Official Transcript of Proceedings
NUCLEAR REGULATORY COMMISSION
Title:
Medical Uses of Isotopes Advisory Committee
Docket Number:
(not applicable)
Location:
(telephone conference)
Date:
Tuesday, January 18, 2005
Work Order No.:
NRC-176
Pages 1-81
NEAL R. GROSS AND CO., INC. Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION + + + + + ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES + + + + + Tuesday, January 18, 2005 + + + + + Telephone Conference Call + + + + + The above-entitled matter came on for hearing, pursuant to notice, at 1:00 p.m, Leon S. Malmud, M.D., Chair, presiding.
COMMITTEE MEMBERS PRESENT: LEON S. MALMUD, M.D. Chair
JEFFREY F. WILLIAMSON, Ph.D., Member DOUGLAS F. EGGLI, M.D., Member RALPH P. LIETO, Member SUBIR NAG, M.D., Member SALLY SCHWARZ, R.Ph., Member ORHAN SULEIMAN, Ph.D., Member RICHARD J. VETTER, Ph.D., Member
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NRC STAFF PRESENT: THOMAS H. ESSIG, Designated Federal Official IVELISSE CABRERA CYNTHIA FLANNERY LINDA GERSEY AARON McCRAW ANGELA McINTOSH RONALD ZELAC, Ph.D.
ALSO PRESENT: LISA DIMMICK, Nucletron Corporation ROSHUNDA DRUMMOND, American Association for Therapeutic Radiology and Oncology LYNNE FAIROBENT, American College of Radiology MELISSA MARTIN, American College of Radiology GLORIA ROMANELLI, American College of Radiology
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I-N-D-E-X Page Opening Remarks (Open Session) T. Essig Mr. Essig, Designated Federal Official, ACMUI, will commence the open session with introductory remarks explaining the purpose of the meeting and welcoming all in attendance Update to Medical Event Criteria Definition (Open Session) (Presenter: The ACMUI's J. Williamson, PhD) 9 4
Subcommittee on review of the NRC's definition will forward its
medical
event
recommendation(s) to the main Committee, for discussion and a final vote. The full ACMUI
will then forward final recommendation(s) to the NRC staff with respect to updating the medical event definition.
4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. ESSIG: On the record. P-R-O-C-E-E-D-I-N-G-S 1:10 p.m. All right. I
would like to open the meeting as Designated Federal Official. I am pleased to welcome you to this
publicly noticed conference call meeting of the ACMUI. My name is Thomas Essig. Material Safety I'm Branch Chief of the Branch and I've been
Inspection
designated as a Federal Official for this advisory committee in accordance with 10 CFR Part 7.11. This is an announced meeting of the
Committee being held in accordance with the rules and regulations of the Federal Advisory Committee Act and the Nuclear Regulatory Commission. The meeting was
announced in the December 22, 2004 edition of the Federal Register. Today's meeting will focus on an
update of the criteria for definition of a medical event. An ACMUI subcommittee has been reviewing this
area and will share its recommendations with the full Committee today. The function of the Committee is to advise the staff on issues and questions that arise on the medical use of byproduct material. The Committee
provides counsel for the staff but does not determine or direct the actual decisions of the staff or the NEAL R. GROSS
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5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Commission. The NRC solicits the views of the
Committee and values them very much. A request that whenever possible we try to reach consensus on the various issues that we will discuss during this conference call, but I also value minority or dissenting opinions. If you have such
opinions, please allow them to be read into the record. As part of the preparation for this
meeting, I have reviewed the agenda for members and employment interests based on the general nature of the discussion we're going to have today. I've not
identified any items that would pose a conflict. Therefore, I see no need for individual members of the Committee to recuse themselves from the Committee's decisions making activities. However, if during the
course of our business you determine that you have some conflict, please state it for the record and recuse yourself from that particular aspect of the discussion. At this point, I would like to perform a roll call of members that may be participating today. Healthcare Administrator and Chairman Dr. Leon Malmud. I think we recognize that he'll be a little bit late. State Representative Mr. Edgar Bailey. Nuclear
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6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Ralph Lieto. NEAL R. GROSS
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Medicine Physician, Dr. Douglas Eggli. DR. EGGLI: MR. ESSIG: Dr. David Diamond. Nag. DR. NAG: MR. ESSIG: Schwarz. CHAIRMAN MALMUD: MR. ESSIG: Leon Malmud. I just called This is Tom Yes, I'm here. Nuclear Pharmacist Ms. Sally I'm here. Okay. Radiation Oncologist
Radiation Oncologist Dr. Subir
Ah, excellent. Good.
your name and you are now here. Essig, Dr. Malmud.
I'm just going through my opening
remarks and I was about ready to turn it over to you or chair the opening part of the meeting myself. But
now that you're here, I'll turn it over to you as soon as I'm done with these remarks. CHAIRMAN MALMUD: MR. ESSIG: Dr. Richard Vetter. DR. VETTER: MR. ESSIG: Williamson. DR. WILLIAMSON: MR. ESSIG: Here. Here. Therapy Physicist Dr. Jeffrey Thank you.
Radiation and Safety Officer
Nuclear Medicine Physicist Mr.
7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 I would MR. LIETO: MR. Representative ESSIG: Dr. Present. Okay. Patient Advocate Schenter. Nuclear
Robert
Cardiologist Dr. William van Decker.
Representative
of the Center for Devices in Radiological Health Dr. Orhan Suleiman. DR. SULEIMAN: MR. ESSIG: quick count here. Present. And let me just do a
Okay.
Seven.
Mr. Chairman, we barely I know ask NRC staff who I'll start with
have a quorum, but we do.
are present to identify themselves.
the individuals in the room here and then we'll turn it over to others of NRC who may be calling in from elsewhere. MS. CABRERA: DR. ZELAC: MR. McCRAW: MS. GERSEY: MR. ESSIG: calling in remotely. MS. FLANNERY: MR. ESSIG: ask members Cindy Flannery. Anybody else from NRC? the public who are Ivelisse Cabrera. Dr. Ronald Zelac. Aaron McCraw. Linda Gersey. Okay. Others from NRC who are
Okay. of
participating if they wish to identify themselves, please. NEAL R. GROSS
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8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 it going? AATRO. MS. ROMANELLI: MR. ESSIG: Gloria Romanelli, ACR. Following the ACR. MS. DRUMMOND: Roshunda Drummond with Corporation. MS. MARTIN: This is Melissa Martin with MS. FAIROBENT: MS. DIMMICK: Lynne Fairobent, ACR. Lisa Dimmick, Nucletron
Okay.
discussion of each item, the Chair at his option may entertain comments or questions from the members of the public who are participating with us today. At
this point, Dr. Malmud, I would turn the meeting over to you. CHAIRMAN MALMUD: Tom, could you just keep I'm on the line but
I have a problem here.
just get it going. MR. ESSIG: Sure. Will do. Thank you. I believe that from
CHAIRMAN MALMUD: MR. ESSIG: Okay.
what I said earlier, the purpose of today's meeting is to hear for the full Committee the recommendation from the Medical Event Subcommittee on the certain criteria associated with the definition of a medical event. So
I would turn to the Subcommittee Chair and we'll start NEAL R. GROSS
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9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Leon. Williamson. ahead. MR. ESSIG: Okay. Subcommittee Chair. Okay. This is Jeff the discussion there and then Dr. Malmud will join us as he can. CHAIRMAN MALMUD: I'm here, but I –- Go
DR. WILLIAMSON:
I hope all of the members of the ACMUI
and the NRC staff have a copy of the revised report that I sent out early this morning, January 18th. What I will do is maybe make a few introductory remarks to explain the process we went through and then simply step through the different recommendations in the report for ACMUI discussion. appropriate, Tom? CHAIRMAN MALMUD: DR. WILLIAMSON: Yes, Jeff. Thank you. Would that be
Oh, you're here now, All right. Well, this
Okay, I didn't realize.
task was assigned to the ad hoc subcommittee on medical events at the ACMUI meeting of October 18, 2004. We were asked to address problems in the
medical event report criterion specifically focusing on permanent brachytherapy implants. This issue was
raised originally by Dr. Nag at our last briefing with the NRC Commissioners. The NRC Commissioners
responded with a staff requirement memo asking the NEAL R. GROSS
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10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 staff with ACMUI advice (a) to evaluate the
appropriateness and justification of the 20 percent threshold currently built into the Medical Event
Reporting Rule and (b) consider appropriate ways for conveying risk, if any, associated with these levels of discrepancy. So to develop some recommendations in this highly controversial and very technically complicated area, the Subcommittee met twice, once on December 7, 2004 and more recently, on January 13th, I believe, in a non-public telephone conference call. So the
lateness of this last meeting or proximity to this meeting is the reason why revised recommendations were not available on a more timely basis. Are questions
about our charge and the process by which we develop the recommendations? CHAIRMAN MALMUD: questions about the charge. This is Malmud. No
Are there questions from If
other members of the Committee to Dr. Williamson? not, please move ahead. DR. WILLIAMSON:
Okay, well let me before
I jump in, I want to acknowledge the important role played by the Subcommittee members who were Dr. David Diamond, Mr. Ralph Lieto, Mr. Subir Nag in addition to myself. I think this was very much a team effort. NEAL R. GROSS
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11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 So with that introduction, I would like to start with the document. The document is divided into
important issues that we considered and then under each issue, there are some recommendations that were made which are indicated in bold type. I think to make the flow of this most logical what I would like to do is start with issue number two and then after we've dealt with two through four, maybe come back and pick up number one if the Subcommittee agrees that's appropriate. I think some
of the issues depend on one another and it would be helpful to get some consensus on the technical points first. CHAIRMAN MALMUD: Thank you, Jeff. Is
everyone agreeable to doing two first? DR. NAG: Yes. Thank you. So the issue number two
CHAIRMAN MALMUD: DR. WILLIAMSON: can be stated as follows:
"Is the 20 percent absorbed
dose threshold a reasonable reporting criterion for over and under doses to the target volume?" And this
is specifically for permanent seed implant although there are some comments for other types of radiation medicine procedures as well. So in general, the Subcommittee rejected NEAL R. GROSS
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12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the concept of replacing a single prescribed dose with a dose range. This is absorbed dose now that we're
talking about for brachytherapy implants on the basis that this is inconsistent with the current mainstream industry practices whereby a prescribed dose is
specified in terms of a single well-defined value rather than a range. that further. recommendation. Maybe it would be helpful if I read the recommendations under this part and then we can decide what to do. The first recommendation is that "20 So we really didn't consider
I guess you could take that as a
percent is a reasonable action level for reporting events of QA significance beam to NRC for temporary and unsealed
implants,
external
treatments
radiopharmaceutical
administrations."
