ML20126C232
| ML20126C232 | |
| Person / Time | |
|---|---|
| Issue date: | 03/10/1982 |
| From: | Page R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20126C180 | List:
|
| References | |
| FOIA-84-720 NUDOCS 8506140349 | |
| Download: ML20126C232 (6) | |
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MAR 10 799, MEMORANDUM FOR:
Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety FROM:
R. G. Page, Chief Uranium Fuel Licensing Branch Division of Fuel Cycle and Material Safety
SUBJECT:
LICENSEE EVENTS INVOLVING I-125 SOURCES I wish to call to your attention licensee events that are being reviewed by AE00. These events involve I-125 seeds used for implants and I-125 sources used in bone mineral analyzers.
Dr. Terry and I believe these events should be considered for possible review by NMSS along the lines that our una review procedure specifies.
If you agree, it is recomended that you request Mr. Singer or Mr. Miller to carry out such a review and prepare a sumary statement which is called for in paragraph 3 on page 2 of the review procedure.
The computer print-outs and the Part 21 report (both attached) provide some background information on these events.
Dr. Terry has additional information which can be made available.
origina? sig >ed by Pa@h G P.:ge R. G. Page, Chief Uranium Fuel Licensing Branch Division of Fuel Cycle and Material Safety DISTRIBUTION RGPage GATerry t/
TFCarter VLMiller BSinger hS06140349041011 FCUF R/F F01A PDR NMSS R/F FC Central File SCHONBE04 4 0 9.V.*.....Y/ a.i..
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.NORLQD'CORFORATION FT ATKINSO WI 7/10/1981 7/10/1981 810151 0481340301 NORLAND INSTRUMENTS FT ATKINSO WI 4/21/1981 4/20/1981 81Q156 481340301 "NORLAND INSTRUMENTS FT ATKINSO WI 9/11/17 1 8/07/1981 810i52 0481340301 U CONN HEALTH CTR FARMINOTON CT 5/22/1981 5/12/1981 810i21 0061302202 U OF INDIANA INDIANAPOL IN 11/23/196A 11/17/1981 810228 0130275203 V1ROINIA COMMONWEALTH U RICHMOND VA 6/17/1981 5/21/1991 810122 0450004817 VIROINIA COMMONWEALTH U RICHMOND VA 7/23/192.1 816123 0450004317 k
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TEM NO.
PROM CODE LICENSE NO.
DOCKET NO.
STATE dITY AO 81-0121 2110 006-13022-02 000-0000 CT FARMINOTON y{s REPORT DATE EVENT DATE LICENSEE AS 5/22/1991 5/12/1981 U CONN HEALTH CTR
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SOLCCE ISOTOPE AMT MANUFACTURER AND MODEL. NO.
INIT u
L 1125 3M BRAND SEEDS (LRP-I-125)
EAT 3
OTHER LIC. NO.
CAU?E CAT.
INIT
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LKS Y
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EXP YBCDO 3
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'i BSTRACT ON 5/6/81 40 1-175 SEEDS (0.61-0.64 MCI EA) WERE INSERTED INTO PROSTATE
[ OF CANCER PATIENT. ON 5/7/01'~I-125 WAS DETECTED IN URINE.
THYROID BLOCKINO
} AOENT WAS ADMINISTERED. ON 5/11/81 URINE ACTIVITY WAS 0.0063 UCI/ML AND T'H BURDEN EST TO BE 2.076 CI (W/ THYROID DOSE OF 9.04 RADS). PLAN TO MOD SEED i
f HANDLINO PROC
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ITEM NO.
PROM CODE LICENSE NO.
DOCKET NO.
STATE
'/jCITY AO B1-0122 2110 045-00048-17 000-0000 VA RICHMOND
.,g REPORT DATE E' VENT DATE LICENSEE-AS j
6/17/1981 5/21/1981 VIROINIA COMMONWEALTH U SOURCE ISOTOPE AMT MANUFACTURER AND MODEL NO.
INIT L
1125 3M I-125 SEEDS EAT OTHER LIC. NO.
CAUSE CAT.
INIT 3
LINK TYPE CODE 1
RLM PAY 2
EXP YBCYG i
Q +.
ON 5/21/81 A MICI' NPLICAICE 5'd1NG USED FOR AN I-125 PROST ATE IMPLANT 6
JAMMED. ONE SEED RUPTURED DURING THE ATTEMPT TO FREE THE AFPLICATOR AND CALI SOME CONTAMINATION. THE PATIENT SHOWED'NO I-12D ACTIVITY. RAD. SAFETY COMM.Te O
REVIEW PROCEDURE BEFORE FUTURE IMPLANTS ARE DONE.
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PROM CODE LICENSE NO.
DOCKET NO.
STATE i,.
S1-0123 2110 045-0004?-17 000-0000 VA RICHMOND C
LICENSEE AS
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REPORT DATE EVENT DATE 7/23/1981 VIRGINIA COMMONWEALTH U
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INIT..hd SOURCE ISOTOPE AMT MANUFACTURER AND MODEL NO.
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1125 3M I-125 SEEDS EAT 4
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OTHER LIC. NO.
CAUSE CAT.
INIT g'n O
i LINK TYPE CODE
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LKS Y
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O EXP YBCDO Z
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ABSTRACT M
CI AFTER COMPLETING A ROUTINE INTERSTITIAL PROSTATE IMPLANT ON 7/7/81, FRAGMENTS OF AN I-125 SEED WERE FOUND IN THE MICK APPLICATOR. THYROID BLOCKB AGENT WAS ADMINISTERED AFTER PATIENT URINALYSIS SHOWED FREE I-125. THYROID lC ACTIVITY PEAKED AT 7.8 UCI ON 7/14/81.
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us ITEM NO.
. PROM CODE LICENSE NO.
DOCKET NO.
STATE T' CITY 4s O
61-0151 3212 048-13403-01 000-0000 WI g ATKINSO
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REPORT DATE EVENT DATE LICENSEE AS 7/10/1981 7/10/1981 NORLAND CORPORATION lC SOURCE ISOTOPE -
AMT MANUFACTURER AND MODEL NO.
