficient number of 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br />.
15 I guess my commentary would be that, in 16 terms of the minimum amount, I think we all agree 17 that the minimum amount should include all the 18 knowledge of radiation biology, physics etcetera.
19 And then the big question becomes how much experience 20 does one need?
21 What I would advocate for is the fact that 22 a radiation oncologist lives and breathes x-ray 23 treatment day-in and day-out, a nuclear medicine 24 physician lives and breathes x-ray treatment day-in 25 and day-out, I think there is a particular value to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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113 1 that when you're delivering therapy. My concern 2 would be that if you have a urologist or a medical 3 oncologist whose primary instrument, urology is 4 surgery, medical oncology is chemotherapy, are they 5 going to have the same insight, knowledge, that one 6 would glean from a four or five-year residency program 7 compared to someone who has a, I'll just use a number, 8 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br />' worth of experience? I don't know, and I 9 think that -- and then I would just ask the committee 10 to really think about that long and hard because if 11 we do decide to make a change and quality and safety 12 become worse, then we're going to kick ourselves, you 13 know, we did the wrong thing.
14 So I would just ask everyone to think about 15 that in terms of if we do make the change, and, again, 16 maybe there's a number that we can come up with, but 17 is that going to be the right number? Therapy is 18 very different than diagnostics, and I think that's 19 very -- and that's been said multiple times in the 20 eight years I've been on this committee is therapy 21 and diagnostics is very different, and now we've been 22 asked to make some comments about can we change the 23 limited scope? I would just be very careful about 24 that moving forward.
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114 1 you. Are you suggesting that perhaps individuals, 2 assuming there were a limited AU pathway, that 3 individuals who go down that path would be required 4 to have more clinical experience in therapeutic 5 administration than someone who's gone through the 6 deemed board pathway?
7 MEMBER SUH: That may be one implication.
8 I'm not saying I'm right or wrong about that, but I 9 think the fact that someone grows up with radiation 10 and knows what's involved with it versus someone who 11 takes it as secondhand -- and I'm not saying anything 12 negative about what other specialists can do. Again, 13 that's just a concern I'm bringing up. I'm not saying 14 I'm completely against an alternative pathway. I'm 15 just mentioning this is something we need to think 16 about as a subcommittee and also as a committee, as 17 well, moving forward.
18 CHAIRMAN PALESTRO: No, I wasn't suggesting 19 that it was negative. Going through in my mind to 20 think if there's a parallel or analogous occurrence 21 in other areas of medicine. And I apologize that I 22 don't remember the numbers exactly, but when PET-CT 23 first exploded onto the scene, the various societies, 24 nuclear medicine societies, the radiological 25 societies, tried to put together or did, in fact, put NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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115 1 together white papers describing the amount of 2 experience that would be required or recommended for 3 an individual to be proficient at reading these 4 studies. And if I remember correctly, and if anyone 5 knows different please correct me, but, if I remember 6 correctly, there were a substantially larger number 7 of studies that should have been read by the nuclear 8 physician, non-radiologist nuclear physician, in 9 order to gain proficiency in the cross-sectional 10 imaging comparable to what the radiologist would 11 have.
12 So there was a discrepancy or discordance 13 in a number of cases with a logical explanation. So 14 if, in fact, that's what you are suggesting or raising 15 as a possibility, I think there's precedent for that.
16 CHAIRMAN PALESTRO: Other comments or 17 questions?
18 VICE CHAIRMAN METTER: This is Darlene 19 Metter again, and thank you for your comments, Dr.
20 Suh. The committee is looking into the idea of the 21 clinical aspect because with a list of agents that 22 are coming up in the pathway, as far as for therapy, 23 they have multiple complex entities that need to be 24 involved, a lot of teamwork, a lot of different things 25 you have to be careful about. And so the committee NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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116 1 is looking at that and is concerned about the clinical 2 experience, too.
3 CHAIRMAN PALESTRO: Mr. Sheetz?
4 MEMBER SHEETZ: I just wanted to express 5 one of the radiation safety concerns with this limited 6 scope alternative pathway for radiopharmaceutical 7 administration. Currently, they're being 8 administered within a nuclear medicine department or 9 a radiation oncology department, and there's other 10 support staff, nuclear medicine technologists, 11 medical physicists, medical health physicists, even 12 RSOs. And so it's really a team approach on these 13 administrations. Everybody has their role.
14 With the current medical specialties that 15 are interested in doing this, they don't normally 16 practice with these other specialties. And so I'm 17 not sure how they would accomplish a lot of the duties 18 that normally are delegated from the AU to the 19 technologist or to a medical physicist or medical 20 health physicist.
21 And so there's just an unknown there on how 22 that would be accomplished. It's not just, you know, 23 brushing the plunger and administering the 24 radioactive drug. It's the whole thing from the 25 receipt, the essay, setting up the administration, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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117 1 responding to spills potentially, and so forth. So 2 it's a much bigger picture than just a quick 3 administration of a unit dose.
4 CHAIRMAN PALESTRO: Dr. Martin?
5 MEMBER MARTIN: I would just reiterate what 6 Mr. Sheetz has been saying. We cover, my physics 7 group covers several hospitals that do these 8 treatments, and in every one of them it involves the 9 physicist being there, as well as the nuclear medicine 10 technologist being there, and all of that staff work 11 has to be in place.
12 I haven't read them and I don't know all 13 the details, obviously, being new. But what I have 14 read is the proposals I don't hear being made for 15 working with the staff. I hear, like, an independent 16 physician wanting to provide these services in 17 smaller community hospitals without that support 18 staff, and I would just reiterate I think it could 19 very well be a hazard because that support staff is 20 not going to be there. And from what I've seen, we 21 find it absolutely crucial to have the nuclear 22 medicine's technology staff and the physicist 23 involved.
24 CHAIRMAN PALESTRO: Mr. Ouhib?
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118 1 item that we should not forget is it is not just a 2 matter of doing an injection or anything like that.
3 There's a patient management after that for patients 4 that have had radioactive material. It's another 5 critical component that require another education and 6 so on and so forth.
7 CHAIRMAN PALESTRO: Any other comments?
8 MEMBER DILSIZIAN: Just was wondering, you 9 know, at a site of nuclear medicine, you know, we're 10 talking about even radiation oncologists, thinking 11 about that, given that the therapy choices are going 12 to be increasing, that, even within our training that 13 we may have, an additional year just dedicated for 14 therapy.
15 So would the subcommittee consider then --
16 again, I'm not saying to do 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. Just consider 17 that if you are coming in as an oncologist with 18 having, again, three years of internal medicine, 19 three years of oncology experience of managing sick 20 patients, what if they would like to have the 21 alternate pathway to be one year of fellowship in 22 therapy? Would you, as a committee, consider it?
23 It's not shortening the pathway. It's actually 24 spending a year learning and they want to be good 25 citizens treating their patients.
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119 1 So I'm just trying to understand what the 2 alternate pathway is, which is why I started saying 3 if you accepted that then you have to define what is 4 that alternative pathway.
5 VICE CHAIRMAN METTER: Thank you for your 6 comments. This is Darlene Metter. There is an 7 alternate pathway already. It's the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> with 8 the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of knowledge in didactics and laboratory 9 and the 500 of clinical. So that is the alternate 10 pathway. So as far as what you're saying, I think 11 this already exists.
12 I think the other thing, too, is, you know, 13 as far as I know, issues have been brought up in 14 regards to patient-ready doses and you don't, you 15 know, that sort of issues. But the thing is that is 16 what? It's the what if. What if this happened? You 17 really have to have the ability to handle the what 18 ifs, and that's why I think it's very important to 19 have the knowledge and the skills and the experience 20 to handle these. These therapies are going to get 21 more complicated, so, at this point in time, you know, 22 I'd be a little bit concerned in shortening the 23 clinical experience because of the other entities 24 that are coming up the pathway, which are a fair 25 number.
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120 1 CHAIRMAN PALESTRO: Any other comments, 2 questions, from the committee? Comments or questions 3 from the attendees?
4 MS. TOMLINSON: Good afternoon. I'm Cindy 5 Tomlinson with ASTRO. So, Chairman Palestro, ACMUI, 6 NRC staff, thank you for allowing me to provide this 7 statement on behalf of ASTRO.
8 I'm responding to the staff paper entitled 9 "Staff Evaluation of Training and Experience 10 Requirements for Administering 11 Radiopharmaceuticals." As we've commented in the 12 past, in past statements to the ACMUI, we strongly 13 oppose any reduction in the training and experience 14 requirements found in 10 CFR 35.390. ASTRO believes 15 that the requirements found in this section are 16 appropriate, protect the safety of patients, the 17 public, and practitioners, and should not be changed.
18 Radiopharmaceuticals are highly effective 19 in treating cancer with possible harmful effects to 20 both the patient and the public if not used correctly 21 and under the supervision of a highly-trained 22 physician. We are pleased that in its report the NRC 23 staff determined that the current requirements of 200 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom and laboratory training hours 25 prescribed under the alternate pathway is reasonable NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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121 1 to acquire the fundamental knowledge that an AU would 2 need to administer any radiopharmaceutical.
3 However, we are concerned that tailoring 4 the number of hours to work experience, of work 5 experience required based on categories of 6 radiopharmaceuticals will lead to confusion and 7 complexity for both licensees, as well as the NRC and 8 agreement states. We are concerned, we are also 9 concerned that if new radiopharmaceuticals are 10 approved for use that do not fit into one of these 11 categories the NRC will have to promulgate additional 12 regulations to include these new agents, a process 13 that could take time to finalize, delaying patient 14 access to potentially life-saving 15 radiopharmaceuticals.
16 The rigorous T&E requirements contribute to 17 the excellent safety record of radiopharmaceuticals.
18 We believe that it is important that the person 19 administering the radiopharmaceutical is 20 appropriately trained in the safe handling, exposure 21 risks, and the management of side effects of 22 radiation.
23 We continue to believe that a thorough and 24 comprehensive review of current T&E requirements is 25 reasonable. Additionally, we fully support a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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122 1 thorough examination of geographic distribution and 2 practice patterns of current AUs under both 35.300 3 and 35.390, as well as seeking greater stakeholder 4 input.
5 As we've mentioned in previous statements, 6 the American Board of Radiology estimates that 7 between 2007 and 2017 approximately 650 radiation 8 oncologists were certified by the ABR with an AU 9 eligibility designation and may become AUs. In 10 addition, we estimate that there are approximately 11 2200 radiation oncology facilities in the United 12 States. Together with current radiation oncology 13 AUs, the 773 radiation oncology residents currently 14 in residency programs and nuclear medicine-trained 15 AUs nationwide, there are likely enough AUs to 16 administer radiopharmaceutical. We caution that 17 changing the current requirements without a 18 comprehensive investigation could result in 19 unintended harm to patients, personnel, and the 20 public.
