Good morning. It's a pleasure on behalf of a group of people who have organized what I hope you'll find to be a very useful session. We have what I hope will be a very useful program. The disclosures are on the first slide and in the swap card. We have intentionally, different from some other sessions, we have multiple speakers. That's intentional because it will provide a whole set of perspectives on how to deal with the important aspects of respiratory protection. Dr. Beckett will talk about pulmonary and cardiac effects. I'll talk about some of the other effects such as subjective and a few words about heat and work impact. Ginisha Pollard, who's the research branch chief at NIOSH for personal protection and the National Personal Protection Laboratory will talk about all the exciting things that happen there. That will be the first hour. The first hour will emphasize the scientific basis and principles. After the break, we will continue in the second hour which will be more focused on how do you apply the science to specific conditions. So Dr. McClellan and I will provide an overview. Bob McClellan has offered to provide a quick overview in addition of sort of the regulatory setting. Dr. LeBow will talk about dermatologic conditions. Dr. Scarry about psychological conditions. Dr. McClellan about pulmonary asthma. And Dr. Berman will talk about conditions requiring special complex insight. And then we'll have a lot of time left for questions and answers. So think about what's appropriate. So physiologic principles, it's a pleasure to introduce Dr. William Beckett who until recently was on the faculty at Harvard and has been my colleague with occupational pulmonary disease for a long time, ever since we met at Hopkins in the ancient years. Thank you. Good morning. So in the next 20 minutes, I want to review the loads of respirators on the lungs, the heart, and heat loads with an emphasis on N95 respirators. But before we launch into this symposium on respirators, I want to return to the NIOSH hierarchy of workplace controls to say that respirators are at the bottom of the list. In terms of reducing a workplace exposure, the first priority is to eliminate the exposure. If you can't eliminate a toxin, next best is to substitute a less toxic toxin. If those are not available, engineering controls like enclosure or area ventilation or local exhaust ventilation are prioritized. After that, administrative controls, limiting individual exposure by rotating workers in and out of exposure. And only at the bottom of this hierarchy list are personal protective equipment like mask respirators, which should really be used only when these other possibilities are not feasible. So the engineering of respirators has evolved hugely over the last 100 years. On the left here is a World War I gas mask that was used to protect lives against phosgene gas and chlorine gas on the battlefield. And on the right we have the market engineering advances of the N95 respirator, which has tremendous filtering capacity for very small bulk and discomfort. We can look at respirators in different ways of categorizing them. Here we have positive pressure respirators and negative pressure respirators. The two panels on the left are positive pressure respirators and SCBA, where clean air is delivered from a tank on the firefighter's back into a full face mask under positive pressure. And the next panel shows a power to air purifying respirator where ambient air is filtered through this pack on the back and carried up into the hood and delivered under positive pressure. So the advantage of these is a better protection factor because positive pressure inside the respirator flows outwards and so contaminants cannot flow inwards. More common are negative pressure respirators like these. We have a full face mask here with dual canisters. This is for removing ammonia from the workplace. The full face mask is all these negative pressure respirators require the wearer to use their respiratory muscles to breathe in and to generate a negative pressure within the mask, which then allows ambient air to flow from the outside to the inside through a filtering mechanism or an absorbing mechanism. So the full face respirator, the half mask respirator, again with dual cartridges, these are for particles. And the N95 respirator, which is also for small particles, which is the least bulky and least uncomfortable. For the design of the N95 respirator, we have to thank this man. This is Dr. Peter Tsai of the University of Tennessee in Knoxville, who made the important engineering leap which made the N95 respirator possible. In 1992, he and his team added to the usual fiber filters of the previous designs of face piece respirators a process of adding electrostatically charged positively, positive and negatively charged polypropylene fibers to the mask matrix. So adding to inertial impaction and interception of fibers and diffusion of very small fibers, they added the electrostatic attraction of these polypropylene fibers shown here as the yellow circle, which allows the N95 respirator to be markedly more effective in removing small particles from inspired air. So the use of respirators in the workplace usually requires at the outset, when you're first characterizing the workplace, the assistance of an industrial hygienist to tell us what contaminants are in the air, what are the maximum concentrations of the contaminants, and whether the concentrations are above the occupational exposure limits. Do we need a respirator or do we need industrial controls? Are the levels so high that there's a hazard? Are the contaminant concentration levels above the immediately dangerous to life and health levels? Because if they're above the IDLH levels, a respirator is not recommended. We know from good studies in the workplace over decades that people who are asked to wear respirators in the workplace don't have them on all the time. And so if there's an immediately dangerous exposure in the workplace, respirators are not going to be an effective means for prevention. And if respirators are appropriate, which cartridges, which kind of filtering or absorbent methods to use, and is the respirator going to be compatible with the job requirements? And in addition, after the industrial hygienist, we need the expertise of health professionals to perform a health evaluation. Is this individual medically able to wear a respirator? And health providers usually must first know the type of respirator and job requirements. I'm sure many of you have had the experience that I have of having a patient sent to me for a respirator certification, but there is no information about what type of respirator, what the job requirements are, where this person is going to be assigned to work. And without that information, it's not always possible to do a respirator certification. And after the respirator certification, the health professional must still be available to meet with the worker to explain their decision. Yes, you can wear this respirator. No, you