FDA Webinar

Moderator: Irene Aihie

07-21-20/12:00 pm ET

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FDA Webinar Series - Respirators for Health Care Personnel 

Use During the COVID-19 Pandemic

Moderator: Irene Aihie

July 21, 2020

12:00 pm ET

Coordinator: Welcome and thank you for standing by. For the duration of today's 

conference, all parties will be in a listen-only mode until the question-andanswer session of the conference. At that time, you may press star 1 on your 

phone to ask a question. I would like to inform all parties that today's 

conference is being recorded. If you have any objections you may disconnect 

at this time. I would now like to turn the conference over to Ms. Irene Aihie. 

Thank you, you may begin.

Irene Aihie: Hello and welcome to today's FDA webinar. I'm Irene Aihie of the CDRH's 

Office of Communications and Education. Welcome to the fourth CDRH 

webinar. In our webinar series on the topic of respirators for health care 

personnel use during COVID 19 pandemic. Today we will be joined by 

experts from FDA Center for Devices and Radiological Health. And

colleagues from Occupational Safety and Health Administration and the 

Centers for Disease Control.

During this webinar, representatives from the FDA and CDC and OSHA will 

answer questions from webinars attendees in open questions and answer 

format. Following a few opening remarks, we will open the line for your 
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questions related to information provided during today's discussion. 

Colleagues from both CDC and OSHA will join us to assist with the Q&A.

Now I give you Doctor Suzanne Schwartz, acting Director of CDRH Office of 

Strategic Partnerships and Technology Innovation.

Dr. Suzanne Schwartz: Thank you. As Irene mentioned, this is the fourth session in our 

biweekly webinar series on PPE where we're continuing our discussion on 

respirators for use by healthcare personnel during the COVID-19 pandemic 

response.

Thus far we've covered a broad overview of the landscape, a presentation of 

FDA imports, as well as a briefing on the CDC NIOSH International 

Respirator Testing program. And most recently, the July 7 session focused on 

the decontamination of respirators.

Today we're going to change things up a bit. Rather than starting with a 

formal presentation and then shifting to operator facilitated Q&A, we're going 

to hold the entire session as a town hall-style. We'll kick things off with 

frequently asked questions that FDA and CDC NIOSH have accrued over the 

past months. And then we'll turn to the operator for live Q&A.

I'm pleased that our partners and colleagues from CDC NIOSH and OSHA are 

on the line as well, and will be fielding questions relevant to their respective 

agency’s work.

We'll start with a few questions that have come into the FDA and to NIOSH 

and while we go through these questions, Irene - can we display the slide that 

has the links to resources for all three agencies?
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So again, I'm going to start with a few questions that have come into FDA 

over the past weeks or months that are common. And we'll start with the 

following: Do the existing EUAs cover non-healthcare uses of 

decontaminated respirators? And the answer to that is: No. The existing EUAs 

do not cover non-healthcare uses of respirators. They are specific in covering 

the scope, which is decontamination of respirators for use by healthcare 

personnel. To add a use outside of healthcare, an amendment would be 

necessary to an existing EUA from the EUA holder.

Another question: What modes of decontamination have been authorized thus 

far, and what are the scientific considerations for review of the various 

modes? The answer is: FDA has authorized EUAs for respirator 

decontamination using several methods. The majority use vaporized hydrogen 

peroxide. One authorization uses moist heat. Another uses hydrogen peroxide 

and ozone. It's important to note that the safety and effectiveness of a 

decontamination method varies, not just by the modality, but also by the 

specific device used and even by the specific settings or cycles within a 

particular device or decontamination system. Please refer to the guidance that 

we published. And note that there are three tiers of decontamination claims 

that are presented in that guidance.

The third question: Is there an EUA for US manufacturers that do not have 

NIOSH approval? And the answer to that is: US manufacturers need to obtain 

a NIOSH approval in order to be covered under the NIOSH-approved airpurifying respirator EUA.

Fourth question: If my product appears on the NIOSH International 

Respiratory Assessment with a filtration efficiency for all the respirators of 

greater than or equal to 95%, am I automatically added to the FDA EUA? And 

the answer is: No. You would need to submit information to FDA 
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demonstrating that you meet one or more of the EUA eligibility criteria.

