ML20198M184
| ML20198M184 | |
| Person / Time | |
|---|---|
| Issue date: | 01/15/1998 |
| From: | Compton E NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Kenneth Lambert AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9801200013 | |
| Download: ML20198M184 (2) | |
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NUCLEAi% REGULAYORY COMMISSION.
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WASHINGTON, o.C. 20666 0001"
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o, Msnt Lambert, CHP A
- Allegheny University Hospitals.
Hahnemann Division Radiation Physics and Safety Office Mall Stop 106 L Broad & Vine Streets Philadehhla, PA 191021192 LI
Dear Mr. Lambert:
)This letter is in response to your application dated May 28,1997 requesting registration of the Mode! 3r0.K04 cpMhalmic brachytherapy source. We are in the process of evaluating your
= request. However, in order to conti.iue our evaluation, the following information is necessary:
1.
There is a discrepancy conceming the written description of the source. Specifically.
the primar'l capsule is indicated to be made of silver, but a later statement indicates that -
all metallic parts are stainless steel 321. ' Please confirm the materials of construction e
for the three metallic parts of the source: body, plug, and window. Furthermore, construction of the primary capsule via soldering is m6ntioned in the written description, but the attached drawing of the source in your application indicates Isser welding techniques. Describe the means of construction of the source.
2.
The materials of construction of the applicator are not indicated in the written description nor on the attached drawing of the applicator in your application. Therefore, indicate the materials of construction of the applicator and the methods of attachment such that the source will not dislocate or fall out during use or in storage. Furthermore, what are storage conditions vihen the source is not in use specifically address the storage container (including materials and construction) and labeling?
3.
It was not indicated in yorr application as to what the expected useful life of this source would bs.. Provide the e.vpected useful life of the source fcc the uses proposed.in your application.
4.
The proposed labeling of the source is acceptable, however when attached to the applicator the information engraved on the back of the sourco will be concealed.
Therefore, please describe what labeling methods or procedures will be taken to alert hosoital personnel that the instrument contains radioactive material, q p
"; 5J The _ description of the survey instrument used to obtain radiation profi!ss was not
- included. Please identify the survey instrument used (type, window, sensitivity, etc.),
as well as the date of calibration in addition, please confirm that the radiation profiles specified in your application are for a 40 mci Sr 90 source.
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6.
Lastly, it is unclest as to vitio is responsible for the qutility control and assurance procedures in ynur application. BEBIG's quality control program has been previously.
deemed acceptable by the state of Illinois. However, specifically what procedures will Alleghe.y University Hespitals' utilite to ensure that the sources are manufactured in accordance with the representations made in your application?
Please provide the requestod information within 30 days of the dcte of this letter, if you have any questions, please contact me at (301) 415-5799 or Steve Baggett at (301) 415-7273.
4 Sincerely,
/s Eric B. Compton, Engineering Aide Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Diskibution, pp, IMNS r/f SSD-97-48 NEC1 DOCUMENT NAME: H:\\ERIC\\COMPLTR\\ALLGHOSP.DEF T3 receeve e copy of th6s document. Indicate in the boa: 'C' = Copy wtthout attachrteent/ enclosure "E" = Copy with attachment / enclosure "N' = No copy OFFICE IMAB-c IMAB
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NAME ECompton /c Slee uy Si3aggett -
DATE 01//S/98 01/ if /98 01/ f5 /98 OFFi'CIAL RECORC COPY 20n001
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