WEDNESDAY, June 21 (HealthDay News) -- The U.S. Food and Drug Administration has issued a warning to health care professionals to properly clean and sterilize reusable ultrasound biopsy transducer assemblies to avoid patient infections due to contaminated equipment.
The warning was prompted by a patient safety alert issued by the Veterans Health Administration after the lumen of a needle guide of an ultrasound transducer assembly was found to be soiled during patient safety rounds.
"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," according to a statement from the FDA. "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 FDA statement gives detailed instructions on cleaning and sterilization procedures and reminds health care professionals that they are required to report to the FDA any deaths relating to the use of medical devices.
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