ML20154Q560
| ML20154Q560 | |
| Person / Time | |
|---|---|
| Site: | 07001718 |
| Issue date: | 04/25/1975 |
| From: | Franklin S SHADYSIDE HOSP., PITTSBURGH, PA |
| To: | Jonathan Brown US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20154Q463 | List: |
| References | |
| 0924, 25218, 924, NUDOCS 8603210194 | |
| Download: ML20154Q560 (39) | |
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'c5 MAY21975 : j f
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Brown, Jr.
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Directorate of Licensing A,.
b' 1N Nuclear Regulatory Commission kh E-. ]l[O N /Q Washington, DC 20555
Dear Mr. Brown:
This letter is in response to the Atomic Energy Commission letter of July 17, 1974; please reference Docket Number 70-17_18.
The following information is in support of our application to -
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participate in the investigational program; the paragraph num-bers correspond to those in your letter:
1.
Please list on our license for participation the following physicians:
/
i CARDIOVASCULAR SURGEONS CARDIOLOGISTS William Bert Ford, M.D.
William B.
- Tuttle, M.D.
Emir A.
- Zikria, M.D.
Shyh-Min Su, M.D.
William H. Miller, M.D.
Clyde D. Schoenfeld, M.D.
Siroos R.
- Samadani, M.D.
Lawrence N. Adler, M.D.
Armas Samuel Kyllonen, M.D.
Manfred L.
- Cohen, M.D.
Joseph G. Antkowiak, M.D.
Copies of the curriculum vitae for all physicians listed are included in Attachment 1.
Experience with implantations and follow-up of pacemakers for these physicians are displayed in as received from the physicians involved.
2.
The office address and telephone numbers for all physicians to be named on the license are listed in Attachment 3.
8603210194 860212 i
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3.
The positions and status of all physicians to be included in the license are set forth in Attachment 4.
4.
The only modification anticipated to the protocol dated March 25, 1974 relates to i
the last paragraph of Section VII.
Shady-side Hospital will not be resterilizing any pacemaker received in a ruptured container but will return such pacemaker to ARCO l
Nuclear for an in kind replacement.
This is confirmed by a letter of agreement from 4
ARCO Nuclear dated September 24, 1974 and i
may be found as Attachment 5.
4 5.
All equipment necessary to properly follow nuclear pacemaker hmplantations is on hand and currently utilized as a'part of our pacemaker clinic.
Please see the equipment description as Attachment 6.
6.
A description of the current pacemaker im-plantation and follow-up program is outlined in Attachment 7.
7.
The methodology for establishing and main-taining records of nuclear pacemaker patients is outlined in Attachment 8.
1 8.
The Hospital is in receipt of Title X, Code of the Federal Regulations, Part 70, and all I
management of the nuclear pacemakers prior to implementation or explanation will be based upon these regulations.
Please see confirming memo as Attachment 5 from ARCO Nuclear which establishes their willingness to deliver the nuclear pacemaker on the morning of implan-tation and further their willingness to pick up the nuclear pacemaker ~during the day of 1
explantation; this should preclude the secur-ity risk that potentially could exist for the Hospital.
Just prior to implantation the nuclear pacemaker will be maintained by the Operating Room Supervisor and will be kept under her constant surveillance, up to and including the time of implantation.
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performed explantations at the time of death will be performed by the Institute of Pathol-ogy and the nuclear pacemaker will be kept under constant surveillance until such time as ARCO Nuclear has picked up the nuclear pacemaker for proper disposition.
9.
Please see Attachment 9 for the procedure to be used by the Hospital telephone operators to respond to an emergency report or inquiry.
10.
The 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 Nuclear Company, even in the event the physicians named in the application to participate in the study are no longer with the Hospital.
11.
The packaging, labeling and shipping instruc-tions furnished by ARCO Nuclear Company will 3
be followed upon the return of the pacemaker for approved dispos,al.
12.
Each physician member of the study team and each administrative support center has re-ceived a separate copy of the research protocol dated March 25, 1974.
The proper degree of familiarity with the research protocol exists to ensure responsible participation in the Clinical Investigation.
An understanding exists that the issuance of a license is conditioned upon the following of the research protocol.
Please inform me if any additional or clarifying information is required in support of issuing the Hospital a license to partici-pate in the clinical investigation of the ARCO Nuclear NU-5 Pace-l maker.
Your cooperation in this matter is greatly appreciated.
Sincerely, M
S Stephen H. Franklin Associate Administrator for Professional Services SHF:dd
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CURRICULUMVITAE (cont'd)
William Bertford, M.D.
Zittsburgh Academy of Medicine Elttsburgh Surgical Society
?an American Medical Association DIPLOMATE Tmerican Board of Surgery,1953 Tellow, American College of Surgeons,1954 Ymerican Board of Thoracic Surgery,1955 7merican College of Chest Physicians,1958 STAFF APPOINTMENTS 1hadyside Hospital R. Francis Hospital 21umbia Hospital M. John's Hospital Yest Penn Hospital Mlegheny General Hospital R. Margaret's Hospital Tuburban General Hospital j
5ttsburgh Hospital lesbyterian University Hospital Xagee Women's Hospital Ihildren's Hospital TcKeesport Hospital R. Joseph's Hospital a
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P CURRICULUM VITAE
. Emir A. Zikria, M.D.
