Well, it's 11.15. We have a full program, so why don't we get started. This session is going to be focused upon application to the clinical evaluations. Also very much science-based, we have asked the speakers to do something incredibly challenging, and that is give a very short talk. It's easier to give an hour talk than a four-minute talk. We're going to start off, Bob McClellan and I are going to briefly provide an overview of the field. Dr. LeBou is going to talk about dermatologic problems. As you point out, she was just elected to the board of ACOM. Bob was, as you know, president of this organization in the past. Marcia Sicari is going to talk about psychological issues. As you can see from the string of her ribbons, she's deeply involved with the organization. Dr. McClellan is going to talk about pulmonary and asthma problems. Dr. Berriman is going to talk about unusual and challenging situations. And then there will be a lot of time for questions and answers, so please think of good questions. The time is short, so let's talk about why do we do these. Well, first of all, one of the main reasons we do it is for regulatory compliance. We do it to predict outcome, and that's the challenge. Normally, you see a patient, you want to know do they have silicosis, how do you treat their back pain? You're treating the current state. Here, particularly for the first use, the initial use, what you're actually doing is trying to predict the future. Will this person be able to use it effectively and safely? That's a little different than a lot of what we do. Accommodation. That means is it a good match between the person and the job or the other environment? That means you've got to understand the work environment. You simply can't assume that it's always going to be the same, or you have to know what the exposures are. You have to know something about the ergonomic hazards. You have to know the social structure. What may work well in one setting may not. Using a complex device may be good protection, but it's not going to work in some other kinds of settings. It's good to have collaboration with the worker and with the employer, because you have to coordinate how to make changes if necessary, and it's based on individual considerations. No checkbox, all persons with asthma cannot use or can use or whatever. As Yogi Berra said, it's tough to make predictions, especially about the future. That's really the challenge in doing these evaluations. We, of course, have to comply with the OSHA regulation, which only applies, of course, to work sites. There are other standards as well. NFPA has standards. Nuclear power plants have separate standards. ALAC has standards if you're in a laboratory setting. The state plans have it. So there are various other standards to apply, so you have to know what compliance is necessary, not just OSHA. We did a small survey as a pilot study through ACOM and through the University of Arizona. I show this mainly to lay out what the questions are. This needs to be done in a bigger, better way. It gives some perspectives on why we do it. It's a pilot study. It emphasizes medical and research and educational centers and was co-sponsored by the Medical Center Occupational Health Group. Well, why are the evaluations being done? Well, it turns out that about 43% of the evaluations overall are being done for initial evaluations, so it was first-time users. Periodic reassessments account for a large bulk of the evaluations. So again, a lot of effort is put into these periodic re-evaluations. Of the respondents, 46% actually did for cause. In other words, I can't use my respirator or I don't think my employee can use it effectively. In other words, they're referred. Again, this is the type being done by your clinic, not the percentage. And user requests, where the user asked for it, were being evaluated by about 40%, which means that 60% of the respondents were not having people who say, I prefer a different type. So again, overall, 30%, 31% of the total evaluations were done for initial users. The rest were done for other causes, mainly the annual re-evaluations. In this particular responding group, it very much included health care. Which device was being used? Again, an N95 is different from an SCBA. How many people even differentiate a P100 from an N95, in terms of how you evaluate them? You know, if you haven't tried it, put one on and try it. They're different. So you have to be in—there's no one-size-fits-all. And we find, most of the time, they're approved without restriction. That is, a composite estimate was 90% just get them approved overall. Because we'd want to know that, if we want to know what's the prevalence of silicosis or of carpal tunnel syndrome, you want to know, how common is it? Well, again, nearly all of the evaluations that are done say, OK, as requested. Some of them are approved with restriction. And of the restriction, the most common restriction is use a PAPR instead of whatever was recommended. Relatively infrequent use of limited duration, or don't use it too long, or don't use it too frequently, it's rare. It's rare to say somebody can't work with the device. So nearly all people get evaluated, get approved, one way or another. We should have asked, but didn't ask about work enablement. Sometimes, in addition to saying, can you use the device, sometimes you actually get referred a patient who could not safely work, but with a device on, may need special protection. Somebody who's immunosuppressed, who may need more protection than the average person. Somebody who may need some, even though it's not a NOSHA requirement, protection against respiratory irritants because they've got a nose or a pulmonary problem. So overall, in summary, a lot of people get approved. That's the large majority do it. And again, very unusual to disapprove, which tells us overall what we're doing. What we don't know is, are we right? That is, the people who are not approved, could they have worked anyway? And of the people we quote, approve, how many of them really have adverse consequences of their work? That was, they don't use it effectively, or they use it, but have so much trouble that it interferes significantly. Again, these are done in so many different ways. I won't show you the data, but sometimes they're done by a nurse only. Sometimes a physician's involved. Sometimes you have a nurse and another. Sometimes you have an NP or PA. Sometimes you get an internet vendor that's off-site and does this all very indirectly. A lot of tools are used. We looked at how often the OSHA questionnaire alone is adequate. How often do you have to do a special follow-up to get more data? How often do you actually have an in-person examination, actually say, you need to be here hands-on? How