The U.S. Food and Drug Administration is warning hospitals to stop using an ultrasound gel produced in the second half of 2011 because it has been linked to at least 16 bacterial infections. The health risk prompted the FDA to call in U.S. Marshals to seize the gel in a raid on the New Jersey producer.
The ultrasound gel, called Other Sonic Generic Ultrasound Transmission Gel, is produced by Newark, New Jersey-based Pharmaceutical Innovations Inc. It’s a nonsterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body, according to the FDA statement.
The investigation was sparked by a report received by the U.S. regulator that involved 16 surgical patients infected with Pseudomonas aeruginosa. They had transesophageal ultrasound procedures while undergoing heart valve replacement.
Pseudomonas aeruginosa is a common bacteria that can cause hospital-acquired pneumonia, particularly in vulnerable patients.
After an FDA analysis found that product samples contained dangerous bacteria, pseudomonas aeruginosa and klebsiella oxytoca, the products were held under embargo by the New Jersey Department of Health and Senior Services at the FDA’s request, according to the statement. The raid seized all lots of the gel manufactured between June and December 2011.
The FDA is warning hospitals not to use Other Sonic Generic Ultrasound Transmission Gel from lot numbers 060111 through 120111. It recommended that hospitals identify patients who have been exposed to the relevant lots of the gel and to review the procedures they underwent along with patient outcomes to determine if further evaluation is needed.
Hospitals have sought to reduce hospital-acquired infections to improve patient outcomes and reduce costs.