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

Founded in 2003, CS Medical LLC is a leader in developing, manufacturing, and marketing medical devices that are designed to provide cleaning and high-level disinfection of ultrasound probes. Our products are engineered and developed with one single objective in mind: to minimize the potential of patient exposure to improperly reprocessed ultrasound probes. Our core products, the TEEClean® Automated TEE Probe Cleaner Disinfector and Ethos Automated Ultrasound Probe Cleaner Disinfector, are examples of our ongoing commitment to innovation and to the health and safety of medical patients and staff.

Beyond cleaning and high-level disinfection of endocavity and surface ultrasound probes, CS Medical believes in managing the quality of care given to delicate ultrasound probes. Our product offering provides solutions for healthcare facilities to minimize ultrasound probe damage and reduce the potential of contaminating high-level disinfected probes prior to use. The products address the following areas: bedside cleaning, point of care cleaning, electrical leakage testing, drying, transporting, and storing the ultrasound probe. Our objective is to manage the care given to each ultrasound probe thus allowing for a reduction in healthcare associated infections.

Located in Creedmoor, North Carolina, CS Medical's products provide quality device care and storage by minimizing healthcare operational costs, improving device readiness, and increasing regulatory compliance.