Revoked EUAs with Stephen Badger

In June 2021, the FDA revoked its Emergency Use Authorization for
Filtering Facepiece Respirators.  Learn what an EUA is and
how it affects the use of non-NIOSH approved N-95 respirator in
healthcare.


 


 


Peter Koch: [00:00:04] Hello, listeners, and
welcome to the MEMIC Safety Experts podcast, I'm your host, Peter
Koch, and the topic today is revoked EUAs. Often I need to hear
or read something a second time to understand what's going on.
And it's not for lack of education or interest. It's just
sometimes a sentence tries to do way too much with too few words
or letters or using abbreviations to try to help with
understanding. So try to wrap your brain around this. Early on in
the sars-cov-2 pandemic, the FDA as a department of the DHHS,
created the FRREUAs for HCP in conjunction with NIOSH and the CDC
to help combat the spread of covid-19 now due to the increase in
availability of NIOSH approved and n-95 FRRs, the FDA has revoked
the FRREUA for [00:01:00] HCP. Got it. Yeah, I don't. I didn't
either. Every one of those, TLAs adds meeting to the message. And
a TLA is a three letter abbreviation, by the way, so that's way
too many TLAs packed into two sentences to be functional and I
expect that if it was in print you would have to read it again
and maybe again and maybe google some of those to figure out what
all the pieces are. But just listening, I expect it was almost as
confusing as it was to read. And if I were to pull a number of us
who heard that headline for the first time, everyone would have a
different opinion on its meaning. And unfortunately, many times
when I'm in the field talking with clients about new regulations
or safety standards, there's often confusion and most often a
different opinion on the meaning or applicability. And the FDA's
recent revocation of the FRREUA is no exception. So to help clear
the air on the [00:02:00] podcast with me today is Steve Badger,
CSP, OHST and safety management consultant with MEMIC. Steve has
more than 35 years of experience working in the paper, medical
sterilization and construction industries. He's an authorized
training instructor for the OSHA Training Institute in
Manchester, New Hampshire, and is a member of the American
Industrial Hygiene Association. Steve uses his experience in
different industries and formal training in industrial hygiene
practices and indoor air quality testing to help the companies he
works with manage their respiratory protections, challenges and
others today. Steve is going to help us shed some light on the
recent FRREUA revocation. So, Steve, welcome back to the podcast.


Steve Badger: [00:02:45] Thank you very much,
Peter. Glad to be here.


Peter Koch: [00:02:47] That's fantastic. It's
been a little while since we've had a conversation here. So I was
really happy to I actually read some information that you sent
out about the revaccinated EUAs and [00:03:00] it sparked the
conversation for us about what they are and why they got revoked.
And I thought it would be an interesting conversation to have on
the podcast and try to get the word out about some of this. So
I'd like to start by jumping right in and define some of those
TLAs or three letter abbreviation. Let's start right with an EUA.
What isn't EUA in the first place and why are they issued?


Steve Badger: [00:03:26] Sure. And an EUA stands
for emergency use authorization is really a mechanism to
facilitate the availability and the use of medical
countermeasures such as vaccines and other medical equipment
during public health emergencies. And you see this happen rarely
they're not done frequently. But as it says in their own
definitions, that the public health emergencies, we don't have a
lot of them, but when we have them, we need to be able to use our
resources and things that are available to try to help us get
[00:04:00] beyond that. And obviously, the covid-19 pandemic has
proved to be that in more than one area, including the vaccines,
as well as the filtering Facebook's respirators. Now, under this
particular EAU, the FDA meeting, the Food and Drug Administration
is the one that issued this particular set of EUAs and they can
do, as I mentioned earlier, medical products, vaccines to
diagnose or treat or even prevent serious life threatening
diseases and conditions when there's no approved or adequate
available alternatives. In this case here, you know, we're
talking about filtering face piece respirators. And as we know
that has been a contentious issue from the beginning as to the
availability of NIOSH approved respirators.


Peter Koch: [00:04:52] Why don't we help people
understand? Because there's lots of different terminology about
respirators and some people just think a mask is [00:05:00] a
respirator or a respirator is a mask. We see we see people in a
doctor's office wearing a mask. We see people on a construction
site wearing a mask. We see firefighters wearing a mask. So when
we talk about an n-95 respirator, what are we talking about and
what's the difference between, say that and like a half face
respirator and maybe that surgical mask that you might find in
your doctor's office?


