FDA Updates Guidance on Ventilator Splitters, Cites Potential Risks | Nutrition Fit



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There may be risks associated with using certain ventilator splitters, and splitters should only be used in situations in which there are no alternatives for invasive ventilation and in accordance with recommendations, the US Food and Drug Administration (FDA) said February 9 in updated guidance to healthcare providers.

Ventilator splitters (also known as multiplexing ventilator tubing connectors) divide the gas flow from a single mechanical ventilator to ventilate more than one patient.

Last March, the FDA issued an emergency use authorization permitting the emergency use of certain ventilator splitters and other accessories to address the projected shortage of equipment because of the pandemic.

The decision was based on data suggesting that ventilator splitters may be effective and that the benefits would outweigh the known and potential risks.

To date, the FDA hasn’t received any adverse event reports related to the use of ventilator splitters authorized for emergency use.

“During the past nine months of the pandemic, clinicians have gained real-world experience with shared ventilators and additional research has been performed on the conditions for safe use,” the FDA said.

In its update, the FDA says healthcare providers and facilities should consider noninvasive ventilation, such as high-flow nasal oxygen or noninvasive positive pressure ventilation, as a first option before using an authorized ventilator splitter.

If invasive ventilation using a splitter is the only option, the FDA said it’s best to limit sharing of ventilation to two patients; to limit time shared to 48 hours; to match patients on the basis of similar ventilatory requirements; and to reserve at least one single-patient ventilator for emergencies or to wean a patient off ventilation, if possible.

The FDA said recent literature indicates that ventilator splitters with reduced risks incorporate specific 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 valves; inspiratory and expiratory tidal volume sensors; and pressure sensors.

Some of the challenges identified with clinical experience include the following:

  • 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;

  • The lack of individual ventilator alarms to alert healthcare providers of individual ventilation problems.

To further minimize risks, the FDA suggests that facilities consider ventilator-sharing protocols, such as the New York–Presbyterian ventilator-sharing protocol.

The FDA regularly updates its list of authorized devices.

The FDA continues to monitor clinical experience with ventilator splitters during the COVID-19 pandemic and to evaluate emergency use authorization of these devices.

Healthcare professionals can report problems they experience using ventilator splitters to FDA’s MedWatch program.

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