ML20198K151
Text
r novemoer 24,-1993 The Honorable Dan Burton O--
United States H:use of R: pres:ntatives 7
j t
Washington, DC.20515
Dear Congressman Burton:
This.is 'in response to your letter to Dr. J. Piccone dated October '19,1995,
~
regarding your personal experience with the Carbon 14 breath test.- At this time we are evaluating your comments-along with over 300 public coments.
received on'the petition for rulemaking.
In your letter, you requested that serious consideration be given to allowing the test to be distributed to physicians without an NRC or Agreement State license.
Let me assure you that the NRC staff is seriously considering an exemption as one possible option to resolve the petition.
I recoqnize the benefits of this test, however, the NRC will need ta,,ei fuim a safety analysis and other evaluations to serve as a technical basis for resolution of the petition. Additionally, the staff recently discussed this issue with the-NRC's Advisory Committee on the Medical Uses of Isotopes and the committee unanimously supported the medical use of this product with minimal regulatory oversight.
At the same time, this product is undergoing a similar review by the Food and Drug Administration (FDA).. NRC intends to resolve this issue in a time frame consistent with the FDA approval, so that the product is made available as soon as practical.
Prior to completion of these reviews, the product could be ured by an NRC medical use licensee under a specific license provided the licenseA is a participant in the ongoing clinical trials associated with the FDA review'and approval process.
We expect to resolve this petition in 1996. Again, your comments on this matter are appreciated and will be considered as part of the resolution of the petition.
" NgNdisigned by Jamedages1MyTaylor Executive Director for Operations Distribution:
JEGlenn R/F HThompson Central Files JBlaha TSpels-CPaperiello, NMSS FCostanzi R8angart, SP ASummerour, RES 950323 PNorry, ADM JMilhoan SECY JPiconne, NHSS MBridgers, ED0 761 (Ref. EDO 34) j OCA DOCUMENT NAME:
9:\\ jones \\ burton 2
- See previous concurrence To receive a copy of this document. Indicate in the box "C" = copy without attachment / enclosure, "B" = copy with attachment / enclosure, "N" = No copy 0FFICE:
DRA/RPHEB DRA/RPHEB D/DRA/RES D/RES NAME:
TSZJones*?"
JGlenn/CTrottier*
BMorris*
DMorrison*
1 07 95 ees uene nnn 0FFICE:
EDO (
OCA i)/7 NAME:
JMTadoh DRathbYn ().LL DATE:
11/y/95-11/-
/95 0FFICIAL RECORD COPY
-gli 30 990109 CF CODE N0.: RES-3A-3 l
30-62FR32552 PDR CGE
.~
O of Og
[j 7pm /
y 4
UNITED STATES g
g j
NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 205$5-0001
%,***.* g#
November 17, 1995 MEMORANDUM TO:
Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Barry A. Siegel, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes
SUBJECT:
CERTIFICATION OF THE MINUTES OF THE OCTOBER 18 and 19, 1995 MEETING OF THE ADVISORY CON 1ITTEE ON THE MEDICAL USES OF ISOTOPES I hereby certify that, to the best of my knowledge and belief, the attached minutes for the meeting of the Advisory Connittee on the Medical Uses of Isotopes held on October 18 and 19, 1995, are an accurate record of the proceedings for that meeting.
A W$
Barry A. 51Fgel, M.D.', Chairman
!Ill?f1$
Date
Attachment:
Minutes - ACMUI Mtg.
10/18-19/95
(
W
y w
+.
l SUMARY MINUTES
-i
' ADVISORY.COMITTEE ON-THE MEDICAL USES OF ISOTOPES-October 18 and 19, 1995
+
i The Advisory Committee on the Medical Uses of Isotopes (ACMUI) held it's semiannual meeting on October 18 and_19 1995. A briefing book with-.
- background information for the issues under discussion was provided to-the s
ACMUI members in advance-of this meeting, and is available through the-Public Document' Room.
ACMUI members present at the meeting:
~
Barry A. Siegel, M.D., Chairman Daniel S. Berman,M.D.
Judith Brown:
Wil B. Nelp,. M.D.
Robert M.-Quillin, M.S.P.H., M.S.
Judith Anne Stitt, M.D.
Dennis P.-Swanson, M.S., B.C.N.P.
Louis K. Wagner, Ph.D.-
David Woodbury, M.D.. FDA-Also present:
Larry W. Camper, Branch Chief, Medical, Academic, & Commercial
'Use Safety Branch, Nuclear Regulatory Commission (NRC), (Designated Federal i
Official for the Committee); Donald A. Cool, Director, Division of Industrial and Medical Nuclear Safety, NRC; Josephine M. Piccone, Ph.D., Section-Leader, Medical' and Academic Section, NRC.
l Mr. Camper officially opened the meeting at 8:40 a.m. with general comments on the meeting and the function of the-ACMUI. Mr. Camper stated that he had reviewed the Committee members' financial and employment interests, and had
[
not identified any conflict of interest with items to be considered during the L
. meeting. Mr. Camper stated that any ACMUI member who becomes aware of a i-potent < a1 conflict of interest during the course of the meeting should so linform him or Dr. Siegel.
Dr. Cool addressed the ACMUI and commented on the agenda for the meeting. Ha acknowledged the ACMUI's work on the licensing modules, and described how the e
modules.will be incorporated within the overall structure of the revised p
regulatory guidance. He stated that the modules are associated with the
~
1arger staff efforts to re-engineer the licensing process.
One of the targeted areas for process re-engineering is the guidance system used by the
- licensees;and NRC staff. The staff has attempted to include a safety analysis of. the system in this process. Another area of particular current interest to NRC is:the emerging medical technology of intravascular brachytherapy, which raises questions regarding: supervision. training and experience requirements, L
Land other activities associated with its use. Additionally, the role of l medical consultants in medical incidents is an important topic of
. discussion.
Dr. Cool provided information regarding recent Incidents involving internal
.P-32 exposures of individuals at tino;1icensed facilities, and the publicity 7
,that these-events have received.; Dr._Siegel asked how the ACMUI could assist n
the NRC-in formulating its response to these incidents.
Implementing E
extremely stringent security measures in reaction to what appear, at least L
_ initially, to _be_ extremely unusual events, could be very disruptive to the E
conduct-of reseav.h and te the practice'of medicine.
Dr. Cool stated that the incident review teams-have~a relatively short time in which to complete their l
2
h..
ACMUI Minutes 2
October 18 and 19, 1995 reports to the Consission. Dr. Siegel suggested that the NRC consider having one or more members-of ACMUI seview the report and provide a perspective on activities within universities and medical institutions that might not be available within the NRC.