about non-routine? In other words, you don't have to have an in-person exam, but for special instances we bring you in. Well, how often do you look at the questionnaire and say, please come in, you need to be examined? How often do you send them out for a consultant or a special test? All this is unknown. It's amazing that we don't understand the overall process, yet we're doing so much of this. With that said, it's a pleasure to introduce Dr. McClellan. Dr. McClellan is an excellent speaker and is going to provide, former president of the organization and a friend and colleague, is going to talk about an overview of respiratory protection and why it's appropriate to use it. Thank you, Phil. And I see you stole this slide of mine, this first one. But the point being that there really are these other standards. It's really important that you recognize the worker population and the state that you're living in to be sure that you're not just following the OSHA standard, but also those other standards that are relevant to your worker population or jurisdiction. So I want to start with really some basics and make sure that we're all on the same page in terms of why, besides compliance, are we doing this? What are the overarching questions? The first question, and there are three overarching questions that I think that every time you do an exam, you need to be thinking about these. First is, can the worker work safely while wearing a specific respirator, named, while performing specific assigned tasks in a specific work environment? Those work environments characterized by the job demands, by the environmental stressors, by the psychological and physical stressors of the particular respirator being worn, and the stressors of any additional PPE. The second overarching question is, will the worker tolerate the proper respirator use? And as we've heard in the first part of this, this is really where the money is in terms of actual protection and also prediction. We need to become better at this, and that is, how likely is it that the person is going to have not used the respirator because of discomfort, inconvenience? Does it get in the way? I think that was one of the findings of the World Trade Center response, was that people were not wearing respirators because you couldn't do the work with a respirator on. Sensory limitations, and then, very importantly, as physicians, we aren't commonly engaged in this, but we've already heard how important company culture is. Can we impact it? Well, if we have a relationship with the employer, we might, especially if we're on site, because as Phil was saying, education about why the respirator is protective can be quite useful in terms of appropriate use. And then the comprehensiveness of the respiratory protection program, it's not simply fit testing, it's not simply the choice of the respirator, but it's how it's cleaned and maintained, et cetera, et cetera, if the respirator is going to do its job. So the third is to think about what could go wrong if the person fails to use the respirator for some reason. And that's going to depend upon what you might think about the extent and duration of the lack of protection, which could range from being a temporary, relatively low-dose exposure to a high-dose exposure to an irritant, an antigen, a toxicant, a carcinogen, or even potentially a risk of death in an IDLH atmosphere, where certainly we would prefer that not to be such work environments, but in fact there are, and people sometimes depend upon respirators and other PPE for protection. So why would we as medical examiners want to limit or accommodate a worker's use of a respirator? One would be because of episodic incapacitation, risking respirator failure and exposure, which might cause grave danger to either the worker, fellow workers, or the public. The second would be because the person is physically unable to safely perform the job even without a respirator. And indeed, this is one of the most important things to be thinking about when someone comes in for a respirator exam, is this person actually going to be physically capable of doing the job regardless of whether they're wearing a respirator or not? Because as we've heard, the added physiologic burden of the respirator is generally not why respirators fail, although sometimes it might in more extreme conditions, either extreme work conditions or extreme medical conditions. And the other reason, which we'll be hearing a case about in a few moments, is psychological impairment that might interfere with safe performance of job tasks while wearing a respirator. So what about the predictive value of this medical evaluation? Well, we wish we knew. Well, one thing that we've learned, I think, in fitness for duty exams and pre-placement exams is if someone's been able to do a job before, you better not say that they can't do the job if they've been doing it very recently before. So past respirator tolerance under similar work conditions is really the best predictor we have out there right now, because there's little research that's identified reliable predictors. There are guidelines and regulations, as we've mentioned, and safety-sensitive industries like the DOT and FAA and RC provide regulations or guidance regarding conditions that can cause sudden impairment or incapacitation that can be used in this decision-making. Now sports medicine also has similar kind of medical guidelines, although that really only pertains to very heavy, heavy work as opposed to more limited work. And there's some scientific literature out there, clearly, that provides some face validity for some of the decisions that we need to make. So some caveats. If the worker has been using the assigned selected respirator while performing similar tasks in a similar work environment, qualify, unless there's some new limiting medical status or change in the work environment. If the worker does not have the capacity to do the jobs safely without a respirator, they're not going to be able to do it with the respirator. So disqualify or consider accommodations, which could be modified job tasks or the type of respirator or, indeed, hopefully go higher up in the hierarchy of controls. So I just want to close with two or three slides about this concept of quality improvement that we've all been exposed to in medicine right now, and it is actually the reason why I ended up writing a book about this. We do a very high volume, hundreds of thousands, I think it's millions, of these respirator exams every year. And for not to be any process of quality improvement is absolutely criminal, I think. And there are all kinds of things that can go wrong. It can begin with poor experience of the examinee, of the staff, of the internal and external customers who depend