America's FDA Eases Restrictions on Mask-Sterilizing Technology Amid Coronavirus Shortages (usatoday.com) 67
USA Today reports:
Ohio Governor Mike DeWine Sunday afternoon said federal officials have promised to ease restrictions on a technology to clean and reuse the masks deemed the safest for healthcare workers and first responders in the coronavirus outbreak....
Officials are scrambling for the N95 masks and other protective equipment for health care workers as the number of COVID-19 cases is expected to spike over the coming months. On Saturday, DeWine publicly pleaded with the FDA to approve an emergency-use permit for [Columbus-based research firm] Battelle's technology amid a shortage of personal protective equipment, including masks.... The U.S. death total has doubled in two days, climbing above 2,300 Sunday. Dr. Anthony Fauci, who has been a leading voice in the effort to curb the outbreak, said 100,000 to 200,000 Americans could die before the crisis is over.
DeWine said those numbers make it urgent for the FDA to clean as many masks as it can... The Battelle process uses "vapor phase hydrogen peroxide" to sanitize the N95 masks, allowing them to be reused up to 20 times, the company said in a statement. Each of the company's Critical Care Decontamination Systems can sterilize 80,000 masks per day, Battelle said... DeWine on Sunday said the FDA authorized Battelle to sterilize just 10,000 surgical masks a day. "They're only approved a fraction of what we can do," DeWine said during the press conference.
But DeWine said in his afternoon press conference that an FDA commissioner told him "this would be cleared up today."
Officials are scrambling for the N95 masks and other protective equipment for health care workers as the number of COVID-19 cases is expected to spike over the coming months. On Saturday, DeWine publicly pleaded with the FDA to approve an emergency-use permit for [Columbus-based research firm] Battelle's technology amid a shortage of personal protective equipment, including masks.... The U.S. death total has doubled in two days, climbing above 2,300 Sunday. Dr. Anthony Fauci, who has been a leading voice in the effort to curb the outbreak, said 100,000 to 200,000 Americans could die before the crisis is over.
DeWine said those numbers make it urgent for the FDA to clean as many masks as it can... The Battelle process uses "vapor phase hydrogen peroxide" to sanitize the N95 masks, allowing them to be reused up to 20 times, the company said in a statement. Each of the company's Critical Care Decontamination Systems can sterilize 80,000 masks per day, Battelle said... DeWine on Sunday said the FDA authorized Battelle to sterilize just 10,000 surgical masks a day. "They're only approved a fraction of what we can do," DeWine said during the press conference.
But DeWine said in his afternoon press conference that an FDA commissioner told him "this would be cleared up today."
Other sterilization methods... (Score:2)
Why not ramp up production of ethylene oxide sterilization units? They are just basiclly sealed cabinets. It is very effective, and works well on sensitive materials that cannot tolorate heat or harsh methods.
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Possibly because the stuff is rather nasty, but that's a solved problem. Industrial gas suppliers sell it for a variety of uses so there should be no shortage. Airgas and Air Liquide sell it (I weld so I knew who to check).
https://www.who.int/medical_de... [who.int]
Re:Other sterilization methods... (Score:5, Informative)
....because Ethylene Oxide has a problem with something like a facemask:
https://www.cdc.gov/infectionc... [cdc.gov]
TL;DR: "ETO is absorbed by many materials. For this reason, following sterilization the item must undergo aeration to remove residual ETO.". There's a large part of the problem with ETO sterilization: you have to let it offgas for X period of time depending on the material sterilized. In the case of N95's, being that you have a wide, wide variety of manufacturers, and therefore different materials with different offgassing rates, to figure out X mask must be offgassed for Y time....forget it. And screwing it up has consequence, because it's a guaranteed exposure to the wearer. They will inhale the unreacted/unaerated ETO. Not good. It has an exposure limit of 1PPM.
Now, VHP is nasty in its own right, but it's whole, whole lot safer if you don't get all of the unreacted peroxide back out of the mask. Yes, it could still cause respiratory tract problems if inhaled. In this case, though, it's the safer bet.
