FDA Clears Silver-Coated Breathing Tube for Marketing

I occasionally run into people who think that the antibacterial properties of silver are "alternative medicine." Of course, that’s because they just have no idea what they’re talking about, but that’s ok.

It does make it all the more interesting when the FDA approves a medical device making specific use of silver of reducing infection risk.

Silver products aren’t without risk though. While there is a clear benefit from colloidal silver, that silver doesn’t just vanish as it moves through and out of your body. We need bacteria. The more ground-up silver we introduce into the environment, the more risk of biological devestation we create. It might be a small risk now, but these things have a way of growing over time.

FDA Clears Silver-Coated Breathing Tube for Marketing – Reduces Risk of Pneumonia for Patients Using Ventilators

The U.S. Food and Drug Administration today announced that it has cleared for marketing a breathing tube coated with a thin layer of silver. The coating, a material known to have antimicrobial properties, reduces the risk that patients on ventilators will acquire pneumonia while in the hospital.

The Agento endotracheal tube, manufactured by C.R. Bard Inc., is intended for patients who must rely on a ventilator to breathe for 24 hours or more.
Patients requiring such a breathing support system are at risk of exposure to hospital-acquired bacteria that can build up on the breathing tube or pass through the tube to their lungs, eventually causing a lung infection known as ventilator-associated pneumonia (VAP).

Fifteen percent of the patients on ventilators develop VAP every year and 26,000 die from the infection, according to the Centers for Disease Control and Prevention.

“Patients who require ventilator support are at increased risk for pneumonia, which poses a significant public health issue. This product can help to lower this risk,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health.

Silver has been known for its antimicrobial properties for decades and has been used for this purpose on several types of devices. This is the first endotracheal tube coated with silver. 

In a multicenter clinical trial comparing the Agento breathing tube to an uncoated tube, the percentage of patients who developed pneumonia was reduced from 7.5 percent to 4.8 percent. The Agento also delayed the onset of pneumonia.
 
The FDA in July issued a proposed guidance document on antimicrobial device submissions stating that when companies claim their product reduces or prevents device-related infections, the claim should be supported by such clinical data.

C.R. Bard is located in Murray Hill, N.J.


I spoke to a doctor once who commented that we’d all be better off if the walls of every hospital were painted with silver-based paints. Hospitals aren’t as clean as they look and are the breeding grounds for the types of germs we don’t want to be around. I could be a neat idea.

Of course, I can imagine this going way over the edge too. Apple juice laced with Colloidal Silver. New home cleaning products laced with Colloidal Silver.

Yea…we might not want that…

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