ML20216D998
| ML20216D998 | |
| Person / Time | |
|---|---|
| Site: | 07002304 |
| Issue date: | 03/31/1976 |
| From: | Ablaza S, Estioko M, Lambert R MEDICAL COLLEGE OF PENNSYLVANIA & HOSP., PHILADELPHIA |
| To: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20216D625 | List: |
| References | |
| 0993, 105925, 993, NUDOCS 8706300626 | |
| Download: ML20216D998 (8) | |
Text
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,f1IS,074 TH E MEDIC AL CO LLEG E OF PEN NSYLVA NI A AN D HOSPITAL I
76 -yg 3300 HENRY AVENUE PJ1L ADELPHI A, PA.19129 215 842 6000 gm IS,gs 4
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Mrs. Patricia C. Vccca T)
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Division of Fuel Ch cle and Materials Safety 94 j{
U. S. Nuclear Regulatory Commission
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Washington, D. C.
20535 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 (<c 4.3 curies)
Dear Mrs. Vacca:
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The following information is submitted in application for a license to participate in the investigational program utilizing the Coratomic C-101 Isotopic
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Powered Pacer.
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Applicant: The Medical College of Pennsylvania A p plic a n t................
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Check No..+.'.'.f. 7.(12.. 7...
3300 Henry Avenue Philadelphia, Pennsylw.nia 19129 Amount. /dRr..ld...........
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Des o f C he ck... 7....I. m. L......
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Physicians responsible for study:
Date Check Rec'd.. 7..N73..m
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Name: James P. Boland, M. D.
Received By........ W.f.[L..... u Office Address: 3300 Henry Avenue, Philadelphia, Pa.
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41ephone Number: 215-842-6568 h
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State in which licensed to practice: Pennsylvania 7
s' ' ud Specialty Board Certification: American Board of Surgery,1964; il
,2 Board of Thoracic Surgery,1964 k;j J fb b
Training: Residency at the Deaduate Hospital of the University of b /
Pennsylvania frorn 357-58 and 1960-62. Residency in Thoracic Mcuuucu
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Q D.>Cm cus A Surgery at Univerdty of Texas Southwestern, Dallas, Texas
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1962-1964.
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' 'Q Position with Applicant: Attending staff Medical College of Pennsylvania Hospital as well as Professor of Surgery at the Medical College of Penna 1vania with 14 years of pacemaker experience.
4 Total Number of permanent pacemaker experience is: 350 pacers A
At the Medical College of Pennsylvania: 150 pacers d%-
"0FFiK E0RD C0T' 8706300626 870205 REG 1 LIC70 y'
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MdiPat ricia C. Vacch e
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N tme: Har.1 Chirtfe, M. D/.
j-Office Ad& ass: 3300 Henry Avenue,1%iladelphia, Pennsylvania i'
Telephone Number: 215-842-6904
' r JY State in which licensed to prp.4W Pennsf vania 1
!Spet?.Altv Board Certification'"M6erican Board of Cardiology 1967 Training-( Residene 7:in Internal Nedicine 1969-1970 at Lemuel Shdtuck F45 peal, Borcon c Massachusetts; Fellow in Cardiology
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,1RT 1971/,,t Lamu'el Shattuck Hospital, Boston, Massachusetts; f
7 Fr Av in Cat:6idogy 1971-1972 at New England Deaconess j
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a Hospital, Boston, Macathusetts; Fellow in Cardiology 1972-1973
.f Teesvascular Unit,,Tufti Circulation Laboratory, Boston j
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c-3 Gity Hospital.
Posiition with applicant: Ascistant Professor of Medicine, Director Non hvasive Laboratory, Division of Cardiology, Department of
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Name: Suiel G. G. Ablaza, M. D.