21 We look forward to working with both the 22 ACMUI and the NRC as you continue your deliberation 23 and review. And I will submit these written comments 24 to staff.
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123 1 comments from attendees?
2 DR. GHESANI: Yes. This is Munir Ghesani?
3 Can you hear me? Hello?
4 CHAIRMAN PALESTRO: Yes, we're taking 5 comments at the moment from attendees here in the 6 room, so we will just hold on for a few minutes.
7 DR. GHESANI: Okay.
8 DR. RAZMARIA: Hi, Mr. Chairman, members 9 of NRC and ACMUI. My name is Aria Razmaria. I'm a 10 senior resident in nuclear medicine and in my final 11 year of training at UCLA Medical Center in California.
12 I'm also the recipient of the Robert Henkin Fellowship 13 of Government Relations with Society of Nuclear 14 Medicine and Molecular Imaging. I speak here on 15 behalf of myself and also on behalf of trainees in 16 nuclear medicine and combined programs in nuclear 17 medicine and radiology as a board member of a nuclear 18 medicine resident organization and fellows 19 organization.
20 I am a graduate of a medical school in 21 Vienna, and I'm trained in family medicine and urology 22 in addition to nuclear medicine. I came to U.S.
23 inspired by the cutting-edge science and excellence 24 in patient care. However, what we are witnessing in 25 nuclear medicine in U.S. is that U.S. is falling NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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124 1 behind at the global level behind many other countries 2 in Europe and Australia. Many new advancements in 3 the field of nuclear medicine, for example in 4 diagnostics, are coming from outside the U.S. The 5 vast majority of research published in U.S.
6 scientific journals are from countries other than 7 U.S.
8 In many instances, patients travel across 9 the Atlantic to receive life-saving or life-10 prolonging therapeutics which are not available in 11 U.S. This is despite the fact that nuclear medicine 12 was invented and first developed in U.S.
13 Losing training requirements will not solve 14 these problems. The reason these countries are ahead 15 of the game are because of a clearly-defined pathway 16 to nuclear medicine and the scope of practice. We 17 in the U.S. are in dear need of dedicated people in 18 nuclear medicine who are thoroughly trained and are 19 eager to push the field of nuclear medicine forward, 20 not people that practice nuclear medicine as a side 21 trade.
22 We, as nuclear medicine and nuclear 23 medicine radiology trainees, are ready and determined 24 to face this challenge and this calling in this 25 country. We oppose any attempts of minimizing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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125 1 training or pathways to nuclear practice of nuclear 2 medicine on limited authorized user pathways or 3 alternate user pathways based off hypothetical 4 concerns of shortage of workforce. This would be 5 similar to equating a specialty training of three 6 years to 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, which is not more than four months 7 of training or less.
8 We would dare to ask if any of our loved 9 ones would be need of receiving radiopharmaceuticals.
10 We rather would consult with an expert who has three 11 years of training versus four months of training.
12 Even in Code of Federal Regulations, 10 CFR 13 Part 35 pertaining to administering of sealed 14 sources, we see as requirement three years and that's 15 rightfully and appropriately three years of training 16 in radiation oncology. Why are we applying different 17 standards in terms of usage of unsealed sources, 18 whereas these agents are distributed to the whole 19 body.
20 Regular considerations of this scope 21 infringe upon autonomy of medical specialties and are 22 in contradiction to evidence-based practice of 23 medicine. In an era of increasing sub-24 specialization, diminishing sub-specialization 25 training and experience requirements appears NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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126 1 irrational.
2 In this regard, we point to recent 3 guideline recommendations by International Atomic 4 Energy Agency as put forward in the most recent 5 meeting in Vienna in June of 2018 which requires as 6 a standard international requirement three to four 7 years of training in nuclear medicine, 3,000 cases of 8 300 or 100 therapies that have been administered.
9 As nuclear medicine and nuclear medicine 10 radiology trainees, we see this regulatory 11 concentration as undermining existence of nuclear 12 medicine as a viable specialty in the U.S., our future 13 as a new generation of nuclear medicine physicians 14 and, above all, endangering highest level of care for 15 our patients.
16 During my fellowship in government 17 relations, I have visited institutions like NIH, NCI, 18 FDA, the Capitol, and I met with patient advocates 19 organizations. I've learned about fascinating new 20 groundbreaking research pertaining to nuclear 21 medicine and molecular imaging at a national level 22 and the readiness of institutions like FDA to provide 23 guidance to take these new discoveries through the 24 regulatory process. I've learned about the support 25 of legislation, representatives, and alliance of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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127 1 patient advocates.
2 Nuclear medicine and nuclear imaging is not 3 about shipping one unit dose across the country to be 4 injected or a pill to be swallowed, rather a new age 5 of targeted and individualized paradigm in 6 radionuclide therapies with exact personalized 7 calculations of radiopharmaceutical therapy with 8 evaluation of indication, sequence of therapies, 9 dosimetry calculation, follow-up of treatment which 10 requires in-depth understanding, and intricacies of 11 the new novel treatments.
12 Thank you for your attention.
13 CHAIRMAN PALESTRO: Thank you. Any other 14 comments from attendees in the room?
15 MR. GUASTELLA: Thank you, Dr. Palestro.
16 I don't have any written comments. I did make some 17 notes. I thought I'd just offer them for the ACMUI 18 to consider.
19 I'm Michael Guastella. I'm the Executive 20 Director of the Council on Radionuclides and 21 Radiopharmaceuticals. And as many of you may know, 22 CORAR does support an alternative to the current 700 23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br />. We were actually one of the stakeholders in 24 the limited outreach that Dr. Metter had mentioned a 25 few minutes ago.
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128 1 And we did, to your point, Dr. Palestro, 2 did provide an overview and kind of scoped out an 80-3 hour program for AU certification. And in doing 4 that, we kind of had several considerations. One, 5 the limited role in handling patient-ready doses that 6 are provided from nuclear pharmacies. Dr. Metter, 7 you had actually mentioned that as one of the things 8 that had been considered and have been commented on.
9 The safety profiles of the radiopharmaceuticals, 10 mostly that these alpha and beta emitters that are, 11 if not already approved, certainly in the pipeline 12 and, importantly we certainly believe is the 13 physician experience for like a hem-onc, for example, 14 in handling chemotherapy drugs, toxic chemotherapy 15 agents.
16 And we've had conversations and have 17 presented to the ACMUI over the last several years.
18 I think one thing to consider, and I'm very sensitive 19 to the safety issues that have been raised by a number 20 of you here today in this meeting, but prior to 2005 21 there were some med-oncs, chem-oncs, that actually 22 were grandfathered in, and we had a couple of 23 presentations made a few years back. And as part of 24 the consideration and the evaluation, it might be 25 helpful to go back and see how those professionals NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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129 1 are doing relative to administering to their 2 patients, if they are depending on local nuclear 3 medicine departments, for example. I can't answer 4 that question today, but I think, in trying to be as 5 comprehensive as possible in your evaluation, these 6 are the types of things that you may want to consider.
7 So I appreciate your time. Thank you.
8 CHAIRMAN PALESTRO: Thank you. Any other 9 comments, questions, from anybody here in the room?
10 Comments, questions, from anyone on the telephone 11 lines?
12 DR. GHESANI: Hi, Dr. Palestro. This is 13 Munir Ghesani. Can you hear me?
14 CHAIRMAN PALESTRO: Yes, we can. Thank 15 you.
16 DR. GHESANI: Okay. So good afternoon.
17 I'm a physician from NYU and board certified in both 18 radiology and nuclear medicine. And today I'm 19 speaking on behalf of the Government Relation 20 Committee and the SNMMI in general. And we in SNMMI, 21 along with the American College of Nuclear Medicine 22 and the American Society of Radiation Oncology --
23 you've heard already from Cindy Tomlinson -- we have 24 formed an ad hoc committee to offer the collective 25 recommendations for the potential updates to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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130 1 Nuclear Regulatory Commission's requirements.
2 We identified some clinical knowledge and 3 skills needed by individuals seeking authorized user 4 status with the alternate pathway, and, as Dr. Metter 5 already described, there's already one in existence 6 with the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.
7 With regards to the training and experience 8 in the initial determination of competency, it is our 9 opinion that the mastery of the curriculum listed 10 below will ensure high-quality practice of 11 radionuclide therapy. This didactic instruction is 12 important for safe and effective therapies and should 13 not be minimized.
14 The use of unsealed sources for the 15 therapeutic applications is complex and has serious 16 medical and safety risks associated with it, not only 17 for the patients but also their family and public at 18 large. As such, we feel that it is important to 19 maintain this high quality of training and 20 experience.
21 We heard a few comments about how stringent 22 some of these training requirements are, spanning for 23 several years. So if we know that that has ensured 24 the safety, why take a risk in minimizing the 25 requirement and have the aftermath of some of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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131 1 complications?
2 Now, my colleague, Michael Razmaria, 3 mentioned about the possibility of exploring the 4 experience of the previous grandfathered medical 5 oncologists, but I would caution that, on that end, 6 it may be a small sample and it was in a different 7 scenario at that time. Some of the complex 8 therapeutic radiopharmaceuticals that are approved 9 now were not in existence at that time. And I think 10 that, on one hand, it would be interesting to get the 11 data, but I would be a little cautious about using 12 the data in any meaningful way.
13 So we have heard from several speakers 14 about being cautious in releasing these requirements, 15 and I would really emphasize that on behalf of the 16 SNMMI, as well as on behalf of the ad hoc committee 17 that we have formed amongst various societies of 18 oncologists to explore this issue. Thank you for 19 your time.
20 CHAIRMAN PALESTRO: Thank you, Dr. Ghesani.
21 Any other questions or comments from anyone on the 22 telephone lines? Comments or questions from anyone 23 here on the committee or attendees in the room? Dr.
24 Ennis?
25 MEMBER ENNIS: I just want to thank --
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132 1 where is he? The trainee, the fellow. What was your 2 name again?