Steve Badger: [00:05:27] Great question. The
really the difference comes down to what is doing the filtering
and filtering face piece respirator. The ones that we're talking
about here, the mask itself is the filter. It's filtering out
everything that you're breathing in. The whole entire thing acts
as a filter and you know it. The same with a surgical mask is
designed to filter out throughout your whole breathing zone
everything that's there as opposed to say, you know, elastomeric
like a half face or a full face, negative pressure [00:06:00]
respirator that is fit tested. They've got it. It's got a seal
that has to seal. And then the ear that's getting to you is being
filtered through actual filters, cartridges that are designed to
filter out different types of contaminants. So there's a big
difference between those and the filtering face piece in its
function and its ability and its protective qualities. Because if
you think about a filtering face piece, it's filtering in both
directions, whereas the elastomeric respirators, the cartridges
you're breathing in, when you exhale, you're breathing out
through an exhalation valve that's not filtered. So this was one
of the reasons why these this particular type of respirator
wasn't the first and best choice when it came to the health care
professionals,


Peter Koch: [00:06:51] Because it's filtering
the filtering face piece or like a paper mask. Respirator would
filter both ways, both in the inhalation and the [00:07:00]
exhalation, as I hear you correctly.


Steve Badger: [00:07:02] Correct.


Peter Koch: [00:07:02] Now, with the filtering
face piece and especially the n-95 respirators, some of the
similarities beyond the filtering on the inhalation, they do have
to be fit tested, is that correct, the n-95 respirators?


Steve Badger: [00:07:18] Yes, that is correct.
They do have to be fit tested. And the initial people that are
first using these things, it was absolutely mandated that
everyone had to be fit tested before they could wear them and
they had to get a medical approval before they could even do the
fit testing to make sure that they were physically capable of
wearing these respirators with the people that had already been
fit tested. And maybe they've been beyond that year from the
initial time that they had been tested. They were given a, I will
say, a waiver, but an extension so that they did not have to get
that additional fit test within that year, that they as long as
they were using the same type and brand of filtering [00:08:00]
face piece respirator, that they could extend that fit test
beyond that year deadline.


Peter Koch: [00:08:07] Oh, good. So that that
actually took some pressure off the numbers of people that would
have to be tested for an n-95 or one of the respirators that
would have been covered under the EUA originally. Now what's the
biggest difference between that filtering face piece and say like
the surgical mask that you might see in the doctor's office or
the dentist office?


Steve Badger: [00:08:34] The largest difference
really comes down to the pore size. And when we talk about pore
size, we're talking about what is the maximum, you know,
filtration of that particular respirator or in this case,
surgical mask. Now, with the filtering face piece, we know that
it will filter out 95 percent of the particles at a certain size
and which is which is a very good filter, a very good filter, 95
percent, [00:09:00] as opposed to a surgical mask, which really
doesn't have the small enough pores to prevent the viruses from
actually getting through that. And they're not fitted as well so
that people, if they don't have them appropriately put across
their nose or across their face, there's still gaps in them that
can allow the escape of the of the virus.


Peter Koch: [00:09:24] Good. So that makes sense
then why someone who would be required to say treat or come into
contact with someone who might have covid-19 needing to wear that
n-95 mask instead of just the surgical mask? But, you know, there
again, that's the requirement, higher level of protection,
especially when there's a significant exposure. And then for
everyone else, when there's other options for us to go out there.
That's why that cloth face mask or even a surgical type mask
would be functional for someone of the public [00:10:00] who
maybe isn't required to come into contact with someone who has
covid-19, I remember early on masks, you couldn't find them, you
couldn't find n-95 mask's anywhere. And I know just outside of
the covid-19 pandemic, I mean, respirators are used in industry
all the time for particulate respiratory protection, chemical
respiratory protection. There's many reasons why you might use an
a 95 respirator and you couldn't find them. You just couldn't
find them anywhere. So I guess this is a good time to maybe talk
a little bit about the history here and to get a better
understanding of why the EUAs were issued in the first place. So
we did talk about the FDA, the federal Food and Drug
Administration, and they are in charge of approving medical
products and vaccines for use, and especially when it comes to
the medical industry themselves to be approved for [00:11:00]
medical use. It's not just, say, NIOSH. Correct. So if I'm going
to use a respirator, an approved respirator for medical use,
NIOSH isn't the only organization that will approve that
respirator for use, is that correct? That needs to be the FDA.


