Government Regulation: The Root Cause of the Current Respiratory PPE Crisis

Scott Augustine MD, CEO, Augustine Surgical Inc.

Why is the most innovative country in the world unable to make a simple facemask that actually protects the wearer, especially healthcare providers?

America is the undisputed innovation engine of the world. 50 years ago, we landed a man on the moon, and now we can even land and reuse the booster rockets. We have deciphered the genome and figured out how to edit its secret code. GPS allows us to navigate with unbelievable precision. The Internet allows us to navigate the unbelievable breadth of the world’s knowledge and communicate with anyone, anywhere--instantly. The list of America’s amazing inventions and technical achievements could easily fill a book. 

Given all that I ask again…why is the most innovative country in the world unable to make a simple facemask that actually protects the wearer, especially healthcare providers?

I believe that this conundrum is the consequence (presumably unintended) of government regulations over the last 40 years. Both OSHA and the FDA have played a role in creating the situation where respiratory PPE provides inadequate protection and is in short supply.

The history of healthcare providers’ respiratory PPE is remarkably brief. The surgical facemask was invented in 1897. Back then, facemasks were made of cloth. Now these masks are made of paper, but they are basically unchanged in 123 years! 

Perhaps the confusion starts with the name: “Personal Protective Equipment.” The obvious implication is that the equipment protects you—that it’s “self defense.” It’s not.

Surgical masks--by far the most common respiratory PPE used in healthcare--are not meant to protect you from aerosolized pathogens at all. Surgical masks are only “source control,” meaning that they partially protect the other person from you—for example, protect the patient from the surgeon. 

I’m an anesthesiologist, and for 40 years I mistakenly believed that surgical masks protected me from airborne pathogens. Frankly, I never gave it a second thought—of course, I must be protected; it’s a facemask. Wrong! Between the ineffective filter material and the massive leaks around the edges, surgical masks provide the user almost no respiratory protection at all, nor were they ever intended to protect the user.

Did you know that the filtering ability of surgical facemasks is not evaluated in any way by the FDA or any other agency?  There’s no need: they don’t claim to filter anything. The FDA only requires that surgical facemasks stop the airborne splatter of fluids from hitting your nose and mouth…and that they don’t burn too fast. If the pathogen is an aerosolized virus such as Covid-19, wearing a surgical mask not only provides no safety, but—even worse—may produce a dangerous illusion of safety.

There is, of course, the now famous N95 filtering facepiece respirator (FFR). Invented in 1973 –almost 50 years ago—the FFR was designed for industrial uses such as coal mining, asbestos work, and sheetrock sanding.  It’s a cup-shaped mask that is generally molded, but sometimes sewn, from non-woven synthetic materials. FFRs do not have sealing gaskets and are not stretchable. Therefore, rather than being designed to conform to the user’s face, tight elastic straps force the user’s face to conform to the molded cup-shaped mask. N95s are well known to cause bruising and sometimes even pressure ulceration to the face during prolonged use.

The N95s were designed for industrial uses, so OSHA (the worker safety agency) commissioned NIOSH (a testing division of the CDC), to develop test standards for industrial facemasks and respirators. The so-called N-95 test standards evolved and are now part of the Federal Code 42 CFR 84.

I know this is TMI, but bear with me…this test standard and the fact that OSHA both rigidly adheres to it and requires healthcare employers to strictly follow it-- is the root cause of why respiratory PPE both provides inadequate protection and is in short supply. Specifically, 42 CFR 84.181(f)(3) and 84.181(e), add absolutely no safety for healthcare providers, but they do make respirator innovation for healthcare use almost impossible.  

• 84.181(f)(3): “The test shall continue until minimum efficiency is achieved or until an aerosol mass of at least 200 mg [sodium chloride, NaCl] has contacted the filter.”

In other words, the test requires first “loading” the filter with salt. The salt physically plugs the filter and neutralizes the electrostatic attraction provided by modern high-efficiency filter materials. The result--filter materials that have far superior filtration efficiencies than the relatively poor filters in the standard N95 FFRs will fail the test because their electrostatic properties are destroyed by the salt load. 

