ML20212P463
| ML20212P463 | |
| Person / Time | |
|---|---|
| Site: | 07002259 |
| Issue date: | 03/12/1978 |
| From: | Peterson O COPLEY MEMORIAL HOSP., AURORA, IL |
| To: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20212P357 | List: |
| References | |
| 0673, 673, NUDOCS 8701300677 | |
| Download: ML20212P463 (6) | |
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AURORA, ILLINOIS 60507 / TELEPHONE 897-6021 ORVILLE PETERSON COPLEY MEMORIAL HOSPITAL, INC.
March 12,1976 i
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,J e ti U. S. Nuclear Regulatory Commission hx,/x Ay Washington, D. C. 20555
'QA g' Attention: Mrs. Patricia Vacca RE: Application for license to participate in a research study involving the implantation of Coratomic C-101 Isotopic Powered Pacemakers, each containing 250 milligrams of Pu-238
(<4.3 curies).
Dear Mrs. Vacca:
The following information is submitted in application for a license to participate in the investigational program utilizing the Coratomic C-101 Isotopic Powered Pacer.
1.
Applicant:
Copley Memorial Hospital Lincoln and Weston Avenues Aurora, Illinois 60507 2.
Physicians responsible for the study:
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a.
Name: Leonard E. Snyder, M.D.
g Office Address:
1870 West Galena Boulevard, Aurora, Illinois 60506 m
Telephone: Office (312)859-6700 so Home (312)859-8865 bb State in which licensed to practice:
Illinois, Wisconsin oo-n Specialty Board Certification:
Diplomat American Board of Surgery S '8 Training:
Northwestern University Medical School, 1961 gg Intern: Wesley Memorial Hospital, 1961-1962 swz Residency: Marquette Affiliated Surgical Residency 5"
Program, 1962-1966 Position with Applicant:
Senior Staff Member DG73 f,u p
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2.
Physicians responsible for the study:
(continued)
Previous clinical experience with pacemakers:
Duration of pacemaker experience:
11 years.
Total number of implants done:
33.
Total number done this facility:
20.
Abbas A. Khawaja, M. D.
b.
Name:
157 South Lincoln Avenue. Aurora, Illinois, 60505.
Office Address:
Telephone Number:
(312)-897-1886 Home (312)-892-8590.
State in which licensed to practice:
Internal Medicine, June 1972.
Specialty Board Certification:Two years fellowship, in Adult Cardiology at Cook Coun Training:
Chicago, Illinois, from July 1,1972 until June 1974.
Position with Applicant: Cardiologist on Staff at Copley Hospital.
Previous clinical experience with pacemakers:
Duration of pacemaker experience:
5 years.
J. A; Sandrolini, M. D.
l c.
Name:
1870 West Galena Blvd.,'. Aurora, Illinois, 60506.
Office Address:
F Telephone Number:
(312)-859-6700.
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States in which licensed to practice:
Illinois and California.
General Surgery.
Specialty Board Certification:B.S.,M.D.,M.S., University of Illinois Medical School, Ch Training:
Internship: St. Luke's Hospital Chicago, Illinois, 1957-1958, Anesthesiology, St. Luke's Hospital, Chicago, Illinois, July Residency:
and September 1958, Pres St. Luke's, Chicago, Illinois, October Pres St. Luke's 1960-July 1961 General Surgery residency:
Hospital, Chicago, Illinois, July 1961-July 1965.
Head and Neck Surgery, University of Illinois, July 1965-July 1966.
Fellowship:
Position with Applicant: Surgeon.
Previous clinical experience with pacemakers:
Duration of pacemaker experience: 7 years.
Total number of implants done:
25.
Total number done this facility:
16.
Herwick, M. D.
d.
Name:
P. Q.
1870 West Galena Blvd., Aurora, Illinois, 60506.
Office Address:
Telephone Number:
(312)-859-6700.
State in which licensed to practice:American Board of Surgery,1971.
Specialty Board Certification:
Training: George Washington University, M.
D., 1965.
Internship: George Washington University, 1965-1966.
Residency: George Washington Univerisity, 1965-1970, Surgery.
Position with Applicant: Surgeon.
Previous clinical experience with pacemakers:
Duration of pacemaker experience: 8 years.
Total number of implants done:
9.
Total number done this facility:
3.
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. e.
Name:
A. L. Abbott, M. D.
Office Address:
1870 West Galena, Aurora, Illinois, 60505.
Telephone Number:
(312)-895-6700.
State in which licensed to practice:
Specialty Board Certification: American Board of Internal Medicine, 1970.
Training: University of Illinois Medical School,1961, University of Illinois, Research and Educational Hospital, 1961-1962, (rotating internship). Internal Medicine, Residency, Univeristy of Illinois, Research and Educational Hospital, 1962-1965.
Position with Applicant: Senior Medical Staff, Vice Chairman, Department of Medicine.
Previous clinical experience with pacemakers:
Duration of pacemaker experience: 7 years.
Total number of implants done: 14.
Total number done this facility:
5.
3.
Protocol to be followed:
HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C-101 RADI0IS0 TOPIC POWERED CARDIAC PACER DATED November 1, 1975.
(On file at NRC).
4.
A maximum of 12 Coratomic C-101 Pacemakers are requested to be implanted annually during the study.
5.
The physical facilities and equipment at Copley Hospital pertinent to the Coratomic C-101 study program include the following:
Pacemakers are implanted in either the Special Procedures Room of the a.
Radiology Department or the Surgical Department, depending on whether the transvenous or epicardial leads are used.
b.
The patient is moved immediately after thoracic surgery to the Intensive Care Unit which contains 5 beds, all of which are equipped with hardwire monitoring units. There is 1 portable defibrillator 1 data scope to monitor arterial pressure and 1 external pacemaker.