INIT:
L 1125 AECL EAT u i(D l
OTHER LIC. NO.
CAUSE CAT.
INIT
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LINK TYPE C' ODE 1
LKS A
'l0 ABSTRACT y.y REPORT OF POSITIVE RESULTS OF LEAK TESTING PERFORMED ON TWO.'I-125 SEAL
- )
SOURCES REC'D FROM AECL. TOTAL CONTAMINATION REMOVED WAS ESTIMATED AT FROM:
0.005 TO O.05 MCI. SOURCES AND PACKAGING WERE RETURNED TO AECL FOR DISPOSAL sp.
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REPORT DATE EVENT DATE LICENSEE AS
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.9/11'/1981 8/07/1991 NORLAND INSTRUMENTS
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COURCE ISOTOPE AMT MANUFACTURER AND MODEL NO.
INIT N.
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CAUSE CAT.
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LINK TYPE CODE n
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LKS
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ABST RACT REPORT OF LEAKING SEALED I-125 SOURCE (100 MCI) WHICH WAS ALSO REPORTED BY BRIGHAM AND WOMEN'S HOSPITAL (ITEM #81-0204)/ SOURCE WAS RETURNED TO THE MAf9UFACTURER (AECL) FOR DISPOSAL. AECL INDICATE fJ F-p' 1.
V.
4 y-ITEM NO.
PRGM CODE LICENSE NO.
DOCKET NO.
STATE CITY AO 81-0156 3212 48-13403-01 000-0000 WI FT ATKINSO
,1 REPORT DATE EVENT DATE LICENSEE AS 4/21/1981 4/20/1981 NORLAND INSTRUMENTS t.
SOURCE ISOlOPE AMT MANUFACTURER AND MODEL NO.
INIT N
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L.
I125 Z
AECL EAT OTHER LIC. NO.
CAUSE CAT.
INIT k-4 KMB LINK TYPE CODE h.,
1 LKS
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2 MSC A
4
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3 FOR
/-
h 11 ABSTRACT LICENSEE FOUND >O.005 UCI ON SHIPPING MATERIALS AFTER I-125 SOURCES HAD BEEN l
REMOVED. CONTAMINATION WAS DUE TO LEAKAGE FROM SOURCES.
SOURCES AND CONTAMINATED SHIPPING MATERIALS WERE SHIPPED BACK TO AECL.
(CONT. ESTIMATED BETWEEN O.005 AND O.05 UCI.
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[4 ITEM NO.
PROM CODE LICENSE NO.
DOCKET NO.
STATE
. CITY A@
81-0204 O
O20-17131-01 000-0000 MA BOSTON i ts
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REPORT DATE EVENT DATE LICENSEE AS S/28/1981 8/07/1981 BRIGHAM Et WOMEN'S HOSPITAL SOURCE ISOTOPE AMT MANUFACTURER AND MODEL NO.
INIT F,?
L I125 D
NORLAND BONE DENSITOMETER EAT J
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LV.S A
- .f-A8STRACT I.$
l NORLAND CORPORATION BONE DENS 110 METER SEALED 1-125 SOURCE (200 MCI) WAS FOUND
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TO HAVE GREATER THAN O.005 UCI LEAVAOE.
SOURCE AND DEVICE WERE' RETURNED TO
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ITEM NO.
PRGM CODE LICENSE NO.
DOCKET NO.
STATE 5 CITY AO 81-0228 2110 013-02752-03 000-0000 IN INDIANAPOL RERORT DATE EVENT DATE LICENSEE As
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11/23/1981 11/17/1981 U OF INDIANA l
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t INITlh SOURCE-ISOTOPE AMT MANUFACTURER AND MODEL NO.
L 1125 D
AMERSHAM EAT ',Jg
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LINK TYPE CODE 1
LKS A
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ABSTRACT TWO (2') 1-125 SEALED SOURCES OF 200 MCI EACH WERE PEC'D FOR' BONE MINERAL ANALYSIS. ONE.0F THE SOURCES WAS FOUND TO HAVE GREATER THAN O.005 MCI LEAKAGE.
THE SOURCE WAS RETURNED TO AMERSHAM.
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A 07 n. h t roe AUTyuR A F F IL I a T I0r:
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Atenic dnergy of Canaca, Ltc.
RECI/IdNI sFFILIATION Director's office, Office of Inspection anc Eniorcement j
SECIP.vAvc Potential Part 21 rect ce cotential defect in Wodels C-235 &
SL5 JECT.
C-320 sealeo sources.All affected clients advised of procier.fcw order elaceo
/oricinal su,colier of friction welceo stoce mat.l. List of clients K mocel specs encl.
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SIZE:__f______
DISTP.IbuTIV4 CODE: IE2us coviES RECEIvEL:
TITLL: Part 21 Reet (39,40,70 OkT)
HCTES:
RECIPIEtT CoelES RECIPIENT CCPTES 10 CODE /NAvt LTIE C e.C L I? CCDE/NAFE L T T.4 ENCL I'TERrAL:
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.EXTEh?GL: iAC FOR 1
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s, Atomic Energy L'inergie Atomique
- I of Canada Umited du Canada, Limit 6e CommercielProducts Produits Commerciaux Tel(613)592 2790 P.O.Bor 6300 CP,8300 Ottawa. Canada Ottawa. Canada Telex.053-4162 K2A3W3 K2A 3W3 VIA REGISTERED MAIL 1982 February 12 File:
Q2.9.4 RA82-2-45 an i *' /
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Dear Sir,
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- ^C 10 CFR 21 NOTIFICATION OF POTENTIAL DEFE TK AECL-CP MODEL C-235 & C-324 SEALED SOURCE 4
'f' In accordance with the requirements of 10 CFR 21.21 we have to notify you of a potential defect which may arise in Model C-235 and C-324 sealed sources manufactured and distributed by AECL-CP; also the acticns which are being taken by the Company to investigate the problem and to institute measures which will reduce the probability of a recurrence.
