ML20211K761
| ML20211K761 | |
| Person / Time | |
|---|---|
| Site: | 07002213 |
| Issue date: | 02/09/1976 |
| From: | Castle L, Sheldon W CLEVELAND CLINIC FOUNDATION, CLEVELAND, OH |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20211K381 | List: |
| References | |
| 0325, 325, NUDOCS 8702260662 | |
| Download: ML20211K761 (2) | |
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CLEVELAND CLINIC
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216/229-2200 = CABLE: CLEYCLINI g
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M Chief, Materials Branch
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Fuel Cycle Facility Licensing G
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20555 Re: Application for license to participate in the research study involving the inplantation of Coratanic C-100 Series nuclear-powered pacemakers.
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'Ihc following information is subnitted in application for a license to participate in the investigational progrz.n utilizing the Coratanic C-100 nuclear powered pacer.
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Cleveland Clinic 9500 Euclid Avenue l' T _ _ O Cleveland, Ohio 44106
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Ion W. Castle, M. D.
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216-229-2200 Extension 1337 States Licensed to Practice in: Ohio and Pennsylvania Specialty Board Certification: Internal Medicine and Cardiology Previous experience in clinical irplantation and follow-up of pacemakers for five years at the Cleveland Clinic. Have implanted close to 500 pacmakers to date. Have an annual follow-up of about 1,600 checks per year by telephone or in Pacemaker Clinic.
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'Ihe protocol to be followed is the human clinical protocol for Coratanic C-100 series radioisotope powered cardiac pacers dated July 1, 1975. A maximum of three Coratanic C-100 series would be requested for an annual inplantation.
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'Ihe pacmakers are inplanted in the Cardiac Catheterization Lab, usually under a local anesthetic. An image intensifier is utilized for fluor-oscopy purposes. Stimulating and sensing thresholds are measured by the Medtronic 5300 pacemaker systms analyzer. 'Ihresholds are checked
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G ief, Materials Branch February 9, 1976 Re: Application for license Page 2 by voltage and millianperage with olmes resistance calculated and millivolts sensing signals are recorded. We are inplanting about 150 pacemakers per year and have about 600 patients in our pacxmCmr follow-up system. 98% of our pacmakers are inplanted by endocardial methcd with about 2% using myocardial 1mM. About 98% of our patients are done under local anesthetic.
Our records are maintained both in the patients chart and in a separate pacmaker file where all patients are listed irxlividually. Because of the size of our follow-up system we are now at the present time beginning to ccmputerize our pacmaker clinic.
Adequate security exists at the Cleveland Clinic to have appropriate control procedures to insure the physical security of the pacmakers.
h units will be kept track of by their serial numbers and locations.
h y will be under lock and key when not in use. 'Ihese should confirm to regulations under Title X, Code of Federal Regulations Part 70.
Follow-up for pacmaker probles cme to the Cleveland Clinic through the pacemaker watts line. 'Ihis is open for information 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a day seven days a week. Ihis number is area code 216-229-8751. We are familiar with Coratamic C-100 series protccol and that we confirm that the applicant institution, neaning us, agrees to continue the follow-up reporting and recovery procedures during the life of the patient and until the &c-ker's recovered and returned to Coratcmic Inc., P. O. Box 434, Indiana, Pa.
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- 13. h applicant, hospital or medical institution hc;~ W requests a license to receive, possess, store, and inplant the Coratmic C-100 Series nuclear powered pacmaker in accordance with this application.
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Cleveland Clinic hw Lon W. Castle, M. D.
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--~m William C. Sheldon, M. D.
Head, Depart 21ent of CardioloJy Reviewed by Mr. Edward S. Chernak, Radiation Safety Officer for Cleveland Clinic