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This is notification of an event in Washington state as reported to the WA Department of Health, Division of Radiation Protection. STATUS: New (this is an preliminary notification due to the lack of required information at this point in time). Licensee: Sacred Heart Medical Center City and state: Spokane, Washington License number: WN-M031-1 Type of license: Medical Date of event: 8 October 2003 Location of Event: on campus (OR) ABSTRACT: (where, when, how, why; cause, contributing factors, corrective actions, consequences, DOH on-site investigation; media attention) The licensee was implanting a source train of I-125 seeds for a lung cancer treatment and during that implant decided the source train in use was longer than necessary. They decided to clip the unwanted part of the train but snipped a source rather than the space between the sources. What is the notification or reporting criteria involved? Leaking source, possibly. If not, no notification is required, if so, then a possible overexposure to the patient (thyroid). Activity and Isotope(s) involved: Iodine-125 therapy seed(s). Overexposures? (number of workers/members of the public; dose estimate; body part receiving dose; consequence) None, with the possible exception of the patient. Lost, Stolen or Damaged? (mfg., model, serial number): This was an Iodine-125 seed, part of a source train of such seeds which was damaged when the licensee attempted to shorten the train but cut through a seed instead of the interstice desired. Disposition/recovery: No loss of seeds. Leak test? Licensee is performing one ASAP but as of this writing there are no results. Vehicle: (description; placards; Shipper; package type; Pkg. ID number): N/A Release of activity? Unknown at this time, if the seed is not leaking, then 'no'. If the seed is in fact leaking then the potential exists for release of material inside the patient. Activity and pharmaceutical compound intended: N/A, the proper nuclide and activity was delivered to the intended treatment site. Misadministered activity and/or compound received: N/A, this was not a misadministration. Device (HDR, etc.) Mfg., Model; computer program: N/A, no device involved.

Exposure (intended/actual); consequences: No unplanned exposure, unless the source turns out to be leaking.

Was patient or responsible relative notified? Unknown at this time.

Was written report provided? Not yet, but it will be.

Was referring physician notified? Yes, referring MD notified by oncologist.

Consultant used? No. This is WA Event Report # WA-03-043.

• * * UPDATE 1830 EDT ON 10/9/03 FROM ARDEN C. SCROGGS VIA EMAIL * * *

New (this is an updated notification). ABSTRACT: (where, when, how, why; cause, contributing factors, corrective actions, consequences, DOH on-site investigation; media attention) The licensee was implanting a source train of 31 (Iodine-125) seeds for a lung cancer treatment along the lining of the pleura and during that implant decided the source train in use was longer than necessary. They decided to clip the unwanted part of the train but snipped two source(s) rather than the space between the sources. The licensee administered large quantities of SSKI within one hour of breaching the seeds. The current plan is to continue administration of SSKI in amounts of at least 0.5ml daily for at least the next two weeks. What is the notification or reporting criteria involved? MISADMINISTRATION via leaking source. Activity and Isotope(s) involved: Iodine-125 therapy seed(s). A total of two seeds with an activity of 0.729mCi each according to the licensee. Overexposures? (number of workers/members of the public; dose estimate; body part receiving dose; consequence) None, with the possible exception of the patient. The primary handler has received thyroid bioassay with negative results. The licensee is expecting results of the pleural fluid sample taken from the patient soon, and will attempt thyroid bioassay of the patient at the 72-hour exposure interval. Lost, Stolen or Damaged? (mfg., model, serial number): These are Iodine-125 seeds, part of a source train of such seeds which were damaged when the licensee attempted to shorten the train but cut through two seeds instead of the interstice desired. The manufacturer is MPI, the model is the 'Oncoseed' 'Rapid Strand'. The licensee will include an enlarged version of the product insert with their written report. Disposition/recovery: No loss of seeds although remains of the two leaking sources are properly stored awaiting decay/disposal. Leak test? Leak test results from the soak test (four hours in plain water) showed 'significant leakage' according to the licensee, and they are assuming a worst-case scenario basis of one entire seed leaking and one-half the second seed leaking. Release of activity? Yes, it is assumed on a worst-case basis that the entire contents of one seed and fifty percent of the second seed has or will leak. Misadministered activity and/or compound received: This was a misadministration by definition because the sources are determined to have leaked. Exposure (intended/actual); consequences: Exposure is limited to the patient only. The licensee will attempt to quantify through both calculation and bioassay the extent of patient/thyroid exposure. Physicians involved expect little or no adverse effects at this point, assuming the SSKI works as expected.

Was patient or responsible relative notified? Yes. Rev 1. 1530 hrs, 9 October 2003 Notified R4DO(Bill Johnson) and NMSS(Holonich).