ML20236H568
| ML20236H568 | |
| Person / Time | |
|---|---|
| Issue date: | 07/29/1987 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| FRN-52FR36942, REF-10CFR9.7, RULE-PR-35 AC65-1-006, AC65-1-6, NUDOCS 8708050248 | |
| Download: ML20236H568 (92) | |
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7 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION l l l
Title:
Briefing on Medical Use of By-Product Materials ana the Medical Administration Rule Location: Washington, D. C. 3 1 Date: Wednesday, July 29, 1987 Pages: 1 - 66 1 Ann Riley & Associates Court Reporters 1625 i Street, N.W., Suite 921 Washington, D.C. 20006 (202) 293-3950
s.. 1 D I S C L A.I MER 2 S 4 5 6 This is an uno#ficial transcript of a meeting-of the. ) l 7 United States Nuclear Regulatory Commission held on 3 7/29/87 In the Commission's office'at 1717 H Street, 9 'N.W., Washington, D.C. The meeting was open to public 10 attendance and observation This transcript has not been 11 reviewed, corrected, or edited, and it may contain j f 12 inaccuracies. g j IS The transcript is intended solely for general 14 informational purposes. As provided by 10 CFR:9.103, it is 15 not part of the formal or informal record of decision of the j 16 matters discussed. Expressions of cpinion in this transcript 17 do not necessarily reflect final determination or beliefs. No 18 pleading or other paper may be filed with the Commission in 19 any proceeding as the result of or addressed to any statement 20 or argument centained herein, except as the Commission may 21 authorire. 22 ES l 24 25
4 TM 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 4 BRIEFING ON MEDICAL USE OF BY-PRODUCT MATERIALS 5 AND THE MEDICAL MISADMINISTRATION RULE 6 7 PUBLIC MEETING 8 9 Nuclear Regulatory Commission I 10 Room 1130 l l 11 1717 H Street, Northwest 12 Washington, D.C. 13 1 14 Wednesday, July 29, 1987 15 16 The Commission met in open session, pursuant to 17 notice, at 10:00 a.m., the Honorable LANDO W. ZECH, Chairman of 18 the Commission, presiding. 19 COMMISSIONERS PRESENT: 20 LANDO W.
- ZECH, Chairman of the Commission 21 THOMAS M. ROBERTS, Member of the Commission 22 FREDERICK M. BERNTHAL, Member of the Commission 23 KENNETH CARR, Member of the Commission 24 25 u -------- -----------
i 1 STAFF AND PRESENTERS SEATED AT THE TABLE. j i 2 1 3 ) l l 4 l 5 l i 6 S. CHILK { 7 W. PARLER 8 B. BERNERO 9 G. TAYLOR 10 N. McELROY 11 R. CUNNINGHAM 12 V. MILLER j 13 H. THOMPSON 14 V. MILLER 15 16 1 17 18 i 19 20 21 22 23 24 25
3 1 PROCEEDINGS 2 CHAIRMAN ZECH: Good morning, ladies and gentlemen. 3 The purpose of the meeting this morning is for the 4 Commission to be briefed on the activities regarding the 5 medical use of by-product material and the medical l 1 6 misadministration rule. 7 The Commission has been interested in this area for quite some time and has a strong commitment to safety in the 8 9 hospital and industrial uses of nuclear materials. 10 I personally visited several hospitals recently and 11 also a manufacturer of radiopharmaceuticals. I've been 12 impressed by what I have seen. I 13 There are many benefits to be gained from the medical 14 use of nuclear materials for the citizens of our country. l 15 However, I believe there is always room for improvement. The 16 Commission, I believe, should do everything we can to minimize j I the problems and reduce the chances of misadministration. I 17 I 18 know that this is not an easy task, because of the many 19 thousands of licensees involved and the many uses of nuclear 20 materials every day throughout our country. 21 On the other hand, misadministration on occasion, 22 although rare, do occur. I think it merits our attention. 23 The staff recently submitted a paper proposing two 24 rulemakings on medical administrations which will be discussed { l 25 at this briefing. I 1
i I - - ~. i ce 1 I would ask at the conclusion of the meeting if my 2 fellow Commissioners would vote on this paper, SECY-87-29(a), t 3 if they haven't already done so, or they vote as soon as they 4 possibly can, so that we can move forward on this important 5 issue. l 6 Do any of my fellow Commissioners have opening 7 remarks to make this morning? 8 COMMISSIONER BERNTHAL: I would just comment that it 9 has taken us a while to get here, but I want to congratulate 10 the staff on a considerably improved SECY paper and proposal 11 compared to at least one or two previous trial efforts in this 12 area. I think the latest proposal looks quite good and has 13 many significant improvements. 14 With that, let's proceed. 15 CHAIRMAN ZECH: Thank you very much. Proceed, Mr. 16 Taylor. 17 MR. TAYLOR: Yes, sir. Good morning. 18 As you noted, Mr, Chairman, the staff has submitted 19 the Notice of Proposed Rulemaking and Advanced Notice of 20 Proposed Rulemaking, both of them directed to imposition of 21 quality assurance type criteria in medical administrations of 22 by-product materials under our regulations. 23 As you mentioned, there are about 8,000 licensees involved and each year, the staff estimates that about 10 24 million patients receive either diagnostic or therapeutic doses 25
^ 1 of by-product material in the practice of nuclear medicine. 2 Today's briefing will touch a little later on the 3 rule but is also intended, as we said in the staff paper to 4 you, to cover the general area in an information briefing on l 5 nuclear medicine. I think as you are briefed by the staff l l 6 today, it is important to keep in mind, and the staff 7 emphasized this to.me in our previous discussions, how rapidly 8 the field of nuclear medicine is changing. It is a field in which new developments are being made and the practices are 9 I 10 changing. The staff, I think, in imposing QA criteria, will be 11 trying to do that against what could be changing targets, 12 practices and methods used in by-product administration. l 13 I will now ask Mr. Bernero to start with the 14 briefing. 15 MR. BERNERO: Thank you. i 16 Members of the Commission, here at the table today, 17 we have on the far right, Dick Cunningham, who is our Director 18 of the Division which handles fuel cycle material work. On my 19 left, I have Vandy Miller, who is Chief of the Medical, 20 Academic and Commercial Use Safety Branch. On Jim Taylor's 21 right is Norm McElroy, who is the leader of the Medical and 1 22 Commercial Use Safety Section of that Branch. 23 Norm is not only an NRC staff member of high value to 24 us, but he is also a member of the adjunct faculty at George 25 Washington University in the Department of Radiology. He is
} 6 m 1 qualified. He will be giving you the briefing. His experience 2 as a radiation safety officer, I think, is a great help in 3 illuminating this subject. Before he starts, I would like to 4 make one personal point. 5 I have appeared before this Commission many times in 6 my career here, speaking of reactor core melts and containment 7 failures and the doses that go with it. Those are theoretical 8 doses, thank goodness, they haven't occurred, at least not in 9 this country. When we speak of a severe reactor accident, we 10 start counting people exposure to the millions of person rem. 11 We are now today talking about real radiation exposure to 12 people in this country, done with care and for benefit under 13 the control of the medical profession and our regulatory 14 authority, which in any one year gives personnel exposure on 15 the same order of magnitude as the worse kind of reactor 16 accident. 17 It's an important regulatory arena. These are real 18 doses and the people are getting them. That underlies the importance of our attention here as well as the medical 19 20 profession's attention to this field. 21 COMMISSIONER BERNTHAL: That's a point well taken, 22 Bob. I see Joe Fouchard smiling in the back of the room and I 23 would also note that the press table is empty today, which I 24 think places matters in a bit of context here. 25 MR. BERNERO: Let me turn it over to Norm.
~ / 1 CHAIRMAN ZECH: Before you do that, I certainly agree 2 with you, Bob. This is a very important matter. The 3 l Commission has been concerned about it for some time. I think 4 it is timely that we are having'this meeting. You are 5 absolutcly right. These are real doses that are" occurring 6 right now throughout the country and throughout the world. 1 7 Even though misadministration and mistakes occur, on 1 8 a rare basis, we are dealing with one of our most professional 9 groups, people are involved in it. I think our attention to 10 this matter -- it has been my desire during this year and the 11 next few years to bring more emphasis to this area. That's why 12 I have tried to visit a few hospitals recently myself and also 13 why you are here today. My fellow Commissioners I know agree 14 with me that this is an area that we want to emphasize and your 15 remarks are well taken and we share that concern. 16 Let's proceed. 17 MR. McELROY: As has been pointed out, we are here to 18 examine rules that will reduce the frequency of ~ 19 misadministration. In the larger scheme of things, we are 20 talking about quality of medical care in this country. What we 21 do as an Agency has the potential for profound impact on the 22 delivery of medical care. 23 Before we take any actions, we think it is important 24 to examine the delivery of medical care in this country today. 25 We will look at radiation care and we will also look at some
l 1 8 1 general business considerations driving the delivery of 2 raedicine that may impact on the efficiency and efficacy of our 3 rulemaking attempts. 4 I'd like to spend a few minutes examining delivery of 5 radiation medical care in this country today. I think you will 6 see very clearly that the key feature of radiation care is 7 change. There is change in technology brought about by 8 scientific breakthroughs and new equipment. There is change in 9 the business of medicine brought about by other activities in 10 the Federal Government. There is change in industry,-brought 11 about by changes in diseases and new technologies that are 12 available. 13 We are looking at licensing whole new categories of 14 individuals who have never before held an NRC license. 15 We will then move on to examine some of the industry 16 quality assurance initiatives that have been going on for more 17 than 15 years in radiation therapy, particularly.
- Finally, 18 examine the initiatives that the staff prepared in response to 19 your directive.
