ML20154Q461

Amend 3 to License SNM-1531 for Shadyside Hosp,Amending License in Entirety

ML20154Q461
Person / Time
Site:	07001718
Issue date:	02/12/1986
From:	Kinneman J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20154Q463	List: ML20154Q461 ML20154Q478 ML20154Q502 ML20154Q515 ML20154Q524 ML20154Q527 ML20154Q534 ML20154Q560
References
NUDOCS 8603210170
Download: ML20154Q461 (2)

Text

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NEC Form 374 i

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MATERIALS LICENSE Amendment No. 03 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 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations g

g heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g

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source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to l

deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This

&j' license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is N

subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any j conditions specified below.

I Licensee i

In accordance with letter dated May 2, 1985 and letter received January 2, 1986, I-

3. License number SNM-1531 is amended in its Shadyside Hospital entirety to read as follows:

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5230 Centre Avenue 4

Pittsburgh, Pennsylvania 15232

4. Expiration date January 31, 1991 l

5. Docket or l

Reference No.

070-01/18

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6. Byproduct, source, and/or

7. Chemical and/or physical

8. Maximum amount that licensee g

special nuclear material form

- may possess at any one time i

'b under this license A. Plutonium (Principal A. Sealed source (s)

A. 10 grams (20 individual

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lN radionuclide Pu-238) sources not to exceed 3

500 milligrams each) id

!N 9.

Authorized use i

! A.

Implantation in humans as a component of ARC 0 Nuclear Model NU-5 nuclear-powered l

l cardiac pacemakers for clinical evaluation purposes.

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lEl CONDITIONS t

i 10. Licensed material shall be used only at 5230 Centre Avenue, Pittsburgh, Pennsylvania.

p 11. The specified possession limit includes all licensed material possessed by the g

licensee under this license whether in storage, implanted in patients or otherwise p

in use, g

E 12.

The 'icensee shall not receive or transfer in any single transaction one (1) gram or more of plutonium 238 contained in nuclear-powered pacemakers without notifying the Division of Safeguards, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, i q

and, in addition, completing and distributing Form NRC-741 as required by Section 70.54 of 10 CFR 70.

N d 13. The licensee shall report to the U. S. Nuclear Regulatory Commission, Region I, i

l Nuclear Materials Section, 631 Park Avenue, King of Prussia, Pennsylvania 19406, y

within twenty-four (24) hours of occurrence, the death of any nuclear pacemaker g

patient, and any adverse reaction and/or malfunction involving a pacemaker system, N

including the leads. A written report giving details of the adverse reaction and/or p

H malfunction shall be submitted within thirty (30) days.

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14. The licensee shall report to the U. S. Nuclear Regulatory Commission, Region I, N

y Nuclear Materials Section, 631 Park Avenue, King of Prussia, Pennsylvania

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q within ten (10) days, loss of contact with a nuclear pacemaker patient.

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SUPPLEMENTARY SHEET h

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CONDITIONS

15. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient.

Procedures for recovery and j

authorized disposal of the nuclear pacemaker bv return to the manufacturer shall i

be followed upon the death of the patient.

16.

Except as specifically provided otherwise by this license, the licensee shall possess and use licensed material described in Items 6, 7, and 8 of this license in accordance with statements, representations, and procedures contained in letter with enclosures dated April 25, 1975; letter dated May 2,1985 and letter received January 2,1986.

1 The Nuclear Regulatory Commission's regulations shall govern the licensee's statements 9

in applications or letters, unless the statements are more restrictive than the regulations.

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For the U.S. Nuclear Regulatory Commission p

FEB 121986 UWad No'7-hl i;Date By Jo M. M m an pj Nuclear Materials Safety and P

i Safeguards Branch, Region I King of Prussia, Pennsylvania 19406 p

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