ML20204B944
| ML20204B944 | |
| Person / Time | |
|---|---|
| Site: | 07002077 |
| Issue date: | 09/29/1975 |
| From: | Jonathan Brown NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Driscoll R SUBURBAN GENERAL HOSP., NORRISTOWN, PA |
| Shared Package | |
| ML20204B848 | List: |
| References | |
| NUDOCS 8607300535 | |
| Download: ML20204B944 (2) | |
Text
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Suburban General Hospital SEP 2 91975 ATTN: Robert W. Driscoll, D.O.
2701 DeKalb Pika Norristown, Pennsylvania 19401 Gentlemen:
This refers to your application dated August 7, 1975, for a special nuclear material license to participate in the investigational program utilising Coratomic C-100 seri.s nuclear powered pacemakers.
During the investigational phase of nuclear pacemaker use licenses are being issued only to medical insitutions that can assure contir.uity of followup of patients with implanted pacemakers, and not to individual physicians. The physicians designated in r.n application as the responsible investigators should have substantial experience with pacemakers in the specialties of thoracic surgery and cardiology, and the applicant medical i insitituion will generally be expected to have an established program j' for the implantation and followup of cardiac pacemakers. With this in mind, you should list and give the training and experience of the cardiologist member of your study team.
With respect to Dr. Robert W. Driscoll, please clarify whether Dr.
Driscoll's residency at Mercy Cathloie Medical Center during the period 1970-1971 was in thoracic surgery or "traumatie surgery" as indiented on i the application. From the application it is unclear whether or not Dr.
Robert W. Driscoll's speciality is thoracie surgery.
j In your application you indicate that the " active medical staff" has a l total of nine years of pacemaker experience. We need to know the l duration of pacemakar experience, total number of implants done, and i number of implants done at your facility for eacit physician named in the I application as a member of your study team.
Under Item 7 of your application, you indicate that telephone transmission and testing of pulse intervals will be used unless individual examinations will be required for followup of pae - hee patients. It is unclear from this statement how all of the information required in Exhibit III,
, Followup Data Form, will be obtained. Particularly, it is unclear how l
information will be obtained from the patient concerning his use of his ID Card and the wearing of his identification braclet. Please clarify.
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8 6 Suburban General Hospital e We will continue our review of your application promptly upon receipt of the information requested above. Please reference Docket No. 70-2077 in your reply.
Sincerely, J. M. Brown, Jr.
Materials Branch Division of Fuel Cycle and Material Safety ec: Richard B. Anderson Administrator Standard Br. Dist.
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