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CATER Mask
Decisions
Join Us on Thursday to Debate the Mask Issues
Media Supply will be Substantial According to
Dave Rousse
Mobile Device to Insure Selection of the Mask
with the Right Fit
Leveraging ASTM Label Initiative for Efficient
Public Masks
Breathing Resistance, Filtration Efficiency and
Media Area
FFP 2 Masks Now Required in Retail Stores and
Public Transport in Austria and Germany
FFP 2 is Close to N95 in Performance
NC State Working on Reliable Ways to Test Mask
Effectiveness
Everyone in Singapore Wears Efficient Masks Why
Not in the U.S. and ROW?
_________________________________________________________________________
Join Us on Thursday to Debate the Mask Issues
We anticipate a lively discussion Thursday at
10AM Central Time to discuss if and how tight
fitting and efficient masks should be quickly
supplied to everyone.
In this Alert you will see summaries of comments
which will be made by some of the participants.
This Alert also has coverage of countries which
already are requiring tight fitting, efficient
masks in public space. So the discussion is not
about whether some country should do it but
whether other countries should follow suite.
The major relevant issues to be individually
debated are:
·
How efficient will tight fitting efficient masks
be in capturing and preventing the spread of the
virus?
·
Can sufficient numbers of tight fitting
efficient masks be made available to have the
short term impact?
·
Is the tight-fitting mask needed when vaccines
will soon provide herd immunity?
·
Are masks the most cost effective option?
Subsidiary and clarifying subjects are:
·
What is the definition of tight fitting and
efficient?
·
What efficiency level should be required?
·
How do you measure air leakage?
·
Who measures air leakage?
·
How long can the mask be used before cleaning?
o
What cleaning procedure should be utilized?
o
What will be the impact on effectiveness
as a result of cleaning?
To register for the webinar click here:
https://home.mcilvainecompany.com/index.php?option=com_rsform&view=rsform&formId=90
http://www.mcilvainecompany.com/CATER/subscriber/default.htm
Dave Rousse, President of INDA will be
participating in the webinar on Thursday and can
answer questions about media supply.
He provided the following summary.
“INDA tracked 34 new Meltblown production lines,
through announcements and/or industry contacts,
that were to be installed and operating by end
of 2021. Since starting this tracking, the
likelihood of five lines has softened, perhaps
due to fears of overcapacity. Nevertheless, we
see 16 of these lines capable of the fine-fiber,
electrostatically charged media that goes into
high performance facemasks.
“We see US N95 respirator production moving up
to 274 million/month from 42 m/m in early 2020.
Combined respirator and medical facemask
production would require about 9500 tonnes of
fine-fiber, electrostatically charged meltblown
per year. We appear to have that covered with
current investments, and capacity available as
well to either make ASTM Level 1 or 2 masks, and
filtration media to meet MERV 12 or14
requirements.
As to the ASTM performance standard, still
moving through the balloting process, it does
attempt to establish MINIMUM performance levels
(20% and 50%) for filtration efficiency (using
the N95 test method, different pass/fail
criteria) and for comfort, as measured by
pressure drop. The higher performance level,
ASTM Level 2, requires a minimum 50% filtration
efficiency and maximum 5 mm H2O pressure drop.
It is the latter requirement (pressure drop)
that will be the most challenging to achieve at
higher efficiency levels. It may require
designing media to the 5 mm pressure drop and
then solving for the filtration efficiency,
which would range from 50% to the highest we
have seen, which is 96% at this level.”
Mobile Device to Insure Selection of the Mask
with the Right Fit
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Keith Dellagrotta
will be participating Thursday to talk about a
very interesting use of mobile devices to insure
the selection of the best fitting mask.
M^3D.ai is a Silicon Valley tech startup that
leverages advanced 3D vision and analytics to
perform high fidelity anatomical scans using a
mobile device. Relevant to the COVID-19
pandemic, the company produces an iPhone app
with which users can take a “selfie” and then,
using photometric and AI technology, the app
converts the picture to a reliable 3D digital
model, stored locally on the personal phone.
