Bacterial Contamination of Vapotherm Devices (Feb 2006)

FDA issued updated information about an association between the Vapotherm 2000i device and the occurrence of positive Ralstonia cultures. Ralstonia are gram-negative bacteria that were formerly included in the genus Pseudomonas or Burkholderia. The Vapotherm device is used to add moisture and warm breathing gases through a nasal cannula in patients receiving supplemental oxygen.

Reports to FDA and CDC from hospitals in 16 states indicate that some Vapotherm devices are colonized by Ralstonia, and the bacteria have also been isolated from patients exposed to these devices. FDA is continuing to work with CDC to determine the source and scope of the Ralstonia contamination, find out whether other organisms may be involved, and evaluate disinfection protocols.

FDA is advising clinicians and institutions to use alternative devices until the source of contamination has been identified. FDA is also advising that patients who've been exposed to the Vapotherm system be monitored for signs and symptoms of infection. These can include changes in temperature, poor feeding, irritability, and blood count changes. Clinicians may want to consider Ralstonia infection in symptomatic patients who've been exposed to a Vapotherm device even if the organism has not been isolated.

UPDATE: On January 25, 2006, Vapotherm Inc. issued a press release stating that any health care facilities that have the Vapotherm 2000i device must return all devices to the company.

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News & Politics

Tags:

• Bacterial
• Contamination
• Vapotherm
• Devices
• FDA
• Ralstonia
• Patient
• Safety
• Infection