ML20199D727
| ML20199D727 | |
| Person / Time | |
|---|---|
| Issue date: | 01/07/1998 |
| From: | Michele Burgess NRC |
| To: | NRC |
| Shared Package | |
| ML20199D627 | List: |
| References | |
| SSD, NUDOCS 9801300270 | |
| Download: ML20199D727 (1) | |
Text
NOTE TO.
NR-0187 5101 S (BEST INDUSTRIES MODEL 81-01)
FROfA MICHELE L B'JRGESS ~r4(d DATE:
JANUARY 7.1998 RE:
CORRECTIONS TO REGISTRATION CERTIFir#TE i
On January 7,1998, I spoke with Mr. Knshitan Suthanthiran of Best Industries to discuss the following:
1.
As per your request, we will remove the reference to cancer.
2.
In order to expand the types of uses listed to include
- intraluminal *, 'intravascular", and l
- topicar treatment as per your request, please submit sufficient information to justify addition of these uses Justification may include copies of documents from the FDA authorizing those uses 3-With respect to the limitations listed in your January 15,1992, letter to the NRC, we will add a Reviewer Note to the Limitations section of the registration certificate that states that the nbbons should not be used after 1,vo months from the date of shipment.
4, With respect to the limitations listed in your January 15,1992, letter to the NRC, we will add a Reviewer Note to the Limitations section of the registration certificate that states that the ribbons are approved for one-time use only. If you wish to request repeated use, please submit informaion justifying repeated use, and listing any limitations of repeated use.
i 9001300270 900113 PDR RC PDR SSD
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December 9,19V Douglas A. Broaddus Mechanical Engineer Division ofIndustrial & Medical Nuclear Safety U.S. Nuclear Regulatory Commission 11555 Rockville Pike - Mail Stop 6113 Rockville, MD 20f 32
Dear Mr. ilroaddus:
Enclosed is th,information you requested on the Certificate of Registration we received dated June 23, 1992 along with correspondence from us to Mr. Steve Daggett dated January 15, 1992. As you can see from the enclosed letter, we described Iridium-192 seeds in nylon ribbons for interstitial and intracavitary removable implants. There was never a limitation of using these ribbons only for cancer.
Iridium 192 seeds in nylon ribbons have been in chnical use since the 1960s before the USNRC came into existence.
They have been used for interstitial, intracavitary, intraluminal, intrevascular radiation therapy and topical uses. These ribbons are normally administered to patients by Radiation Oncologists. Up until a few years ago, Radiation Oncologists were referred to as Radiation Therapists or Therapeutic Radiologists. At t
t present Radiation Therapy Technologists are called Radiation Therapists.
Radiation Oncologists worldwide use the term " interstitial brachytherapy" as a general term to include interstitial, intracavitary, intraluminal, intravascular and topical uses. Iridium-192 seeds in nylon ribbons can be used multiple times should the ribbons be used in a sealed (closed end) catheter upon inspection by the user, liospl.als have reused the ribbons, particularly in single ribbon use in instances such as bronchial or intravascular applications.
Unfortunately in recent years field inspectors from USNRC started to interpret the term
" interstitial" to a narrower definition which is contraiy to the use ofIridium 192 seeds in nylon ribbons in actual practice and the interpretation by the user, the Radiation Oncologists.
Also this misinterpretation extended to the cancer and non-cancerous tumors. llistorically radiation has been used to treat both benign and malignant tumors by Therapeutic Radiologists.
As you are aware, during the past three years Best has met with regulatory oflicia!s from USNRC and FDA. More than a year ago FDA classified the intravascular brachytherapy as a significant risk and USNRC and FDA agreed that FDA would formulate the r
7643 Fullenon Road
- Springfield, Virginia 22153
- USA 703-4512378
- B00-336-4970
- FAX: 703-4515228
.j ngeyn _
Mr. Douglas A. Droaddus December 9,1997 Page Two guidelines for the clinical trials There were no requirements during these meetings by the USNRC to require specific approval for a registered source for intravascular brachytherapy. We wrote to you in October 1997 informing you of the approval from the FDA for multi center trials. The on going clinical trial willlast from one to three years.
