FDA issues guidelines for reprocessing ultrasound transducer assemblies

July 6, 2006

After finding the lumen of a needle guide of an ultrasound transducer assembly soiled during patient safety rounds at a VA hospital, the FDA has issued a public health notification about the importance of properly cleaning and sterilizing reusable ultrasound biopsy transducer assemblies and guidelines for doing so.

After finding the lumen of a needle guide of an ultrasound transducer assembly soiled during patient safety rounds at a VA hospital, the FDA has issued a public health notification about the importance of properly cleaning and sterilizing reusable ultrasound biopsy transducer assemblies and guidelines for doing so.

During a biopsy, the transducer assembly should be covered with a sterile barrier sheath because it is likely to come into contact with blood, other bodily fluids, or feces, according to the FDA alert. Because insertion of the biopsy needle is often repeated through the guide, the needle and needle guide should be reprocessed as critical devices.

The biopsy needle and its containing guide must always be sterilized. This should apply even if a sterile barrier sheath is used on the transducer assemblies during a biopsy procedure, as the sheath is compromised by the penetration of the needle. The device should also be cleaned before sterilization to ensure no residue remains on the needle guide lumens from the previous procedure.

The full notification and guidelines can be viewed at www.fda.gov/cdrh/safety/061906-ultrasoundtransducers.html.