upon reliable and time-efficient return of our opinions. Harm has resulted from respirator failure of proper use. So we want to try to get this right, and also I am struck by the inter-examiner differences in the absence of following guidance, which leads to inequities and also potentially liability. So how do we go about this? Well, you've got to start by choosing and tracking some quality indicators. You've got to identify who your customers are so you know what quality means to them, and characterize their expectations, and then outline a process for meeting those expectations, and then checking in terms of whether you are. So you need to go about selecting these quality indicators based on good medicine, but also on your internal and external customers. So there's administrative processes. Do you have a copy of the Employer Respiratory Protection Program as the OSHA standard? Should you have? How many of you have ever gotten this from an employer? I have never gotten one. What about the, even more importantly, the availability of information about the job task, the work, the environment, the selected and required respirators, or is the person simply sent to you to do a respiratory evaluation? I am confident that many of you are put in this uncomfortable position of qualifying someone without this critical information. Another type of indicator might be the client and examinee experience, or clinical and professional metrics. So the percent of questionnaire-based evaluations requiring follow-up, how often does that occur? Is there a percent consistency with published guidance might be another criteria. Is there documentation of the rationale for denying or limiting respirator use, particularly from a liability perspective? It's so important to do that. And then is there inter-observer variance in your clinic between examiners presented with the same data? So these are just a few of the kind of things that you might want to choose to think about that. So with that, I'd like to move on to a bunch of cases that I think will illustrate the application of some of the science. So first up are some dermatologic considerations by Dr. Leibu. Good morning, everybody. Today I want to talk about some of the dermatologic conditions that you may see with respirator use, especially extended respirator use. I don't know how many of you have seen this now with COVID. Raise your hand if you've had a lot of issues with dermatologic conditions. And pre-COVID, put your hands down if you didn't have pre-COVID. So yes, COVID has definitely moved this to the forefront. So there are many different facial dermatoses that can be associated with respirator use, including acne and something known as acne mechanica, which can result from just the physical irritation of the mask on someone's face. There are also facial dermatitis, dermatitis. There's itching that can occur. You can see various pressure injuries. And even nickel allergy can result from the metal that's in the face, the nose piece. But what predicts the likelihood of having a reaction is really how long is the mask worn. And that seems to be the most significant factor when we're looking at these different conditions. And also chemical components of the mask and cosmetic and disinfectant residues can also lead to different irritant and allergic reactions. So one of the things that I'm going to talk about in a few minutes is actually using patch testing when people are coming to see us in the office for different facial issues. And although there's no standardized extract or material to use for patch testing, what we do is we use the available masks that the person is having a reaction to. So there are many ideological factors that can set somebody up to having issues with their skin when they're wearing respirators. Some people just have sensitive facial skin. And the area on your cheeks, the bridge of your nose, and around your ears are the most sensitive areas. There's a, as I said before, there's a significant correlation between how long the mask is worn and the appearance of skin symptoms in patients. People that have pre-existing facial conditions, though, may have less skin reactions, paradoxically, because they're educated on how to care for their skin, make sure it's moisturized, and they actually are not the people that we are usually seeing. And also, men showed a significantly less risk of developing symptoms. There are two reasons that were found for that. It's because females may have a lower threshold for reporting their reactions, but also men are used to the daily skin irritation of shaving for those men that don't have beards or mustaches. The skin manifestations that you can see from wearing a respirator is you could see some erythema, there's increased sebum production, also there's an increase in pH and a higher trans-epidermal water loss, which can lead to dehydration of the skin. And all these factors can lead to a pro-inflammatory microenvironment, and you may see triggering of psoriasis or seborrheic dermatitis, and also you could see acne mechanic, as I mentioned a little bit earlier. There have been case reports of seborrheic dermatitis, psoriasis, and rosacea after prolonged mask use, and also mask wearing can induce an itch-scratch cycle that can result in a Koberner phenomenon, and people remember Koberner phenomenon is from physical irritation or friction on the skin. Now I want to present a very interesting case that we had at our institution. It was a 37-year-old nursing assistant, and she had a history of multiple drug-induced reactions, including some GI complaints to antibiotics. She also had an urticarial reaction to latex, and she had angioedema with radiocontrast material and Percocet. She was complaining of an erythematous, plaque-like, xerotic of lesions that developed over the last few months with her wearing a respirator. So she had contact with both an N95 mask and a facial shield, and she was developing lesions on her cheeks and also on her forehead where the face mask was resting. She worked about two days a week and noted intensification of these symptoms with work and a decrease in intensity when she was at home, and that's classic pattern for something that may be work-related. And she did use hair dye, but that was several months ago and was not currently using any cosmetics on her face. So as I said, where the lesions were, so what ensued was we sent her to an allergist, and they did patch testing to the N95 mask, the foam on the facial mask, as well as a surgical mask that she was using. And the patch testing showed that she was allergic to all of those things. They gave her Elecon to treat the rash and also recommended dermatologic follow-ups so that they could work with her to ensure that she had, her skin