DeWine disappointed with FDA's decision to limit technology that could sterilize up to 160,000 face

[OhioChick]

Source: Newsnet5

10:34 AM, Mar 29, 2020

COLUMBUS, Ohio — The U.S. Food and Drug Administration has authorized Columbus-based 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.

Battelle Memorial Institute, an applied science and technology development company headquartered in Columbus, has developed new technology that would allow healthcare workers to sterilize up to 80,000 face masks per day, per machine, Gov. Mike DeWine said.

DeWine said he was disappointed with the FDA's decision to limit the use of the technology.

"The FDA's decision to severely limit the use of this life-saving technology is nothing short of reckless," said DeWine. "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."

DeWine said he plans to fight their decision.

Read more: https://www.news5cleveland.com/news/continuing-coverage/coronavirus/dewine-disappointed-with-fdas-decision-to-limit-technology-that-could-sterilize-up-to-160-000-face-masks

---

What's wrong with the FDA?


Original article that excited many healthcare workers:

https://www.news5cleveland.com/news/continuing-coverage/coronavirus/new-technology-in-ohio-could-sterilize-up-to-160-000-medical-face-masks-a-day-if-approved-by-fda

[bronxiteforever]

1. Kick and recommend for visibility.

[cos dem]

2. What's wrong with the FDA? Same thing that's wrong with this entire administration.

Massive arrogance combined with massive incompetence.

https://www.nytimes.com/2020/03/28/us/testing-coronavirus-pandemic.html?action=click&module=Spotlight&pgtype=Homepage

[dansolo]

10. Don't forget corruption

They probably aren't getting a cut

[marble falls]

3. The Orange Disgrace says we're on our own - the governors are in charge ...

Take charge Gov DeWine!

Obviously the Trump and Kushner families have no stake in Battelle. Who do they have money in?

Like Speaker Pelosi said this morning on Meet the Press:


“First let me say how sad it is that ever since the president’s signing of the [stimulus] bill, the number of deaths reported has doubled from 1,000 to 2,000 in our country,” the California Democrat began. “This is such a very, very sad time for us. So we should be taking every precaution. The president? His denial at the beginning was deadly. His delaying of getting equipment to where it — his continued delay in getting equipment to where it’s needed is deadly."

"The President fiddles and people are dying."

[CitizenProle]

5. Not for Profit

Batelle is a non-profit

[marble falls]

7. Like I said, Trump has no money in Battelle, who does he have money in?

[dewsgirl]

4. K and r

[Hoyt]

6. Has FDA announced a reason? Maybe FDA doesn't believe they can handle that many.

[jberryhill]

27. Commercial vendor unhappy with regulatory decision

[drmeow]

8. The process they want approved

has only gone through early phase testing.

As far as I can tell, this has never been tested on humans (i.e., with people using the masks). I suspect that one of the concerns is whether the process leaves any residue on the masks which health care workers would then be inhaling directly into their lungs. The process uses Bioquell Hydrogen Peroxide Vapor (HPV) to decontaminate the masks. The FDA probably approved 10,000 initially to make sure there are not any short term disastrous effects on the people using the masks.

The tests were on (I believe) a bacteria, not a virus, so I'm assuming that what they asked to be approved was some new tests on a virus (or maybe not - again, we don't have enough data to say). The process was pretty damn effective on bacteria. It did destroy the elastic after about 30 cycles. I do not know how many cycles it took to decon the masks.

I know it is hard to trust anyone associated with the government right now but I've met people who work for the FDA and I work with someone who works with the FDA - the rank and file are like the rank and file at the CDC. This was probably a very difficult decision for them to make because they are fully aware of how significant this could be. Although not in as horrible a situation as the MDs, they are in a pretty horrible situation. If they say "clean as many as you want" and it turns out the process is toxic to the people using the masks, they've killed a bunch of people. If they say "clean a limited number to make sure it isn't toxic" and it is not then they've potentially killed a bunch of patients for seemingly no good reason. Damned if you do, damned if you don't.

[ToxMarz]

13. Agree, have to remember this is a For Profit company with "monopoly" on a potentially critical need

product. They have $$$ interest in rushing FDA approval, so aren't really an impartial voice. I would think in this case the FDA would be as lenient as possible to approve if they felt comfortable.

[Botany]

17. Battle is a non profit

n/t

[mr_lebowski]

16. No offense, but I don't buy this excuse ...

First off, hydrogen peroxide in the quantities that could possibly remain as residue is not going to be toxic. We CLEAN OPEN WOUNDS with the stuff. The chemicals used to make the masks in the first place have got to be worse.

Secondly, if that's the concern, why would you allow 10K to be treated per day? That's 1000's of dead health care workers in short order.

I suspect it's more because Trump and/or Republicans are exacting no tribute ($$$) from the process. Possibly found out that people at the top of the company donate to Democrats.

[drmeow]

19. This kind of caution is typical of the FDA

I know it is hard to trust anyone associated with the government right now but I've met people who work for the FDA and I work with someone who works with the FDA - the rank and file are like the rank and file at the CDC. This was probably a very difficult decision for them to make because they are fully aware of how significant this could be. Although not in as horrible a situation as the MDs, they are in a pretty horrible situation. If they say "clean as many as you want" and it turns out the process is toxic to the people using the masks, they've injured a bunch of of health care providers. If they say "clean a limited number to make sure it isn't toxic" and it is not then they've potentially injured a bunch of patients for seemingly no good reason. Damned if you do, damned if you don't.

I'm a scientist and I work with medical scientists every day - this decision does not really surprise me at all. The reason you try 10,000 is cause you've got to test it somehow. This is why clinical trials of drugs start with small phase I "first in humans" dose escalation tests and then medium size phase II before moving on to full scale clinical trials like what we think of - and even then they sometimes have to cancel those trials early cause of things they didn't know about the effect of whatever they are testing.

This is 10 x's as strong as the hydrogen peroxide people use to clean wounds - hydrogen peroxide is very corrosive. The stuff you buy in the store is 3% - this stuff is 35%:

"Inhaling food grade hydrogen peroxide can cause:

sore throat
cough
nausea
dizziness
headache
shortness of breath

If you have inhaled H2O2, contact your doctor."

Cleaning wounds with hydrogen peroxide is no longer considered wise as it may kill healthy skin as well as bacteria

[mr_lebowski]

20. 10K a day seems like an awfully large number for 'trials' ... not to mention you're sending them out

Into the 'wild', as it were, i.e. really not doing a properly controlled experiment.

Also doesn't H2O2 give up it's oxygen pretty readily to the atmosphere? If you're using it's vapor as a cleaner, that implies heating it to it's boiling point. I would that would cause rapid decomposition to H2O and O2.

Strikes me as unlikely that, after drying the mask, that a significant amount of H2O2 would remain, and the concentration of what remains would be extremely low.

I assume these are NOT paper (or the like) masks as I'd assume those would take on too much liquid and likely decompose quickly due to the oxidizing nature of H2O2.

I'm all for an abundance of caution, but I kinda feel like if you think it's cool to send 10K a day out to medical pro's, you better be already pretty damn confident your process isn't going to kill people.

I appreciate your well-advised input in any case

[drmeow]

22. I don't know enough about the chemistry

I just know the way medical researchers think. Obviously, I could be completely wrong about why but I just find it hard to believe that the people making this particular decision are that strongly influenced by Trump - it doesn't jive with what I know about how the FDA works (besides, Trump is highly unlikely to have known about the request).

It is so effing easy to get paranoid these days with that %*$^*& in the White House!

Plus (disclaimer) I generally get really frustrated with American's tendency to get outraged by regulations and regulatory processes when they think its preventing something they think is good while also turning around and blaming the regulators for not doing their jobs when the outcome is something bad. There was a case in Arizona where a kid started doing roof rat mitigation work (climbing on people's roofs and screening off holes, etc.) and the contracting regulators made him stop - everyone was livid. But if he'd fallen off the roof and broken his neck or if he'd been an undocumented immigrant and had damaged some old lady's house the same people would have been screaming "why did the regulators allow this to happen!" This feels like the same sort of thing. I refuse to assume that the FDA does not have a reasonable, science based reason for this decision (the people who make these decisions are PhDs and MDs). (Minor )

Thanks for being cool about it - I've gotten some real nasty, anti-science responses at DU (hence the low number of posts despite a long tenure here).

[mr_lebowski]

23. I hear ya ... all good ...

I admire your faith

It just kinda seems like if there's an actual danger, you'd definitely do proper trials. Which sending 10K out into the wild doesn't seem to me to constitute a proper trial.

And if there's really not (using H2O2 to sterilize medical gear is definitely nothing new in general), then you should go whole hog, esp. given the circumstances.