20 If you turn to the first slide, we have an example of 21 conventional nuclear medicine. This is where the 10 million individuals get dosed every year for diagnostic imaging 22 23 purposes. Radiation has been used in medicine since Roentgen 24 discovered x-rays in 1895 for diagnostic purposes. Within 25 months after his discovery of radioactivity, Becquerel was
/ 9 1 fabricating radium plaques to treat skin lesions. 2 Today, in this particular slide, we are looking at a 3 diagnostic examination. 4 CHAIRMAN ZECH: Excuse me. Do we have slides 5 available? 6 MR. McELROY: We submitted photocopies of the 7 briefing. 8 CHAIRMAN ZECH: I think they are going to print up 9 some more. I don't know if they have been printed up yet or 10 not. Can anybody tell me? 11 Will you distribute them to the people in the i l 12 audience when we get them, please? I think we all have a book 13 but not everybody has the book, that's my point. Since you 14 don't have slides to show either, we will get copies for the 15 people in the audience as soon as they are available. l 16 Sam, would you make sure they get passed out, please, 17 when we get them? 18 MR. CHILK: Yes. i 19 CHAIRMAN ZECH: You may proceed. 20 MR. McELROY: On page one, you have an example of a 21 heart imaging procedure. The patient has been injected with 22 about 30 millicuries of pertechnetate that goes into the blood 23 pool. By examining the images, the physician can determine the 24 efficiency with which the heart is working. We will see some 25 different kinds of images a little later on. l
10 ~This kind of study was not available as little as 10 11 2 years ago because the computers needed to do the image 3 processing were not available in the community hospitals. We 4 will look a little more at imaging in just a moment. 5 I want to mention in passing that radioactivity is 6 also used in test tube work in the hospital' setting. You have 7 all sent blood samples down to the lab, somewhere down in the 8 basement. 9 Radioimmunoassays is a technique that was developed by i 10 the late Sol Berson and Rossalyn Yallow, who now holds a Nobel 11 Prize for that work. It is a test tube technique in which.the 1 12 radioactivity is not administered to the patient but rather 13 used in a test tube process to measure trace chemicals in the 14 blood pool. It may be used to measure the concentration of a i 15 natural hormone such as thyronine. It may be used to trace the 1 16 concentration of an administered drug, such as digoxin that is 17 used to treat some kinds of heart' disease. 18 The test tube process alone in this country results 19 in about 100 million measures requiring 200 million tubes of 20 radioactivity with trace amounts, nanocuries levels of I-125. 21 Following that little tangential note, we will go 22 back into the administration of radioactivity to patients. 23 COMMISSIONER BERNTHAL: May I ask a question? You 24 mentioned I-125. That raises an issue that you may not want to 25 address now but at some point before we leave today, I would
fE 11 1 like to get some comment on. Nothing we can do anything about, 2 at least not without congressional action, but as I understand l 3 it, we don't have any regulatory authority over Iodine 125 4 because it is not a by-product material from nuclear reactors. 5 It is an accelerator produced material. We have this l 6 regulatory anomaly, that side by side, you can have Iodine 131, 7 which does happen to be a by-product material, and Iodine 125. 8 One is regulated by the NRC. The other is regulated, I don't I 9 know by whom, FDA, I suppose. I don't even know who regulates i L 10 this. 11 MR. McElROY: The individual states have the j I I 12 authority to regulate the norm material that comes out of a l 13 cyclotron or is natural radioactivity. There is no Federal j 14 organization regulating norm radioactivity. 15 COMMISSIONER BERNTHAL: That's the anomaly. They are t 16 absolutely the same in terms of effect and usage in any l 17 reasonable respect. I would like to get some comments on that i 18 at some point, now or later. I 19 MR. McElROY: If you move to slide two, you will see 20 an example of the image that physician actually looks at to 21 make a diagnosis. This is an example of a new drug that came 22 on the market in the last few years, the generic name is 23 disofenin. It is used for imaging liver and gallbladder 24 disease. About 5 mil 11 curies of radioactivity is administered 25 to the patient by injection. It is immediately taken out of l .J
i 12 1 the blood pool by the liver and then passed into the 2 gallbladder. i 3 This can be used to diagnose or stage or determine J 4 the extent of liver disease or gallbladder disease. 5 You might note that the il3ustration here is not as 6 crystal clear as an x-ray. You might wonder, well, should we j 7 reduce the amount of radioactivity administered, reduce the 8 dose. It certainly couldn't reduce the quality of the image 9 very much. To reduce the dosage in an attempt to riluce the 10 radiation dose to the patient, it would likely compromise the l l 11 study. It would no longer have any medical utility at all. i l 12 The physician has to balance the optimum amount of 13 radioactivity administered with the imaging equipment, the 14 patient's condition and so on, to get the best image available l 15 for that patient. 16 This is an example of what we call a static study, 17 where a single view of an organ is taken. If you turn to page i 18 three, we have an example of a serial study, that provides a 19 good illustration of the impact of computers. 20 Again, the material was injected into the patient. 21 You see a series of pictures taken of the liver. This patient 22 had presented the physician with abdominal pain, non-specific origin, and suspecting gallbladder disease, the physician 23 24 administered the drug at 35 minutes, the first image on the 25 second row, he administered a dosage of sincalide, which is a
l 13 ^ 1 fat mimetic. If the gallbladder is working correctly, it will 2 dump the radioactive compound into the small intestine to begin 3 fat metabolization. I 4 In fact, you see a lot of the radioactivity hangs up 5 in the gallbladder. A second dose of sincalide was 6 administered at 50 minutes, and then the gallbladder starts to 7 release its content. i 8 on surgery, the patient was found to have a 9 gallbladder disease that was correctable. 10 The impact of computers in diagnostic radiation care 11 has been incredible. They were not there when I was in the 4 12 field in the early to late 1970s. The best example of all, I 13 think, is with an x-ray machine. You have all heard of CAT 14 scanners or CT scanners. 15 When I did the dosimetry on the first available CT 16 scanner in this country in 1973, it took the machine 5 minutes 17 to go through its gyrations and 15 minutes to do a foray l 18 transform, and gave two cross sectional images of the brain. 19 It was 20 minutes to get two pictures. 20 Ten years and three generations later, the machine 21 took half a second to go through its gyrations and half a 22 second to do a fast foray transform. One generation later, we 23 have real time CT scans. That is five generations in 15 years. 24 I don't think this Agency is used to dealing with that rapid 25 pace of technological evolution.
14 ^ 1 We can't assure quality today with our regulations 2 and then guarantee you that 5 years down the road, we will have 3 the same level of assurance. 4 There are some new drugs being developed. One of l 5 them is illustrated on page four. There is some research going 6 on in developing new drugs for both brain studies and heart I 7 studies. This is an example of a drug called isopropyl i lodoamphetamine, that goes to the brain. We have two rapid 8 9 developments illustrated on page four. 10 This is a tomograph using nuclear materials taken at 11 the eye level in the brain. On the left, is a normal patient 12 who has been administered the material, on the right, a 13 patient suffering from Alzheimer's disease. You can see there i is reduced uptake in the temporoparietal region of the brain, 14 15 which is indicative of Alzheimer's. 16 This kind of drug can also be used to diagnose other 17 neural diseases, such as Huntington's chorea. Again, it 18 involves the administration of about 5 millicuries of 19 radioactivity. 20 The test is so sensitive that this kind of 21 examination has to be done in a quiet, darkened room, or less 22 the natural metabolism of the brain will contort the results of 23 the test. 24 In addition to the drug, the idea of having a camera 25 that can take these cross sectional pictures is new. It wasn't l
i 15 1 available in the clinic 5 years ago. Now, this is available to i 2 every community hospital in the country. Again, rapid 3 evolution, new klods of care that weren't even dreamed of 10 4 years ago. 5 COMMISSIONER BERNTHAL: Why does the PET imaging ] 6 require an on-site cyclotron? Is that because they are using 7 the short life isotope? 1 8 MR. McELROY: The radioactivity has a half life on { 9 the order of 2 minutes to 10 minutes, depending on which l 10 species, nitrogen, oxygen and carbon are all available, very, 11 very short half lives. 12 We have the evolution of a new class of chemicals 13 here and a new piece of equipment, that as I mentioned, were 14 not available just a couple of years ago. The most exciting 15 development, which makes us jump from the 1890s up to the 1990s 16 in one step, is illustrated on page five. 17 A 19th Century German physician by the name of Paul 18 Ehrlich postulated the immuncresponse theory that is the basis 19 for disease in medicine today. He conceived of a thing called 20 a magic bullet, an antibody that would go only to a certain kind of diseased cell, some kind of drug that is specific to 21 22 the disease at hand. 23 In fact, the illustrations in his first monographs 24 that he published are just like illustrations that are used 25 today.
16 ~ 1 This development of new drugs represents genetic 2 engineering, hybridization of cell lines. The example you have l 3 here, we have two mice that were injected with the monoclonal 4 antibody that is specific to human colon cancer. These images 5 were taken serially for four days. The mouse on the top has a 6 human colon tumor grafted to his flank. The mouse on the 7 bottom is a normal control. 8 You see the radioactivity concentrates at the tumor site on the mouse on the top, who has the disease specific for-9 10 the monoclonal antibody that has been administered. The' mouse 11 on the bottom doesn't have the right kind of disease, so all 12 the radioactivity is flushed out of his body and promptly, 13 within a day or two. 14 COMMISSIONER BERNTHAL: What is the time span here? 15 MR. McELROY: Days one through four. 16 This represents possibly the most exciting 17 development we will have in radiopharmacy. This monoclonal 18 antibody could be labeled with a low toxicity radioactive 19 compound and used to diagnose and stage disease, determine if 20 it has migrated beyond the original site. If a disease is not 21 present, the radioactivity is simply flushed out of the body. 22 If the disease is present, perhaps the same compound could be 23 labeled with a highly toxic form of radioactivity, such as iodine or perhaps even an alpha emitter, and used for therapy, 24 25 I stress again, disease specific. 1 i ____________.__-__._________________.____J
17 ^ l The quality assurance that would go along with the \\ 2 development of these drugs, the handling of l 3 radiopharmaceuticals that have hundreds of millicuries of I-131 j t 4 attached, is something we will have to consider. 5 COMMISSIONER BERNTHAL: You don't happen to know if this particular sequence was done with an alpha emitter or beta 6 7 gamma? 8 MR. McELROY: I believe this was done with I-131. I 9 believe for a mouse, you need about 8 microcuries,, 10 So far, we have examined radiopharmacy. where 11 radiopharmaceuticals are injected into patients. There are 12 other methods of using radioactivity for diagnosing disease and 13 a very interesting example is on page six. 14 This machine is called a lixiscope. It is a real i 15 time x-ray imaging device hand held. There are no hidden power 16 cords here anywhere. It is battery operated. It has sealed 17 source of 200 millicuries of I-125 in the capsule at the end of 18 the stick, where the yellow sticker is. 19 This provides a physician with a tool that is much 20 less expensive than a conventional x-ray machine. It exhibits 21 a much lower dose rate to the patient. You have probably seen 22 one of these, if you watch professional football on television. 23 of course, the arm that holds the radioactive source to the image intensifier is much larger, so it can fit around a 24 25 fcotball player.
18 1 We mentioned the possibility of licensing new 2 categories of individuals. Podiatrists have never held NRC 3 licenses before. In emergency medicine, either on the sports field or in a rescue vehicle responding to a traffic accident, 4 5 this device could play a very important role. We are looking 6 at the potential of having a device like this on every rescue 7 vehicle in.the country that has to respond to an automobile 8 accident, because if you move a patient with a broken bone, you risk severing the spinal chord and end up with instead of minor 9 i 10 injuries, a quadriplegic. 11 I am not suggesting that is what is going to happen. \\ 12 There is a very real potential for that kind of need for this 13 device as it gets out in the marketplace. 14 We are dealing not only with new technology here, but 15 new classes of users. 16 In addition to new devices, we have new diseases in l this country, as illustrated on page sever.. ) 17 I 18 COMMISSIONER BERNTHAL: I would just comment that is i 19 a very impressivo device. It also has a pretty impressive i 20 loading of Iodine 125, your point about a new class of users is 21 well taken. One hopes they are well trained. 22 MR. BERNERO. This goes right to your point, Mr. 23 Bernthal, about who regulates it. 24 MR. CUNNINGHAM: Iodine 125 is regulated by us, i 25 COMMISSIONER BERNTHAL: It is? How does that happen?
