ML20056F766
| ML20056F766 | |
| Person / Time | |
|---|---|
| Issue date: | 07/08/1993 |
| From: | NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | |
| References | |
| NACMUI, NUDOCS 9308310024 | |
| Download: ML20056F766 (76) | |
Text
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NUCLEAR REGULATORY COMMISSION 2
3 4
5 ADVISORY COMMITTEE ON THE 6
MEDICAL USES OF ISOTOPES 7
8 9
10 Nuclear Regulatory Commission 11 One White Flint North 12 11555 Rockville Pike 13 Rockville, Maryland 20852 14 THURSDAY, JULY 8, 1993 15 16 The above-entitled matter commenced at 11:40 a.m.,
17 when were present:
18 19 20 J
21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.
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1 PARTICIPANTS:
I 2
Barry A.
- Siegel, M.D.,
Chairman [via telephone]
3 Peter R. Almond, Ph.D.
[via telephone]
l 4
Judith Brown [via telephone]
l t
5 Melvin Griem, M.D.
[via telephone]
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6 Joan A.
McKeown [via telephone]
7 Carol S. Marcus, Ph.D.,
M.D.
[via telephone]
8 David Woodbury, M.D.,
FDA [via telephone]
l 9
John E.
- Glenn, Ph.D.,
NRC 10 Larry Camper, NRC l
11 Donald Hamilton, FDA l
l 12 Richard Vollmer, NRC i
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14 15 1
16 17 l
1 18 i
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20 t
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1 P R O C E E D.I N G S I
2
[11:4 0 a.m. )
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3 DR. GLENN:
Good morning, ladies and gentleman.
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4 am pleased to welcome you to Rockville, Maryland, and to the
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5 telephone circuit for.a meeting on the Advisory Committee on l
6 the Medical Use of Isotopes.
7 My name is John Glenn.
I am the Designated B
Federal official for this meeting.
I am also Chief of the 9
Medical and Commercial Use Safety Branch of the Nuclea" 10 Regulatory Commission.
t i
11 This is an official meeting of the Advisory 12 Committee on the Medical Use of Isotopes.
It is being held 13 in accordance with the rules and regulations of the General 5
14 Services Administration and the Nuclear Regulatory l,
1 15 Commission.
This meeting was announced in the Federal l
I 16 Register on July 1, 1993, and the Federal Register notice 17 stated that the meeting would begin at 11:30.
18 The function of the committee is to advise the NRC 1
19 staff on issues and questions that arise on medical use of
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20 byproduct materials.
As such, it is an advisory committee.
21 It does not direct the staff, but provides counsel.
22 This is a slightly unusual meeting in that we are l
i 23 holding it by telephone.
Most of the members are not, in
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24 fact, present here in Rockville.
The meeting was put l
t 25 together on relatively short notice.
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1 For the record, the Advisory Committee members are i
2 either present here or on by telephone.
The participants j
3 are Dr. Barry Siegel, Dr. Carol Marcus, Dr. Melvin Griem, 4
Dr. Peter Almond, Ms. Judith Brown, Dr. Donald Hamilton from j
5 the FDA, Dr. David Woodbury from the FDA, and Ms. Joan 6
McKeown.
7 I believe that is the extent of the participation 8
of committee members.
Have I left anyone out?
9
[No response.]
i 10 DR. GLENN:
There will be some difficulties, I'm 11 sure, because of the fact that we aren't seeing each other 12 face to face.
There are members of the public present in 13 the room here in Rockville.
I imagine that there will be i
14 questions that will come up.
15 What I would like to ask is that if questions come 16 up, a note be passed to me.
Then I can bring those to the i
17 attention of Dr. Siegel,'who is the Chairman of the 18 Committee, and is in charge of the conduct of the meeting.
l 1
19 I will, from time to time, try to alert him to the fact that 20 there are some questions.
21 With that, I would like to turn the meeting over 22 to Barry Siegel.
I will mention that Richard Vollmer of the 23 NRC's Office of Policy and Planning is here and is prepared 24 to give an opening statement as to the reason for this 25 meeting.
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CHAIRMAN SIEGEL:
Thank you, John.
2 This is, obviously, going to be difficult.
It is 3
a fairly complicated set of issues that we are going to try 4
to deal with over the next undefined period of time.
We 5
have never dealt with such a complicated group of things by 6
conference call before.
Usually, we have had much more 7
constrained issues when we have met by conference call.
8 This will challenge our skills of communication.
9 It is very important for purposes of the 10 transcriptionist that everybody, including the people there 11 in Rockville, identify themselves so that the people who 12 can't see know who is talking, and so that the 13 transcriptionist knows who is speaking at that moment in 14 time.
15 Obviously, you won't be able to raise your hand.
16 You will have to wait for a pause, the way I think this l
17 circuit is working, to get into the circuit.
That's because 1
l 18 I think the active circuit kind of captures the whole 1
19 circuit at the moment, as I have been observing the way this 20 is working.
21 Consequently, I urge everybody to try to make your 22 comments as succinct as possible, so that we can keep a 23 dialogue maintained and net lose people on their different 24 ends of the phone, if they are in the midst of hearing 25 someone else go on for a long period.
That may be ANN RILEY & ASSOCIATES, LTD.
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difficult, given the topics that we have to deal with.
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2 Therefore, with that, I think it would probably be j
3 best to let Mr. Vollmer take the stage and tell us what the l
i 4
task force has been up to and set the plan for us here.
j 5
MR. VOLLMER:
Thank you, Dr. Siegel.
I'm Richard i
i 6
Vollmer, Director of the Office of Policy Planning with the 8
7 NRC.
We certainly appreciate the fact that the committee is l
S responding to this request of ours, recognizing that the I
9 issues are complicated and the time is short.
l 10 I will only give a couple minutes of background.
11 If it raises any questions, we can deal with those at your i
12 leisure, right now or later, as you see fit.
l 13 Erwever, in terms of background, as you know, the 5
14 Senate Cc=mittee on Governmental Affairs met on May 6 of 15 this year to consider issues regarding the allocation of l
i j
16 regulatory responsibility for radiation safety in the l
i 17 medical uses of ionizing radiation.
l 18 This Committee requested a report from the f
i 19 Commission on options for' improving the current regulatory l
t i
20 program and the NRC's Chairman Selin committed to provide a i
t 21 preliminary report by August 6th of this year.
A task force j
i 22 was then convened by the NRC to develop this report for the i
23 Commission, and hence, the Congress.
l
.l l
24 The task force was asked by the Commission to set 25 as its fundamental objective the effort toward I
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I characterization of the problem, to the greatest extent i
2 possible, based on currently available information.
We were 3
also asked to identify options that ultimately should be 4
closely evaluated, and asked to identify the database that a
5 might be necessary to allow a productive evaluation to be 6
performed.
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i 7
.The Commission also pointed out to the task force I
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that we should bear in mind that the object of this f
9 preliminary effort is not to recommend a final solution to i
i 10 the issues.
That should not be considered until the l
t 31 independent assessment and outside review of the Medical Use 12 Program by the National Academy of Sciences has been 13 completed.
That process is underway.
i 14 Therefore, with that background, I would lite to
[
i 15 identify who the task force constituents are and what we 16 have done so far, to give you that background.
The task l
17 force includes representatives from a number of the NRC l
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18 offices and also from the Food and Drug Administration.
i 19 Don Hamilton, Whom you all know, represents FDA on 20 the task force.
Internally, we have Josi Piccone, 21 presenting NMSS; John Teleford, representing Research; Lloyd 22 Bolling, representing State Programs; Maria Schwartz, 23 representing the Office of General Counsel; Chuck Norelius, 24 representing the regions, and he is out at Region 3.
25 Darrell Nash and Janet Lambert from my Office of Policy ANN RILEY & ASSOCIATES, LTD.
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Planning are also involved in this.
I chair the task force i
2 effort.
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3 What we did, in keeping with the Commission's
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direction, was develop a list of issues, which we sent to a 5
number of parties.
I'll discuss that later.
i 6
These are ;he issues that we will be discussing at
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7 this meeting.
Those issues include many of those that were i
i 8
raised at the Glenn hearing, and also have been issues j
9 identified by this committee -- by ACMUI, that is -- and by i
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10 others in keeping with problems that have Deen identified 11 and raised over the years.
12 This issues were transmitted to the states, to the i
13 selected Federal user groups, and selected private users and j
14 manufacturers in the regulative community; and, of course, 15 to the Advisory Committee on the Medical Uses of Isotopes.
l 16 You were all sent, basically, the same draft _ set 17 of issues and asked for your views on the importance of the 18 issues of overall patient to work protection, and input
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l 19 concerning resolution of'the issues, and possible options l
20 for changing the current regulatory structure, if j
l 21 appropriate.
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i 22 This request is a broad one in nature.
We ealize 23 that.
We are dealing entirely with sources of radiation, 24 many of which are beyond NRC's regulatory responsibility.
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1 25 Thus, our request is oriented tu how best, on a national j
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1 basis, should the protection of the radiological health and I
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safety be ensured.
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3 Is change, for example, necessary or appropriate?
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4 We have no preconceived ideas en this.
The Commission's
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5 direction to us is not to go into it that way; but to go i
6 into it openly, 7
What we request of this committee is your views on 8
the issues, your perception on whether the problems exist or i
9 don't, based on your unique experiences and training.
We i
t 10 request the advice of ACMUI to assist us in preparing the 11 best possible advise to the Commission; and, ultimately, to j
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12 Congress.
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13 I think that is a'uout all I have to say now, John.
j 2 tnose, then we can handle them-i 14 If there are any questions c:
15 now or later, as appropriate.
i 16 CRAIRMAN SIEGEL:
This Dr. Siegel.
i 17 Mr. Vollmer, were members of the FDA on the task i
i 1
18 force as well?
I guess you said that Mr. Hamilton was.
19 MR. VOLLMER:
That's correct.
We met with FDA 20 early on the process and agreed that we should have their
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21 representation on the Task Force, and Don Hamilton is that j
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22 representation.
He is here with us today.
j 23 CHAIRMAN SIEGEL:
Okay, that's very good.
This-is l
24 Barry, again.
25 You've got a fairly long list of issues.
We can l
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deal with this in a number of ways.
I don't know what the 2
best way to do it is.
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One way is, one or more of us can try to frame the 4
problem or the overall prot]em in some way that we have been l
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5 working through in our own minds.
Alternatively, we could
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6 go through the 3ist, item by item.
I have a feeling that we 7
are likely to get bogged down if we follow that approach.
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8 As a third option, I wonder if you, Mr. Vollmer, have any 9
particular areas on the list that you think are problematic i
10 and most likely to benefit from ACMUI input that we might go 11 for first.
That is a question to you.
l 12 MR. VOLLMER:
Based on, I think, what we have seen I
i 13 so far in response to our questions of others, there are a i
j 14 couple of areas that seem to rise to the top.
Let me a
i 15 identify those.
i 4
j 16 I'm not trying to be all inclusive here, but it is 4
17 just my best recollection.
One of the issues here that 18 certainly the states and others have raised is the question j
19 of uniformity, and whether or not it is detrimental to the j
20 effective application of the medical use of radiation, and 21 the regulation thereof, to have somewhat of a piecemeal 22 approach to that, in both the states and on the national l
l 23 front.
24 Therefore, uniformity certainly was one issue that
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25 was raised considerably.
It is felt that in order to deal l
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1 with the issue broadly, one would have to deal with the l
2 issue of uniformity first, perhaps.
That is because if one t
3 can't get consensus, then that is an issue to deal with, and 4
one that can be dealt with.