Details of this 10 CFR 21.21 (3) report are as follows:
(i)
Informant Eric F. Ridout, Manager, Regulatory Affairs Branch, Quality Assurance Division, Atomic Energy of Canada Limited, Commercial Products (AECL-CP),
P.O. Box 6300, Ottawa, Ontario, Canada.
K2A 3W3 Telephone:.
(613) 592-2790
. Telex:.
053-4162 (ii)
Identity of Ecuipment Involved AECL-CP Model C-235 and C-324 sealed sources. '
Our i
records indicate that there are 129 serials of these models which may be affected by this Notification and' which may still be in use in the USA (the earliest distribution date of the sources under consideration was 21 August, 1981).
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. (iii).
Manufacturer Atomic Energy of Canada Limited, Commercial Products, (AECL-CP).
Address as specified in Item (i)
(iv)
(a)- Nature of Potential Defect A random failure of an active Model C-324 (Serial 1170) occurred during the final ultrasonic cleaning process in the AECL-CP production laboratory facilities in Ottawa.
Both Models C-235 and C-324 are similar in that the body of the source capsules used
~'
are bimetal and fused together with a friction weld.
In the incident under consideration the 125I cead friction weld separated, exposing the to the atmosphere.
More than 2,000 friction welded sources of this type have been manufactured by'AECL-CP since 1969 and this incident during manufac-ture is the first case of its type on record since that time.
Specification drawings of both sources currently in use are attached for your examination.
(iv)
(b)
Potential Safety Hazard The majority of these sealed sources are used in in-vitro medical devices such as bone densit-ometers.
In the unlikely event that a similar failure occurred at a user site, the potential for hazard would be a function of the type of receptacle used to house the source.
If the source is housed in a collimating' device then failure would result in a slight, but detectable, leakage of source material; very limited release of contamination may occur.
If the source is being handled at the time of failure it is possible for the activity (125r deposited on a charcoal bead) to become free from the source capsule and significant potential for contamination would result.
0
. ' A preliminary assessment indi. cates that " rough" handling could contribute significantly to this failure mode.
In the reported incident ultra-sonic cleaning may have caused the failure.
Also, the investigation has revealed that the supplier of friction welded stock material was.
changed for sources distributed af ter 21 August, 1981 and the possibility of a deviation in the manufactured. product is being investigated.
(v)
Date of Reported Incident O
5 February, 1982.
(vi)
Distribution Data A listing of recipients of Model C-235 and Model C-324 sources distributed af ter 21 August, 1981 is attached as Appendix
'A'.
(vii)
Corrective Actions 1)
All direct account clients with sources shipped between 21 August, 1981 and present are being advised immediately via AECL-CP Warning Notice IPG-WN-82-1 of the nature of the problem, the potential consequences and the measures to be taken to reduce the These probability of a leakage incident.
customers are being advised to return spent sources in appropriate receptacles for dis-posal.
Warning Notices will be distributed by 26 February, 1982, 2)
A new order has' been placed with the original supplier of our friction welded stock material for immediate delivery.
3)
Qu'ality assurance measures for acceptance of friction welded bar stock are being're-inforced.
These measures are expected to be complete by 5 March, 1982 and it is anticipated that the warning period will end with production of
. sources from new friction welded stock material' estimated to be 31 March, 1982.
. 4)
All direct account clients ace being advised to avoid unnecessary source h.indling and to upgrade wipe test frequency to once every month until further notice.
Clients who decline to comply with these requirements will be denied further shipments.
We trust that this Notification meets the intent of the Regulations under 10 CFR 21.
If we can be of
.further assistance in'this matter, please contact this office at your convenience.
Yours sincerely,
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E.F. Ridout, Manager, Regulatory Affairs, EFR/EB Quality Assurance.
Enclosures:
Spec. C-235 Spec. C-324 Appendix
'A' G
APPENDIX
'A' Re:
10 CFR 21 Notification of Potential Defect AECL-CP M6 DEL C-235 and C-324 Sealed Sources C-235 C-324 U.S.A. Customers 5
104 1.
Norland Corporation Norland Instruments, Norland Drive,
~~
Fort Atkinson, Wisconsin 53538 3
2.
Bendix Field Engineering Corp.
U.S. Dept. of Energy, Grand Junction Office, Grand Junction, Colorado 81501 3
3.
Lixi Inc.
1438 Brook Drive, Downers Grove, Illinois.
60515 1
4.
Emmanuel Hospital, 2725 N. Ganterberin Avenue, Portland, Oregon.
97227 1
5.
University of Wisconsin-Madison, C.O.R.D.
317 North,Randall Avenue, Room 9, Madison, Wisconsin 53706 3
6.
Mayo Foundation, Rochester, Minnesota.
55901 3
7.
Wellington Resources, Campbell Centre II, Suite 975, 8150..N. Central Expressway, Dallas, Texas.
75206 3
8.
Memorial Sloan-Kettering Cancer Centre, 411 East 67th Street, New York, New York.
10021 1
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Continued APPENDIX
'A' C-235 C-324 9.
Kuakini Medical Centre 2
347 North Kuakini Street, Honolulu, Hawaii 96817 W
10.
University of Washington,.
1 Division of Nuclear Medicine, N.N. 203, RC-70, Seattle, Washington, 98195 E.T. Ridout 1982 February 9 9
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UNITED STATES 4
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MAY 2 51932 MEMORANDUM FOR: John G. Davis, Director /
Office of Nuclear Material Safety and Safeguards Richard C. DeYoung, Director Of fice of Inspection and Enforcement FROM:
Carlyle Michelson, Director Office for Analysis and Evaluation of Operational Data
SUBJECT:
AE0D REVIEW 0F 10 DINE-125 SEALED SOURCE LEAKAGE INCIDENTS AE0D has reviewed several recent incidents involving leaking Iodine-125 sealed sources that are used in radiation therapy. The enclosed report presents the review.
Based on AE0D work to date, we believe that there may be generic problems associated with the use of I-125 seeds and we recommend the following actions be taken by IE and NMSS:
1.