Steve Badger: [00:11:17] Well, it is the NIOSH
does the approval and how to look at this is that they do the
testing, they do the approval. And then the FDA says, OK, based
on the NIOSH testing and approval, we will accept these
particular respirators.


Peter Koch: [00:11:35] Gotcha, I think that's a
that's a good point for qualification there. So NIOSH still doing
the testing. And then the FDA is saying that these are the group
of respirators that are going to be functional for a health care
setting. Awesome. All right. So let's look more about the
historical context. And if we all remember back to the start of
the covid-19 pandemic, which seems like forever [00:12:00] ago,
but it wasn't all that long ago, actually, that the virus was
determined to be transmitted through the air and into the
respiratory system via the droplets expelled when an infected
person coughed, sneezed or they spoke. What wasn't really well
understood then was how a mask could protect you and why someone
in a health care settings should wear an approved n-95 mask and
someone not in health care could wear a mask that wasn't
approved. So let's talk a little bit about what an n-95 is and
then what makes it approved and then we'll get into the timeline.
So Steve, take us through what an n-95 respirator n-95 mask is
and what makes it approved versus a mask that might not be
approved.


Steve Badger: [00:12:41] You know, certainly the
n-95 respirator is exactly what it sounds. It's designed to
filter out 95 percent of the particles within its range, what
it's approved for. And so, you know, when we take a look at
what's on the outside of the respirator [00:13:00] and what gets
inside, it's designed to filter out 95 percent. And that approval
process, as we mentioned earlier, is done by NIOSH, the National
Institute of Occupational Safety and Health. And they do a lot of
testing on these respirators and they put them through their
paces to make sure that they really are what the manufacturer
tells us they are and that they're going to, you know, meet those
standards. Now, to take that one step further, these n-95
respirators, which were, you know, being approved obviously very
quickly, the supplies of these got used up. And so they started
looking at these different alternatives as to, OK, maybe these
aren't approved yet, but there are respirators out there that
have been through other trials, through other organizations
throughout the world that may be good enough to be able to
provide some protection for the health care professionals.


Peter Koch: [00:13:58] Oh, all right, I
[00:14:00] think I understand so NIOSH is going to approve an
n-95 respirator based on their testing and it has to meet a
minimum qualification for the for filtering out 95 percent of a
certain size particle or particles above a certain size. But
there are other organizations I know Canada has their own
organization and other countries have their own certification
organizations for different types of personal protective
equipment. So but it might not be the same testing method or it
might not be they might not have the same standard possibly that
NIOSH does so when the supply got short. Am I correct that
businesses started to look for other supply chains that might not
be approved by NIOSH? Am I correct in that?


Steve Badger: [00:14:50] Absolutely, that is
correct. They started looking outside of the U.S. because of the
fact that the U.S. supplies fell [00:15:00] behind very quickly.
And so they started looking at countries that everywhere from,
you know, Vietnam to New Zealand to places Europe, Italy, that
that had companies that were creating respirators that met their
standard for it would be an n-95. But they had not yet approved
them for use in the United States.


Peter Koch: [00:15:24] Very good. So that that
sets up kind of sets up a challenge. Right. So as your safety
person at the hospital or OSHA or the FDA are going to say, these
are the things that you have to use, the companies might not have
enough of those things. So they go look someplace else, find
other respirators that meet a certain standard, but not the NIOSH
standard. So now there's a challenge there. There are companies
that are trying to protect their workers, but there aren't enough
of the NIOSH approved [00:16:00] n-95 filtering face pieces to go
around. So the FDA takes the next step. And I'm expecting that's
the emergency use authorization, correct?


Steve Badger: [00:16:12] Correct. You know, any
time that there is an emergency use authorization, there has to
be some reasoning behind it. And for this case here, you know,
they gave three main reasons as to why they wanted to implement
this. And, you know, first of all, it was the sars-cov-2 virus
that causes covid-19 causes serious life threatening disease.
There was no question about that at this point, including severe
respiratory illness. The second reason was that based on
scientific evidence available to the FDA, that there was some
benefit of using these filtering face piece respirators, even
though they were not NIOSH approved. And third of all is that,
you know, there just wasn't any other available alternatives.
There was just nothing else out there that was in the pipeline
that could possibly [00:17:00] take the place of that or help
supplement that. So this is why the FDA decided that this was a
good time to implement this particular EUA.


