Blease 700/900 Series Ventilators
Spacelabs Healthcare is providing the following information in response to questions regarding the use of Blease 700/900 Series Anesthesia Machine Ventilators beyond their current US Food and Drug Administration (FDA) cleared indications for use to assist in the response to the COVID-19 pandemic. Per the FDA’s March 2020 guidance regarding ventilators and other respiratory devices, the FDA indicates that a modification in use, allowing anesthesia gas machines to be used for patients needing mechanical ventilation, would not create an undue risk.
Please review the information below, and the following documents, to facilitate use of the Blease 700/900 Series Anesthesia Machine Ventilators:
Indications for Use
- Blease 700/900 Series Anesthesia Machine Ventilators are cleared for mechanical ventilation of adult and pediatric patients under general anesthesia (K112729).
Statement of Change to Indications for Use
- Use of Blease 700/900 Series Anesthesia Machine Ventilators on adult and pediatric patients, not under general anesthesia, has not been cleared by the FDA.
- When considering use of Blease 700/900 Series Anesthesia Machine Ventilators to treat adult and pediatric COVID-19 patients, not under general anesthesia, it is necessary to assure that knowledgeable clinical intervention is available to assure patient safety. Further, clinical expertise is required to tailor procedures and equipment to assure use of appropriate ventilator settings and breathing circuit materials.
- Anesthesia machines generally have highly capable ventilators that meet the needs of most patients with respiratory disease requiring mechanical ventilatory support. Anesthesia professionals should provide consultation and support to ensure that anesthetics are not delivered by mistake and ventilator settings are managed properly.
- ICU ventilator shortages are expected to be a problem if the number of COVID-19 infected patients with ventilatory failure exceeds the supply of ventilators.
Blease Ventilator Usage Recommendations
- Use of the proximal flow sensor is essential to assure adequate tidal volume delivery to the patient and to optimize breath sensing.
- OPTION 1 (Recommended if there is an adequate supply of COZ absorbent and an anesthesia professional attending the machine): Reduce total fresh gas flow substantially below minute ventilation. 1-2 Liters per minute should be adequate for most patients and will conserve both oxygen and humidity. Monitoring will require that alarms be set for minimum inspired oxygen concentration and an inspired CO2 of 5 torr. In addition, inspection should include looking for humidity in the breathing circuit and collapse of the reservoir bag due to leaks. It is prudent to increase FGF every four hours to exceed minute ventilation to help dry the internal components of the circuit. If managing excess condensate becomes a barrier to good care, increasing fresh gas flow can reduce the accumulation of water. Be aware that Blease CO2 canisters are not self-sealing when removed. The patient will require manual ventilation when changing out the CO2 canisters.
Note: if the circuit is disconnected from the patient, put the ventilator into Manual Mode first. This will preserve gas in the circuit. Otherwise high flows maybe needed to restore the volume of the reservoir bag after disconnection.
- OPTION 2 (Recommended if there is a shortage of COz absorbents and the supply of oxygen is not a concern): Increase total fresh gas flow to meet or exceed minute ventilation. CO2 absorbents will be utilized very little, if at all, since the goal is to reduce rebreathing. If inspired CO2 is present on the capnogram, increasing total fresh gas flow until the inspired CO2 is zero will eliminate rebreathing. The lack of humidity in the fresh gas may become a problem. At the very least, an HME or HMEF will be needed and an active humidifier should be considered. Using high fresh gas flow is not the preferred option due to the high utilization of oxygen and difficulty delivering humidified gases. Monitoring is easier but will still require alarms for inspired CO2 and oxygen concentrations. CO2 absorbent should still be left in place, but at continuous high flows it will not need to be changed often if at all.