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.

Go deeper

U.S. coronavirus updates

Data: The Center for Systems Science and Engineering at Johns Hopkins; Map: Andrew Witherspoon/Axios. This graphic includes "probable deaths" that New York City began reporting on April 14.

Virginia Gov. Ralph Northam announced plans Tuesday to make wearing face coverings mandatory statewide for most people over the age of 10 when inside public places. The measure is effective Friday and applies to places like retailers, on public transportation and government buildings.

By the numbers: More than 98,900 people have died from the novel coronavirus and over 1.6 million have tested positive in the U.S. Over 384,900 Americans have recovered and more than 14.9 million tests have been conducted.

The final data for remdesivir is in

Gilead is ramping up production of remdesivir. Photo: Josh Edelson/AFP via Getty Images

Remdesivir, officially branded as Veklury, does indeed work for patients hospitalized with COVID-19, according to expert reads of the data that were published in the New England Journal of Medicine.

Yes, but: The benefits remain rather limited, as patients on the drug leave the hospital in 11 days vs. 15 days.

WHO temporarily suspends trial of hydroxychloroquine over safety concerns

Photo: Fabrice Coffrini/AFP via Getty Images

The World Health Organization is temporarily pausing tests of the anti-malarial drug hydroxychloroquine as a coronavirus treatment in order to review safety concerns, the agency's director-general Tedros Adhanom Ghebreyesus said Monday.

Why it matters: The decision comes after a retrospective review published in The Lancet found that coronavirus patients who took hydroxychloroquine or its related drug chloroquine were more likely to die or develop an irregular heart rhythm that can lead to sudden cardiac death, compared to those who did nothing.