That seeming lack of consistency (to me anyway) seems ... not 'suspect' per se, but I'd like to understand it a bit better, put it like that.

Have a safe day

[drmeow]

24. I can tell you that they probably aren't

just sending 10K out into the wild. There are undoubtedly strict requirements to report back.

Also, clinical trials are always a trade off between internal validity (did you control everything to the point that you are sure that any difference are because of what you did) and external validity (is this how it will work in the real world). While sending out 10K cases like this doesn't have strong internal validity, the external validity is huge! From a research methods perspective, its not as outrageous as it may seem.

[Botany]

9. Trump wants to kill us ... no reason for the FDA to stop this technology

Just my opinion.


In Columbus, OH the C-19 wave hasn't hit yet but it will and we will need those masks and i
guarantee that if Battelle has that capacity it could ramp up to do millions.

BTW Battelle and or Ohio State (next door to Battelle can test the 1st run of the masks to see
if they are virus clean).

[GeorgeGist]

11. Since states are on their own in this war ...

DeWine should exempt Battelle.

[paleotn]

12. Do it anyway.

This is presumably on Ohio's dime, so fuck the feds. We'll deal with the legal aspects later. People's lives are in danger.

[sinkingfeeling]

14. Is there any logical reason as to why from the FDA?

[Steelrolled]

21. "Cautious" is FDA's middle name.

Because there is always the danger of moving too fast and having people suffer or die as a result. I don't know if that is the reason in this case, but it could be.

[LittleWoman]

15. Now Trump is getting involved

"President Trump calls for quick FDA approval of Battelle technology to sterilize masks"

Based on past behavior I think this whole decision by the FDA was rigged from the start to make Trump look good. The importance of Ohio in the election is no small matter--No Republican has won the White House without Ohio in recent years. Add to the fact the Governor of Ohio is a Republican and you can see where this might be going. In spite of the way I feel about Dewine I do think for the most part he has done a good job in this crisis. Except for the abortion issue. I can even make allowances for the primary election screw up given the chaos of the time.


Read: https://www.10tv.com/article/president-trump-calls-quick-fda-approval-battelle-technology-sterilize-masks-2020-mar

[KY_EnviroGuy]

18. Here's Battelle's web page on this process and FDA's report.

Battelle CCDS™
Personal Protective Equipment (PPE) decontamination for reuse

Link: https://www.battelle.org/inb/battelle-critical-care-decontamination-system-for-covid19

Their Q&A:

How does it work?

Battelle CCDS™ can decontaminate thousands of N95 respirators using concentrated, vapor phase hydrogen peroxide. The respirators are exposed at the validated concentration level to decontaminate biological contaminants, including the SARS-CoV-2. Battelle CCDS can decontaminate the same respirator multiple times without degrading N95 respirator performance.

Regulatory, safety & efficacy

Battelle CCDS draws on decades of research and is grounded on an FDA study Battelle completed following a 2016 contagion. Battelle is currently conducting research to validate that other equipment, including surgical masks and ventilator components, can be decontaminated using this process.

How do healthcare systems use Battelle CCDS?

Healthcare systems will collect worn N95 respirators each day in accordance with an approved procedure, and the PPE will be labeled with a barcoded serial number for tracking the chain-of-custody throughout the decontamination process. This procedure ensures that the hospital system receives its own respirators back.

The site also presents several papers on their methods and research and the FDA report.......

Investigating Decontamination and Reuse of Respirators in Public Health Emergencies
Content current as of: 03/24/2020

FDA Report: https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/investigating-decontamination-and-reuse-respirators-public-health-emergencies


KY.....

[DenverJared]

25. The FDA is a bunch of pencil pushers who read the laws literally

If buckets needed FDA approval and there is a fire about to burn down a house, the FDA would still insist that all buckets be approved before being used. There is no sense of emergency and no limited use exemptions for the fire at hand.

[dchill]

26. "'... nothing short of reckless,' said DeWine"

Sounds like a political decision.

[jberryhill]

28. We need to have as many health workers as possible breathing through chemically treated masks...

...using a process that is not fully tested.

Because, heck, what could go wrong.

[procon]

29. Trump's pals (and him, too?) must have investments

in the manufacturing of new masks. If he allows old masks to be sterilized and reused then it cuts into their profits.

Can't have that, can we?

[gibraltar72]

30. This is battlefield surgery. Fuck em do what's needed. Explain later.

[Duppers]

31. K & R