ML20248C012
| ML20248C012 | |
| Person / Time | |
|---|---|
| Site: | 07002974 |
| Issue date: | 02/17/1977 |
| From: | Ferguson J NORTH KANSAS CITY MEMORIAL HOSP., NORTH KANSAS CITY |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20248B868 | List: |
| References | |
| 6098, NUDOCS 8904110104 | |
| Download: ML20248C012 (8) | |
Text
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' North Kansas City Memorial' Hospital 1
- The Medic' l and Dental Staff a
s Chief, Radioisotopes Licensing Branch U.S. Nuclear Regulatory Commission Washington, D.C.
20555 Re:
Application for a license to participate in the investigational implantation of Cordis Nuclear Omni-Stanicor #184 nuclear powered pacemakers Gentlemen:
The following information is submitted in application for a license to participate in the investigational program utiliz-ing Cordis Nuclear Omni-Stanicor nuclear powered pacemakers.
.1.
Applicant:
North Kansas City Hospital 2800 Hospital Drive North Kansas City. MO 64116 2.
Physicians responsible for study:
A.
Name:
Robert D. Williams, M.D.
Office Address:
6700 Troost, Suite 348 Kansas City, MO 64131 Office Telephone No.:
(816) 333-9332 State in which licensed Missouri and Kansas to practice:
Speciality board American Board of Surgery, nN A certification:
1965 American Board of Thoracic Surgery, 1965
$k Position with applicant:
Active Staff in Thoracic
$33 Surgery
_16 Em*f Experience in the clin-Resident in general and ical implantation and thoracic surgery at the mam follow-up of pacemakers:
University of Mississippi (1960-1965) r RECEfVED BY LFMS Has implanted approximately T;mc...., M-t7-7 F Date.,A 250 pacemakers since 1965 with the greatest majority p;,h?gg By,,,,g p implanted at North Kansas
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City Memorial Hospital.
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"""" Hospital Drive, North Kansas City, Missouri 64116 (816) 221 1600
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North Kansas City Memorial Hospital The Medkal and Dental Staff.
B.
Comer Bates, M.D.
2700 Hospital Drive North Kansas City, MO 64116 (816) 421-4240 Licensed to practice in Missouri Board certification with American College of Physicians (1945)
Position with applicant:
Active Staff Internal Medicine Experience in the clinical implantation and follow-up cf pacemakers:
Resident in Internal Medicine at the Cleveland Clinic, Cleveland, Ohio 1949 C.
Larry E. Benson, M.D.
2700 Hospital Drive North Kansas City, MO 64116 (816) 421-4240 Licensed to practice in Missouri and Kansas Board certification with American Board of Internal Medicine (1966);.American College of Physicians (1975)
Position with applicant:
Active' Staff in Internal Medicine Experience in the clinical implantation and follow-up of pacemakers:
Resident in Internal Medicine at University of Kansas (1965)
D.
Bryan T. Bownik, M.D.
2700 Hospital Drive North Kansas City, MO 64116 (816) 421-4240 Licensed to practice in Missouri
-Board certification with American College of Physicians, 1973 American Board of Internal Medicine, 1976 Position with applicant:
Active Staff in Internal Medicine Experience in the clinical implantation and follow-up of pacemakers:
Resident in Internal Medicine at the University of Columbia, New York, N.Y.
(1976) 2800 Hospital Drive, North Kansas City, Missouri 64116 (816) 221 1600
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North Kansas City Memorial Hospital The Medical and Dental Staff E.
Newton C. McCluggage, M.D.
2700 Hospital Drive North' Kansas City, MO 64116 (816) 421-4240 I
Licensed to practice in Missouri and Kansas Board certification with American Medical Association (1965)
Position with applicant:
Active Staff in Internal Medicine Experience in the clinical implantation and follow-up of pacemakers:. Resident in Internal Medicine at Kansas City General Hospital, 1969 Doctors Bates, Benson, Bownik and McCluggage comprise the largest group in Internal Medicine at North Kansas City Memorial Hospital.
Because of that, they have referred
'the greatest majority of both temporary and permanent pacemakers implants.