Mr. Camper then introduced the members of the ACMUI and the medical consultants who would be participating later in the meeting.
Dr. Siegel stated that the NRC had received three requests to provide public comments (or to provide written testimony) to the ACMUI.
He indicated that these comments would be addressed during the specific agenda items to which they applied.
ACMUI Review of Trainine and Experience Exemptions At the outset of this discussion, Dr. Siegel emphasized that this item was not intended to be a discussion of the broader issue of physician training and experience criteria. Sally Merchant, Medical, Academic, and Commercial Use Safety Branch, NRC, discussed procedures for ACMUI review of training and experience exemptions. This item was prompted, in part, by the ur. willingness of ACMUI at its May 1995 meeting to provide specific guidelinss that could be used by the staff in granting exemptions. Applicant physicians whose training and experience do not completely fulfill the requirements in. Part 3S must receive an. exemption in order to become authorized users. Section 35.19 provides for Commission review of exemption requests with the assistance of the ACMUI. The staff has developed a proposed procedure for handling these requests, which formalizes the process for ACMUI review.
This proposal specifies that requests for exemptions be submitted to the Office of Nuclear Material Safety and Safeguards (NMSS) in the form of a technical assistance request (TAR) from the region. The TAR must include all supporting documentation regarding the applicant's classroom instruction and laboratory training, and the duration of supervised work and clinical experience. The NMSS staff member assigned the TAR will prepare a 3ackage for the ACMUI, with a cover memorandum indicating the procedures for tie review and the time frame to complete the review (typically two weeks). ACMUI members would then conduct an independent review of the exemption request and forward their views to the NRC in writing.
For applications involving unusual or atypical uses, a conference call meeting of the ACMUI may be arranged to discuss the request.
This will require a notice of meeting and preparation of a transcript.
Minutes will also be prepared.
These conference calls and minutes will be conducted as closed sessions to protect the privacy of the individual whose application is being reviewed.
The following questions were posed to the ACMUI: tihich members will perform
'the reviews? Should the review be perfemd by all ACMUI members or only by those individuals with experience in tha. specialty for which the applicant is applying? Should groups be formed to serve for a specified period of time?
Mr. Camper pointed out that there will be an increase in the number of
c ACMUI-Minutes 3
October ~18 and 19, 1995 t
l exemption requests for authorized use for radionuclide imaging, because there
- has been a misinterpretation of the potential opportunity for concurrent
^
training to encompass both the 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience and the 4
500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of clinical-' experience. Dr. Siegel stated for the record that the c
whole issue of training and experience criteria needs to be reviewed 1
thoroughly by the NRC and by ACMUI, and that this could not be accomplished in the context of this more limited discussion. There were numerous comments on the current number of such exemption requests, to which Mr. Camper replied that the number is unknown, but is probably around 30-40 per year. Dr. Berman believes that there-could be as many as 200 requests per year if there is any flexibility in the 1200-hour total requirement specified in Section 35.920(b).
Dr. Siegel clarified that most of the cases the ACMUI had reviewed in the past 1'
involved applicants whose training was obtained unoer unusual circumstances or i
by unusual methods.
The ACMUI should not define allowable" exemptions to the
- number of hours specified by regulation so long as the current regulations remain in place. The NRC needs to focus on reviewing the requirements, and
-altering the rule. Additio.ially, the ACMUI should not discuss the training and experience criteria before the National Academy of Science report is j-released. Mr. Camper stated that Section 35.19 allows for consideration of exemptions, and such requests are not limited to the structure or form of the training. The NRC staff cannot decide a priori that it will not consider applicants with fewer hours of training than the number specified in the regulations. Dr. Siegel believes that it is not appropriate for the Commission to exercise judgment on a case-by-case basis when the fundamental principals need to be addressed. Dr. Berman stated that we cannot eliminate this conceptual issue from the discussion as the ACMUI needs to have some guidelines on what is acceptable. There was major discussion over these two approaches.
Manuel D. Cerqueira, M.D., F.A.C.C., representing the American College of Cardiology and the American Society of Nuclear Cardiology, provided public 3
comments on this issue (written statement included in Attachment 1).
L Dr..Cerqueira expressed a concern that there may be a potential conflict of interest in the ACMUI review of applications, that may arise over " turf" battles. Additionally, there is strong. support by the represented organizations that the review be conducted only by ACMUI members possessing board certification -in cardiology or nuclear medicine / radiology, i
-Dr. Siegel stated that review of a cardiologist's application for exemption by i
the ACMUI would mot occur withcut' involvement of'the cardiologist member of the ACMUI.
All reviews would be conducted as fairly as possible. Mr. Quillin -
-l stated that the review should not be limited to just those two groups of individuals specified by Dr. Cerqueira. Dr. Siegel then suggested that the reviews-be conducted by the ACMUI as a whole. The ACMUI could review as many i
applicaMons as possible during its regular biannual meetings. -Other reviews.
could be conducted by conference call statings. An independent review by members will deny the opportunity for full d'scussion of each application and for exchange of views among the Committee members. Conference call meetings f
5
ACMUI Minutes 4
October 18 and 19, 1995 would require a quorum. Dr. Siegel suggested that these procedures be put in place while the NRC is dealing with the overall issue of training ar.d experience criteria.
He proposed conducting an additional meeting, with extensive opportunity for public commentary, to create a set of exemptions for ACMUI to use until the final issue is resolved.
Further discussion emphasized that review by the ACMUI as a whole would be cumbersome. Dr. Siegel suggested that the Committee must choose one of three ways to approach the procedure:
- 1) ACMUI members conduct an independent paper review of exemption requests (as proposed by the staff), 2) the Committee, as a whole, reviews exemption requests, either in regular meetings or by telephone conference call meetings, or 3) two subcommittees be constituted to conduct the reviews, one relating to nuclear medicine, composed of Drs. Berman, Nelp Siegel, Wagner and Woodbury and Mssrs. Swanson and Quillin, and the second relating to radiation oncology, composed of Drs. Stitt and Flynn, the' new therapy medical physicist member, and Mr. Quillin.
Ms. Brown can serve on either or both subcommittees, as she desires.
A motion was made and seconded to review exemption requests by means of the two subcommittees defined above. The ACMUI unanimously passed the motion.
Undate on Rulemakinas Cheryl Trottier, Office of Nuclear Regulatory Research (RES) discussed various rulemakings and regulatory guidance.
1.
" Wrong Patient" Rule The final rule was published in the Federal Reaister on September 20, 1995.
The final rule clarified that the medical administration of radiation or ra,dioactive material to any individual,
- even an individual who was not supposed to receive a medical administration, is regulated by Part 35 rather than Part 20.
