ML20245H109
| ML20245H109 | |
| Person / Time | |
|---|---|
| Site: | 07002134 |
| Issue date: | 07/20/1981 |
| From: | Shawn Williams GRANDVIEW HOSP. & MEDICAL CENTER, DAYTON, OH |
| To: | Vacca P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20244B344 | List: |
| References | |
| 19442, NUDOCS 8902150468 | |
| Download: ML20245H109 (4) | |
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-GRANDVIEW HOSPITAL 405 GRAND AVENUE
- DAYTON,01110 45405.
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July 20,.1 1
Patricia C. Vacca M:terial Licensing Branch Division of Fuel Cycle and Material Safety Nuclear Regulatory Commission
' Washington,'D.C.
20555 Re: License Number SNM-1603
Dear Mrs. Vacca:
This letter is to inform you of continued loss of contact with nuclear pacer patient R..Myers, originally of Point Pleasant, West Virginia, in our' efforts to. locate Mr. Myers, I have spoken with his mother, Mrs. Clarence Myers, in February, May and July. The family has moved' from Point Pleasant, and now resides in Ruskin, Florida. They have seen Ronald very rarely, whenever he stops in to visit them. The last information' the mother has is. that he may be in jail in Tampa, Florida.
This patient, according to the mother, has not held a regular job since a
he' received the pacer, nor has a known address.
She also believes, as
'l stated to me, that Ronald has " mental" problems. Because of this l
unstable situation, Grandview Hospital will continue to communicate with l
the mother at six month intervals with the hope that eventually the patient will co-operate with his follow-up medical care.
To prevent recurrences of this situation, a special meeting of the Medical isotopes Connittee was held February 4,1981. Authorized users
' involved with implantation of nuclear pacemakers were present. NRC requirements and the Cordis MASTER PROTOCOL were reviewed by the Radiation Safety.0fficer. A Nuclear Pacer Review Committee was eppointed which includes the Radiation Safety Of ficer, Vice-President,
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Medical Affairs and the Chief of Medicine or their designees. Any cardiologist wishing to implant a nuclear pacer must submit a completed
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application (copy enclosed) to the Pacer Review Committee for prior l
j approval of the implant, KEDSPT l
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SNM-1603 PNU oL
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P:tricia C. Vacca Page 2 To ensure follow up of all pacer patients, the Radiation Safety Of ficer routinely verifies the follow up exam dates of all current pacer patients through communication with physician office personnel.
Implementation of thece policies and procedures will assure compliance with the requirements of the Special Materials License.
If you have further suggestions regarding this license, we will be happy to consider them.
Sincerely, et
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Shirley Toebes Williams, M.S.
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Q dix B Conditions for' Patient Consent k
1.
At all times.to wear the identification bracelet or necklace, to carry the identification card supplied to me at the time of the -
pacer implantation identifying me as the bearer of a nucicar-powered pacer, and to carry the donor card authorizing the removal of the pacer.
2.
To notify the hospital or its designated representative in writing of any change in address, phone number, or plans for any trip 1 might take which would involve my Deing away from my permanent address for more than one month.
3.
To notify the hoapital prior to any travel outside the United States. Since the use of nuclear powered pacers is closely controlled by the Nuclear Regulatory Commission of the United States and its foreign affiliates, it will be necessary for the hospital to inform Cordis Corporation of any patient traveling outside the United States.
Cordis will in turn inform the licensing agency.
4.
To present myself at the hospital or its designated representative for the purpose of undergoing medical examination and tests according to the schedule given to me at the time of implantation and subsequent instruction.
5.
To allow the hospital or its designated representative to remove the nuclear powered pacer and to perform examinations as its authorities or representatives consider necessary upon my death.
6.
To allow the hospital or its designated representative to recover
, and to retain possession of, or dispose of, the nuclear powered j
i pacer upon its removal for any reason or in the event of my death.
7.
The nature and purpose of cardiac pacer therapy, the risks involved, the possible consequences, and the possible
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complications have been fully explained to me by my physician.
I acknowledge that a replacement pacer may be required at any time and that no guarantee or assurance has been given to anyone as to the service life to be expected from the pacer before a replacement is required.
I acknowledge the possibility that the pacing lead may have to be repositioned or replaced at any time.
I consent to the furnishing of information about this l
implantation to ttie pacer manufacturer.
8.
I fully understand that pacers employing chemical batteries as of power sources are the usual therapeutic method for treatment j-my medical condition and that such a device would be utilized in l
lieu of the nuclear pacer had this been my wish.
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IV.
Does patient possess sufficient temperamental stability such that it IbdC3 j
is likely that he will comply with the long-term follow-up requirements?
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T]yf Appendix B
- 1 [
. Cardiologist. Application > Form for implantation :of Nuclear Pacer s~
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-Pdtient Name:
SS Number a
lY" i h
. Address:l
,Ph'one Number:-(Home)~
(Work) i t :.
How. long,at this address?
Employment:
Huw. long at; this position?
Nrmes and addresses of'two persons who will always know-location of pItient.
Name:
.. Address:
,. y
' Phone Number:
1.
History of mental health / social problems?
If-yes, please describe ~on attached page.
11.
Any co-existant disease which will probably limit life expectancy of patient to less than ten years?
If yes, describe on attached page.
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- 111... Does patient thoroughly understand and agree to all conditions of 7i E ^
lthe consent form which is as follows?
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