was well hydrated and she was being treated appropriately from her underlying condition. So they, because she was allergic to the N95, we suggested that she use a PAPR. She couldn't tolerate a PAPR. The PAPR made her skin symptoms worse. So we were stuck in terms of giving her protection at that level. So what we did was we sent her back to the allergist and he did patch testing with the various surgical masks, and we found that there was one mask that she could tolerate. So after five days with the patch test, she was able to tolerate the Mid9 mask. So then we did a trial with her wearing that particular surgical mask for an hour to see if she developed any symptoms, and she was tolerant of wearing that. So we found something she could wear. So then we had to make sure that she was able to go back to her work environment in a safe manner. So we enlisted the help of her manager to make sure that they were aware that she could no longer float to areas where she had to take care of patients that were in airborne isolation, and also to let the manager know that this was an indefinite restriction. So this, you know, this wasn't going to go away overnight. And we also made sure that infection prevention approved the use of the mask that she could tolerate. So she is back at work and she's doing very well. Skin integrity is really the key when dealing with these issues and minimizing the length of time that you wear a respirator. It's really important to use care bundles that prioritize skin care, and that can include use of facial wipes and facial moisturizers. Now be very careful with prophylactic dressings. I know that there are some institutions that were using ostomy tape and films on team members' faces. Those films can compromise the integrity of the mask. So if somebody is wearing an N95 and they have one of those films on, they really need to be fit tested every time they put that film on to make sure that they have an appropriate fit because there's really no way to guarantee that somebody is going to put it in exactly the same spot each time, even if the first fit test shows that the respirator was fit tested properly. Next we're going to be talking about psychological considerations, and Dr. Issacari is going to be presenting. Good morning, everybody. Well, before I start, I would like to thank everybody for investing two hours on respirator, a very important topic, but I don't want to be too much in between the lecture and the lunch. So we're going to talk about a pretty simple topic that is very common for... Green button. Green button. Okay. Let me just go back. Come back to my introduction. I came from UC San Diego, and not only health system, but we also have a large biotech and airspace industry in the area. So we're going to talk about claustrophobia. That's the most common psychological issue that correlates to the use of respirator. So also with SARS-CoV-2 crisis, we had a large increase of high containment labs and a large amount of researchers that will then join the high containment lab and with much more strenuous PPE use. So the new job assignment to high containment lab using high concentrated SARS-CoV-2 and TB. So I think the vast, vast majority of all the biotech and research at universities would involve these two agents. The standard use will be a half face with goggles and the PPE water resistant hooded overalls, shoes and gloves. Well, as I said, claustrophobia, it's the disease that would impact the most of use of the respirator and sometime would be impossible to use the respirator with severe claustrophobia. So claustrophobic is an anxiety disorder characterized by clinical significant fear or particular object or situation that typically leads to avoidance and behavior. Most common female associated with a possible amygdala response, comorbid, general anxiety, alcohol dependency, mood disorder, and PTSD. On this specific case, a young researcher system and say yes on the history of claustrophobia. Exam was pretty much normal, but the GAD score, generalized anxiety disease score, she scored mild. So that's something I would like to introduce is a very easy to use anxiety score. So you would have then a validated metric for documentation in case you have to engage in one-on-one interaction for accommodation. So it's only seven questions and the scores would be between zero to four mild, a minimum of five to nine mild, moderate, 10 to 14, and severe. And it would be most concerned on the moderate and severe. And how do I associate that with the claustrophobia? So I adapted with Dr. McGlellan permission, right, and made this easy to use table. So the best predictor is the prior history of use of tolerance of use of the respirator. So in this case study, this person tolerated use of N95 with no problems and N95 without no problems. What would be a red flag in tolerance to similar PPP and SCBA use? Type of environment, this person was mostly close to park ride or just a specific part but not really related to the work. What would be a red flag similar to proposed work activities? You want to be cautious on ID, LH environment. The history of anxiety is controlled. Of course red flag would be not controllable. And the symptoms, would the symptoms have poor judgment, hallucination, psychomotor impairment or suicide ideation, denies any of that. The GAD that we used was mild and the exam was normal. So all green flags. And no red flags or symptomatic or GAD of moderate to severe. Medication controlled with SSRI, a red flag would be psychotropic and effective treatment. So potential accommodations of our work trial, if work environment permits a PAPR with large vision panels. Temporary restrictions if there are exacerbations. Restrict to IDHL atmosphere. Also possible restrict the use of respirator and job modification type of activities. And you want to keep an eye on this person doing a more periodic evaluation, six months to a year. So that was my short talk. Dr. Bannon. So the two speakers so far have included this concept of work trial. And I hope we have some time to talk about that a bit more. To recognize that in your medical exam, you're not making a decision for a year or for life. And that when there, especially when there are uncertainties, the value of thinking creatively about how to try a respirator use in a particular setting is something to really think about. So I'm going to talk about asthma and a case about a 35-year-old woman who presents for work in a spray booth and has never used a respirator. And fortunately, in this case, we know about her job and work environment. Though again, beware when you're making these decisions when you don't know about this. She's going to work on spraying on a truck bed liner for eight hours a day. And the spray contains an