The group is currently following 30 pacemaker patients (approximately).
F.
Robert H.
Hodge, M.D.
2029 Burlington Street North Kansas City, MO 64116 (816) 474-9232 Licensed to practice in Missouri and Colorado Board certification with Diplomat American Board of Internal Medicine (1956)
Position with applicant:
Active Staff in Internal Medicine.
Experience in the clinical implantation and follow-up of pacemakers:
Resident in Internal Medicine at Kansas City General-Hospital, Kansas City, Missouri, 1956.
G.
William R.
Prather, M.D.
2029 Burlington Street North Kansas City, MO 64116 1
(816) 474-9232 Licensed to practice in Missouri and Colorado 2000 Hospital Drive, North kansas City, Missouri 64116 (814 2211600 i
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North Kansas City Memorial Hospital The Medical and Denul Staff l
l Board certification:
Associate American-Board of l
Internal Medicine (1976 )..
Pending full, fellowship-J American Board'of Internal' Medicine (July, 1977).
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Position with applicant:
Active Staff in Internal Medicine.
Experience in the clinical implantation and follow-up of pacemakers:
Resident in Internal Medicine at the University of' Colorado, Boulder, Colorado.(1976).
Doctors Hodge and Prather formed their partnership in August of 1976.
Prior to that time, only Doctor Hodge referred patients for temporary or permanent pacemakers.
Approximately fifty (50) patients have been referred for permanent implant with twenty (20) patients are currently
-being followed.
- 3. Protocol to be followed:
Master Protocol for Clinical Evalua-tion of the Programmable Cordis Nuclear Omni-Stanicor Pacemaker dated October 30, 1974.
4'. Number-of Cordis Nuclear Omni-Stanicor #184 pacemakers to be implanted annually during the study:
Six (6).
.5.
Description of physical facilities and equipment at the applicant hospital or medical institution for implantation and follow-up of pacemakers:
A.
Pacemakers with transvenous leads are implanted in the Radiology Department and pacemakers with myocardial leads are implanted in the Surgical Suite.
The Radiology Depart-ment has a General Electric fl6droscope with image intensifier which is used routinely in all Yadiology procedures.
The Radiology Department and all operating rooms used for surgery have electrocardiographs with oscilloscope and written copy readouts, model 156B external pacemaker for capture and sensing threshold measurements, model 5980 external pacemakers for temporary pacing, and American Optical portable defibrillators.
B.
The Cardiac Care Unit into which the patients are moved immediately after implantation of their pacemaker contains ten (10) beds, each with American Optical hardwire monitors and is equipped with three (3) portable defibrillators and four (4) external pacemakers, i
6.
Description of applicant's present pacemaker implantation and follow-up program: 2000 Hospital Drive, North Kansas City, Missouri 64116 (816) 221-1600
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North Kansas City Memorial Hospital The Medkal and Dental Staff Approximately 150 pacemakers have been~ implanted at ' North Kansas City Memorial Hospital since'1965 and 50 patients are being followed at the present time.
For nuclear pacemakers, capture and sensing thresholds are measured from the implanted electrodes prior to attachment to the' pacemaker and the. programmable Nuclear Omni-Stanicor Pacemaker is set accordingly.
At a minimum, EKG's are taken at implantation, 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> post implanta-tion and one week post _ implantation.
The Registration and Implant Data Form (Form 1, page B-2 of Protocol) will be completed and returned to Cordis Corporation within 10 days after implanta-tion.
- 7. Methods applicant will establish to maintain records of im-plantation and follow-up of patients separate from routine hospital records:
All nuclear pacemakers will be followed by both the implanting surgeon and the referring Internal Medicine specialist.
At monthly intervals during the first six months and at three month intervals between semi-annual follow-up examinations, the performance of each pacemaker will be deter-mined either by telephone monitoring or by a visit to the physician's. office.
Each follow-up examination or pacemaker performance determination will obtain the data on Form 2, page B-5'of the' protocol, and a copy of the form will be returned to Cordis Corporation.
- 8. All nuclear pacemakers received by North Kansas City Memorial Hospital will be delivered immediately upon receipt to Mrs.
