Information Notice 1991-02, Brachytherapy Source Management
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS
WASHINGTON, D.C.
20555
January 7, 1991
NRC INFORMATION NOTICE NO. 91-02: BPACHYTHERAPY SOURCE MANAGEMENT
Addressees
All Nuclear Regulatory Commission (NRC) medical licensees authorized to use
byproduct material for medical purposes.
Purpose
This information notice is intended to emphasize to medical use licensees the
potential radiation hazards resulting from improper handling of brachytherapy
sealed sources. Licensees are expected to review this information for
applicability to their radioactive sealed source procedures, distribute the
notice to those responsible for radiation safety and quality assurance, and
consider actions, if warranted, to establish procedures to prevent similar
problems from occurring at their facilities. However, suggestions contained
In this notice do not constitute any new NRC requirements, and no writter
response is required.
Description of Circumstances
The following cases are recent events reported to NRC that have resulted
in unintended radiation doses to humans as a result of improper handling of
radioactive sealed sources:
Case 1:
On December 14, 1989, during preparation for a brachytherapy
procedure,-the medical physicist noted that there were only two sources present
within the source storage safe drawer, instead of the expected three sources.
The missing source contained 53 millicuries of cesium-137.
The Radiation
Safety Officer was notified, and together with the physicist, made a physical
search and radiation survey of the area. Radiation surveys were performed with
a Geiger Mueller meter and a gamma scintillation detector. The search and survey
were expanded to the remainder of the facility, but the source was not found.
After a review of the brachytherapy source inventory records, it was
determined that the source had not been returned to the source storage safe
after completion of a brachytherapy procedure on October 19, 1989. The root
cause of the loss of the source was the failure to return all brachytherapy
sources to the source storage area promptly after removal from the patient-, and
failure to document that transfer procedure. A contributing factor was the, white color of some sources, which are easy to lose among white linens, paper, and debris. At this facility, all sealed sources are color-coded according to
their nominal activity. For example, 20-mg sources are color-coded in white.
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IN 91-02 January 7 1991 The licensee speculated that the 20-mg (white) source may have been mistaken
for cut pieces of white nylon spacers, and may have been inadvertently
placed in normal trash. The licensee failed to perform radiation surveys of
disposable waste material at the completion of the October 19, 1989 procedure.
Personnel monitoring devices did not indicate unusual levels of radiation
exposure, although one technologist who was involved in the October procedure
did not wear the required ring badge.
Since no information exists to document
who came into contact with the source, or for how long, additional dose estimates
would be unreliable. In conclusion, the source is probably in a local landfill, and if there, is buried in an active burial area and is approximately 25-40 feet
below the surface.
Case 2: A patient to receive an endobronchial iridium-192 treatment received
an unintended therapy dose to the face. The misadministration occurred when a
nylon ribbon, containing 25 seeds of 3.5 millicuries each of iridium-192, was
inserted via a catheter into the patient's bronchi. The nylon ribbon became
completely dislodged from the catheter, was expelled outside of the lung, and
came to rest next to the patient's face.
The catheter remained in place in
the lung. The duty nurse noticed the dislodged source at approximately midnight, but took no action at that time. At 2:00 a.m. that same night, the duty nurse, using bare hands, taped the end of the ribbon containing the iridium-192 seeds
to the left side of the patient's face. At approximately 4:15 a.m., the charge
nurse, while attending the patient, noticed the dislodged source. The charge
nurse called the Radiation Safety Officer, who directed the removal of the
ribbon, using a remote handling tool. The sources were removed from the
patient, and placed in a shielded container. The estimated dose to the patient
was: 1,032 rem to a portion of the left side of the face, 282 rem to the eyes, and 357 rem to the scalp (at one point the patient had folded the ribbon back
into her hair). The duty nurse received an estimated 17.6 rem to her hands.
In addition to the source becoming dislodged, the cause of this event was the
inappropriate response of the duty nurse to the dislodged source. The root
cause is the failure of the licensee to provide radiation safety instruction
to all personnel caring for a patient undergoing implant therapy.
Corrective
actions undertaken included: removing the duty nurse from the care of patients
receiving brachytherapy implant therapy until additional training has been
completed, and a written examination of personnel, after training, that requires
an 80% passing score. In addition, the catheter that contains the iridlum-192 seeds will be crimped to prevent the seeds from leaving the catheter.
Case 3: A total of seven seeds in nylon ribbon, each containing 7.2 millicuries
of iridium-192, were acquired to be used in the treatment of a patient with
lung cancer.
It was decided that only five of the seven seeds would be needed
to deliver the prescribed dose. On July 5, 1990, the ribbon was cut into two
pieces.
