ML20204B967
| ML20204B967 | |
| Person / Time | |
|---|---|
| Site: | 07002077 |
| Issue date: | 09/18/1975 |
| From: | Richard Anderson, Bolden D, Driscoll R SUBURBAN GENERAL HOSP., NORRISTOWN, PA |
| To: | Jonathan Brown NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20204B848 | List: |
| References | |
| 1937, NUDOCS 8607300539 | |
| Download: ML20204B967 (10) | |
Text
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REGULATORY FILE CY i70-2077
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SUBURB AN GENER AL HOSPITAL s-
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k ATTENTION:
MR. J. BROWN GJ e
Gentlemen:
tu DOCKET #70-2077 RE:
Amendment to application for license to participate in a research study involving the implantation of Coratomic C-100 Series Isotopic Powered Pacemakers, each containing 250 Milligrams 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, Pa.
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 New Jersey Specialty Board Certification:
Board Eligible, American Board of Osteopathic Surgeons Training:
Residency in General Surgery, Cherry Hill Hospital Cherry Hill, New Je*sey from 1968 to 1972.
Third year residency taken at Mercy Catholic Medical Center, Department of Traumatic Surgery, 1970-1971.
7 Specialized training in Thoracic Surgery and Trauma Surgery 8607300539 860610 REG 1 LIC70 SNM-1581 PDR 1"^""
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Mr. J.
Brown September 18, 1975 Pg. 2 Position of Applicant:
Attending Staff Surgeon Department of Surgery Suburban General Hospital
- Experience:
Active medical staff provides experience in clinical implantation and follow-up of pacemakers.
A Duration of Pacemaker Experience:.__9_. years s
Total Number of Implants Done:
35 _-
cN x Total Number Done at this facility (new building, 1972)
Total Number of Pacemakers at this institution (Suburban General Hospital) formerly known as Riverview Osteopathic Hospital:
70 in last three years b.
Name:
ALBERT J. FORNACE, D.O.
Office Address:
901 Sandy Street Norristown, Pennsylvania 19401 Telephone Number:
(215) 275-4606 State License in which to practice:
Pennsylvania Specialty Board Certification:
American Osteopathic Board of Internal Medicine
,s t ' 11 Training:
Graduate Training at Philadelphia College of Osteopathic Medicine - 1945 to 1950.
Position of Applicant:
Attending Medical Staff Chairman, Department of Internal Medicine with extensive experience in clinical implantation and follow-up of pacemakers.
Duration of Pacemaker Experience:
9 years Total Number of Implants Done:
10 b-Total Number Done at this facility (S.G.H./R.0.H.):
70 s
cI.
Name:
JAMES E. MCHUGH, D.O.
Office Address:
901 Sandy Street Norristown, Pennsylvania 19401 Telephone Number:
(215) 275-4606 State License in which to practice:
Pennsylvania Specialty Board Certification:
American Board of Internal Medicine (AMA)
Training:
Residency in Internal Medicine, Mercy Catholic Medical Center, Misericordia Hospital, Philadelphia, 1970-1973.
Position of Applicant:
Attending Medical Staff Duration of Pacemaker Experience:
7 years Total Number of Implants Done:
40-Total Number Done at this facility:
10
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Mr. J.
Brown September 18, 1975 Pg. 3 d.
Name:
DAVID M. BOLDEN, D.O.
Office Address:
Suburban General Hospital 2701 DeKalb Pike Norristown, Pennsylvania 19401 Telephone Number:
(215) 272-9400 Ext. 385 State License in which to practice:
Pennsylvania New Jersey Specialty Board Certification:
Diagnostic Radiology, Therapeutic Radiology, Radium Therapy, and Nuclear Medicine -
American Osteopathic Board of Radiology.
Training:
Diagnostic Radiology, Therapeutic Radiology, Radium Therapy, and Nuclear Medicine, Cherry Hill Hospital, Cherry Hill, New Jersey 1966 Residency Diploma.
Position of Applicant:
Attending Medical Staff Chairman of Department of Radiology
/ Chairman, Isotope Use Committee Radiation Safety Official Hospital Isotope License:
- 37-13509-01 3.
PROTOCOL TO BE FOLLOWED:
HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C-100 SERIES RADIO-ISOTOPE POWERED CARDIAC PACER DATED JULY 1, 1975. (On file at NRC)
[v 4.
A maximum of forty Coratomic C-100 Series Pacemakers
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quested 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 telcuetry monitoring units.
There are two portable de-fibrillators and two data scoper, to monitor arterial pressure, and four external pacemakers.