Are there
comments on that and specifically from our Chairman, do you want to entertain votes on these piece by piece or do you want to hear the whole thing? CHAIRMAN MALMUD: I think it would be more
efficient if we did it piece by piece. DR. WILLIAMSON: CHAIRMAN MALMUD: Okay. Is there agreement among
the Committee to do it piece by piece? DR. VETTER: Yes.
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13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 beyond the a question. CHAIRMAN MALMUD: DR. VETTER: charge of Yes. motion? MR. LIETO: Second. This is Ralph Lieto. Is CHAIRMAN MALMUD: MR. LIETO: Yes. Thank you. All right. Thank you.
CHAIRMAN MALMUD:
So, Jeff, what's the first piece? DR. WILLIAMSON: The motion is that in
concordance with Dr. Siegel's assessment and past ACMUI discussion the motion is 20 percent is a
reasonable action level for reporting events of QA significance to NRC for temporary implants, external beam treatments and unsealed radiopharmaceutical
administration. CHAIRMAN MALMUD: Is there a second to the
CHAIRMAN MALMUD:
Thank you, Ralph.
there any discussion of the motion? DR. VETTER: This is Dick Vetter. I have
This motion seems to go the Committee in that it
recommends including (Beep sound) radiopharmaceutical administrations. by this Since those were not addressed here specifically, I'm wondering
subcommittee
whether the motion shouldn't be limited to temporary NEAL R. GROSS
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14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 do not. CHAIRMAN MALMUD: MR. LIETO: Don't agree with Dick? implants. CHAIRMAN MALMUD: agrees with that observation? DR. NAG: I agree with Dick. All right. I Is there anyone else who
CHAIRMAN MALMUD: MR. LIETO:
I –- This is Ralph Lieto.
No, I think it's within the
charge if you will in the March 16, 2004 notice from the Commissioners as to what the question was that we were supposed to address. It mentioned all
modalities. DR. WILLIAMSON: This is Jeff Williamson.
As having tried to dig out from the transcript of October 16 I believe what exactly our charge was, it's not especially clear that it was limited exclusively to permanent implants although that's certainly what we emphasized in the majority of our discussions. DR. ZELAC: Dr. Malmud. Yes. Who is this?
CHAIRMAN MALMUD: DR. ZELAC:
This is Dr. Zelac. Yes, Ron.
CHAIRMAN MALMUD: DR. ZELAC:
I just wanted to put in a At the October
little historical perspective on this. NEAL R. GROSS
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15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 repeating meeting of the Advisory Committee, this question was considered and the various modalities for which the plus or minus 20 percent might be appropriate based on the information from Dr. Siegel that I had provided was considered. The decision at that meeting of the
Advisory Committee was that the plus or minus 20 percent was an appropriate criterion of all modalities with the possible exception of permanent implant
brachytherapy and it was on that basis that the subcommittee was formed to consider that specific modality. However, this recommendation from the
Subcommittee is in line with the earlier vote and decision by the whole Committee that the plus or minus 20 percent was in fact an appropriate criterion for all the other modalities. CHAIRMAN MALMUD: Thank you, Dr. Zelac.
Dr. Vetter, would you care to comment? DR. VETTER: that explanation. CHAIRMAN MALMUD: Thank you. With that I did. I'm satisfied with
explanation, do we accept Dr. Williamson's motion as presented. DR. NAG: because But I think that motion is has already been accepted
that
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16 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 unanimously. motion? (No response.) CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: Thank you. The motion moves forward Any abstentions? before by the whole Committee and it was only the So, yes, we
permanent implants that was in question.
have that motion, but this has already been voted on and has been accepted. We're just repeating something
that has been accepted in public record in the whole Committee. DR. WILLIAMSON: This is Dr. Williamson.
I would suggest if there's not opposition to it we accept it so that there is a single document, kind of a coherent body, of ACMUI accepted motions. CHAIRMAN MALMUD: of the motion? Any further discussion
If not, all in favor of the motion.
(Chorus of yeses.) CHAIRMAN MALMUD: Any opposed to the
Dr. Williamson, next item. Okay. We continue. For
DR. WILLIAMSON:
permanent implants, the Subcommittee did not agree with the above recommendation. two recommendations. absorbed dose So basically there are
The first is "the 20 percent is not justifiable for
threshold
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17 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 motion? motion. detail permanent implants." This was adopted on a 3/0 vote
with myself abstaining. CHAIRMAN historically. DR. WILLIAMSON: So I think that is a MALMUD: That is correct
The rationale is listed here and the reasons reasonably well in the report but it's
basically felt that due to the limited control the radiation oncologists have on positioning sources accurately, the issues of objectively and reproducibly defining the target volume and so forth, it was felt that a 20 percent threshold is simply too close to the kind of implant-to-implant variability seen in routine clinical practice to be useful as a criterion for distinguishing good implants from bad implants or good QA programs from bad QA programs. CHAIRMAN MALMUD: presenting this as a motion? DR. WILLIAMSON: CHAIRMAN MALMUD: Dr. Nag? DR. NAG: Yes. It's been moved and All in favor? Yes. Is there a second to the Dr. Williamson, are you
CHAIRMAN MALMUD: seconded by Dr. Nag.
Any discussion?
(Chorus of yeses.) NEAL R. GROSS
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18 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 discussion. this motion? DR. NAG: Yes. Dr. Nag. Thank you. CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: It passes unanimously. Any abstentions? Any opposed?
Next, Dr. Williamson. DR. WILLIAMSON: Okay. The next point is
a follow-on to this.
"Defining medical events for
permanent implants in terms of percent thresholds of absorbed dose delivered to the target volume is not a useful and practical approach." saying not only is the 20 This is basically not good but
percent
basically this is the wrong approach conceptually to defining a medical event for permanent seed implant. CHAIRMAN MALMUD: Is there a second to
CHAIRMAN MALMUD: DR. NAG:
Dr. Nag, yes. The motion is open for
CHAIRMAN MALMUD:
Is there any discussion of this motion? DR. WILLIAMSON: This is an area where I So for the record, I
personally had some concerns. would like to note my concerns. CHAIRMAN MALMUD:
Dr. Williamson's concern
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19 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 concern? CHAIRMAN MALMUD: DR. WILLIAMSON: Please do. Okay. The concern is is noted, though he has made the motion. DR. WILLIAMSON: Subcommittee. Well, I am Chair of the
It is my duty to make the motion. Yes, we recognize that
CHAIRMAN MALMUD: and appreciate it. DR. WILLIAMSON:
So may I state my
encapsulated in the last paragraph on page three of my report. Basically, in mainstream prostate
brachytherapy practice, the authorized user describes treatment intention in units of absorbed dose to the target volume. Through treatment planning, the source
strength, number of seeds and seed arrangement are identified to realize this prescription. So the concerns that I have and this foreshadows future recommendations is that if we omit dose as part of the reporting criterion, then
essentially all error pathways related to treatment planning and the conversion of the physician's
statement of intention from absorbed dose to number of seeds and total activity will be beyond the scope of regulatory oversight. This seems like a large class
of errors to omit from this process and inconsistent NEAL R. GROSS
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20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 response? DR. NAG: No, not really. I just made the with regulatory approach for other modalities. that states my concern. I will add the other this concern and So
Subcommittee
members
recognize
likewise I recognize the appeal and simplicity and unity of the majority approach. DR. NAG: This is Dr. Nag. I do see Dr.
Williamson's point of view. you go back in time,
However, historically if the prescription for
brachytherapy used to be made in terms of millicuries. Implants even now in some places the prescription for the symmetry for, let's say, cervix cancer and other forms of cancer are made in terms of too many
milligram hours.
So although in most places, we do
prescribe in terms of how much dose, I do not see it being inconsistent to prescribe for centers in that terms use of the
millicuries
especially
approach that for certain volumes you need certain number of millicuries. CHAIRMAN MALMUD: DR. NAG: Yes. Are you looking for a I hear Dr. Nag.
