ML20211K706
| ML20211K706 | |
| Person / Time | |
|---|---|
| Site: | 07002213 |
| Issue date: | 04/19/1976 |
| From: | Castle L, Cook G, Sheldon W CLEVELAND CLINIC FOUNDATION, CLEVELAND, OH |
| To: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20211K381 | List: |
| References | |
| 1931, NUDOCS 8702260654 | |
| Download: ML20211K706 (5) | |
Text
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1931 CLEVELAND CLINIC THE CttN!C 01NTER
- 9300 E'.; CUD AVENUE. CLEVEL AND. OHIO 44106. U S A.
212 '44 2200 CABLE: CLEvCttN:C Civ.
April 19, 1976 Mrs. Patricia Vacca Chief, Materials Branch Divisicn of Paterals and Fuel Cycle Facility Licensing U.S. Nuclear Regulatory Comnission Washing on, D. C.
20555 Re: Application for license to participate in the research study involving the inplantation ofOnni-Stanicor184 nuclear powered pacemakers.
Dear Mrs. Vacca:
The following inforaation is subnitted in application for a license to participate in the investigational program utilizing the Coratamic C-101 nuclear podered pacenaker.
1.
Clereland Clinic 95C'> Euclid Avenue Clereland, Ohio 44106 2.
Icn W. Castle, M. D.
Clereland Cliaic 9503 Euclid Avenue Clereland, Ohio 44106 216-444-6792 Sta_es licensed to Practice in: Ohio and Pennsylvania Position: Head Section of Cardiac Pacanakers Training: Medical School - Terple University, Philadelphia, Pa.
Fedical training - Gersinger Medical Center, Darnville, Pa.
and VSAF Hospital, Little Rock, Arkansas Cardiology Fellowship - Cleveland Clinic Specialty Board Certification: Internal Medicine and Cardiology Precious experience in clinical implantation and follow-up of pac-rakers for five years at the Cleveland Clinic.
Have implanted close to 500 pacanakers to date. Have an annual folloa-up of about c
1,E00 checks per year by telephone or in Pacercaker Clinic.
I 8702260654 861021
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' Chief, Materials Branch April 19, 1976 Re: Application for license Page 2 2.
William C. Sheldon, M. D.
Cleveland Clinic 9500 Euclid Avenue Cleveland, Ohio 44106 216-444-6725 States licensed to Practice in: Ohio, Illinois, and Wisconsin Position: Head, Department of Cardiology Training:
B.S. - Northwestern University, Evanston, Illinois, 6/15/53 M.D. - Northsestern University, Chicago, Illinois, 6/17/57 Intern - Passavant Memorial Hospital, Chicago, Illinois, 1957-1958 Internal Medicine Residency - Veterans Administration Research Hospital, Chicago, Illinois, 1958-1960 Fellowship - Cardiovascular Disease, Cleveland Clinic Foundation, 1960-1962 Associate and Assistant Staff - Department of Prvliatric Cardiology
& The Cardiac laboratory, 1962-1964 Staff - Department of Cardiovascular Disease &
The Cardiac Iaboratory, 1964-1975 Chairman -- Department of Cardiology,1975 -
Certified: National Board of Medical Exannners, July 9,1958 American Board of Internal Medicine, April 27, 1967 American Board of Cardiovascular Disease, May 10, 1969 3.
Protocol to be follcwed:
HUMAN CLINICAL PROICOOL FOR THE ONI-STANICOR RRADIOSOIOPE POPERED CARDTAC PACERS DATED Noventr 1,1975.
4.
A maximum of 20 Quni-Stanicor184 pacemakers is requested to be implanted annually during the study.
5.
a) Paccmakers are implanted in the Cardiac Catheterization Iaboratory, usually under local anesthetic. An image intensifier is utilized for fluoroscopy purposes (transvenous electrode). Stinulating and sensing thresholds are measured by the Medtronic 5300 pacemaker systans analyzer. Thresholds are checked by voltage and milli-amperage with Ohms of resistance calculated and millivolts sensing signals are calculated.
b) The Heart Floor into which the patient is moved after surgery contains 19 semi-private roans. These contain hard wire cardiac monitoring units. There are six portable defibrillators, eight datascopes to monitor aterial pressure, and Medtronic external pacarakers which are kept in the Cath Iab Pacemker Room.
