ML20210G988
| ML20210G988 | |
| Person / Time | |
|---|---|
| Site: | 07002224 |
| Issue date: | 10/06/1986 |
| From: | Whiston P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20210G990 | List: |
| References | |
| NUDOCS 8702110362 | |
| Download: ML20210G988 (2) | |
Text
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O l NRC Form 374 1
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U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE Amendment No. 02 i
t Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 -438), and Title 10, g
Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y
g heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p
1 source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to l
N deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This N
N license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of l';54, as amended, and is I
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any g
conditions specified below.
In accordance with letter dated l
March 26, 1986 il a
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1.
Rush-Presbyterian-St. Lukes Medical
- 3. License number SNM-1620 is amended in g
Center its entirety to read as follows:
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Radiation Safety Office I
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,4. Eipiration date
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1753 West Congress Parkway Gf, J
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9 Chicago, IL 60612 October 31, 1991 ji s
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- 5. Docket or
^1 070-02224 E
g s e Reference No.
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- 6. Byproduct, source, and/or 4
- 7. Chemical and/or physical V 8., Maximum amount that licensee i
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- ymay possess at any one time E
special nuclear material form b
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,u'nder this license c
/r A. Plutonium (Principhlf
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n A. 9.0 grams jR (40 individual l
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O sources not to radionuclide Pu-238) l qc-g 3Q ;s$t, y w d exceed 225 g
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- 9. Authorized Use
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Implantation in humans as'a' component [ m h J 'd ca:rdiac pacemakersl s
ofenuclear.-powere A.
y for clinical evaluation purposes, 6 iW 'N Y
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CONDITIONS
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N 10.
Licensed material shall be'used<only at the licensees facilities located at g
Rush-Presbyterian-St. Lukes Medi~ cal 4 Center,)1753' West Congress Parkway, Chicago, s
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- 11. The specified possession limit includes all licensed material possessed by the p
N licensee under this license whether in storage, implanted in patients, or otherwise E
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in use.
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12.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, y
ATTN:
Chief Nuclear Materials Safety and Safeguard Branch, 799 Roosevelt Road, y
N Glen Ellyn, Illinois 60137, 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 i
i pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker N
l system, including the leads.
A written report giving details of the adverse reaction g
and/or malfunction shall be submitted within 30 days.
g i
g 13.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, y
q ATTN:
Chief, Nuclear Material Safety and Safeguard Branch, 799 Roosevelt Road, g
4 Glen Ellyn, Illinois 60137, within 10 days of loss of contact with a nuclear i
i pacemaker patient.
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H' 8702110362 861006 p
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C Form 374A U.S. NUCLEAR REIULATcRY COMMISSl!N PAGE OF PAGES I
License number l
l MATERIALS LICENSE 0
l SUPPLEMENTARY SHEET 0 0-02224 P
Amendment No. 02 y
E
- 14. The licensee shall continue patient follow-up and replacement procedures for the h
nuclear pacemaker during the life of the patient. Procedures for recovery and N
E authorized disposal of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the patient.
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- 15. The licensee shall not receive or transfer in any single transaction one (1) gram i
or more of plutonium-238 contained in nuclear powered pacemakers without notifying i
the U. S. Nuclear Regulatory Commission, Region III, ATTN:
Chief Nuclear Materials N
E Safety and Safeguards Branch, 799 Roosevelt Road, Glen Ellyn, Illinois 60137, and, in addition, completing and distributing; Form NRC-741 as required by Section 70.24 f
of 10 CFR 70.
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16.
Except as specifically prov'ided otherwise in this license, the licensee shall i
conduct its program in'accordance with the statements,- representations, and l
procedures contained in'the documents including any enclosures, listed below.
y The Nuclear Regulatory Commission's regulations shall govern,unless the statements, y
representations and procedures in the licensee's application and correspondence are p
E more restrictive <than the, regulations, j
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J A.
Letters dated March 11, 1976', February 23, 1981 and March'26, 1986.
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R For the U.S. Nuclear Regulatory Commission g
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Original Signed g
bg By Patricia J. Whiston f,
Date Materials Licensing Section, Region III l
5 COPY I
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