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Coronavirus
Technology Solutions
Mask Policies
Need to be
Revised
NXTNano Can
Contribute
Nanofiber
Advantages
Armbrust
American is
Ready to Step Up
with Substantial
Production
Increases
TMS Can Increase
Production by 16
Million per
Month
Shortage of N95
Masks for
Medical Workers
Still Exists
ASTM Standard
for Respiratory
Fit will
Encourage Better
Designs
SPG Tests Show
That Flat Fold
N95s Provided
Better Seal Than
Cup Shaped
Eight Million
Deaths Caused by
Polluted Air
Each Year
___________________________________________________________________________
Mask Policies
Need to be
Revised
The initiative
for OSHA was
covered in the
Alert yesterday.
There is
agreement that
tight
fitting
efficient masks
will save
thousands of
lives which will
otherwise be
lost by people
wearing cloth
masks. Erick
Couch is working
with INDA and
McIlvaine to
present evidence
which could be
helpful in
guiding the
Biden
Administration
to create
appropriate
policies and
funding. Facts
and insights are
needed in four
areas.
QUALITY:
Minimum
standards such
as being issued
by ASTM provide
the first step
in insuring
quality. Expert
guidance will
result in the
best choices
using both
qualitative and
quantitative
methods.
The role of
government will
be to embrace
the minimum
standards and to
encourage the
reliance of
purchasers on
expert advice.
Air leakage,
breathability,
and particle
removal are all
important.
USE: The
motivation has
to be push and
pull. Push or
enforcement has
to be minimum
standards such
as ASTM. Pull
can be education
as to the
advantages of
effective masks
but also the
creation of safe
bubbles where
with effective
masks more
normal life can
be enjoyed.
AVAILABILITY:
The mask need
assessment
should include
uses by the
medical
profession,
other
countries, and
for other
applications as
well as for the
U.S. public. The
timing by which
additional masks
can be made
available needs
to be
determined.
COST: Initial
mask cost and
life are needed
to assess total
cost. Since mask
deterioration
with time may be
slow and steady
there is
opportunity
to
decrease cost
and increase
availability.
NXTNano Can
Contribute
Nanofiber
Advantages
NXTnano supplies
nanofiber media
for masks and
cites the life
as well as
efficiency as
attractive
features.
Here is
our interview
with Andy
McDowell.
Bob: What is the
relationship
between NXTnano
and suppliers of
masks?
Armbrust
American is
Ready to Step Up
with Substantial
Production
Increases
Lloyd Armbrust
replied
to the Couch
request with a
forecast
of substantial
production
increases should
funding be
available “We
originally
designed our
Texas facility
to produce 1.4
Billion masks
annually,
complete with
vertical
integration
making all of
the nonwoven
fabric in house.
We are partially
through this
building process
having already
invested nearly
$10M.
Additionally, we
have real MEPCA
implementation
plans, existing
factory space,
plus many of the
machines
actually on the
ground here in
Texas.
“In fact, I
would bet that
we are the only
company in the
world that has
nonwoven
equipment
capable of
producing 300
tons per month
ready to be
hooked up in
less than 30
days’ time in
the US. The
only issue is
that our current
FDA-registered
facility doesn't
have the
appropriate
power
requirement.
Because of this,
we decided to
build a new
facility which
has pushed our
production
timeline back.
However, we have
all of the
original plans
and approvals to
move forward
with our
existing
facility if we
wanted to pay to
the premium
price to bring
4000amps of
power into that
building.
TMS Can Increase
Production by 16
Million per
Month
Dan Grayson
replied to the
Couch request.
He
estimates that
with government
funding
production could
be
increased
by 16 million
masks per month
over the next
four months.
Shortage of N95
Masks for
Medical Workers
Still Exists
There is a
shortage of N95
mask. So Don
Milton, MD and
Professor at the
University of
Maryland thought
it was notable
that
FEMA has
authorized US
N95
manufacturers to
export 1 million
N95 masks per
month.
