ML20214M563
| ML20214M563 | |
| Person / Time | |
|---|---|
| Site: | 07002199 |
| Issue date: | 12/15/1975 |
| From: | Gavazzi A VETERANS ADMIN. MEDICAL CENTER, WASHINGTON, DC |
| To: | US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20213D562 | List: |
| References | |
| 10196, NUDOCS 8609110176 | |
| Download: ML20214M563 (7) | |
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December 15, 1975 ib M [W(REPLY 49
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REFEM TO:
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Chief, Materials Branch hM Directorate of Licensing and Regulation jil
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Dear Sirs:
g 19 Re: Application for license to participate in the'sTiTdy involving the implantation of Caratomic 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 nuclear powered pac; maker.
1.
Applicant: Veterans Administration Hospital 50 Irving St., N.W.
Washington, DC 20422 2.
Physicians responsible for the study:
a.
Name:
Ross D. Fletcher, M.D.
Office Address: VA Hospi tal, 50 I rving St., N.W., Washington, DC Telephone ilumber:
(202) 389-7261, 7262 State Medical License:
District of Columbia Speciality Board Certification: American Board of Internal Medicine American Board of Cardiovascular Disease Training: Residency in Internal Medicine at University of Michigan Hospital; Fellowship in Cardiology,. University of Michigan Hospital; Fellowship in Cardiology, Georgetown University Medical Center, 1968 - 1969 Position with Applicant:
Chief, Cardiology Section Co-Director, Pacemaker Clinic
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b.
Name: Albert A. Del Negro, M.D.
Of fice Add ress : VA Hospi tal, 50 I rving St., N.W., Washington, DC Telephone Number:
(202) 389-7261 State Medical License: District of Columbia Training: Residency in Internal Medicine from 1970 to 1972.
Fellowship in Cardiology at Georgetown University Medical Center f rom 1972 to 1973 Fellowship in Cardiology at 8609110176 860029 REG 1 LIC70 SNM-160S PDR bq.Ot Show reteran's fall name, Vi fle number, and social secarity number on all correspondence.
l Chief, Materials Branch December 15,1975 Page 2 Veterans Adminstration Hospi tal,1973 through 1974.
Position with Applicant: Senior Staff physician, Department of Med icine. Co-Di rector, Pacemaker Fol low-up Clinic.
c.
Name: Creighton Wright, M.D.
Of fice Address: VA Hospital, 50 Irving St. N.W. Washington, D.C.
Telephone: (202) 389-7266 State Medical License: District of Columbia Speciality Board Certification: American Board of Surgery American Board of Thoracic Surgery Training: Residency in General Surgery at the University of Virginia, 1966-1970. Chief resident and assistant attending surgeon, Division of Thoracic and Cardiovascular Surgery, University of Virginia, 1970-1971.
Pos it ion wi th Applicant: Senior Staff Physician, Department of Surgery. Chief, Cardiovascular Surgical Section.
d.
Name: W.K. Halsty, M.D.
Office Address: Veterans Administration Hospital,50 Irving St. N.W.
Washington, D.C. 20422 Telephone: (202) 389-7261 State Medical License: District cf Columbia Speciality Board Certification: American Beard of Internal Medicine Training: Residency in Internal Medicine at Northwestern University, Chicago Wesley Memorial Hospital, July 1967-June 1969 Computer Applications in Cardiology, VA Research Center for Cardiovascular Data Processing, VA Hospital, Washington,D.C.
July 1970-June 1971.
Fellow in Cardiology, Catheterization Laboratory, Division of Cardiology, VA Hospital, Washington, D.C., May-June 1974.
Position with Applicant: Staff Cardiologist e.
Name: J.A. Snow, M.D.
Of fice Address: VA Hospi tal, 50 f rying ST. N.W., Washington, D.C.
Telephone: (202) 389-7261 State Medical License: District of Columbia Speciality Board Certification: American Board of Internal Medicine American Board of Cardiovascular Disease Training: Residency in Internal Medicine, Tufts Medical Service, Boston City Hospi tal,1966-1967 Fellowship in Cardiology Tufts University, School of Medicine, 1967-1969 Position with Applicant: Senior Staf f Physician. Department Ass t Chief, Card 1o1ogy Sect lon.
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Chief, Materials Branch December 15,1975 Page 3 f.
Nane : Fredric Siegel, M.D.
Office Address: VA Hospital,50 Irving St. N.W. Washington,D.C.
Telephone: (202) 384-7261 State Medical License: District of Columbia Speciality Board: American Board of internal Medicine Training: Medical Officer U.S. Public Health Service, Health Care Technology, Rockville, Maryland, 1969-1971. Resident in internal Medicine, Georgetown University, School of Medicine,1971-1972. Fellowship in Cardiology at Georgetown University School of Medicine,1972-1973 Fellowship in Cardiology at George Washington University School of Medicine,1973-1974.
