FDA Alerts

FDA Clears Ethos Automated Ultrasound Probe Cleaner Disinfector

CS Medical has announced clearance of a new Class II medical device by the U.S. FDA, Ethos Automated Ultrasound Probe Cleaner Disinfector.

Wed Jul 12 2023By FDA

“Ethos is the first medical device cleared in North America which provides both cleaning and high-level disinfection of endocavity and surface ultrasound probes,” according to a press release. “Ethos marks a new era in the reprocessing of reusable medical instruments. The health care professional simply places a point-of-care cleaned ultrasound probe into Ethos and follows simple prompts on the color touchscreen display. Ethos guides the health care professional through an FDA validated workflow for effective reprocessing of soiled transvaginal, transrectal or surface ultrasound probes. Electronic record retention is part of Ethos with the ability to store more than 15,000 sessions in system memory. The user interface allows data entry through a scanner or manual keypad entry on the large 7inch color LCD touchscreen.”

Ethos delivers a new method for cleaning and high-level disinfection of soiled probes with AquaCide cleaner disinfectant, the first of its kind to obtain FDA clearance. AquaCide cleans and disinfects each ultrasound probe in only 3 minutes. The combination of AquaCide cleaner disinfectant and QwikCheck liquid chemical indicator removes the manual process of cleaning, disinfection and user validation of chemistry efficacy. Ethos reduces the time and amount of human labor spent to reprocess an ultrasound probe. By removing the manual process and creating a repeatable and validated process CS Medical and Ethos have taken the guesswork out of the reprocessing of endocavity and surface ultrasound probes. An advanced vapor management system is incorporated, as well as a high-quality water filtration system through an FDA registered Class II device. Ethos rinses each cleaned and high-level disinfected ultrasound probe with a 5 nanometer (.005 micron) water filter that retains bacteria, viruses and endotoxins.

“Today’s news marks a new era in the reprocessing of endocavity and surface ultrasound probes. Health care professionals can now have confidence in the cleaning and high-level disinfection of soiled ultrasound probes. It is now possible within one machine, Ethos, to clean and high-level disinfect. Ethos is the first automated cleaner disinfector for endocavity and surface probes. At CS Medical, we have listened to our TEEClean customer base to design and deliver a product with the same characteristics and ease of use as TEEClean for TEE probes. Ethos automated cleaner disinfector will provide health care professionals with the same ease of use and confidence when reprocessing endocavity and surface ultrasound probes. A new era in the reprocessing of all ultrasound probes is possible through the innovations and commitment of CS Medical and its staff over the past decade. Ethos and TEEClean together can provide any health care facility with confidence and compliance when reprocessing an endocavity or surface ultrasound probe. Ethos is the combination of years of research, development and commitment by our entire staff,” CS Medical President Mark Leath said. “Ethos is another example of our continued commitment to working with health care professionals and other professional organizations in the reduction of HAIs and increase awareness for a better and safer health care system. In addition to our employees, I am thankful and appreciative of the cooperation and assistance given to us by various ultrasound probe manufacturers, without whom Ethos would not be the product it is today.”

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