ML20196C203
| ML20196C203 | |
| Person / Time | |
|---|---|
| Issue date: | 06/19/1984 |
| From: | Steven Baggett, Jonathan Brown NRC |
| To: | |
| Shared Package | |
| ML20137U384 | List: |
| References | |
| SSD, NUDOCS 9906230356 | |
| Download: ML20196C203 (13) | |
Text
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l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE t
N_0 :
NR-136-S-255-S DATE: M y p pp.;
PAGE.1 E 5 SOURCE TYPE:
Brachytherapy Source MODEL: CDC.Tl 1
MANUFACTURER / DISTRIBUTOR:
Amersham Corporation 2636 South Clearbrook Drive Arlington Heights. IL 60005 i
MANUFACTURER / DISTRIBUTOR:
ISOTOPE: Cesium-137 MAXIMUM ACTIVITY:
80 millicuries LEAK TEST FREQUENCY:
6 months PRINCIPAL USE:
(V) General Medical Use CUSTOM DEVICE:
YES X
N0 9906230356 990622 l
PDR RC D
SSD PDR
900837 18 f.s
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE I8 NO:
NR-136-S-255-S DATE:
PAGE 2 0F 5 SOURCE TYPE:
Brachytherapy Source DESCRIPTION:
The Model CDC.T1 brachytherapy tube sources will contain up to 80 millicuries of Cesium-137. They are constructed and packaged as follows:
o Cesium-137 as chloride is dry mixed with zirconium phosphate and sintered at high temperature.
The resultant mixture is a highly insoluble high melting point powder which can be used to " powder load" narrow bore tubes.
o The powder is loaded into a piece of narrow bore 316L tubing which has had i
a cap brazed onto one end to seal it. After loading, the other end is sealed with a cap by brazing.
o The outer capsule is also manufactured from 316L stainless steel.
The inner capsule is loaded into the outer and then a plug is tig welded in to complete the seal.
Finally, the weld region is machine polished to ensure that there are no uneven sections. The overall dimensions of:these tubes are:
External Length 20.05 mm (maximum)
Active Length 13.5 mm (nominal)
Diameter 2.65 mm Wall Thickness 0.46 mm (minimum)
Each source is packed individually in a glass specimen tube.
This specimen tube j
is supported in a lead container which has an appropriate shielding thickness.
The lead container is supported in a sealed can by the use of expanded polystyrene packing pieces and the can is similarly supported in an outer transport carton.
This packaging has been tested and conforms with the requirements of the U.S.
j DOT for Type A packaging. The packaging is not designed for re-use or for permanent storage.
I LABELING:
l The source is permanently engraved with the following information:
l o A unique serial number o The product code o An activity code j
Space restrictions prevent the addition of further information.
The specimen' tube in which each source is stored is labeled with the following information:
o The manufacturer's name l
o The isotope (Cesium-137) l o The words " Caution-Radioactive Material" t
000837 18 REGISTRY OR RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NN191gg NO:
NR-136-S-255-S DATE:
PAGE 3 0F 5 SOURCE TYPE:
Brachytherapy Source LABELING (Cont'd):
The intermediate container (sealed can) is labeled in accordance with the requirements of Section 32.74,10 CFR 32.
The.odter container is marked in accordance with the requirements of the U.S.
00T for Type A containers.
DIAGRAM:
A sketch of this assembly is shown below and engineering drawings are attached
-(3A 61002 and 3A 61003).
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1 CONDITIONS OF NORMAL'USE:
The Model CDC.Tl sources are intended specifically for medical use and exclusively for use in a medical environment.
The sources are used either use)pplicators (e.g., Fletcher-Suit or Heyman applicators for intracavitary in a or, on occasion, for direct interstitial implantation in the treatment of various forms of cancer. They are not expected to be subjected to excessive extremes of temperature, physical shock or to corrosive environments.
