ML20148B501
| ML20148B501 | |
| Person / Time | |
|---|---|
| Site: | 07002683 |
| Issue date: | 07/13/1977 |
| From: | Marik J DOYLESTOWN HOSP., DOYLESTOWN, PA |
| To: | Singer B NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20148B147 | List: |
| References | |
| 07333, 7333, NUDOCS 8801250023 | |
| Download: ML20148B501 (6) | |
Text
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DOYLESTOWN HOSPITAL 595 WEST STATE STREET h
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'OOYLESTOWN, PENNSYLVANI A 18901 d
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U.S. Nuclear Regulatory Commission
\\ Y' Washington, D.C. 20555 ATTENTION: Mr. Bernard Singer RE: Application for license to implant Medtronic* Model 9000 Isotopic Pulse Generator Gentlemen:
The following information is submitted in application for a license to implant the Medtronic Model 9000, l.
Applicant: Doylestown Hospital
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Physician responsible for study-9 D%c..f.7/ C Name: Joseph F. X. McGarvey, M.D.
- 1... e D-Office Address: 14 B Memorial Drive P/.
I' M Doylestown, PA 18901 FrM:
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Telephone Number: (215) 345-6050 cy a State Licensed to Practice In: Pennsylvania Aci w NU bI-I Medical School Affiliation: None Specialty and Board Certification: Cardiology Position with Hospital: Active Staff l
l Doctor McGarvey has more than ten years exoerience with pacemaker patients, and he follows about 120 pacemaker patients.
3.
Other physicians and surgeons participating:
Name: Williara E. Monteith, Jr., M.D.
Office Address: Landmark Building Doylestown, PA 18901 Telephone Number: (215) 348-4572 State Licensed to Practice in: Pennsylvania and Massachusetts Medical School Affiliation: None Specialty and Board Certification: Thoracic and Cardiovascular Surgery Position with Hospital: Active Staff Doctor Monteith is the primary implanting surgeon for pacemaker pro-cedures at Doylestown Hospital. He implants about 30 pacemakers per year and has nine years experience in pacing.
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i e v0MMuNITY HOSPITAL OWNED AND OPER ATEo DY THE vlLLAGE IMPROVEMENT ASSOCIATION OF ooYLESToWN
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Protocol to be followed: Medtronic* Model 9000 Isotopic Pulse Gen-
'erator protocol dated March I,1973, revised October I,1975.
5.
Number of Medtronic Model 9000 units requested to be implanted annually during study: Five 6.
Description of physical facilities and equ!pment:
Doylestown Hospital is a 161-bed facility with a 10-bed CCU. We have a Medtronic Model 5300 Pacing Systems Analyzer to take the threshold measurements required by the study. The hospital has a nuclear medi-cine license.
7.
Description of applicant's present pacemaker implantation and follow-up program:
About 30 pacemakers per year are implanted at Doylestown. Pace-makers have been implanted at the hospital for more than nine years.
Patients are followed in visits to Doctor McGarvey's office.
8.
Description of methods used to maintain separate records:
The records of the nuclear pacemaker patients will be kept separate from the records of the rest of the hospital and the rest of the pace-maker patients. They will be kept in specific folders with dates of return visits so that we con recognize when the patient has another follow-up oppointment, and we will be able to tell if he does not show up for the appointment. We are also reminded of the patient's follow-1 up schedule by Medtronic's follow-up data forms which are sent on a j
regular basis. The folders and the separate files will also contain infor-motion on the patient's location and phone number where the patient con be reached if he does not show up for a follow-up exam.
1 9.
Written Instruction for Telephone Operators:
See attachment.
We represent that we are familiar with the Medtronic Protocol and Technical Manual for the Medtronic Model 9000 and understand that the issuance of a license is conditioned upon use of this protvcol and the use of instructions in the technical manual on "transporting, handling and sterilization of the pulse generator." We agree to have the patient visit our office for the required follow-up examinations.
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We will establish appropriate control procedures to ensure that the pulse generators are not lost or stoien. These procedures will include keeping track by serial number of the locations of each pulse generator and requiring that 07333 J
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they be kept under lock when not being used. We represent that we have adeqbate fire protection in case of emergency, ar.d we will conduct all activi-
- ties in accordonce with the NRC's regulations published in 10 CFR 70.
We agree to continue the follow-up reporting and recovery procedures required under Medtronic's protocol in the event the physician responsible for the study or any other physician or surgeon participating in the study is no longer assoc:ated with this hospital.
Doylestown Hospital hereby requests o license to receive, possess, store and implant Medtronic* Model 9000 Isotopic Pulse Generators in accordance with this application.
Signed:
Application:
By:
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A J. tocrik, Administrator Physicians Responsible for Study:
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JosepyF. X. McGarvey, M~.D.
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OLbbb ?/,lll0 William E. Monteith Jr., M.D.
a pab Attachment 1
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4 INSTR,U, OTIONS, TO TELEPHONE OPERATOR CONCERNING NUCLEAR PACEMAKERS I.
Accept any collect call with reference to nuclear pacemakers.
2.
Any call involving a patient with a nuclear pacemaker requires immediate action to ensure that there is no danger of radiation exposure and recovery of the nuclear pacemaker.
3.
Obtain as much information from the caller as is possible including:
Caller's name and where he may be reached.
Patient's name, status, and where he may be reached.
Attending Physician (if any) and where he may be reached.
(Information from Patient I.D. Card)
Patient's Social Security Number Date of Implant Pacemaker Serial Number 4.
Notify immediately:
Name:
Joseph F. X. McGarvey, M.D.
Address:
14B Memorial Drive Doylestown, PA 18901 Phone No:
(215) 345-6050 if he cannot be reached, notify:
Name:
William E. Monteith, Jr., M.D.
j Address:
Landmark Building
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Doylestown, PA 18901 Phone No.
(215) 348-4572 If neither can be reached, contact physician on duty for the Cardiac Care Unit; inform him that this involves a nuclear pacemaker; and advise him of the information you have and the urgency of the matter.
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L L 2- / (, o BETWEEN: William O. Miller, Chief g7 License Fee Management Branch Office of Administration
...John E. Glenn, Chief Nuclear Materials Section B Division of Engineering and Technical Programs LICENSE FEE TRANSMITTAL A.
REGION l
1.
APPLICATION ATTACHED i
Applicant / Licensee:
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- /- 8 Application Dated:
Control No.:
License No.:
SNM - / 765' 2.
FEE ATTACHED
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Amount:
Check No. :
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COMMENTS Signed
)J Ab Date
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LICENSE FEE MANAGEMENT BRANCH 1.
Fee Category and Amount:
6P 76
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Correct Fee Paid.
Application may be proces*.. <cr.
Amendment Renewal License Signed
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Date t
REGION I FORM 213 (MARCH 1983)