ML20235E142
| ML20235E142 | |
| Person / Time | |
|---|---|
| Site: | 07002032 |
| Issue date: | 06/04/1975 |
| From: | Gent D, Schen S WELBORN MEMORIAL BAPTIST HOSP., EVANSVILLE, IN |
| To: | NRC |
| Shared Package | |
| ML20235E046 | List: |
| References | |
| 1204, NUDOCS 8902210228 | |
| Download: ML20235E142 (12) | |
Text
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?*lMatory Weborn 4o16 c. 6ixth street. cvonsviiie indono 477ta. (812> 426-8ooo baptdhoy>bl 3
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'9 Chief, Materials Branch j
Division of Materials and Fuel Cycles Facility Licensing U.S.
Nuclear Regulatory Commission Washington, D.C.
20555 RE:
Application for license to participate in the research study involving the implantation of ARCO Medical Products Company Model Nu-5 Nuclear Powered Cardiac Pacemaker Gentlemen:
The following information is submitted in application for a license to participate in the investigational program utilizing ARCO Medical Products Company Model Nu-5 Nuclear Powered Cardiac Pacemakers:
1.
Applicant:
Welborn Memorial Baptist Hospita]
401 Southeast Sixth Street M
y Evansville, Indiana 47713 d
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Persons responsible for the study:
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-6 Office Address:
Welborn Clinic i"df](
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Name:
Mell Welborn Jr.,
M.D.
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421 Chestnut Street Evansville, Indiana 47713
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Telephone:
(812) - 426-1292 d
State Licensed in Which to Practice:
Indiana, Georgia, Tennessee Specialty Board Certification:
American Board of Surgery American Board of Thoracic Surgery Position With The Applicant:
Surgeon b.
Name:
John F. Lawler,:M.D.
Office Address:
Welborn Clinic 7ce!
421 Chestnut Street
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Evansville, Indiana 47713 t
Telephone:
(812) - 426-1292 9
State Licensed in Which to Practice:
Indiana, Texas 13-1674'Id7 Specialty Board Certification:
Diplomate American Board of Surgery dec.
Fellow American College of Surgeons T7[76 Position With The Applicant:
Surgeon, President-elect / Medical Staff 8902210228 880217 16 nf 4UI REC 3 LIC70 SNM-1557 PNU
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June 4, 1975 k-
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Name:
Sanford E.
Schen, M.D.
Office Address:
Welborn Clinic 421 Chestnut Street Evansville, Indiana 47713 Telephone #:
(812)- 426-1292 State Licensed in Which to Practice:
Indiana, Texas, Ontario Specialty Board Certification:
American College of Cardiology, Board Eligible Internal Medicine Position With The Applicant':
Director, Cardiac Catheterization Laboratory d.
Name:
Eugene L.
Hendershot, M.D.
Office Address:
Welborn Memorial Baptist Hospital 401 Southeast Sixth Street Evansville, Indiana 47713 Telephone #:
(812)- 426-8321 State Licensed in Which to Practice:
Indiana, Illinois Specialty Board Certification:
American College of Radiology Position With The Applicant:
Department Chairman of Radiological Services, Radiation Safety Officer, Isotope Committee member e.
Name:
Alfred P. Lessure, M.D.
Office Address:
Welborn Memorial Baptist Hospital 401 Southeast Sixth Street Evansville, Indiana 47713 Telephonc #:
(812)- 42C-8321 State Licensed in Which to Practice:
Indiana, Ohio Specialty Board Certification:
American College of Radiology, (dip. )
Certified American Board or Radiology for Nuclear Medicine Position With the Applicant:
Radiologist, Isotope Committee membe:
f.
Name:
Marshall S. Miller, M.D.
