The PPE Crisis: Strategies for Meeting a Critical Need in a Pandemic -- PART 1

Activity Transcript

Hansa: Welcome back to Tech Tips and Tricks: Enhancing Your COVID Response. Today I'm very excited to welcome Dr Emily Blum, and we will be talking about personal protective equipment (PPE). So let's start with what's going on. We know that we are having a shortage of PPE in this coronavirus disease 2019 (COVID-19) pandemic, and on April 18th, the Johns Hopkins Center for Health Security estimated that 236 million masks, N95 respirators and medical masks together, would be needed for approximately 100 days of a COVID-19 wave, but unfortunately we are still lacking enough supply.

Hansa: We're well over 100 days now, and the Infectious Disease Society of America posted a living document outlining necessary PPE for COVID-19 and for conventional care for COVID-19 suspected patients and contingency care in the case of PPE deficits. Amongst other recommendations from that, either a surgical mask or N95 or PAPR, powered and supplied air respiratory protection respirator, is recommended for routine patient care in a conventional setting and either a surgical mask or reprocessed respirator, as opposed to no mask for routine care in a contingency or crisis setting.

Hansa: Dr Emily Blum and her team discussed, basically came up with a creative way in terms of handling the shortage of PPE or actually coming up with potential solutions. So Emily, would you just let us know a little bit about your background and training, and then we'll jump right in.

Dr Blum: Absolutely. Thank you so much for having me. I look forward to having this conversation and educating everyone out there about what we've been doing and what everyone can do to help, and kind of the struggles that face us as we continue on through this crisis. So a little bit about me, I am a practicing pediatric urologist with Georgia Urology here in Atlanta, and we operate out of the Children's Healthcare of Atlanta network of hospitals. And I split my time between being that practicing physician and also doing medical device innovations work as the medical affairs liaison with the m, a Georgia Tech affiliate.

Dr Blum: So we had a very unique opportunity in this COVID situation where Georgia Tech has what's called the Pediatric Technology Center, headed up by Sherry Farrugia and Liam West, among other people, and they know and work closely with the Global Center for Medical Innovation (GCMI) and one of their physicians, Joanna Newton from Shoah, an Aflac physician who's a hematologist and oncologist, came to them and said, "We need to get PPE into the hands of providers. There's a shortage, there's going to be a shortage, we need to do something."

Dr Blum: At that point in time, we collaborated between the 3 of us, Joanna Newton and the pediatric technology center, the mechanical engineering (ME) department, and GCMI, to give clinical feedback to these face shield designs. GCMI has been working with the design from the ME department to make sure that it meets manufacturing specs, that we aren't doing anything that's improper in terms of FDA, phone calls with the FDA to make sure that everything is up to good manufacturing practices, and bringing that forward into mass distribution, where we're well on our way to be over 200,000 face shields that have been distributed at this point.

Dr Blum: This has all been because of partnerships that we've had with industry, et cetera. ExxonMobil has been a huge help with securing supply chain, and Aflac has been a huge help in terms of supplying funding. They gave us $2 million and said, "Help us get PPE into the hands of people that need it."

Hansa: Emily, I want to just roll back a little bit about what you talked about, and I think there's some really great aspects of your story here. So you and Dr Joanna Newton basically said, "Hey, let's do something about this," right?

Dr Blum: Yeah.

Hansa: How exactly? Did you have a discussion and say, "Hey, we can come up with a design" or was it your network that helped you get that underway? That's my first question. The second question is I do want to go loop back to ExxonMobil and how you got connected to them as well, only because that's really exciting to be able to connect to people and collaborate with people to get something done. So let's go with the first part first, if you don't mind.

Dr Blum: The whole thing with Joanne Newton coming to us, people around the country are working on this. It's not like we're the only people doing this, right? Some people are doing that in a box and solo and saying, "I can design these and I can manufacture these and get these out into society," but they're not taking the whole picture into the equation. I think that's one of the big pitfalls that we're seeing are makers that are making things that aren't necessarily needed by the hospitals. So we knew we could have designed our own face shields, we had a design that was somewhat of a variation, probably easier to manufacture, but maybe not as good technically of a design, but we knew of what was going on at the ME department and we said, "Why don't we all work together?"

