FDAnews Device Daily Bulletin

HEALTH ALERT: PROSTATE BIOPSY DEVICES MAY BE CONTAMINATED

May 15, 2006
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The U.S. Department of Veterans Affairs is sending letters to thousands of possible victims tested between 1997 and 2001. During a routine inspection at a Maine hospital, VA staff found contamination in one BK Biopsy Transducer device. Officials also found some lack of clarity in the instructions for disinfecting and sterilizing the equipment. In Portland, more than 2,200 VA patients may be at risk. However, VA officials say the chance of exposure is small.
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