IE, with the assistance of NMSS, prepare an infonnation notice to supplement IE Information Notice #80-35, titled " Leaking and Dislodged Iodine-125 Implant Seeds." The notice should contain a summary of recent I-125 seed leakage incidents and information extracted from the September 23, 1981 letter from 3M.
(The 3M letter is part of the enclosed AEOD report.) This would quickly alert hospitals using I-125 seeds.
2.
NMSS obtain a medical consultant to provide an evaluation of the risks to the patient from the current seed implant system (including seed and applicator designs, implant and removal procedures, etc.) and recommendations concerning changes to the seed implant system and/or current NRC requirements, if warranted. The evaluation should consider (a) whether it is advisable to provide guidance to licensees on patient bioassay, and (b) whether thyroid blocking agents should be routinely administered to patients prior to I-125 seed implant procedures.
This study was conducted by Eugene Trager. Should you have detailed questions on the review, please contact either Gene or Kathleen Black in my office.
f Carly e Michelson, Director Office for Analysis and Evaluation of Operational Data S inCOT q 0)'
Multiple Addressees 2-
Enclosures:
As stated-cc w/ enclosures:
~
RHaynes, Region I JP0'Reilly, Region II JKeppler, Region III
- JTCollins, Region IV RHEngelken, Region V GWKerr, SP.
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UNITED STATES E
NUCLEAR REGULATORY COMMISSION E
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MAY 181982 MEMORANDUM FOR:
C. J. Heltemes, Jr., Deputy Director Office for Analysis and Ev'aluation of Operational Dat i
THROUGH:
Kathleen M. Black Office for Analysi and Evaluation of;0perational Data FROM; Eugene A. Trager Office for Analysis and Evaluation of Operational Data
SUBJECT:
AE00 REVIEW 0F 10 DINE-125 SEALED SOURCE LEAXAGE INCIDENTS i
Introduction Three separate hospitals (two NRC licensees and one agreement state licensee) reported leaking Iodine-125 sources, some of which resulted in thyroid uptake by_ the patierit..
A report on 5/22/81 from the University of Connecticut Health Center ( Attach-ment 1) described an incident involving the leakage of an Iodine-125 implant source and thyroid uptake by a patient.
Reports from the Virginia Commonwealth University (VCU), Medical College of Virginia on 5/29/81 and 7/23/81 (Attach-ments 2 and 3) described two additional I-125 implant source leakage incidents, the second of which resulted in a significant patient thyroid uptake.
In addition, in September 1981 a third incident occurred at VCU that involved leakage from implanted seed (s).
The Radiation Safety Officer (RS0) for the Medical College of Virginia, Mr. Dean Broga, had contacted Region II (Potter) concerning this but was informed that a written report to the NRC was not necessary because the seed (s) had not failed (ruptured).
A Decedber 2,1981 letter from the Rhode Island Department of Health to the Office of State Programs ( Attachment 4) described two related incidents involving leaking I-125.
In these incidents the I-125 seeds were damaged and leaked possibly as a result of a surgical procedure.
The Rhode Island letter notes that "While these incidents do not appear to meet abnomal incident reporting criteria, we feel that they may have generic signifi-cance and are bringing them to your attention."
The nonreactor group began a review of this type of event because leaking I-125 seeds can lead to significant uptakes and doses to the thyroid of 50 to 100 REM. An evaluation was begun because it was detemined that this might be an unrecognized generic problem.
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I V
g}jg C. J,. Heltemes, Jr. - '
s
1 Background
The routine use of I-125 seeds
- in therapy is a relatively recent development.
On June 25, 1975, Group VI of 10 CFR 35.100 was expanded to include Iodine-125 as seeds for interstitial treatment of cancer (following approval of this use by the Advisory Committee on the Medical Use of Isotopes). Generally, the FDA approves radiopharmaceuticals for routine clinical use and the NRC issues licenses for the possession and use of the byproduct material contained in the radiophamaceuticals. Because FDA did not get involved in medical sealed sources until 1976 (since enactment in 1976 of the Medical Devices Amer.dments to the Federal Food, Drug, and Cosmetic Act),
FDA was probably never involved in the review or evaluation of the I-125 i
i seeds, as it routinely is for radiophamaceuticals.
Since FDA did not participate in authorizing the use of I-125 seeds, users follow the procedures recommended by the sole producer of the seeds (3M).
In addition, whereas the FDA collects and evaluates voluntarily submitted data on the use of radiophamaceuticals, it is unlikely that thyroid uptakes from leaking I-125 seeds would be reported to FDA.
4 2.
Discussion a.
Events 4
(1) University of Connecticut
==
Description:==
,0n 5/6/81, 40 1-125 seeds having an activity
" range of 0.61' 'to 0.64 niilitcuries each were inserted into the
~
l prostate of a patient. On 5/7/81 the patient's accumulated i
urine was monitored for dislodged seeds. No dislodged seeds were found but activity was detected.
A thyroid blocking agent was administered.. On 5/11/81 the thyroid burden was estimated to be 2.076 pCi and the infinite dose to the thyroid was calculated to be 9.04 rad.
Licensee Action: Licensee's investigation found that the individual who had inserted the seeds into the implant instrument's plastic tubes had difficulty in making the insertions and extra force was required.
(Note:
One seed is loaded per plastic tube in preparation for the implant procedure, at which time the seeds are fed to the application device.) A few seeds had been crimped by the forceps during the process, 4
but leak tests on these seeds at the time did not reveal any
+
removable activity. Seed damage was not noticed. There was no apparent difficulty in feeding the sterilized seeds from the plastic tubes into the implant instrument, a Henschke type pemanent interstitial implant instrument manufactured by Mick Radio-Nuclear Instruments, Incorporated.
In order to prevent future incidents of this nature, the licensee stated that seed handling and loading procedures would be reviewed and modified i.
to eliminate as far as possible any potential for damage to the seeds.
9 See Attachment 5 for a description of the I-125 seeds.
p 1816k
, C. J. Heltemes, Jr.,
(2)
VCU Medical College of Virginia (a) -Description:
On 5/21/81 a Mick applicator being used during a prostate implant jammed during the procedure. The resident tried to free the gun and subsequently ruptured one of the seeds. The doctor's hand and the gun were contaminated.
