New tee probe disinfector with high-level disinfectant cleared by FDA
CS Medical announced in a press release the U.S. Food and Drug Administration (FDA) and Health Canada clearance of a new Class II medical device – the TD 200 Automated TEE Probe Disinfector with TD 12 AquaCide high-level disinfectant.
Building off the TD 100 platform, TD 200 with TD 12 AquaCide provides customers with a faster high-level disinfection time and an overall quicker total cycle time of ten minutes. TD 200 is the first medical device cleared in North America which provides high-level disinfection in three minutes. The single-use biocide, TD 12 AquaCide comes in granulated form. The TD 12 AquaCide bottle is pierced inside the TD 200, is mixed with water, and heated to create a liquid high-level disinfectant. Step-by-step instructions are displayed on the LCD screen for the end-user.
“Today’s news shows CS Medical’s continued commitment to providing products and services that effectively reprocess TEE ultrasound probes. TD 12 AquaCide provides new and exciting opportunities for CS Medical. With a quicker high-level disinfection claim than TD 5 or TD 8, as well as not requiring deactivation prior to disposal, TD 12 AquaCide will reduce reprocessing time and reduce potential ecosystem damage,” said Mark Leath, CS Medical President. “TD 200 with TD 12 AquaCide is another example of our pledge to work with healthcare professionals and other professional organizations to reduce HAIs and increase awareness for a better and safer healthcare system.”