19 1 It's a daughter product of a reactor produced material? 2 MR. McELROY: I believe it can be produced in either j 3 fashion, and unless the user can prove that it came from a i 4 cyclotron, he falls under our regulation. 5 COMMISSIONER BERNTHAL: You can't produce it as a 6 primary product in a reactor? It may be a daughter product of 7 reactor produced material. ( I 8 MR. McELROY: On page seven -- 9 MR. CUNNINGHAM: I might add on your comment of new 10 class of users, this kind of device also presents a lot of 11 opportunity for abuse. 12 COMMISSIONER BERNTHAL: That is right. 13 MR. BERNERO: You remember the shoe examiners. 14 COMMISSIONER BERNTHAL: I don't even want to think 15 about them. 16 [ Laughter.] 17 COMMISSIONER BERNTHAL: I remember them too well. 18 MR. McELROY: Those were x-ray devices. Of course, 19 we didn't regulate those. 20 COMMISSIONER BERNTHAL: I know! 21 CHAIRMAN ZECH: Let's proceed. 22 MR. McELROY: In addition to new devices, we have new 23 diseases in this country. You have seen printed or television 24 press on the disease, osteoporosis. It potentially affects 25 25 percent of the older female population in this country. Being
20 1 confined to a wheel chair perhaps might not be all that 2 terrible, but in fact, many of the individuals suffering from 3 this disease fall. You have heard the phrase "she fell and 4 broke her hip," "she fell and landed on the pubic bone." They 5 have been so demineralized by this disease process, that it was 6 not able to withstand the impact and shattered when the patient 7 fell. 8 Alternatively, simply by taking a misstep, putting a 9 little too much pressure on that bone, it can cause it to 10 shatter. In either case, the patient is sent to bad with a 11 cast, but recall, she is suffering from a bone degenerative 12 disease. The break doesn't heal very rapidly. Confinement may 13 last as long as a year. 14 Something on the order of 30 percent of those falls 15 are fatal within a year, either because of opportunistic 16 infection or secondary conditions that come on, that accompany 17 extended bed confinement. This is something that potentially 18 costs a lot of money and a lot of human life with this disease. 19 This tool again loaded with the 200 millicuries iodine source actively measures bone density. It allows the 20 21 physician to scan the patient, simply scan the forearm with a 22 pencil beam of radiation on an initial visit and then perhaps 23 every six months to determine the progress of the disease or if 24 it has initiated. As yet, the best method of care has not been 25 determined by the medical community. Again, a device that is
21 l 1 getting out into the market and may be used by a new class of 2 physicians who have not before had an NRC license to use 3 materials. 4 I would point out on page eight that what we see is 5 the possibility of actually having nuclear medicine serving as 6 the gatekeeper of the hospital in the 21st Century. I confess 7 to having gotten.this slide from a nuclear medicine physician 8 who had eves on the chair of the Chief of Staff, but 9 nonetheli.s2, it is not outlandish. 10 luu have seen a lot of different techniques that 11 nuclear medicine has in its armamentaria to diagnose disease. { 12 That is a quick survey of diagnostic use of radiation. 13 If you turn to page nine, you have an example of 14 radiation therapy. This is a Cobalt treatment unit that has 15 5,000 to 10,000 curies of Cobalt-60. The patient would be 16 treated usually for cancer using this device. This requires interaction of a variety of medical professionals; a physician 17 18 who prescribes the amount of radiation to be administered and 19 how large a treatment volume is necessary; a dosimetrist who 20 would calculate how long the unit has to be turned on to 21 deliver the prescribed dose; a technologist who actually 22 administers the radiation dose every day; a physicist who 23 checks the calculations to determine they are correct and also 24 actually measures the output of the radiation therapy unit. 25 Radiation has been used alone. It can also be used
22 1 with adjuvant therapies. It can be coupled with the 2 administration of certain chemicals that can kill the tumor. 3 Some hospitals have facilities in which the primary tumor can 4 be excised in surgery and while the patient is still open, have 5 the patient transported to the radiation therapy clinic and have the tumor bed irradiated to kill any remaining cells that 6 7 were not removed during surgery. 8 You have seen examples of monoclonal antibodies that 9 can be administered in conjunction with. radiation therapy. 10 Tumors are typically deficient in oxygen tension, 11 therefore, they are less sensitive to radiation damage. There 12 are various mechanisms used to increase the amount of oxygen in 13 the tumor bed, whether by having a patient breathe pure oxygen 14 or putting him in a high pressure room for a few minutes before 15 radiation is administered. Heating coupled with radiation also 16 may be beneficial. 17 This raises a very important technical question which 18 the staff will have to deal with. We have a definition of 19 misadministration. Should that definition go out to encompass 20 the adjuvant therapies that are used. Should we define a 21 misadministration as failure to achieve the correct tumor 22 temperature when using hyperthermic before administering the 23 radiation. It is simply a technical question presented to 24 demonstrate the difficulty of the task that the staff will be 25 dealing with.
23 1 On page 10, we have an actual example of a treatment 2 plan. Here egain, you see the impact of computers in radiation 3 therapy. A CT scanner was used to determine patient contour, 4 the tumor volume to be treated and also radio sensitive 5 surrounding healthy tissue. That CT scan can be fed directly 6 into a treatment computer that is used to calculate dose 7 profiles. 8 For this particular patient, the physician is using a i 9 three pcrt regimen in which the beam will be delivered for one i 10 minute from beam location two at about 7:00, and the machine l I 11 will be turned off. The technologist would go in and rotate 12 the machine over the top of the patient, shine the beam in from 13 12:00 for one minute and shine in from 5:00 for one minute. 14 This is done to spare the healthy overlying tissue i 15 wi e providing maximum treatment dose to the tumor volume. {
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- in, an example of evolution.
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When I was working in radiation therapy in the early I .18 1970s, these computers weren't available. We did this on a few 19 patients using templates taken out of textbooks. This 20 represents a really evolutionary step. 21 You have demonstrated some concern about the quality 22 of the back-up devices used by our licensees. This treatment 23 planning computer is certainly one of the most important. It might be importantgto have an independent agent other than the 24 i 25 computer manufac'u:ter verify the validity of these programs. c = k
i 24 4 1 This program is sufficiently complex that ) 1 verification is outside the capability of most community 2 3 hospitals. You will see a little later on in the briefing that 4 some professional organizations, scientific organizations, have 5 established committees to examine this kind of problem. The industry is taking some steps and we will take a look at those 6 1 7 a little later. 8 I think you can see now the complexity of the problem 1 9 we are dealing with. 10 We have an example of a new development on page 11, 11 which is called a remote afterloader. I mentioned that 12 Becquerel tried using radium plaques to treat skin lesions l l 13 early on. That was unsuccessful due to the high beta dose rate 14 coming off the plaque. The implant of radioactivity within the l 15 tumor volume has been around for a long time. Radium seeds 16 were developed early on that could be used for tumors. For 17 some kinds of tumors, success rates as high as 95 percent have 18 been achieved using implanted radioactive seeds. 19 This is a relatively new device demonstrated here. 20 It is called a remote afterloader. Down at the bottom of page 21 11, you see a physician has pre-implanted nylon catheters in 22 the treatment volume, after using an x-ray to determine they 23 are in the correct position. The machine can be coupled to the implant and then the radioactive seeds can be inserted into the 24 25 machine, into the implant site.
25 1 1 This higher activity that can be used with this 2 machine holds promise of great benefit because if a lower l i 3 activity seed is manually implanted for this kind of treatment, 4 the patient is normally confined, conscious and to bed for as 5 long as three days, completely immobile. A Draconian measure i 6 but in many cases, successful. Using this device, 7 administering a higher amount of radioactivity allows for a shorter treatment time. l l 9 You can see on 12, it is obviously a lot more i 10 comfortable for the patient. 11 On page 13, again we have an example of a dose 12 distribution for that patient; 7 catheters were implanted into 13 the breast tissue. The computer has been used to calculate the 14 isodose curves here in rads per hour. This is a fairly simple 15 implant, yet you see we have a fairly complex set of isodose i 16 lines surrounding implant volume. 17 One of our misadministration definitions requires 18 that a hospital report a misadministration if the dose is more 19 than 10 percent different than prescribed. Taking that 20 definition and this illustration, it led one of the members on 21 our Advisory Committee on the medical use of isotopes, to 22 characterize that as being similar to trying to define the 23 topography of the United States with an integer. 24 COMMISSIONER BERNTHAL: How long have we had that 10 25 percent criterion?
26 1 MR. McELROY: That was in the original rule,.in 1979. 2 COMMISSIONER BERNTHAL: Close to 8 years. That is 3 when the first rule dealing with that came out? 4 MR. McELROY: That's correct. 5 COMMISSIONER BERNTHAL: It does seem a bit 6 unreasonable. 7 MR. McELROY: A bit difficult to make clear to the 8 licensed industry exactly when a report is required or when we l ) 9 have made a determination that a misadministration has in fact I 10 occ.urred. Again, a technical problem that the staff is going 11 to have to deal with, establishing definitions that apply to 12 current methods of treatment. I 13 In 1979, when these maps were not available, it was a 14 little bit more reasonable, it was given to misinterpretation. 15 MR. BERNERO: We have thought for years in terms of a l 16 doctor designating a dose of 2,000 rad and the sole question 17 is, did you get 2,000 or 2,200 or 1,800, a rather simplistic view, but as the sciences develop, you are really talking about 18 19 a very complex exposure and a very complex system of other 20 factors, temperature, pressure, the conditions, there are so 21 many peripheral things, that it makes it a far more complex thing to say, how far off the mark was this administration of 22 23 radioactive exposure, how misadministered was it. 24 It doesn't lend itself to that very simple plus or 25 minus something.
4 27 i 'l COMMISSIONER BERNTHAL: I don't recall exactly how we 2 dealt with this in the proposed rule, this particular issue, 1 1 but it seems to me that a fairly straight forward principle 3 I 4 suggests itself, and that is what the prescription is. In ) 5 other words, that we make a clear distinction between what 6 happens in the patient, if the prescription is followed. Was 7 the prescription by the doctor correctly followed and then of 8, course I suppose there is a separate question of whether it was 9 accidentally or completely the wrong prescription. 'That is a 10 different matter. 11 MR. BERNERO: As long as the prescription is rather simply stated, but the prescription becomes a plan really. 12 l 13 Just recently we were discussing a case where the prescription i 14 was rule out osteomyelitic. It was a strategy, it was an 15 objective. There is a plan. In this particular case, this 16 patient, the plan is to attack this tumor by a distributed 17 dose, by a strategy, that has many numbers, many exposure 18 levels, distributed over a volume of tissue. That is where you 19 start to bog down, the conditions under which they were applied 20 and the distribution of doses. It gets farther and farther 21 away from anything that lends itself to a simple plus or minus, 22 how close did you hit the mark. 23 MR. TAYLOR: We really follow the prescription; 24 right? 25 MR. McELROY: That's correct.
