ML20210H294
| ML20210H294 | |
| Person / Time | |
|---|---|
| Site: | 07002224 |
| Issue date: | 03/11/1976 |
| From: | Skypeck H RUSH-PRESBYTERIAN-ST. LUKE'S MEDICAL CENTER, CHICAGO |
| To: | Mason J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20210G990 | List: |
| References | |
| 0418, 418, NUDOCS 8702110406 | |
| Download: ML20210H294 (10) | |
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RUSH-PRESBYTERI AN-ST. LU S. MEDICAL CENTER
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U.S. Nuclear Regulatory Commission s1 Washington, D.C.
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RE:
Application for license to participate in the research study involving the implantation of Cordis Nuclear Omni-Stanicor 184A Nuclear Powered Pacemakers
Dear Sir:
The following information is submitted in application for a license to participate in the investigational program utilizing the Cordis Nuclear Omni-Stanicor 184A pacemaker. "
1.
Applicant:
Rush-Presbyterian-St. Luke's Medical Center 1753 West Congress Parkway Chicago, Illinois 60612 RESPONSIBILITY:
The Radiation Safety and Radioisotope Committee is responsible for the implementation of the regulatory require-ments contained in this application.
The members of the Committee are on file with NRC Medical Board License #12-00929-13.
The Chairman of the Committee is Howard Sky-Peck, and the Radiation Safety Officer is Anthony Chung-Bin.
Dr. Hauser is responsible for this Committee for implementation of the clinical requirements for this application.
2.
Physicians Responsible for Study:
a.
Name:
Milton Weinberg, Jr., M.D.
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Address:
1725 West Harrison Street ai Chicago, Illinois 60612 Telephone Number:
(312) 942-6583 co on State in which licensed to practice:
Illinois oM@
Training:
During the past 15 years, Dr. Weinberg has had
"-Q extensive experience in all aspects of clinical una pacemaker implantation, including a variety of NE generator and lead electrode types and locations, Lwm and the management of pacemaker implications.
Over the past 15 years, implantation of over 200 pacemakers has been done at the applicant institution.
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Position with applicant:
Senior Attending Depertment of Cardiovascular and Thoracic Surgery b.
Name:
James G. Clark, M.D.
Address:
1725 West Harrison Street Chicago, Illinois 60612 Telephone Number:
(312) 942-5900 State in which licensed to practice:
Illinois Specialty Board Certification:
Internal Medicine Training:
Dr. Clark has participated in more than 200 pacemaker implantations at Rush-Presbyterian-St. Luke's Medical Center since 1965.
Position with applicant:
Associate Attending, Section of Cardiology c.
Name:
Robert G. Hauser, M.D.
Address:
1753 West Congress Parkway Chicago, Illinois 60612 Telephone Number:
(312) 942-6025 State in which licensed to practice:
Illinois Specialty Board Certification:
Internal Medicine Training:
Since 1968 Dr. Hauser has participated in implantation of more than 200 cardiac pace-makers at Rush-Presbyterian-St. Luke's Medical Center.
In addition, he has primary responsibility for the Pacemaker Surveillance Program that conducts follow-up surveillance of more than 150 pacemaker patients.
Dr.
Hauser has also had research experience with the Atom Cell nuclear battery in a study spon-sored by the National Heart and Lung Institute at the IIT Research Institute.
Position with applicant:
Assistant Attending Section of Cardiology d.
Name:
harshall D. Goldin, M.D.
Address:
1725 West Harrison Street Chicago, Illinois 60612 Telephone Number:
(312) 942-6645 State in which licensed to practice:
Illinois Training:
Since 1965 Dr. Goldin has participated in implantations of over 200 pulse generators at the applicant institution.
Position with applicant:
Assistant Attending Department of Cardiology 3.
Protocol to be followed:
MASTER PROTOCOL FOR CLINICAL EVALUATION OF THE PROGRAMMABLE CORDIS OMNI-STANICOR PACEMAKER DATED OCTOBER, 1974.
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4.
A maximum of 15 Nuclear Omni-Stanicor 184A Pacers are requested to be implanted annually during the study.
5.
Facilities and Equipment:
Pacemaker implantations are performed in one of four cardiovascular thoracic operating suites; each suite exceeds 400 square feet in floor space and has adjoining storage areas for spare electrodes and leads, pacemakers, repair kits, monitors, and other essential equipment.
Only " clean" surgical cases are per formed in these rooms.
Each operating suite is equipped with wall mounted ECG amplifiers, large screen video displays, defibrillator, jexternal pacemaker and strip chart recorder.
Back-up equipment is immediately available, since these rooms are mutually supportive.
Emergency equipment available within each room includes airway suction apparatus, cardiac emergency drugs, direct current defibrillator, mechanical hand ventilator, endotrachial and oral air-ways, and external pacemakers for internal and trans-cutaneous pacing and oxygen.
Standard equipment available for pacemaker implantation includes floroscope with image intensifier (9") capable of positioning in the antero, posterior, and lateral projections; television viewing system; instrumentation required for determining threshholds and endocardial sig-nals, standard surgical instruments, suture materials and intravenous fluids.