Upon completion of a successful clinical trial with positive results, we are planning to submit the information to both the USNRC and the FDA for approval for general distribution.
The sites which are approved by the FDA for clinical trial have been requested to submit information to the respective regulatory ageacies to obtain necessary approval to carry out the clinical trials.
Please feel free to contact me upon receipt of this information.
With kind regards, l'
Q drishnen Suthanthiran l
President KS/gd Enclosures I
pn (tov O'
UNITED STATES n
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.i NUCLEAR REGULATORY COMMISSION
'f W ASHINGTON. D.C. 20%5
%*****J June 23, 1992 Krishnan Suthanthiran President Best Industries, Inc.
7643 Fullerton Road Springfield, VA 22153
Dear Mr. Suthanthiran:
Based on the information and test data submitted in your application dated January 15, 1992, with enclosures thereto, we have approved your request for amendment to SSD registration certificate no. NR-187-S-101-S.
We conclude the Model 81-01 therapeutic seed sources are acceptable for interstitial and intracavitary use in accordance with the conditions of the enclosed registration certificate.
Furthermore, we continue to conclude that the sources are acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate.
A copy of this certificate has been forwarded to our Region II office.
Please read over the registration certificate in its entirety and notify us immediately if there are any errors.
If you have any questions, please contact me at '(301) 504-2503 or Mr. John Lubinski at (301) 504-2689.
Sincerely, u
/
Doug as A. Broaddus, Meenanical Engineer Scaled Snurce Oafety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated Sandra Kimberly, LFOCB (w/ encl.)
cc:
Jin Smith, IMAB (w/ encl.)
I OO Cf C
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 5
SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
HQxt NR-187-S-101-S DATEt June 24, 1992 EA9P. 1 OF 7 SOURCE TYPEt Brachytherapy Seed Source MODEL:
81-01 MANUFACTURER /DISTRIBUTORt Best Industries 7643 Fullerton Rd.
Springfield, VA 22153 ISOTOPEt MAXIMUM ACTIVITY:
Iridium-192 33 millicuries (1.22 GBq)
LEAK TEST FREQUENCY:
6 months PRINCIPAL USEt (V) General Medical Use CUSTOM SOURCEt YES x
NO f
4 REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SCALED SOURCE (Amended in its Entirety)
HQtt NR-187-S-101-S DATE!
June 24, 1992 PAGE 2 OP 7 SOURCE TYPEt Brachytherapy Seed Source DESCRIPTION Best Industries claims that the Model 81-01 sources are identical in design and construction to RAD / IRID, Inc., Model R/1 sources and other sources which have been in use since 1960.
Each seed contains Iridium 30% - Platinum 70% alloy source material in the form of a wire doubly encapsulated in Type 304 stainless steel.
The capsules are cold welded at each end (machine crimped) to a nominal length of 0.13 inches (3 mm).
Nominal outer diameter for the Iridium / Platinum wire is 0.003 inches (0.076 mm).
Nominal outer diameter of the inner stainless steel capsule is 0.012 inches (0.305 mm) with a nominal thickness of 0.0085 inches (0.216 mm).
Nominal outer diameter of the outer stainless steel capsule is 0.020 inches (0.508 mm) with a nominal thickness of i
0.007 inches (0.178 mm).
Following batch irradiation in a reactor, the completed seeds are forced into nylon ribbons which have an inner diameter less than the outer diameter of the sources in order to prevent movement.
Spacing of the sources along the ribbon is typically 0.4 inches (1 cm) center to center, however, up to 3 seeds per centimeter can be accommodated.
Each ribbon will be supplied with approximately 39.4 inches (100 cm) of inactive leader at one end to facilitate handling and about 1.2 inches (3 cm) on the other.