This model allows prediction of how a mask will
lie on an individual’s face.
M^3D.ai recently teamed up with Vogmask to help
customers make educated and confident online
shopping choices with the app regarding which
mask size to buy without having to physically
try it on.
Additionally, the deidentified scan calculations
can assist in future mask design iterations by
providing information on the variance and mean
facial measurements of customers.
Originally My Mask Movement, the company was
founded to help address the shortage of PPE at
the start of the pandemic by creating
custom-fitted, 3D printed N95 masks. The
underlying core IP that facilitated creation of
the personalized masks evolved into the
company’s current capabilities. They still
continue to donate respirators to individuals in
need according to their mission to save as many
lives as fast as possible.
Leveraging ASTM Label Initiative for Efficient
Public Masks
Erick Couch will participate on Thursday and
chart a course for public acceptance of more
efficient masks using the ASTM label as a major
selection criterion.
Eric believes
a power point presentation which is viewed at
http://home.mcilvainecompany.com/images/Roadmap_to_High_Performance_Masks-BCTF.pdf
provides a meaningful
depiction that can be comprehended by the
general public...illustrated ranges with
indicators for performance of N95s, cloth face.
•
ASTM
– Respected Industrial Standard Body
•
Essence:
•
Allows use of widely available materials that
provide high performance filtration without
impacting N95 supply to frontline responders.
•
New and Existing Mask Fabricators Can Scale
Supply within 6 Weeks
•
Performance Measures
•
Sub-micron Particle Filtration (i.e. 95%)
•
Breathability
•
Inward Leakage Assessment
•
Eliminates Lengthy Testing / Approval Process
•
Chaired by CDC Deputy Director
Jonathan Szalajda
•
Impact: Immediately contrasts surgical and
cottage industry non-sealing masks with a high
performing masks made to measurable standard.
•
Jan 4
Vote
Jan 12 Special Meeting
Feb 12 Release
•
NOTE: Establishes measurement method, defines
ranges.
•
Exact performance of a point design can vary
within the range.
Erick shared the following thoughts
“I have had to emphasize with both
Biden’s team as well as the Aerosol Experts that
in fact the standard is a “Measurement
Framework” that provides “ranges” (20-50,
50-100). It does not specify performance levels
needed for any use case.
“We should adopt a different way of referring to
the ASTM standard going forward.:
ASTM @ Filtration XX, Breathability YY,
and FIT ZZ . Why is this important ?
“There is already too much confusion regarding
mask assertions. The public message needs to be
concise, consistent, and comprehensible by the
general public. Social science research has
found that more than three elements that require
choice results in confusion.
“I am a fan of your use of CATER to calibrate
interested parties to all aspects of mask
design. This is very important to the mask
advocacy community, however I would not
recommend putting this to the general public as
this is altogether a different construct. I
believe we will be pushing the envelope just to
get them to understand there is a new standard
and they should make decisions based on the
three primary factors.
“I also appreciate FFE as a simplification, yet
as you noted, fit and filtration are
independent. For this reason, I still come back
to the public messaging...that the simplest we
can achieve is “ ASTM
@ Filtration XX, Breathability YY, and FIT ZZ”.
“As an aside, I’ll share my thoughts on Level 1
and Level 2. While the standard defined Level 1
and Level 2, I find these constructs not helpful
since there are only three true figures of
merit: filtration, breathability, and fit.
Levels seem to be only an abstraction and given
the confusion, unnecessary added complexity
should be avoided.
Breathing Resistance, Filtration Efficiency and
Media Area
McIlvaine would like to see more data on the
relationship between media area and resistance
or breathability. Resistance rises as the square
of the velocity. If the resistance is 16 ” mm
H2O. and then you double the amount of media the
resistance drops to 4 mm
H2O.
Conversely if we are disqualifying a
media with 7 mm H2O
and want to reduce it to 5 mm we only
have to make a small increase in filtration
area.