“Loading” a filter with salt may make some sense when testing for use in dusty industrial applications. However, salt-loading makes no sense whatsoever for filters used in the relatively particle-free (certainly salt-free) air found in healthcare facilities. Using aerosolized salt that kills high-efficiency filters during NIOSH testing is the primary impediment to innovative new respirator designs. Innovative respirators such as the Covex Shield? and O2Canada? have not been able to pass CFR 84.181(f)(3). Therefore, healthcare workers are left with “N95s”—50-year-old technology that is relatively ineffective, terribly uncomfortable, and in short supply because only a few companies make them…but they can pass “the test.”

To survive salt-loading, the filter in N95s must be protected by a layer of melt-blown non-woven fabric that creates a very fine sieve, physically preventing the salt particles from reaching the filter. The melt-blown layer adds significantly to the breathing resistance, which is compensated for by making the filter much bigger. For example, the filter area of an N95 FFR is approximately 30 sq. in. The need for large filters in order to pass 84.181(f)(3) results in clunky designs like the sock-like N95s and the WWI gas mask elastomeric respirators.  The added breathing resistance also encourages air to preferentially pass through any gaps between the mask and the face, rather than passing through the filter.  

In place of CFR 84.181(f)(3), a much more logical test would be ASTM Standard F2100-19 Standard Specification of Performance of Materials Used in Medical Face Masks. The related F2299M ASTM Standard does not require any salt loading and uses Latex Spheres (electrical charge neutral) as the test particles so as to not destroy the electrostatic properties of the high-efficiency filter materials.  

• The second test that innovative respirators have difficulty passing is 84.181(e): “…filters shall be tested at a continuous airflow rate of 85 liters per minute.” 

85 LPM may make sense for use during heavy exertion such as shoveling coal; remember, the test was designed for industrial applications. However, healthcare personnel do not exceed “mild” exertion in their normal workday. Peak airflows during mild exertion are in the 20-30 LPM range.  Unrealistically high peak airflow requirements during testing results in respirator designs with undesirably large filters, like the 30 sq. in. of an N95.

A more logical test would be ASTM F2299M Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres, which calls for much lower airflows, which do not “penalize” smaller filter areas.  32 LPM is commonly used.

In the 1990s, N95 FFRs migrated into healthcare, but they were never designed for healthcare… and the demands of healthcare are very different from the demands of industry. Healthcare encounters very few particles, but the particles may be deadly viruses. “N95” means that the filter (not the mask, but the filter alone) has been tested to filter at least 95% of 0.3 micron-sized particles. 95% filtration efficiency may sound pretty good, but 5% of potentially deadly particles are still passing through and that does not count particles freely passing through the leaks. Even with “fit testing,” N95 masks are well-known to leak. A 2006 report from the US Institute of Medicine of the National Academies showed that 95% of properly N95 fit-tested subjects had at least 80% protection from test particles.  Clearly “fit-testing” does not ensure security.

Moreover, these masks are painfully uncomfortable, causing users to regularly reposition them on their faces to relieve the pressure points. Shifting the mask moves it away from the optimal “fit test” position, leading to a time-average filtration that may be much less than the 80-90% range.  Additionally, getting sheetrock dust from your hands onto your face during mask repositioning doesn’t matter much, but transferring viruses from contaminated hands to your face during mask repositioning is a well-known vector of self-contamination. 

Finally, when that single-use mask is reused for the tenth time; when the mask was stapled together after it broke; when the mask has been disinfected by processes never   approved by the manufacturer, does it still even qualify as N95? When the N95 certification means little and shortages require reuse, perhaps it’s time to look beyond the   N95 FFR for protection. 

I invented my first medical device (Bair Hugger?) in 1984 and since then have been awarded more than 200 US patents on medical devices. My Team and I are pretty good at innovation…however, we have abandoned all work on high-end respiratory PPE solutions. We believe substantive respirator innovation is impossible as long as 42 CFR Part 84 is the test standard. The N95 design is virtually unchanged in 50 years and because of the regulations, is not likely to change. The N95 is a poor design for healthcare, but with the current regulations preventing innovation, healthcare is stuck with the design. 

