A letter published by the US Food and Drug Administration (FDA) provides recommendations for health care providers and facilities, based on the recently issued guidance, regarding the use of devices with patients who develop respiratory compromise from COVID-19 or other respiratory disorders. These are important guidelines to follow in order to implement ventilator supply mitigation strategies in the US but can be useful for healthcare institutions, product suppliers and government institutions in other parts of the world affected by the COVID-19 outbreak.
The FDA’s recommendations are intended to augment, not replace, specific controls and procedures developed by health care organizations and the Centers for Disease Control and Prevention (CDC). In general, the FDA recommends health care providers and facilities, wherever 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 where 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 the number of ventilators in a medical facility is running low – as is expected to be the case in a growing number of regions (not just in the US), medical professionals can 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 continuous ventilators labeled for home use, in order to help increase availability for any patient needing ventilatory support. These 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, similar to those presented in recent publications by MIT, Leitat and VentilAid, 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.
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 the 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.