ML20214C013
| ML20214C013 | |
| Person / Time | |
|---|---|
| Site: | 07002427 |
| Issue date: | 10/07/1976 |
| From: | Chase P, Lemmon W, Papa L KENNEDY MEMORIAL HOSPS., CHERRY HILL, STRATFORD & |
| To: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20214B865 | List: |
| References | |
| 106368, NUDOCS 8705200506 | |
| Download: ML20214C013 (6) | |
Text
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toria sfs'la LAUREL ROAD, TRATFORD, N JERSEY 08084 Q
THE JOHN F. KENNEDY MEMORIAL HOSPITAL laurel Road Stratford, New Jersey 08084 October 7,1976 RECEIVZD BY LFMB l
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Mrs. Patricia C. Vacca Ti m e... M1...........
Division of Fuel Cycle and Materials Safety l cy,,,,7g,cg,,,,,,, y U. S. Nuclear Regulatory Commission Fro m....
Cy to................ g Washington, D. C.
20555 Acdon Compi. /0.7h?h.
Dear Mrs. Vacca:
Re: Application for a 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)
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:
John F. Kennedy Memorial Hospital Laurel Road Stratford, New Jersey 08084 2.
Physicians Res:ensible for the study:
a.
Name: William M. Immmon, M. D.
Office Address: 1320 Race Street, Philadelphia, PA 19107 Telephone Number: 215-LO-3-4540 State in which licensed to practice: New Jersey, Pennsylvania Specialty Board Certification: American Board of Surgery,1901; American Board of Thoracic Surgery,1961.
Training: Residency in General Surgery, Boston City Hospital, Boston, MA, 1953-1954; Residency in Pediatric Surgery, Children's Medical Center, Boston, MA, 1954-1955; Chief ResidertColumbia Hospital, Columbia South Carolina, 1955-1956; Research Fellow NIH, Hahnemann Medical College and Hospital Thoracic Surgery,195G-1959; Chief Resident, Thoracic Sutgery Philadelphia General Hospital, Philadelphia, PA,1958 Position with Applicant: Chief of Cardio Thoracic Surgery providing fourteen years experience in the clinicalimplantation and follow-up of pacemakers.
Total number of implants done: 1000 Total Number of implants done at this institution: 150 8705200506 870129 s
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Mrs. Patricia C. Vecca y
October 7,1976 Page 2 2.
b.
Name: Iouis A. Papa, D. O.
Office Address: 18 East Inurel Road, Stratford, New Jersey 08008 Telphone: 609-784-4034 Specialty Board Certifications: Board Eligible Internal Medicine Training: Medical Residency, John F. Kennedy Memorial Hospital, Stratford, NJ, 1971-1973; Cardiology Fellowship Thomas Jefferson University Hospital, Philadelphia, PA, 1973-1975 Position with Applicant: Director of Heart Station and Non Invasive Laboratory; Head of Cardiac Intensive Care Unit; Chairman of Department of Cardiology c.
Name: Paul J. Chase, D. O.
Office Address: Laurel Road, Stratford, NJ 08084 Telephone: 609-784-4000 Specialty Board Certification: American Osteopathic Board of Radiology,1969; American Board of Nuclear Medicine,1972; American Osteopathic Board of Nuclear Medicine,1976 Trainig: Residency in Radiology, Cherry Hill Hospital, Cherry Hill, NJ, 1965-1368; Fellowship in Radiation Therapy, American Osteopathic Foundation, Hahnemann Medical College and Hospital,1975 Position with applicant: Vice Chairman Department of Radiology and Nuclear Medicine Section Head Nuclear Medicine 3.
Protocol to be followed:
HUMAN CLINICAL PROTOCL FOR THE CORATOMIC C-101 RADIOISTOPE POWERED CARDIAC PACER DATED November 1,1975 (On file at NRC) 4 A maximum of 10 Coratomic C-101 pacemakers are requested to be implanted annually during the study.
5.
The physical facilities and equipment at the John F. Kennedy Memorial Hospital pertinent to the Coratomic C-101 study program include the following:
a.
Pacemakers are implanted in the special procedures room of the Department of Radiology using personnel from the Operating Room, b.
Patients are moved to the Medical Intensive Care Unit immediately after surgery. The unit contains nine beds. Eight beds contain hardwire monitoring units that go to a central console that is equipped with alarm and write-out.
There are two Medtronic 5880A external pacers and one portable defibrillators on hand at the unit.
c.