I'm going to now move on to a few questions that have come into NIOSH, as 

well, as a sampler. So, the first question is: Can a NIOSH-approved respirator 

with an exhalation valve be used as source control? And I'm going to ask 

Colleen Miller if she could provide a response.

Colleen Miller: Hi, thank you, Suzanne. Respirators with exhalation valves provide protection 

from COVID-19 for the individuals wearing them, but they may not prevent 

the spread of the virus from the wearer to others, as a source control. Until 

data are available to demonstrate the extent to which respirators with 

exhalation valve also slow the spread of the virus from the wearers to others, a

respirator without an exhalation valve should be worn when both source

control and respiratory protection are required. If only respirators with 

exhalation valves are available, the exhalation valve should be covered with a 

surgical mask, a procedural mask or a cloth face covering that does not 

interfere with a respirator fit - when the individual is unable to maintain social 

distance from others who are not wearing respiratory protection.

Dr. Suzanne Schwartz: Thank you Colleen. Another question: Does decontamination 

extend the life of a respirator? And I'm going to ask if Ed Fisher is available 

from CDC NIOSH to provide a response.

Ed Fisher: Sure, thank you. Does decontaminates extend the life of a respirator? Well, 

there are many factors that can limit the life of a respiratory including fit, 

filtration performance and the presence of pathogens trap on the FFR which 

can present the cross-contamination hazard. FFR decontamination will reduce 

or eliminate the risk of cross decontamination, but it will not increase the 

number of times or hours that an FFR can be worn. FFR performance will 

decrease as the number of hours of use and number of times (unintelligible) 
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increases. The number of times the FFR to be reused would likely be limited 

by fit because the coverage can become weaker or stressed after each time is 

placed on the face of the user.

Manufacturer guidance on how many times an FFR can be gone is not 

available. The CDC recommends limiting the number of users to no more than 

five per device. This recommendation is based on limited data per FFR fit 

over multiple bodies.

Fit performance during limited reuse which may include decontamination 

should be monitored by the respiratory protection program manager or 

appropriate safety personnel. Thank you. 

Dr. Suzanne Schwartz: Thank you very much Ed.

So why don't we go ahead now and turn to the live Q&A. Operator, may I 

have the first question, please?

Coordinator: Thank you. As a reminder for those on the phone, if you would like to ask a 

question, please press star 1 and record your name. Your name is needed in 

order to introduce your question. If you choose to withdraw your question, 

please press star 2. Again, if you would like to ask a question, please press star 

1. It will take a few moments for questions to come through. Please stand by.

The first question will come from and allow me to announce the name.

(Greg Ounion): (Greg Ounion).

Coordinator: Your line is open.
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(Greg Ounion): Hi, I've got a question and this might be for a combination of the hosts there. 

First, CDC recommended guidelines for extended use of N95 respirators. It 

seems there's a fair amount of anecdotal evidence that suggests the health care 

professionals are now routinely using their N95 respirators for eight hours or 

more for an entire shift. My question is assuming that an aerosol-generating 

event or other obvious soiling of blood or other bodily fluids, et cetera does 

not exist on the outside of a respirator, subjects extended use by definition, 

when does that respirator become quote-unquote soiled masks, considering 

this load of sebaceous secretions and facial oils?

Dr. Suzanne Schwartz: Thank you very much. I'm going to turn to our NIOSH colleagues. 

I don't know if it’s Ed that wants to address that, or Colleen.

Colleen Miller: I would actually -- this is (Colleen). I would appreciate it if Harold, Jonisha or 

Ed could answer this question.

Dr. Suzanne Schwartz: Okay.

Ed Fisher: This is (Ed). So, I think the extended use currently we recommending 8 to 12 

hours of use. Again, I'm not sure I mean if it's obviously visibly soiled, though 

we would say you should discard the mask. As soon as you notice that it is 

soiled. But, you know, we have an 8 to 12-hour recommendation for the 

extended use you affirm that addresses specific for this question.

(Colleen Miller): I would also consider user instructions as well.

(Greg Ounion): Okay, thank you.

Dr. Suzanne Schwartz: Can we have the next question, please?
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Coordinator: The next question comes from (Jessica), your line is open.