Then maybe the rest can be j
6 5
effectively dealt with.
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6 CRAIRMAN SIEGEL:
Let me suggest that maybe there j
i 7
is another issue that takes precedence over uniformity.
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8 That is your Issue 4, which in many ways is related to your J
9 Issue 3; specifically, the health and safety implications of 10 the radiation use in medicine, and the database upon which l
11 we make those judgments.
12 It seems to me that as I have observed.this
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13 process over the last few years, and as I have watched
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14 something of the response to the " Cleveland Plain Dealer" 15 series, and as I read the transcript of the hearings before i
16 Senator Glenn's committee, one fundamental issue here is one 17 of focus, and what I, not meaning to be pejorative, might
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18 refer to as NRC tunnel vision.
l 19 By that, I mean'to imply that the NRC has been 20 charged by. statute with a very specific set of 21 responsibilities which have an impact and a relationship to 22 a very limited part of the practice of medicine.
The NRC 23 and the state agencies that carry out parallel functions 24 worked very hard to make sure that their programs are 25 resulting in what they try to make in their outcome, the i
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lowest number of errors, the least nutber of mistakes of any l
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sort, the fewest patients injur l, the fewest workers anc-j 3
members of the general public exposed to radiation.
4 The problem with the approach is that it loses t
5 sight of all of the rest of medicine.
Trying to reduce the i
misadministration rates even further becomes an issue of l
6 4
7 ALARA, but ALARA within the limits that are available for i
6 the practice of medicine in the United States.
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9 Therefore, to me, the single most important 10 problem, and the best thing that this task force could i
11 recommend, would be that the Government, once and for all, i
12 scientifically evaluates where the problem areas are in all t
13 of medicine, and determine whether or not injuries that l
a 14 occur as a result of radiation are a big problem, a little 15 problem, or just an average problem.
4 j
16 This is so we can determine whether throwing more i
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17 regulation, more statutes, and more dollars at this l
18 particular problem is sensible in the light of an overall i
i 19 expanding health care budget, which is soon to be i
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20 constrained.
i 21 Therefore, I would urge you to focus on the j
22 database that allows us to make these decisions about i
i 23 nuclear medicine and radiation oncology versus surgery, in 24 general, and internal medicine or cardiology or orthopedics, 25 in general, to find out whether the bad things that we do -
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- and I acknowledge that we occasionally do bad things in i
2 the United States -- are significantly more frequent, less 3
frequent, more injurious, or less injuries to the American l
4 public.
l 5
If we do that, I think that it is very important 6
that the database in the study be designed in a way that it 7
is scientifically impeccable; and that this, perhaps, is B
something that, either by Congressional directive or by NRC f
9 contract, should go to an agency like the Institute of i
10 Medicine and the National Academy of Sciences, so that it l
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11 can really be quite an independent study of a particular 12 Federal agency.
13 Therefore, I throw out on the table that that 14 probably is the single most important thing to find out 15 before we worry about all the rest of the specifics.
16 MR. VOLLMER:
Let me respond to that, Dr. Siegel.
i 17 I understand and agree with your logic here.
It J
18 may turn out to be exactly as you portray it.
I think I l
19 have heard a number of people express those views.
l 20 First of all, I would assure you that the NRC 21 wouldn't be doing this broader look if it weren't that we 22 were requested by Congress to do so.
We are not in any way
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23 trying to expand our scope; or I think you characterized as 24 it as lowering the misadministration rate.
25 What we are simply trying to do is to respond, as ANN RILEY & ASSOCIATES, LTD.
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I said in my opening remarks, and to identify and i
2 characterize the problem.
That problem my be characterized I
3 as, there is no problem.
I'm not sure that we can tell what 4
it is in the broader sense, partly because there is a lack f
'l 5
of uniformity in reporting and other things.
l 6
However, again, going to my opening remarks, as to i
7 whether change appropriate or necessary; that is something 8
that, certainly, we are not ready to answer yet.
It may j
9 very well not be.
It may very well be that when you 10 characterize the broad issue of adequate protection of the r
11 public health and safety in this arena, you will find that
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l 12 it is not appropriate or cost effective to do anything.
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j 13 Or, you may find that it is appropriate and cost l
14 effective to make some minor changes; or there may be some 15 rather global things in terms of setting standards, and.
i 16 letting the current system operate the way it has been.
You i
17 may find that that is the appropriate thing.
j 18 We are not trying to answer it by focused j
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19 recommendations.
I think'we are trying to get views such as i
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20 yours on what is the appropriate focus.
We agree that the l
21 database isn't there, necessarily, to articulate the larger l
22 problem.
i' 23 CHAIRMAN SIEGEL:
No, I think we actually are in i
d 24 fair agreement on this.
I would not expect you, based on l
4 I
25 anything that we would tell you, to report that there is no l
i i
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1 problem.
You might say, "We really can't tell you if there I
2 is a problem."
That might be a response to Congress.
It is l
l 3
not the kind of response that people would like to make.
I l
4 understand that.
i 5
However, I think the truth of the matter is, we 6
don't have a very good perspective on the risks from 7
radiation therapy or nuclear medicine, relative to the risks 8
from the rest of medicine.
9 There is some data out there.
There are a series 1
10 of studies from a couple of years ago that were published in 11 the "New England Journal of Medicine."
These were studies f
12 done at the Harvard School of Public Health and Harvard 13 Medical School, where they looked at the adverse events that
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14 occurred to hospitalized patients, and characterized those l
i 15 events.
They also looked at malpractice-related outcomes 16 arising from those events.
1 17 I think one telling thing in this list of 1
18 thousands and thousands of admissions and thousands of j
19 events was that radiation' oncology-related events don't 20 appear on the list.
I have discussed this issue with the 21 investigators at Harvard Medical School.
Unfortunately, l
22 they are not able to dissect the database much better than 23 that.
24 However, in the broad picture of national health 25 care, in my opinion, we are talking about a very small ANN RILEY & ASSOCIATES, LTD.
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1 problem.
Getting better data to characterize the problem, I 2
personally think, should be the highest priority, before we 3
launch on the other things.
1 4
That doesn't mean that we won't talk about some of i
5 these other things.
However, I really wanted to get that ou 6
the table first.
I guess, at this point, I would like to j
7 hear from other members of the committee to find out whetner
-i 8
you think that is on the right track, and whether this 9
represents any kind of consensus, or if you think I'm off in i
10 left field somewhere.
11 DR. WOODBURY:
Barry, this is Dave Woodbury 12
'I think that you are certainly on the right track.
I i
13 It turns out that back in 1978, the NRC did a rather in-
-l 14 depth study of misadministration in terms of diagnostic use l
15 of isotopes.
4 16 The consensus at that time was that it was a very, 17 very small event.
I don't remember the exact numbers.
18 However, it was something like four mis-events in something' f
i 19 like 10,000 administrations or less.
The numbers may have 20 been broader.
21 At that time, it was the consensus of the ACMUI I
22 that it was virtually not a problem.
It was something that 23 should be continually looked at, but it was certainly not j
24 one to invest further resources and time in.
i 25 However, I don't think that the statistics have q
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changed significantly from the standpoint of' diagnostic 2
radioisotopes.
I don't think the statistics in 3
misadministration have changed from 1978 to this time.
i 4
I don't have any figures relative to therapy dose i
5 and that sort of thing.
However, I don't think the 6
statistics have changed in that area.
l 7
CHAIRMAN SIEGEL:
This is Dr. Siegel, again.
8 No, I agree.
I think, David, that it is fair.to 9
say that we are focusing more now on those types of I
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10 misadministration events that at least, in theory, have the 11 potential to cause harm and would, therefore, be the things l
12 that would be tripped by the new definition of f
2 13 misadministration.
s 14 I think that we, as a committee, and the NRC, by 15 virtue of changes in its rules, acknowledge that that large i
i 16 portion of misadministration reporting that was related to
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t 17 diagnostic events associated with the very low doses was not j
r la an appropriate focus of attention.
l I
i 19 Now I am saying'that the number of therapeutic j
t 20 misadministration, based on what we know about data that is j
21 starting to roll in, after the onset of the quality i
22 management rule, is low..
I t
t 23 Knowing that, in and of itself, is not good enough l
24 without knowing whether this is an area of medicine that is 25 associated with a larger number of such events per patients l
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treated and dealt with than our other area of medicine, so 2
that we understand where the national quality control t
3 efforts need to be directed.
t 4
Dr. Griem, is that correct?
5 DR. GRIEM:
As far as radiation oncology is f
r 6
concerned, there has been the study done by the college.
t 7
There were approximately 1,000 evaluated.
Then, five and 8
ten years later, the results were looked at as far as the 9
outcome of whether the patient was healthy or not.
This was 10 a general evaluation of ten specific diseases.
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i 11 Therefore, there is a database available l
12 concerning the types cf practice and surveys, and the B
13 relation finally as how to this affected the ultimate health 4
14 of the patient.
I think that this database should be looked i
i 15 at.
It's about ten years ago.
However, it is available for j
i 16 prostate, larynx, breast -- several of the major diseases i
17 managed by radiation oncologists.
i 18 There are only 2,500 radiation oncologists in the l
19 country.
There are 2,000' linear accelerators.
It is a very j
i 20 small group of physicians that are involved.
I would think 1
21 that an update of this could be done to provide you with 9 22 more data.
23 CHAIRMAN SIEGEL:
Again, this is Barry.
I agree, 24 but to just look at radiation oncology patterns of care and j_
25 not to also be looking at patterns of care and outcome A
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analysis in other aspects in all of medicine -- again, we 2
lose the perspective problem.
3 I think that still is the key issue here.
We've 4
got to know where we stand in relationship to global U.S.
5 medical care, especially in light of revolutionary changes 6
that we think are going to be occurring in medical care.
7 Carol or Judith, do you want to comment on that?
8 DR. MARCUS:
First, I agree completely with your 9
suggestion that we need hard data before we discuss any kind 10 of change whatsoever.
I would agree completely with the 11 concept of giving this charge to the institute of medicine.
12 I understand that NRC has not finalized its 13 contract with the Institute of Medicine.
Perhaps before it 14 does, it can add this request on to the work order.
15 Recent data that came out of NRC that Dr.
16 Paperiello presented in his Commission briefing on the 24th 17 of June is of interest here, I think.
18 Apparently, Dr. Pollycobe did a study of 19 misadministration reported in 1992, from the point of view 20 of which of them had adverse reactions.
What he showed was 21 that only four percent of them had adverse reactions.
22 Perhaps we really ought to look seriously at what 23 NRC is calling a misadministration before we look at i
24 misadministration, and concentrate just on the adverse 25 reaction.
If 96 percent of these reported situations are ANN RILEY & ASSOCIATES, LTD.
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20006 (202) 293-3950 i
i 20 1
not hurting anyone, then maybe it is time to reevaluate the 2
definition.
Before we tell everyone to run off and go look 3
at these things, we ought to decide what these things ought i
4 to be.
P 5
We have the new FDA MEDwatch program.
It is now t
6 required by law to report adverse reactions for devices, for 7
example.
FDA is catching these things.
It has to catch l
8 them.
9 I'm wondering if much of this effort at NRC is not 10 either unnecessary, in that we are reporting things that 11 aren't important; or redundant, in that the things that are 12 important are already being done by FDA.
I i
13 CHAIRMAN SIEGEL:
Judy, can you comment on this 14 general issue of the need for a better database before
[
t 15 drastic actions are taken?
16 MS. BROWN:
Well, I agree that we need hard data i
t 17 before discussing change.
However, it is difficult for me j
u i
18 to imagine getting hard data when the states are so variable
~
19 in what they collect.