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Chief, Materials Branch April 19, 1976
- Po : Application for license Page 3 1931 5.
c) 'Ihe Heart Floor, which is four wings of 19 semi-private rooms is staffed by cardiac trained nurses and technicians. Pacemaker patients are monitored closely for 5-7 days before being discharged.
6.
At the tune of each pacenaker implant the epicardial or endocardial electrccardes threshold stimulation, R wave sensing, are measured with the Medtronic 5300 pacer systen analyzer. The same electrode testing procedure is also done with all pacemaker replacements. At each implant an EU is obtained and a follm-up and reporting pro-cedure is utilized during the life of the pacemaker. Present exami-nation times at which DG's are taken, are at initial implant approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after inplant, at time of discharge, and at two nonth intervals thereafter. Records are kept in the Pacemaker Clinic located within the Cleveland Clinic.
7.
Our records are maintuned both in the patients chart and in a separate pacenaker file where all patients are listed individually.
Because of the size of our follow-up system we are nw at the present tire beginning to cotiputerize our Pacemaker Clinic. At each follm-up examination, an EKG strip with and without application of a magnet to irduce fixed rate operation of the pacer is utilized. This follm-up proc-dure is corducted at the follwing intervals after implant one racnth, two months until pacer is removed. It is recognized that general medical care may be more frequent than this, but this is the nunimal tine between tests of pacer function for purposes of this study.
The following forms will be executed as discussed in the Caratcmic-C-101 Novreber 1, 1975 protocol:
a) Registration and inplantation data form b) Follm-up data form c) Pacer failure and removal of patient death form d) Inform consent for surgical implantation or radioisotype powered cardiac pacer form e) Donor cards for adults or donor cards for minors f) Properly executed instructions for hospital telephone operator and patient identification cards g) Instruction for hospital telephone operator is shown as attachrant #1 of this subnission All pacenaker records are kept at the Cleveland Clinic, Paccnaker Clinic.
All referring physicians will receive pacemaker evaluation report.
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C Chief, Materials Branch April 19, 1976 Re: Application for license Page 4 8.
Adequate security exists at the Cleveland Clinic to have appropriate control procedures to insure the physical security of the pacmakers.
The units will be kept track of by their serial nu:rbers and locations.
They will be under lock and key when not in use. 'Ihese should confirm to regulations under Title X. Code of Federal Pagulations Part 70.
9.
The pacenaker coordinators, Patricia Golden and Gloria Newton, are responsible for all pacmaker follw-up examinations. They will be responsible for giving the hospital telephone operators written instructions concerning the notification of appropriate individuals upon receipt of mergency report and inquiry concerning a pacemaker bearer. The coordinators will also be responsible for personal discussions with each telephone operator. 'ihe form used for this purpose is shown as Attachment 1.
- 10. The physicians responsible for and participating in the study have certified that they are fail. tar with theQani-Stanicor 184 Protocol and the Quni-Stanicor184 isotopic pacer. They understand that the issuing of a license amendment is conditional upon the following of the protocol.
- 11. '1he Cleveland Clinic agrees to continua tha follow-up reprting and recovery procedures during the life of the patient and until the pacemaker is recovered and returned to Cordis Corporation, P.O. Boy.
370428, Mianu., Fla. 33137 even in the event the physicians naned in the application to participate in the study are no longer associated with the applicant.
- 12. 'Ihe packaging, labeling and shipping instructions founded by Cordis Corp.
will be follmed upon return of the pacmaker for approved disposal.
- 13. 'Ihe Cleveland Clinic hereby requestis a license to receive, possess, store, and irplant the Quni-Stanicor Series nuclear powered paceraker in accordance with this applicatien.
CONTINUED ON NEXT PAGE FOR PHYSICIANS SIGWIUIES
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. Chief, Materials Branch April 19, 1976 Pe: Application for license Page 5 1S31 Mr. Gilbert Cook Hospital Mministrator
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- b Lon W. Castle, M. D.
Head Section of Cardiac Pacemakers L
William C. Sheldon, M. D.
Head, Department of Cardiology i
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