ML030240101
| ML030240101 | |
| Person / Time | |
|---|---|
| Issue date: | 01/14/2003 |
| From: | NRC/NMSS/IMNS/MSIB |
| To: | Best Medical International |
| References | |
| NR-0187-S-102-S | |
| Download: ML030240101 (7) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-0187-S-102-S DATE:
January 14, 2003 PAGE 1 OF 4 SOURCE TYPE: Brachytherapy Sources MODEL: 81-02 MANUFACTURER/DISTRIBUTOR:
Best Medical International, Inc.
(Formerly Best Industries, Inc.)
7643-B Fullerton Road Springfield, VA 22153 ISOTOPE: MAXIMUM ACTIVITY:
Gold-198 33 millicuries LEAK TEST FREQUENCY:
Not Required PRINCIPAL USE:
(V)
For use in accordance with 10 CFR 35.400 through 35.491 (Subpart F) or the equivalent state regulations CUSTOM SOURCE: YES X NO
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-0187-S-102-S DATE:
January 14, 2003 PAGE 2 OF 4 SOURCE TYPE: Brachytherapy Sources DESCRIPTION:
The Model 81-02 gold seeds are manufactured by Engelhard Industries of Canada (Part No.80-451, Drawing No. 88630041). Each batch of seeds received by Best Medical International, Inc.(formerly Best Industries) is certified by the manufacturer as to the contents and sizes.
These seeds are gold (99.99% pure) encapsulated in platinum (99.99%
pure, iridium free). Each seed is 2.5 millimeters long and 0.8 millimeters in diameter and contains 8.6 milligrams + 0.6 milligrams of gold. Best Medical International, Inc. (formerly Best Industries) has each batch of the seeds irradiated in a nuclear reactor. Following irradiation and when supplied to Best Medical International, Inc. customers, each seed may contain up to 33 millicuries of gold-198. The most commonly used activity is 1 millicurie per seed.
LABELING:
The labeling of individual seeds is impractical due to their small size. The shipping container is labeled in accordance with criteria established in Best Industries letter of application dated July 24, 1981.
DIAGRAM:
See Attachments 1 and 2.
CONDITIONS OF NORMAL USE:
These sources are designed for use in hospital and clinical environments for the treatment of cancer under the normal conditions encountered in clinical practice.
PROTOTYPE TESTING:
No additional prototype testing was performed by Best Industries.
Best Industries claimed that these gold seeds have been in clinical use without problems with source design. Both metallic gold and iridium-free platinum are insoluble in body fluids.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-0187-S-102-S DATE:
January 14, 2003 PAGE 3 OF 4 SOURCE TYPE: Brachytherapy Sources EXTERNAL RADIATION LEVELS:
For the most common used activity of 1 millicurie/seed the dose rate is 92 mR/hr at 5 cm and 2.55 mR/hr at 30 cm.
Source container's radiation profile:
Maximum Reading With Maximum Activity Best/4 (500mCi) Best/5 (1 Curie)
Top 50 mR/hr 110 mR/hr Bottom 60 mR/hr 100 mR/hr Side 60 mR/hr 100 mR/hr QUALITY ASSURANCE AND CONTROL:
Each batch of seeds received from the manufacturer, Engelhard Industries is certified as to content and size. Following irradiation, a Capintec isotope calibrator is used for calibrating all gold seeds. The calibrator has been standardized with a standard of known activity by Capintec. The calibrator is double checked with a similar gold seed calibrated in exposure rate. This exposure rate calibration is traceable to the National Institute of Standards and Technology. Each batch of seeds is given a code number for traceability and are grouped so that variation among seeds is not more than +/-5% from the stated average activity. Seeds are smear tested for contamination to an acceptable limit of 1O-6 microcuries. A Certification of Assay (Attachment 2) accompanies each shipment.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
These sources may be distributed to persons specifically licensed pursuant to 10 CFR Part 35, Subpart F, or under equivalent regulations of Agreement States.
Leak testing of this product is not applicable due to the 2.7 day half life of gold-198.
Handling, storage, use, transfer, and disposal: to be determined by the licensing authority.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
NO.: NR-0187-S-102-S DATE:
PAGE 4 OF 4 SOURCE TYPE: Brachytherapy Sources LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (contd):
This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the information contained within the references cited below, we continue to conclude that the Best Medical International, Inc. (formerly Best Industries, Inc.) Model 81-02 gold-192 seeds are acceptable for licensing purposes. These sources are for use by trained radiotherapists for the interstitial treatment of cancer and have extensive history of successful use for this purpose. Since the high purity of gold encased in platinum is essentially inert, the possibility of contamination from loss of containment is considered minimal. However, the extremely small size of these sources (2.5 mm x 0.8 mm) will require a higher level of accountability during use to prevent source misplacement and loss.
An amendment dated June 20, 1985, increased the maximum activity a user can receive from 11 millicuries to 33 millicuries.
REFERENCES:
The following supportive documents for the Best Medical International, Inc. (formerly Best Industries, Inc.) 81-02 gold seeds are hereby incorporated by reference and are made a part of this registration document.
Best Industries letters dated July 24, 1981, September 2, 1981, September 3, 1981, July 26, 1984, with enclosures thereto.
Best Medical International, Inc. letter dated November 26, 2002, and electronic mail dated January 10, 2003.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date: 1/14/03 Reviewer: /RA/
John P. Jankovich Date: 1/14/03 Concurrence: /RA/
Ujagar S. Bhachu
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
NO.: NR-0187-S-102-S DATE:
January 14, 2003 ATTACHMENT 2 DEVICE TYPE: Brachytherapy Sources REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
NO.: NR-0187-S-102-S DATE:
January 14, 2003 ATTACHMENT 1 DEVICE TYPE: Brachytherapy Sources
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
NO.: NR-0187-S-102-S DATE: January 14,200 ATTACHMENT 3 DEVICE TYPE: Brachytherapy Sources
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
NO.: NR-0187-S-102-S DATE: January 14,200 ATTACHMENT 3 DEVICE TYPE: Brachytherapy Sources