Dr Blum: Because this is something that you're seeing universally throughout the country right now is this collaboration between the hospitals, the doctors, the engineers, and industry, to get things working and going. So it wasn't one person leading the charge, it was people unifying around a common cause. This whole situation has been a fascinating look at human behavior and how a stressor and human behavior turns the "I" into "we" and that's really the hallmark of what happened with this project, is with the right people connecting and the right Rolodex going, we were able to start this project and get something out there that should never have gotten out there as quickly as it did.

Hansa: So if it was just you and Joanna working without this network of collaborators, you're saying that you may not have been able to go fast forward as quickly?

Dr Blum: We would not have. There's no way we could have done it. The engineer and the design specs that need to go in to everything, it takes so much time and experience to do, that knowledge is priceless. The connections in terms of knowing who to call for manufacturing, who to call at the FDA. We had, thinking back on this, we probably had well over 25 people on any given day working on different aspects of just the face shields, which is what we are considering our quick win project. Our quick win project took weeks to get up and running, weeks to make sure it was safely done, and lots of people. And we're working on more complex projects for PPE that I'd love to talk about a little later on as well. There, you're talking about dozens of people in multiple different states working on that and we're still probably a month out on that project.

Hansa: What do you think are, and we'll loop back to that as well, but right now just quickly, what do you think are the major limitations in the supply chain? I mean, why can't we just get these PPEs to the doctors and nurses that need them?

Dr Blum: There's so many problems with this supply chain right now and that's one of the things where ExxonMobil has come in to play for us. There's been a fun, little connection there where Joanna Newton posted on her Facebook about the project that we were doing and one of her friends re-posted it, and someone from ExxonMobil saw that repost and said, "Let's help them." And the reason why ExxonMobil and having a big partner like that is important is because one of the hallmarks of getting something manufactured is you need the basic materials.

Dr Blum: People don't think about that. They say, "Okay, great, I'm going to make this" and they don't realize that if you're going to make a hundred million of something, even a million of something, you've got to figure out where you're going to get your supplies from. And the supplies are dwindling very quickly as everyone in the country is trying to make face shields. Everyone in the country is trying to make face masks, and you need to make sure that you have those materials available because the actual shield itself from face shields is very hard to find that material right now because so many people are trying to make them.

Dr Blum: A lot of people are trying to make them and they're not making products that are up to standard so hospitals aren't going to accept them. And when that happens, you're wasting part of the critical elements of the supply chain that are needed for people that actually do have quality-controlled products that hospitals are willing to purchase or accept as donations. We're doing both.

Hansa: The blueprint that you are... Maybe I'm not saying the right word, but the design that you came up with, Emily, with Joanna, that is a design that you are just doing or you've actually shared it?

Dr Blum: The design itself, the Georgia Tech ME department came up with the design.

Hansa: Okay.

Dr Blum: So Georgia Tech's ME department came up with this design and Joanna Newton and I, as well as some of the other engineers from GCMI sat down with their design and went through iterations of it to make sure that it fit all the needs of the clinicians; that it was long enough, that it covered the chin and it covered the neck, that it came back far enough and covered the side of the face. So it was really critical between all these working entities to come together and make sure that the design fit the needs of the clinicians and it wasn't just the engineers designing it.

Hansa: So what I'm hearing from you is that there's a lot of chefs in the kitchen, right?

Dr Blum: Yes.

Hansa: There's clinicians, engineers, private sectors, Georgia Tech, academia. It sounds like you had a whole team of people with different valuable assets that you brought to the table to get this done.

Dr Blum: Yes, very, very much so. It's been really awe-inspiring to see how everyone's been able to work together. Again, I've said it time and time again, without this collaboration, there is no way we could have done everything that we've done in such a short time period and made such a significant impact.

Hansa: For people out there who might have an idea, whether it's clinicians or engineers, I mean what would you say to them in terms of challenges on your journey or wins in your journey?

Dr Blum: Challenges of the journey, there have been a lot of hiccups. There've been a lot of headaches. Not everyone is going to see eye to eye on design specs. Not everyone is going to see eye to eye on how to get a product to market. And being flexible and understanding other people's mindsets, I think is really important. If you want a successful product to go to market, you need to understand everyone's going to have different opinions and you need to put a product out there that's going to address most of those opinions and be flexible in that respect as well.

Dr Blum: Initially, it was important... Well, not initially, but it's been important through all of this to realize that if there's something that is critical, if there's something that's critically important that other people might not realize, it is right to stand up for your ideas. I have to credit Joanna a lot in her pursuit of making sure that face shields extend far enough back on the face, because that's something that she was very passionate about. That has made it into the standards now, whereas when we talked to some other people at some other hospitals, the general feeling was "Just get us something, we don't care." But realistically, for a safety aspect, it's important to make sure the sides of the face are covered. And the feedback that we get is really remarkably positive in terms of how far back that face shield does extend.

