The US Food and Drug Administration (FDA) is urging healthcare providers to immediately stop use of and discard all Eco-Med ultrasound gels and lotions because of risk for bacterial contamination with Burkholderia cepacia complex (Bcc). In early August, the Centers for Disease Control and Prevention (CDC) and the FDA announced an outbreak of at least 15 Bcc infections associated with contaminated ultrasound gel. According to the FDA, as of August 31, Eco-Med ultrasound gels have now been linked to at least 66 infections, 60 of which were blood infections.
The FDA identified this recall as FDA Class I, the most serious type of recall, according to an updated statement on September 10.
On August 4, the Canadian pharmaceutical company, based in Etobicoke, Ontario, initiated a voluntary recall of certain lots of EcoGel 200 Ultrasound gel because of contamination with Bcc, but now the FDA warns that all Eco-Med's ultrasound gels and lotions are at risk.
"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 (such as inappropriate testing of finished product, inadequate testing of raw materials, and a lack of environmental controls)," the FDA said in a letter to healthcare providers published August 18.
The letter lists 25 products manufactured by Eco-Med that are sold by distributors in 10 different countries, including the United States and Canada. The list may not be completely comprehensive, the organization notes.
Eco-Med has ceased all operations and is no longer manufacturing or distributing products, according to the FDA statement. Both phone numbers listed for the company were not in operation at the time of reporting.
Beyond stopping use of and discarding Eco-Med products, the FDA recommends that healthcare providers and facilities stop purchases of Eco-Med products, contact distributors with product disposal questions, and follow professional society guidelines and CDC guidelines for ultrasound use and cleaning products. Providers are encouraged to report adverse events related to Eco-Med ultrasound gels or lotions through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
Although Eco-Med is listed as one of the "prominent players in the ultrasound gel market," according to a June 2020 report by Grand View Research, the announcement will likely not cause many issues, Lauren Golding, MD, chair of the American College of Radiology Commission on Ultrasound, told Medscape Medical News in an email.
"Fortunately, several companies produce ultrasound gel. Barring unforeseen circumstances, we do not expect this FDA action to have a widespread impact on patients' access to ultrasound exams in the United States," she said.
Cite this: FDA Warns Clinicians to Stop Using Eco-Med Products Because of Contamination Concerns - Medscape - Aug 18, 2021.