3 DR. RAZMARIA: Aria.
4 MEMBER ENNIS: Dr. Aria. I don't know.
5 His comments really struck me in two ways. One of 6 them I thought about before, but I think he really 7 articulated it and we haven't here. And I guess it's 8 best, I think, to think of this as an analogy. I 9 can't imagine, like, going to an urologist who only 10 has had to do a TURP, a simple urologic procedure, 11 even if that's all that I needed, because so many 12 times in medicine things are way more complicated 13 than that. And if he doesn't have the broad expertise 14 of all of urology at least, I can't imagine going to 15 him. I can't imagine going to a cardiologist who 16 only knows about high blood pressure, doesn't know 17 about cholesterol, doesn't know about angina. And 18 it's kind of what we're kind of saying here. Well, 19 maybe we can do alphas with a certain half-life in a 20 single-dose vial. Is it really going to be that 21 simple? I think it's really an apt analogy for us 22 to think carefully about do we want to go down that 23 kind of a pathway? It certainly goes against the 24 current of the entire rest of medicine, how medicine 25 is done.
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133 1 And number two, I think his public policy 2 issues that he raised I had not thought of before but 3 I think is quite valid. There's a lot that can be 4 done in all areas of medicine, and the safety to 5 quality of nuclear medicine going forward is somewhat 6 in the purview of NRC and can be affected by NRC 7 policy. And thinking about safety, not case-by-case 8 safety, and thinking downstream ten years and 9 thinking of a lot of agents, I couldn't agree more 10 with his comments that to empower the specialists who 11 really make this their lives is going to lead to 12 significantly more safety at that high-level view of 13 imparting it to people for whom it's just a side show.
14 CHAIRMAN PALESTRO: Any other comments or 15 questions? Dr. Metter?
16 VICE CHAIRMAN METTER: This is Darlene 17 Metter. Thank you, Dr. Ennis, for that comment. It 18 made me think about another analogy that you bring 19 up. If I go to a driving school and let's say I want 20 to learn how to drive, so I go to a driving school 21 and I take the courses and everything, as opposed to 22 my friend who goes and their father teaches them, we 23 get the end result. We both get a driver's license.
24 So that's kind of what I think we're looking at here.
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134 1 how to drive. I know how to go forward, I know how 2 to go backwards, I know how to turn right, I know how 3 to turn left, I know how to park, and I know how to 4 drive on the highway and on other roads. Now, if I 5 were just going to go ahead and drive forward, because 6 I know how to drive forward, maybe I could do that.
7 I could just learn just a limited thing just learning 8 how to drive forward. But if I have to stop, well, 9 maybe they can teach me that, too. But if I can't 10 go backwards, I might have to just go around the 11 block. So it's a limited pathway. I can go forward, 12 but that's all I can do.
13 My car has an automatic start, and I'm ready 14 to go when I hit that button and the car starts. You 15 know, I kind of see that as an analogy. Let's just 16 think about that. I think you really have to have a 17 broad basis because if I want to drive forward, what 18 happens if a car comes right in front of me or there's 19 a big detour sign or I have to reverse? I can't do 20 that.
21 CHAIRMAN PALESTRO: Any other comments or 22 questions? All right. Thank you all for your 23 participation and your input. And, Dr. Metter, thank 24 you and your subcommittee for all your hard work.
25 We're going to continue now with the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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135 1 training and experience. Maryann Ayoade will discuss 2 stakeholder outreach plan.
3 MS. AYOADE: All right. Good afternoon, 4 everyone. My name is Maryann Ayoade, and I'm a member 5 of the Medical Radiation Safety Team at NMSS. And 6 today I'm going to be presenting to you the Part 35 7 medical training and experience stakeholder outreach 8 plan that is going to be coming up, hopefully, right 9 now.
10 So the purpose is to conduct a more 11 extensive outreach with the medical community focused 12 on assessing the options to tailor the training and 13 experience requirements for medical uses authorized 14 under 10 CFR Part 35.300, which is for 15 radiopharmaceuticals that require a written 16 directive.
17 So just to give you a little bit of 18 background, and Dr. Metter talked about the 19 Commission direction. So in August 2017, the 20 Commission directed the NRC staff to evaluate whether 21 it made sense to establish tailored training and 22 experience requirements for different categories of 23 radiopharmaceuticals, to evaluate how those 24 categories should be determined, to evaluate what the 25 appropriate T&E requirements would be for each NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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136 1 category, and to evaluate whether those requirements 2 should be based on hours of training and experience 3 or competency.
4 Next slide, please. So the evaluation 5 included a limited outreach in April - May time frame 6 of 2018, and that outreach we did in the form of a 7 questionnaire that was sent out to some medical 8 stakeholders, including some medical licensees, some 9 medical professional societies, a regulator, an 10 industry trade organization which we had CORAR 11 speaking here today. And so we sent the 12 questionnaire out to them. We also shared and worked 13 with the T&E Subcommittee on the questionnaire, as 14 well. And the results of that evaluation were 15 documented in an information SECY paper which is SECY-16 18-0084 that was recently made publicly available.
17 And so the evaluation concluded that it may 18 be feasible to establish tailored training and 19 experience requirements for different categories of 20 radiopharmaceuticals and to create a means of 21 authorizing the administration of certain categories 22 of radiopharmaceuticals, which is a limited 23 authorized user status. It also concluded that there 24 are viable options for creating a competency-based 25 approach to demonstrating acceptable training and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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137 1 experience requirements for limited authorized users 2 and that also the staff plans to do a more extensive 3 outreach, which is what I'm going to talk about today.
4 And the results of that limited outreach 5 were discussed during a teleconference on July 16th 6 with the ACMUI, and we also have a summary of the 7 responses from that limited outreach in the SECY 8 paper, as well, if you want to look at that.
9 Next slide. Okay. So what is the staff 10 planning to do for the outreach? This is just a list 11 of some of the outreach activities that we were 12 planning to have. We plan to publish in the Federal 13 Register a notice with questions that are going to be 14 related to training and experience requirements, and 15 I will go over an overview of some of the questions 16 in an upcoming slide.
17 We also plan to conduct public meetings and 18 webinars that will discuss the Federal Register 19 notice questions, as well as this initiative. We 20 plan to have a website dedicated to training and 21 experience with this information, information on the 22 initiative, as well as information about the Federal 23 Register notice questions, as well.
24 We also plan to send out letters and emails 25 to the stakeholders, which I will go over in the next NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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138 1 slide, as well as do poster presentations, posters 2 and presentations at the upcoming professional 3 society meetings. We also plan on writing articles 4 in the newsletters for these professional societies.
5 Next slide, please. So in addition to the 6 Federal Register notice and the public meetings and 7 all of the activities that I mentioned in the previous 8 slide, we plan to do some additional information 9 gathering. And this was a result of feedback that 10 we received from the ACMUI, as well as feedback that 11 we received from the, the comments that we received 12 from the first outreach. And so we want to look at 13 the evaluation of the authorized user shortage 14 regarding patient access, also to include patient 15 access as it relates to geography as well.
16 We also plan on reviewing medical and 17 radiation safety events to look to see if there are 18 any trends in these events and to see if any of the 19 trends indicate a need for a change in our training 20 and experience requirements. And we also want to 21 look at what's being done in the international scene 22 to see what are they doing for their 23 radiopharmaceutical training and experience 24 requirements right now and to see if they have any 25 kind of tailored training and experience requirements NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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139 1 that may be similar to what we're trying to look at 2 now.
3 And so this is a list of the stakeholders 4 that we plan on reaching out to. We collaborated 5 with the Training and Experience Subcommittee 6 recently to make sure that we have a comprehensive 7 list of stakeholders, so we plan on reaching out to 8 more medical licensees, more regulators, medical 9 specialty boards, some patient health organizations 10 and advocacy groups, some trade organizations and 11 industry groups, more medical professional societies, 12 the medical specialty training and fellowship 13 organizations, and the medical oncology community.
14 Next slide, please. And so this just gives 15 an overview of the Federal Register notice questions 16 that we're going to be putting out. We also have 17 worked with the T&E Subcommittee to make sure that we 18 have questions that will give us information that 19 would be useful as we move along with this project.
20 And so we have some questions regarding 21 establishing tailored training and experience 22 requirements for the radiopharmaceuticals that 23 require a written directive. We have questions 24 regarding competency, so the assessment of knowledge, 25 skills, and abilities, and questions regarding NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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140 1 patient access.
2 Next slide, please. And so one of the next 3 steps following outreach. So we plan to analyze the 4 public comments and information that we receive from 5 the outreach that we conduct, and then we also plan 6 to continue to engage the ACMUI in our efforts, as 7 we've been doing. We also plan to keep the Commission 8 informed of the outreach efforts. And as a result 9 of everything that we've done, we will determine 10 whether the changes to the current T&E requirements 11 are warranted.
12 That's it for my presentation. I will take 13 any questions you may have.
14 CHAIRMAN PALESTRO: Any questions or 15 comments from the committee? Attendees here in the 16 room?
17 MR. BOLLOCK: So the question was about the 18 time lines. Yes, we are still working to finalize 19 that through our management chain, roughly it will 20 end in 12 to 14 months but I can't say for sure. But 21 the FRN, then those questions, that is being developed 22 right now, so that would be in the next two months.
23 VICE CHAIRMAN METTER: Yes, that's correct.
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141 1 forward.
2 MR. GUASTELLA: Maybe Mr. Bollock can 3 repeat my next question. So if there is --
4 CHAIRMAN PALESTRO: Excuse me. Would you 5 identify yourself for the transcriptionist, please?
6 MR. GUASTELLA: Oh, hi. Michael Guastella 7 from CORAR.
8 MR. BOLLOCK: Okay. So Mr. Guastella from 9 CORAR as the second question.
10 MR. GUASTELLA: Assuming an alternate 11 pathway is recommended, is that, are we talking about 12 expedited rulemaking or are we talking going through 13 the general rulemaking process? Just kind of 14 curious.
15 MR. BOLLOCK: So the question regards if a 16 change to the training and experience authorized user 17 requirements is determined to be warranted by the 18 staff, what would the rulemaking process go? Right 19 now, I mean, by default, it's the normal rulemaking 20 process, so it would have to go through, you know, we 21 would develop a rulemaking plan, present that to the 22 Commission. The Commission would approve and then 23 go on with development of a draft rule, public 24 comment. So, yes, the normal process is the default 25 there.
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142 1 MR. GUASTELLA: This is Michael Guestella 2 to say thank you.
3 MR. BOLLOCK: And Mr. Guastella thanked us.
4 CHAIRMAN PALESTRO: Dr. Martin, I believe 5 you had a question.
6 MS. AYOADE: And just to add to that. If 7 no changes are needed, we will still be relaying that 8 to the Commission in another SECY paper, so we'll 9 share that with you guys, as well.
10 CHAIRMAN PALESTRO: Dr. Martin?
11 MEMBER MARTIN: This is Melissa Martin. I 12 was just noticing your list of societies that you 13 were going out to, and I'd try to encourage you to 14 actually engage the AAPM because we're the medical 15 physicists that are going to be working with the users 16 of this material, regardless of what their profession 17 is.