Hansa: That's really an important point because it seems to me that what you're saying is that not only do you need these other team members, but it's critically important to have a person who's a clinician, a doctor, a nurse to actually tell people what happens on the ground, how important certain facets of the design really are, and this is why I feel like, and I think that you feel, we both feel that it's important to have a clinical perspective when these things are designed, correct?

Dr Blum: Yeah, absolutely. I mean, you look at these rapid prototyping of ventilators that are coming out right now, and there's no way that a company in isolation, an engineer in isolation would be able to get a ventilator out in 30 days, which is what they did at University of Minnesota. They collaborated with industry, the physicians, and the healthcare system and engineers, and they got something out there in 30 days. That is an astronomical feat in the field of medical device development.

Hansa: Now what about those... There might be people wondering right now that, "Well, why manufacture it here when you can get these masks from China?" But recently, as you pointed out in an email to me, the United States pulled the emergency authorization use role, and it's now directing everyone to certain manufacturers. Is that going to be a limitation?

Dr Blum: Oh, that's going to be a huge limitation. We're talking now about the N95. The face shields, they haven't put any stops on anything coming in from China. But N95 masks, absolutely. There've been some scary statistics of people that have randomly tested these masks that they've gotten because a friend of a friend knew someone that had a connection in China and they could get you face masks or, "Oh, I've bought these face masks. I need 50% down." And this is what we call quote unquote, gray market purchasing of these face masks. And for a long time, a long time in COVID world, this was acceptable because of this emergency use authorization that said things like you can use KN95s, you can use masks that have fit this emergency use authorization, which is an authorization put out by the FDA that says, "Listen, you can use this stuff, but it hasn't gone through the rigorous testing that we typically have, but we're okay with you using it in this situation."

Dr Blum: It offers a little bit of guidance, it alleviates a little bit of liability, but what they were finding from a lot of these masks coming in from China is that they were counterfeit and they weren't meeting the N95 specifications. Their filtration ability didn't meet that specification. So for everyone out there, I think it's important to understand what that N95 actually means. Most people that are going to be listening to this are physicians so I hope that they understand that concept of an N95 mask has to tightly fit the face and pass what's called a fit test, meaning that when they spray saccharin or a bitter substance into a air hood and you go through a series of events, that none of that material is going to get through around the edges. You're not going to taste it, you're not going to sense it.

Dr Blum: That's great. That tells you only about the fit of the mask. So these N95 masks, these counterfeits, these ones that don't meet the filtration standards, probably could still pass a fit test so people are assuming that they're safe. The fit test does not tell you anything about the actual filtration of the mask. N95 stands for the fact that, well, the N stands for the fact that they're not oil resistant, but the 95 says that they're able to filter 95% of these small particles, these 0.3 micron particles. The only way to do that is through specific testing standards and a fit test is not one of them. So it really took people to take these masks and realize that the fit test wasn't enough to say that these were safe, send them off and have them tested in laboratories to realize that some of these masks weren't meeting that standard.

Dr Blum: Now we're in a conundrum because a lot of people were getting their face masks from these outside suppliers. I believe it was 60 suppliers that have now been removed from the FDA as being okay for purchasing from. I think the number was that it's down to 14 that are safe to purchase from, and we need millions, we need arguably billions, if these are being truly used properly. So then we have to start looking at alternative solutions. That's one thing that's one of the first projects I mentioned, our face shields were a quick win project, but our long term win project was the concept of, we need something reusable. We need a reusable N95 mask out there. So that's been our long play, if you will.

Dr Blum: We knew that we would never get this out to market in a month or 2 months, and even the concept of getting something out to market in 3 or 4 months is a huge, huge win because you have to do it safely. The consequences of not doing it safely are too drastic and too dramatic, and so we're working on this N95 project now.

Hansa: Great. I think that you made some really great points. So basically what Johns Hopkins had said in terms of the 236 million masks really is going to have some challenges in terms of sustainability, right, as this crisis is going.

Dr Blum: Yeah.

Hansa: So that question is really is it time to actually figure out a proper way to reuse these masks, right, Dr Blum? We're coming close to our close, but I did want to ask you that one last question about what are your thoughts about sustainability? Is that something that we need to get a certified way of sustaining these masks through sanitization? Or is there other ways to do it? What are your thoughts on that?

