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Aug. 28, 2020

MSU receives FDA-authorization to decontaminate reusable N95 masks for hospitals

Vaporized hydrogen peroxide treatment modified by a Michigan State University veterinary team to decontaminate N95 masks for health care workers has been approved on an emergency basis by the Food and Drug Administration. The team is continuing to work with the FDA towards a September start of large-scale decontamination operations. MSU is the first and only public institution to receive this authorization to date.


When Columbus-based Battelle Memorial Institute received emergency use authorization for its VHP process in March, Gov. Gretchen Whitmer and MSU President Samuel L. Stanley Jr., M.D., tasked an effort that included the conversion of an animal housing area into a nine-room decontamination center now capable of cleansing tens of thousands of masks each week. 


University Veterinarian F. Claire Hankenson, Director of Campus Animal Resources, is leading the project along with the MSU Office of Regulatory Affairs.


VHP was already in use at MSU sanitizing animal areas when the COVID-19 pandemic sparked widespread shortages of personal protective equipment for physicians, nurses and other medical personnel.


“We estimate that within our dedicated facility, running the VHP cycles five days a week, we can effectively decontaminate and redistribute approximately 14,000 masks per day (7,000 masks per cycle and two cycles per day) and up to 70,000 masks per week,” Hankenson said. “Over the coming fall and early winter, with a potential second surge of COVID-19 cases in the state (which may converge with influenza season), the MSU VHP decontamination process could ultimately recycle more than one million PPE devices back into the supply for the state of Michigan.”


Having received the FDA’s Emergency Use Authorization, MSU can expand its service beyond the original two partners in the pilot phase of the program: Sparrow Health System based in Lansing and Henry Ford Hospital System in Detroit. 


“These health care partnerships will be essential for the successful execution of this project,” Hankenson said. “The Governor’s Office, the Attorney General’s Office and the office of Congresswoman Elissa Slotkin and others have all been heavily invested in the FDA EUA application and share in the success of this approval.”


Masks are critical for the prevention of exposure to pathogenic airborne particulates. According to the emergency use authorization rules, N95 masks can be decontaminated up to three times using MSU’s VHP process. Sanitation extends mask life during shortages as well as saving health care dollars when PPE supply chains are stressed or interrupted.


“This is big: MSU experts working with Sparrow Hospital gave us the ability to sanitize masks for our health care workers fighting on the frontlines against COVID-19 –– and the FDA has approved that sanitization process," Slotkin said. 


"Michigan, like so many other states, has been at the mercy of a medical supply chain with production, middlemen, and customs officials in other countries, and we just can’t let that happen again as we prepare for a potential second wave of COVID-19, said Slotkin, D-Holly. “Now that the FDA has approved this process, our community will be better prepared and protected if cases spike again. I’m grateful to the FDA for its approval and to the professionals at MSU for their hard work, dedication and ingenuity.”

By: Emilie Lorditch

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