ML19332E327
| ML19332E327 | |
| Person / Time | |
|---|---|
| Site: | 07002989 |
| Issue date: | 06/16/1988 |
| From: | Corry M OUR LADY OF LOURDES MEDICAL CENTER, CAMDEN, NJ |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML19332E308 | List: |
| References | |
| 120560, 22523, NUDOCS 8912070081 | |
| Download: ML19332E327 (12) | |
Text
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1600 Haddon Avenue
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'.- (609) 757 3500 R.gion.1 oisiysi ena Transplantation Center ll Regional Perinatal Center t
ll Regional RehabWitation Center June 16, 1988 L CC:(
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l Director, Office of Nuclear Material N;p7 I
l Safety and Safeguards.
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- U.S. Nuclear-Regulatory. Commission Washington, D.C. 20555 t
' Gentlemen:
The following information is submitted in. application for renewal of Nuclear Pacemaker License.
A.
License number - SNM-1923
.B.
Our Lady of Lourdes Medical Center 1600 Haddon Avenue Camden, New Jersey 08103
,C.
Pacemakers to be authorized:
Cordis Nuclear Omni-Stanicor Pacemaker Model # 184A Series # 205 Model # 184A Series # P11530 D...The principal reasons for renewing pacemaker licenses are to' follow patients with implanted pacemakers and to return explanted pacemakers to the manufacturer for proper disposal- (but not to implant pacemakers in the future).
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Physicisns responsible for the program:
2E Francisco Enriquez, M.D.,,Marvin Grossman, M.D.,
Ernest E. Flegal, M.D.,
Vincent McDermott, Jr., M.D.,
and Charles P. Lisa, M.D.
- =0 Our Lady of Lourdes Medical Center herby requests a renewal license in g_
accordance with this application.
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ister M. Elfenbeth Corry Administrator l
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June 23, 1983 U.S.' Nuclear Regulatory Commission l
Material Licensing Branch
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- Re DOCKET NO. 70-2319 New License' for Special Nuclear Material I
Gentlemen In reference _to-La recent telephone conversation, a written request is being made to apply for a new'SNM' license.
- In May of.1976,- we applied for a license to participate in a program to im-plant Coratomic C101. Isotopic Powered Pacemakers - License # SNM 1650.
Sub-sequently, we also applied =for amendments to use Cordis Nuclear Omni-Stanicor Model 184A, Biotronic, and Medtronic Model 9000 cardiac pacemakers.
We will not be implanting any more Nuclear. Pacemakers. We have four patients
.in whom Cordis Nuclear Pacemakers are functioning now.
These-patients.are checked for pacemaker function by Anthropometrics on.a monthly basis. They are also checked by their faLily physicians or cardiologists routinely. We
..willl continue the follow-up reporting and recovery procedures during the life-of the patient and until the pacemaker is recovered and returned to the manu -
facturer per his instructions. We will also continue to have an emergency procedure,should a patient have an emergency, which has been developed with
-.the_ hospital operators and the pacemaker coordinator.
Alltphysicians listed on the previous SNM license are current.
Sister M. Elizabeth Corry, OSF has been transferred and Anthony Peters, Administrator has assumed these responsibilities.
' Please let us know if further infonnation is needed.
Sincerely, h6
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Anthony Pete s e
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ATIDITION :'Mrs. Pat Vacca
. RE:' Amendment of our license -number SNM-1650- to include the Medtronic Model 9000-7sotopic N1se Generator 1
Gentlemen:
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~ We ;wish to amend our license-to include the Medtronic Model 9000. We are familiar
- with the Medtronic Model 9000 protocol.. dated March 1,1973, revised Octob 1, 1975.
We wish to implant ten model 9000s-annually.
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. Physicians Responsible for Study:
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Charles P L a, M.D.
Ernest E. Flegel, M.D.
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Vincent T. McDennott Jr.,'$1.D.
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CAMDEN. N. J. 08103 "The Botty is otten curetite, the sout is one st PHONE 000 W 757 351)v october 5,1976
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Chief, Materials Branch Directorate of Licensing Regulations Nuclear Regulatory Agency Washington, D.C.
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Subject:
Amendment to License N9. SNM-1650 for implantation.~of Nuclect.i powered pacemakers.
Dear Sir Since Our Lady of Lourdes llospital is licensed to implant Nuc1 car Pace-makers under the license number SNM-1650, dated July 16, 1976, we re-quest an amendment for our license that would permit us to include the Cordis Nuclear Omni-Stanicor Model No. 184 Catalog No. 307-C05. %
will follow explicitly the master protocol, dated October 30, 1974, provided by the Cordis cr,eporation and approved by your office. You l-can be assured that all institutional commitr.ents previously submitted are binding. Any changes in this initial commitment are enclosed.
If any additional forms or information are required, please notify up as soon as possible.