l 28 1 MR. BERNERO: So many percent off the mark. That 2 happened to match the technology of some years ago. 3 MR. McElROY: You have seen the calculated dose 4 distributions. In the past, the physician would simply I 5 prescribe 5,000 rads to the tumor volume and say where the 6 tumor volume was. Now, with the availability of the treatment 7 planning computers, he can prescribe not only that, but he can 8 also prescribe a homogeneity coefficient within the treatment 9 volume. 2 10 If you don't have an absolutely uniform dose 11 throughout the prescribed treatment volume, you go back and you j 12 calculate another treatment plan. It's not just the 5,000 13 rads. It is every cell in there gets within the 5,000 rads. 14 The prescriptions can become much more complex than in past 15 times. 16 COMMISSIONER BERNTHAL: We certainly don't want to 17 engage in hair splitting or second guessing. At the same time, 18 there is a world of difference between that and some of the 19 huge factors of ten. 20 COMMISSIONER CARR: You are also able to administer 21 it with more accuracy than before, too. When you can get a 22 plan like this, the reason you get a plan like this is because 23 you are able to administer it with some degree of accuracy. 24 MR. McELROY: I would suggest that the greater improvement has been in actually being able to examine what the 25
29 1 dose distribution is going to be. The actual accuracy of 2 administration, setting up the patient and the x-ray machine or 3 the Cobalt machine, granted, have improved with new devices but 4 nearly so much as the description of the radiation dose profile 5 within the patient. l 6 COMMISSIONER CARR: It will lend itself to putting 7 some kind of a film under the patient and re-figuring what you 8 gave them after the fact. 9 MR. McELROY: We are examining the feasibility of 10 that. 11 One of the consultants that we hired to assist in 12 this project said it was just too damn measurable. 13 CHAIRMAN ZECH: I hope we are consulting with experts 14 in the medical profession because our views are regulatory, of 15 course, and we want to make them as sensible and protective of l 16 the public as we should. On the other hand, with all the 3 17 advances that you are describing, it certainly seems to me that 18 the medical people themselves should be able to advise us as to 19 maybe higher or lower doses or perhaps even more or less of a 20 figure that might be used, more than 10 percent or less than 10 21 percent in certain cases, that would not harm the patient but j 22 would allow perhaps some disease to be eliminated. 9 23 With the advances in medicine, we hope we are -- 24 certainly, I don't think it is appropriate that we get involved j l in the medical decisions but that we confine ourselves to the 25 1 k i
30 1 regulatory, and I think we need to keep very close touch with 2 the experts in the medicine and the various diseases. 3 As we are making progress, which you are describing, 4 I think it is wonderful. I hope we are working very closely 5 with those who are experts in the medical field, too. 6 MR. McEIROY: We certainly are. The rules that you 7 have on the table were reviewed by all of the members of our 8 Advisory Committee. We have retained consultants to work l 9 specifically on this project, both very well known and highly 10 qualified individuals. The scientific committees of the l 11 appropriate organizations are gearing up to assist the staff 12 when the paper is made publicly available. They were just told 13 to get some committees ready to examine this matter. 14 MR. BERNERO: I might add, when we get public 15 comments on this, we will rely on these advisors again to 16 assist in interpreting the comments. We' intend to provide an 17 opportunity for the Commission to hear directly from those 18 advisors as well. 19 CHAIRMAN ZECH: Excellent. We will look forward to 20 that. 21 COMMISSIONER BERNTHAL: Taking the particular case in 22 hand here, looking at number 13, I would assume that is the 23 product of a therapy procedure that makes use of the 24 instrumentation in number 11; is that correct? 25 MR. McEIROY: That's correct. l
31 1 COMMISSIONER BERNTHAL: It would seem to me that our 2 responsibility is not where those catheters happen to be inserted, what the pattern that shows up on 13 happens to be 3 particularly, but whether in fact the number of sealed sources 4 5 that were supposed to be implanted somewhere in the tubes of 6 that device were implanted and removed at the appropriate time. 7 Any detail beyond that is basically in some sense not a 8 responsibility of the NRC. 9 Number 13, I would say, is not our responsibility, 10 provided the insertions were done as programmed and planned. 11 MR. McELROY: Your point is exactly the goal of the 12 regulatory text that we have provided. We are trying to assure 13 that whatever the physician has prescribed is in fact 14 administered. We have not gotten into a determination of which 15 is the correct prescription. 16 CHAIRMAN ZECH: Very good. Let's proceed. 17 MR. PARLER: That is none of our business. That is 18 certainly the way the General Counsel understands it. If he is 19 wrong, somebody should correct him. 20 CHAIRMAN ZECH: I think that is the way we all 21 understand it. That was my point, too. I don't think we 22 should tell the physicians what to prescribe. I think 23 Commissioner Bernthal is making the same point. Our business 24 is regulatory. We want to make sure that our regulatory 25 requirement is sensible and reasonable. That's our business. i _______-------Y
l 1 32 1 Let's proceed. 2 MR. McElROY: On page 14, you have an example of some 3 of these implant sources, the nylon catheters and so on. A 4 very interesting one is at the left of the pencil. That is in 5 fact a platinum plated gold seed that will be used for 6 permanent implant. It has a very short half life, about 2.7 7 days. It has a very nice energy for radiation therapy. Here is a case where the seed is not removed from the patient after 8 i 9 treatment but is simply inserted within the tumor volume and ) 10 left there for the duration. Again, a different twist on the l l 11 science of brachytherapy. f i 12 We have talked about evolution of technology. We can j examine evolution of medicine or a particular disease, i 13 for l 14 example. I 15 CHAIRMAN ZECH: Are we on page 15 now? 16 MR. McELROY: Page 15. We talk about quality of 17 care. The delivery of medical care is evolutionary. There are 18 well documented regional variations in practice. A disease is 19 quite likely treated differently in Massachusetts than it is in 1 20 California. It is not uncommon to go to a scientific meeting 21 and have a dais of five nationally known medical experts be 22 given a real case history with the patient interview, the x-ray 23 pictures, the lab results, the biopsy slides and so on, have 24 the same case given to five physicians and have five different 25 prescriptions given for that patient's care.
33 1 It is not always clear what is best for the disease. 2 We have covered this in our discussion in the last couple of 3 minutes. I 4 Taking that one step furthcr, it may not always be 5 absolutely clear what quality assurance methods are absolutely 6 necessary or in fact, available. In some cases, there is a 7 severe shortage of the technologists available to do the kinds 8 of quality assurance work that we envision. We particularly 9 requested comments from the public on that in the Register i 10 notices. 11 I think you are beginning to see a high menpower 12 intensive industry. It is not 150 men running a 1300 megawatt 13 power plant. You have four individuals that have to work 14 together to take care of an individual patient. It is a much 15 different situation there. You have to deal with the 16 interactions and the availabilities of the various trades. 17 So much for medicine as a technology. I mentioned 18 there were some business factors. 19 COMMISSIONER CARR: The same four individuals can 20 work with a lot of people. 21 MR. McELROY: That's correct. They will typically 22 work with as many as 40 or 50 patients a day who would be 23 receiving treatment off a single unit. 24 Turning to 16, we mentioned there were some business 25 considerations. We are not the only Federal agency that i
34 1 regulates medical care. When Medicare and Medicaid were 2 designed by Congress a few years ago, the staffers who were assigned to do a cost / benefit analysis of that regulation 3 4 underestimated the need for medical care in this country by 5 about a factor of ten. The Federal Government was going broke 6 covering medical bills for 30 million patients a year. 7 A couple of years ago,.the Department of Health and 8 Human Services instituted an alternative method of reimbursement called diagnostic related groups, in which the 9 10 hospital is reimbursed up front based on the admission's i 11 diagnosis. For example, if you entered the hospital emergency l 12 ~ room with a simple forearm fracture, the hospital would get a 13 flat fee to take care of you. It wouldn't get additional money 14 depending on how many splints or how much gauze or how many 15 aspirin were administered. 16 This turned the business of medical care literally i 17 upside down. Instead of making more money by providing more 18 care, the hospital was now cutting into its lump sum payment by 19 providing more care. 20 The participation of some professionals in the 21 medical care process, specifically radiologists, 22 anesthesiologists and pathologists, was not properly, some have 23 said, taken into account. They don't provide care directly to 24 the patient. They provide a consultative service to the 25 primary care physician.
35 1 In radiation therapy, I think you see that having a 2 medical physicist on hand becomes very important, because he is 3 measuring amounts of rndiation coming from sources and he is i 4 measuring or auditing the calculations. Yet, his participation 5 as a professional service was not recognized. He was lumped 6 down there with the technologist after having completed as much 7 formal schooling and as much on the site training as the 8 physician had completed. 9 There are some business things, business matters, 10 driving delivery of medical care. 11 I hesitate to get involved in the matter of 12 insurance. It is granted a normal business expense for a 13 physician, but not too many of us as individuals are used to 14 dealing with $130,000 a year liability premium, which is what 15 physicians have to face. A back of the en ope calculation 16 this morning indicated that every time you go to the physician, 17 the first $20 of your bill goes toward his liability insurance. 18 It is that much of an operating expense. It has gotten so 19 great that some physicians have chosen to care for indigent 20 patients or going without liability insurance, because the 21 patients can't afford their portion of the physician's 22 liability insurance. 23 A business matter that should not drive our 24 deliberations but should be taken into account. It should 25 appear as a parameter in our deliberations.
l 36 1 COMMISSIONER BERNTRAL: Maybe we need a Price-1 2 Anderson plan for the medical profession. 3 MR. PARLER: Somebody is already working on that. ) 4 [ Laughter.] ) 5 MR. PARLER: They have gotten the word and are making l 6 progress. I don't know whether it would be sound public policy 7 or not but that is for somebody else to say. 8 MR. McELROY: On 17, there is concern for the quality i 9 of medical care and the quality of prescriptions. In fact, the I l 10 American College of Radiology got started on this about 15 11 years ago with a thing callad patterns of care study, in which 12 they developed not a survey, but a census list of every 13 radiation therapy center in the United States, about 1,150 of 14 them, if I remember correctly, and actually examined what kind 15 of prescription is given for this kind of disease at this 16 stage. They are still, 15 years later, in the process of 17 examining that data. Reports on the mean dose distribution for 18 the 12 most common kinds of cancer have been published in the 19 literature for guidance to the medical community. 20 The American Association of Physicists in Medicine 21 comprised primarily of physicists who either participate in 22 radiation therapy or the diagnostic use of radiation, has 23 established over 30 scientific committees, examining single ad 24 hoc quality assurance topics. 25 I mentioned, for example, the validity of computer
37 1 programs. They are examining the best way to measure the 2 radiation coming off one of the implant sources. They just 3 completed a ten year project that redefined the way radiation 4 dose coming from a Cobalt unit or a high energy x-ray machine 5 should be measured, what tools are needed, and what measurement 6 processes should be used, to calculate the dose coming from 1 7 that machine. 8 The Society of Nuclear Medicine, another key j 9 organization, has five general oversight quality assurance 10 committees and establishes ad hoc committees as necessary. 11 We are prepared to deal with all of these 12 organizations and in fact the groundwork has been laid, so that 13 our endeavors don't reduce the quality of medical care in this 14 country. I 15 That is dealing with medical matters or clinical 16 matters. In addition to that, there are physical quality 17 assurance matters. For example, the AAPM project on measuring 18 radiation dose from treatment units, measuring the 19 radioactivity in treatment seeds, and here are some examples of initiatives that have taken place recently. 20 21 An intercomparison workshop at a regional meeting in which each physicist takes his measuring instrument to a single 22 site and compares it with everyone else's instrument, to ensure 23 24 that all the instruments respond the same, to the same dose of 25 radiation.