Dr Blum: There's been a lot of research over the years on the use of elastomeric reusable half face mask respirators, and that's the concept that we took within our project as well. The thought process of in a surge situation that the only sustainable option is a reusable face mask that can be sterilized, cleaned, the filters can be disposable, but if you properly design your face mask, your filter life itself will be longer than your standard disposable N95 respirators. These N95 respirators that are being used right now in the hospital that when you hear the talk about hydrogen peroxide vaporization, and UV sterilization, and heat and ozone, et cetera, these are all being used on products that aren't meant to be reused.

Dr Blum: We are in a desperation mode right now, and so we're trying to figure out how to reuse a non-reusable product and using all these testing strategies to salvage something, to get us to a safe point. But we still need to work on how to get to that safe point, otherwise we're just going to be in a hamster wheel and continue to spin. So it's great and I commend the efforts of everyone that's looking into the ability to decontaminate these face masks, but there are things like the elastic breaks down, the fit doesn't fit right, the nose pieces get kinked and bent and you can't get that good seal again.

Dr Blum: I remember talking to someone in one of the hospital systems recently who said that she saw someone wearing a face mask that had been UV-sterilized or decontaminated 7 times. And she's like "The thing looks terrible. There is no way that still had a good fit on this person's face." And so when we say, "Yes, you can reuse these, you can decontaminate them 7 times, 10 times," whatever the number that the FDA approves it for, I think that one thing that we're not taking into close consideration for that is the wear and tear on that mask over the course of those 7 to 10 days as well, that crush factor, whatever. So these elastomeric masks are an answer.

Dr Blum: When I say elastomeric mask, a lot of people aren't familiar with this concept, it's that concept of the face mask that you see people when they're painting cars and things like that are wearing these big things. We're trying to scale it down to be more friendly for the medical community, something as simple as they have exhalation valves. So you breathe in filtered air, but you exhale whatever it is that is in your lungs directly into the environment. We're trying to take that out of the equation because you want to protect people in both directions. There's a very big misconception in the world, really, but primarily the US that forcing people to wear masks and encouraging people to wear masks is to protect those people. And it's my body, my right, right? That's the thing that I've seen talked about a lot.

Dr Blum: What they don't realize is that it's not about you. It's about the 10 people around you. That mask is only going to do a little bit to protect you unless you're wearing the truly fit tested certified N95 mask. The mask is to protect the 10 people around you in case you cough, you sneeze, and you don't get your elbow up to your mouth fast enough or something like that. These are all important things for us to consider going forward.

Hansa: Yeah, no, I think that's really important and I think your point about making a mask that is designed to be reused is really important, right? Because what we don't want is using those masks that aren't designed to be reused. And to your point, the fit is not appropriate so it's not even doing its job the way it's supposed to, right?

Dr Blum: Exactly.

Hansa: That's great. Okay. Well, Dr Blum we're going to wrap this up, but I just wanted to ask you, if there was clinicians listening to this and there will be, what are 1 or 2 takeaways that you would tell them about in terms of getting involved in a crisis?

Dr Blum: Speak up I think is the most important thing. Don't be scared to speak up, and make sure that your voices are heard as a collective. Because I think that one person speaking up tends to be an opinion, a group of people speaking up is a rallying cry. I think that physicians right now, nurses, frontline healthcare workers, we all need to rallying cries to make sure that patients are taken care of properly, we are taken care of properly as medical providers, and it's the only way to get our country through this situation is to make sure that we're doing this together and joining forces.

Dr Blum: I said it before, I'll say it again, and it's one of the things that I think is the most important thing. There is no "I" in getting through this. One person shouldn't be leading the charge. It needs to be a group. It needs to be people working together with a greater good in mind, without self-interest, without ulterior motives going forward and just charging ahead. It pains me to hear about people that are profiteering off of this stuff and making it sound like they're doing good. That's not what this should be. This should be all about us trying to help each other as society.

Hansa: That's wonderfully said. So come together as a "we" not as an "I" to get to the other side.

Dr Blum: Yeah.

Hansa: Thank you very much, Emily. That was wonderful, and thank you for all the great work you're doing with GCMI, with Joanna, with everyone that you've worked with. Really appreciate it.

Dr Blum: Everyone has been so instrumental in this.

Hansa: Thank you, Emily. It's great to have you here.