isocyanate, MDI. The effort is estimated around between four and five mets. The temperature varies substantially depending upon the season, up to as high as 90 degrees F. And she's going to be wearing a full face piece supplied air respirator in a pressure demand mode while she sprays. And then when she's not spraying but going into the booth after spraying, she'll be wearing a full face piece air purifying respirator with a combination organic vapor and N95. The PPE includes chemical resistant hooded overalls, shoes, and gloves. So her medical history is positive for asthma, wheezing, and the use of medications. She's had mild. And then so you go back and you say, all right, so what does that mean, right? You don't just say, OK, she has asthma and we can't approve her. So what we find out when we talk to her that she has mild intermittent asthma for about 10 years. Not too bad. She's never been hospitalized, never been to the ED. Triggers include common allergens like cat dander, seasonal pollens, and strenuous exercise. But she's able to walk four miles three times a week. And her medication is simply daily inhaled steroid and albuterol as needed. Her last work involved arguably a physical job, lifting boxes in a shipping department. She has used spray paints at home, although best as we can tell, not containing isocyanates. And she has worked with volatile organic chemicals, which can trigger some asthmatics without problems, without a respirator. And her spirometry at her most recent routine health exam was, quote, OK. So we get medical records and it corroborates her history. And that, in fact, her spirometry at the last office visit was normal. However, of a five-year-old, lab-based spirometry showed mild obstruction that was reversed with bronchodilation. On exam, she has normal vital signs, skin, and a cardiorespiratory exam. And her office spirometry, unsurprisingly, is normal. So what do we have here? We have an atopic woman with mild intermittent asthma, well-controlled, and in regular primary care. She tolerates moderate exercise. And her triggers have not included known sensitization to isocyanates. So however, we know that this job has its hazards. It has its pulmonary hazards associated with it. And I would argue that this is a very important role that maybe we don't play often enough. And that is in this concept of shared decision-making. And as you probably are familiar with the ADA, it requires this individualization of a conversation about what's going to happen. And I am of the opinion that the hazardous communication standard as it exists could be improved upon by clinical conversation such as with this person. And so inform her that at the very least, there could be an irritant effect of the spray that could aggravate her asthma if respirator use is not used properly or if the spray hood is not working properly. But I will also say that based on the knowledge that we have right now in the research literature that her atopy does not present an increased risk of sensitization. So let's analyze it kind of along the lines that I did before in terms of our overarching approach here. Can this worker perform the job safely with the PPE and the required respirators? As far as we can tell, the answer to that is yes. Basically, she's capable of doing this amount of work without triggering her asthma. And after discussion of the potential risk and the encouragement to report symptoms, she wants the job after that kind of back and forth risk communication. Now the question is, is she going to tolerate the work while using the required PPE? Probably. She has the physical capacity. She's never worn this equipment before. So predicting the future is hard, according to Yogi Berra. And we do encourage her to report symptoms that may drive her to remove her PPE. In other words, not symptoms of asthma, but symptoms of discomfort, et cetera. And then what may be the consequences? Well, they could be serious here. They could lead to sensitization and ultimately serious medical consequences. My recommendation's here to approve for the use of the required respirators. But she may need temporary restrictions from this work if symptomatic with an underlying condition. She does have asthma. She may develop an asthma attack. And the supervisor needs to be alerted that she may need to break out if she is suffering from an attack. Importantly, I feel, is to recommend follow-up with a nurse in six weeks. How is it going? How is it going? This is this kind of concept of a work trial. And then with the clinic, every six months, as a part of a, not a respirator approval, but as part of a respirator health surveillance program, at which time, of course, you can also check to see whether or not the individual is tolerating the respirator. So with that, I think we're going to move on to Dr. Berman. Thank you so much. And thank you for joining us for our couple of hours this morning. Yes. My name is Amy Berman. I'm from here in Philadelphia at the University of Pennsylvania. And I was asked to address special considerations and special conditions in respirator clearances and safe utilization, which is a pretty darn broad category. So I had to pick something for this short presentation. And I hope you will consider it not just as a single example, but in the light of the presentations that my expert colleagues have made over the course of the last couple hours. So I'm going to run through this fairly quickly and then hope that we can segue into a brisk discussion among ourselves and also including you that will help us all. So if you cast your mind back not to our most recent public health emergency, but about 10 years to 2014, I'm going to present a case that had to do with respiratory protection and PPE in preparation for potential Ebola cases in this country. Can you all hear me OK without a big echo? OK, great. Terrific. And I also want you to please remember this in the context of 2014, where in the first months of the outbreaks in Africa, we were dealing with a relatively unknown situation in terms of the details of transmission mechanisms, that it was extremely clear that health care personnel were in grave danger in the areas where the outbreaks were actually occurring, up to and definitely including deaths from their occupational exposures. And that even the small number of cases that were presented and were cared for in this country did include transmission to health care personnel. So the level of anxiety at this point was enormous, even though looking back from the context of 2023, the numbers were pretty darn small. So many, every large hospital, and especially those that were designated as, I forget the exact terminology, but as those that could receive patients under investigation or diagnosed Ebola