The implant was stopped, the patient closed, and decontam-ination began.
Licentee Action:
Subsequent bioassays showed only the resident had received a thyroid burden (30 nanocuries) as a result of this incident. The licensee's Radiation Safety Cominittee would review the implant procedure before other implants were done.
(b)
==
Description:==
After completing a routine interstitial prostate implant on 7/7/81 fragments of an I-125 seed were found in the upper chamber of the Mick applicator used to perfonn the implant.
Contamination was also noted on a number of surgical drapes.
Evaluation of the patient's urine the next day revealed free I-125. Exogenous iodine was administered to block the patient's thyroid. Thyroid activities measured by bioassays done on July 8 and July 14 were 0.8 and 7.8 pCi, respectively (note: activity peaked on July 14).
Licenseehetion:
In the report of the licensee's investigation it is noted that the radiation therapy resident felt, some re-sistance while inserting one of the seeds and rather than force the applicator had pulled back on the inserting rod a second time and proceeded to insert the seed with no further dif-ficulty. The licensee's RSO planned to further evaluate the implant device.
(c)
==
Description:==
A September 1981 incident was summarized by Mr. Dean Broga (VCU's RS0) as follows:
clean, undamaged I-125 seeds were implanted without problems on 9/2/81 at which time the patient's urine contained 1.1 nCi/mi 1-125. On 9/4/81 the patient's urine had an activity of 8.4 nCi/ml and thyroid blocking agent was administered. Thyroid burden peaked at 2.365 VCi on 9/18/81 (approx.10 rad thyroid dose even after thyroid blocking had been perfonned).
Licensee Action: Licensee's RSO contacted Region II by phone. RSO planned to continue to evaluate problems with seeds and/or applicator. The RSO and a urologist are preparing _a paper on the subject which will be presented at a urologists' conference next month and at a Health
~'
Physics Society c'onference this summer.
e i
C.- J. Heltames, Jr. MAY 181982
-In discussions between Dean Broga and E. A. Trager on 12/10/81 and 12/16/81, Mr. Broga expressed his opinion that I-125 seed leakage problems could be wide-spread and may go un-noticed (and unreported) if poor patient bioassay techniques are used to detect I-125 in uiine after imp 1 ant procedures.
In fact, Mr. Broga stated that his conversations with other hospitals indicated that many hospitals had discontinued patient bioassay after finding that the bioassay results were always negative.
(3) Agreement State (Rhode Island) Licensee (a)
==
Description:==
Implant done on 7/21/81 of 3M Model 6701 seeds each with an activity in the range of 0.625-0.813 mci. Trans-urethral resection (TUR; surgical removal of the center core of prostate tissue surrounding the urethra) done on 11/4/81 (at which time estimated average activity of implants was 170 pCi).
None of the five recovered seeds was found to be leaking, but about 60 $1 1-125 was found in the Operating Room (OR) suction and drainage fluids. The patient was thyroid blocked with KI within hours of the TUR. An additional 140 pCi 1-125 was excreted by the patient at a decreasing rate over the subsequent six day period.
f (b)
==
Description:==
Implant done on 8/26/81. TUR done on 11/5/81. '
Of the l'5 recovered seeds several were leaking and about 470 pCi I-125 was found in the OR fluids. The patient was thyroid blocked.
130 pCi was excreted at a decreasing rate over the next 5 days.
Licensee Action: Because the loss of I-125 seeds subsequent to a TUR was considered likely, the licensee had developed procedures to locate and recover seeds lost during this period.. It was during conduct of this precautionary pro-i cedure that the licensee discovered contamination of the patients' urine.
The licensee found that a loss of seed integrity was related to the use of electronic cauterization during the TUR procedure.
l It is important to emphasize the following:
1.
Seeds had been implanted for over two months before the TUR was perfomed during which time average seed activity decreased by over 75%.
ii.
The licensee had developed procedures to monitor for lost seeds following the TUR and thereby detected I-125 in the patient's urine.
However, it is not clear what,.
monitoring was done following the implants.
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C. J,. Hel tame s, Jr. MAY 181982 iii. The licensee believed that seeds were damaged by i
electronic cauterization. Testing did not reveal leakage of undamaged / intact seeds.
b.
WMSS Actions On 7/20/81, FCMC wrote to 3M concerning the University of Connecticut seed leakage incident.
3M responded on September 23,1981 (Attachment 6).
i The response by 3M expresses their opinion that rough handling caused seed damage and leakage. A iMSS evaluation of the 3M response was not formally documented, although we believe that some portions of the response warrant an evaluation. For exemple, when asked whether the instructions to the user were sufficiently detailed with respect to seed handling procedures, 3M responded that the procedures were adequate for an incident ~ in which a seed (s) had received " obvious" damage, however, "The instruction 'does not pertain to a slightly damaged source, which may have no obvious cracks, fissures or broken end welds, but which may in fact have developed a microscopic crack, not visible to the unaided eye. When an I-125 Seed of this latter description is implanted, body fluids could potentially seep into the capsule through the crack and remove I-125, distributing it into surrounding tissue and eventually throughout body fluids according to nomal metabolism of iodine. This risk of exposure is largely confined to the patient."
The resolution of the proble$n'by 3M was to add a " warning" within the
~~
I-125 seed shipping carton which instructs against damaging seeds and against the use of " visibly" damaged seeds.
However, in the 3M responses it is clearly stated that microscopic cracks may exist in seeds and that i
only a special leak test procedure would enable detection of the cracks.
c.
IE Actions
- An earlier May 1980 incident involving leaking I-125 seeds resulted from seed damage during another part of the seed implant process -
the sterilization of seeds. The incident, which was reported by a
. Veterans Administration Hospital in Buffalo ( Attachment 7), resulted in a dose of 80 REM to the patient's thyroid.
