番茄社区

Use of Eco-Med ultrasound gels or lotions for healthcare procedures -- or for any other use -- should "immediately stop," and the products should be discarded, the FDA on Wednesday.

Earlier this month, the Canadian pharmaceutical company one of its products -- EcoGel 200 (distributed under various names) -- but the agency has determined that all of Eco-Med's gels and lotions pose a risk for bacterial contamination with Burkholderia cepacia complex (Bcc), which can cause serious infections resulting in sepsis or death.

"The FDA recently received information from the CDC indicating that unopened bottles of nonsterile, multi-use ultrasound gel, manufactured by Eco-Med, tested positive for Bcc," the agency said in a letter addressed to healthcare providers. "While investigating this issue, the FDA independently confirmed that distributed product tested positive for bacterial contamination."

To date, at least 59 Bcc infections across six states have been linked with Eco-Med products, resulting in 48 bloodstream infections, the reported. Many involved patients who underwent ultrasound-guided procedures where the company's MediChoice M500812 ultrasound gel was used. Additional infections associated with the gels and lotions may have gone unreported as well.

"Eco-Med has shut down all operations and is no longer manufacturing or distributing any products," the FDA said, and the agency said it is now working with distributors to stop further circulation. Beyond the U.S. and Canada, products were also shipped to multiple countries across the globe.

Healthcare providers and facilities should refrain from any additional purchases of the more than 2 dozen applicable products -- such as EcoLotion, Liquasonic, and MediChoice Ultrasound Gel -- and "immediately stop using and discard all ultrasound gel and lotion products manufactured by Eco-Med."

Providers and facilities are also encouraged to seek consultation from the CDC or guidelines for appropriate device cleaning protocols in light of the contamination risk.

FDA said it remained concerned that "the root cause and extent of bacterial contamination was not identified" during an Eco-Med investigation, resulting in the agency's broad actions. The extent of the contamination continues to be under investigation by FDA, along with the CDC and local health departments. Additional updates are expected.

Adverse events (AEs) or suspected AEs associated with the products should be reported to .

Comment