A risk of bacteria contamination has forced the Food and Drug Administration to warn off healthcare providers from using gel used during ultrasound procedures.
Certain lots of the product, known as Other-Sonic Generic Ultrasound Transmission Gel, were recently discovered to have been contaminated with Pseduomonas aeruginosa and Klebsiella oxytoca. These two strains of bacteria pose an imminent health threat to persons exposed. The former, which is typically found in water or soil, can cause a condition known as inflammatory dermatitis. And the latter, which is actually fairly common in humans’ digestive tract, can cause bloodstream infections or pneumonia if it comes into contact with the lungs.
Three lot numbers of the gel, which was produced by Pharmaceutical Innovations, were affected: 0601111, 090111, and 120111. The product was available in either 5 liter containers or 250 milliliter bottles. The gel is non-sterile and is used as a means to improve the signal of the ultrasound.
The FDA is also asking all healthcare professionals and facility personnel who have noted an adverse affect from using this product to report what happened to the agency. They are particularly interested in learning the lot number, the container size, the date and type of procedure, and the nature of the adverse event.
I’m sorry to see a seemingly benign item pose a threat to safety. Patients rely on the equipment being used during their procedures to keep them safe, and it’s my hope as a personal injury attorney in Bakersfield that no one gets hurt by this flawed product.