should not wear this respirator. And also to evaluate any symptoms that might occur when the worker goes into the workplace with the respirator and may have problems or questions. So there are three common types of N95 designs. We're going to be focusing a lot, I'm going to be focusing a lot on the loads of N95 respirators. There are the cup, the pouch, or the duckbill, and the trifold. And if I were responsible for buying a large number of respirators for a group of workers in a workplace, I would really want to dip into the literature because there have been now good head-to-head comparisons of the acceptability of these different kinds of N95 respirators, which are in terms of efficacy pretty equivalent, but in terms of how workers accept them, how they feel about them, they can be quite different. So depending on who your workforce is, you might really want to look at some of these head-to-head comparisons before buying a large volume of respirators. So now I'm going to move on to the physiologic loads of respirators, starting with pulmonary loads, and I'm going to start with dead space. You remember the World War I gas mask? There's a huge volume of air within the mask. Current respirators have reduced dead space a lot. Anatomic dead space, for all of us, that is gas that's not in contact with gas-exchanging alveoli, is about 150 cc. So we're all flushing out our 150 cc's of dead space with every breath. The added dead space of an N95 respirator is not much. It's about the same. It's about 100 to 175 cc's. So we've got that 150 cc's within the cavity of this mask, but actually there is not perfect mixing. And so the actual measured dead space of a mask may actually be more than the functional dead space of a mask because of imperfect mixing. Normal subjects, it turns out, when tested in the laboratory or in the workplace, including pregnant subjects, can compensate very easily for this very small dead space. It turns out that the dead space of currently approved respirators is quite small. But there are some patients with advanced COPD, and I emphasize advanced. I mean people with an FEBB1 less than a liter, or very severe heart disease. And again, I mean poorly compensated, bad congestive heart failure, may have higher blood CO2 levels when wearing N95 respirators. So we need more research for these very extremely compromised individuals. But these are people who, for the most part, would not be in the workplace or would be in a desk job. Second pulmonary load is increased carbon dioxide and reduced oxygen within the cavity of the mask in the inspired air of the mask. Normal expired air, normal ambient air has about 0.04% carbon dioxide, but we're producing carbon dioxide. And as we breathe that into the mask, the dead space contains a level of carbon dioxide that may be something like expired air, 3 to 8%. And so because of the higher level of carbon dioxide in the mask, it displaces oxygen, so ambient oxygen is also lower by about 3 to 8%. Turns out healthy adults tolerate this very well, even with high levels of exercise. And these small pulmonary loads, it turns out, are not strongly related to the widespread mask discomfort that we all know about that people experience with N95 masks. But for patients with severe lung disease, the ability to tolerate respirators during exercise, particularly high levels of exercise, needs further study. Another pulmonary load is the resistance, the work that you have to do to overcome the resistance of the mask when you're breathing in. One nice thing about N95 respirators is that the whole mask is a filter, and so the resistance is spread out over a large surface area, as opposed to this small canister, for example, of the World War I gas mask. The added inspiratory resistance of an N95 respirator is relatively little, but it can increase at high levels of exercise. The more we exercise, the more we breathe, but also the resistance can be nonlinear, so the actual resistance of the device can go up with high levels of exercise. It turns out that, with regards to comfort, expiratory resistance of the same amount as inspiratory resistance in a respirator is more uncomfortable in blinded laboratory studies than the inspiratory resistance. But with a negative pressure respirator, when you breathe out, you create positive pressure in the mask. Some of that air can leak out around the edges without compromising the effectiveness of the respirator, and some respirators come with expiratory flap valves, like this one, which can reduce the expiratory resistance. So, to summarize the pulmonary load effects, there's a slight increase of inspired carbon dioxide, and for some subjects, a slight increase in blood carbon dioxide. There's a slight decrease of inspired oxygen, but if you look at blood saturation during exercise with the respirator on, blood oxygen saturation is normal, so healthy, normal individuals compensate for this very well. There's a slight increase in nasal resistance. When you put on an N95 mask, some people's cross-sectional area of their nasal passages actually goes down a little bit, so the nasal resistance changes, and the oral-nasal breathing pattern can change a little bit. There's a slight increase in the work of breathing from the resistance, as well as the dead space. There's a slight decrease in minute ventilation with high levels of exercise. There's a slight decrease in maximal exercise at the exhaustion level for some adults, but overall, these effects are not clinically significant in healthy, normal adults, pregnant subjects, and those with milder lung conditions, and further study is needed for those with severe heart and lung disease. Now, let's look at the cardiovascular effects of respirators. So, first of all, the main cardiovascular effect has to do with the weight of SCBAs. SCBAs can weigh, in terms of the entire kit, as much as 30 pounds. Most of them don't weigh that much, but for someone who's going to be approved for an SCBA, you really have to consider the cardiovascular loads in terms of, does this person have cardiovascular disease? And this load can be added to the weight of the other turnout gear that's used for firefighting, mine rescue, and disaster management. During exercise, N95 respirators may cause a slight increase in the already increased. I mean, when we exercise, our heart rate and our blood pressure should go up, and some people who wear an N95 during high levels of exercise, their heart rate and blood pressure is measurably higher, if you look at groups, but not so much that it's clinically significant. And the inspiratory and expiratory resistance can cause small swings in pleural pressure, but again, this is not enough to cause significant cardiovascular loads. Now, let's turn our attention to the thermal loads of respirators. As we breathe out into a respirator, our exhaled breath is 100% saturated, so it's 100% humidity, and the breath starts out at body temperature, 98.6, so by the time it gets into the mask, it's still highly saturated and quite hot. Air temperature