18 MS. AYOADE: Yes, that's correct. We have 19 the AAPM on our list, along with some other medical 20 professional societies. Thank you.
21 CHAIRMAN PALESTRO: Any comments or 22 questions from anyone on the telephone lines? Any 23 other comments or questions from anyone? All right.
24 Thank you, Ms. Ayoade.
25 Now we'll move on to some lighter fare.
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143 1 And I'd just like to briefly review with you the 2 results of our, really my opinion of the joint ACMUI-3 Society of Nuclear Medicine and Molecular Image 4 session, what's up for you and your patients that we 5 ran at the annual meeting of the society this past 6 June.
7 As you may recall, my predecessor as chair, 8 Dr. Phil Alderson, had sought to establish improved 9 communications and outreach with various professional 10 organizations and societies and these are our efforts 11 with the Society of Nuclear Medicine and Molecular 12 Imaging. Dr. Metter, myself, and Dr. Daibes-Figueroa 13 all took part in the session.
14 Dr. Metter gave an introduction and 15 overview, and she provided information on guidelines 16 for the nursing mothers. I talked about training and 17 experience for authorized users and a patient release 18 project for I-131 and question and answer period all 19 three of us participated in.
20 So how did we arrive or how did we identify 21 topics that would be of interest? And they were 22 really selected based on feedback from the Society of 23 Nuclear Medicine and Molecular Imaging. And we were 24 fortunate that we were able to run this not only as 25 a continuing medical education session but also a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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144 1 self-assessment module session. And, interestingly, 2 there were only two rooms, if I understood correctly, 3 available at that meeting for SAMs, so we were 4 delighted that we had the opportunity to present it 5 as a SAM.
6 Overall, it was well attended and I 7 personally was particularly impressed with the 8 audience who were clearly engaged. And there was an 9 excellent dialogue between the audience and the 10 speakers, and I want to highlight Dr. Daibes-Figueroa 11 because I think that the best way to describe it is 12 he put a face on the name of the NRC. I thought he 13 did an excellent job interacting with the attendees 14 coming across as a peer, rather than coming across a 15 regulator or a person of authority, if you will. So 16 I think he really did an excellent job, and we would 17 certainly, I would certainly recommend that these 18 sessions should be held on an ongoing basis and we 19 intend to try to repeat it again this coming year.
20 Comments or questions from the committee?
21 Mr. Green?
22 MEMBER GREEN: Just to back up your 23 comments, you were a presenter. I was in the 24 audience, and I think your assessment is 100-percent 25 spot-on. It was very well received, a lot of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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145 1 interaction with the audience beyond the point that 2 the meeting was over and it continued in the hallway, 3 it continued in the aisles. Very productive session 4 and a very good face for the NRC.
5 CHAIRMAN PALESTRO: Any other comments or 6 questions? Dr. Metter, your impression?
7 VICE CHAIRMAN METTER: Yes, I think it was 8 a very good session and there were lots of questions 9 and really the NRC has a very good face. It was a 10 very interactive session. They had a lot of 11 questions about the regulators and I actually think 12 that was a very good outreach, and they invited us 13 back so we plan on doing that again next year.
14 CHAIRMAN PALESTRO: Dr. Dilsizian.
15 MEMBER DILSIZIAN: I was in the audience, 16 as well. I have to say, you know, when you're 17 designing these scientific sessions, this would be 18 the last one I would think that people would show up 19 to, never mind making it a SAM session. I was really 20 surprised. I mean, I have to say, in the past, in 21 order to make sure there were enough people, we would 22 combine the FDA with NRC because, you know, the new 23 things, a food fast. So the combination actually was 24 even better.
25 But I think there were so many questions.
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146 1 I was surprised and I do encourage to continue this.
2 This is great. Congratulations.
3 CHAIRMAN PALESTRO: Any other comments or 4 questions from the committee? Questions or comments 5 from any of the attendees in the room? Questions or 6 comments from anyone on the phone lines?
7 All right. Mr. Bollock?
8 MR. BOLLOCK: Doug Bollock, NRC. So Dr.
9 Palestro and Dr. Metter, you know, worked with us to 10 try to support these meetings. We, the NRC, continue 11 to try to support the meetings as best we can. I've 12 brought this up many times. You know, unfortunately, 13 sometimes there are budgetary constraints, so we 14 can't send people to the meetings. We've been very 15 successful, I think, over the past year or so at least 16 sending one person, one representative from a medical 17 team at most of the major society meetings. I believe 18 we have been able to go to AAPM annual meeting this 19 year, SNMMI, ASTRO last year. I think right now 20 we'll be sending staff to ask for this year, and we'll 21 continue to try to support this as best we can.
22 We believe, as you say, this is important 23 to keep the lines of communication.
24 CHAIRMAN PALESTRO: Dr. Metter?
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147 1 for supporting this. This was our second year that 2 we had done the session, and the first year was on a 3 short notice and it was an odd time but we still had 4 a fair number of people that attended. Clearly, a 5 lot more this year. It was publicized and it was at 6 a good time and people are aware of it. And people 7 have told me they are looking forward to this as a 8 regular session.
9 CHAIRMAN PALESTRO: Any other comments or 10 questions? Mr. Ouhib?
11 MEMBER OUHIB: Yes, I'd just add that we 12 had a representative, actually, to the ABS also that 13 went very well talking about the approve rules, and 14 I think that went very well also.
15 CHAIRMAN PALESTRO: All right. Thank you.
16 All right. The next presentation, Dr. Metter will 17 discuss the Nursing Mothers Guidelines Subcommittee's 18 final report for exposure from diagnostic and 19 therapeutic radiopharmaceuticals. Dr. Metter?
20 VICE CHAIRMAN METTER: Thank you, Dr.
21 Palestro. So I'll be presenting the report of the 22 Subcommittee on the Nursing Mother Guidelines for the 23 Medical Administration of Radioactive Materials.
24 This is a revised report. It was based on stakeholder 25 input that has been incorporated into the final NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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148 1 document from an ACMUI public conference call earlier 2 this year in February. And in it, the final document, 3 it includes acknowledgments of the benefits of 4 breastfeeding and also additional calculations and 5 the table modifications regarding changing the units 6 to the SI units, incorporating gamma constants, and 7 correcting certain references. And I'll be 8 presenting one of the tables later on in this 9 presentation.
10 I'd like to first start by thanking the 11 members of my subcommittee: Dr. Vaskin Dilzisian, Dr.
12 Christopher Palestro, and Dr. Pat Zanzonico.
13 Now, breastfeeding is the feeding of an 14 infant from the female breast. Lactation is a 15 process of milk production, and lactation will cease 16 approximately six weeks after the last breastfeeding.
17 So the nursing mother guidelines charge was to review 18 the radiation exposure from diagnostic and 19 therapeutic radiopharmaceuticals, including 20 brachytherapy, to the nursing mother and child.
21 Now, we know that radiation safety 22 principles is we rely on the ALARA principle as our 23 guidance for radiation safety. Fortunately, we know 24 that many nuclear medicine procedures are elective, 25 thereby allowing a temporary or, at times, complete NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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149 1 cessation of nursing or breastfeeding.
2 Patient release. Now, a patient may be 3 released, and in this particular instance nursing 4 mother, if the total effective dose to any individual, 5 and in this case the nursing child, will be less than 6 5 millisieverts. If, however, the exposure could 7 exceed 1 millisievert, written instructions and 8 information regarding adverse consequences to include 9 the written instructions if nursing is not stopped 10 and guidance on the discontinuation of breastfeeding.
11 Radiopharmaceuticals. Many drugs and 12 radiopharmaceuticals we know enter the breast milk.
13 It is estimated that less than ten percent of any 14 administered drug or radiopharmaceutical will enter 15 the breast milk with an average of about 0.3 to 5 16 percent. We also know by our physics is that after 17 ten physical half-lives a radionuclide will decay by 18 99.99 percent.
19 Most radiopharmaceuticals administered 20 will require a temporary cessation of breastfeeding.
21 Now, if you have pumped radioactive breast milk, it 22 can be held for ten physical half-lives before 23 feeding the milk to the nursing infant.
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150 1 this non-radioactive milk to feed her infant during 2 the cessation of breastfeeding.
3 A few radiopharmaceuticals, however, if 4 administered, may require complete cessation of 5 breast feeding. This one exception, and this section 6 really refers to modification of the agent to decrease 7 the maternal breast dose, and this is I-131. To 8 decrease the maternal breast dose because it gives a 9 very, very high dose to the lactating breast, for 10 example 150 millicuries of sodium iodide, 131, 11 approximates about 200 rads to the maternal breast.
12 Therefore, if I-131 is administered, it requires 13 cessation of breastfeeding six weeks prior to 14 radiopharmaceutical administration, thereby allowing 15 for the cessation of lactation, and the cessation of 16 breastfeeding needs to continue for that child. The 17 mother, however, may breastfeed future children.
18 Next slide. So let's look at the radiation 19 exposure during nursing, and you have two 20 individuals: the mother which is obvious to exposure 21 from the administration of the radioactive material 22 and the child comes from two sources, the external 23 source which is the mother and an internal source 24 which is the ingested radioactive milk.
25 So let's look at this external exposure.
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151 1 The mother is a very significant source of exposure 2 to the child. And if we look at the ALARA principle, 3 which is as low as reasonably achievable, we know 4 that time and distance is going to be a factor.
5 During routine childcare, there's an increased time 6 with the radioactive source, the external source, to 7 the infant, and the distance is decreased and, hence, 8 the mother can be a significant radiation source to 9 exposure to the nursing child.
10 Next slide. Radiation exposure to the 11 nursing child by internal source is ingestion of 12 radioactive milk, and what is the dose? Well, it 13 depends on the radiopharmaceutical, and, as I 14 mentioned, it approximates about 0.3 to about 5 15 percent if the initial administered activity enters 16 the milk, again, except for sodium iodine, where the 17 mother needs to cease breastfeeding for six weeks 18 before administration and then for the remainder of 19 that child. However, she may breastfeed for future 20 children.
21 Next slide. So the subcommittee came up 22 with recommendations in regards to if a nursing mother 23 is administered radioactive material. There must be 24 an interruption of nursing in the sense of she needs 25 to stop nursing for the following agents: as we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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152 1 mentioned, I-131, sodium iodide, beginning six weeks 2 prior to the administration, for I-124 sodium iodide, 3 any alpha emitters, and any diagnostic or therapeutic 4 doses of 177 Lutetium octreotate. There's no 5 cessation required for O-15 or rubidium-82, about one 6 hour6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for C-13 and N-13, four hours for fluorine-18, 7 and, actually, this chart, Ga-68 was in the initial 8 chart but, after recalculation, you really do not 9 need to cease breastfeeding for gallium-68.