532 S. Aiken Avenue Pittsburgh, Pennsylvania 15232 BIRTHDATE June 28,1929 Kabul, Afghanistan EDUCATION American University, Beirut, Lebanon Pre-hiedical 1951 John Hopkins University School of Medicine Medical June 1956 INTERNSHIP Henry Ford Hospital 1956-1957 RESIDENCY General Surgery, Henry Pord Hospital 1957-1962 Thoracic and Cardiovascular Surgery Western Pennsylvania Hospital 1962-1964 DIPLOMATE American Board of General Surgery 1963 American Board of Thoracic Surgery-CC3 so-7f SOCIETIES Allegheny County Medical Society Pennsylvania Medical Society American Medical Association STAFF APPOINTMENTS Shadyside Hospital St. Francis Hospital,
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McKeesport Hospital St. John's Hospital Pittsburgh Hospital Suburban General Hospital Columbia Hospital St. Margaret's Hospital
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CURRICULUM VITAE (cont'd) 1 l
l Emir A 7sikrla, M.D.
St. Joseph's Hospital West Penn Hospital LICENSURES Pennsylvania-December 1963 Ma ryland-1956 e
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s CURRICULUM VITAE William H. Miller, M.D.
532 S. Aiken Avenue Pittsburgh, Pennsylbania 15232 BIRTHDATE
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December 22, 1929 McVeytown, Pennsylvania EDUCATION Juniata College Degree, B.S.,1953 Hahnemann Medical School Degree, M.D.,1957 INTERNSHIP Presbyterian Hospital Philadelphia, Pennsylvania 1957-1958 MILITARY SERVICE Captain, United States Air Force Dischrged 1961 RESIDENCY Presbyterian Hospital Philadelphia, Pennsylvania Ger eral Surgery 1958-1959 1961-1964 Cleveland Clinic Thoracic Surgery 1966-1968 FELLOWSHIP Lahey Clinic General Surgery 1964-1965
, TEACHING ASSIGNMENTS Asst. Instructor in Surgery University of Pennsylvania 1958-1959 1961-1964 Instructor in Surgery University of Pennsylvania 1968-1969 DIPLOMATE American Board of General Surgery 1968 L
CURRICULUM VITAE (cont'd)
L,I William H. Miller, M.D.
American Board of Thoracic Surgery 1970 SOCIETIES American Medical Association Pennsylvania Medical Society Allegheny County Medical Society The Society of Thoracic Surgeons STAFF APPOINTMENTS Shadyside Hospital Western Pennsylvania Hospital Pittsburgh Hospital Columbia Hospital St. John's Hospital Suburban General Hospital St. Margaret's Hospital St. Joseph's Hospital i._,1 h
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CUREULUM VITAE Siroos Saadani, M.D.
532 S. liken Avenue Pittsburgh, Ihnsylvania 15232 BIRTHDATE July 28,1938 Zanjan, Iran EDUCATION Alborz College, Tehran, Iran i
National Science Degree,1956 University of Tehran School of Medicine Degree, M.D.1963 INTERNSHIP St. Francis General Hospital (j
1963-1964 RESIDENCY St. Francis General Hospital General Surgery 1964-1967 Ohio Valley General Hospital General Surgery 1967-1968 St. Francis General Hospital i
Thoracic Surgery 1968-1970 SOCIETIES American Medical Association Allegheny County Medical Society Ponnsylvania State Medical Society STAFF APPOINTMENTS Shadyside Hospital Western Pennsylvania Hospital.
Columbia Hospital Pittsburgh Hospital St. John's Hospital Suburban General Hospital St. Margaret's Hospital St. Joseph's Hospital
{',ICENSURES Pennsylvania 1971 DIPLOMATE Am. Board of Gen. Surgery, 1973
s.
'Ah E t Armas Samuel nen, M.
D.
' OFFICE:
4815 Liberty Avenue, Pittsburgh, Penna.
15224; 683-2533 RESIDENCE:
3 Fieldvue Lane, Pittsburgh, Pa. 15215; 781-9307 BIRTH DATE & PLACE:
Monessen, Pa.
4-19-18.
EDUCATION:
Boston University - B.
S.,
M.
A.
1939-41 Boston University - M.
D.
1944 TRAINING:
Intern - Mass. Memorial Hosp.
1944-45 Resident - Gen. Surg. - Mass. Memorial Hosp. 1945-46, 1949-51 Resident - Thoracic Surg. - Boston City Hosp. - 1948-49, 1951-52 s
MILITARY SERVICE:
Medical Corps,- U.
S.
Army; Captain 1946-48.
HOSPITAL APPOINTMENTS:
West Penn - Chief, Thoracic and Cardiovascular Surgs Senior Staff Montefire Hosp. - Associate Staff Forbes Hosp. System - Active Staff Homestead Hosp. - Consulting Staff Braddock Hosp. - Consulting Staff C.
Howard Marcy State Tuberculosis Hosp. - Consultag Shadyside Hosp.