Mildred Thiel, Operating Room Supervisor, who will maintain records, by serial number, of the receipt and use of each pacemaker and will securely store all such pacemakers under lock and key until they are delivered to Radiology or the Operating Room immediately before implantation.
All activities involved in the receipt and use of nuclear pacemakers will be conducted in accordance with the regulations under Title 10, Code of Federal Regulations, Part 70.
- 9. The telephone operators of North Kansas City Memorial Hospital will be given instructions, copy attached, about receiving re-
-ports or inquiries about ' nuclear pacemakers, the information to obtain and the immediate reporting of such information to the appropriate physician (s).
- 10. The physicians responsible for the study confirm that they are familiar with the Cordis protocol referenced in Section 3 above and with the Cordis Nuclear Omni-Stanicor #184 pacemaker and they understand that the issuance of a license is conditioned upon the following of this protocol.
- 11. North Kansas City Memorial Hospital and the undersigned physi-cians agree to continue the follow-up, reporting and recovery - 2800 Hospital Drive, No,th Kansas City, Missouri 641 % (316) 221 1600
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North Kansas City Memorial Hospital The Medical and Dental 5taff procedures as long as the nuclear pacemaker is in a patient and until the pacemaker is recovered and returned to Cordis Corporation.
In the eveat that one or more of the physicians named in this application are no longer associated with North.
I Kansas City Memorial Hospital, the hospital will designate
, other. qualified physicians to carry out these responsibilities i under the license.
- 12. North Kansas City Memorial Hospital will follow instructions furnished by Cordis Corporation for packaging, labeling and shipping nuclear pacemakers for return and disposal.
- 13. North Kansas City Memorial Hospital hereby requests a license to receive, possess, store and implant the Cordis Omni-Stanicor
- 184 nuclear powered pacemaker in accordance with this applica-tion.
North Kansas City Memorial Hospital B
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Williams, MlD.
Comer Bates, M.D.
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Larry E.
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William R.
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~ 2800 Hospital Drive, North Kansas City, Missouri 64116 (816) 221 1600
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o North Kaiisas City Memorial Hospital The Medical and Dental Staff INSTRUCTIONS FOR TELEPHONE OPERATORS CONCERNING' NUCLEAR PACEMAKERS 1.
Accept any collect call with reference to "A Nuclear (or Radioactive) Pacemaker."
2.
Any call concerning a radioactive pacemaker requires-immediate
-action in order to avoid danger of radiation exposure and to ensure recovery of the radioactive pacemaker.
3.
Obtain as much information from the. caller as is possible including:
Caller's name Where he may be reached (caller's address)
Telephone No.
Patient's name Where he may be reached (patient's address)
Telephone No.
(Information from patient I.D. card)
Physician's name Patient's address Patient's telephone no.
Social Security no.
Pacemaker Type:
Cordis Nuclear Omni-Serial no.
i Date of implantation 4.
Notify immediately:
(1) Dr. Robert D. Williams at (816) 333-9332 If he cannot be reached:
(2) Notify immediately one of the following physicians:
Dr. Larry E. Benson at (816) 421-4240 Dr. Comer Bates at (816) 421-4240 2800 Hospita' Drive, North Kansas City, Missouri 64116 (816) 221 1600
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North Kahsas City Memorial Hospital The Medical and Dental Staff Dr. Bryan T. Bownik at.(816) 421-4240 Dr. Newton C. McCluggage at (816) 421-4240 Dr. Robert H.
Hodge at (816) 474-9232 Dr. William R. Prather at - (816) 474-9232 l
(T[le patient's attending physician and/or phys'ician-on-call should take priority)
If 1 or 2'above cannot be reached:
Contact a physician on duty in the Coronary Care Unit or the Nursing Senior Team Leader in the Coronary Care Unit.
Inform the individual con-tacted that the call involves a nuclear pacemaker and advise of the information received above and of the urgency of'the matter.
If one of the physicians listed in 1 or 2 above was not contacted, one of them should be contacted.as soon as x-possible and report the information. 2800 Hospital Drive, North Kansas City, Missourl 64116 (816) 2211600
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