Jessica: I have two questions. One is that I have a really hard time justifying throwing 

away a perfectly good N95 mask because it's been on and off five times,

especially if it has been left in the bag for five days and it's supposed to be 

decontaminated. And then my second question is that I was reading yesterday 

on the CDC Web site where they were saying that if you've been using a mask 

in an aerosol-generating situation that it should be discarded. And we have 

been having many people that were, you know, either unknowns or nebulizer 

aerosol treatments. You know I worried that (unintelligible) throw away every 

time that you've been in a room with aerosol treatment. Thank you.

Dr. Suzanne Schwartz: All right, thank you for that. I think this question goes back to 

NIOSH again regarding the recommendations regarding repeated usage.

(Ed Fisher): Yes, so the recommendation for five times is based on a study that looked at 

most of the FFR. You know, over the model, most models (unintelligible) to 

perform sufficiently for five (dawnings). Obviously, there were some models 

that performed fine after five (dawnings) and, you know, up to 20 (dawnings). 

But that was a limited number of models. And some FFR models weren't 

unable to perform up to five (dawnings). So, this recommendation is based on 

what we thought would provide the safest, a little bit of security and the 

number of dawning these respirators can be used. It's a recommendation. If 

these respirators are able to perform and fit after five (dawnings), obviously, 

we would encourage people to use those. But those should be assessed by the 

respiratory program manager or some other safety personnel.

And I apologize. The second part of the question.

(Jessica): The second part of the question was that I was reading about how on the CDC 
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they were saying that N95 should be discarded in situations and one of them 

was after an aerosolized treatment. And my question here is you have like 

several patients and they are just unknown, or negative test and you’re going 

into an aerosol treatment situation, are you supposed to then discard that after 

every single time that you're in the room with this treatment?

(Ed Fisher): We would recommend that you discard the respirator after an aerosolgenerating procedure. That just based on trying to limit the risk, reduce the 

risk of self-contamination. Assuming that aerosol during a procedure is 

creating a highly concentrated aerosol with the virus (unintelligible) become 

the trap on the surface with a respirator. So that will be the reason, the only 

reason we would say to - why we recommend that you discard the record after 

aerosol during procedures.

(Jessica): Well I understand that, but like, we will be discarding, a lot of N95s for that 

reason.

(Colleen Miller) We understand your concern and at this point, we can certainly take it forward 

to our CDC colleagues that are working on the guidance and ask them if they 

can better address your question.

Dr. Suzanne Schwartz: Okay, thank you. Can you take the next question, please?

Coordinator: As a reminder for those on the phone, if you would like to ask a question, 

please press star 1 and record your name. For those asking questions from the 

net conference, please address all questions to Irene Aiher and not to the host. 

Again, to ask a questions on the phone, please press star 1 and record your 

name. The next question comes from (Joe), your line is open.

(Joe Marker): Yes, this is (Joe Marker). I'm curious to the reaction, that its ironically, it was 
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published the day of your last WebEx, which is on July 7, a test study that was 

published in JAMA. And it pertained to a revisit of the subject of 

decontamination respirators particularly using the hydrogen peroxide system. 

And, were there any comments from March to that study because they seem to 

demonstrate a significant concern about repeat decon, particularly more than 

once, actually. So, any remarks to that. I don't know if it goes to Dr. Fisher or 

whom.

Dr. Suzanne Schwartz: Thank you very much. This is Suzanne. I'm going to direct that 

question to FDA colleagues to start here and Liz Claverie, can you take that 

question?

Liz Claverie: Sorry Dr. Schwartz, I am going to ask my colleague, Dr. Clarence Murray or 

Dr. Jon Weeks if they are able to field that question for us, please.

Dr. Clarence Murray: This is Dr. Murray. So, first of all, thank you for the question. I haven't 

read the latest version, just as the update to that report, can you share a little 

bit more information and rephrase your question for me, please.

(Joe Marker): You bet. So published in JAMA, July 7 and the study was a correlation 

between N95 extended use (unintelligible) and fit failures in emergency 

departments. And they, so UCSF they did testing on 58 subjects and found to 

be a failure rate, particularly among duckbills somewhere in the range of 

70.6% after anywhere from one to four reuse or decontamination. A little less 

though in domed masks, so about 38% failure rate.