10 Next slide. So for technetium-99m, one 11 time frame was used which was the 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, and it's 12 because there are various different agents that we 13 use for technetium and there are very different times 14 of temporal cessation. So the subcommittee chose a 15 one-time period to simplify the guidance and avoid 16 error. So we chose 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of nursing cessation.
17 For I-123, sodium iodide, the initial 18 recommendation was seven days. It currently is three 19 days. This is a newer chart in the sense of we did 20 actual recalculations with the initial ones being 21 placed on extrapolation. Thallium-201 four days, 22 indium labeled white cell and octreotate six days, 23 and gallium-67, 89 zirconium 28 days.
24 Now, this is the revised chart from our 25 teleconference call, and, actually, it does include NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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153 1 what was recommended at that time, the 100 and 500 2 millirem dose limit to the newborn tissue. It is 3 listed as 0.1 rad, but in the submitted document it 4 has been revised to the millirem dose limits.
5 I also would like to point out that under 6 indium labeled white cells, the dose is listed as 5 7 millicuries. That needs to be corrected to 0.5 8 millicuries.
9 The other corrections I have made, as I 10 mentioned, regarding the calculation was the initial 11 one for fluorine-18 was 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />. It is currently 12 four hours. For gallium-68, it was 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />. It's 13 currently no interruption is needed. And I mentioned 14 before, I-123, it was initially seven days. It's now 15 three days.
16 Sealed sources. Y-90 microspheres, 17 there's no need to interrupt breastfeeding for this.
18 Breasts and sentinel lymph node sources, no 19 interruption is needed as long as the source is not 20 within the mother.
21 And, lastly, it's important to inform the 22 nursing mother or mothers planning to nurse in the 23 near future who are scheduled for a nuclear medicine 24 procedure. And they must be informed that certain 25 radiopharmaceuticals, if theyre received during this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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154 1 procedure, may require radiation safety precautions 2 and such patients are advised to notify the nuclear 3 medicine staff or nuclear medicine physician prior to 4 their procedure.
5 Next slide. So in summary, the 6 subcommittee presented its draft report during the 7 February 1st, 2018 public ACMUI teleconference call.
8 The report at that time was endorsed by the full 9 committee with some caveats, which I have reviewed on 10 this presentation. One was a wording addition of the 11 benefits of breastfeeding which was incorporated into 12 the final written document and then the revisions on 13 the calculations and the modifications of the table 14 which is in the final document.
15 So I'm asking the committee to recommend 16 that this final report be approved as presented.
17 CHAIRMAN PALESTRO: Any questions or 18 comments from members of the subcommittee? Questions 19 or comments from members of the committee? Dr.
20 Ennis?
21 MEMBER ENNIS: Just for my own personal 22 clarification, so for sodium iodide we're talking 23 about six weeks before administration as the 24 requirement?
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155 1 be for therapeutic or diagnostic, correct.
2 MEMBER ENNIS: But all the others, the 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> we're talking about are hours after 4 administration until you can breastfeed again?
5 VICE CHAIRMAN METTER: Correct, correct.
6 MEMBER ENNIS: Okay. So for someone who's 7 not, like, familiar with that, that wasn't clear.
8 VICE CHAIRMAN METTER: Okay. I'm sorry.
9 MEMBER ENNIS: No, it's okay. Maybe you 10 just make sure everyone else is clear.
11 VICE CHAIRMAN METTER: Right. The 12 breastfeeding interrupt time frame was the time 13 that's listed, correct. Thank you for the 14 clarification. CHAIRMAN PALESTRO: Any 15 other questions or comments from the committee? Mr.
16 Green?
17 MEMBER GREEN: Beyond the report, will this 18 document go and be submitted by the NRC or become 19 license guidance? I mean, does it stop here? Does 20 it go beyond this?
21 CHAIRMAN PALESTRO: Mr. Bollock?
22 MR. BOLLOCK: So the committee can 23 recommend to us how -- I mean, once the report is 24 given to us, it's going to go on our, the ACMUI public 25 website for all to see and then use as they wish. If NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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156 1 the committee has a recommendation they'd like to see 2 us try to make in some other guidance, a regulatory 3 guide incorporate, we are currently working on 4 updating Reg Guide 839, which is the patient release.
5 You know, that could be something where we incorporate 6 it as an enclosure in that. There are options.
7 If there's an option that, if you'd like to 8 hear other options, I can share that. If you have 9 any thoughts that you have, you can share that with 10 us and the committee can give a recommendation what 11 they recommend the staff does, and then we will 12 respond. We will, you know, we may do exactly what 13 you recommend, we may do something slightly 14 different. We will respond to you all and tell you 15 what we do. At the very least, it will be on our 16 public website.
17 And we have, you know, we've internally 18 discussed possibilities of what to do. We just 19 haven't made a final decision yet.
20 CHAIRMAN PALESTRO: Ms. Shober?
21 MEMBER SHOBER: Yes, this is Megan Shober.
22 I would recommend that the cessation times be included 23 in NUREG-1556, Volume 9 in Appendix U, which provides 24 instructions to licensees.
25 MR. BOLLOCK: And NUREG-1556, Volume 9, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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157 1 Appendix U, that now references Reg Guide 839. So 2 if we put into Reg Guide 839, that will --
3 MEMBER SHOBER: It will take care of that?
4 MR. BOLLOCK: Yes. For clarification.
5 CHAIRMAN PALESTRO: Any other comments or 6 questions from the committee? Mr. Ouhib?
7 MEMBER OUHIB: Yes, just a minor question 8 here is that is there a statement in the document 9 somewhere that state that this is applicable only to 10 these particular isotopes or any new isotope should 11 now be considered as being part of -- you know what 12 I'm saying? Let's just say next year there's another 13 one that pops up in the market now and then it's sort 14 of similar use for this same treatment or something 15 like that. How are you going to deal with that?
16 VICE CHAIRMAN METTER: I'm not 17 understanding your question. You mean the same 18 radionuclide?
19 MEMBER OUHIB: Right.
20 VICE CHAIRMAN METTER: These were based on 21 radionuclides, like, for example, the technetium one 22 day, gallium-68 really no interruption, and those are 23 based on that.
24 MEMBER OUHIB: Right. It's only 25 applicable to the listed nuclide --
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158 1 VICE CHAIRMAN METTER: Correct.
2 MEMBER OUHIB: Is there a statement there 3 that this is applicable only to these listed nuclides 4 in here?
5 VICE CHAIRMAN METTER: It's in the final 6 report. This is just a summary of that.
7 MEMBER OUHIB: Okay.
8 CHAIRMAN PALESTRO: Ms. Weil?
9 MEMBER WEIL: Am I understanding you 10 correctly -- this is Laura Weil, I'm sorry -- that 11 you're asking what if tomorrow there's a new approved 12 radionuclide, is there a statement in this report 13 that says these are the radionuclides FDA approved in 14 use as of this date, other -- this does not include 15 anything that may have come on the market after this 16 date? I mean, Lutetium is new, right? And the 17 application is new, so you wouldn't have included it 18 had you written this report two years ago. So two 19 years from now there may be another drug that will 20 not be included in this report but which is relevant.
21 MEMBER OUHIB: Right. That's what I'm 22 getting at.
23 VICE CHAIRMAN METTER: They're not included 24 in this report. This is the current one, and these 25 are listed as -- and there's actually a little NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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159 1 explanation as to the rationale of how these interrupt 2 time frames were obtained.
3 MEMBER WEIL: If I may just respond, I 4 think what we're getting at here is that there should 5 be a statement perhaps in the report stating that, as 6 of this date, this is comprehensive but that if you're 7 reading it three years from now you should know that 8 there may be additional information that you need to 9 access.
10 VICE CHAIRMAN METTER: Okay. I 11 understand. Yes, we can add that.
12 CHAIRMAN PALESTRO: Any other questions or 13 comments from the committee? Questions or comments 14 from attendees in the room? Questions or comments 15 from anyone on the telephone lines?
16 All right. Then I believe it's time to act 17 on subcommittee's recommendation to accept the final 18 report. That's a motion, so can I have a second? Go 19 ahead.
20 MEMBER ENNIS: Is the subcommittee going 21 to ask NRC to do something with the report? We left 22 that hanging.
23 MR. BOLLOCK: So you have a report. The 24 subcommittee has a report, so you can vote on the 25 report and then you can separately give us a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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160 1 recommendation, vote on a recommendation to staff on 2 what you want us to do with it, as an option.
3 CHAIRMAN PALESTRO: Mr. Green?
4 MEMBER GREEN: I would move to approve the 5 report with the addition of a paragraph describing 6 that this is all the drugs approved at the time of 7 this authorship, that practitioners should evaluate 8 other resources for other nuclides and drugs that are 9 not currently listed. If there's that included, I 10 would be able to approving.
11 CHAIRMAN PALESTRO: I'm not going to object 12 to that, but I just find it confusing that if I don't 13 see something -- why do I need a statement to tell me 14 that what's in these pages is all that it's applicable 15 to? I mean, if there's another drug that's out there 16 and it's not on those pages, how would I presume to 17 extrapolate something from what's there? Do you 18 follow what I'm saying? If you got a list of drugs, 19 list of radiopharmaceuticals, and it gives you the 20 prescribed times of stopping breastfeeding, so why do 21 I need a statement to say that this is valid only for 22 the agents that are listed here?
23 MEMBER GREEN: Yes, it may be confusing.
24 I think some of the references are nuclide-specific, 25 but some are drug-specific. I-131 sodium iodide, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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161 1 which is a different animal from I-131 iodohippurate 2 or I-131 MIBG. So there are references to nuclides 3 and others are chemical compounds associated with 4 that isotope, so there may be current isotopes with 5 new flavors, new drug compounds attached to that.
6 So I think there's some statement, and I'm 7 not sure what that statement should be, but I agree 8 with the two comments we've heard previously.
9 CHAIRMAN PALESTRO: Okay. Any other 10 comments? Well, we have a motion to approve the 11 report as written, presented I should say. Do we 12 have a second?
13 MEMBER SHEETZ: Second.
14 CHAIRMAN PALESTRO: Mr. Sheetz. All in 15 favor? Any opposed? And now Mr. Green or perhaps 16 it was Dr. Metter, I don't recall, suggested, once 17 the report was approved, to make a recommendation on 18 behalf of the committee to add a statement. All 19 right. So we can proceed with that, if we can develop 20 a formal statement. I'd like to do that now.