Office Address:
Welborn Clinic 421 Chestnut Street Evansville, Indiana 47713 Telephone #:
(812)- 426-1292 State Licensed in Which to Practice:
Indiana, Kentucky Specialty Board Certification:
American Board of Internal Medicine American Board of Nuclear Medicine Position With the Applicant:
Director of Nuclear Medicine, Chair-man of Isotope Committee Surgery Experience John Lawler, M.D. has been implanting pacemakers at Welborn since 1968.
Since that year, he has implanted 20 new pacemakers and has replaced 32.
Dr. Lawler, who received his training with Dr. Michael E.
Debakey at Baylor University, has had substantial surgical experience.
He is a Diplomate of the American Board of Surgery
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.'[ Chief,.MntarialsBrr~ch June 4, 1975 U
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Pnga 3 PACEMAKERS l
NEW IMPLANTS REPLACEMENTS 6
i 1968 5
1968 0
1969 1
1969 2
1 1970 8
1970 5
t 1971 3
-1971 2
1972 0
1972 9
1973 1
-1973 5
1974 1
- 1974, 6
I 1975 1
1975 3
i TOTAL 20 32 Mell Welbor'n Jr., M.D. has a history of outstanding achievements in cardiac surgery.
He is certified by the American Board of Surgery and the American Board of' Thoracic Surgery.
In his cardiovascular Fellowship training at St. Louis University, he participated in over l
350 surgery cases which involved cardiovascular defects.
These cases involved congenital, acquired vascular, and ischemic heart disease.
During his training, he was'also responsible for the postoperative care of each of these patients.
At Welborn, Dr. Welborn Jr. has been very much involved in the pacemaker program.
Since 1971, he has implanted l
28 new pacemakers and has replaced 12.
NEW IMPLANTS REPLACEMENTS 1971 6
1971 0
1972 10 1972 0
1973 3
1973 1
1974 5
1974 9
1975 4
1975 2
12 TOTAL 28 Cardiology Experience Sanford E.
- Schen, M.D., Board Eligible in Internal Medicine and a member of the American College of Cardiology, has had outstanding experi-ence in the field of cardiology.
From 1969 until 1972, he was a Special Fellow of the Cardiovascular Department and Cardiovascular Laboratory l
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l-Paga'4-of the Cleveland Clinic.
At the Cleveland' Clinic, he performed over 400' cardiac catheterizations and implanted over 400 pacemakers. At Welborn,.
Dr.-Schen continues to do cardiac.cathet'erizations as well as pacemaker implants; since'1973 he has implantedo36 new pacemakers and replaced 3.
NEW IMPLANTS' REPLACEMENTS 1973 12 1973 0
1974:
.19 1974 1
l 1975 5
1975 2
TOTAL 36 3
Nuclear Medicine Experience-j Welborn Memorial Baptist Hospital has three'physicianh experienced in nuclear medicine.
Marshall S. Miller, M.D.,
is the'only Board' Certified-Internist and Board Certified Nuclear Medicine physician in Evansville and the tri-state area..
Dr. Miller has worked with the Radiologic' Health
> Division of the United States Public Health Service.
At the Nevada test l
site, he was involved with whole body radionuclides medicine.
Dr. Miller-was also a Fellow in Nuclear Medicine at the University of Cincinnati.
l Dr. Miller is currently the Director of Nuclear Medicine activities at l
Welborn Hospital; he is a member of the Society of Nuclear Medicine and.
j Chairman of the Radio-Isotope Committee.-
~
Eugene Hendersh'ot, M.D., the Radiological Department. Chairman, began the-l Radio-Isotope program at Welborn in 1955 and was its director until Dr.-
j Miller' joined the hospital in 1968.
Dr. Hendershot currently has overall i
supervision of all radiological services and is the Radiological Safety 1
Officer for the hospital.
Dr. Hendershot is a member of the American College of Radiology and the Radiological Society of North America.
I I
Alfred P. Lessure, M.D., a member of the American College of Radiology l
and certified by the American Board of Radiology for Nuclear Medicine, l
has had substantial experience in the field of nuclear medicine.
