UF-led pandemic ventilator moves forward in meeting milestones toward approval for COVID-19

 

University of Florida-led international project to rapidly design and build a low-cost, DIY ventilator using hardware store parts is meeting preliminary milestones toward being approved by the U.S. Food and Drug Administration for Emergency Use Authorization in case it is needed in the battle against COVID-19.           

With the support of a worldwide network of coders, engineers, ham radio operators and physicians, a UF Health team led by longtime UF professor of anesthesiology Samsun Lampotang, Ph.D., is moving toward securing Emergency Use Authorization, or EUA, approval by the FDA for a fixed-design prototype based on UF’s open-source design, for use in hospitals when other ventilator options have been exhausted.

Step-by-step instructions for the ventilator, made of plentiful components outside the ventilator supply chain such as air-tight PVC water pipes, lawn-sprinkler valves and an Arduino microcontroller board all costing less than a total of $250, will be provided for review by the FDA. EUA approval of the fixed design is needed for the ventilator to be used in U.S. hospitals; for volunteers across the world seeking to build ventilators, the open-source design will be publicly available.

From an idea that took root in Gainesville home offices and garages in mid-March, the project has quickly gained momentum and rippled through ham radio networks and across the world, from South Africa to Canada to Irelan        

Among new developments:

  • The team has filed a pre-Emergency Use Authorization application, the first in a two-step process of the FDA to approve emergency use of medical devices during the COVID-19 pandemic. The pre-EUA is an important milestone because of how much preparation in a short time is required to get to that point, said Lampotang, the Joachim S. Gravenstein Professor of Anesthesiology in the UF College of Medicine, part of UF Health, and the director of UF’s Center for Safety, Simulation & Advanced Learning Technologies, or CSSALT.
  • The CSSALT team intends to file the complete EUA by the end of next week, depending on how quickly they can complete the extensive paperwork. “Usually this is done over a year, so we’re trying to compress it into a week or two,” Lampotang said.
  • One of the valves on the ventilator has now clocked more than 1 million cycles during testing — an important milestone because if a patient requires a ventilator for three weeks at 30 breaths per minute, the ventilator would need to cycle 907,200 times, Lampotang said.
  • As inquiries continue to pour in from countries around the world, the UF International Center has joined the effort to assist with outreach.
  • Engineers, coders and other interested volunteers can send an email to get involved.

Previous milestones have included:

  • A proof-of-concept prototype was created March 21 in the garage of lead engineer Dave Lizdas and a video was quickly uploaded to YouTube.
  • A successful full-system integration of the ventilator, including an Arduino-based user interface, was conducted March 27. The team then pivoted to verifying the design’s safety, including making available a live feed of the endurance testing.
  • A list of materials was uploaded March 29. Volunteers seeking to build the open-source version — distinct from the fixed-design prototype to be submitted to the FDA — are advised to determine what parts are available or unavailable in their countries or towns, identify equivalent parts and use them to build and test a ventilator. 

Story Banners
Story Banners
Story Banners

Related posts