According to a letter to health care providers released online on Aug 18 by the US Food and Drug Administration, all ultrasonography gels and lotions manufactured by Eco-med Pharmaceutical Inc.
should be immediately stopped and discarded owing to the potential of bacterial contamination.
All ultrasound gels and lotions manufactured by Eco-med Pharmaceutical Inc. should be stopped and discarded immediately by health care practitioners, risk managers, and procurement employees. Medi Choice Ultrasound Gel, which is sold by both Owens & Minor and Mac Medical Supply Co. Inc., is one of the brand names for these items.
FDA: Stop Using EcoMed Ultrasound Gel And Lotion
Eco-Med issued a voluntary recall on Aug. 4, 2021, to stop using Eco Gel 200 Ultrasound Gel due to a potential of bacterial contamination. According to an FDA ruling, all ultrasound gels and lotions manufactured by Eco-med are at risk of bacterial contamination with Burkholderiacepacia complex.
The notice is recently issued by the FDA after going through the impacts of these gels and lotions among patients from across the nation. The patients have to suffer from different health issues after the application of these gels and lotions and hence medical experts are advised to refrain from using these brands at present.
FDA has taken serious note of several samples collected from different parts and a thorough investigation is launched.
Health care providers and facilities are urged to stop using and discarding all Eco-Med ultrasound gel and lotion products immediately; not to purchase Eco-Med ultrasound gels or lotions; to consult the US Centers for Disease Control and Prevention and professional society guidelines regarding ultrasound gel use and ultrasound cleaning procedures; and to consult the US Centers for Disease Control and Prevention and professional society guidelines regarding ultrasound gel use and ultrasound cleaning procedures to contact distributors about product disposal, and to report any bad reactions or quality issues encountered while using these items.
Eco-Med announced a voluntary recall of EcoGel 200 Ultrasound Gel on August 4, 2021, owing to the danger of bacterial contamination. The FDA, on the other hand, has found that all Eco-Med ultrasonic gels and lotions are bacterially contaminated.
The FDA’s decision is based on concerns that the company did not complete its investigation of the issues, that the root cause and extent of bacterial contamination were not identified, and that manufacturing issues associated with the company’s ultrasound gel could affect multiple products (such as inappropriate testing of the finished product, inadequate testing of raw materials, and a lack of environmental controls).
Eco-Med has ceased operations and will no longer manufacture or distribute products. The FDA recently received information from the CDC suggesting that unopened bottles of Eco-nonsterile Med’s multiuse ultrasound gel tested positive for Bcc.
The FDA independently confirmed that the distributed goods tested positive for bacterial contamination while examining this matter.
Bcc can cause anything from no symptoms to life-threatening infections, such as bloodstream infections that can lead to sepsis or death.
Eco-Med ultrasonography gels have been linked to at least 59 illnesses, including 48 bloodstream infections, to date. The usage of Eco-Med ultrasonic gels may have resulted in the spread of other infections.
Due to the risk of Bcc bacterial contamination in products other than those included in Eco-recall, Med’s the FDA is working to ensure that health care providers, risk managers, and procurement staff are notified to immediately stop using and discard all ultrasound gel and lotion products manufactured by Eco-med.
The FDA is working directly with distributors now that it has learned that Eco-Med has ceased operations. Product samples are also being tested by FDA laboratories to establish the extent of the contamination.