38 1 The M.D. Anderson Hospital and Tumor Institute in 2 Houston, one of the two meccas for radiation therapy in this 3 country, has recently begun a mail order thermoluminescent 4 dosimetry service, in which a client hospital can be mailed TLD 5 chips, irradiate them, and calculate how much dose was given to 6 the chips. The chips are read out back in Houston and the 7 amount of dose actually administered can be compared with the 8 calculated dose, that verifies that the correct arithmetic was I being done for individual treatment plans. 9 1 10 COMMISSIONER CARR: Before you leave that one, I 11 noticed at the bottom, it talks about simulator use at CT 12 facilities. Is that for training? 13 MR. McELROY: The CT facility would be the marriage 14 of the CT Unit with the treatment ccmputer to determine dose 15 distributions inside the patient. A simulator is a modified 16 conventional x-ray niu: hine that has all of the degrees of 17 freedom of a therapy bachine. If you want to take a radiograph 18 of the patient, you can do that with a Cobalt unit or high 19 energy x-ray machine, but the picture would be of incredibly 20 poor quality, because of the physics of interaction of high 21 energy radiation with matter. 22 A simulator can be developed and there are several on 23 the market now, that looks similar to the high energy x-ray 24 machine or Cobalt machine, but instead of a high energy target 25 or Cobalt source, it has a conventional x-ray tube in there, so
39 1 you can mimic the manipulations that you will be using on the 2 treatment unit, but then get a nice high quality radiograph of 3 the patient and the surrounding tissue, which is just not i 4 obtainable with the treatment unit. That is what a simulator 5 is. 6 CHAIRMAN ZECH: I presume that is using computers to 7 give you that picture in the simulator? 8 MR. McEU OY: No. The simulator is a conventional 9 fluoroscopic x-ray machine but it has different ways of moving 10 than a conventional x-ray machine like you have seen in a 11 diagnostic radiology clinic. 12 CHAIRMAN ZECH: It doesn't use computers to give you 13 a simulated picture? 14 MR. McELROY: No. It is a real fluoroscopic picture 15 or a film picture. 16 CHAIRMAN ZECH: Why do you call it a simulator? 17 MR. McELROY: Because it simulates the configuration 18 of the treatment machine. 19 CHAIRMAN ZECH: So it's a configuration? 20 MR. McELROY: Of the patient and how far the patient 21 is from the treatment machine and how large the fields are and 22 so on. These are things that conventional x-ray machines can 23 do. 24 MR. TAYLOR: That would be used preparatory to the l 25 actual therapy. n
40 1 MR. McELROY: That's correct. That's used to plan 2 the treatment. 3 CHAIRMAN ZECH: Fine. 4 MR. McELROY: We have on page 19 taken some staff 5 initiatives on this matter. I think the most important thing i 6 here is developing good relations with newsletter editors. The 7 NRC can send out bulletins and reminders to its licensees, and 8 all too often it may be interpreted as: Here comes the Federal 9 Government again telling us how to practice medicine, but they 10 aren't paying for our malpractice insurance. 11 By working with the newsletter editors over the last 12 few years, we are essentially working hand in hand with the 13 scientific organizations, and having our information appear in 14 their newsletters, I think, lends a scientific or technological 15 credence that is not available with an NRC logo on medical 16 matters. 17 We intend to continue working with the editors in the 18 future, and they have demonstrated interest in running our 19 articles on an occasional basis. 20 COMMISSIONER BERNTHAL: I am not sure I'm getting the 21 point here. You are suggesting that one of these articles was 22 reported inaccurately or that it was giving the wrong -- 23 MR. McELROY: No, my point is that all of these 24 articles have gotten into the associations newsletter. These 25 were not NRC reports that were mailed out with an NRC i
41 1 letterhead. We are getting the word out to the community 2 through the newsletter that they read every month, but it is 3 the newsletter of their own organization. We are working hand 4 in hand with the scientific organizations, and when the Society 5 of Nuclear Medicine goes hand in hand with the Nuclear l 6 Regulatory Commission, a physician or a technologist would be 7 very hard pressed to question the statements made. 8 COMMISSIONER CARR: I think he is saying if Joe 9 Fouchard releases it, it's not believable, but if it's inside 10 NRC, it's okay. 11 [ Laughter.) 12 MR. TAYLOR: I don't think we are intending that we l 13 would no longer issue information notices. We would continue. 14 This is another vehicle to get the word around in a very large 1 15 community, and when we have issued these information notices, 16 the mailings are very extensive, so it is a little easier to 17 issue them to power reactor licensees. It's a much smaller 18 community. This is a big community. I think Norm is 19 emphasizing that here is a method of getting some of the 20 regulatory information out to the broader population. 1 21 Is that right, Norm? j 22 MR. McELROY: That is correct. I also would mention 23 that we only license about one-third of the hospitals in the l 24 country. The other two-thirds are under agreement states. I 25 This gets the words out to everybody at the same time, so we I l
i ~42~ i 1 have complete national coverage with this information method. 2 COMMISSIONER CARR: I assume we send those to the 3-agreement states, too. 4 MR. McELROY: They are,.but I'm not certain how' 1 5 promptly they distribute. 6 MR. TAYLOR: Yes, we do send them. 7 MR. McELROY:. We did come down.to discussing 8 rulemakings. We have laid on the table two Federal Register i 9 notices'for your consideration. There is an advanced notice of: 1 10 proposed rulemaking that. asks the public to comment on certain ) 11 questions, that asks about current standards of quality, should j 12 the NRC get involved in quality assurance,.how should it go 13 about getting involved, and so on. 14 In addition, we have on the table a notice of I l 15 proposed rulemaking for basic quality assurance. The regulatory 16 text for that proposal was developed after'an examination of 17 the mis-administration events reported to us. We estimate, and 18 it is speculative, but we estimate that had the notice-of-19 proposed rulemaking been in effect and implemented,'it would 20 have eliminated approximately three<-fourths of the mis-21 administration events reported to us. 22 We developed that by examining the events and by-23 examining in a theoretical sense-the radiation therapy process, 24 the diagnosis of disease, the staging of disease,.the 25 administration of radiation and follow-up. That is how we
43 ^ 1 arrived at the -- i 2 CHAIRMAN ZECH: I presume you are telling us that is l 3 good. Tell us why that is good. ) 4 MR. McELROY: The staff had a hard time figuring out i 5 how to improve on a process that goes wrong once every 10,000 l 6 times. That's the frequency of reported mis-administrations. 7 l Every event that we have a report on is different from every ( 8 other. They exhibit perhaps the same color here and there, but i 9 they are different events, and to try and draft a proposed rule 10 that would eliminate all therapy mis-administrations without ) 11 negatively impacting the delivery of medical care in this 12 country is a very difficult process. I 13 As a medical consumer, I wish I could do that, but we i 14 have not had the insight and the resources to go any further 15 than this, especially with the schedule that you have requested 16 we follow. 17 COMMISSIONER CARR: But eliminating 75 percent is,a 18 big step ahead. 19 CHAIRMAN ZECH: But I presume the 75 percent you are 20 eliminating you are telling us the mis-administrations in those 21 cases are not significant; is that right? 22 MR. McELROY: I don't believe that's what I said. 23 CHAIRMAN ZECH: Tell us what you said, then. 24 MR. McELROY: We are doing the best we can given the 25 schedule we had and the resources we had. It is also very a
44 ' difficult in-this kind of process-to make it 100 percent fail 1 2 safe. 3-CHAIRMAN ZECH: No, I understand that. 4 MR. McELROY:. I'm just giving you human error. 5
- CHAIRMAN ZECH:
I understand that, but therefore you l 6 aro saying that the 75 percent that you are eliminating, what i kind of assurance do you have that we are taking a conservative 7 8 and proper approach to'our' regulatory responsibilities? I t 9 MR. TAYLOR: I'think Norm is saying that what we did 10 was to consider after looking at these events what were'the 11 causative' features. Then we said, gee, if there had been the 12 extra check, if there had'been the extra steps taken, we could 13 have stopped about three-quarters or 75 percent of those 14 occurrences. 15 CHAIRMAN ZECH: Do you mean they would not have 16 occurred in the first place, or they wouldn't have been 17 reported to us? 18 MR. TAYLOR: Thsy would not have occurred in the 19 first place. 20 MR. McELROY: 'They would not have occurred. -1 H21 CHAIRMAN.ZECH: That is the important thing I was 22 wanting you to emphasize to me. } 23 MR. TAYLOR: Right, sir. The idea, of course, is to-24 use measures that don't totally constrict the medical process 25 but to put in place steps, quality control type steps that we
^ 45 1 think are reasonably straightforward and can be delivered at a 2 reasonable cost. 3 CHAIRMAN ZECH: Sure. If we by regulatory rules can 4 help prevent the occurrences of mal-administration in the first 5 place, then that is a very positive thing for us to do. 6 MR, TAYLOR: That is the objective. 7 CHAIRMAN ZECH: I presume that's what you are telling 8 me. Is that correct? l 9 MR. McELROY: That is what I'm telling you. 10 CHAIRMAN ZECH: That's very important for us to know. l 11 MR. TAYLOR: But I think it is strictly an estimate, 12 but that was from all the features we could put in, roughly l 13 three-quarters of them that had occurred, had been reported. I 14 CHAIRMAN ZECH: The main thing I wanted you to 15 emphasize, and I think you have now, is that the three-quarters 16 that you are talking about that we might have prevented 17 happening in the first place -- that's important -- but it's i 18 not that you just didn't want three-quarters of the reports to i l 19 come in. 1 20 MR. McEIROY: Oh, no, no. 21 CHAIRMAN ZECH: I just want to make sure that that is 22 clear. 23 MR. McELROY: We are trying to -- we think we have 24 proposed rules that will eliminate three-fourths of the future 25 events.
46-1 CHAIRMAN ZECH: From happening in the first place. 2 MR. TAYLOR: Based on the reported events. 3 CHAIRMAN ZECH: That is important, you see, to be 4 understood. 5 MR. CUNNINGHAM: And I also want to emphasize, Mr. 6 Chairman, that these are the obvious, relatively easy steps to 7 take now. We are pursuing it further. 8 CHAIRMAN ZECE: I understand it is very complicated, 9 but if we can improve o7 we can eliminate even a few, l 10 contribute to eliminatory a few of the mis-administrations, 11 then we are taking a very responsible action. I think that is 12 what you are telling me. I just wanted to make sure that that 13 was emphasized and underrtood. 14 MR. McELROY: That is the point that was being made. 15 CHAIRMAN ZECH: Fine. 16 COMMISSIONER BERNTHAL: I think your concern is well 17 taken, Lando. If one gets side-tracked by looking at the 18 statistics of small numbers, there are so many of these things, 19 so many administrations, and after all, it's only 10 to the 1 20 minus 4 or whatever the number is. It sort of begs the 21 question. In the first place, the principle is as low as i 22 reasonably achievable in some sense, and secondly, it may well 23 be that only one person in 10,000 that goes through Central 24 Park gets assaulted, but that doesn't change the fact that -- 25 that may not quite be an accurate statistic -- doesn't change
47 1 the fact that you would like to do something abcut that one 2 person that gets assaulted. So I think the principle is the 3 same here. 4 CHAIRMAN ZECH: Right. 5 MR. McELROY: Gentlemen, that concludes the technical 6 portion. We have one last slide that Mr. Bernero will speak 7 to. 8 MR. BERNERO: We just appended a budget slide. You 9 are separately reviewing the budget. I just wanted to 10 emphasize that this program, as perhaps all of you recognize, 11 has not enjoyed a surfeit of resources in the past. We have 12 only a modest amount of our resources in this area. We 13 recognize the importance of it and we are preparing, in fact 14 seeking effective, innovatiye ways not merely to increase how 15 frequently we inspect things -- you know, doing it the way we 16 did before, only twice as fast -- we are looking for better 17 ways, perhaps through quality assurance, perhaps through other 18 initiatives, to more effectively regulate nuclear medicine 19 without hindering its proper application to the proper health. 20 Remember here the medical profession is trying to use 21 radiation technology to benefit the public health, and it is 22 the optimal use of that radiation exposure that is the common 23 goal. So we are increasing resources, we are seeking further 24 increase of resources, and we welcome your attention to this field because we think it is a very important one. 25 i )
