FDA Tells Medical Industry to Stop Using Eco-Med Ultrasound Gels and Lotions Due To Bacterial Contamination
Medical providers are being urged by federal health officials to stop using Eco-Med Pharmaceuticals ultrasound gel, due to a risk of bacterial contamination.
The U.S. Food and Drug Administration (FDA) issued a letter to healthcare professionals on August 18, indicating that any use of Eco-Med ultrasound gels and lotions should be ceased, and the products should be discarded.
The warning comes in the wake of an Eco-Med ultrasound gel recall announced earlier this month, following at least 15 reports of bacterial contamination in the United States. However, the FDA has now determined Eco-Med failed to carry out a proper investigation into the root cause of the contamination, which has yet to be identified. As a result, the agency is urging healthcare professionals to avoid using any of the company’s ultrasound gels or lotions.
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Eco-Med has shut down its operations and ceased manufacturing of all products, according to the FDA letter.
The original recall affected products including EcoGel 200, Chattanooga Conductor USA, Conductor Australia, DJO Conductor, Liquasonic, Medico, Medline, Omni, Red Medical Ultrasound gel Blue and Smart 200. A full list of product names and countries where they were sold is available in the original recall notice.
The bacteria, Burkholderia cepacia complex is sometimes harmless, but can also cause serious bloodstream infections resulting in sepsis and even death.
At this time, the use of Eco-Med ultrasound gel has been tied to over 59 infections with 48 being bloodstream infections. There may be additional infections unknown at this time.
The FDA letter included a list of recommendations to healthcare providers and facilities, including:
- To Immediately stop using and discard any Eco-Med ultrasound gel and lotion products.
- To not purchase any ultrasound gels or lotions made by Eco-Med.
- To consult the U.S. Centers for Disease Control and Prevention and professional society guidelines to determine safe and appropriate use of ultrasound gels, as well as appropriate cleaning procedures
- To contact the distributor who supplied the affected ultrasound gels and lotions for answers to any questions
The FDA is still investigating the issue with Eco-Med to find the source of the contamination and is also testing the products to determine the extent of the bacterial infection.
The agency requests any adverse reactions or quality problems be reported to the FDA MedWatch Adverse Event Reporting program.
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