What can healthcare providers do to get better high-end respiratory protection? Lobby OSHA to drop 42 CFR Part 84 testing for healthcare PPE.  Lobby for ASTM Standard F2100-19 Standard Specification of Performance of Materials Used in Medical Face Masks instead.  As long hospitals rely on OSHA for respiratory PPE advice and OSHA relies on NIOSH testing, the current, pretty awful N95 FFRs are as good as it gets.

It is equally absurd that the country that landed men on the moon asks 300 million Americans to wear surgical or cloth facemasks that offer almost no protection to the wearer. We believe that much could be accomplished by simply upgrading the current “source control” facemasks to actually provide protection for the wearer—“self defense.”

Several companies offer filters (of varying quality) that can be inserted into a pocket in a  cloth facemask. This obviously does not prevent air from leaking around the sides of the mask, but any air that does pass through the filter will be cleaner. The net filtration efficiency might improve from a baseline of 5% with the cloth alone to 30% with the filter (most of the ventilation air is leaking around the filter).  Filtration technology is well developed and easy to provide if you don’t have to survive the ridiculous NIOSH salt-loading test. 

Given the current regulatory constraints, we believe that respiratory PPE innovators should focus on adding a filter and improving the seal of existing surgical and cloth facemasks.  Facemask “enhancements” can be done independently of the regulations. The key to improving respiratory PPE is in the filter-to-face seal. Absent a seal, the wearer will breathe unfiltered air passing around the sides of the filter. Airflow follows the path of least resistance; any gap between face and filter or mask will be that path.  

If a filter is added to an existing mask, the gasket must be positioned between the filter and the face in order to create a seal (not between the mask and the face). The seal needs to be effective on most faces and be comfortable so that it can be worn for extended periods. If the facemask holds the filter and gasket against the face, the seal must be achievable with minimal pressure. Obviously, it should be inexpensive.

One solution: Simply place a ComfortSeal? Filter inside your favorite surgical or cloth facemask. Your favorite mask can be easily upgraded from “source control” (protecting the other person) to self-protection (protecting the wearer).

A ComfortSeal foam gasket is added to the circumference of a high-efficiency filter leaving a unique small gap to accommodate the end of the nose. The foam gasket creates a comfortable seal against the face while forcing inhaled air to pass through the high efficiency electrostatic filter. The filter has a Viral Filtration Efficiency (VFE) of > 99.99975%! 

This unique and simple solution discretely enhances protection for all who need to be in close proximity to other people.  In addition to improved protection, the ComfortSeal? Filter will make your own facemask more comfortable, allow you to breathe more easily, feel cooler, and prevent your glasses from fogging. 

Our filter material has been shown in independent laboratory testing to be superior to N95 filters. Preliminary testing of our face-to-filter seals has shown excellent seals that that can be tolerated for long periods of time. Better filtering and excellent sealing… yet we will never be “N95” because our electrostatic filters cannot survive a preload of salt. 

For healthcare providers forced to wear N95s, we hope for your sake that lobbying OSHA will get the rules changed. For the 300 million Americans who don’t care about the “N95” designation, our comfortable, gasketed high-efficiency ComfortSeal? Filters will effectively enhance your “source control” facemask to make it real personal protection: “self-defense.” Experience shows that effective respiratory self-defense also provides peace of mind, especially in higher-risk situations such as in a crowd, or meeting, or riding public transit.  If your mask effectively protects you, you won’t need to worry if others wear their mask incorrectly—or not at all.

I have no doubt that there will eventually be many variations of gasketed filters for surgical and cloth facemasks available from many companies. At the risk of both bragging and plagiarizing, this simple innovation is a small step for man, but it may well be a giant leap for mankind.  

The ComfortSeal? Filter is available today to provide effective personal respiratory protection for everyone. Visit myvictorymask.com for more information.