Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
January 31, 1992
NRC INFORMATION NOTICE 92-10: BRACHYTHERAPY INCIDENTS INVOLVING
IRIDIUM-192 WIRE USED IN ENDOBRONCHIAL
TREATMENTS
Addressees
All Nuclear Regulatory Commission (NRC) licensees authorized to use
iridium-192 for brachytherapy; manufacturers and distributors of iridium-192
wire for use in brachytherapy.
Purpose
This information notice describes two events in which iridium-192 wire
attached to an unirradiated, flexible guide wire became detached from the
guide wire. The use of iridium-192 wire for intracavity brachytherapy
treatment is not authorized under 10 CFR 35.400, and may only be authorized
by a customized license review and amendment. In one event, a portion of
the iridium-192 wire remained in the patient's thorax. It is expected that
licensees will review this information for applicability to their programs,
distribute it to members of the Radiation Safety Committee and to
responsible staff and hospital management, and consider actions, if
appropriate, to prevent similar incidents from occurring at their
facilities. Suggestions contained in this information notice do not
constitute new NRC requirements, and no written response to the notice is
required.
Description of Circumstances
Two brachytherapy incidents have been reported that involved endobronchial
treatment of patients using iridium-192 wire. The brachytherapy device
consisted of activated iridium-192 wire of specified activity content
attached to a nonradioactive guide wire.
On January 6, 1989, an iridium-192 wire used for an endobronchial
brachytherapy treatment 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 not encased in the closed-end nylon tube, described in the
manufacturer's instructions. The unencased wire, attached to a flexible
nonradioactive guide wire, was placed in an opened-end catheter and the
catheter was introduced into the patient's thorax through a bronchoscope.
The calibrated activity of the iridium-192 wire was 86.9 millicuries, and
the length was 7 centimeters.
9201280345
.
IN 92-10
January 31, 1992
Page 2 of 3
While inserting the wire into the catheter, personnel noticed that the wire
could not travel down as far as they had planned. The wire was pulled back
to determine the cause of the obstruction. Approximately 5 cubic
centimeters of saline solution were introduced into the catheter to
facilitate removal of any possible obstruction and reinsertion of the wire.
However, before a second attempt was made to reinsert the wire, personnel
noticed that the wire was markedly shorter than its original length. At
that point, personnel presumed that the radioactive part of the wire was
withdrawn but broken off in the catheter. After withdrawing the catheter,
personnel found that the missing radioactive part had slipped through the
catheter and remained in the patient. The bronchoscope was withdrawn.
Surveys conducted on the patient's chest revealed an elevated exposure rate
confirming that a portion of the iridium-192 wire remained in the patient's
thorax.
A bronchoscope was re-introduced into the patient, and several unsuccessful
attempts were made to locate and remove the wire. A thoracotomy was
performed on the patient and the wire was removed with no further
complications. In this event, the iridium-192 was neither encased in a
nylon tube when it arrived 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 an
endobronchial treatment was received unencased and then used in an open-end
catheter. The wire had a calibrated activity of 157.7 millicuries and a
length of 4 centimeters.
Upon completion of the treatment, the guide wire was withdrawn from the
patient and placed in the shielded transport container. The patient was
immediately surveyed, in accordance with procedures, with a Geiger counter
that showed readings in excess of 300 mR/hr. Assuming that the iridium-192
wire had remained lodged in the patient, the personnel involved in this
procedure immediately withdrew the open-end catheter used to contain the
wire. A subsequent survey of the patient showed background readings. A
wipe test of the room and the guide wire that was attached to the
iridium-192 wire showed no removable contamination.
An autoradiograph of the catheter showed that it contained the intact
4-centimeter iridium-192 wire. Personnel concluded that the radioactive
wire became detached from the guide wire when it was being withdrawn from
the patient and remained inside the catheter.
Discussion
Although neither of these incidents was a reportable misadministration, the
first incident resulted in an unanticipated surgery and constituted a health
risk to the patient. In each of the two events, all or part of an
iridium-192 source attached to a nonradioactive guide wire became detached
from the guide
.
IN 92-10
January 31, 1992
Page 3 of 3
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
laboratory prior to implantation.
The iridium-192 wire for brachytherapy endobronchial treatments will
be inserted using fluoroscopy.
The licensees will contact the manufacturer about the possibility of
obtaining an iridium-192 wire encased in a closed-end tube.
If resistance is encountered while the iridium-192 wire is being
withdrawn, no force will be used to remove it, because such force may
break or dislodge the radioactive wire. Instead, the catheter
containing the wire will be removed.
This information notice requires no specific action or written response. If
you have any questions about the information in this notice, please contact
the technical contact listed below or the appropriate regional office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Harriet Karagiannis, AEOD
(301) 492-4258
Attachments:
1. List of Recently Issued NMSS Information Notices
2. List of Recently Issued NRC Information Notices
.