Electrical safety precautions are strictly enforced to avoid electric shock hazards to patients and staff.
All equipment has been certified as meeting the requirements of the City of Chicago elec-trical safety code.
Immediate and post-implantation patient monitoring is available in one of three intensive care units with a total capacity of 40 beds.
The Medical Intensive Care Unit (14 beds) is equipped with wall mounted ECG moni-tors and video displays, arrhythmia detectors, chart record-s, and it is staffed by Registered Nurses special-izing in acute coronary care and trained in the care and management of patients following permanent or temporary pacemaker insertion.
The Surgical Intensive Care Unit (20 beds) is likewise equipped with wall mounted ECG amplifiers and large video displays, strip chart recorders, and is staf fed by Registered Nurses with special exper-tise in the care of post-operative cardiovascular patients.
The Pediatric Intensive Care Unit (6 beds) is staffed by nurses trained in all aspects of pediatric intensive care
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4, including special instruction in the care of pediatric patients having cardiovascular surgery; the Pediatric Intensive Care Unit is equipped with physiologic moni-toring equipment similar to the medical and the surgical intensive care units.
Each of the intensive care units has one or more cardiac defibrillators, wall mounted oxygen and vaccuum gas sources and equipment for emergency transvenous pacing.
At the time of the pacemaker implantation, pre-implantation measurements of pacemaker electrical characteristics are v' obtained in the operating room with a pulse generator f
operating into a 500 ohm external resistive load; values for pulse period, pulse width, and current / voltage output, and a photograph of the pulse stimulus waveform are ob-tained to insure that the pulse generator meets the manu-facturer's specifications.
Operative measurements of the /
threshhold of stimulation and the intra-cardiac potential via the lead electrode are obtained using a calibrated
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constant current external pulse generator with a calibrated sensing amplifier.
The threshhold of stimulation and the threshhold hysteresis are obtained for the bipolar electrode configurations with the cathode as the stimulating electrode.
Either the voltage threshhold or the direct measurement of myocardial impedance is also performed.
Threshhold measurements are obtained using a stimulus pulse which is adjusted to plus or minus.05 milliseconds of the pulse duration of the pulse of the unit to be implanted.
For Omnicor units, programmable functions are verified at the time of implantation.
6.
Present Pacemaker and Follow-Up Program:
Rus h -P re s by te ri a n-S t. Luke's Medical Center has been actively implanting cardiac pacemakers since 1960.
Between 125 and 150 pulse generators are implanted or replaced annually.
The implantation of a cardiac pace-maker involves the participation of the attending staff from both the Section of Cardiology and the Department of Cardiovascular and Thoracic Surgery.
A committee of cardiologists and cardiovascular surgeons has been estab-lished to periodically review all aspects of the care and management of all pacemaker patients at the medical center.
The committee is particulark concerned with reviewing pace.-
maker performance data including thorough evaluation of new pacemaker models and ongoing analysis of implanted pacemaker operation, longevity and failure modes.
Further the committee makes recommendations to the hospital regarding resources re-quired to meet standards such as those established by the Intersociety Commission for Heart Disease Resources.
l 5.
.The majority of pacemaker patients are referred from physicians in the greater Chicago area.
In order to pro-vide for adequate pacemaker surveillance, the Medical Center established a Pacemaker Surveillance Program within the Section of Cardiology.
It is staffed by full-time cardio-logists, registered nurse, two bio-medical technicians, and administrative personnel.
The Pacemaker Surveillance office maintains patient and pacemaker files separate from the v' hospital records.
Technical pacemaker follow-up is performed by outpatient waveform analysis and transtelephonic moni-toring.
Pacer patients are seen in the clinic at the fol-lowing intervals. post-op: 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, 1 week, 1 month, 3 months, and 6 months, until impending battery failure is detected, at which time patients are seen weekly.
The equipment available for technical follow-up includes:
l a.
Tektronix 7613 Variable Persistence Storage Oscilloscope with 7A22 differential amplifier 7M13 read-out unit, 7B53A dual time base, and j
C-53 camera.
b.
Tektronix 530 Universal Counter.
Transtelephone monitoring (equipment,3), transmitters (50),
including c.
Cordis Commucor receiver universal counter, and Burdick EK/5A ECG, pre-amplifier and strip chart recorder.
d.
Avionics 24-hour ECG monitoring equipment, including two-channel recorders (5) and model 660 scanner.
e.
Exercise treadmill and related instrumentation.
f.
Custom equipment for chest-wall stimulation for evaluation of sensing function, g.
Cordis Omnicor programmers (2).
The Pacemaker Surveillance Program is responsible for technical follow-up surveillance, while the patient's family physician, cardiologist, and/or surgeon is respon-l sible for clinical follow-up.
Outpatients are guaranteed 24-hour access to the Pacemaker Surveillance Program.
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7.
Records Maintenance and Follow-Up:
Rush-Presbyterian-St. Luke's Medical Center will establish procedures to maintain records of implantation and follow-up of patients separate from hospital records.