Office Addrese,1335 West Tabor Road, Philadelphia, Pennsylvania Telephone Number: 215-LI-9-7214 State in which licensed to practice: Pennsylvania Specialty Board Certification: American Board of Surgery,1963; American Board of Thoracic Surgery,1964 j
Training: Residency in General Surgery at Maryland General Hospital, Baltimore 1953-1955; St. Joseph's Hospital, Baltimore, Maryland 1955-1957; Residency in thoracic surgery Hahnemann Hospital, Philadelphia, Pennsylvania 1957-1959; New England Deaconess Hospital, Boston 1958; Charlotte Memorial Hospital, Charlotte North Carolina 1960-1961; Fellow at Bailey Thoracic Clinic, Philadelphia 1957-1959; Fellow at Overholt Thoracic Clinic, Bocton 1958 Position with Applicant: Clinical Professor and Head section of Thoracic and Cardiovascular Surgery with 12 years in Clinical Implantation and follow up of cardiac pacers.
Total Number Implanted: 500 Total Number at this Institution: 100 l
d.
Name Manuel R. Estioko, M. D.
Office Address: 1335 West Tabor Road, Philadelphia, Pennsylvania Teleph'ne Number: 215-LI-9-7214 State in which Licensed to Practice: Pennsylvania
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Mrs. Patricia C. Vacca March 31,1976 Page 3 2.
d.
Manuel R. Estioko, M. D. - continued Specialty Board Certification: American Board of Surgery 1971; American Board of Thoracic Surgery 1972
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Training: Residency in General Surgery Mount Sinai Hospital, New i
York, New York 1964-1969 - Chief Resident 1968-1969; j
Residency in Cariothoracic Surgery Mount Sinai Medical Center, i
New York, New York 1969-1971 - Chief Resident 1970-1971; j
Educational fellow in Cardiothoracic Surgery, Mount Sinai School of Medicine of the City University of New York, New York 1971-1972.
Total Implanted: 250 Total Done at this Facility: 50 c.
Name: Suresh Chandra Ghosh, M. D.
Office Address: 1335 West Tabor Road, Philadelphia, Pennsylvania Telephone Number: 215-LI-9-7214 State in which licensed to practice: Pennsylvania Specialty Board Certification: American Board of Surgery 1971; j
American Board of Thoracic Surgery 1974 l
l Training: Residency in General Surgery at the Albert Einstein
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Medical Center, Philadelphia, Pennsylvania, 1966-1970; j
Fellow in thoracic and cardiovascular surgery Albert Einstein l
Medical Center 1970-1971 Position with Applicant: Attending Thoracic Cardio Vascular Surgeon j
with 5 years in clinicalimplantation and follow up of cardiac l
pacers.
Total Number Implanted: 150 Total Number Done at this Institution: 15 l
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3.
Protocol to be followed:
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HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C-101 RADIOISOTOPE POWERED CARDIAC PACER DATED November 1,1975 (on file at NRC).
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4.
A maximum of 20 Coratomic C-101 pacemakers are requested to be implanted q
annually during the study.
5 The physical facilities and the equipment at the Medical College of Pennsylvania and Hospital pertaining to the Coratomic C-101 study program include the 1
following:
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Mrs. Patricia C. Vacca March 31,1976 Page 4 5.
a.
Pacemakers are implanted in the Cardiac Catheterization Laboratory or the Operating Room depending on whether the transvenous or epicardialleads are used. A portable X-ray unit with Image Intensifier is available so that cardiac surgery can be done in any of the nine rooms,
b.
The MedicalIntensive Care Unit into which the patient is moved after the pacer implant contains 7 beds, all equipped with hardwire monitoring units. The unit also contains one defibrillator and 3 Medtronic 5880A external pacing units.
6.
The Medical College of Pennsylvania and Hospital's present pacemaker implantation and follow up program.
3 Stimulation thresholds and sensing thresholds of all pacemaker implants are measured intra-cardiac with the Medtronic Model 5300 Pacer System Analyzer at the time of initial implant and also for a pulse generator replacement. At each implant, an electrocardiogram is obtained and a follow up and reporting procedure is utilized during the life of the battery pacer. Present times at which electrocardiograms are taken are at initialimplant, approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> from implant, at time of discharge, at one month, at approximately the third month and at six month intervals, thereafter.
l The surgeons involved in this study presently use the follow up program described below. All nuclear patients and control group patients are sent to the referring cardiologists at the check up interval times described in the Coratomic C-101 protocol. Both the patients with nuclear pacemakers and the control patients are then sent the day after, with EKG strip taken at the Cardiologist's office, to the implanting surgeon's office for a further follow up examination - the other types of pacers presently being implanted are Cordis, Medtronic, Biotronic and Intermedicunits.