and humidity inside the mask are higher than the ambient air, unless the person is in a very hot, humid environment. The skin temperature inside the mask is higher than outside, and this leads to discomfort. It's uncomfortable in normal and hot conditions. In cold conditions, as some of us have experienced, the mask is actually kind of more comfortable. So thermal comfort is determined primarily by the overall ambient temperature and humidity. If you ask people, how are you feeling in terms of hot and cold, the outdoor temperature and humidity are the most important factors, but if you vary the temperature and humidity inside the mask, we can see that mask temperature is also important. We're all aware that when it's hot and we fan our faces, we feel a lot better, even though our body temperature stays the same. We human beings are really sensitive to just fanning our faces, and on the other hand, covering our faces is uncomfortable. But even in hot conditions, the higher temperature inside the mask, the higher skin temperature inside the mask, does not result in a higher core body temperature. So we're dealing really here with not a whole body thermal stress, but a comfort stress. So respirators add small loads to the respiratory system. They may cause slightly increased breathing and slightly increased CO2 levels in some subjects. These are compensated well by healthy adults, except at the highest levels of exercise. The cardiovascular load may cause slight increases in heart rate, systolic blood pressure, and peak performance during strenuous exercise. A significant load is related mainly to the weight of the SCBA, and facial and skin temperature and humidity do rise with respirators, causing discomfort, but they don't affect core body temperature. Pulmonary, cardiovascular, and thermal loads are small and not clinically significant for healthy adults or those with mild heart and lung disease, and effects are not seen in all studies except with high exercise levels. A small number of subjects, however, may have atypical responses, and the common discomfort of filtering face space for respirators, N95s, is not clearly linked to the small pulmonary and cardiovascular loads, but could be more related to heat and moisture of the face or increased nasal resistance. Thank you for your attention. Thank you for a great, as usual, a great talk, Bill. In the next few minutes, I'm going to talk about some of the other topics. One of the impacts, as you know, is this interferes with communication. So we know that a fair bit about the pulmonocardiac effects. I'm going to briefly touch some of the others as we go. Conflicts are already explained. We're going to talk about the scientific basis with, I'm going to emphasize a little bit about the things you need to think about to deal with the complex situations and to look ahead to what's coming. There have already been big changes. Things have evolved from using these mainly for minors and gas warfare to much more extensive use in industry. Regulations got added in the early part of the 20th, early and mid-20th century, culminating in some of the OSHA regulations and the NIOSH regulations on certifying respirators. then a big thing happened with moldable drug resistance and SARS-1, not the current one, that got healthcare workers involved. Before there was many healthcare settings refused to use these, they became acceptable. Along with the MDR-TB and healthcare use, a lot of things switched, and that gets directly to the medical evaluation from hands-on evaluations and more extensive testing, the maximum voluntary ventilation, et cetera, to much more reliance on a questionnaire, per se. And of course, the N95 came along, as Dr. Beckett pointed out, that changed a lot. As Robert Zimmerman said, or Bob Dylan, as you may know him, times are changing. What's happening now? First of all, there's some movement away from exposure measurement to hazard assessment. The exposure measurement, the industrial hygiene, how much is in the air technique, may not be easily applicable to the healthcare setting, where you don't, it's not easy to measure how many SARS-CoV-2 viruses are in the air, et cetera. So there's a movement more to exposure assessment, which makes the formula of take the ratio of the chemical in the air to the recommended limit, and take the ratio, and that's how much protection you need, and then throw in a safety factor. It's a little more complicated. A lot of respirators are being used, increasingly outside the OSHA paradigm, and it was not just in workplaces. They're being used in the community for wildland fires, air pollution episodes. They've been widely used in Asia for air pollution a long time, and of course they're being used by children, who in many ways differ from adults. Again, traditionally we do fit testing, and we train them. It's the employer's responsibility, and Dr. McClellan's going to provide a good discussion of the OSHA requirements, albeit brief, in this area. But that's hard to do on a community setting, and it may even be hard to do in many of the small shops, retail, mom and pop shops, if they still exist. Supply and cost. The pandemic clearly showed there were supply issues. A big issue is not just how many are available, but are they available to the people who really should get them? There are serious equity issues that Janish Pollard's going to talk about. Training. How do you train people most effectively to use it? I think we've all seen people, and we go look at how they're doing it, and they've got the mask on upside down. That's a training failure. And again, what's the role of the healthcare provider? Is it just to meet the minimum OSHA, or is it to really understand the background and provide a fair bit of expertise? So heat and humidity, I think Dr. Beckett did such a thorough job, I'm not going to say much about it, except to point out that N95s and similar FFRs are generally better tolerated projectively than most other types, except for heat. Numerous studies have shown that heat discomfort is greater in the N95, particularly if there's no exhalation valve, which of course we probably don't want to use if we're using it in a COVID setting. So that becomes a big deal within the N95. In some studies, it's actually the leading cause for not using it. When we think about this, of course, as Dr. Beckett pointed out, it's really the facial heat that matters, not so much the whole body stress. It's the local sensation that matters. In evaluating patients and workers, we need to distinguish two consequences, the direct and the downstream. For example, the direct effect is the discomfort reported or cardiovascular effects. Downstream effects are those such as making dermatologic conditions more prominent, and Dr. LeBeau is going to be dealing with that later, fogged glasses, which can be a problem for people. So again, the downstream effects can be important also. Let's skip this. Obviously, there's a study out of the NIOSH NPPTL that when Ebola was prominent, combining the respirator