ENS Event | |
|---|---|
15:00 Mar 14, 2008 | |
| Title | Possible Medical Event - Leaking Brachytherapy Seeds |
| Event Description | Description: Three patients were scheduled for transperineal permanent prostate seed brachytherapy implantations on March 14, 2008. Three separate packages of seeds in preloaded needles were received; surveys showed no surface contamination or contamination outside the inner sterile containers. On March 14, 2006, after 12 of 106 seeds were implanted in the first patient, a survey meter showed a small amount of radioactive contamination on the inside of the sterile packaging. This implantation was stopped. The survey meter showed contamination on the tips of three of the four needles that had been used, the greatest being 5000 cpm (420 Bq if an efficiency of 20% is assumed). This patient was administered stable iodine to block his thyroid in case of a leaking seed. The seed vendor was notified by telephone.
To determine if the remaining patients should be implanted, the remaining two packages of seeds were opened and the interiors of the sterile packaging were surveyed. No contamination was found. An implant procedure was performed on the second patient. At the end of the procedure, the used needles were surveyed. A survey meter showed contamination on the tips of two of the needles; it was about 1000 cpm (83 Bq if an efficiency of 20% is assumed) on each. The seed vendor was again notified by telephone. A urine bioassay of this patient showed no radioactivity. Implantation of the third patient was cancelled. The needles of preloaded seeds were supplied by Best Medical International. The seeds contained I-125 and were Best Model 2301. The three batches of seeds were Lot Numbers 23017, 23019, and 23018 (not implanted). At this time, it is uncertain whether any seeds were leaking. A possibility is that the contents of the sterile packages were contaminated by the vendor, but no seeds were leaking. Effect on Patients: The VA is still evaluating this event. At this time, no adverse effects to the patients are expected. Patient notification: The permittee is in the process of ensuring that the referring physicians and patients were notified. We will notify the NRC Project Manager, Cassandra Frasier, of NRC Region III. 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. |
| Where | |
|---|---|
| Va Medical Center - San Francisco San Francisco, California (NRC Region 4) | |
| License number: | 03-23852-01Va |
| Organization: | Department Of Veterans Affairs |
| Reporting | |
| 10 CFR 35.3045(a)(2) | |
| Time - Person (Reporting Time:+9.12 h0.38 days <br />0.0543 weeks <br />0.0125 months <br />) | |
| Opened: | Edwin Liedholdt 00:07 Mar 15, 2008 |
| NRC Officer: | Jeff Rotton |
| Last Updated: | Mar 15, 2008 |
| 44065 - NRC Website | |
Va Medical Center - San Francisco with 10 CFR 35.3045(a)(2) | |
WEEKMONTHYEARENS 440652008-03-14T15:00:00014 March 2008 15:00:00
[Table view]10 CFR 35.3045(a)(2) Possible Medical Event - Leaking Brachytherapy Seeds 2008-03-14T15:00:00 | |