FDA Webinar

Moderator: Irene Aihie

10-13-2020/11:00 pm ET

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FDA Webinar Series –

Respirators and Other Personal Protective Equipment (PPE) f

or Health Care Personnel Use During the COVID-19 Pandemic

Moderator: Irene Aihie

October 13, 2020

12:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participants are in a 

listen-only mode until the question-and-answer session of today’s 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 call 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: 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 10th CDRH webinar in our PPE webinar series. The FDA 

will share information about protective barrier enclosures and representatives 

from the FDA and OSHA will be available to answer your questions.

Following a few opening remarks, we will open the lines for your questions 

related to the information provided during today’s discussion. Now I give you 
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Moderator: Irene Aihie

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Dr. Suzanne Schwartz, Director of CDRH’s Office of Strategic Partnerships 

and Technology Innovation.

Dr. Suzanne Schwartz: Thank you and welcome everyone. As Irene mentioned this is the 10th 

session in our biweekly webinar series on personal protective equipment, PPE. 

Today I’m pleased to introduce Dr. (George Gibeily) Medical Officer in 

CDRH’s Office of Health Technology or OHT4 Surgical and Infection 

Control Devices within the Office of Product Evaluation and Quality, who 

will provide an overview on FDA’s approach to protective barrier enclosure 

devices intended for use in the COVID-19 response. Dr. (Gibeily) will cover 

the Emergency Use Authorizations or EUAs for these devices. 

After (George)’s presentation, we'll return the operator - we will turn to the 

operator for live Q&A. Our federal partners and colleagues from OSHA are 

on the line with us and they are available to field questions relevant to their 

respective mission, roles and responsibilities. 

At this time, I’d like to turn the webinar over to (George).

Dr. (George Gibeily): Thank you Suzanne and good afternoon everyone. Thank you for the 

opportunity to present FDA’s current thinking on protective barrier 

enclosures.

Protective barrier enclosures were created in response to the COVID-19 

pandemic as an adjunct to and not to replace personal protective equipment to 

further protect healthcare workers from particle aerosol, splashes, droplets 

containing SARS-CoV-2 the agent of COVID-19, because there were no real 

good alternatives available.
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Their proposed benefit is to prevent contagion from SARS-CoV-2, surface 

contamination through droplets and splashes as well as airborne viral 

contagion. These devices can be single use or reusable and are of two different 

types. The first - can I have the first slide - next slide please, Irene.

The first are passive protective barrier enclosures that is without negative 

pressure. They’re defined as a transparent device much like a box 

(frequently), designed to cover a patient’s head and upper body and 

incorporates one or more ports through which healthcare personnel can pass 

their arms and hands to perform medical procedures providing an extra layer 

of barrier protection. These devices are frequently acrylic or plexiglass 

enclosures that are not airtight and may have sharp edges with limited internal 

space to perform procedures.

The second main type of enclosure is the protective barrier enclosure with 

negative pressure, that is airflow, defined as a transparent device with 

negative pressure that partially or fully covers a patient to prevent healthcare 

personnel exposure to pathogenic airborne particles. These barrier enclosures 

include ports for medical care and procedures. They have an air intake source 

and suction which can be fixed or portable with airflow such that there’s a 

constant air exchange.

The intake and output filters are, HEPA filters are placed in line with intake 

and output conduits. These enclosure barriers may be tent-like with plastic or 

metal reusable disposable struts covered with a polyvinyl sheet much like a 

tent or they can be fixed acrylic enclosures. Can I have the next slide, Irene.

(So) Emergency Use Authorization for protective barrier enclosures with 

negative pressure have been authorized only for in-hospital use for airway 

management, respiratory treatments, direct patient transport to different levels 
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of care in a hospital with a nurse or physician in attendance while monitoring 

the patient’s EKG, vital signs, blood oxygen levels and carbon dioxide levels 

when available through end-tidal CO2.

The ultimate purpose of these Emergency Use Authorizations for protective 

barrier enclosures with negative pressure is to increase the negative pressure 

treatment areas in hospital for COVID-19 patients. You might remember in 

China they built two full-service hospitals to house and isolate and treat 

COVID-19 patients.

Some of the negative pressure barriers that we review may increase negative 

pressure isolation treatment areas within hospitals that are already existing in 

the US and globally rather than building completely new enclosed hospitals.