So, in both those cases. That's significantly higher failure rates compared to 

several other studies that were out there. So, I'm curious to the reaction and or 

if there’s an opportunity later to come back to that.
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Dr. (Clarence Murray): So, this is Dr. Murray. I appreciate you giving me a little bit more 

context. One other quick question that would be helpful. Did they describe 

what platform was used to do the decontamination for the hydrogen peroxide?

(Joe Marker): Not that I saw. It just simply states that they did - that's the process that they 

use. They used to qualitative (unintelligible) which has its own challenges in 

and of itself, but they did not describe the actual decontamination process.

Dr. Clarence Murray):So, this is Dr. Murray again. So, thanks thank you so much. One thing I 

would say is we will look into that. One thing I would say is that all platforms 

are not equal. So, each hydrogen peroxide has its own unique challenges. And 

so, they can range from being as gentle as a lamb to being pretty violent like 

the Tasmanian devil. And so, that would be a critical piece of information to 

understand clearly about these decontamination platforms that was used.

(Joe Marker): Understood. In fact, what I've got now is I have a group of about 50 or 60 

emergency room physicians who got their hands on to this study and they're 

adamantly opposed now to any decontamination process because they believe 

that this is a significant risk. So, I would look forward to any further remarks.

Dr. Clarence Murray):This is Dr. Murray again. I think if you would like to pose that as a 

question, please feel free to send that question into our email address that we 

have and that would be something we would be interested in discussing 

maybe offline.

Dr. Suzanne Schwartz: Dr. Ashar, I am wondering if there's anything that you might want 

to add, in addition to what Dr. (Murray) provided?

Dr. (Ashar): Thank you, Dr. Schwartz. You know, we really appreciate that question. 

When the pandemic started, we did everything that we could think of doing to 
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increase the availability of our respirators. Whether that was increasing the 

supply of new respirators or making available systems for their 

decontamination. As time has gone on, we have learned more information. 

And this report is evidence of that. And so, this is why we recommend that 

individuals need to use respirators always choose a new respirator over a 

decontaminated one, that they always self-perform a self-test to ensure 

appropriate fit. And, that they monitor--if they have to use a decontaminated 

respirator-- they monitor the number of cycles that that respirator has 

undergone for decontamination.

I think, you know, it is important to understand as Dr. Murray mentioned that 

not all decontamination systems are the same. Some of them they've been 

authorized for more decontamination rounds than others. However, as we 

know, just even without decontamination there is wear on the respirator. So 

again, we would recommend the lowest number of reuses. That being said, we 

are continually evaluating the information and modifying our 

recommendations and this study is among the things that we are considering. 

So, thank you very much for the question.

(Joe Marker): Thank you.

Coordinator: The next question comes from (Momtha Tasay). Your line is open.

(Momtha Tasay): Hi, thank you for taking my question. We have a question. Can we allow staff 

to bring in their own N95 respirators from home? And if yes what are the 

guidelines.

Dr. Suzanne Schwartz: Thank you for this question. I'm going to start off by asking our 

OSHA colleagues if you have any, you know, thoughts or considerations here, 

with regard to worker safety that would pertain to this question.
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(Andy Levinson): Sure, this is (Andy Levinson) from OSHA. So, the respirator needs to be used 

within the context of an OSHA Respiratory Protection Program, and the 

employer absolutely can allow employees to bring in their own devices, 

there's nothing that prohibits that. The only thing that would have to happen in 

that case is that the employer was making sure that when it was used in the 

context of the setting where respirators that were required, like for COVID in 

health care workplace, that the respirator was properly fitting and fit tested for 

the employee, that they were taking care of maintenance and cleaning and 

decontamination. So, the employer just think that if the employee is bringing 

it in doesn't get a pass on all of the other requirements for the rest of their

Respiratory Protection Program. But absolutely, yes that's allowable. If it’s a 

voluntary use situation where the employee is not required to wear a respirator 

but wants to and pre-COVID that was most commonly, for example, people 

who were doing cleaning and we're worried more about dust. There are very 

limited requirements in terms of just making sure that the respirator doesn't 

become a hazard, in and of itself.

(Momtha Tasay): Thank you and is this information available on OSHA website? Can you 

direct us to that link?

(Andy Levinson): Yes, you can find that within the OSHA respiratory protection standard which 

is 29 CFR 1910 134. You can find the link to that, from OSHA's website. And 

then we also have a number of frequently asked questions that are also up on 

OSHA's website.