Signed:
Applicant D
'Our Lady cif60:>urdes llospital /k,,g 1600 IInddon Avenue Camden, NJ 08103 l(), p By: ).cr e c.t s. e e nA Franc 1 Boo Enriquez, M.D. [
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Dear hirs,
Vacca:
1 RE: Application for license to participate in an investigational program involving the implantation of Coratomic C-101 Isotopic Powered Pacemakers, each containing 250 milligrams of Pu-238 ( < 4,3 curics)
The following information is submitted in application for a license to participate in the investigational program utilizing the Coratomic C-101 Isotopic Powered Pacert 1
Applicant Our Lady of Lourdes !!ospital 1600 Haddon Avenue Camden, New Jersey 08103 2
Physicians responsibic for study:
a.
Name - Francisco Enriquez, ht.D.
Office address - 8 S. Haddon Ave.,, liaddonficia, N.J. 08033 Telephone - (609) 429-2232 Specialty Board Certification - Board cligibic Thoracic Surgery Training - 1st and 2nd year surgical residency at Newton Wellesly llospital, Newton, biass, 1959-1961; 3rd year surgical residency at the Genesec Hospitalin Rochester, N.Y.
1961-1962; 1st year Thoracic and Cardiovascular Surgical Resident at the Presbyterian llospital, Philadelphia, Penna, 1962-1963; 2nd year Thoracic and Cardiovascular Surgical Resident Tempic University IIospital, n.,
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d' vascular Surgery Temple University Hospital, Phila., Pa, 1964-1965 Position with applicant - attending staff with 9 years experience in the gw/h gM clinicalimplantation and follow-up of cardiac pacers, 7 h M 3/ -ot (7/
Total number of pacers implanted 275 Total number donc at this institution 50 da'l,
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Name - Marvin Grossman, M.D.
Office address - 409 East State flighway #70, Cherry 11i11, N.J.
Telephone number - (609) 428-5857 State in which licensed to practico - New Jersey Specialty Board Cortification - American Board of Internal Medicine; Subspacialty in Cardiovascular Disease Training - Residency in Internal Medicine, Great Lakes Navalllospital 1964-1967; Fellowship in Cardiology, Philadelphia Naval llospital, 1967-1969 Position with Applicant: Chief of Cardiology c.
Name - Ernest E. Flegel, M.D.
Office address - 501 IIaddon Ave., IInddonfield, N.J. 08033 Telephone number - (609) 429-1110 State in which licensed to practice - New Jersey, Pernsylvania Specialty Board Certification - Board Eligible Cardiology Training - Residency in Internal Medicine, Jefferson Medical College IIospital, Phila., Penna, 1966-1967; Jefferson Medical College llospital (Philadelphia General liospital Division), Phila., Pa.
1969-1970; Chief Resident in Internal Medicine, Jefferson Medical College (Philadelphia Generalllospital Divsion), Phila,, Pa.
1970-1971; Fellowship in Cardiology Jefferson Medical College Ilospital, Philadelphia, Penna, 1971-1973 Position with Applicatt - Attending Physician d.
Name - Vincent T. McDermott, Jr., M.D.
Office address - 1533 IIadion Ave., Camden, N.J. 08103 Telephone number - (609) 964-3110 Stato in which licensed to practico - New Jersey Specialty Board Certification - Eligible in Internal Medicine Training - Residency in Internal Medicine, St. Michacis llospital, Newark, N.J. 1961-1963; Cardiology Fellowship llahnemann llospital, Phila., Pa. 1963-1965 Position with Applicant - Associato Staff L
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Name - Charles P. Lisa, ht.D.
Office address - M7 IIaddon Ave., Haddonficid, N.J. 08033 Telephono number - (609) 795-0299 Stato in which licensed to practice - New Jersey, Pennsylvania Specialty Board Certification - American Board of Internal hiodichio, Subspecialty in Cardiovascular Disease Training - Residency in hiodicine at Hahnemann Medical CoHego and Hospital, Phila., Penna. 1968-1970; Cardiology Fellowship Indiana University Ilospital, Indianapolis, Indiana 1970-1971; Cardiology FeBowship Ilahnemann Medical CoHege Ilospital, Philadelphia, Pa.,
1973-1974 Position with Applicant - Program Director Department of Medicino f.
Name - Ralph Caccso, M.D.
Office address - 1600 Haddon Ave., Camden, N.J.
Tclephone number - (609) 963-4300 State in which licensed to practice - New Jersey Specialty Board Certification - American Board of Radiology Endorsed by American Nuclear Medicine Society 1957 Position with Applicant - Radiation Safety Officer Isotopic License No.
20-06431-01 3
Protocol to be followed:
HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C-101 RADIOISOTOPE POWERED CARDIAC PACER DATED November 1,1975 (On filo at N.R.C. )
4 A maximum of 10 Coratomic C-101 pacemakers are requested to be implanted annually during the study.
5 The physical facilities and equipment at Our Lady of Lourdes Hospital perti-nent to the Coratomic C-101 study program include the foHowing:
a.