As a result of the incident IE Infomation Notice #80-35, titled " Leaking and Dislodged Iodine-125 Implant Seeds," was issued on October 10, 1980. The notice stated that licensees (1) should " review handling procedures for the sealed sources, including methods of sterilization, to eliminate those procedures which establish procedures could physically damage the sealed sources," and (2) i "to assure that, following implantation, proper surveys are perfomed for detecting leaking on dislodged sources." Although the IE Infomation Notice did not eliminate the problem, it apparently brought it to the attention of hospital personnel.
4 9
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C. J. Heltemes, Jr. '
MAY 181882 3.
Findings and Conclusions a.
It is possible that leaking I-125 seed incidents occur more frequently than reported, because they are not detected. 3M has stated that the seeds may develop microscopic cracks and that standard wipe testing would not detect leaking seeds.
This would be a serious problem if patient bioassay for I-125 is poor or non-existent.
b.
There are no FDA-approved procedures for the use of I-125 seeds, and current NRC licenses require bioassay only tc detemine occupational radiation exposure of hospital personnel. Therefore, it appears that question of.1-125 thyroid uptake by patients from sealed sources is not currently being addressed in the licenses.
c.
A review of infomation submitted by 3M on the Model 6701 1-125 sealed source (to obtain a certificate of approval by NRC) indicates that certain infomation relevant to sealed source containment inte-grity was never provided. For example, (1)
Data was not provided to support 3M's claim that seeds provide adequate durability when subjected to nomal handling procedures.
(a)
Data was not provided on seed response to forceps pressure.
Although 3M warns that seeds should not be handled with unnecessary force, the warning might be difficult to understahd unless the user is aware that the seeds may develop microscopic cracks that are not visible to the unaided eye and that a nomal wipe test procedure could not be used to detect seeds that might leak after being impl anted.
(b)
Data was not provided to show that routinely produced seeds would perfonn as did the prototype seeds.
- i. Alth'ough routine production quality control pro-cedures require sampling of seeds to check certain seed characteristics, testing of seeds does not include batch sampling and impact, percussion, and bend testing. Although three prototype seeds (from the same batch) were crushed flat and did not leak, data was not provided to show that production batches could similarly be expec.ted to maintain containment integrity.
ii. Although seeds are sampled to check that the outer diameter is within tolerance, data were not provided to show that the inner diameter tolerances of the recommended seed applicators are compatible.
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MAY 181982 7-C. J. Heltemes, Jr.
(2) Data were not provided to show how seeds with microscopic cracks might behave after being implanted in the body.
It is concluded t:.at additional consideration should be given to the leakage problems associated with the use of I-125 implant seeds.
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M.
/t Eugene A. Trager Nonreactor Assessment Staff I
Office for Analysis and Evaluation of Operational Data
Enclosures:
As stated i
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M UNIVERSIT*.* OT CONNECTICUT H.5.1.7H CENTI?.
R:diatien Safet:-
May 22, icEl Regico I Office of Inspectics ar.d Inforcenent U1:UtC g
631 Park Avenue 8
King of Prussia, PA 19,406
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Reference:
USSRC Byproduct h terial License So. 06-13022-02, University of Ccenecticut Eealth Center, Tar =insten, CT 06C32
+.-
" Gentle =en:
nis letter is sub=1tted in support of a telephone repert to Region I, USNRC, cade on May" 12, 1981.
At that time the Universiry of Cennecticut Eealth Center reported an unusual occurrence involving iodine-125 sealed source seeds used for interstitial treat =ent of prostate cancer.
On Wednesday, by 6,1981, forty iedine-125 seeds havi=g an activity range of 0.61 to 0.64..:
curies each ver ted inte the prostate of a 59 year eld caucasian patient ~
' The seeds were 3M brand
,t e patient's accu =ulated urine was cen-
'I-125 seeds (LRF-I y
itored for disledged sources.
No dislodged seeds were found but activity was detected in the urine.
An aliquet of the urine was assayed in a 3 s 3 in:h well type Na1 crystal.
The Radionuclide was identified as icdine-125 vith an esti=ated activity of 0.0C42 uCi/=1.
The patient was given a thyroid bleeking agent te restritt the uptake of radiciodine by the thyrcid.
On May 8,1:51 an esti=ife' o.
iodine-125 thyrcid burden was cade using 5 x 2 inch ::a1 trystal and a Suelear Lata TL100 nulticht:nel analyzer.
The syste= vas calibrated using a neck phante= and a siculated iodine-125 sta=dard sourca Thyrcid burden was est'-= ted to be 0.688 uti. The i finite dose to the thyroid was calculated to be three rads, using MIED dosimetry calculatien procedures.
On May 11, 1951 the urine activity was 0.0063 uti/=1 and the thyreid burden was est'i=ated to be 2.076 uC1.
The i=fi=ite dose to the thyroid was calculated to be 9.04 rads for this iodine-125 burden.
The patient was discharged frc= the hospital en May 12, 1981 and vill be fel-leved on an outpatient basis.
A thyroid blocking agent has been prescribed and 'urina and thyroid iodine-125 activity vill be deter =ined at periodic intervals.
One seed vas found in ine during his hespital stay. This occurred during the af ternoon c. May 7,1981, the day af ter the seeds vere i=:ltstad.
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Westigation was made in an atte=pt to dete:=ine the possible cause Sine-125 fcund in the urine.
The interie cf the vial conta'ining the x..-
socn svabbed with a cetton tipped applica:or at the time the shiptent
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$nto th2 inplant instrument's plastic tutes stated he had some difficultv
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3d. No activity was detected en the swat. The individual that inserted
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khe i=sertic=s.
So=e seeds did ntt slip czsily into the tubes and er.tra I,S$.. ~. N Required.
A few seeds were slightly cA m ed by the forceps durinc the M ' E ' *#*'
i kcok tests.on these seeds at that ti=F' did net reveal a=y re=ovabie 7.I.T. f*/N
z It is possible that dur'ng the insertion of the seeds into the tubing 5D '. ' #'
da= aged and not notice There was no apparent difficulty in feeding M.E',D;O$$f
$zad sesds fre= the plastic tube 81nto the i= plant instrument a Eenschke
^ :;qi[ *.; [*!,ef.'-
%e=t interstitial implant instrument =anuf actured by Mick Radio-Nuclear O 2['b'..!jd t
D, Incorporated.