Therefore, to me, I think everything l
20 pivots around getting the states to come up to NRC 21 regulations to the letter.
j 22 Secondly, in terms of comparing your specialty 23 with other medical specialties, that just never seems very i
24 useful to me.
I think you know that I think your specialty i
25 is wonderful, and that others should come up to it.
i 1
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Clearly, Congress is alarmed -- or at least certain members 2
are -- by what they hear in the anecdotal reports.
I'm 3
alarmed when I hear them.
I don't think, well, how does 4
this compare to surgery.
5 I look at your specialty in isolation.
I think 6
you can deal with it that way, looking at it in isolation.
i l
7 I wouldn't go along with saying, take an overview of all 8
medical specialties before you isolate radiation medicine to l
9 take a closer look at.
1 10 CHAIRMAN SIEGEL:
This is Barry, again.
11 Judy, I don't completely disagree with what you 1
l 12 are saying.
However, I do, partially disagree.
That's 13 because, to look at --
l 14 MS. BROWN:
I expect everyone to disagree, Barry.
15 CHAIRMAN SIEGEL:
That's okay.
We all don't have 16 to disagree.
17 First of all, my suggestion that we look at this l
18 globally is not meant to be a stalling tactic.
It is meant l
19 to be a mechanism to make'sure that we use our resources 20 wisely.
Those resourcex include all kinds of resources.
21 It is not just how much we are paying for health 22 care; but it is how effectively the people who participate i
23 in this particular aspect of health care can use their time 24 during the course of the day, and whether their time should 25 be better spent actually taking care of patients, or l'
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1 creating a paper trail that can be used for NRC or FDA or-a r
2 state or other inspector to figure out at some later time 6
i 3
whether they did their job adequately.
4 There is an increasing trend in all of medicine i
5 for physicians to spend less and less of their time actually 6
doing things, and more and more of their time documenting j
7 that what they did.
j 8
The net result of that is that we are going to end j
9 up with very, very inefficient doctors, even worse than we 10 have right now.
I don't know a physician in any specialty i
11 who isn't troubled by that.
That is a generic problem in t
12 medicine.
i 13 In nuclear medicine and radiation oncology, we i
14 kind of take a double hit.
Not only do we have the JCAHO to 15 deal with, and local hospital quality assurance committees 16 to deal with, and state law regarding the practice of 17 medicine to deal with, but we get kind of a double whammy i
18 from the NRC and our state agencies, putting a very careful i
19 focus on the way we use these things, with a special kind of 1
20 paper trail, some of which is, indeed, justified by 21 radiation safety concerns to workers and members of the 22 general public.
However, much of this may not be justified.
23 I think a key issue is that if we don't look 24 globally, then we can't know whether the shrinking pot for 25 health care in the United States is being distributed wisely ANN RILEY & ASSOCIATES, LTD.
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4 23 1
to help the health of the American people.
2 MS. BROWN:
I'm not sure that that is the concern 3
of this committee, though.
I think we are supposed to look 4
at things from a narrow radiation medicine perspective, and 5
advise Congress as such.
Obviously,'they are going to 6
allocate the dollars and decide whether it is a big problem 7
or a little problem.
i 8
However, what about my first concern -- that we 1
9 can't tell them whether it is a big problem or a little i
10 problem, because of the apples and oranges that exist in 11 collecting data from the agreement states versut the NRC 12 states?
Do you have a comment on that?
13 CHAIRMAN SIEGEL:
Yes, I do.
That problem is, in 14 fact, close to being fixed, by virtue of the existence of 15 the quality management rule which is --
16 MS. BROWN:
In 1995 -- is that when they have to 17 come up to speed on that?
18 CHAIRMAN SIEGEL:
I wasn't responsible for when 19 they decided that the states had to be in compliance.
20 Therefore, I take no personal responsibility for that.
If 21 NRC thought they could have made it faster, in terms of what 22 they could accomplish in negotiating with the states, they 23 probably would have made it faster.
However, that was the i
24 compromise position that was accepted.
25 MS. BROWN:
They are doing everything a lot l
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1 faster.
I think that is what they are asking us; do they j
2 need to step in and make things faster?
3 DR. MARCUS:
This is Dr. Marcus.
4 I would like to bring you a very different point 5
of view on your question, Judy.
l 1
6 Certain agreement states, such as the state of 7
California, are still operating under NRC's old definition 8
of misadministration, which is much more inclusive than 9
NRC's new definition of misadministration.
Therefore, 10 California is reporting more things than an NRC state.
6 11 The difference between California and NRC states 12 is that in California, all therapy doses must be l
1 13 administered with a physician physically present during the i
2 1
t 14 administration.
We have few of these to report.
That is 15 because it is very hard to have a misadministration.
16 It is not that certain agreement states are j
17 terribly under-reporting.
It is that many of them have a
18 other systems in effect that create fewer therapeutic l
i 19 misadministration to report in the first place.
l t
20 The assumption going around that because NRC 21 states seem to have higher rates of therap', and 22 misadministration than agreement states, that it,means that 23 agreement states aren't reporting them, ia not necessarily 24 true.
25 MS. BROWN:
That was not my assumption at all.
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,m y
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DR. MARCUS:
California represents 20 percent of 2
the nuclear medicine of the United States.
Although NRC has 3
about one-third of the licensees, probably their total 4
amount is no more than maybe 25 percent of the total nuclear 5
medicine in the United States.
6 Therefore, the differences in the agreement stage 7
and what they call misadministration may be the most 8
important thing to compare for the NRC.
If agreement states 9
are perhaps different or closer to the mark on what is 10 important to report, then instead of the agreement states 11 taking a definition of a misadministration, which NRC has 12 now, which picks up things, 96 percent of which are not 13 causing adverse reaction, and some of which are actually 14 intellectually silly, then I wouldn't push NRC's definition 15 on the states.
16 What I would do is push NRC to take a good look at 17 what it really ought to be calling a misadministration.
18 Then I think that you would find that people would be very 19 much more in agreement as to having a common definition.
20 DR. MCKEOWN:
This is Joan McKeown.
21 I think that that goes directly to Judy's point in 22 the first place.
There is a lack of uniformity in 23 reporting, because we have these questions among the 24 agreement states as to who does what and who does what 25 b'etter.
What we need to do is look at everybody with the ANN RILEY & ASSOCIATES, LTD.
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same point of view.
2 MR. VOLLMER:
Dr. Siegel, this is Dick Vollmer.
3 I would like to remind everybody that, again, we 4
are talking about all sourcec of radiation.
What we have 5
been asked to do, al beit, someone out of the NRC's 6
regulatory responsibility -- we are trying to take the 7
broader look.
8 That is why your advice and the advice of the 9
advisory committee is so important.
We are looking at all 10 sources.
We recognize that reporting is fractionated and it 11 is different from one type of product material to another, 12 as well as it is different from state to state.
Therefore, 13 those are the types of issues that we need your help on.
14 CHAIRMAN SIEGEL:
Okay, does anybody else want to 15 comment on the general theme here?
16 DR. ALMOND:
This is Peter Almond.
17 Although, I think, in uniformity, it has had some 18 problems, but certainly, sampling techniques in this day and 19 age are such that one should be able to get a fairly good j
l 20 view of what is happening nationally.
You don't have to go 21 and get all of the data.
You can sample it and know the 22 parameters under which those samples are taken, and then, I 23 think, draw fairly good conclusions from it.
24 It doesn't bother me as much to think that there 25 are differences between the states and the NRC.
If the ANN RILEY & ASSOCIATES, LTD.
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1 1
study is done very carefully, with that taken into account, I
2 I think you will be able to get good data.
3 I do disagree with Judy on this.
I really think 4
that should be globally looked at to see where the use of 5
radiation fits in with the rest of medicine, simply because
{
l l
6 we have come to a time when we've got limited dollars to 7
work with.
l 8
The QA ruling is putting increasing pressure upon i
i 9
where those dollars are going.
It is costing us more money j
l 10 to do our QA in the hospitals than if we had more of a 11 requirement than just being able to afford it.
We have to 12 look very carefully at how we spend the money.
13 The other thing I want to comment on is this.
I j
14 agree with Carol.
I think we need to look at what she calls 15 adverse reactions -- at what the information we have that is 3
16 the definition of serious injury.
l t
17 That is going to be very hard to come up with.
18 However, I think she is probably right.
About four percent 19 of misadministration result in "some kind of mysterious
{
20 injury or adverse reaction."
21 In my experience, in misadministration, only on i
4 22 very rare occasions does this lead to anything that is t
23 permanent damage to the patient.
i 24 MR. VOLLMER:
Dr. Siegel, This is Dick Vollmer l
25.
again.
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1 One final point on this is getting to the issue of l
1 2
the different types of medicine.
I think what we are trying 3
to determine is your views on whether radiation therapy is
}
4 more or less regulated than anesthesiology.
For example, j
1-i 5
should the operators of linear accelerators be regulated j
6 differently than Cobalt 60 units?
7 That gets to the broad context of the question l
B that we have been asked for.
In compiling a database on j
9 that, the uniformity issue seems to pop up every time; j
10 uniformity in reporting, that is.
I 11 CHAIRMAN SIEGEL:
This is Barry again.
Yes, I 12 agree with that, Dick.
l l
13 Let me try to focus this for a second here.
If we
?
14 look on page 2 of the document that we were given, at Item i;
15 3,
which is database, and Item 4, which is health and safety
{
16 implications, remember that our job here is not to answer i
17 these questions.
Our job is to figure out whether they have j
t 18 picked the right questions that need to be looked at.
l 1
19 I think as I rehd down this list, in Items 3 and 20 4,
we have touched on nearly all of these points, and we are 21 in agreement that these are appropriate things that any 22 study of this problem should be looking at.
t 23 I want all of you.just to take a second and just
[
24 kind of scan that list.
I think this is most important, and 25 it reflects what my introductory comments were.
We need to t
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establish a safety goal for the medical uses of ionizing 2
radiation.
3 The safety goal that all of us would like, if it 4
were achievable, is to have a perfectly safe practice of 5
medical uses of ionizing radiation.
However, the truth of 6
the matter is that human activities cannot be made perfectly l
l 7
safe, even if the resources are infinite.
That is not a j
8 cop-out.
That is just the truth.
9 To not look at medical uses of ionizing radiation 1
i 10 in some scientific fashion, compared to the medical uses of l
11 everything else, I think, is a mistake, and does a t
12 disservice.
13 Judy, when you made your comment, you used a very o
14 important word in your description of events.
The word you 15 used was " anecdotes."
I cannot emphasize enough the 16 importance of distinguishing between anecdotal events and a i
17 true scientific database.
18 Risk assessments that involve millions of dollars
(
19 and the way lots and lots of people spend their lives should f
\\
20 be made on a scientific basis, and not as is so often done i
21 by the United States Government, based on the reaction to i
22 the last bad event.
23 MS. BROWN:
Which is why I made the first j
24 statement that I did, that we do need hard data before we 25 discuss this.
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CHAIRMAN SIEGEL:
I think, Dick, the one thing 2
that you can walk away with, unless someone chimes in now, 3
is that we are of a consensus, even with maybe minor dissent 4
on the part of Judy, that having a good scientific databas'e 5
and a good scientific evaluation of this problem and the 6
byproduct material end of it, as well as the linear 7
accelerator end of it, but in relationship to the rest of 8
medicine, is a key starting point for your attack on the 9
overall problem.
10 MR. VOLLMER:
We appreciate that.
11 CHAIRMAN SIEGEL:
Does anybody on the committee 12 want to disagree with that, as a consensus statement?
