(You are encouraged to copy and distribute this notification.)
Date: February 1, 2007
Dear Health Care Practitioner:
Vapotherm, Inc. has reintroduced the 2000i [Respiratory Gas Humidifier] System. This system was recalled in 2005 due to possible contamination with Ralstonia spp. cultures.
In an earlier publication (see above), FDA noted that premature neonates, immunocompromised patients and those with underlying respiratory illness (such as cystic fibrosis) or malignancy may be at particularly high risk for infection if exposed to breathing gases from a contaminated Vapotherm® device. Though the specific cause for Ralstonia spp. has not been identified, Vapotherm, Inc. has been interacting with the CDC and FDA in updating the Operating Instruction Manual and implementing additional corrective actions to minimize the risk to patients. The FDA continues to monitor the device and encourages you to report any problem. In addition, the FDA recommends that you take the following steps before using the reintroduced device:
- Confirm that your base unit has been disinfected by Vapotherm, Inc. as part of the recall corrective plan, or send your unit back to Vapotherm, Inc. ( 198 Log Canoe Circle, Stevensville, MD 21666) to undergo the manufacturer’s disinfection process.
- Discard all used Vapor Transfer Cartridges.
- Discard all used disinfection kit components and all opened disinfection kits.
- Contact your distributor to exchange unopened Vapor Transfer Cartridges with product codes VT01-A and VT01-B for new ones with product codes VT01-AS and VT01-BS.
- Obtain the latest 2000i Operating Instruction Manual and closely follow the revised instructions. Note especially that:
- Each new Vapor Transfer Cartridge is for a single patient-use and must be discarded after 30 days of use.
- Each disinfection kit, including all components in the kit, is for a single use and must be discarded after one use.
- Only sterile water is to be used in the device.
The 2000i Operating Instruction Manual can be obtained by contacting Vapotherm, Inc. by phone at 410-604-3977 or 866-827-6843, by fax at 410-604-3978, or by emailing email@example.com.
In August 2005, a Pennsylvania healthcare facility reported isolation of Ralstonia spp. in cultures obtained from several patients using the Vapotherm® 2000i. Surveillance conducted by the CDC identified additional institutions that have recovered Ralstonia spp. from clinical specimens or Vapotherm® devices. In response, Vapotherm, Inc. issued new infection control procedures to reduce the risk of infectious disease transmission on October 13, 2005. This information was published in the October 21, 2005, issue of a CDC MMWR.
CDC’s evaluation of a Vapotherm® 2000i, subjected to the chlorine dioxide disinfection protocol provided by the manufacturer, showed that the method may not achieve sustained bacterial control. On October 27, 2005, the FDA published a Preliminary Public Health Notification informing the health care community of these events. CDC updated the October 21, 2005, MMWR on November 4, 2005, with details of the CDC’s evaluation.
Reports to the FDA and the CDC from more than two dozen hospitals in 16 states indicated that some Vapotherm® devices were colonized by Ralstonia spp. The bacteria were cultured from used Vapotherm® cartridges, from Vapotherm® devices that were disinfected according to the original instructions for use, and from devices disinfected according to newly issued instructions provided by the firm. The bacteria were also isolated from patients exposed to Vapotherm® devices. Cultures of unused Vapotherm® cartridges performed at two hospitals also yielded Ralstonia. However, cultures of other unused cartridges from some of the same lots performed by the cartridge manufacturer, by the FDA, and by CDC did not reveal any organisms. CDC updated the November 4, 2005 MMWR on December 20, 2005, with these new reports. On the same day, the FDA updated the Preliminary Public Health Notification to recommend the use of alternative devices.
Though the specific cause for Ralstonia spp. has not been identified since the firm’s introduction of the 2005 infection control procedures, Vapotherm, Inc. has been interacting with the CDC and FDA to developing additional preventative measures to minimize the risk to patients.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of Vapotherm® 2000i [Respiratory Gas Humidifier] System, you should follow the reporting procedure established by your facility.
We also encourage you to report adverse events related to Vapotherm® 2000i [Respiratory Gas Humidifier] System that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787; or online.
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
Daniel G. Schultz, MD
Center for Devices and Radiological Health
Food and Drug Administration
If you have questions about this Notification, please contact FDA's Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at firstname.lastname@example.org or by phone at 1-800-638-2041 or 301-796-7100