with impermeable clothing, and it's not a good mix. The treatment, this is going to be important. What do you do about it? Well, first of all, of course, you control the exposure. You control whether you need it. You control the ambient conditions. You can limit the duration of use because many of the problems related to heat and others are related to how long you have to use it at any time. Obviously, you can switch to a PAPR or perhaps even a half mask. In some instances, you can switch to one with an exhalation valve. And of course, you can treat the symptoms. What I think probably should not be done is put various kinds of barrier creams and things to prevent skin irritation, unless you're sure that's not going to create a leak. There's some experimental work, putting tiny little fans in the masks and developing materials that transport water better. Now, I'm going to talk very briefly about what I think is really the big problem we face, symptoms. There's a real conundrum. Symptoms are common, but when you're talking about the N95-like devices, the physiologic loads are not very great. So the question is, why do you have people say, I just can't use it, when we know, as Dr. Beckett pointed out, the loads are not that great in normal or even people with mild disorders. We had studied a bunch of people with mild disorders. So this means one of two things. Either the symptoms aren't real or aren't worthwhile to pay attention to, or maybe we're asking the wrong question. Maybe we shouldn't, when we do our medical evaluations, ask, are you able to overcome the resistance and the dead space, or are you able to effectively use this, et cetera? I think we may have been focused on not necessarily the right questions all along. A lot of the early work was really derived, interestingly, from Navy divers, historically, who were using SCUBA, not SCB, but SCUBAs. And a lot of the resistance and various approaches used really were derived from that important work. But that's a little different from this. So another thing to think about is the context. And that's why this is a little tricky, because it's not just a question of, well, check the box and ask, do you have asthma and silicosis, but rather to think about, are you willing to accept the symptoms? For instance, on Tuesday and Saturday mornings, if I can, I want to get a little tachycardic, diaphoretic, and tachypneic, and have my hamstrings get sore, because when I can, I go to spinning early in the morning. And if I don't develop symptoms, I feel that I've wasted my money on my gym membership. So why do I accept it there? But why wouldn't I accept it when I'm wearing one of these? So I think a lot depends on the perceived threat, and we'll talk about that in a minute. If you think that it's a really big risk, like if I breathe in a COVID virus, I'm going to die, you might be willing to accept the symptom that you wouldn't normally take when I have to wear this all day to stand around and visit the exhibits. Perceived efficacy. Do you think it'll work? Well, I mean, as we know, this has been politicized, and there's a lot of information out there that said, well, these are worthless. So, of course, some people don't think they mean much. Again, in case this doesn't ring a bell, this is the health belief model. There's a conceptual model for why people behave. And obviously, whether you do certain health behaviors depends on your self-efficacy and how important the problem is. Another element that became prominent here is self-directed versus mandated. In other words, if somebody says, you will wear this, the natural response is to say, no, I won't. I had the pleasure of working with some people in the Department of Communications and Computer Science, et cetera. So we looked at about two million tweets. This is not a particularly profound paper, but it was sort of interesting. Two million tweets about COVID. And Steve Rains led this particular analysis. Reactance theory explains it well. It was nice because states mandated it at different rates, so you can see when the anger — you know, the computer can read a tweet and say whether it's angry or happy or whatever. And you can see when the anger went up. Surprise, surprise. The state says, you will wear it, and that's when the anger coming out of that state goes up. Okay. The symptoms, unlike a lot of the physiologic work, the heat work, et cetera, has really weaker science. There are a lot of studies, particularly since the pandemic — the paper that Bill referenced in the AJIM — I think there were like 800 papers, 60 percent of which — 70 percent of which were published since the pandemic started. But the methods are incredibly variable. It precludes aggregation across studies, and many of them have no comparators. In other words, how is it with the respirator versus without, or et cetera, especially the post-pandemic ones. There are potential biases. You can see you're going to get a different answer to the question if you ask, have you ever had itchy skin versus — have you ever had skin discomfort when wearing a respirator versus how does the respirator make you unable to use the respirator? You see, I mean, very — and a lot of the one — so a lot of the prevalences of symptoms vary depending on how the question is asked and who's being asked. Questionnaires can be wrong. Symptom detection may differ from significance. In other words, I pointed out that when I go spinning, I — it's okay for me to have some symptoms. Now this is an example of an excellent paper that shows questions can be wrong. And Donovich is, in my view, one of the most careful, well-organized investigators around. And they did a study in 2009 that basically talked — did a very quasi-experimental study with crossovers and all the right stuff, and asked how long do you think you could keep wearing it. And very few of the users thought they could use it for eight hours. But surprise, surprise, when it came pandemic time, I don't know what the number is, but a lot of them were able to use it. So clearly the self-projection was different than just the 33 percent — the 33 — they found that only 33 percent projected they could use it eight hours. A lot of them took it off, didn't actually use it in the design for the full eight hours. But when it came pandemic time and they felt threatened, they could do it. Diagnosis — here again, why — how do you deal with symptoms? You diagnose it the way you do almost anything else. You have to ask, is it organ-specific, or is it general? I just can't stand it. In other words, is it my skin? Is it my lungs? Is it my heart? Is it my anxiety, or it's just — I just don't — I just can't handle it. Is it individual or cultural? In other words, does everybody in that particular site have that complaint? Does it indicate an underlying — underlying medical problems? My skin really bothers me. Oh, you've got acne. Maybe if you treat — you know, maybe treating the acne will be better. I have anxiety. You know, maybe that's the treatment, not dealing with the respirator