There is also a surgical ICU adjacent to the medical ICU, Four beds in the unit contain portable monitoring equipment. There is a portable defibrillator located in the unit.
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7 Mrs.' Patricia C. ' Vacca October 7,1976 Page 3 6
John F. Kennedy Memorial Hospital's present Pacemaker Implantation and Follow-Up Program At the present time, the stimulation thresholds and sensing thresholds of all pacemaker implants are measured intra-cardiac with a Medtronic 5880A external pacer. This is done by personnel from the Operating Room under the guidance of the implanting physician. At each implant, an electrocardiogram is obtained and a follow-up and reporting procedure is utilized during the life of the pacer. Present times at which electro-ccrdiograms 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 implant, at time of discharge, at the third month after implant and once every six months thereafter.
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 periodan 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, the third month, and once every six months until removal of the pacer.
The following 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 on Patient Death Form, Informed Consent for SurgicalImplantation of Radioisotope Powered Cardiac Pacer Form, Donor Cards for Adults or Donor Cards for Minors, properly executed Instructions for Hospital Telephone Operators, and Patient Identification Cards. The instructions for the hospital telephone operator are shown as l of this submission.
Separate records will be kept on nuclear pacer patients in the Medical Records l
Department of the hospital 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 any referring cardiologist.
l 8
Control Procedures i-i John F. Kennedy Memorial Hospital will establish appropriate control procedures and be responsible for the physical security of the pacemaker while in possession 4
O C
Mrs. Patricia C. Vacca October 7,1976 Page 4 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. John F. Kennedy Memorial Hospital will also assure that all activities are conducted in accordance with the regulations under Title 10, Code of Federal Regulations, Part 70 9.
Emergency Procedures Mrs. Suzanne Griffin, R. N., Head Nurse of Medical and SurgicalIntensive Care Unit will be assigned as Pacemaker Coordinator and will be responsible for giving the Hospital Telephone Operators written instructions concerning the notification of appropriate individuals upon receipt of emergency report and inquiry concerning a pacemaker bearer. The coordinator will also be responsible for personal discussion with each telephone operator. The form used for this purpose is shown as Attachment 1.
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 pacer. They understand that the issuing of a license amendment is conditional upon the following of the Protocol.
11.
The John F. Kennedy 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, 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.
The John F. Kennedy Memorial Hospital hereby requests a license to receive, possess, store and implant the Coratomic C-101 isotopic powered pacemaker in accordance with this application.
Physicians Responsible for Study:
Signed M h k vhM Applicant:
William Lenamon, M.'D.
John F. Kennedy Me rial Hosp.
Iouis A.
D.
By:
su+t[>v
.o t 8, Augustin//R. Pirolli, Administrator W
Paul J. Chase, p.
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E' ATTACHhfENT 1 INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPIIONE OPERATORS CORATOhtIC C-101 ISOTOPIC PUISE GENERATOR Project Nuclear Pacemaker Instructions to Operator:
~1.
Accept any collect calls with reference to " Project Nuclear Pacemaker".
2 Any call concerning " Project Nuclear Pacemaker" involves a patient with a nuclear pacer and requires immediate action to insure that there is no danger of radiation exposure and recovery of the nuclear pacer.
3.
Ob tain 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
' Implanting Physician 4
Notify Immediately: William Irmmon, AI. D.,1320 Race Street, Philadelphia, Pa, Telephone: 215-LO-3-4540 If he cannot be reached, notify: Iouis A. Papa, D. O.,18 East Laurel Road, Stratford, New Jersey 08008, Telephone: 609-784 -4034 If neither can be reached, contact the Pacemaker Coordinator, hirs. Suzanne Griffin, R. N.
Telephone: 609-784-4000 "0FRC3. RECORD COPY"
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If h BETWEEN: William 0. Miller, Chief License Fee Management Branch Office of Administration John E. Glenn, Chief Nuclear Materials Section B Division of Engineering and Technical Programs LICENSE FEE TRANSMITTAL REGION %
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1.
APPLICATION ATTACHED Applicant / Licensee:
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Application Dated:
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Control No.:
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2.
FEE ATTACHED Amount:
Check No. :
3.
COMiENTS Sign 6
N Date B.
LICENSE FEE MANAGEMENT BRANCH 1.
Fee Category and Amount:
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Correct Fee Paid. Application may be processed for:
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Amendment Renewal N License Signed
.j Date
/ / / /'1/ f il REGION I FORM 213 (MARCH 1983)
.