Information Notice 2003-21, High-Dose-Rate-Remote-Afterloader Equipment Failure
| ML033250492 | |
| Person / Time | |
|---|---|
| Issue date: | 11/24/2003 |
| From: | Chris Miller NRC/NMSS/IMNS |
| To: | |
| References | |
| IN-03-021 | |
| Download: ML033250492 (7) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555-0001 November 24, 2003 NRC INFORMATION NOTICE 2003-21: HIGH-DOSE-RATE-REMOTE-AFTERLOADER
EQUIPMENT FAILURE
Addressees
All medical licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to inform
addressees of a recently reported medical event that occurred during the conduct of a high- dose-rate-remote-afterloader (HDR) brachytherapy procedure. The medical event involved
error in selection of ancillary equipment--transfer tube--required for use of the HDR unit, resulting in failure of the sealed source to reach its intended position for treatment, and failure
of the sealed source to retract on completion of the procedure.
It is expected that recipients will review this information for applicability to their licensed
operations and consider actions, as appropriate, to avoid similar problems. However, suggestions contained in this IN are not new NRC requirements; therefore, no specific action
nor written response is required.
Description of Circumstances
An Agreement State licensee reported that a 170.2 gigabecquerel (4.6 curie) iridium-192 sealed
source contained in a Nucletron MicroSelectron HDR afterloader device--Model Number 31324-
-failed to retract on completion of a patient treatment. The physicist entered the treatment room
and attempted to manually retract the sealed source, which was stuck in the transfer tube, the
source conveyor device between the HDR unit and the applicator used for the procedure.
Manual retraction of the sealed source failed. The physician entered the treatment room, disconnected the apparatus from the patient, and dropped the transfer tube into a lead
container. Both the physicist and physician then moved the patient out of the room. The
physicist observed that 2 minutes had elapsed since he entered the treatment room. The
physicist surveyed the patient with a radiation detection instrument to confirm that the source
had been removed. The physicist then re-entered the room to perform a radiation survey. He
confirmed that the source was within the transfer tube and that it was shielded by the lead
container. The physicist measured 0.1 millisievert (mSv)/hr at 0.91 meters [10 millirem
(mrem)/hr at 3 feet] from the shielded container. The room was locked and posted until the
manufacturer's representative arrived. The manufacturers representative also was unable to
retract the source from the transfer tube into the HDR unit. He then disconnected the transfer
tube from the HDR unit, placed the transfer tube, containing the sealed source, into a shipping
container, and arranged for returned of the transfer tube to the manufacturer, for further
investigation.
Doses to the patient, physicist, and physician (as originally reported) were estimated as
follows: (1) patients skin dose, at 10 centimeters (cm) [3.9 inches (in.)] from the sealed source, was 0.61 sieverts (Sv) (61 rem); (2) physicists whole-body dose (deep-dose equivalent), for the
2-minute exposure, was 0.45 mSv (45 mrem); (3) physicians whole-body dose (deep-dose
equivalent) was 1.25 mSv (125 mrem), and extremity dose was 0.15 Sv (15 rem).
The Agreement State and NRC are continuing to investigate this event. Because of the
importance to licensees of the information contained in this IN, it is being issued before
completion of the investigation of this event.
Discussion:
Although the transfer tube used was manufactured by Nucletron for use with the Nucletron
MicroSelectron HDR afterloader device, it was a rigid gynecological-type tube, not designed for
use with the Proxima Therapeutics Mammosite applicator being used by the licensee for the
procedure being performed. Nucletron indicated that the licensee should have used its flexible
transfer tube, approved for use for non-gynecological-type treatments, which is designed to
accommodate the Mammosite applicator.
As a result of the incorrect choice of transfer tube (i.e., an incorrect transfer tube being used
with the Mammosite applicator) during the procedure, the sealed source was inadvertently
positioned inside the transfer tube at a distance of 10-14 cm (3.9-5.5 in.) from the patients
breast, not in the breast, as planned. That is, the source of the radiation never arrived at the
intended treatment site within the patients body. Also, the use of the incorrect Nucletron
transfer tube for the Mammosite applicator apparently caused the subsequent failure of the
source to retract.