Position with Applicar.t: Senior Staff Physician, Department of Medicine.
g.
Name: N.P.D.Smyth, M.D.
Office Address: Washington Hospital Center, uashington, D.C.
Telephone- (202) 593-5565 State Medical License: District of Columbia Training: Residency in general surgery at Henry Ford Hospital, Detroit Michigan from 1951 to 1955. Residency in Thoracic surgery at tiie George Washington University Hosp!tal, Washington, D.C.
from 1957-1959 Position with Applicant: Consultant in Thoracic Surgery, Veterans Administration Hospital.
- 3. Protocol to be followed:
HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C 101 RADl0lSGTOPE POWERED CARDI AC PACER DATED NOVEMBER 1,147;(on file at NRC).
- 4. A maximum of 20 Coratomic C-101 pacemakers is requested to be implanted annually.
- 5. The physical facilities and equipment at the VA Hospital pertinent to the Coratomic C-101 study program include the following:
a.
Pacemaker; are implanted in the cardiac catheterization laboratory where image Intensifier facilities are available and where appro-priately isolated electrical equipment are in use.
b.
The intensive cace unit into which the patient is transferred Immediately post implantation contains eight beds, all of which are equipped with hard-wired monitoring units. There are two portable defibrillators and four data scopes for monitoring arterial pressure. The Intensive care unit has 3 external demand pacemakers and one external transthoracic pacemaker.
- 6. Present Pacemaker implantation and Follow-up program.
At the time of pacemaker implantation, stimulation thresholds are
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Chief, Materials Branch December 15,1975 Page 4 determined utilizing a Medtronic Temporary external pacemaker (Model
- 5300). The magnitude of the intracavitary signal is measured by recording from the pacing wire directly with an isolated EKG machine.
This recording is done by members of the cardiology and cardiovascular surgical staff who follow the patient throughout his hospital course.
Patients are monitored contirously in the MICU for a period of not less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Prior to discharge, measurements of pacer stimulus duration and pacing interval are obtained. These are compared with parameters obtained in the follow-up clinic. Facilities exist for telephoning measurements of pacing intervals in selected patients.
Records are maintained in the of fices of the Cardiology Section.
7 Maintainence of records in implantation and follow-up of patients for 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 rou tine hospital records kept on every patient. At each examination period an electro-cardiogram will be obtained with and without the application of a magnet to induce fixed rate operation of the pacer. Follow-up examinations will be conducted at the following intervals af ter implant. At one month, three months and six months following the insertion of the pacer until removal. Telephone transmission and testing of pulse intervals will be used unless individual examinations will be required depending upon the patient's status. It is recognized that general medical care may be more frequert than this, but this is the minimal time between tests of pacer function for purposes of this study.
The following forms will be executed as discussed in the Coratomic C-101, November 1, 1975 Protocol: Registration and Implantation Da ta 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 Instructions for the hospital telephone operator are shown as Attachment 1 of this submission.
Records will be kept in the cardiology offices and duplicate records will be kept in the VA Hospital record room.
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n hief, Materials Branch 0::cember 15,1975 Page 5 8.
Control Procedures The VA 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.
The VA Hospital will also assure that all activities are conducted in accordance with the regulations under Title 10, Code of Federal Regu-lations, Part 70.
9 Emergency Procedures A pacemaker coordinator will be assigned and will be responsible for giving the hospital telephone operators written instructions concerning the noti fication of appropriate individiuals 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 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 Pacer. They understand that the issuing of a license amendment 10 conditional upon the following of the Protocol.
- 11. The VA 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, Ind iana, Pa.,15701, even in the event that 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., wIi1 be foi) owed upon return of the pacemaker for approved disposal.
- 13. The VA llospital hereby requests a license to receive, possess, store and implant the Coratomic C-101 nuclear powered pacemaker in accordance with this application.
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Chief, Materials Branch December 15,1975 Page 6 Signed:
Applicant:
VA Hospital Washington, D.C.
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.a irector-A.A. Gavazzi Physicians responsible for study:
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Ross D. Fletcher, M.D.
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Albert A. DelNegr6, M.D.
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ATTACHMENT 1 INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS Coratomic C-101 Series 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: Albert DelNegro, M.D.
50 Irving St., N.W.
Washington, D.C. 20422 Phone: (202)389-7261 (Name, address, telephone number of physician responsible for study.)
I f he cannot be reached, noti fy: Ross Fletcher, M.D. 50 I rving St.N.W.
Washington, D.C. 20422 Phone:(202)389-7261 (Name, address, telephone number of alternative physician.)
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 that you have and the urgency of the matter.
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