Mr. J. Brown September 18, 1975 Pg. 4 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 register 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 portable defibrillators available.
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 the Medtronic Model #5300 Pacer System Analyzer at the time of initial implantation or pulse generator replacement or electrode replacement.
This is done by the personnel from the Department of Surgery, who will later full load the patient in the Intensive Care Unit for the first twenty-four hours postop.
At each implant, an electrocardiogram is obtained and a follow-up and reporting procedure is utilized during the life of the pacemaker battery.
Present exa,ination times at which electro-cardiograms are taken are at initial implant, approximately twenty-four hours af ter ;2pi att, at time of discharge, and at three month intervals thercafter.
In addition, every six months, the patient is brought to the pacemaker clinic for a complete
/ phycical examination to include electrocardiogram, wound in-spection, pacemaker generator pocket inspection, full electronic analysis of pacemaker function as is technically feasible in a non-invasive fashion, and the electrocardiogram is telemeteried to a computer-based analysis center.
If any malfunction is ob-served, corrective action will be immediately undertaken.
Ad-ditional telephone transmission to centralized computer analysis and testing of pulse intervals will be used depending upon the patient's condition.
Records are presently kept in the pace-maker clinic (Heart Station) located in 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 Pace-maker is removed.
This follow-up will be separate from the routine hospital records kept on every patient.
At each exa-mination period, an electrecardiogram 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.
MUB
Mr. J.
Brown September 18, 1975 Pg. 5
<F - Telephone transmission and testing of pulse intervals will be used unless individual examination will be required depending e'
upon the patient's data.
It is recognized that general medical care may be more fre-quent than this, but this is the minimal time between tests of pacer function for purposes of this study.
The following forms v~.ll be executed as discussed in the Coratomic C-100 Serie July 1, 1975 Protocol:
Registration and Implantation Dr Form, Follow-up Data Form, Pacer Failure and Removal at Patient's Death Form, Informed Consent for Sur-gical 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 Information Cards.
The instructions for hospital telephone operator is shown as Attachment 1 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 responsible for the individual patient examination.
These records will also be made available to referring cardiologists 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 The pacemaker coordinator (Dr. Robert W. Driscoll) will be assigned and will be responsible for giving the hospital tele-phone operators written instructions concerning the notification of appropriate individuals upon receipt of emergency report and inquiry concerning a pacemaker bearer.
The coordinator or his designee (see below) will also be responsible for personal dis-cussions with each telephone operator.
The form used for this purpose is shown in Attachment 1.
Mr. J. Brown September 18, 1975 Pg. 6 The alternate coordinators in the event of Dr. Driscoll's unavailability shall be either Dr. Albert J. Fornace and/or Dr. James E. McHugh.
If either of the two alternate coordinators are unavailable, Dr. Joseph V. Koehler, Internist or Dr. Martin D.
- Bascove, Internist (any one of which has the capability of implantation or replacement of a pacemaker generator) will assume the re-sponsibility for the alternate coordinators.
It has been our experience to date that at no time during our experience with pacemaker patients that anyone of the above have been unavailable at the same time.
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 Coratomic C-100 Series Pacemaker.
They understand that the issuing of a license amendment is condi-tional upon the following of the Protocol.
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 Cor-atomic, Inc., P.O.
Box 434, Indiana, Pennsylvania 15701, even in the event the physician named in the application to parti-cipate 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 Genera] 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: \\
u.k d-ht e Richard B. Anderson Administrator SUBURBAN GENERAL HOSPITAL
% hh By:
David M.
- Bolden, D.O., Chairman RADIOLOGY DEPARTMENT Physician responsible for the study:
b-f$
}lGA Robert W. Driscoll, D.O.
~
ATTACHMENT I INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-100 ISOTOPIC PULSE GENERATOR PROJECT NUCLEAR PACEMAKER INSTRUCTIONS TO OPERATOR:
1.
Ac.;ept 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: Albert J. Fornace, D.O.
901 Sandy Street Norristown, Pennsylvania 19401 Telephone Number (215) 275-4606 James E. McHugh, D.O.
901 Sandy Street Norristown, Pennsylvania 19401 Telephonc Number (215) 275-4606
If he can not be reached, notify:
Martin D.
Bascove, D.O.
901 Sandy Street Norristown, Pennsylvania 19401 Telephone Number (215) 275-4606 Joseph V. Koehler, D.O.
901 Sandy Street Norristown, Pennsylvania 19401 Telephone Number (215) 275 4606 If none of the above can be reached, contact the physician on duty for the Coronary Care Unit; inform him that this involves a nuclear pacemaker; and advise him of the information you have and the urgency of the matter.