ML20199D147

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: ML20199D147 ML20199D152
References
NUDOCS 8606200053
Download: ML20199D147 (2)

Text

{{#Wiki_filter:0 . A i i u :. ..L L' f i'.E..i_*1 E_ _W h_ri. A_%M_M_*#4 W A__.. W' Dr' U.S. NUCLf. AR REGULATORY COMMISSl!N 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 f heretofore made by the licensee. a license is hereby issued authorizi. g the licensee to receive, acquire, possess, and transfer byproduct,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 is I 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 %j l h.WestVirginiaUniversityHospitals,Inc. 1

3. License number SNM-1948 5

Radiology Department ,I e l ll2. Medical Center Box 6401 ' E^ Morgantown, West Virginia 2650 f-{' 4.hpN.h!e February 28, 1987 ti p 1; h

5. Docket or 7 070-03017/SNM - 1713 l

ll Reference No. /,_ r lj 6. Byproduct, source, and/or

7. Chemical and/or physical U. Maximum amount that licensee i

5 special nuclear material form .{ / [jpder this license may possess at any one time I f kJ \\) 1- \\\\ N / l O \\ I A.y n I l A. Plutonium (Princp,a1 g q d cs y i A. {.2 grams (20 individual t p s,qdrcesnottoexceed I radionuclide Pu 238) p' m, l ,1 1, 9. Authorized use g^g% f Q3 { y dc fi MJ Model 0 Nuclear powered t . A. Implanation in h sa ~ va}///t d N NUulti q urppsts. I cardiac pacemakers r (:: [cli i L 9 CO yNDI IONS o l ~ s Licensed material shall be usk-ogly Ja WesthginiaUniversityHospitals,Inc., lj 10. 6 Morgantown, West Virginia. A Kh j 11. The specified possession limit includes all licensed material possessed by the l l licensee under this license whether in storage, implanted in patients or other-g I wise in use. I g 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. l q 20555, and, in addition, completing and distributing Form NRC-741 as required by l;i Section 70.54 of 10 CFR 70. y 11 p k 13. The licensee shall report to the Material Licensing Branch, U.S. Nuclear Regulatory I g 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, l

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including the leads. A written report giving details of the adverse reaction and/or i l malfunction shall be submitted within thirty (30) days. I i a606200053 e60409 4 l l REG 2 LIC70 C' I SNM-1948 ,dD]_ _ __ _ _ _

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1 7_._.__ m, m,,e,.9 _,;.g.4 L Fgm o, U.S. P.UCLE Ah......a Al un, s w..m.u6vh3 ; g g g 1 o i u ns r.umhr 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 f i nuclear pacemaker during the life of the patient. Procedures for recovery and gl authorized disposal of the nuclear pacemaker by return to the manufacturer shall p l 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 possess and use licensed.Mterial described in ItemsT6),7, and 8 of this license I i f in accordance with s4*athments, representations, and 'ppo9edures contained in L l' application and letter dated February 14, 1977 signed Wadir Khuri, M.D., and ( 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 The Nuclear Reg @etory Comm k regula ' Jihal),goved the licensee's L I! statements in appPicatihdiitr'l tter tuth g[.4 e~s%tements7re more restrictiv [ l than the regulatiYn's. g4% g f t 1 o s t l K %dt< l 1 t I L I l l 1, l I L 3 i l FOR THE U.S. NUCLEAR REGULATORY COMMISSION f 1 i I EARL G. WRIGHT t [ct[ M/ MMdf R 09 1985 Date t By g; Region II, Nuclear Matfr,fals ( 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 .}}