21 MEMBER GREEN: On the spot.
22 MR. BOLLOCK: It's a committee 23 deliberation, so this is, you know, we're in a public 24 setting right now. If we don't do it now and then 25 you'd have to come back and have another vote on it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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162 1 later in a public setting.
2 MEMBER GREEN: Just off the top of my head?
3 MR. BOLLOCK: So we can give you time. You 4 can do it tomorrow.
5 MEMBER GREEN: Thank you.
6 MR. BOLLOCK: We'll give you a little bit 7 of time.
8 CHAIRMAN PALESTRO: Yes, I just don't want 9 to leave it hanging after the end of the meeting 10 because things like that disappear, so we can just 11 add that to the open forum tomorrow.
12 All right. Last item on today's agenda, 13 Dr. Suh is going to discuss the ACMUI comments on the 14 draft revision of the Leksell Gamma Knife Perfexion 15 and the Leksell Gamma Knife Icon licensing guidance.
16 MEMBER SUH: Thank you, Dr. Palestro. I 17 want to start out by thanking the subcommittee 18 members: Dr. Ron Ennis, Mr. Zoubir Ouhib, Ms. Megan 19 Shober, and Ms. Laura Weil. I also want to thank the 20 NRC staff resource, Ms. Sophie Holiday.
21 So the original subcommittee charge was to 22 propose the appropriate physical presence 23 requirements for the Leksell Gamma Knife Icon 24 radiosurgery unit. And just as an introduction for 25 the new committee members in the ACMUI, so there are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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163 1 different types of Leksell gamma knifes, so there's 2 the Leksell Model B, C, and 4C. And for purposes of 3 this discussion, I'm going to group them altogether.
4 The gamma knife is a unit that allows high-dose, high-5 precision radiation to be delivered to an 6 intracranial target, mostly used for malignant brain 7 tumors. It can also be used for benign brain tumors, 8 as well as vascular conditions and some functional 9 disorders such as trigeminal neuralgia.
10 The Model B, C, and 4C has 201 cobalt-60 11 sources which are stationary. There's external 12 helmets which are attached to the machine. These are 13 eight 14 to 18 millimeter commandeer helmets. The 14 Model B unit has manual trunions which are set by a 15 physician or medical physicist, whereas the Model C 16 and 4C is an automatic positioning system that does 17 not require manual manipulation of the X, Y, and Z 18 coordinates.
19 Next slide, please. The Gamma Knife 20 Perfexion (2006) uses, rather than 201 cobalt-60 21 sources, uses 192 cobalt-60 sources which move within 22 eight permanently-installed independent movable 23 sectors which are 4, 8, and 16 millimeter beams.
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164 1 sectors, and there's an automatic movement of the 2 robotic treatment table. So this is a different 3 design compared to the Model B, C, and 4C, and the 4 picture is shown there.
5 Next slide, please. In 2016, the Gamma 6 Knife Icon was developed. This also has 192 cobalt-7 60 sources which move within the eight permanently-8 installed independent moveable sectors which have the 9 4, 8, and 16 millimeter beams. Again, there's one 10 body with different size holes corresponding to 11 different positions of the sectors. They also have 12 an automated movement of the robotic treatment chart 13 table.
14 What's different about the Icon versus 15 Perfexion is outlined in blue. It has an integrated 16 stereotactic home beam CT image, which is shown there 17 in the lower right-hand picture. It also has an 18 online adaptive dose control and also allows for a 19 frameless mass base treatment. So I just wanted to 20 give you direction in terms of the various gamma 21 knives.
22 Next slide, please. So in terms of the 23 background of the current regulation, all Leksell 24 Gamma Knife procedures follow the physical presence 25 requirements outlined in 10 CFR Part 35.615(f)(3)
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165 1 that, "An authorized user," which was AU, " and an 2 authorized medical physicist," which is referred as 3 AMP, "are physically present throughout all 4 treatments involving the unit."
5 The NRC defines "physical presence" as a 6 distance "such that each can communicate with the 7 other within hearing distance of normal voice." So 8 Model B, C, and 4C are licensed under 10 CFR 35.600, 9 whereas the Perfexion and Icon are licensed under 10 10 CFR 35.1000.
11 In 2018, the subcommittee was asked to make 12 recommendations. And looking at the very low number 13 of reported medical events with the Perfexion which 14 total 12 from 2006 to 2012 and advances with the Icon 15 unit the subcommittee recommended that an authorized 16 user and authorized medical physicist be physically 17 present during all, during the initiation involving 18 all treatments involving the units, and this is for 19 the Icon system; the authorized medical physicist be 20 physically present throughout all patient treatments 21 involving the unit.
22 Next slide, please. In addition, one of 23 the modifications we suggested was that, in terms of 24 the physical presence requirements, that the current 25 physical presence for the requirements for the AU be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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166 1 modified by allowing the AU to be present within a 2 two-minute walk to the console area and immediately 3 available to come to the treatment room. In addition 4 to AU and AMP, we recommended as good medical practice 5 that appropriately-trained nursing or auxiliary staff 6 be present at the end of treatment to respond to any 7 immediate medical needs. And then, finally, at the 8 conclusion of treatment, the AU must be present at 9 the console to discuss any treatment or patient issues 10 with patient, physicist, and nurse.
11 So those are the recommendations of the 12 subcommittee report which was endorsed by the ACMUI 13 committee in February 2018.
14 The working group reviewed the 15 subcommittee's recommendations and reports and also 16 reviewed the comments submitted from Elekta, as well 17 as Michael Sheetz our current ACMUI radiation safety 18 officer. And the workgroup proposed revisions to the 19 recommendations that the subcommittee put forward on 20 February 2018.
21 So the working group and management were 22 not supportive of the two-minute walk as they felt 23 that this was very ambiguous. And they proposed that 24 the physical presence requirements be similar to that 25 of high-dose rate brachytherapy. In addition, they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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167 1 proposed the requirements include both the Perfexion 2 and Icon units. Since I outlined earlier, many 3 components of the Icon and Perfexion unit are similar.
4 Next slide, please. So the working group's 5 recommendations were the following: Number one, AU 6 and AMP be physically present during the initiation 7 of all patient treatments involving the Perfexion or 8 Icon unit. In addition the AMP and either an 9 authorized user or a physician under the supervision 10 of an authorized user who has been trained in the 11 operation and emergency response for the unit will be 12 physically present during continuation of all patient 13 treatment involving the Perfexion or Icon unit and 14 the authorized user will return to the Perfexion or 15 Icon unit console if there's an interruption of 16 treatment to evaluate the patient, to review any 17 information related to an abnormal situation, and to 18 ensure that the treatment is being delivered in 19 accordance with the treatment plan and written 20 directive prior to the re-initiation of the 21 treatment.
22 So the subcommittee reviewed the working 23 group's recommendations and these are our current 24 recommendations based on the review of the working 25 group's recommendations. We agree that an AU and AMP NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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168 1 will be physically present during the initiation of 2 all patient treatments involving the Perfexion or 3 Icon unit.
4 In addition, we believe that the proposed 5 physical presence requirements is similar to that of 6 HDR brachytherapy. The subcommittee believes that 7 this definition is not ambiguous and will be easier 8 to enforce than the two-minute walk that was 9 originally proposed by the subcommittee in February 10 2018.
11 In addition, we agreed that the AU will 12 return to the Perfexion or Icon unit console if 13 there's an interruption of treatment. And one of the 14 changes with the workgroup recommendations versus 15 what we originally proposed to the subcommittee was 16 to incorporate both the Perfexion and Icon in this 17 recommendation. So since the Perfexion and Icon are 18 licensed under 10 CFR Part 35, Subpart K, 10 CFR 19 35.1000, and are mechanically similar to each other, 20 the subcommittee endorses a draft revision to the 21 Leksell Gamma Perfexion and Leksell Gamma Icon to 22 include both the physical presence requirements for 23 both units.
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169 1 report from February 2018, we endorse the Leksell 2 Gamma Perfexion and Leksell Gamma Knife Icon 3 licensing guidance. We encourage licensees to 4 continue to audit and monitor their programs, to adopt 5 best practice including a high-liability system 6 approach to ensure quality and safety, and, finally, 7 the ACMUI and NRC review any negative trends that may 8 occur as a result of change in guidance.
9 I'll take any questions. And the next 10 slide is just the acronyms that were used as part of 11 this report. Thank you.
12 CHAIRMAN PALESTRO: Any questions or 13 comments from the subcommittee? Questions or 14 comments from the ACMUI? Mr. Sheetz?
15 MEMBER SHEETZ: I would like to thank the 16 ACMUI subcommittee and the NRC working group for 17 working together on this effort and arriving at this 18 final version for the physical presence requirements.
19 I think it will provide significant relief to 20 licensees for the authorized user, not having to be 21 there for very long treatments and also be, at the 22 same time provide, you know, equivalent patient 23 safety. Thank you.
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170 1 from the attendees here in the room?
2 MS. TOMLINSON: Cindy Tomlinson with ASTRO.
3 Again, thank you, Chairman Palestro for allowing me 4 to provide this statement on behalf of ASTRO. We are 5 responding to the ACMUI's or I guess the 6 subcommittee's report. Because the NRC's working 7 group, their draft guidance is not public, our 8 comments reflect only the ACMUI subcommittee's review 9 and comments.
10 The safety records for both the Gamma Knife 11 Perfexion and Icon are excellent. Because of the 12 required training for physicians, physicists, and 13 therapists, the safety features embedded within the 14 machines, and, most importantly, because of 15 authorized user presence during the procedure.
16 Given that both the Perfexion and Icon use 17 high doses of radiation to treat cancer, the presence 18 of the AU is essential to ensure patient safety.
19 According to the subcommittee report the NRC's, 20 working group is proposed the following requirements 21 for both Perfexion and Icon. An authorized user and 22 an authorized user medical physicist will be 23 physically present during the initiation of all 24 patient treatments involving the Perfexion or Icon 25 unit.
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171 1 An authorized user medical physicist and 2 either an authorized user or a physician under the 3 supervision of an authorized user who has been trained 4 in the operation emergency response for the unit will 5 physically, will be physically present during 6 continuation of all patient treatments involving the 7 Perfexion or Icon and an authorized user will return 8 to the Perfexion or Icon unit console, and an 9 authorized user will return to the Perfexion or Icon 10 unit console if there's an interruption of treatment 11 to evaluate the patient , to review any information 12 related to an abnormal situation, and to ensure that 13 the treatment is being delivered in accordance with 14 the treatment plan and written directive prior to re-15 initiation of the treatment.