13 MS. BROWN:
You're giving me a minor dissent --
14 well, yes, okay.
15 CHAIRMAN SIEGEL:
Well, I don't think you are 16 dissenting from that in a major way.
I 17 MS. BROWN:
As long as I have a minor dissent 18 there, I am fine with it.
Let's scale my dissents, because j
19 there will probably be a' lot of them.
We'll give that a 20 five.
l 21 CHAIRMAN SIEGEL:
Well, I'm not sure that there is 22 going to be a lot of them.
You'll be surprised.
23 Okay, where do we go next?
The issue of 24 uniformity is one that Dick said that he was particularly 25 interested in.
I know that there are many different ANN RILEY & ASSOCIATES, LTD.
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opinions on this.
t 2
We have, as a committee, in the past, in a i
3 briefing of the Commission -- and I don't remember the exact 4
words, because I don't have my viewgraphs in front of me --
5 expressed the opinion that setting national standards that t
6 are uniform is an appropriate goal for a program that is 7
designed to regulate the medical uses of ionizing radiation.
i 8
This is true for a variety of reasons.
One is so 9
that people are not confused in terms of understanding what 10 the rules are with respect to a Cobalt 60 teletherapy 11 machine, versus a linear accelerator; or, thallium, which is 12 non-byproduct material, versus technetium, which is l
13 byproduct material.
14 This is so that practitioners, as they move from i
15 state to state, don't find themselves faced with a widely i
16 different set of regulations that they have difficulty i
17 adjusting to; and, in addition, so that better data can be le gathered to understand the magnitude of the problem.
19 The issue of uniformity, in some ways, is whether 20 there has to be uniformity by statute, uniformity by 21 regulations, or whether uniformity is achievable by virtue 22 of standard setting by such bodies as the NCRP and the like.
23 There are studies that come out of the National Academy of 24 Sciences.
To be honest with you, I don't know the answer to 25 that.
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Therefore, I would like to open that topic up for f
2 discussion and see if anybody has thoughts on how this 3
uniformity issue might be approached, number one; and number 4
two, if we think that the questions that have been posed i
5 with respect to uniformity are the right questions.
6 DR. MARCUS:
This is Dr. Marcus.
}
7 Barry, I think you hit it right at the end with, l
8 the question of whether these the right questions.
Before 9
we even begin the discussion, I think we have to divide up 10 two kinds of standards or two kinds of uniformity.
11 One is the basic radiation safety standard in the 12 United States.
Basically, this is what NRC calls, 10 CFR, 13 Part 20.
That is an item of compatibility in every state in 14 the United States.
These are the radiation levels for 15 workers, for the general public, for radiation laws, for
)
16 air-borne emissions, water-borne emissions, sewage emissions 17
-- the basic radiation standard.
f 18 This must, in my opinion, be uniform, because you i
19 can't have any kind of decent interstate commerce or 20 coordinated activity without it.
I would doubt that anyone I
21 would really find a problem with that.
22 We have a minor problem with Part 20, in that 1
i 23 because of the desire of people to apply the general 24 radiation standard to all sources of radiation -- and, Dick, 25 this is probably something that you should realize -- we try J
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33 1
to take Part 20 and apply it to radiation-producing j
i 2
machines, and to accelerator-produced radioactive material, i
i 3
and to naturally-occurring radioactive material, t
4 Part 20 is really written for byproduct, without i
i 5
being ideally suited to being made uniform with all sources' 6
of radiation.
Whether or not the NRC is the agency to write 7
a radiation standard for the United States for all sources 8
of ionizing radiation is not really what we are here to talk t
9 about today.
10 However, I do think that we could use one national 11 standard for all ionizing radiation.
I think that is the 12 message that NRC could send Senator Glenn.
13 The other kinds of standards, and the other kinds l
I 14 of uniformity that we are talking about, and we keep getting 15 them mixed up, are regulations that tell you how to practice
{
16 your profession to achieve the standards of Part 20.
The
'f 17 whole purpose of Part 35 is to make sure that, basically, lo Part 20 is respected.
19 The problem is'that there are an infinite number I
\\
20 of ways to praccice your activity in order to achieve Part i
21 20, which includes the ALARA portion.
When NRC picks one of j
22 them and tries to impose one way on many people with many 23 types of practices, it doesn't fit.
I 24 You will find that many of the problems that we 25 are having are not with the basic radiation stan ard of the ANN RILEY & ASSOCIATES, LTD.
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United States, which is uniform, but with the directions on i
2 how to get there.
I don't think that we should have 3
uniformity in the pathways to get to Part 20.
L 4
CRAIRMAN SIEGEL:
We have lost somebody on the l
5 phone line.
Let's go off the record for a moment.
6
[ Discussion off the record.]
r 7
DR. MARCUS:
I want to finish up on the uniformity
(
B concept.
I really want to end by saying that uniformity in 9
how you get to Part 20 is not a good idea, because it i
f 10 precludes improvement; and, in my opinion, Part 35 needs 11 gigantic improvement.
12 However, with the concept of uniformity in the 13 basic national standard, I don't think that anyone would i
14 argue with that.
However, I think that many of us belaeve 15 that 10 CFR, Part 20, needs to be improved, in and of 16 itself, and needs to be improved so that it can apply to all 17 sources of ionizing radiation.
18 Thank you.
19 CHAIRMAN SIEGEL:
Does anybody want to disagree 20 with that approach?
21 DR. GRIEM:
This is Dr. Griem in Chicago.
22 The question I have is in the practice of 23 therapeutic radiology.
Should we be practicing a specialty 24 that is different from Canada, Britain, or Sweden in terms 25 of the management of patients, because of this Governmental ANN RILEY & ASSOCIATES, LTD.
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regulation?
2 DR. MARCUS:
You should practice the best quality 3
medicine that you can.
4 DR. GRIEM:
No, but as far as do.z-c are concerned i
5 and this type of thing, should the Government specify that?
I 6
DR. MCKEOWN:
No, absolutely not.
7 CHAIRMAN SIEGEL:
Was that Joan?
8 DR. MCKEOWN:
Yes.
t 9
CHAIRMAN SIEGEL:
Yes.
I think that the consensus i
10 of this committee over the years has been that the last 11 thing in the world that we want is a Government-imposed 12 procedural manual, that says that this is the way that you i
e 13 have got to do a brain scan or a bone scan, and this is the 14 way that you have got to treat cancer of the cervix.
15 That would be a disaster.
That would stifle 16 medical innovation completely.
The last place that we would 17 want it coming from would be the NRC, where it would not be 18 coming from the wisdom of an assembled group of physicians.
19 We may find ourselves with national procedural 20 manuals in terms of practice standards and practice '
21 parameters that are being developed now, predominantly as a 22 mechanism to reduce the nonuniformity of medical practices 23 that are observed, regionally, throughout the country; and 24 to develop algorithms for patient care.
i 25 To the extent that those become very, very ANN RILEY & ASSOCIATES, LTD.
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36 f
I confining, they will, in fact, have just the impact that I 2
have expressed in terms of stiflir7 innovation.
However, to 5
l 3
the extent that they make medicine more efficient and large j
i 4
groups of doctors sign off on them as appropriate and 5
sensible algorithms, they will help make American medical 6
care better.
[
7 However, I do not think that we are-anywhere near l
B wanting to recommend that NRC or a purely radiation-related i
9 advisory agency or regulatory agency would be creating such i
lo a procedural manual.
l n
l 11 That gets kind of gets at the heart of what Carol i
12 was driving at.
Uniform standards or reasonable uniform l
13 prescrip*i.ve regulations are probably something that should l
^
f 14 be avoided.
l 1
i 15 Are there other comments?
What about this Item
)
I 16 1(a).
I think Item 1(a) is what we were just addressing, in g
i 17 a way.
For Item 1(d), I think we have got mixed feelings on f
i 18 that, based on what I have heard, up to this point.
i t
19 one could make'the argument that in national j
20 uniformity in misadministrating, once one has agreed on what
[
4 t
21 an appropriate definition of a misadministration should be 22 for purposes of scientific decision-making, you could argue l
+
23 that national uniformity would be a laudable goal.
j 24 You could equally argue that techniques of j
i 25 scientific sampling would allow you to do your risk i
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' ?~ l
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assessments without having every piece of data in the United 2
States captured, for purposes of making intelligent 3
judgments.
4 Therefore, upsetting the apple cart with probably s
5 an impacting set of rules, that affected every practitioner 6
in every state, to get this reporting requirement into place j
7 very, very quickly might or might not be a good thing to do.
l
?
I J
e What about this Item 1(c)?
That is, "The need for l
a 9
one national regulatory authority to ensure uniformity in
]
10 areas that are now handled by multiple agencies; for l
i 11 example, certification of sealed sources and devices, and 12 notification of referring physician and patients of a 1
i 13 misadministration, and the likely consequences."
j i
14 Does anybody want to comment on that one?
i 15 DR. MCKEOWN:
This is Joan McKeown.
16 That sounds to me like a way to create another l
17 bloat in the already bloated bureaucracy.
18 I have a great fear that anything that has been t
j 19 set up is only going to get bigger and not smaller, and then i
20 it is going to cost more money.
j 4
4 21 DR. ALMOND:
This is Peter Almond.
i j
22 I agree with that.
There is a danger here that we 23 will just put in another level of bureaucracy with the other t
24 levels that we already have.
l 25 Some of these goals, I think, are very worthwhile..
k i
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However, we need only to try and reduce the level of 2
bureaucracy, reduce duplication, and make life simpler, and i
3 not make it more complicated.
4 DR. WOODBURY:
This is Dave Woodbury.
i 5
I quite agree that adding another level of l
6 bureaucracy will further impede the delivery of medical 7
Care.
8 I think that most of what we need to attend to on 9
the whole draft is that we have the mechanism and the 10 authority and the regulatory agencies all set up.
It is 11 just a matter of determining which aspect we need to give j
attention to; and not set up another layer of bureaucracy.
l
.c i
13 DR. MARCUS:
This is Dr. Marcus.
14 15 I think that David said something very important 16 just now.
That is, the bureaucracy is set up, and we have 17 to look at which areas to give attention to.
18 I think that the Center for Devices and 19 Radioisotopes, for example, has all the statutory authority i
20 that it needs.
It needs more resources in order to do its 21 job well.
It sees a need for resources in the area of i
22 computer software evaluation in the medical environment.
It 1
23 needs more people for inspecting GNPs and manufacturing
]
i
)
24 operations.
If it had the resources, it has the brains and i
i 25 the structure to do it.
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-o
l 39 1
Therefore, I would agree with David that what you j
l 2
have to look to is to make sure that the groups that need l
i i
3 the attention get the attention.
I think that CDRH just 4
needs more people, and then it will be able to do the things i
5 that the Food, Drug, and Cosmetic Act hr, culd it to do.
6 In terms of things like certification of sealed 7
sources, this came out of the Indiana / Pennsylvania incident.
8 From what I understood, the state of Louisiana did a l
l 9
perfectly good testing of the sealed source.
10 There is no evidence that the agreement states are 11 any less capable of doing this than the NRC.
In fact, if 12 you talk to certain people in agreement states, they think 13 that some agreement states are better at it than the NRC.
14 Therefore, I don't see that there is a problem here to be 15 solved.
16 As far as the second portion of Part C, I think a 1
l 17 lot of this is being overdone by the Office of the General I
18 Counsel at the NRC at present.
That this is not broken.
[
i 19 NRC is making it into something that maybe shouldn't be done 20 by anybody different those who-have been doing'it all along.
j 21 I agree with'what the previous person said that we 22 don't need any more bureaucracy.
l 23 CHAIRMAN SIEGEL:
Are there any other comments?