CHAIRMAN MALMUD:
statement that although I do see Dr. Williamson's point of view, the point the Subcommittee was making NEAL R. GROSS
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21 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 with is not inconsistent with –- medical practice. CHAIRMAN MALMUD: is noted in the record. DR. VETTER: This is Dick Vetter. Dr. Vetter. Thank you. Your concern
CHAIRMAN MALMUD: DR. VETTER:
I think there is a corollary therapy. The nuclear
radiopharmaceutical
medicine physician wants to give a certain dose to the thyroid for example and he back calculates activity. The prescription actually indicates the activity that would be administered to the patient not the dose to the thyroid. CHAIRMAN correct, Dr. Vetter. varies by 20 MALMUD: You are of course
The prescription however if it could fall under this
percent
recommendation even though the dose to the thyroid is not really discussed. So that my understanding of
this, Dr. Vetter, is that if I were to write a prescription for ten millicuries of I131 and if it was plus or minus the ten millicuries irrespective of the dose received by the thyroid, my prescription would valid if it were within 20 percent of the dose that I ordered, meaning the number of millicuries ordered. DR. VETTER: Yes, I understand that and I
think the recommendation of the Subcommittee would NEAL R. GROSS
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22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 result in the same kind of a scenario for permanent implants. What I'm suggesting is that the two would
be consistent with each other. CHAIRMAN MALMUD: DR. WILLIAMSON: Thank you. They would be but they
would be inconsistent with the current standard of clinical practice. With due respect to Dr. Nag's
point, it's certainly true that at one time that maybe a few outlying practices really don't think in terms of absorbed dose for permanent implants. Basically
all of the literature in the field is analyzed with respect to absorbed dose to a target volume and all of the current recommendations for how to treat prostate cancer with permanent seed implants are stated in terms of absorbed dose. So I think it's fine to exempt this
activity from regulatory practice, but one should be cognizant of the significance of this. been reported significant There have and
misadministrations
medical events due to dose calculation errors which would lead to an erroneous estimate of total source strength. CHAIRMAN MALMUD: We duly note your
concern, Dr. Williamson. MR. LIETO: This is Ralph Lieto. I have
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23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 staff. Tom? MR. ESSIG: Yes, Dr. Malmud and Mr. Lieto, We can, knowing me. MR. LIETO: I don't know who it should be a point of clarification in terms of the report. I
don't know if this should be addressed to Tom Essig or the Chair, but will the report itself be an attachment to the minutes of this meeting or incorporated? The
reason being that I'm asking this is Dr. Williamson's reservations would be incorporated into the record in total as he specified. CHAIRMAN MALMUD: It's not a question to
directed to, but I will direct it to the Chair for appropriate redirection. CHAIRMAN MALMUD: I have to direct it to
we can handle it one of two ways. that all that we've
said today is part of the It would
transcript.
We can certainly include it.
embedded in there, but I think probably the other way and the way I would prefer to do it is a memorandum recommending with these recommendations that have been voted on today that memorandum on ACMUI letterhead to Dr. Charles Miller. In fact you could include any minority views as part of the recommendation. NEAL R. GROSS
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Remember in my
24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 opening remarks I said that we valued dissenting or minority views. So an example of that would be that
we could include a minority view in the recommendation or as a note right after the individual recommendation. CHAIRMAN MALMUD: So we do have the
opportunity to present this as a matter of information as a minority view. DR. WILLIAMSON: CHAIRMAN Yes, we do. Would that be
MALMUD:
satisfactory, Mr. Lieto and Dr. Williamson? MR. LIETO: That sounds fine with me. Yes, no problem. Thank you. May we now
DR. WILLIAMSON: CHAIRMAN MALMUD: move forward on this motion? DR. ZELAC:
Excuse me, Dr. Malmud. Dr. Zelac, yes?
CHAIRMAN MALMUD: DR. ZELAC:
I have a suggestion for
consideration by the Advisory Committee. CHAIRMAN MALMUD: the suggestion. DR. ZELAC: The suggestion is to look at We would love to hear
the motion or the significant recommendation that's being considered now and think about whether it would be improved expanded to include to Dr. Williamson's NEAL R. GROSS
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25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Williamson. would be. concern by adding one word to it as follows. As it
reads now, it starts "Defining medical events for permanent implants in terms of percent of thresholds" etc. If we were to consider placing the word
"exclusively" after the word "implants" so it would read as follows. "Defining medical events for
permanent implants exclusively in terms of percent of thresholds" etc., would that be of any value? CHAIRMAN MALMUD: It seems to me that it
Dr. Williamson, your comment? DR. WILLIAMSON: I - potentially but in
light of the recommendations downstream, I mean I'm not sure it would help. I think that it will perhaps
be clear by the time we get to the end of the recommendation I think that this cannot be handled without a revision of the rule. opinion. At least, that is my But I
You will have to see for yourselves.
think at that time we might entertain additional proposals to consider whether the treatment planning component of the process of planning and delivering such implants should have a role in the revised definition of medical events should that arise in these considerations. CHAIRMAN MALMUD: Thank you, Dr.
Dr. Nag, do you have a comment about the NEAL R. GROSS
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26 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Okay. hear you. DR. NAG: No. No comment. Dr. Vetter. insertion about the adverb "exclusively"? DR. NAG: No. I'm sorry. I didn't
CHAIRMAN MALMUD:
CHAIRMAN MALMUD: DR. VETTER:
No, I have no comment. All right. So shall we
CHAIRMAN MALMUD:
move the motion forward as it is then? DR. VETTER: I would suggest so. All right. All in favor
CHAIRMAN MALMUD: of the motion?
(Chorus of yeses.) CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: DR. WILLIAMSON: CHAIRMAN MALMUD: Thank you. DR. WILLIAMSON: Now we come to a more Any abstentions? I abstain. Dr. Williamson abstains. Any opposed?
positive suggestion for a replacement strategy for medical events for no. permanent 3. implants. This is
recommendation
I will read it. The
Recommendations, here we are, the first bullet.
Subcommittee proposes the following recommendation: NEAL R. GROSS
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27 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 "For permanent implants, the NRC should recommend to licensees that the authorized user specify in the written directive the treatment site in terms of the organ to be implanted (e.g. prostate), the
radionuclide and total source strength.
A medical
event occurs if the source strength actually implanted in the target organ is not within 20 percent of the prescribed total source strength." CHAIRMAN MALMUD: That is the motion. Is
there a second to that motion? DR. NAG: I would like to modify that last
sentence a little bit and that is that if the activity was implanted into the correct target organ, but subsequently migrated to other sites that the portion that migrated would not be within that 30 percent. DR. WILLIAMSON: Okay. So I think the
proposal is to after the occurrence of "20 percent, excluding seed migration,". DR. NAG: Yes. I think there is already
some words similar to that. DR. WILLIAMSON: CHAIRMAN MALMUD: That is correct. So the recommendation of
Dr. Nag is that your recommendation, Dr. Williamson, have inserted into it after the words "20 percent" a comma and then a –NEAL R. GROSS
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28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 continue on. DR. WILLIAMSON: That's correct. And the DR. WILLIAMSON: CHAIRMAN MALMUD: DR. WILLIAMSON: CHAIRMAN MALMUD: A phrase. –- prepositional phrase. Yes. And then a comma and
phrase is "excluding seed migration." CHAIRMAN MALMUD: second to that amended motion? DR. NAG: I second. Okay. Let me just note Very good. Is there a
DR. WILLIAMSON:
a few of the remarks to start off the discussion. This particular recommendation as it stands alone would seem to be implementable without a rule change because of a recent ruling of the Office of General Counsel stating basically that total source strength and absorbed dose are interchangeable in the other brachytherapy category for written directive. Ralph will correct me if I make any There was controversy over
mistakes here about this.
the terminology used and I want to be sure that technically the motion we have is correct and precise. The second technical point is in the context of modern brachytherapy practice. Total source strength which
is used in the definition of dose for low dose rate NEAL R. GROSS
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29 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Nag agree. DR. WILLIAMSON: So maybe a question to Dr. Nag. CHAIRMAN MALMUD: Dr. Williamson and Dr. implants in Part 35 is the product of air-kerma strength per see or equivalently apparent activity in mCi and the number of seeds implanted. This is different from the quantity
contained activity which is 25 to 100 percent larger than the apparent activity due to self-absorption infiltration. Subcommittee. So I think I'm speaking for the We really didn't vote on this, but I
believe the intent of the Subcommittee was that the concept of total air-kerma strength or equivalently apparent activity was the quantity intended by their recommendation. DR. NAG: Yes, that is correct. This is
the staff would be is there any technical or juridical objection to this interpretation? CHAIRMAN MALMUD: Dr. Williamson is
addressing a question to NRC staff regarding this. DR. ZELAC: Dr. Malmud. Yes, Dr. Zelac.
CHAIRMAN MALMUD: DR. ZELAC:
My opinion, we would always
have to get our Office of General Counsel's input, but NEAL R. GROSS
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30 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 a question. CHAIRMAN MALMUD: DR. VETTER: Yes, Dr. Vetter. my opinion is that is not the most difficulty for this particular regulation grouping. If we were talking
however about shipment, transportation, that would be another issue. apparent But in this context, I think using should be a satisfactory
activity
appropriate. CHAIRMAN MALMUD: DR. WILLIAMSON: most of my remarks. Thank you, Dr. Zelac. Okay. Well, those are
You can read the other notes
those who are interested. DR. VETTER: This is Dick Vetter. I have
Does the Subcommittee intend
to restrict this to organs or does organ include tissues? In other words, today we're talking mostly Tomorrow we may be talking
about prostate implants.
about some other kind of an implant that might be in a tissue rather than in an organ. DR. NAG: This is Dr. Nag. The charge to
us was stated as for permanent implants especially as applied to prostate. However, I do agree with your For
concern that we do implant in other areas.
example, we implant tumor beds after reception of the organ because therefore there is no organ that feeds NEAL R. GROSS
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31 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the tumor bed. But I think if we say off the target
area and the target would be the organ, the target would be for example the area and so I think this will still allow you to prescribe as a physician intends to without violating that this is only an organ. the area surrounding you can call it I think very
some
prosthetic tissue. be allowed.
I mean I think that will be still
DR. WILLIAMSON: potential modification. to read as follows
Let me suggest maybe a
We could easily modify this and that would handle the
objection.
