FDA: clinicians urged to stop using certain ultrasound gel
(HealthDay) -- Hospitals, clinics, and health care professionals should immediately discontinue using Other-Sonic Generic Ultrasound Transmission Gel due to risk of bacterial contamination in certain batches, according to a safety communication issued April 18 by the U.S. Food & Drug Administration.
Sixteen patients developed colonization or infection with Pseudomonas aeruginosa following exposure to the gel during ultrasound. An investigation revealed the ultrasound gel to be contaminated with Pseudomonas aeruginosa, which can cause inflammatory dermatitis, and Klebsiella oxytoca, which can result in pneumonia and other series infections when exposed to lung or other tissues.
The contaminated lots, numbers 060111, 090111, and 120111, were manufactured between June and December 2011 by Pharmaceutical Innovations and can be identified only by the lot numbers on their containers.
According to the FDA, clinicians are urged to "NOT use Other-Sonic Generic Ultrasound Transmission Gel from lot numbers 060111 through 120111; identify patients who have been exposed to these lots; review the procedures they underwent and the outcomes of those procedures; then, determine if further evaluation is needed."
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