The Dangers of Infection with the B-K Medical Transrectal Ultrasound Transducer

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Va Hospital Prostate Biospy Defective Products

B-K Medical Systems, Inc, a subsidiary of the multinational Analogic Corportation, is the manufacturer of a medical device called a transrectal ultrasound transducer, which has been on the market since 1992. This device is used to obtain tissue samples from the prostate gland, usually to test for cancer. The transducer is inserted into the rectum and guided by ultrasound until it is near the prostate gland. Then a hollow needle is inserted into the prostate to obtain a tissue sample.
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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