"For permanent implants, the NRC should
recommend to licensees that the AU specify in the written directive the treatment sites..." and then "(for example, the organ to be implanted) the
radionuclide and total source strength."
That would
handle it and reduce the term "organ" rather than being a defining characteristic of treatment site an example. DR. NAG: One thing, I would say you
cannot say "for example, the organ" but you can say "for example the prostate." Because if you say "for
example the organ to be implanted, well that is what we are going to implant. the prostate." NEAL R. GROSS
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So I would say "for example,
32 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 unanimous. NEAL R. GROSS
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CHAIRMAN MALMUD:
This is Malmud.
Would Would
it be acceptable to say "the organ or tissue"? that be sufficiently inclusive? DR. WILLIAMSON: DR. NAG: Yeah. This is Ralph. I think so.
MR. LIETO:
I would
definitely say Dr. Malmud's suggestion for amendment. DR. WILLIAMSON: CHAIRMAN agree? DR. VETTER: said. CHAIRMAN MALMUD: Ralph agreed with me, I missed part of what Ralph MALMUD: Okay. Dr. Vetter, do you
but I had suggested inserting "the organ or tissue." DR. VETTER: tissue." CHAIRMAN MALMUD: amendment. I'll submit that as an Yes, I prefer "the organ or
Are all in favor of the motion as amended? (Chorus of ayes.) CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: All right. That's Any nays? Any abstentions?
33 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 McIntosh. CHAIRMAN MALMUD: MS. McINTOSH: Yes, Angela. Welcome. MS. McINTOSH: Dr. Malmud. This is Angela us. MS. SCHWARZ: Dr. Malmud, I have just I
joined the conference call about ten minutes ago. apologize for being late. CHAIRMAN MALMUD: Is that Sally? MS. SCHWARZ: CHAIRMAN Yes. Thank you, Sally.
Thank you for joining
MALMUD:
Since there were a couple
of amendments to the original recommendation for the record so that we have a clean statement about what is recommended and can't be confused, can you restate in one statement the complete recommendation? CHAIRMAN MALMUD: Yes. Thank you. Better
than my restating it, I will ask Dr. Williamson to restate it. DR. WILLIAMSON: is as follows. Okay. The amended motion
"For permanent implants, the NRC
should recommend to licensees that the authorized user specify in the written directive the treatment site, in terms of the organ to be implanted (e.g. prostate), the radionuclide and total source strength. NEAL R. GROSS
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A medical
34 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Williamson. record. event occurs if the source strength actually implanted in the treatment site is not within 20 percent, excluding seed migration, of the prescribed total source strength." CHAIRMAN MALMUD: Thank you, Dr.
We hope that that is clear for the
May we move onto the next item? DR. WILLIAMSON: Yes. The next item is
merely advisory.
It is the second black bullet near It is basically to point out Users could
the bottom of page four.
at this point this is a recommendation. continue using absorbed dose.
This is simply an item
of information that in adjudicatory a medical event, of determining whether an implant is a medical event, when the AU has used absorbed dose to specify written directive would require essentially the licensee and the NRC to agree upon the relevant dosimetric index such as D90, the anatomic target volume, that is the organ and any margin used, and the imaging modality and timing of this imaging procedure used to visualize the target volume. That if you don't agree on any of these things, if there is disagreement, there could well easily be 20 percent discrepancies just because the individuals involved are not talking about the same NEAL R. GROSS
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35 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 not. thing. This is not a motion. item based It is just an our December 7th
information deliberation.
upon
CHAIRMAN MALMUD:
Does the information
item presented by Dr. Williamson require any further discussion by the members of the Committee? (No response.) CHAIRMAN MALMUD: Thank you, Jeff. DR. WILLIAMSON: DR. NAG: All right. Dr. Nag. The silence suggests
I have one question.
After that sentence that Jeff read, it says that individual variations may and do deviate by more than 20 percent and these variations do not constitute a medical event. Now if you put that, then if someone
is prescribing a dose and has to the prostate and very prostatic organs, what will constitute a medical event then? DR. WILLIAMSON: A 20 percent variation
whatever the authorized user wrote in the written directive. But other dosimetric quantities, other You were not there
deviations of these, we discussed.
at the teleconference but the staff agreed that under the current medical event definition, 20 percent
variations in any of these other quantities would not NEAL R. GROSS
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36 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 constitute a medical event. CHAIRMAN MALMUD: you, Dr. Nag? DR. NAG: Yes. Just for example if Does that clarify it for
someone writes that the D90, I'm prescribing a D90 of 145 grains and the D 90 turns out not to be within 20 percent of that. That will be a medical event then. That's correct.
DR. WILLIAMSON: DR. NAG:
Well, I mean as along as the
authorized user realizes that, I don't know why he would want to open himself to that kind of a problem. DR. WILLIAMSON: questions will arise again. Well, I think that your As we go through some of
the other recommendations, I think it will maybe become clear that it might not be tenable to offer even as a possibility or an alternative to the
authorized user to use absorbed dose.
So I would
suggest maybe we come back to this point if it's relevant after reviewing the other recommendations. CHAIRMAN MALMUD: on to the next recommendation. DR. WILLIAMSON: Okay. The next series of The No. Thank you. We'll move
recommendations is contained in Issue No. 4. 4 issue can be stated as follows. medical event criterion, that
Is the wrong site is 35.3045(a)(3),
NEAL R. GROSS
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37 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 workable especially in the case of prostate seed implant? And the Subcommittee thought not. "The
Subcommittee unanimously agreed that this criterion is completing impractical clinically for permanent sealed source implants." That is a recommendation that dose-
based criterion contained in 35.3045 for wrong-site medical event criterion is completely impractical clinically for permanent sealed source implants. CHAIRMAN MALMUD: That's a correct summary
of the Subcommittee's conclusions. DR. WILLIAMSON: CHAIRMAN MALMUD: I believe so. So do we wish to make an
motion that we feel that it is an impractical item? DR. NAG: So moved. So moved. It's been moved and All who would
DR. WILLIAMSON: CHAIRMAN MALMUD:
seconded by Drs. Williamson and Nag. agree? (Chorus of ayes.) CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: Dr. Williamson. NEAL R. GROSS
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Any opposition?
Any abstention?
Thank you.
Next item,
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38 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DR. WILLIAMSON: a recommendation to fix this. is "Permanent implants on Okay. The next item is
So the recommendation written directives
specifying total source strength implanted in the treatment site should be exempted from the wrong site medical event reporting requirement, 35.3045(a)(3)." CHAIRMAN MALMUD: Williamson's motion? DR. NAG: I think –- I'm not really –- I Is there a second to Dr.
know we went through some of this, but I don't think we finalize the thing in the Subcommittee. anyway, let's go on with the discussion. come back to it. CHAIRMAN MALMUD: DR. WILLIAMSON: Okay. It's on the table. Let But
Maybe we
me review some of the discussion points that I thought of during the meeting and some that were discussed during the meeting. are. I think Dr. Nag is right. There
This is a very complicated issue and there may So the main
be some words missing that are necessary.
rationale for this proposal is that wrong site medical events would be adequately covered by treatment sites, delivery criteria failures which is paragraph (a)(1) of 3045. Whenever more than 20 percent of the
implanted seeds are placed in an organ outside the NEAL R. GROSS
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39 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 this target volume, then less than 80 percent of the seeds would remain in the target. So in kind of why you need to have two separate criteria, the thought was that since we've decided to go to a geometric criterion based on what fraction of the implanted activity is in the target volume, why not incorporate wrong site and over/under dose of the target into a single criterion? think it makes since. A second discussion point is implementing recommendation would require a rule change. I do
Without changing recommendation three which was the previous recommendation we voted on that medical
events should involve 20 percent error in delivering the seeds to the prostate. from recommended guidance Without changing three to a recommended rule
revision, eliminating the wrong site criterion might not be practical. Here we get now to this piece, as we get more deeply into this to come up with a consistent approach, the more radical revision of the whole regulation may be needed. I will note that I had
personally, well, sympathetic with this whole general approach of defining wrong site medical event in terms of geometry, basically where the seeds are placed. NEAL R. GROSS
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40 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 bottom of I had a technical concern which is at the page five and top of page six which
basically is if an authorized user, or I'll give a hypothetical example, prescribed one hundred seeds to the prostate but accidently implanted one hundred seeds in the rectal wall and the observed this and compensated for this by implanting an additional seeds in the prostate, this individual would comply with the revised 35.3045(a)(1) but by all reasonable estimates, this would still involve a wrong site administration. My suggestion is to tinker. Well, a
suggestion is to basically modify Recommendation 3 to read as follows. "Any implant of the medical event if
(a) the total source strength implanted in the patient exceeds the written directive by more than 20 percent OR (b) the total source strength implanted in the target volume deviates from the written directive by more than 20 percent." fanciful case. This would exclude that rather
So personally while having sympathy
for this approach, I thought technically it needs some work. CHAIRMAN MALMUD: DR. NAG: Yeah. Any comments? I think that will still
present some difficulty.
