ML20214V399
| ML20214V399 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 02/10/1977 |
| From: | Shawn Smith MEDTRONIC, INC. |
| To: | Singer B NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20197E336 | List:
|
| References | |
| 6160, NUDOCS 8610020272 | |
| Download: ML20214V399 (2) | |
Text
Medtronic, Inc.
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20555 to o)
ATTENTION: Mr. Bernard Singer
- 4 b,. dBii Gentlemen:
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The purpose of this letter is to apply for an amendment of the SNM-ll56 license granted September 30, 1969 and renewed on September 30, 1974.
This license and amend-ment accurately described conditions for use of sealed sources of plutonium in our facility except as outlined in this letter.
In a letter dated April 8, 1976, from Terry Stewart to Bernard Singer requesting renewal of SNM-ll56, a des-cription of the Radiation Safety Committee was provided to you.
The description of the Radiation Committee should be changed to read as follows:
Chairman of the Radiation Safety Committee and Radiation Safety Officer, Bob Griffin; Project Manager, Nuclear Pacemakers, Stephen Smith; Legal Counsel, Tom Lindstrom; Regulatory Affairs, Dave Juncker and Dr. Donald Barber (certified health physicist and professor of hygiene at the University of Minnesota) ; representatives of Quality Assurance, Finished Goods, and Physiological Research Laboratory.
In addition, the following changes are requested:
Amendment 11, Condition 10:
should be amended to add the following section:
"F.
The periodic leak test does not apply to sealed sources contained in pacemakers that have been sterilized and packaged."
Amendment 13, Condition 7:
should be amended to read "125 grams of plutonium," instead oN'-100' grams crf---
l, plutonium."
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cadment 14, dition 11:
should be ame d as follows:
- 1) change "May 23, 1977" to "May 23, 1978."
- 2) change "at the end of this four-year period, not more than 960" to "at the end of this five-year period, not more than 1,200."
We are requesting the addition to Amendment 11, Condition 10 because a leak test of sealed sources in packaged pacemakers would required resterilizing and repackaging the pace-maker.
We have never received a power source that failed the leak test.
We do not believe that exempting packaged pacemakers from a semiannual leak test presents any risks.
We are requesting the change to Amendment 13, Condition 7, because we are presently receiving nuclear power sources at a rate greater than we are selling Model 9000 pacemakers.
(Purchase orders for the power sources were placed approxi-mately three years ago, and assumed routine use and significantly expanded sales of nuclear pacemakers.)
We are requesting the change in Amendment 14, Condition 11, because our license to implant Model 9000s will expire on May 23, 1977 unless an extension is granted.
Your prompt attention will be greatly appre.:iated.
Sincerely, MEDTRONIC, INC.
'bd-rt hW Stephen Smith Project Manager Nuclear Pacemakers SS:awt
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October 7, 1976
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Mr. J. M. Brown, Jr.
Radioisotope Licensing Branch Division of Fuel Cycle and Material Safety U.S. Nuclear Regulatory Commission Washington, D.C.
20555
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Dear Mr. Brown:
Medtronic, Inc. would like Mr. Kenneth Clow to become i
its Radiation Safety Officer.
Attached in a brief I
v summary of his qualifications.
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Mr. Clow has an extensive background in security systems that qualifies him for the job.
Although Mr. Clow has no specific radiation safety training, he can receive excellent technical support from l
Doctor Donald E. Barber, a certified Health Physicist and consultant, and Mr. Bobby Griffin, former Medtronic Radiation Safety Officer.
If Mr. Clow is approved as
- Radiatign Safety Officer, I would like all correspon-dence concerning safety regulations sent to him.
Please notify me,if you have any further questions.
Sincerely, MEDTRONIC, INC.
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x Stephen C. Smith Manager of Nuclear Development 1721 SCS: jab E
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QUALIFICATION OF RADIATION SAFETY OFFICER l.
KENNETH CLOW I
EDUCATION B.S.
University of Maryland -- 1960 y
Major in Business Administration Minor in Political' Science g
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WORK EXPERIENCE
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Government, Central Intelligence Agency.-- 1960-1975 Medtronic, Inc., Corporate Security and Safety Administrator -- 1975 - present e
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Medtronic, Inc.
3055 Old Highway Eight Minneapolis, Minnesota 55418 USA Telephone 612 781-6061 Cable: Medtronic Telex: 29-0598 October 7, 1976 9f
.y Mrs. Pat Vace a Radioisotopes Licensing-Branch Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, D.C.
20555
Dear Mrs. Vacc a:
Medtronic, Inc. requests that the restrictions on the number of hospitals receiving licenses to implant Medtronic Model 9000 pulse generators be lifted.
Currently about 135 hospitals have these licenses.
Only 70 of these hospitals have ever implanted 9000's, and an even smaller number of hospitals have performed implants within the last year.
We believe that lifting the restrictions on the total number of licenses, but requiring hospitals to petition individually for licenses would satisfy the needs of the hospitals, the NRC, and Medtronic.
If you do not wish to remove the restrictions com-pletely, Medtronic, Inc. requests that the total number of licenses be increased to 300.
C ~NS..tlM 5 Sincerely, c.
3 MEDTRONIC, INC.
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as7 Stephen C. Smith k
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