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U.S. Department of Health and Human Services

Safety

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Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures

Audience: Hospital healthcare professionals, surgical center staff, and risk managers

[Posted 06/20/2006] FDA issued a Public Health Notification regarding the proper cleaning and sterilizing of reusable ultrasound biopsy transducer assemblies (i.e., transducer device and associated accessories). 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. This could lead to patient infections. Therefore, 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 Public Health Notification also provides recommendations for cleaning the devices.

[June 19, 2006 – Public Health Notification – FDA]