UPDATE @ 2:06 p.m.:
The FDA has issued an Emergency Use Authorization to Battelle for its Critical Care Decontamination System in order to decontaminate compatible single-use N95 respirators for reuse by healthcare professional, according to Stephen Hahn, FDA Commissioner.
The FDA commissioner has assured Gov. DeWine the technology would be fully approved today, said DeWine.
Dear @POTUS, our team at @US_FDA is actively working with @Battelle to help them scale up their N95 decontamination efforts. Everyone is working together quickly! @GovMikeDeWine
— Dr. Stephen M. Hahn (@SteveFDA) March 29, 2020
“We are thankful that the Food and Drug Administration granted Emergency Use Authorization to operate Battelle CCDS at our facilities,” said Battelle.
“We continue to work with FDA to maximize the impact of the Critical Care Decontamination System by expanding use to other locations as well as increasing the number of respirator masks that are allowed to be processed each day.”
INITIAL REPORT:
The FDA has decided to limit the use of new technology to sterilize surgical masks in Ohio and other parts of the United states, according to a release from Gov. Mike DeWine.
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“The FDA has authorized Columbus-based Battelle to sterilize only 10,000 surgical masks in Ohio each day, despite their ability to sterilize up to 160,000 masks per day in Ohio alone,” the release said.
Gov. Mike DeWine and Lt. Gov. Jon Husted expressed deep disappointment in this decision made by the FDA.
"The FDA's decision to severely limit the use of this life-saving technology is nothing short of reckless," said DeWine.
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"Battelle's innovative technology has the capability to protect healthcare professionals and first responders in Ohio and across the country, but in this time of crisis, the FDA has decided not to support those who are risking their lives to save others. This is a matter of life and death. I am not only disappointed by this development, but I'm also stunned that the FDA would decline to do all it can to protect this country's frontline workers in this serious time of need," he said.
