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Ventilator Sharing Acknowledged as Life-Saving Last Alternative by FDA

05/17/2021

By Carolyn Schierhorn, MA,  Executive Editor, Global Publications

Editor’s Note: The Joint Commission does not endorse or oppose ventilator splitting but is committed to providing comprehensive authoritative resources on all aspects of COVID-19. (For more information on co-ventilation, click on the “Ventilators and Other Respiratory Support” tab on The Joint Commission’s “Coronavirus Resources” webpage.)

Under normal circumstances, patients would not share ventilators. However, significant shortages of life-saving mechanical ventilators and other needed medical equipment forced health care organizations to improvise during the pandemic. 

Nevertheless, ventilator splitting or sharing (also known as co-ventilation) remains a controversial practice.

During the first wave of the COVID-19 pandemic and in response to the shortage of mechanical ventilators, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) allowing ventilator splitters (also known as multiplexing ventilator tubing connectors) to be used during the public health emergency. Immediately following the EUA, several leading medical societies, including the Society of Critical Care Medicine and the American College of Chest Physicians, issued a joint statement on why they do NOT recommend placing more than one patient on a single mechanical ventilator. Hazards included:

  • challenges to monitoring and measuring the pulmonary mechanics of individual patients
  •  potential adverse impact on oxygen distribution to the other patient(s) sharing a ventilator should one patient deteriorate rapidly.

These concerns notwithstanding, when the need for ventilators exceeds supply during a public health crisis, and in situations in which no alternatives for invasive ventilatory support are available, the FDA believes that ventilator splitting as a stopgap solution should be considered as a last resort and only if specific precautions are followed. In February 2021, the FDA issued new guidelines on ventilator splitting.

Recommendations If Splitting Cannot Be Avoided
Noninvasive ventilation, such as high-flow nasal oxygen or noninvasive positive-pressure ventilation, should be a first option for patients prior to deciding on ventilator splitting.

If using an authorized ventilator splitter is the only option, the FDA offers the following guidelines:

  • Limit sharing of ventilation to two patients
  • Try to match patients based on similar ventilatory requirements
  • Restrict the duration of ventilator sharing to 48 hours
  • If possible, reserve at least one single-patient ventilator for emergencies or to wean a patient off the ventilator. 

Additional suggested safety measures can be found in New York Presbyterian Hospital’s April 2020 publication on the working protocol, which is based on several hospitals’ experience and other insights regarding ventilator splitting.

Ventilator Recommendations
Choosing the right ventilator is key to reducing risk. The FDA advises hospitals to select ventilators with the following safety features:

  • 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

Co-Ventilation Risks
Prior to the pandemic, the only study on ventilator sharing was a 2006 pilot study concluding that four human lung simulators could be connected to a single ventilator for 12 consecutive hours.

Now, there is greater research and real-world experience on the risks and benefits of splitting ventilators.  FDA has identified the following risks:

  • Swinging air from one co-ventilated patient to another (the pendelluft phenomenon) may result in lung injury due to overdistension of the alveoli or inspired carbon dioxide
  • There are no individual ventilator alarms to alert clinicians if a particular co-vented patient is having difficulties
  • Clinicians must continually balance differences in respiratory mechanics of co-vented patients
  • The likelihood of patient–ventilator asynchrony increases, requiring the need to use deep sedation and induce temporary paralysis, which can affect patient recovery

Still, in the short term when no other recourse is available, the FDA notes that ventilator sharing can save lives.

Other Mitigation Strategies
ECRI appears to be in agreement with the FDA in endorsing ventilator splitting as a last resort. In Ask ECRI: Ventilator Selection, Allocation, and Optimization Ask ECRI: Ventilator Selection, Allocation, and Optimization and ICU Utilization during Pandemic, ventilator sharing is listed as the 8th and final option in the ventilator selection sequence. Preferable allocation measures include using:

  • subacute/home care ventilators
  • hospital noninvasive ventilators
  • modified or unmodified home bilevel positive-airway-pressure (BiPAP) sleep apnea therapy devices, among others

Other mitigation strategies have been implemented successfully to provide mechanical support for patients in respiratory failure, consider:

  • borrowing equipment from state regions not experiencing outbreaks 
  • adapting anesthesia machines and other respiratory devices 

For more information, please read the complete article in the May issue of The Source.

Carolyn Schierhorn, MA, is an Executive Editor, Global Publications, at Joint Commission Resources (JCR). She edits Environment of Care® News and other JCR publications.