Contaminated Ultrasound Gel Warning

The U.S. Centers for Disease Control and Prevention (CDC) has received reports of the presence of the environmental bacterium Paraburkholderia fungorum in blood cultures collected from patients at healthcare facilities in four US states and two other countries. Healthcare facilities confirmed to the CDC that some of these patients had undergone ultrasound-guided percutaneous procedures prior to culture collection.

The effected non-sterile ultrasound gel products were manufactured by NEXT Medical Products Company of Branchburg, New Jersey:

• MediChoice® lots: 240302, 240306, and
  
• ClearImage® lots: 230221, 230256, 240227, 240230

The CDC continues to investigate and cautions that the use of non-sterile ultrasound gel for percutaneous procedures could result in patient harm — risks not limited to scenarios where there is known product contamination, as microorganisms may be present in non-sterile products in general.

The CDC recommends the following:

• Use only single-use ultrasound gel products labeled as “sterile” for ultrasonography in preparation for or during percutaneous procedures.
• Personnel who perform ultrasounds and ultrasound-associated procedures should be trained in the appropriate use of ultrasound gel products.
• 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.

Visit the CDC for additional information and resources.

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