ML20204B927
| ML20204B927 | |
| Person / Time | |
|---|---|
| Site: | 07002077 |
| Issue date: | 10/24/1975 |
| From: | Richard Anderson SUBURBAN GENERAL HOSP., NORRISTOWN, PA |
| To: | Jonathan Brown NRC |
| Shared Package | |
| ML20204B848 | List: |
| References | |
| 2169, NUDOCS 8607300531 | |
| Download: ML20204B927 (5) | |
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MR. J. BROWN 1,
7 Gentlemen:
DOCKET #70-2077 RE:
RESPONSE TO LETTER OF SEPTEMBER 29, 1975 REQUESTING CLARIFICATION OF APPLICATION PROCEDURE FOR RESEARCH STUDY PARTICIPATION INVOLVING IMPLANTATION OF CORATOMIC C-100 SERIES ISOTOPIC POWERED PACEMAKERS EACH CONTAINING 250 MILLIGRAMS CF Pu-238 (lESS THAN 4.3 CURIES).
In response to your letter of September 29, 1975 referenced above, we submit the following additional information in clari-fication.
We fully understand that licenses are to be issued only to medical institutions that can assure continuity of follow-up of patients with implanted pacemakers and not to individual physicians.
The physicians designated in the application, dated September 18, 1975, include the surgeon, Dr. Robert W. Driscoll, responsible for the implantation, and two of four cardiologists, who will be participating in the study, Dr. Albert J. Fornace and Dr. James E.
McHugh.
In addition, the letter of September 18, included the name of Dr. David M. Bolden, Chairman of the Department of Radiology, Chair-man of the Isotopic Use Committee, and Radiation Safety Officer.
The Department of Medicine at Suburban General Hospital is made up of five internists, four of whom have extensive experience in Cardiology and pacemaker implantation both in transvenous and per-d
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Pg. 2 Discussions of this specific point with Dr. Albert J. Fornace, one of the physicians named as being responsible in the study, cor-rects the information supplied in the letter of September 18, 1975 noting that the total number of permanent implants at Suburban General Hospital /Riverview Osteopathic Hospital over the last ten years, approaches two hundred.
In addition, this number does not include the number of temporary transvenous pacemakers placed at the hospital, either in this building or the old building.
With respect to follow-up on the pacemaker patients, each of these patients is seen by the surgeon at regular postoperative in-tervals, however, no less frequently than every six months following the first six months after implantation.
In addition, they are fol-lowed at regular intervals by the Department of Internal Medicine with regular electrocardiograms taken at prescribed intervals.
Paragraph 3 of your letter of September 29, 1975, specifically with reference to Dr. Driscoll's residency at Mercy Catholic Medical Center during 1970-1971, this was taken as the third of four years in a General Surgical Residency, which included both abdominal and thoracic surgery training.
Dr. Driscoll is trained as a general surgeon, both in general and thoracic surgery, and has a subspecialty in Traumatic Surgery alternating emergency room call for all trauma cases with another similarly trained surgeon on the hospital staff.
Paragraph 4 of the aforementioned letter appears to ask for clarification and a restatement of the information in our letter of September 18, 1975, which is included below:
a.
ROBERT W. DRISCOLL, D.O.
Duration of Pacemaker Experience:
3 years Total Number of Implants Done:
35 b.
ALBERT J. FORNACE, D.O.
Duration of Pacemaker Experience: 10 years (Correction of letter of September 18, 1975)
Total Number of Implants Done:
(Permanent - 10 Transvenous - approx. 60) c.
JAMES E. MCHUGH, D.O.
Duration of Pacemaker Experience:
2 years Total Number of Implants Done:
40 Total Number Done at this facility:
10 Combined total years of pacemaker experience for the above three named applicants is 15 years, and this does not include the experience of the two alternate named physicians from the Department of Medicine, Dr. Joseph V. Koehler and Dr. Martin D.
Bascove, both of whom? have similar experience but will not be considered prime investigators in this protocol.
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Brown October 24, 1975 Pg. 3 It must be pointed out that the discrepancy between the number of implants done by the above team and the total number done at this facility is due to the fact that the primary surgeon who did a signi-ficant number of implants at this facility is no longer active at this facility and his responsibilities have been assumed by a younger surgeon, Dr. Driscoll.
Paragraph 5 of your letter of September 29, 1975 with respect to the sentence, '. '... telephone transmission and testing of pulse inter-vals will be used unless individual examinations will be required de-pending upon the patient's data", on Page 5 of our letter of September 18, 1975 demands clarification.
What is implied in this statement is that the patients will be examined at regular intervals in accordance with the protocol and where there exists any doubt as to the interpre-tation of the electrocardiographic readout, telephone transmission to computerized center will be employed both as necessary and at regular intervals to confirm the printout.
The telephone transmission is not to be used as a substitute for individual examination in any situation.
In addition, under paragraph 5 of your letter of the above date, you request clarification as to how information will be obtained from the patient concerning information required in Exhibit III of the pro-tocol specifically Follow-up Data Form will be obtained.
It will be our practice at each of the regular and/or special examinations of the patient in the Coratomic C-100 Series Isotopic Pulse Generator Protocol, all of the information requested in Exhibit III Follow-up Data Form will be completed and made part of the patient's permanent record.
The specific questions that you raised with respect to the patient's use of his I.D.
Card and the wearing of his identification bracelet will of course be answered in the follow-up examinations on the regularly scheduled basis in complete compliance with Exhibit III of the Protocol.
In accordance with your telephone conversation with Dr. Driscoll today, I would expect that this clears up the difficulties, ambiguities, and confusions which may have arisen out of our original application dated August 7, 1975 and the second one, dated September 18, 1975 which is my understanding was received following the transmittal of your letter of September 29, 1975.
Therefore, please make the following corrections or changes to the letter of September 18, 1975; specifically on page 2, under Physician Responsible for the Study - Robert W. Driscoll, D.O.,
the last section entitled Total Number of Pacemakers at this Institution, change this to 22 in the last three years; in paragraph b.,
Albert J.
- Fornace, D.0.,
the bottom line, change total number done at this facility to 10.
There are no further changes applicable to the letter of September 18, 1975, other than those corrections which are supplied in this com-munication.
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hh Br'wn October 24, 1975 Mr.
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4 If any further questions or clarification is needed on this application, please feel free to contact me by telephone or letter at any time.
We are anxious to see that the hospital is licensed for the implantation and participation in the C-100 Series Isotopic Powered Pacemaker Protocol, but will not do so until the application is completed to your unqualified satisfaction.
Sincerely yours, Richard B. Anderson Administrator RBA/pce
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