ML20137V092
| ML20137V092 | |
| Person / Time | |
|---|---|
| Site: | 07002116, 07003028 |
| Issue date: | 09/19/1985 |
| From: | Kinneman J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Beattie J LAWRENCE MEMORIAL HOSP. OF MEDFORD, MEDFORD, MA |
| References | |
| NUDOCS 8510030381 | |
| Download: ML20137V092 (1) | |
Text
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i SEP 19 585 i
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Docket No. 70-02116 License No. SNM-1578 l
Lawrence General Hospital i
ATTN: James W. Beattie, M.D.
j Director of Laboratory Medicine 1 General Street i
Lawrence, Massachusetts 01842 Gentlemen:
Subject:
Inquiry No. 85-01 1
This refers to your letter dated June 27, 1985, in response to our letter i
dated June 7, 1985.
I We have received your application for a new license covering the materials on 1
your expired license. Your new license, License No. SNM-1960, has been issued j
and we have retired License No. SNM-1578.
Your cooperation sith us is appreciated.
1 l
Sincerely, j
Original Signed By:
j John D. Kinaeman i
John D. Kinneman, Chief Nuclear Materials Section A 2
Nuclear Materials Safety & Safeguards Branch f
Division of Radiation Safety & Safeguards i;
cc:
Public Document Room (PDR)
Nuclear Safety Information Center (NSIC)
Commonwealth of Massachusetts I
j bcc:
Region I Docket Room (w/ concurrences)
M. Taylor, DRSS 1
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'Kinneman i
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l OFFICIAL RECORD COPY INQ LAWRENCE - 0001.0.0 09/12/85 l
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8510030381 850919 i
REG 1 LIC70 RETURN ORIGINAL TO gg g.,
j SP#f-1578 PDR REGION I ICUl'\\
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One General Street. Lawrence. Massachusetts 01S42 Tel. (617 )683-4000 22ibO June 27, 1985 "SECTION COPY" Region I U.S.
Nuclear Regulatory Commission ATTN: Chief, Nuclear Materials Sections A 631 Park Avenue King of Prussia, Penn.
19406 Gentlemen:
i
SUBJECT:
Notice of Violation, Docket #070-02116 In 1975, this hospital was issued License #SNM-1578 for the implantation of nuclear pacemakers.
Names on the license application were the hospital administrator, three thoracic surgeons, and a cardiologist.
Under this license, two pacemakers were implanted in 1976.
One of those pacemakers was explanted in February 1985 and this was returned to the manufacturer, Arco Medical Products Company, with the appropriate paper work.
That incident was my first knowledge of this license.
Since we no longer intend to implant any additional nuclear pacemakers, it was suggested that we cancel this license.
I now understand that this is in violation of NRC regulations.
The license apparently expired in 1981.
In order to comply with NRC policy, I am requesting that this license be reinstated, solely for the purpose of following the one patient with a nuclear pacemaker implanted.
When the pacemaker is explanted, we intend to return it to the manufacturer and terminate the license.
No additional nuclear pacemakers will be implanted.
The patient involved is currently under the regular card of one of the physicians originally named on the license application.
We intend
^
to follow all protocols as contained in the original application.
The pacemaker involved was manufactured by Arco Medical Products Company and it is Model #NU-5D-592, Serial #B-251 83-481.
An ammendment or extension of the license was applied for in 1977 to cover Cordis pacemakers, but none of these were ever received or implanted and we do not need this portion of the licence in effect any longer.
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.g The name of the hospital Administrator on the criginal license, R.
Ashton Smith, should be changed to the current Administrator 1
~
Tho!aas F.
Hennessey.
We currently hold a Nuclear Medicine license fcr diagnostic and limited theraputic purposes.
This license is 20-05655-01.
I under-I stand that no fee for the pacemaker license re-application is necessary.
Now that we in the Department of Suclear Medicine are aware of the necessity for maintaining the license until the outstanding pacemaker is returned, we will do everything to assist those named in the license applicaticn to comply with all NRC regulaticns.
Sincerely, mussyf Ac /@
[ James W.
Be:i t t ie, M.D.
Director of Laboratory Medicine JWB/jt l
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