ML20211K538

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Application for Renewal of License SNM-1659,authorizing Use of Pu-238 for Implantation in Humans as Component of nuclear-powered Cardiac Pacemakers
ML20211K538
Person / Time
Site: 07002213
Issue date: 07/09/1986
From: Aron S, Auble J, Go R
CLEVELAND CLINIC FOUNDATION, CLEVELAND, OH
To:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
Shared Package
ML20211K381 List:
References
81679, NUDOCS 8702260624
Download: ML20211K538 (2)
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THE CLEVELAND CLINIC FOUNDATION 03x)I?uclid Avenue Cleveland Ohio 44106 A National iteferral Center An International llcalth itesource r

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%h U.S. Nuclear Regulatory Conunission, Region III Materials Licensing Branch 799 Roosevelt Road 7

Glen Ellyn, IL 60137

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%7 July 9, 1986

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L_Date Completed The Cleveland Clinic Foundation wishes to renew its Special Nuclear Materials license, Number SNM-1659.

The institution's name and mailing address as they ait to har in items 1, and 2 of the renewed license are as follows:

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Cleveland Clinic s

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9500 Euclid Avenue N

Cleveland, Ohio 44106 We request that items 6, 7, and 8 as they appear on the license be as follows:

6A. Plutonium (Principal 6B. Plutonium (Principal 6C. Plutonium (Principal radionuclide Pu-238) radionuclide Pu-238) radionuclide Pu-238) 7A. Sealed Source (s)

78. Sealed Source (s) 7C. Sealed Source (s) 8A. 10 grams (40 individual 8B. 1.35 grams (6 individual 8C. 15 grams (60 individual sources not to exceed sources not to exce<d sources not to 250 milligrams each) 250 milligrams each) exceed 250 milligrams each)

The authorized use is as follows:

9A.

Inplantation in humans as a component of Coratomic Model C-101 nuclear powered cardiac pacemakers for clinical evaluation purposes.

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Implantation in humans as a component of Cordia Nuclear Omni-stanicor Model 184A nuclear powered cardiac pacemakers for clinical evaluation purposes.

Inplantation in humans as a couponent of Coratomic C-101-P isogpj.gw i: D 9C.

pacemakers.

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Page 2 July 9, 1995 Materials Licensing Branch A listing of physicians, (their qualifications and associated information) who are involved in our pacmaker program will be fowarded as soon as this information is received from our Cardiology Department.

Should you have any questions regarding this license renewal, please do not hesitate to call me at (216) 444-6645.

Sincerely, Steven J. Ron, Jr.,10f.D.

Radiation Safety Officer Q--

b Raymurido T. Go, M.D.

Chairman, Isotope Consnittee S C^-

JohriA. Auble Sec etary and General Counsel coaTnot so q' 16 7

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THE CLEVELAND CLINICFOUNDATION 0300littell(! Ave 1tse ClevelitrMl. 01110 44IOG,']L'.S.A.

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Ibuti.ition Safety 21(i/444 ti4 44.'s Augusi;[10,1984 U.S. Nuclear Regulatory Conmission hhterial Licensing Branch Division of Fuel Cycle & 1hterial Safety 799 Roosevelt Road Glen Ellyn, Illinois 60137 Gentlenen:

Please amend the following Cleveland Clinic Foundation Nuclear Regulatory Conmission licenses to name Steven J. Aron, Jr., Ph.D.

as Radiation Safety Officer.

1.

Cobalt-60 Teletherapy License (CCF Incation),

License Number 34-00166-02 l

CECEIVED BY LFf.B L.

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Cobalt-60 Teletherapy License (NASA location),

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License Number 34-00466-03

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Cesium-137 Irradiator_ License By...

censeTumber'34-0G166:01 Orig. Te.

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Special Nuclear Material License, Action Compt... p......

License Number SNM-1659 Documentation of training and experience are attached.

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A check for $580.00 total is enclosed to cover amendment fees of $230.00 for each of the two teletherapy licenses and $120.00 l

for the Cesium-137 irradiator license.

RECEIVED AUG 151934 EEGICM III tew['d tontrol No. 77298

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T uclear Regulatory Ccanission N

Letter to U.

August 10, 1984 Page 2 Should you have any questions, please do not hesitate to -'-

contact me at (21G) 444-2665.

Sincerely,

!Q' Steven J. Arpf, Jr., Ph.D./j Radiation SaTety Office U

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Raymundo T. Go, M.D.

