Information Notice No. 91-02: Brachytherapy Source Management

                                 UNITED STATES
                        NUCLEAR REGULATORY COMMISSION
              OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS
                          WASHINGTON, D.C.  20555 
 
                               January 7, 1991
 
 
Information Notice No. 91-02:  BRACHYTHERAPY 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 written 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.
 
 
9012280297 
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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 receiving 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 iridium-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 
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explanted 10 hours 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 hours, 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 1 
and 3 may have caused significant unintended exposure to a number of people 
during 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 10 CFR 35.406(c).
 
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 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.
.