ML20204C003
| ML20204C003 | |
| Person / Time | |
|---|---|
| Site: | 07002077 |
| Issue date: | 08/07/1975 |
| From: | Richard Anderson, Driscoll R SUBURBAN GENERAL HOSP., NORRISTOWN, PA |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20204B848 | List: |
| References | |
| 1731, NUDOCS 8607300547 | |
| Download: ML20204C003 (7) | |
Text
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n,.p August 7, 1975 Nr 6.' f v6 Chief Materials Branch I
f[ri". fy2./. g$ F~fEr.* 'h Division of Materials and O
Fuel Cycle Facility Licensing U.S. Nuclear Regulatory Commission h.Vifh'
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Washington, D.C.
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ATTENTION:
MR. J.R. MASON Gentlemen:
RE:
APPLICATION FOR LICENSE AMENDMENT TO PARTICIPATE IN A RESEARCH STUDY INVOLVING THE IMPLANTATION OF CORATOMIC C-100 Series, Isotopic Powered Pacemakers, each containing 250 mgs. of Pu-238 (less than 4.3 curies).
The following information is submitted in application for a license to participate in the investigational program utilizing the Coratomic C-100 Series Isotopic Powered Pacer.
1.
APPLICANT:
SUBURBAN GENERAL HOSPITAL 2701 DeKalb Pike Norristown, Pennsylvania 19401 2.
PHYSICIAN RESPONSIBLE FOR THE STUDY:
a.
Name:
ROBERT W. DRISCOLL, D.O.
Office Address:
551 Plymouth Road Plymouth Meeting, Pennsylvania 19462 Telephone Number: (215) 275-2950 State License in which to practice:
Pennsylvania w,
New Jersey Specialty Board Certification:
Board Eligible, American
/7,'M, Board of Osteopathic Surgeons
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3 Training:
Residency in General Surgery, Cherry Hill FMpital C
Cherry Hill, New Jersey from 1968 to 1972.
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.r Third year residency taken at Mercy Catholic b
'nj Medical Center, Department of Traumatic Surgery, TX D Y v. '. U/
1970-1971.
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/rg Position of Applicant:
Attending Staff Surgeon 8607300547 860610 Department of Surgery EVCink g g 70 Suburban General Hospital PDR fee.
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Mr. J.R. Mason August 7, 1975 Pg. 2 Experience:
Active medical staff provides experience in clinical implantation and follow-up of pace-makers.
Duration of Pacemaker Experience:
9 years Total Number of Implants Done:
35 Total Number Done at this facility:
20 3.
PROTOCOL TO BE FOLLOWED:
HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C-100 SERIES RADIOISOTOPE POWERED CARDIAC PACER DATED JULY 1, 1975 (ON FILE AT NRC) 4.
A maximum of forty Coratomic C-100 Series Pacemakers is L' "
requested to be implanted annually during this study.
5.
The physical facilities and equipment at Suburban General Hospital pertinent to the Coratomic C-100 Study Program include the following:
a.
Pacemakers are implanted either in the X-ray Department or in the Department of Surgery depending on whether transvenous or epicardial leads are used.
A portable x-ray unit with image intensifier is available so that cardiac surgery can be done in any one of the three operating rooms in the hospital.
b.
The Intensive Surgical / Coronary Care Unit to which the patient is moved immediately after thoracic surgery contains six beds, which are equipped with hard wire monitoring units,and two with telemetry monitoring units.
There are two portable defibrillators and two data scopes to monitor arterial pressure, and four external pacemakers.'
c.
The Progressive Cardiac Unit contains two rooms with one or two patients per room.
These rooms can be equipped with radiotransmitter telemetry units, all of which re-gister on multiple channel scopes with an alarm system and writeouts in the Intensive Coronary Care Unit.
There are at least two external powered pacemakers on standby at all units with pertable defibrillators available.
W1B "O" CIAIC0E COPY"
o Mr. J.R. Mason August 7, 1975 Pg. 3 6.
Suburban General 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 intracardiac with Medtronic Model #5880A Pacing System Analyzer at the time of initial implantation or pulse generator replacement.
This is done by personnel from the Department of Surgery, who then transfer the patient to the Intensive Coronary Care Unit for forty-eight hours.
After each implant, the electrocardiogram is obtained and a follow-up and reporting procedure is utilized during the life of the battery pacer.
Present examination timed at which electrocardiograms were taken are at initial implant, approximately twenty-four hours after implant,at the time of discharge,and at three month intervals thereafter.
Telephone transmission and testing of pulse intervals is used depending on the patient's condition, but is done no less than every six months.
Records are presently kept in the Eaart Station located within Suburban General Hospital.