patients, had to develop workflows, PPE ensembles, and of course, engineering and administrative controls to protect their staff. The way this kind of worked out, translated in practice for us, and I think for most of you, please, by the way, feel free to interrupt. I'm your last speaker, interrupt at any point, was infection control protocol, which was basically enhanced airborne and contact precautions appropriate to a hemorrhagic virus. We anticipated that the work effort would be light to moderate, probably significantly more than the light effort involved in typical patient care because of the demands of donning, doffing, and handling the patients while minimizing the number of health care personnel who were actually on the front line and hence at risk. We knew that it would involve people getting the PPE donned and doffed, always a consideration how you will do that without increasing the risk of transmission during the doffing process in particular, and particularly during this high virulence hemorrhagic fever protocol development. Um, we decided we would control the work environment by keeping the shifts short. Um, and I think four hours looks pretty short in the context of COVID, but it actually looked pretty long in the context of Ebola. We knew that we and all of our peer institutions, I'm sure many, if not most of them represented in this room, would do extensive training for donning and doffing, and this was done with the guidance and leadership and a lot of onsite training from the CDC, which was much appreciated. Our own PPE ensemble, and again, I'm going back to the period where we were all developing these kind of in parallel. Ours would include a Max Air PAPR, which was the model that we happened to have, and it had good use, good experience with. Stryker shroud and hood to provide full impermeable protection over the head and neck. A Tyvek suit, an impermeable gown over the Tyvek suit. See, we're beginning to build up some heat in this process, even in a hospital setting. And over that, an impermeable and reusable apron that tied at the neck as well as in the back. And this is fairly extensive PPE. It was pretty typical. We were not, oh, and booties, excuse me, and double gloves, including ones that came up higher over the gown. So this is a lot, and although we were not doing exactly what the CDC was recommending at that point, we were certainly following all of the principles. And I will say that I trained on this ensemble and had the privilege of going to the CDC to trial it in their PPE testing facility at that point, and it performed very well in terms of the GloGerm trials. We were concerned about several physiological issues with this, and probably the first one was heat stress, which as you heard from, I think, Dr. Harber at the very beginning of our first session is a major consideration. We were concerned about anxiety and claustrophobia driven not only by the extensive nature of the PPE, but also, frankly, the pretty terrifying nature of the pathogen. And we were very concerned about people's agility. It was hard to get this stuff on and off without getting GloGerm all over yourself. And we also realized as we went through this that people would be standing continuously through their patient care four-hour shifts and also during the donning and doffing, except when they were squatting or having brief use of a stool. So it's kind of demanding physically. This is actually, there's a link in your handouts, which I hope stayed live, to the guidelines that ACOM actually developed at that time, led by the Medical Center Occupational Health section, to try to address some of the special considerations for PPE, including respiratory protection, for this particular challenge. And I'm not, in our short time, gonna obviously go through these line items, but we really tried to think through a little out of the box in terms of things that might interfere with people's ability not only to tolerate the work in the PPE, but to justify the cost of their extensive training based on whether we expected them to be able to continue in that role. So for instance, if you knew somebody had elective surgery coming up, even if they were perfectly well at the time, we would not have cleared them to become part of the training team. It's important to say at this point that we had PUIs in our facility. We never had an Ebola patient. So the hazards came up after the medical clearance and during the training period retrospectively. My case for you today is a somewhat older, at the time it seemed older to me, now this just seems normal, 66 year old, very experienced, very valued, frontline nurse leader in our medical intensive care unit. All of the staff who went onto this team were volunteers. There was just a stunning response in terms of the number of people eager to step forward into the role. This individual, his OSHA questionnaire was negative except for reasonably well, somewhat well-controlled hypertension. On exam, he really had a normal exam except for mildly elevated blood pressure. And the fact that his body, this is a really big guy, six foot six, over 300 pounds, a large person, fit, motivated, highly experienced, otherwise normal exam, normal EKG, normal spirometry. And we cleared him, I cleared him without a whole lot of hesitation to go on with the training. So the training was repetitive, always a good idea, and he returned after the third training having suffered a medical incident during the process that was pretty worrisome. He described being somewhat dyspneic for the first couple hours of his four hour training shift but feeling that he would have been able to function with a patient. At two hours, when he was squatting, which was necessary to help with the donning and doffing of a co-worker under our protocol, he became acutely short of breath, somewhat presyncable, very short of breath. And in his own words, again, a MICU nurse, air hungry. As soon as he ripped off his PPE, again, we were in a training setting, there was no pathogenic danger, his symptoms resolved promptly, and he denied everything else at that point, including feeling of vertigo or syncope or dyspnea or chest pain or anything else. He was reevaluated, of course. He had that, by the time he felt clinically recovered and we got our hands on him, he had a normal exam, a normal EKG, and again, normal spirometry. So our feeling with this was that this was, could have certainly had a claustrophobic, significant claustrophobic and anxiety component, similar to what Dr. Issacari just described, that it was possible and concerning that he could have had a medical event, but we could not find any actual evidence of that. And that it, of course, these things could happen together, but that probably the most significant event