FDA Issues New Ventilator Guidance To Increase Supply Without Decreasing Safety Standards

Federal regulators issued new ventilator guidance, as the number of Americans falling ill to the coronavirus continues to grow and medical supply chains are strained to the breaking point.

On Sunday, the FDA issued a new guidance on its enforcement policy for ventilators and other respiratory devices during the coronavirus outbreak. The guidance expands the availability of ventilators and other respiratory devices for use on patients during the coronavirus pandemic.

The novel coronavirus, officially named coronavirus 2019 and abbreviated COVID-19, began to emerge in December 2019 in the Wuhan province of China. It has spread to more than 100 countries with more than 300,000 illnesses worldwide and was recently named a global pandemic by the World Health Organization.

According to a U.S. Centers for Disease Control and Prevention March 20 update, there are more than 15,000 confirmed cases and 14,000 suspected cases, as well as 200 deaths in the U.S. alone.

As a result of the outbreak, which affects the lungs and causes respiratory problems, hospitals worldwide are reporting, or expecting, a ventilator shortage.

In response, the FDA issued the guidance focusing on ventilator use during the COVID-19 epidemic. The guidance makes several key recommendations, including:

• Hospitals and providers should use FDA cleared ventilators when available to support patients with respiratory failure.
• Manufacturers can make modifications to FDA-cleared ventilators when necessary to treat patients with respiratory failure.
• Premarket notification for changes to FDA-cleared ventilators is not necessary, as long as the modification will not create undue risk to patients needing treatment.
• If a healthcare facility runs low on ventilators, the FDA urges the facility to consider alternative devices capable of delivering breaths or pressure support to satisfy medically necessary treatment practices for patients requiring support. Alternative uses of respiratory devices to address shortages might include the following continuous ventilators, emergency transport ventilators, anesthesia gas machines, and continuous positive airway (CPAP) machines.
• Continuous ventilators labeled for home use may be used in a medical facility depending on the features of the device and provided appropriate monitoring of the patient’s condition is available.
• Emergency transport ventilators may be used for prolonged ventilation in a medical facility.
• Anesthesia gas machines that can provide controlled ventilation can be used outside of the traditional use, but supervision by an anesthesia provider is recommended.
• Continuous positive airway (CPAP) machines used to treat sleep apnea may be used to support patients with respiratory insufficiency with appropriate monitoring.

The guidance also indicates healthcare facilities may extend the shelf life and duration of the devices used to treat patients depending on the availability of resources.

The FDA is also taking steps to make ventilators that are not currently FDA cleared available for use to support patients during the current pandemic.

The policy is being implemented without a public comment period because of the public health emergency and is being implemented immediately. The new FDA guidance policy will remain in effect only during the public health emergency related to COVID-19.