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cr.to prevent future incidents of this nature, the seed handling and c;durcs are being reviewed and codified to el'-4: ate a's far as pcssible r't-*N*5%
Iid al for da= age to the seeds.
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Si=cerely,
-,: ? '.' :: 6' L$C
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Edvard I. Morse, M.D.
Chair:an, Fadioisotopes Cc==1ttee l.
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%c4 VIRGINIA COMMONWEALTH UNIVERSITY g
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MCV Station. Richrnond.Virginta 23298 Box 549 e,,
ecu co.tict a n= >.a seus s:e.s E **""
June 17,1981 ma tses I
ymery m:cwas s: co.s 3Ans wh Mr. Wi1Tiam Perry o
Cir s Acting Chief, g,7,,,
Materials and Radiation Protection Section U.S. Nuclear Regulatory Commission Region II y
101 Marietta Street N.W. Suite 3100 Atlanta, Georgia 30303 I$ ear Mr. perry:
REPORT ON 125I SEED RUPTURE On May 21, 1981 a Mick applicator being used for a rostate implant jammed during the procedure.
The resident, tried -to f ree the gun and subsequently ruptured one o the seeds.
This action resulted in the contamination of the Doctor's band and the gun.
Conta.mination was also spread to the tray holding the gun and applicators.
The implant was " stopped, the patient closed, and deconta=ination begun.
A number of bioassa were done on the key individuals involved.
Only
-showed any detectable thyroid burden; approximately 30 nanocuries.
The therapy patient i
had both urinalysis and a thyroid analysis done for.1251 l
Neither revealed any statistically significant ac'tivity.
It 'was assumed that none of the sources in the patient were leaking, and that the surgical field was not contaminated during the incident.
The Therapy Department is presently reviewing the procedure and considering replacing the gun.
The Radiation Safety Committee will review the procedure with Therapy before any future implants are cone.
Mr. William Perry June 17, 1981 e
Page 2 e
e Mr. Dean W. Broga, Director of Radiation Safety, reported this incident to you by telephone on May 27, 1981.
This report is therefore a formal recapitulation of the incident.
Should you have any questions regarding this report please contact Mr. Broga.
Sincerely, L.
. Woods, Ph.D, M.D.
Acti.ng V.P. k Asso.
V.P. for Health Sciences e
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.' ;f Y JiEDICAL COI.LEGE OF VIRGINIA 0AA VIRGINIA COMMONWEALTH UNIVERSITY MCV Station. Richmond. virginia 2320s f
NRC License M 5-00048-17 July 23, 1981
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[*Q' Mr.17illiam Perry km:r Acting Chief, s:::tva.ceutt :ns Materials and Radiation N.I.3 sw:o protection Section g g g,,,
U.S. N6 clear Regulatory Commission Region II t e.m.e.
101 1.!arietta Street N.ti. Suito 3100 Atlanta, Georgia 30303
Dear Mr. perry:
REPORT OF 125I SEED RUPTURE Upon cor.pletion of a routine interstitini prostate implant on Tuesday, July 7,.1981, f ragments of an 125I cocd were
-fot:nd in th'e upper ~ chamber of the Mick applicator used to' perform the implant.
Contamination was also noted on a number of the surgical drapes.
None of the O.R.
staff were contaminated.
An evaluation of the patient's urine by the Radiation Safety Of fice (RS0) early the next day revealed f ree 125I.
Dr. Warren Koontz, the referring physi'cian, was informed of the findings.
.It was decided at the time that the patient should be put on exogenous iodine to block the thyroid.
Dr. Koontz informed the patient of the situation and indicated to.him that he would be placed on exogenous iodine.
The procedure was reviewed with the staff to try and identify when or how the rupture occurred.
The Radiation Therapy resident noted that while inserting one of the seeds be felt some resistance.
Itather than force the
- ,pplicator he pulled back on the inscrting rod a second time and proceeded to insert the secd with no npparent problem.
Except for this incident no other notable prob 1cm could be recalled.
Subsequent urin 217 sis revealed constant icvels of 125 I dono on July [Thyrcid activitics measured by binass:tvsand in the urine.
Urinalysis d ne on July 15 indicated a decrease'-in excretc
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- 5. r. a1111am Perry July 23, 1981 Page 2 concentrations.
The patient vias discharged on July 15 and ar.ked to remain on exogenous iodine until follow-up urinalysis indicates a significant drop in excreted 125I Icycls.
The Mick applicator used in this procedure was borrowed from the McGuire V.A. Hospital, Richmond, Virginia and had never been used.
Previous experience with this device indicated that there may be an inherent problem either. with the app 11cator or the seeds.
The RSO in planning to further evaluate the device using some clear
~
gelatin molds.
It is hoped that this evaluation may shed some light on the reason for seed ruptures.
~
The seed rupture and leakage was originally reported to you by phone on July 9,1981.
This report is a formal restatement of the incident and serves to bring the NRC up-to-date on the situation.
Should you have any questions please contact Mr. Dean W. Broga in the Radiation Safety Office at (804) 786-.
9131.
Sincerely, Y
ohn J. Salley,D.D.S.,ph.D.
Vice President for Research, Dean of Graduate Studies
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NRC Document Management Branch e* *+
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STATE OF RHODE Is!.AND AND PROVIDENCE P A ATIONS DEPARTMENT OF HEA1.TH.
2 December 1981 75 Davis Street
' Providence, R.1.02908 Mr. Donald A. Nussbaumer Assistant Director for State Agreements Program Office of State Programs U.S. Nuclear Regulatory Connission 20555 Wpshington,DC U-
Dear Mr. Nussbaumer:
Subject:
Loss of Integrity of Iodine 125 Seeds
'A medical licensee has infonned this Agency of two instances in which the loss of. integrity of I'-125 seeds was possibly caused by a surgical procedure.
While these incidents do not appear to meet abnormal incident reporting cri.teria, we
~
feel that they may have generic significance and are, bringing them to your at-tention.