Chainrnn Department of Nuclear Medicine

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4hattuck Vi. Hartwell, Jr., M.( l Director, Division of Professional'4ffairs SJA/ soc Attachment 1

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POnda NRC413MSUPPLEMENT A

"*8 U.S. NUCLEAR REOULATORY COMMISSION TRAINING AND EXPERIENCE AUTHORIZED USER OR RADIATION SAFETY OFFICER

1. NAuE OF AUTHORIZED USER 04 MADIATION SAFETY OFFICER
2. STATEbA TERR 4 TORY IN Steven J. Aron, Jr., Ph.D.

WWNICM LICENSED TO eAACTica uspiCmc 1 CERTIFICATION N TY80ARD CATEGOAV A

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4. TRAINING RECEIVED IN mASIC RAOf 0080 TOPE HANDLING TEQWlOUES

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P6ELO OF TRA4NWG LECTUmst swamVsSEO A

LOCATION AND OATEIB) OF TRA8N8880 LAaOAATOAY LAeORATeav e

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s. AAOIATmN PHYSICS ANO

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h. RADIATION PAOTECTION i

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5. EXPERIENCE WITH RADIATION. (Ashast um *# """~ er f~J" t Emperdensel IsofcpE naaviaanma AnnouseT wwsne axesatssecs was casuso GuaAnces or exesassaece Type op w e SEE ATTACHED LIST i

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' LOCATION AND DATES OF TRAINING 1.

Cleveland Clinic Foundation November, 1982 - Present i

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Republic Steel Corporation i

December,1963 - September,1982 3.

Case Western Reserve University September,1964 - June,1969 4.

Michigan State. University September,1962 - December,1963 5.

University of Detroit September,1958 - June,1962 k

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' WORK' EXPERIENCE.

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November, 1982 - Present Assistant Radiation Safety Officer for the Cleveland Clinic Foundation Worked closely with the Foundation's Radiation Safety Officer since November, 1982 to present.

Performed all duties normally handled by the Radiation Safety Officer.

See List.

2.

December, 1963 - September, 1982 Nuclear Systems Specialist for Republic Steel Corporation Responsibilities included research and development for the safe use of radiation sources in the steel industry.

Worked in the Nucleonics Division and in the Chemistry Department.

Other duties included teaching radiation detection techniques, radiation safety, and spectrometric principles.

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RADIATION SAFETY DUTIES Administrative Functions Personnel Monitoring Program Film Badge Reports to Personnel Radiation Safety Documentation Interact with Users of Radiation Sources Bioassay Program Semi-Annual Radiation Safety Audits and Inspections Alara Program License Renewals and Amendments Cesium-137 Irradiator Program Survey Meter Calibrations Radiation Safety Lectures and Seminars I

Sealed Source Leak Tests Radiation Therapy Interlock Checks Purchase, Use and Disposal of Radioactive Materials l

Dose Calibrator Program Quarterly Radioisotope Committee Meetings l

Compliance with NRC, FDA and other Regulatory Agencies Reports to NRC On-Site NRC Inspections j

Radiation Safety Office Activities Report (Quarterly) l

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' EDUCATION I

University of Detroit B.S. Physics, Mathematics 1958-1962 Michigan State University M.S. Physics 1962-1963 Case Western Reserve University Ph.D. Nuclear Engineering i

1964-1969 SUPPLEMENTAL' EDUCATION Nuclear Medicine Associates l

Medical Radiation Safety Officer's Course January,1983 i

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' PERTINENT C0VRSE' WORK University of Detroit' Courses Hours

  • University Physics I lb0 Chemistry I 80 Calculus I 80 University Physics II 100 Chemistry II 80 Calculus II 80 Differential Equations 60 Advanced Calculus I 60 Theoretical Mechanics I 60 Thermodynamics 60 Advanced Calculus I'I 60 Advanced Physics Laboratory 20 Theoretical Mechanics II 60 Electricity and Magnetism 60 Senior:' Physics Seminar 40 Applied Mathematics I 60 Wave Motion and Sound 60 Modern Physics 60 Advanced Mechanics Lab 20 Senior Tutorial 40 Advanced Acoustics Lab 20 Physical Optics 60 Applied Mathematics II 60
  • Semester Basis 4

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Michigan ~ State University ~ Courses Hours

  • Theoretical Mechanics 39, Classical Electrodynamica 39 Atomic Physics I 39 Theoretical Mechanics II 39 Classical Electrodynamics II 39 Atomic Physics II 39 Theoretical Mechanics III 39 Classical Electrodynamics III 39 Atomic Physics III 39 Physics Research I 78 Complex Variable Theory 52 Quantum Mechanics 39 Physics Research II 78
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Case Western: Reserve University Courses HUurs*

Nuclear Reactor Analysis I

$0 Nuclear Electronics 20 Applied Nuclear Phenomena 60 Nuclear Reactor Analysis II 60 Nuclear Measurements Laboratory 60 Quantum Mechanics I 60 Quantum Mechanics II 60 Partial Differential Equations 60 Experimental Nuclear Physics 60 Mathematical Probability 60 Thesis I 180 Thesis II 180 i

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' EXPERIENCE'WI7H' RADIATION 1.