Eight of these negative pressure enclosures has already been authorized 

through our EUA program to date. The use of enclosures and procedures such 

as endoscopy, bronchoscopy, ENT and oral surgical procedures as well as 

transportation of patients outside hospitals and use in nursing homes at this 

time are not being considered. They present unknown additional risks to 

patients with existing respiratory compromise which can further worsen by the 

need for sedation and inconsistent monitoring. 

If additional procedures are necessary, they are likely more safely performed 

in these COVID-19 patients having placement of a definitive airway prior to 

the procedure which should virtually eliminate uncontained aerosol 

generation.

Regarding the passive protective barrier enclosures we initiated an umbrella 

emergency use authorization because we initially felt these passive devices 

posed a minimal risk and provided protection to healthcare workers. In order 
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to expedite their entry into the marketplace we outlined minimal testing 

requirements in an umbrella EUA and if met the device could go directly to 

market immediately protecting healthcare workers at greatest risk from 

aerosols containing SARS-CoV-2.

Subsequently we found that studies performed through simulation testing and 

published in anesthesia peer reviewed medical literature suggested that these 

protective barrier enclosures without negative pressure may not reduce 

healthcare provider risk to aerosol exposure and may in fact increase such risk 

by concentrating and accelerating aerosol through existing breaks in the 

barrier.

We found that the enclosure could damage personal protective equipment 

primarily gown sleeves damaged while inserting arms through the barrier 

portals exposing the healthcare worker’s skin to contamination. These 

enclosures decrease the probability in some studies of first pass endotracheal 

intubation and increase the time required and complexity of airway 

establishment all increasing the risk of hypoxia in the COVID-19 . These 

patients already have existing respiratory disfunction due to COVID-19 and 

can least tolerate an additional cause of hypoxia

.

So out of an abundance of caution FDA revoked the umbrella Emergency Use 

Authorization on August 20, 2020. For more details and further information 

please find the link to our website provided on the resource slide at the end of 

this presentation.

FDA will continue to review protective barrier enclosure submissions to the 

pre-Emergency Use Authorization pathway on a case by case basis. We 

review performance testing of all protective barrier enclosure devices to 
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ensure that the internal environment of these devices do not become hostile to 

the patient and yet provide healthcare workers with enhanced protection from 

COVID-19 generated aerosols.

So the following performance testing may be required for these protective 

barrier enclosure devices and will be reviewed by FDA as applicable. We ask 

that you provide aerosol leakage testing using an aerosol generator within the 

device enclosure for example a saline nebulizer which can be activated 

periodic timepoints within a predetermined time interval of device use for 

example every 30 seconds for 5 minutes. This is to simulate a human cough.

The same test can be done using human volunteers simulating coughing. 

This test should include a study arm with the enclosure ports or slit cuts left 

wide open thus providing a worst-case scenario for aerosol leakage and 

pathogen droplet and splash containment. 

Then using an industrial particle counter, we ask that you provide aerosol 

generated particle counts with special consideration for particles that are less 

than five microns in size to assess the risk of airborne contagion. There is 

evidence that mucus and water particles containing SARS-CoV-2 virus can 

remain airborne for a few hours and float for longer distances than droplets 

and microdroplets. 

These particles may be the more concerning vector of contagion because as 

they remain suspended and their water content evaporates, they can become 

lighter potentially allowing them to spread even further than anticipated and 

smaller allowing them to bypass the mucus, ciliary, and lymphatic tissue 

defenses of our upper airways facilitating travel of the SARS-CoV-2 virus to 

the deepest regions of the lung where it can inflame and destroy critical tissue 

for oxygenation causing the patient to present first with fever, dry cough and 
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in some cases profound shortness of breath ; ultimately, hopefully rarely,

respiratory failure.

Particle counts should be gathered within and outside the enclosure device at a 

level of the healthcare provider’s head at different distances from the 

enclosure device and at different points around a hospital bed, operating table 

or stretcher where the protective barrier enclosure device may be in use.

The fluorescein dye and smoke testing may be used to demonstrate leaks of 

larger droplets and splash containment within the enclosure device. Both 

studies, the particle counts and the fluorescein testing, provide important 

safety information, particle counts assessing the risk of airborne transmission 

while the smoke and fluorescein dye also tests the extent of surface 

contamination.

