ML20214B801
| ML20214B801 | |
| Person / Time | |
|---|---|
| Site: | 07002232 |
| Issue date: | 04/29/1976 |
| From: | Beth Brown, Enriques F WEST JERSEY HOSP., CAMDEN, NJ |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20214B621 | List: |
| References | |
| 0911, 911, NUDOCS 8705200417 | |
| Download: ML20214B801 (5) | |
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NORTHERN DIVISION CAMDEN, N.J. 08104 SOUTHERN DIVISION BERLIN, N.J. 08009 o)
EASTERN DIVISION VOORHEES, N.J. 08043 April 29, 1976
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Chief, Materials Branch 3
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Re: Application for license to participate in the research stur N
involving the implantation of Nuclear Omi-Stanicor #184 nuclear-powered pacemakers.
Gentlemen:
The following information is submitted in application for a license to participate in the investigational program utilizing Nuclear Omni-Stanicor #184 nuclear-powered pacemakers:
1.
Applicant:
West Jersey Hospital (Hospital or Fedical Institution)
Mt. Enhrim and Atlantic Avenue (Address)
Camden, New Jersev 08104 (State and Zip Code) 2.
Physicians responsible for study:
Name: Francisco Enriques, M. D.
Uffree Address: 8 South Haddon Avenue, Haddonficid, N. J.
08033 Telephone Nunber:
(609) 429-2212 State Licensed in which to Practice: New Jersey Specialty Board Certification: Surgery (12/13/73)
Position with the Applicant: Hospital Surgical Staff Previous experience in the clinical inplantation: Dr. Fariques follows all pacer patients through Anducpstrics in 01erry Hill, N. J.
He has implanted pacers for 9 years and at this time has implanted approxinntely 200.
(170 have been implanted at this institution.)
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WEST JERSEY IDSPITAL Application for license to participate in the research study involving the implantation of Nuclear Omi-Stanicor #184 nuclear-powered pacemakers - Continued Name: Elliott Rosenberg, M. D.
DTtTee Address:
1555 Haddon Avenue, Camden, N. J.
08103 Telenhone Ntnber: (609) 365-5360 State Licensed in which to Practice:
N. J. and Pennsylvania Specialty Board Certification: Internal Medicine - 1968 Position with the Applicant:
Hospital Medical Staff Previous experience in the clinical follm-un: No direct implants, but managing pacer patients since approximately 1966 - approximately 40 per year.
Name: Jamie Coll, M. D.
OTfTce Address:
520 Mickle Blvd., Carrien, N. J.
08103 Telephone Ibnber:
(609) 966-1610 State Licensed in which to Practice:
N. J.
Specialty Board Certification: Internal Medicine Position with the Apolicant:
Hospital Medical Staff Previous experience in the clinical follow-up: No direct implants, but managing pacer patients since 1966 - approximtely 40 per year.
Name:
Emmons G. Paine, M. D.
OffTce Address:
15 E. Euclid Avenue, Haddonfield, N. J.
08033 Telephone Number: (609) 428-3126 State Licensed in which to Practice:
N. J.
Specialty Board Certification: Internal Medicine (Sub-Specialty-Cardiology-1975)
Position with the Anplicant:
Hospital Medical Staff Previous experience in the clinical follow-up:
No direct implants, but mnaging pacer patients since 1%4 - approximately 40 per year. Dr. Paine follows all pacer patients through Anthropmetrics in Cherry Hill, N. J.
3.
MASTER PROIDOOL FDR CLINICAL EVALUATION OF ' DIE PROGRK! TABLE 00RDIS i
NUCEAR GNI-STANICOR PACDfAKER, DATED OCIDBER 1974.
4.
h annual number of Nuclear Omni-Stanicor #184 pacemakers expected during the study is 10, 5.
Battery cha y,es will take place in the operating room. h se roons are equipped with the necessary monitoring, resuscitation and life saving equipment such as defibrillators, external pacers, electrocardiogram mchines, etc. For primary implants, the hospital uses the X-Ray Dept, and these rooms are also eculpped with these life saving and mnitoring devices. h X-Ray machines are in leaded rooms to screen out rays emitted by them, h external pacers are used in both rooms to measure stimlation thresholds and "R wave" potentials, h Coronary Care thit is thoroughly g
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s WEST JERSEY HOSPITAL Application for license to participate in the research study invohing the inplantatic af Nuclear Omni-Stanicor #184 nuclear-pomrcd pacemakers - Continued equipped to nonitor pacer patients and any critically ill cardiac patient.
Manufacturers of equipment:
External Pacers: Chronicor III, Cordis Corp.