The main focus
of the Alert
today is to
address the
potential with
OSHA and masks
for the U.S.
public. But we
need a holistic
approach. If
there is still a
shortage of
masks for
medical workers
then it will be
more challenging
to suppl masks
to the public.
Also until the
poorer countries
have masks or
vaccines, the
U.S. will be
impacted
economically but
also by the
transmission of
new variants.
The poorer
countries also
account for the
majority of the
8 million people
per year dying
due to air
pollutants (see
article in this
Alert). So mask
demand has to be
viewed
holistically
from a
geographic and
application
perspective.
A year ago,
hundreds of
desperate
consumers were
emailing Mike
Bowen's Texas
medical supply
factory every
day, looking to
buy N95 medical
respirator masks
that can filter
viruses: "Scared
Americans and
moms and old
people and
people saying,
'Help me,' "
Bowen recalls in
an interview
with NPR.
Today, most
consumers still
aren't able to
buy N95 masks
because the
supply available
to retailers
remains very
limited. Even
hospital workers
are still being
asked to ration
and reuse their
supplies of N95s,
and the website
of the Centers
for Disease
Control and
Prevention says,
"N-95
respirators
should not be
used [by the
general public]
because they
should be
conserved for
healthcare
personnel."
Meanwhile,
consumer demand
for N95s and
medical-grade,
surgical-style
masks keeps
growing as the
Biden
administration emphasizes
the use of masks
by the public to
slow the spread
of the
coronavirus —
especially as
new variants of
it spread
rapidly around
the world.
From the start
of the
coronavirus
pandemic,
Bowen's company,
Prestige
Ameritech, and
most other
makers and
distributors
have prioritized
supplying health
care workers,
who say they
still don't have
enough masks and
other personal
protective
equipment.
The Biden
administration has
invoked the
Defense
Production Act to
prioritize
production of
N95s and other
medical
supplies. But
even with those
measures, U.S.
hospitals remain
worried about
their supply of
these medical
masks — more
formally called
respirators —
despite efforts
by factories to
churn out
billions more.
The story of N95
production over
the last year in
many ways
reflects
shortages seen
throughout the
U.S. medical
supply during
the pandemic —
from ventilators
and exam gloves
to syringes and
vaccines. The
demand is global
and sustained,
putting pressure
on a fragile
supply chain
that remains
stressed and
unable to keep
up.
"Global demand
continues to
outpace
production,"
says Nancy
Foster, vice
president of
quality and
patient safety
at the American
Hospital
Association.
Availability of
N95 masks has
improved since
last spring,
Foster says, but
"we are
continuing to
use conservation
measures within
hospitals to
protect
the supplies we
have, to extend
the wear of N95s
designed for
one-time use."
That includes asking
hospital workers
to wear each
mask longer.
Costs for N95s —
and other
medical
supplies, like medical
gloves and
gowns — have at
least doubled.
The use of N95s
has increased
500% since
July, according
to Premier,
a
company that
buys medical
supplies on
behalf of about
40% of U.S.
hospitals.
"In most of the
hospitals,
nurses are
wearing their
N95s for five
shifts," or up
to 60 hours,
says Mary
Turner,
president of the
Minnesota Nurses
Association and
an intensive
care nurse
working with
COVID-19
patients. "It's
becoming the
norm to not wear
N95s the way
they're supposed
to be
used."
A November
survey by
National Nurses
United found the
lack of
protective gear
like N95s
remains a huge
safety concern
for its members.
More than 80% of
nurses reported
reusing
single-use items
like N95
respirators, and
about 20% of
hospitals had
recently limited
the use of N95s.
Before the
pandemic, there
was little
consumer demand
for these
products.
Purchasers
included people
with compromised
immune systems
or others
working in wildfire
areas or on
dusty home
improvement
projects.
That has
changed.
