What You Need To Know
The Centers for Disease Control (CDC), in collaboration with New Jersey Department of Health (NJDOH) Communicable Disease Services (CDS), are assisting in a multistate investigation involving use of non-sterile ultrasound gel for ultrasound-guided percutaneous procedures. Product testing identified Paraburkholderia fungorum in two non-sterile ultrasound gel products, distributed under the MediChoice® and ClearImage® brands, both manufactured by NEXT Medical Products Company, Branchburg, NJ. Genetically similar isolates of P. fungorum were also detected primarily from patient blood cultures; some of these patients were known to have undergone ultrasound-guided percutaneous procedures prior to culture collection.
As of May 8, 2025, CDC is aware of 40 isolates of P. fungorum primarily isolated from patient blood cultures. As of June 3, 2025, there have been no cases reported in New Jersey.
Recommendations for clinicians and other healthcare personnel:
- Report any cases of P. fungorum with history of percutaneous non-sterile ultrasound use to the local health department.
- Select the right product: Only use single-use ultrasound gel products labeled as “sterile” for ultrasonography in preparation for or during percutaneous procedures.
- Train personnel: Personnel who perform ultrasounds and ultrasound-associated procedures should be trained in the appropriate use of ultrasound gel products.
- Review the label: An ultrasound gel product label’s claim of “bacteriostatic” or “preservative” without a specific indication of sterility should be considered “non-sterile” for clinical purposes.
Use of non-sterile ultrasound gel for percutaneous procedures could result in patient harm. These risks are not limited to scenarios where there is known product contamination, as microorganisms may be present in non-sterile products in general. Learn more: Full Recommendations
Providers should report any adverse events or quality problems experienced with the use of any ultrasound gel products to the product manufacturer, FDA’s MedWatch Adverse Event Reporting program, and DOH.CDS.HAIAR.EPI@doh.nj.gov.