FDA Issues Enforcement Policy for Ventilators Amid Shortage Concerns

Ventilator shortages dominated the coronavirus-related news cycle over the weekend with Elon Musk revealing ventilator discussions with Medtronic, and FDA implementing an enforcement policy for ventilators and accessories, along with other respiratory devices. The policy went into effect immediately and will remain in effect for the duration of the coronavirus (COVID-19) public health emergency.

“Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate,” the agency noted. That said, anyone can submit online or written comments on any guidance at any time.

FDA said the policy is intended to foster the continued availability of certain safe and effective medical devices while being flexible regarding manufacturer modifications made to ventilators, anesthesia gas machines, and other respiratory devices, and their accessories, in response to the COVID-19 public health emergency.

FDA recommendations include:

  • FDA wants hospitals and providers to, whenever possible, use FDA-cleared conventional/standard full-featured ventilators when available to support patients with respiratory failure.
  • Under the policy, manufacturers may make certain modifications to FDA-cleared indications, claims, or functionality of these devices without prior submission of a premarket notification, as long as the modification will not create an undue risk in light of the public health emergency. In such circumstances, FDA recommends that the manufacturer provide clear instructions delineating FDA-cleared indications and claims from those that are not FDA-cleared, in addition to a general statement about changes that have not been cleared by FDA.
  • If healthcare facilities run low on ventilators, FDA urges them to consider alternative devices capable of delivering breaths or pressure support to satisfy medically necessary treatment practices for patients requiring such ventilatory support. Healthcare provider should use their judgment based on the condition of the patient and the circumstances in the facility to choose the best option, the agency noted. Examples of alternative uses of respiratory devices to address shortages might include the following, depending on patient needs, FDA said:
    • Continuous ventilators labeled for home use may be used in a medical facility setting depending on the features of the device and as long as appropriate monitoring of the patient’s condition is available.
    • Emergency transport ventilators may be used for prolonged ventilation in a medical facility setting.
    • 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. The agency urges providers to 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 labled for sleep apnea.
    • Continuous positive airway pressure (CPAP), auto-CPAP, and bilevel positive airway pressure machines typically used for treatment of sleep apnea may be used to support patients with respiratory insufficiency, provided appropriate monitoring (as available) of the patient’s condition.

FDA also said healthcare facilities may consider extending the shelf life and duration of use of these products for treating individual patients, depending on the availability of resources. The agency also said it is okay to extend the duration of use of passive humidifiers for up to one week, depending on patient condition and availability of resources.

While the agency prefers that U.S. healthcare facilities use FDA-cleared ventilators where possible, the agency said it is taking steps to make available ventilatory support devices that are not currently on the U.S. market to support the wider availability of devices during the public health emergency.

See FDA’s letter to healthcare providers for more information.

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