His j
training at the Oak Ridge Institute of Nuclear Studies in 1961 enabled j
him to initiate Welborn's scanning program in 1965.
Currently, Dr. Lessure has responsibility for carrying out Cobalt 60 radiation therapy treatments.
He currently serves as a member of Welborn.'s Isotope Committee and is very much involved with the policies and pr.ocedures governing nuclear safety.
3.
Protocol To Be Followed:
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 ten (10) ARCO Medical Products Company Model Nu-5 pacemakers annually.
. Chief, Materials Br ~ h O
June 4, 1975 v
Page 5 5.
Description of Welborn Memorial Baptist Hospital:
Welborn Memorial Baptist Hospital has resources which are unique to southern Indiana.
It is a fully accredited JCAH hospital with 487 beds. We have a medical staff membership of 155 physicians of which 73 are active / associate staff.
Of these 73 physicians, a majority are Board Certified specialists who belong to a free-standing private association called the Welborn Clinic.
The Welborn Clinic physicians are responsible for approximately 85% of our admiss-ions, and provide the primary expertise for our pacemaker and nuclear medicine programs.
The Welborn medical staff, because of its interest in specialty cases, plays an important ' role in o' r community.
u Our pediatric medical staff, for example, is composed of 5 Board Certified.
pediatricians -- this is 70% of the Board Certified pediatricians in the community.
We have similar type ratios in other specialties and we feel this specialty physician base is crucial to a successful regional hospital.
Facilities In addition to our CCU and ICU, Welborn has a comprehensive high risk nursery'and a pediatric intensive care unit.
Welborn also contains such specialty units as two~ psychiatric floors (one floor open, one closed),a skilled nursing facility, and a heliport which is used in conjunction with the MAST program. Welborn Memorial Baptist Hospital also contains a floor which is being expressly dcVeloped for cancer patients.
We have an ongoing certified Tumor Registry program and we are expanding our expertise in treating cancer patients.
An important feature which adds to our overall versatility is our strong re.lationship with the Southwestern Regional Mental Health Center which is across the street from our psychiatric facilities.
Welborn has the capacity to provide the facilities for the treatment of numerous diagnoses.
This capability and subsequent experience l
in numerous diagnoses qualifies Welborn as an excellent patient l
i data base for research information.
Other pertinent resources available at Welborn include a cardiac catheterization laboratory; a Cobalt 60 supervoltage unit; angiography; special procedures in _
radiology, and neurology; an expanded nuclear medicine cardiology, capability directed by a Board Certified physician in nuclear medicine; l and a modern surgical suite and recovery room completed in 1972.
Welborn Hospital has excellent teaching and conference facilities.
i We have a modern 144 seat capacity auditorium capable of implementing i
a variety of audio-visual programs.
In the hospital, each nursing 1
unit has a conference room whereby physicians can hold informal l
The hospital also has a suitable medical library and we meetings.
are re-arranging our present allocation of rooms in order to expand it.
Its Welborn Memorial Baptist Hospital is a regional medical center.
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madical staff is highly specialized and the hospital is expanding
Chiicf,MaterialsBhh-O E
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. June 4, 1975-EPage 6
- . c its facilities and programs to meet the innovation within the numerous = fields.of patient care.
Statistical Data of General. Interest:
Total Admissions 11/700-Total Patient Days 111,500 693.
Births Operating Room Procedures 4,535 Nuclear Medicine Procedures 1,744' Radiological Procedures 42,592 Emergency: Room Visits 14,008 Laboratory' Procedures 338,506 EEG's and EMG's 1,759 Physical Therapy-Treatments 64,462 Description of Implant Facilities Although the' hospital has 6 operating rooms and two cysto rooms, the implant facilities are located in the cardiac catheterization laboratory.
The cardiac catheterization laboratory is equipped with the following:-
X-Ray' Equipment 1.
2 - 1000MA, 150 KV 3 phase x-ray generators by CGR for:.bi-plane' radiography.