Peter Koch: [00:17:13] That's great. And as I
understand it, too, there were multiple or at least there were
two EUAs that were issued. So talk to us about the first EUA that
was issued and then we can talk about the second one.


Steve Badger: [00:17:26] Sure. The first EUA was
the imported NIOSH Non-NIOSH approved disposable filtering face
piece respirators, and that one really covered respirators that
were made outside of the United States everywhere but China. And
we'll talk about a little bit about that in the second one as to
why they separated those. But this particular one this first one
was for every other country, the Italy, the Australia, the New
Zealand that were making respirators that had not been previously
[00:18:00] NIOSH approved. And within that EUA, they had what's
called exhibit one. Exhibit one was the list of approved
filtering face piece respirators that could be used by health
care professionals under this EUA.


Peter Koch: [00:18:17] Ok, so once that EUA was
issued, they had a list of all the different respirators. So the
health care community could go out and choose from that list.
They couldn't find NIOSH approved filtering face pieces. They
could then look at which ones were then being approved through
the emergency use authorization. That's cool. So that list one
was a pretty critical list for people to have get their hands on.
And then I think it was still hard to find some of those. And
then there was another EUA that was issued and you referenced
that earlier. That was the one for respirators manufactured in
China. So can you talk a little bit about that one?


Steve Badger: [00:18:56] Yes. The first EUA
approved about 50, [00:19:00] I believe it was 54 different types
of respirators from different countries. And as we talked about
the use and the need and far outweighed the number that were
available. So the second EUA was issued in October of 2020, and
that was for respirators that were constructed in the country of
China. Now, that particular list was also quite extensive and
they actually had about 200 approved respirators that went into
Appendix A of that EUA that were approved from that point that
the EUA was initiated. So now they've brought in the they had the
rest of the world will say in the. First, the EUA and then China
and their respirators were the second EUA.


Peter Koch: [00:19:55] Right, and so through
your reading, were you able to determine why they had a
[00:20:00] separate EUA for the respirators made in China versus
the ones that may have been made in the other parts of the world?


Steve Badger: [00:20:07] There's been nothing
that I've been able to find in the reading that would indicate
why? You know, there's a lot of conjecture out there as far as,
you know, thinking about the fact that, you know, early on they
thought that maybe, you know, they wouldn't have to go to that
extreme to get enough respirators available. But, yeah, there's
definitely nothing in writing that I've been able to find that's
indicated as why it was separate after the fact. You know, when
we talk about here later on, but after the fact, it became
obvious that there were a lot of knockoffs and a lot of, you
know, fake respirators that were being sent in, ones that weren't
nearly close to approval. And so, you know, after the fact, they
started, you know, weeding out those pretty quickly when they
started testing them.


Peter Koch: [00:20:59] Yeah. [00:21:00] So I do
remember some of that information coming through. There were a
number of respirators that were packaged to represent themselves
as being NIOSH approved or had the OSHA seal of approval, which
isn't a thing. You know, she doesn't approve those. They just say
you're supposed to wear a particular type of PPE. And then there
were some testing information that was placed out there, too,
about how the NIOSH respirators and respirators made in other
parts of the world and even some of those in China did come it
did come very close to meeting that NIOSH standard over the
samples that they had. But there are others that didn't do it at
all. And so part of the approval, as I see it, is how I've come
to understand this as a safety professional is one of the reasons
that you want in a third party testing and approving is because
it provides you with some information about [00:22:00] the
minimum amount of protection that you're going to get. So if you
buy something that's going to have the stamp of approval on it,
you should you should be able to feel comfortable that it will
that it will protect you at this particular level. And so then if
you take that protection level and then you look at what you're
trying to be protected from, if they match up and you use it the
way it's supposed to, you have managed the hazard or exposure to
that hazard in a good way. But if it's not going to meet that
base level of approval, then it may very well put you at greater
risk if you're going to use something that that doesn't have that
minimum level of protection.


Peter Koch: [00:22:42] Let's take a quick break,
integrating workplace safety into your business is a key part of
the long term success of any company. And like most components of
success, there is no one size fits all solution. MEMIC is
committed to partnering with employers across all industries for
workplace [00:23:00] safety. And we recognize the key to that
partnership is understanding the unique demands of the industries
that we ensure our safety experts bring experience from the
industries that they serve. And this experience provides a unique
perspective through a critical eye when it comes to understanding
the particular exposures and challenges of an industry from
construction, retail and manufacturing to hospitality and health
care. Our team of experts will work with policyholders to
identify opportunities to improve safety. Interested in finding
more about MEMIC, check us out at MEMIC.com. Or better yet,
contact your local independent insurance agent for more
information. If you're already insured by MEMIC, then check out
our safety resources at MEMIC.com/workplacesafety and sign up for
access to our video lending library, our LMS platform or our
Safety Director Resource Library. Now let's [00:24:00] get back
to today's episode.


