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@example.com. 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.
- CDC. Ralstonia associated with Vapotherm® oxygen delivery device---United States, 2005. MMWR 2005;54:1052--3.
- CDC. Update: Ralstonia associated with Vapotherm® oxygen delivery device---United States, 2005;54:1104--5.
- CDC. Update: public health notification regarding Ralstonia associated with Vapotherm® respiratory gas administration devices---United States, 2005. MMWR 2005;54:1286--7.
* Additional information is available at http://www.fda.gov/cdrh/devadvice/314.html.
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