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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 5350613 July 2018 04:00:0010 CFR 30.50(b)(2)
10 CFR 30.50(b)(3)
En Revision Imported Date 8/21/2018

EN Revision Text: MEDICAL EVENT The following information is a synopsis of information received via E-mail: A HDR (high dose rate) brachytherapy incident occurred in Brunswick, Georgia, on July 13, 2018. No one, including the patient, was exposed to excessive radiation. SE Georgia Health Systems treated a Gyn (gynecology) patient using the GammaMed Plus HDR unit and a Tandem and Ring applicator set, both supplied by Varian. Upon completion of the treatment, the source wire retracts back into the shielded HDR unit for safe storage. At that time the room was checked with a survey meter and no exposure readings above background were measured. The HDR unit was surveyed to ensure that the source wire had retracted. The exposure reading on the surface demonstrated that the wire had retracted, and the room was safe. Upon scanning the patient's surface, however, a reading of approximately 2.5mR/hr was measured, which was higher than the expected background reading. The applicator was removed from the patient and scanned, the increased exposure reading was in the applicator. The applicator was placed into a large shielded container provided by Varian and immediately placed in safe storage. The patient, the bedding, and all other materials associated with the implant were re-scanned with no readings above background. The patient was removed from the room, deemed safe and released. The time was recorded to be approximately 5 to 6 minutes and will be used for dose estimates. The HDR unit was re-scanned along with the Linac vault. All were deemed clear and safe. The HDR unit was locked and secured. Patient treatments in the Linac continued. The applicator device was then scanned one piece at a time and it was determined that the Ring portion of the Tandem and Ring set was contaminated. It was assumed that the contamination was secure inside the ring which is a rounded hollow metal tube. Exposure readings at the surface of the ring were 96 mR/hr at the surface and approximately 30 mR/hr at 6 inches. SE Georgia Health Systems notified the Georgia Radiation Protection Programs, and Varian Medical Systems of this incident. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

  • * * RETRACTION FROM KATHY ARZATE TO HOWIE CROUCH AT 1050 EDT ON 8/7/18 * * *

After investigation and arrival on site to determine the cause of the contamination, it was found there was no contamination on the patient's body. It was not a failure of the device. We (Varian) inspected the device. We attempted to remove the contamination from the applicator, but were unable to. Therefore, the manufacturer of the source took the applicator back to their facility and were able to remove the contamination there. Ultimately, there was no equipment failure per 10 CFR 30.50(b)(2) or (b)(3). Notified R1DO (Cahill), R2DO (Sykes), R4DO (Vasquez), and NMSS Events (by email).

  • * * UPDATE FROM KATHY ARZATE TO OSSY FONT AT 1127 EDT ON 8/20/18 * * *

The following was received via email from Varian and is part of their retraction on 8/7/18: The Varian Radiation Safety Officer (VRSO), the Varian Field Service Engineer (VFSE), and the AOS Radiation Safety Officer (ARSO) arrived on the site on July 15, 2018 at 0830 EDT. They were met by the site Radiation Safety Officer and medical physicist. Utilizing a RADEYE B20-ER Geiger meter, an initial contamination wipe was performed on the afterloader turret. No results above background were found. The VFSE began the process of transferring the potentially contaminated wire from the afterloader to the transport safe. The VRSO then began decontamination steps to remove the particle from the applicator. The decontamination effort involved running a dummy cable completely through the applicator to the closed end. Once the cable reached the end of the applicator, the wire was moved back-and-forth in the location of the contamination while rotating the applicator. Once the site was agitated for an appropriate amount of time, the cable was slowly pulled from the applicator while holding a wipe on the wire. This action was performed for approximately 45 minutes without success. Once the old source wire was removed from the afterloader, the afterloader was scanned to determine if any contamination was present in the source wire tubing. No results above background were found. The new wire was installed into the afterloader. The plastic transfer catheter was wiped. No results above background were found. All gloves, wipes, and dummy cable were scanned for potential contamination prior to placement in the biohazard waste stream. No results above background were found. The ARSO took the contaminated applicator back to the AOS facility. Further efforts at that facility allowed the applicator to be cleaned and returned to the customer site. The results of all testing indicate that the afterloader was clear of possible radiological contamination. A new source wire was installed and the customer was able to resume treatments as scheduled. There was no indication that the contamination was from a leaking sealed source, but rather external contamination on the wire. There is no indication of patient contamination or equipment failure. Therefore, the NRC Event Report 53506 has been retracted. Notified R1DO (Young) and R2DO (Sandal), R4DO (Taylor) and NMSS Events by email.