per se. Is it important? Will it reduce the likelihood that you use it when you need it? Will it interfere with the work or other life activity? And of course, does it have a physiologic effect? These are the things you want to ask when it comes time to evaluate a — do a medical evaluation. You know, the — well, if they have symptoms, give them a PAPR may not always be the optimal approach. And you treat based on the underlying condition. Sometimes you modify the job, as Dr. Beckett pointed out, in the hierarchy of controls. You want to ask, what is underlying it? Is it an unusual severe stressor? That is, it's really hot. Or I'm — we're using an SCBA in an awkward posture. Is it an organ-specific problem of COPD or acne? Is it a psychophysiologic sensitivity? Some people are more sensitive to noise and light than other people. Is that really what it is? Or is it interpretation? In other words, is this acceptable? And part of this is our job to educate our users about what might be acceptable. And of course, there's the social acceptability. Will I tolerate it? That's the risk-benefit consideration. You know, do you really — do I really need this? Yes. If you can show them that they really need it, they may tolerate a symptom better or accept it. And of course, the social context, you know, the boss made me do it, whether the boss is the government or is the immediate supervisor. So these really matter. And that's what you need to get at. This is just an example of the kind of study that showed that perceived threat really matters. Stell Heinz did a simple study at the University of Maryland where she asked people, would you prefer an N95, a PAPR, or an elastomeric health mask? And if it was just rural LTB, the blue line, they all mostly preferred N95s. But if it was something really bad like active TB or pandemic, this was H1N1 or SARS-1, no, I'd be much more willing to accept an elastomeric. So again, it's really important to ask, what is the patient's or the worker's perception of the situation? And so part of the treatment for symptoms may be to explain why you really need it in this situation. Diagnosis-based treatment, I'll quit. Work impact, that's the third thing to think about. Obviously, some of them have impact on your mobility. If you're using an SCBA or an airline respirator, you can't climb ladders as a painter. Some things limit your absolutely maximal exertion. A lot block communication. There's a lot of impact on speaking, vision, hearing, trusting, and perceiving. It's cultural. In some cultures, reportedly, you depend on the eyes. In the U.S. culture, we depend on the mouth to perceive and communicate feelings. So again, this may affect us. And of course, attention and cognition become important. So again, one thing we want to do when we evaluate workers is not just check that they have asthma, et cetera, but also, will it impact their work? So the key points are, number one, things are changing. That's why I think it's really important to understand the basis and think through what to do. That broadening the scientific basis is needed, and that's Janisha Pollard is going to tell us about the exciting work that NIOSH is doing in just a minute. Subjective effects are quite common, and serious research and high-quality research, preferably not limited to the best medical centers where acceptance may be better or to only people who sign up for studies, who may be a biased sample, is really needed, and we need good techniques for that. Thermal effects really matter. And Janisha Pollard is going to speak now, but after the intermission, please come back because we've got some great speakers who are going to be talking about application of this. So now it's my pleasure to introduce Janisha Pollard, who's the chief of the research branch of NPPTL, and she'll explain exactly how important that role is. I should say, Bill and I wrote a paper. We looked at like 800 publications, and an amazing number of them came from NPPTL. So it's a pleasure. Thank you, Phil, and thanks for the invitation. I'm very happy to be standing here before you today to tell you about a little bit of the research that we're doing at NPPTL. And I am saying a little bit because I was asked to only speak about respiratory protection, but I'm really focusing on the work that we're doing related to the healthcare setting as well. So I'm sure most people know NIOSH, but I did just want to make it clear that we are a part of the Department of Health and Human Services under the U.S. Centers for Disease Control and Prevention, and NPPTL is a part of the National Institute for Occupational Safety and Health. So throughout my slide deck, I do have some QR codes, which are in the upper right corner, and that just takes you to the links that have information relevant to whatever I'm presenting on the slide. So that QR code does take you to our webpage. NPPTL was established at the request of Congress in 2001 with our mission of preventing work-related injury and death by advancing the state of knowledge related to the application of personal protective technology. So we often get questions about, well, why can't I use this respirator in this setting, and why can't I use this respirator in another setting? And I'm here to tell you that that is not NIOSH. So on the screen, you will see that NIOSH does establish their approval requirements for respirators, and then NIOSH and FDA work together on the requirements for healthcare, and then specifically in mining, NIOSH and MSHA work collaboratively. When it comes time to workplace use requirements, that's when OSHA sets the standards for what needs to be there within the workplace for respirator use, and then MSHA sets those establishments for mining, and then FDA sets those for healthcare settings. So if you were to ask NIOSH what respirator you can use in healthcare, we'll say, what are the hazards? But then it was really up to FDA to determine what level of protection is required. Another thing that we're really excited about is that we're establishing and finalizing our NIOSH healthcare PPT targets for 2020 to 2030, and this is really going to guide all the research that we're doing in the healthcare setting, and it's really establishing a roadmap for what NIOSH feels is important right now, what areas we've identified as being major gaps and key needs. And as you can see, we posted a federal register notice to solicit input. We got a lot of input. We did have to extend the deadline just to be able to allow more people a chance to input. We got information from rehabilitation clinics, allied health services, you know, we got a lot of things about, hey, your glove testing isn't enough, you need to do more. We got a lot of things about, you know, there's diverse bodies, you know, women are not just small men, and it's very difficult to design and develop and evaluate PPE when you just look at females as smaller version of men. And we did receive, you know, input from a diverse group of respondents. So we're finalizing these PPT targets. There