FDA Grants Approval of Mask Cleaner After Governor Complains (1)

March 29, 2020, 11:12 PMUpdated: March 30, 2020, 3:41 AM

The Food and Drug Administration granted approval Sunday for a machine that can sterilize used medical face masks.

Masks are in such short supply that hospitals nationwide have asked people with sewing machines and cotton cloth to make them. The equipment by Ohio-based Battelle can sanitize as many as 80.000 masks a day, the company said.

The emergency approval came after Ohio Gov. Mike DeWine (R) expressed frustration about an FDA decision to allow the machines to be used on 10,000 masks a day.

“If we can clean 80,000 of these a day. Let us do it,” DeWine said at a Sunday press briefing, about eight hours before the FDA revised its ruling.

DeWine said he called President Donald Trump, who “said he would do everything he could to get this done today.”

FDA Commissioner Stephen Hahn said the emergency approval was “an example of everyone working quickly to help find a solution.”

“After receiving Battelle’s request today, we turned it around in a matter of hours and issued a new authorization allowing them to ramp up their capability to decontaminate more respirators,” Hahn said.

(Updates throughout to reflect FDA's decision change. )

To contact the reporter on this story: Adrianne Appel in Boston at aappel@bloomberglaw.com

To contact the editors responsible for this story: Roger Yu at ryu@bloomberglaw.com; Katherine Rizzo at krizzo@bgov.com

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