We ask that particulate clearance times be measured to determine the amount 

of time required after an aerosolizing respiratory treatment is necessary before 

the barrier can be removed to avoid unwanted spread of the SARS-CoV-2 

virus. This information will inform device labeling.

Using human volunteers, we ask that measurement of CO2 levels, CO2 

production reported in parts per million, temperature, humidity within the 

chamber over a maximum of time of enclosure use or until the level of these 

measured datapoints plateau. 

Examples of why this is important, increased CO2 greater than 5000 parts per 

million taking note that normal atmospheric CO2 is about 400 parts per 

million, can lead to rebreathing hypercarbia which can result in unwanted 

increases in heart rate and blood pressure in patients who may be at risk for 

cardiovascular events. High relative humidity inside an enclosure may lead to 
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condensation and disruption of visualization of the patient’s anatomy through 

the enclosure and may cause HEPA filter malfunction.

Airflow exchange rates inside the enclosure device should be calculated and 

typically we look for greater than 12 air exchanges per hour. If applicable 

provide details of the negative pressure source, its ability to maintain negative 

pressure as well as negative pressure variations over time. This is especially 

important if portable suction and tanked medical air is used to transport these 

COVID-19 patients.

Please ensure that there’s adequate visualization of the patients in the 

enclosure; communication with the patient is adequate with measurement of 

noise decibel levels within and outside the chamber with and without negative 

pressure airflow; ease of access to accessories inside the enclosure device and 

assessment of adequate space for medical equipment needed to monitor and 

treat the patient safely; characterization of the HEPA filters if applicable, their 

type, are they authorized, are they disposable or reusable frequency of 

exchange, the method of disposal and if reusable the method of sterilization.

We ask that you give us electrical and EMC testing, viruses and any fire 

retardation testing if appropriate, cleaning and disinfection reprocessing 

validation testing if applicable.

We also ask that a human factor study is performed using 15 specialists of 

different experience levels from different clinical settings. Typical clinical test 

scenario may be a simulation of establishing a definitive airway with a barrier 

device in place. It is important to record the time required to establish a 

definitive airway with and without the barrier device. And after simulation 

testing with a mannequin, the participants should be asked to respond to a 
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questionnaire reviewing what they like and what they dislike about the device 

and this may be accomplished with a five-point Likert scoring system. 

Participants should be given the opportunity to enter free text into the 

questionnaire as well. And the questions should evaluate the ease of access to 

a simulated airway recording the time required to establish a definitive airway 

with and without PPE, space restrictions for essential equipment, visualization 

of the anatomy of the patient’s airway, communication with the patient while 

in the enclosure with and without suction and fans and any other factor that 

might interfere with critical airway management.

Please take note that sponsors using human volunteers in these tests should 

abide by the rules of a clinical study whereby all protection of human subjects 

is insured. An IRB may need to review your protocol for approval or 

exemption. 

Labeling of these devices should include a risk-benefits statement, possible 

adverse events, indications, contraindications, warnings and precautions. 

These should be consistent in all the fact sheets, directed at healthcare 

workers, patients, facilities along with assembly, cleaning, disinfection and 

safe disposal instructions. A step-by-step emergency procedure for a device 

removal should also be included in these instructions.

Typical contraindications for use of these enclosure devices which should be 

in the fact sheets include: use in patients with known difficult airways, 

patients who are hypoxic and require emergency intubation, patients with 

anatomic abnormalities restricting neck mobility such as cervical spine injury 

or arthritis, or the morbidly obese patient with short thick necks occupying 

much of the space within the enclosure limiting the healthcare provider’s 

ability to maneuver also limiting neck mobility, patients who are less than 45 
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pounds or in the pediatric age group are among some of the contraindications 

we would like to see included.

COVID-19 patients using these protective barrier enclosures should receive 

supplemental oxygen. Please note that manufacturers are required to report 

deaths, injuries, malfunctions for all EUA devices to FDA within 30 days of 

becoming aware of these events.

Currently we have not received many MDRs on protective barrier enclosures.

Any product issues may be reported voluntarily by any individual to FDA 

through our MedWatch site listed in our next slide I believe, our next resource 

slide. Irene, if you can advance the slides to that please, yes.

And with that I’ll take any questions and open it up to the audience.

Coordinator: If you would like to ask a question please press Star then 1, unmute your 

phone and record your name clearly when prompted. If you’d like to withdraw 

your question press Star 2. One moment while we wait on our first question.