. Associate Central Medical Pav$
UNIVERSITY APPOINTMENTS:
Pittsburgh Un'iv. - Clinical Instructor Chairman of Thoracovascular Surg. - Postgrad.
Educational Program - West Penn Hosp., Pgh., Pa.
tERTIFICATIONS:
American Board of Surgery 13-55 Board of Thoracic Surgery 20-57 i
MEDICAL SOCIETIES:
Allegheny County Medical Society Pennsylvania Medical Society American Medical Association American College.of Surgeons - Fellow Society of Thoracic Surgeons - Founding Fellow i
Penna.
Association for Thoracic Surgery Pittsburgh Surgical Society W
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'Ar[nas S.
Kyllonen, M.
D.
N PUBHCATIONS SSAPPEARING RIBS Annals of Thoracic Surgery, T61.
4, No. 6; P.
559.
Dec. 1967 IIOME SUCTION APPARATUS FOR TRACliETTOMY PATIENT Western Pennsylvania IIospita1 Bulletin Vol.
1, No. 1; p.
- 18. 7-67 ADVANTAGES OF OPEN NEEDLE TilORACEITESIS Western Pennsylvania llospita1 Medical Bulletin, Vol.
2, No.
2, P.
61 7-68.
MEDIASTINOTOMY: TO AVOID FUTILE TSRACOTOMY IN LUNG CANCER Western Pennsylvania llosp. Mei. Bul.
Vol.
5, No. 1; P.
- 11. 1-71.
"Trachoo-oso ihagoal Fis tula Follo@g Blunt Trauma".
Antkowiak, J.
G.,
Cohon, M. L. artiKyllonen, A. S.
Accep.ted for 1971r publication in'&chivos of Surgery.
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.,_.~..v-NAME:. Manfr'ed Lessi hen, M.
D.
O F F,I C E :
4815 Liberty Avenue, Pittsburgh, Pa. 1 68'3-2533 PUSIDENCE:
5 Old Timber Trail, Pgh., Pa. 15238 963-7744 i
BIRTH DATE & PLACE:
1_19-40,; Torrington, Connecticut.
EDUCATION:
University of Connecticut - B.
A.
1951 Ohio State University - M.
D.
1956
.edwfa n Intern - Interk:
Montefiore Hosp. 7-56 to 7-57 TRAINING:
Resident - Gen. Surg. - Montefiore Hosp.
7-57--7-60 Resident - Thoracic Surg. - Peter Bent Brigham Hosp.,
B nton, Mans 7-60--6-62 Resident - Thoracic Surg. - Maimoni. des Hosp. 7-62--6-63
~
Bryoklyn, New Ywk MILITARY SERVICE: 'None Commission - Naval Reserve -
Lt. Commander l
HOSPITAL APPOINTMENTS: West Penn Hosp. - Associate Contral Medical Pavilf Shadyside Hosp. - Associate Montefiore Hosp. - Associate Pittsburgh Hosp. - Active f
Braddock Hosp.
-Consultant Homestead Hosp. - Consultant i
C. Howard Marcy State TB Hosp. - Consultant
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UNIVERSITY APPOINTMENTS:
University of Pittsburgh - Clinical Instruct.or in Surg.; 1959-60.
l Harvard Medical School - Instructor in Surg. 1960-q State Univ. of New York - Instructor in Surg.1962-(
' CERTIFICATIONS:
American Board of Surgery - 1964 Board of Thoracic Surgery - 1965 I
MEDICAL SOCIETIES:
Allegheny County Medical Society Pennsylvania Medical Society American Medical Association American Heart Association American College of Cardiology Pennsylvania Thoracic Society American College of Surgeons 5
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5-15-73 NAME:
Joseph Geral tkowiak, M. D.
OFFICE:
4815 Liberty. Avenue, P it tsburgh, Pa.
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100 Oxford Dr., Monroeville. P a.,, 15146, IESIDENCE:
,3-4-34, Buf f alo, New York BIRTH DATE & PLACE:
EDUCATION:
Canisius College, Buf falo, N.
Y.
- B.A.
- 1956 Y.
- M.D.
- 1960 University of Buf f alo, Buf f alo, N.
Y.
6-60 to 6-61 TRAINING:
Intern - Mercy Hosp., Buf f alo, N.
Geo. Washin(Jton U.
Hosp. Program Resident - Gen. Surg.
1963-1967 Resident - Pediatric Surg. - Children's Hosp., -Pgh. 1968 Francis, Shadyside, West Pent Resident - Thoracic Surgery - St.
Hospitals.- 1969-1971 i'
MILITARY SERVICE:
U.
S. Navy - Lt. - Disch. 7-1963 3
West Penn - Assistant Staf f HOSPITAL APPOINTMENTS:
Pittsburgh - Assistant Staff
.y Homestead - Courtesy Braddock - Consulting
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Shadyside - Active j
Forbes Hospital System - Consulting UNIVERSITY APPOINTMENTS j
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CERTIFICATIONS:
1968 American Board of Surgery 1
1972 Board of Thoracic Surgery 1
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MEDICAL SOCIETIES:
Allegheny County Medical Society Ponnoylvania Medical Society
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i American Medical Ancociation I
American College of Surgeona - 1974
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j PUBLICATIONS:
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Archives of Surgery, Vol. 9 8, # 4.
