ML20126B463
| ML20126B463 | |
| Person / Time | |
|---|---|
| Issue date: | 12/07/1992 |
| From: | Martin T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Calfee R OMNITRON INTERNATIONAL CORP. |
| References | |
| REF-PT21-92 CAL-1-92-18, NUDOCS 9212220097 | |
| Download: ML20126B463 (4) | |
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CAL No.1-92-018 Omnitron International, Inc.
ATTN:
Richard V. Calfee, Ph.D.
President and Director 8990 Kirby Drive, Suite 200 liouston, Texas 77054
Dear Dr. Calfee:
This refers to the conversation between you and Drs. Carl J. Paperiello and Mohamed Shanbaky of the U.S. Nuclear Regulatory Commission (NRC) on December 4,1992, ca the Indiana Regional Cancer Center. This conversation concerned the diagnosis by Omnitron International, Inc., of the apparent failure of an Omnitron Model 2000, Serial Number 0100, liigh Dose Rate (llDR) Afterloader at the Indiana Regional Cancer Center. This device is marketed, distributed and used in locations subject to the NRC's jurisdiction. We also discussed your obligations under 10 CFR Part 21.
Based on the above discussion, it is our understanding that you have taken or will take the following actions, which will be completed by the dates specified:
1.
The IIDR's active wire will be tested to determine the probable cause(s) of the wire failure. Tests are anticipated to be completed by December 23,1992.
2.
Prior to performance of the tests, Omnitron will provide detailed written testing procedures including methods and equipment used for each test that will be performed. This will be submitted by overnight mail or delivery service to:
U.S. Nuclear Regulatory Commission ATTN: Dr. Carl J. Paperiello, NRC-IIT Team Imider 7735 Old Georgetown Road Bethesda, Maryland 20814 (301) 492-4848 Dr. Paperiello may be reached through the NRC Operations Center at (301) 951-0550.
3.
The NRC Staff or any NRC representative will be permitted to observe all tests performed. You will notify the NRC-IIT Team Leader of all intended tests a minimum of three days prior to the performance of these tests. All test data, interpretation, and reports will be submitted immediately upon completion to the NRC-IIT Team leader.
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No tests, maintenance, operations, or any modifications will be performed on the ilDR unit without prior authoritation from the NRC-IIT Team leader.
5.
Omnitron will issue a written notification / bulletin to all of their clients that own or use an Omnitron 2000 llDR unit describing the incident and providing any additional safety precautions including radiation monitoring of all patients after llDR treatment and prior to their release from the treatment area. This will also be submitted to the NRC IIT Team 12ader at the same time such notification / bulletin is issued to the users.
Pursuant to Section 182 of the Atomic Energy Act,42 U.S.C. 2232, and 10 CFR 2.204, you are required to:
1.
Notify the NRC immediately if your understanding differs from that set forth above; 2.
Notify the NRC if for any reason you cannot complete your investigation within the schedule specified in this Confirmatory Action Ixtter, dated December 7,1992, and advise me in writing of your modified schedule in advance of the change; and 3.
Notify the NRC in writing when you have completed the actions addressed in this Confirmatory Action letter.
Issuance of this Confirmatory Action letter does not preclude the issuance of an Order formalizing the above commitments or requiring other actions on the part of Omnitron International, Inc., nor does it preclude the NRC from taking enforcement action for violations of NRC requirements that may have prompted the issuance of this letter.
The responses directed by this letter are not subject to the clearance procedures of the Office of Management and Iludget, as required in the Paperwork Reduction Act of 1980, Pub. L.96-511. In accordance with 10 CFR 2.790(a), a copy of this letter will be placed in the NRC Public Document Room.
Your cooperation with us is appreciated.
Sincerely, original S1Enod By Thomas T. Martin Regional Administrator
3 cc:
CJ. Paperiello, IIT Leader State of louisiana State of Texas State of Ohio Commonwealth of Pennsylvania U.S. Food and Drug Administration Public Document Room (PDR)
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