FDA PPE Webinar

Moderator: Ivory Howard

04-27-21/12:00 pm ET

Confirmation # 2093231

Page 1

FDA PPE Webinar

Moderator: Ivory Howard

April 27, 2021

12:00 pm ET

Coordinator: Welcome everyone and thank you for standing by. I would like to advise you

that today’s call is being recorded. If you have any objections you may 

disconnect at this time. All participants will be in listen-only mode until the 

question-and-answer session of today’s conference. I would now like to turn 

the call over to Ivory Aihie (sic). Thank you. You may begin.

Ivory Howard: Hello and welcome to today’s FDA Webinar. I am Ivory Howard of CDRH’s

Office of Communication and Education. Welcome to today’s PPE Webinar.

During this Webinar the FDA will share the updated information on respirator 

decontamination systems during the COVID-19 public health emergency. 

Representatives from the FDA, NIOSH and OSHA will be available to answer 

your questions.

Following the presentation we will open the line for your questions related to 

information provided during today’s Webinar. Now I give you Dr. Suzanne 

Schwartz from CDRH’s Office of Strategic Partnership and Technology 

Innovation.
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Dr. Suzanne Schwartz: Thank you Ivory. Good afternoon everyone and welcome. This is

the 15th session in our Webinar series on personal protective equipment or 

PPE. In prior Webinars we’ve 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 N95s.

We’re at a very different place in the pandemic today regarding respirator 

availability then we were in the March or April of last year. As a result of 

increased NIOSH-approved respirator supply, FDA is recommending that 

healthcare personnel and facilities transition away from crisis conservation 

strategies including the use of decontaminated disposable respirators.

In today’s Webinar Dr. Aftin Ross from CDRH’s Office of Strategic 

Partnerships and Technology Innovation or OST will present information 

about FDA’s April 9, 2021 letter to healthcare personnel and facilities which 

recommended this transition. After the presentation we’ll turn to the operator 

for live Q&A.

CDC NIOSH has also updated its strategy for optimizing the supply of N95

respirators to clarify the application of surge capacity strategies such as 

respirator decontamination. And we are joined by our colleagues from NIOSH 

and OSHA for the question and answer portion of the session. With that I am 

pleased to turn the Webinar over and introduce Dr. Aftin Ross. Aftin?

Dr. Aftin Ross: Good afternoon. My name is Aftin Ross. And I am a Senior Science Health 

Advisor in CDRH. I have been working on PPE supply chain activities as part 

of the COVID-19 response.

We recognize that many of you are on the front lines of care and appreciate 

your commitment and hard work during the pandemic. Please know that as a 
FDA PPE Webinar

Moderator: Ivory Howard

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part of its commitment to protecting and promoting public health FDA is 

working diligently to support your efforts by ensuring PPE availability. We 

greatly appreciate you taking time out of your busy schedule to attend today’s 

Webinar.

Today, I am going to provide an overview of the letter to healthcare personnel 

and facilities FDA released earlier this month recommending that facilities 

transition from the use of decontaminated disposable respirators. We’ll then 

provide a resource slide for attendees and along with our NIOSH and OSHA 

colleagues answer any questions you may have regarding this topic.

On April 9, 2021 FDA released a letter to healthcare personnel and facilities 

recommending that they transition from the use of decontaminated disposable 

respirators. Respirators decontamination and bioburden reduction were one of 

the most extreme measures of respirator conservation,

in that there were crisis capacity conservation strategies that were only to be 

used when new NIOSH-approved or FDA cleared or authorized N95 filtering 

facepiece respirators are not available. The domestic supply of new NIOSHapproved disposable respirators has significantly increased since the use of 

respirator decontamination and bioburden systems began last year.