The two ribbons, one containing two seeds, and the other containing
five seeds, were placed in a storage/transport container and taken to the
patient's room.. The five seed ribbon was implanted into the patient and
IN 91-02 January 7 1991 explanted 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> later. The two seed ribbon was left in the storage
container in the patient's room during the 10-hour treatment period. At the
time of source removal, the radiation therapy physician counted the seeds
removed from the patient and verified that it matched the number of seeds
Implanted. At the completion of the explantation procedure, a radiation survey
of the patient's room was conducted, and showed no detectable radiation above
background.
On July 27, 1990, an inventory of the seeds, in preparation for
their return to the supplier, revealed that the ribbon containing two seeds was
missing. A search revealed the two seeds within a crack between the carpeting
and the wall, in the patient's room where the July 5th brachytherapy procedure
took place.
It is assumed that the seeds were pushed into the crack when the
room was vacuumed, after the patient was released on July 6, 1990. The seeds
remained In the room for 22 days before being recovered.
The room remained
empty until July 26, 1990, when another patient was admitted to the room. The
patient and his wife remained in the room for the next 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />, at which time
the sources were found and removed. The cause of this incident was the failure
to promptly conduct a source inventory, after removing them from the patient, as described in 10 CFR 35.406. Documenting the return of the sources as
required would have made it obvious that not all the sources that had been
removed from storage had been returned.
Licensees are reminded of the importance of ensuring the safe performance of
licensed activities in accordance with NRC regulations, requirements of their
licenses, and accepted medical practice. Sealed sources for therapeutic use
are capable of delivering significant unintended exposures to patients, health
care workers, and members of the general public, when source management
procedures are not followed. The lost sources in Cases I and 3 may have
caused significant unintended exposure to a number of people durihg the time
they were out of the licensees' control.
In view of these and other recent Incidents involving mismanagement of
brachytherapy sources, licensees are reminded of their responsibilities to:
1. Provide radiation safety instruction to all personnel caring for the
patient undergoing implant therapy, and ensure that the instructions meet
the requirements of 10 CFR 35.410.
2. Maintain a record log for brachytherapy source use, that includes the
names of individuals properly trained, instructed, and permitted to handle
the sources as described in 10 CFR 35.406(b)(1).
3. Immediately after implanting the sources in a patient, make a radiation
survey of the patient and the area of use to confirm that no sources have
been misplaced. A record shall be made of each survey as described in
IN 91-02 January 7 1991 4. After the sources are removed from the patient, conduct a radiation survey
of the patient to confirm that all sources have been removed as required in
10 CFR 35.404(a), and survey the area of use, to include linens, disposables, and debris, to prevent the inadvertent eisposal of a source into regular
trash.
5. 'Return brachytherapy sources to the storage area promptly upon their
removal, and count the number returned to ensure that all sources taken
from storage have been returned as required by 10 CFR 35.406(a).
6. Maintain a record to include the number and activity'of sources removed
date of removal and return, the number and activity of sources remaining
in storage after removal and return, and the initials of the individuals
who'removed and returned the sources as described in 10 CFR 35.406(b'(?).
No-specific written response is required by this information notice.
If you
have'any questions about this matter, please contact the appropriate regional
office or this office.
7hu n m
,D Directori_
Division of Industrial and V'
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Sally Merchant, FIMSS
(361) 492-0637 Attachments:
1. List of Recently Issued NMSS
Information Notices.
2. List of Recently Issued NRC
Information Notices.
IN 91-02 January 7 1991 4. After the sources are removed from the patient, conduct a radiation survey
of the patient to confirm that all sources have been removed as required in
10 CFR 35.404(a), and survey the area of use, to include linens, disposables, and debris, to prevent the inadvertent disposal of a source into regular
trash.
5. Return brachytherapy sources to the storage area promptly upon their
removal, and count the number returned to ensure that all sources taken
from storage have been returned as required by 10 CFR 35.406(a).
6. Maintain a record to include the number and activity of sources removed
date of removal and return, the number and activity of sources remaining
in storage after removal and return, and the initials of the individuals
who removed and returned the sources as described in 10 CFR 35.406(b)(2).
No specific written response is required by this information notice.
If you
have any questions about this matter, please contact the appropriate regional
office or this office.
Richard Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Sally Merchant, NMSS
(301) 492-0637 Attachments:
1. List of Recently Issued NMSS
Information Notices.
2. List of Recently Issued NRC
-
Information Notices.
Distribution
SMerchant
IMNS Central Files
-NRC file Center- IMAB r/f
NMSS r/f
RECunningham
GSJoblom
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NMSS Dir r/f
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Pag 4 of 4
4. After the sources are removed from the patient, conduc a radiation survey
of the patient to confirm that all sources have been emoved as required In
10 CFR 35.404(a), and survey the area of use, to in ude linens, disposables, and debru, to prevent the inadvertent disposal of/a source into regular
trash.