Another factor is leakage. If half the air is
leaking around the mask the resistance is only ¼
of what it would be with a tight fit
Erick Couch talks about keeping things simple
for the purchaser. That is good advice. But the
designers and regulators need to keep the
velocity vs resistance formula in mind. Dave
Rousse talks about designing the media first
around the 5 mm H20. Just designing the mask
with more media should be one of the variables
to consider.
One of the design options might be an internal
brace. A small extension would substantially
increase the media area.
FFP 2 Masks Now
Required in Retail Stores and Public Transport
in Austria and Germany
FFP2 masks will now be required in all retail
shops and supermarkets, along with public
transport throughout Austria.
Previously, cotton masks or scarves were
sufficient to satisfy the regulation.
Austria put in place a range of stricter rules
after a meeting on January 17th, including
extending the lockdown until February 7th.
While FFP2 masks are more expensive than
standard medical masks, the government has
promised that they will be available to
Austrians at cost price.
People on low incomes would be entitled to the
masks for free, a government spokesperson said.
Supermarkets Lidl, Spar and Rewe told APA on
Sunday that they would be selling the masks at
cost price - although they were unable to
confirm the exact costs of the masks on Sunday.
A spokesperson from Rewe told Der Standard that
the masks would be offered “as cheaply as
possible”.
The retailers also indicated that there would be
no issues with supply, even as demand is set to
spike as a result of the new law.
“Any mouth and nose protection is good, but the
FFP2 mask is massively better," said Health
Minister Rudolf Anschober (Greens) on
Sunday. FFP2 masks offer better protection
against the coronavirus and other pathogens,
with up to 94 percent of aerosols filtered out.
Germany is weighing up following Austria and
Bavaria’s lead in making it compulsory to wear
full protective filter masks on public transport
and in shops, as the country remains on high
alert about the impact of possible coronavirus
mutations.
In Germany’s largest and southernmost state,
Bavaria, a similar requirement for trains,
trams, buses and supermarkets came into force on
Monday, though the new rule will not be policed
until 24 January and allows for exemptions for
bus drivers, ticket inspectors and children
under the age of 15.
When fitted properly, FFP2 masks promise to
filter out at least 94% of particles but are
also more expensive, usually retailing at
between €2 and €5 per mask. If FFP2 masks were
made mandatory before suppliers are unable to
meet the new demand, prices are expected to rise
further. Some virologists warn a new compulsory
mask rule could end up being counterproductive.
“In theory, the move to more professional masks
is welcome,” said Jonas Schmidt-Chanasit, a
German virologist and Professor of Arbovirology
at the University of Hamburg. “But I’d be wary
of simply copying the Bavarian model without
considering the possible downsides.
“In most cases FFP2 masks will be ineffective if
they aren’t professionally fitted: people will
end up breathing through the gap between mask
and face rather than through the designated
filter.” Virologists also say that beards can
prevent the masks from sealing properly around
the face.
“I can see how FFP2 masks could be a useful
emergency solution for workplaces where you
cannot easily guarantee safety ventilation,”
Schmidt-Chanasitsaid. “But I am skeptical of
making them mandatory on public transport, where
there are other ways to avoid the risk of
aerosols, and where passengers may be forced to
wear masks for longer than the 75 minutes
advised by regulatory authorities.”
Andreas Podbielski, director of Rostock
University’s Institute of Medical Microbiology,
Virology and Hygiene, described the new mask
requirement at “populism and nonsense”. “I don’t
see a gain in safety but plenty of risks,” he
told Munich’s Abendzeitung newspaper.
Questions around the availability of FFP2 masks,
which are equivalent to N95 filtering facepiece
masks in the United States and the KN95 standard
in China, have also yet to be answered.
In Germany,
the government has
since 15 December sent out vouchers for FFP2
masks to 34.1 million citizens aged over 60 or
with a history of illness such as cancer, with
the aim of supplying 15 masks to every person in
that category before the end of January.
A spokesperson for the Federal Union of German
Associations of Pharmacists said its members had
so far coped well with the demands of this trial
run. “But to supply filter masks to 80 million
people, that’s a different challenge. I wouldn’t
want to speculate on the outcome.”
