ML20237G051
| ML20237G051 | |
| Person / Time | |
|---|---|
| Site: | 07001331 |
| Issue date: | 05/10/1972 |
| From: | Gage A VETERANS ADMIN. MEDICAL CENTER, BUFFALO, NY |
| To: | Malaro J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20236P571 | List: |
| References | |
| 1263, 2982, NUDOCS 8708130292 | |
| Download: ML20237G051 (4) | |
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VETERANS ADMINISTRATION HoSPITA1.
YW 3495 GMLEY AVENUE BUFFALO. NEW YORK 14215 May 10,1972 Regulatory g
YOUR FILE REFERENCES IN REPLY REFER TOs M Mr. James C. Malaro O'
4 Assistant Chief, Materials Branch
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United States Atomic Energy Commission
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Dear Mr. Malaro:
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This is in response to your telephone conversation of May 2,1972 with Dr. W. M. Chardack and your request dated May 4,1972 for additional information to Veterans Administration Hospital Application 23758. I will answ er your questions in the order in which you raised them.
- 1. The form to be used to obtain the patient's consent is Standard Form 522 used by United States Government facilities. Copica of this con-sent form are enclosed. Paragraph (2) of the form uses broad language and implies informed consent. We also propose to use additionallanguage on the back of this form which will indicate that the patient has been informed that the use of the isotopic pulse generator is still under clinical investiga-tion. He will be apprised of the prevailing status of that unit, that is of the approximate number of patients who have received this device and of the
- general nature of the results. He will be informed of the alternate forms of therapy, specifically of the availability and performance of conventionally powered pacemakers and these explanations will be given to him by the principal investigator, Dr. Andrew A. Gage, or his designate, in the presence of a second physician, who will be from a department other than the Surgical Department which will perform the operation. We believe that the Chief of the Cardiology Service or his designate would be an appropriate second physician for this purpose. Both physicians will witness page I cf the consent form and the addendum on the reverse side.
2.
We will obtain permission by the patient for removal of the iso-topic pulse generator in case of death. This permission will be obtained by means of the Uniform Donor Card which is a legal document under the Uniform Anatomical Gift Act or similar laws. We have consulted Dr.
George E. Schreiner, Professor of Medicine at Georgetown University School of Medicine, who has been instrumental in initiating passage of 8708130292 070730
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- REG 1 LIC70 SNM-1305 PDR Include Zip Code in your return address and give veteran's social security number.
Show veteran s fall name and VA fle number on all comspondence. If VA number is unknown, show service number.
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Page 2.
Mr. James C. Malaro May 10,1972 this act. A comprehensive review of the provisions of this act can be found in a publication of his which appeared in The Journal of the Ame rican Pharmaceutical Association. A reprint of this article is enclosed as well as a sample card which is used by the National Kidney Foundation. The card used by us will be the same except that the institution listed will be the Veterans Administration Hospital, Buffalo, New York. Dr. Schreiner has informed us that the Uniform Anatomical Gift Act has now been passed by all 50 4ates. The patient will be informed that his permission may be broad as indicated in lines (A) and (B) on the card or that he may limit it to removal of the pacemaker system and surrounding tissues. This card will be enclosed in a plastic jacket which also will contain the patient's identifica-tion card (see paragraph 3) which he will carry on his person.
3.
The manufacturer has agreed to furnish an identification card which will be of the general type used for credit cards made of a thin metal plate surfaced by a plastic material. The card will show the patient's name, his address and his social security number which is now being used on all Veterans Administration records. It would also state that "the patient has an implanted isotopic cardiac pacemaker, Laurens-Alcatel Model 9000, Number It contains 2.5 curies of PU-238. In case of emergency, accident or hospitalization, call Dr. Andrew A. Gage, Veterans Administra-tion Hospital, Buffalo, New York, telephone number 716-834-9200 and notify the operator that the call concerns Project-238. " This card and the Uniform Donor Card will be placed in a plastic jacket. The telephone operator at this hospital will forward this call to Dr. Gage, or his designate in case of his absence, and 24-hour coverage will be provided for. The operator will have standing instructions to notify other interested parties, such as the manu-facturer and a designated per son in your office. We are also enclosing a photograph of the identification card used by the French investigators. The legend we are proposing for the identification card could, of course, be modified in accordance with any recommendations you may wish to make.
Enclosed is a photograph of the identification bracelet (and a sample of the bracelet itself) which the manufacturer has furnished for the French patients.