I mean trying to weed out
one very unlikely scenario may introduce a practical NEAL R. GROSS
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41 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 problem for the majority of the practitioners. I
think I'm not really happy with it the way it is at the moment, but I want to hear some discussion. DR. WILLIAMSON: problem, Subir? DR. NAG: I think when we do an implant, What is the practical
let's say other than prostate, we implant a tumor bed and we want to lay as many seeds as we can about one centimeter apart within the tumor bed. We don't
really know what exactly is the bond link (PH) and many times technically because of other blood vessels and other tissues you lay as many seeds as you can in the neighborhood of the area you're treating. It's not a very well-defined organ. How
can you say when you are outside your target, when you are inside your target, and I could very easily place more than 20 percent of the seeds in the tumor bed because it is near the tumor bed. So I mean there is
a problem if you are trying to implant the prostate and you're implanting the rest and implant it in the wrong site or you are trying to implant the prostate and you implant the penial bulb instead. That's an
entirely wrong site, but if you are in the vicinity of that, you may have more than 20 percent of your seeds just outside your target area. NEAL R. GROSS
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42 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 impression oncology DR. WILLIAMSON: But I would respond that
if you look ahead to Recommendation No. 5, that would be a conscious decision on the part of the radiation oncologist to put more seeds than he or she originally anticipated. So a simple follow-up would be simply to
revise the written directive because you are able to take advantage of anatomic exposure issues and so on to do a better implant. So you put down 120 seeds
within 24 hours and that seems to me to be quite appropriate. CHAIRMAN MALMUD: This is Dr. Malmud.
Jeff, may I ask you a practical question since I'm not a radiotherapist. When ordering seeds from the
supplier for the patient, would you normally have that many extra seeds around where someone who was
irresponsible and planted 180 rather than 100 seeds? DR. is WILLIAMSON: that skilled are For prostate, my physics pretty and radiation about
practitioners
good
estimating accurately how many seeds they need and depending on the level of experience and the size of the inventory they have, they probably would not order very many more. But I think if haste came about such
as Dr. Nag mentioned and the treatment team were clear that the boundaries were not well defined and couldn't NEAL R. GROSS
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43 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 really be appreciated fully until they were in the middle or maybe even near the end of the operative procedure, I think then the physicist would order on the high end based on consultation with radiation oncologists. DR. NAG: This is Dr. Nag. For prostate,
usually you can emate the prostate really well before the procedure until you have an accurate idea of the number of manipuly (PH) you want. But there are many
other times when you are implanting tumor bed where the tumor has been receptive and therefore you have no idea how much you are going to place, that you would have higher variation, but that is not a medical event because you are changing or you are making a conscious decision to change at the treatment table. DR. WILLIAMSON: I think that should be
incorporated in any legitimate cluster of definitions of written directive, medical event and rules for allowing revision. CHAIRMAN MALMUD: Well, my concern, this
is Malmud, my concern is that we not become too prescriptive because if we become overly prescriptive, we will create unintended consequences that will limit the ability of physicians to practice medicine in best practice. This also should not exceed our mission NEAL R. GROSS
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44 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 is to the table? DR. NAG: No, not really because we wanted which is the issue of radiation exposure, not the practice of radiation oncology. DR. NAG: This is Dr. Nag. My feeling on
this is that we have said that more or less than 20 percent to the target area will constitute
misadministration or medical event.
That thing itself
should cover ourselves because rather than placing 20 percent to a wrong site, that first definition is enough. It will keep the bad actors away. DR. WILLIAMSON: Do we have a motion on
to have this discussion. DR. WILLIAMSON: exempt permanent The motion on the table seed implants from
35.3045(a)(3). DR. VETTER: This is Dick Vetter. I'm not Can
in my office and can't grab my regulations. anyone read that paragraph 35.3045(a)(3)? DR. WILLIAMSON: DR. VETTER: DR. ZELAC: could read it. materials.
I could paraphrase it. Could you please? I
All right.
Yes, this is Ron Zelac.
Let me read what's in the preceding So (a) is "A licensee
This is (a)(3).
shall report any event except for an event that NEAL R. GROSS
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45 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 benefit. results from patient intervention in which the
administration of byproduct material or radiation from byproduct material results in," now here is three, "a dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 sievert (50 rem) to an organ or tissue and 50 percent or more of the dose expected from the administration defined in the
written directive exceeding for permanent implants seeds that were implanted in the correct site but migrated outside the treatment site." DR. WILLIAMSON: I will note for the ACMUI
The reason we didn't like this is that the
criterion implies that even if one voxel of normal tissue receives a dose that deviates by 50 centigrade or 50 percent, this could constitute a medical event depending on what you took to be the correct plan. So
to us, it seemed like this was a dose, if the dosebased criterion is dubious for specifying the dose to the target volume, a dose-based criterion compared to a geometric criterion is even more dubious for
specifying the wrong site. I think the sense of the Subcommittee is one way or another it should be defined geometrically in terms of where the source is put in the right place or the wrong place and not was the absorbed dose in NEAL R. GROSS
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46 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 based. DR. WILLIAMSON: It is totally dose-based. excess of 50 percent relative to some other site which is very vague and it's not really been tested by OJC or anyone. DR. VETTER: But as I understand it in
order for to be classified as a medical event, you have to satisfy both criteria, 50 rem to that voxel and 50 percent of the prescription, is that correct, which is based on activity. DR. ZELAC: The intent is 50 rem or 50
percent of the dose that was expected to be received in the administration by that particular tissue or organ. DR. VETTER: Okay. So it's totally dose-
The proposal, I think, the broad proposal is to, which even I agree with, maybe Dr. Nag no longer does, but at the time the Subcommittee agreed it was reasonable to do away or exempt permanent implants at least from this provision of medical event and make sure that the primary definition of medical event which is activitybased covers wrong site administration. would only be essentially one criterion. DR. NAG: Yes, I think the definition that So there
is there is so vague that I don't think anyone would NEAL R. GROSS
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47 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 you. Malmud. that be able to enforce it anyway and I think even if we leave it the way it is it doesn't add or take anything away. No matter how you rewrite it, it's very So even if
difficult to say what the wrong site is.
we leave the way it is, correct me, I don't think the NRC can take any actions at least with the wrong site unless the seed were placed in an absolutely different area of the body. CHAIRMAN MALMUD: Dr. Nag, this is Dr.
Do you understand your statement to be stated
you believe that the current regulation as is sufficiently adequate to cover most
written
situations without restricting unduly the practice of radiation oncology? DR. NAG: Yes, and that's simply because
it's so hard to quantitate what would the dose, that portion of alternated would have been because you can see that. Therefore no one will be able to enforce
that in any way. CHAIRMAN MALMUD: Let me ask a question of
Has the NRC ever attempted to enforce that in a
way which Dr. Williamson was concerned about with respect to the burden borne by even on voxel? DR. NAG: As far as I know, no, but I
think Ron Zelac would be able to say that better than NEAL R. GROSS
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48 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 I would. CHAIRMAN MALMUD: DR. ZELAC: Dr. Zelac.
Actually even the better
source of information if she were on the line would be Dr. Donna Beth Howe. She's been involved in this However, from her, it is my
activity for a goodly long time. conversations that I've had with
understanding that there has never been such a pointed attempt to enforce this regulation. That there's been
the thought of reasonableness that has always entered into any actions associated with events where this might come into play. Keep in mind, of course, that
this section 35-3045(a)(3) is intended to apply to all therapeutic modalities and it's in that context that we're now looking at possibly a different approach for permanent implant and permanent implant only. CHAIRMAN MALMUD: you, Dr. Zelac. You are correct. Thank
Since your concern, Dr. Williamson,
is a theoretic one which we've not experienced to the best of our knowledge, might you be willing to accept the maintenance of the current wording? DR. WILLIAMSON: is very strange. Well, I mean the argument
The argument is that the regulation
is so absurd no one would dare enforce it. DR. NAG: Exactly.
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49 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 your simple. DR. WILLIAMSON: I would say that's not a
very good basis for rule-making in my opinion. DR. NAG: Yes, but the problem is to make
something better is going to be so difficult that I don't think we'll be able to do it in the next 45 minutes. DR. WILLIAMSON: But it's actually very
If we simply extrapolate your very own
activity-based criterion one step further, you have a limitation both on the total number of seeds you can place in the patient and the fraction of seeds that must be in the specified treatment site. If one of
those criterion is not met within 20 percent, it's a medical event and you have now defined wrong site medical event as any permanent implant in which more than 20 percent of the seeds were unintentionally placed by the physician outside the treatment site. So now it's no more burden to go back to post-op example. The first criterion we
discussed is no more problem to enforce than this one. So my suggestion would be that it could easily be fixed. CHAIRMAN MALMUD: This is Malmud. I have
a naive question as a non-radiotherapist.
I recall
that the original discussion related to not only the NEAL R. GROSS
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50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 my placement of the seeds but the migration. Are there
instances in which more than 20 percent of the seeds migrate? DR. NAG: Usually, they are not. The only
way I think more than 20 percent may migrate without any harm would be if the seeds were placed in the bladder and the patient automatically either passed it through the urine or we usually go into the bladder and retrieve the seeds. possible instant. So that probably is the only
Otherwise, the usual variation to
the number of seeds migrating is about two to five percent activity. CHAIRMAN MALMUD: question is, I ask Then the other part of of the radiation
this
oncologists, in the course of good medical practice is it uncommon for more than 20 percent of the seeds to be misplaced. DR. NAG: It's very uncommon for more than
20 percent to be misplaced when you're talking about the prostate or any defined organ. However if you are
having an ill-defined organ where you don't know where that organ is, you could have more than 20 percent outside depending on how you define that volume. That
is what I'm afraid of that you can have 20/30 percent outside in the immediate vicinity so that if you tried NEAL R. GROSS
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51 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to –- more than 20 percent outside the volume and you say the target or the area that you want to implant was in the pancreas and you have more than 20 percent of the seeds just outside the pancreas, someone could mistakenly or if someone wanted to say you wanted to implant the pancreas and now you have 20 percent of the seeds outside the pancreas or just outside the pancreas. DR. WILLIAMSON: You know my response to
that would be that this same objection could be raised against the motion we voted, No. 3, where we said permanent implants that the NRC should recommend to licensees that they specify the written directive in terms of total activity implanted in the treatment site. The NRC and physicians and everybody, you have to realize what clinical reality is. In certain
setting, for example, the post-op case, there is no way to define the target boundary precisely and the only thing you can do is ask the question "Are the seeds reasonably in the correct region of the body" and that's it. You can do no more.
