I've been working on an N95 mask production project with a team for about a week now.

We just got off the phone with NIOSH. They told us that approval for a new mask production facility in the US will take at minimum 45 days, but more likely 90.

A lot of people are gonna die. https://twitter.com/EricLiptonNYT/status/1240467730689593344
This process can't even begin until we have our facility set up, even if we're planning to use equipment and material identical to other N95 mask fabricators. My dad is gonna be intubating people with a bandana around his face by the end of next week.
Some context, since this offhand comment seems to be getting some traction:

Over the last week we've assembled a working group that we're tentatively calling the Open PPE Project. Our goal is to enable distributed fabrication of effective personal protective equipment at scale.
We initially started hearing stories about shortages from friends and family in the medical field, and they all went something like "we've been handed one N95 mask and we've been told to make it last until it falls apart". This is, as you might imagine, not in the CDC guidelines.
If you're following first world standards of care for people with viral pneumonia, masks get changed out between patients. Even reusing a mask between patients who have the same diagnosis is a target rich activity from a malpractice lawsuit perspective under normal conditions.
Sadly, as you all know by now, these are not normal conditions. For example, my dad helps run an ICU in Michigan. Absent adequate PPE he's going to be breathing in a lot of infected aerosols when he's putting people on ventilators. Obviously we want to do something about this.
We've run into several systemic roadblocks. First is the lack of material. After the initial outbreak in Wuhan the PRC spun up a bunch of mask production and bought up the vast majority of mask-ready polypropylene filter media in stock. That's all in warehouses in China now.
Second is the regulatory environment. In order to ship masks with the N95 certification you need to complete a bunch of paperwork, run your own tests, submit preliminary data, wait on the NIOSH PPE lab to test your gear as well, and submit to an on-site field inspection.
This is all assuming you're using equipment and processes that are deployed and making masks right now in other locations for other manufacturers. The whole situation is a systemic hairball on so many different levels. There's something for every critique to sink its teeth into.
The regulations are over the top and onerous. We should be able to start an application without a facility in place yet for one thing. In fact, our ideal outcome here is that every hospital system would have a line like this in a basement so they could take care of themselves.
That outcome isn't feasible under current regulations. I spoke with the NIOSH PPE lab earlier today. They're just as trapped in this system as we are. In fact, as federal employees they're restricted from traveling right now, so they'd need to get approval to leave Pittsburgh.
The polypropylene scarcity issue is kinda ridiculous. We *should* have the raw material lying around, but that doesn't seem to be the case based on our calls. If you know of anybody who does, please put me in touch. If we can solve this then we can work the rest of the problems.
Ultimately we want people in many different situations and contexts to have the ability to spin up mask fabrication quickly, easily, and cheaply so that they can respond to events like this. This isn't possible right now. We hope that there's decisive action to make it possible.
Lives are at stake and the basic structures of our global macroeconomy and our state institutions are getting in the way of an effective response. I'm tired, I'm angry, and my opinion of this country and our ability to do much of anything has been degraded by this experience.
While we wait for the material and regulatory issues to get solved we're going to pivot to an ad hoc positive pressure PPE design that we've been considering so that we can get *something* out the door for the first big wave of cases to hit hospitals nationwide.
The design we're kicking around is basically some plastic sheeting, some hose, and a blower with an off-the-shelf HEPA filter connected to the air intake. It will look dumb and probably require an extension cord, but it'll be reusable, fairly cheap, and hopefully protective.
Anyway, I've been posting updates about this on my feed on a daily basis. If you're interested in following along or helping out, check there for more info. I've been up all night and on calls all day, so I'm gonna try to get an hour or two of sleep, and then get back at it.
You can follow @mattparlmer.
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