ML20147H435
| ML20147H435 | |
| Person / Time | |
|---|---|
| Site: | 07002580 |
| Issue date: | 04/22/1977 |
| From: | Claypool W, Settle H, Sutorius D VETERANS ADMIN. MEDICAL CENTER, CINCINNATI, OH |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20147H261 | List: |
| References | |
| 06417, 6417, NUDOCS 8803080480 | |
| Download: ML20147H435 (5) | |
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ERANS ADMINISTRATION
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April 22, 1977 F
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Radioisotopes Licensing Branch
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C ATTENTION: Mr. Bernard Singer
/WK_y RE: Application for license to implant Medtronic Model 900G Iso't6)ic k,fbh
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Pulse Generator y -
9 Gentlemen:
The following information is submitted in application for a license to implant the Medtronic Model 9000.
1.
Applicant:
Veterans Administration Hospital, Ci ocinnati, Oh ic 2.
Physician responsible for study:
Name:
Darryl J. Sutorius, M.D.
Office Address:
Veterans Administration Hospital Department of Surgery x
3200 Vine Street C$
Cinc inna t i, Oh io 45220 Q
Telephone Number:
(513) 221-2325, ext 660 or 661 O
State Licensed to Practice In: Ohio O
Medical School Affiliation:
Chief of Surgery, Veterans Admini-QO stration Ho spital, Cincinnat i, Ohio; Associate Professor of Surgery, p
guj Division of Thoracic and Cardiovascular Surgery.
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University of Cincinnati, Cincinnati, Ohio ocE Specialty and Board Certification: American Board of Surgery;
$N American Board of Thoracic and Cardiovascular Surgery Position with Hospital:
Chief of Surgical Service
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P"evious experience:
I have been implanting pacemakers at this RECD g ey ! F,B hospital since I assumed the position of Chief of Surgery in
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9-t/ sy 1972. We implant approximately 30 pacemakers per year.
I am
{ Dam /i the primary implanting surgeon and supervise all implants except 1'
'ggtm lthose done while I am out of town at a meeting or on vacation at
'which time another member of the faculty in the Division of r
h1 FM Thoracic and Cardiovascular Surgery is responsible.
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INSTRUCTIONS 10 TELEPHONE OPERAIOR CONCERNING NUCLEAR PACEMAKERS 1.
Accept any collect call with reference to nuclear pacemakers.
2.
Any cell involving a patient with a nuclear pacemaker requires immediate action to ensure that there is no danger of radiation exposure and recovery of t'm nitelear pacemaker.
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 Implaat Pacema'rar Serial Number 4.
Not' y immediately:
Dr. Darryl J. Sutorius 3200 Vine Street, Cincinnati, Ohio 45220 (513) 221-2325 or (513) 221-5522 (Name, address, telephone number of physician responsible for study)
.e If 1-can.iot be reached, notify:
Dr. Harold Settle 3200 Vine Street, Cincinnati, Ohio ' 45220 (513) ??l-2325 or,513) 221-5 22 (Alternative physician)
If neither can be reached, contact plyed.cian on duty for the Cardiac Care Unit; inform him that this invotves a nuclear pacemaker; and advise him of che information you hve and the urgency of the matter.
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Other physicians and surgeons participating:
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Name: James A. Helmsworth, h.D.
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Office Address: Holmes Hospital iT u 3 ji Department of Surgery 3,h Q.!
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Division of Woracic and Cardiovascular Surgery h*4 :~.
Eden and Bethesda Avenues Cincinnati, Ohio 45219 M !.5 (;,
Telephone Number:
(513) 872-7717 y;
State Licensed to Practice In: Ohio g W9 D
'5 Medical School Affiliation: Professor of Surge ry, Unicarsity of Cincinnati, Cincinnati, Ohio; W
I Director, Division of horacic and
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,7 Cardiovascular Surgery, University of Cincinnati,
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Cineinnati, Ohio gy
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J. Tracy Schreiber, M.D.
