ML20214V309
| ML20214V309 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 06/26/1985 |
| From: | Swanson C MEDTRONIC, INC. |
| To: | Mallett B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20197E336 | List:
|
| References | |
| 79277, NUDOCS 8610020238 | |
| Download: ML20214V309 (6) | |
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MedtrOniC U 30TE"Notwayeignt P.O. Box 1453 Minneapolis, MN 55440 USA Telershone: (612) 574-4000 June 26, 1985 Cable: Medtronic Telex: 29-0598 Dr. Bruce Mallett Materials Licensing Section U.S. Nuclear Regulatory Commission 799 Roosevelt Road Glen Ellyn, Illinois 60137 Gentlemen:
The purpose of this letter is to apply for renewal of License SNM-1156 initially granted September 30, 1969.
This license expires June 30, 1985.
Information for license renewal as specified in Title 10 CFR S70.21, S70.22 and S70.33 is provided below or incorporated by references to the license and amend-ments.
Seven copies of this license reneuul appli cati ^n nva _
enclosed.
Applicant. g CgJJtL,,,
Cl:eck H. 3-jMQ 1)
Applicant 2-d Am UniJet Typeu ree f M
Medtronic, Inc.
U 3055 Old Highway Eight P. O. Box 1453 Dale [! cck Sc; 1 7.
,,I,1, Minneapolis, Minnesota 55440
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Medtronic, Inc. is incorporated in the State of innesota with Corporate Headquarters at the address listed above.
Principal Officers of the Corporation and their residential addresses are as follows:
Earl Bakken Richard Sauter 5424 West Bavarian Pass 205' Kentucky Avenue North Fridley, MN 55432 Golden Valley, MN 55427 Raymond Dittrich Donald Stone 685 Old Long Lake Road 1721 Canyon Lane Wayzata, MN 55391 New Brighton, MN 55112 Richard Pact Michael Boris 5656 Woodcrest Drive 18205 Third Avenue North Edina, MN 55424 Plymouth, MN 55447 Lowell Jacobsen Franklin Rick 6750 Olde Sturbridge 15879 Tonkawood Drive Hamel, MN 55340 Minnetonka, MN 55343 Dale Olseth John Pfouts 132 Homedale Road 5912 Schaefer Road Hopkins, MN 55343 Edina, MN 55436 Gerard Planchon 4701 Golf Terrace RECEIVED JUL 2 1985 Edina, MN 55424 8610020238 860811 JUL 011985 REG 3 LIC30 SNM-1106 PDR gg g,7gg77
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With the! exception of-Mr. Gerard Planchon who is a' citizen of France, all principal officers are U.S. citizens.
No control or controlling stock ownership is exercised over Medtronic, Inc. by any alien, foreign corporation or foreign-government.
-2)
Activity for Which the Special' Nuclear Material is Requested Sealed plutonium sources are used as a power source for a cardiac pacemaker, specifically the Medtronic@ Model 9000.
Medtronic,:Inc. no longer manufacturers or sells nuclear powered cardiac pacemakers.
License renewal is requested for the possession of sealed plutonium sources where the primary activity is associated with the receiving, analyzing and storing of explanted pacemakers.
No tests or-other activities will be performed that will in any~way compromise the containment of the encapsulated plutonium source.
As described in our license (SNM-1156) and amendments, anal-ysis.and stcrage of sealed nuclear sources and nuclear powered. cardiac. pacemakers will occur at the following locations:
Rice Creek Facility 7000 Central Avenue Minneapolis, MN 55432 Research Facility 1500 Northdale Blvd.'
Minneapolis, MN 55433 The following facility is no longer being used for analysis and storage of sealed nuclear sources and nuclear powered pacemakers:
St. Anthony Facility 3055 Old Highway Eight Minneapolis, MN 55418 Also, as described in our license and amendments, we are allowed to store one Medtronic Model 9000 pacemaker at each of seven of our District Offices.
This was done to minimize delays and uncertainties in shipping these pacemakers to physicians and their patients.
Medtronic wishes to retain storage capability at the District Offices listed below to provide a way-station, if necessary, in the return of explanted nuclear pacemakers to Medtronic's facilities in Minneapolis.
