ML20214B863
| ML20214B863 | |
| Person / Time | |
|---|---|
| Site: | 07002427 |
| Issue date: | 01/29/1987 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20214B865 | List: |
| References | |
| NUDOCS 8705200451 | |
| Download: ML20214B863 (2) | |
Text
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QU.S. NUCLE AD CE",ULATO?Y COMMISSION
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MATERIALS LICENSE Amendment No. 05 pj Pursuant to ti e Atonne I nergy Aa of 1954 as amended, the Energy Reorganuation Act of 1974 (PuWie Law 93 -438). and Title 10, E.
,4 Code pf Federal Regulations. Chapter I. Parts 3u. 31,32,33. 34. 35,40 and 70. an,' m rehance on statements and rep f heretofore maJe by the hsensee, a h cnte is herchy inu:J authorving the beensee to receise, aequuc. Possess,and trarater by product, 4 source, and special nuclear material designated below; to use such material for the purpose (O and at the place (O designated below,to !
d dehver or transfer su h materut to persons authorved to resche it in accordance with the regulations of the appheable Part(sh Thu bcense shall be deemed to 6ontain the conditions ipecined m Section 183 of the Atomic Energy Act of 1954, as suh ect to all appheabic rules, regulatiora and orders of the Nuclear Regulatory Commission now or hereafter in etteet and to any h
f conditions specified below.
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If in accordance with letter dated October 23 1986 i
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l-Kennedy Memcrial Hospital 3 l""" numbe',
SNM-1690 is amended in h
University Fedical Center its entirety to read as follows:
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18 E. Laurel Road 4 b i'2hoa d
Stratford, New Jersey 08084 P
January 31, 1992 j
- 5. Dodel or Referenee k 070-02427 fl h 11) product. source, and/or
- 7. Chemical and/or physical
- 6. Maimum amount that beensee
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special nuJe.it matero!
form may possess at any one tirne j
l under this license
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N A. Plutonium (principal A. Sealed Source A. 2.5 grams (individual
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raritonuclidc Fu-238) sources not to exceed
.I 250 milligrams each)
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i E. Plutonium (principal B. Scaled Source B. 2.25 grams (individual p'
1 radionuclide Pu-238 sources not to exceed Pi hl 225milligramseach)
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d C. Plutontun (p-incipal C. Scaled Source C. 0.5 grams (inoividual f
g radionuclide Pu-238 sources not to exceed 250milligramseach)
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4 9.
Authorized use DI A.
Implantation in humans as a component of Coratomic Model C-101 nuclear-powered D
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.i cardiac pacemakers for clinical evaluation.
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Implantation ir. humans as a component of Cordis Nuclear Omni-Stanicor Model 184A q
nuclear-powered cardiac pacemakers for clinical evaluation.
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W. C.
Implantation in humans as a component of Coratomic Model C-101-P nuclear-powered l>I 4
pacemakers in accordance with the " Human Implantation Protocol for Caratomic l
C-101-P Radioisotope Powered Cardiac Pacemaker," dated March 2,1983.
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q 0705200451 070129 a
REG 1 LIC70 CONDITIONS lp q-SNM-1690 PDR I.
10.
Licensed material shall be used only at kennedy Memorial Hospital, 18 C. Laurel 9
Road, Stratford, New Jersey.
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11.
The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or otherwise
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in use.
I f12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I,
[5 ATTN:
Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, m ja !
king of Prussia, Pennsylvania 19406, 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 MLip q
of any nuclear pacemaker patient, and any adverse reaction and/or malfunction q
involving a pacemaker system, including the leads. A written report giving details l
of the adverse reaction and/or malfunction shall be submitted within 30 days.
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070-D2427 p
Amendment No. 08i it h
(continued)
CONDITIONS c
- 13. The licensee shall report to the U.S. huclear Regulatory Commission, Region 1 ATTN: Chief. Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a nuclear pacemaker patient.
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- 14. lhe licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient.
Procedures for recovery and 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. Sealed sources or detector cells containing licensed material shall not be opened or
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sources removed from detector cells by the licensee.
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- 16. The licenseo may transport licensed material in accordance with the provisions
[f of 10 CFP Part 71, " Packaging and Transportation of Radioactive Material".
- 17. Except as specifically provided otherwise in this licer.se, the licensee shall conduct its program in accordance with the statements, representations, and b
- l procedures contaired in the documents including any enclosures, listed below.
-l The Nuclear Regulatory Commission's regulations shall govern unless the statements,
- l representations and procedures in the licensee's application and correspondence are more restrictive than the regulations.
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A.
Application transmitted with letter dated October 7, 1976 p
B.
Letter dated March 3, 1977 j,
C.
Letter dated October 4, 1977 D.
Letter dated October 28, 1981 h_
E.
Letter dated October 23, 1986 k
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k For the U.S. Nuclear Regulatory Commission Origirmi Signed By:
John 8 01'na Date JAN 2 01987 By huclear Materials Safety and Safeguards Branch, Region i King of Prussia Pennsylvania 19406
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