16 ASTRO is pleased with the direction of the 17 working group's proposed requirements. We think that 18 it has the potential to strike the appropriate balance 19 between safety and efficient medical practice and is 20 in line with ASTRO's position on physical presence 21 requirements for Gamma Knife.
22 We look forward to continuing to with the 23 ACMUI and the NRC on this issue. And, again, I will 24 send our written statement to your staff.
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172 1 comments or questions from the attendees in the room?
2 MS. LOHMAN: Yes. I'm Susan Lohman, 3 clinical applications manager for Elekta. And on 4 behalf of Elekta, we'd like to thank the opportunity 5 to engage both ACMUI and the NRC on this issue.
6 We believe the revised guidance is a step 7 in the right direction. However, we are wary about 8 the fact that HDR and Gamma Knife procedures are being 9 considered substantially similar for physical 10 presence requirements.
11 Once the revised guidance is issued, Elekta 12 would like to continue dialogue with the ACMUI and 13 NRC for further revision of the guidance. In the 14 meantime, thank you for your attention to this issue 15 and we appreciate and look forward to further 16 collaboration.
17 CHAIRMAN PALESTRO: Thank you. Any other 18 comments or questions from attendees here in the room?
19 MR. BOLLOCK: Hi, Dr. Palestro. This is 20 Doug Bollock, NRC. So a few of us in the NRC have 21 reviewed the workgroup's report and we just have, you 22 know, we have another final concurrence on the working 23 group's guidance. So there's not a question but more 24 of a philosophical thing that we're considering.
25 Icon and Perfexion is 35.1000 guidance.
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173 1 The intent of anything that goes in 35.1000 guidance 2 will eventually go into the rule. So if these Gamma 3 Knifes go into 35.600, what would that do for the 4 physical presence part of the rule? I'm not saying 5 it can't happen. So what are the differences? And 6 this is, I think there is, there are answers to this.
7 One of the differences with these units that make 8 them safer so that the, basically, the equivalent 9 level of safety is there with, essentially, a lowering 10 of physical presence requirements. I believe the 11 answer is there. I believe there is an answer. We 12 just need to, when we develop the guidance.
13 And I don't know if Sophie is going to 14 respond to me, but she just heard this from me 15 recently. And it's a question maybe Sophie can 16 consider answering. I just want a perspective from 17 the ACMUI on that because that is, that's going to be 18 important going forward, right? If this was brought 19 back into the rule, to keep a consistency amongst the 20 rule for other, you know, what about these units are 21 safer than the 35.600 units that you can have that 22 difference? I believe it's there. I'm just 23 wondering what your thoughts are, and I'll let Sophie 24 Holiday from my staff speak to this first.
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174 1 Sophie Holiday. Technically, from Doug Bollock's 2 branch, we're currently on detail to the Office of 3 Enforcement, but I was the NRC co-chair for the 4 working group that developed this draft revised 5 guidance.
6 So just one thing I want to clarify to start 7 off with is that, you know, you've heard comments in 8 here where the subcommittee supported the working 9 group's recommendations. ASTRO also came to the 10 microphone and said that they supported it. We heard 11 from Lohman.
12 Just to clarify, as Doug said, we have not 13 issued the final guidance yet. I'm actually still 14 in the process of resolving all of the comments that 15 I've received from the agreement states and NRC 16 regions relating to this guidance, so this is not to 17 say that this will be the final physical presence 18 requirements that come out from this guidance 19 document.
20 Second, to address what Doug said related 21 to possibly how this will affect if it's rolled into 22 rulemaking. During the spring 2018 meeting, one of 23 the items that we closed from the agenda was a very 24 longstanding item where the committee had asked NRC 25 to move the Perfexion from 1000 into 35.600.
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175 1 Comparatively, they also asked to move yttrium-90 2 microspheres brachytherapy to somewhere in the Part 3 35 regulations.
4 There was a lot of discussion between the 5 committee and staff related to the benefits of 6 pursuing those recommendations from the ACMUI. And 7 what ultimately came from the committee was that you 8 would close those items, as you guys were supportive 9 of keeping both the yttrium-90 microspheres 10 brachytherapy and the Perfexion and now Perfexion 11 Icon guidance in 35.1000 space because it allowed us 12 to be nimble to make these types of changes.
13 As you know, the yttrium-90 is on revision 14 9 currently, pursuing revision 10. But what Doug is 15 asking you to do is think about in the future if we 16 do move this to incorporate Perfexion and Icon unit 17 into the regulations under 35.600, which, as you know, 18 include all gamma stereotactic radiosurgery units.
19 We are aware of other gamma stereotactic radiosurgery 20 units that are on the horizon or currently approved 21 by the U.S. Food and Drug Administration. What is 22 it that we would be able to caveat in our regulations 23 or what would be the conditions that we could do in 24 order to allow such physical presence?
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176 1 are not saying that Gamma Knife treatment or Gamma 2 stereotactic radiosurgery treatment is similar to HDR 3 in any sense. We're just trying to draw the parallel 4 that there are physical presence requirements such as 5 this for the HDR unit. Currently, all Gamma 6 stereotactic radiosurgery units have to have both AU 7 and AMP, so, in order to draw that parallelism, that's 8 why we say this is what it is for HDR.
9 Okay. So I just wanted to offer those 10 comments. Thank you.
11 CHAIRMAN PALESTRO: Thank you. Any other 12 comments from attendees in the room? Comments or 13 questions from anyone on the telephone lines?
14 DR. TAPP: I guess I'll go back to Mr.
15 Bollock's question. This is Dr. Tapp with the NRC.
16 Sophie pointed out there are new emerging Gamma 17 stereotactic radiosurgery units coming out right now, 18 and the NRC has formed a working group with the 19 agreement states to start developing guidance for 20 these documents. And going back to Mr. Bollock's 21 comments was if the committee could comment on what 22 were some things that you see with the Perfexion Icon 23 that you thought were important that allowed to change 24 in the physical presence? Was it the imaging? I'd 25 get some comments on that.
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177 1 So when I'm forming my physical presence or 2 the working group is forming the physical presence 3 requirements for these new units, we have some 4 guidance there.
5 CHAIRMAN PALESTRO: Mr. Sheetz?
6 MEMBER SHEETZ: I'd like to comment on Mr.
7 Bollock's question about the safety of the Icon and 8 Perfexion in relation to the other Gamma Knifes. In 9 my experience, and we were the first licensee of a 10 Gamma Knife, the U unit, 1987. We've had every Gamma 11 Knife model, and we currently have an Icon and a 12 Perfexion.
13 The Perfexion and Icon are safer. There's 14 less intervention in setting up patient treatments.
15 There's no helmets. There's a lotless of micro-16 switches and involvement for hands-on. So the Icon 17 and the Perfexion are much more automated in the 18 treatment process once the treatment plan has been 19 developed and it's imported into the treatment 20 console.
21 With respect to the Gamma Knife units that 22 are currently in 35.600, my perspective and my 23 experience with the Gamma Knife units is the proposed 24 physical presence requirements similar to the HDR 25 requirements would be adequate for those units also.
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178 1 I've always been under the impression that the 2 physical presence requirements for the AU and AMP to 3 be physically present through the entire Gamma Knife 4 treatment was excessive, and I'm comparing that to 5 HDR. HDR is a much more complex procedure. There 6 are many more things that can go wrong with the device 7 with applicators.
8 So to allow the AU to leave and another 9 physician be present, and I'm not against that 10 physical presence, I'm just saying to be more 11 stringent on Gamma Knife. It really was not, in my 12 perspective, appropriate or risk-based. Thank you.
13 CHAIRMAN PALESTRO: Any other comments or 14 questions? Ms. Shober?
15 MEMBER SHOBER: This is Megan Shober. I 16 was just wondering how many of the older style Gamma 17 Knife units are still in the United States? Are 18 there still a lot, or are there basically no old 19 school ones left?
20 MS. LOHMAN: This is Susan Lohman from 21 Elekta. There are approximately 14 of the older 22 style Gamma Knife units still in use in the U.S.
23 MEMBER SHOBER: Okay. And can you comment 24 about, like, if you add Perfexion and Icon together, 25 how many are those?
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179 1 MS. LOHMAN: In total, there are 2 approximately 135 --
3 MEMBER SHOBER: Okay. So we're down to 4 like --
5 MS. LOHMAN: -- United States.
6 MEMBER SHOBER: Yes, we're down to, like, 7 ten percent of the older 35.600.
8 MS. LOHMAN: Approximately, yes.
9 MEMBER SHOBER: Okay. That's helpful.
10 Thank you.
11 CHAIRMAN PALESTRO: Dr. Martin?
12 MEMBER MARTIN: There's one -- I'm 13 following up on the question before about the other 14 brands that are coming in, but maybe this is going to 15 be confusion because I have one of the other brands 16 c coming in down the street from our office and I had 17 a question of what they were going to do and how they 18 were going to apply the on-site rules because it is 19 definitely going to be operated by a very economical 20 radiation oncologist who will not be there most of 21 the time is my understanding, and that's why I was 22 like what kind of rules are we applying to these other 23 brands?
24 CHAIRMAN PALESTRO: Mr. Bollock?
25 MR. BOLLOCK: I can't speak for California.
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180 1 We just don't know that. I don't know that answer.
2 But as far as, you know, the NRC's, we call it the 3 35.1000 licensing guidance. What it really is is we 4 are developing specific license conditions necessary 5 for the safe use of emerging medical technology that 6 doesn't fall under the other subsections of Part 35.
7 And those are specific to NRC licensees, and the 8 agreement states, for the NRC to agreement states, 9 there are certain levels of regulations that states 10 have to follow based on the compatibility and the 11 sections of the regulations. 35.1000 is a 12 compatibility D, which means that the agreement 13 states do not have to follow what we say in the 14 regulations. They can create their own licensing 15 guidance, licensing conditions, and license --
16 MEMBER MARTIN: I apologize. I forgot that 17 it wasn't yours.
18 MR. BOLLOCK: It's quite all right.
19 CHAIRMAN PALESTRO: Any other comments or 20 questions?
21 MEMBER SUH: So I just want to just 22 emphasize what Mr. Michael Sheetz said. So there are 23 a fundamental difference between the Model B, C, and 24 4C versus the Perfexion and the Icon system. I've 25 had 21 years experience with the Model B, C, 4C NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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181 1 Perfexion and Icon. I fully agree with his 2 assessment. The Icon and Perfexion is safer than the 3 Model B, C, or 4C, so I feel very comfortable in 4 lumping those two units together in terms of any 5 changes we make in terms of physical presence 6 requirements.