24 MS. BROWN:
This is Judy Brown.
25 I'm not sure that I understand the item.
Are they I
i i
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1 talking about the creation of a new authority or the 2
shifting of authority to a central, already existing place, i
3 like FDA or NRC?
j 4
MR. VOLLMER:
This is Dick Vollmer.
4 I
5 The issue is whether or not it is needed to put it f
l 6
in a central authority -- for example, FDA -- rather than I
7 having these things being the responsibility of multiple t
8 agencies.
9 Therefore, the issue is, would it be helpful and 10 would it deflate the bureaucracy, perhaps, to have it done 11 in one place with the resources and the authority to do it; l
^
12 rather than have it spread out.
That is the issue.
f 13 MS. BROWN:
Does that also include the various
~
14 state agencies, so that they also would be under the i
15 umbrella or under the national regulatory authority?
16 CHAIRMAN SIEGEL:
There is no reason why the focus l
17 can't be limited in that respect.
J 18 For example, if an outcome of this analysis were
_j i
19 that Congress were to change the Atomic Energy Act, so that l
l 20 under NRC's purview responsibility for other sources of i
21 ionizing radiation used for therapeutic purposes, including l
~
u 22 and for example, linear accelerators, then the. authority, in 23 current NRC regulated states would now transfer to the NRC.
24 Then, presumably, in agreement states, there would i
1 25 be NRC oversight of what goes on in those agreement states, I
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1 with now those additional sources of ionizing radiation.
2 This has impact, both at a Federal level and a state level; j
3 and in the case of some localities, a local level as well.
J 4
Is that correct, Dick?
5 MR. VOLLMER:
That's right.
6 MS. BROWN:
Well, now that I am pretty sure that I I
7 understand the item, I would advocate the need for one j
i 8
national regulatory authority.
l t
9 CHAIRMAN SIEGEL:
Why, Judy?
l l
10 MS. BROWN:
To avoid duplication; to put the best l
11 thinkers in one place.
12 DR. MARCUS:
You would think that the best i
13 thinkers would be in a Federal regulatory agency.
I 14 MS. BROWN:
To put the best thinkers within 15 Federal regulatory agencies and state regulatory agencies, 16 given that you kind of have to have them in one place, as 17 opposed to scattered around the states and various other i
18 agencies; I would advocate having one.
19 Also, it is so' people will know where to go.
I j
q 20 mean, who knows where to go?
It would be whether they i
l 21 should go to FDA, or'NRC, or a state health department, or a l
i 22 state environmental department.
I would like to see some 23 national oversight.
i 24 DR. MCKEOWN:
I would hate to see that happen in 25 that it would require the addition of a tremendous number of l
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people and a huge amount of resources, to set it up and do 2
it.
3 MS. BROWN:
I query as to why it would require 4
additional numbers, as opposed to shifting.
5 DR. MCKEOWN:
It is because you can't shift state i
6 employment to the Federal Government.
l 7
DR. MARCUS:
This: is Dr. Marcus.
l 8
I would like to introduce one problem here in what 9
we are talking about.
One thing is radiation safety.
i 10 Another thing is medical practice.
People who do well in l
11 the very basic areas of radiation safety do not necessarily l
5 i
12 have any expertise in medical practice.
13 It is not so unreasonable to think about one group 1
a l
14 that takes care of very basic radiation safety issues.
I l
l 15 certainly would not want such a group to have anything to do l
i 16 with medical practice.
l 17 The way things, I thought, were supposed to work l
18 was that FDC took care of drugs and devices and software; 19 NRC took care of radiation safety; and the states took care
]
20 of the practices in medicine and pharmacy.
I think that 1
21 that is a good way for it to work.
i 22 There would be some uniformity in medical and 23 pharmacy planning.
This is actually because of the Federal i
24 Government reimbursement thing.
Basically, the radiation i
i 25 safety part of the NRC should end at radiation safety.
The l
i
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1 problems happens when it tries to get out into other areas 2
that use radiation, but are the professional expertise of j
i 3
the agency.
l l
4 Radiation, itself, is not enough of a unifying 5
factor to take every activity that uses it and put it under f
6 the purview of one agency.
The medical part of nuclear I
7 medicine is 95 percent of nuclear medicine.
The nuclear r
8 part is only five percent.
9 Therefore, please be careful when you talk about l
i I
10 one agency, and what you are really talking about -- whether-
)
I 11 it is radiation protection or medicine.
12 DR. ALMOND:
Barry, this is Peter Almond, again.
13 I think we should realize, also, that the j
i 14 Conference of Radiation Directors, or whatever that group 15 is, have certainly put out suggested state regulations.
All l
16 states get those and can review them, and in most states, 17 they adopt those.
i 18 These are very comprehensive with regard to 19 radiation safety and all the aspects that we have talked 20 about today.
Therefore, byproduct material and linear 21 accelerators are described in detail, as to what the quality l
22 assurance should be for nuclear medicine, radiation, and j
23 oncology.
l i
24 Therefore, if you like, there is a uniform 25 suggested way to adopt those.
Whether the states adopt l
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1 those is up to the individual states, and some states happen j
)
2 to adopt those pretty well as written by that national 3
group.
I suspect a lot of other states do as well.
1 1
4 As far as I'm concerned, it is a whole lot easier 5
dealing with my radiation office; where I know who they are; 6
they are local, in terms of being within the state.
The i
7 state regulatory requirements that I have, as far as I know, l
[
8 are uniform with many other studies.
j 9
Therefore, in terms of uniformity, I think it is i
10 there, to a large extent.
There are some states, obviously, 11 that don't adopt them; however, a good many do.
i a
12 CRAIRMAN SIEGEL:
As I listen to this discussion, 1
13 I am wondering if Alexander Hamilton is anywhere close by, I
1 14 participating in the process.
i 15
[ Laughter.)
4 a
16 CHAIRMAN SIEGEL:
That's because we are getting at 17 issues of central authority versus state sovereignty that 18 are really pretty interesting.
19 Let me put another twist on this argument.
That 20 is, I think one can make arguments for uniformity and J
21 national regulatory authority.
22 However, I will go back to my fundamental concept 23 that if there is going to be a national regulatory 24 authority, that.it ought to rest with an agency that has all 25 of medicine as its focus, and not with an agency that has l
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2 tunnel vision with respect to one particular group of i
2 medicine.
l 3
In a way, if you think about it, if we look at all f
4 the rest of the questions on this document, or most of the 5
rest of the questions on this document, they take a very 6
interesting twist, i. you do the following thing.
?
7 Let's just look at Page 2, Question 2 (a).
Let me I
8 read it to you a different way.
9 "Need for a national program to monitor uses of l
I 10 orthopedic surgery, including emerging technologies and new 11 trends, and identify safety issues that need new or
.{
12 additional regulatory oversights."
13 Why is the United States not asking that question?
[
14 Why is it only asking this question about radiation-related
[
3
-f 15 things?
Again, I keep coming back to this fact that we
[
16 shouldn't really mess with any of this stuff, until we 17 understand -- and I mean really understand -- what the r
18 magnitude of this problem is, beyond anecdotal.
19 In a way, I don't know if we have reached a l
20 consensus on this issue of uniformity.
It may be that we l
21 would recommend that it be addressed in a very, very f
22 cautious fashion.
You have probably asked reasonable I
23 questions.
l 24 MS. BROWN:
Does silence imply consensus or 25 agreement with what you just said regarding orthopedic i
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surgery, or do I have to pipe up?
2 CHAIRMAN SIEGEL:
Of course, you have to pipe up.
3 I was going to give you a chance, 4
MS. BROWN:
There is a danger in orthopedic 5
surgery to workers or the public at large, or large groups i
1 6
of patients, from one single error.
That is my point.
7 DR. MARCUS:
If you have a device, though, in a 8
hip which causes the need for a re-operation on the patient, j
i 9
then that is a danger to the patient.
However, FDA does the l
1 10 best job that it can in evaluating the license.
j 1
11 DR. MCKEOWN:
We get far more damage from blood-i 12 borne passages than people are exposed to in the operating 1
i 13 room, than we do damage from occupational exposure to j
14 radiation.
i 15 CHAIRMAN SIEGEL:
I go back to something that.we 16 have agreed on as a committee, that has appeared on slides i
17 that we have used for Commission briefings in the past.
18 That is, ionizing radiation and byproduct material are not
]
]
19 uniquely dangerous things, used in medicine.
20 Chemo-therapeutic agencies used for treating i
i 21 cancer are just as carcinogenic as radiation is.
They have 22 to be appropriately environmentally controlled, just the 23 same way that ionizing radiation does.
24 MS. BROWN:
Well, maybe that should be your 25 example, rather than orthopedic surgery.
)
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CHAIRMAN SIEGEL:
Well, with orthopedic surgery, 2
with all those passages getting sprayed around by bone saws, 3
it puts the workers at amazing risk, Judy.
4 MS. BROWN:
Absolutely.
5 CHAIRMAN SIEGEL:
I'm just telling you that what 6
we do is no better or no worse -- but my bias says it is 7
better -- than the rest of medicine in terms of the danger 8
to the general public, and the danger to workers, and the 9
danger to patients.
That is what needs to be evaluated.
10 We need not to get bent out of shape by the 11
" Cleveland Plain Dealer" using scare tactics about this 12 particular focus.
If the " Cleveland Plain Dealer" did an 13 in-depth survey of orthopedic surgery, medical oncology, 14 psychiatry, and on down the list, they could write just as 15 alarming an expose about any of those other specialties, if 16 they chose to, in the kind of focus that they chose to take 17 in those articles.
18 Therefore, I think that we shouldn't be fooled 19 into thinking that they have uncovered the Rosetta Stone of 20 making American medical care better; because they haven't.
21 DR. GRIEM:
This is Dr. Griem in Chicago.
22 You should have picked plastic surgery, silicone 23 breast implants, and all the recent stuff that has been on 24 television, which I think that the FDC has handled j
25 magnificently.
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i 1
CHAIRMAN SIEGEL:
Well, not everybody would not l
2 agree with that.
t 3
We seem to be having some phone connection 4
problems again.
Let's go off the record briefly.
5
[ Discussion off the record.]
i i
6 CHAIRMAN SIEGEL:
Judy, where we were was, we were t
7 giving some examples.
I just want to restate my belief, as i
8 a practicing physician, that what I do for a living doesn't 9
need to be looked at with any more or less scrutiny thaa i
10 what needs to be done in the rest of medicine.
Therefore, 11 giving it an intensive focus in an independent Federal 12 agency may not be the appropriate way to regulate it.
l I
13 MS. BROWN:
Well, it already has a focus in 1
14 several agencies.
I'm certainly not worried about what you 15 do in your practice.
I am worried about, as I said, the guy 16 who graduated last in his class.
17 DR. MARCUS:
That person would still know more l
18 medicine than anyone at the NRC.
)
19
[ Laughter.)
20 DR. MARCUS:
That is really the issue for the 21 medical society.
The guy that graduated last in his class 22 is still a doctor.
23 MS. BROWN:
Right,.he knows more about medicine.
24 However, does he or she know more about safety, or does he 25 or she know all the things that are encompassed in.this Alai RILEY & ASSOCIATES, LTD.
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f 1
area?
I'm not talking about medicine, and I don't think 2
that NRC is either.
3 CHAIRMAN SIEGEL:
We may be getting a little bit 4
off the beaten path here.
4 i
5 DR. GLENN.
This is John Glenn As the discussion i
6 has gotten a little more heated, you are forgetting to l
7 identify yourself when you come on.