A question was raised to clarify whether the training requirements applied to family members and other members of the public who might be exposed to doses in excess of 100 mrem from patients containing radioactive material who are released in accordance Section 35.75. The staff responded that the more specific dose limits of Part 35 are applicable (rather than those in Part 20), and that, moreover, training was required by Part 20 for occupationally exposed individuals and not for members of the public.
NRC staff further indicated that Part 20 regulations will be modified by the pending patient release rule to state that exposures received from patients will be regulated by Part 35 requirements.
'2.-
Release of Patients The rule is currently under review by the Executive Director of Operations (EDO). The EDO had several concerns with the rule, which RES has
'4 ACMUI Minutes 5
October 18 and 19. 1995 e
addressed.. The ACMUI reviewed the current proposed rule language on October 18 and then addressed the draft Regulatory Guide (distributed at the meeting on October 18) as an added agenda item on the next day.- For purposes of clarity, these two agenda items are discussed together below.
WithregardtoproposedSection35.75(b),theACMUIhadconcernswiththe l
t phrase...information on the consequences of failure to follow the guidance" included in the instructions to be provided to patients who are breast-feeding an infant or child. The ACMUI believed that this is very strong, negative language given that there is no scientific basis to suggest that there would be " consequences of failure" to interrupt breast-feeding for the majority of administrations of-radioactive material (with the exception of I-131 sodium iodide). There was also concern that there is potential-for confusion and misinterpretation on the part of inspectors reviewing the instructions. There was a motion to change the last j
sentente-in this paragraph to read:-
"If the dose to a breast-feeding infant or child could exceed 1
'l mil 11 sievert (0.1 res), assuming there were no interruption of breast-feeding, the instructions shall also include guidance on, and the rationale for, the interruption or discontinuation of breast-feeding."
The ACMUI unanimously recommended this change.
Section'35.75(c) discusses record keeping requirements. Mr. Swanson questioned the meaning of' item I regarding determination of release acces,tability with the use of an "... activity other than the activity administered." -Mr. Camper stated that this was needed to account for other methods of determining suitability for release, such as with use of the biological or effective half-life. After further deliberation, the ACMUI initially indicated that this item was redundant with the remaining parts of the paragraph.
There was a unanimous recommendation on October 18, with one abstaining vote, to eliminate item 1.
However, during discussion of the Regulatory Guide'on October 19, the rationale for the original language bccame apparent both to the Committee and to the staff
-at the meeting. Accordingly, the ACMUI changed its recommendation to restore item I but to alter it to read:
...using-the retained activity rather:than the activity administered." This revised recommendation was
'made unanimously.
Item 2 under Section 35.75(c) states:
...using an occupancy factor-other than 0.25 at one meter."
It was noted, however, that.for an isotope with a half-life of less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, Table 1 in the regulatory guide authorizes release based on an occupancy factor of
.l.0. -Thus,-the rule would appear (inadvertently and inappropriately) to necessitate making a record whenever a patient given an isotope with a half-life of under-24 hours was released in accordance with the guidance in' Table 1. - The Committee unanimously recommended that the
^
g 4
l
' ACMUI< Minutes'
- 6 j
October.18 and 19.-1995
~
s rule language be modified to read "...using an occupancy factor less than 0.25 at one meter."
2Section 35.75(d) adds a rscord keeping requirement documenting that -
i instructions were provided to a' woman breast-feeding an infant or child
-if the dose could result in a total effective dose equivalent'to the l
infant or child exceeding 5 millisieverts (0.5 res).
The Committee unanimously recommended clarifying this further by modifying the rule language to state:
... instructions regarding interruption or 1
- discontinuation of breast-feeding...."
The ACMUI-recommended several changes to the regulatory guide.
Dr. Siegel reminded the staff that if any of the Committee's recommended changes were made in the rule. language, the conforming
- changes in the regulatory guide will-be necessary.
The specific recommendations to alter the regulatory guide are as follows:
a.:
Table I contains both byproduct and non-byproduct radionuclides.
Previously, the ACMUI recommended that a footnote be added to the table-stating that the information regarding the non-byproduct radionuclides is provided for licensee guidance, even though use of these radionuclides is not subject to regulation under the
-Atomic Energy Act. The same recommendation also pertains to Table 2.
'b.
A phrase should be added to Columns 1 and 2 in Table 1 to refer the reader to Column 3 in order to ascertain whether instructions are required. This is because once an individual determines that the patient may be released in accordance with the entry in Columns 1 or 2, the individual will not typically read further to realize that instructions may still be required.
c.
The staff should consider using more than one significant figure for the numerical values in Table 1.
-d.
0n page 9, Item 2.2, the guide states that the instructions should include a contact and-phone number.
The Committee questioned how compliance with this " recommendation" would be-inspected? If NRC believes this-is'important, it-should be added to the rule language.
It was noted that there is a discrepancy between how
= the licensed community views "should" statements in regulatory guides versus'NRC's. intent. Dr. Siegel suggested using the words,
'"it is recom-Med that instructSns include a contact and phone number."
- e.
On page 10, item 2.3, and Table 2 discuss release criteria and the need for instructions relating to breast-feeding. Dr. Siegel n
4 n
...-,4
-r
-,e,-r-w.
6.ar+e-,.,
- -r-e,-
,%~-.-r+-_
---,-w-.
.,3-e.
-.m-,
y e-
i ACHUI Minutes
.I L
-October 18 and 19,11995 expressed concern with the statement:
"In order to use this-table -
-it will. be necessary to determine the breast-feeding ' status of-1 i
women patients receiving some administrations." He stated that-this statement is vague, and asked how the NRC will inspect 1
against:it.- There wa= discussion about how the status of breast feeding is determined n clinical practice and for what procedures-
-it is really necessary.
i f.
The ACMUI recommended that more detailed references be provided to substantiate the values in Table 2.
These references will also help licensees who need to make their own calculations for a radiopharmaceutical not currently included in the Table. There are several radiopharmaceuticals and chemical forms that are not t
included. The Committee also recommended that all radiopharmaceuticals currently commiercially available in the United. States be listed in the table.
,i Dr. Siegel stated that this rule is important for several reasons:
it resolves the existing conflict between Part 35 and Part 20; it allowsithe release of patients with higher levels of activity than was possible heretofore; and thus has the potential to reduce the i
cost of care of patients treated with byproduct radionuclides.
The ACMUI unanimously agreed that the rule, with the recommended changes proposed by the Committee to the rule and to the regulatory guide should be acted upon by the staff, and forwarded to the Commission for approval as quickly as possible.
3.
Guidance for the Radiopharmacy Rule The ACMUI reviewad the guidance during its last meeting in May 1995.
