A Medical Device Daily

The FDA has issued an alert concerning the importance of properly cleaning and sterilizing reusable ultrasound biopsy transducer assemblies (i.e., transducer device and associated accessories), and provided recommendations for doing so.

The agency said that if these 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, possibly leading to patient infections.

The agency said that on April 3, the Department of Veterans Affairs ' (VA; Washington) Veterans Health Administration issued a Patient Safety Alert related to a particular company's ultrasound transducer assemblies. During patient safety rounds, the lumen of a needle guide of an ultrasound transducer assembly was found to be soiled.

The alert provided recommendations on reprocessing that brand of transrectal ultrasound transducer, which is widely used throughout the VA. The FDA said it was issuing a notification as a supplement to the VA alert “because we believe inadequate reprocessing procedures may be a problem for all invasive ultrasound transducer assemblies.”

The FDA's general recommendation is “to follow the manufacturer's labeling with regard to the use of sterile covers for each particular device in order to reduce the risk of patient infection.”

It continued: “Insertion of the biopsy needle is often repeated through the guide. Since a biopsy needle contacts the needle guide before it penetrates sterile tissue for biopsy, 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.”

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