If you would, please i
8 identify yourselves.
r 9
MS. EROWN:
This is Judy Brown.
Can I ask a I
i 10 question, please?
j d
11 DR. GLENN:
Yes.
l 12 MS. BROWN:
What is going to become of or what has j
l 13 been done with the comments that we sent back to you?
d 4
14 That's because I am not sure if I need to reiterate d
15 everything that I wrote to you,'Barry.
16 CHAIRMAN SIEGEL:
The answer to that question is 17 that those comments were intended to help me understand 18 people's initial reactions to the draft questions that we 19 got, so that I could help coach us through the telephone i
l l
20 conference call.
I J
21 They were not meant, per se, to be part of the 1
i i
22 record.
You are entirely welcome to read your thoughts or I
i 23 to get your thoughts into the record for purposes of this 24 discussion.
25 MS. BROWN:
Well, I would formally' request that ANN RILEY & ASSOCIATES, LTD.
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1 they do make it into the record, because they were much more i
2 thoughtful than my remarks are here.
However, I certainly 3
don't need to read them.
4 CHAIRMAN SIEGEL:
I don't mean, read them.
5 However, if you want to make additional comments, based on i
6 what you wrote --
7 DR. GLENN:
This is John Glenn.
We can certainly 8
attach those to the transcript of this proceedings.
9 MR. VOLLMER:
We will consider all the written i
10 material that we get.
There are things from the committee 11 that we will not have consensus on, obviously, and we will 12 have individual views on.
We will all look at this and it 13 will help us in preparing our report.
14 The things that we have consensus on are, of 15 course, in a sense, more helpful.
However, everything that 16 we receive, both in this particular meet'ing and written, l
3 17 will be considered by the task force in preparing its report 18 to the Commission and Congress.
19 MS. BROWN:
That's great.
One of my concerns is i
s 20 that we not spend too much time with people trying to i
21 dissuade me of my opinions.
As long as my opinions are part 22 of the record, I am happy not to be very forceful with them.
23 That's because I don't think they that.they are at all going j
24 to be part of any consensus.
25 CHAIRMAN SIEGEL:
Judy, first of all, you j
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1 shouldn't feel so sensitive.
We respect your opinions and l
2 we fully acknowledge that we will not always be able to l
3 reach a consensus on this committee, because we come to the 4
table with different viewpoints.
]
5 Most of us are members of the regulated community.
6 You serve a very important role by bringing a public focus 7
to the table.
Therefore, you don't have to apologize for l
8 it.
9 John, I need to ask you a procedural question, f
10 The comments that Sally has in hand from Peter Almond, from i
11 Mel Griem, and from Judy, were comments that were directed j
12 to me, and were not officially sent to the NRC.
Can we i
i 13 introduce them into the record by my so doing that, at this j
i 14 point?
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j 15 DR. GLENN:
Very easily, and we will be glad to do l
16 that.
17 CHAIRMAN SIEGEL:
I hope that is not creating a 18 procedural problem, because of the way that these documents-
[
19 were gathered, outside of'an advisory committee activity.
j 20 DR. GLENN:
I think since they are being discussed 21 during this conference call, then we can put them in as part 22 of the record.
23
[The referenced documents were made 24 a part of the record.]
25 CHAIRMAN SIEGEL:
Thank you.
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1 Judy, that is fine.
If you feel that you want to 2
add anything to what you have said up until this point about 3
what you wrote in your letter, you may feel free to do so.
f 4
MS. BROWN:
Thank you.
{
5 DR. WOODBURY:
Barry, may I comment on Judy's l
6 concern?
3 l
7 CHAIRMAN SIEGEL:
Please, David, go ahead.
)
8 DR. WOODBURY:
Judy, I think that you play a very I
9 important role.
That's because the questions you raised are l
I 10 the same questions that nonmedical people on the 11 Congressional committees or the state legislators are 1
12 raising.
t 13 As you raise them, it helps us to focus or to try 14 to correct what we feel may be ill-focused.
Therefore, I 15 think you right on track.
+
16 MS. BROWN:
Thanks, David.
I'm not sure that was 17 a compliment, but I liked part of it.
You can head off from 18 where the questions from left field are coming from.
i 19
[ Laughter.]
20 DR. WOODBURY:
That's all right.
t 21 MS. BROWN:
Great.
i 1
22 CHAIRMAN SIEGEL:
Okay, let's get us back on track
{
23 at this point.
We have been on the phone now for an hour j
24 and a half, which is an amazingly long time for a conference 25 call, which actually has gone much more smoothly than I had
}
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1 expected it would.
l l
2 There are a series of questions that we could go l
i 3
through and try to see if there are specific things that we 1
4 think are either out of focus or have missed the target, or 5
that there are items that are missing from those questions.
6 Under any circumstances, I think the introductory I
i 7
concept of perspective is one that applies across the board.
j a
i 8
That was something that we came up with at the outset, with j
3 9
a reasonable level of consensus.
l I,
10 Is it worthwhile, Dick or John, from your i
11 perspective, and the committee, from everybody's j
.i 12 perspective, to try to work through these other items, on a i
13 case by case basis, or will that not be a terribly effective i
4 14 use of our time?
9 15 MR. VOLLMER:
This is Dick Vollmer.
l t
16 I think if there are issues here that would raise 17 to your consciousness that they are important ones; then, j
18 certainly, yes, we would like that.
If the rest of these l
19 are not important issues ~in the committee's view, then that 20 is fine, too.
21 I guess we would look for your guidance as to what 22 is important and what is not.
I think that is the focus 23 that you have given us so far.
i 24 DR. MARCUS:
This is Dr. Marcus.
l 25 I don't want to leave the training and experience l
1 i
i i
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issue untouched, Barry.
I would appreciate it if I could 2
make a few comments about it.
3 CHAIRMAN SIEGEL:
Okay.
4 DR.. MARCUS:
I think that NRC's focus on training 5
and experience should really be based on what the advisory 6
committee suggested last May at its meeting, in terms of 7
looking at basic radiation safety, education, training, and 8
experience; and staying out of medical board-type issues or 9
medical training, as opposed to radiation safety training.
10 I think that the degree of quality of medicine --
l l
11 and this is something that Judy should be interested in --
i l
12 that a patient gets is basically a function of the quality 13 of the physician, the physicist, the technologist, the 14 pharmacist -- all the people who play a role in the care.
I 15 Those states that wish to have a very high level 16 of quality will have higher levels of requirements in 17 training for people.
Some states are going through 18 legislation now for licensing of physicists.
Many states 19 now have regulations requiring licensing of the 20 technologists.
21 This makes medicine more expensive.
It usually 22 makes it better.
This is a quality judgment that is made, 23 basically, on a state-by-state basis.
I think that there 24 should be very little attention paid by NRC to training and 25 experienea, except from the point of view of basic radiation ANN RILEY & ASSOCIATES, LTD.
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55 l
I safety; which, in fact, in medicine, as opposed to nuclear 2
reactors, is very, very simple.
l i
4 3
It probably is getting more billing than it really j
t 4
needs.
It is difficult to injure someone with radiation, j
i 5
for example, in nuclear medicine, in the day-to-day.use of l
6 isotopes.
7 Therefore, I would like to leave professional l
8 training to the state.
'I would like to really ask NRC to l
9 look at what the advisory committee said in May at its f
10 meeting.
I don't think that we ever articulated it better i
11 than what is in the minutes of that meeting on training and i
t 12 experience.
l 13 MR. VOLLMER:
This is Dick Vollmer.
't 14 We will go back and look at that.
15 There is one clarification that I have.
When you
.j 16 talk about radiation safety, are you including in that the f
17 ability to calibrate and things of that nature?
Are you 18 talking about the broad issue of radiation safety?
19 DR. MARCUS:
Safety, to me, in nuclear medicine, j
i i
20 means that I understand the instru antation used to detect j
i 21 radiation; whether it is on a dose calibrator, a well l
22 counter, or anything that I am using.
I 23 It is the basic radiation knowledge that I think
[
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t 24 the committee believed that you had to have if you were f
25 using radioisotopes.
I'm not sure if the whole committee 1
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agrees with me.
_j l
2 Did I answer your question, Dick?
l 3
MR. VOLLMER:
Yes.
I mean, calibration of i
4 devices, too.
That is what I was getting at.
I was l
5 wondering what your definition of radiation safety would be.
t i
6 Did it include calibration of devices and things of that s
7 nature?
d 8
DR. MikCUS:
There are calibrations of SPEC i
1 9
cameras in order to try to optimize your resolution, that 10 get into imaging resolution.
It is very specialized.
4 3
11 Generally, the company-trained people come out and do a lot j
12 of those calibrations.
It is not simply taking a simple i
13 source and doing things the way we did years ago.
j J
t I
14 DR. GLENN:
This is John Glenn.
i 15 I just want to remind Carol that Mr. Vollmer is
{
a 16 thinking in a much broader context, including calibrating 17 Cobalt 60 units.
He is looking at all of radiation 18 medicine, and not just nuclear medicine.
j i
19 DR. GRIEM:
This is Dr. Griem in Chicago.
j 20 I think if you look at what the AAPM has done, and i
21 also the computer national groups, like ICRP or ICRU, and 22 all of the handbooks that are available; then, certainly, a 23 tremendous amount of work has been done over the past 20 or 24 30 years on the whole question of calibration, methodology, 25 confirmation of field size, and all the rest of that.
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57 l
l 1
All of that exists and is pretty much fc11 owed in l
l 2
the United States.
Maybe Dr. Almond would want to comment 3
further on that.
j 4
DR. MARCUS:
Let me just get one comment in.
5 I think the point of letting the professionals 6
recommend how to do it, the way you just said, is an 7
excellent way to go about it.
That is because if you let a 8
regulatory agency do it, you end up with the sort of 9
regulations that NRC has for dose calibrators, which are 10 appropriate to machines that were built 20 years ago, but 11 are no longer appropriate today, because they were never 12 changed.
13 Whereas, the professional societies stay up-to-14 date and, I think, do a better service to the country in 15 cost effective quality than a regulatory agency that has 16 spent years getting a regulation in place, and then doesn't 17 revisit it unless there are huge screams for years and 18 years.
19 CHAIRMAN SIEGEL':
We are getting off focus again, 20 a little bit.
21 Dick, in partial answer to your question, what the l
22 committee discussed at its last meeting -- which is what I l
23 labeled the " paradigm shift," in terms of training and j
24 experience criteria for licensure -- would, in fact, include 25 the things you are concerned about, from a radiation j
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i 58 1
ontology point of view.
[
2 The training and experience that should be 3
required, as well as the way the NRC or the states go about 4
validating their training and experience, would be tied to
-j i
5 the type of ionizing radiation used for this, as is l
6 proposed.
7 Therefore, someone who only wants to do blood 8
volume measurements needs, obviously, a different set of 1
9 training and validation than someone who wants to do tele-
[
10 therapy with Cobalt 60 or with a linear accelerator.
The' 11 approach acknowledges that.
i 12 MR. VOLLMER:
Okay, thank you.
j i
13 CHAIRMAN SIEGEL:
I thought we were going to get l
a 14 away from not having to discuss training and experience at 15 this one meeting, but I could even get that this time.
Are 16 there any other comments on specific points?
17 In many ways, we covered a lot of these questions f
18 at the last two meetings when we talked about the medical 19 issues.
Also, at the last meeting, we talked about training 20 and experience, radiation safety officers, and many of the
.j 21 questions that are in these documents as items still worthy 22 of further analysis.