Everyone — from
front-line
grocery workers
to travelers to
teachers to
people visiting
vulnerable
family members —
is looking for
the specialized
masks.
N95s are the
gold standard in
masks because
unlike cloth,
surgical and
KN95
alternatives,
they're tested
and approved by
a federal agency
as having
demonstrated
that "they can
filter out a
minimum of 95%
of airborne
particles under
worst case test
conditions," according
to the CDC.
Nonetheless,
N95s are still
rarely available
to consumers.
Shepard Medical
Products,
an
Illinois-based
company that
sells supplies
to drugstores
and other
retailers,
hasn't sold a
single N95 since
March of last
year. That's
when makers of
N95s called the
company's
president, Chris
Humbert, to tell
him, " 'We're
done — we won't
have any more
product
available for
2020.' "
So far this
year, Humbert
says, that
shortage hasn't
yet eased. Some
wholesalers
large enough to
order directly
from factories
in China
occasionally can
get N95s to sell
at hardware
stores, for
example, but
"it's still very
fragmented." The
priority, he
says, has been
to supply health
care facilities
and government
agencies. "I
stopped trying,
until hospitals
are covered."
Fraud is also a
major concern.
Everyone, from
nurses,
hospitals,
manufacturers
and
distributors,
says vetting
fake suppliers
or identifying
copycat N95
masks has been a
huge concern.
Humbert says
many new
upstarts tried
to sell him
products billed
as N95s, but
because he
couldn't verify
their quality or
efficacy, he
decided it would
be safer to
remain out of
stock.
"We didn't like
being out of
stock and
disappointing
any of our
customers by not
being able to
supply, but we
did not feel
that we had a
reliable source
that could
provide those
products for us
on par with the
product that we
had in place,"
Humbert says.
Exactly when
American
consumers might
once again gain
broader access
to N95s depends
on a lot of
factors.
"I think if the
vaccine rolls
out faster,
you're going to
be able to get
N95s faster," as
the risks
diminish and
fewer people
need N95s, says Kaitlin
Wolak,
a supply chain
expert and
assistant
professor at the
University of
Notre Dame.
(Public health
workers urge
even those
immunized to continue
pandemic
precautions —
including
consistent
mask-wearing —
for now,
until the
pandemic is
tamed.)
Broader
availability of
N95s also
depends on
manufacturing
speed, Wowak
notes, and on
when backlogged
orders from
hospitals and
other medical
facilities can
be filled.
The Biden
administration
has touted its
plans to use
the Defense
Production Act to
stimulate
production.
Wowak says that
might mean
manufacturers
get more federal
help finding the
raw materials
needed or
coordinating
distribution of
supply. But it
won't address
some of the main
challenges that
affect the speed
of
manufacturing.
Wowak says how
fast products
like N95s are
made is
determined by
three primary
factors: the
complexity of
the equipment
used to make the
product, the
availability of
raw materials
and the
availability of
trained workers.
Making vats of
hand sanitizer
at a rum
distillery, in
other words, is
very different
from ramping up
an N95 factory,
because of the
cost and
complexity.
Managing those
costs and
complexities has
made the past
year extremely
busy for Mike
Bowen, the
co-owner of
Prestige
Ameritech. He
and his partner
started the
company in 2005;
it is one of the
few makers of
N95s based in
the United
States. Demand
overwhelmed his
factory a year
ago when China
stopped
exporting the
masks that most
U.S. hospitals
relied on for
most of their
supply.
"I've gotten
requests for
maybe a billion
and a half masks
if you add it
up," Bowen
told NPR in
late February of
last year. At
the time,
Bowen's company
could produce
75,000 N95s a
month.
He was troubled
by the influx of
orders, he said.
They put him in
a bind.
To make more
N95s, Bowen
would need new
mask machines,
each of which
takes four
months to custom
build and costs
as much as $1
million. To
justify building
extra machines,
he needed
assurance that
U.S. hospitals
and government
agencies
wouldn't just go
back to buying
cheaper
Chinese-made
masks once the
pandemic was
over.
He'd been burned
before. A decade
earlier, during
the H1N1 flu
pandemic,
Prestige had
made what Bowen
called "the
mistake" of
investing in new
machines and
ramping up
production for a
need that dried
up as suddenly
as it began.
"One day — and
it is literally
one day — it
just quits,"
Bowen told NPR
last spring.
"The demand is
over."
He eventually
did decide to
expand last
spring, as the
COVID-19
pandemic
worsened.
Bowen asked U.S.
hospitals to
sign multiyear
deals for N95s.
That gave him
the funds to
build nine new
N95 machines,
some of which
are still coming
online. The
factory now
makes 80 times
more masks than
it did a year
ago.
"We're now
selling 6
million [a
month], and we
have another 4
million coming
on board," he
says.
For the first
time in a very
long time, Bowen
says, he has
some excess
supply he could
start selling
into the
consumer market.
ASTM Standard
for Respiratory
Fit will
Encourage Better
Designs
An evaluation of
the new ASTM
standard was
posted on the
NIOSH
website January
26,
2021 by Christopher
Coffey, PhD;
Lisa Brosseau,
ScD, CIH; M. E.
Bonnie Rogers,
DrPH; and
Jonathan
Szalajda, MS.
One of the most
important
criteria for any
filtering
facepiece
air-purifying
respirator to be
effective is
that a good seal
is formed
between the
respirator’s
facepiece and
the wearer’s
skin. The
ability to
achieve this
seal is called
the respirator’s
fitting
characteristic.
In 1995, when
NIOSH put Title
42 Code of
Federal
Regulations Part
84 (42CFR84)
into operation,
it did not
include an
evaluation of
the fitting
characteristics
of respirators
approved only
for
particulates.1 In
addition, no
voluntary
consensus or
other
government-unique
standards
existed to
evaluate the fit
capability of a
filtering
facepiece
respirator prior
to it being used
in the workplace
in an
OSHA-regulated
fit testing
program.
Therefore,
several studies
have been
conducted to
determine how
well
NIOSH-approved
particulate
respirators,
especially
filtering
facepiece
respirators, fit
wearers.2-8 These
studies found a
high number of
filtering
facepiece
respirators on
the market at
the time had
poor fitting
characteristics.
Filtering
facepiece
respirators that
do not fit most
employees place
an unacceptable
burden on
respirator
program
administrators,
who must then
provide many
models and sizes
to ensure that
every wearer can
find a
respirator that
fits properly.9 In
addition, poorly
fitting
respirators
increase the
number of fit
tests required,
increasing
costs.10
The ASTM RFC
Standard will
enable
respirator
manufacturers to
develop better
designed models
that fit the
worker
population.
Respirators
passing the RFC
Standard test
method are
expected to have
better fitting
characteristics.
The RFC standard
will lower costs
to respiratory
protection
programs by
reducing the
number of
different models
needed in the
program.
Purchasers of
particulate-only
respirators
could reference
ASTM F3407 in
their
procurement
packages to
ensure receiving
those with good
fitting
characteristics.
The RFC Standard
can be used by
organizations,
such as NIOSH,
to ensure a
minimum
performance
level of for all
respirators used
within an
approval
program.16 Both
conventional
respirator
designs as well
as novel
respirators
(such as ones
without the
prevalent
two-strap head
harness to
provide adequate
tension during
use and even
distribution of
pressure) can be
evaluated using
the RFC
standard.19
Ultimately, this
RFC Standard
defines
performance
requirements
that could be
used as part of
a conformity
assessment
program to
ensure that
NIOSH-approved
respirators will
fit a specified
percentage of
the intended
user population,
thus providing
workers with
better
protection. This
is crucial in
all industries
in which workers
are exposed to a
variety of
agents, one of
the most notable
examples being
the Healthcare
and Social
Assistance
industry sector.
Healthcare
workers may be
exposed to
biological
agents, e.g.,
seasonal
influenza,
Ebola, Severe
Acute
Respiratory
Syndrome (SARS),
Influenza A
H1N1, and more
recently
SARS-CoV-2, the
virus that
causes COVID-19,
as well as to
chemical agents.17-19
ASTM F3407 can
be read for free
at https://www.astm.org/COVID-19/ or
purchased at https://www.astm.org/search/fullsite-search.html?query=Respirator%20fit%20capability.
NIOSH
September
Observations on
EHMPRs
The high demand
and limited
supply of N95
filtering
facepiece
respirators (FFRs)
during the
COVID-19
pandemic have
led
organizations to
rely on other
types of
respirators,
such as reusable
elastomeric half
mask respirators
(EHMRs).
Photo Courtesy
of MSA
CDC developed
strategies to
optimize the
supply of EHMRs
during
conventional and
surge demand
situations, as
experienced
during the
COVID-19
pandemic.1 NIOSH-approved EHMRs
provide an
alternative
respiratory
protection
option capable
of reducing the
total number of
respirators
required because
EHMRs may be
cleaned,
disinfected, and
reused numerous
times.1 Unless
the EHMR filter
cartridges
become visibly
soiled or wet,
visibly damaged,
or if the
respirator
becomes notably
harder to
breathe through,
current practice
shows that
conservatively,
the filters
could be used
for at least one
year.1 Although
more popular in
industry
settings, EHMRs
have been
leveraged both
before and
during the
COVID-19 public
health emergency
and have been
highlighted in
several recent
media reports.2-5
Although EHMRs
require a higher
up-front cost
than N95 FFRs,
the EHMR
facepiece and
cartridge
reusability may
provide
cost-savings
advantages and
may create less
hospital waste
compared to the
disposable N95
FFR.6 For
example, due to
COVID-19 N95 FFR
shortages, one
large academic
medical
center—comprising
12
hospitals—purchased
and deployed
10,000 EHMRs
that reduced N95
FFR usage to
zero.7,8 The
center reported
a significant
cost benefit.
The one-time
cost and storage
of EHMRs was 10
times less
expensive after
one month of use
when compared to
disposable N95
FFRs.7,8
Research has
shown that user
acceptance, fit
testing, and
disinfection
are not barriers
to implementing
EHMRs.9-12 With
proper use, fit,
and maintenance
training, EHMRs
provide an
effective
solution to
supplementing
the supply of
N95 FFRs.
Generally, EHMRs
have exhalation
valves, which
should be taken
into
consideration
before use in a
sterile setting
or for use as
source control.
Until more
research is
available, masks
with exhalation
valves or vents
should NOT be
worn to help
prevent the
person wearing
the mask from
spreading
COVID-19 to
others (source
control). Here
are some tips
when it comes to
exhalation
valves:
https://blogs.cdc.gov/niosh-science-blog/2020/09/08/elastomeric/
SPG Tests Show
That Flat Fold
N95s Provided
Better Seal Than
Cup Shaped
Twenty subjects
underwent
quantitative
respirator fit
testing with two
styles (flat
fold,
cup-shaped) of
N95 filtering
facepiece
respirators (N95
FFRs). Passing a
fit test was
followed by
stereophotogrammetry
to determine the
face seal area
and computation
of seal
pressure. There
were
significantly
different seal
pressures (p <
0.01) between
standard size
flat fold and
cup-shaped N95
FFRs but no
significant
differences in
face seal area.
No significant
differences were
noted in fit
factors, but
more individuals
passed fit
testing wearing
flat fold
respirators. The
ability of flat
fold N95 FFRs,
at lower seal
pressures, to
obtain similar
fit factors as
cup-shaped N95
FFR at higher
seal pressures
offers the
possibility of
enhanced facial
comfort without
a loss of
protection.
