ML20207U071
| ML20207U071 | |
| Person / Time | |
|---|---|
| Site: | 07002281 |
| Issue date: | 03/19/1976 |
| From: | Plzak L, Tracy Scott, Kevin Williams BRYN MAWR HOSP., BRYN MAWR, PA |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20207T988 | List: |
| References | |
| 0762, 762, NUDOCS 8703240584 | |
| Download: ML20207U071 (6) | |
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k THE BRYN M AWR HOSPITAL BRYN MAWR. PA. 19010 g
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Mrs. Patricia C. Vacca Materials Branch IFilf. Men'.
Division of Fuel Cycle and Materials Safety 80 Og U. S. Nuclear Regulatory Commission Washington, D. C. 20555 Attention: Mrs. Patricia C. 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, ( <C 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:
The Bryn Mawr Hospital gmx Bryn Mawr Avenue s9 Bryn Mawr, Pennsylvania 19010 t,
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Physicians responsible for study:
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Name - Kirkley Richard Williams, M. D.
q Office Address -
207 Bryn Mawr Medical Building
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%y Bryn Mawr, Pennsylvania 19010
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Telephone Number - 215-527-1185
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State in which licensed to practice - Pennsylvania Specialty Board Certification - American Board of Surgery,1961 American Board of Thoracic Surgery,1962 Training - Assistant Resident Barnes Hospital, St. Louis, Missouri, 1956 - 1959; Resident in surgery at Barnes Hospital, St. Louis, Missouri, 1959 - 1960; Fellow in Thoracic and Cardiovascular surgery, Washington University and Barnes Hospital, 1960 - 1962 l
Position with Applicant - Attending Surgeon in charge of cardiovascular surgery with 16 years of experience in permanent pacemaker implant and follow up.
Total Number of Implants done - 400 Total Number done at this facility - 200 OJg9 O"
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Chi:f, Mat: rials Errne March 19,1976 Page 2 2.
b.
Name - Louis F. P12Ak, M. D.
Office Address - Bryn Mawr Medical Building Bryn Mawr, Pennsylvania 19010 State in which licensed 'o nractice - Pennsylvania Specialty Board Certisication - American Board of Surgery,1966, American Board of Thoracic Surgery,1967 Training - Residency in general and cardiovascular surgery at the Peter Bent Brigham Hospital, Boston, Massachusetts, 1958 - 1966 Position with Applicant - Staff Surgeon bringing 16 years of experience in the clinicalimplantation and follow up of pacemakers.
Total number of implants - 200 Total number done at this facility - 30 c.
Name -
F. Thomas Hopkins, M. D.
Office Address - Glenbrook Medical Building 864 County Line Road Bryn Mawr, Pennsylvania 19010 Specialty Board Certification - American Board of Internal Medicine, 1961, American Board of Internal Medicine (cardiovascular diseases),
1967 Training - Medical resident at John Hopkins Hospital, Baltimore, Maryland, 1954 - 1956 National Heart Institute Trainee - University of Pennsylvania Hospital, Philadelphia, Pennsylvania, 1956 - 1957 National Heart Institute Trainee - Pennsylvania Hospital, Philadelphia, Pennsylvania, 1957 - 1958 Position with Applicant - Attending Cardiologist d.
Name - Frank S. Harrison, Jr., M. D.
Office Address - 933 Haverford Road Bryn Mawr, Pennsylvania 19010 Telephone Number - 215-LA-5-1202 State in which Licensed to Practice - Pennsylvania Specialty Board Certification - American Board of Internal Medicine, 1968; American Board of Cardiology,1973 Training - 1st year Radiology residency at the University of Pennsylvania Hospital, 1965 - 1966; Junior resident in Internal Medicine at Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, 1966 - 1967; Chief Resident at Bryn Mawr Hospital, 1967 - 1968; Fellow in Cardiology at the University of Pennsylvania, 1968 - 1970 Assistant Attending Cardiologist Position with the Applicant
Ohinf, Mat:riala Branch March 19,1976 Page 3 3.
Protocol to be followed:
HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C-101 RADIOISOTOPE POWERED CARDIAL PACER DATED November 1,.1975. (On file at NRC) 4.
A maximum of 20 Coratomic C-101 pacemakers are requested to be implanted annually during the study.
5.
The physical facilities and equipment at Bryn Mawr Hospital pertinent to the Coratomic C-101 study program include the following:
a.
