ML20248F393
| ML20248F393 | |
| Person / Time | |
|---|---|
| Site: | 07002908 |
| Issue date: | 09/27/1989 |
| From: | Riedlinger B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | |
| Shared Package | |
| ML20248F396 | List: |
| References | |
| 71005, NUDOCS 8910090010 | |
| Download: ML20248F393 (8) | |
Text
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2 PAGE OF PAGES l
p 40 U.S. NUCLEAR REOULATcRY COMMISSION Amendment No. 3
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MATERIALS LICENSE l
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act cf 1974 (Public Law 93-438 Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations l
I heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, I
scurce, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to I
deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This I
license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954. as amended, and is l
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any l
conditions specified below.
i l
- *"S**
In accordance with letter I
dated June 2, 1989 1
1.
Veterans Adm'nistration Medical Center
- 3. License number SNM-1859 is amended in l
its entirety to read as follow 4 I
I 2.
3350 La Jolla Village Drive O
b I
San Diego, California 92161*h,d '
4'. ExpIrntianliate September 30, 1994
. \\(f
- 5. Docket or N
0-02908 I
Reference No.
l I
- 6. Byproduct, source, and/or h
- 7. Chemical and/or physical (B. Maximum amount that licensee I
form (may possess at any one time (q
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under this license QI
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Plutonium (Princ'C I
l ipal A.jSealedSources Wj A.p"l.05 grams A.
j bo (5 individual Ea'/
radionuclides Pu-238)
B, b ' '% TN '
i c sources not to l
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$.. t > qfg 7 [ 'f J. y y exceed 210 I
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c = milligrams each).
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Authorized use g
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ImplantationInhumans"asa<componentof,MedtronicModel9000nuclearpowered V
cardiac pacemakirs for clinical devaluation"purposesQ I
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I 40NDITIONS p
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Licensed material shall be used only'at/V.A.IMedical Center, 3350 LaJolla l
10.
l Village Drive, San Diego, California.
I I
- 11. The physician responsible for implantation, follow-up, explanation, and return l
of nuclear powered pacemakers to the manufacturer for proper disposal is Ralph Shabetai, M.D.
i I
I
- 12. The Radiation Safety Officer for the activities authori2ed by this license is l
I John W. Verba, Ph.D.
l
- 13. The specified possession limit includes all licensed material possessed by the l
licensee under this license whether in storage, implanted in patients or l
I otherwise in use.
1 I
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8910090010 090927 l
REG 5 LIC!y0 l
SNM-1Bb9 PDR L___--______________ __ _ _.____ _ ____ _ _ _ _ m
p-m----...-------------------.-:---.mmm----m-.--...u..g U.S.NUCLEA3 REGULATORY COMMISSION PAGE 7
or
? PAGES l
NIC Fum 3b*.A
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L6 cense number l
MATERIALS LICENSE 5NM-}859 h[
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SUPPLEMENTARY SHEET 070-02908
[
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Amendment No. 3 1.
l l
l l
CONDITIONS I
l (continued)
\\
I The licensee shall not receive or transfer in any single transaction,1 gram or l
14.
more of plutonium 238 contained in nuclear powered pacemakers without notifying l
the Division of Safeguards, U. S. Nuclear Regulatory Commission, Washington, D.
C. 20555, and, in addition, completing and distributing Form NRC-741 as required i
i I
by Section 70.54 of 10 CFR Part 70.nE RFo4.
I The licensee shall report to the Nuclear Materials, Safety and Safeguerds Branch, N
15.
U. S. Nuclear Regulatoiy Commission,1450 Maria Lane,tSuite 210; Walnut Creek, li California 94596, within,24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear pacemaker patient, and'any adverse reaction and/or malfun6 tion involving a pacemaker system, including the leads.
A written report siving detail of the i
g adverse reaction and/or malfunction shall be submitted within 30 days.
N The licensee shall portko NuclearMateriaisS'afetyan Safeguards Branch, 16.
U. S. Nuclear Regulatory Commission,1450 Maria lane, Suite 210; Walnut Creek, I
California 94596c]within 10 day'sj, loss of contact ~with a nucle l
7, (n@%./-
(>g '
h patient.
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The licensee sha117 continue patient # follow-up and~ replacement-procedures for I
17.
the nuclear pacemaker during the life of!the patient; and procedures for l
recovery and authorized disposal ofothehiuclear. pacemaker bydeturn to the
~
i manufacturer shall"be followed uponitheideath'of_the patiento.
v o.
mms Except as specifica11y',provided hthdrw[sI b'y'thisflicense,[the licensee shall g
N 18.
possessanduselicensedmaterialdescribe~dinItems6(7,and8ofthis 5
licenseinaccordancewith~ statements,representationsiandprocedures l
contained in letter dated June 21, 1973 signed by. Turner Camp, M.D., Director y
andRichardA.Carleton,M.D.;hetterdatedSeptember 27, 1973 signed by Turner
(
R Camp, M.D., Director all submitted-in supportt of License Number SNM-1425; N
letter dated April 23, 1974 from Robert W. Brawley, M.D., Director, Ralph Shabetal, M.D. and James Smith, M.D. letter dated December 14, 1981 signed by l
John W. Detzler, Director, and Ralph Shabetai, M.D.; and letter dated July 23, 1984, signed by Normal Hensley; and letter dated June 2, 1989, signed by Ralph y
Shabetal, M.D. and Thomas Trujillo, Medical Center Director.
