CS Medical announces FDA clearance of TEEClean Automated TEE Probe Cleaner Disinfector

CS Medical announces FDA clearance of TEEClean Automated TEE Probe Cleaner Disinfector

Press releases may be edited for formatting or style | June 07, 2019 Ultrasound
CREEDMOOR, NORTH CAROLINA – CS Medical® is pleased to announce the successful clearance of a new Class II medical device by the US FDA, TEEClean® Automated TEE Probe Cleaner Disinfector. TEEClean is the first medical device cleared in North America which provides both cleaning and high-level disinfection of a TEE ultrasound probe. TEEClean marks a new era in the reprocessing of reusable medical instruments. The healthcare professional simply places a bedside cleaned TEE probe into TEEClean and follows simple prompts on the color touchscreen display. TEEClean guides the healthcare professional through an FDA validated workflow for effective reprocessing of soiled TEE probes. Electronic record retention is part of TEEClean 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 7‑inch color LCD touchscreen. TEEClean utilizes the same disinfection technology as the TD 100®. TD‑5® or TD‑8® high-level disinfectants can be used in TEEClean while the cleaning is completed with TEEZyme® enzymatic detergent. TEEClean utilizes the same advanced vapor management system as the TD 100 and incorporates a new, high quality water filtration system through an FDA registered Class II device. TEEClean rinses each TEE probe with a 5 nanometer (.005 micron) water filter that retains bacteria, viruses, and endotoxins.

"Today's news marks the next era in the reprocessing of TEE ultrasound probes, cleaning, and disinfection within one machine, an automated TEE ultrasound reprocessor. Here at CS Medical, we have listened to our TD 100 customer base and have delivered the next generation in TEE ultrasound probe care. TEEClean is the combination of years of research, development, and commitment by our entire staff." said Mark Leath, CS Medical President. "TEEClean is another example of our continued commitment to working with healthcare professionals and other professional organizations in the reduction of HAIs and increase awareness for a better and safer healthcare system. In addition to our employees, I am thankful and appreciative of the cooperation and assistance given to us by the TEE ultrasound probe manufacturers, without whom TEEClean would not be the product it is today."

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About CS Medical
CS Medical, LLC, has pioneered the automated disinfection process for Transesophageal ultrasound probes with the development and release of the TD 100 Automated TEE Probe Disinfector. In 2005, the TD 100 was the first FDA cleared automated disinfection process with printed verification for transesophageal (TEE) ultrasound probes. During the disinfection process, the TEE probe receives high-level disinfection in five minutes from TD‑5 or TD‑8, followed by five complete rinse cycles before disinfection confirmation is acknowledged and a report is printed. The verification report indicates probe contact time with the high-level disinfectant as well as the average temperature of the single-use disinfectant during each cycle.

For more than 13 years and over 4 million high-level disinfections, the TD 100 Automated TEE Probe Disinfector has eliminated manual high-level disinfection of delicate and expensive TEE ultrasound probes, while also providing a repeatable and FDA cleared disinfection process. TEEClean will continue the TD 100's work by automating the required cleaning process for the TEE probe before high-level disinfection. TEEClean, with electronic record data logging, printed verification reporting, FDA cleared cleaning, and high-level disinfection will be the standard of care for TEE ultrasound probes.

CS Medical's TEE Complete Care® products provide quality device care and storage by minimizing healthcare operational costs, improving service readiness, and increasing regulatory compliance.

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