ML20245L709
| ML20245L709 | |
| Person / Time | |
|---|---|
| Site: | 07001404 |
| Issue date: | 07/12/1988 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20245L712 | List: |
| References | |
| 120516, NUDOCS 8905080113 | |
| Download: ML20245L709 (5) | |
Text
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NRC' Form 374 O
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l~ OF 2__.PAGES l (h80 U.S. NUCLE AR REGULATORY COMMISSION II i
MATERIALS LICENSE Amendment No. 07
!g Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 -438), and Title 10.
Code of Federal Regulations. Chapter I, Parts 30,31,32,33,34. 35,40 and 70, and in reliance on statements and representations l y heretofore made by the licemee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, y f source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to ig l
deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This l, heense shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is i,
J subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.
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- g Licensee h
In accordance with application dated j
l' 3'
S' Clara Maass Memorial Hospital SNM-1371 is amended in its entirety to read as follows:
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I N{N 2.
U One Franklin Avenue Belleville, New Jersey 07109
- 4. Expiration date June 30, 1993 lg
- 5. Docket or Reference No.
070-01404
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- 6. Ilyproduct, source, and/or
- 7. Chemical and/or physical
- 8. Maximum amount that licensee special nuclear material form may possess at any one time under this license A. Plutonium (principal A. Sealed source A. 10.5 grams (50 individual l radionuclides Pu-238) sources not to exceed 210 milligrams each) i B. Plutonium (principal B. Sealed source B. 3.75 grams (15 individual l radionuclidePu-238) sources not to exceed 250 milligrams each) i i
9.
Authorized use
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I A.
Implantation in humans as a component of Medtronic Model 9000 nuclear-powered cardiac pacemakers for clinical evaluation.
B.
Implantation in humans as a component of Coratomic Model C-101 nuclear-powered j
cardiac pacemakers for clinical evaluation.
4 CONDITIONS 10.
Licensed material shall be used only at Clara Maass Memorial Hospital, One Franklin Avenue, Belleville, New Jersey.
ff 11.
The specified possession limit includes all licensed material possessed by the i
licensee under this license whether in storage, implanted in patients, or i
otherwise in use, j
j 12.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN:
Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of j
l 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 of any i
nuclear pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads.
A written report giving p
details of the adverse reaction and/or malfunction shall be submitted within 3
d5-
"0FFICIAl RECORD COPY""' -
- 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region 1,
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ATTN:
Chief. Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a nuclear l
pacemaker patient.
8905080113 880712 iiDuR@m.waimUisiUeDiUsiVirmsmu h@l1$70
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Ucense number l
MATERIALS LICENSE l
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070-01404 l
Amendment No. 07 p
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(Continued)
CONDITIONS l
- 14. The 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.
i 15.
Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders or detector cells by the licensee.
- 16. The licensee may transport licensed material in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material".
- 17. Except as specifically provided otherwise in this license, the licensee shall y
conduct its program in accordance with the statements, representations, and p
4 procedures contained in the documents including any enclosures, listed below.
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The Nuclear Regulatory Conmission's regulations shall govern unless the N>
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statements, representations and procedures in the licensee's application l
and correspondence are more restrictive than the regulations, f
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g A.
Letter dated May 18, 1973 p
p B.
Letter dated February 14, 1974 F
4 C.
Letter dated December 9, 1975 W
D.
Letter dated June 8,1983 h
E.
Letter dated May 4,1988
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i For the U.S. Nuclear Regulatory Commission N
Original Sir;aed ByI h
12 JUL 1988 l
Date ey mmt.cmm q
Nuclear Materials Safety Branch q
Region I N
I King of Prussia, Pennsylvania 19406 4
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12 JUL 1988 i
License No. SNM-1371 Docket No. 070-01404 Control No. 120516 Clara Maass Memorial Hospital One Franklin Avenue l
Belleville, New Jersey 07109 Gentlemen:
Please find enclosed the renewal of your NRC Material License.
Please review the enclosed document carefully and be sure that you understand all conditions.
If there are any errors or questions, please notify the
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Region I Material Licensing Section, (215) 337-5239, so that we can provide
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appropriate corrections and answers.
please be advised that you must conduct your program involving licensed.
radioactive materials in accordance with the conditions of your NRC license, representations made in your license application, and NRC regulations.
In J
particular, please note the items in the enclosed, " Requirements for Materials Licensees."
l We note that your application was sent.to our Washington, D.
C., office.
Future
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applications and other correspondence concerning your license should be sent to the USNRC, Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406, to the attention of Nuclear Materials Safety Section.
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It is our understanding from a telephone discussion on June 20, 1988, between Steven Courtemanche of this office and Barbara Kroll of your staff that Adrian Sabety, M.D. no longer performs activities authorized by your license and you wish her name dropped from the list of authorized physicians.
Further, it is our understanding the Melvin Freundlich, M.D. may only explant nuclear powered pacemakers.
It is also our understanding that even though you are only following two patients and do not have plans to perform any more implantation that you wish to maintain your possession limits and procedures.
as stated in your license.
If our understandings are-incorrect, please. inform us in writing.
Since serious consequences to employees and the public can result from failure l
to comply with NRC requirements, the NRC' expects licensees to pay meticulous attention to detail and to achieve the high standard of; compliance which the NRC expects of its licensees.
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0FFICIAL RECORD COPY ML SNM-1371/LTR - 0001.0.0 06/28/88
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2 You will be periodically inspected by NRC. A fee may be charged for inspections in accordance with 10 CFR Part 170.
Failure to conduct your program safely and in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in prompt and vigorous enforcement action against you.
This could include issuance of a notice of violation, or in case of serious violations, an imposition of a civil penalty or an order-suspending, modifying or revoking your license as specified in the General Policy and Procedures for l
NRC Enforcement Actions, 10 CFR Part 2, Appendix C.
We wish you success in operating a safe and effective licensed program.
Sincerely, Original Signed By 8 JohnE. Glenn John E. Glenn, Ph.0., Chief Nuclear Materials Safety Section A Division of Radiation Safety and Safeguards
Enclosures:
1.
Amendment No. 07 2.
Requirements for Materials Licensees 3.
NRC Forms 3 and 313 l
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UNITED STATES NUCLEAR REGULATORY COMMISSION e '-
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.. j REGION l
'f 475 ALLENDALE ROAD
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KING OF PRUSSIA, PENNSYLVANIA 19406 25 MAY 1988 Clara Maass Memorial Hospital ATTN:
Robert S. Curtis, President 1 Franklin Avenue Belleville, NJ 07109 Docket No.
070-01404 License No.
,. e, Control No.
120516
SUBJECT:
LICENSE RENEWAL APPLICATION Gentlemen:
This is to acknowledge receipt of your application for renewal of the material (s) license identified above.
Your application is deemed timely filed, and accordingly, the license will not expire until final action has been taken by this office.
Any correspondence regarding the renewal application should reference the control number specified and your license number.
Sincerely, M8121 Signed By.
DOMS 3Joster John E. Glenn, Ph.D., Chief Nuclear Materials Safety Section B Division of Radiation Safety and Safeguards "0FFDAL RECORD COPY"Kll