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Update: Ralstonia Species Associated with Vapotherm Oxygen
Delivery Devices --- United States, 2005
This report updates information on
Ralstonia species associated with
Vapotherm™ oxygen delivery devices (Vapotherm
Inc., Stevensville, Maryland) (1). CDC has obtained new
information from a test developed by CDC and performed by
The Children's Hospital of Philadelphia (Pennsylvania) to assess the efficacy of the new chlorine dioxide disinfection
protocol recommended by Vapotherm. Although limited, this information suggests that the new protocol for disinfecting
Vapotherm devices and cartridges might not achieve sustained bacterial control in certain situations. At this time, the optimal protocol
to disinfect machines and cartridges that might contain very heavy biofilms is not known.
Before development of the new disinfection protocol in October 2005, certain institutions had reported no growth
of Ralstonia spp. in samples obtained from machines and cartridges disinfected according to the
previousprotocol. In addition, in an experiment conducted by an independent laboratory contracted by Vapotherm, a laboratory-generated
biofilm (consisting of a mix of organisms) was grown in a Vapotherm device and cartridge for 3 weeks. The device and cartridge
were then subjected to the new chlorine dioxide disinfection protocol. Results from this trial revealed no growth during the 4
days after disinfection.
However, in a single trial designed by CDC and involving one machine, The Children's Hospital of Philadelphia subjected
a Vapotherm device and used filter cartridge to the new chlorine dioxide disinfection protocol. The device and cartridge
were known to be contaminated with
Ralstonia spp., and the unit had been out of service and not disinfected for multiple
weeks. Samples obtained immediately after disinfection grew no organisms. The trial was initially designed to run for 30
days; however, after 7 days of continuous operation of the unit with no patient contact, samples from both the vapor
condensate and the filter cartridge grew
Ralstonia spp. in culture at CDC.
Whether the presence of an unusually heavy biofilm in the machine and cartridge in the hospital experiment resulted in
the failure to eradicate Ralstonia spp. is unknown. Similarly, the impact of testing a laboratory-generated biofilm instead of a
use-generated biofilm is not known. The varying results achieved with the new disinfection protocol might indicate that
its efficacy depends on the maturity of any biofilm contained within Vapotherm machines or cartridges.
Testing is being conducted by a private laboratory and CDC to further assess the efficacy of and possible improvements
to the new disinfection protocol; CDC continues to search for the source of
Ralstonia spp.contamination in Vapotherm
devices. Clinicians should continue to weigh the potential risks for
Ralstonia spp. contamination of Vapotherm devices against
the benefits of using the device in patients requiring humidified oxygen therapy.
Clinicians are encouraged to report findings of
Ralstonia spp. in patients using any Vapotherm 2000 respiratory
gas administration device directly to the device manufacturer,
local or state health departments, or CDC by
telephone, 800-893-0485. Cases or any other adverse events related to medical devices should be reported to MedWatch, the Food
and Drug Administration's voluntary reporting program online at
http://www.accessdata.fda.gov/scripts/medwatch; by
telephone, 800-FDA-1088; by fax, 800-FDA-0178; or by mail, MedWatch, Food and Drug Administration, HF-2, 5600 Fishers
Lane, Rockville, MD 20857.
Reported by:The Children's Hospital of Philadelphia, Pennsylvania. Div of Healthcare Quality Promotion, National Center for
Infectious Diseases, CDC.
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