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a CURRICULUM VITAE Name:
William B. Tuttle, M. D.
Add ress:
203 Duckingham Road Pittsburgh, Pennsylvanin 15215 Birth date:
February 6,1924 Place of birth:
Wilkinsburg, Pa.
Nationality:
U. S. A.
Religion:
Protestant Marital Status:
Married - Mary Jane Miller, June 17, 1950 i
I Tre-Medical Education:
liigh School: Wilkinsburg Elementary, Jr. & Sr.111gh a
Penn State University 1941 - 1942 University of Pittsburgh 1942 - 1944 Graduated University of Pittsburgh, B.S. Degree 1947 Itdical Education:
Hahnemann Medical College, Graduated 1950 M.D. degree i
Internship:
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Hahnemann Hospital, Fhiladelphia, Pa.
1950 - 1951 4
U Essidencies:
Hahnemann Hospital, Resident in Itdicine 1951 - 1953 VA Hospital, Pittsburgh, Pa., Resident in Itdicine 1954 - 1955 t
l Location and length of Practice:
l 532 S. Aiken Avenue since 1956 Pittsburgh, Pa.
15232 Practlee Limited to:
l Internal Medicine and Cardiology i
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Licensed to practice in:
State of Pennsylvania since 1951 Utaff Affiliations:
Shadyside Hospital,1956 thru present, Director Medical Cardiovascular Services (includes Direct.or of Heart Station and Cardiac Care Unit).
Presbyte ri an-Unive r.w i t.y Hospi tal, 198// thru prenant., Assi star.t utnrI.
thgec-Womens Hospital, 1958 thru present.
A A: -
Clyde D. Schoenfeld, M.D.
Page 2 Mocterships:
Medical Societies - Dade County Medical Association Florida Medical Association Pan /corican !!cdical Association Heart Associations: - Greater Miani Heart Association Florida Heart Association knorican IIcart Association 1.eu York Academy of Sciences i
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r GILOCRT MRAUSE, M.D.
SEYMOURE KRAUSE, M.D.
LAWRCNCE N. ADLER M.D.
FOREST HILLS PL AZ A
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YOST HLVO. AT A RDMORE ULVD.
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PITT SHURGri, PA.15221 PHONE 243-7300 August 19, 1974 Mr. Stephen H. Franklin Assoclate Administrator Shadyside Hospital Pittsburgh, Pa. 15232
Dear Mr. Franklin:
l In reply to your letter of August 14, 1974 l
the following information is submitted:
I. NR.E:
Lawrence N. Adler, M.D.
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II. SPECI ALTY BOARD CERTICICATION: Certified by the American Board of Internal Medicine 1964.
Also certified in Cardiovascular Disease in 19 69.
I III. PP,EVI_OUS EXPERIENCE WITH PACWAKERS :
I have been involved since 1963 with pacemaker implantation O"
and have done 100-200 of these proceedures.
These have been done at several hospitals and I have only used a few myocardial leads.
The bulk of them have been done with the use of endocardial leads.
I trus t this information will be helpful to you, and if there is any other information you desire, I
please do not hesitate to call on me.
Sincerely yours, V
k.
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LAWRENCE N. ADLEPs, M.D., F.A.C.C.
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PACEMAKER INSERTIONS BY FORD TEAM ENDOCARDIAL MYOCARDIAL 1964 45 6
i 1965 43 3
i 1966 66 5
1967 98 19 i
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1968 155 7
1 1969 87 10 1970 30 0
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1971 32 1
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i 1972 47 3
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1973 52 2
1974 13 (TIIIS IS FOR FIRST 6 MONTHS)
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532 50DT11 AIKl:N AVENUE I'llTSHUl(Gil, l'ENNSi LVANIA 15232 Inf anal Medicine September 6, 1974 Stephen H. Franklin, Assoc. Administrator Shadycido Hospital 5230 Centre Avenue Pittsburgh, Pennsylvania 15232 Dcar Mr. Franklin:
The follouing is the information you requested in your letter of August 28, 1974 concerning the clinical investigation of the ARCO Nuclear IlU-5 Pacemaker for the Atomic Encrcy Comission.
l The group participating in the follouup activitics of the Atomic Energy Project trill be the members of the Pacemaker Evaluation Ccntor of Shadyside Hospital.
Those members include:
i l
William B. Tuttic, M. D., Certified Board of Internal Medicine (Curriculum Vitae attached).
I i
Shyh-Min Su, M. D., Certified Board of Internal Medicine (CurriculumVitacattached).
Clyde D. Schoenfeld, M. D., Certified Board of Internal i
Medicine, and Certified American Board of Cardiovascular l
Diccases (Curriculum Vitac attached). Dr. Schoenfold l
cpent six years at Mt. Sinai Hospital in Mianti, Florida as Accociate Chief of Cardiology involved in the Pacemaker Clinic.
This Clinic regularly followed betueen 50 and 100 I
patients with implanted demand pacemakers. Follouup was by means of clinical examination, standard c1cetrocardiogram, I
and wave form analysis.
