ML20214B788

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Application for License to Participate in Investigational Program Involving Implantation of Coratomic C-101 Isotopic Powered Pacemakers,Each Containing 250 Mg of Pu-238. Supporting Documentation Encl
ML20214B788
Person / Time
Site: 07002232
Issue date: 05/26/1976
From: Coll J, Enriquez F, Paine E
WEST JERSEY HOSP., CAMDEN, NJ
To:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20214B621 List:
References
NUDOCS 8705200412
Download: ML20214B788 (8)
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L-WEST JERSEY X@@FTal NORTHERN DIVISION CAMDEN, N.J. 08104 SOUTHERN DIVISION BERLIN, N.J. 08009 EASTERN DIVISION VOORHEES, N.J. 08043 May 26,1976 t

Mrs. Patricia C. Vacca Division of Fuel Cycle and Materials Safety U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Mrs. Vacca:

RE:

Application for a license to participate in an investigational program involving the Implantation of Coratomic C-101 Isotopic Powered Pacemakers, each containing 250 milligrams of Pu-238 (44.3 curies)

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:

West Jersey Hospital Northern Division i

Mount Ephraim and Atlantic Ave.

Camden, New Jersey 08104 Eastern Division Evesham Road Voorhees, N.J. 08043

2. Physicians responsible for study:

I-a.

Name - Francisco Enriquez Office Address - 8 S. Haddon Ave., Haddonfield, N.J. 08033 Telephone Number - (609) 429-2212 l

State in which licensed to practice - New Jersey Specialty Board certification - Board Eligible Thoracic Surgery kgf[fh2870127I" SNM-1646 PDR-

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--WEST JERSEY Page 2 NORTHERN DIVISION CAMDEN, N.J. 08104 SOUTHERN DIVISION BERLIN, N.J. 08009 I

. EASTERN DIVISION VOORHEES, N.J. 08043 i

I Training - 1st and 2nd year surgical residency at Newton Wellesly Hospital,'

Newton, Mass.. 1959-1961 3rd year surgical residency at the Genesee Hospitalin Rochester, N.Y.- 1961-1962 1st year Thoracic and Cardio--

vascular Surgical resident at the Presbyterian Hospital, Philadelphia, Pa.' 1962-1963 2nd year Thoracic and Cardiovascular Surgical Resident

- Temple University Hospital, Philadelphia, Penna, 1963-1964. Chief Resident Thoracic and Cardiovascular Surgery Temple University Hospital, Philadelphia, Penna, 1964-1965.-

Position with Applicant - Attending surgical staff with 9 years experience in the clinical implantation and follow-up of cardiac pacers.

Total number of pacers implanted 275 j

Total number done at this facility Northern Division 175 Eastern Division.

50 b.

Name - Emmons G. Paine, M.D.

c Address - 15 East Euclid Ave., Haddonfield, N.J. 08033 Telephone - (609) 428-3126 -

State in which licensed to practice - New Jersey Specialty Board Certificatios - American Board of Internal Medicine F

American Board of Cardiology Training - Residency in internal Medicine, Temple University Hospital j

1958-1961; Fellowship in Cardiology,- Temple University Hospital 1961-1962 f~

Position with Applicant - Attending Staff Physician l.

c.

Name - Jaime Coll, M.D.

Address - 600 Somerdale Road, Voorhees Township, N.J.

L Telephone - (609) 795-4049 i

State in which licensed to practice - New Jersey Specialty Board Certification - Board Eligible in Cardiology Training - Residency in Internal Medicine at Mount Sinai Hospital, Miami, Florida 1964-1967; Resident in Cardiology, Pennsylvania Hospital, f

Philadelphia, Penna,1968 Position with Applicant - Director of Diagnostic Ultra Sound Laboratories l

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LWEST JERSEY X@@PTlal NOATHERN DIVISION CAMDEN, N.J. 08104 SOUTHERN DIVISION BERLIN, N.J. 08009 EASTERN DIVISION VOORHEES, N.J. 08043 Page 3 i d.

Name - ElliottRosenberg, M.D.'