Peter Koch: [00:24:04] I think as we as we start
to look at the EUAs this, you know, the podcast is pretty short
today. There is a pretty focused topic. There's not a ton that we
need to go through. But we learned about what an EUA is, what the
FRRs are, who does the approval process, who issued the emergency
use authorization in the first place and why. Now, let's talk
about the well, the title of the podcast is that they have been
revoked or the EUAs have been revacated. So why were the EUAs
revoked here? Why did the FAA pull the EUAs for those filtering
face pieces?


Steve Badger: [00:24:48] Yeah, looking at, you
know, the beginning of this, where they were authorized, the EUAs
were issued from that point on, we had a list for [00:25:00] the
exhibit one and also for Appendix A for the second. And that list
of respirators were really, you know, for lack of a better term,
we're really unknowns. And so what NIOSH did was they started
doing testing on these particular filtering face piece
respirators to see if they met the n-95 standard that 95 percent
filtration. And so the process that they would go through is they
would take ten samples that were sent to them by the
manufacturers. They would test them and come up with an average
filtration. And so as they started going through and doing these
testing, they found out early on that there were many that either
didn't make it or that were very bad respirators that they could
tell that they were bad, they tell that they were they were the
fakes, that they were the fraudulent ones. And so what they did
was they started [00:26:00] eliminating some of these from that
list, from that approved list and a couple of different times
during 2020, they took some of these out, started weeding them
down to the ones that actually that they could say would filter
out 95 percent. Now, it's important to note at this point that
this did not give them a NIOSH approval. OK, what all this did
was that NIOSH did this testing and that they were able to say
that in this testing that it did reach that 95 percent. So none
of these respirators were able to gain NIOSH approval numbers
from this particular testing. So as time went on, the
manufacturers that NIOSH had approved previously started catching
up on the numbers of respirators that were being in demand as the
pandemic, you know, slowly started coming down and the number of
cases and the health care workers were able to better protect
themselves with NIOSH respirators. [00:27:00] These lists, this
Appendix A and exhibit one, they started becoming less and less
important. And so in the end of June or actually towards the end
of June, the FDA decided to revoke both of these EUAs, meaning
that these respirators are no longer approved for use by health
care professionals.


Peter Koch: [00:27:25] And that's another
interesting point to note, that the lists were kind of live. So
the Appendix A. And the list one, as NIOSH started testing, they
actually eliminated some of the respirators from those list. Is
that correct? Did I hear that correctly?


Steve Badger: [00:27:43] Yes, they did, they
initially they eliminated from the second EUA, the ones from
China there was about I want to say it was about 75 respirators
that did not meet the first cut right out of the gate. And there
was a there was several from [00:28:00] the first the UK from the
European and other nations that were creating them. And so they
were slowly, you know, they would get several of these on that
list and they would eliminate them. And so they would, you know,
say, OK, from this point on, from this date on, these are no
longer part of this EUA and therefore the health care providers
should not be using these.


Peter Koch: [00:28:23] Yeah, and I think that's
a good point, because if this ever does happen again and another
EUA is issued for non-NIOSH approved filtering face pieces that.
The purchasing groups for these health care organizations need to
understand that, unfortunately, we can only work as fast as we
can work and that those lists could be live. So are the lists
will be live. And as more testing gets done, those lists might
change. So it's important to go back to those lists on a regular
basis, work with your suppliers to make sure that you have
[00:29:00] you're working off the most accurate list and you're
getting the equipment that's best suited for your for your
workers. So we come to the end and the EUAs are revoked and what
I'm hearing, Steve, is that you're saying because manufacturing
picked up enough with the NIOSH approved n-95 respirators, that
that there are enough now to go around to outfit the needs of our
health care professionals. So that's really the reason why they
were revoked, because there wasn't a need for emergency use
anymore. We were able to use the approved respirators in most
cases. Is that correct?