Resusitation Equip.: Menen Greatbatch Monitoring Equip.: Burdick X-Ray Equip.: Seimens and Westinghouse Electrocardiograph: Burdick 6.
h physicians folls all pacer patients both transtelephonically and by a schedule of office visits to check on the pacer, patient and bracelet to be worn by the patient. h first surgical office visit is two weeks after discharge. h e Master Protocol will be followed for subsecuent visits. In addition to the surgeon occassionally seeing the patient, the medical doctor also has a more frequent schedule of office visits. %is serves as a back-up to insure proper patient foll w-up. We transtelephanic system used is Anduur+trics on Marlton Pike in Cherry Hill, N. J.
(Tel. # (609) 795-2220) h total amount of pacers implanted by the sponsor physician is approximately 200. h endocardial approach is used in almost all cases. He has been implanting pacers for 9 years.
7.
he physician does all the follow-up of pacer patients. On all pacer patients wit.h Nuclear Onni-Stanicors we (the applicant) will receive a duplicate of that follow-up frm the sponsor physician and Anthropmetrics in Cherry Hill, N. J. to insure continuity of follow-up and determining any possible loss of follow-up with a patient.
8.
N institution will take the appropriate security measures to insure the safety and security of any and all Nucicar &ni-Stanicors in their possession.
h pacers will be kept from time of receipt, until time of implantation, under lock and key. Notation of dates, serial numbers, etc. will be made.
h pacer will not be ordered until one or, at the most, two days before the operation and implantation. All activities will be conducted in accordance with the regulations under Title 10, Code of Federal Regulations, Part 70.
9.
Each operator will be given verbal and written instructions regarding the notification of appropriate individuals upon receipt of an emergency report of inquiry concerning a pacemaker bearer.
- 10. Sponsor physician is familiar with the MASTER PPBIOOOL FUR CLINICAL EVALUATION OF THE PROGR4MABLE CORDIS NUCLEAR @NI-STANICOR PACH4AKER, DATED OCI0BER 1974 and the Institutions for use of the 184 Model and understands that the issuance of a license is conditioned upon the following of this protocol.
- 11. h applicant institution agrees to continue the follow-up re mrting and recovery procedures during the life of the patient or until the pac maker is recovered and returned to Cordis Corporation, even in the event the physician named in the applicaticn to participate in the study is no longer associated with the applicant. As a contingent plan, Cordis has a Guaranteed Surveillance Program which transtelephonically monitors patients with cardiac pacers, his plan would be put into effect only as a contingent plan.
"DECEECO2 COPY" RM c-9 o
WEST JFASEY HOSPITAL Application for license to participate in the research study inv61ving the inplantation of Nuclear &ni-Stanicor #184 nuclear-powered pacemakers - Continued
- 12. We confirm that packaging, labeling, and shipping instructions to be furnished by Cordis Corporation will be followed upon the return of the pacmaker for approved disposal.
- 13. The applicant hospital or medical institution hereby requests a license to receive, possess, store, and inplant the Nuclear Onni-Stanicor #184 nuclear-powered pacemaker in accordance with this application.
Signed:
Applicant:
,We9 Jersey Hosnical b
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Barry Browql, President West Jerset Hospital Physician responsible for study:
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Francisco Enriques, M 3
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WEST JERSEY X@@FT6L NORTHERN D' VISION CAMDEN, N.J. 08104 SOUTHERN DIV!$10N BERLIN, N.J. 08009 EASTERN DIVISION VOORHEES, N.J. 08043 I!STRUCTIONS MR TELEP110NE Om%IOR Instructions to Operator:
1.
Accept any collect call with reference to "A Radioactive Pacer."
2.
Any call concerning a radioactive pacenaker requires inmediate action in order to avoid danger of radiation exposure and to ensure recovery of the ratioactive paesnaker.
3.
Obtain as nuch information from the caller as is possible including:
Caller's Name there He May Be Reached (Caller's Address)
Telephone No.
Patient's Name there He May Be Reached (Patient's Address)
Telephone No.
(Information from Patient I.D. Card)
Physician's Name Patient's Address Patient's Telephone No.
Social Security No.
Pacemaker Type: Cordis Nuclear Onni-Serial No.
Date of Implantation tDrIFY IFtEDIATELY:
F. Enriques, M.D. - (609) 429-2212 IF IE CHRin' BE REACEED 00tEACT: Elliott Rosenberg, M.D. - (609) 365-5360 (or)
Jamie Coll, M.D. - (609) 966-1610 (or)
Emons G. Paine, M.D. - (609) 428-3126