These incidents involved two patients who underwent transurethral resection l
The (TUR) subsequent to receiving I-125 seed implants for prostate therapy.
Original activity" sealed so'urces.used in both cases were 3M Company Model 6701.
~
of the sources was in the range of 0.5 - 0.65 mci compensated.
~
A TUR is the surgical removal of the center core of prostate tissue ' surrounding the urethra. The licensee believes that the loss of seed integrity is related,
to the use of electronic cauterization during the TUR procedure.
l The loss of iodine seeds subsequent to a TUR is very likely.
It may occur during catheter removal and also whenever the patient voids during the next several days l
following catheter removat 'Therefore, the licensee had developed procedu~res to locate and recover any seeds lost during this period.
It was during the conduct..
of this precautionary procedure that the licensee discovered contamination of the TUR patients' urine.
The manufacturer of the sealed sources, 3M Company, has been notified by the l
. licensee.
Some facts regarding the licensee's assessment and h' ndling of this pro'blem are a
as follows:
Patient No. 1_:
Implant done on 7/21/81.
TUR done on 11/4/81.
Five seeds were recovered during the TUR. None of these seeds was found to be leaking 1-125.- About 60 uti 1-125 was found in Operating Room -.
suction and drainage fluids.
An additional 140 uti was excreted at a continuously decreasing rate over a six day period.
For example:
day 1,12 hour1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />' collection - 52 uCi; day 2, 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> collection - 16 uti; day 6,12 hour1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> collection - 0.5 uCi. The estimated average, activity of the implants was 1.70 uGi on.11/4/81.
This patient was thyroid blocked with KI within hours following A thyroid uptake done on,11/10/81 indicated 1.5 uti
$ G-M Fi-O C ]
g the TUR.
present.
No 1-125 was measurable in a blood sample.
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.Mr. Donald A. Nussbaumer
~
' Page 2 2 December 1981
(
Patient'No. 2:
Similar to patient no'.1: ~ Implant on B/26'/81.
TUR on 11/5/81.
15 seeds recovered during TUR.
470 uti in OR.floids.
130 uti excreted at decreasing ' rate' over five" days."Last 12 hour1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> collection = 0.25 uti.. Estimated remaining activity.- 201 uti/
seed.
Thyroid burden 0.1 uti.
Of the 15 seeds.' recovered.in the OR, several were found to be leaking. These have been saved for s'tudy.
An additional 9 seeds voide'd by the patient.were intact.
the licensee's corrective actions may be summarized as:
1) prompt thyroid l
blocking; 2) precautions against contamination from excreta; 3) notification of this Agency and the source manufacturer; and 4) retention of leaking seeds for follow-up study.
We will inform you of any significant changes or addition to this report.
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Very truly yours.
C0!EUNITY H5ALTH' SERVICES W$
James E. Hickey, Chief g'
l Division of Occupationtl Health
.and Radiation Control 1
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Iodine-125 Sealed Source Description The 3M Company Model 6701 1-125 " Seed" consists of a cylindrical titanium capsule containing two ion exchange resin spheres with absorbed Iodine-125, welded at both ends. The two resin spheres are separated by a 0.6 mm diameter gold sphere, which serves to enhance the visibility of the sources in a radiograph. A schematic diagram of the model 6701 seed is presented as Figure 1.
Radioactive iodine-125 is affixed to the resin by simple ion exchange in an aqueous solution. The model 6701 for permanent interstitial implants contains 0.125 to 1.25 mci (nominal 0.688 mci) per seed. This is followed by two washes with distilled water and drying prior to placement within the titanium can.
3M stated (September 28, 1981 letter) that the titanium capsule material was chosen because of its strength, low atomic number and low density, and that the wall thickness of about 0.06 mm (Figure 1 specification is actually 0.051 1.0.013 mm) was felt to provide " adequate durability when seeds are subjected to normal handling procedures..., and yet absorption of contained radioactivity is kept to a reasonable level of 161."
In addition, the seeds passed certain prototype tests (impact, percussion and bend tests) required of sealed sources.
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DISTRIBUTION
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July 20,1981 g,
NM55 R/F FC Central File MCPB R/F Minnesota Mining and j
Manufacturing Company ATTN: Mr. T.H. Lahr 3M Center St. Paul, Minneso'ta 55144 Gentlemen:
22, 1981 which was filed by the This refers to a report dated May University of Connecticut with HRC Region I, Office of Inspection and e
Enforcement,. The report deals with an event involving apparent'
~' leakage :if I-125 from your Model'6701 Type Therapeutic Seeds (copy enclosed).
According to the report, the individual who inserted the seeds into the inplant instrument's plastic. tubes experienced difficulty in making.the Some seeds did not slip easily into the tubes and extra insertions.
force was required.
A few of the seeds were slightly cripped by the forcepts dyri,r!gthe process.
However leak tests of the seeds at that time did not nyell any rem'ovable activity.
' Follow up urine and thyroid testing of the patient did reveal iodine in the urine and in the thyroid.
From this we conclude that some of the s'eeds leaked iodine.
reperting this event sta,ted that seed handling and loading The licensee procedures are being reviewed and modified to eliminate as far as possible any potential for damage to the seeds.
As a further follow up to the above described e. vent, we ask that you provide us with:
1.
Your assessb.ent as to the cause of the event.
Do you believe this event indicates a potential design defect in'
.2.
the Model 6701~, i.e., is the capsule wall thickness too thin?
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2-3.
Were instructions to the ' user sufficiently detailed with respect to seed handling procedures?
4 Why do you think the licensee's leak test failed to reveal the presence of contamination on the damaged capsules?
5.
Are you aware'of a specific leak test procedure which might predict leakage of damaged sources subjected to body fluids?
.6.
What modifications.do you plan to make to either the design of the Model 6701 or!to your recomended handling procedures to prevent recurrence of this type incident?
-please call me on (301) your pror.pt attention, If you have questionsk Please give this matter 427-4240.
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Sincerely, Earl G. Wright Material Certification and Procedures Branch Division of Fuel Cycl e and Material Safety J
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