MISSING BRACHYTHERAPY SEEDS
"[The licensed material lost is] Palladium-103, 3.56 mCi in a solid brachytherapy seed form.
"Forty-nine Pd-103 seeds were ordered from the local radiopharmacy, Pharmalogic in Bridgeport, WV. The order was for three cartridges of 15 seeds and one cartridge of four seeds. The package containing the seeds was received in Nuclear Medicine on 6/12/20. As per procedure, the package was checked in and surveyed and checked against the manifest. Four cartridges were locked inside the container which matched the manifest. The individual seeds were not counted. To count the individual seeds requires opening the entire package and unscrewing the cartridges from the container and then inspecting each cartridge carefully. That same afternoon, the package was transferred to Sterilization. [The RSO] interviewed the director of Sterilization and [they] confirmed that the container was not opened except to crack it to insert a tag indicating that the package had completed sterilization. The package, now wrapped in sterile cloth, was returned to Nuclear Medicine for storage until Monday, 6/15/20, when it was transferred to the Operating Room (OR) for implantation into the patient.
"In the OR on 6/15/20, the Authorized User (AU) unwrapped the sterile cloth around the package and began to prepare the seeds for implantation. The AU immediately noticed that something wasn't right. The cartridge that was supposed to contain 4 seeds was empty. The AU stopped the procedure and a survey of the OR and the container was undertaken. No loose seeds were found. The AU determined that 45 seeds was sufficient to complete the procedure, amended the Written Directive to indicate such and completed the procedure.
"Immediately following the procedure, Sterilization, Nuclear Medicine and the trash were surveyed with no seeds found. Pharmalogic was notified and they surveyed their preparation areas, packaging/shipping materials which had, by this time, been returned and the truck that made the delivery on 6/12/20. No seeds were found.
"[The licensee doesn't] know what happened to the seeds. After careful evaluation, [they] can find no breakdown in our process that would have allowed an opportunity for the seeds to disappear. [The cartridges] were screwed to the inside of the canister and were not removed until they were in the OR in preparation for implantation. It appears from [the licensee's] end that the four seeds were never in the cartridge that was screwed into the canister. The pharmacy insists that they were.
"Given the extremely small size of the seeds, the small number of seeds and their very low external dose rate, even if the seeds were lost on [hospital] premises, it is unlikely to produce any meaningful external exposure to anyone."
* * * UPDATE ON 6/22/20 AT 0911 EDT FROM MARK PERNA TO THOMAS KENDZIA * * *
The following update was received via telephone:
The pharmacy determined that they had not put the four seeds in the canister and that they had possession of the seeds. The seeds were not lost.
Notified R1DO (Janda), ILTAB (email) and NMSS Event Notifications (email).
THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL
Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf |