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Moderator: Irene Aihie

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FDA PPE Webinar Series: 

Updated Information on Respirator Decontamination Systems

Moderator: Irene Aihie

February 23, 2021

12:00 pm ET

Coordinator: Welcome and thank you for standing by. All lines have been placed in a 

listen-only mode for today’s presentation. The call is being recorded. If you 

have any objections you may disconnect at this time. I would now introduce 

your conference host, Ms. Irene Aihie. You may begin.

Irene Aihie: Thank you. Hello and welcome to today’s FDA Webinar. I am Irene Aihie of 

CDRH’s Office of Communication and Education. Welcome to the 14th 

CDRH Webinar in our PPE Webinar Series.

During today’s Webinar the FDA will share information about the updated 

information on respirators and decontamination systems during the COVID19 public health emergency. Representatives from the FDA, CDCs National 

Institute for Occupational Health, [excuse me] CDCs National Institute for 

Occupational Safety and Health and the Occupational Safety and Health 

Administration will be available to answer your questions. Following a few 

opening remarks, we will open the line for your questions related to 

information provided during today’s discussion. Now I give you Dr. Cynthia 

Chang from CDRH’s Office of Surgical and Infection Control Devices.
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Dr. Cynthia Chang: Good afternoon everyone and welcome. As Irene mentioned this is the 

14th session in our Webinar series on Personal Protective Equipment or PPE. 

In prior Webinars we have discussed the regulation of a variety of devices 

during the COVID-19 pandemic including Filtering Facepiece Respirators and 

decontamination systems for Filtering Facepiece Respirators including N95

respirators.

Today we will be discussing updated information regarding Emergency Use 

Authorizations or EUAs for respirator decontamination systems. Dr. John 

Weeks from CDRHs Office of Science and Engineering Laboratories and Dr. 

Anjana Jain from our Office of Surgical and Infection Control Devices will 

provide an overview of these updates.

After the presentation we will turn to the operator for live Q&A. Please note 

that we are joined by our colleagues from OSHA and NIOSH for the questionand-answer portion of the session. With that I am pleased to introduce Dr. Jon 

Weeks.

Dr. Jon Weeks: Thank you Dr. Chang. Good afternoon I’m Dr. Jon Weeks and we will be 

talking with you today about our recent updated information on respirator 

decontamination systems. Next slide please. In the presentation we will 

discuss reauthorized decontamination systems, the scopes of reauthorization, 

resources and finally we will take questions from the audience.

Next slide please. During the coronavirus disease 2019 COVID-19 public 

health emergency the FDA has authorized the use of certain devices for 

decontamination of Filtering Facepiece Respirators for healthcare personnel. 

The FDA considers decontaminated respirators as those that have been treated 

in an authorized decontamination system using an authorized decontamination 
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cycle. The decontaminated respirators should be used only when new NIOSH 

approved or FDA cleared or authorized Filtering Facepiece Respirators are not 

available.

Next slide please. We understand that during shortages of Filtering Facepiece 

Respirators healthcare personnel may not have access to new NIOSH 

approved or FDA cleared or authorized respirators. For such circumstances 

FDA has authorized through the Emergency Use Authorization the use of 

decontaminated respirators. We would like to reiterate that CDC only 

recommends for decontamination of respirators to only be used when new 

NIOSH approved or FDA cleared or authorized N95 Filtering Facepiece 

Respirators are not available.

Even during surges of COVID-19 infections we anticipate a reduction in the 

use of decontaminated respirators as there are more new respirators available. 

The ultimate goal is to get facilities back to conventional capacity strategies as 

the availability of NIOSH approved respirators increases. Please refer to 

CDC’s resources linked on Slide 9.

Next slide please. Authorized decontamination systems have been reviewed

for their ability to reduce microorganisms including SARS-CoV-2 on N95

respirators. Additionally sponsors have provided evidence to demonstrate the 

compatible N95 respirators may maintain their performance after 

decontamination.

To date FDA has authorized 14 decontamination systems for decontaminating 

of Filtering Facepiece Respirators. These systems use chemical or moist heatbased mechanisms of microbial reduction. For a complete list of authorized 

decontamination systems please refer to the FDA Web site provided later in 

this presentation.
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Since the initial authorization of these decontamination systems FDA has 

continued to receive and review information regarding the use of 

decontaminated respirators. This includes recent publications regarding fit of 

respirators donned multiple times. In light of this additional information we 

have updated our thinking regarding the number of cycles that respirators may 

maintain their integrity through.

On January 21, 2021 FDA reauthorized EUAs for certain decontamination 

systems. These included decontamination systems using vaporized hydrogen 

peroxide, steam and a combination of vaporized hydrogen peroxide and 

ozone. The EUAs were reauthorized based on additional information received 

and reviewed by FDA regarding respirator fit following decontamination. I 

will now turn it over to Dr. Anjana Jain to further discuss the reissued letters. 

Dr. Jain.

Dr. Anjana Jain: Thank you Dr. Weeks. Next slide please. Now we will be talking about the 

reauthorizations for the EUAs of the decontamination systems and the updated 

conditions of authorization. These changes were based on the FDA’s 

increased understanding of the performance and design of these respirators as 

well as based on review of additional data about device performance as it 

became available from NIOSH testing and other information on 

decontamination and reuse of Filtering Facepiece Respirators or FFRs.

The following are the changes made to the letters of authorization and 

authorized labeling. The revisions to the scope of authorization limit the 

number of decontamination cycles to four or less if the data provided in the 

EUA does not support up to four cycles. There is evidence demonstrating that 

significant respirator fit failure occurs after five donnings and doffings.
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Compatible N95 respirators should not be reused more than five times 

regardless of whether they undergo to camp contamination unless there is

explicit guidance from the respirator manufacture. If manufacturers of 

decontamination systems would like to request authorization for more than 

four decontamination cycles then respirator performance data should be 

provided to demonstrate that the respirators maintain fit and filtration 

efficiency.

A new condition of authorization is a post-authorization study to confirm that 

the authorized number of decontamination cycles remain appropriate. The 

revised letter of authorization requires that manufactures complete the study 

within 60 days which from the date of reissuance March 22, 2021 or before 

1500 compatible N95 respirators have been decontaminated whichever is 

later.

The study results must be submitted to the agency for review within 15 days 

of study completion. The post approval studies must be conducted on 

compatible N95 respirators that have been used by healthcare personnel and 

sent to manufacturers of authorized decontamination systems for 

decontamination. This is real world use data.

In general the study will include fit testing, filtration efficiency and chain of 

custody markings with a minimum sample of ten respirators. The letters of 

authorization provided detailed information on the acceptance criteria and 

protocols. We expect that the post-authorization study will provide real world 

use data with while not being overly burdensome. Additionally it should be 

noted that timely communication of the post-authorization studies results must 

be included in your authorized labeling such as the instructions for use for 

healthcare facilities, healthcare personnel and the fact sheet.
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Next slide please. Another new condition of authorization is that authorized 

labeling for decontamination systems authorized for multiple user reuse must 

instruct healthcare personnel to either receive the same model of 

decontaminated respirator for which they were fit tested or undergo fit testing 

if the healthcare personnel receives an alternate model of decontaminated 

respirator. The revision was made to ensure continued respirator fit for 

healthcare personnel who may receive a different respirator after 

decontamination.

Next the reauthorized labeling including the instruction for healthcare 

personnel and for healthcare facilities as well as fact sheets instruct healthcare 

personnel to perform an OSHA self-seal check upon donning a

decontaminated respirator. This revision is aligned with OSHA standards for 

individuals who use tightfitting respirators to perform a user seal check to 

ensure that an adequate seal is achieved each time a respirator is donned.

Lastly the authorizations were revised to exclude respirators with 

antimicrobials and duckbill respirators from decontamination. This is based on 

available evidence regarding post decontamination, fit and performance.

Next slide please. Here are several links for resources that are available to you 

for further information regarding the decontamination and reuse of Filtering 

Facepiece Respirators. The first link is for the Division of Industry and 

Consumer Education Web site to access the previously recorded Webinars on 

Personal Protective Equipment. The second link was mentioned by Dr. Weeks 

on Slide 5 when he was describing the types of decontamination systems that 

were reissued. The other links provided helpful resources on the CDC and 

OSHA Web sites.
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Next slide please. Please note that for any questions you may have after this 

Webinar may be sent via email to the address on the screen. Also for a copy of 

the presentation, transcript or the Webinar recording that may be found at the 

Website on the screen under the heading Specialty Technical Topics and 

subheading Personal Protective Equipment. We have come to the conclusion 

of our presentation and will be answering any questions that you may have 

now. Operator we would like to open the line for questions now.

Coordinator: We will now begin our formal question and answer session. If you would like 

to ask your question please unmute your phone press Star 1. Only record your 

first and last name. 

Please be advised only limit yourself to one question. Once again if you do 

have a question you may press Star 1 on your telephone keypad. One moment 

for the first question.

Dr. Cynthia Chang: Hello. This is Cynthia Chang. While we are waiting for questions from the 

audience I would like to provide an opportunity for our colleagues from 

OSHA and NIOSH to share their comments on the presentation. Let me turn 

to OSHA first. Could OSHA please comment regarding your stance on 

respirator decontamination?

Dr. Dionne Williams: Yes. This is Dionne Williams from OSHA. Firstly, let me say that the 

decontamination of single use Filtering Facepiece Respirators for reuse is 

prohibited under OSHA’s Respiratory Protections Standard. However, for the 

purposes of addressing severe shortages of Filtering Facepiece Respirators

due to the pandemic, OSHA issued several enforcement memoranda providing 

specific enforcement discretion and one of these addresses decontamination of 

single use respirators.
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Now the memos outlined some flexibility that OSHA compliance staff may 

consider when evaluating an employer’s noncompliance with OSHA 

standards under crisis capacity scenarios. It should be made clear that OSHA 

has not waived its requirements and any discretions that are described in 

OSHA’s memoranda, including those related to decontamination of single use 

respirators, are intended to be time-limited and applied on a case by case basis 

and they’re applicable only under crisis situations. 

So, as Dr. Weeks mentioned in his presentation, where new respirators are 

readily available OSHA’s enforcement discretions are not in effect. Thank 

you.

Dr. Cynthia Chang: Thank you very much. Now I would like to turn to NIOSH. CDC has 

described different capacity strategies for optimizing the supply of N95

respirators and indicates that respirator decontamination is a crisis strategy. 

Can you please describe these strategies and what considerations healthcare 

organizations should take into account to determine which strategy is 

applicable to them?

Ed Fisher: Sure I’d be happy to do that. That’s - this is Ed Fisher with NIOSH. So the 

CDC developed the framework and it’s based on surge capacity to help the 

healthcare facilities plan for surges in demand for hospital-based services 

during the COVID-19 pandemic.

And surge capacity is comprised of three levels you have conventional which 

was talked about, contingency and crisis capacity strategies. It’s important to 

note that each of these levels have an engineering, and administrative and PPE 

controls, you know, but I’ll keep it to the PPE and specifically the respiratory 

protection and N95s.
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So the first one is conventional capacity strategies, and these are things that 

should already be implemented in a general infection prevention and control 

plans in healthcare settings. So this is more of the normal operations but point 

out that healthcare personnel can use NIOSH approved alternatives to N95

respirators specifically Filtering Facepiece Respirators when feasible.

These would include other classes of Filtering Facepiece Respirators. There’s 

the N class, P class and R class. You have 95’s, 99’s and 100’s. There are 

elastomeric half masks, there are powered air purifying respirators. And all of 

these alternatives will provide equivalent or higher protection levels than N95

respirators.

So if you have supply of NIOSH approved respirators that provide a level of 

protection equal to or greater than N95s that can meet your demand then there 

is no need to move to the contingency crisis capacity strategy. So I think that’s

something very important to point out that there’s other alternatives to N95s

that can be used.

So once you get into contingency and crisis capacity strategies, you know, 

these are temporary, you know, that are used to help conserve respirator 

supplies during anticipated or experienced shortages. And going to these 

strategies is where we start to kind of deviate from I guess lack of a better 

word usable practices. So, you know, you want to really think about your 

status when you - before you go to these strategies.

So contingency capacity strategies may be used temporarily when there is an

expected shortage of N95 respirators or other respirators and they should only 

be implemented after conventional capacity strategies have been 

implemented. So, you know, if you recognize that the future supply is not 

going to keep up with your demand you may want to move into the 
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contingency capacity strategies. And obviously this could be due to an 

increase in the number of respirators being used because you’re having more 

patients’ visit the hospital or healthcare facility or you recognize

(unintelligible).

And the main contingency capacity strategy that’s being used is an extended 

use of N95 respirators. And that’s where you put on a N95 Filtering Facepiece 

Respirator and wear it for multiple patient encounters before it is doffed and 

discarded. And if extended use and other contingency capacity strategies are 

enough to keep up with demand then you should not be going and using crisis 

capacity strategies.

And crisis capacity strategies should only be implemented after considering 

and implementing obviously the conventional capacity and the contingency 

capacity strategies. And facilities could consider crisis capacity strategies 

when the supply is not able to meet the facilities current demand or 

anticipated utilization rates.

So some of the crisis capacity strategies (unintelligible) manufacturer

designated shelf life for healthcare delivery, use of respirators that are similar 

to NIOSH approved respirators so we’re talking about respirators that are not 

NIOSH approved that are approved according to standards used use in other 

countries. NIOSH has assessed the performance of some of these international 

respirators and has the results posted online.

And then there’s also limited reuse. An N90 - N95s and this is when it’s 

donned from one patient contact then doffed and stored before being used for 

another patient contact for a limited number of donning’s up to five. Limited 

reuse may also include decontamination. And decontamination should be the 

last crisis capacity strategy employed if necessary.
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And so, you know, this is kind of complicates how do you know when to 

move into these different strategies? And really there’s two important factors 

the status as well as a number of respirators being used. And the CDC has 

developed a burn rate calculator that will allow the users to calculate the 

average rate of PPE consumption which is also referred to as burn rate, and 

the average rate of PPE consumption per patient and then the number of days’ 

worth of remaining PPE.

So the supply chain and the other resources to obtain respirators should be 

checked frequently. This includes other types of classes of NIOSH approved 

respirator protection that are part of conventional capacity strategies that I 

spoke about. 

And, you know, the goal is to get back to conventional capacity strategies and, 

you know, so it’s very important that you weigh your utilization rate with the 

supply on hand and then what’s in the supply chain so that you can get back to 

those conventional capacity strategies as soon as possible. Thank you.

Dr. Cynthia Chang: Thank you so much to our colleagues from OSHA and NIOSH for those 

very helpful responses.

Irene Aihie: Operator we’ll go ahead and take our first question.

Coordinator: And the first question is coming from (Galen). Your line is open.

(Galen): Yes, I was just wondering if you have a non-disinfection method in mind like 

a - we have our home care staff waiting 72 hours before they re-don of mask 

that they may have worn in a COVID patient’s house. Without the 
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disinfection cycles would it still be a recommended only five reuse for an

N95?

Dr. Cynthia Chang: Hi. This is Cynthia Chang. So the question is about whether for home care 

staff if there’s specific recommendations regarding donning and doffing and 

reuse. And with that question in mind let me turn to my colleagues from 

OSHA to see if they have any questions or any comments for that.

(Galen): Thank you.

Mike Bergman: Hello. This is Mike Bergman from NIOSH.

(Galen): Hi.

Mike Bergman: I can speak to that question. We recommend limiting the donning’s to five 

unless the manufacturer has specific guidance to extend that. And it wouldn’t 

matter if the donning’s are 72 hours apart or if they’re just a few minutes apart 

we recommend five donnings total.

(Galen): Okay. So with or without...

Mike Bergman: Thank you.

(Galen): ...it’s five re-donnings and that’s it unless manufacturer states differently, got 

you.

Mike Bergman: That’s correct. Thank you.

(Galen): Thank you.
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Andy Levinson: All right sorry this is Andy from OSHA I was on mute. I think it’s important 

to understand one of the reasons for concern in this type of method of decon is 

that these devices were never intended to be decontaminated and reused. And 

that the ways in which they could be damaged and/or not fit properly are not 

always obvious. And so the limitations are important because in the act of 

taking it on and off and storing it people could crease the face feel area and 

they may not realize that they’re not getting an adequate seal.

(Galen): That makes sense. Yes thank you.

Coordinator: The next question is coming from (Russ Olmstead). Your line is open.

(Russ Olmstead): Yes, thank you for faculty for this session this is very helpful. I was curious if 

FDA has any EUAs issued for UVC methods for decontaminating N95

respirators?

Dr. Cynthia Chang: Hi. This is Cynthia Chang. So the question is whether FDA has issued 

EUAs for UVC methods for decontamination. So first I would like to point 

out that our authorized EUAs may be found on our Web site. And I believe we 

do have a link to the resource on the Web site and in the slides so you can 

check those resources specifically for each of the authorized EUAs.

I would like to note that we do have EUAs for decontamination systems of 

topic and the scope of today’s Webinar. And in terms of the updated EUAs 

that we have issued they are specific to respirator decontamination systems 

using the modalities that we outlined which do not include UVC. However 

there - I will turn it over to my colleagues and OHT4 to comment on any 

additional EUAs that we have issued regarding UVC.
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Dr. (Murray): Thank you Cynthia. To follow-up with that you are absolutely correct we have 

not authorized any decontamination systems for UVC. What you would find 

to the person who is asking the question you will find on that Web site that 

there is one system that’s for bioburden reduction.

Dr. Cynthia Chang: Thank you very much Dr. (Murray).

Coordinator: The next question is coming from (Amy Fowler). Your line is open.

(Amy Fowler): Hello. This is (Amy Fowler). And actually I have a question related to the 

510(k) performance testing requirements for surgical mask FXX. And I would 

like to just take a quick moment to direct a question to Dr. Chang. Industry is 

looking for clarity on the number of test samples and number of 

nonconsecutive lots required for a 510(k) for surgical mask FXX.

I have seen recently in January 510(k) summaries being posted where there 

was only like five test samples per performance test. But of course we’ve had 

communication since last summer saying that it was required to be 32 test 

samples of three nonconsecutive lots. And I think there’s a lot of confusion 

out in industry. I would love to have some clarification on this point. Thanks.

Dr. Cynthia Chang: Hi. This is Cynthia Chang. So thank you for the question. The question is 

about the number of samples that are needed to be tested for products in Pro 

Code FXX which is surgical masks. So that is actually outside of the scope of 

today’s Webinar which is specific to decontamination EUAs for respirators 

and nonsurgical masks.

However I would like to refer you to our prior Webinars which are available 

on our Web site as we have discussed this topic previously regarding surgical 
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masks. Thank you. And for any specific questions I should add you may 

consider reaching out to the review division specifically. Thank you.

Coordinator: The next question is coming from the (Natalia Gutierrez) your line is open.

(Natalia Gutierrez): Hi. Good morning. Can you hear me?

Dr. Cynthia Chang: Yes.

(Natalia Gutierrez): Okay perfect. Thank you. We are a new manufacture for the N95s here in 

South Florida. And I basically have almost the same question as the previous 

lady about the 510(k). We did several testing’s actually with Nelson Labs. But 

it seems like when you go to the FDA and then NIOSH it kind of contradicts 

each other on the procedures to get these approved or certified. And I wanted 

to know if there is anyway do you guys have on the Web site or actual people 

or consultants that help you how to guide - that can guide me to get this 

certified basically or approved?

Dr. Cynthia Chang: This is Cynthia Chang. So thanks for that question. It is a about the 

approval process for N95 respirators I believe. And I do want to note that 

FDA has been working closely as you can see with our colleagues from 

NIOSH and OSHA throughout the pandemic and especially on these specific 

issues regarding respirators. And so it might be best if I turn it over to our 

colleagues at NIOSH to talk about the approval process.

Mike Bergman: Hi. This is Mike Bergman from NIOSH. The best way to get questions 

answered about NIOSH certification I’ll give you an email address right now 

which is ppeconcerns@cdc.gov, ppeconcerns@cdc.gov. And if you send an 

email there that’s a mailbox that has managed here at NIOSH which houses 

the National Certification Program.
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Just send an email there and they can take care of any questions you have 

about NIOSH certification. NIOSH does review the data for the surgical N95

respirator certification. So I would just recommend sending an email there and 

they will get in contact.

(Natalia Gutierrez): Okay. I - can you specify one small thing...

Mike Bergman: Thank you, yes.

(Natalia Gutierrez): ...for me please?

Mike Bergman: I could try. Yes.

(Natalia Gutierrez): Okay. I noticed that you have the N95 that are the folds right the one that 

has the little, you know, the nose wire right in the earlobes. And then you have 

the actual cup. 

I know that the ones that are for the cup that have like a more fit to the face 

that has the headbands those are the ones that are being prioritized right now 

and not the ones with the earlobes. Will these eventually I mean are they still 

considered N95s and would eventually be approved just like the cup?

Mike Bergman: I think that’s a better question for the certification program to handle.

(Natalia Gutierrez): Okay.

Mike Bergman: I’m actually in the research program so I can’t answer too many questions 

about certification.
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(Natalia Gutierrez): Okay, okay, okay. Thank you so much for everybody’s time.

Mike Bergman: You’re welcome. Thank you.

Dr. Cynthia Chang: Thank you very much. And I would also like to note -- this is Cynthia 

Chang -- that we have discussed respirator regulatory paths as well and in our 

PPE Webinar Series. And we do have information on our Web site regarding a 

variety of topics related to respirators and PPE. So those are some additional 

resources in addition to the information provided by our NIOSH colleagues. 

Thank you.

Coordinator: The next question is coming from (Carlos). Your line is open. The next 

question is coming from...

(Carlos Burdell): (Carlos Burdell).

Coordinator: Your line is open. You may ask your question.

(Carlos Burdell): Hi there. I was wondering if I can get a clarification of what a duckbill N95

FFR is?

Dr. Cynthia Chang: So this is Cynthia. Thank you very much for the question which is 

regarding clarifications on what respirators may be considered to be

duckbilled. Respirators are FFRs. And we do want to start by saying the 

respirator manufacturers are best positioned to accurately describe their 

respirators and products. 

And we do recommend that you reach out directly to manufacturers for 

specific questions about the products that they are marketing. And let me turn 
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to my colleagues from NIOSH and OSHA to see if they have anything to add 

on this topic.

Mike Bergman: Hi. This is Mike Bergman again. It’s kind of a general term duckbill. You 

know, some of the other general terms are like cup shaped or flat folds. So I’d 

say from a NIOSH perspective it may not be an official NIOSH term but I 

would think yes it’s best to check with the manufacturers of the products if 

they can provide a more official classification.

Andy Levinson: Right. And this is Andy Levinson from OSHA. We actually don’t make a 

distinction at all. The only thing that matters to us is that it is a NIOSH 

approved respirator. And all half-mask respirators get the same assigned

protection factor regardless of the design and construction.

Dr. Cynthia Chang: Thank you very much to our NIOSH and OSHA colleagues for the 

response there.

Coordinator: At this time we have no further questions in queue.

Irene Aihie: Thank you. Before we close out Cynthia did you have any closing remarks?

Dr. Cynthia Chang: Yes. This is Cynthia Chang. I do want to thank everyone for their time and 

attention this afternoon on this important topic. And I do want to extend a 

special thanks to our colleagues from NIOSH and OSHA who have joined us 

to address some of the questions today. Thank you.

Irene Aihie: Thank you Cynthia. Again 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/cdhrlearn by Thursday, March 4.
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If you have additional questions about today’s presentation 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 Webinar please complete a short 13 

question survey about your FDA CDRH Webinar experience. The survey can 

be found at www.fda.gov/cdrhwebinar immediately following the conclusion 

of today’s live Webinar. Again thank you for participating and this concludes 

today’s Webinar.

Coordinator: This concludes today’s conference. All parties may disconnect at this time. 

Speakers, please allow for a moment of silence.

END