is a link on the screen that takes you to our draft, but we're hoping to have that finalized version out very soon. And then I'm here just to speak to you about the work we're doing within the research branch. So the research branch really supports the mission of NPPTL. We collaborate with standards development organizations to develop and propose new PPT standards. We formally conduct research that really informs how PPT is used and recommended and selected in many workplace settings. And then we really try to maintain a responsive research portfolio. So if you've ever submitted a question to NIOSH on our webpage related to a piece of personal protective equipment, whether it was a respirator or gowns, those typically come to me. And then they go to our subject matter experts to answer those questions. So we try our best to be very responsive to the needs of the user populations. So like I said, I'm here today mostly to talk about respirators, but I did just want to make you all aware that our research program includes a lot of other things. It includes protective clothing, respirator research related to respirator filtration, respirator fit, respirator performance, physiological effects of using respirators, physiological effects of using full body PPT systems, comfort. We're also doing a lot of surveillance and intervention research, equitable PPE, and as always, pandemic planning. So I'm sure as you've all seen during the COVID-19 pandemic, as well as Ebola and H1N1, NPPTL research did inform PPE use guidance and recommendations. So one of the things we did is we supported research to understand respirator use in the sterile field. So Phil mentioned a little earlier about, hey, maybe you don't want to use that respirator with the exhalation valve if you're considering COVID. So we actually did a study to determine, okay, what comes out of these exhalation valves? What do we need to know when we're recommending respirator use when they would typically use an N95 or a surgical N95 and they just aren't any available? So we quantify the level of bacterial contamination. It was in a simulated surgical setting. They wore PAPRs and N95 and elastomeric half-mask respirators. They did some different speaking techniques. And then we actually sampled it in the air to determine where the bacteria was found, the size of the bacteria, how much was present. And what we found is that the airborne concentration resulting from either use of PAPRs, they weren't significantly different from surgical masks. And as we all know, surgical masks is what you would need to wear in that setting. So what that tells us is, based on the performance of PAPRs in healthcare settings, they would be fine for use. However, FDA establishes those use requirements, not us. But this paper is available. It is published. If anyone has any specific questions on anything I'm presenting, feel free to send me an email and I will respond as soon as I can. Another thing we did was we informed the FFR reuse strategy. So I'm sure a lot of you have heard of the brown bag technique where you have a respirator, you put it in a brown paper bag, you allow the bacteria to die off, and then you can reuse it. So we did a lot of research to inform that. We worked with Patel Labs, and we found that, you know, we saw a 93.4% reduction in viable virus for the most challenging conditions, which is very low relative humidity. And we exceeded 99% reduction for all other conditions. So what that tells us is, yes, it is safe to put a respirator in a brown bag, to leave it there for five days, and to wear it again, and you do not have to worry about the bacteria living on the surface of that respirator. And then our exhalation valve research really did inform CDC's guidance. So when we got to the point where we only had respirator exhalation valves available and people were worried about source control or asymptomatic spread of COVID, we had our researchers in the lab at our facility in Pittsburgh, and they did a really thorough study looking at what can we do, what's coming out of the exhalation valve, and how do we stop it? And so one of the things we tried was a little bit of tape, duct tape, and then we also used an electrocardiogram pad. So one of the models of respirators we used was 3M, so we used one of the 3M electrocardiogram pads. We stuck it on the inside. That was enough to fully block the exhalation valve, and that's something that 3M actually recommended for use of their respirators. So that's something that came directly from our lab, very practical, very inexpensive, using things you already have, but it really did create a solution to an issue that were plaguing a lot of people. We also looked at what happens when you block the exhalation valve of an elastomeric half-mass respirator. We did find that it did increase the exhalation resistance, and it did increase the CO2 levels, but not beyond those that would be required for our testing and approval. So it was still in full compliance with our respirator testing. So I'm going to go back a little bit, because in 2017, NIOSH and PPTL did implement a study looking at how do we bring elastomeric half-mass respirators into healthcare settings. So a lot of people refer to elastomeric half-mass respirators as industrial respirators, and we don't really like that term because, like we said, we develop requirements for respirators based on their use conditions. We don't have a respirator for healthcare, a respirator for construction. They're all respirators to us. So we were really looking at how do we bring this respirator into use in healthcare settings because it is reusable, it fits more people better, you have these filter pads that you can reuse a lot, and we really thought that it would be something that supports future pandemics, so pandemic planning. We did not foresee the COVID-19 pandemic, though. So we did do three different hospital demonstration studies. We looked at the ability of a healthcare system to rapidly fit tests on their personnel to switch from N95 FFRs to elastomeric half-mass respirators. We also looked at a study looking at how we can better understand their feasibility for patient use because, you know, if you're used to having a doctor or a medical professional come in with nothing on, and then they suddenly come in with an elastomeric half-mass respirator, that may be a little startling, even frightening for patients. So we wanted to understand how better to support implementation of those in hospital settings. And then we also wanted to look at how do you clean them? I mean, do you just use whatever sterile wipes you have on site, or is there a specific technique you need to be aware of? Where would the bacteria actually grow? And so we concluded the first two, and we're still finalizing the third one. But we're also starting a new contract where we're looking at assessment best practices and preferred uses in healthcare settings. So this contract we just started last year. We haven't determined exactly which elastomeric half-mass