Revoked EUAs with Stephen Badger

<p>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.</p> <p> </p> <p> </p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Steve Badger:</strong> [00:02:45] Thank you very much, Peter. Glad to be here.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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,</p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Steve Badger:</strong> [00:07:02] Correct.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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?</p> <p><strong>Steve Badger:</strong> [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.</p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Steve Badger:</strong> [00:39:27] You're very welcome, Peter. Thank you for having me.</p> <p><strong>Peter Koch:</strong> [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.</p> <p><strong>Steve Badger:</strong> [00:39:50] Thank you.</p> <p><strong>Peter Koch:</strong> [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.</p> <p> </p>