7.
Maintenance of records of implantation and follow-up of patients for the C-100 Series Program:
Careful follow-up and recording procedures will be followed during the life of the patient or until the C-100 Series Pacemaker is removed.
This follow-up will be se-parate from the routine hospital records kept on every patient.
At each examination period, an electrocardiogram will be obtained without 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, three months, and six months following insertion of the pacer until removal.
Telephone
)l transmission and testing of pulse intervals will be used unless individual examinations will be required depending upon the patient's data.
It is recognized that general medical care may be more frequent 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-100 Series, July 1, 1975 Protocol:
Registration and Implantation Data Form, Follow-up Data Form, Pacer Failure and Removal at Patient's Death Form, Informed Con-sent for Surgical Implantation or Radioisotopic Powered Cardiac Pacer Form, Donor Cards for Adults, or Donor Cards
g Mr. J.R. Mason August 7, 1975 Pg. 4 for Minors properly executed, Instructions for Hospital Telephone Operator and Patient Information Cards.
The instructions for hospital telephone operator is shown as Attachment I of this submission.
Records will be kept at the Central Data Center in the Heart Station at Suburban General Hospital, and duplicate records will be kept in the offices of the physician re-sponsible for the individual patient examination.
These records will also be made available to referring cardiolo-gists.
8.
CONTROL PROCEDURES Suburban General Hospital will establish appropriate control procedures and be responsible for the physical security of the pacemakers while in the possession of the applicant.
These procedures will include keeping track of serial number of the location of each pacer and requiring that they be kept under lock and key when not being used to guard against loss or theft.
Suburban General Hospital will also assure that all activities are conducted in accordance with the regulations under Title X, Code of Federal Regulations, 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 notification of ap-propriate individuals upon receipt of emergency report and inquiry concerning a pacer bearer.
The coordinator will also be responsible for personal discussions with each telephone operator.
The form to be used for this purpose is shown in Attachment I.
10.
PHYSICIANS RESPONSIBLE The physicians responsible for and participating in the study have certified that they are familiar with Coratomic C-100 Series Protocol and the Coratomic C-100 Series Pacemaker.
They understand that the issuing of a license amendment is conditional upon the following of the Protocol.
"0RC1. ECORB COPY"-
g Mr. J.R. Mason August 7, 1975 Pg. 5 11.
Suburban General 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 the Coratomic, Inc., P.O.
Box 434, Indiana, Pennsylvania 15701, even in the event the physician named in the appli-cation 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.
Suburban General Hospital hereby requests a license to receive, possess, store, and implant a Coratomic C-100 Series Isotopic Powered Pacemaker in accordance with this application.
SIGNED APPLICANT:
SUBURBAN GENERAL HOSPITAL 2701 DeKalb Pike Norristown, Pa.
19401 BY:
Richard B. Anderson Administrator f h[],
J Robert W. Driscoll, D.O.
Physician Responsible for Study RBA:RWD/pce "DFiC AL RECOTO COPY"
g ATTACHMENT I INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-100 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 pacemaker and requires immediate action to insure that there is no danger of radiation ex-posure 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's I.D.
Card Patient's Social Security Number Date of Implant Pacer's Serial Number
- 4. Notify immediately:
Robert W. Driscoll, D.O.
551 Plymouth Road Plymouth Meeting, Pennsylvania 19462 Telephone Number:
(215) 275-2950 If he can not be reached, notify Internal Medicine Associates Suburban General Hospital Norristown, Pennsylvania 19401 Telephone Number: (215) 272-9400 If neither can be reached, contact physician on duty for the Cr.rdiac Care Unit, inform him that this involves a nuclear pacemaker and advise him of the information you have and the urgency of the matter.
i E El a'E t t.:
WillistO.F.iiO.casef O
L ic t r.st I t t P.a r.g gere n t Er enc h Of fice of Administration John E. Glenn chief Nuc1 car Materials Section 8 Division of Engineering and Technical Programs LICENSE FEE TRANSMITTAL A.
REGION 1.
APPLICATION ATTACHED Applicant / Licensee:
behurhnn O,Gywn) k\\ty Cd k
Application Dated:
in 31 ss5
- LO4579 Control No.:
License No.:
%h \\cTis) 2 FEE ATTACHED Amount:
O Check No.:
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COMMENTS p
Signed (to n b kn3hc I
Date
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LICENSE FEE MANAGEMENT EPJE~H f
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Fee Category and Amount:
2.
Correct Fee Paid.
Application my be processed for:
Ar.endment Renewal
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License Signed O
n c (t.C)
Date
, ) / c / cfI r
l REGION I FORM 213 (PARCH 1983)
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