Pacemakers are implanted in the operating room. A portable x-ray unit with image intensifier is available so that cardiac surgery can be done in any of the eight operating rooms in the hospital.
b.
The Intensive Care Unit into which the patient is moved immediately after Thoracic surgery contains 14 beds all with hardwire monitoring to a central console with alarm and write out. The unit contains two portable defibrillators and two 5880A medtronic external pacemakers.
6.
Bryn Mawr 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 the Medtronic Model 5300 Pacer System Analyzer at the time of initial implant or pulse-generator replacement. This is done by personnel from the Operating Room. At each implant an electrocardiogram is obtained and a follow up and reporting procedure is utilized during the life of the pacemaker. Examination times at which electro-cardiograms 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 /> af ter implant, at time of discharge,first month, three months and at six month intervals thereafter for the life of the pacemaker. Records are presently kept at the office of Kirkley R. Williams, M. D., where the Pacemaker Clinic is run. The clinic has been in existence 11 years and at present time is following 200 patients. The patients presently being followed have Cordio Omnicors, Medtronic Xytron and Arco Lithium Pacemakers implanted.
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 and pacemaker clinic 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 af ter implant: at one month, three months, and six months following the
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continue'd insertion of the pacer, until removal.
. Ibe following foms will be executed as discussed in the Cbratamic C-101.
Ibvember 1,1975 Protocol: Ibgistration and Implantation Data Ebrm, Follow-up Data Ebrm, Pacer Failure and Penoval or Patient Death Ibnn, Inforned Cbnsent for Surgical Implantation of Radioisotope Ibwered Cardiac Pacer Ebrm, Dcnor Cards for Adult.c or Donor Cards for Minors, properly executed Instructicms for INscal 'Iblephcne Operators and Patient Identificaticn Cards. 'lhe instructions for the Ibspital telephcne operator is shown as Attachnent I of this subnission.
Iboords will be kept at the Cbntral Ihta area in the pf=ker clinic in Kirkley R. Willimrs, M. D. office and duplicate records will be kept in the offices of the physicians responsible for the individual patient examinaticns, these records will also be made available to referring Cardiologists.
8.
Control Procedures Dryn Mawr Hospital will establish appropriate control procedures and be respcnsible for the physical security of the pacemaker while in possessim of the applicant. These procedures will incluch keeping track by serial number of the location of each pacenaker and require that they be kept under lock and key when not being used to guard against loss or theft. 'Ihe Bryn Mawr Ibspital will also assure that all activities are conducted in accordance with the regulations under Title 10, Code of Federal Regulations, Part 70.
9.
Dmrgency Procedures A pacemaker coordinator will Le assigned and will be respcmsible for giving the hospital telephcne operators written instructions concerning the notification of appropriate individuals upcn receipt of emergency report and inquiry ccncerning a pacemaker bearer. 'Ihe coordinator will also be respcnsible for perscnal discussicns with each telephone operator. The fonn used for this purpose is shown as Attachtent I.
Mrs. Maryanne Heberer, Cardiac Ca+duterization Iab, will be the Pa-dr (bordinator for Bryn Mawr Hospital.
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Chief, Materials Branch March 19,1976 Page 5 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 Bryn Mawr 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 if 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 Bryn Mawr Hospital hereby requests a license to receive, possess, store and implant the Coratomic C-101 Isotopic Powered Pacemaker in accordance with this application.
Physicians Responsibic for study Signed Applicant A
The Bryn Mawr Hospital Ybc. 0 - [w bhbis eb f),
Kirkley R illiams, M. D.
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Thomas L. Scott
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/'1 Assistant Vice President Administration Louis F. Plzik, M.
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A/VMaen thD frank S. Ha'rrison, Jr., M. Dl.
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F. Thomas Hopkins', M. D.
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-ATTACHMENT 1 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 Number Dace of Implant Pacer Serial Number 4.
Notify immediately: Kirkley R. Williams, Jr., M. D., 207 Bryn Mawr Medical Building, Bryn Mawr, Pennsylvania,19010, Talephone 215-527-1185.
If he cannot be reached, notify: Louis F. Plaik, Bryn Mawr Medical Building, Bryn Mawr, Pennsylvania 19010, Telephone: 215 - L AS-7 ft8 If neither can be reached, contact physician on duty for the Cardiac Care Unit (CCU); inform him that this involves a nuclear pacer and advise him of the information you have and the urgency of the matter.
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