Mar 23, 2020 - Health

FDA eases rules for ventilator production, but hurdles remain

Photo: Roland Weihrauch/picture alliance via Getty Images

The U.S. Food and Drug Administration on Monday temporarily relaxed certain policy guidelines that could allow manufacturers to produce more ventilators.

Why it matters: Automakers, parts suppliers and other industrial companies have offered to lend their manufacturing expertise in a wartime-like mobilization to combat the global pandemic. But without some easing of the FDA's strict validation process for medical devices, it can't happen.

What's new: The FDA issued new temporary guidelines that would give ventilator manufacturers more flexibility in the design of the machines, the materials used and manufacturing processes to clear existing bottlenecks.

  • They could, potentially, purchase a different type of motor from an alternate supplier, or use different types of plastic in the ventilator tubes, for example.
  • "We believe this approach will help manufacturers that want to add production lines or manufacture at alternative sites which may have different manufacturing equipment to increase manufacturing capacity," the FDA said.

President Trump caused confusion Sunday when he tweeted: "Ford, General Motors and Tesla are being given the go ahead to make ventilators and other metal products, FAST!"

Reality check: Carmakers are starting from a standstill, trying to learn about ventilators, who makes them, what their capacity issues are, and how the auto industry can help.

  • There is no federal orchestration of the process, so companies are leveraging their own networks for information.
  • Nor is it clear if automakers, whose own businesses are reeling from virus-related shutdowns, will be paid, and by whom.

The most likely scenario: Companies like GM and Ford could use their global scale to lean on suppliers, including raw materials suppliers, to speed delivery of components to ventilator manufacturers.

  • They could also share high-volume production techniques to maximize output.
  • Car factories switching to ventilator manufacturing is a long shot, but it could happen down the road.

The big question: Can any of this happen quickly enough to make a difference?

  • Gov. Andrew Cuomo has said New York is days away from running out of ventilators and other medical supplies.
  • Honeywell, which already makes N95 masks, said Sunday it could take 30 days to start up a new production facility in Rhode Island.

The bottom line: There's a desperate need for medical equipment, and it's not clear how manufacturers will be able to meet the need.

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Why it matters: The United States was caught flat-footed by the surge in demand for medical supplies. If the federal government had enlisted manufacturers earlier, when the virus was beginning to spread throughout the world, GM and other manufacturers could already be producing thousands of ventilators per month.

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At President Trump's urging, automakers have mobilized with astonishing speed to help medical equipment makers produce much-needed ventilators and masks to fight the coronavirus.

But, but, but: With pressure mounting as the pandemic spreads and mixed signals coming from the White House's emergency response team, an agitated president lashed out at GM and Ford Friday morning on Twitter.

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