Additional comments were incorporated into the guidance, and it should be published for a 180-day public comment
- period soon. There will be a one-day public workshop during the public conmient period.
4.
Pregnancy and Nursing This rule has been put on hold. The staff is waiting for data from the contractors. -- There will not be any decisions on this rule for at r
least six months, so discussion will be held for the next ACMUI
-meeting
'Dr. Siegel agreed.
Intravascular Bractytherapy Issues
-Jim Saith, Medical, Academic, and Commercial Use Safety Branch, NRC, discussed intravascular brachytherapy procedures. -He discussed the purpose of these procedures and the techniques currently under investigation. The 4
American Association ~ of Physicists in Medicine is organizing a task group Lto. assess this' new technology and to develop ' safety standards, c~
l N
L_
=e 1
l).,
H ACNUI' Minutes =
8 j
-October 18 and_-19, 1995 5
Intravascular. brachytherapy. has been studied in animal models and is. now being evaluated -in patients-after balloon:angicolasty of coronary and peripheral; artery stenosis, in an effort to prevent restenosis,;which
- occurs in 40-60% of-patients. !Various medications and mechanical methods have been used to prevent restenosis. Animal studies have shown.that-
- local. intraluminal irradiation of the angioplasty site (with doses of one to several-thousand rads) reduees the frequency of restenosis.. If this technique proves to be clinicady useful. it is estimated that the nus' ?r
,of procedures performed each year could be nearly 400,000. -Several man 9facturers have approached the NRC with plans to produce brachytherapy
. sources and afterloading devices for intravascular brachytherapy. The l
activity of the: sources ranges from microcuries for permanent seta-emitting
. radioactive stents to curies for high-dose-rate (HDR) treatments. This
- procedure-is not currently authorized under 10 CFR 35.400.
The American Society for Therapeutic Radiology and Oncology (ASTRO)
-provided a written statement to the Committee (Attachment 2), principally
. relating to the training and-experience needed to perform or supervise
!t intravascul e brachytherapy, i
Mr.-Camper steted that the training and experience requirements to perform brachytherapy are currently.quite extensive. Cardiologists will likely be primarily involved with this new procedure, but it is unlikely that most will be able to fulfill the current training and experience requirements.
Other members stated that intravascular brachytherapy could also involve
.interventional radiologists, vascular surgeons, and other physician specialists.
' Dr. - Siegel asked-about the extent of involvement of the Food and Drug Administration' (FDA), and specifically the Center for Devices and Radiological Health (CDRH), in the regulation of these devices at the current: stage of development. Mr. Smith stated that the NRC has had joint meetings with CDRH and three manufacturers.
FDA has:to approve the 4
facility's Institutional Review Board's review of the treatment before the facility can use the' procedure. Additionally, FDA currently does not
-consider intravascular brachytherapy to be generically included with other types of Intraluminal brachytherapy.
.s Drv Siegel stated that this,is an emerging technology that clearly seems to
^
' require the expertise of. cardiologists and/or other physicians-trained in vascular. system diseases,_with: thorough-knowledge of the use and complications of intravascular catheterization and with expertise in
= assessing the significance of vascular stenoses to-determine whether they
-need:to be-treated. There is also substantial ~ potential for problems related to radiation safety, for. both-HDR sources and pemanently implanted low-dose-rate sources, whic;rwarrants the expertise of a team of
' ' individuals (radiation oncologists medical physicists and others)
(normally involved.n brachytherapy. procedures in a radiation oncology
- department. Dr.-Siegel recommended that the NRC encourage this team N
- u.w.
~ ~..
a -.
ACMUI Minutes 9
October 18 and 19, 1995 approach when it evaluates license applications for this new technology.
Dr. Stitt commented that the questions the NkC has posed (see below) are a good starting point for discussion, and that the radiation safety considerations are the most important problems at this point.
She believes that the number of misadministrations will rise without a team approach to the use of such devices.
Steven Teague, with Nucletron Corporation, was provided the opportunity to make a public comment. He stated that the NRC should consider developing
-more realistic training and experience requirements for certain applications as it revises Part 35 over the next several years, rather than only requiring the training and experience needed for certification by professional boards. He objected to the narrow view, expressed in the written statement provided by ASTRO, that only radiation oncologists have the training and experience to use any sealed sources safely for brachytherapy. Additionally, the radiation safety issues regarding the technology can be addressed in the design and_ testing requirements prior to licensing of a device or source for use in humans.
There was additional discussion on who should be involved in these procedures and the amount of training and experience needed to perform
'these procedures. Dr. Siegel stressed once again that the NRC needs to re-evaluate physician training and experience criteria in their entirety.
Rather than starting with the training requirements for existing medical specialties and trying to make the NRC's criteria fit the models of those existing medical specialties, the NRC should evaluate what training is eally necessary for an individual to work safely with each of the various types of applications of byproduct material, irrespective of the physician's medical specialty.
NRC staff posed several questions for consideration by the ACMUI.
1.
Should the NRC alter its training and experience requirements to
_ allow cardiologists to be named as authorized users for this
- modality?
The ACMUI stated that it would be premature for NRC to alter its training and experience requirements to allow cardiologists to be named as authorized users for this modality. When the NRC and States start licensing use of these devices, a team approach, as outlined
.above, should be used to ensure that the technology develops properly.
2.
Should the microcurie-range parmanent implants require less training than the HOR treatments?
This answer to this question essentially reflects back to that of question 1.
Once it is clear what this procedure involves, the ACMUI
+
~,
-_. _ ~..
4.
ACMul Minutes:
10 October 18-and 19, 1995
' 1 anticipates that it will probably agree that-less training is needed d
for the safe use of these sources, i
o For permanently implanted beta-emitting coated stents, should the NRC j
-3.
use the same criteria-for misadministrations as migrated seeds for i
the coating thrt flakes off and irradiates other tissues?.
s The ACMUI-stated that the NRC should not be focusing on misadministrations-at this stage of development. -Mr. Swanson-stated t
that the NRC needs to coordinate with FDA as the licensing process >
develops to minimize the probability of misadministrations occurring.
4.
Should the NRC interpret " intraluminal" as lncluding "intravascular"?
ACMUI cannot make this interpretation during such a short discussion without more detailed evaluation of the treatment.
i 5.
Are there unique-radiation safety considerations associated with this modality? Where is the most likely location within the medical 7
institution for such implantation?
The ACMUI agreed that there are unique medical and radiation safety considerations with this modality that will warrant careful-consideration (e.g., how a dislodi,e1 HDR source would be removed from a coronary artery in a clinically unstable patient). The locations of. use in. an institution can' vary, but could include the catherization laboratory or radiation oncology suite. There will be associated shielding requirements. Dr. Berman emphasized that the Committee's discussion had largely focuses on the HDR sources, and that there will be much different radiation safety concerns with the use of low-dose-rate beta-emitting stents.
