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Trump's FDA Cuts Through Red Tape, Approves of Process To Decontaminate Single-Use Masks

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Hospitals and medical facilities nationwide are on the front lines of the coronavirus pandemic and require the proper equipment to protect health care workers.

One important piece of equipment is the N95 respirator mask, which is in short supply due to the high demand.

In an effort to combat this shortage, the U.S. Food and Drug Administration announced an emergency use authorization Sunday for Advanced Sterilization Products of Irvine, California, to use a process for sterilizing N95 and similar masks.

The process, which would relieve critical mask shortages by turning the single-use respirators into reusable products, has the potential to sterilize 4 million masks per day nationwide, according to the FDA.

President Donald Trump previously had sought to address the shortage by using the Defense Production Act to put pressure on 3M, which manufactures the masks.

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“We hit 3M hard today after seeing what they were doing with their Masks. ‘P Act’ all the way,” he wrote. “Big surprise to many in government as to what they were doing – will have a big price to pay!”

This newest FDA approval circumvents the need for new masks and is easy to implement as it uses existing hospital sterilizing machines made by ASP, which has its sterilization equipment in around 6,300 hospitals, according to a TechCrunch report.

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It is the second such permission for a sterilization process that uses hydrogen peroxide gas. Another company, Battelle Memorial Institute, a nonprofit research science and technology innovator based in Columbus, Ohio, already had an emergency process created and was granted its FDA emergency authorization on March 28, according to a letter from the FDA.

Battelle’s solution came to be used because of a twist of fate. Dr. Laurie Hommema, medical director of provider and associate well-being at OhioHealth, was having an after-dinner conversation about the shortage of face masks with her husband, Kevin, who is one of Battelle’s principal research scientists.

The couple quickly worked out the problem, and what resulted was a partnership between OhioHealth and Battelle led by Dr. Hommema, WBNS-TV reported.

The Hommemas recapped the series of events in an interview with Stephanie Gosk on NBC’s “Today” show Tuesday. It began when Laurie Hommema lamented the shortage of masks and her husband simply asked, “Why don’t you just clean them up?”

After working out the details and securing a partnership between the two organizations, the next step was FDA approval.

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“I think it was a total of 14 days where we had the green light from the FDA,” Laurie Hommema told Gosk.

“Now, I don’t know how often you deal with the federal government, but that is blazingly fast,” Gosk astutely pointed out.

Battelle’s method is capable of sterilizing 80,000 masks per day and is already being used in select locations.

The newest approval for ASP’s process will exponentially augment that capacity.

Both of these quick approvals are an example of government getting out of the way when it needs to with great results for the American people.

This is not the first time the Trump administration has eased regulations to benefit Americans during the pandemic. The FDA quickly approved the use of existing malaria drugs that showed promise in fighting the disease, and people such as Democratic Michigan state Rep. Karen Whitsett credit the drugs with saving their lives.

Trump is not afraid to use his executive power when necessary, but he is also quick to get government out of the way when it benefits Americans.

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Christine earned her bachelor’s degree from Seton Hall University, where she studied communications and Latin. She left her career in the insurance industry to become a freelance writer and stay-at-home mother.
Christine earned her bachelor’s degree from Seton Hall University, where she studied communications and Latin. She left her career in the insurance industry to become a freelance writer and stay-at-home mother.




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