ML20248A659
| ML20248A659 | |
| Person / Time | |
|---|---|
| Site: | 07001388 |
| Issue date: | 06/23/1988 |
| From: | Fahle L GRACE HOSP., DETROIT, MI (FORMERLY MT. CARMEL MERCY |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20248A621 | List: |
| References | |
| 0273, 22326, 273, 2778, 385692, 85692, NUDOCS 8906080175 | |
| Download: ML20248A659 (12) | |
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MERCY l
H o s pit als & H e cit h-
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.j P.O. Box 35-9 4 5, Det t cit, Ml 4 8235 l
A Divraon of the Sisters of Mercy Health Corpo ation '
June 23,1988 1
~ U.S. Nuclear Regulatory Commission
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. Region III-l Material Licensing Section -
l 799 Roosevelt Road.
-l Glen Ellyn, Illinois 60137
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Subject:
Renewalof NRC License #SNM-1374
Dear Sir:
I am writing this letter to request renewal of the NRC License #SNM-1374 currently held by Mount Carmel Mercy Hospital.
l The hospital name. and mailing address should be listed on the license as follows:
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Mount Carmel Mercy Hospital 6071 West Outer Drive Detroit, MI 48235 -
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The reason for renewal of the license is to follow patients with implanted-pacemakers and to return explanted pacemakers to the marfufacturer for proper disposal. We will not be implanting any nuclear pace' makers in the future.
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p, The physicians involved in the nuclear pacemaker pr5 gram $fe 0
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1, Dr. Ronaldo N. San Juan
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6001 West Outer Drive, Suite 330 d h
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(313) 864-9200
-J Dr. San Juan is licenced in Michigan. He is an active member of our medical staff and has interpreted pacemaker follow-up tests in his office and here at Mount Carmel Mercy Hospital for more than 10 years.
.89060B0175 880726 fI h9 7 REG 3 LIC70 9
[MVE IV E D JUL 0119BB Mount Carmel Mercy Hospital Mercy R2mily Cote samaritan Health Center 6071 West Outer Drive 10201 E. Jef f erson Ave.
5555 Conner Avenue l
D e t r o i t, M I' 4 8 2 3 5 D e t r o i t, MI 48214 Detroit, MI48213 HEGION III
. P h o n e: 313/927 7000 P h o n e: 313/024-7866 P h o n e: 313/579-4000
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NRC License #5NM-1374 Page 2.
Dr. Ramegowda Rajagopal 22341 Eight Mile Rd.
Detroit, MI 48219 -
(313) 538-4700 Dr. Rajagopalis licenced in the state of Michigan. He is board certified in intemal medicine and cardiology. Dr. Rajagopalis the President-Elect of the Medical Staff at Mount Carmel Mercy Hospital and has been interpreting pacemaker follow-up tests for more than 10 years in his office and here at the hospital.
If you require further information, please do not hesitate to contact me.
Sincerely, h Y&
oy.. Fahle rept.nt and C.E.O.
Met y Hospitals and Health Services of Detroit CONTROL N0.85 6 9 2
a D8 MOUNT CARMEL~-
MERCY HOSPITAL 6071 West Outer Drive, Det roit, M148235 Phone: 313 / 927 7000 Mercy Hospitals & Health Services of Detroit A Dmsion of The Sisters of Mercy Health Corporahon U. S. Nuclear Regulatory Commission Region 111
~ Material Licensing Section 799 Roosevelt Rd.
Glen Ellyn, Illinois 60137 Re: NRC License #SNM-1374
Dear Sir:
This is to state that I am familiar with the Medtronic Pacing Systems' NRC-approved protocol for follow-up of nuclear generators and agree to follow that protocol.
Sincerely, LO$dok-Llaw,u<'ll.
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Ronaldo N. San Juan, !.D.
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Mount @
maq Carmel MERCY HOSPITAL June 9,1983
'83 # 15 P3:07 Ms. Patricia C. Vacca Material Licensing Branch U.S. Nuclear Regulatory Commission Washington, D.C. 20555
Subject:
Renewal of NRC License #SNM-1374 l
Dear Ms. Vacca:
I am writing this letter to request renewal of the NRC License #SNM-1374 currently held by Mount Cxmel Mercy Hospital.
The hospital name and mailing address should be listed on the license as follows:
Mount Carmel Mercy Hospital 6071 West Outer Drive Detroit, MI 48235 The reason for renewal of the license is to follow patients with implanted pacemakers and to return explanted pacemakers to the manufacturer for proper disposal. We will not be implanting any plutonium pacemakers in the future.
The physicians involved in the plutonium pacemaker program are Drs. Seymour Wilhelm and Joseph Bassett as listed on the current license. We wish to involve no other physicians in the program at this time. Please note, however, that Dr. Wilhelm is no longer in private practice, but is a full-time member of the Mount Carmel Mercy Hospital staff. Correspondence for him should be sent to Mount Carmel Mercy Hospital. His office telephone number is (313) 927-7000, Ext.
7085.
If you require any further information, please do not hesitate to contact me.
Sincerely,
}T$by 4! Edk -
/ LeRoy,D: Fahle
,SeniobVice-President
/ Ope' ations T
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LDF/ala 6071 West Outer Dnve Detroit, Mk higan 4823; 313!927 7000
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Mr. Cecil R. Buchanan, Asst. Chief '.
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Materials Branch D I' ~ '
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Dear ~Mr. Buchanan:
S In reply to your letter of February 1,1974 regarding the modification of license #SNM-1374--we have reviewed the modifications and do consent to these.
