FDA seizes contaminated ultrasound gel

April 18, 2012

U.S. marshals seized ultrasound gel produced by a New Jersey company after the government found two dangerous strains of bacteria in the product.

The Food and Drug Administration, which announced the seizure Wednesday, did not comment on how widely the gel was distributed. But it warned health-care professionals to immediately stop using the product — “Other-Sonic Generic Ultrasound Transmission” by Pharmaceutical Innovations in Newark.

The agency discovered the contamination after a hospital reported that 16 of its patients were infected with Pseudomonas aeruginosa following heart valve replacement surgery. In such surgeries, ultrasound probes are inserted into the esophagus to get a clear image of the heart, and the gel helps improve transmission of the sound waves.

The FDA said in a statement that patients exposed to the bacteria on the surface of their skin could develop severe skin inflammation. Invasive biopsy procedures can carry the strain into tissues, causing an abscess or blood poisoning. The microbe also can move from one part of the body to another.

Upon testing samples of the gel, the FDA also found that it contained Klebsiella oxytoca, which often lives in the digestive tract without posing any health risks. But the strain can cause pneumonia and other serious infections if exposed to the lungs and other tissues.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” Dara A. Corrigan, FDA’s associate commissioner for regulatory affairs, said in a statement. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”

The New Jersey Department of Health and Senior Services held on to the product until U.S. marshals seized it under a court order sought by the FDA.

The New Jersey health agency said that Pharmaceutical Innovations was not licensed by the state.

While ultrasounds are commonly used during pregnancy to provide images of the fetus, it is unclear if any of the product was used for such purposes. But the likelihood of getting an infection from an abdominal ultrasound is remote unless the patient has a cut on her skin, an FDA spokesman said. If the patient had a transvaginal ultrasound, then the risk would be greater.

Ultrasound technology also can be used to look inside the body in a non-invasive way to spot anything from ovarian masses and gallstones to aortic aneurysms in the abdomen.

Dina ElBoghdady covers housing policy for The Washington Post.
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