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The Pacemaker Evaluation Center at Shadycido Hospital currently has 57 patients registered.
These include those under direct follouup, and thoco being followed by telephone trancalesion.
l Sincerely, p_)
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William B.
- Tuttle, M.D.
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532 South Aiken Avenue Pittsburgh, PA 15232 Phone - (412) 683-4111 9.
Shyh-Min Su, M.D.
532 South Aiken Avenue Pittsburgh, PA 15232 Phone - (412) 683-4111 r
I 10.
Clyde D. Schoenfeld, M.D.
532 South Aiken Avenue j
Pittsburgh, PA 15232 Phone - (412) 683-4111 11.
Lawrence N. Adler, M.D.
Forest Hills Plaza Y st Boulevard at Ardmore Boulevard j
o Pittsburgh, PA 15221 i
Phone - (412) 243-7300
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1.
William Bert Ford, M.D.
Active Staff and Chief, Division of Cardiovascular and Thoracic Surgery 2.
Emir A.
- Zikria, M.D.
Active Staff, Division of Cardiovascular and Thoracic Surgery 3.
William H.
- Miller, M.D.
s Active Staff, Division of Cardiovascular and Thoracic Surgery i
4.
Siroos Samadani, M.D.
l Active Staff, Division of Cardiovascular and Thoracic Surgery I
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5.
Armas Samuel Kyllonen, M.D.
Active Staff, Division of Cardiovascular and Thoracic Surgery
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6.
Manfred L.
- Cohen, M.D.
Active Staff, Division of Cardiovascular and Thoracic Surgery I
7.
Joseph G.
Antkowiak, M.D.
Active Staff, Division of Cardiovascular and Thoracic Surgery I
8.
William B.
- Tuttle, M.D.
i Active Staff and Chief, Division of Cardiology and Chairman, Medical Audit committee 9.
Shyh-Min Su, M.D.
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Active Staff, Division of Cardiology w!
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clyde D.
Schoenfeld, M.D.
i Active Staff, Division of Cardiology 11.
Lawrence N. Adler, M.D.
Active Staff, Division of Cardiology I
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ARCO Nucitar Corrpany Subsidiar f AtlanticRichfieldCornpany 4h Post ex 54G
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Leect Pennsylvania 15656
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8' Tctephone 412 845 8111 X
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September 24, 1974 Mr. Jan Jennings Shadyside Hospital 5230 Centre Avenue Pittsburgh, Pennsylvania
Dear Mr. Jennings:
This is to inform you that ARCO Nuc1 car Company will j
agree to deliver the NU-5 nuclear pacer to Shadyside i
Hospital on the designated day of implant.
- However, this does not release the hospital of maintaining
,f accurate accountability and record keeping as j
required by the March 25 protocol. Likewise, we will further assist you by agreeing to pick up any pacemaker which for any reason is explanted.
l In the unlikely event that you receive a pacemaker with the protective sterilized bag ruptured, we will replace that pacemaker.
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Sincerely, k0> lwd
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D. A. Stevens Technical Engineer DAS:nmg e
d
g PACEf'AKER CLIf11C EQUIPiiEtigRIPT0f1
.PATIEllT TRAllSillTTER UtilT This unit is a small light weight modulator capable of transmitting the patient t.
E.C.G. and pacer artifact over a public telephone or directly into a hospital clinic based receiver.
To use the unit, the patient clears his forearm of any clothing, then slips the left expansion bracelet on his left forearm, and does the same procedure for the right bracelet.
He then places his home telephone handset in the patient unit cradle. The handset depressor a button to turn the unit on without requiring the patient to operate any controls.
This same procedure is performed by a technician during hospital visits.
A characteristic high pitched carrier (2 KHZ) is heard emanating from the unit.
Cardiac activity causes a clearly audible change in the pitch of the tone.
It is this frequency modulated carrier which transmits the E.C.G. and pacer artifact to the hospital demodulator (MEDIC UtilT).
Specifications for the unit are listed below.
i Weight - 5 lbs.
Minimum sensed E.C.G. signal
.1 mv i
E.C.G. Signal Bandwith l.5 HZ to 40 HZ Maximum signal on phone line
- 9dbm Minimum sensed pacer artifact signal 1 my E.S.B. MEDCOR - Medic Unit
( ' E.C.G. and pacer artifact signals generated by the patient modulator.
This unit acts as a hospital based demodulator to receive and display the patient's This unit providet three functions; demodulator, chart recorder, and pacer rate (interval) meter.
The unit also includes a reverse signal capability to turn on a light at the patient unit to signal the patient to talk on the telephone.
Specifications for the Medic Unit -
- 1) Pacer Pulse Interval 250 - 1600 ms
- 2) Pacer P,ulse Rate 40 - 240 BPM
- 3) Pulse Accuracy 1
.05 pulses / min
- 4) Recorder Linearity 1% of full scale Sensi tivi ty 10 mv/rm Chart Speeds 25 & 50 mm/sec TEKTR0'1ICS 434 Oscilloscope This instrument is a dual trace storage oscilloscope (DC - 25 MH) which is used to examine the pacer artifact obtained from the two limb E.C.G. electrodes. A picture of the pacer artifact waveshape is then taken using a Polaroid CR-9 Land Oscilloscope camera.