Seeds and ribbons are supplied in sets.
A standard set consists of 14 ribbons containi.; 12 seeds each with 1 cm spacing.
Ribbons can be customized with up to 7.9 inches (20 cm) of active length according to user specifications.
The most commonly supplied activity is 10 mil 11 curies per seed, however, the user may request up to 20 millicuries (1.11 GBq) per seed.
DIAGRAMt See attachments 1 and 2.
LABELINGt Because of their small size, individual seeds and ribbons are not labeled but rather', each shipping container will be labeled.
Additionally, ribbons may be color coded to designate various activity levels as of the date of shipment.
Hewever, color selection is not dependent upon a specific activity level.
- -.. - - -. =.... -. - - _
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
EQt NR-187-S-101-S DATE:
June 24, 1992 PAGE 3 OF 7 SOURCE TYPE Brachytherapy Seed Source LABELING: (Cont'd)
Seeds in ribbons are supplied as a set with the activity of each ribbon within a range as specified by the end user.
The ship containers for each set bear labels containing the following: ping 4
" CAUTION - RADIOACTIVE MATERIAL" Radiation Symbol, Isotope, Amount, Date Best Industries, Inc.
7643-B Fullerton Road Springfield, VA 22153 Ship-To:
Date of Shipment P.O. Number Activity on Date of
- of Ribbons
- of Seeds Shioment (ma Raea)
Code
- Color **
Note:
- Internal code to identify reactor irradiated batch of seeds.
Ribbons may be' color coded to designate the activity on date of shipment (milligram radium equivalent).
Typical colors used are white, red, or blue.
For seeds above 11 mci (0.407 GBq) the following label will be added:
CAUTION:
These Iridium-192 seeds are considered high activity sources because of the high dose rate.
The dose rate per mci of Iridium-192 seeds at 1 cm is 4.6 R/hr.
At 5 cm_the dose rate is 184 mR/hr.
At 30 cm the dose rate is 5.1 mR/hr and at 100 cm it is 0.46 mR/hr.
Use extra care and' follow all instructions included in the bill of lading.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
HQt:
NR-187-S-101-S DATE!
June 24, 1992 PAGE 4 OF 7 SOURCE TYPEt Brachytherapy Seed Source CONDITIONS OF NORMAL USE The seeds in ribbons are designed for use in hospital or clinical environments for the interstitial or intracavitary treatment of cancerous tumors.
The sources are designed to withstand autoclave or steam sterilization temperatures up to 270'F (132'C) and pressures up to 15 psi (103 kPa for up to 10 minutes.
However, ethylene gas sterilization) methods using temperatures between 120*F (49'C) and 140'F (60'C) are recommended.
The sources shall not be subjected to dry heat sterilization.
l PROTOTYPE TESTINGt Prototype testing of the sources has not been performed by Best Industries, Inc., due to the fact that essentially identical sources have bean manufactured and in use since 1960.
The manufacturer has stated that the sources are identical in size and construction to RAD / IRID Model R/1 sources and that neither Best Industries, Inc. nor RAD / IRID have encountered any problems with the sources in clinical practice.
RAD / IRID sources have been subjected to the following tests:
Exposed to water and cold and warm isotonic saline solutions (0.25 percent sodium chloride by weight) for periods up to six months without signs of corrosion or deterioration.
Prolonged exposure to concentrated "aepherin" (antiseptic solution) of up to six months without signs of corrosion or deterioration.
Sources were autoclaved at pressures up to 350 psi and temperatures up to 250'F for 30 minute periods without any adverse effects noted.