The Coronary Care Unit contains 4 rooms with one patient per room. All c.
rooms are equipped with hardwire monitors and there are 4 hardwire monitor units all of which register on a 4 channel scope with an alarm system and write outs. One temporary Medtronic external powered pacer is on standby at all times along with a portable defibrillator.
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The Intermediate Care Area contains 13 rooms of which 8 have telemetered monitoring, which register on 8 channel scope with alarm and write out.
One defibrillator is available.
6.
Copley Memorial Hospital's Present Pacemaker Implantation and Follow-up Program:
At the present time the stimulation thresholds and sensing thresholds of most pacemaker implants are measured intra-cardiac with the Medtronic Model 5300 Pacer System Analyzer at time of initial implantation or pulse generator I
replacement, whenever it is available. This is done by personnel from the Coronary Care Unit or attending Cardiologist. At each implant an electro-cardiogram is obtained and a follow-up and reporting procedure is utilized during the life of the battery pacer.
P. 'sent examination times at which electrocardiograms are taken are at inif il implant, approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after implant, at time of discharge and ac three month intervals thereafter.
Records are presently kept in the Medical Records Department within Copley Memorial Hospital.
7.
Maintenance of Records of Implantation and Follow-up of Patients for the C-101 Program:
Careful follow-up and recording procedures will be followed during the life of the patient or until the C-101 pacemaker is removed. This follow-up will be separate from the routine hospital records.kept on every patient. At each examination period an electrocardiogram will be obtained with the application of a magnet to induce fixed rate operation of the pacer.
Follow-up examination will be conducted at the following intervals after implant: at one month, three months and six months following the insertion of the pacer until removal.
It is recognized that general medical care may be more frequent than this, but this is the minimal time between tests of pacer function for purposes of this study.
The following listed forms will be executed as discussed in the Coratomic C-101 November 1, 1975 Protocol:
Registration and Implantation Data Form, Follow-up 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 Exhibit 1 of this application.
Records will be kept at Copley Memorial Hospital in the Medical Records Department and duplicate records will be kept in the offices of the physicians responsible for the individual patient examinations. These records will also be made available to referring cardiologists.
8.
Control Procedures Copley Memorial 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 theft.
Copley Memorial 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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. 9.
Emergency Procedures A pacemaker coordinator will be assigned and will be responsible for giving the hospital telephone operators written instructions concerning the notifi-cation of appropriate individuals upon receipt of emergency report and inquiry concerning a pacemaker bearer. The coordinator will also be responsible for personal discussions with each telephone operator. The form used for this purpose is shown as Attachment I.
The Copley Memorial Hospital Pacemaker Coordinator is Ann Van Sickle, R. N.,
Chief Nurse of CCU.
- 10. Physicians Responsible The physicians responsible for and participating in the study have certified that they are familiar with the Coratomic C-101 Protocol and the Coratomic C-101 Isotopic Racer. They understand that the issuing of a license is con-ditional upon the following of the Protocol.
11.
Copley Memorial Hospital agrees to continue the follow-up reporting and recovery procedures during the life of the patient and until the pacemaker is recovered and returned to Coratomic, Incorporated, P. O. Box 434, Indiana, Pennsylvania, I
15701, even in the event the physicians named in the application to participate in the study are no longer associated with the Applicant.
12.
Upon return of the pacemaker, the packaging, labeling and shipping instructions founded by Coratomic, Incorporated, will be followed for approved disposal of same.
13.
It is hereby requested by Copley Memorial Hospital to receive, possess, store, and implant the Coratomic C-101 Isotopic Powered Pacemaker as submitted in this application.
C0 iEM0 RIAL HOSPI L, INC.
By I 1S.
Orville Peterson, President Physicians r sponsible for study:
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L. E. Snyder,fl. D.
P. Q. Herwick, M. D.
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A. A. Khawaja, M. D.
A. L. Abbott, M. D.
Letc s
J.(f.Sandrolini,M.D.
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o ATTACHMENT I e
INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-101 ISOTOPIC PULSE GENERATOR
' Project Nuclear Pacemaker i
Instructions to Operator:
1.
Accept any collect call with reference to " Project Nuclear Pacemaker."
2.- Any call concerning " Project Nuclear Pacemaker" involves a patient with a i
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.
Immediately notify one of the following listed, indicating a call has been received concerning a nuclear pacer, and relaying the information you have and the urgency of the matter:
l Leonard E. Snyder, M. D.
Paul Q. Herwick, M. D.
1870 West Galena Boulevard 1870 West Galena Boulevard Aurora, Illinois 60506 Aurora Illinois 60506 Telephone:
(312)-859-6700(Office)
Telephone:
(312)-859-6700(Office)
(312)-859-8865(Home)
(312)-859-2156 (Home)
Abbas A. Khawaja, M. D.
Arthur L. Abbott, M. D.
157 South Lincoln Avenue 1870 West Galena Boulevard Aurora, Illinois 60505 Aurora, Illinois 60506 Telephone:
(312)-897-1886(Office)
Telephone:
(312)-859-6700(Office)
(312)-892-8590 (Home)
James A. Sandrolina, M. D.
r 1870 West Galena Boulevard l
Aurora, Illinois 60506 Telephone:
(312)-859-6700(Office)
(312)-851-3515 (Home)
If above cannot be reached, contact physician on call for that doctor, inform him that this involves a nuclear pacer; and advise him of the information you have and the urgency of the matter.
5.
Pacemaker Coordinator: Ann Van Sickle, R. N., Chief Nurse of CCU. Phone: (312)-859-6700.
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