FDA this week ized respiratory support devices developed by Fitbit and NASA for use in the treatment of COVID-19 patients.
In addition to the list of ized ventilator devices flagged by the agency Tuesday, FDA disclosed greenlights for Fitbit Flow, an emergency resuscitator designed by the wearable device company, and for a second emergency ventilator developed by NASA Jet Propulsion Laboratory.
FDA has now ized close to 80 ventilators, tubing connectors and accessories since the start of the coronavirus crisis, with ResMed, Philips Respironics, Vyaire Medical, GE Healthcare, Medtronic's Covidien, Boston Scientific, Hillrom, Formlabs and Stryker Instruments all among the still-growing list.
The onset of COVID-19 pushed the U.S. to rapidly increase its supply of respiratory support devices, a need too overwhelming for traditional ventilator manufacturers like Medtronic, Philips, Getinge, Drager and others to immediately fulfill on their own.
Fast forward to June and wearables maker Fitbit is OK'd by FDA to be part of that effort. Fitbit revealed to CNBC last month it was preparing to seek emergency use ization for a ventilator device. The company, which researching the role such devices can play in the early detection of coronavirus infections.
Ventilators are outside of Fitbit’s traditional areas of focus, but the company saw an opportunity to convert its supply chain to the production of respiratory support devices. The result is Fitbit Flow, a device FDA describes as an emergency resuscitator, a classification given to eight devices on FDA's running list of ized ventilators list so far, including the so-called Coventor device developed by the University of Minnesota and Boston Scientific.
Fitbit's device consists of a reusable mechanical actuator and disposable tubing. By pairing the actuator with a manual resuscitator, healthcare professionals can use Fitbit Flow to provide patients with respiratory support at times when there are no FDA-cleared clinical ventilators available. The device has a feature that enables it to support breaths triggered by the patient.
NASA’s device is a more fully fledged ventilator. The emergency ventilator OK'd this week is a revised version of the VITAL Compressor ventilator that FDA ized in April. NASA’s original ventilator used wall gas as a pressure source. The product given the nod this week derives energy from an internal compressor designed to enable it to provide three to four months of respiratory support.
In designing the device, NASA made use of components not found in existing ventilators produced by medtech companies. FDA highlighted that point in a statement, noting that it means NASA’s device “does not impact the existing supply chain of currently made ventilators.”
The use of alternative components could enable NASA and its eight U.S. manufacturing partners to continue producing VITAL ventilators in the event of disruption to the supply chains of conventional ventilators.
Such disruption was one of many concerns early in the crisis, but it is now plausible that the U.S. will end up with far more ventilators than it needs. As the COVID-19 crisis has evolved, medical experts have questioned whether they're being overused and if the country might actually wind up with a glut of the devices.
In March, President Donald Trump said the U.S. would make 100,000 ventilators in 100 days, leading to contracts with companies including General Motors and Ford. Last month, Trump said the U.S. is giving “thousands and thousands” of ventilators away to countries including Italy, France and Spain.