CDC investigating outbreak linked to contaminated ultrasound gel used in image-guided procedures
The Centers for Disease Control and Prevention is investigating a bacteria outbreak stemming from two ultrasound gels used in interventional procedures.
Authorities said they’ve received reports of an environmental bacterium (Paraburkholderia fungorum) associated with imaging delivered in 2024 and 2025 across multiple states. As of May 8, the CDC was aware of at least 40 cases of P. fungorum, pinpointed via patient blood cultures.
“Use of nonsterile ultrasound gel for percutaneous procedures can result in patient harm,” the CDC said in an update published May 13. “Microorganisms that may be present in nonsterile ultrasound gel can spread to sterile body sites (like the bloodstream) through procedures involving skin or tissue puncture, which can cause serious infections.”
The Minnesota Department of Health in September notified the CDC about a cluster of P. Fungorum—rarely associated with human illness—detected in blood cultures from patients treated at multiple facilities. Most did not appear to have clinical infection with this organism, the CDC noted. These isolated incidents were linked by genome sequencing, with the outbreak occurring across four U.S. states and two other countries.
Product testing determined the bacteria came from “at least” two ultrasound gel products manufactured by Next Medical Products Company, Branchburg, New Jersey. These include MediChoice (lots 240302 and 240306) and ClearImage (lots 230221, 230256, 240227 and 240230). Further investigation, the CDC said, confirmed some patients had undergone ultrasound-guided percutaneous procedures prior to testing. Such procedures involve puncturing the skin or tissue for purposes such as placing central and peripheral IV catheters, amniocentesis, paracentesis, biopsies, and surgeries.
The CDC issued three recommendations for healthcare providers related to the outbreak:
- Stick with single-use ultrasound gel products labeled as “sterile” for ultrasound in preparation for or during percutaneous procedures.
- Ultrasound-guided procedures should only be performed by providers who are trained in the appropriate use of related gel products.
- Ultrasound gel products labeled "bacteriostatic" or "preservative" without a specific indication of sterility should be considered “nonsterile for clinical purposes.”
The American Hospital Association alerted its members about the outbreak in a news update published Monday.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.