FDA Cautions Providers on Using Ventilator Splitters

Agency hasn't received reports of adverse events during emergency use, but risks remain.

Use of ventilator splitters, a lifesaver during a pandemic that overtaxed existing ventilator supplies, remains a concern of the U.S. Food and Drug Administration (FDA), according to an agency advisory issued last week.

So far, the FDA has not received any reports of adverse events related to use of ventilator splitters. The FDA sanctioned their use during the COVID-19 pandemic due to a general shortage of ventilators.

"Recent literature describes risks that may be associated with using certain ventilator splitters," the FDA advisory stated. Challenges 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, and possible lung injury when swinging air from one co-vented patient to another, among other issues.  

The FDA urged providers to 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.

In the event that invasive ventilation with such splitters is the only option, the FDA offered the following recommendations:

• 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 those from New York Presbyterian Hospital, to minimize risk

The FDA stated that recent literature indicates ventilator splitters that incorporate the following 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-exploratory pressure (PEEP) valves
   
• Inspiratory and expiratory tidal volume sensors
   
• Pressure sensors

Ventilator splitters divide the gas flow from one mechanical ventilator to deliver a tidal volume to more than one patient, and collect expiration from these patients.

During the pandemic, clinicians gained experience with shared ventilators, and along with research conducted on this sharing, the FDA said much knowledge has been gained over this short time on potential risks and benefits of shared use.