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Sun Mar 29, 2020, 10:35 PM

DeWine makes second plea to FDA for approval of technology to sanitize thousands of masks a day

Source: Newsnet5

2:45 PM, Mar 29, 2020

COLUMBUS, Ohio — On Sunday during his daily press conference, Ohio Governor Mike DeWine made yet another plea to the Food and Drug Administration to approve the machine that could sanitize much-needed N-95 respirator masks that are critical now more than ever with the COVID-19 pandemic at hand.

DeWine talked to Lewis Von Thaer—the head of Battelle Memorial Institute, the company that created the sanitizer systems—around 8 a.m. Sunday and was informed that they had not been cleared by the FDA to sanitize 80,000 masks a day. The FDA had only approved technology that sanitizes 10,000 masks a day.

There are currently two machines that Battelle has already developed and are waiting for FDA approval. The two machines would allow the state of Ohio to sterilize 160,000 masks per day.

The new technology uses a machine that cleans the masks with a concentrated hydrogen peroxide vapor for several hours. It decontaminates the masks for viruses and bugs even stronger than COVID-19. The masks get loaded into the containers, decontaminated and sent back to healthcare workers around the state and around the country, according to Von Thaer.



Read more: https://www.news5cleveland.com/news/continuing-coverage/coronavirus/dewine-makes-second-plea-to-fda-for-approval-of-technology-to-sanitize-thousands-of-masks-a-day



Fingers Crossed.

16 replies, 1381 views

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Arrow 16 replies Author Time Post
Reply DeWine makes second plea to FDA for approval of technology to sanitize thousands of masks a day (Original post)
OhioChick Mar 29 OP
rzemanfl Mar 29 #1
elleng Mar 29 #2
Philostopher Mar 29 #5
sandensea Mar 29 #3
catsudon Mar 30 #14
Journeyman Mar 29 #4
RazBerryBeret Mar 29 #6
James48 Mar 29 #10
James48 Mar 29 #7
marble falls Mar 29 #8
Yonnie3 Mar 29 #9
C Moon Mar 30 #11
bucolic_frolic Mar 30 #12
Alex4Martinez Mar 30 #13
OhioChick Mar 30 #15
karynnj Mar 30 #16

Response to OhioChick (Original post)

Sun Mar 29, 2020, 10:40 PM

1. Just one finger is needed. Flip it at the FDA and start sterilizing masks.

The administration has demonstrated its incompetence. Lives are on the line.

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Response to OhioChick (Original post)

Sun Mar 29, 2020, 10:41 PM

2. Is DeWine popular enough to cause,

deliberately or not, significant # of OH voters to reject tr due to his abhorrent behavior?

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Response to elleng (Reply #2)

Sun Mar 29, 2020, 10:57 PM

5. Not sure - probably not.

Ohio Republican voters only look for the "R" - they can vote for any number of people who hate each other, have conflicting policies/platforms, etc. They don't look any farther than the "R" and that's the one they mark. I do know a lot of Democratic voters in Ohio are grudgingly willing to credit he's doing better than they expected, including me. He never struck me as a Trump cultist, though. And I could be wrong - if it becomes obvious President Lumpy is obstructing a well-meaning effort to benefit people, it might, at least, discourage some wafflers from voting in 2020.

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Response to OhioChick (Original post)

Sun Mar 29, 2020, 10:47 PM

3. Any minute now, Cheeto will start calling him 'de Whiner'

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Response to sandensea (Reply #3)

Mon Mar 30, 2020, 02:36 PM

14. well

his plea was successful and he credited trump

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Response to OhioChick (Original post)

Sun Mar 29, 2020, 10:51 PM

4. None of the articles I've seen gives FDA's reason for denying approval. . . .

Are there serious questions about the machine's capabilities? Does the risk of too rapid use of (perhaps) untested technology pose too great a risk to hospital staff? Or is there some idiotic bureaucratic holdup? A need by some mid-level manager to have his ego stroked before he grants approval?

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Response to Journeyman (Reply #4)

Sun Mar 29, 2020, 11:09 PM

6. i was gonna say the same thing

I can't find any info on why?
why not approve and let them go full capacity?