FDA and CDC believe this increase along with the availability of NIOSHapproved reusable respirators such as Powered Air Purifying Respirators or 

PAPRs, and elastomerics provide adequate respirator supply to facilitate a 

transition away from the use of decontamination and bioburden reduction 

systems. From our engagement with various healthcare facilities we know that 

many have already started phasing out respirator decontamination. And we are 

recommending that everyone do so as we take a staged approach to getting 

back to contingency and eventually conventional respirator use.
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In support of this transition, FDA will not be reviewing or authorizing any

more decontamination systems. During the public health emergency one of 

the ways FDA used its Emergency Use Authorization authority to expand the 

availability of respirators for healthcare personnel was by issuing the NIOSHapproved respirator EUA in March 2020.

Under this EUA, NIOSH-approved air purifying respirators including 

disposable respirators and respirators that are designed to be reusable were 

authorized for use by healthcare personnel. Once a respirator received NIOSH

approval, its automatically authorized under this umbrella EUA until the US 

Department of Health and Human Services HHS Secretary’s declaration that 

circumstances exist justifying authorization is terminated or the EUA is 

revoked.

From January 2020 through April 2021 NIOSH has approved over 875 

respirator models or configuration with some of these manufactured by 

approximately 20 new domestic NIOSH approval holders. To give you further 

insight into the magnitude of respirators available, I would like to highlight 

that today there are over 6400 total respirator models or configurations on the 

NIOSH certified equipment list which meet the NIOSH-approved EUA 

criteria and thus are FDA authorized.

These wide-ranging respirator types include more than 600 FFR models of 

which there are over 530 N95 FFR models, over 360 PAPR configurations 

and over 5500 elastomeric respirator configurations including new elastomeric 

respirators without an exhalation valve. Availability of elastomerics without 

an exhalation valve is significant.
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As one of the obstacles limiting the wider use of these reusable respirators in 

healthcare settings has been the inclusion of exhalation valves as a design 

feature which means the respirator cannot provide source control and cannot 

be used in the operating room because exhaled air can transmit respiratory 

secretions which could transmit infection or contaminate the sterile field.

Our April 9, 2021 letter had several key recommendations that I would like to 

highlight which are as follows. One, the need to limit decontamination of 

disposable respirators. We cannot emphasize enough that respirators 

decontamination and bioburden reduction as crisis capacity strategies were the 

most extreme respirator conservation strategies that should only be used when 

there is insufficient supply of new FFRs or if you are unable to obtain any 

new respirators.

Transition away from crisis capacity strategies such as decontamination of 

N95s and other FFRs as respirator supply has increased. And third, increase 

your inventory of available NIOSH-approved disposable respirators including 

N95s and other FFRs. Reusable respirators including Powered Air Purifying 

Respirators or PAPRs and elastomerics. including elastomerics without an 

exhalation valve that can be used in operating rooms.

Currently a surplus of respirators exists in the respirator supply chain. Thus

even if you are unable to obtain the respirator model you prefer, FDA 

recommends that you obtain and use a new respirator before decontaminating 

or bioburden reducing a preferred disposable respirator.

FDA has been actively monitoring the respirator supply chain throughout the 

pandemic and will continue to do so as facilities systemically transition away 

from the use of crisis capacity strategies and work towards a return to 

contingency and eventually conventional respirator use practices. We will 
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watch to see how respirator availability is impacted by transitioning away 

from decontamination to further inform our next steps as it relates to the use 

of other respirator crisis capacity strategies such as the use of non-NIOSH

approved respirators.

FDA is taking this phased and measured approach such that an adequate 

supply of respirators is maintained for the healthcare personnel that need 

them. Though we are beginning a phased approach towards the ultimate goal 

of returning to conventional respirator use practices, respirators specifically 

surgical respirators, presently remain on the FDA’s device shortage list as 

conservation strategies are still being used.

Please note that the shortage list reflects the categories of devices the FDA has 

determined to be in shortage at this time and will be maintained and updated 

as the COVID-19 public health emergency evolves. FDA is committed to 

being as transparent as possible with our stakeholders. As such, we will 

continue to keep healthcare personnel and the public informed if new or 

additional information becomes available.

