This emergency policy includes modified anesthesia gas hardware, positive pressure breathing devices as well as home continuous positive airway pressure machine used to treat sleep apnea, portable oxygen generators for chronic obstructive pulmonary disease, and nasal cannulae hoses.
The Emergency Use Authorization issued by the FDA enables use of these machines for treating COVID-19 patients following a manufacturer’s official request; the agency will be compiling a public listing of all permitted devices.
In addition to the emergency use authorization the agency also told healthcare providers that certain ventilators may be able to support multiple patients at the same time using air tube splitters.
Previously the agency has told the industry that it would allow manufacturers to modify and deploy previously cleared ventilators without needing to resubmit them for review, and the agency gave providers permission to use ventilators beyond their indicated shelf life.
GE Healthcare and Medtronic are working to ramp up production of their ventilators. GE reports setting up additional manufacturing lines, increasing shifts and hiring new employees, and will also be boosting their output of CT scanners, ultrasound devices, mobile X-ray units and patient monitors. Medtronic reports increasing global production by over 40%, and plans to double its total capacity.
General Motors will be working with Ventec Life Systems to increase production of ventilators. After offering 1,255 free ventilators and 50,000 N95 masks to help with the shortage, Tesla is also having engineering discussion regarding ventilator production and the possibility of working across industries.
