Virginia is one of at least six states investigating bacterial infections linked to contaminated ultrasound gels, Health Commissioner Dr. Norman Oliver announced in a clinician’s update earlier this month.
So far, the Virginia Department of Health has identified a cluster of eight Burkholderia stabilis infections in the northwest region of the state, according to spokeswoman Cheryle Rodriguez. The bacteria has been linked to multiple infections associated with contaminated medical products, including pre-moistened gloves and disinfectants.
No deaths have resulted from exposure to the gels, but “the infections can be serious if entering the bloodstream,” Rodriguez wrote in an email on Thursday.
VDH would not provide more detailed information on the location or severity of the cases. According to the U.S. Centers for Disease Control and Prevention, at least 48 of the roughly 59 cases identified across all six states were bloodstream infections, and many had undergone ultrasound-guided procedures prior to their infections.
The infections, in Virginia and other states, have been linked to a non-sterile ultrasound gel manufactured by the company Eco-Med Pharmaceutical. As of Wednesday, the U.S. Food and Drug Administration has directed providers to stop using and discard all ultrasound gels and lotions made by the company.
“The FDA’s determination is based on concerns that the company did not complete its investigation of the issues, the root cause and extent of bacterial contamination was not identified and multiple products could be affected by manufacturing issues associated with the company’s ultrasound gel,” the agency wrote in a release.
Oliver said it’s “unknown” how many and what types of facilities in Virginia currently have products from the recall list. VDH did confirm that multiple providers have been using MediChoice Ultrasound Gel, the original product involved in the investigation.
Non-sterile medical and pharmaceutical products aren’t uncommon. But when they’re water-based, they have a higher risk of becoming contaminated during the manufacturing process, according to Rodriguez.
A CDC investigation found that the non-sterile gel was likely used inappropriately during invasive procedures, including guiding the placement of IV catheters. “Ultrasound procedures that are invasive — involve open skin or mucous membranes — should not utilize non-sterile gel, as that could allow the introduction of the contaminant into normally sterile body sites, including the bloodstream,” Rodriguez wrote.
Both VDH and the CDC said providers should always use sterile, single-use ultrasound gel packets for all invasive procedures. But “using non-sterile gel on intact skin (like a pregnant woman’s abdomen) is safe and should not cause infection,” she added.
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