On this slide you will find several links for resources that are available to you 

for further information. The first link is for the letter to healthcare personnel 

and facilities that FDA released April 9, 2021 regarding transitioning away 

from the reuse of decontaminated respirators.

As I mentioned earlier in the presentation FDA has authorized the emergency 

use of certain FFRs for use in accordance with CDC recommendations during 

the public health emergency. The second link can help healthcare facilities 

identify respirators for use and directly link to NIOSH-approved respirators on 

the NIOSH certified equipment list. The other links on this slide provide 
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helpful resources on the CDC and OSHA Web sites with the third link taking 

you to CDC’s recently updated N95 respirator optimization strategy.

Please note that any question you may have after this Webinar may be sent via 

email to cdrhcovid19surgicalmask@fda.hhs.gov. Also for a copy of the 

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

www.fda.gov/training/cdrhlearn under the heading Specialty Technical Topics 

and sub heading Personal Protective Equipment.

We have now come to the conclusion of our presentation and will be 

answering any questions that you may have. Operator we would like to now 

open the line for questions. As the operator does so, I will turn the call back 

over to Suzanne Schwartz.

Dr. Suzanne Schwartz: Thank you so much Aftin for that overview. While we’re waiting 

for questions from the audience I’d like to provide an opportunity for our 

colleagues who have joined us from NIOSH and OSHA to share their 

comments as well with perspectives to this topic area. Let me first turn to 

NIOSH.

So since February 2020 CDC has provided different strategies for optimizing 

the supply of N95 respirators based on that framework of surge capacity. Can 

you please provide or describe the recent updates that you’ve made to crisis 

capacity strategies for N95 respirators?

(Chad): Thank you Suzanne. This is (Chad) with NIOSH. On April 9 CDC updated 

the strategies for optimizing the supply of N95 respirators. This update 

removed some crisis capacity strategies that are less protective to healthcare 

providers and clarified other conventional, contingency, and crisis capacity 

strategies.
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These updates were done in collaboration with stakeholders from healthcare, 

respirator manufacturers and distributors and federal partners. These updates 

were based on new research, a significant increase in the supply and 

availability of NIOSH-approved respirators over the last several months and 

because CDC was still hearing that front line healthcare personnel are having 

difficulties accessing respirators and are still practicing crisis capacity 

strategies such as reuse of disposable N95 respirators.

Updates to the crisis capacity strategies included removing the strategy of 

using non-NIOSH approved respirators developed by manufacturers who are 

not NIOSH approval holders, highlighting that the number of reuses should be 

limited to no more than five uses or five (donnings) per device by the same 

healthcare provider to ensure adequate respirator performance, removing 

decontamination of respirators as a strategy with limited reuse, emphasizing 

that facemasks for caring for a patient with suspected or confirmed SARSCoV-2 infection should only be used as a last resort if the supply of respirators 

are severely limited. And lastly removing the table “Suggested well-fitting 

facemask or respirator use based on distance from patient with suspected or 

confirmed SARS-CoV-2 infection and use of source control.”

Dr. Suzanne Schwartz: Thank you so much (Chad). I really appreciate that overview. I’d 

like to now turn to our OSHA colleagues. Could OSHA please provide 

comment on its stance regarding respirator decontamination at this stage of 

the pandemic?

Dr. Dionne Williams: Yes certainly. This is Dionne Williams from OSHA. Thank you for the 

opportunity to comment on OSHA’s stance on this. 
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During the early and peak stages of the pandemic OSHA issued several 

enforcement memoranda through which the agency provided specific 

enforcement discretions that were intended for addressing severe respirator 

shortages. The memos outlined some flexibilities that OSHA compliance staff 

could consider when evaluating an employer’s noncompliance with OSHA 

standards under crisis capacity scenarios. 