Address - 1555 Haddon Ave., Camden, N.J. 08103

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-Telephone - (609) 365-5360 State in which licensed to practice - Pennsylvania, New York, New Jersey

. Specialty Board Certification - American Board of Internal Medicine Training.- Residency in Internal Medicine, Bronx, Veterans Administration Hospital, Bronx, N.Y. 1958-1960; Residency in Internal Medicine, Montefiore Hospital, Bronx, New York 1960-1961 Position with Applicant - Director of Cardiac Rehabilitation - Eastern-Division.

' 3. Protocol to be followed:

. HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C-101 RADIOISOTOPE POWERED CARDIAC PACER DATED November 1,1975 (On file at NRC)

4. A maximum of 15 Coratomic C-101 pacemakers are requested to be implanted annually during the study.
5. The physical facilities and equipment at West Jersey Hospital, Northern Division pertinent to the Coratomic C-101 study program include the following:

a.

Pacemakers are implanted in the Surgical Department. A Siemens Fluoroscoping xray unit is available within the operating room for cardiac surgery, b.

The intensive care unit into which the patient is moved immediately after thoracic surgery contains 10 beds, 4 of which are equipped with hardware monitoring units. The units are equipped with writeout and alarm. The unit contains one portable defibrillator unit, c.

The Coronary Care unit is located in'an adjacent hall on the same floor.

. It contains six beds, all with hardware monitoring to a central console equipped with writeout and alarm. The unit contains 5 meditronic

'5880A external pacing units and one portable defibrillator.

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WEST JERSEY I@@FTal (NORTHERN' DIVISION CAMDEN, N.J. 08104

' SOUTHERN DIVISION BERLIN, N.J. 08009 EASTERN DIVISION VOORHEES, N.J. 08043 Page 4 a

i d.

The physical facilities and equipment at the Eastern Division of West.

Jersey Hospital pertinent to the Coratomic C-101 study program include the following:

1. Pacemakers are implanted in Room One of the surgical suite. This room contains a Siemens Fluoroscopic xray unit for doing cardiac surgery.

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2. Immediately after surgery the patient is moved into the Special Care Unit. The Special Care Unit contains 10 beds. All beds have hardware.

monitoring to a central console with write out and alarm.-.The unit has one Cordis Chronocor In external pacemaker and one meditronic i

5880A External Pacemaker. It also contains one portable defibrillator.

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6. West Iersey Hospitals present Pacemaker Implantation and Follow-Up Program.

Eastern and Northern Divisions. At the present time the stimulation thres-holds and sensing thresholds of all pacemaker implants are measured intra-cardiac with a Cordis Chronocor III External Pacing Unit. This is done for either an initial implant or a generator replacement. This is done by the nurs-l

.ing personnel from the operating room under the guidance of the implanting surgeon. At each implant an electrocardiogram is obtained and a follow-up and reporting procedure is utilized during the life of the battery pacer. An electro-cardiagram is taken at the following time intervals: at initialimplant, approxi- -

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mately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after implant, at time of discharge,. at the third month after l

implant, and at least once every six months thereafter. Records are kept in l~

the offices of the patient's referring physicians and duplicate records are kept at the hospital.

7. Maintenance of Records of Implantation and FoHow-up of Patients for the
C-101 Program.

Careful follow-up and recording procedures will be followed during the life of thepatientor untIl the C-101 pacemaker is removed. This follow-up will be separate from the routinehospital records kept on every patient. At each examinat{on period an electrocardiogram will be obtained with the application of a magjet to induce fixed rate operation operation of the pacemaker. Follow-up examidation will be conducted at the following intervals after implant. At-one month, the third month, and at least once every six months following the insertion of the pacemaker until removal.

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WEST JERSEY X@@F M NORTHERN DIVISION CAMDEN, N.J. 08104 SOUTHERN DIVISION BERLIN, N.J. 08009 EASTERN DIVISION VOORHEES, N.J. 08043 Page 5 The foHowing forms win 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 Surgical Implantation of Radioisotope Powered Cardiac Pacer Form, Donor Cards for Adults or Donor Cards for Minors, properly executed Instructions for Hospital Telenhone Operators and Patient Identification Cards. The instruc-tion for the hospital telephone ' operator is shown as Attachment 1 of this submission.