PROTOTYPE TESTING:
Amersham Corporation provided test data'on the Model CDC.Tl source design showing that the sources have been tested according to the requirements of ANSI N542 (.1977).and achieved'a performance' rating of C64344, In addition, the sources have been tested accurding to the requirements of ANSI N44,1 and ANSI N44,2-1973 'for brachytherapy sources and passed the specified temperature, drop and percussion tests.
D00837 18
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETYCEVALUATION OF SEALED SOURCE N 1 9 1984 N0:' NR-136-5-255 5 DATE:
PAGE 4 0F.
5 SOURCE TYPEc.
Brachytherapy Source EXTERNAL RADIATION LEVELS:
Amersham Corporation states that a cesium source with a content of 10 millicuries might be expected to generate dose rates as follows:
Distance Dose Rate 5 cm 1.3 R/hr 30 cms 38 mR/hr 100 cms 4 mR/hr j
-QUALITY ASSURANCE AND CONTROL:
Amersham Corporation states that all materials used in the fabrication of this product are checked against suppliers specifications prior to manufacture.
Finished sources are checked for freedom from leakage and contamination by bubble, wipe and immersion testing. Removable activity must be less than 0.005 microcurie before the source can be released. The customer is provided with a certificate documenting the leak test and the radiation emission measurements.
LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:
o The sources shall be distributed only to persons specifically licensed by the NRC pursuant to Sections 35.13 or 35,14 and 35.100 of Title 10, Code of Federal Regulations, Part 35 or equivalent provisions of Agreement State Regulations.
1 o The sourcs shall be leak tested at six month intervals using techniques capable of detecting 0.005 microcurie of removable contamination, o Handling, storage, use, transfer' and disposal: To be determined by the licensing authority.
o The sources shall not be subjected to environmental or other conditions of use which exceed the test specifications for selected brachytherapy sources contained in ANSI N44;1, N44.2-1973.
This registration sheet and the'information contained within the references o
shall not be changed or transferred without the written consent of the NRC.
000837 18 REGISTRY OF ~RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE j
NO: NR-136-S-255-S DATE:
JUN19584 PAGE 5 0F 5 SOURCE TYPE:
Brachytherapy Source SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data contained'in' the references cited below, we conclude that the Model CDC.Tl brachytherapy source-d'esign is acceptable for licensing purposes.
Furthermore, we conclude that the Model CDC.Tl l
sources would be expected to maintain their containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REFERENCES:
The following supporting document for the Model CDC.T1 brachytherapy source is hereby incorporated by reference and is.made a part of this registry document:
o Amersham Corporation's letter dated October 28, 1983, and enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
Reviewer:
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Date:
.E N I3 554 Concurrence:
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26% s. clearbniot i>rn e December 15 1994 12 s,c ;.m Arhnp>n Heighh, il 60001 e:.
27;h tuom m. coo
,,.tn Mr. Charles G. Vinson Illinois Department of Nuclear Safety 7AmefSham 1035 Outer Park Drive
.,, n.,, m,... o..
Springfield, IL 62704
Dear Mr. Vinson:
I am writing in reply to your letter of November 7,1994 (received here November 17, 1994) concerning the complaint that the labelling on our Cesium-137 brachytherapy sources Model CDC.Tl (Registry Number IL-136-S-255-S) is difficult to read.
There were many telephone conversations between the customer and our Medi-Physics Technical Services Department before the customer's submission of the MEDWATCH REPORT. In these conversations the customer was advised that a remote optical system could be used to limit the dose received during identification of the sealed source serial number.
1 1
This is the procedure we use, e.g. video endoscope, during final control, and is the technique
.we recommend to customers. ' As stated in your letter, a ring coding system is used to identify the radioactive content of each of these sources.
it is not possible to enlarge the engraved serial number because of the size of the source.
Even with the present size of the engraving, the source has to be rotated slightly to read the serial number. If the size of the engraving was increased, it would then cover much of the circumference of the source, making it even more d'.fficult to read the serial number.
i My colleagues in Medical Regulatory Affairs have also reviewed the MEDWATCil report and concluded that a Medical Device Report was not required.
j I
9 9
Mr. Charles G. Vinson l
December 15, 1994 l~
Page 2.
l Please let me know should you have any questions concerning the information I have provided. I shall be pleased to discuss them with you and I may be reached at 708/593-6300, extension 379.