Stereophotogrammetry
offers a
relatively
simple,
non-invasive
technology to
evaluate various
properties of
N95 FFR fit.
SPG enables the
determination of
geometric
properties from
photographic
images. This
process involves
estimating the
three-dimensional
(3D) coordinates
of points on an
object.
Photographs are
taken from
multiple
locations (lines
of sight) and,
using the
principle of
triangulation
(mathematical
intersection of
lines of sight),
the X, Y, and Z
coordinates of
each point of
interest are
determined.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4545596/
Eight Million
Deaths Caused by
Polluted Air
Each Year
New evidence on
the harm caused
by air
pollutants needs
to be considered
when creating
HVAC and mask
strategies.
More than eight
million people
around the world
die each year as
a result of breathing
polluted air that
contains
particles from
fossil fuels, a
new study has
found.
Burning fossil
fuels such as
coal and oil
produces
greenhouse gases
that trap solar
radiation in the
atmosphere and
cause climate
change. But it
also releases
tiny poisonous
particles known
as PM2.5. Small
enough to
penetrate deep
into the lungs,
these particles
can aggravate
respiratory
conditions like
asthma and can
lead to lung
cancer, coronary
heart disease,
strokes and
early death.
Research has
also found a
link between
higher levels of
long-term
pollution and
more deaths from
Covid-19.
In a study
published in the
journal
Environmental
Research on
Tuesday,
researchers from
Harvard
University, in
collaboration
with the
University of
Birmingham, the
University of
Leicester and
University
College London,
found that
exposure to
particulate
matter from
fossil fuel
emissions
accounted for
18% of total
global deaths --
almost one in
five -- in 2018.
The figure is
much higher than
previously
thought. As
recently as in
2019, scientists
were estimating
that 4.2 million
people die each
year from
outdoor airborne
particulate
matter
pollution, a
figure that
included people
who die because
of pollution
from dust and
smoke from
wildfires and
agricultural
fires.
The new study
shows that in
2018, estimated
8.7 million
deaths were
linked to fossil
fuel emissions
alone
Eloise Marais,
an associate
professor in
physical
geography at UCL
and a co-author
of the study,
said the
research adds to
the "mounting
evidence" that
air pollution
from fossil
fuels is
detrimental to
global health.
"We can't in
good conscience
continue to rely
on fossil fuels,
when we know
that there are
such severe
effects on
health and
viable, cleaner
alternatives,"
she said in a
statement.
The scientists
used a global 3D
model of
atmospheric
chemistry
developed at
Harvard to get a
better picture
of pollution at
a more local
level.
Traditionally,
satellite and
surface
observations
were used to
estimate the
average global
annual
concentrations
of PM2.5
particles in the
air. By using
the 3D model,
the scientists
were able to
divide the globe
into a grid with
boxes as small
as 50 kilometers
by 60 kilometers
(31 miles by 37
miles) and look
at pollution
levels in each
box
individually.
This allowed
them to assess
the impact of
the pollution in
places where
people live and
to distinguish
between
different
sources of
pollution.
They found that
China, India,
parts of the
eastern US,
Europe and
Southeast Asia
were the worst
impacted.
According to the
data, as many as
30.7% of deaths
in Eastern Asia,
16.8% in Europe
and 13.1% in the
US can be
attributed to
fossil fuel
pollution.
To model the
pollution, the
researchers used
real emissions
and meteorology
data, mostly
from 2012. The
year was picked
to eliminate the
influence of the
El Niño
phenomenon,
which can worsen
or improve
pollution
depending on the
region. They
then updated the
data to reflect
a 44% fall in
fossil fuel
pollution in
China between
2012 and 2018.
The researchers
estimate that
China's move to
cut its fossil
fuels emissions
saved 2.4
million lives
worldwide,
including 1.5
million in
China.
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