Sincerely, Thomas R. O' Donovan GM Administrator g
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t 30 zu r ver MOUNT CARMEL MERCY HOSPITAL AND MEDICAL CENTER 6071 West Outer Drive, Detroit, Michigan 48235 - (313)864 5400 April 23,1973 e
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Washington, D. C.
20545 Attention: James C. Malaro TM Re: Application for License to Implant Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator Gentlemen:
The following information is submitted in application for a TM license to implant the Medtronic Laurens-Alcatel Model 9000:
1 1.
Applicant:
Mount Carmel Mercy Hospital and Medical Center 2.
Physician Responsible for Study:
Name: Joseph S. Bas sett, M. D.
Office Address: Suite 205 Northland Medical Building 20905 Greenfield Road, Southfield, Michigan 48075 Telephone Number: 313-353-8031 State Licensed to Practice In: Michigan Medical School Affiliation: Wayne State University, School of Medicine, Detroit, Michigan Specialty Board Certification: Thoracic Surgery
/ Position with Applicant: Chie.f, Section of Thoracic and Cardiovascular Surgery
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l Previous crbeience lh the clinical use of imp ntable pace-makers by physician: 200 pacemaker implantation since f J {g 7 1969 with 150 of these done at Mount Carmel Mercy Hos-V pital and Medical C nter and 1/3 of these having myocardial leads.
3.
Other physicians and surgeons participating in study:
Name: Thomas B. Stock, M. D.
Office Address: 17000 West Eight Mile Road, Southfield, Michigan 48075 Telephone Number: 313-357-0030 State Licensed to Practice In: Michigan Medical School Affiliation: Wayne State University, School of Medicine, Detroit, Michigan Specialty Board Certification: Internal Medicine v' Position with Applicant: Chief, Section of Cardiac Phy-siology and Cardiovascul.ar Laboratories Previous experience in the clinical use of implantable pace-makers by physician: Engages in clinict.1 follow up of patients with implanted pacemaker at Mount Carmel Mercy Hospital and Medical Center since 1964.
Name:
S. K. Wilhelm, M. D.
Office Address: 13011 West McNichols Road, Detroit, Mich-igan 48235 Telephone Number: 313-861-7920 State Licensed to Practice In: Michigan Specialty Board Certification: Medicine
/ Position with Applicant: Chief, Section of Electrocardio-graphy Previous experience in the clinical use of implanta.ble pace-makers by physician: Has been active in pacemaker implan-tations and follow up at Mount Carmel Mercy Hospital and Medical Center since 1960.
4.
Protocol to be followed: Medtronic Laurens -Alcatel Model 9000 Isotopic Pulse Generator Protocol dated March 21, 1973.
Modifications to Protocol: None TMLaurens-Alcatel Model 9000 re-5.
Number of Medtronic quested to be implanted annually during study:
25 to 30 k "
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Description ((/p,hysical facilities and equiprr~.t at appli '
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Modern operating suite is available for pacemaker implan-tation with general anesthesia as required. Equipment will be available for intra arterial blood pressure monitoring and electrocardiographic monitoring. Pacemaker implan-tation and other cardiovascular surgery is performed re-gularly. There is post operative intensive care unit and cardiac care unit with facilities available to monitor a total of 8 patients at one time. A pacemaker clinic has been estab-lished for the close follow up of patients with implanted pace-makers. Equipment includes: Standard electrocardiogram,!
portable electrocardiogram monitors or dynamic cardiogram, Q oscilloccopy for measuring pulse width and equipment to vary pulse width of implanted pacemakers.
Description of Applicants present pacemaker implantation 7.
and follow up program:
Physicians and Technicians will be available at all times to follow and examine patients with implanted pacemakers.
A 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> answering service is maintained by the Applicant and Physician responsible for study to establish close follow up care of patients with implanted pacemakers. Present pacemaker implantation and follow up program includes approximately 100 patients. The longest period of follow up is approximately 10 years. Patients with endocardial and myoRrdial lea,ds are being followed at the present time.
d The physician responsible for the study represents that he is familiar with Medtronic's Protocol and Technical Manual for the MedtronicTMLaurens-Alcatel Model 9000 and understands that the issuance of a license is conditioned upon the use of this Protocol and is conditioned on the following of the instructions in the Tech-nical Manual regarding " Transporting, Handling and Sterilization of the Pulse Generator", and " Comments on Implantation Procedure (myocardial leads)".
Applicant will establish appropriate control procedures to insure that the pulse generators are not lost or stolen. These procedures will include keeping track by serial number of the location of each pulse generator and requiring that they be kept under lock when not being used. Applicant represents that it has adequate fire protec-tion equipment in case of emergency and that all activities will be conducted in accordance with the regulations under 10 code of Federal Regulations, Part 70.
The Applicant agrees to continue the follow-up, reporting and I
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.- recovery procch.eee recluired under.Medtronic's rotocol in the :
W event the Physician Responsible for the Study or any other
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physician or surgeon participating in the study is no longer
, 7, associated with Applicant.
Applicant hereby requests a license to receive, possess, store-D and implant the Medtronic Laurens-Alcatel Model 9000 Iso-
. topic Pulse Generator in accordance with this application.
. Signed:
Applicant: - Mount Carmel-Mercy Hospital and Medical Center by
%:l Physician Responsible for Study:
Joseph
. Bas sett, D.
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