Although this is current practice in the Pacemaker Surveillance Program Office, a separate restricted access file of nuclear pacemaker patients will be established within the Program Office.
Each patient receiving a Cordis Nuclear Omni-Stanicor Pacemaker will be followed according to the protocol established by Cordis, Incorporated and, in addition, will be placed on monthly transtelephone monitoring in order to obtain technical data and to insure continuity of follow-up.
Particular attention will be directed to insure complete ongoing patient compliance with the terms of the written agreement obtained prior to im-plantation, including carrying of the identification card and identification bracelet or necklace, and donor card, scheduled follow-up examination, need to notify hospital of any change in address, telephone number, or persons to be contacted in case the patient cannot be located, and to notify the hospital prior to any travel outside the United States.
The patient, the patient's family, or his/her desig-nated representative will be instructed in the procedure to contact the physician-on-call for the Pacemaker Surveillance Program during non-working hours.
8.
Control Procedures:
Rus h-P re s by te ri a n-S t. Luke's Medical Center will establish appropriate control procedures to insure the physical security of the pacemaker while in its possession.
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 theft and loss.
Rush-Presbyterian-St. Luke's Medical Center will conduct all activities in accordance with the regula-tions under Title X, Code of Federal Regulations, Part 70.
9.
Emergency Procedures:
The applicants procedures to assure notification of appro-priate individuals upon receipt of an emergency report and inquiry concerning a pacemaker bearer includes the instruc-tions to the telephone switchboard operators shown on Attach-ment #1.
Upon receipt of an emergency report or inquiry, the switchboard operator will contact one of the four respon-sible investigators; in the event that none of the responsible investigators are not immediately available by telephone, the telephone switchboard operator will immediately contact the physician-on-call for the Pacemaker Surveillance Program.
bN 7.
The responsible investigator (or the physician-on-call for the Pacemaker Surveillance Program) will obtain all the pertinent information regarding the patient and the pace-maker.
In the event of patient death, the responsible in-vestigator or the physician-on-call for the Pacemaker Sur-veillance Program will take immediate steps to recover the nuclear-powered pacemaker.
Likewise, he will be responsible for notifying the Materials Branch, Directorate of Licensing, U.S. Nuclear Regulatory Commission, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the occurrence of death of the pacemaker patient.
In the event of an adverse reaction or malfunctioning involving the pace-maker system, the responsible investigator will provide a written report giving the details of the adverse reaction or malfunction within 30 days.
Rush-Presbyterian-St. Luke's Medical Center will notify the Materials Branch within 10 days of loss of contact with a nuclear pacemaker patient.
10.
The physician responsible for, and participating in, this study represent that they are familiar with the Cordis Nuclear Omni-Stanicor Protocol and the Cordis Nuclear Omni-Stanicor 184A Pacer, and the Instructions for Use of the Omni-Stanicor 184A Pacer and understand that the issuance of a license is conditioned upon the following protocol.
11.
Rush-Presbyterian-St. Luke's Medical Center agrees to con-tinue the follow-up reporting and recovery procedures during the life of the patient, or until the pacemaker is removed and returned to Cordis, Incorporated, even in the event that the physician's name in the application to participate in the study are no longer associated with the applicant.
To maintain this continuity, the Committee will appoint a Cardiologist with recommendation of respective Chairman, to be responsible for patiet follow-up.
The personnel radiation monitoring device and instructions for its safe handling will be provided to assure the re-quirements of 10 CFR 19 and 20 are met.
12.
All incoming pacemakers will be wipe-tested for contamination, upon receiving, returning for storage af ter use, or returning to Cordis, Incorporated by the Radiation Safety Officer.
The packaging, labelling, and shipping instructions to be furnished by Cordis, Incorporated will be followed upon return of the pacemaker for approved disposal.
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13.
Rush-P.*esbyterian-St. Luke's Medical Center hereby requests a license to receive, possess, store, and implant the Cordis Nuclear Omni-Stanicor Pacemaker.
By:
Howard Sky-Peck, Ph.D.
- Chairman, Radiation Safety and Radioisotope Committee i
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INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-101 ISOTOPIC PULSE GENERATOR Project Nuclear Pacemaker 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 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: Robert G. Hauser, M. D.
1753 West Congress Parkway Chicago, Illinois 60612 (312)942-6025 If not available:
Milton Weinberg,Jr., M. D.
1725 West Harrison St Chicago, Illinois 60612 (312)942-6583 If not available:
James G. Clark, M. D.
1725 West Harrison Street Chicago, Illinois 60612 (312)942-5900 If not available:
Marshall D. Goldin, M. D.
1725 West Harrison Street Chicago, Illinois 60612 (312)942-6645 If the physicians listed above cannot be reached, immediately contact the physician-on-call for the Pacemaker Surveillance Program at Rush-Presbyterian - St. Luke's Medical Center.
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Physicians responsible for study:
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Nilton Weinberf, Jr., M. D.
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Jamef G. Clark,X D.
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A obeft G.~ KauMr. M. D.
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Parsyll D. Goldi6. M. D.
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