{s, Marquette 2000 & 3000 Series 3 Channel Electrocardiograph
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PACEMAKER FOLLOW-UP FACILITIES AT SHADYSIDE HOSPITAL
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The pacemaker clinic facilities at Shadyside Hospital include the capability to do accurate rate (interval) measurements and pacemaker artifact wave form a nalysis.
The equipment used permits transmission of the E.C.G. and pacer artifact from the patient's home via telephone as well as regular checkups in the hospital pacemaker clinic.
Present clinic policy requires the patient to follow a schedule similar to the one outlined in the Medicare guidelines.
Patients start with an initial interview to explain the purpose of the clinic, the operation of patient home transmitters, and their role in providing consistent scheduled follow-up data.
The present schedule requires the patient to initially have rate (interval) beasurements and pacer artifact pictures taken at the time of admission to the clinic.
Depending on the implantation date, the patient is placed appropriately using the enclosed schedule.
The results of the rate measurement (with and without magnate) pacer waveform analysis and E.C.G. tracings are reviewed by a clinic physician to insure pacemaker capture and no significant changes in rate and pulse width since the last clinic visit. Any observed abnormal operating characteristics are then immediately telephoned to the patient's physician.
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Patients are informed of normal operation and a report forwarded to the physician.
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MONITORING CALL SCllED. t.
h This schedule follows parameters set by Social Security Adminis-tration as being acceptable for reimbursement under Medicare.
There are three forms of patient service -
A.
Clinic Evaluation Only.
B.
Transtelephonic Monitoring.
C.
Combination of Clinic Evaluation and Transtelephonic Monitoring.
b A. Clinic Evaluation Only.
Month 1 - 12 13 - 18 18 - 24 24 - 30 Frequency 3
3 4
4 (Clinic Evaluation)
- 4/ additional 6-month periods.
B. Transtelephonic Monitoring.
I([j Month 1-6 7 - 15 16 - 18 19-Failm i
Frequency Every 2 months Monthly Every 2 weeks Weekly i
(Calls)
C.
Clinic Evaluation and Transtelephonic Monitoring.
f Month 1 - 12 13 - 24 25 - 36 j
Frequency 3
4 4
j (Clinic Evaluation 1
1 l
Month 1-6 7 - 15 16 - 18 19-Failm Frequency.
Every 2 months Monthly Every 2 weeks Weekly i
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SHADYSIDE IIOSPITAL PITTSBURGH, PENNSYLVANIA
~
ADMINISTRATIVE POLICIES AND PROCEDURES April 25, 1975
SUBJECT:
RECORDS MAINTENANCE AND FOLLOW-UP OF NUCLEAR PACEMAKER PATIENTS 8
PURPOSE Records will be maintained on implantation and follow-up data on all nuclear pacemaker patients in the Tumor Registry.
The e
following procedure will be strictly adhered to so as to insure C',
effective follow-up of nuclear pacemaker patients and to insure compliance with the research protocol for the clinical investi-gation:
1.
The Tumor Registry shall receive from the Medical Records Department the blue copy l
of the " Accountability and Implant Data Form" and a copy of a fully executed
" Informed Consent for Surgical Implanta-tion of Radioisotope Powered Cardiac Pacemaker."
At this point, the Tumor Registry will open a separate medical record for all documentation and follow-up data pertaining to nuclear pacemaker recipients, to include:
a.
Blue copy of the Accountability and Implant Data Form. (Attach-ment 1).
b.
A fully executed copy of the
" Informed Consent for Surgical
()
Implantation of Radioisotope h
- p. /(*/A j\\.i Maay('
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sidiary of AtlanticRichfie
- mpany P.O. Box 54G t Lt I CHuuRG.F E P.NsVL V AN11. l*X'A t U S A. / I'Ho?.L (4121 e4$ BIII t
FOLLOW-UP DATA FORM (To be uscd each time patient is contacted and/or examined including telephone transmission of ECG.)
PATIENT IDENTIFICATION SHEET Patient Name
~
Last f orst 3rnstf al Patient Hospital Record No.
Pacemaker Serial No.
Date of imp!antation Date of Fo!!cw-Up Name of Physician Address City State-Zip-Arca Code and Telephone No.
Patient has I.D. Card: Yes No Patient is wearing Bracelet or its Equiva!ent: Yes No Contact maintained with patient: Yes No a
PACEP.1AKER FUNCTION
~
Satisfactory Unsatisfactory Stimulation Rate: with f.iagnet w/o f.iagnet -
Change from previous rate Change from injtlal rate
~
j fAEDICAL EXAMINATION Summary:
Reposition: Pacemaker / lead /both Reason Explantation: Pacemaker / lead /both Reason i
Autopsy Results (if applicable)
}
Title
~
Cause of Death (if applicable)_
j Date l
Signature This form should be completed and returned to the manufacturer within 10 days of taking follow-up data.
~
l For urgent questions and for assistan.ce concerning this pacemaker, please call 412-845-811'1.
i i
(MANUFACTURER *S COPY)
Seal Here Af ter Foldsng FIGURE 2 i
g ATtM 2.