Licensees performing HDR brachytherapy procedures are expected to review this IN and:
- Assure that ancillary devices to be used with an HDR brachytherapy unit for a
therapeutic procedure are designed for use with, or are known to be compatible with, both the HDR afterloader unit and with any applicator(s) to be used during
the procedure;
- Assure that all HDR afterloader brachytherapy unit users are familiar with the operating
procedures and applicable usage restrictions of all equipment to be employed in a
procedure before actual use of such devices and ancillary equipment;
- Encourage device and equipment users to review all of the vendors pertinent
documentation and to clarify any concerns with the vendors, regarding particular
devices, before using the devices for patient treatments. If, based on prior review of a vendors documentation, and possibly discussion with a vendor, a user considers that
directions provided by an on-site vendors representative may perhaps be in error, licensees are expected to clarify any such discrepancies with the manufacturer before
use of the device(s); and
- Promptly report all system malfunctions to the vendors, and if required, to the licensing
authorities.
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact the technical contact below, or the appropriate
regional office.
/RA/
Charles L. Miller, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Ronald E. Zelac, Ph.D., NMSS
301-415-7635 e-mail: rez@nrc.gov
Attachments:
1. List of recently issued NMSS Information Notices
2. List of recently issued NRC Information Notices vendors documentation, and possibly discussion with a vendor, a user considers that
directions provided by an on-site vendors representative may perhaps be in error, licensees are expected to clarify any such discrepancies with the manufacturer before
use of the device(s); and
- Promptly report all system malfunctions to the vendors, and if required, to the licensing
authorities.
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact the technical contact below, or the appropriate
regional office.
/RA/
Charles L. Miller, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Ronald E. Zelac, Ph.D., NMSS
301-415-7635 e-mail: rez@nrc.gov
Attachments:
1. List of recently issued NMSS Information Notices
2. List of recently issued NRC Information Notices
ADAMS Accession#:ML033250492
- See previous concurrence or e-mail
Document Name: G:\IMNS\Cabrera\dft IN for PNO-IV-03-040A.rev 2.wpd
OFFICE MSIB MSIB MSIB NMSS MSIB IMNS
NAME: RZelac* ICabrera* RTorres* EKraus* TEssig CMiller
DATE: 10/23/03 10 /24/03 10 / 26 /03 10 /29 /03 11 / 5 /03 11/20/03 OFFICIAL RECORD COPY
Attachment 1 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2003-20 Derating Whiting Cranes 10/22/2003 All holders of operating licenses
Purchased Before 1980 for nuclear power reactors, except those who have
permanently ceased operations
and have certified that fuel has
been permanently removed from
the reactor vessel; applicable
decommissioning reactors, fuel
facilities, and independent spent
fuel storage installations.
2003-16 Icing Conditions Between 10/06/2003 All 10 CFR Part 72 licensees and
Bottom of Dry Storage System certificate holders.
and Storage Pad
2003-12 Problems Involved in 08/22/2003 All holders of 10 CFR Parts 32, Monitoring Dose to the Hands 33, and 35 licenses.
Resulting from the Handling of
Radiopharmaceuticals
2003-10 Criticality Monitoring System 08/04/2003 All U.S. Nuclear Regulatory
Degradation at BWX Commission (NRC) licensees
Technologies, Inc., Nuclear authorized to possess a critical
Products Division, Lynchburg, mass of special nuclear material.
2003-09 Source Positioning Errors and 07/16/2003 All medical licensees.
System Malfunctions During
Administration of Intravascular
Brachtherapy
Note: NRC generic communications may be received in electronic format shortly after they are issued by
subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the
message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit
Attachment 2 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2003-20 Derating Whiting Cranes 10/22/2003 All holders of operating licenses
Purchased Before 1980 for nuclear power reactors, except those who have
permanently ceased operations
and have certified that fuel has
been permanently removed from
the reactor vessel; applicable
decommissioning reactors, fuel
facilities, and independent spent
fuel storage installations.
2003-19 Unanalyzed Condition of 10/06/2003 All holders of operating licenses
Reactor Coolant Pump Seal or construction permits for
Leakoff Line During Postulated pressurized water reactors
Fire Scenarios or Station (PWRs).
Blackout
2003-18 General Electric Type SBM 09/26/2003 All holders of operating licenses
Control Switches With for nuclear power reactors, Defective Cam Followers except those who have
permanently ceased operations
and have certified that fuel has
been permanently removed from
the reactor vessel.
2003-17 Reduced Service Life of 09/29/2003 All holders of operating licenses
Automatic Switch Company for nuclear power reactors.
(ASCO) Solenoid Valves With
Buna-N Material
2003-16 Icing Conditions Between 10/06/2003 All 10 CFR Part 72 licensees and
Bottom of Dry Storage System certificate holders.
and Storage Pad
Note: NRC generic communications may be received in electronic format shortly after they are
issued by subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following
command in the message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit