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2020-03-30 -Signs, Portents, and the Weather-

FDA dithers over BMI (Battelle Memorial Institute) mask technology approval

[PJ] Ohio Attorney General Dave Yost has had enough of the FDA's dithering over approval of an innovative process that could get millions of N95 masks to hospitals and other healthcare facilities, where they are in critically short supply as the Chinese coronavirus continues to stretch their resources. "If this isn't cleared up by morning, I'm ready to sue the FDA," Yost wrote on his Facebook page on Sunday afternoon.

What's the problem? Yost says the FDA is limiting the number of masks that an Ohio Company, Battelle Memorial Institute, can sterilize for reuse. The company has pioneered a technology that uses hydrogen peroxide vapor to make N95 masks safe for reuse and wants to ramp up production at their facility so they can send the masks where needed, but the FDA essentially shrugged and seemed to say, 'what's the big hurry?'

"The Food and Drug Administration -- after dithering all week -- finally gave Battelle approval to sterilize a measly 10,000 masks a day," Yost said. "They could be doing 160,000 per day."

And while the FDA dithers, grandmas across the nation are hunched over their sewing machines, heroically pumping out handmade masks to help fill the need for the critical protective masks.

"Gov. Mike DeWine has called the President. The FDA commissioner assured him that this would be taken care of. But as of this writing, the FDA has not moved," said Yost.

President Trump praised Battelle on Twitter Saturday, and urged the FDA to move quickly to approve increased production of the masks:

Posted by Besoeker 2020-03-30 02:23|| || Front Page|| [11129 views ] Top

#1 Ron White had a great skit regarding the national color scheme danger program.

As I recall:
He thought it should be resolved down to 2 layers.
Green-go about your business
Yellow-get your helmet
Red-put it on

We're prob in the red stage now.

Posted by Skidmark 2020-03-30 03:19|| 2020-03-30 03:19|| Front Page Top

#2 "The Food and Drug Administration -- after dithering all week -- finally gave Battelle approval to sterilize a measly 10,000 masks a day," Yost said. "They could be doing 160,000 per day."

Pinheads. Or maybe they didn't get the memo?

Posted by gorb 2020-03-30 06:51|| 2020-03-30 06:51|| Front Page Top

#3 Evidence point #5,456,677,862 that government has no business being in the health business. Or any other business.

Posted by DarthVader 2020-03-30 09:59|| 2020-03-30 09:59|| Front Page Top

#4 /\ Amazing, many of the Orange Man's solutions involve the private sector.

Posted by Besoeker 2020-03-30 10:01|| 2020-03-30 10:01|| Front Page Top

#5 /\ Amazing, many of the Orange Man's successful solutions involve the private sector.

Posted by Skidmark 2020-03-30 11:58|| 2020-03-30 11:58|| Front Page Top

#6 Superseded by events again — President Trump has indeed been busy. Per Politico:

The Trump administration has approved the first system for sterilizing specialized face masks worn by front-line health workers battling the coronavirus, potentially easing the severe shortage of the protective gear.

The FDA also reversed course on a daily cap for the decontamination system, less than 24 hours after Ohio’s Republican governor criticized the FDA on Sunday morning for the limit.

As of Sunday night, the agency will let the machines be deployed to sites around the country and there won’t be a limit on the number of masks they’re allowed to clean each day.

At issue was the FDA’s decision to allow emergency use of a Battelle system that decontaminates specialized N95 face masks, allowing doctors and nurses to safely reuse them. On Saturday, the FDA approved Battelle’s Columbus headquarters to sterilize 10,000 masks per day, even though the company says its machines have the capacity to decontaminate 80,000.

“The FDA’s decision to severely limit the use of this life-saving technology is nothing short of reckless,” Gov. Mike DeWine, whose state is home to the company that makes the technology, said in a statement Sunday morning.

DeWine said he appealed directly to President Donald Trump to allow broader adoption of the system, and Ohio’s attorney general threatened to sue if FDA didn’t act quickly to authorize more extensive use.

Posted by trailing wife 2020-03-30 19:59|| 2020-03-30 19:59|| Front Page Top

#7 NO FAIR! He didn't give the MSM to meme their responses!

Posted by Frank G 2020-03-30 20:27|| 2020-03-30 20:27|| Front Page Top

07:22 NN2N1
07:18 trailing wife
07:14 Richard Aubrey
07:10 NN2N1
07:09 Besoeker
07:03 NN2N1
06:58 NN2N1
06:58 Besoeker
05:28 Whiskey Mike
05:23 Whiskey Mike
05:21 Whiskey Mike
05:18 Whiskey Mike
05:15 Whiskey Mike
05:13 Whiskey Mike
05:08 Whiskey Mike
05:05 Whiskey Mike
05:03 Whiskey Mike
03:23 Besoeker
02:05 Grom the Affective
02:04 Grom the Affective
01:26 49 Pan
00:22 EMS Artifact
00:16 Skidmark