ML20211K376

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License SNM-1971 for Cleveland Clinic Foundation,Authorizing Implantation of Pu-238 in Humans as Component of nuclear- Powered Cardiac Pacemakers
ML20211K376
Person / Time
Site: 07003044
Issue date: 10/21/1986
From: Mccann G
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20211K381 List:
References
NUDOCS 8702260593
Download: ML20211K376 (2)
v • d • e


Text

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g NRC Form 374 1

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PAGE OF PAGES g 15 84)

U.S. NUCLEAR REGULATORY COMMISSION U

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MATERIALS LICENSE y

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, y

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

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

N 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 g

conditions specified below.

g Licensee N

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1.

The Cleveland Clinic Foundation

3. License number SNM-1971 M

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2.

9500 Euclid Avenue g13 l

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4. hip (iration,date October 31, 1990
E Cleveland, OH 44106

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5. Docket or y

070-03044 N

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6. Byproduct, source, and/or

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7. Chemical and/or physical QMaximum amount that licensee N

special nuclear material form

%may possess at any one time U

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A. Plutonium (Principab/

SealedSource,s['I A. 10 grams (40 lg A

b radionuclide Pu-238)-

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-r / +p) ([R l

individual sources f

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J not to exceed 250 l

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milligrams each)

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B. Plutonium (Principal)

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B.) Sealed ~Soupces' f:

B. 15 grams (60 g

radionuclide Pu-238)

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milligrams each) l 6 T jjsi

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individual sources N

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C.gSe'aled Sou[cesVi/

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% 'y C. 1.35 grams (6 y

C. Plutonium (Principal Y,s radionuclide Pu-238) '//f

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individual sources y

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not to exceed 225 N

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9. Authorized Use N

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A. Implantation in humans as a component of Coratomic Model C-101 nuclear powered cardiac l N

pacemaker for clinical evaluation purposes, j

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B. Implantation in humans as a component of Coratomic Model C-101P nuclear powered cardiac g

pacemaker for clinical evaluation purposes.

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C. Implantation in humans as a component of Cordis Nuclear Omni-stanicor Model 184A g

N nuclear-powered cardiac pacemakers for clinical evaluation purposes.

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CONDITIONS N

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10. Licensed material shall be used only at the licensee's facilities located at y

9500 Euclid Avenue, Cleveland, Ohio.

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260593 5

l OCT 21 1986 SN"~MP COPY h k - m _ _ _PDR h\\)

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R Form 374A U.S. NUCLEAR REIULATf.RY COMMISSION 7

7 Lici.nse number l

MATERIALS LICENSE 9NM 1971 Dodeur Referem nmnkt SUPPLEMENTARY SHEET n70 0'4044 l

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

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

in use.

12 The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, l

ATTN:

Chief Nuclear Materials Safety and Safeguard Branch, 799 Roosevelt Road, y

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 cccurrence, the death of any nuclear y

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

system, including the leads. A written report giving details of the adverse reaction I and/or malfunction shall be submitted within 30 days.

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13. The licensee shall report,to,the U.S. Nuclear Regulatory Commission, Region III, Chief, Nuclear Materi' l Safety and Safeguard' Branch, 799 Roosevelt Road, ATTN:

a Glen Ellyn, Illinois 60137, within 10 days of loss of ~ contact with a nuclear i

pacemaker patient.

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14. The licensee shall continue patient follow-up and replacemenbprocedures for the l

nuclear pacemaker during the life of the patient.

Procedures'for recovery and y

authorized disposal of the nuclear pacemaker by return to the manufacturer shall be y

followed upon theTdeath of the-patient..

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15. The licensee shall follow the manufacturer.'s protocol dated March 2, 1983, for the Coratomic, Inic. Model C-101-P~ Nuclear-Power Pacemak'ers.

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16. Except as specifically'provided'dth'erwise;in this license, the licensee shall l

i conduct its program in accordance'~with the! statements,' representations, and procedures contained in the!documentsiincluding any enclosures', listed below.

The Nuclear Regulatory Commission's regulations.shall govern'unless the statements, representations and; procedures in the. licensee's. application and correspondence are l

more restrictive than the regulations.

A.

Letters dated February 9,.1976, April 19, 1976, July 9, 1976, May 14, 1981, b

August 10, 1984 and July. 9,1986.

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For the U.S. Nuclear Regulatory Commission R

I Original Signed Date October 21, 1986 By George M. McCann F

Materials Licensing Section, Region III R

P COPY I

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