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Monday, March 30, 2020

FDA Allows Full Use of Columbus Company's Surgical Mask Sterilization Tech After Pressure from Gov. DeWine

Posted By on Mon, Mar 30, 2020 at 12:30 PM

click to enlarge THE OHIO CHANNEL/SCREENGRAB
  • The Ohio Channel/screengrab
The 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.

In a release March 29, Battelle described the functionality of its machine as: "The Battelle CCDS Critical Care Decontamination System is now operating at Battelle’s West Jefferson, Ohio facility under the EUA and is capable of decontaminating up to 80,000 respirator masks per system each day using concentrated, vapor phase hydrogen peroxide (VPHP). The respirator masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including SARS-CoV-2. Battelle CCDS can decontaminate the same respirator mask up to 20 times without degrading the mask’s performance."

A story published Monday in USA Today says that the FDA has amended its previous decision and will now allow Battelle the full use of its ability to sterilize surgical masks.

In a letter to Battelle, the FDA says that it has revised its previous decision to limit the sterilization tech to "protect the public health or safety" in response to the company's request to operate "the Battelle Decontamination System at multiple locations."

The decision allows Battelle's CCDS Critical Care Decontamination System "for use in decontaminating compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms, for a maximum of 20 decontamination cycles per respirator, for reuse by HCP to prevent exposure to pathogenic airborne particulates during the COVID-19 pandemic."

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