The other dilemma that I think Dr. Nag raises is also false because at the time of the seed implantation, the authorized user always has the right NEAL R. GROSS
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52 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 than making that anyway. to revise the written directive upwards if 20 percent more seeds are needed to complete the implant in his or her judgment. DR. NAG: Exactly, and that is why – So this is a dilemma. Dr. Nag. That is why I'm
DR. WILLIAMSON: DR. NAG: Okay.
saying that, yes, now I can place a few more seeds into the area I want. But the problem is I have more
than 20 percent just outside the area and we are making up quantities by putting more seeds inside the area. DR. WILLIAMSON: the area is expanded. Well, then you say that
You have the right to revise
the definition of treatment site, too. DR. NAG: Well, but it's not right to do
Then I can revise wrongly implanted to
rectal and say immediately after I did that, that now I'm going to implant the prostate and the rectal. if I want to cheat, you cannot prevent me So
from
cheating. DR. WILLIAMSON: That's correct. We
certainly cannot. DR. NAG: this That is why I'm saying rather
-- not to make the thing too
complicated.
So long we are getting to a reasonable NEAL R. GROSS
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53 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 degree, I think we should stop there and not try to make it over complicated. CHAIRMAN MALMUD: May we get another
opinion besides those of Dr. Williamson and Dr. Nag? DR. VETTER: This is Dick Vetter. Yes. Since
CHAIRMAN MALMUD: DR. VETTER:
If I may.
Recommendation 3 specifies the dose or dosage if you will in terms of radionuclide and total source strength, then it makes sense to me if subsequent regulation are also related to radionuclide and total source strength. So I'm trying to understand some of
the complexities that Dr. Nag is trying to educate us on. But simply to be consistent, it seems to be that
the medical event should be based on source strength rather than dose. DR. NAG: Yeah, and the medical event we
have already discussed and we have already solved that. Now we are talking about the wrong site and
what I'm trying to say is that it sometimes can be very complex to say how exactly we define the wrong site. say. Something that is far removed is very easy to Something that is in the near vicinity is very
hard to say what exactly is the wrong site. DR. WILLIAMSON: Agreed. It's very true.
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54 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 dose. CHAIRMAN MALMUD: Is the wrong site an NRC
issue or is it a medical care issue? DR. SULEIMAN: This is Orhan. Yes.
CHAIRMAN MALMUD: DR. SULEIMAN:
If it's part of the
inherent uncertainty with performing the examination, it's a medical issue. If it borders on negligence or
somebody did something very wrong, I think it clearly is a regulatory issue. And let me discuss my perception on the I mean the calculation of absorbed dose is very You have the target volume. You have the
complex.
activity of the source and a lot of times the activity of the source is synonymously and really incorrectly used as a dose when we're talking about radiationabsorbed dose. So why not for simplicity focus on what's being administered because that's easy to verify and check, but separate from that, at some point you have to validate the dose that you're calculating. these as two separate types of calculations. I don't know if these recommendations are really addressing that or maybe they should focus on it and the site, are you talking about a proximal site or something that's further away? NEAL R. GROSS
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I see
The further away
55 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 you are, the contribution to the dose is going to be less and less significant. DR. WILLIAMSON: I think the intent of the
recommendation was just to basically address wrong site in terms of did you implant the seeds in the right site plus or minus 20 percent or did you put more than 20 percent of the total by mistake into the wrong site, not as a medical intention? So the burden
is on the authorized user to specify the medical intention and if necessary, revise it at the time of the procedure. DR. SULEIMAN: How would this be enforced?
How would this be identified? DR. WILLIAMSON: A typical scenario maybe
Ron Zelac or Donna Beth Howe could clarify, but my understanding is in the series of implants mishaps that were identified, prostate implants were found subsequently on, I guess, day after or 30-day later CT imaging. It was incidently discovered that the seeds
had been placed essentially in the wrong organ and in some cases, the majority of seeds were placed in the rectal wall or bladder wall. While at the time of the
procedure using only ultrasound, the physician thought they were in the prostate. So this was a mistake in
terms of interpreting the ultrasound images I guess. NEAL R. GROSS
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56 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DR. VETTER: This is Dick Vetter. It
seems to me that the physician at the completion of the procedure ought to be able to describe what the target volume was and therefore, I'm uncomfortable suggesting that we should exempt these permanent
implants from wrong site medical event reporting. DR. NAG: Now again, I think after I –- I
did think about this and from what happened medically. My feeling was that our previous definition of administration of medical implants would catch the wrongdoers and let's not rewrite the definition of the wrong site. Leave the phasing as it is in the –- Part Sometimes when you
35 and let's not try to redo that.
redo something, you create more problems than you solve. DR. VETTER: But is that even applicable
since subparagraph (3) is based on dose, not based on source strength? DR. NAG: talking about. DR. 35.3045(a)(3). DR. NAG: Right. That says it's a medical VETTER: Well, paragraph I don't know exactly what you're
DR. VETTER:
event if the dose in the extra-target volume tissue is NEAL R. GROSS
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57 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 more than 50 rem or more than 50 percent of, I forgot the exact words, the prescribed dose. prescription is not based on dose. source strength. DR. NAG: But that is why I'm saying that Whereas the
It's based on
without even writing anything, you don't even need to say permanent implant at exam because permanent I mean this
implant are being prescribed differently.
paragraph is something that you really cannot enforce anyway. We didn't want to waste the time trying We can
revise it because it's not applicable anyway. put "Not applicable." permanent implant
But to write something that is not or permanent implant
need
statement also at this point, I don't think we really need to. DR. WILLIAMSON: Well, you know I would
guess the reason why this has not been tested by NRC is that everyone's afraid to apply it. If they did,
I think there could potentially be thousands and thousands of implants that would agree and if one person decided to test the system and the Office of General Counsel ruled that that was a legitimate interpretation of this, it could cause mayhem. honestly think this is a –The Commissioners have handed us an So I
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58 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Lieto. opportunity to fix something that's really broken. The activity-based methodology that Dr. Nag has
introduced is a potential fix for this. simple and straightforward.
It's very
It doesn't have all this
complexity of dose calculation for permanent implant. I think it's something that should be considered. MR. LIETO: Jeff and Subir, this is Ralph
Then basically it sounds like what you are
saying in answer to the Item 4 question is we've already addressed it in that first recommendation and really we should just kind of maybe cancel out the reminder of that because what we're trying to do is fix something that obviously is not going to be fixed in a meeting of this length and is going to require a lot more input even if it is fixable. DR. NAG: Yes, I would say that let's
continue with our meeting because we have only half an hour more and there is not going to be any major problem with this the way it is now because you are defining now permanent implant in terms of the termini some much administered activity and you cannot now go back and enforce that you are going to have more than 50 percent of what the dose would have been until I think that it will not apply. DR. WILLIAMSON: So let's –-
That is not true, Subir.
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59 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 The way the rule is written certainly the two parts are independent of one another and they certainly could enforce this. DR. NAG: I mean how can you say that. How are you going to enforce the
thing that you are going to have 50 percent higher dose or –- The other thing is that that would be true even for a removable implant. I mean in a removable
implant a certain portion will be getting a pretty high dose. So unless you are really implanting into
the wrong area of the body, you really cannot enforce it. DR. WILLIAMSON: That's why I'm
recommending we change it to adhere to that insight that you have just had. Because you notice the last
bullet under this point at the top of page six, it basically permanent says this is a problem not only for
seed implants but perhaps for all of
brachytherapy. So I think it seems very strange we would, perhaps we can't fix it now and we just leave it. We've already said it's broken. We've agreed with
that and we could agree we need maybe to have a more detailed proposal to discuss this at some later time. CHAIRMAN MALMUD: May I ask another naive It is broken. Is
question from a non-radiotherapist? NEAL R. GROSS
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60 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Let's see. there any evidence that it has been broken? DR. NAG: My feeling is that no because I
don't think –- You know it's very hard to identify what is a wrong place site of the unless body. it's totally in a
different
So just leave it
slightly vague like it is and then if there's an implant on the left side of the body rather than the right side, it will be applicable right away. If you are implanting something that's very far away instead you are implanting the liver, you are implanting the pancreas, that's very
definite.
And if there is some way it is very so So my feeling
vague, you really cannot bring it up. is leave this out for the time being. CHAIRMAN MALMUD:
Thank you, Dr. Nag.
Mr. Lieto, Dr. Vetter, any comments about
Dr. Nag's recommendation to be left as it is. DR. VETTER: Well, I think we're having a So I guess I would
little trouble getting past this. agree with Dr. Nag.
If we have time, we can come back
to it but that we go on for the time being. CHAIRMAN MALMUD: MS. SCHWARZ: Thank you. Sally Schwarz.
Dr. Malmud.
CHAIRMAN MALMUD: MS. SCHWARZ:
Yes, Sally.
I just wanted to mention.