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....because Ethylene Oxide has a problem with something like a facemask:
https://www.cdc.gov/infectionc... [cdc.gov]
TL;DR: "ETO is absorbed by many materials. For this reason, following sterilization the item must undergo aeration to remove residual ETO.". There's a large part of the problem with ETO sterilization: you have to let it offgas for X period of time depending on the material sterilized. In the case of N95's, being that you have a wide, wide variety of manufacturers, and therefore different materials with different offgassing rates, to figure out X mask must be offgassed for Y time....forget it. And screwing it up has consequence, because it's a guaranteed exposure to the wearer. They will inhale the unreacted/unaerated ETO. Not good. It has an exposure limit of 1PPM.
I'm not sure it's that bad. The EtO fifteen minute exposure limit is 5 ppm. If some small fraction of a mL of gas remains in the mask and the final outgassing is into the wearer's lungs over a period of fifteen minutes, it would be well within the exposure limit. Assuming an average volume of respiration, I calculate almost 0.5 mL of ethylene oxide would be allowed, but let's say it should be 0.1 mL since it will be respired quickly, not over the whole fifteen minute timespan. The point is that residual EtO
Another "Problem" (Score:2)
https://www.youtube.com/watch?... [youtube.com]
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I wonder if something as simple as baking them for a few minutes at the lowest setting of an oven (175F/80C) would work for this virus.
I've done that with ski gloves to eliminate stinky gym sock bacteria. It worked great for that, and didn't seem to have any adverse effect on the gloves.
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I wonder if something as simple as baking them for a few minutes at the lowest setting of an oven (175F/80C) would work for this virus.
According to this study 80-90C would be fine for the mask, which is as important as whether it kills the virus:
https://www.ncbi.nlm.nih.gov/p... [nih.gov]
But since an oven cannot maintain a constant temperature, you would need to put the items in an insulated box or a large thermal mass like a preheated dutch oven. And measure! Your oven's 80C could easily be 100C.
The next questions are: is wet heat (tray of water in the oven) equally harmless to the mask? It should already be known and published whether wet heat kil
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the virus is not alive its a protein
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the virus is not alive its a protein
You're thinking of a prion.
Viruses are not just protein; they contain DNA or RNA.
Re: Other sterilization methods... (Score:2)
Not so fast, bucko!
The question as to whether viruses are âoealiveâ is still being hotly debated:
https://www.ncbi.nlm.nih.gov/p... [nih.gov]
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Re: Other sterilization methods... (Score:2)
Also, how about Cobalt sterilization, or other radiological methods?
Just take a pile down to Radiology, crank up the juice, wait a few minutes. Nothing lives.
Perhaps the lab where they nuke patientâ(TM)s immune systems to treat out of control autoimmune conditions might be a place to start...
Also, if Covid-induced Multiple-Organ-Failure (MSOF) is indeed caused by a Cytokine-storm released by a personâ(TM)s out of control immune system; why canâ(TM)t steroids or other immune-suppresive treatme
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Re:Isn't it interesting? (Score:4, Informative)
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Not every rule or regulation constituting the corners being considered has uniform value at all points, and "cutting that corner" may both save lives and involve little risk.
Maryland distillery shows what free markets can accomplish in a pandemic [washingtonexaminer.com]
A Maryland distillery has halted production of its whiskey and rum products in favor of mass-producing hand sanitizer to combat the COVID-19 pandemic. . . . The owners experimented first with a recipe that called for ethanol, glycerol, aloe vera gel, lemongrass oil, and vitamin E oil. As they messed around with the recipe, they also applied for a license to produce the sanitizer. They were approved almost immediately by the federal government, which, honestly, is a sentence I thought I would never write. "The federal government said the application typically takes three weeks for approval. We got approval in two days," the distillery's general manager, Jonathan Shair, told the ABC affiliate.
Distilleries trying to keep up with demand for hand sanitizer, follow federal guidelines [tennessean.com]
Darek Bell, who owns the Corsair Distillery, said his phone has been ringing off the hook with requests from everywhere, including hospitals, nursing homes, police departments and fire departments. "You name it," Bell said. "I'm hoping things start to calm down, but I have a feeling it's going to get worse." Bell and other distillery operators, such as Kris Tatum, said they have been following the guidelines put forth by the World Health Organization, but are concerned that if they don't follow FDA regulations they may face penalties, such as tax bills for using undenatured alcohol. Tatum, who is the general manager of the Old Forge Distillery in Pigeon Forge, said some firefighters drove from Michigan to pick up 50 gallons of sanitizer from him. . . . Tatum said the sanitizer he's producing is safe. He said the FDA made three revisions in the last week to its guidelines — addressing everything from the way sanitizer is labeled to the alcohol used. "This is a pivot point," Tatum said. "We have a need, and we are providing. I promise you I am making nowhere near what I make when we do liquor. And we are giving away a lot, too."
If you've never heard of or encountered a government rule or regulation that you thought was stupid you probably have no business advocating for them. And then there is the
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Re:Isn't it interesting? (Score:5, Insightful)
True. If they hadn't arbitrarily banned easily-produced remedies such as radium water and opium-laced tinctures, then most people would already be cured of this coronavirus ailment.
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Re: Isn't it interesting? (Score:2)
Re:Isn't it interesting? (Score:5, Interesting)
I think we should ask why they ever had any power to impede doctors and emergency workers from doing their jobs in the first place.
Without agreeing with the premise of the question:
Because the cost/benefit analysis of a regulation changes when a new, sterile face mask is $1.50, compared to when it cannot be had.
Because a diagnostic test that is normally not specific enough to warrant beginning treatment can still give treating physicians, patients, and epidemiologists useful information when the infection rate is increasing at something like 30% per day.
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Because the cost/benefit analysis of a regulation changes when a new, sterile face mask is $1.50, compared to when it cannot be had.
The cost to benefit ratio becomes irrelevant in case of emergency because the infrastructure to support the alternative will not exist because of the previous FDA decision.
The FCC made a similar argument a couple years ago when tests of broadband over power line revealed that it interfered with HF emergency communications. The FCC said that since power would be down during an emergency, it did not matter if it interfered with HF communications, which completely misses the point that if it interferes during
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Because the US has a terrible history of quackery and dangerous health and beauty products. Ie, medicine that kills, even folk remedies, hair products that could scar the skin, and that's just stuff that people thought should work and not counting outright frauds. Just like today, people trying to make money often have zero concern for the public's safety. We could get away with guidelines instead of regulations if people and companies weren't so insistent on making a buck by any means necessary.
This is als
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Is it that hard to guess?.could use competent gov! (Score:4, Insightful)
There is always a case for evaluating regulations and tuning them, but in about 90% of the cases, they are in their for a good reason and removing them would cause a lot worse harm than leaving them in. Sterilizing masks is a great example...when you're in an emergency situation, it's OK, if a little bacteria remains or the lifespan is shortened if it helps in the fight against COVID-19...but under routine cases, yes, you don't want the wearer getting or transmitting an infection because either the process wasn't effective enough or it destroyed the integrity of a mask.
People shock me...we're seeing a disaster play out in slow motion and it's shocking people like you make comments like this and Trump's approval rating is unchanged. We're going to lose 100s of thousands of people and our economy is shut down and our trust in basic living conditions is shattered...in a crisis like this, I want competent government. I want a competent CDC, FDA, FTC and national guard. I figured most of the country would now be reconsidering their libertarian and nihilistic leanings....yeah it was fun to say "fuck you" to the man and the liberal elites and elect a reality show host to president who has no interest in government...now look what's happening...lots more people are going to die because he's president and petty about assisting governors who he doesn't feel kiss his ass enough. Thousands of people are going to die because of those actions...for his ego...because he cannot lead and has no interest in government and only cares about the people in states he can win the electoral college votes for in 2020.
I figured this crisis would be a sobering wakeup call...especially for his elderly base as they watch their friends die....
NY is building emergency hospitals. FL is acting like nothing is wrong. The red states are acting recklessly while the blue ones, often with younger populations overall and much much more to lose economically are doing the right thing. I figured this would make people appreciate the role competent government can play in reducing the impact of a crisis...but you appear to have the same view you had before...that gov is the problem, not the solution....that old Reagan chestnut...stupid then, fatal now.
I really can't believe that someone would question the value of the FDA. Reading comments like this and seeing that Trumps poll numbers are completely unchanged really make me lose faith in humanity.
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I figured this crisis would be a sobering wakeup call...especially for his elderly base as they watch their friends die....
Darwin rules.
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Think of it as evolution in action (for those of you who know the origin of the phrase, tee hee stupid Libertarians.)
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"Think of it as evolution in action"
This is only correct, in both the general case and in our specific situation, when you realize that evolution works at the species level, not the individual.
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Think of it as evolution in action (for those of you who know the origin of the phrase, tee hee stupid Libertarians.)