48 .i 1 CHAIRMAN ZECH: All right, fine. [ 2 Any questions from my fellow commissioners? Mr. 3 Bernthal. 4 COMMISSIONER BERNTHAL: I want to ask a question or 5 two here that focuses really more on the proposed rule, if I 6 may. Before I get to that, though, I don't think we spent much' 7 time on the last page here that has to do with money and the B budget. I know the chairman is always very interested in that. l l 9 I also noticed that one of the things that you are proposing j b 10 for the implementation of the proposed rule would be that the l 11 fiscal year 1989 budget provide for the increase of, I guess d a 12 almost doubling the number of inspections that we do in 13 hospitals or medically-related facilities. 14 MR. BERNERO: Something equivalent to that. We don't 15 simply intend to turn the rheostat up by a factor of 2, but 16 essentially equivalent to that. 17 COMMISSIONER BERNTHAL: Do we have any good sense yet 18 where the money is going to come from for that?.How much more 19 money is it? 20 MR. BERNERO: It's stated there, the:$1 million and 21 $2 million going out, you know, the contractor dollars. Due to 22 the pressure on FTEs, the.decicion there was to seek the i initial cut at implementing the rule through the use of support 23 24 contract. 23 MR. TAYLOR: That money would be to assist the staff
l 49 1 in going out and making sure once the rule is out that they do l 2 have the quality assurance steps prescribed by the rule, that 1 3 they put them in their procedures, that people have been 1 4 trained, that they are ready to use them. It is that type of l 5 big, first wave review which the money would help the staff to i 6 accomplish. 7 CHAIRMAN ZECH: The chosen emphasis on this program, increased inspections and increased emphasis. 8 9 MR. TAYLOR: Yes, sir, and we would like to get 10 around to the population over a period -- after the basic 11 quality assurance rule goes into effect -- we would like to get 12 to that population within two or three years. That is the i 13 plan. 4 14 MR. BERNERO: Keep in mind the average frequency of inspection now is perhaps once every three years for a 15 16 licensee. It is a rather rare event. What we are trying to do l 17 is be quite a bit more timely than that. 1 18 COMMISSIONER BERNTHAL: I certainly support that. I 19 guess I am still a little confused here. Where were you 20 reading that $1 million? 21 MR. BERNERO: On page 21, down at the bottom, for 22 fiscal year '89. 23 COMMISSIONER BERNTHAL: Oh, I see. Okay. Very good. 24 I was also curious about the point that you make, 25 which is true in a sense, I guess, it seems like, about l
50 1 technology advancing very rapidly. It seems like perhaps the industrial sector has something to learn about technology 2 3 transfer because it does seem to occur fairly quickly in 4 medicine, by and large. But it does raise the question of how 5 an organization like ours, which too typically takes a couple 6 of years to get anywhere on a rulemaking, sometimes five years, 7 where we have frem time to time been accused of inhibiting the 8 transfer of needed technology to nuclear power plants, for. 9 example, and I think there is probably not much question that 10 that has been true in some cases. 11 How do you deal with that as a regulatory matter? Do 12 you respond by -- I hope you are not advocating this. Do you 13 respond by simply writing very loose regulations that can deal 14 with almost any possible eventuality? Do we have a philosophy in how we approach that sort of aroblem in this particular 15 16 area? l 17 MR. MILLER: I would like to speak to that subject, 18 Mr. Bernthal. Let's take for an example the Lixiscope that we 19 talked about earlier today. For example, we would write down 20 some standards that we would consider this policy for the 21 branch, and once that becomes policy, until such time as we can 22 regulate it more formally, that will be it. We would not let 23 something that would cause a health and safety problem out 24 there to be used, whether the regulation is there or not. We 25 would write Branch positions. l l
c 51 1-COMMISSIONER BERNTHAL: So we don't necessarily bach 2 off from whatever proscription you might -- a different use of 3 the word " proscription" -- whatever proscription you might feel is necessary and warranted in our regulations, but you are 4 5 saying that to be fast on our feet, wr. rely, then, on staff 6 policy positions, essentially? 7 MR. MILLER: Yes. I used the Lixiscope as an B example. We have a very good document on that device. 9 COMMISSIONER BERNTHAL: How often does that sort of 4 10 issue arise where staff has to announce to the world, to the 11 medical nuclear medicine industry and profession that something 12 that doesn't quite fit in to our regulations has popped up and 13 this is going to be our policy from this time forward? Is that 14 a common occurrence? 15 MR. MIL 12R: It happens occasionally. We were pushed 16 to come up with a position because of a licensing problem with 17 the licensees. Every time I give you something, you said that 18 is not correct, so we had to get some document in a policy-type 19 position that they would be able to follow. 20 MR. TAYLOR: The license becomes the vehicle by which 21 the technical imposition, like in the Lixiscope, what are the 22 basic criteria for safety and protection of the radioactive 23 material so it doesn't get out loose or a patient get over-24 exposed? So the staff takes its positions and then tries to incorporate them in licensing that type of device. 25
l 52 ) I 1 Am I correctly characterizing it? So as these devices are developed and the requests come in, the staff 2 3 examines those types of features and tries to make that a 4 condition of the license. Of course, the person or company 5 manufacturing them desires to get a license, so they indicate 6 the type of precautions that are necessary to use it. 7 Is that not a characterization, Vandy, quickly? 8 MR. MILLER: That's correct. I 9 MR. TAYLOR: Anu that way we keep up with the 10 technology of development. 11 COMMISSIONER BERNTHAL: I guess what I am trying to 12 get at is is this a problem or not? It doesn't sound like it's 13 a big problem, and yet it sounded like it could be a big 14 problem. If it's not a problem, then let's quit talking about 15 it. I 16 MR. CUNNINGHAM: We go through several generations, 17 and we have tried to keep the regulations up with some 18 generations of new medical uses. For example, a few years ago, 19 five or six years ago, we revised our medical regulations when 20 we had this whole new program using technesium compounds. We 21 changed those regulations so that by simple amendments, as FDA 22 approved certain drugs that fall in very specific categories 23 that had some similarities, that by simple regulation change 24 allowed physicians to use those drugs. That is one kind of 25 thing.
53 1 As new things come on the market, we try to stay 2 ahead of them. Right now, though, we see on the horizon some i 3 new and unique uses that will require us to rethink what we are 4 doing. For example, the use of the monoclonal antibodies for I I 5 therapy. We are going to run into use of alpha emitters in the l I 6 laboratories, nuclear medicine laboratories, never done before. 7 Something brand new. Some of these things are going up i 8 exponentially. We have been able to keep up with that in the 9 past through regulation changes roughly compatible with what 10 has happened, but the pace is more rapid now. 11 If you look at the FTEs for program development in 12 1987, what you are looking at is Norm part-time. We are i 13 increasing that in fiscal year 1988-89 to keep up with these 14 very things that we are concerned about that we see on the 15 horizon and are going to demand constant attention. { l 16 COMMISSIONER BERNTHAL: Okay, but basically your 17 answer is that we are dealing with this, in your judgment, 18 fairly well. 19 MR. McElROY: I would just like to offer the minority 20 opinion on that. 21 COMMISSIONER BERNTRAL: Well, it sounded like you 22 were offering a different opinion earlier. 23 MR. CUNNINGHAM: We are dealing with it the best we 24 can, but thn point here is we have dealt with it in the past as 25 best we can, there was an ideal, but now we are seeing more
54 1 things, and one of the purposes of this briefing is to point 2 out and I think you can appreciate how dynamic nuclear medicine 3 is, and it is just going to take a lot more attention, introducing better quality control procedures, which is great, 4 5 and it is going to take even more attention because of new 6 emphasis on this. 7 I might also add that what we do in quality control, 8 I think, offers great benefits that go beyond the things we 9 regulate. For example, our guides in use of teletherapy are 10 used for linear accelerators for the same type of therapy. I 11 think what we will see here are some side benefits for medicine 12-as a whole because they will start using these things in other 13 areas also, but we have got to keep up with this and we have 14 got to be ahead of it. 15 MR. McELROY: Commissioner, if I may, I would like to 16 address your comment. We sort of do keep up by addressing new 17 safety issues in the licensing process, but in the nine years i 18 that I was working in the field, but for my presence here today l 19 I would have characterized that as a victim of the licensing 20 process. The two difficulties with dealing with new issues by 21 license condition are, first of all, the staff does not get the 22 benefit of wide public comment on technical decisions, and in 23 this package that we have before you and the revision of Part l l 24 35 that we presented to you last year, important changes were 25 made due to technical comments submitted by the public. When u
o 55 4 1 the staff develops a licensing policy, you lose that 2 opportunity. 3 tacondly, for the licensee who is not familiar with licensing policy and doesn't know to write and get a copy of 4 licensing policy, he may have submitted an application that has 5 6 a portion of his radiation safety program that he thought was 7 sufficient. The staff, playing the conservative role, might 8 add some license conditions onto the license that is finally j 9 supplied. So the licensee has requirements now in his j 10 application and he has requirements that he never heard about l \\ 11 in his license. i I i 12 This can lead to confusion and it leads to difficulty in managing a radiation safety program. So although it covers 13 14 all of the bases and it covers the theoretical responsibility, 15 it is a difficult thing for the radiation safety officer on 16 site to administer when we do it that way, and I speak from i 17 experience. 18 COMMISSIONER BERNTHAL: Maybe that is enough said on l 1 19 the subject. I would hope if there is some regulatory 1 innovation that would allow us to respond in a non-confusing 20 21 way more rapidly and in a more timely manner, that the staff i 22 would suggest that to the Commission. 1 l 23 MR. TAYLOR: That is part of Norm's job now; isn't 24 it? i 25 MR. McELROY: Yes, sir. I'll have everything fixed I l i
56 4 1 by the end of the year. 2 (Laughter.) 3 MR. BERNERO: Bite your tongue! 4 COMMISSIONER BERNTHAL: A quick question on the 1 5 Advanced Notice of Proposed Rulemaking and the proposed rule. 6 I noticed that you have made an isotope spccific designation 7 for diagnostic applications for radiciodine. If one wanted to ] ) 8 be flexible in one's regulations, wouldn't you want not to limit yourself to a single isotope for which we are going to 9 10 specify diagnostic misadministration, but rather recognize 11 there may be others in the future? 12 MR. McELROY: That is correct. We examined what is i 13 currently available in diagnostic radiopharmacy. I-131 is the 14 sole nuclide commonly used that is capable of giving a large 15 radiation dose if improperly handled. That is why it was 4 16 singled out. There are no other radiopharmaceuticals in the 17 community hospitals' radiopharmacy that are nearly as i 18 radiotoxic. It does stand alone. 19 We do not perceive the quick introduction of other 20 similarly toxic diagnostic pharmaceuticals. They would have to 21 go through a lengthy Food and Drug Administration review before 22 they got out into the community hospitals, thus, the 23 differentiation. 24 COMMISSIONER BERNTHAL: What are we doing to try to 25 get a handle on the kind of problem that we had recently, where ________________-_a
i 57 I 1 a computer or the program of a computer or a misunderstanding l 2 of a program of a computer, whatever it was, led t.o a rather 1 3 serious event? 4 MR. BERNERO: This is the x-ray machine? The 5 software was bad. 6 COMMISSIONER BERNTHAL: I think so. I 7 MR. BERNERO: Gave serious doses for the number of 8 uses. 9 COMMISSIONER BERNTHAL: What is the follow-up on 10 that? What are we doing to prevent that sert of thing? 11 MR. McELROY: I think I just heard two different 12 cases laid out on the table. Are you referring to the high 13 energy x-ray machine that is managed by a computer and it gave 14 a very, very high radiation dose to the patient? 15 MR. BERNERO: It was on 60 Minutes about a mo' nth ago. 16 MR. McELROY: 20/20. 17 COMMISSIONER BERNTHAL: There was another case where 18 I think the technician assumed an element was not in the 19 software of the program when in fact it was. 20 MR. McELROY: That is correct. The proposed rule 21 requires that an independent second individual working in the l 22 hospital examine the complete computer print-out for the 1 23 patient, to assure that all of the correct numbers have been 24 entered into the computer program. 25 Secondly, the treatment configuration is out of the
