Other-Sonic Ultrasound Gel May Be Linked to Risk of Infection, Colonization

Other-Sonic ultrasound transmission gel and generic equivalents may have bacterial contamination that could lead to infections, health regulators warned this week. The warning comes in the wake of an outbreak of infections that hit at least one hospital using the gel. 

Contamination has been found in three lots of Other-Sonic ultrasound gel and could be present in generic versions as well, the FDA warned in a drug safety communication issued on April 18.

U.S. Marshals raided the New Jersey facility of the manufacturer, Pharmaceutical Innovations, Inc., seizing all lots of Other-Sonic made between June and December of 2011.

The warning and seizure came after reports were received from an unidentified hospital that it had seen 16 patients develop colonization or infection with the bacteria Pseudomonas aeruginosa. All of the patients who contracted the hospital-acquired infection underwent a transesophageal ultrasound probe using Other-Sonic.

Following investigation, the ultrasound gel was found to be contaminated with the same bacteria making patients sick. It was also found to be contaminated with Klebsiella oxytoca, another bacterial contaminant.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” FDA Associate Commissioner for Regulatory Affairs Dara Corrigan said in a press release. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”

Other-Sonic Ultrasound Transmission Gel is considered a non-sterile gel, even though it is not labeled as either sterile or non-sterile. The gel is used widely throughout the healthcare industry, but most people are familiar with it as the gel rubbed on pregnant women’s bellies to get good ultrasound images.

The contamination is believed to affect at least three lots of Other-Sonic Ultrasound Transmission Gel manufactured from June through December 2011. The lot numbers of the affected gel are 060111, 090111 and 120111. The lots were sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers.

Pseudomonas aeruginosa can cause inflammatory dermatitis on skin, even when the skin is not broken. If it gets into the upper airway, lower GI tract or into female genitalia it can cause an infection or colonize. Colonizing occurs when the bacteria reproduces but does not cause an infection. Colonies can, however, spread to others where the bacteria could cause infections.

Klebsiella oxytoca is a bacteria that is often found in the digestive tract, where it rarely causes harm. However, when the bacteria is spread to the lungs or other areas of the body it can cause serious infections or pneumonia.

The FDA has sent a warning letter to Pharmaceutical Innovations, Inc. over the incident, saying that the company violated good manufacturing practices in letting the contamination occur.

The agency is recommending that health care professionals do not use the affected lots of Other-Sonic, identify patients that any affected gel was used on and review their cases and conditions, and to use proper disposal methods to get rid of remaining stocks of affected Other-Gel.

Customers with questions or adverse events to report can contact Pharmaceutical Innovations at (973) 242-2900.