FDA Clears Automated TEE Probe Disinfector

By Renee Diiulio, January 11, 2012 in

CS Medical’s TD-100 is designed to reduce probe damage and improve disinfection quality control

There are two main reasons hospitals approach CS Medical LLC, Creedmoor, NC, about the TD-100, an automated transesophageal echocardiogram (TEE) probe disinfector that recently received 510(k) clearance by the FDA. Biomeds can likely guess one, if not both. “We receive interest from hospitals that want to reduce TEE probe repair and replacement costs and those interested in disinfection quality assurance,” says CS Medical general manager Steve McManus.

A compact unit with a small footprint (8 x 24 x 44 inches), the TD-100 can be placed near the point of use, reducing the need to transport the delicate transducers across the hospital for disinfection. The automated process takes roughly 15 minutes and requires only 1 minute of operator time. With an unattended processing time that is less than half that of the fastest manual methods, according to CS Medical, the system can also help to improve productivity.

“The TD-100 reduces damage to expensive TEE probes by preventing oversoaking and eliminating the numerous handling steps required by manual methods,” McManus says. “Clinical engineering is often the champion for the TD-100, especially if repairs or replacements are charged against the clinical engineering budget, because it minimizes costly repairs and replacements.”

TEE probes are used in transesophageal echocardiogram procedures that typically take place in the echo department and cardiac surgery procedures in the cardiovascular OR. A specialty transducer, they are quite expensive; McManus estimates the replacement cost of a 4D TEE probe is approximately $40,000.

“The cost of the TD-100 is less than half the cost of one avoided 4D TEE probe replacement,” McManus says, adding that based on the avoidance of repairs and replacements due to oversoaking, TD-100 users estimate the return on investment to be less than 12 months.

Simple Service
Currently, there are more than 600 of the devices installed, with some units in use longer than 6 years. Service and maintenance is relatively simple, revolving primarily around filters and cleaning.

Two vapor management filters must be replaced annually. One is located in the front of the unit and involves the removal of the door; the second sits atop a PVC drain fitting.

A mesh screen, designed to catch debris, must also be cleaned twice yearly—a simple matter of removing it, rinsing it, and returning it to its spot, McManus notes. The instrument itself must be kept clean as well, with a basic daily cleaning and a more thorough process performed twice yearly.

“That’s really the only PM required,” McManus says. “The biomed department typically handles this maintenance as well as the ordering of parts.” As another service, CS Medical offers a performance check as part of its extended warranty.

Quality Assurance
In addition to its benefits regarding cost, use of the TD-100 can also help to enhance infection control quality assurance, particularly compliance with the related standards of regulatory agencies. Failure to provide evidence of appropriate disinfection can result in a finding during an audit.

“Hospitals need to demonstrate that their disinfection equipment is operating within manufacturer specifications,” McManus says. “Many of our initial contacts are from customers who are responding to a Joint Commission audit finding.”

He suggests that TEE probes are a type of specialty endoscope that tend to be overlooked when health care organizations consider automation as a quality initiative. “Hospitals can invest a lot of money in an automated endoscope reprocessor or AER and forget about the TEE probes,” McManus says.

The first automated TEE disinfector on the market, according to CS Medical, the TD-100’s automation reduces the opportunity for operator error while continuous self-tests confirm proper operation. The results are printed in a report after each cycle. The date, time, disinfectant lot number, and identity of both operator and probe are recorded.

“Endoscope technicians have enjoyed this type of automated disinfection for a while now, and we’ve brought this same convenience and time savings to anyone tasked with handling and cleaning TEE probes,” Greg Dobbyn, CS Medical’s chief executive officer stated in the release.

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