ML20205C108
| ML20205C108 | |
| Person / Time | |
|---|---|
| Site: | 07002116 |
| Issue date: | 10/15/1975 |
| From: | Rich Smith LAWRENCE GENERAL HOSP., LAWRENCE, MA |
| To: | Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML20205C061 | List: |
| References | |
| 2070, NUDOCS 8509200098 | |
| Download: ML20205C108 (5) | |
Text
. O LAWRENCE GERERAL HOSPITAL P.O. BOX 18 9 ONE GENERAL STREET LAWRENCE. M ASSA CHUSETTS 01842 TEL. AREA CODE Sl7 883 9471 6
October 15, 1975 ADMINISTRATIVt OFFICE.
PR ESID ENT Chief, Materials Branch Division of Materials and Fuel Cycle Facility Licensing U.S. Nuclear Regulatory Commission Wasnington, D.
C.
20555 Gentlemen:
Re:
Application for license to participate in the research study involving the implantation of ARCO Medical NU-5 Nuclear Powered Paccmaker The following information is submitted in application for a license to participate in the investigational program utiliz f Jy ing ARCO Medical NU-5 nuclear powered cardiac pacemakers.
\\V 1.
Applicant:
Lawrence General Hospital 6(-
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Lawrence, Massachusetts 2.
Persons responsible for the study:
a.
Name:
Rudolph Muto, M.D.
Office Address:
100 Amesbury Street, Lawrence, MA.
01840 Telephone Number:
683-2217 State Licensed in which to practice:
Massachusetts Specialty Board Certification:
American Board of Thoracic Surgery American Board of Surgery j
Position with the Applicant:
Senior Surgeon - Thoracic
/
Surgery b.
Name:
William A.
- Cook, M.D.
Office Address:
100 Amesbury Street, Lawrence, MA 01840 Telephone Number:
683-2217 States Licensed in which to practice:
Massachusetts, New York, Wisconsin, Texas l [e<A 6'/, ehf T '
Specialty Board Certification:
American Board of Thoracic Surgery No b"^
7 American Board of Surgery Mu je flM/
Position with the Applicant:
Courtesy staf f with senior 3 privileges in Thoracic (7/>)
8509200098 850906 REG 1 LIC70 Surgery D=h
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r U.S. Nuclear Regulatory Commission Page two c.
Name:
Alan I. Burbank, M.D.
Office Address:
100 Amesbury Street, Lawrence, Mass.
01840 Telephone Number:
683-2217 State Licensed in which to practice:
Massachusetts Specialty Board Certification:
American Board of Thoracic Surgery American Board of Surgery Position with the Applicant:
Senior Surgeon - Thoracic Surgery Director - Pacemaker Clinic /
d.
Name:
Mahmond Kowsari, M.D.
Office Address:
101 Amesbury Street, Lawrence, Mass.
01840 Telephone Number:
687-2225 State Licensed in which to Practice:
Massachusetts Specialty Board Certification:
Cardiology v-Position with the Applicant:
Associate Staff Previous experience in the clinical implantation and follow-up of pacemakers by physicians:
The surgeons of Muto Thoracic Clinic, Inc. are engaged in private practice as a group with experience and responsibil-ity for patients shared interchangeably.
During the past eight years, we have implanted approximately %00 permanent pacemakers in which, in the large majority, we have utilized endocardial electrodes.
We have employed myocardial elec-trodes with placement in approximately 20-30 instances.
Most of the pulse generators we have used have been of the
" demand" type.
Although various commercial pacemakers have been used, in recent years we have been using Cordis units in most instances with a smaller number of Medtronic and Vitratron units.
3.
Protocol to be followed:
v' The study team and the hospital have agreed to follow the March 25, 1974 Protocol without exception.
4.
The hospital is requesting a license to implant fifty (50)
ARCO Medical NU-5 Nuclear Powered Pacemakers annually.
5.
Description of physical facilities and equipment at the ap-plicant institution or hospital:
The Lawrence General Hospital has one cardiac catherization i
laboratory equipped for measuring pacemaker electrode J
U.S. Nuclear Regulatory Commission Page three threshold values and general pacemaker evaluation such as electronic pacemakers.
There is also available cardiac catherization image intensifier equipment:
six beds in the Coronary Care Unit, nine beds in the Intensive Care Unit, and seven beds in the Step Down Unit equipped with suitable monitoring equipment and the ability to handle pacemaker patients.
6.
Description of applicant's present pacemaker implantation and follow-up program:
Our experience with pacemaker implantation has been indi-cated in Item 2 of this application.
