ML20235B350
| ML20235B350 | |
| Person / Time | |
|---|---|
| Site: | 07002174 |
| Issue date: | 12/17/1975 |
| From: | Strickler J SOUTHEAST MISSOURI HOSP., CAPE GIRARDEAU, MO |
| To: | US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20235B300 | List: |
| References | |
| 2458, NUDOCS 8902130229 | |
| Download: ML20235B350 (6) | |
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SOUTHEAST HOSPITAL C.
J 1701 Lacey, Cape Girardeau, Mo. 63701 Phone (314) 334-4822 Lg W
December 17, 1975 (b
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Chief, Materials Branch i
Directorate of Licensing and Regulation U. S. Nuclear Regulatory Commission Washington, D.C.
20545 Re: ' Application for License to Participate in the Research Study Involving the Implantation of Coratomic C-101 Series Nuclear Powered Pacemaker, Containing 250 Milligrams of Pu-238--4.3 Curres.
Gentlemen:
The following information is submitted in application for a license to participate in the investigational program utilizing the Coratomic C-101 series nuclear powered pacer.
1.
Applicant:
Southeast Missouri Hospital 1701 Lacey Street Cape Girardeau, Missouri 63701 g
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Physicians responsible for study:
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Name:
C. R. TALBERT, JR., M.D.
Office address:
14 Doctors' Park Telephone number:
314-334-4444
' State license in which to practice:
State of Missouri j$
Specialty Board Certification:
Eligible for Internal Medicine M JD Board Examination Em'i Training Internship: The Jewish Hospital, St. Louis, Mo. 1959-60; NE Residency, Internal Medicine, The Jewish mxm Hospital, St. Louis, Mo. 1960-62.
Fellowship: Clinical Cardiology, University of Missouri, 1962-63 Position with applicant: Active Staff member Southeast Hospital and St. Francis Hospital, Cape Girardeau, Mo.
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Chief, Section of Cardiology, St. Francis Hospital, 1967-1971 I
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Chairman, Intensive Care Committee, St. Francis Hospital, 1970-71 k
Chairman, Coronary Care Committee, Southeast Hospital, 1970-73 s
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Consultant, Missouri Regional Program i
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Automated Patient History Study L-
- iji, Project Director, " Cardiac Care Missouri" demonstration project g
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1971-present l
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U. S. Nuclear Regulatory Commission December 17, 1975 Page 2 h
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Name: WILLIAM KIEKLAND BOWMAN, JR., M.D.
Office address:
14 Doctors' Park Telephone number:
314-334-4444 Stace. license in which to practice: Mississippi, 1960, Tennessee, 1966, i
Kentucky, 1967, Missouri, 1972 Training: University of Tennessee, Memphis, Tennessee, 1957-60
' John Gaston Hospital, Internship, Memphis, Tennessee, 1960-61 John Gaston Holpital, Internal Medicine' Resident, 1961-1963 Renal Fellowship, D.C. General, Washington, D.C... 1963-64 Cardiology Fellowship, University of Tennessee, 1964 Position with applicant: Active Staff member Southeast Hospital and St. Francis Hospital, Cape Girardeau, Mo.
Half-time instructor and private practice, Memphis Tennessee, 1966-67 Tover Clinic, Madisonville, Kentucky, 1967-72.
Internal Medicine Group, Cape Girardeau, Mo., 1972 - present c.
Name: JERRY L. KINDER, M.D.
Office address:
10 Doctors' Park Telephone number:
314-334-3074
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State license in which to practice: Missouri Specialty board certifications: American Board of Surgery Training:
Internship, St.-Louis City Hospital, St. Louis, Mo., 1960-61
' Residency City Hospital, St.-Louis, MO., July 1961-November 1961 Louisiana State University, New Orleans, La.. VA Hospital and Charity Hospital of La., 1963-66 Position with applicant: Active Staff member, Southeast Hospital, Chief of Surgery, Active Staff member, St. Francis Hospital Surgery, Cape Girardeau, Mo. 1966 to present; incorporated with three other Board Certified surgeons.
d.
Name: ROBERT S. HUNT, M.D., F.A.C.S.
