Does FDA Clearance Matter?

Does FDA Clearance Matter?

At CS Medical, we make a big fuss about the fact that our automated TEE probe cleaners and high-level disinfectors (TEEClean® Automated TEE Probe Cleaner Disinfector, the TD 100® Automated TEE Probe Disinfector, and the TD 200® Automated TEE Probe Disinfector) are cleared by the U.S. Food and Drug Administration (FDA) for safely reprocessing TEE probes. But what is the FDA and what does it even mean to say that a product has been cleared for use by the FDA and how is such clearance obtained?

U.S. Food and Drug Administration

The FDA was actually started under a different name, the Pure Food and Drugs Act, in 1906 by President Theodore Roosevelt. This act, under the authorization of the Bureau of Chemistry, was intended to prevent the selling of misbranded and "adulterated" food and drugs. In 1927, the Bureau of Chemistry and everything under its supervision was reorganized and rebranded the FDA as we know it today.

The FDA is no longer relegated simply to the control of food and drugs. Today’s FDA promotes public health through the control and supervision of food, tobacco, supplements, pharmaceutical drugs and medications, vaccines, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal feed, and veterinary products.

Every Class II and Class III medical device needs to be reviewed and cleared or approved by the FDA without exception. While no one enjoys wading through the sea of red tape for months and even years to gain FDA clearance, consumers reap significant benefits from the work the FDA does on their behalf. The goal of the FDA is much the same as it was in 1906: to protect consumers from dishonest retailers selling harmful or ineffective food, drugs, and medical devices.

FDA Clearance

FDA 510k clearance is obtained for a Class II medical device to ensure the public that the device is safe for use and will accomplish its intended purpose. The language often employed by the FDA to describe this is that the benefits of the use of a device outweigh the risks and that the medical device is safe and effective for its intended use.

To achieve FDA clearance for a Class II medical device, like our disinfectants, automated cleaners, and high-level disinfectors, a company must submit large and incredibly detailed reports on the functionality of the device(s) they are seeking to clear. Often, a new device resembles an already existing medical device and functions in a similar way. If that other device has already received FDA clearance, then the second, newer device can piggyback on that clearance. If the new device is deemed substantially equivalent to the predicate (previous) device by the FDA, the new device will receive clearance.

Why Does it Matter?

FDA clearance is critical to helping ensure the safety and well-being of the public. When a product has undergone the rigorous testing required by the FDA for clearance or approval, consumers can rest easy knowing that the products they are purchasing have been vetted by the largest and strictest regulatory agency in the world.

Additionally, when a product has been submitted for FDA clearance, it says a lot about the company submitting it. This shows that the company is committed to transparency and to the safety of their customers. Obtaining FDA clearance is a process that can take anywhere from a few months to several years of work by individuals or even teams of people at a company.

In CS Medical’s case, our automated TEE probe cleaners and disinfectors (TEEClean Automated TEE Probe Cleaner Disinfector, the TD 100 Automated TEE Probe Disinfector, and the TD 200 Automated TEE Probe Disinfector) have all been cleared for use exclusively with TEE ultrasound probes. Facilities must be cautious when using reprocessors designed for other devices. If a device has been cleared for use as an endoscope reprocessor, for example, it should not be used to reprocess TEE probes. When reviewing CS Medical’s 510k form under the section titled, "Indications for Use," one can see that our reprocessors are made specifically to clean and/or high-level disinfect TEE ultrasound probes.

FDA clearance can be a long and arduous process, but for CS Medical, we believe that labor is worthwhile. We have put in the late nights and the long hours to ensure that our automated cleaners and high-level disinfectors have all received FDA clearance for use with TEE ultrasound probes. We are happy to do the work required to give our customers the satisfaction of knowing that our products are safe for use and will do everything we say they will.

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.

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