2.
2 - over-head tube stands for bi-plane radiography.
1 - Angix special procedure table with sterile control: handle-3.
to operate cradle and electric locks.
1 - image amplification system 4.
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a.
6" - 9" image tube b.
70 mm spot film camera 35 mm cinefluorography system with 400" magazine
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Plumicon TV system with videotape i
l 5.
Franklin Bi-plane film changers with programmer.
I 6.
Viamonte Hobbs pressure injector.
7.
Oscar Fisher Cine Processor j
8.
MG/AN X-omat film processor
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Electronic Monitoring Equipment 8 channel EKG, $CG monitoring equipment with
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1.
Gould Brush 200, video scan converter with video tape.
L Siemens Defribulator - Sirecust BS1 with chart recorder and EKG 2.
monitoring.
I Emergency Equipment Emergency cart supplied with specified emergency medication.
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'Junn 4' 1975 i )
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Oxygen Satu' ration Equipment 1.
Oximeter by American Optical Company Cardiac Out-Put Equipment 1.
Model 9500 Cardiac Out-Put machine by Edwards Laboratory Vectocardiograph Machine 1.
ICR instant VCG Miscellaneous 1.
5 - cardiac catheterization instrument trays 2.
1 - 3M gas sterilizer 3.
2 - pacemaker implant trays 4.
Miscellaneous catheters 5.
Miscellaneous expendible supplies The Cardiac Intensive Care Unit consists of 12 beds.
Electrocardio-graphic and strain gauge monitoring units with paper and oscilloscope read-outs are permanently located adjacent to each bed.
This data is also communicated to monitors in the nursing station.
Our current on-hand inventory consists of three Medtronic 5880A demand pacemakers and a supply of Cordis Perveanous 370-110 temporary leaas.
A Tektronix Oscilloscope with the following equipment is used to test the threshold levels of pacemakers and leads:
1.
7313 Storage oscilloscope 2.
7A22 Differential Amplitia 3.
7B53A Time Base 4.
7D15 Universal Counter / timer 5.
C59R camera w/ rollback 6.
203-2 Scopemobile cart Welborn has a substantial supply of respirators and resuscitation equipment; we have inhalation therapists on duty twenty four hours per day.
We use the following kinds of respirators:
560 Ohio Volume, Air Shield Volume, Bennett and Bird, using the Hudson Demand Valve and the Air Shield Ambu Bag for resuscitation.
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The following items are used for general anesthesia in pacemaker cases:
~
DISPOSABLE EQUIPMENT REUSEABLE EQUIPMENT 1.
Rebreathing Circuit 1.
Gas Machine 2.
Mask 2.
Suction Machine 3.
Endotracheal Tube 3.
Monitor 4.
Airway 4.
Laryngoscope 5.
IV 5.
Suction Tip (oral) l 6.
Suction Catheter 7.
Suction Tubing l
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a.Jnn3 4, 1975
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Radiation Safety A list of radioisotope licenses and radiation monitoring equipment is submitted for review:
NUCLEAR LICENSES Cobalt 60
- 13-01674-02 Specific License for Radionuclides
- 13-01674-01 RADIATION SAFETY EQUIPMENT Victoreen Survey Meter Thyac III, Model 490 S.N.
1576 Victoreen Survey Meter Cutie Pie, Model 740D S.N.
1929 Geiger. Counter Picker X-Ray Corporation, Universal Transistor Products Corporation, Model 2980 S.N.
5845 The hospital also retains the consultant services of John E.
Durlacher, a radiation physicist who monitors all our radiological equipment.
NUCLEAR MEDICINE EQUIPMENT Nuclear-Chicago Pho/Gama III High Performance gamma camera with high resolution, high sensitivity, diverging-converging and pinhole collimators, anatomical marker, conventional cassette and high speed Nikon film systems.
Persistence oscilloscope for immediate readout and accurate positioning of gamma camera studies.