The first question is from (Julian Goldman), your line is now open.

(Julian Goldman): Hi thank you for taking my question. I’m curious as to the kind of strong 

direction to eliminate patients who are - have certain physical characteristics 

that you outlined and who, you know, are classically - have difficult to 

manage airways and may be difficult to intubate. 

I’m puzzled by that since if anything there’s greater value in providing 

additional protection for personnel with additional and a more extensive and 

lengthier airway manipulation including the potential need to rescue the 

airway during intubation and with the rescue of say bag mask ventilation.
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So I read that initially online when you posted that information. I was puzzled 

at that time and since I heard it repeated now, I think it’s worth digging into 

that a little bit, thank you.

Dr. (George Gibeily): Yes (George Gibeily), thank you for that question. You know, that’s a 

very important question and I think you’re right in some cases these patients 

may be more likely to spread aerosol without the enclosure especially if they 

are combative and put the healthcare providers at risk.

I just feel that what we're seeing is that with these added barrier protections it 

may be difficult to actually maneuver your arms and hands within the 

enclosure to effect expeditiously establish a definitive airway. And many of 

the anesthesiologists that I have personally talked to because I still practice 

surgery and frequently counter anesthesiologist who feel that with 

PAPRdevices to protect them and full personal protective equipment they can 

establish an airway expeditiously without the hinderance of these additional 

protective barrier enclosures.

And so it really comes down to judgement of the healthcare provider, of the 

anesthesiologist for example. But to struggle to establish an airway because of 

the protective barrier enclosure resulting in harm to the COVID patient, i.e. 

hypoxia, failed intubation resulting in the need for an emergency 

tracheostomy for example. I think that is really a clinical issue that needs to be 

determined by the clinician but FDA’s position is to maximize both health 

care worker and patient safety and we believe that the contraindications I 

mentioned should be considered prior to using these protective barrier 

enclosures.

You know, I hope that answered your question. I know it can be controversial.
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(Julian Goldman): Not, well not necessarily. I think the point your bringing out is a different 

point about what is the best approach to the patient. But if you’re talking 

about a device, a barrier if it’s been sized appropriately for the correct patient 

population and if in the judgment of the clinical team it’s appropriate for that 

patient, I’m still having difficulty understanding why there should be a blanket 

prohibition that it be used with large or obese patients and folks with, you 

know, all the other characteristics you mentioned. 

That’s what I was reacting to that there should be an exclusion upfront, a 

priori, without really considering the conditions.

Dr. (George Gibeily): You know, I think we’re learning as time goes on, as I think all of us are 

and that’s the purpose of the human factors testing. If in fact, you know, 

through human factors and like I said 15 specialists of different experience 

levels from different healthcare settings will be asked to perform these 

procedures with full PPE and is there enough room in the enclosure to 

establish an airway without a struggle I we may be able to eliminate some of 

these contraindications. 

(Julian Goldman): Okay...

Dr. (George Gibeily): But again, in an abundance of caution I think these should be included in 

the labeling. They’re not slated in stone necessarily, they can be challenged, 

but we ask that appropriate testing be accomplished and data presented to 

show that it is safe to remove a contraindication that’s all.

(Julian Goldman): Yes and I propose that the ability to rapidly remove it to gain access for 

unanticipated procedures is, you know, vitally important. Anyway, thank you 

very much for taking the time to dig into this a bit.
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Dr. (George Gibeily): Thank you.

Coordinator: The next question is from (Stephanie Herbert), your line is open. Ms. 

(Herbert) please check your mute button. I’m showing no further questions. 

At this time, I would like to (turn the) conference back over to Ms. Irene 

Aihie.

Irene Aihie: Thank you. Before I close Suzanne do you have any closing remarks for the 

group?

Dr. Suzanne Schwartz: Thanks, Irene. Yes, I would like to thank (George) for his presentation 

and recognize everyone who has participated today whether from FDA and 

we've also had from OSHA some subject matter experts available on standby.

Thank you to everybody who had tuned in. The next session is slated to take 

place in two weeks which would be Tuesday, October 27 at noon Eastern. 

Announcement of 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’ll turn this back now to Irene who will close out this session.

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 webpage at www.FDA.gov/training/CDRHlearn by Wednesday 

October 21. 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 
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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 participants may disconnect at this 

time. Speakers please standby for a post conference thank you.

END