The US FDA has issued recommendations for healthcare providers for the potential use of ventilator splitters in situations in which no alternatives for invasive ventilatory support are available.
The FDA has told healthcare providers to first consider noninvasive ventilation options rather than sharing ventilators between patients. In the event NIV options are not possible, the FDA says authorized ventilator splitters should be limited to two patients with similar ventilatory demands and limited to a maximum of 48 hours. (See the full recommendations below.)
On March 25, 2020, the FDA issued an Emergency Use Authorization (EUA) that authorizes the emergency use of certain ventilators and ventilator accessories for treating patients during the COVID-19 pandemic to address the observed and anticipated shortages of ventilators and ventilator accessories. The FDA updates the list of authorized devices regularly, see Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories.
Some of the challenges identified in reported clinical experience include:
- The need to continually balance differences in respiratory mechanics of both co-vented patients;
- The need for paralysis and deep sedation to prevent asynchrony;
- Swinging air from one co-vented patient to another (pendelluft), resulting in lung injury due to overdistension of the alveoli (volutrauma), or inspired carbon dioxide;
- The increased complexity of clinical decision making; and
- The lack of individual ventilator alarms to alert individual ventilation problems.
“These findings highlight the importance of only using ventilator splitters in situations where there are no other alternatives for invasive ventilation, and in accordance with the recommendations outlined [below],” the FDA said.
Considerations for Healthcare Providers
Healthcare providers and facilities should review the considerations listed below:
- Consider noninvasive 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:
- 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, and
- Pressure sensors.
“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. After considering this recent literature, the FDA is informing healthcare providers and health care facilities that the literature indicates that certain features are associated with better performance,” the FDA said in an advisory.