ML20199D147

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License SNM-1948 for West Virginia Univ Hosps,Inc, Authorizing Use of Pu-238 for Implantation in Humans as Component of Medtronic Model 9000 nuclear-powered Cardiac Pacemakers for Clinical Evaluation Purposes
ML20199D147
Person / Time
Site: 07003017
Issue date: 04/09/1986
From: Wright E
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:
Shared Package
ML20199D148 List:
References
NUDOCS 8606200053
Download: ML20199D147 (2)


Text

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                           ,                                U.S. NUCLf. AR REGULATORY COMMISSl!N                                 -

N5 g l,d . MATERIALS LICENSE I g Pursuant.to the Atemic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Pubbe Law 93-438). and Title 10, I i Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,40 and 70, and in rehance on statements and representations heretofore made by the licensee. a license is hereby issued authorizi. g the licensee to receive, acquire, possess, and transfer byproduct, f y j sot.rce, 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 l l license shdi be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and I is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any

   ,         conditions specified below.

4 Licensee E

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3. License number SNM-1948 5 h.WestVirginiaUniversityHospitals,Inc.

Radiology Department ,I e ll2. Medical Center Box 6401 ' E^ l Morgantown, West Virginia 2650 f-{' ' 4.hpN.h!e ti p February 28, 1987 1; ll h 5. Docket or 7 070-03017/SNM - 1713 Reference No. /,_ l r lj 6. Byproduct, source, and/or 7. Chemical and/or physical U. Maximum amount that licensee i 5 special nuclear material 1- form - may possess at any one time I f\\ .{ / [jpder this license N kJ \)

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I A. Plutonium (Princp,a1 I A.y ,

                                                                                                      .:               O                                   n g q       d           cs       y i              A.    {.2 grams (20 individual             t l                 radionuclide Pu 238)                     p'             m, p                     s,qdrcesnottoexceed                 I l                                    -
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9. Authorized use "'

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             . A.      Implanation in h                sa                                        MJ        Model           0 Nuclear powered               t cardiac pacemakers

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o s l lj 10. Licensed material shall be usk-ogly Ja WesthginiaUniversityHospitals,Inc., 6 Morgantown, West Virginia. A Kh j

   !!          11. The specified possession limit includes all licensed material possessed by the l                   licensee under this license whether in storage, implanted in patients or other-                                                     l g

I wise in use. g I I 12. The licensee shall not receive or transfer in any single transaction one (1) gram l l or more of plutonium 238 contained in nuclear powered pacemakers without notifying I l the Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. q 20555, and, in addition, completing and distributing Form NRC-741 as required by l l;i y Section 70.54 of 10 CFR 70. p 11 g k 13. The licensee shall report to the Material Licensing Branch, U.S. Nuclear Regulatory I  ! f Commission, Division of Fuel Cycle and Material Safety, Washington, D.C. 20555, I i within twenty-four (24) hours of occurrence, the death of any nuclear pacemaker i patient, and any adverse reaction and/or malfunction involving a pacemaker system, ly *l l including the leads. A written report giving details of the adverse reaction and/or ' i l i malfunction shall be submitted within thirty (30) days. I l a606200053 e60409 4 l REG 2 LIC70 C' I

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               ,                                                                                                                           l l'        *           .         MATERIALS LICENSE                                                         SNM - 1948                     l ll
  • SUPPLEMENTARY SHEET l g, ,
                                                               .                                            070-03017                      ;

l' L i SNM - 1713 l 1 I I I f(cont'd) CONDITIONS [ l r q 14. The licensee shall report to the Material Licensing Branch, Division of fuel Cycle p i and Material Safety, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, t - 1l within ten (10) days, loss of contact with a nuclear pacemaker patient. f ll L li 15. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient. f i Procedures for recovery and p gl l authorized disposal of the nuclear pacemaker by return to the manufacturer shall  ; be followed upon the death of the efj {G 1 ll16. Except as specifically prov d otherwise by t )i[Jjcense, the licensee shall l l i possess and use licensed.Mterial described in ItemsT6),7, and 8 of this license I f in accordance with s4*athments, representations, and 'ppo9edures contained in application and letter dated February 14, 1977 signed Wadir Khuri, M.D. , and L l' ( I! others and Eugene Sta;iles, . Administrator; letters dated Must 10, 1977 signed [ Hl M. Douglas Allan, gnuary' *1982 signed Thoma ' fnay,41.D. , and others and [ l W. Robert Biddingt%; D.D.h, tprim Vice Pr t', Decembqr 12, 1984 signed I fl William E. Collinh Ph.D. , zSt phe $ )S1 c h'. D . , Makd1, 1985 signed I William E. Colli Ph.D.,a[id y en a ' ,1 . Q ll I! The Nuclear Reg @etory Comm statements in appPicatihdiitr'l tter tuth k regula ' Jihal) ,goved the licensee's L [ l than the regulatiYn's. g4% g[.4 e~s%tements7re g more restrictiv f t 1 o s t l 1 K %dt< lt I L I 1, l l l I L 3 i l FOR THE U.S. NUCLEAR REGULATORY COMMISSION f 1 i I EARL G. WRIGHT t g; Date R 09 1985 By [ct[ M/ MMdf Region II, Nuclear Matfr,fals t y Safety Section ( g 1, 101 Marietta Street, Suite 2900 l I; Atlanta, GA 30323 l l i L l' l I r I, [ li L NfCMWMMMMMwMMW KTKiiiYrMK+W.#KiinDnwM.WMM@ ## w.w = Mr#CiwXiM.'niwaviib .}}