A similar metallic bracelet will be made available to our patients. It will be engraved by the manufacturer and bear the patient's name, serial number of the implanted pulse generator and the legend: "In case of emergency, j
accident or hospitalization, call Veterans Administration Hospital, Luffalo, New York, 716-834-9200. Give operator' Project Number 238. " Again, this sugget ted language could be amended to conform with your recommenda-tion s.
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Page 3.
Mr. James C. Malaro May 10,1972
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- 4. The records kept on each patient will be of tw o types:
(1) The patient's hospital record will consist of the standard forms pre-scribed by the United States Government for use in Veterans Administration hospitals. A sample set of these records is enclosed and each sheet is identified by an abbreviated addressograph identification plate. The admin-istrative parts of the record are identified by a more complete set of identification data issued for each patient at the time of admission to the hospital. The jacket in which the patient's clinical record will be kept will be labelled: " Patient has isotopic pulse generator Number
, and the Registrar of the hospital has agreed to maintain these records in a separate file. There are no restrictions on the use of these records within the various
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branches of the United. States Government and a xerox copy of the record 3
would be available to your office. C opies of the clinical summary and other parts of the record are routinely furnished to outside physicians and other interested parties provided consent of the patient has been obtained.
(2) A second set of records on each patient will be maintained by the principal investigator or his designates and this record will conform to the comprehensive protocol established by the French investigators. This protocol includes data on the patient's medical history, the operation, data on the pulse generator generator and a number of recommended examinations to be performed at the follow-up clinic visit at three-month intervals. This protocol is com-prehensive and tw o copies (one completed and one uncompleted) are enclosed.
The form for these data has been prepared by the manufacturer in cooperation with the French investigators and will be furnished to us. Copies of the com-pleted forms will be available to your office and (after deletion of patient identification) to Dr. Paul Laurens, Hopital Broussais, Paris, France, other interested and qualified investigators and the manufacturer.
- 5. The condition of the pacemaker implant will be appraised by the electrocardiogram indicating presence of the pacemaker stimulus and capture of the heart. Since the pulse generator is of the " demand type,"
a complete electrocardiogram will be procured, follow ed if necessary by another electrocardiogram, taken with the external magnet in place to revert the pulse generator to the fixed rate mode. The parameters of the pulse generator's function will be checked by oscillographic measurement of the pulse generator's output pulse as detected on the body surface. Pulse width, amplitude, pulse interval and other appropriate parameters will be determined in accordanc e with the foll'ovC-up protocol. Determinations on the eventual removal and replacement of the pulse generator (in the course of normal events) will be based on the findings at these follow-up visits, findings which will be evaluated in consultation with the manufacturer and other investigators.
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Page 4.
Mr. James C. Malaro May 10,1972 6.
The course of patient treatment following pacemaker degradation or failure will be determined on the basis of the specific diagnostic findings in each patient. All available diagnostic procedures will be performed to differentiate betw een failure modes involving the pow er source of the pulse generator and those attributable to a malfunction of the electronic circuitry or the electrodes. If it can be established either before or at the time of operative intervention that the power source is not implicated in the failure mode, another isotopic pulse generator may be used as a replacement if otherwise warranted. For instance, this procedure would be follow ed if malfunction of the system is clearly attributable to the electrodes. If, on the other hand, the failure mode involves the pow er source or if such a failure mode cannot be excluded with certainty, a conventionally pow ered pulse generator will be used as a replacement. No further implantation will then be made of the isotopic pulse generator until the nature of the malfunction has been c1carly established and effective remedial steps have been taken. As indicated in our initial application, your office will be notified of such events.
7.
Progress reports on each patient and on the program in general will be submitted to your office at six-month intervals or more often if appropriat e.
8.
Every effort will be made to maintain control of any patient bearing a nuclear powered pacemaker. Our ability to do so w ill be greatly facilitated by the fact that patients will be cared for by Veterans Administration hospitals.
Many, if not most, of these patients are recipients of veterans benefi% and compensation and their whereabouts is usually known. Also, pacemaker patients in general are extremely desirous to be followed closely and our experience over the past ten years has been that virtually a 100% follow-up can be obtained for such patients. At each follow-up visit, a specific inquiry will be made as to any possible travel plans of the patient especially in regard to travel abroad. Every effort will be made to maintain the best possibic follow-up in this program without undue hardship on the patients. The loss of control of any patient bearing a nuclear powered pacemaker will be reported to the Atomic Energy Commission without delay.
Yours truly, C
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Andr ew A. Gag e, M. D.
Chief, Surgical Service Chief of Staff Associate Professor of Surgery State University of NY at Buffalo Encl.
School of Medicine