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Update: Ralstonia Species Contamination Associated with
Vapotherm® 2000i Respiratory Gas Humidifier Systems --- United States, 2005--2006
This report updates previously published information
regarding contamination of
Vapotherm® 2000i respiratory gas humidifiers (Vapotherm, Inc., Stevensville,
Maryland)with Ralstonia species
(1--3). The manufacturer took corrective actions
(Table) and reintroduced the device in January 2007, after meeting Food and Drug Administration (FDA)
510(k) submission requirements.*
CDC and FDA recommend that clinicians using the Vapotherm device ensure that they are following the
most recent recommendations and have the most recent instructions for the device and its components; the 2000i
operating instruction manual can be obtained by contacting Vapotherm, Inc., by telephone: 410-604-3977 or 866-827-6843, fax:
410-604-3978, or e-mail: [email protected]. Additional information regarding use of the reintroduced device is available
from FDA at http://www.fda.gov/cdrh/safety/020107-vapotherm.html.
FDA encourages reporting of adverse events related to the use of medical devices; such reports can be submitted
to MedWatch, FDA's voluntary reporting program, by telephone: 1-800-FDA-1088, by fax: 1-800-FDA-0178, by
mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787, or online:
http://www.fda.gov/medwatch/report.htm. Clinicians who would like to conduct surveillance for health-care--associated infections
in patients using the Vapotherm device can use
strategies similar to those used for surveillance of ventilator-associated infections.
Reported by:A Srinivasan, MD, National Center for Preparedness, Detection, and Control of Infectious Diseases (proposed); M Jhung, MD,
EIS Officer, CDC.
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Department of Health and Human Services. CDC is not responsible for the content
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