Information Notice 1992-10, Brachytherapy Incidents Involving Iridium-192 Wire used in Endobronchial Treatments

Brachytherapy Incidents Involving Iridium-192 Wire used in Endobronchial Treatments

ML031200703
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	01/31/1992
Revision:	0
From:	Cunningham R E NRC/NMSS/IMNS
To:
References
IN-92-010, NUDOCS 9201280345
Download: ML031200703 (5)

UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555January 31, 1992NRC INFORIATION NOTICE 92-10: BRACHYTHERAPY INCIDENTS INVOLVINGIRIDIUM-192 WIRE USED IN ENDOBRONCHIALTREATMENTS

Addressees

All Nuclear Regulatory Commission (NRC) licensees authorized to useiridium-192 for brachytherapy; manufacturers and distributors of iridium-192wire for use in brachytherapy.

Purpose

This Information notice describes two events in which iridium-192 wireattached to an unirradiated, flexible guide wire became detached from theguide wire. The use of iridium-192 wire for intracavity brachytherapytreatment is not authorized under 10 CFR 35.400, and may only be authorizedby a customized license review and amendment. In one event, a portion of theiridium-192 wire remained in the patient's thorax. It is expected thatlicensees will review this information for applicability to their programs,distribute it to members of the Radiation Safety Committee and to responsiblestaff and hospital management, and consider actions, if appropriate, toprevent similar incidents from occurring at their facilities. Suggestionscontained in this information notice do not constitute new NRC requirements,arid no written response to the notice is required.Descriptioi' of CircumstancesTwo brachytherapy incidents have been reported that involved endobronchialtreatment of patients using iridium-192 wire. The brachytherapy deviceconsisted of activated iridium-192 wire of specified activity contentattached to a nonradioactive guide wire.On January 6, 1989, an iridium-192 wire used for an endobronchial brachytherapytreatment of a patient was not retrievable and had to be removed surgically.When the iridium-192 wire was received by the hospital staff, it was notencased in the closed-end nylon tube, described in the manufacturer'sinstructions. The unencased wire, attached to a flexible nonradioactive.guide wire, was placed in an opened-end catheter and the catheter was introducedinto the patient's thorax through a bronchoscope. The calibrated activity ofthe iridium-192 wire was 86.9 millicuries, and the length was 7 centimeters.320128352S~h- i/C-(\X IN 92-10January 31, 1992 While inserting the wire into the catheter, personnel noticed that the wirecould not travel down as far as they had planned. The wire was pulled backto determine the cause of the obstruction. Approximately 5 cubic centimetersof saline solution were introduced into the catheter to facilitate removal ofany possible obstruction and reinsertion of the wire. However, before a secondattempt was made to reinsert the wire, personnel noticed that the wire wasmarkedly shorter than its original length. At that point, personnel presumedthat the radioactive part of the wire was withdrawn but broken off in thecatheter. After withdrawing the catheter, personnel found that the missingradioactive part had slipped through the catheter and remained in the patient.The bronchoscope was withdrawn. Surveys conducted on the patient's chestrevealed an elevated exposure rate confirming that a portion of the iridium-192wire remained in the patient's thorax.A bronchoscope was re-introduced into the patient, and several unsuccessfulattempts were made to locate and remove the wire. A thoracotomy was performedon the patient and the wire was removed with no further complications. Inthis event, the iridium-192 was neither encased in a nylon tube when itarrived at the hospital, nor was it placed in a closed-end tube.On July 7, 1989, at a different facility, an iridium-192 wire for anendobronchial treatment was received unencased and then used in an open-endcatheter. The wire had a calibrated activity of 157.7 millicuries and alength of 4 centimeters. -Upon completion of the treatment, the guide wire was withdrawn from thepatient and placed in the shielded transport container. The patient wasimmediately surveyed, in accordance with procedures, with a Geiger counterthat showed readings in excess of 300 mR/hr. Assuming that the iridium-192wire had remained lodged in the patient, the personnel involved in thisprocedure immediately withdrew the open-end catheter used to contain the wire.A subsequent survey of the patient showed background readings. A wipe testof the room and the guide wire that was attached to the iridium-192 wireshowed no removable contamination.An autoradiograph of the catheter showed that it contained the intact4-centimeter iridium-192 wire. Personnel concluded that the radioactive wirebecame detached from the guide wire when it was being withdrawn from thepatient and remained inside the catheter.DiscussionAlthough neither of these incidents was a reportable misadministration, thefirst incident resulted in an unanticipated surgery and constituted a healthrisk to the patient. In each of the two events, all or part of an iridium-192source attached to a nonradioactive guide wire became detached from the guide IN 92-10January- 31 1992Page 3 of* wire. The involved licensees adopted the following procedural measures to-prevent this type of event from reoccurring:The iridium-192 wire will be inspected and tested in the hot laboratoryprior to implantation.The iridlum-192 wire for brachytherapy endubronchial treatments will beinserted using fluoroscopy.The licensees will contact the manufacturer about the possibility ofobtaining an iridium-192 wire encased in a closed-end tube.If resistance is encountered while the iridium-192 wire is beingwithdrawn, no force will be used to remove it, because such force maybreak or dislodge the radioactive wire. Instead, the cathetercontaining the wire will be removed.This information notice requires no specific action or written response. Ifyou have any questions about the information in this notice, please contactthe technical contact listed below or the appropriate regional office.Richard E. Cunningham, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand SafeguardsTechnical contact: Harriet Karagiannis, AEOD(301) 492-4258

Attachments:

1. List of Recently Issued NMSS Information Notices2. List of Recently Issued NRC Information Notices IN 92-10January 31, 1992 wire. The involved licensees adopted the following procedural measures toprevent this type of event from reoccurring:The iridium-192 wire will be inspected and tested in the hot laboratoryprior to implantation.The iridium-192 wire for brachytherapy endobronchial treatments will beinserted using fluoroscopy.The licensees will contact the manufacturer about the possibility ofobtaining an iridium-192 wire encased in a closed-end tube.If resistance is encountered while the iridium-192 wire is beingwithdrawn, no force will be used to remove it, because such force maybreak or dislodge the radioactive wire. Instead, the cathetercontaining the wire will be removed.This information notice requires no specific action or written response. Ifyou have any questions about the information in this notice, please contactthe technical contact listed below or the appropriate regional office.Richard E. Cunningham, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand SafeguardsTechnical contact: Harriet Karagiannis, AEOD(301) 492-4258

Attachments:

1. List of Recently Issued NMSS Information Notices2. List of Recently Issued NRC Information Notices*See previous concurrences.EKraus, Tech Editor 10/08/91OFC: IMAB :IMAB :IMAB :IMOB :IMNS :IMNSNAME:*JSmith :*LWCamper:*JEGlenn :*JHickey :*JGreeves:*RECunninghamDATE:01/15/92 :01/22/92 :01/23/92 :01/23/92 :01/24/92 :01/24/92-^_t-- nrzn rVn .Afl tnWFICIAL KMUUKU WeTIN VC-1U LTS PROGRAM Codes21102120212122002201