(Momtha Tasay): Thank you.

Dr. Suzanne Schwartz: Thank you.
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Coordinator: So next question comes from (Laurie Rasul), your line is open.

(Laurie Rasul): Hi this is (Laurie Rasul), thank you for taking my question. I wanted to ask. I 

want to go back to the aerosols and procedures and discarding the N95. Is 

there any allowance for wearing a surgical mask over the N95 to protect N95 

and then throwing the surgical masks away but being able to retain the N95 

itself?

Dr. Suzanne Schwartz: Ed, do you want to take this question or anybody from NIOSH 

regards to recommendations that have been either provided on the CDC 

website or through Q&A that you've already received?

(Ed Fisher): So, you know, again, our recommendations obviously don't cover every 

situation that has been presented or you know, that arises when the questions 

come up. So again, so we recommend that the FFR are discarded when used in 

the presence of an aerosol generating procedure. But we also recommend that 

you know facial preferably in a surgical mask can be placed over FFR to 

reduce contamination. You know there's limited data on how effective that is 

especially, you know, in the presence of an aerosol generating procedure. You 

know, we expect the critical masks to provide some protection to the FFR in 

terms of limiting contaminations. But again, these are, you know, situations 

that are not covered in the recommendation and as written right now the 

recommendation is to discard the FFR.

(Andy Levinson): This is Andy from OSHA. Let me also jump in. I think one of the concerns 

about putting face masks over a respirator, particularly filtering facepiece 

respirator, is that you can deform the respirator and effect the fit of the 

respirator. For example, if somebody tied a face mask too tightly over the 

respirator. So the preference for face shields is also to reduce contact 

andreduce pressure so that the respirator sits on the face as intended, and as fit 
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tested, while still providing some barrier between the aerosol-generating 

medical procedure and the respirator.

(Laurie Rasul): Thank you very much.

Coordinator: The next question comes from (Wendy Stevenson). Your line is open.

(Wendy Stevenson): Thank you for taking my question. I was calling in regards to- of course in 

working at a hospital we have a critical shortage at this point in time of N95s

and we're not able to get additional N95s in. I'm sure that's a common 

situation. We're currently using a BioQuel machine, designed to disinfect 

rooms with vaporized hydrogen peroxide. We're using this to clean our N95s. 

Currently, we don't have a EUA for that. What would your recommendation 

be for us in the interim until we can get additional N95s in?

Dr. (Suzanne Schwartz): FDA group, Binita and others, is there a response that you’d like to 

provide to this question?

Binita Ashar: This is Binita Ashar. I can potentially address it and then turn to my 

colleagues to see if they have anything to add. So thank you for this question. 

I’m sorry to hear that your hospital is facing this dire shortage. Our 

recommendation would be that you utilize an authorized decontamination 

system over one that has not been authorized simply because the system has 

been very carefully evaluated. The critical parameters of temperature, time, 

humidity and other factors has been taken into account to justify that it 

performs a high level of decontamination.

If it’s possible for you to be able to partner with another hospital facility or 

other system where they are using an authorized system that would probably 

be something to pursue if you have that available. At this time we can't make 
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recommendations about systems that have not been authorized. And I don’t 

know do others on the FDA team have other thoughts or suggestions?

(Andy Levinson): So this is Andy from OSHA. I think the other thing that I think is important 

for you to consider is looking at other types of respirators and trying to buy 

elastomeric respirators or trying to buy powered purifying respirators and 

things that are designed to be durable and reusable as opposed to looking only 

at filtering facepiece respirators. There’s a lot more on the market than just 

filtering facepiece respirators that will probably actually help you in the long 

run manage your respiratory protection needs.

Dr. Suzanne Schwartz: And this is Suzanne just to add also reference to the conservation 

strategies or the optimization strategies that both FDA has posted on its Web 

site as well as the guidance from that, that CDC has posted in order to, you 

know, extend the use life of any single respirator. And that, you know, can 

serve as a good resource in case you have not seen those documents as yet.

Woman 1: Great, thank you.

Coordinator: The next question comes from Greg. Your line is open.