While some German suppliers have started to
specialize in manufacturing FFP2 respirators,
the bulk of masks is made in China and can take
up to four weeks to deliver.
Germany’s disease control agency, the Robert
Koch Institute, on Monday reported 7,141 new
infections in the last 24 hours, the lowest rate
since 20 October. “After a sharp increase in the
number of cases at the beginning of December, a
decrease during the holidays and a renewed
increase in the first week of January, the
number of cases seems to be stabilizing again,”
the RKI wrote in its report on Sunday evening.
But Germany remains well below its stated target
of 50 new infections per 100,000 inhabitants
within the space of seven days, in spite of
several weeks of restrictions. “The numbers need
to come down further,” the health minister, Jens
Spahn, said on Monday.
FFP 2 is Close to N95 in Performance
Europe uses two different standards. The
“filtering face piece” score (FFP) comes from EN
standard 149:2001. Then EN 143 standard covers
P1/P2/P3 ratings. Both standards are maintained
by CEN (European
Committee for Standardization).
NC State Working on
Reliable Ways to Test Mask Effectiveness
Researchers at the North Carolina State
University Textile
Protection and Comfort Center are
working on consistent and reliable ways to test
the effectiveness of cloth face masks used by
the public to limit the spread of the
coronavirus, building on their expertise in
testing protective equipment for firefighters
and first responders. The NC State News
Abstract interviewed one of these
researchers.
“In March, we saw that people were making cloth
masks, and we realized there were no
specifications or consistent testing for them,”
said Bryan
Ormond,
assistant professor of textile engineering and
chemistry in the NC State Wilson College of
Textiles. “We started looking at: How do we look
at making better tests?”
The Center for Disease Control and Prevention recommends the
general public wear multi-layer cloth masks to
prevent transmission of SARS-CoV-2,
the virus that causes COVID-19, by reducing
spread of the virus through respiratory droplets
as well as to reduce inhalation of droplets by
the wearer.
To learn about strides in testing cloth face
masks, the Abstract sat down with Ormond
to talk about research into testing cloth masks
for the public, which are considered the last
line of defense against the spread of the
coronavirus.
The NC State News Abstract:
Can you describe some of the tests you’re doing
on face masks worn by the general public?
Ormond:
We worked during the pandemic at our homes, some
in the lab, to put together a couple tests to be
able to just get a screening level using ambient
air particles. We wanted to see how well the
materials filter.
We essentially put fabric in a cell, passed air
through it and counted the particles on either
side. That gives us an idea of the filtration
efficiency. We recently added an aerosol
generator to give us a consistent level of
particles at a consistent size because you can’t
really control ambient air from day to day.
The other approach is to look at the full
product. When you make a cloth face covering, it
is not a flat piece of material. It has the
openings around the face, the nose. It has a fit
factor that also affects the performance.
We have an animatronic breathing head form that
we can control. Testing masks on our articulated
head form allows us to simultaneously get a
measure of filtration efficiency and fit.
TA:
How do cloth face masks protect people?
Ormond:
Any time you’re dealing with some sort of hazard
you’re trying to protect people from, you look
at this hierarchy of strategies for how you can
control the hazard. Typically, you’re starting
with administrative and engineering controls. In
this case, that refers to keeping six feet of
distance, washing your hands and staying at home
– those are going to separate you from the
hazard.
The PPE, the respirators and the face coverings
are a last line of defense in any situation, not
just in respiratory protection.
The other is this idea of getting everyone to
realize that a mask, a face covering is just one
of the tools that we can use. It’s a public
health strategy. Every single person wearing a
mask just cuts things down a little bit from
spreading.
TA:
Are there standards for cloth face masks?
Ormond:
Right now there is no certification process or
specification for cloth face coverings for the
general public. The American
Association of Textile Chemists and Colorists,
AATCC,
came out with a design specification or
guideline on how to construct them.
Now, a task group of ASTM
International’s
subcommittee on respiratory protection – with
experts from around the country – is coming
together to put together a specification. That
involves setting design and performance
requirements so every mask can be certified
through a process. We also have to pick the
correct test methods that provide relevant
performance to the use conditions.
TA:
What do you look for in a face mask?
Ormond:
There are three main performance characteristics
you want to look at. One of those is filtration
efficiency. If you pass air with particles
through that fabric, how many particles does
that fabric actually stop?
The next thing that you want to look at is
breathability. Filtration and breathability
typically have an inverse relationship, so as
you increase the filtration performance, the
material or composite becomes less breathable.
So the balance between these two is critical for
an effective face covering.
The last one that’s most important for providing
any protection to the wearer is the fit. If the
mask doesn’t fit and seal to the face, you can
have the best filtration material possible, it
can block everything in a material level test,
but if you put it on your face, what’s going to
happen is the air you’re breathing in is
actually going to follow what we call a “path of
least resistance” and move around the material
instead of through it. This is less of a concern
if you are intending the face covering to only
function as a means to limit spread and protect
others from the wearer.
TA:
What’s your ultimate goal for face mask testing?
Ormond:
We want to be able to develop a rating system.
Right now a regular person shopping for a mask
is looking at four, five different masks, and
has no real way of comparing those. If you have
a specification in place, you at least know that
these have been through a process, that they
have been tested, shown to work to some level
that has been agreed upon by a group of experts.
The other thing you could do is you can show how
one varies in breathability or material
filtration. What you want to have is to get a
measurement or a rating of how breathable
something is so people can make an informed
decision.
A YouTube presentation on the mask testing work
is found at
https://news.ncsu.edu/2020/12/nc-state-experts-study-performance-of-face-masks-for-the-public/
Everyone in Singapore Wears Efficient Masks Why
Not in the U.S. and ROW?
Zeynep Tufekci and Jeremy Howard have a new
article in the Atlantic posing the
question of why we are still not wearing
efficient masks.
It is based on a previous paper.
“We first released the paper as a preprint back
in April, and it took nine months to go through
peer review. We’re happy that it’s published
but, to be honest, we’re also deeply
disappointed that it’s still relevant. We’d
hoped that by 2021 supply chains would have
ramped up enough to ensure that everyone had
better masks. Cloth masks, especially homemade
ones, were supposed to be a stopgap measure. Why
are so many of us still wearing them? “Don’t get us wrong; everything we said about the efficacy of cloth masks stands the test of time. Wearing them is much better than wearing nothing. They definitely help reduce transmission of the coronavirus from the wearer and likely protect the wearer to some degree as well. But we know that not all masks are equal, and early on in the pandemic, there was a dire shortage of higher-grade masks for medical workers. During those emergency conditions, something was much better than nothing. There are better possibilities now, but they require action and guidance by the authorities.
Even all cloth masks are not equal.
Construction, materials, and fit matter, and
these can’t be tracked or certified with
homemade masks. Unlike cloth masks,
medical-grade masks (also called respirators)
that adhere to standards such as N95 (in the
U.S.), FFP2 (in the European Union), and KN95
(in China) do a much better job of protecting
the wearer and dampening transmission. Ideally,
they should also come with instructions on how
to wear them and ensure that they fit properly.
“Because we have written about masks, we’ve
become informal advisers to friends, family, and
strangers on the internet. We’re not much help,
though. When our friends ask us simple questions
like “Where should I buy a mask?” or “Is my mask
any good?,” we don’t have great answers. We can
mumble generalities: Make sure it fits well; here
are some guidelines about layers; try to
avoid fake N95s. But if we can’t give wholly
satisfying answers to such basic questions, then
how is the general public expected to fare?
“Tragically, America is swamped with fraudulent
medical-grade masks, some of which are only 1
percent effective. Many masks do not have labels
clearly indicating their manufacturer. Some
official mask-testing methods are inappropriate,
including the use of far higher pressure than
normal breathing exerts. No reasonable
certification is available for the most useful
masks generally available to the public. All of
this means that everyone has to somehow figure
out for themselves which masks are effective.
“We routinely get PR pitches for excellent new
solutions as well as snake-oil remedies, and we
sometimes have trouble telling them apart—how is
an ordinary person supposed to evaluate
competing claims? When we share our articles
about masks on social media, we are asked where
to buy proper masks. Not only do we have no
answer, but we often find that marketers will
answer instead, directing readers to unreliable,
overpriced masks. Worse, the supply situation
apparently remains so dire that the CDC still
“does not recommend that the general public wear
N95 respirators,” because they’re crucial
supplies that must continue to be reserved for
health-care workers and other first responders.
“Not all countries have this problem.
Taiwan massively scaled up its manufacturing of
masks at the start of 2020, such that by April
every citizen received a fresh supply of
high-quality masks each week, and the
distribution system was regulated by the
government. Taiwan’s COVID-19 death rate per
capita is more than 1,000 times lower than that
in the U.S. Hong Kong has
been distributing patented six-layer masks (the
efficacy of which has been laboratory tested) to
every citizen. Singapore is on at least
its fourth round of distributing free, reusable,
multilayer masks with filters to everyone—even
kids, who get kid-size ones. In Germany, Bavaria
has just announced that it will be requiring
higher-grade masks. If all of these places can
do this, why can’t we?
Fixing this problem is more urgent now that a
new variant of the coronavirus, known as the
B.1.1.7 lineage, is making its way around the
world. This variant is believed to be about 50
to 70 percent more transmissible than earlier
strains of the virus. Masks are an important
part of the battle against this new variant
because they decrease transmission by reducing
the number of infectious particles spread by a
mask wearer (known as “source control”) and by
reducing the amount that a mask wearer inhales.
The cloth masks that we focus on in our paper do
a good job at source control, but on their own
they do not protect the wearer as well as
medical-grade respirators do. That’s why
health-care workers wear respirators, and that’s
why leaving existing supplies for them was
important early on—they were dealing directly
with COVID-19 patients, so they needed the
protection. Right now, while the CDC language on
supply shortages has not been updated, it’s
unclear if that’s because the shortages are
really that dire or because this topic has not
been paid sufficient attention. In either case,
the CDC should update us on the situation. And
if, indeed, we are still suffering from
shortages, emergency measures should finally be
implemented to manufacture such masks at home.
Not having higher-grade medical masks or even
reliable, certified cloth masks distributed to
the population means more transmission. But
that’s not all. If we could confidently tell
people that the masks would also help protect
the wearer from infection, we would
likely get more people to wear them. Appealing
to solidarity is excellent (“My mask protects
you; your mask protects me”) but being able to
confidently add self-interest to the equation
would be even better.
Ideally we would have ramped up supply and been
able to produce and distribute certified
higher-filtration masks to the whole population.
At a minimum, we should have created a
certification program and a distribution channel
that allows people to purchase higher-grade
masks with confidence. Even better, we could
have distributed them to the public for free
like so many other places. It’s not just that
many other countries showed us the way: Many
experts have been urging a switch to
better-grade masks as soon as possible. For
example, Abraar Karan and his co-authors wrote
on the same topic many, many times, in May,
June, October, and even this month. As Karan
pointed out to us, the fact that some people
refuse to wear masks makes it even more imperative
that we distribute higher-grade masks to those
willing to wear them. We need the CDC and the FDA to step up and provide simple, clear, actionable, and specific information that would allow the public to know which masks are reliable and where they can get them, as well as how to upgrade and better wear their existing options. Initial studies suggest that widely available surgical masks, combined with a mask brace, could increase the effectiveness of the surgical masks. Cloth masks can be upgraded with a nose wire (for fit) and a filter insert—and more than 100,000 types of these masks are available on Etsy. A good supply of KN95 masks is available from China, with many supermarkets and pharmacies now selling them for a couple of dollars each. But none of these solutions can work widely as long as the public has little guidance on which masks are reliable and certified.
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