Petition for Rul
---kine:- - C-tion for C-rcial-Distribution for Is Fivs Test' na Chery1:Trottier, RES, discussed the petition for rulemaking submitted by Tri-Med Specialties. The petition ~is requesting that the Commission permit 1the commercial. distribution, possession, and human use of-capsules-containing one microcurie of C-14 urea-for in vivo diagnostic testing (for-L #ef fcobacter pylorf infection) either under general licenses or by
-exemption to the regulations. As the proposed use does not fall-under a-i=
categorical' exclusion, an'envirormental impact assessment has to be performed. - RES-is now in the process of getting a contractor to perform
' this' assessment.
The petition was noticed in the Federal Reaister, and about 300 comment lett:x: were received. The majority of the. comments were
~
in support of the petition.- Human;use of small quantities of byproduct z
radionuclides was previously authorized under general licensing provisions in Part 35,' which were subsequently eliminated because of disuse when-4 5
.- - -.m.-
s e
W. -ww- -. -
,-e-<--
+, - - -,.
- a E-p,-e 3-an
,a f
m
E,
~
]
+-
~-
ACMUI Minutes.--
11:
i October 18 and 19. 1995 t
.Part'.35 was revi wd in 1987.
d
-Representatives from Tri-Med Specialties submitted written statements
_(Attachment 3) and were_ available to answer questions.
There was a question as to how this procedure _would be. regulated by the FDA.- -The application is. currently with FDA for approval, anc the test (and the radioactive drug) would be prescribed by a physician, according to FDA and. state regulations governing the use of prescription drugs.
The ACMUI indicat94 that it endorsed the wide availability of this
- diagnostic test _and that the radioactive drug could be used under a general
-license or an exemption, whichever the NRC thought to be procedurally-
. easier.
Insnection Manual 1360 - Role of Medical Censultants Denni 3erig, Ph.D. -Operations Branch, NRC, discussed the Inspection Manual Chapter 1360 (IMC 1360) and the role of medical consultants.
c Management. Directive 8.10 (M 8.10): specifies the basic requirements for the NRC's Medical Event Assessment _ Program. MD 8.10 states that the group L.
reviewing a medical event must be composed of an NRC medical consultant, if l
warranted by the.. specific circumstances outlined in IMC 1360.
L Additionally, a physician consultant must be a member'of the group, if the
-event is a misadministration that resulted in an: overexposure to the patient. A scientific consultant, such as a medical physicist, may also L
need to be. included.- IMC 1360 establishes the policy and procedures for use of physician and scientific consultants as given.in 2 8.10.
Dr. Serig discussed the circumstances under which a medical (physician or scientific) consultant is required.. IMC 1360 specifies the right of a medical-consultant to decline to provide assistance, if, in the consultant's opinion, consultation is not warranted.- The consultant is then asked to provide a written statement that provides the basis for this decision. The Director-of the Division of Industrial-and Medical Nuclear Safety (IMNS)
'must then approve not using a consultant, on the basis of the consultant's written justification.
-Dr. Sarig' indicated that IMNS would like to eliminate the need for the Division _ Director's approval, in order to expedite the process.
Dr. Siegel-asked.how often the Division Director had overruled the opinion L
of the medical consultant. Dr.-Serig stated that this has never happened.
- Dr. Siegei raccordingly stated:that the.NRC is making the' process too L
complicated. The NRC should have. confidence in its consultants and their l
?professionalcopinions concerning-the need for a consultant.-
1 The consensus' of the ACMUI is that a consultant's declination to review an event:because medical consultation'.is unnecessary serves-as a de facto p
j L!
4
e.'4, 1
ACMI Minutes'-
12
_ October.18 and-19 1995-1
. consultation,'and that'further review by the Director of IMNS is not needed. ' Documentation can be by a--letter from;the consultant or via 1
completion of a form letter (to be prepared by the NRC).
The Committee-asked the NRC also to' consider whether a communication from the consultant by electronic mail _would be_ satisfactory.
o Hanual Chapter en Patient Follow-us Cathey Haney, Operations Branch NRC, discussed the Manual Chapter on-Patient Follow-up. m 8.LC-provides instructions for handling follow-up of~
medical events, and is used by the regions for follow-up of 4
i misadministrations.; In the case where there is an indication by the
- medical consultant that_ there could be long term medical effects, the.
' director of-the Office of Nuclear Material Safety and Safeguardr, in conjunction with the Executive Director for Operations, will make a' decision as to whether long term medical follow-up should be established.
This issue was discussed during the November 1994 ACMUI meeting. The NRC has followed one patient for a year, and has received monthly reports on L.
= the patient's status.- Based on this-case and the discussion with the ACMUI L
i in November 1994, the staff has put the manual chapter on hold for further evaluation after the NAS report is released.
Essert on 'a--
ittee Review of Draft Licenine "- ales Patricia Holahan, Ph.D., Medical Academic, and Commercial Use Safety
- Branch, NRC, discussed the draft licensing modules and the broad issues, applying to all of the modules, that were addressed at the subcommittee h
meetings-on-September 27, 28, and 29, 1995.- The NRC should ensure, whenever possible, that all modules are consistent with respect to
- overlapping issues such as training.
Information on authorized-user training requirements should be discussed within each module. The modules should-include a comprehensive list of the _ records and retention i
requirements:related to each module,'or consider such a list in the body of Regulatory Guide 10.8.
Standard license conditions ap>11 cable to each
- module should be included so that applicants can see wiat typical commitments will entall. Additionally,L conforming language, consistent with the pending patient release rule, needs to-be incorporated into
- several modules. - The subcommittee members-discussed the need to revise the P
appendices to' Regulatory Guide 10.8 when the main body ^.s amended, and the b'
modules are added. Many of these revisions will be incorporated as part of the Business' Process Re-engineering effoit. Modules affected by the Quality _ Management rule should include specific guidance addressing the c
~ rule.
- The specific issues addressed for-each module were' then presented to the Committee by staff and/or subcommittee members. There were no major issues 4:
requiring resolution by the full-- ACMUI.
p 4
e w-
-.*a e4 ww --
e se +'
A e
e------
eA-n+m
=--r-ir
-e-r--ia-aw-
_us-,i+.wm
.---wm+<-
--v-,,
-=
w --
+ --
=evi
-r'
=
sw
p ACMUI Minutes 13 --
j October 18'and.19,.1995-y Update en National Academy of Sciences Review c
The National-Academy of Science report was submitted to the NAS peer review
- process'on August 25, 1995.. Once.the report is. approved, Drs. Paperiello 4
and Rathbun w 11' be allowed-to. read the report at the NAS. They will receive a confidential copy 10 days later. Dr. Siegel stated that he had 3
3
-understood,_from a conversation with Kate-Louise Gottfried at NAS, that ACMUI might be able to. see the report as early as November. However, it appears that-the document will not be available until January 1996.
