Information Notice No. 80-35: Leaking and Dislodged Iodine-125 Implant Seeds

                                                       SSINS No.: 6870  
                                                       Accession No. 
                                                       8006190046 
                                                       IEIN 80-35 

                               UNITED STATES 
                       NUCLEAR REGULATORY COMMISSION 
                    OFFICE OF INSPECTION AND ENFORCEMENT 
                           WASHINGTON, D.C. 20555 
                                     
                              October 10, 1980 

Information Notice No. 80-35:   LEAKING AND DISLODGED IODINE-125 IMPLANT 
                                   SEEDS 

Description of Circumstances: 

During surveys performed following the implant of iodine-125 seeds for 
interstitial treatment of cancer of the prostate, iodine-125 was detected in
the patient's urine and thyroid. As a result of the iodine leakage, the 
patient's thyroid received an estimated eighty (80) rem dose. 

The cause of the leakage of iodine-125 was determined to be physical damage 
to one of the seeds prior to implantation. The hospital staff had inserted 
the seeds into nylon tubing prior to steam sterilization in an autoclave. 
The nylon tubings were supplied with a permanent interstitial implant 
instrument, Model #6501, manufactured by Mick Radio-Nuclear Instruments, 
Incorporated. After autoclaving for six (6) minutes at 275F (135C) 
and 30 psi, the iodine-125 seeds could not be pushed out of the nylon 
tubing. Forceps and scissors had to be used to free the seeds and place them 
into the implant instrument. It was determined that, during this process, 
one of the iodine seeds had been superficially cut. 

The surveys performed after the surgery indicated that some iodine-125 seeds
had been dislodged. Some seeds were found on the floor, the operating table,
and in suction liquids collected during surgery. In addition, an iodine-125 
seed was found in the patient's urine specimen collected on the sixth day 
following implant surgery. 

Notice to Licensee: 

Your staff responsible for preparation and implantation of sealed sources of
byproduct material should be made aware of the contents of this Information 
Notice. They should review handling procedures for the sealed sources, 
including methods of sterilization, to eliminate those procedures which 
could physically damage the sealed sources. Necessary procedures should be 
established to assure that, following implantation, proper surveys are 
performed for detecting leaking or dislodged sources. 

No written response to this Information Notice is required. If you need 
additional information regarding this subject, contact the Director of the 
appropriate NRC Regional Office.