Sincerely,
.?
A 10 ss d 'b c
/W Bryan W. Baker, Ph.D.
Corporate Manager Nuclear Licensing and Industrial Liaison BWB:beb
-cc: John Karets I
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....w STATE OFTLLINOIS DEPARTMENT OF NUCLEAR SAFETY 1035 OUTER PARK DRIVE SPRINGFIELD, ILLINOIS ' 62704 lim Edcar' Thomas W. Ortciger Governor 217-782-6133 (TDD)
Director i
i November 7, 1994-i Bryan W. Baker, Ph.D.
Corporate Manager Nuclear Licensing and Industrial Liaison Amersham Corporation-2636 South Clearbrook Drive Arlington Heights, IL 60005-4692
Dear Dr. Baker:
We have received a Food and Drug Administration (FDA) complaint regarding the labeling of your Model CDC.T1, Cs-137 brachytherapy sources. The report indicates that the labeling on these sources is somewhat small for technologists to identify during accountability procedures before and after use.
There is apparently some confusion in the notification as to whether this is a brachytherapy or teletherapy source. After searching for the model number CDC.T1, the source is, in fact, a brachytherapy source (Registry No.
IL-136-5-255-S).
The registry indicates that you have recently implemented a ring coding system for these sources to alleviate the very problem discussed in the report.
We have enclosed a copy of the report. Please review this document a.nd comment within 45 days from the date of this letter on the concerns regarding source identity including suggestions regarding corrective actions implemented to rectify this problem.
We appreciate your cooperation in this matter.
If you need further information, you may contact our office at (217) 785-9947 or FDA at (301) 594-3585.
Sincerely,
}f.
[]
Charles G. Vinson Licensing Section CGV:ren Enclosure om.
r 1,
.s.
'J EEVICE REPORT!!!3 SYST
.7-OCT-?4
~
EVENT FEPORT DETAIL *IST!::3 Pace:
?Of RELEASABLE FORMAT
~
RECORDS .EETI::G QUERY CRITERIA
,foternal Report No: '5529 Date Received: 25-AUG-74
/
/gsporting Facility Type: VOLUNTARY 1
I PATIENT INFORMATION i
Age:
DOB:
Sex:
Weight: kgs/
Olbs ADVERSE EVENT OR PRODUCT PROEI.EM
\\
Adverse Event: N Product Problem: Y Outccmes attributed to event: RADIOACTIVE SOURCE I ZNTIFICATION l
Event Date: 01-JUN-94 Date of Report: 16 - AUG-9 4 Event'
Description:
j IT IS DUFDELY DIFFICULT T3 RF10 TE 3:. CAL :TJEERS G1 TE 'IEE S1?CS. 'UE 0;LY ' RAY IS 'IO HID 3D! '.ERY CEEE. USUG FTGIIFIERS. MIS RESUL"5 31 BADIATICI CEEE O 'IFE ETE hMIGi ARE ECSSIiI.
SUCE FFR IS CLT4ETTLY 'DE crTE FfD/IEER OF 'DEE. SOUK22. SEY EGED EE CIFIm 'IO !%KE 'UE SERIAL TJEERS ET43ILY DICCERIABIE L"r2 NUIHER !GR'S hut &2ut SZ'l SIGFED GKHG 'US{. @I E t&C FEUIRES 'UMT EGITIVE SJURI ID EE MAIE POJTHELY, EEUE A:0 AFIER ETGi t.EE. 'LM.E, FERSGitEL j
LEDG QE SCUFCES ARE IUJrDELY CGGr3 'IO HIGi rm FA'IES. ACDI'~~3;TJ11l. 'DE EARELY immrr SERL:I.,
NLNBEFS CMI EASIII EE C3 REED, /40 'IFZ IUIElr!AL ECR HEERI'HG A WGUi-IEGITIFIED SOLKE DTIO A l
Fr IS SIGJIFICMTr. 'UE WHE FImr~4 CM1 EASIIX EE ANOIIID BY DF/":G 'UE SCUFCES hTHi N ID i
NLNBER5.
