ML20245H086
| ML20245H086 | |
| Person / Time | |
|---|---|
| Site: | 07002134 |
| Issue date: | 03/23/1988 |
| From: | Mccann G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20244B344 | List: |
| References | |
| NUDOCS 8902150455 | |
| Download: ML20245H086 (2) | |
Text
jCRCForm374'
- TA2E T 1 OF ] _ PAGES l )
, y (5 84 ' U.S. NUCLEAR REIULATT.RY COMMISSION Amendment No. 06
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MATERIALS LICENSE l ]
- Pursu* ant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, I Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations g l l heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct. l l source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to l I deliver or transfer such material to percons authorized to receive it in accordance with the regulations of the applicable Part(s). This I license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any l conditions specified below.
- y I 1 Licensee I In accordance with letter dated 1 I February 13, 1986 I
- 1. Grandview Hospital 3. Ucense number SNM-1603 is amended in l l l Department of Medical Physics its entirety to read as follows: g I b y 2. 405 Grand Avenue .
I I Dayton, Ohio 45405 4. Expiration date April 30, 1993 1 ,
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! erenb No. 071-02134 l l 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee I N special nuclear material form
- may possess at any one time I
, under this license l
3 A. Plutonium (Principal A. Sealed Source (s) A. 9 grams (15 I radionuclides Pu-238) ; individual sources l not to exceed 225 l
- g i milligrams each) g i N 1 9. Authorized Use N I N!
l A. As a component of . Cordis Nuclear Omni-Stanicor Model 184A or Model 184B ll nuclear-powered cardiac pacemakers for clinical evaluation purposes. ,
i N I Thislicenseauthorizespossessionofthesepademakersforpurposesofexplantation, g N recover and disposal, but not for implantation or reimplantation. I N I CONDITIONS l
l 10. License material shall be used only at Grandview Hospital, 405 Grand Avenue. Dayton, H Ohio.
l i 11. The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or otherwise l in use.
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unc rom mA u.S. NUCLEA'1 RE!ULAT*RY COMMISSION l PAGE 2 of 2 PAGES
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, License number l MATERIALS LICENSE f l!
oockei er Reference number SUPPLEMENTARY SHEET 070-02134 l l F 1 Amendment No. 06 l l l .i I
l 12. The licensee shall not receive or transfer in any single transaction,1 gram or more y I of plutonium-238 contained in nuclear-powereed pacemakers without notifying the a
, I Division of Safeguards, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, 5 I and, in addition, completing and distributing Form NRC-741 as required by Section N l 70.54 of 10 CFR Part 70. l
. i, i 13. The licensee shall report to the U.S. Nuclear Regulatory Comission, Region III, gj ATTN: Chief Nuclear Materials safety and Safeguard Branch, 799 Roosevelt Road, WI 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 occurrence, the death of any nuclear P pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker I lg system, including the leads. A written report giving details of the adverse reaction and/or malfunction- shall be submitted within 30 days. l g
I . N
- 14. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, R Chief, Nuclear Material Safety and Safeguard Branch, 799 Roosevelt Road, I
g ATTN:
Glen Ellyn, Illinois 60137, within 10 days of loss of contact with a nuclear E
l g pacemaker patient. y l .
i i 15. The licensee shall continue patient follow-up and replacement procedures for the E, I nuclear pacemaker during the life of the patient. Procedures for recovery and l authorized disposal of the nuclear pacemaker by return to the manufacturer shall be l followed upon the death of the patient.
I I 16. Except as specifically provided otherwise in this license, the licensee shall I conduct its program in accordance with the. statements, representations, and ,
I procedures contained in'the documentsLincluding any enclosures, listed below. l l The Nuclear Regulatory Commission's regulations shall govern unless the statements, i representations and procedures in the licensee's application and correspondence are i more restrictive than the regulations. !
E I A. Letters dated Jan'uary 16, 1976, January 21, 1981',' July'20, 1981, I February 13, 1986 and February 18, 1988.
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l l 1 El l Nl 11 H l N lJ 1 hl l For the U.S. Nuclear Regulatory Commission h I !P I P l f1 I Original Signed h l Date: March 23, 1988 By George M. McCann, Chief g Materials Licensing Section, Region III l 4
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