4 EXTERNAL RADIATION LEVELS:
External radiation levels for a 10 mci (0.37 GBq) source are as follows:
Distance from Ir-192 Measured radiation levels source Seed Activity (mrem /hr)
(mSv/hri 5 cm (1.97 in) 10 mci (0.37 GBq) 1840.0 18.4 30 cm (11.81 in) 10 mci (0.37 GBq) 51.0 0.51
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1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE i
(Amended in its Entirety) liQs. - NR-187-5-101-S DATEt June 24, 1992 PAGE 5 OF 7 uSOURCE TYPE:
Brachytherapy Seed Source QUALITY ASSURANCE AND CONTROL:
Best Industries, Inc., states that quality assurance and control are provided routinely throughout the manufacture and use of the sources.
The stainless steel tubing from which the capsules are made is certified by the manufacturer to be type 304. stainless i
steel hypodermic needle tubing with chemical composition and 1
mechanical properties tested and notarized.
The manufacturer of the Iridium / Platinum wirt gEnglehard
-Industries) certifies it to be an alloy of 30 percent iridium and 70 percent platinum.
During seed fabrication, reprerentative numbers are individually inspected with a magnifying glass to ensure the integrity of the cold weld when fabrication is complete.
All seeds are individually inspected for_ uniformity and bent or damaged seeds are discarded.
After seeds are irradiated, they are comparatively measured with a standard of known activity.
Representative seeds are then smear tested for possible contamination.
All Model 81-01, iridium-;92 sources and ribbons are calibrated -
to millicuries using a calibrator which has been standardized by the National-Institute of Standards and Technology _(NIST).
A specific Gamma Ray Constant of-- 4.6 R cm hr mCid is used for 8
4 converting millicurie values into milligram radium equivalent.
-Best Industries further states that their rigid quality control program insures that iridium seeds are produced with close tolerances and that they are uniform in their activity.
All assembled ribbons are calibrated before shipping and no ribbon is sent to customers if it varies more than 1 5 percent from the stated average activity.
The factor used for the conversion of millicuries of iridium-192 to milligram radium equivalent is 0.56, assuming a specific Gamma 8
4 Ray Constant of 8.25 R cm1 hr mci" for radium-226.
Each batch of seeds'is given a code number for traceability and ribbons are smear tested for contamination to an acceptance limit of-10 4 microcurie / ribbon.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
EQA:
HR-187-S-101-S DATEt June 24, 1992 PAGE 6 OF 7 SOURCE TYPEt Brachytherapy Seed Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The Model 81-01 source shall be manufactured and distributed' according to the requirements of Section 32.74, 10 CFR Part 32 and distributed only to persons specifically licensed by the NRC or an Agreement State.
The sources shall not be exposed to concentrated acids or alkaline fluids or sterilized by dry heat methods.
The sources shall not be exposed to autoclave pressures in excess of 15 psi (103.4 kPa) and temperatures in excess of 270'F (132.2'C), nor to these temperatures and pressures for periods in excess of 10 minutes.
The sources shall not be autoclaved in plastic tubing or plastic containers (only autoclave suitable material such as stainless steel, glass, nylon, teflon, lead or tin should be used).
The sources shall be leak tested at intervals not to exceed six months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
REVIEWER NOTE:
P13ase ensure the safety procedures outlined in 10 CFR Part 35 Subpart G are adhered to, especially as they pertain to the handling of the sources.
Specifically, r l,. ons should be used only in closed end catheters or completely closed outer catheters to prevent direct contact with tissue.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority.
The sources shall be handled only with appropriate equipment (due to the high activity of the sources forceps are recommended).
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
HQ2:
NR-187-S-101-S DATE!
June 24, 1992 PAGE 7 OF 7 SOURCE TYPEt Brachytherapy Seed Source SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below and the past history of similar source designs, we continue to conclude that the Best Industries, Inc., Model 81-01 sealed sources are acceptable for licensing purposes.
Furthermore, we continue to conclude that these sources would be expected to maintain their containment integrity for normal and accidental conditions of use which might occur during the-uses specified in this registration sheet.
REFERENCESt The following supporting documents for the Best Industries, Inc.,
Model 81-01 sealed source are hereby incorporated by reference and are made a part of this registry document.