Steve Badger: [00:29:43] Yes, it is correct and
you know, and obviously there's a couple of reasons for that. I
mean, one, we don't have the certainly have not had the number of
cases that we had initially early on, you know, and also, you
know, we have to think about respirators as they are. They're the
last [00:30:00] line of defense. And so when we think about, you
know, you know, hazards and controls that, you know, the controls
that have been put into place have also helped eliminate a lot of
these potential exposures to the point where maybe not as many
respirators are needed to be used because they are that last line
of defense. And therefore, you know, if something happens to
them, the respirator fails, that person could still be exposed.
So we want to try, you know, to eliminate those hazards initially
before you get to that respirator point.


Peter Koch: [00:30:32] Very good now. All right.
So the EUAs are revoked the non NIOSH approved respirators are no
longer approved for use in a health care setting. What do I do,
I've got maybe a stockpile of respirators that were once approved
by the EUA and they're no longer functional or at least no longer
proved to be used in a health care setting. So does the FDA have
[00:31:00] any recommendations going forward?


Steve Badger: [00:31:03] Yes, they do. They have
several recommendations for the stockpiles of these things
that  they're assuming that are out there for the health
care professionals. And just because these respirators are no
longer a part of this EUA, doesn't mean that they can't be used
for other purposes outside of the health care organizations that
you could, you know, actually, you know, redistribute these
through, you know, into non health care settings, such as, you
know, construction or even general industry? You might be able to
you know, they offer the suggestion that maybe you could donate
them to other countries or other places where approved
respirators are still in very short, you know, short quantities
as they're very much in demand. They also, you know, tell us that
we may even consider, you know, holding on to them to [00:32:00]
be used for other purposes so that's where they've kind of left
it with us, that we don't want to just, you know, we just don't
want to throw these things away, that there are other uses for
them. And I think that's very good advice.


Peter Koch: [00:32:12] Yeah, I think it's great
advice as well. So just because you have a resource, make sure
you're using the resource appropriately just for that health care
setting of if I'm a health care professional and I'm going to be
exposed to someone who potentially has covid-19, I want to make
sure I'm protected. So you want to make sure you're using that
NIOSH respirator. And since you should be able to have sourced
enough of those for the exposure potential that that is out there
now. But like you said at the end, there again, it's a good idea.
As we you know, we look at where we are currently and there's
starting to be an uptick in cases, an uptick with the Delta
variant and maybe some other variants that are coming down the
road. It's [00:33:00] always good to be prepared. So we don't
want to be in a place again where we're scrambling to find
respirators. We want to make sure that we have things in stock.
So, you know, good advice, use it or do with those stockpiled
respirators, what you, as your company feels is going to be the
best use for them. And if that is a donation grade, if that's
moving them to a different industry, fine, too. If that is
holding on to them just in case, that's not a bad idea either.
So, Steve, why don't we try? So we learned a lot today in a very
short time. And I think most of it is kind of clearing up some of
those three letter abbreviations like EUA and FRR and even some
larger abbreviations like NIOSH or CDC. So why don't we take that
sentence those two sentences we had in the intro and let's try to
add the actual words that come up and see if it makes any more
sense to us. So here we go. Early [00:34:00] on in the sars-cov-2
or Severe Acute Respiratory Syndrome coronavirus two pandemic the
Food and Drug Administration as a Department of the Department of
Health and Human Services created the filtering face piece
respirator emergency use authorization for health care providers.
They did this in conjunction with the National Institute for
Occupational safety and Health, or NIOSH and the Centers for
Disease Control, or CDC, to help combat the spread of covid-19.
Now, due to the increase in availability of the NIOSH approved
n-95 filtering face piece respirators, the Food and Drug
Administration has revoked the filtering face piece respirator
emergency use authorization for health care providers. Makes a
little more sense. Still a mouthful to say, but there seems to
make more sense to that. So I [00:35:00] guess at the end here,
Steve, as you were going through the emergency use authorization,
the process and how they were revoked, is there anything else
that you want to add to that or maybe something that you found
really interesting as you were going through that?


Steve Badger: [00:35:17] Yeah, you know, I would
say that I probably one of them the most interesting things that
I found going through this was, you know, the ability of the
government organizations to be able to work together to get to
that point where these EUAs were being issued. Because, you know,
it wasn't just the FDA. They had to rely on the NIOSH group for
their testing and approval. And, you know, and that all, you
know, in conjunction with the CDC, the Centers for Disease
Control, that they had to all work together to make this work.
And I think that that's the part that really drove home to me.
The point that, you know, when we're in a crisis and these things
happen, that these people can work together, that they can, you
[00:36:00] know, do you know the right thing and get these things
out to people and in a big hurry. I mean, this was these are not
something that typically happens overnight. And in this case,
here it did. These were given this temporary approval and this
emergency approval. And so they were they were able to help that
health care professionals out of a very tough position.


Peter Koch: [00:36:26] Yeah, I think that's a
really good point. The working across departments at the federal
level can be challenging at times. And they definitely
collaborated well together and came up with a with good response
for a very, very challenging situation for sure. So, Steve, if
someone had more questions about the FDA or and or the emergency
use authorizations, something happens in the future. They see
something over the Internet that there was a new EUA or they want
to learn more about these [00:37:00] EUAs in particular, where
would they go for more information?


Steve Badger: [00:37:05] Certainly the Food and
Drug Administration, the FDA has a website that you can go on
and, you know, you can look and search for EUAs under that
website and it will bring up all of them. And they're, quite
frankly, right now there's quite a few of them out there for
different types of medical processes and procedures. And also the
vaccines, the very vaccines that we're taking to prevent covid
fall under these EUAs. So you kind of have to do a little bit of
searching through there. And the other place that I would look in
regards to the filtering face piece respirators is whether or not
the respirator that you've chosen that you have in your hand, is
it NIOSH approved or not? Easy enough to go on to the NIOSH
website and actually determine that you can do a search and look
to see which respirators are really approved? You know, it's not
just stamped [00:38:00] on the box from, you know, someplace, you
know, out of nowhere that you can actually make sure that that
thing is actually what it says that it is so that you're getting
that protection factor that you're expecting.


Peter Koch: [00:38:12] That's a great point. And
to not all, you know, don't always trust the packaging. So if
you're looking to purchase n-95 respirators, a  good idea is
to double check them against the list there for the NIOSH
approved respirators. And you'd find that you said right on the
NIOSH site or is that the FDA site, Steve?


Steve Badger: [00:38:33] You would find it on
the NIOSH site for which respirators are approved and they will
be given approval number. And you can determine that, you know,
from that list is whether or not that one you have in your hand,
if it's NIOSH approved, it's going to have a number associated
with it that matches up with that NIOSH site.


Peter Koch: [00:38:53] Very good. And most of
your reputable distributors are going to be familiar with that
and be able to help [00:39:00] you if you're purchasing PPE for
your organization, whether your health care or not, they should
be able to work with you and then know what's approved and what's
not approved. And if you ask them questions, is it on it? What's
the number they should be able to give you that. So if you're
wanting to double check, you can always ask those questions of
your supplier. All right. Very good. Steve, thanks so much for
coming on and sharing your expertise with us today.


Steve Badger: [00:39:27] You're very welcome,
Peter. Thank you for having me.


Peter Koch: [00:39:29] Excellent. We'll have to
bring you on again and talk some more about respirators. I, I
know we've been chatting back and forth about a podcast, around
respiratory Protection, and it's a pretty enormous topic. And
we've got to kind of whittle it down so we can fit it in within
our podcast format here. So we'll have you back on again. And I'm
looking forward to speaking with you.


Steve Badger: [00:39:50] Thank you.


Peter Koch: [00:39:50] Perfect. So thanks again
for joining us. And to all of our listeners out there today on
the MEMIC Safety Experts podcast, we've been speaking with Steve
Badger, safety management [00:40:00] consultant, with a MEMIC
about the Food and Drug Administration's revoked emergency use
authorizations for filtering face piece respirators. If you have
any questions or would like to hear more about a particular topic
on our podcast, e-mail me at podcast@MEMIC.com. Also, check out
our show notes at MEMIC.com/podcast, where you can find
additional resources and our entire podcast archive. Did you know
we've had more than 50 episodes so far and we're still going
strong and hope to do another 50. And while you're there on the
website, sign up for our safety net blog so you never miss any of
our articles or safety news updates. And if you haven't done so,
I'd appreciate it if you took a minute or two to review us on
Stitcher, iTunes or whichever podcast service that you found us
on. And if you've already done that, thanks, because it really
helps us spread the word. Please consider sharing this show with
a business associate friend or family member who you think will
get something out of [00:41:00] it. And as always, thank you for
the continued support. And until next time, this is Peter Koch
reminding you that listening to the MEMIC Safety Experts podcast
is good, but using what you learned here is even better.