(Greg Ounion): Hi. This is Greg. I’d like to have a follow-up question on the soiled mask that 

I asked about earlier. The question is: Given extended-use respirators become 

soiled by facial secretions, by definition, how can you decon - - the efficacy 

of contact decontaminants say like HPV or any other chemical for that matter 

be assured? And can you point me to any science studies that document this? 

Thank you.

Dr. (Suzanne Schwartz): Thank you. FDA team Dr. Murray would you like to provide a 

response to this question?
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Dr. Murray: So thank you Dr. Schwartz. I think Dr. Weeks would provide a stronger 

answer than I would. Dr. Weeks?

Dr. Jon Weeks: Hi this is (Jon). So we have seen data to suggest that that soiled respirators can 

be decontaminated; and that in some cases, there are chemical reactions such 

as interactions with blood and hydrogen peroxide that would inactivate it, so 

that would not be recommended.

But we have seen that the - that peroxide is able to penetrate into the 

respirators and it adequately decontaminates respirators that have been 

inoculated. And so we are also requesting for other modalities that you 

provide evidence that demonstrates that soils presence do not interfere with 

the ability of the agent used for decontamination to prevent inactivation of 

microorganisms. So basically, we're asking for sponsors to be able to provide 

us with evidence that their mode of decontamination is not affected by soils. 

And that is something that we are concerned about and is part of our guidance.

Dr. Suzanne Schwartz: Thank you.

Dr. Suzanne Schwartz: Take the next question please.

Coordinator: The next question comes from (Monica). Your line is open.

(Monica): Hi. Thanks for taking my question. My question is can we allow ear loops to 

get N95 for our healthcare worker for COVID patients?

Dr. Suzanne Schwartz: Let me make sure I understand the question. Are you asking if 

KN95s with ear loops are okay to be utilized in a healthcare setting?
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(Monica): Yes for airborne or for COVID patients?

Dr. Suzanne Schwartz: Okay. So I will start off and then I’ll - FDA - will turn to CDC 

NIOSH as well and OSHA for that matter. All three can answer. There are -

under the existing EUA for respirators manufactured in China - there are 

KN95s with ear loops that are authorized. FDA recognizes that there are -

there can be limitations with regard to fit of those respirators as opposed to the 

N95s with head straps. And fit is, as you know, an extremely important 

consideration with regards to the functionality and the adequate protective 

barrier that the device is conferring. 

So it becomes really critical to make sure that the fit of the respirator is 

appropriate and is adequate. We have included those respirators with ear loops 

under the EUA precisely because of the shortage situation that the United 

States has found itself in, and recognize that even having these respirators 

available becomes an important medical countermeasure, if you will, in 

protecting health care personnel. In the best of all possible worlds, it’s 

preferred that the respirator be one with head straps that has an appropriate fit. 

I’m going to ask CDC and OSHA if you’d like to weigh in here as well.

Colleen Miller: Hi. This is Colleen from CDC NIOSH and, you know, I think that what 

Suzanne has just explained is right all along the way I was thinking in terms 

of how I would respond to your question. Obviously from the public health 

response perspective, CDC has included these types of devices for contingent 

and crisis need, as Suzanne explained.

From the respirator approval program perspective we are not accepting or 

prioritizing applications for NIOSH approval of devices that have ear loop

suspension because we understand that the traditional two head straps 

suspensions provide better fit so we're focusing on those respirators that we 
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can, you know, approve and get out to the market quickly and have 

confidence that will fit better. And I think now if (Andy) or my colleagues at 

OSHA have anything to follow up with please do so.

(Andy Levinson): Yes this is (Andy) from OSHA. And I think the first thing that I would say is 

particularly with respirators they must be protective. Particularly we have had 

anecdotal evidence that people are not able to fit test their workers, were not 

able to achieve a fit test of workers wearing the ear loop KN95s. And so I 

think if you’re even thinking about using that as an option, you need to be 

very careful about whether or not you’re able to achieve a fit test.

Generally, if you’re looking at a hierarchy or respirators, the ear loop KN95s 

are only slightly above essentially a facemask. So they are definitely, you 

know, we're looking at them as a lower quality alternative that would be much 

lower in the hierarchy of alternatives for respiratory protection.

((Crosstalk))

(Monica): One more thing so can we - like my question is we tried to use those for fit 

test and tried to fit test and we have like 30% failure rate on those masks for 

fit testing. So my question is we don’t really use it unless the staff is fit tested 

they would use it for a high-risk procedure. But my concerns are can we use it 

routinely for going into COVID room as non-fit tested N95 mask?

