FDAnews Device Daily Bulletin

VAPOTHERM REPLIES TO FDA, CDC DEVICE ADVISORIES

Nov. 8, 2005
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Vapotherm recently issued a response to the FDA and the Centers for Disease Control and Prevention concerning possible infections from using its respiratory gas administration device.

The company argues that its own testing shows that hospitals that followed routine disinfecting procedures were able to avoid infections. But Vapotherm also said that low-level disinfectants might not be sufficient to kill all potential bacterial infections. The company is recommending that hospitals use higher-level disinfection to ensure that infections do not develop.