7 CHAIRMAN PALESTRO: Mr. Ouhib?
8 MEMBER OUHIB: Yes. I just have a 9 question. If you could recall the fact that you have 10 used all these basically, looking back, how often did 11 you have to actually intervene in these different 12 ones and somebody else couldn't do what needed to be 13 done?
14 MEMBER SUH: So I've had two patients seize 15 on the table at 11:00 at night. So, yes, it was 16 important that I was there. One of the changes that 17 we have made with our practice is that we put a pulse 18 oximeter on every single Gamma Knife patient because 19 when you have a long treatment you monitor them 20 through cameras, you hope the patient is doing okay.
21 The last thing I want to do is have a patient come 22 out of the machine and they were not okay.
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182 1 thousands of these cases, you just get an inherent 2 sense of what you should and shouldn't do. So that's 3 why I'm just a big believer that when it comes to 4 training and experience -- one of the things you said, 5 to Elekta's credit, when it comes to the Gamma Knife, 6 it's very regimented in terms of the training and 7 experience that's required. So as these units, you 8 went from a Model C to a 4C to a Perfexion to an Icon, 9 you go to centers to learn how to use that device, 10 which I think is a very good model of how do you 11 understand it.
12 And, again, the machines themselves, are 13 there big differences? You could argue there's not 14 big differences, but that extra training is very 15 helpful.
16 CHAIRMAN PALESTRO: Any other questions or 17 comments? Mr. Bollock, does the committee needs to 18 approve the report, endorse the report?
19 MR. BOLLOCK: Yes.
20 MS. HOLIDAY: Dr. Palestro, this is Sophie 21 again. Before the committee makes a motion to vote 22 on the report, if I can kind of respond to what Mr.
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183 1 say the AU necessarily, it says an AU or a physician 2 under the supervision of an AU who has been trained 3 in the operation and emergency response for the unit.
4 So this is a physician who should be able to handle 5 a medical emergency, but they have the necessary 6 training to know how to operate and perform in an 7 emergency response capacity for the unit.
8 So just to remind the committee about that.
9 Thank you.
10 CHAIRMAN PALESTRO: Mr. Ouhib?
11 MEMBER OUHIB: Yes, the only reason I asked 12 that question, I just wanted to see some of the 13 differences between these units and some might be 14 requiring more attention than others based on where 15 the technology is basically.
16 CHAIRMAN PALESTRO: Mr. Green?
17 MEMBER GREEN: Is there a way to, this is 18 trying to move, I think, from a 35.1000 into a 35.600 19 for all these devices and capture future devices.
20 Rather than calling them them out by model numbers, 21 is there a way to describe attributes of these devices 22 that would allow you to designate certain physical 23 presence requirements without naming names and model 24 numbers?
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184 1 want to be able to not have it say, if you have an 2 Icon or Perfexion you get this and if you have 3 everything else you get 600. We try to be consistent.
4 We do everything we can to be consistent in our 5 regulations and consistent with our licensing, and 6 that consistency is built on the safety of it. That's 7 why I brought up I believe this is there. I mean, 8 from early discussions with Sophie and other, you 9 know, my understanding of these devices, I think they 10 have these features that help do that. And that's, 11 you know, we want to make sure, and this will be for 12 the working group to make sure if I am comfortable 13 with incurring with it and getting it out, that that 14 is clear because that's what will make, that's what 15 will carry that consistency across for any of these 16 Gamma stereotactic radiotherapy units, right? So we 17 can be consistent, so Sophie's group is looking at it 18 the same way as Dr. Tapp's group.
19 That's what, that's all we're trying to 20 get, so that's exactly the point. I think it is 21 there. It's just, you know, one of those features, 22 and I believe it's there but we just need to be 23 consistent with what those are. If you have these 24 types of, if you have this feature, this feature, 25 this feature, this feature, you can do, if we're going NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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185 1 to have separate physical presence requirements these 2 are the things that make you do that.
3 And I understand Mr. Sheetz's point, as I 4 take it -- I don't want to put words in your mouth -
5 - is all the Gamma stereotactic units should have 6 something -- you don't agree or you think it's overly 7 burdensome with the current 600 requirements for 8 physical presence; is that correct?
9 MEMBER SHEETZ: That is correct.
10 MR. BOLLOCK: Okay. And that's a fair 11 enough point. For us, if we are going to make it 12 different, it can't, that's essentially what we've 13 been doing is changing all the rules just for these 14 two because they're new. It's not because they're 15 new, it's because they have other features or we'd 16 have to go back through a rulemaking process. We 17 have to be consistent in what we do.
18 CHAIRMAN PALESTRO: Any other comments or 19 questions? Mr. Sheetz?
20 MEMBER SHEETZ: Yes. I guess I would like 21 to make sure I understand correctly. If you're going 22 to move the Perfexion and Icon back into 35.600, that 23 would require --
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186 1 --
2 MEMBER SHEETZ: And so you would have to 3 eliminate a lot of the prescriptive safety procedures 4 and spot checks and so forth that are currently in 5 there.
6 MR. BOLLOCK: That's exactly what we --
7 MEMBER SHEETZ: And then you would have to 8 account for all the new types of Gamma Knifes coming 9 down the line and what they will do.
10 MR. BOLLOCK: Right. We can't say --
11 MEMBER SHEETZ: I guess my recommendation 12 --
13 MR. BOLLOCK: -- and different things like 14 that and then have it cover all the units that are 15 out there.
16 MEMBER SHEETZ: I guess I'm a fan of 17 35.1000, and I think that would be very challenging 18 to come up with a useful set of regulations in 35.600 19 to cover all current and future Gamma Knife 20 stereotactic units.
21 MR. BOLLOCK: And that would be the goal.
22 That would be --
23 MEMBER SHEETZ: Please don't put me on the 24 subcommittee.
25 MR. BOLLOCK: That would be the goal of any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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187 1 changes to 35.600 is to make it not so specific to 2 make it be able to account for all the Gamma 3 stereotactic radiotherapies, not any specifics. And 4 there are specifics. There are differences, and it's 5 clear and there's a basis for that. That is all.
6 CHAIRMAN PALESTRO: Any other comments or 7 questions? Ms. Holiday?
8 MS. HOLIDAY: So because Mr. Sheetz just 9 mentioned my favorite word, subcommittee, might it be 10 a suggestion, since this is a question that Mr.
11 Bollock has posed to the committee about what exactly 12 would it be that you believe our physical presence 13 requirements should be so that it can apply to all 14 Gamma Stereotactic radiosurgery units? Should the 15 ACMUI consider forming a subcommittee to review this 16 question? Obviously, we don't know the answer.
17 Similar to a tailored T&E approach, should there be 18 a subcommittee to look at this as well? So that when 19 staff is ready to pursue this in future rulemaking 20 that we already have the committee's position noted 21 on the record.
22 CHAIRMAN PALESTRO: Okay. Comments or 23 questions on that?
24 MR. BOLLOCK: That would be at the 25 discretion of the -- this is Doug Bollock. That NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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188 1 would be at the discretion of the committee. If you 2 feel it's important enough to review now and form a 3 subcommittee, that is well within your rights and 4 purviews.
5 CHAIRMAN PALESTRO: Ms. Holiday, let me ask 6 you, is this something that would start now or is 7 this established in a subcommittee for the future?
8 MS. HOLIDAY: As Mr. Bollock said, it's up 9 to your discretion. For the purposes of what Dr.
10 Suh's subcommittee did, that is going to affect the 11 existing 35.1000 guidance. That's staying in 35.1000 12 for now because we're very far away from rulemaking.
13 So as the chair of the committee, it's your 14 prerogative when you would like to start that 15 subcommittee, if you start it at all. I just wanted 16 to throw that out as an item for consideration.
17 CHAIRMAN PALESTRO: Okay. I think I'm 18 going to defer on that for a moment until I've had 19 time to think about it a little bit and maybe discuss 20 it more.
21 MS. HOLIDAY: Absolutely.
22 CHAIRMAN PALESTRO: Thank you.
23 MS. DIMMICK: So if I could add as you 24 think about it, the other value that it could have is 25 not just for a rulemaking but for future 35.1000 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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189 1 guidance documents for different GSR devices. The 2 current working group is actually working on two 3 different, very different GSR devices and the working 4 group is going to have to address physical presence 5 in those, and they'll need to have an idea of will 6 they need, can they apply a criteria similar to what 7 the Perfexion/Icon working group is proposing for 8 physical presence or will they need to follow the 9 rule?
10 So I guess, going forward, in terms of 11 thinking of what safety barriers do the devices 12 provide where there could be a different physical 13 presence requirement than what is in the rule. So 14 it's not just for rulemaking. It could be for future 15 guidance documents, as well, for GSR devices.
16 CHAIRMAN PALESTRO: All right. Thank you.
17 As I said, I want to think about it a little bit and 18 I want to go over the number of subcommittees that we 19 have and do my best to avoid overloading the members 20 of the committee, the ACMUI, with responsibilities on 21 multiple subcommittees. I just can't think of it off 22 the top of my head.
23 Any other comments or questions? All 24 right. there's a motion to approve Dr. Suh's report, 25 the subcommittee's report. Is there a second?
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190 1 MEMBER SHEETZ: Second.
2 CHAIRMAN PALESTRO: Sheetz. Any further 3 discussion? All in favor? Any opposed? Approved.
4 Mr. Bollock any other business that we need 5 to address today?
6 MR. BOLLOCK: No, that is it.
7 CHAIRMAN PALESTRO: Ms. Dimmick?
8 MS. DIMMICK: At some point, we wanted to 9 come back to the charge for the Medical Event 10 Subcommittee, so if we could try to phrase that charge 11 that would be great. Thank you.
12 CHAIRMAN PALESTRO: Dr. Ennis?
13 MEMBER ENNIS: I'll give it a try. The 14 subcommittee will review the appropriateness of the 15 required elements of medical event reporting, the 16 adherence to these requirements, and recommend 17 actions to improve reporting.
18 CHAIRMAN PALESTRO: That's certainly 19 acceptable to me, and we already have the members of 20 the subcommittee.
21 MEMBER ENNIS: We do.
22 CHAIRMAN PALESTRO: And you will chair.
23 MEMBER ENNIS: I will.
24 CHAIRMAN PALESTRO: All right. Staff 25 liaison?
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191 1 MR. BOLLOCK: I got a volunteer. Ms.
2 Dimmick, the medical team leader, will be the staff 3 resource for that.
4 CHAIRMAN PALESTRO: Okay. Ms. Dimmick 5 will be staff resource. Thank you very much. All 6 right. Any other business? All right. Then we're 7 adjourned until 8:30 tomorrow morning. Thank you 8 all.
9 (Whereupon, the foregoing matter went off 10 the record at 4:48 p.m.)
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