In response to medical events discovered at the
VA Medical Center Philadelphia, which have been reported under Event Number 44219, reviews are ongoing of samples of patient charts from other
VA facilities with permanent prostate
iodine-125 seed implant
brachytherapy programs.
As the result of these ongoing reviews, medical events were discovered on October 7, 2008, for 6 patients treated at the VA Medical Center in Cincinnati, Ohio.
These 6 medical events involved seed distributions in the patients that resulted in D90 doses less than 80% of the prescribed doses. These circumstances were interpreted to meet the definition of a medical event under 10 CFR 35.3045.
A 15-day written report on these 6 medical events will be submitted to NRC Region III. We have notified our NRC Project Manager, Cassandra Frazier (NRC Region III), of these medical events.
- * * UPDATE AT 1520 EDT ON 07/23/09 FROM ED LEIDHOLDT TO S. SANDIN * * *
Following the notification of the NRC on October 7, 2008, of the six medical events described in Event Report No. 44548, the NHPP initiated a reactive inspection on October 16, 2008. As a result of this inspection and related clinical reviews, the NHPP is notifying NRC of one additional medical event at the Cincinnati VA Medical Center, for a total of 7 medical events at this facility. This event, also involving prostate brachytherapy with I-125 seeds, was discovered on July 22, 2009. Like the previous six medical events, this additional medical event involves a D90 dose less than 80% of the prescribed dose.
We note that the D90 doses for all seven events were based upon CT scans performed one day after the implants, when the prostate is subject to edema from the procedure which often causes underestimation of the true D90. Furthermore, the prescribed doses were 160 gray, instead of the more common 145 gray. Thus, most if not all of these patients likely received clinically adequate dose distributions, despite the percent-wise slightly low D90s. Adverse biological effects to these patients are not expected.
The facility has notified the patient.
A written report on this additional medical event will be submitted to NRC Region III pursuant to 10 CFR 35.3045. We will notify the NRC Project Manager, Cassandra Frazier, of NRC Region III.
Notified R3DO (Hills) and FSME EO (Villamar).
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.