Office address:
10 Doctors' Park Telephone number:
314-334-3074 State license in which to practice: Missouri Specialty Board certification: American Board of Surgery 4 Training:
Internship, Barnes Hospital, St. Louis, Mo., 1963-64 Residency, Barnes & Affiliated Hospitals, St. Louis, Mo. 1964-68 Position with applicant: Active Staff member, Southeast Hospital and St. Francis Hospital, 1970-present Chief of Surgery 275th Surgical Hospital, Republic of Viet Nam 1968-70 j
Surgery, Cape Girardeau, Mo. 1970 - present e.
Name:
CHARLES P. McGINTY, M.D.
Office address:
10 Doctors' Park Telephone number:
314-334-3074 State license in which to practice: Missouri
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U. S. Nuclear Reguletory Commiesion December-17, 1975 Page 3 e.
Dr. McGinty (Continued)
Specialty Board certification: American Board of Surgery,1958, American College of Surgeons, Member, Board of Governors, Co-Chairman Committee of Chapters, Cancer Liaison, Fellow for State of Missouri Training: Residency, Barnes Hospital, St. Louis, Mo., St. Luke's Hospital, St. Louis, Mo. finishing June 1955 Position with applicant:
Southeast Hospital, Active Staff, Chief of Staff, 1965, St. Francis Hospital, immediate Past President, presently Chief of Surgery Missouri Delta Community Hospital, Sikeston, Mo., Consulting Staff Surgery, Cape Girardeau, Mo., 1955 to present f.
Name: MELVIN C. KASTEN, M.D.,
F.A.C.S.
Office address:
10 Doctors' Park Telephone number:
314-334-3074 State license in which to practice: Missouri
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Specialty Board certification: American Board of Surgery Training: Internship, Columbia Hospital, Wilkinsburg, Pennsylvania Residence, St. Louis County Hospital, St. Louis, Missouri Position with applicant: Active Staff, Chief of Staff 1973-74, St. Francis Hospital, Active Staff 3.
Protocol to be followed:
Human Clinical Protocol for the Coratomic C-101 Series Radioisotope Powered Cardiac Pacer dated November 1,1975 (on file at NRC).
4.
A maximum of 60 Coratomic.C-101 Series Pacemakers is requested to be implanted annually during the study.
5.
Physical facilities and equipment: The physical facilities and equipment at Southeast Hospital pertinent to the Coratomic C-101 Series Study Program include the following:
a.
Pacemakers are implanted in the Surgery Departcent. A portable X-ray unit with image intensifier is available so that cardiac surgery can be done.
b.
The Intensive Care Unit contains 4 beds equipped with hardwire monitor units.
Coronary Care has 4 beds with hardwire monitor units, 6 telemetry units and 1 portable defibrillator for each unit.
Intensive Care and Coronary Care 1 data scope to monitor arterial pressure and 1 external j
pacemaker and 2'Burdick electric external pacers.
c.
The Progressive Cardiac Unit, 1-East, contains 4 telemetry units.
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U U. S. Nuclear Regulatory Commission December 17, 19.75 Page 4 6.
Present Pacemaker Implantation and Followup Program. At the present time
/ the threshold of all pacemaker implants are measured intra cardiac with the
/Medtronic5880AExternalDemandUnit. This is performed'by the cardiac con-sultant and a cardio-vascular nurse from The Internal Medicine Group. At each implant an EKG strip is run during and after the procedure.
An electro-cardiogram obtained before discharge from Hospital. Another is obtained at followup exam in physician's office 6 weeks, 3 months and 6 months.
7.
Maintenance of records of implantation and followup of patients for the C-101 Series Program.
Careful followup and recording procedures will be followed during the life of the patient or until the C-101 Series Pacemaker is removed. This followup will be separate from the routine Hospital records kept on every patient. At each examination period an EKG strip will be run WITH the application of a magnet to induce fixed rate operation of the pacer. Pulse width, BP, checked each month at Pacemaker Clinic,14 Doctors' Park, Cape Girardeau, Missouri.
This service is in addition to routine office visits for EKGs and Pulse Width checks along with the routine records kept on the patient at the office.
There is a special pacemaker file which is routinely revised each six months.