Ihm CC.':SI:.T FOR SURGIC71 Irg'sTICU OF JmD101E010PE TCEPID C7FDITC hm NR I understand that for the treatmnt of my cardiac c ndition - a disturbanc2 of nor::ul cardiac conductica - a cardiac pacemaker is to be inplanted in re.
I also understand that the surgical procedure (ray /will) require the placerent of a new electrode and lead into or onto the surfac2 of my heart and the inplantaticn of a new cardiac pace:r.ter, and I understand that v. tile the surgical procedure is not of unreasonable risk, the possibility of caiplications or even death exists. Tne precedure has bmn exnlained to re, in a ranner that I could understand, and I have had the opportunity to ask any questions thich I would like.
It is my understanding that a radioisotope pcwered cardiac pacer.ier, which is ncw undergoing its initial clinical use in approxirately 480 persons, will be utilized for the inplantatien.
I have been told that the paceraker design has bcen extensively tested over a period cf several years.
I have been told that on the basis of these c:g>2rirmts in anirals and in the laboratcry, units of this typ3 are predicted to have a reliable life exmctancy ccmarable to (and hopefully 02nsidarably in excess of) that of current standard cardiac pacerakers.
Ho.ceve.;, I understand that it is i:qcssible to be certain of the pamraker's actual reliability, and no guarantee has been given to re concerning the results v.tich ray follow.
I understand that the paceraker dcas produce radiatica, but I have bcen told by my attending physician that it is the redical judgent that this radiation presents a neglicible hazard to re and the renbers of my household.
I understand that in ccnsentinE to the inplantation of th's pace: raker, i
J I am authorizing, as well, all standard operating precedures, including the administratica of anesthetics which reay be incident to the ejeration.
l For the purpose of advancing radical and scientific kno.eledge, I consent to the admittance of observers to the operating room.
l I
' Ultirrately - after my death or earlier, if the useful life of the pace: raker is exc2eded, if it ceases to function effectively for my nodical 3
needs, or if I request to have it removed - the paceraker rust be renoved and returned to JaCO Nuclear Conpany or to its designee, (Clinic). Accordingly, I agree to contact (Clinic) at regular intervals of no less than three renths during the first year and every six renths thereafter and v.henever I change af residence.
I will always carry the appropriate identification card on my persca and will at all tires wear the standard identification bra let.
7 Notwithstanding my contacting the inplanting clinik follcwing the insertion of a cardiac pace: raker of any sort, I agree to rcrain in pericdic contact with my perscnal physician.
I will also instmet all rc:rbers of my household and inform those who have extended contr.ct with ne that I have received a radioisotope pcuered cardiac pacer inplant.
0 8
the radioirotcpc pc>.:ered hic paormter is an I understa-a cx1x' rim 2ntal unit.
In order to, assess the effectivcness of the device, and to nenitor =j parsenal well-being, (clinic)
(
is interested in collecting data uyn the device.
- ccareir. gly, I agree to visit (Clinic) in parson or to transmit by telephone (witn the aid of a device supplied to ne and applied to the surfao2 of my skin) nj electiccardiocram and an indication of the functioning of the pncenaker.
I agree to permit this rcnitoring to be perforned at least once every three ncnths for the first year and every six nunths thereafter.
I further cgrce to provide infomation on ny clinical ccnditica as it Fertains to the paccraker at no less than six nanth intervals.
Furthernre, I consent to disclosure by the clinic of any inforration acquired by the clinic in regard to the irplantation of the radioisotcpc pc. ered cardiac paceraters; provided, he. ever, in no event shall such disclosures include ny identificatica without ny spacific written approval.
I understand and agree that I nust notify (Clinic)
prior to any travel outside of the United States.
I have had the cpportunity to ask any cuesticas partaining to the surgical procedure, the radioisotcp2 pc.:ered cardiac paceraker, and the nundatory folle.:-uo procedure, and these questicas have been answered to my satisfaction.
The pcssible alternate nethods of treatrent, including the use of conventional chcrical battery pc ered paceaakers, have been called to my attention, 'and I have been given an opportunit,y to ask any questions about these alternative nuthods.
With these facts in mind and with the intent of being legally bound, I release any right to claim that the irplantatica of a rcdioisotope pc.:ered cardiac pace aker was not properly authorized, and I agree to the follo.e-up procedures and the ultirate return of the unit as detailed above.
I agree to asstre the risk of the inplantation of a radioisotopa p,. ered pacer and release and discharge lad Nuclear, the irplanting clinic and ny physician from failures not caused by their fault or negligence.
Witncss (preferably a relative)
Date Date '
Patient's signature or two Date persons authorized to, consent
' for the patient.
7 Palationships to the patient si ing if other than the patient.
I certify that I have explained the above procedure.
l 0
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James E.
Jones 1132 Pennsylvania Avenue Oakmont, PA 15062
Dear Mr. Jones:
A \\!,
Your check-up in the Pacemaker Evaluation
, Center on (date) shows that your pacemaker is working properly.
Your next follow-up appointment is scheduled for (da te.) at (time) in the Pacemaker Evaluation Center here at Shadyside Hospital.
Sincerely, C. D.