The District Offices are:
Medtronic, Inc.
Executive Place V, Suite 204 60 Mall Road Burlington, MA 01803 Medtronic, Inc.
l Summit Square, Suite 102 Langhorn, PA 19047 Medtronic, Inc.
I 1901 North Moore Street, Suite 802 Arlington, VA 22209 Medtronic, Inc.
29100 Northwestern Highway, Suite 265 Southfield, MI 48034 Medtronic, Inc.
23811 Chagrin Blvd., Suite 335 Beachwood, OH 44122 l
Medtronic, Inc.
60b6 bsn 1e L
Medtronic, Inc.
111 Westport Plaza,- Suite 1015 St. Louis, MO 63146 3)
Time Period of License License renewal is requested for a period of five (5) years i
through June 30, 1990.
4)
Name, Amount and Specifications of Nuclear Material The plutonium sources (Alcatel-GIPSIE) contain Pu as the principle isotope.
Possession limit under licggge SNM-1156 I
is 125 grams total with no more than 1 gram Pu per source.
It is requested that this limit be continued.
Detailed information with respect to the chemical and phys-ical form of plutonium sources has been supplied previously under license SNM-1156 (Docket No. 70-1209).
5)
Oualification of Applicant Medtronic has had over ten years of experience in the design, manufacture and testing of implantable nuclear powered car-diac pacemakers.
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'Mr. Thomas Hawkinson is the Radiation Safety Officer for Medtronic.
His qualifications are provided in Attachment 1.
Current members of the Radiation Safety Committee are as follows:
Thomas Hawkinson, Chairman and Radiation Safety Officer; Charles Swanson, Ph.D., Director of Regulatory Affairs; Kenreth Kopesky, Manager of Product Analysis; Richard Holm, Manager of Configuration Assurance; and Rama Padmanabhan, Staff Scientist.
All Medtronic personnel responsible for the handling and
' testing of sealed nuclear sources and nuclear powered pace-makers have been instructed in proper handling and storage procedures as required by our License (SNM-1156).
6)
Equipment and Facilities Facilities in which sources are held and equipment used in monitoring and measuring are described in license SNM-1156 and amendments.
7)
Procedures to Protect Health <and Minimize Danger Security precautions and monitoring procedures to protect health and minimize danger to life or property are described in license SNM-ll56 and amendments.
As required by 10 CFR 170, a check for $350 is enclosed as the renewal fee for this license renewal application.
Communicetions with respect to this application for license renewal should be directed to Charles H.
Swanson, Ph.D. at the i
telephone number listed below.
Sincerely, MEDTRONIC, INC.
VW Charles H.
Swanson, Ph.D.
Director, Regulatory Affairs (612) 574-3409 CVs Att.
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conmot so. 7 92,% %
CURRICULUM VITAE THOMAS E. HAWKINSON Home Telephone: (612) 789-4832 4349 McLeod Street N.E.
Office Telephone: (612) 574-3655 Columbia Heights, MN 55421 PROFESSIONAL EXPERIENCE:
MEDTRONIC, INC., Minneapolis, Minnesota January 1985 to Present Health, Safety and Environmental Affairs Administrator Duties include management of corporate health, safety and environmental strategy and program.
Padiation Safety Officer for sealed and non-sealed isotopic sources and nonisotopic sources, including SNM Licenses 1156.
MEDTRONIC, INC., Minneapolis, Minnesota July 1978 to December 1984 Industrial Hygienist Duties include industrial hygiene assessments of workplace hazards, de-sign of engineering controls, coordination with other corporate health services, radiation surveys for isotopic and nonisotopic sources of ra-diation in the plant, and advising line managers on proper disposition of nuclear materials.
Radiation Safety Officer, NRC SNM 1156.
UNIVERSITY OF MINNES0TA Department of Environmental Health Septembe 1977 to August 1978 Teaching Assistant Duties included lecturing, supervising laboratorias, preparing and cor-recting problem sets, labs, and examinations, anc planning coursework for Environmental Health faculty.
