ML20198Q691
| ML20198Q691 | |
| Person / Time | |
|---|---|
| Site: | 07001396 |
| Issue date: | 06/06/1985 |
| From: | Dagenais J HURLEY MEDICAL CENTER, FLINT, MI |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20198Q653 | List: |
| References | |
| 25862, NUDOCS 8606090310 | |
| Download: ML20198Q691 (3) | |
Text
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HURLEY ME[IC4L CEtTER Off HURLEY PLAZA.FLNT.FECKGAN e8502 PHONE (313) 257-9000 l0-/bh
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RECEtVED Bf LFMB Dats. hd.h. Y June 6, 1985
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By U.S. Nuclear Regulatt j Commission O rig. To. -
Materials Licensing Branch Action Compt.6s 4 -
Di.ision of Fuel Cycle and Material Safety Washington, D.C.
20555 Gentlemen:
Please terminate our plutoniiri pacemaker license #SNM-1393. We no longer wish to utilize ther laterials.
All pacemaker patients are currently being followed and all pacemakers will be returned to the manufacturer upon removal from the patient.
If you have any questions concerning this amendment, please contact me.
Thank you.
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Distribution Date Sheet No.
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Nurley Medical Center STANDARD PRACTICE FOLLOW-UP ON NUCLEAR PACEMAKERS An active file will be kept on every patient receiving a nuclear pacemaker in the Cardiovascular Study Unit at Hurley Medical Center.
These individuals will be contacted by office personnel in the C.V.S.U.
(Presently Brenda Brown) once every six months.
The following information is to be obtained when the patient is contacted:
I.
If the patient is living A.
Are you currently being followed by a physician?
Yes Need name, address and phone of physician no Contact Medtronics in writing B.
Has the pacemaker been replaced?
Yes Explant date Was it returned to Medt: onics?
If not returned, contact Medtronics Ask reason for replacement.
C.
Has the patient had any complications since the last follow-up?
II.
If patient has died since last followup A.
Date of death B.
Is cause of death known?
C.
Was it caused by the pacing system?
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Hurley Medical Center STANDARD PRACTICE D.
Was the device returned to Medtronics?
If not, contact Medtronics E.
IIas Hurley received of ficial notification that pacer was returned to Medtronics?
If not: CVSU office will request written verification from the Physicirn's office or clinic following the patient.
III.
Nuclear Regulatory Commission requi,res that they be contacted A.
Within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the death of a pacemaker patient.
B.
Within 10 days after loss of contact with a pacemaker patient.
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May 30, 1985 Mr. Don Srcniawski, Chief U.S. Muclear Regulatory Conunission 799 Roosevelt Road Glen Ellyn, Ill 60137 ATTN:
Material Licensing Section
Dear Sir:
Hurley Medical Center is currently following three patients with. Nuclear Pacemakers.
They are as follows:
Shire] Na tions 518 Elms Street Donald Steniacker 209 Riddle Street Harry Williams Mt. Morr is, MI 48458 Howe 1J, M1 P.O.
Bo): 98 Serial #5R004'>
Grubbs, Ark 74213 9erial i) 4 R0003 0 Implanted 11-2--7 6 Serial #3R00248 lnp] anted 5-13-74 e
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_.ce-y Two patients we were previously following have e>:pli2[T6i$1"
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pacemakers have haen ren oved a i.nce your last check in 1981."
Tney itre:
Ull) lam F'o] ey Ib i 3 Da.ister Serial #Gn00345 Serial G3H00241 Implanted 1-11-]7 Implanted 12-11-73 E>:pired 1--16-8 5 E>:pired 11-84 We are presently attempting to get written verification these two pacemakers have been properly returned to the NRC
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so that we can complete our files on these patients.
We are also requesting at this be c>: tended to every 6 months. time that our followup con tacts Our UnC License is fSNM-1393 Thank you, n,
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Maurene Heckvian, RN, Supervisar Cardiovascular Study Unit One Hurly Pla'za Plint, M.ichigan 48502 (313) 257-9085 11 -
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Cab!c Medtronic Telex: 29-0598 May 20, 1985 itaureen Beckman, R.N.
Cardiovascular Study Unit Hurley Medical Center One Hurley Plaza Flint, MI 48502
Dear Ms. Beckman:
Re: Model : 9000 S/N:
BR00040 d M - u Model :
9000 S/ft:
6R00345 c /# 47 The above referenced pulse generators have been received by Medtronic.
After the devices have been analyzed by our Product Analysis Laboratory, special precautions are taken regarding their storage.
The units are stored in a nuclear pacemaker storage box which is located in a properly secured locked nuclear. storage cabinet.
Annually an inventory of all nuclear material which is stored in the locked cabinet and an audit of the i
nuclear pacemaker logbook is conducted.
s tie welcone the opportunity to address your concerns. Should you need ad-ditional information, please write me or contact Gary Francis, your Med-tronic Representative.
Sincerely, MEDIR0!!!C, INC.
I y WV Kathleen Ryan, R.N., Coordinator Medical Consumer Affairs (612) 574-4651 cc:. Gary Frencis 30-01-25 Daye Horanic 30-01-00 KR:fmg 1
6' NUCLEAR PACEMAKER CONTACT REPORT FOR MAY 1985 l
ACRE, FREDERICK Implant 4/26/76 Removed November, 1981 6630 Sherman St.
