ML20211K731
| ML20211K731 | |
| Person / Time | |
|---|---|
| Site: | 07002213 |
| Issue date: | 03/30/1976 |
| From: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Castle L CLEVELAND CLINIC FOUNDATION, CLEVELAND, OH |
| Shared Package | |
| ML20211K381 | List: |
| References | |
| NUDOCS 8702260658 | |
| Download: ML20211K731 (2) | |
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45..% MAR 3 01976 w ..
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ATTH: Lon W. Castle, M.D.
The Clinic Center a4 Wit - W ,.9500 Euclid Avenue '
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- Clevaland, Ohio 44106 ayN"
Dear Dr.' Castle:
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hy q This refers to your application to participate in the clinical evaluation 7.l'W "- of the Nuclear Dani-Stanicor No.184A nuclear-powered pacemaker. .
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The implantation of nuclear powered pacemaker in patients is being licensed only' on a 11 sited investigational basis and until it can be established that: (1) nuclear pacemakers are safe and reliable, (2) wide-scale use will not subject the public to undue risk, and (3) the benefits to be derived by patients using a nuclear-powered pacemaker will outweigh the .
risks, however small, to the public that might occur through an accident involving a pacemaker bearer or loss of the pacemaker to the environment.
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. , u. During the investigational phase of nuclear pacemakar use, licenses are s@. .being issued only to medical institutions that can assure continuity of follow-up of patients with implanted pacamakars and not to individual physicians. The physician (s) designated in an application as a responsible investigator (s) should have substantial experience with pacemakers in
> 'in- .the specialities of cardiology and thoracic surgery, and the applicant
% 4' medical institution will generally be expected to have an established program for the implantation and follow-up of cardiac pacamakars. A w 4; ,
.a study team approach is emphasized. With reference to the above, your EQ
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' application should be supported with the additional information listed below:
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,;,.R 1. List the cardiologist and surgeon member (s) of your study team and l ,42 supply the following information on each physician: (a) name,
,7 (b) office address, (c) telephone numeer, (d) state in which
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licensed to practice, (e) specialty board certification, (f) position with the applicant, (g) previous experience in the clinical implantation 4
- and follow-up of pac =makars by the physician. .
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- 8702260658 861021
,. . REC 3 LIC70 .
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Form AEC-318 (Rev. 9-531 AECM 0240 A u E ' anv s. .w =, ...=te=e'erenc e se*>-e no . -- -
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"'YC Cleveland Clinic l CFA .
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M . 2. Each physician member of your study team should indicate his familiarity with the Cordis Master Protocol and his comitment to j{0 '
. adhere to it. .
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, 3. Please submit a copy of instructions to telephone operators. This may be similar to Appendix H, page H-2 of the Cordis Master Protocol, but should be modified to include the names and telephone numbers of 2 several physicians on the study team.
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- 4. It is not clear from your letter how the WATTS Line will be used for follow-up of pacemaker problems. Will you use it solely to keep in 9.h,., contact with patients and to answer inquiries? Or will it be used to Tis monitor the performance of the pacemaker? If you plan to use it in ggd .
the latter manner, how will you obtain the necessary information
$7; required on the Cordis follow-up form, specifically, determination
- C that the patient is carrying his' ID card and faithfully wearing the
)(~ approved jewlery?
N~ 5. Your response to this letter should also include a statement of 4; . concurrence by the Clinic Administrator or other individual authorized to make legal commitments for the Clinic. .This statement
, should also include acknowledgement of the institution's long-term
,q comitment and responsibility for follow-up and recovery of nuclear
..s.Km pacemakers.
. ;I M-M' To assist you in preparation of your response, we are enclosing a guide for pacemaker licensing. Pages 5 and 6 are marked indicating areas of our concern.
M subsuem s
Please refer to Docket No. 70-2213 in your reply. We will continue our 3, - review upon receipt of this information. -,
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Sincerely, N$$.
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. Patricia C. Vacca Radioisotopes Licensing Branch Division of Fuel Cycle and
':.t ?. t Material Safety j
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Enclosure:
[.5 Licensing Guide (Marked)
, nf C. cc: Mr. Norm Baker M. . Cordis
'i[ff 210 Northeast 18th Street Nb o. p
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l p Form AEC.M8 (Rev. 9-53) AECM 0240 W v s novan=n. ant enistime orrica. verswoo-ass .