Records wiH be kept in the offices of the physicians responsible for the individual patient examination. These records will also be made available to referring cardiologists. A duplicate file will be maintained at both the Eastern and Northern Division of West Jersey Hospital.

8. Control Procedures West Jersey Hospital (Northern and Eastern Divisions)will establish appropriate control procedures and be responsible for the physical security of the pace-maker while in possession of the applicant. These procedures win include keep-ing 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 West Jersey Hospital (Northern and Eastern Divisions) win also j

assure that all activities are conducted in accordance with regulations under l

Title 10, Code of Federal Regulations, Part 70.

9. Emergency Procedures l

A Pacemaker Coordinator will be assigned at both the Eastern Division and j

Northern Division of West Jersey Hospital and will be responsible for giving the hospital telephone operators written instructions concerning the notifica-tion of appropriate individuals upon receipt of an emergency report and inquiry l

concerning a pacemaker bearer. The coordinator will also be responsible for l

personal discussions with each telephone operator. The form used for this l

purpose is shown as Attachment 1 Pacemaker Coordinator Northern Division: Ms. Irene Marlowe, R.N.

Head Nurse Coronary Care Unit l.

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WEST JERSEY X@@FT6L

' NORTHERN DIVIStCN CAMDEN. N.J. 08104 SOUTHERN DIVISION BERLIN, N.J. 08009

, EASTERN DIVISION VOORHEES, N.J. 08043 Page 6 Pacemaker Coordinator Eastern Division:

Mrs. Muriel Johnson, R.N.

Head Nurse Special Care Unit

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 thz.t the issuing of a license amend-ment is conditional upon the following of the protocol.
11. The West Jersey Hospital (Northern and Eastern Divisions) 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, Penna 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 West Jersey Hospital (Northern and Eastern Divisions) hereby requests a license to receive, possess, store and implant the Coratomic C-101 Isotopic Powered Pacemaker in accordance with this application.

Physicians Responsible for the Investigational Program:

Signed:

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etaoW Francisco Enriquez, M.D. [

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West Jersey sp'th1 h

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k?fff$$9 0 4"M By Emmons G. Paine', M.D.

Barry D.

rown, President I

WEST JER EY IIOSPITAL SYSTEM fa By 4

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Jai' e doll, M.D.

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ElliotfRosenberg, M.D.

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ATTACHMENT I INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-101 ISOTOPIC PULSE GENERATOR PROTECT NUCLEAR PACEMAKER Instructions to Operators (Northern Division):

1 Accept any collect call with reference co " 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 Date of Implant Pacer Serial Number Implanting Physician

4.. Notify immediately:

Francisco Enriquez, M.D.

8 S. Haddon Ave.

Haddonfield, N.J. 08033 (609) 429-2212 If he cannot be reached notify:

Jaime Coll, M.D.

600 Somerdale Road Voorhees Township, N.J.

(609) 795-4049 If he cannot be reached notify:

The Pacemaker Coordinator who is:

Ms. Irene Marlowe, R.N.

Head Nurse - Coronary Care Unit (609) 963-8830 "O"!C A. RECORD COPY" J

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ATTACHMENTI INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-101 ISOTOPIC PULSE GENERATOR PROTECT NUCLEAR PACEMAKER Instructions to Operators (Eastern Division) 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 Date of Implant Pacer Serial Number Implanting Physician 4

Notify immediately:

Francisco Enriquez, M.D.

8 S. Haddon Ave.

Haddonfield, N.J. 08033 (609) 429-2212 If he cannot be reached notify:

Elliot Rosenberg, M.D.

1555 Haddon Ave.

Camden, N.J. 08103 (609) 365-5360 If he cannot be reached notify:

The Pacemaker Coordinator who is:

Mrs. Muriel Johnson, R.N.

Head Nurse - Special Care Unit (609) 795-3000

" OTIC A. RECORD CDPY"

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