The U.S. Food and Drug Administration has begun approving for use during the COVID-19 pandemic bag resuscitators that have been converted to respiratory ventilators.
Late in March, the FDA issued an Emergency Use Authorization (EUA) that cleared the way for such modifications by eliminating a mandate that manufacturing facilities follow current good manufacturing practices (CGMP), including quality system requirements, when making ventilators under the EUA.
Suspending the CGMP practices, which typically involve a significant amount of procedure documentation and record keeping, allowed non-medical manufacturers such as Ford and GM to begin ventilator production. The EUA also allowed commercially available bag resuscitators and other devices to be modified in a way that allows them to fill in as ventilators.
The first of these converted bag resuscitators have now been approved by the FDA. Among those designs getting the agency’s blessing is one developed by the University of Minnesota and produced by Boston Scientific and a second device developed and manufactured by Dan T. Moore Co. in Cleveland, Ohio.
The speed and means by which these devices were developed and approved is noteworthy. Medical devices must meet literally dozens of electrical and safety standards before their commercial introduction. The EUA for ventilators, for example, lists more than 22 IEEE and IEC standards that modified devices must adhere to. The usual means of demonstrating compliance with these technical standards is through testing by independent labs such as UL, CSA, or TÜV SÜD. But it looks as though the devices approved under the ventilator EUA won’t need to be tested by independent labs.
Officials involved with obtaining FDA approval of the Cleveland-based effort, called SecondBreath, describe a process in which device developers ran their own tests, then sent the result to the FDA for review. SecondBreath spokesman Windsor Ford says the firm’s interactions with the FDA were mainly through email. No FDA personnel inspected the manufacturing facility which consists of unused space in a Dan T. Moore warehouse. And no FDA personnel supervised testing.
Nevertheless, there was “an enormous amount of testing” involved in proving the modified resuscitators complied with FDA requirements, Ford said. Some of this testing took place on a breathing simulator called an ASL 5000 which can “breath” while hooked up to a ventilator. The SecondBreath device also had to go through ARDS Net (Acute Respiratory Distress Syndrome) compliance testing which took place in cooperation with local hospitals. “We provided the FDA with extensive video and other documentation of our tests that made them comfortable that we had performed all the tests correctly,” he added.
