The needle used for the procedure is disposable, but the needle guide that holds the needle is cleaned and reused. If the device is not cleaned properly, fecal matter and blood, called bioburden, can collect in the needle holder that may contain dangerous viruses, including hepatitis B, hepatitis C, and HIV/AIDS. If the needle holder is contaminated, bits of bioburden could be injected into the prostate gland when the tissue sample is taken.

Concerns have been raised about adequate cleaning procedures at Veterans Administration (VA) facilities after a routine inspection revealed that the needle holder of a transrectal ultrasound transducer at a VA facility was still soiled after it had been sterilized and was believed ready for use. A survey of other VA facilities revealed that a variety of methods were used to clean the device at different VA facilities, and many methods were possibly inadequate.

The VA is now in the process of notifying men who have had tissue samples taken with the B-K Medical transrectal transducer, offering them a free blood test for hepatitis and HIV. See The Veterans Administration Discovers Inadequately Sterilized Biopsy Device for more information.

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