HCP Q&A

1. Where do the masks come from?

These masks come from an FDA-registered operator (manufacturer) in Guangdong, China. Four weeks ago, I had been sourcing surgical masks at $69.99 per pack of 25 and cloth-based N95s for $44 per piece to freely give away to physicians, senior citizens, and rare disease patients I personally knew.

I did this for the first 2,500 before realizing (1) all the units possessed markings of Chinese-testing/-certification, (2) the N95s were originally KN95s (Vogmask)/considered “counterfeit” under FDA guidelines, and (3) community-level human-human transmission of SARS-CoV-2 (the virus that causes the disease COVID-19) was uncontainable/unavoidable.

I traced the source of manufacturing and followed what companies like Vogmask, Cambridge Mask, and Viral Tech did (I was briefly in touch with Viral Tech’s manufacturer, actually) to bring their products to US soil. I wasn’t keen on the 5-50x markups of US-sold/Chinese-manufactured masks I was seeing. It was unfair toward Americans, who still need mass quantities pumped into our ecosystem to sustain us through the coronavirus pandemic. At the time I could choose between producing a fabric KN95/N95 mask or a surgical masks; I chose the latter because the cost of personally footing that bill was $4.3 per piece vs. $0.60 per piece (with a minimum order test run of 2400 units). Also it would be easier to get top-down systemic blessing longterm for a new surgical mask design vs. cloth/N95/combination of the two (my longterm forecasts are defined in 4 weeks, 8 weeks, and so on).

 

 


2. What is the US view toward foreign-sourced masks?

It’s complicated. Although just recently KN95s became recognized as equivalent to N95s, the source can land you in murky waters. China produces the vast majority of the world’s supply in masks (as well as the supplies to make them). Tracing is difficult without some sort of global agreement/adoption of blockchain to verify each point of hand-off.
 

 


3. Why can’t we just manufacture masks here?

I agree that local manufacturing and “bringing PPE production home” is a noble endeavor worth pursuing. You can find my statements on the matter in JAMA (https://jamanetwork.com/journals/jama/fullarticle/2763590 and https://jamanetwork.com/journals/jama/fullarticle/2763590). Unfortunately there are a number of blockades that prevent us from simply doing that: (1) every new medical/humanitarian use device maker must go through a process as specified by our rules of governance, (2) most supplies to make PPE are overseas, so for a truly American product you still have to figure out supply chain for PPE-making, (3) I didn’t have the luxury of enough time/money to choose the path of most vs. least resistance. My goal was simply to do the right thing—and fast.
 

 


4. How effective are DIY masks like those outlined by Deaconess and Providence? Are these PPE too?

DIY masks are not PPE, though they may have some protective qualities (it’s unknown but reported to be around 30% equivalent BFE/PFE). Indeed, they’re certainly no substitute for social distancing, washing your hands, staying 6 feet apart, etc. Generally fabric face masks are more appropriate for the general public when going out into crowded places—as opposed to widespread medical community adoption. In situations of dire need, the CDC does recommend that DIY masks can be used as a “last resort” medical purpose masks not intended for high fluid barrier protection. These designs can be found at Deaconess and Providence.
 

 


5. What’s the difference between FDA (EUA) authorization, FDA registration, and CDC-recommended?

FDA emergency use authorization is what the FDA has done in order to hopefully safely lax regulations enough to improve community health outcomes. It’s a fine balancing act between making the market a complete free for all (endangering lives) and being too strict (endangering lives). For the most part, EUA guidelines have been issued in lower-risk topics (masks, testing, etc.)—where the benefit of lowing barriers to entry for players is predicted to outweigh the risks.

FDA registration means that the mask-maker has gone through the effort of testing, probably received some regulator-recognized certifications, and meets minimum health and safety requirements according to enforcement/regulation polices of the FDA. For us, during this time of EUA, it was voluntary to undergo registration. However we wanted to have the peace of mind that our masks could in fact effectively help protect our healthcare provider heroes. So we underwent testing and submitted for registration.

CDC recommendations are separate from the FDA. The latter regulates/enforces, while the former gives guidance to a number of stakeholders in the healthcare industry (e.g., state/county public health officials, hospitals, doctors, the general public, and the FDA too). Both work together to protect the health and safety of the community.

 

 


6. Are surgical masks appropriate for high liquid barrier protection-demanding conditions?

Not. Well, they do offer some protection. They’re certainly not intended for situations of aerosolization exposure.
 

 


7. What’s BFE and PFE? Does that mean my surgical mask is the same as an N95?

BFE stands for bacterial filtration efficiency. PFE stands for particulate filtration efficiency. Both measurements give an indication of how much germs can pass through either from the wearer to someone else, or from someone else to the wearer. 3M's standard procedure mask offers 95% BFE protection. My patent-pending (USPTO provisional patent registration 29729526) surgical mask went through additional testing to demonstrate a microbial cleanliness of <20CFU/g. It felt personally important to be able to provide science-based peace of mind to healthcare workers of the safety and efficacy of the design.

Note that even though N95s and my masks have similar BFE/PFE stats, this doesn't mean they are close to equal. N95s must undergo testing to prove filtration capabilities (95% or higher) against germs (bacteria, viruses, fungi, and protozoa) of as small as 0.3 microns in size. Surgical masks? They are tested against bad guys between 1 and 5 microns in size. That's a big (small) difference. The size of coronavirus? 0.6 to 1.4 microns in size for virus particles, with the average being 1.2 microns in size (
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1563832/ and https://www.nejm.org/doi/full/10.1056/NEJMoa2001017). Note that they're also lipid-enveloped (oily).

 

 


8. What is face seal leakage and why is it important to fit test?

You hear a lot about negative pressure rooms/tents/suits because in an ideal world, we'd be able to leverage these precautions of biocontaimnent to control exposure risk. Nothing bad goes in, and we know exactly what's coming out. When you inspect a respirator device, you similarly want to verify localization of a negative pressure environment to ensure it's doing its job.
 

 


9. What does this mean?

 

It means no/as minimal as possible face seal leakage. Health professionals don't want their germs placing extra burden on patients (the sickest ones often suffer from coinfections compounded with their already stacking list of problems associated with COVID-19). They also don't want the patient's germs threatening their own health and safety. Taking precautionary measures to ensure fit (flexible nose piece, sufficient facial area coverage) makes sure as little potentially pathogenic particulates are getting in -- and out. As a side benefit, it will intrinsically help reduce the amount of fogging to glasses/goggles.
 

 


10. Does everyone need an N95?

N95s have not been recommended to the general public or even health professionals who arent' in direct contact with COVID-19 patients/are exposed to risk of aerosolization (incubating, invasive mechanical ventilation procedures/etc.).
 

 


11. If N95s are so great, why can’t I get one?

N95 global supplies are rapidly diminishing as the world's cases tops 1 million. The supplies to make them are also being impacted. The stories you hear about warehouses full of N95s may not have proof of life/existence or may be "fakes" (they'd still work as masks, they're just not the almost mythical N95s).
 

 


12. What are the benefits of surgical masks? Of N95 masks?

Both provide protection to the wearer in exposure risk situations. N95s offer some additional benefits in especially situations where the virus may become aerosolized. But again, there are a number of reasons why N95s are not being even recommended for all nurses and physicians to wear.
 

 


13. What are the limitations of surgical masks? Of N95 masks?

The virus is small and "oily" (in a sense). It's uncertain if the latter impacts PPE's efficacy. Neither type of mask was intended for extended use or reuse. It's the situation we're in, and we're rapidly evolving our understanding of PPE's ability to withstand significant additional wear while still offering protective benefits. N95s offer greater protection against smaller virus particulates.
 

 


14. I heard that nurses and doctors are reusing PPE. Is this safe? Why are they doing it?

They're reusing/wearing masks longer than originally intended because they have to. There's a severe global shortage. Even if 3M, McKesson, Moldex, Makrite, and the other players ramped up production to produce 1 billion masks, we wouldn't have enough. A pandemic indicates rapid, widespread transmission on the community-level -- except on a global level. A small country like Taiwan calculated it needed 43 million masks to flatten its curve. The US is 14 times bigger (so we'd need at least 600 million masks to see us through); as a side, on the whole our country has never had the seasoning of dealing with SARS before.
 

 


15. How are you able to promise that every HCP will receive masks who asks for it? Isn’t it near impossible to obtain, not to mention expensive?

So far we've been able to meet this mission. And we will continue to push every day/have faith that God (or "universal energy") will provide. There are around 17 million healthcare professionals in this country. At the point in time 100% of our nation's healthcare providers start sending traffic to this site -- we'll still be working as hard as ever to make good on our promise.