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'(~ ]' h Office Address: Holmes Hospital Department of Surgery M
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Division of horacic and Cardiovascular Surgery
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. -f Cincinnati, Ohio 45219 Pp.yjf. '
Telephone Number:
(513) 872-7717 Ap State Licensed to Practice In: Ohio and Missouri Medical School Affiliation: Associate Professor of Surgery, 5:f' - 7 ')
4 $M University of Cf.ncinnati, Cincinnati, Ohio; Assistant Director, Division of
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horacic and Cardiovascular Surgery, University of Cincinnsti, Cincinnati, Ohio
^m Specialty and Board Certification: American Board of Surgery; American Board of Woracic and Cardiovascular Surgery Name: Harold Settle, M.D.
l Office Address: Veterans Administration Hospital 9
Depart. ment of Medicine 3200 Vine Street Cincinnati, Ohio 45220 Telephone Number:
(513) 221-2325, ext 325 State Licensed to Pcactice In: Ohio Medical School Affiliation: Assistant Professor of Medicine, University of Cincinnati, Cincinnati, Ohio Specialty and Board Certification: American Board of Internal Medicine Position with Hospital:
Chief of Cardiology Division
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Previous experience:
Dr. Settle has been in charge of the Pacemaker Clinic at. the Hospita.1 since 1973. He follows all implanted pace ukers on a regular basis and has approxi-g b
m.:aly 50 to 100 patients under follow-up at any one time.
He sees all implanted pacemaker patients unless he is out of 5-is designated to be responsible.
town at which time another member of the Cardiology Division 4.
Protocol to be followed: Medtronic Model 9000 Isotopic Pulse Generator protocol dated March 1,1973, revised October 1,1975.
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Number of Medtronic Model 9000 units requested to be implanted l
r annually during study: Three
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Description of physical facilities and equipment: The Cineinnati Veterans Administration Hospital has 430 beds and there are five 1
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Coronary Carc Beds. Our Operatint, Room is equipped with portable I
flouroscopic facilities so that all implants are performed f a a
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standard Operating Room. We have a Medtronic Pacing System Analyzer which we use to check all thresholds und pacing utaits at the time of implantation. We have a Nuclear Mcdicine Division associated with m
the Nuclear Medicine Division at the University of Cincinnati and a Nuclear Medicine License.
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7.
Description of applicants present pacemaker implantation and p
follow-up program: Approximately 30 pacemakers are implanted i
annually at the Veterans Administration Hospital. We have been implanting pecemakers for 10 years. Patients are followed i
through regular, visits to the pacemaker clinic at the hospital.
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We are currently following 50 to 75 patients at any one time and are seeing these patience, at three month intervals for the first q
18 months, then every month until replacement. On each visit
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they have spike analysis which gives amplitude, pulse width, and spike-to-spike interval. The patients are also checked with g
and without a magnet. We are currently not using telephone g
iL monitoring.
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8.
Description of methods to applicant we use to maintain separate records:
Ihe records of the nuclear pacemaker patients s-7 will be kept separate from the records of the rest of the hospital
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and the rest of the pacemaker patients. They will be kept in specific folders with dates of return visits so that we can recognize wiirn the patient has another follow-up appointtLant, and K
we will be able to tell if he does not show up for the appointment.
We are also reminded of the patient's follow-up schedule by Medtronic's
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follow-up data forms which are sent on a regular basis.
The folders and the separate files will also contain informatior on the patient's R
location and phone number where the patient can be reached if he does k
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not sh w up for a follow-up exam.
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Written In s t ruc t ion for Telephone Operators:
See attachment.
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We represent that we are familiar with the Medtronic Protocol and y
Technical Manual for the Medtronic Model 9000 and understand that the
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issuance of a license is conditivuea upon use of this protocol and the
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use of instructions in the technical manual on "transporting, handling, by M' %-
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and sterilization of the pulse generator." We agree to have the patient d.[f.$;jf F
visit our office for the required follow-up examinations.
We will establish appropriate control procedures to ensure that the pulse generators are not lost or stolen.
These procedures will include 7
keeping track by serial number of the locations of each pulse generator
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and requiring that they be kept under lock when not be ing. sed.
We represent that we have adequate fire protection in case of emergency,
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regulations published in 10 CFR 70.
We agree to continue the follow-up reporting and recovery procedures required under Medtronic's protocol in the event the physician respon-p sible for the study or any other physician or surgeon participating in the study is no longer associated with this hospital.
Veterans Administration Hospital hereby requests a license to receive, k
possess, store and implant Medtronic Modal 9000 Isotopic Pulse Generators in accordance with this application.
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Signed:
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APPLICANT:
By 3 "M; "
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Hospital Director Phfsicians Res nsible for Study;
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