FDAnews Device Daily Bulletin

RESPONDING TO VA ALERTS, FDA ISSUED ALERT ON REPROCESSING BIOPSY TRANSDUCERS

June 28, 2006
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The FDA recently issued a public health notice on the instructions for cleaning and sanitizing, or "reprocessing," ultrasound transducer assemblies used in biopsy procedures. The agency said it was responding to a patient safety alert issued April 3 by the U.S. Department of Veterans Affairs (VA) related to the cleaning and sterilization of the devices, which are used by the VA to screen patients for prostate cancer.

If the devices are not correctly reprocessed between patients, "residual material from a previous patient may contaminate the biopsy needle and needle guide when the system is reused for biopsies [and] could lead to patient infections," the FDA said, emphasizing the need for clear and complete reprocessing instructions.

The FDA notice does not mention the name of the company that manufactured the devices purchased by the VA, Denmark-based B-K Medical. According to the VA, the firm's devices were "not being disinfected properly at some of our medical facilities." The agency has attributed the problem to the products having been delivered without complete reprocessing instructions. As a result, patients undergoing prostate biopsies as far back as 20 years ago could have been exposed to serious infectious diseases including Hepatitis and HIV, the VA said.

To view the FDA notice, go to http://www.fda.gov/cdrh/safety/061906-ultrasoundtransducers.html (http://www.fda.gov/cdrh/safety/061906-ultrasoundtransducers.html).