Republic Steel Corporation December, 1963 - September, 1982 Isotope Amount Type of Use

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Cs-137 1 Ci Safety Ray Development Co-60 1 mci Backscatter Experiments Am-241 1 Ci X-Ray Fluorescence Cf-252 1 mg Process Mn Measurement Fe-55 5 mci Cr and V Analysis Na-22 10 mci Blast Furnace Stock Gaging

- C-14 0.1 mci Radioisotope Tagging H-3 0.5 mci Radioisotope Tagging Pu-238 20 mci X-Ray Fluorescence Analysis Cd-109 5 mci X-Ray Fluorescence Analysis I-125 50 mci Low Alloy Steel Analyzer P-32 1 mci Plate Thickness Measurement Am-Be 1 Ci Neutron Activation Work TH in Ore Natural Radiation Safety U in Ore Natural Radiation Safety Cr-51 1 uCi Neutron Activation Ra-Be 1 mg Moisturay Studies Other Type of Experience Electron Beam Welder Shielding Design for Radiation Safety of i

Equipment and Radiation Dosimetry of Installation X-Ray Diffractometer Quantitative Analysis Electron Microprobe Semi-Quantitative X-Ray Analysis Neutron Howitzer Activation Analysis 2.

Case Western Reserve University September,1964 - June,1969 Isotope Amount Type of Use Tc-99 5 uCi Laboratory Experiments Po-210

.1 uCi Laboratory Experiments Ra-DEF Laboratory Experiments P-32 Small Laboratory Experiments Sr-90 Small Laboratory Experiments Cs-137 10 uCi Laboratory Experiments

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' EXPERIENCE WITH RADIATION (Continued)

Other-Neutron VanDeGraff Generator Neutron Slowing Down Time Measurement 4

3.

Cleveland Clinic Foundation November, 1982 - Present Isotope

' Amount Experience /Use Tc-99m 30 mci Dose Calibrator Linearity Testing I-131 1 mci Bioassay Program Mo-99/Tc-99m 2.7 Ci Elution, Dose Measurement Shielding and Waste Disposal of Generators (Syncor International Corp.)

All Research Therapeutic Radiation Safety Survey of, Measurement of, and Medical Diagnostic Shielding for and Associated Personnel Radioisotopes Research Monitoring (Semi-Annual Leak Tests for all Used at the Quantities SealedSources)

Cleveland Clinic Foundation Including Brachy Therapy Sources, Co-60 Teletherapy Units (2) and Cs-137 Irradiator Equipment e

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TRAINING RE(,EIVEd DURING THE 6,.

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4 Handling Radiation Accident Victims Decontamination Procedures Waste Disposal k

+ r Calibration of Survey Meters Review of Radioimmunoassay Procedures Code of Federal Regulations,10 CFR Parts 19,20,30.11,32dnd3$

Radiation Safety in the Therapeutic Use of Sealed Sources and I-125 Seeds Including Nursing Instructions, Receipt / Shipment Records, Use Records, Radiation Survey Fonns, Wipe Tests for Contamination Guidelines for Emergency Surgery or Death of the Radioalctive Patient Radiation Safety Procedures and Nursing Instructions for Therapeutic Use of Radiopharmaceuticals Instructions to Housekeeping for Cleaning in the Nuclear Medicine i

Department i

NRC Violation Categories and Fines t n Diagnostic and Therapeutic Misadministrations Under 10 CFR 35.41 Procedures and Precautions for Use of Radioactive Gases (Xe-133) i 4

Personnel Monitoring / Film Badges - Notifications, Reports, Records Standards of Radiation Protection in Diagnostic Radiology and X-Ray 4

Therapy Including Specifics of Patient Radiation Protection Rules for Safe Handling of Radiation Sources (NRC and NCRP)

Regulatory Guides for the Preparation of Applications for Medical Programs Shipment / Return of Radioactive Material and Department of Transportation Regulations i

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TRAINING RECEIVED DURING THE MEDICAL RADIATION SAFETY'0FFICER'S COURSE x,,

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R.egulatory Guide for Alara and Bioassay Programs Guidelines for Applications for Registration of Devices Guidelines for Applications for Registration of Sealed Sources Model Program for Maintaining Occupational Radiation Exposures at Medical Institutions'ALARA

s zj Nuclear Medicine Department Records Including NRC License State

.c License, Instrumentation (Cameras, Wells, Scanrers, Up-Take Probes, Dose Calibrators and Survey Meters), Radiopharmaceutical Receipts, Radiopharmaceutical Utilization (Generator Systems, Kits, Multi and Uni-Dose Vials), Waste Disposal, Sealed Sources, Radiation Safety Sources and Signs and Notices Dentrol No. 77298

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/&fintW MB cop,ytt%;., gU OMATic;m f (p;pp7pp THE CLEVELAND CLINIC FOUNDATION 7

7"~~DMsion of Radiology

  • 9500 Euclid Avenue. Cleveland. Ohio 44106. U.S. A.
  • 216/444 2200
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U.S. Huclear Regulatory Commission Region 3 qA Glen Ellyn, Illinois 60137

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Dear Dr. Cooper,

With receipt of this letter please renew our special Nuclear Material License (SNM-1659), which is expiring on July 31, 1981.

As per our telephone. conversation, I understand no license fee need be included for this renewal.

We have never implanted a nuclear pacemaker nor is it intended in the foreseeable furture that such a pacemaker will be inserted.

However, we do wich to sustain this possibility by maintaining the license.

Should you has. any questions please do not hesitate to con-tact me.

Sincerely, I

RECEIVED Y 1.FMD hf

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William pavlicek, M.S.

Radiation Safety Officer

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cc: Dr. Lon Castle

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