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Response to Journeyman (Reply #4)

Sun Mar 29, 2020, 11:40 PM

10. You can't grant "Approval"

On something that there is no standard for approval.

You can only grant a “waiver” of a regulatory requirement.

But if it is a new, novel approach, there IS no existing regulatory requirement to grant a waiver from.

It’s kind of a regulatory catch-22.

They will figure out something to say by , oh, about Thursday.

(27-year government employee)

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Response to OhioChick (Original post)

Sun Mar 29, 2020, 11:37 PM

7. Because it is SUNDAY.

The FDA isn’t open until Monday.

Then the head exec guys will call down to whoever is the section that is working that project, and demand that the first line manager make a power point to brief the execs on what the issues are, and then they will have to consult with the risk analysis statisticians, and then call the company to clarify exactly what it is they want to do. And then the expects will go into some meetings, and talk with each other, and call over to Mike Pence’s office to give him the heads up that they are considering Dewines request.

Should be granted about Thursday.

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Response to OhioChick (Original post)

Sun Mar 29, 2020, 11:37 PM

8. He's a GOP governor, Trump must be planning to sell a bunch of masks.

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Response to OhioChick (Original post)

Sun Mar 29, 2020, 11:40 PM

9. his plea was successful


Governor Mike DeWine ✔
@GovMikeDeWine

Thank you @realDonaldTrump and @SteveFDA! @US_FDA has now given Columbus-based @Battelle full approval of the use of new technology to sterilize desperately-needed N95 masks in #Ohio and other parts of the United States.
2,911
10:45 PM - Mar 29, 2020




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Response to OhioChick (Original post)

Mon Mar 30, 2020, 02:52 AM

11. WTF is DeWine thinking? Before anything like this is approved...

Trump and the GOPutin need to figure out how they are going to make money from it!
You can't just willy-nilly resolve an issue that people are making millions of dollars on.

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Response to OhioChick (Original post)

Mon Mar 30, 2020, 09:54 AM

12. Is this UV technology?

UV is used for sterilization in many ways, in-line home water systems and dental procedures for example. Users might need eye protection.

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Response to bucolic_frolic (Reply #12)

Mon Mar 30, 2020, 11:20 AM

13. Hydrogen Peroxide based. eom

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Response to OhioChick (Original post)

Mon Mar 30, 2020, 05:39 PM

15. U.S. FDA OKs expanded use of new mask-cleaning technology after pressure from DeWine, Trump

COLUMBUS, Ohio — In a quick about-face, the U.S. Food and Drug Administration, responding to criticism from Gov. Mike DeWine, has granted expanded approval for a new device developed by an Ohio research firm that sterilizes the protective masks used by health-care workers.

The FDA on Sunday night issued an amended approval order, revoking a Saturday order that only permitted Battelle to use the device at its headquarters in Columbus, and only to clean 10,000 masks per day. The limited order angered DeWine, leading him to rebuke the agency publicly Sunday morning and seek intervention from President Donald Trump. Before the limited order, Battelle had planned to immediately deploy to New York City its new technology, which it said could clean up to 160,000 masks a day in Ohio alone.

The new, expanded order still requires Battelle to operate the devices and report results to the FDA, but instead says the firm can sanitize 10,000 masks per chamber load at its headquarters and at “satellite facilities," as long as Battelle provides “confirmation that all chambers, critical parameters, logistics, processes, containment systems, and labeling are identical and in place."

Like the earlier order, each mask is approved to be sanitized and re-used up to 20 times. DeWine administration and Battelle officials said the technology will help increase the availability of the respirator masks, also used by first responders, amid a national shortage.

https://www.cleveland.com/open/2020/03/us-fda-oks-expanded-use-of-new-mask-cleaning-technology-after-pressure-from-dewine-trump.html

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Response to OhioChick (Original post)

Mon Mar 30, 2020, 07:03 PM

16. Kicking so people who heard this happened because it was an original Trump idea and he asked them to

But I guess this is lie # 9999999999

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