$TEP Device U
_ Sally Merchant, NRC, discussed the STEP device and provided a brief
> description of the purpose of the device. The device is a source container
- with-a shutter shield that is affixed to the rotating gantry of a multidetector scintillation camera.- The usual sources are Tc-99m, Co-57,
~
or Gd-153.
The device is used during acquisition of myocardial perfusion SPECT images.to-obtain tr nsmission measurements for attenuation correction.
The staff peformed a radiation safety analysis to L
-demenstrate that this device poses minimal risk to health and safety of workers and members of the public. The dsvice is not considered to be a calibration or reference source, and is not authorized-under the current
~
regulations..Therefore, specific licensees'of limited scope must seek, and be granted an exemption from the requirements of 10 CFR 35.49.
Specific i
licensees of broad scope, if approved for any byproduct material with r
atomic numbers 3 through 83, in any form, do not need an exemption.
Licensees were notified of the licensing requirements in the June / July 1995
' issue:of the "NMSS Licensee Newsletter." This issue also will-be addressed during the major revision of Part-35.
Mr. Swanson. asked why the manufacturers are not penalized for distributing
-the device =to-licensees that are not authorized to receive or possess the
- source, while;the NRC licensees could receive a severity level IV-violation.
Ms'. Merchant stated that current. inspection guidance is to
-exercise enforcement discretion and, in many cases, no enforcement action would be initiated. - If the licensee is using a device that has not-undergone:the required radiation safety review by either the NRC or an
- Agreement State,. then there could be'a severity level IV violation, Mr. Swanson believes that the problem still lies with the manufacturer that o
distributes.the device in violation of the regulations.
Mr.' camper stated-that each -case. should be looked at independently; if a licensee is aware
.that_ a ' device is.not authorized and is still using it, a violation may be
. in order. - The second problem is that the manufacturers are not necessarily l-
'NRC licensees. 'Dr. Siegel stated that this should be an opportunity to L
resolve concerns by working with FDA via 'the memorandum of understanding
?
between the NRC and the FDA.
l_
1.:
n
__.--,-._-___.4__--,__----_.u.--_
l
-l y.z_
~
l.
c.;
(
ACMUI Minutes --. --.
14 October 18 and:19,1995' L
. Dinea**sion of "*RE en *-- Factors Evaluatlans_gf
~
' h otherapy and Brachythsrppi
- +
Dennis Serig, Ph.D., NRC discussed the two NUREGS on human factors l
evaluations of-teletherapy 'and brachytherapy. Dr. Serig provided an overview ^of human factors and the goals in human facars evaluation.
Dr.'Serig discussed the strengths and weaknesses of each of the reports ~,
and provided a brief-suenary of the results.
Both studies identified human 3
factors problems, and identified process " defects" that could contribute to o
these problems.: Both studies prioritized human factors problems and identified a number of critical tasks, i.e. human factors problems likely-to lead to misadministrations or personnel-exposures. The reports identified alternatives for improving system performance of the critical.
tasks. LThe-reports. recommended several technical changes. The ACMUI took no action on this information ites.
't A kinirAtttive Issuas Several ~.inistrative issuer, were discussed. Those of most importance relate' to The vacant ACMUI positions for a radiation therapy '
F technologist / medical dosimetrist and a therapy medical physicist.
i An individual was selected for the radiation ~ therapy technologist / medical dosimetrist position, and approved by the Commission. The individual
_ subsequently withdrew her rcmination due to time constraints. The 6
- alternate candidate was notified and has accepted the nomination. Her nomination is currently in the process of Commission approval.
-The. staff received 26 nominations for the therapy medical physicist position. The screening panel established to review the nominations met on September:12,.1995, and ranked the-three top candidates. The staff is in
'the process of receiving Commission approval of the selected candidate.
Dr. Siegel' asked about the status of requesting nominations in the Federal 7
Renister for the nuclear radiologist position, which will be vacant at the completion of his term in September 1996..The-staff has prepared a Commission paper and is-awaiting Commission approval to call for nominations for_.this position. Dr; Siegel stated that it has taken far too
- long to-fill' the therapy medical physicist position and stressed that it'is critical to the work of the ACMUI that the nuclear radiologist position.not be-vacant.when his own' term expires.z.
The^ meeting adjourned at 12:13 p.m.
' Attachments: Written Statements-
-1.-
American College of Cardiology and lAmerican Society of Nuclear. Cardiology
-2.
.American Society of Therapeutic Radiology and Oncology
-3.
'Tri-Med Specialties, Inc.
o 4.
~;.,
-,_._.-.-m.
..-._-..c,__...-.---
.j
9 e
4 ATTACHMENT 1
. TESTIMONY OF THE AMERICAN COLLEGE OF CARDIOLOGY and THE AMERICAN SOCIETY OF NUCLEAR CARDIOLOGY ON TRAINING AND EXPERIENCE CRITERIA FOR AUTHORIZED USERS Presented to THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Wednesday, October 18,1995 Presented by:
Manuel D. Cerqueira, M.D., F.A.C.C.
-.~
-e, On behalf of the American College of Cardiology and the American Society of Nuclear i
iCardiology, I would like to thank Chairman Siegel and the rest of the Advisory Committee for giving me this opportunity to addre : the issue of training and experience criteria for authorized
[
users. The mission of both the College and ASNC is to foster optimal medical care for patients through professional education, development of standards and formulation of health policy.
- We are in complete agreement with the Committee shout the importance of radiation safety.
Stipulating a certain number of hours or months for training was developed as a vehicle to ensure an adequate level of training necessary for public health and safety. Our organizations have always
- maintained that a nuclear cardiologist is concemed only with the imaging of a single organ the heart, and maintaining a radiation risk to the patient that is as low as is reasonably possible.
9 We believe that the previously acceptable practice of allowing physicians to concurrently complete the required supervised clinical and work experience has worked well and is sufficient to assun: radiation safety in the practice of nuclear cardiology. To change this policy is potentially 1
arbitrary and restrictive. Furthermore, we have no knowledge of any egregious violations of.
radiation safety among nuclear cardiologists licensed under the current interpretation of the regulations.
m
. Our concern is that ACMUI reviewers may experience a conflict of interest in judging the fapplications. A discussion of" turf," as happened at the last ACMUI meeting, clearly demonstrates the validity of this concem.-
,e e.
p--.-
e m-
The College and ASNC strongly recommend that the Committee maintain the current method of licensing that recognizes concurrent traitJes e a viable and accepted standard. Ilowever,if the Committee decides to move forward with a review of each exemption case, we would support the review of nuclear cardiologist credentials being done only by individuals with board certification in both cardiology and nuclear medicine / radiology.