The following forms will be executed as discussed in the Coratomic C-101 Series: Protocol, Registration and Implantation Data Form, Followup Data Form, Pacer Failure and Removal of Patient Death Form, Informed Consent for Surgical Implantation or Radioisotope Powered Cardiac Pacer Form, Donor Cards for Adults or Donor Cards for Minors, properly executed Instructions for Hospital Telephone Operator and Patient Identification Cards. The instruction for the Hospital telephone operator is shown as Attachment 1 of this submission.
Records will be kept at Southeast Hospital.
Duplicates will be kept in the offices of physicians responsible for the individual patient examination, also in the pacemaker clinic files.
These records will also be made available to referring cardiologists.
8.
Control Procedures:
Southeast Hospital will establish appropriate control procedures and be responsible for the physical security of the pacemaker while in possession of the applicant.
These procedures will include keeping track by serial number of the location of each pacemaker and requiring that they be kept under lock and key when not being used to guard against loss or thef t.
Southeast Hospital will also assure that all activities are conducted in accordance with the regulations under Title 10, Code of Federal Regulations, Part 70.
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Emergency procedures:
Mrs. Dolores Gerhardt, Surgery Supervisor, will be assigned as pacemaker coordinator and will be responsible for giving the
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Hospital telephone operators written instructions concerning the notification of appropriate individuals upon receipt of emergency report and inquiry con-cerning a pacemaker bearer.
The coordinator will also be responsibic for personal discussions with each telephone operator. The form used for this purpose is shown as Attachment 1.
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U. S. Nuclear Regulatory Commission December 17,.1975
.Page 5 I
- 10. -Physicians Responsible: The physicians responsibic for and participating in,
the study have certified that they are familiar with the Coratomic c
C-101 Series Protocol and the Coratomic C-101 Pacer. They understand that the issuing of a license amendment is conditional upon the following of 1
the Protocol.
- 11. Southeast Hospital agrees to continue the followup reporting and recovery procedures during the life of the patient and until the pacemaker is recovered and returned to Coratomic, Inc., P. O. Box 434,' Indiana, Pa.
15701, even-in the event the physicians named in the application to participate in the study are no longer, associated with'the applicant.
12..
The packaging, labeling and shipping instructions founded by Coratomic, Inc.
will be followed upon return of the pacemaker for approved disposal..
13.
Southeast Hospital hereby requests a-license to receive, possess, store, and implant the Coratomic C-101 Series nuclear powered pacemaker in accordance with this application.
i Signed:
Applicant: SOUTHEAST MISSOURI HOSPITAL f-
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/ James R. S' tricker, Administrator
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Physicians responsible for study:
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. Robert S. Hunt, M.D.
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Charles P. McGintyi M.D.
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W. Kirk Bowman, Jr. / M.D.
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9 Melvin C. Kasten, M.D.
Jerry L. Kinder, M.D.
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,j ATTACHMENT 1 U.*
- INSTRUCTIONS FOR HOSPITAL OR CLINIC'IELEPHONE OPERATORS
'CORATOMIC C-101 ISOTOPIC PULSE GENERATOPp Pro' ject Nuclear Pacemaker Instructions to Operator:
- 1., Accept any collect call with reference.to " Project Nuclear Pacemaker."
1 2.
'Juty call' concerning " Project Nuclear Pacemaker" involves a ' patient with a a nuclear pacer and: requires immediate action to insure that there is no danger of radiation exposure and recovery of the. nuclear pacer.
3.
Obtain as much information from the caller as is possible including:
Caller's name and where he may be reached.
Patient's name, status and.where he may be reached.
Attending physician (if 'any) and where he may be reached.
Information from Patient I.D.' Card Patient's Social Security No.
Date of Implant Pacer Serial Number 4.
Notify immediately:
C. R. Talbert, Jr., M.D.
14 Doctors' Park Cape Girardeau, Missouri: 63701 Phone #314-334-4444 If he cannot be reached, one of the seven doctors will be on call from Dr. Talbert's office, 14 Doctors' Park, Cape Girardeau, Missouri, 63701, i
phone #314-334-4444.
If neither can be reached, contact physician on duty for the Cardiac Care Unit, inform him that this involves a nuclear pacer, and advise him of the information you have and the urgency of the matter.
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