FAQ: The Importance of Annual Device Verification

FAQ: The Importance of Annual Device Verification

The TD 100® and TEEClean® are reliable machines. The oldest TD 100 in use has been disinfecting TEE probes for almost 15 years. The three things that ensure reliability are starting with a quality product, training on how to properly use the equipment, and Annual Device Verification by a CS Medical approved (authorized) representative.

Our CS Medical team receives a lot questions regarding Annual Device Verification, so we’ve put together a list of some of the most common concerns and their responses:

Q: What is included in Annual Device Verification?

A: We dispatch a CS Medical representative to come to your facility, inspect your unit, perform any necessary repairs, test the time/temperature of the high-level disinfection cycle, provide documentation that the unit has been verified by and meets the manufacturer’s recommendation for performance and conduct an in-service training with your staff.

Q: How long will the Annual Device Verification take?

A: Our service technician will be on-site for a full day of work. The actual testing and documentation of the units’ performance will take 4-6 hours and the single in-service training will be an additional hour.

Q: Is Annual Device Verification Required?

A: Yes, CS Medical requires Annual Device Verification of both the TD 100 and TEEClean. The devices are FDA cleared with a predetermined condition for operation. This condition is critical to device performance parameters to ensure the claims with the FDA are being met for time and temperature during high-level disinfection.

Q: What topics are covered during the in-service training?

A: Proper operation, routine maintenance, and safety procedures for the device.

Q: Why is CS Medical the exclusive provider of this service?

A: The CS Medical representative performing this procedure has gone through extensive training and is using specialized verification tools to allow us to stand behind the annual device verification. The cost of the verification tools for an event that occurs once per year and the fact that the verification tools are required to be on an annual calibration schedule typically leaves most customers of the opinion it is cheaper to use CS Medical. The benefit of on-site staff training or re-training is an added bonus.

Having a subject matter expert on-site yearly is a proven method to teach best practices to end users, avoid disruptions, and ensure the continued, smooth operation of your department. By adding TD 100 or TEEClean to your annual maintenance log, you can effectively manage the device’s performance and ensure compliance to the manufacturer’s IFU.

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 ultrasound probes. During the disinfection process, the TEE probe receives high-level disinfection in (5) five minutes from TD-5® or TD-8® followed by (5) 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 15 years and over 4 million high-level disinfections, the TD 100 Automated TEE Probe Disinfector has eliminated manual reprocessing of delicate and expensive TEE ultrasound probes while also providing a repeatable and FDA cleared disinfection process. The TEEClean® Automated TEE Probe Cleaner Disinfector 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.