The problems relate to things that we j
23 have already discussed.
i 24 Does anybody else think that any of these other 25 questions are either inappropriate points of focus for this ANN RILEY & ASSOCIATES, LTD.
j Court Reporters 1612 K Street, N.W.,
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59 1
task force,-and for the overall Federal effort to reevaluate i
2 this problem, or are there things that are missing?
Are 3
there any other comments?
4 DR. MCKEOWN:
This is Carol McKeown.
5 I think that the major thing that we haven't I
6 talked about yet, which should be the primary concern, is j
7 the communication issue, which is the next question.
j 8
CHAIRMAN SIEGEL:
Okay.
9 DR. MCKEOWN:
I think that what they really need j
10 to do, and what we really all need to do, is find out what i-11 each of us does, take out the duplicates, and get organized.
l 12 CHAIRMAN SIEGEL:
We don't disagree with Item A, i
13 as a point of action.
l 14 DR. MCKEOWN:
Right, but I think that what we need i
15 to do is say, hat indeed we support the investigation of f
16 improving communication.
17 CHAIRMAN SIEGEL:
It's hard to argue with the need l
'l 18 for improved communications.
That is one of the major 19 problems in our society these days.
20 Does anybody else want to comment on that?
21
[No response.]
I 22 CHAIRMAN SIEGEL:
Okay, it sounds that we have i
23 reached a stage of near quiet.
24 Dick or John, do you have any other questions that t
25 you want to pose to the group, while you have got us all G
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assembled here?
2 DR. GLENN:
I guess, I have just one question.
i l'
3 Since we have had the discussion of adding some of some of 4
your notes to the record, I was just wondering if there are 5
any other members of the committee who want to submit 6
something in writing and have it attached.
7 I guess we have received copies of communications B
from Peter Almond, Melvin Griem, and Judith Brown.
We would i
9 invite, if the others want to submit anything, that we would 10 include those in the record.
11 CHAIRMAN SIEGEL:
Okay.
Does anybody else have 12 comments?
13 DR. GLENN:
Those will need to be submitted to us i
14 very quickly.
If you could prepare them and fax them to us j
15 tomorrow, we would appreciate that.
If not, we can attach 16 them later.
I 17 CHAIRMAN SIEGEL:
That's just in case, anybody 18 didn't want to be under any pressure.
I 19
[ Laughter.]
20 CHAIRMAN SIEGEL:
Does anyone else from the NRC in 21 the audience want to pose any questions to us while we are 22 here?
f 23 MR. VOLLMER:
Dr. Siegel, this is Dick Vollmer.
24 I think we have posed the questions that we need 25 to.
You have answered our issues.
I want to thank you and
[
l l
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Court Reporters 1612 K Street, N.W.,
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61 j
f 1
the committee for taking the time and the effort to go 2
through these.
l t
3 I think it is going to be helpful for us to l
4 deliver the type of product that we need to, which is really i
5 something that, hopefully, will be thought-provoking, and l
6 not have any substantive recommendations, as such that we I
7 were asked to do anyway.
i 8
I think what you have given us today, particularly j
9 on the areas that you find important and that we find l
l 10 consensus on, will be very helpful to us.
We appreciate it.
l 11 John?
12 DR. GLENN:
It doesn't appear that anyone in the j
13 audience has any questions.
14 I,
too, want to express my appreciation to the l
15 members of the committee for participating in this special 4
i 16 meeting.
I realize that there were technical difficulties.
17 I appreciate your patience.with that.
f 18 The one thing that I will ask is for the committee l
i 19 members to remain on for'just a few minutes after I I
1
- 1 20 officially close the meeting, so that the transcriber can 21 ask some questions about spellings and names and so forth.
l i
22 With that, I officially close this meeting of the 23 ACMUI.
24
[Whereupon, at 1:15 p.m.,
the meeting was 25 adjourned.]
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7
l REPORTER'S CERTIFICATE This is to certify that the attached proceedings before the United States Nuclear Regulatory Commission in the matter of:
Advisory Committee on Medical
[
NAME OF PROCEEDING:
Uses of Isotopes DOCKET NUMBER:
PLACE OF PROCEEDING: Rockville, MD t
were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear Regulatory Commission taken by me and thereafter reduced to typewriting by me or under the direction of the court reporting company, and that the transcript is a true and accurate record of the foregoing proceedings.
i n 410t1/n n n Official Reporter Ann Riley & Associates, Ltd.
l l
l 1
I i
D R
A F T
ISSUES RELATIVE TO RADIATION SAFETY IN THE MEDICAL USES OF IONIZING RADIATION The Central Issue:
Does the present allocation of authority and responsibilities among Federal and State regulatory bodies meet the nationwide goal of ensuring adequate protection of the radiological health and safety of the public, including patients and health care workers in the medical uses of ionizing radiation?
The following is a preliminary list of subissues we believe need further study or resolution prior to making recommendations on the central issue.
These subissues have been grouped into six broad categories.
The task force would appreciate your suggestions on these or other subissues that should be added to this list.
Also, please indicate if any of these subissues should be deleted from this list.
We would appreciate receiving your specific options to resolve any of these subissues that you believe should be addressed.
Options may range from no change or minor modifications to the current regulatory system up to and including recommending legislative changes (e.g.,
to the Atomic Energy Act).
For each of these, we would like you to describe the associated pros and Cons.
In your development of options, a major consideration should be whether they accomplish the nationwide goal of ensuring adequate protection of radiological health and safety.
Other considerations include impacts on resources (e.g., personnel, funding, and sources of funding), as well as impacts on the responsible regulatory bodies considering current responsibilities and regulatory or legislative ramifications.
(1)
Uniformity (a) need for national uniformity in regulations and their implementation for each source of ionizing radiation (i.e., byproduct, NARM, and machine produced)
(b) need.for national uniformity in misadministration reporting requirements for each source of ionizing radiation (c) need for one national regulatory authority to ensure uniformity in areas that are now handled by multiple agencies (e.g., certification of sealed sources and devices and notification of referring physicians and patients of a misadministration and the likely consequence)
(2)
Reculatory Oversicht m.
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i (a) need for a national program to monitor uses of ionizing radiation (including emerging technologies and new trends) and identify radiation safety issues that need new or additional regulatory oversight (b) need to identify effective enforcement sanctions for each regulatory authority (i.e.,
Federal and State) for each source of ionizing radiation I
(c) need to identify source of funding for regulation development and implementation (3)
Database (a) need to develop common definitions of administration l
and misadministration for each cource of ionizing radiation (b) need to d>termine the number of administrations for each source of ionizing radiation (e.g., drugs, devices) and the uncertainty in each estimate (c) need 'co determine the number of misadministrations for i
each source of ionizing radiation and the uncertainty l
in each estimate (d) need to determine the number of adverse incidents involving medical devices that deliver ionizing i
l radiation and the uncertainty in the estimate (FDA) r (4)
Health and Saft.tv Imolications l
l (a) need to establish'a common definition of serious injury for each source of ionizing radiation j
(b) need to determine the frequency of occurrence of serious injury related to the use of each source of ionizing radiation and the uncertainty in each estimate l
(c) need to compare the individual frequencies of occurrence developed in (a) above, and compare the j
frequency of occurrence of serious injury related to all ionizing radiation therapy procedures versus other individual cancer therapy procedures (e.g., surgery, chemotherapy)
(d) need to compare frequency of occurrence of serious injury from misadministration versus properly conducted administrations for each source of ionizing radiation (e) need to establish a safety goal for the medical uses of ionizing radiation (5)
Trainina and Exoerience
(a)
Physicians need to have a 9gulatory authority establish training and e.perience criteria for physician authorized users for each source of ionizing i
radiation need t' have a regulatory authority implement physician authorized user training and experience criteria, including history of regulatory and i
legal compliance need to have a regulatory authority periodically reassess the qualifications of each physician authorized user (b)
Ancillary Personnel need to have a mandatory licensing or certification program for activities utiliving each source of ionizing radiation i
need to have a regulatory authority establish and implement the training and experience criteria for i
ancillary personnel i
need to have a regulatory authority periodically reassess the qualifications of ancillary personnel
^
(c)
Radiation Safety Officer j
need to have a regulatory authority establish the duties, responsibilities, and authorities to include each source of ionizing radiation need to have a regulatory authority establish and implement minimum training and experience requirements to include each source of ionizing radiation need to have a regulatory authority periodically reassess the qualifications of each radiation safety officer
1 h
(6)
Cornunication (a) among Federal Agencies (primarily in this case, NRC and i
FDA) l need to clarify respective responsibilities need to coordinate device reviews need to coordinate regulations for the nanufacture and distribution, compounding, and use of radiopharmaceuticals and radiolabelled biologicals, and the manufacture and use of l
radiation therapy devices need to share information on events and incident reports and coordinate the responses (b) among States and between each State and the Federal
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Government
+
need to share information on topics including event reports, proposed and final regulations, regulatory guides, information notices, enforcement cases, and product recalls t
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i MEMORANDUM
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- m r :, 3:egd S.111y Merchant TROM:
Adith Erown OATE:
.uly 6, 1993 Tnis as n response to the packet of material solicit:.ng comments frcm ACMUI members on the draft, " Issues Relative to Radiation Safety in the Medical Uses of Icnising Radiation."
Af ter naving served on this committee for nearly two years, I have formed some strcng impressions while viewing the issues from the public's perspective.
Althougn I do not have the background to address all tne issues item by item, as set forth in the draft document, I see this as an in:portant opportunity to weigh in with seme general recommendations based on my impressions.
Uniformity I see a very strong need fer national uniformity in nearly all regulations dealing with radiation medicine.
Before I became a member of this committee, I assumed that patients were receiving treatment in this very dangerous area of medicine that varied only in the relative competence of the physician they chose and the relative sophistication of the equipment and materials that the physician had at his or her disposal.
It alarms and baffles me that the quality of care may also differ vastly depending on which state one chooses or, more often, is stuck with. Patients have very few tools with which to assess the quality of their care in the arcane area of radiation medicine. Tc compound that difficulty with the near impossible task of figuring out waxch state agencies or professional boards may have certified, licensed or inspected people and things involved with the treatment is cruel.
People entering this scary environment need to know that their health and safety will be protected in the best possible way, as determined by the most experienced thinkers in the field.
Uniform national standards must be adopted and enforced.
I can see little justification in allowing states to be all over the map in terms of how the practice of radiation medicine - its procedures, personnel, equipment and materials is overseen in this country.
Radiation medicine is inherently so much more dangerous than other specialties because of the possibility that a single error could affect many patients and, potentially, the public at large.
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One of the other strik2ng observations I have made is the f act that I
1:near accelerators are so commonly used and so loosely regulated.
l Clearly, tnis issue needs to be addressed quickly and could be an opportunity to establish across-tne-board regulations for the l
medical uses of these devices.
l As a final observation for purposes of this memo, I wanted to i
reiterate my concerns about Radiation Safety Officers.
Regardless of existing regulations, certification and training, I have heard enough to ce very concerned about the fact that it is possible for these people to be operating at a substandard level and not be j
detected by the system.
i I advocate, to the extent possible given budgetary restrictions, the establishment of national programs to monitor radiation i
medicine saf ety issues. This would require the fullest coordination between FDA and NRC.
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t NRC ISSUES, July 2,
- 1993, M.L.
Griem, ACMUI page 1 i
70; Barry A.
- Siegel, M.D.
FAX 314-362-2006 Chairman ACMUI NRC I
Sally Merchant FAX 301-504-2620 ACMUI, NRC Wash.
D.C.
i FROM: Melvin L.
- Griem, M.D.