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61 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 possible. DR. WILLIAMSON: I think this is very Is it possible since really other than the
subcommittee that's dealt with all these issues, we haven't really, I mean it would be nice to have additional time to kind of reread what all has been presented in that maybe we could discuss this again at the April meeting at least this particular point. CHAIRMAN MALMUD: That's certainly
reasonable to simply table this second recommendation under point number four. CHAIRMAN MALMUD: All right. Let us table
–- All in favor of tabling it? (Chorus of ayes.) CHAIRMAN MALMUD: on to the next item. DR. WILLIAMSON: Issue No. 5 is "Does the Thank you. Let's move
option of revising the Written Directive as per 35.40(a)(6)(ii) prior to completing the procedure create an opportunity for AUs to avoid reporting technically inferior implants as medical events?" Basically, the answer seems to be yes. There are
several cases in which a large fraction of the seeds were implanted in the wrong organ. The AU revised the
written directive weeks after performing the procedure NEAL R. GROSS
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62 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to lower the intended dose arguing that the underdose would be compensated by additional radiotherapy and so forth. So this has happened and been a concern that I think the ACMUI has been supportive of in the past. The general recommendation the Subcommittee
made was that for your consideration "that written directive revisions, intended only to avoid NRC
enforcement actions and that do not address legitimate medically-indicated revisions of the treatment plan, are not justified and that either rule changes or changes in enforcement policies should be undertaken to close this loophole." under part 5. CHAIRMAN MALMUD: Are there any comments That's recommendation one
about this recommendation one under part 5 which is on page six of the material? DR. NAG: The only question someone may
have is how can we say that that was made or intended for only to avoid an NRC enforcement. slight problem I see. hard to say. That's the only
I know what we mean, but it's
It's like going into a legal battle.
You do it only to avoid the NRC rules. DR. WILLIAMSON: Well, we're not making This is a
the claim about any specific person. NEAL R. GROSS
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63 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 fine. CHAIRMAN MALMUD: one of you second it? NEAL R. GROSS
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statement of a problem. rule.
It is not a regulation or a
So you don't need to have a decidable criterion
for applying it. CHAIRMAN MALMUD: Well, I understand, this Perhaps we
is Malmud, Dr. Nag's comment about intent.
should simply drop out that part of the statement and leave the rest of the statement in. The SC
unanimously agreed that written directive revisions should only at best legitimate medically-indicated reasons. MS. SCHWARZ: I agree with that revision. Would that be acceptable
CHAIRMAN MALMUD: to you, Jeff? DR. WILLIAMSON:
Yes.
Do you want to It's your
propose the exact text you have in mind? revision. CHAIRMAN MALMUD: Okay.
"The SC
unanimously agreed that written directive revisions should address only legitimate medically-indicated revisions of the treatment plan." DR. NAG: I think that's plain enough. Yeah, I think that's
DR. WILLIAMSON:
If that's a motion, will
64 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 you. MS. SCHWARZ: Second. All in favor?
CHAIRMAN MALMUD: (Chorus of ayes.) CHAIRMAN MALMUD: (No response.) CHAIRMAN MALMUD: Next item. DR. WILLIAMSON: fix to the problem.
Any nays?
All in agreement.
Thank
The next proposal is a
"For permanent implants based on
written directives specifying total source strength implanted in the treatment should be site, amended 35.40(c) to and
35.40(b)(6)(iii)
require
completion of the written directive and documentation of any written directive revision within 24 hours of completing the source insertion procedure." the recommendation. 35.40(b) and (c) are the definitions of written directive for other brachytherapy. So what That's
this is a proposal to add some verbiage which for permanent implants only would require written
directive revisions to be made within 24 hours of the completion of seed insertion. DR. NAG: Actually, this follows very much That written
the rules for other implants as well.
directive should be within 24 hours of completion of NEAL R. GROSS
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65 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the procedure. The only problem in the permanent
implant was that there was no indication as when the radiation created a procedure ever ended and therefore it
loophole and putting the word "source
insertion procedure" does many to close that loophole. CHAIRMAN MALMUD: This is Malmud. May I
make a suggestion that it be within one working day of completion of the source insertion procedure? So that
if a department is only open Monday to Friday, it could be done on a Monday for Friday's work. DR. WILLIAMSON: MS. SCHWARZ: Seems okay.
Yes. May I make a couple
DR. WILLIAMSON: comments about this? CHAIRMAN MALMUD: DR. WILLIAMSON:
Please. I think in the case where
the physician uses source strength and number of seeds, this is reasonable and it's based on the assumption that any medically-legitimate deviation from the original written directive would be known to the authorized user during the implant procedure and would be the result of a conscious decision to alter the implant geometry interoperatively. Okay. So there is a concern however if
this would not be practical for the people who choose NEAL R. GROSS
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66 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 true. where to prescribe use absorbed absorbed dose dose in is the written not
directive
because
often
calculated definitively until many weeks after the implant. So therefore a revision of an absorbed dose
written directive could not be made within 24 hours of a completion of a permanent prostate seed implant for most practitioners. I want to basically point out
that this recommendation is consistent only if the physician writes the written directive in terms of apparent activity. DR. NAG: Well, that's not necessarily
I mean first of all you don't want a situation a practitioner is doing the iso-dose (PH)
calculation
and then finding that the iso-dose
calculation did not meet or did not match with what he had prescribed and then he would change it. not want that time lag anyway. Secondly, I mean that's the main thing. It's immaterial when they do the dosimetry. You want So you do
to know what their intent was at the time of the implant and as they completed the implant. So I think
within the 24 hours of completion of the source insertion procedure you would discover their intent. DR. WILLIAMSON: Nag's point in general. I think I agree with Dr.
My only point is that the
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67 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 recommendation we have voted for previously under Issue No. 3 of our report was that we would recommend to licensees that they specify the written directive in terms of apparent activity, not require. So the
problem is that unless we change that recommendation from recommendation to recommend to the users they do this to require the users to do this, there is in inconsistency in the regulations. DR. NAG: That's my point. I don't think
This is Dr. Nag.
that's a problem because if I'm prescribing in terms of a dose and let's say I want to give a second amount and while I'm putting my seeds in I find for whatever reason I want to increase or decrease that dose, I can write a revision as I finish my implant saying I wanted to give 10,000 but now I want to give 12,000 or 15,000. do that. DR. WILLIAMSON: What if you don't do But I don't need much more than 24 hours to
imaging of the implant for 30 days and you don't have a treatment plan so you'll never know whether it was 80 gray, 90 gray, 110 gray, 130 gray, 140 gray? might know but most people –DR. NAG: give a second dose. Wait. But my intention was to You
Now if I did not, that's the
reason –- I mean if I'm allowed to change my dose NEAL R. GROSS
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68 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 require it. in the best depending on the dosimetry I do later, then I could say that I implant by mistake. I implanted twice or I then
three times the amount and I doubled the dose.
go back after any implant I planned and I say I initially wanted to give 125 grain. 250 grain. Now I'm giving
So I think you are going to defeat the
purpose if you allow any revision beyond that 24 hours. DR. WILLIAMSON: No, you misunderstand.
My proposal would be to amend the recommendation in paragraph three to require authorized users to write the written directive in terms of implanted activity. Then there's full consistency in the regulation. DR. NAG: I don't think you really need to
I mean if someone wants to I think it is interest of the authorized user to
prescribe it in terms of millicuries but you don't have to force them to use it. be inconsistent. I don't think it would
I think a wise authorized user will
write in terms of millicuries but if you don't, I mean you could I think if you wanted to have the authorized user avoid having too many unnecessary medical events. You could put it as a suggestion and the reason why you suggest to prescribe in terms of activity rather than those, but I don't think you want to require NEAL R. GROSS
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69 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 them. DR. WILLIAMSON: dilemma here. I think there is a
You know not all revisions of the
absorbed dose written directive need be illegitimate. It may be that the authorized user implanted the seeds in a certain way to avoid overdosing the urethra or because of unavoidable anatomic constraints and the dose plan will show a reduced dose and it would be reasonable to put that reduced dose in the chart and maybe contemplate other actions to fix the dose
distribution to the prostate or improve it by other treatment modalities or procedures. So I think it
leaves a dilemma in place and there's an inconsistency which is not very satisfying which could be easily remedied. DR. NAG: No, but, this is Dr. Nag, I
still feel that if you allow to revise your dose after your permanent implant, after everything has been done, and then you wait a month and then you get dosimetry and then you revise your dose, that is going to open up to anyone who has made a mistake to revise the dosimetry to cover up their mistake. would be major problem if you allow. DR. WILLIAMSON: I think that
I'm sorry.
Well, I think that I'm
agreeing with you and I'm suggesting it would be fixed NEAL R. GROSS
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70 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 seconded? by eliminating it as a possibility. CHAIRMAN MALMUD: Any other comments So is
besides those of Dr. Nag and Dr. Williamson? there a recommendation? DR. WILLIAMSON: recommendation.
I think there is a
It's been stated on the table for
consideration and a vote. CHAIRMAN MALMUD: It has been ruled and
Was there a second to that, Dr. Williamson? DR. NAG: Yes, Dr. Nag seconds. All in favor?
CHAIRMAN MALMUD: (Chorus of ayes.) CHAIRMAN MALMUD: (No response.) DR. WILLIAMSON: CHAIRMAN MALMUD: All other are in favor. DR. ZELAC:
Any opposed?
I will abstain. Williamson abstains. Next item.
Thank you.
Excuse me, Dr. Malmud. Yes, Dr. Zelac.
CHAIRMAN MALMUD: DR. ZELAC:
Just for clarification, the
recommendation that was just voted on, is it as it appears on page six for permanent implant based on written directives specifying total source strength implanted in the treatment sites? CHAIRMAN MALMUD: That's my understanding.
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71 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DR. WILLIAMSON: DR. NAG: Yes. That's what I voted for. Okay. Thank you. I think that's so.
DR. VETTER: DR. ZELAC: MS. SCHWARZ:
Was that changed for the 24
hours to within one working day? CHAIRMAN MALMUD: MS. SCHWARZ: Yes, it was.
All right. I thought it was. Am I
CHAIRMAN MALMUD: correct, Dr. Williamson? DR. WILLIAMSON:
Let me mention.
