The U.S. FDA is informing healthcare providers and healthcare facilities about up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available.
Although the FDA has not received any adverse event reports related to the use of ventilator splitters authorized for emergency use during the COVID-19 pandemic, recent literature describes risks that may be associated with using certain ventilator splitters. Based on this information, the FDA is providing information about ways to reduce risk and certain features that are associated with better performance.
Considerations for Healthcare Providers
Healthcare providers and facilities should review the considerations listed below:
- Consider non-invasive ventilation such as high flow nasal oxygen or non-invasive positive pressure ventilation as a first option prior to using an authorized ventilator splitter.
- If invasive ventilation using an authorized ventilator splitter is the only option:
- Limit sharing of ventilation to two patients
- Try to match patients based on similar ventilatory requirements
- Limit duration of sharing ventilation to 48 hours
- If possible, reserve at least one single patient ventilator for emergencies or to wean a patient off ventilation support
- Consider updated ventilator sharing protocols, such as the New York Presbyterian Ventilator Sharing Protocol: Dual-Patient Ventilation with a Single Mechanical Ventilator for Use during Critical Ventilator ShortagesExternal Link Disclaimer to minimize risk
- The recent literature indicates that ventilator splitters that incorporate these features may reduce certain risks:
- One-way valves in the breathing circuit
- Flow restrictors or pressure regulators at each inspiratory limb of the circuit
- Individual positive end-expiratory pressure (PEEP) valves
- Inspiratory and expiratory tidal volume sensors
- Pressure sensors
For more information, visit FDA.