And that included circumstances where employers were relying on 

decontamination to expand their availability of single-use respirators. Keep in 

mind however that this is a practice that is prohibited under OSHA’s 

respiratory protection standard. So on March 12th of this year OSHA updated 

its interim response plan for COVID-19 and in this update OSHA informed its 

compliance staff that shortages were becoming less of a barrier to compliance.

In this document, OSHA also reminded its staff and the public that OSHA had 

not previously waived any of its requirements and that any enforcement 

discretions that were granted in the peak of the pandemic were intended to be 

time limited and applied on a case-by-case basis. So, enforcement discretion 

under OSHA are not applicable in the absence of crisis capacity conditions. 

And that means that where NIOSH-approved respirators or associated 

supplies and services are readily available OSHA will not exercise 

enforcement discretion. So the updates that have been described by Aftin and 

(Chad) from the FDA and CDC NIOSH regarding increased availability of 

NIOSH-approved respirators and the recommendations that healthcare 

facilities begin transitioning away from crisis capacity strategies like 

decontamination of single-use respirators fully align with OSHA’s updated 

guidance to employers and compliance staff.
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Dr. Suzanne Schwartz: Thank you very much Dionne. Really appreciate that. Operator, I 

think we are ready at this time for the first question.

Coordinator: Yes absolutely. Just a quick reminder if you would like to ask a question at 

this time please press Star 1 on your phone, unmute your line and record your 

name so you can be introduced. Again to ask a question please press Star 1. 

Give me just a few moments to see if any come in. Thank you. Speakers I will 

continue to monitor but I am showing no questions at this time.

Dr. Suzanne Schwartz: Okay thank you. Let’s give it about another minute or so.

Coordinator: Absolutely. And just a reminder to press Star 1 and record your name if you’d 

like to ask a question. And we do have one question from (Leslie). Go ahead 

please. Your line is open.

(Leslie): Hi. Yes I’m in dentistry and we’re unable to eliminate the hazard of SARSCoV-2 definitively. So if we are performing aerosol generating procedures 

must employees wear N95 respirators according to OSHA?

Dr. Suzanne Schwartz: I’m going to turn - that question was addressed over to OSHA if 

OSHA would like to respond.

Dr. Dionne Williams: Yes. This is Dionne Williams from OSHA. We do have guidance on our 

Web site. The link that Aftin provided should be helpful to get you to some of 

that guidance. And it basically describes for you that your exposure, your 

hazard assessment needs to be based on the tasks that people are conducting.

The most recent updated interim response plan is helpful and it is on the 

OSHA Web site. And for people who are conducting aerosol generating 

procedures we do expect that you would put those individuals in respirators. 
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An N95 is the minimum required respirators but as described in (Chad)’s 

response to his question there are other types of respirators that can also be 

substituted if N95s are not available.

(Leslie): Thank you.

Dr. Suzanne Schwartz: Operator, are there any additional questions?

Coordinator: I am showing no further questions at this time.

(Chad): Suzanne, this is (Chad), just for that last question I will point out that CDC 

does have specific guidance for dental settings on their COVID response Web 

pages.

Dr. Suzanne Schwartz: Okay. Thank you for that. So, I think without any further questions 

I am going to turn this back to Ivory to close out this particular Webinar. I will 

say that we are all committed to continuing to provide information to the 

public as new guidance and new activities are released from the agency. And 

with that again one last time no questions we’ll turn it back to Ivory to close 

out this Webinar.

Ivory Howard: Thank you. This is Ivory Howard. We appreciate your participation and 

thoughtful questions. Today’s presentation and transcript will be available on 

CDRH Learn at www.fda.gov/training/cdrhlearn by Thursday, May 6. If you 

have any 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 the 

Webinar. Please complete a short survey about your Webinar experience. The 

survey can be found at www.fda.gov.cdrhwebinar immediately following the 
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conclusion of this Webinar. Again thank you for participating. This concludes 

today’s Webinar.

Coordinator: That will conclude today’s conference and we thank you for participating. 

You may disconnect at this time. Speakers please stand by for your post 

conference.

END