5. Return brachy erapy sources to the storage ar a promptly upon their
removal, and co t the number returned to en
re that all sources taken
from storage have been returned as required y 10 CFR 35.406(a).
6. Maintain a record t include the number
d activity of sources removed
date of removal and
turn, the number
d activity of sources remaining
in storage after remov 1 and return, a d the initials of the individuals
who removed and returne the sources s described in 10 CFR 35.406(b)(2).
No specific written response I requir
by this information notice. If you
have any questions about this m ter, lease contact the appropriate regional
office or this office.
i ard Cunningham, Director
Dvi
ion of Industrial and
Med al Nuclear Safety
Office f Nuclear Material Safety
and Sa eguards
Technical Contact:
Sa y Merchant, NMSS
( 1) 492-0637 Attachments:
1. List of Recentl Issued NMSS
Information No
ces.
2. List of Recen
Issued NRC
Information
ices.
Distribution
SMerchant
/
IMNS Central Files
NRC File Cent
IMAB r/f
/
NMSS r/f
RECunningham
GSJoblom
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JEGlenn
NMSS Dir r/f
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OFFICIAL RECORD COPY
Attachment I
January 7, 1991
Page 1 of I
LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
Information
Date of
Notice No.
Subject
Issuance
Issued to
90-82
Requirements for Use of
Nuclear Regulatory Cenm- ission-(NRC-)Apprcved
Transport Packages for
Shipment of Type A Quanti- ties of Radioactive Materials.
12/31/90
90-81
Fitness for Duty
12/24/90
90-75
90-71
90-70
Denial of Access to
Current Low-Level Radio- active Waste Disposal
Facilities
Effective Use of Radiation
Safety Committees to
Exercise Control Over
Medical Use Programs
Pump Explosions Involving
Ammonium Nitrate
License and Fee Require- ments for Processing Fin- ancial Assurance Submittals
for Decommissioning
Potential Security Equip- ment Weaknesses
Management Attention to the
Establishment and Maintenance
of A Nuclear Criticality
Safety Program
12/5/90
11/6/90
11/f/90
11/6/90
10/29/90
10/03/90
All registered users
of NRC-approved
packages.
All U.S. Nuclear
Regulatory Commission
(NRC) and non-power
reactor licensees.
All Michigan holders
of NRC licenses.
All NRC licensees
authorized to use
byproduct material
for medical purposes.
All uranium fuel
fabrication and
conversion facilities.
All fuel facility and
materials licensees.
All holders of OLs or
CPs for nuclear power
reactors and Category 1 fuel facilities.
All fuel cycle licensees
possessing more than
critical mass quantities
90-38, Supp. 1
°0-67
90-63 OL = Operating License
CP = Construction Permit
Attachment 2
January 7, 1991 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
Information
Date of
Notice No.
Subject
Issuance
Issued to
91-01
90-82
Supplier of Misrepresented
Resistors
Requirements for Use of
Nuclear Regulatory Comm- ission-(NRC-)Approved
Transport Packages for
Shipment of Type A Quanti- ties of Radioactive Materials.
01/04/91
12/31/90
All holders of OLs or
CPs for nuclear power
reactors.
All registered users
of NRC-approved
packages.
90-81
Fitness for Duty
12/24/90-
All U.S. Nuclear
Regulatory Commission
(NRC) material and
non-power reactor
licensees.
90-80
90-79
/
90-78
90-77
88-23, Supp. 3 i
90-76
Sand. Intrusion Resulting
in Two Diesel Generators
Becoming Tnoperable
Failures of Main Steam
Isolation Check Valves
Resulting in Disc Separation
Previously Unidentified
Release Path from Boiling
Water Reactor Control Rod
Hydraulic Units
Inadvertent Removal of Fuel
Assemblies from the Reactor
Core
Potential for Gas Binding of
High-Pressure Safety Injection
Pumps During A Loss-Of-Coolant
Accident
Failure Of Turbine Overspeed
Trip Mechanism Because of
Inadequate Spring Tension
12/21/90
12/20/90
12/18/90
12/12/90
12/10/90
12/7/SC
All holders of OLs or
CPs for nuclear power
reactors.
All holders of OLs or
CPs for nuclear power
reactors.
All holders of OLs or
CPs for boiling water
reactors (BWRs).
'I
All holders of OLs or
CPs for pressurized- water reactors (PWRS).
All holders of OLs or
CPs for pressurized- water reactors (PWRs).
All holders of OLs or
CPs for nuclear power
reactors.
OL = Operating License
CP = Construction Permit