From Oath of Fealty, by Larry Niven, published in 1981. A book hailed by Libertarians who somehow completely missed that Todos Santos was a medieval monarchy, complete with a nobility (the company's CxOs), despite it being alluded to in the damn title and described as such explicitly in the text. Still a very good sci fi novel, one of my favorites, despite people's bizarre inability to understand it.
A similar sentiment, though not that exact phrasing, appeared in one of the Gil the ARM short stories, publ
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The FDA has a history of violating freedom of speech and press, and the FDA's illegal actions were eventually overthrown by the Supreme Court. FDA has actually jailed people for making truthful claims about supplements, and threatened legal action against a firm reprinting medical research.
The FDA does some good things, but their flagrant abuse of power continues.
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The U.S. avoided Thalidomide because the FDA wasn't willing to accept test data from other countries, and wanted the drug company to conduct new tests in the U.S. While that was a
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There's an inherent contradiction in your post. First you claim that the government isn't competent, then you say you figured the people who don't think the government is competent would be reconsidering the idea that they need the government more.
Umm..... it's a private business in this situation who is ready to sterilize 160K masks/day with a process they sent to the FDA in 2016 for approval... four years ago. In what reality is the lack of government regulation in this situation the problem???
The reality
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The world had to learn the hard way to be careful pumping pregnant women full of drugs.
Iirc the FDA only succeeded because they slowed the process down until other countries detected it, and not because of any required tests of their own.
In any case, the choices aren't rampant, uncontrolled, deadly snake oil, or 10 years and a billion dollars of testing. That's the rhetoric of idiots with political goals. We can be more risky, even in normal times because delays cost lives as well, almost certainly more.
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Facebook? Bottom Line: USA wants to spy on you and sell your data.
Exxon? Bottom Line: USA wants to cover up climate change and pay world leaders to pretend it doesn't exist.
That last one might actually be true.
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Social media is an internet service.
Climate change is not mask expected to work.
An oil company is a company that works with oil and oil products.
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American hospitals shouldn't be in the position of having to sterilize disposab
What about home mask sterilization? (Score:2)
If you live in a dense city and are lucky enough to have masks, you might consider sterilizing your own masks. What are our options? I can think of:
- Hydrogen peroxide vapor sterilization, as in this article. Requires a dehumidifier, an ultrasonic humidifier, and an outlet timer.
- Wet pasteurization using a dutch oven/thermal ballast inside an oven (85-90C) (possibly harmful to the mask).
- Dry pasteurization using a dutch oven/thermal ballast inside an oven (85-90C) (okay for the mask but possibly not effec
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It's come to my attention that while vapor H2O2 is okay, liquid H2O2 may not be. Alcohol solutions can degrade the electrostatic filtering employed by better masks. The current best recommendation is to heat at 70C for half an hour, but it's unclear how many times this can be done with no impact on mask effectiveness.
Ovens can be used to disinfect N95 masks (Score:2)
In summary bleach and microwaves were failures at point of care because the bleach gases (skin and respiratory irritants) remained after multiple strategies were used to remove them, the microwave melted the masks and soaking them first led to reduced filtration. EtO, UVGI, and hydrogen peroxide decontamination were s
Re: Ovens can be used to disinfect N95 masks (Score:2)
Can one get enough UV from sunlight, say over 48 hours?
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I am not sure.
I've been reading a lot about uv-c (band) and how its good for breaking down viruses ('deactivating').
if you go to amazon, you'll see tons of uv-c lamps in glass/mercury and also LED. you can buy bare bulbs (I got some) and I'm looking to DIY some black boxes to disinfect masks and even received shipped items from mailorder.
do not look at the uv-c and do not expose to skin! this is why they often come with timers or remote on/off switches.
hack-a-day had an article on the uv sensor modules (a
Trump should fire FDA decision makers (Score:2)
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.
"Here's the thing," Yost said, "if the technology is safe and works, there is no rational basis
Re: Trump should fire FDA decision makers (Score:1)
UV sterilization? (Score:2)
A local company built a machine that is basically a conveyor belt with UV lamps on it, to be used for mask disinfection [kitchenertoday.com].
It is the same lamp that is used in some HVAC systems.
Seems to be much better than using chemicals, which may leave residues that are inhaled by those who reuse the mask.
But is it effective? Does it have to be used on both sides? What about particles caught inside the material, and so on ...
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