ML20207T987

Amend 5 to License SNM-1637 for Bryn Mawr Hosp,Amending License in Entirety

ML20207T987
Person / Time
Site:	07002281
Issue date:	08/04/1986
From:	Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20207T988	List: ML20207T987 ML20207T995 ML20207U002 ML20207U006 ML20207U018 ML20207U022 ML20207U028 ML20207U033 ML20207U042 ML20207U057 ML20207U063 ML20207U071 ML20207U079
References
NUDOCS 8703240475
Download: ML20207T987 (2)

Text

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1 g! NEC Form 374 PACE OF PAGES g (s. s 4 U.S. NUCLEAR REIULATORY COMMISSION E

MATERIALS LICENSE Amendment No. 05 i "

g; Pursuant to the Atomic Energy Act of 1954, as arnended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10 g Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g(k deliver or transfer such material to persons authorized to rece j source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to !

f license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amen 4 subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any j g conditions specified below. , ,

g k Licensee . I1 J M. 'i J J L . ~Ul I f l In accordance with application dated March 13, 1986,  !

gl q I- The Bryn Mawr Hospital 3. Ucense number SNM-1637 is amended in  !

Nj its entirety to read as follows:

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2-Bryn Mawr Avenue cbh ' .Dration N

Bryn Mawr, Pennsylvania 19010 '4.ti" Exp / 'date. August 31, 1991 l 5. Docket er 4' 070-02281

( Reference No.

6. Byproduct, source, and/or 7. Chemical and/or physical v 8. Maximum amount that licensee special nuclear material ,

form - Q.may possess at any one time l

under this license A. Plutonium (principal A. Sealed Source 'I ~ A. 0.5 grams (individual radionuclide Pu-238) sources not to exceed $*

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t 250 milligrams each)  ;

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N Authorized use -

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li A.9. V< b , WJ) L Ill \W ,% p  %

y Implantation in humans as a component )ofls Corotomic Model C-101"Tuclear pow

( cardiac pacemakers for clinical evaluation. , , ,

l%l CONDITIONS j.

f 10. Licensed material shall be used only at the Bryn Mawr Hospital, V Bryn Mawr Avenue, g Bryn Mawr, Pennsylvania.

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g The specified possession limit includes-all -licensed material possessed by the !d dl licensee under this license whether in storage, implanted in patients, or  !'

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' otherwise in use.

12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, 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 a: of any nuclear pacemaker patient, and any adverse reaction and/or malfunction o@ involving a pacemaker system, including the leads. A written report giving

@ details of the adverse reaction and/or malfunction shall be submitted within jpg, g 30 days.  %

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$ 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, g euN ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, p, D King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a pj,J nuclear pacemaker patient, ont l/l M 14. The lict.nsee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient. Procedures for recovery k h f ;

4 and authorized disposal of the nuclear pacemaker by return to the manufacturer f, '

R shall be followed upon the death of the patient. I 4

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i NTC Form 374A U.S. NL , R cEEULATCY COMMISSION , pgg [ g, 2 PAGES I

1. • D License number N I

SNM-1637

! MATERIALS LICENSE Dockem Rekonce numW l g

l SUPPLEMENTARY SHEET

070-02281 y I ,

9 l Amendment No. 05 l -

1 CONDITIONS R l (Continued) l 15. Sealed sources or detector cells containing licensed material shall not be I opened or sources removed from detector cells by the licensee.

I I 16. The licensee may transport licensed material in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material".

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! 17. Except as specifically provided otherwise in this license, the licensee shall I conduct its program in accordance with the, statements, representations, and l l procedures contained in the documents iric)udi[ig any enclosures, listed below. lu l The Nuclear Regulatory Commission's'riegulations thall govern unless the state-ments, representations and procedures in the licensee's application and corre- l, l spondence are more restrictive than the regulations.

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.V g n A. Application transmitted with letter dated March 19, 1976 p i B. Letter cated January 13, 1977 7 > b I C. Letter dated April 27, 1981 F I Letter dated May 19, 1981 //f- I D. m l E. Letter dated March 13, 1986 l:

i F. Letter dated July 10, 1986 r kG ' -

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1 E For the U.S. Nuclear Regulatory Commission l l Original Signed ByI g l

l Date AUG 0 41986 By I I Nuclear haterials Safety and F I Safecuards Branch, Region I I I King of Prussia, Pennsylvania 19406 l 1

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