It
appears that this addresses only permanent implants only when the written directive specifies total source strength. So what we are voting on I guess does not
address the issue of dose-based written directives. So Dr. Nag's point is still hanging out there and in fact, I can change my vote now and I can vote for this as stated because it's consistent at least. CHAIRMAN MALMUD: Let the record state
that there's unanimity in support of this and that the one changed printing that you see on page six under the third bullet under Item 5 is that instead of saying "within 24 hours" it's "within one working day of completing the source insertion procedure." DR. WILLIAMSON: That's correct, but it
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72 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 allows actually the authorized user who writes the written directive in terms of absorbed dose to wait as long as he or she chooses to. So I think that it
should be pointed out that is a consequence of this motion. CHAIRMAN MALMUD: DR. ZELAC: Thank you.
I should point out that the
consequence of the motion that Dr. Williamson just described is understood to be an issue by us at NRC as a, if you will, glaring loophole, the kind that Dr. Nag was referring to that the unscrupulous
practitioner could take advantage of. DR. NAG: I think what you could then say
you don't need to –- In the previous motion, you don't need to say "based on written directive specifying total source strength" etc. " –- for permanent You could do it that way. So there's another new
implant" so and so.
DR. WILLIAMSON:
proposal then which strikes out the words "based on written directives specifying total source strength implanted in the treatment site" which could be voted on now, I guess. CHAIRMAN MALMUD: I have to admit that May we first
I've lost track of the statements.
reconfirm that bullet no. 3 under Item 5 has been NEAL R. GROSS
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73 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 of Dr. Nag approved. approved with one change in wording to be "within one working day"? DR. WILLIAMSON: I believe that's so.
(Chorus of yeses.) CHAIRMAN MALMUD: All right. It's been Was it in
Now what is the next motion?
response to Dr. Zelac's concern? (Chorus of yeses.) DR. WILLIAMSON: or he could I could make it on behalf make it since it's his
proposal. DR. NAG: Yeah. My proposal is that on
the previous item that we voted on to prevent the loophole preclusion of striving in terms of dose, we restate that paragraph to say "For permanent implants item 35.40(c) and 35.40(b)(6)(iii) should be amended to require the completion of the written directive and documentation within one working day of completion of the source insertion procedure," basically striking out "written directives specifying total source
strength" etc. so that it will apply for both those who are prescribing in terms of dose and to those who are prescribing in terms of activity. CHAIRMAN MALMUD: DR. VETTER: Ths is a motion.
The consequences of that
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74 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 would be that a practitioner would not be allowed to do imaging 48 hours later to confirm placement of the sources. He has to do within one working day. MS. SCHWARZ: DR. Is that a problem? I think many
WILLIAMSON:
practitioners would consider it so. MS. SCHWARZ: "within 48 hours"? DR. NAG: No, but you don't want the Can it then be changed to
practitioner to do the imaging, do a dosimetry and then change his prescription. The prescription or his
intent has to be stated before he's implanting and he should be allowed to change it while he's implanting, but not after. I mean if you wait until he's done the
dosimetry then he has the ability to change the prescription to show what the dosimetry came out to. DR. WILLIAMSON: Well, I mean there may be
legitimate reasons for doing that actually. MR. LIETO: This is Ralph. I think
basically what we want to do is establish a time line when the treatment has been done as far as the written directive state and I think within one working day is totally acceptable. I think we're going to end up
pushing this time period back farther and we're going to be into this is it two days or 30 days. NEAL R. GROSS
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I think we
75 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 concern? CHAIRMAN MALMUD: DR. VETTER: Yes. vote? CHAIRMAN MALMUD: I'm asking for a vote. DR. VETTER: May I express just one Yes. This is Malmud. should leave it right where it's at as already
approved. DR. NAG: The only difference being taking
out that phrase "based on written directive specify total source strength." CHAIRMAN MALMUD: DR. WILLIAMSON: Is that acceptable? Are you asking for a
I don't feel adequately
informed about this relative to if you specify the prescription in terms of dose and then while you're doing the procedure, you recognize that something isn't quite as you expected. The motion as stated
would require that you do imaging within one working day. DR. NAG: No, it doesn't require you to do
any imaging, what you wanted to –- Imaging is not going to give you the dose. The only way to get the
dose is from the imaging to do calculation and do a dosimetry. NEAL R. GROSS
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76 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 intent. that? DR. SULEIMAN: That's Orhan. Thank you, Orhan. Well, it's not it's only that. DR. VETTER: Right. Yes, I understand
What I'm saying is if you implant your sources
in a pattern other than what you originally intended, then don't you have to re-image or can you with your dose –DR. NAG: No, basically you need to know
your intent, what did you intend to, what dose did you intend to give and basically, that's why from the beginning I have been saying that we should get away from dose and say the medical implant and so on could be defined in terms of the implanted activity. DR. SULEIMAN: Yes, I agree. The purpose
of the imaging in this context is to validate that the number of seeds or whatever is where they were
intended. CHAIRMAN MALMUD: May I ask who just said
CHAIRMAN MALMUD: DR. WILLIAMSON:
It's other intent is to quantify the absorbed
dose you've given the target and the critical anatomy and it's a very important number. The numbers derived
from that are very important and they are used in clinical study to rule data from different
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77 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 yes. institutions. DR. SULEIMAN: Isn't that a slightly –- I
agree but isn't that a slightly different intent? That's where whether it's an unsealed source or a sealed source. You want to valid somehow that the
activity is, that the counts that you're seeing with your imager are in fact correlating with the
administered radioactivity. DR. WILLIAMSON: have the right idea. No, I don't think you
One doesn't use a radioactivity
counting method when a transmission x-ray CT imaging finds where the seeds are, one finds where the
prostate and one calculates the 3-D dose distribution. DR. SULEIMAN: on your imaging? validate. But do you have consensus
I just heard ultrasound is used to Are you doing CT?
Are you doing x-ray?
Are we clear on the imaging modality and how accurate it is in the first place? DR. WILLIAMSON: Within certain limits,
I mean there's a variation among practitioners.
Some practitioners do it right away with ultrasound imaging if they are doing intra (Beeping sound)
planning. procedures. legitimate
Others would use x-ray, CT day of Others prefer to wait 30 days and arguments can be made for all three
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78 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 methods. the Whatever we agree on has to not constrain because that's constraining the
practitioner
practice of medicine. DR. VETTER: This is Dick Vetter. If Dr.
Nag who made the motion can live with it, I can certainly support it. DR. WILLIAMSON: As it's stated, I'm going
to vote against it because it's simply inconsistent. I think there are other and more consistent ways of achieving the same goal Dr. Nag wants to achieve which I sympathize with. MS. SCHWARZ: What other ways, Jeff? I would suggest go back
DR. WILLIAMSON:
to issue 3 and revise the written directive to require the written directive to be specified in terms of activity and then the 24 hour rule works and it doesn't punish anybody for doing their imaging at 30 days or one day or anything else. consistent approach to the problem. It would be a Wrong site, wrong
dose, written revisions all would be a consistent package. That is I think the virtue of Dr. Nag's
original proposal and what we have now is a mishmash of inconsistent dose-based and activity-based
prescriptions which I'm uncomfortable with. DR. VETTER: I agree. I'm actually
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79 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 we have bothers me. uncomfortable with that as well. DR. SULEIMAN: I'm confused. Why would
you validate 30 days after the fact? want to do it sooner? DR. WILLIAMSON:
Why wouldn't you
Because many
practitioners believe that you can't get an accurate dose plan right after the implant because prostate edema is at its maximum and you need to wait for that to resolve in order to get a better feel for what the average dose is to the prostate. DR. SULEIMAN: What if there's been a What
gross migration of the seeds during the implant? if it hasn't been done properly at all?
Or are you
saying the ultrasound would solve that initially? DR. NAG: doing it at 30 days. DR. SULEIMAN: I mean inherently that just No, that is the drawback of
I'm not going to lie to you. DR. WILLIAMSON: The majority of the field That's my feeling. A lot
I think does it that way. of people do it at 30 days. MR. LIETO:
Mr. Chair. Yes. It seems like
CHAIRMAN MALMUD: MR. LIETO: two issues
This is Ralph. here.
One has to do with
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80 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 we should validating treatment planning and so forth and the other is to basically establish a QA indicator that what was in the written directive most likely occurred and I think what we've done already has established that. I'm getting a little confused also because we're making so many changes as we go along. I'm not
sure if we're even being consistent with some of the other things that we've done already. the clock and I know we're going And looking at to be hearing
somebody pretty soon –DR. NAG: MR. LIETO: do is take Two minutes. –- I'm wondering if maybe what what we've done so far,
distribute it to the committee as a whole and redraft this and try to resolve it, either come up with a final before the April meeting or maybe we might just have to take that long to get all these pieces
together.
It seems like as we've been digging, the
deeper we get the more difficult we're running into other issues like for example what we just had before regarding wrong site. Just a suggestion. I would propose we table
DR. SULEIMAN:
this for exactly as Ralph suggested for the April meeting. NEAL R. GROSS
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CHAIRMAN MALMUD:
Dr. Suleiman suggested Is there a
we table this for the April meeting. second to that? DR. VETTER: Second.
CHAIRMAN MALMUD:
Any further discussion
on tabling this item to the next meeting? MR. LIETO: This is Ralph again. I would
like that we continue to work on this and not wait for our next draft until then because it sounds like there's a lot of other input that might be need from other members for clarity that I think would be very, very valuable, to make this maybe an entire committee project to complete. DR. NAG: This is Dr. Nag. My strong
suggestion would be that we involve at least two or three radiation oncologists who do a lot of permanent seed implants because otherwise the discussion will be between people who are not practically doing the implant. Right now, the only member of the team who
is doing this every day is myself. (Meeting ended due to termination of
telephone conference.) (Whereupon, at 3:00 p.m., the above-
entitled matter concluded.)