Air Collective Forum

FDA Enforcement Policy for Ventilators

Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Their report includes info on

  • Modifications to FDA-Cleared Indications, Claims, or Functionality
  • Hardware, Software, and Material Changes to FDA-cleared Ventilators and Anesthesia Gas Machines
    *Use of Ventilator and Anesthesia Gas Machine Breathing Circuit Devices Beyond Their Indicated Shelf Life and Duration of Use
  • Validation of Changes Made to Hardware, Software, Materials, or Duration of Use
  • Labeling of Modified Devices

From Ventilator Supply Mitigation Strategies: Letter to Health Care Providers:

If the number of ventilators in your facility is running low, consider alternative devices capable of delivering breaths or pressure support to satisfy medically necessary treatment practices for patients requiring such ventilatory support. Health care providers should use their judgment based on the condition of the patient and the circumstances in the facility to choose the best option. Examples of alternative uses of respiratory devices used to address shortages might include the following, which the FDA believes may help increase availability:

  • For any patient needing ventilatory support, continuous ventilators labeled for home use may be used in a medical facility setting depending on the features of the ventilator and provided there is appropriate monitoring (as available) of the patient’s condition.
  • For stable patients, emergency transport ventilators may be used for prolonged ventilation in a medical facility setting.
  • For any patient needing ventilatory support, anesthesia gas machines capable of providing controlled ventilation or assisted ventilation may be used outside of the traditional use for anesthetic indication. Because of significant differences between the anesthesia gas machine and traditional critical care ventilators, use or supervision by an anesthesia provider is recommended. Refer to the manufacturers’ websites for specific instructions on safe use of anesthesia gas machines for this indication.
  • Noninvasive Ventilation (NIV) Patient Interfaces capable of prescribed breath may be used for patients requiring such ventilatory support, including NIV Patient Interfaces labeled for sleep apnea.
  • Continuous Positive Airway Pressure (CPAP), auto-CPAP, and bilevel positive airway pressure (BiPAP or BPAP) machines typically used for treatment of sleep apnea (either in the home or facility setting) may be used to support patients with respiratory insufficiency provided appropriate monitoring (as available) and patient condition.
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Note, the FDA just approved the use of these devices in emergency situations:

http://www.fda.gov/medical-devices/letters-health-care-providers/ventilator-supply-mitigation-strategies-letter-health-care-providers

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These additional FDA documents for the Emergency Use Authorization letter for ventilators include a Patient Fact Sheet, a Health Care Provider fact sheet and Appendix A: Criteria for Safety, Performance and Labeling:

Ventilator-EUA-Patients.pdf (125.9 KB) Ventilator-EUA-HCP.pdf (132.8 KB) Ventilator-EUA-AppendixA.pdf (213.9 KB)

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