The following information was received via facsimile:
On July 19, 2012, the licensee reported the identification of 15 medical events that were discovered on July 18, 2012, involving permanent implants of iodine-125 for prostate brachytherapy where the total dose delivered differs from the prescribed dose by 20% or more. During a recent inspection, DHS [Department of Health Services] inspectors determined that the licensee was not reviewing prostate brachytherapy cases against the medical event criteria. The licensee established dose based criteria used by post-operation CT, prostate D90 values <80% or >130% for classifying medical events. The licensee has evaluated all prostate implants performed since 2001.
"--Overdose to the prostate (medical event criteria used -D90>130%):
08/20/2009: 137.3%
"--Underdose to the prostate (medical event criteria used -D90<80%):
07/15/2005: 79.27%
03/13/2006: 79.17%
03/15/2006: 67.10%
07/26/2006: 72.35%
07/26/2006: 57.06%
02/13/2006: 78.37%
05/14/2009: 78.67%
"--Overdose to the rectum (medical event criteria used -V100>2cc):
12/13/2006: 2.42cc
12/19/2007: 2.23cc
03/03/2009: 2.54cc
07/08/2009: 3.32cc
11/19/2009: 2.89cc
05/05/2010: 2.41cc
05/20/2010: 3.92cc
DHS inspectors conducted an investigation of these medical events and are awaiting completion of the licensee's review.
Wisconsin Event Report ID No.: WI120008
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.