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FDA Allows Full Use of Columbus Company's Surgical Mask Sterilization Tech After Pressure from Gov.
FDA Allows Full Use of Columbus Company's Surgical Mask Sterilization Tech After Pressure from Gov. DeWineThe U.S. Food and Drug Administration (FDA) has amended a previous decision regarding the use of Columbus, Ohio-based science and technology institute Battelle's CCDS Critical Care Decontamination System after Ohio Gov. Mike DeWine and Lt. Gov. Jon Husted spoke about their disappointment in the national agency in a press conference on Sunday, March 29. The system sterilizes health care workers' used personal protective equipment (PPE).
According to a release from DeWine, as of Sunday, the FDA had authorized 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." That decision also limited the company's ability to send its tech to COVID-19 hot spots like New York and Washington state.
"The FDA's decision to severely limit the use of this life-saving technology is nothing short of reckless," said DeWine in a press release. "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."
According to DeWine, Battelle wanted to send a machine to New York City; Stony Brook, New York; Washington state; and Washington, D.C. The company had also planned to ship four more CCDS Critical Care Decontamination System units next week and 15 more in the coming weeks.
Read more: https://www.clevescene.com/scene-and-heard/archives/2020/03/30/fda-allows-full-use-of-columbus-companys-surgical-mask-sterilization-tech-after-pressure-from-gov-dewine