(Andy Levinson): The requirement is when you’re going into a COVID room to be wearing a 

respirator, so if it’s not fit tested you don’t know if it's providing any 

protection.

(Monica): But fit tested respirator is for aerosol generating procedure.
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(Andy Levinson): No, fit testing is for any respirator. You only know that a respirator is 

providing protection when it's fit tested. If it’s not fit tested you don’t know if 

it’s fits tightly enough to provide protection against small particles. Aerosol 

generating medical procedures are a higher risk procedure where, in general, 

the federal government has actually recommended higher levels of respiratory 

protection if possible.

(Monica): Yes so like I agree with you. So from droplet so, you know, we are using if 

it’s a droplet then you move and to fit test a KN95s mask and of its airborne 

and you’re doing aerosolize in your procedure then you move into the PAPR. 

So COVID for our local public health criteria is the droplet that contact 

isolation. So then our protocol is for any aerosolizing procedure you use fit 

tested N95 mask. But if the patient is in the room and it's is not creating any 

aerosol then you don’t really have to have a fit tested KN95s mask. 

(Andy Levinson): So...

(Monica): So is that my understanding or...

(Andy Levinson): No. So in healthcare settings when you’re dealing with people who are known 

or suspected to have COVID you’re supposed to be wearing a respirator -

period, regardless of whether you’re doing aerosol generating procedures or 

not. That patient, when they’re coughing, talking or breathing, is still 

generating bio aerosols in their room. Aerosol generating medical procedures 

are a higher level of risk because you’re doing sputum induction, 

bronchoscopy or some other nebulizer type treatment. But anywhere in a 

healthcare setting, with a known or suspected health COVID patient, you're 

supposed to be wearing a fit tested respirator and following the airborne 

precautions.
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(Monica): Well we - I mean CDC and LA Department of Public Health has not changed 

from droplet to airborne yet. I know there's some controversy in the news

lately about being airborne but the local public health and CDC has not 

changed it to airborne yet.

(Andy Levinson): Well I guess what I can say to you is if you’re in California, Cal/OSHA is the 

enforcing agency. They have their own standards that in some cases are 

actually more protective than Fed/OSHA, and you should look at what 

Cal/OSHA is directing you to do.

(Monica): Okay thank you.

Coordinator: The next question comes from (Dan Dilly). Your line is open.

(Dan Dilly): Hi (Eileen). How are you? My question relates to NIOSH specifically and 

particularly as a result of the addressing growing need for as far as for our 

staff and teams is there an expedited NIOSH procedure to approve newly 

developed and manufactured PPEs? And is there a path and intermediate path 

of PPEs that have yet to be granted with the NIOSH be approved until the 

final NIOSH process is been completed?

Dr. Suzanne Schwartz: Colleen, I think this is for you.

(Colleen Miller): Yes thank you. So to answer that second question there is no intermediate

step. We do not authorize anything to be labeled for use that has not been 

approved and received a NIOSH TC number, the TC number is the approval 

number. There is a lot of misconception out there in the world that getting a 

three-digit manufacturer code from us is somehow an intermediate step and it 

is not.
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A three-digit manufacturer code is simply the way that we follow a particular 

approval application or approval holder's application through our process and 

how we refer all their documents. It really doesn’t have anything to do with 

achieving what the NIOSH approval number is. It's just part of our process. So 

we are prioritizing existing manufacturers that are coming in with applications 

to can get more product to market soonest. And we are prioritizing new 

domestic applications particularly for air purifying particulate respirators that 

can be PAPR or APR air-purifying respirator, (half facepiece or full 

facepiece) elastomeric respirator with filters providing you know, particulate

protection.

We do have a prioritization notice out there and we're working very much 

hand-in-hand with people. We have an innovation team that’s working with 

folks that are coming in with things that are kind of outside of what we 

traditionally see because of the pandemic. So we are working to do things in 

an expedited way and we have some public health emergency approvals that 

we have posted on the certified equipment list, PHE PAPRs and filtering 

facepiece respirators. And those approvals are very specific for working with

new domestic manufacturers that started contacting us way back in March and 

April.

Dr. Suzanne Schwartz: Thank you.