that happened was that his, the ligatures, unfortunate term, that were holding his shroud and hood around his neck, along with the apron ties, which it turned out were tearing, so they were getting shorter with each training period, had probably created a re-breathing situation with a lot of dead space, and then he probably had become subacutely or acutely hypercapnic. And we thought that perhaps his very tall stature had exacerbated this for an ensemble that was well-tolerated by his smaller colleagues. I can't prove that to you, but that's what we thought was happening most likely. And the questions were, and now I'm gonna echo, of course, Dr. McClellan's beautiful summary, could this worker perform this job safely with this PPE? I'm sorry, my transitions aren't working here, but clearly the answer was no, this was not tolerable. Would he tolerate bedside work with its high cognitive demands in this situation? Really not. I mean, the consequences in his, I tried to actually get quotes into the note. I couldn't concentrate enough to help my colleagues. Clearly he couldn't perform critical care. And we felt, again, not a surprise that in this context, the consequences of continuing, if we got to the point of an actual hemorrhagic fever patient could be serious, indeed fatal, not only to him, but also potentially to his patients and even his co-workers if he was not able to assist with the critical doffing process. Was there reasonable accommodation? I'll tell you, this individual, like many, was highly eager to continue. He really wanted accommodation. He was high value, extremely experienced, just the kind of, just the person you'd wanna see coming around the corner if I would wanna see if I were critically ill. And he requested that we alter the ensemble to try to address what we thought was most likely the source of his intolerance. So I actually, sorry about that, didn't mean to go blank. I will leave those questions for you and also for our audience. Would you have accommodated this person should we have altered the PPE? Would this have been a different discussion if he had been a younger person? And those are the questions I leave. Thank you. Okay, well, while anybody who has questions goes to the microphones, there are microphones up front. I wonder if somebody wants to address Dr. Barrowman's question and then Dr. McClellan has a question for others. But if there are any questions, well, first of all, what about other panel members? Would you have said yes or no? I would have considered another simulated, several in training. I wouldn't have put him right in with a patient, that's for sure. I think he needs more of a work trial. I'm not sure whether the infection control folks would okay the assemblage change. That would be a critical issue. Yeah, my concern, I'll go ahead. My concern here was that if this was truly not a hypercarbic event, but was a claustrophobic event, or if not claustrophobia per se, some anxiety. By the way, could you two guys please come join us up front? Because we want to hear from you. I'm sure we're gonna hear something about NIOSH's solution to the he doesn't fit into the PPE. Because you showed that picture already, I think. But basically, if that was the case, under the added stress of a real live Ebola patient, it might go worse and he would rip it out. And again, this is a situation where one exposure is potentially catastrophic. So that I might be a little more nervous. We have some microphones here, if any of you want to comment differently. If not, we have a question, whoops, a question here. Hi. Great job. All three sessions on respirators this morning have been really terrific, so thank you. First is a question for Bob. I hear from Curtis that your book is in progress to have an update, your respirator book, Bob McClellan. Is this true, is there a date? I've heard this rumor. Well. Well. Second is a comment, since Bob's gonna dodge that. Not exactly a skin thing, but we saw, and I've heard of many, and they're in the literature, corneal abrasions from masks going on and off in the flurry of COVID. So just another sort of side effect of the mask use that we saw a lot of. Thanks again. Any comments from anyone else? But I think the, Janice Powell showed a picture of an accordion-type PPE that's got ridges and expands like an accordion if the worker is very large. Too bad that wasn't available back then. I don't know if it's available as yet. I've heard that there are also some that are being developed that actually have cutoffs, so if it's too long, you can remove, you know, it's got like etched strips on it. Yeah, there are lots of things under development. We don't know anything that's come to approval just yet. How about this one? 50% of the microphones work. Yeah, so that model with the accordion design is a concept, so we don't think they've come to approval yet by the FDA. And then the one with the tear-out, I'm not familiar with the brand of that. The same size problem occurs with respirators, per se. As many of you know, the original fit test panel was Air Force recruits, all male, and of course, that's how they were designed, and that's part of the reason behind NIOSH expanding the panel and still trying to expand it to be representative of all people. Another thing that's interesting is for the NIOSH respirator approval program, there is no fit requirement for a respirator that just has, you know, the typical suspension with the two straps. So if you have an N95 that has those two straps, we don't do any type of fit testing for those. We do fit testing when you have a respirator that's considered to have a novel suspension. So for example, the respirator that adheres to the face of the respirator may have ear loops or may have, you know, an S-clip or something like that. But one of the things we're bringing into the program is a respirator fit capability test, because we still wanna know that the respirators that we're approving will fit people well. And that hasn't been a requirement because U.S. workplaces, if you're gonna wear a respirator, you have to be fit tested anyway. So, you know, it really wasn't a need to make sure the manufacturer does all the fit testing because you have to be fit tested for use, but we do acknowledge that there are issues with fit, and so that's why we're bringing in a respirator fit capability test. Okay, we have a question back here. Yes, medical support, thank you for an excellent presentation on respirator use. Could you speak a little louder or into the microphone? Yeah, can you hear me now? Yeah, close. Okay, all right. Thank you for the excellent presentation on the respirator use. My question is about claustrophobia. And I have a couple of patients who were claustrophobic, and all of them were able to use