DEVICE IDENTIFICATION Brand: CESIUM-137 TUBE SOURCE i
Generic: CESIUM-137 TUBE SOURCE Product Code: IWH(RA) - SOURCE, TELETHERAPY, RADIC:lUCLIDE 1
Manufacturer: AMERSHAM CORP.
Shortname: AMERSHAM Address:
ARLINGTON HEIGHTS, IL 60005-Model: CDCTI Catalog:
D:vice Operator: HEALTH PROFESSIONAL Expiration Date:
D:vice Available For Evaluation?: Y l(
From:
KLINGER "KLINGER"
.-NOV-1994 09:49 To:
Vinson CC:
Subj:
Please respond to Steve and me on each of Steve's concerns.
Thanks
Begin message from COLLINS 4-Nov-94 From:
COLLINS 4-N0V-1994 09:40 To:
Klinger CC:
Subj:
Size of id on sealed sources This is written on E-mail so you can forward it to the appropriate person for response.
Is Amersham /Medi+ Physics aware of the complaint or do we know? Have we contacted AI/MP regarding the complaint? Has FDA taken any action regarding the " medical device"/ sealed source complaint.
Someone please phrase an E-mail response that is in complete statements that stand alone in an understandable fashion so it can be forwarded to other if I want to.
Thanks.
" Collins"
End forwarded message i
i CAL DEVICE REPORTING SYSTEM 17-OCT-
'VEllT REPORT DETAIL LISTIN Page:
FOI RELEASABLE FORMAT 4
RECORDS MEETIl1G QUERY CRITERIA Internal Report tio : 15529 Date Received: 25-AUG Report.ing Facility Type: VOLUNTARY PATIENT INFORMATION Age:
DOB:
Sex:
Weight: kgs/
Olbs ADVERSE EVENT OR PRODUCT PROBLEM Adverse Event: N Product Problem: Y Outcomes attributed to event: RADIOACTIVE SOURCE IDENTIFICIsTION Event Date: 01-JUN-94 Date of Report: 16-AUG-S Event
Description:
IT IS E<DEMELY DIFFICULT 'IO PEAD 71E SERIAL IU4EERS Of TIE TEE SJUFES. 'UE OlLY h70' IS TO IIID
'11H4 VERY GGE[UEtIILY TE SIE FFWIEER OF 71ESE. SOICESUSUG MTGIFIERS.
SUCE MFB IS CU
'DEY SOUU) EE CDG4TIIT) 70 VAKE 'UE SERIAL PAMEG EASILY DISCERIAFlE LIKE NUDER VER'S hTEE $EtwE TEY sa.Fvw VAKHG 'UE4. TE 15 tac REI,)UllES 711AT IGITIVE SJUIE ID IE MVE fGJrHELY, EDUE ND AFIER ETOi IEE. 'DiLS[:
FER502EL lEDG 'I1E SOUICES ARE TmrHELY EXIGED '10 FUGi DIE FA'IES. AEDITIORILY ' die EARELY-TF TMF' SERIAL lAMME CAN EASILY EE EMGED, NO 'UE IUIDirIAL FG HSERTUG A WEUGLI-ILUlrIFIED SJURCE ETIO A Pr IS SIGNIFICNir. TE h1GE FfmF?4 CNJ EASILY BE AtOIDED Eri VNERG 'DE SOUFCES hTIH IAFCER ID tAMME.
DEVICE IDENTIFICATION Brand: CESIUM-137 TUBE SOURCE Generic: CESIUM-137 TUBE SOURCE Product Code: IWH(RA) - SOURCE, TELETHERAPY, RADIONUCLIDE Manufacturer: AMERSHAM CORP.
k Shortname: AMERSHAM
\\g Address:
J ARLINGTON HEIGHTS, IL 60005-Model: CDCTI Catalog:
Device Operator: HEALTH PROFESSIOriAL Expiration Date:
Device Available For Evaluation?: Y