(Dan Dilly): Thank you very much. 

(Colleen Miller): You’re welcome.

Coordinator: The next question comes from (Kendra). Your line is open.

(Kendra): Hi there. There are circumstances where patients often with severe disabilities 
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like spinal cord injuries have caregivers provide healthcare in their home. An 

N95 respirator is intensely needed because they may have a COVID positive 

situation and many aerosol generating procedures are being performed in the 

home while caring for that patient.

When the caregiver is employed by the patient which is often the case, not by 

an agency or a healthcare facility or entity, are there options for fit-testing of 

the N95 respirator in the field? In this case the field would be potentially a 

home environment. Are there any recommendations for getting that fit-testing 

done appropriately? 

Dr. Suzanne Schwartz: Andy, do you have any resources or directions for this questioner?

Andy Levinson: I think probably the only thing that I would suggest is that you may want to go 

to the American Industrial Hygiene Association Web site, AIHA. I believe it’s 

.org and they may be able to direct you to local industrial hygienist who could 

do fit testing. But that’s generally going to be a service provided by a third 

party, you know, private provider. That’s not something that OSHA would do.

(Kendra): Right, right potentially through a contract or something like that.

(Andy Levinson): Yes.

(Kendra): So the American Industrial Hygiene Association for resources? Excellent. 

Thank you very much. It’s been a challenging question just to find any 

information about. Thank you.

Andy Levinson: You’re welcome.

Colleen Miller: (Andy) this is (Colleen). I think a face shield is also, you know, an additional 
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good option for personal protective equipment above and beyond the N95

FFR.

(Kendra): Thank you.

Coordinator: Our last question comes from (Mike Wright). Your line is open.

(Mike Wright): Hi. This is for the OSHA representative. Under what circumstances would 

federal OSHA cite a health care employer for violations related to respirator 

use in a COVID-19 environment first? And second, has such a citation in fact 

ever been issued?

(Andy Levinson): (Mike) I think I’m going to hand this off to Dion.

(Dr. Dionne Williams): Yes I’m on the line. I’m going to take that question. So we have 

actually recently issued respirator violations. The circumstances will depend 

on what we find at the facility. For the case where we have issued violations, 

the violations were related to not providing respiratory protections for 

employees who required respirator use.

So, there are going to be some situations, specifically in healthcare facilities,

where respiratory protection might not be accessible due to shortages and so 

there might be some limitations on whether we are able to issue a violation. 

We have put out some enforcement guidance relating to the sections for which

we are providing case-by-case enforcement discretions. So, I would direct you 

to look at the memoranda on our Web page that describe some of the 

conditions under which we would provide enforcement discretion. But, we 

would look at each of these cases on a case-by-case basis and weigh whether 

or not the employer has done due diligence to comply.
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(Mike Wright): Thank you.

Dr. Suzanne Schwartz: I think we have time for one more question if the operator is able 

to provide another one.

Coordinator: One moment. We show no further questions at this time.

Dr. Suzanne Schwartz: Okay, all right. So on behalf of FDA I want to first off recognize 

all of the subject matter experts who joined us today from across our 

respective agencies from OSHA, from CDC NIOSH NPPTL and my FDA 

colleagues.

Thank you to all of you who tuned in today to the Webinar. The next session

will take place in two weeks on Tuesday, August 4 at noon Eastern. 

Announcement of the topics will be forthcoming and please don’t hesitate to 

share with us any topics of interest that you’d like to hear more about. I’d like 

to now turn the session back to Irene who will close it out.

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and 

thoughtful questions. Today’s presentation and transcript will be made 

available on the CDRH Learn Web page at www.fda.gov/training/cdrhlearn 

by Wednesday, July 29.

If you have additional questions about today’s discussion please use the 

contact information provided at the end of the slide presentation. As always 

we appreciate your feedback. Following the conclusion of today’s live 

Webinar please complete a short 13 question survey about your FDA CDRH 

Webinar experience. The survey can be found at www.fda.gov/cdrh Webinar 

immediately following the conclusion of today’s live discussion. Again thank 

you for participating. This concludes today’s Webinar.
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Coordinator: That does conclude today’s conference. Thank you for participating. You may 

disconnect at this time. Speakers, please allow a moment of silence and 

standby for your post-conference.

END