respirators will be included, but one thing we are doing is we're including those newer models that don't have exhalation valves that came out during the pandemic. So our research and working with manufacturers during the COVID-19 pandemic and determined that there may be a great potential for contamination through the exhalation valve. We worked directly with manufacturers. They did implement a few models that don't have exhalation valves, and then a model that actually has a filter on that exhalation valve. So we're planning to include those in our study, because there is still some concern that what happens when you wear those for a prolonged period? Is there too much dead space? Do you have the dizziness from, you know, carbon dioxide and things like that? So as part of that, we're doing workplace activities, and we're doing physiological measurements including transcutaneous CO2, oxygen saturation, respiratory rate, inspired temperature, and then moisture content, because that's one of the biggest complaints we hear. It's too hot. It's too humid. My face is sweaty. I'm having skin breakdown, and we really want to understand what we can do to reduce that and exactly when it occurs and how it occurs. As part of that, we're trying to develop a respirator specifically for healthcare personnel, and this is coming out of our studies looking at those other elastomeric half-mass respirators, understanding what users feel are important features, what users feel are features that are getting in the way, and what would be the ideal reusable elastomeric respirator for healthcare settings specifically. So we are conducting tests with different filter media. We're doing a lot of computational fluid dynamics to understand where the air would travel, how to support reducing moisture, reducing heat, and things like that, and then we'll have to implement this at our contract at the hospital setting. What I do want to make clear, and this is our, that little yellow label is from our approval program, NIOSH doesn't make respirators. So NIOSH is designing a respirator, but it would be up to a manufacturer to decide that they would like to make that, and then they would still have to go through the full NIOSH approval process. But by us designing it, doing all the work, doing all the research, it really is taking away some of the issues with getting someone to make it. So we're doing all the work for them. They'll just have to do the part of developing and manufacturing it and actually seeking NIOSH approval. So this is our first very, very rough prototype design. It does include a solid modeling, and it does have some prototypes. It considers the shape and profiles that healthcare personnel are used to, so it is a quarter mass respirator. It is more of the form factor of an N95. It does have better field of vision around it, below, and beside, and it definitely removes exhaled breath out of the respirator dead space, so you don't get that accumulation in the dead space. It also uses two exhalation valves so that it quickly removes that exhaled breath, and our prototypes are being incorporated into our demonstrations contract right now. I don't have an updated picture. We're hoping to get new prototypes within the next couple of months. We also looked at what happens when you modify an elastomeric half-mass respirator for source control. So for a while, we saw people covering their elastomeric half-mass respirator with surgical masks, and we looked at, well, what does that really do inside of the respirator? So we did find that you do have an increased exhalation resistance, because that would be obvious. You're taking something that is valve, you're covering it, so now you have more resistance. It does still meet the NIOSH requirements, but we did find that it did increase exhalation resistance, but not always the CO2. So we think it's okay if you have to do that, but now there are NIOSH models that don't have these exhalation valves. And another thing that we're hoping to bring to production is we looked at a lot of the elastomeric half-mass respirators on the market in use in healthcare settings, and we're trying to develop a retrofit. So what this means is that the respirators that are already in use in healthcare settings that do have these exhalation valves, the manufacturer could then take our design and actually build a filter adapter that would just snap on. So in times when they need that source control, they'll be able to add this. At times when they don't, they don't have to use it. So this is another thing that we're really hoping will make a big change, because now you don't have to go out and buy 10,000 new respirators if you already have one of the four models that we're developing it for. We're also looking at how do we support implementation of elastomeric half-mass respirators in healthcare settings, because we realize it's more than just saying, hey, take this respirator, wear that. It can have a huge impact on a safety culture within the workplace, and how do we best support that? So another thing we're doing is we're looking at settings outside of just hospitals. We're looking at health delivery settings, including, excuse me, we're looking at, which one is this? Firefighting, law enforcement, and dentist's office. So as part of the S&S distribution of respirators, we reached out to the people that received respirators from the strategic national stockpiles. We said, hey, we're doing a study. We'd like to understand how you can best support implementation of these respirators. Will you please work with NIOSH to understand that? We did have some people that said, sure. We also had some people that said, no, thank you. So along with those groups, we're working to identify how do they best support the implementation, what challenges were present, and what we can do to recommend guidance for further implementation in the future. We're also looking at safety climate metrics to establish some evidence-based guidelines for PPE management practice. So this includes health care personnel and EMTs during public health emergencies. We're identifying programmatic implementation guidance for incorporating new respiratory protective devices. So this is not just a last-dimmer half-mast respirator. This could be someone who's never used a respirator, and now they're trying to use N95, or someone who's used N95s, and now they're trying to use PAPRs. We're really trying to understand how best to support them with implementation of respiratory protective devices. And then our future focus is really being PPE protections for everyone, not just those people that come from really expensive hospital systems. You know, we're really looking at how do we support the home health care aide that doesn't get a respirator from their workplace? How do we support the pregnant woman that has to wear a surgical gown in an OR setting that doesn't fit her well? So what we're developing is a strategic framework, and we're trying to establish a roadmap that documents the existence of characteristics, gaps, and