Picker 5 inch crystal' rectilinear magna scanner with color attachment.
Picker sodium iodide probe and well detector with pulse height spec-trometer allowing for analysis of multiple isotopes in same sample or patient.
Rad-X dose calibretor 6.
Pacemaker Follow-up The nuclear pacemakers will be implanted by Doctors Schen, Welborn, and Lawler, and they will conduct the pacemaker follow-up.
The patients will be checked at regular intervals as described by the March 25 Protocol.
Follow-up data will be submitted to Chief Radiological Technologist, Don Montgomery, and ' ARCO Medical Products Company.
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. Chipf, Materials Bra ch
- June 4, 1975 (3) f Page 9 The physicians involved with the pacemaker program already engage in a rigorous pacemaker follow-up program.
They have matched or exceeded the minimum follow-up examinations recommended by the protocol (once every three months the first year, once every six months the subsequent years).
Welborn also maintains a communications and. call system for pacemaker emergencies.
The hospital is in the midst of attaching a telephone-EKG transmitting system to our existing Tektronix equipment described on page seven.
This will enable local and o*t-of-town patients to communicate such u
significant information such as interval and wave formation analysis.
This capability will enable the hospital to closely monitor all pace-maker research - both battery and nuclear - with relative ease for the patient.
7.
Records I
The AID form will be completed by Doctors Schen, Welborn, and Lawler and submitted as follows:
White Copy to ARCO Medical' Products Company Blue Copy to Patient's Medical File Green Copy to Surgeon's File Gold Copy to O.R.
File The records will be kept in a separate filing system.
The follow-up form will se completed by Doctors Schen, Welborn, and Lawler and a copy sent to ARCO Medical Products Company and Don Montgomery, Chief Radiological Technologist.
8.
Control Procedures The Radiation Safety Officer is familiar with the storage regulations of isotopes and will provide a theft-proof / fire-proof storage area which meets federal. regulations.
Accountability of nuclear pace-makers will be maintained in accordance with existing federal require-ments.
9.
Emergency Notification In the event of receiving an emergency report concerning a nuclear pacemaker bearer, the member of the study will immediately notify ARCO Medical Products Company.
If a hospital telephone operator receives an emergency call, she will immediately contact a member of the study team and ARCO Medical Products Company.
10.
The membern of the study team have reviewed the protocol and under-stand that the issuance of a license is conditioned upon following the protocol.
11.
Welborn Memorial Baptist Hospital agrees to continue the follow-up reporting and recovery procedures during the life of the patient and until the cardiac pacemaker is recovered and returned to ARCO Medical Products Company even in the event the physicians named in the application to participate in the study are no longer associated with the, applicant.
7 Chief,MaterialsBraggp
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June 4, 1975 Page 10 12.
Packaging labeling, and shipping instructions to be furnished by ARCO 42Cical Products Company will be followed upon the return of the pacemaker for approved disposal.
13.
Welborn Memorial Baptist Hospital hereby requests a license to receive, possess, store, and implant the ARCO Medical Products Company Model Nu-5 Nuclear Powered Cardiac Pacemaker in accordance with this application.
Signed:
Applicant:
W; Memorial ptist Hospital By:
,YM Donald
. Gent Executive Director Physic *a.
res nsible for study:
n up, Spnford E.
Schen, M.D.
pm CURRICULUM VITAE OF STUDY GROUP Marshall S. Miller, M.D.:
b '34, Allentown, PA M.D.
Cornell University Med. College
'60.
Intern "60 - '61. University of Chicago Clinics. Jr. and Sr. Assistant Res. Int. Med. '61 - '63 University of Cincinnati.
Fellow in Ronal Disease '63 - '64 Geo. Wash. University U.S.P.H.S.
'64 - '66 National Center of Radiologic Health.
Fellow in Nuclear Medicine '66 - '67 Univ. of Cincinnati.
" Staff, Welborn Memorial Baptist Hospital", Evansville Indiana.