FAX 312-702-0610 O.
ofC.. Member ACMUI Phone 312-702-6983 RE: ISSUES RELATIVE TO RADIATICN SAFETY I
1.
Educations A.
Need to establish refresher courses for:
- 1) Technicians
- 2) Nurses
- 3) Physicists
- 4) Pharmacists
- 5) Pnysicians
- 6) Administrators
- 7) Radiation Safety Officers
}
B.
Need to consider recertification i
1). Radiation Oncologists have all ready considereo
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this 2) others in A.
4 C. Need to evaluate what has been effective in other disciplines involving safety issues.
e.g.
power l
reactors - TMI, industrial experience with radiographers f
- 2. Need to evaluate the type of medical error problem. A
)
system analysis is needed to evaluate, patient error, f
technician error, physicist arror, machine error (be it hardware or software)
What is the experience in other industries and in other l
medical disciplines. Consider drug administrations in the setting of in-patient and out-patient situations.
- 3. What enecks should be used to prevent problems.
What can be learned from other industries such as the complex process of building an automobile?
j 4.
Wnat data bases are there for therapeutic radiology.
Certainly the Patterns of Care an Outcomes must be studied. How many individual treatments are given per year and how many errors have occurred? In this ccmplex process where is the error occurring? Can the CDC help in such an
)
evaluation?
What statistical methods shoulo be used to l
look at the problems?
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4 1-I NRC ISSUES, July 2,
- 1G93, M.L.
Griem, ACMUI page 2 I
- 5. A cost benefit-analysis is needed. What does this cost given the osbt reduction progran of the current administration.
- 6. How does one get the federal government executive branch to function with a unified program. NCI. FDA, NAS, NRC, NCRP, EP4, OSHA, ete?
[
7.
How should this unified program interact with the international programs?
- 9. What can we learn from Sweden, England. Canada, France, Germany or the Dutch. Certainly the. British Commonwealth l
has data e.g. Australia, New Zealand etc.
I 9.
Given the vast area of the U.S. with only a few i
i facilities in scarsely populated areas, how does one provide education, evaluation, service and support?
How do we use new computer techno, logy? What preventative i
l measures should be developed.
s At this point 1 think that we should develop a change in j
attitude from the process of enforcement and fines to one of l
prevention and education. Certainly the latter will be cheaper in the long run from the general standpoint of the health and well being of the U.S. population.
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TO:
Barry Siegel, M.D.
Mallinckrodt institute of Radiology l
i Sally Merchant U.S. Nuclear Regulatory Commission i
FROM:
Peter R. Almond, Ph.D.
g i
James Graham Brown Cancer Center j r1 SUBJ:
Special Meeting DATE:
July 1,1993 j
i issues (1) & (2) Uniformity and Regulatory Oversight i
These are good ideas and in general I agree with them. Can they however be done by the states? I don't think we need another super agency issuing rules and regulations - we need to make the present system more efficient and uniform and.
l eliminate duplication.
t:
issue (3) Database l
This information is needed.
I issue (4) Health and Safety implications i
This will be very difficult if not impossible to do. How do you' define ' serious l
injury" and what of cost (i.e. serious injury) versus benefit (cure) considerations?
l i
i Issue (5) Training and Experience i
This should be looked at in light of what is already done. Certification is the purview of the various boards and licensing is a state requirement. However, the _
l whole area needs looking at.
1 Issue (6) Communication Obviously, there needs to be communication and avoidance of duplication.
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UCLA ECHOOL OF Mr.DICIKC July 9 1993 nARs n.ucu utoicat.cmii DEPARDdENT OF RADIO!.OCY 1000 CAR 5ON ST!T.CT TORRANCE. CALIPORNI A 00500 Richard H. Vollmer i
Director, Office of Policy Planning U.S.
Nuclear Regulatory Commission 11555 Rockville Pike One White Flint North Rockville, MD 20852 i
Dear Mr. Vollmer:
t This is my response to your draft issues paper relative to radiation safety in the medical uses of ionizing radiation.
I wish to have these comments included in the official transcript of the Advisory Committee on Medical Uses of Isotopes (ACMUI) held on 8 July 93.
i The Central Issue:
Does the present allocation of authority and responsibilities among Federal and State regulatory bodies meet the nationwide goal of ensuring adequate protection of the radiological health and safety of the public, including patients and health care workers in the medical uses of ionizing radiation?
A.
I believe that the answer to this question is an unequivocal "yas".
However, I also believe that changes in the present system in the direction of state control of medicine and pharmacy's radiation activities would result in extremely large healthcare savings with no decrease in the standard of radiation protection for any group.
I believe that this would increase the quality of accessibility to medical care performed by nuclear medicine practitioners because the decrease in dual regulation and bureaucracy combined with the change in style in nodical regulation would give us more time to spend with our patients.
i I do not believe that the very rare harmful event caused ac;identally in my field constitutes a " problem" to be " solved".
Hrwaver,-I believe that NRC, ill-suited to considerations of medical and pharmaceutical issues, needs to acquire a definitive database and analysis from the most qualified and independent group in the country, the National Acadeey of Sciences-Institute i
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July 9, 1993 Richard H.
Vollner Page ~2-of Medicine, in order to be convinced.
Perhaps then NRC will have an unbiased basis upon which to make much-inproved regulatory policy decisions.
I also believe that FDA's Center for Devices and Radiologic Health (CDRH) is a more natural "home" for federal medical radiation issues than is NRC and feel strongly that increased resources for CDRH in the area of radiologic devices and device-controlling software would cost-effectively increase pationt safety even more than we have today.
B.
Uniformity in basic radiation safety standards in the 10 CFR Part 20 sense is essential in order to achieve sensible national goals and efficient interstate commerce.
This was achieved from the start when the AEC was created.
However, uniformity with how compliance with these standards is reached, while optimizing the care of patients, should not be uniform but should vary between states and within states.
I do not believe that prescriptive regulation is of any value here.
We cannot become cost-effective without the freedom to continually improve our professional activities while ever-honoring the basic radiation standards.
Good ideas are quickly spread from state to state through the Conference of Radiation Control Program Directors and the various professional societies.
" Continuous quality improvement" cannot be achieved with prescriptive regulation " carved in stone".
Uniform prescriptive or " performance-based" (i.e. " prescriptive")
regulation does not promote safety thinking because it discourages thinking at all.
It leads to mediocrity and stagnation and at a very high cost.
I think that it would be best to have a basic national radiation standard that differs from the present 10 CFR Part 20 in that it includes natural, accelerator, and nachine-produced ionizing radiation as well as byproduct matarial.
The new 10 CFR Part 20, slated for nationwide acceptance by Jan.
1, 1994, has significant flaws for byproduct natorial and some very significant problems when one tries to apply it to other radiation sources.
After i
much consideration, I feel that no federal agency should create this national radiatica~ standard for all sources of ionizing radiation.- I feel that this critical responsibility should be placed in the hands of a national institution with superb credentials for standard-setting and access to the nost highly qualified radiation scientists in the country for prinary J
participation in this endeavor.
I recommend the United States j
Pharmacopeia (USP) for this purpose.
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.L July 9, 1993 Richard H. Vollmer Page The issue of standard reporting requirements should remain moot until the NAS-IOM report is completed and we have decided that which is important to report.
Recordkeeping, reporting, data collection, analysis, and archiving are expensive endeavors on a nationwide basis, and cost / benefit considerations must apply.
In accition, if NRC is to require any recordkeeping and reporting in the medical area there must be a nochanism built in for us to be reimbursed for our costs.
At present, we are not only not reimbursed, but charged higher User Fees for NRC's collection and I
analytical efforts.
None of this is reimbursable at present.
C.
Regulatprv Oversicht needs to be divided up into (1) medicine and pharmacy issues, which aro the purview of the states entirely, (2) drugs, devices and associated software,and guidelines for the radiation protection of patients, which by.?aw are the purview of the FDA, and (3) basic radiation safety, which is the purview of Agreement States and NRC.
Each responsible entity has regulatory oversight, with the caveat of careful attention to avoid dual regulation.
This is not NRC's present policy, and I believe that a change is long overdue.
For example, NRC's present overlapping requirements are incompatible with state medicine law, state pharmacy law, FDA, and JCAHO.
I D.
The need for a database was covered in "B" under " reporting requirements".
It is moot at present.
There is no question in my mind, however, that the definition of a " medical misadministration" must be thoroughly revised.
NRC's own data from 1992 show that 96% of " medical misadministrations" caused no adverse effects.
NRC's ACMUI unanimously voted against the definition in May of 1991.
I would ask NRC to look at FDA's definition of adverse events used in their MEDWATCH program, and then consider abandoning the entire concept of
" misadministration" reporting because the appropriate way to look at this issue is the FDA's way and the FDA is already doing this, by law.
E.
As far as health and safety inDlications are concerned, I do not believe that NRC has a true need to get involved with any of this, but it might need to have the NAS-Il0M study (4) (c) in order to be convinced.
Those entities that regulate medical practice, allocate medical resources, or determine medical reimbursement, quality, or educational programs will decide whether they need any more of this information, but I do not think there is any great need for it.
To what constructive use e wa-se
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Pm c : 3125337159 Jul. 09 19c3 12: 34PM P-July 9, 1993 Richard H. Vollmer Page i l
could much of this information be put?
F.
Trainine and exterlence in medicine, i
technology is already in very competent hands. pharmacy, science, and i
here.
NRC does have a role in determining education,NRC has no role activities utilizing byproduct material,and experience in radiatio training itself to that.
and NRC should limit i
NRC's medical program is in grave disarray at present not respectable by knowledgeable practicing professio with a view of the credibility of the regulator. perception of non-compliance NRC's will survive if it is not respected by the leadership of theNo regulatory system regulated community.
Why should it?
+
Medical leadership, by nature, is conservative, and practice quality that enhance the health of the medicalestablishing specialty involved.
Ionizing radiation medical s no different from any other medical specialties. pecialties are specialty than anyone else.better how to achieve radiation protection in t We know far to think of and we don't want to get hurt,After all, we have our reputations 1
either.
Regulation needs to be a cooperative venture.
establish an appropriate regulatory sWhen NRC works with us to a much higher level of " compliance". ystem NRC will probably see i
It is perhaps not so much a matter of education, training, and experience as a matter of professional respect for sensible safety practicas and contempt for arbitrary, capricious, dual regulatory, burdensome medically dangerous requirements.
and even G.
Compunication between NRC and all medical entities, federal t
state, and professional, are poor and need to be improved.
of all, NRC has to stop and re-read Section 104 Most Energy Act; of the Atomic doing; look at what other agencies and organizations are the regulated community and among the other regulatory en NRC's regulation of byproduct medicine should be auch easier than I
it was in the 1950's, because of enormous increase in responsibility given to FDA.in 1975 (Safe Medical Devices Act),(Consumer-Patient Radiation Health a 1981 and 1991 and the rise of board certifiable with all their advisory and standard-setting groups. medic i
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1993 J$cbardH.Vollmer R
Pags i l
l It night well be that when Senator Glenn convened his hearing to i
discuss the lurid and sensationalist stories in the Cleveland Plain Dealer that he should not have called in the NRC at all, but should have called in representativen of State Boards of Medicine, specialty medical boards, and the JCAHO.
His fears would most probably been allayed by knowledgeable medical professionals very quickly, as documentation of the truth is l
readily available.
Thank you for the opportunity to contribute these comments.
Sincerely, Carol S. Marcus, Ph.D., M.D.
Director, Nuclear Med. Outpt. Clinic and Assoc. Prof. of Radiological Sciences UCLA l
cc:
Senator John Glenn l
CSM:sfd 1
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