We look forward to the review of the current regulations by the National Academy of Sciences.
The A merican College of Cardiology and the American Society of Nuclear Cardiology also look forward to working with NRC staff and the Advisory Committee on the most effective training for our members that will insure the highest level of radiation safety.
Thank you, iT 63193.nw
e r-I i
1 I
ATTACHMENT 2 l
f 1
l l
8o=,
AMERICAN SOCIETY FOR THERAPEUTIC RADIOLOGY AND ONCOLOGY 1891 Preston White Drive, Roston, Ver0 inia 22091 (703) 648-8900 Comments of The American Society for Therapeutic Radiology and Oncology (ASTRO) on Intravascular Brachytherapy Meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI)
October 18-19,1995 The American Society for Therapeutic Radiology and Oncology (ASTRO) strongly believes that the current federal regulations which define training and experience of physicians to qualify them to use ionizing radiation sources for brachytherapy purposes should not be modified.
The application of brachytherapy is a radiation oncology procedure. Radiation oncologists have developed this area of practice, and brought it to the current level of technical sophistication, safety and efficacy. Radiation oncologists are the only physicians with training and expertise in the use of scaled radioactive sources, and in performing all brachytherapy procedures.
Intravascular brachytherapy is an experimental, invasive, therapeutic procedure involving significant doses of ionizing radiation (up to 20 Gy). Any procedure involving this level of radiation needs to be reviewed not only for the efficacy of the procedure itself, but also for its long term effects on normal tissue tolerance and possible carcinogenic effects on sensitive structures.
Radiation oncologists are unique in that their medical training and experiene requires them to learn how to perform brachytherppy procesfures and enables them to evaluate their patients for the short tertn and iond term effects of radiation on normal tissue. The radiation oncologist routinely makes professional judgments as to the appropriateness of utilizing therapeutic procedures involving icnizing radiation for specific patients.
The dosimetry associated with this procedure is not well established. Parameters to be defined include the radionuclide itself, the optimal dose and dose rate, and the radiation doses at various distances from the source. The radiation oncologist is the only medical specialist with the training and experience in analyzing dose distributions for both brachytherapy and external beam procedures.
l l
l
\\
Perhaps most importantly, there are si;;nificant radiation safety issues negarding this procedure relating to the patient, the staff, and the general public. Use of radiation sources requires physicians to work in concert with non physician support to effectively address issues of radiation safety. This support is provided by the medical physidst and the radiation therapist, among others. Radiation oncologists have the appropriate experience in en sting and directing such a team.
With respect to intravascular brachytherapy, radiation safety concerns include source receipt, source handling, source calibration, radiation exposure levels, and quality assurance on the treatment device. The radiation oncologist routinely makes judgments that all safety and technical standards have been met prior to initiation of treatment. We believe that the training and experience of the radiation oncologist is imperative in assuring that the interests of the patient, other health care pro fiders, and the public are well served.
This procedure is a therapeutic one, which involves significant doses of radiation to the patient. Significant doses may be delivered to other locations besides the vessel at risk, depending upon the source and the method chesen to deliver the radiation, it is not appropriate to compare this procedure to diagnostic procedures, such as nuclear cardiology, which involve significantly less risk to the patient.
ASTRO recognizes that in certain instances, established good clinical practice requires multi-specialty involvement. For example, in the management of gynecologic cancers, there is routine collaboration of the radiation oncologist and the gynecologic oncologist in performing many brachytherapy procedures.
However, the radiation oncologist is the primary specialist responsible for this treatment and for radiction safety. The same is true for brain implants (with the neurosurgeon), cedobronchial brachytherapy (with a pulmonary physician) and many other circumstances, it is only through this type of collaboraMon that we are able to maintain the current excellent record of radiation safety in these and many other forms of treatment.
The current system of requiring the physician authorized user to meet well-defined trainmg and experience requirements lias serded tlic patient, the health care industry, and the general public well. For established brachytherapy procedures, the standard of practice requires years of training and experience for a abysician to become an authorized user. We see no rationale or argument to iower these standards, nor do we see how it would serve the good of the patient or the public. ASTRO strongly urges you to carefully consider the potentially serious ramifications of authorizing physicians who have no formal training in the delivery of radiation to use this modality. We strongly recommend that the current federal regulations not be modified.
Thank you for the opportunity to comment on this important issue.
A 4
8 e
v h
6 ATTACHMENT 3
- +
u m comt.
Public statement concerning docket PRM 3512 on the agenda of the Advisory Committee for the Medical Use of isotopes Meeting, October 18,1995.
From: Matthew J. Combs, Ph.D. *ME Scientific Coordinator of "C Projects Tri Med Specialties, Inc.
1500 Avon St. Extd.
Chariottesville, VA 22902 This is a statement in support of ti e petition for rulemaking, docket PRM 3512 submitted by Tri-Med Specialties, Inc. The purpose of the petition is to allow an exemption or generallicense for possession and use of the i pCl "C urea breath test for the detection of H pylod.
The test has been used throughout the world since 1987 (1,2) with administered doses primarily ranging from 5 to 10 pCl and the radioactivity being in a liquid form. Tri Med Specialties has developed a 1 pCl breath test with the radioisotope in a gelatin capsule. This modification allows for a convenient, safe, and easy to use form for delivering the radiopharmaceutical to the patient.
The test is similar to in vitro diagnostics under generallicense The "C urea breath test is a diagnostic test using minute amounts of "C urea like other diagnostic tests under generallicense in 10CFR 31.11. The differences between this test and many of the others under general license is that 1) less radioactive material (1 pCl) is used in our test unlike the 210 pCl found in other tests and 2) our test is an in vivo diagnostic test instead of an k1 v#ro test.
Safe and easy handling The "C-urea in the PYlest' is in a dry solid form inside a gelatin capsule unlike many other tests using liquid in glar,s vlais (1,2), it is not likely to come out of the capsule since the patient simply ingests the capsule like any other pill Over 1,500 of these tests have been used without incident at 42 sites.
Disposal The disposal of the PYtest' constituents is below limits already set. The "C is excreted by the patient through urine and breath (3.4,5). Patient excreta are not subject to restriction (10CFR 20.2003 b). The "CO collected in balloons is suitable for shipping without restriction (< 2 nCl/g, 2
10 CFR 71.10). The scintillation media used in the test can be disposed of without regard to its d
radioactivity (10CFR 20.2005) since typical concentrations are on the order of 2x10 pCL/g compared to the limit of 0.05 pCL/g.