At the present time, we utilize endocardial electrodes except in occasional patients in whom persistent problems arise with endocardial placement or in whom thoracotomies are performed for other reasons.
It has been and at the present continues to be our usual practice to change the conventional pulse gener-ators electively and prophylactically.
We have been in-creasing the time interval gradually as experience justifies it.
Currently, we are replacing pulse generators of Med-tronic and also the others we use at approximately 24 months.
Patients generally are hospitalized for at least five to seven days following initial implantation in order to ob-serve for satisfactory wound status and to monitor pacemaker performance.
If a patient requires permanent institutionalization such as a nursing home, follow-up is usually through the physician who is seeing the patient in that institution.
If a patient is living at home, the patient or a responsible family mem-ber is instructed in checking the pulse daily and advised to report to us if change occurs.
We ordinarily see ambulatory patients in follow-up approxi-mately ten days after implantation, which is our routine time for removal of sutures.
We see them within a month of discharge if they have remained hospitalized for various reasons more than ten days.
At the time of the initial follow-up visit, in addition to a physical examination, electrocardiogram tracings are given as a baseline for our office records.
After the initial postoperative visit further follow-up visits are conducted at the Pacemaker Clinic of Lawrence General Hospital.
This clinic is conducted by Dr. Alan I.
Burbank.
It is Dr. Burbank's policy to see the patients first on a one month interval, then the are seen again at itwo-monthintervals, and then at month intervals until the patient approaches twenty months from the date of 29
U.S. Nuclear Regulatory Commission Page four implant.
Then they are seen at monthly intervals until it is deemed necessary to do a replacement.
As the patient approaches within one to two months of the projected re-placement of the pulse generator we contact the referring physician by telephone and by letter and arrange for read-mission for the elective replacement of the pulse generator.
We have a separate filing system for pacemaker patients' 7
records.
7.
Describe methods applicant will establish to maintain rec-ords of implantation and follow-up of patients separate from routine hospital records:
Records of all patients with ARCO Medical NU-5 Nuclear Powered Pacemakers will be filed separately at our Pace-maker Clinic.
Our group will assume responsibility for the follow-up of such patients, according to the require-ments of ARCO Medical NU-5 Nuclear Powered Pacemaker proto-col.
We will provide follow-up reporting and retrieval of the pulse generators as required.
The interchangeable natures of our method of practice is such that if any one of us is away, incapacitated, or no longer with the group, the remaining members will maintain continuity of care of these patients.
8.
The Lawrence General Hospital, prior to the receipt of ARCO Medical NU-5 Nuclear Powered Pacemakers, shall estab-lish adequate control precedures while in its possession.
These procedures will include keeping 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 + gainst loss or theft in accordance with the reg-ulations aider Title 10, Code of Federal Regulations, Part 70.
9.
Describe the applicant's procedures to assure notification of appropriate individuals upon receipt of an emergency report of inquiry concerning a pacemaker bearer:
Our office maintains 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> daily coverage throughout the year by means of a first and second man call system which is scheduled and printed in advance.-
After secretarial hours our office telephone number switches to an answering service.
The doctors on call are available ap home.
The y hospital switchboard, and also our office and our answering service, will be given the following written notice:
All calls concerning patients with nuclear powered pacemakers are to be regarded as emergency calls, and the doctor receiving calls for for Muto Thoracic Clinic at that time on 683-2217 is to be notified immediately; also ARCO Medical.
W Gd U.S. Nuclear Regulatory Commission Page five 10.
The surgeons of Muto Thoracic Clinic represent that they are familiar with the ARCO Medical Research Protocol and Technical Manual for the ARCO Medical NU-5 Nuclear Powered Pacemaker and understand that the issuance of a license is conditioned upon the use of this protocol and is like-wise conditioned on the following of the instructions in the technical manual regarding the maintenance of the rec-ords.
11.
The Lawrence 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 ARCO Medical, even in the event the physicians named in the application to participate in the study are no longer asso-ciated with the applicant.
12.
The Lawrence General Hospital will follow packaging, label-ing, and shipping instructions to be furnished by ARCO Medical upon the return of the pacemaker for approved disposal.
13.
The Lawrence General Hospital hereby requests a license to receive, possess, store, and implant the ARCO Medical NU-5 Nuclear Powered Pacemaker in accordance with this applica-tion.
SIGNED:
Applicant:
The Lawrence General By:
Hospital R. Ashton Smith, President Physicians responsible for study:
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'Rudolph Muto,
.D r William A.
- Cook, M.D.
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' $f&{ h Alan I'.
Burbank, M.D.
Mahmond Kowsari, M.D.
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