1 58 1 normal range, which that particular case was, the patient was i 2 being treated at a much greater distance from the source than 3 normal. 4 The proposed regulation would require the physicist 5 to make a physical measurement of the dose rate in that unusual 1 l 6 configuration before treating the patient. l 7 COMMISSIONER BERNTHAL: There is some quality control 8 now being imposed at the front end on software, I would hope, 9 up stream and in training to make sure people understand what I 10 the software does. 11 MR. McELROY: The requirement to have a second 12 individual examine the data entry for the computer program is i 13 done as I mentioned. The computer programs are sufficiently 14 complex, to examine the validity of the program itself. I 15 COMMISSIONER BERNTHAL: Not in every hospital. 16 MR. McElROY: It simply can't be done. We would l 17 expect that any hospital be knowledgeable in the use of 18 equipment before it is provided for patient use. 19 COMMISSIONER BERNTHAL: I think I will stop for now. 20 I would like, however, maybe when Commissioner Carr is finished 21 with any questions he might have, I would still like to hear 22 your comments on this strange anomaly that is not our fault, 23 but it is an anomaly nevertheless in the regulatory world of isotopes side by side that are NRC regulated and some that 24 25 aren't, and I don't whether any of that makes sense. l l l
a 59 9 1 COMMISSIONER CARR: I would compliment you on the 2 briefing. I think it has been a very good briefing. I think 3 we are long overdue in this area, taking care of public health 4 and safety. Since I have been here, the odds of any particular 5 person in the country being radiated are much higher in this 6 area than any other area we look at. I think we are long 7 overdue in taking those steps which we can take to make sure it 8 is administered safely and done better. 9 If that means putting you on full time -- 10 [ Laughter.) 11 COMMISSIONER CARR: I would support that. 12 CHAIRMAN ZECH: Why don't you respond to Commissioner 13 Bernthal's question, please. 14 MR. BERNERO: This is a problem, this mixed 15 jurisdiction, and in a way, one of the things we are studying 16 is look at what happened in uranium mills. The whole purpose 17 of the regulation for uranium was as a source of fissile 18 material and yet, our regulation is focused, as is EPA's, on 19 the naturally occurring radioactivity and how the radon comes 20 out after the pile is there. 21 In this particular case, the mixture of jurisdiction, ( 22 whether it is a Cobalt-60 machine or an x-ray machine, I think 23 since our general approach is one of assuring that the medical 24 plan was followed, that the intended medical procedure was 25 properly applied, I think there is a very good sharing for a
60 1 benefit, that if you have quality assurance for procedures involving by-product material that we license, those quality 2 3 assurance procedures are very likely to cover the NARM that is 4 used in the same hospital by the same people in essentially the 5 same circumstances, different procedures. 6 It is my perception that the nightmare that would be 7 attendant with let's get NRC out and get authority to regulate 8 NARM and all of the attendant things, and I deliberately 9 brought up uranium milling and other things, where we would be 10 in a field far broader than we are now. 11 I don't see that the medical uses of NARM are so i 12 distinctly different and contrary to the medical uses of by-j l 13 product isotopes, that there would be a substantial need for i i 14 the NRC to go after authority of some sort. l l 15 COMMISSIONER BERNTHAL: You are saying that in effect 1 16 the jurisdiction on by-product materials rubs off on the other 17 materials? 18 MR. BERNERO: Yes; I think it does. 19 COMMISSIONER BERNTHAL: I want to make a distinction. 20 I certainly don't consider the distinction that is made between 21 machines and radiopharmaceuticals and radioactivity to be one - 22 - I think that is one that is easily maintained. I think we 23 can live with that very easily. It still seems to me that the 24 crazy situation, in the same cabinet, side by side, you have 25 radiopharmaceuticals, some of which we are responsible for,
61 1 others which I suppose in principle, if they were misadministered -- would we have any authority at all in terms 2 3 of enforcement? 4 MR. McELROY: We have no authority there. 5~ COMMISSIONER BERNTHAL: That is just bizarre. 6 MR. BERNERO: Yet, it will come up that you are 7 looking at a program and misadministration or mishandling of 8 NARM material can be.a contributing piece of information. Our i 9 regulation is on the application of by-products. 10 MR. PARLER: Certainly if there is a mixture in the 11 program and they are intertwined, we have jurisdiction there. 12 What you are talking about, as I understand it, if you have 13 NARM stuff sitting out, isolated, et cetera, do we have 14 anything to do with that. The answer is no, we don't have the l 15 authority. 16 COMMISSIONER CARR: You could if you wanted. It 17 j sounds like that is a place looking for a hcme. I 18 (Laughter.) l 19 MR. CUNNINGHAM: I'd like to make a few comments on 20 this, certainly from a technical standpoint, there isn't a 21 logical division between NARM and the isotopes we regulate. 22 The reason we regulate some and not the others stems from what 23 is behind the Atomic Energy Act, which we all know. 1 24 Having said that, I think there are two things.
- One,
{ 25 we ought to be looking at other ways to achieve the same goal
62 1 with respect to NARM other than regulating it, working with the 2 agreement states, the agreement states taking control of NARM. 3 I would also point out that this of course is 4 strictly, whether we regulate it or not, is an important policy 5 decision. The dimensions of the problem, I think, have been l 6 understated in many instances. 7 I heard a paper given at the NCRP annual meeting 8 about three years ago, in which it was stated there are 50,000 9 radium sources used in this country today. I don't know what 10 the division is in medicine or industry but I know a lot of 11 them are used in medicine. These sources are not manufactured 12 now. They were manufactured in the 1930s, 1940s and perhaps 13 the 1950s. We don't know who the users are. We don't know how I 14 the sources were constructed. We know that radium is very 15 radiotoxic. It gives off raf.on. We don't know anything about 16 the quality of the sources. 17 Assuming that we were to regulate NARM, these 18 sources, to the same extent we regulate other things, we have a 19 problem of defining criteria for radium sources, identifying 20 the users of radium sources, and then determining whether those 21 radium sources meet the criteria which we establish. That is a 22 big job. 23 One more example. Use of cyclotrons to produce NARM. 24 Some cyclotrons are used in the laboratory to make a short 25 lived radioisotope, as Norm mentioned. You irradiate your
9 63 1 target, you do some quick chemistry on it and you go to the 2 patient. It is very difficult, if you are going to regulate 3 that, to separate out the cyclotron from the radioisotope. You 4 are dealing with the same people who are going to operate the 5 cyclotron and do the hot chemistry and go to the patient. 6 There are other questions that come up. Years'ago, 1 7 not too many years ago, we looked at drug safety and efficacy 1 8 until such time that FDA was able to take that over. FDA's 9 rules, as you know, are tied to the Interstate Commerce Act. 10 There are questions as to whether or non we, tnder our 11 statutes, should then have to look at drug safety and efficacy 12 for the short lived radioisotopes. 13 Again, it is a very resource intensive problem. 14 COMMISSIONER BERNTHAL: I don't think we ought to 15 look the other way because we don't have the resources to 16 handle it. We look the other way right now because we don't 17 have the authority to deal with it. f 18 My question is, who does pay attention to these 19 radium sources and to the isotopes that are produced by 20 accelerators and other naturally occurring materials?- Does 21 anybody? 22 MR, CUNNINGHAM: The agreement states do. 23 COMMISSIONER BERNTHAL: Who else? 24 MR. THOMPSON: I think it is an'important issue, 25 Commissioner, and it is one that has fairly significant policy
9 64 1 implications. I think we recognize it is an issue with the 2 agreement states. I think we owe the Commission a better 3 detailed analysis of this issue. If I may, I'd like to commit 4 to make that type of analysis and recommend some options that 5 the Commission might want to consider. 6 CHAIRMAN ZECH: I'm glad you volunteered. I was i 7 about to say it seems like this is a E'tbject that we ought to 8 hear from the staff on, with recommendations. I agree that we 9 shouldn't just let it hang out there. In any case, it seems to 10 me it would be important enough for the staff to give us a 11 paper on with some recommendations. We will take it up as a 12 separate issue. 13 MR. PARLER: It would be an updating of work they I 14 have done in years past. It hhs been looked at before. 15 CHAIRMAN ZECH: Yes, I'm sure it has. It is an open 16 question. I think this commission would like to review it. If 17 the staff would do that, we would all appreciate it. 18 COMMISSIONER CARR: It is fair to say it is an issue 19 that has been looked at a lot and set aside every time. 20 COMMISSIONER BERNTHAL: I agree, Mr. Chairman. I 21 don't want to ruah in and suggest we want to seek new 22 regulatory turf here. I do remember in the Sequoyah event and in Oklahoma, we were speaking about regulatory vacuums and 23 24 things dropping through the cracks. Just saying that we don't 25 have the responsibility and forgetting about it is probably not
65 1 the responsible thing to do. 2 HR. PARLER: That area, we did look at. That is a 3 different type of problem. 4 COMMISSIONER BERNTHAL: Let's have a look at it. I 5 agree. 6 CHAIRMAN ZECH: Anything else from my fellow 7 Commissioners? i 8 [No response.] i 9 CHAIRMAN ZECH: Let me thank all of the staff for a 10 fine presentation this morning. I believe the presentation was 11 very helpful. I certainly agree with the other comments my 12 colleagues have made. You know my personal interest in this 13 matter, which I have emphasized to you before. We should be i 14 emphasizing this area of our responsibilities and bringing it l 15 to light more often than we do. 16 I hope we can give implementation to those desires of l 17 my colleagues and my desire to move out in this area, do more 18 than we have in the past. We expect you to follow through on 19 that and make sure that we do. 20 I would urge my fellow Commissioners to vote on SECY-21 87-29(a), if they haven't done so. I do think we need to move l 22 forward on that, to publish the rulemakings in the Federal 23 Register and move ahead. 24 I think from what we have heard today, I guess the 25 staff still supports those two proposals. Is that correct? . _. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ - _ ~
'66 1 MR.. TAYLOR: Yes, sir. 2 CHAIRMAN ZECH: We will hopefully. move out on that. 3 soon. If there are no other questions or comments from my 4 fellow Commissioners, we will stand adjourned. Thank you'very. 5 much. 6 (Whereupon, at 11:45 a.m., the meeting was 7 adj ourned.'] 8 9 10 11 12 13 14 ) 15 16 17 18 19 20 i 21 22 23 1 24 25 i
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1 1' 2 REPORTER'S CERTIFICATE 3 4 This is to certify that'the_ attached events of a 5 meeting of the U.S. Nuclear Regulatory Commission entitled: j 6 t 7 TITLE OF MEETING: Briefing on Medical Use of By-Product Ma terials and the Medical Misadministration Rule 8 PLACE OF MEETING: Washington, D.C. 9 DATE OF MEETING: Wednesday, July 29, 1987 i 10 4 11 were held as herein appears, and that this is the original 12 transcript thereof for the file of the Commission taken-(' 13 stenographically by me, thereafter reduced to typewriting by 14 me or under the direction of the court reporting company, and i 15 that the transcript is a true and accurate record of the 16 foregoing events. 17 18 4 [21M::cd ME.'./.?^/ Suzannef'.'Yop 19 20 21 22 Ann Riley & Associates, Ltd. 23 24 25 i
) D i t I MEDICAL USE i OF 1 i i L. BYPRODUCT M ATERI AL l ) I i l i I i i l l COMMISSION BRIEFING MEDICAL USE OF BVPRODUCT MATERIAL JUlv 29, 1987 I Current Uses and Trends Radiopharmaceuticals Diagnostic Devices Teletherapy Implant Therapy ] 1 Business Considerettons Industry Initiatives for Cuality NRC Initiatives for Quality Vnluntary Efforts 'l Misadministration Rulemakings 3 NRC's Medical Use Budget i __]
o Number of Clinical Cases Nationwide Each Year i Diagnostic Imaging 10 Million Test Tube 100 Million o Number of Licensees %RC I Hospitals 2000 4600 Private Practitioners 300 600 I There are about d000 hospitals in the United States. 2Medical regulations have historically not been a matter cf compatibility the Commissicn's recent directive to require all Agreement States to establish a misadministration reporting program set a precedent. Future quality assurance requirements will likely be a matter of compatibility. [ ? 1 I i ? 'f. i h'J 1 um V .....A
i $ CME COMMON #A0f09HARMACEUTfCALS Highest Whole Pharmaceutical Orcan Cesage M gan 00se endy Dose l 1 i Pertechnetate Brain 10 mci Thyroid. 1.3 rads 0.1 rads Heart 30 mci Thyroid 3.9 rads 0.3 rads j FYP Scee 10 mci tidneys - 1.4 rads 0.2 rads 44A Lungs 4 mci Lungs 1.0 rads 0.1 rads 31uceptste Kidneys 20 MCI Kidneys - 4.8 rads 0.2 rads Xenon gas Lungs 10 mci Lungs 0.1 rads 0.001 rads Teallium enloride Heart P mci Kidneys 2.4 rads 0.4 rads j l 1 w. = HEPATOLITE' a l Technetium Tc 99m Disofenin Kit For Diagncstic Use e The 'Best Universal Agent" for nepatooiliary imaging
- e First comtnerciaoy avadaois ICA agent-Discionin j
e Better overall performance 4. regat Fecatc 5.c f I' ' Wt accat c cact com en ee94t.c cuct \\ ( '^' 4 -(ytt c cuct i lIN, <or" mon moe cuct 'e3u o n g4,tc;4c::er _e-e Demonstrates oihary costructiore e Nionest target to cacagrouno ratio * '0"* Y' ' ' '" 'I e Sucenor hver tispf ake and washout '
- better inan cmer ICA agents e Effective at rugn omruoin ieweis.