LYogdocsVvctceneep doc,1o/17!95 a
untetew comte Benefits of the test There is l#tle question that this test is beneficial 19 peptic ulcer patients since it is one of the most l
accurate means of detecting H pyfod (6). Lives can be improved or even saved through detodion and treatment of Hpyfodin patients suffering ulcer disease and gastritis. This test can also be used to prevent cancer by diagnosing H pylorf which is associated with gastric cancer locluding MALT lymphoma (6). The cancer preventing benefit far outweighs the miniscule risk associated with the test.
Minimal or no risks to the patient The radiation dose associated with this test has been examined in great detail. Published reports (3,4,5) examining the excretion and dosimetry of ingested "C ures indicate that almost all of the radioisotope is rapidly excreted in the breath and urine of the patient. The maximum organ dose associated with the test is 0.3 mrem which is negligible when compared to annual background radiation doses of 80-200 mrem. The lifetime risk factor asociated with the test using the maximum dose of 0.3 mrem is 1.5 x 10 Although we are requesting a simpler NRC licensing, this drug will still be regulated by the FDA and prescribed by physicians, ensuring safe and proper use of the test.
Comparison with other sources of "C The amount of radioactivity generated from use of this test is minute compared with other sources of "C such as natural production, nuclear power, and weapons testing (7).
Prohibitive nature of 38,100 licensing Currently, a physician wishing to perform this test would need to be licensed under 10CFR 35.100. The uros breath test is the best non-invasive method available for detection of H.pylod (6). Specific licensing requirements wiil make the test more difficult and costly to perform since this unique and simple test willlikely be the only radiolabeled in vivo kit used by the physician, This licensing modification will give more physicians access to the test, allowing them to better serve their patients by reducing costs and providing more accurate diagnosis than other means of testing for H.pylod.
Summary We hereby encourage your recommendation for exemption or generallicensits *.his test based on the fads that this is a safe, effective test with a positive impact on the public by helping eradicate peptic ulcer disease and prevent cancer tweensosweeceroem see, atwas :
3
i Matthm Combs I
O References
(
- 1. Bell GD, Weil J. Harrison G, Morden A Jones PH et al. "C-urea breath analysis, a non-i invasive test for Campylobader pylort in the stomach. Lancet, June 13,1987.
- 2. Marshall BJ, surveyor 1. "C ures breath test for the diagnosis of Campylobacter pylori associated gastritis. J NucIMed 1988;29:11 16.
Nuct Med 1993:34:021825.
- 4. Munster DJ, Chapman BA, Burt MJ, Dobbs BR, Allanfyce RA, Bagshaw PF, Trou9hton WD, Cook HB. The fate of ingested "C urea in the ures breath test for Hescobacterpylorf infection.
ScandJ Gastroenterol1993 28:661-666.
- 5. Combs MJ, Stubbs JB, Buck DA, Marshall BJ. Dosimetry and reproducibility of a capsule-based C.14 uros breath test.- J Nuct Med 1995:36:98P (abstract).
- 6. NIH Concensus Development panel on Helicobacter pylort in peptic ulcer disease.
Helicobacter pylori in peptic ulcer disease. JAMA 1994;272:65-69.
- 7. National Council on Radiation Protection and Measurements. Carbon 14 in the environment.
Report 81 May 1985.
i 4
W P
g
A r
t Public statement concerning docket PRM 35-12 on the agenda of the Advisory Committee for the Medical Use of isotopes Meeting, October 18,1995.
From: Susie R. IlofTman R.N. IISN Product Development Coordinator Tri Med Specialties,Inc.
1500 Avon Street Extended Charlottesville, Virginia 22902 This is a statement in support of the petition for rulemaking, docket PRM 3512 submitted by Tri-Med Specialties, Inc. The purpose of the petition is to allow an exemption or general license for possession and use of the i pCi C urca breath test for the detection of11.
pylori.
I am Susic f loffman, the product development coordinator with Tri-Med Specialties, the company submitting this petition. I am a registered nurse and have worked with Dr. Marshall, 6 developer of this test for the last 8 years. Over that time we have conducted the clinical belopment work on this test. The clinical trials have now been completed and the NDA application is in front of the FDA for their review. The test was developed to provide a non.
invasive means of diagnosing a bacteria named llelicobacter pylori. This bacteria has been demonstrated to cause ulcers and gastric cancer. The only other means of diagnosing current infection is via an endoscopy. This is an invasive procedure usually requiring sedation which generates some risk to the patient. At the time of the endoscopy a biopsy is takch to test for the bacteria. This is an expensive and time-consuming procedure.
The PYtest or "C-urea breath test involves the patient ingesting a gelatin capsule containing i pCi ofC urea. Ten minutes later the patient blows up a mylar balloon. This completes the administration of the test. (Demonstrate contents of the kit and blowing up the balloon.) The balloon is then taken to a laboratory where the breath sample is removed from the balloon and collected into a scintillation vial containing a collection fluid which traps the CO -
2 The sample is then counted in a scintillation counter for approximately 5 minutes. The test gives a sensitivity and specificity of 95%.
During development work on the test, it was administered to approximately 2000 patients in research trials at the University of Virginia. The current version of the test involving the C-urea encapsulated in a gelat n capsule has been administered to approximately 1700 patients i
during the last two years. There have been no reports of adverse events which were felt to be related to the test. The fact that the "C urea is encapsulated in a gelatin capsule maves the possibility of any spillage very unlikely. There are presently 42 sites using the test in research protocols. Because the test is very simple to perform and analyze, it is very easy to train penonnel in its use.
The patient response to this test has been phenomenal. While administering the test over the last 8 years, I have had patients come from as far away as Alaska and llawaii to the E Vmofkeintuus. doc,10/1W95 l
J University of Virginia to obtain this test. 'lhey greatly appreciate another option to the expense and discomfort of an endoscopy. Last February this petition was printed in the Federal Register for public comment. I have with me over 300 replies sent to the NRC, Only 2 of these responses were against the petition. Many of the responses came from fonner patients who had to travel long distances to obtain the test. They felt strongly enough about this issue to send a letter to the NRC urging you to approve this petition.
Tri Med Specialties is committed to bringing a quality product to market. The added time and expense of obtaining a materials license from the NRC will unfortunately make this test unobtainable to some patients in rural areas of the country. We have proven the pYtest is a simple, safe and accurate test which is in demand from the patient population. We urge you to j
grant approval of our petition so that all patients will have this option.
Approximately 4 minutes.
I r
- Ehsofrwe\\nresus doc,10/17MS 2
..