Precautions in Using Vapotherm Humidifier
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Precautions in Using Vapotherm Humidifier
The Vapotherm 2000i Respiratory Gas Humidifier, which had previously been recalled because of potential bacterial contamination, has now been re-introduced to the market. The company has taken steps to correct the problem, but FDA is cautioning healthcare facilities to take certain precautions before using the re-introduced device. The Vapotherm device uses a nasal cannula to deliver moisture and warm breathing gases to the patient. When the device was recalled, FDA noted that certain patients, including premature neonates and the immuno-compromised, would be at particularly high risk for infection if they were exposed to breathing gases from a contaminated device. If using the re-introduced Vapotherm 2000i, here are the precautionary steps to take: • Be sure that the base unit has been disinfected by Vapotherm under the recall's corrective plan. Do not use the unit if this has not been done. Send it back to the company for disinfection. • Discard all used Vapor Transfer Cartridges, all used disinfection kit components, and any disinfection kit that has been opened. • If you have unopened Vapor Transfer Cartridges with product codes VT01-A and VT01-B, contact the distributor and exchange them for new ones with product codes VT01-AS and VT01-BS. • Get the latest users manual from the company, and closely follow the revised instructions, particularly three important precautions: - Each new Vapor Transfer Cartridge should be used only on a single patient and must be discarded after 30 days of use. - Each disinfection kit is for a single use, and must be discarded after it is used. - Only sterile water should be used in operating the device. Additional Information: FDA Public Health Notification. Precautions In Using the Reintroduced Vapotherm 2000i [Respiratory Gas Humidifier] System. February 1, 2007. http://www.fda.gov/cdrh/safety/020107-vapotherm.html CDC MMWR Weekly. Update: Ralstonia Species Contamination Associated with Vapotherm® 2000i Respiratory Gas Humidifier Systems --- United States, 2005--2006. Volume 56, Number 8. March 2, 2007. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5608a6.htm?s_cid=mm5608a6_e
YouTube | May 5, 2008
