Ralsontia sp. Contamination of Vapotherm Devices

ISSUE: The use of devices which provide high flow, heated, humidified oxygen provides benefits to both neonate and infant patient populations with respiratory compromise exhibiting symptoms of apnea, hypoxia and/or intolerance to Continuous Positive Airway Pressure. One such device, Vapotherm 2000i (VT) was introduced in January of 2005 for use in our Neonatal Intensive Care Unit (NNICU). During January-October 2005, there were no cultures positive for Ralstonia sp. or identified complications as a result of the device use. On October 21, 2005, the MMWR publication reported that Vapotherm 2000i was identified as a potential source for Ralstonia sp. infection/colonization. PROJECT: Based on this report, it was determined that environmental culture collection was needed to detect the presence of Ralstonia sp. contamination in VT therapy devices. Disinfection protocol was adapted as per manufacturer recommendation and environmental cultures were collected from VT circuit systems on a weekly basis for eight weeks. Cultures were collected by respiratory therapists trained in specimen collection technique. A report of gram negative bacillus growth triggered immediate VT device replacement. RESULTS: During November-December 2005, a total of 19 single patient devices were cultured from the VT circuits, 21% (4/19) of the total were identified as positive for Ralstonia sp. As documented by the CDC, it was determined that the use of the chlorine dioxide disinfection protocol did not produce a long term control of bacterial growth. One clinical isolate was identified in a patient with a history of VT use. Four of our purchased VT devices were subsequently returned to the manufacturer in response to a voluntary recall. Another device has replaced the VT for heated, humidified oxygen delivery. LESSONS LEARNED: This experience has demonstrated the need for infection control participation in evaluating for use in patient care, any product which has the potential to negatively impact patient safety. In this instance, infection control consultative services would have been advantageous in the identification of issues that would impact disinfection practices. Infection Control consultation in patient equipment selection requiring sterilization or disinfection procedures must be supported by organization leadership. ISSUE: The use of devices which provide high flow, heated, humidified oxygen provides benefits to both neonate and infant patient populations with respiratory compromise exhibiting symptoms of apnea, hypoxia and/or intolerance to Continuous Positive Airway Pressure. One such device, Vapotherm 2000i (VT) was introduced in January of 2005 for use in our Neonatal Intensive Care Unit (NNICU). During January-October 2005, there were no cultures positive for Ralstonia sp. or identified complications as a result of the device use. On October 21, 2005, the MMWR publication reported that Vapotherm 2000i was identified as a potential source for Ralstonia sp. infection/colonization. PROJECT: Based on this report, it was determined that environmental culture collection was needed to detect the presence of Ralstonia sp. contamination in VT therapy devices. Disinfection protocol was adapted as per manufacturer recommendation and environmental cultures were collected from VT circuit systems on a weekly basis for eight weeks. Cultures were collected by respiratory therapists trained in specimen collection technique. A report of gram negative bacillus growth triggered immediate VT device replacement. RESULTS: During November-December 2005, a total of 19 single patient devices were cultured from the VT circuits, 21% (4/19) of the total were identified as positive for Ralstonia sp. As documented by the CDC, it was determined that the use of the chlorine dioxide disinfection protocol did not produce a long term control of bacterial growth. One clinical isolate was identified in a patient with a history of VT use. Four of our purchased VT devices were subsequently returned to the manufacturer in response to a voluntary recall. Another device has replaced the VT for heated, humidified oxygen delivery. LESSONS LEARNED: This experience has demonstrated the need for infection control participation in evaluating for use in patient care, any product which has the potential to negatively impact patient safety. In this instance, infection control consultative services would have been advantageous in the identification of issues that would impact disinfection practices. Infection Control consultation in patient equipment selection requiring sterilization or disinfection procedures must be supported by organization leadership.