Diplomate American Board of Internal Medicine and American Board of Nuclear Medicine.
Sanford E. Schon, M.D.: b '41, Windsor, Ontario, Canada, M.D. degree Univ.
of Western Ontario, Faculty of Medicine '66. Rotating Intern and Medical Res., St. Joseph's Hospital, McMaster University, Hamilton, Ontario '66 -
'68.
Univ. of Toronto, Sunnybrook Hosp. Senior Medical Res. '68 - '69.
i Special Fellow Cardiovascular Dept. and Cardiovascular Laboratory, Cleveland '
Clinic, Cleveland, Ohio '69 -
'72.
Board eligible Internal Medicine.
Beta Sigma Rho. " Staff, Welborn, Deaconess, and St. Mary's Hospitals", Evansville,f Indiana.
American Heart Association.
American Medical Association and American College of Cardiology.
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'Chipf, Materials Bra ch
"..,JGne 4, 1975 I
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John F.
Lawler, M.D.:
b '32 Mercedes, Texas, M.D. Degree Baylor Univ.
Col.-of Medicine '51 -
'55.
Rotating Intern Univ. of Penn. Hosp.
'55- '56.
Res. Gen. Surg.,Baylor Univ.' Col. of Medi. cine Affiliated l
Hospitals '58 -
'62.
Fellowship in Pediatric Surg. Children's Hospital Louisville, Ky. '62 -
'63.
Two years active duty. Capt. USA Med. Corps
'56-
'58.
Inactive reserve.
Diplomate American Board of Surg. Phi Chi.
" Staff, Welborn, Deaconess, and St. Mary's Hospitals", Evansville, Ind. Fellow American College of Surgeons. A.O.A.
Mell B. Welborn, Jr., M.D.:
b '38, Evansville, Ind. M.D. Degree Emory Univ.
'62.
Internship Vanderbilt Univ. Med. Center, Nashville, Tenn.,
'62 -
'63.
Res. Gen. & Thoracic Surgery Vanderbilt Univ. '63 -
'68.
MAJ, MC, AUS Thoracic & Gen. Surgeon, 22nd Surgical & 95th Evac. Hospital, Vietnam '68 -
'69.
Thoracic Surgeon Ft. Gordon Army Hospital '69 -
'70.
Fellowship in Cardiovascular Surgery, St. Louis Univ.
'70 - '71. Phi Beta Kappa.
Phi Chi.
" Staff, Welborn, Deaconess, and St. Mary's Hospitals",
Evansville, Ind. American Board of Surgery, American Board of Thoracic Surgery, and American College of Surgeons.
A.O.A.
Eugene L.
Hendershot, M.D.:
b '22, Evansville, Indiana - Graduated Ind.
University School of Medicine
'46.
B.S.
Degree.
Internship Methodist Hospital of Indianapolis '46 -
'47.
Postgraduate work Veterans Admini-stration Hospital, Himes, Ill.
Fitzsimons Gen. Hospital, Denver, Colorado.
Member, Vand. County Med. Society, Indiana State, AMA, American l
College of Radiology, Radiological Society of North Ameri'ca.
" Staff, l'
Methodist Hospital, Henderson, Kentucky".
" Staff, Welborn Memorial Baptist Hospital", Evansville, Indiana.
Alfred P.
Lessure, M.D.:
b '29, Cincinnate.
B.S. Degree. Grad.
'51.
Med. School U.
of Cincinnati.
M.D. Degree.
Grad.
'55.
Internship Cincinnati Gen. Hosp. '55 -
'56.
Res. Cincinnati Gen. Hosp. Radiology
'55 -
'61.
Instructor in Radiology '61 -
'62.
Assistant attending Cincinnati General Hosp. '61 -
'62. Member Vand. County Medical Society, Indiana State, AMA and American College of Radiology.
" Staff, Welborn Memorial Baptist Hospital", Evansville, Ind.
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