Schoenfeld, M.D.
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(Attachment 5)
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ij30 r C
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ARCO Nuclear Company P. O. Box 546 Leechburg, PA 15656 Attention:
D. A.
Stevens Technical Service Engineer
Dear Mr. Stevens:
This is to notify you that on (date) the nuclear pacemaker leads were replaced / repositioned (patient name), nuclear pacemaker recipient.
on If additional information is required, please feel free to contact me.
Belle Somach Nuclear Pacemaker '
Program Coordinator
~
CL (Attachment 7)
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EO re adY tw.aio 04
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James E.
Jones a
1132 Pennsylvania Avenue Oakmont, PA 15062
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Dear Mr. Jones:
We are conducting a routine check of our
)
nuclear pacemaker patient's records.
Our records reflect your address as shown above and your phone number is Please return the enclosed post card in support of our records check.
~
Your cooperation in this matter is most appreciated.
Sincerely, Belle Somach Nuclear Pacemaker ~
Project Coordinator
..L (Attachment 8)
SHADYSIDE HOSPITAL
(
PITTSBURGH, PENNSYLVANIA ADMINISTRATIVE POLICIES AND PROCEDURES April 25, 1975
SUBJECT:
PROCEDURE FOR TELEPHONE OPERATOR RESPONSE TO NOTIFICATION OF EMERGENCY FOR, OR DEATH OF A NUCLEAR PACEMAKER RECIPIENT PURPOSE I
These instructions are designed to insure rapid response to a notification of emergency from a nuclear pacemaker recipient (s
and to comply with the Research Protocol for Clinical Investi-gation of the ARCO Nuclear NU-5 Pacemaker, dcted March 25, 1974.
+
1.
Any collect calls received by the Hospital 3
concerning nuclear pacemakers will be accepted.
i 2.
The operator should obtain as much information from the caller as possible including:
a.
Caller's name and where to reach him/her.
b.
Patient's name, condition and l
where to reach him/her.
I c.
If a physician is with the patient; and if so, his name and where he can be reached.
d.
Condition of pacemaker, if known (i.e.,
expelled or still implanted).
(
e.
Information on patient's ID card, if possible.
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3.
The operator shall contact the Hospital Radia-tion safety Officer and the responsible doctor while keeping the caller on the line and standing by.
(Fuch calls represent potentially severe emergencies).
4.
If the Radiation Safety Officer or the respon-sible physician or designated alternate cannot be reached, contact the Thoracic Resident on duty and advise of the situation and what infor-mation is available.
5.
If the caller indicates that the nuclear pace-maker recipient has died, the procedures of paragraphs 2-4 will be followed.
However, sub-sequent to accomplishing the foregoing, the j
Tumor Clinic shall be notified that the death has occurred.
If the incident occurs during other than normal working hours, the operator should leave a message for the Tumor Clinic to be notified of the death at 8:30 a.m.
following the incident.
3
-(.
6.
The telephone operator will utilize the attached checklist in collecting the necessary information l
from the caller (Attachment 1).
I I
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CHECKLIST FOR HANDLING EMERGENCY CALL REGARDING NUCLEAR PACEMAKER RECIPIENT 1.
Collect calls will be accepted by the Hospital.
2.
Try to obtain as much of the following information as possible.
If the caller is unaware of the certain elements of the requested information, refer the caller to the wallet-sized " Medical Alert" card, which should be in the possession of the nuclear pacemaker recipient:.
a.
Caller's name and where to reach him/her:
Phone No.
(
Address b.
Patient Data:
Name Condition Phone where patient can be reached Address If physician is with the patient:
c.
Physician's Name
(_.
Phone where Physician can be reached Address
@Nkeb JU
T e,
f.
(
d.
If known, condition of the pacemaker e.
If possible, information on patient I.
D.
card:
Name of Attending Physician (s) ; if the name of the responsible physician (s) is not provided by the caller, refer to the nuclear pacemaker re-cipient roster prd'vided by the Tumor Reg stry.
f.
While keeping the caller on " hold", contact the Hospital Radiation Safety Officer and the responsible physician, or If unavailable, contact the Thoracic Resident on duty and advise of the situation and what infor-mation is available.
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. Willia ~J 0. Mikro Chiel' n
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license roe M5Wigearnt Branch V
,' Difice of Administration 1
... Regional License Section Kateriai Licensing Branch
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FCMS, Office of Nuclear Material l
Safety 8' Safeguards l
LICENSE FIE TRAN5MITTAL
'A.
REGION
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APPOCATION ATT ACHED n.N 7('/M C/C6s /70 TU/ Yd/
Applicant / Licensee:
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Application Dated:
W',('cr i n) n ic Control No. :
__ U13W]'~f$',.Dl License No. :
- 2. ' FEE ATT ACHED' N
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Amount:
Check No.:
Signed.'-.
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3.
COMMENTS Date f
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t LICENSE FEE MANAGEMENT BRANCH-
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Te Catesory and Arnount:
s Applic4 ion irpiy be processed for:
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' 2. C0rrect fee Paid.,.
Amendment
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Renewal p
Signed Th*AMNn A/$w i
License
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5/ 9lPQ Date.
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