respirator, including N95, proper half and full face. And I'm just curious, now how often do you find claustrophobia preventing use of respirator in your practice? And I mean, the case you had over here is, you know, the person had claustrophobia with underlying anxiety. Maybe that contributed to the problem, but for simple claustrophobia with no underlying issues, how often that is a problem preventing use of respirator? Does somebody want to address that? So I, you know, in preparation for here, we transitioned to electronic medical records. Our medical questionnaire, we do about 8,000 of them last year. And actually 230 answered that they had history of claustrophobia. But with all of them, we did not need to engage in accommodation change activities. We have around a 10,000 panel of N95 proper users. That it's very rare that we'll have to end up having to have job modification, sometimes with a pamper. But, you know, we'll triage them with a nurse or they will bring them to the clinic. So it's still the rate that the claustrophobia impacts the use of respirators is still quite low. But again, it's a case by case scenario. Yeah, there's an old adage that 10% of people have claustrophobia, but there's not a lot of support, as far as I can tell, for having said that. Second, things that pass for claustrophobia may actually be, I don't like, I'm concerned about Ebola, I'm concerned about the work site, et cetera. So, you know, I really think that an awful lot of the situation, it's situationally determined, not determined by an underlying, what used to be called an access to psychiatric diagnosable disorder. So I think we really, we shouldn't lump everything together and say it's all psychiatry, but we really need to pick that apart, just the way we would pick apart somebody who said, I can't breathe. We wanna know whether it's the heart or the lungs or whatever. So I think we really need to take that apart. Next question. Excellent presentations, thank you. Two questions. One, I apologize if you already did cover this, but I'm curious, have there been any discussions about changing the frequency with which respirator fit testing is performed? And then second would be, what are the requirements for who performs those evaluations? There was the survey that you did with nurses or nurse only physician. And I'm wondering if there's any stated requirement in the guidelines to say it has to be this level of a provider, or if it's a completely negative survey or negative questionnaire that can be signed off by a nurse. What's the guidance on that? Well, first of all, it depends on the setting. And I think Bob may wanna address this also. But again, if it's covered by OSHA, only certain situations are covered by OSHA. Workplace settings are covered by OSHA. You have to be a physician or a professional licensed healthcare provider. And it has to be within the scope of the work, the scope of your work as determined by the state. In other words, OSHA turfed it to the state. Unfortunately, as Bob, Dr. McClellan pointed- Federal, so I'm kind of curious how that works. That's even more complicated. But basically, as Dr. McClellan pointed out, there's not a lot, there's nothing really says you have to be trained or actually know exactly what you're doing. And indeed, some of these are probably not being done very well. There's a real need, as Bob pointed out, for quality improvement. There's like no, at least for some standards, before you do spirometry in the workplace, a person should have taken an IOSHA-approved so-called cotton dust course. There is not much, there's nothing out here. So anybody could do it. To, in answer to your question. Anyhow, well, next question? I hope that's been helpful. If not, let's discuss it after. Yeah, sure. The other question was about if there's been any discussion of changing the frequency with which respirator fit testing is done, particularly in terms of- Yeah, that's an ongoing question. But there's an editorial in Chess last year that I wrote saying, we don't have much evidence. It's not clear why we're actually doing it every year. I mean, personally, I think it would make more sense to do it once and then do it again relatively soon. But we need to get empirical data about when you do it year by year by year by year, what's the value of that? That accounted, at least in the little survey we did, that accounted for a high, the annual re-evaluations account for a high proportion of effort. Is the juice worth the squeeze? And that, we really need to find that out. The other thing that I've thought about personally is when you do the port account test, the quant, you get a number. But, you know, anywhere from 100 to 600 is going to make you pass an N95. But, you know, it's very different. If someone's a 101, I might want to test them sooner than if somebody is a 500. You know, because there's noise in the test. So I think it really needs some attention. But I think there's a shortage of data. Let's move on to the next question. And then I'm sure other people on the panel have a lot of useful thoughts for you. Or we'd like to hear your thoughts. So just want to thank all the panelists. This has been a great presentation as well as the other two earlier today. So I wanted to point out what Dr. McClellan said, which is often when we're doing these evaluations, we don't have access to all of the things that go into an RPP. And it's one of the greatest frustrations. And so I always, when I run into a problem, particularly IDLH, many of you know, I used to be at Dow Chemical and was the North America medical director there before I came to the company I'm with now. And this is all I do is respirator medical approval now. So, you know, 175,000 came through my desk last year. And I do have some claustrophobia in numbers that anyone that wants to talk about it, we can later. But so this concept of knowing the hazards, knowing the job tasks and knowing that employee, I often have to spend lots of time on the telephone and you know, it's all 50 states I'm covering. So there's so much variability. Anyway, I'm working on a solution to that. But I just really appreciated you, Bob, bringing that up because it's one of our greatest challenges. Right, well, thank you, Dr. Hemel for pointing out these important topics. Okay, thank you so much for attending. I think we scratched the surface, but the panel is gonna hang around for a few minutes if anyone has any more insights, because I think everybody would like to get your insights. Thanks again. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.

respiratory protection

respirators

clinical evaluations

dermatologic problems

psychological considerations

asthma

pulmonary issues

challenging situations

regulatory compliance

future outcomes