Best Industries,-Inc., application dated July 24, 1981.
Best Industries, Inc., letters dated September 3,
- 1981, July 26, 1984, January 15, 1992 and April 14, 1992 and enclosures thereto.
ISSUING AGENCY U.S. Nuclear Regulatory Commission Date:-
June 24. 1992 Reviewer:
b 78 Date:
June 24. 1992 Concurrence:
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SA?ETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
&s NR-187-S-101-S DATEt June 24, 1992 ATTACHMENT 1 3-2 3-3 3-1 1.D. 3-2 1.0005 coi e,LO.0200 00.0035 u
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1.D. 3-3 0.130 *0.005 Notei Both ends are crimped 3-3 TUBE O.D. 00.020 S.S. 304 2 TUBE O.D. e0.012 S.S. 304 3-1 VIRE O.D. 00.003 Pt - Ir NO.
DESCRIPT10N MATERIAL l--
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REGISTRY OF RADIOI. IVE SLALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE 1
(Amended in its Entirety)
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HQ.a.
HR-187-S-101-S DATE June 24, 1992 ATTACHMENT 2 1
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with 12 iridium-192 seeds spaced 1 cm
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apart from the center of one seed to another.
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Mindustries Inco A Trusted Name in Radletto Therapy January 15, 1992 Mr. Steve Baggett U.S. Nuclear Regalatory Commission 11555 Rockville Pike Mail Stop 6H3 Rockville, MD 20852 Dear Mr. Baggetti Enclosed is the updated registration information for Iridium 192 seeds, Model No. 81-01.
I hope this information is satisfactory.
If you need additional information, please feel free to contact me.
With kind regards, Krishnan Suthanthitan President KS/gd Enclosure 7643 Fullerton Road 1 703-451 2378 Springfield, Virginia 22153 1-800-336-4970 Cable code: BEST Telex: 854083 Easylink: 62812378 FAX: 1703 45'15228
-f96-/$$aE46-
DEST INDUSTRIES MODEL 81-01 IRIDIUM 192 SEEDS Calibration:
All Best industries Iridium 192 seeds are manually assembled into ribbons.
Each order is custom prepared and the accuracy of calibration and spacing is iS%.
When seeds are assembled end to end, there may be gaps of up to 1 mm between each seed.
An isotope calibrator is used for the calibration of all sources. The activity of the seeds and seeds in nylon ribbons is measured in mci. The calibrator is standardized against an Iridium 192 seed calibrated by the National Institute of Standards aad Technology.
Limiting Conditions and Conditions of Normal Use:
Iridinm 192 seeds in nylon ribbons may be used for removable interstitial or intracavitary implant only.
Iridium seeds in nylon ribbons are designed for one-time use only.
Repeated sterilization or repeated use could damage the integrity of the ribbons.
Ribbons show brittleness in approximately two months due to radiation damage and should not be used after two months from the date of shipment.
l Soaking in cleaning solution could make the ribbons swell and allow the seeds to move inside, as the nylon used in ribbon assembly hrs a tendency to absorb moisture.
Iridium 192 seeds in nylon ribbons should not be used in fully open-end needles for interstitial applications. For template applications they may be used in partially closed needles supplied by manufacturer only, In blind-end technique cases Iridium-192 seeds in nylon ribbons should be inserted into completcly closed outer catheters.
For intracavitary therapy, Iridium 192 seeds in nylon ribbons may be used only in fully closed-end needles, catheters, or applicators.
Iridium 192 seeds should not be removed from the nylon ribbons.
It is recommended that the ribbons containing the Iridium seeds do not come into direct contact with tissue.
Recommended Sterilization Procedure:
Use ethylene oxide gas sterilization method.
Sterilization temperatures are between 120' and 140' Fahrenheit for a period of two to three hours, Aeration time is eight to twelve hours.
Dry heat sterilization should not be used.
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