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4 / i 11 .J IMPAC'i 0F COMPilTE05 ON CONVENTIONAL TMAGE Of$ PLAY ] i o Image Display Sequential imaging ) Composite motion pictures j l o image Enbencement Smoothing ) Packground subtractico c Quantitative Analysis Uptake /Escretion curves Organ uni formity l o Filina Inexpensive storage Cuick retrieval i i i { ( i i k 5 min to min is min 20 men 25 min 30 min s m\\p 3s mes ao mm 45 min 50 rivn 55 min 60 min list 00sel .2n0 00sel MEPATOUTE e Tecnnetium Tc39m Disotonin Kit-necarooniary stuoy Patient hvetory:46 year.cid temate with recurrent ^cnt smcahoe cominatration causea 10% evacuation of gais-wecer owaarant cam. cur 9cauy diagnosed as navmg etacoer contents. a second cose at 50 mmutes causec sv arome of cihary sysnines:a Chciecystograony and 15% evacuation nocmalis ac to S0*.i Pat e pain repucating her cunical symptoms on a'ent enceriencea , I s strasouno we o aormal 2mmestration of "#U'"**' 9 # #**'" Study mietprmation:Protact necatte uptane hitooed by viewaHZation Cf Common Gwet. gallDiadder and Out asinm Fellowup: Surgery comonstrated enronic chosecyst+s. 30 mmutes Ai masimum humg of gantuaccer 135 mmutest tonowmg enciecysiectomy patient was pan free s..
e ADVANCE $ IN IMAGING 1 o SPECT (lingle P,hoton f, mission C,omputed lomography) Improved visualization of complex aratomy e Higher dosage e o New radiepnermaceuticals !<onitrile compoinds for the bes t ) Amphetamine corpcunds for the brain c PET (Positron {missier Iomography) ] SeQuires on site cyclotron Low cose Uses natura117eoccurring Cercounds i g. ~ - i.. ' Ib. Mj.. j r. g Q q 1, ; u s 6 t s \\ g, l ~,e 1 (.f i- , y, l s 4.; g.. i ' f....',- .' 'i, f :) a y e< . o .;'We
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MON 0Ct0NAL ANTIBODIES o Disease specific Diagnosis Therapy o Beta-Gamma emitters todine 131 Rhenium 186. 188 Copper 67 Yttrium 90 o Alpha emitters l fdi 7 s l' t ..Ac.. -%. l J. la pw gs. V~ b [. i - f) n, p .j 7 i i j g,. j g,... C 'D-i j
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Applications Emergency room Professional and amatebr sports Emergency vehicles a i ~ T .S I
l l 1 I l BONE MINERAL ANALYZER o Osteoporosis affects 25% of post menopausal women o Falls are frecuently fatal within one year o No widely accepted treatment Calcium supplement Estronen t t'e r a py 1 - m usumummmu l w l Mh ff t { v s y \\;!s, u, - f .i .. m.. e, u i 9 9. " ,s t ( l g(.. h,..1 f# e -.. r + ,,.c - I i. S e . l t w. l o
TRENDS IN MEDICAL CARE o Untti 1950's Examination by physician at home or office Medication or surgery o Until 1970's " Tests" recuired hospitalization Mecication or surgery o Future Extensive battery of tests on an outpatient basis Specialized citnics and care factitties Holfstic medicine ". i.. ' . %# di h c,s.u care f "m ' b ) l{~*. Ou/p nenf ~ s". wW~ ua,yy p l\\ Nuclep N g* qe %, ame .,.....,.3..,*' 7}, i 7 ~.-_na, ,s ~ /
l 1 I l TE' ETHEp APV o Number of Clinical Cases each year nationwide X-ray therapy (not under hPC) 300,000 Cobalt therapy 100,000 o Number of hospitals or clinics providing teletherapy nationwide Cobalt only 280 X-ray only 350 Cobalt and X-ray 520 Total 1150 o Typical regimen: $000 rads as 200 rads / day for 25 days o Adjuvant therapy Chemotherapy Intreeperative application Monoclonal antibodies Hyperthermic l Hyperbaria HypoXit radiosensitiiers N as I l l i g l [- c u_. ,4 I E "l l e l . -3,c.. f t' I '2:. .n v el 3 = .s J + pg T: /, \\= j~.- h (. I 1 .I
J I e I l i l COMPutras IN TELETHERAPY CT (C, computerized tomography) s. ray scans to contour patient. o organs, tumor ) Treatment computer Define treatment volume 1 l Highlight healthy radiosensitive tiss6 Correct dose distributions for tissue inhomogeneities i Optim12e the treatment plan l l l i I I 1 l l l l I ?f.A ', ; ^ ' ^., i I cr. :.., a,,s,.s A--patient cent:ur ecs= s::t -s: :t e -.c::t -t t4: at:ca* =acatst r: t 3--tt#1cr volume c c:.t: C--spiral cord . e a..s.: -s a ...a a i.ce 0--53'1 1secese centour ! ' N.l.$ N $ M U E--cose reference ;oint N N.N /. n \\, %$dh-1 f Niend/t, "'a-g \\ h[j/.A{G&Q {y QT9,k,,,, '_\\ c.; /
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i l l 4 toACNYTH(RAPV o Sealed Sources Cesfum 137 Iridium 192 todine 125 o Typical regimen: 5000 rads in 3 days ,. ', ' *g.] %*&-2..'.;.. ^ ' y, i-7' l. ! ;'c 3 ~ ~ I 4: h 0EN*].**' ? p
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i I 1 IMPLANT DEV _ ICE _S l o Rigid catheter-tipped implant needle o Catheter for iridium implant 1 o Iridium seeds in nylon ribbon ) o Remote afterloading cesium source o Needle for iridium catheter o Platinum. plated gold seed l pr-1 l 1 , -.,;;,c. i9* l w ma p W.* Wir M / a / / / 6-
9 fv0LUT10N OF ME01 CINE As A TECHN0Le5f USING CANCED A$ AN F I A M Pt ".. o Diagnosis Methods: Physical exam. Screening program Cues: Personal habits. Income. Education. Race o Treatment Methods: Surgery. Radiation, Chemicals. Hormones Parameters for success: Type of cancer. Stage. Patient's age and general health ] o improvements in therapy by trial and error i i 1 ,) ,I. -{ a s (+ /,.' h[ h**. h 5"f .s ~. -% % SCIENTiflC 4 y ' M R111 C.G '* ~ '" '* ~ * ' --' ' '"u..,I, %. Q>e.., n ro w Q'N;Ql<~,,[,, %, The Treatment of Diseases to.t.. and the War against Cance
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BU$1NE$$ ?#(ND$ IN ME01 CAL CARE o DRG's (Diagnostic Related groups) o RAP DRG's (Radiologists. Anesthesiologists.
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o Unbilled professional physics support o Right to dispense o Insurance premiums I l Fairfax Hospital Devises Strategy to Keep Bottom Line Healthy j i g .mmmmme ~ -..- - me i FEEE:':!E Q I . Strong sales ban ._..... __..__ ~ .i . ~.. _ .:=.,= =.- ~== _...c_., _.~..._.i.: n:::.~. - - - ~,.. _._.,... ...n. m_. .. ~. oer. 5 ac tan. . ~. SeheaOM treudbring3 6 einptybecs r~M* y/,r*g.g 'M,,s noseia seau 8,mediesfor Hi " C*l d. 8 s- .~r..**,$~5 M"~;I ~5@,I@v,. c.. . ur43.d,,,b. ?@e;55 g e 2 e ."."L ~%";GE $5E 530 hik:.%~,? D R Smisj.5' W S 5 S!S9: 2 Ors file $3 ~ k hhh, fet theirinsuYBnce boc Ohsbfr$($hf'b$f a Ga&:' t%. . @.: w c.: :.::t a : x. &, :::2e. 2.=:: 5 N.5 2 5.i [ k IO:I.E.7.$::: $ $ h,n[n: m.- g n, ~ ~ n $:~c
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l l i INDUSTRY INITIATIVES o American College of Radiology (ACR; 20.000 physician members) 1 Patterns of Care Study ) l I o American Association of Physicists in Medicine (AAPM; 5,000 physicist members) Thirty scientific committees on cuality assurance topics o Society of Nucitar Medicine (ShM; 8,000 physician and 4,000
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Five cuality assurance committees l i i I 1 i i i 1 l l j: (. @ g 1 7,, s yeasuring the ct jh$kg medica 1 CaTC* *
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l i w fMOU$TRY INitfAffyES IN PHY$fCAL OUAlffV ASSURANCE o Independent pnysical measurements o Dosimetry intercomparison meetings o Visitations o $cientific committees l ) DO51 METRY SERVICES The Uruversity of Texas System trom Affg k g7 The Department of Radiation 4 D C
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NeC INFORMATION INITfAffvES UNDER WAY o Four articles in nationally-distributed newsletters since July 1986 o AE00 case study report on therapy misadministration distributed to all licensees o !even information notices since 1984 o Training film on preventing diact'ostic misadministration is being developed l NRC REPORTS ON MISADMINISTRATION jg UsAssOuscED SAFETY IN.SPECTIONS . n.i, - gfsTogy mas asuus gjoo diage "N #*"" T, cs Nusm ans.mory Ca.aaa** **C "** xcasamd T. cm.s son F""
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PHYSICIAN REMOVED FROM NRC LICENSE wrYe* *=eg face o,use;;ll=,,,,,,,, FOR FA!WRE TO REPORT MISADMINISTRATION ((***%,,((md r,w en a==. *** ,,, wMsc. g.e., g,'",',,"*,"*,,,,,',.'*. =se
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4 NRC RUlfMAK!NG IN!TIATIVf3 UNDER WAY o ANPR for Comprehensive Quality Assurance o NPR for Basic Quality Assurance MI [ 9... l i o topics in Comprehensive Quality Assurance ANPR Current standards Areas in need of improvement Methods of implementation o Topics in Basic Cudlity Assurance NPP Written prescriptions for therapy Resolution of discrepancies Physical measurement of brachytherapy sources Expanded teletherapy calibration Independent check of teletherapy output Independent cPeck of dose calculations Special requirements for todine use m
.O I NRC 800GFT FOR MEDICALUSE PROGRAM l o Program development o Licensing o inspection i , a ,3 ..,..,?, ,7%l, ..S'- tt ' ' ' ' * ' 'f' i FV87 FY88 FYF9 FY90 FY91 estimate estimate estimate estimate estimate $k FTE sk FTE $k F?E $k FTE Sk F?E Program Develcoment (H0) 0.8 200 4.2 4.0 4.0 4.0 Licensing (Regions) 7.3 7.6 6.9 7.3 7.3 Inspection (Regions) 12.5 17.T 12.2 12.:! 12.2 Over ceil ng 1000 2000 2000 -}}