Pacemakers are implanted either in the Cardiac Catheterization Laboratory or in the Surgical Department, depending on whether Transvenous or Epicardia11 cads are used and if the surgery is an initial pacemaker implant or a battery replacement.
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The Coronary Care Unit into which the patient is moved immediately after thoracic surgery contains 8 beds, all of which are equipped with hardware monitoring to a central monitor equipped with write out and alarm. The unit also contains 1 portable defibrillator, 3 5880A external i
medtronic pacers, and 1 MedData high rate atrial pacing unit.
6 Our Lady of Lourdes liospital 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 a Cordis Chronocor III External Pacing Unit. This is done by nursing personnel from the oper-ating 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. Present examination times at which electrocardiograms are taken at initialimplant, approximately 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 approximately the third month after implant, and once every six months thereafter. The most commonly used pacemaker at present is the Cordis Omnicor. Records are kept in the office of the patients' referring physicians and duplicate records are kept on file at the hospital.
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 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 after implant.
At one month, the third month, and atleast once every six months there-after until removal of the pacer.
The following forms will 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 SurgicciImplantation of Radioisotope Powered l
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PHONE 609 963A300 Page 5 Cardiac Pacer Form, Donor Carus 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 is shown as Attachment 1 of this submission.
Records will be kept in the offices of the physicians responsibic for the individual patient examinations. These records will also be made availabic to referring cardiologists and duplicate records will be kept on file at the hospital.
8 Control Procedures Our Lady of Lourdes Hospital will establish appropriate control procedures and be responsible for the physical security of the pacemaker while in pos-session of the applicant. These procedures will include kooping 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.
Our Lady of Lourdes Hospital will also assure that all activities are con-ductedin accordance with the regulations under Title 10, Code of Federal Regulations, Part 70 9
Emergency Procedures A pacemaker coordinator will be assigned and will be responsibic for giving the hospital telephone operators written instructions concerning the notifi-cation of appropriate individuals 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 I. The pacemaker coordinator will be: Mrs.
Helen Blackwell, R.N., Head Nurse of the Coronary Care Unit.
10 Physicians Responsible The physicians responsible for an 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.
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- g "The Body is atten curable, the Soulis ever so" PHONE 609 9634300 Page 6 11 Our Lady of Lourdes 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, Penna, 15701, evenin 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 shipoing instructions founded by Coratomic Inc.
will be followed upon return of the pacemaker for approved disposal.
13 Our Lady of Lourdes Hospital hereby requests a license to receive, possess, store, and implant the Coratomic C-101 Icotopic Powered Pacemaker in accordance with this application.
Physicians responsible for the Signed:
invesHgational program:
Appifcant f
g Our Lady of Lourdes Hospital b ern a w )
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Francise, Enriquez/M D. /'
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/ ister M. Elikabeth Corry, OSF /
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Mpivin Grossma ' M.D, 1A'l/
l Ernest E. Fleglil, M.W.
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' Vincent T McDermott, JE, M.D,
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8 ATTACIIMENT I INSTRUCTIONS FOR IIOSPITAL OR CLINIC TELEPIIONE OPERATORS i
CORATOMIC C-101 ISOTOPIC PULSE GENERATOR Proiect 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 nucicar pacer, 3
Obtain as much information from the caller as is possible including:
Caller's name and where he may be reached.
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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 Nmnber Implanting Physician 4
Notify immediately:
Francisco Enriquez, M.D.
8 S. Iladdon Ave., IIaddonfield, NJ 08033 (609) 429-2212 If he cannot be reached, notify:
Marvin Grossman, M.D.
409 East State Highway #70 Cherry 11111, N.J.
(609) 428-5857 If he cannot be reeched notify:
Mrs. IIelen Blackwell, R N.,
(Pacemaker Coordinator)
IIead Nurse, Coronary Care Unit (609) 757-3500 0FFICIAL RECORD COPY [mm 1/A0 9 0
1.
(FOR LFMS USE)
INFORMATION FROM LTS BETWEEN.
License Fee Management Branch, ARM
! Program Code: 22160 and
- Status Code: 2 Rsgional Licensing Sections
- Fee Category: EX 7C Emp. Date: 19880831
- Fee Coment s:
LICENSE FEE RANSMITTAL A.
REGION
. APPLICATION ATTACHED Applicant / Licensee: OUR LADY OF LOURDES MEDICAL CTR.
Received Date:
880623 s 's Docket No:
7002989 Control No.
120560 License No.:
- ction Type:
Renewal 2.
FEE ATTACHED
/
Amount:
/
Check No..
/
- 3. C0te4ENTS Si ned 4
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Da e V -- J 4 -M W f6
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-.. '.. :. - o B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03.is entered / J )
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Fee Category and Amount:
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Correct Fee Paid.
Application may be processed for: /
g6 Amendment
/
/
Renewal p
License
. OTHER Si ned SN r Da e r /.
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