The Nuclear y
l Regulatory Commission's regulations shall govern the licensee's statements in 4
applications or letters, unless the statements are more restrictive than the 8
l regulations.
l FOR THE U.S. NUCLEAR REGULATORY COMMISSION 4
Date By d R Z7. N /
9 Betti A'. Riedifnger//
l Health Physicist (Heensing)
Nuclear Materials Safety Section
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Region V
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huysaammesas-w murmwxmm wwwemwmesar --ar m =w - --ammmmmsura
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f0 l]M S1W 1l lpm 6 WW66 45D3 SEP 2 71989 Docket No. :
070-02908 License No.:.SNM-1859 Control No.:
71005 Veterans Administration Medical Center 3350 La Jolla Village Drive San Diego, California 92161 Attention:- ThomasTrujillo Medical Center j-Gentlemen:
L Enclosed is the NRC license, renewal which you requested.
Please review the enclosed document carefully and be sure that'you understand all conditions.
If there are any errors or questions, please notify us so that we can provide appropriate corrections and answers.
Any future correspondence relating to your license should specifically reference your license and docket numbers to expedite your inquiry.
Sincerely, j
or@/a/ Signd 1
Beth A. Riedlinger Health Physicist (Licensing)
Nuclear Materials Safety Section
Enclosure:
Attachment A (original)
Amendment No. 3 to License No. SNM-1859 (original and copy) i4 l
i
'j
)
/
ISO 9 Distribution bec w/ original concurrence ~ copy of license, and original correspondence:
License docket folder (Peggy) bec w/ copy of license and correspondence:
Inspection folder (Peggy) bec w/ copy of license:
Reading file (Frances) bec w/ correspondence and 2 copies of license:
Maurice Messier, LFMB, MNBB 4503 license only:
State of California y'
4t4%
' [ 6.5/
F.B e
J.Mont gome B.RM'*fer 1
REQUEST 00Py ] REQUEy COPY ] RfQUEST COPY ] REQUEST GQfY ] REQUEST COPY ]
YES / N0/ ] YES f NO
] VES
/ NO
] YES / /h0) ) YES / NO
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"6, i
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r M:dic:1 C:nt:r 3350 La J:lli Villige Drivs Sin Diego CA 92161 M Veterans
%E# Administration June 29, 1989 in Reply Refer To: 664/151 Ms. Beth Riedlinger U.S. Nuclear Regulatory Commission Region V c_
1450 Maria Lane, Suite 210 c:.
]$
Walnut Creek, CA 94596 c, = 0
Dear Ms. Riedlinger:
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~m I am enclosing a copy of the letter of request'for renewal.of <.C License No. SNM1859 signed by the Medical Center Director,And e
Chief of Cardiology Section which was sent to you throughcn Department-of Veterans Affairs Central Office.
A copy of the cover letter to Ms. Malaskiewicz is also enclosed.
It was our intention to give these to you personnaly when you where here on June 22nd.
Unfortunately, I was unaware that you had completed your visit, and the file was still on my desk.
I hope you will understand the oversight.
Sincerely,
/
0%<
o MIMI DEIANEY Secretary Radiation Safety Office l
Enclosures:
2
" America is #1-Thanks to our Veterans" Ql
w T
JUN 2d W l
. Docket'No..:' -070-02908 License No.:. SNM-1859 Control No.:- 71005 Veterans % administration Medical Center 3350 La Jolla Village Drive 6,
LSan Diego, California'92161
. Attention:' Thomas Trujillo~
- Medical Center:
SUBJECT:
LICENSE RENEWAL-APPLICATION Gentlemen:
t.
p This is to acknowledge receipt of your application for renewal of the material (s) license identified above. Your application is deemed timely filed, and accordingly, the license will not expire until final action has been.taken by this office.
'Any correspondence regarding this renewal application should reference the control number specified above and your license number.
-1 f
Sinc are
)
V(
Frances Browne Licensing Assistant Nuclear Materials Safety Section i
l
.,....,.,i.,...
=.
Distribution bec:
License docket folder (original concurrence) (Peggy)
Inspection folder (Peggy)
Reading file (Frances)
Ma rice Messier, LFMB, MNBB 4503 F.Brownb
(() Y V$n REQUEST OP 1
(/j.E YES / NO l
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,e
.,n pl) i jj:m gii l
e
Medic 1 C:nt:r 3350 La Jolla Villiga Drivs San Dirgo CA 92161 M Veterans
..ui v
%G# Administration June 7, 1989
.!22
^9: 35 in Reply Refer To: 664/151
.Ms. Helen Malaskiewicz Program Analysis Department of Veterans Affairs 810 Vermont Ave., N.W.
Washington, D.C.
20420
Dear Ms. Malaskiewicz:
I am enclosing the
- original, signed letter to the Nuclear Regulatory Commission for application for renewal of our license to implant or follow patients with plutonium-powered pacemakers and a copy for your records.
It is my understanding that you will process this through Dr. Fletcher and forward the original letter to the Nuclear Regulatory Commission's Licensing Branch in Walnut Creek, California.
~
Thank you for your cooperation and assistance.
Sincerely, IbnDC 4
?
MIMI DELANEY Secretary Tg Radiation Safety Office f
kfu!/h gM ' M - 4
Enclosures:
2 e'
/
t/m/n l
JAMES W. FLETCHER, M.D.
Director, Nuclear Medicine Service (115)
Veterans Administration Washington, DC 20420
,;'. "/,I t r,,
s.
7 /00 5
" America is #1-Thanks to our Veterans"
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