FDAnews
www.fdanews.com/articles/82022-fda-warns-of-infections-from-oxygen-device

FDA WARNS OF INFECTIONS FROM OXYGEN DEVICE

October 28, 2005

The FDA has issued a public health notification about the potential for patients using the Vapotherm Respiratory Gas Administration device to be exposed to Ralstonia bacteria cultures.

In the notice, the agency explained that new information obtained by the Centers for Disease Control and Prevention (CDC) states that chlorine dioxide disinfection protocol, recommended by the manufacturer for disinfecting the device, may not control bacteria in some instances. The device is used to add moisture and warm breathing gases through a nasal canula in patients receiving supplemental oxygen.

The notice recommends that doctors continue to weigh the potential risks of bacterial contamination versus the benefits of using the device. The CDC adds that clinicians must "bear in mind that immunocompromised patients are at particularly high risk for infection if exposed to a contaminated Vapotherm device."