Serial #5R00040 Returned to Medtronic Otter Lake, MI Contact ongoing (313) 793-6846 DURKEE, ARCHIE Implant 10/21/74 Expired January,1981 Box 2120 Horton Bay Rd.
Serial #3R0085 Returned to Medtronic Boyne City, MI 49712 Contact ongoing l
(616) 582-7020 JfNKINS, LENA Implant 8/8/73 Removed March, 1974 2950 Mallery Serial #3R00085 Returned to Medtronic Flint, MI Removed 3/5/74 (513) 232-9883 SMITH, CLAYTON Implant 7/10/75 Removed July, 1981 l
2908 Birch Dr.
Serial #4R00093 Returned to Medtronic Farwell, MI 48622 Contact ongoing DEISTER, EMIL Implant 12/11/73 Expired November,1984 2602 E. Dr.
Serial #3R00241 Pacemaker sent to NRC Fort Wayne, IN Contact ongoing Information obtained (219) 484-5605 from Lutheran Hospital Pacemaker Clinic i
FOLEY, WILLIAM Implant 1/11/77 Expired January, 1985 i
16439 Highland Trail Serial #6R00345 Returned to Medtronic Linden, MI 48451 Contact ongoing (313) 629-6489 NATIONS, SHIREL WM.
Implant 1/12/76 5/20/85 OK 518 Elms St.
Serial #5R00042 Followed by Dr. Breece i
Mt. Morris, MI 48458 Contact ongoing l
(313) 686-4074 1
STEINACKER, DONALD Implant 5/13/74 5/13/85 OK 200 Riddle St.
Serial #4R00030 Folluwed by Dr. Breece Howell, MI Contact ongoing (517) 546-2841 WILLIAMS, HARRY Implant '4/30/74 5/2/85 Good Health P.O. Box 98 Serial #3R00248 EKG 6 wks. ago per Dr.
Grubbs, ARK 74213 Contact ongoing Robinet Family Practice (501) 252-3428
-Jonesburrow, Arkansas
- Have received official notification pacemaker was returned to Medtronics l
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Hurley Medical Center O'
STANDARD PRACTICE
Purpose:
Quarterly Check on Sealed Isotope Sources Procedure:
All radioisotope reference sources will be inventoried quarterly, recorded, and dated on inventory sheet provided.
O All technologists, please read and sign below:
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Hurley Medical Center STANDARD PRACTICE i
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Pu rpose :
Linearity Check on Dose Calibrator i
Procedure:
The linearity test.to check the dose calibrator is to be l
Derformed on a auarterly basis.
This test involves the measurement of Tc-99m activity on oiven dates and times-and then recorded.
This test is now scheduled to be
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performed in the months of June. September, December and March.
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Effective Date 6/6/85 Bulletin No.
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Hurkur Medical Center STANDARD PRACTICE Purpose :
Wipe test of sealed radioactive sources Procedure:
The wipe test of sealed radioactive sources to check for background activity is to be done every six (6) months, January; and July by Dr. M. Bank, Radiation Physicist.
Wipe tests are to be performed on the follawing sources:
Radium-226 capsules Cobalt-60 needles Cesium-137 needles and capsules l
Cesium-137 after loading sources Strontium-90 applicators Victoreen Radium Standard Each sealed source is to be wiped with an alcohol moistened cotton swab, dried and counted as follows:
Cobalt-60 sources:
Counted in Picker Well-type 73 scintillation detector and Spectroscaler III-A scaler-pulse
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height analyzer.
Cesium-137 sources:
Counted in Picker Well-type scintillation detector and Spectroscaler III-A scaler-pul se height analyzer.
Strontium-90 and Victoreen Radium Standard:
Counted with a Victoreen Thyac III GM coun ter.
Radium-226 capsules:
Capsules are.to be placed in a sealed, cotton-filled test tube for a minimum of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
The tube is then counted for Radon activity in the Picker Well counter with a window setting of 600-1500 kev.
Readings will be recorded and kept on file in the Radiation Therapy Department.
Barbara Hammonds, Radiation Therapy Supervisor, will be responsible for compliance with the policy.
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STANDARD PRACTICE PURPOSE:
Surveying and Recording of used M0-99/Tc99m Generators to be Returned to Manufacturer.
Procedure:
Used M0-99/Tc99m generators will be stored in the radioactive storage room (cave) for a minimum of six weeks or background level.
The radiation levels at box surface and at 1 meter from the surface will be measured and recorded.
Wipe test of the surf ace will also be performed and recorded.
I All technologists, please read and sign below:
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Hurley Medical Center STANDARD PRACTICE Purpose :
Disposal Procedures Disposal of decayed radiopharmaceuticals and con-taminated mater.ials, such as needles and/or syringes.
Procedure:
Safe handling procedures for decayed radioisotopes and contaminated materials shall.be observed during all disposal activities.
Protective clothing such as lab coats and plastic gloves are to be worn.
All radioactive waste will be held for decay in storage to background levels or below.
All radio-
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active waste will be surveyed as to activity by a survey meter and recorded in log book.
Background
levels are to be measured and recorded also.
O These materials can then be considered as non-radio-active and disposed of by ordinary means if they are-at background level or below.
All. labels indi-cating radioactive material should be removed or def aced before disposal.
All technologists, please read and sign below:
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