challenges related to equitable PPE protections. We did our first step by having an equitable PPE protections workshop. As part of that, we are identifying and organizing collaborators across the PPE community. And the PPE community is not just manufacturers. PPE community is manufacturers, researchers, end users, purchasers, distributors, anyone that has any type of influence or impact on PPT or how people use PPT. Those people will be a part of our community. So all of you here today listening, if you're interested, you would be very welcome to be a part of our PPE community. And then we're going to identify viable solutions and approaches that address the gaps and the challenges that were identified early in the stages. We're also going to establish a prioritization framework for meeting these gaps and challenges, which can be difficult because some gaps require a lot of money, and we don't always get a lot of funding. But that's really our goal. You know, if we can tell people, hey, this is the issue, this is the need, maybe there's someone else that can support the research or another university that can conduct the research. We're going to identify and describe roles for the members, and then we're going to establish a roadmap. One of the things that we've been really successful with recently is leveraging crowdsourcing challenges because we are small and mighty, but we can't do it all. So where possible, we try to engage those innovators in those communities and small businesses and universities to come up with solutions for some of our PPT challenges. So the first thing you see in the upper left corner is our protective clothing fit challenge. So that was a challenge that went out saying, hey, give us your best idea to address equity issues related to the fit of protective clothing. And our winner is actually this company here. So as you see, this is a surgical gown, but it does have that accordion-type folds. And that's really to support women during different stages of pregnancies. It's also to support people of different body shapes and sizes. And it's just designed to be something that can accommodate more fit and more anthropometric dimensions of bodies than a standard surgical gown. We also have a respirator fit challenge. So this is a challenge that's out right now where we're looking to identify new, better, improved, cheaper, faster, leaner, less calories ways to assess respirator fit. Because not everyone has the ability to purchase a port account. If you are a small business or if you are a home health care agency, is there a better way that you can assess the fit of respirators that you provide your staff? And then we're also doing a counterfeit respirator challenge. Because during the pandemic, a ton of counterfeit respirators came to our workplaces. And NIOSH was really instrumental with doing a lot of testing. We worked with U.S. Border Control. We stopped respirators there. They came to our lab. We did testing. We determined how well they performed. And then we would say, they seem to be well performing or they're not. And that may continue to be an issue. So we need to be better suited to deal with that issue in the future. So we're soliciting support from people saying, hey, what should we do? What do you think will work? What have you tried in other industries that's been successful? And we're also continuing to look at respirator fit. So on the screen is three of our current projects. One of them is looking at the user seal check and how it applies to elastomeric half-mask respirator. So if you're not familiar, when you do DON and N95 FFR, you're supposed to do a user seal check where you put your hands on, take deep breath in and out, and then you're supposed to feel that vacuum effect. We don't know how well that works for elastomeric half-mask respirator. So that's a study that we're hoping to start sometime soon in our laboratory to assess is that something that's feasible, or do we need a new technique, and how well does it work at actually making sure you're getting a good seal. We're also working with the University of North Texas to develop a real-time fit sensor using a surface acoustic wave sensor. So this test system is really designed to determine when there is a break in the seal of your respirator. Right now, we have a very rough prototype, but it's quite large. So we will need to do some more refinements in that design to make it something that's more suitable for real-world use. And then we also have that NIOSH respirator fit evaluation challenge. Another thing that we're really excited about is we're looking at the mobile facial scanning technologies on the market today. And we're hoping to capitalize off of those little computers that we all have in our pockets or our purses and our briefcases to help aid us in respirator selection. So the goal of the mobile application will be you'll take a scan of your face, and then we'll actually match you to a NIOSH panel seal with the hope of if we know which NIOSH panel seal you're in, we can potentially recommend a respirator that may be well-fitting for you. This will be a challenge because there's so many respirators on the market, but it is a really good starting point to support the use of respirators in those settings where they don't have, you know, OSHA RPP programs or for use in the general public. So right now, this is a contract that we do have going through procurement. We don't have a timeline just yet, but we're really hoping to have something in the next two years. Another thing that I think is critically important is making sure that during the testing and evaluation we look for diversity of facial shapes and facial sizes and skin tones and nose breaths and things like that. And one of the hopes is that if you do a facial scan and you don't fit well into the panel, that you can send that information back to us at NPPTEL to say, hey, I didn't fit your panel because that could tell us these panels doesn't fit this specific population. Do we need a new panel for this population or do we need better panels or do we need different measurements? So that's really the goal of this app. And even though I spent a lot of time talking about respirators, I did just want to highlight that we're also supporting medical gown research. We're looking a lot right now at the interface between the gown and the glove and how that affects transmission of fluids, blood, body fluid through there, and we're developing a robotic test system now to help develop a new test standard for that evaluation. And as always, the next generation of preparedness is going to depend on PPT. Even though it is the last line of defense, it's the first thing that people go to. And I think we're on time for break, but I'm happy for questions whenever we get there. Let's ask one question. Let's ask one question now. You know what?

respiratory protection

pulmonary effects

cardiac effects

subjective symptoms

NIOSH

scientific basis

dermatologic conditions

equity

personal protective equipment