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 routing office 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 exami-nations will be conducted at the following intervals after implant: at one month, j
the third month and every six months thereafter, following the insertion of l
the pacemaker until time of removal, m
E iVirs. Patricia C. Vacca March 31,1976 Page 5 7.
continued 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 or Patient Death Form, Informed Consent for SurgicalImplantation of Radioisotopic Powered Cardiac Pacer Form, Donor Cards for Adults or Donor Cards for Minors, 3
properly executed Instructions for Hospital Telephone Operators and
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Patient Identification Cards. The instructions for the Hospital Telephone j
operator is shown as Attachment 1 of this submission.
Records will be kept in the Hospital's Department of Cardiology as well as i
duplicate records in the offices of the physicians responsible for the individual patient examinations. These records will also be made available to referring cardiologists.
8.
Medical College of Pennsylvania and Hospital will establish appropriate control procedures and be responsible for the physical security of the pacemaker while in possession of the applicant. These procedures willinclude keeping track by serial number of the location of each pacemaker and require that they be kept under lock and key when not being used to guard against loss or theft.
The hospital will also assure that all activities are conducted in accordance with the regulations under title 10, Code of Federal Regulations, Part 70.
l 9.
Emergency Procedures
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George Raudenbush, Supervisor of the Cardiac Catheterization Laboratory 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 nuclear 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.
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 C-101 Isotopic Pacer. They understand that the issuing of a license amendment is. conditional upon the following of the protocol.
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Mrs. Patricia C. Vacca March 31,1976 Page.6 11.-
The Medical College of Pennsylvania 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, Pennsylvania-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 Medical College of Pennsylvania hereby requests'a license to receive, possess, store and implant the Coratomic C-101 Isotopic Powere pacemaker
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in accordance with this application.
1 Physicians responsible for study:
Signed Applicant:
Medical College of Pennsylvania
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Sariel G. G. Ablaza,4C D.
By:
f pbert L. Iddert, MiD.-
f Medical Director a
hianuel R. Estioko, IM. D.
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/Suresh C. Ghosh, M. D.-
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' James P. Boland, M. D.
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d l,ht*f-Lff Raul Chirife, *M. D.
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i er ATTACHMENT I INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-101 ISOTOPIC PULSE GENERATOR
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a Project Nuclear Pacemaker i
l Instructions to Operator:
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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.
.i 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 i
Patient's Social Security No.
Date of Implant Pacer Serial Number 4
Notify immediately: Raul Chirife, M.D., 3300 Henry Avenue, Phila., Pa, 19129 If he cannot be reached, notify: Sarici G.G. Ablaza, M.D. or Manuel R.
Estioko, M.D. or Suresh C. Ghosh, M. D. at 1335 West Tabor Road, Phila-delphia, Pennsylvania, Telephone: 215-LI-9-7215, or James P. Boland, M.D.,
3300 Henry Ave., Philadelphia, Penna. Telephone 215-842-6568 If none can be reached, contact the physician on duty for the Cardiac Care -
Unit (C.C.U. ). Inform him of the information you have and the urgency of the matter.
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Wuclear Materials Section B
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Division of Engineering and Technical Programs
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REGION 1.
APPLICATION ATTACHED Applicant /ttcensee: 'The Mcdrn' Co\\lena o-P 9png:dygyg r
a Application Dated:
7 98 E 10$925 Control No.:
License No.:
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2 FEE ATTACHED Amount:-
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Check No.:
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COWINTS Signedkkomh9Serh:.
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LICENSE FEE MANAGEMEhT ERANCH 1.
Fee Category and Amount:
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App 1tcation w.y be processed f r::
- c.endment Renewal
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License j h Signed
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