The FDA issued a wide-ranging emergency policy allowing alternative devices to be used as potentially lifesaving ventilators as shortages begin to impact hospitals’ responses to the coronavirus pandemic.
This includes modified anesthesia gas hardware and positive-pressure breathing devices—as well as home continuous positive airway pressure, or CPAP, machines used to treat sleep apnea, plus portable oxygen generators for chronic obstructive pulmonary disease and nasal cannulae hoses.
However, the American Society of Anesthesiologists put out guidance last month recommending that healthcare professionals take extra precautions when using such non-invasive respiratory devices, which may disperse unfiltered droplets and increase the spread of infection through the air.
The agency’s broad Emergency Use Authorization enables their use for treating COVID-19 patients following a manufacturer’s official request, and the FDA will be compiling a public list of permitted devices. In addition, the FDA told healthcare providers that certain ventilators may be able to support multiple patients at once using air tube splitters.
Earlier this week, the FDA told the industry it would allow manufacturers to modify and deploy previously cleared ventilators without needing to resubmit them for agency review and gave providers permission to use ventilators beyond their indicated shelf life.
Meanwhile, Medtronic and GE Healthcare are working to ramp up ventilator production. Medtronic, maker of the Puritan Bennett brands, said it increased global production by more than 40% and plans to more than double its total capacity. GE Healthcare said it is setting up additional manufacturing lines, increasing shifts and hiring new employees and will boost output of CT scanners, ultrasound devices, mobile X-rays and patient monitors as well.
Editor's note: This story has been updated with additional information from the American Society of Anesthesiologists.