E EDUCATION:
UNIVERSITY OF MINNES0TA, School of Public Health Minneapolis, Minnesota 55455 1978 Master of Science in Environmental Health Coursework included concepts of health physics, radiation measurements and dosimetry, and environmental radioactivity.
ST. OLAF COLLEGE, Northfield, Minnesota 55057 1974 B.A., Chemistry PUBLICATIONS AND PRESENTATIONS:
Fruland, J.E., R.C. Patterson, T.E. Hawkinson, " Evaluation of Two Ethylene Oxide Monitors for Interference by Selected Organic Solvents," American Industrial Hy-giene Conference, Las Vegas, Nevada, May,1985.
Pollock, R.A., T.E i awkinson, " Implementing a Hazard Communication Program," Amer-ican Industrial Hygiene Conference, Las Vegas, Nevada, May,1985.
Korpela, D.B., T.E. Hawkinson, " Surface Contamination Effects on Organic Vapor Monitors," American Industrial Hygiene Conference, Las Vegas, Nevada, May,1985.
CURRICULUM VITAE
-TdOMASE.HAWKINSON Home Telephone: (612) 789-4832 4349 McLeod Street N.E.
Office Telephone: (612) 574-3655 Columbia Heights, MN 55421 PROFESSIONAL EXPERIENCE:
MEDTRONIC INC., Minneapolis, Minnesota January 1985 to Present Health, Safety and Environmental Affairs Administrator Duties include management of corporate health, safety and environmental strategy and program.
Radiation Safety Officer for sealed and non-sealed isotopic sources and nonisotopic sources, including SNM Licenses 1156.
MEDTRONIC, INC., Minneapolis, Minnesota July 1978 to December 1984 Industrial Hygienist _
Duties include industrial hygiene assessments of workple e hazards, de-sign of engineering controls,. coordination with other corporate health services, radiation surveys for isotopic and nonisotopic sources of ra-diation in the plant, and advising line managers on proper disposition of nuclear materials.
Radiation Safety Officer, NRC SNM 1156.
n IVERSITY OF MINNES0TA Ctaartment of Environmental Health September 1977 to August 1978
_ Teaching Assistant Duties included lecturing, supervising laboratories, preparing and cor-recting problem sets, labs, and examinations, and planning coursework g
for Environmental Health faculty.
EDUCATION:
UNIVERSITY OF MINNES0TA, School of Public Health Minneapolis, Minnesota 55455 1978 Master of Science in Environmental Health Coursework included concepts of health physics, radiation measurements and dosimetry, and environmental radioactivity.
ST. OLAF COLLEGE, Northfield, Minnesota 55057 1974 B.A., Chemistry PUBLICATIONS AND PRESENTATIONS:
Fruland, J.E., R.C. Patterson, T.E. Hawkinson, " Evaluation of Two Ethylene Oxide Monitors for Interference by Selected Organic Solvents," American Industrial Hy-giene Conference, Las Vegas, Nevada, May, 1985.
Pollock, R. A., T.E. Hawkinson, " Implementing a Hazard Coninunication Program," Amer-ican Industrial Hygiene Conference, Las Vegas, Nevada, May,1985.
~ Korpela, D.B., T.E. Hawkinson, " Surface Contamination Effects on Organic Vapor Monitors," American Industrial Hygiene Conference, Las Vegas, Nevada, May,1985.
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K:rpsla, D.B., C.E. McJilton, and T.E. Hawkinson, " Ethylene Oxide Disp 3rsion from s
Gas Sterilizers," American Industrial Hygiene Association Journal, August 1983.
" Auxiliary Air Hood Field Evaluation," American Industrial Hygiene Conference, Philadelphia, Pennsylvania, May 1983.
" Radiation Aspects of Industrial Hygiene," University of Minnesota, Minneapolis, Minnesota, February 1983.
Hawkinson, T.E. and D.E. Barber, "The Industrial Hygiene Significance of Small Air Ions," American industrial Hygiene Association Journal, October 1981.
"The Industrial Hygiene Sionificance of Small Air Ions," American Industrial Hygiene Association Conference, Houston, Texas, May 1980.
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