>> Caitlin McClain: Thank you for joining us all this morning. My name is Caitlin McClain, and I am an RI's Fellow, doing research at NIOSH NPPTL, the National Institute for Occupational Safety and Health National Personal Protective Technology Laboratory. Today's webinar concerns the study - the assessment of the elastomeric respirators and healthcare delivery settings, routine elastomeric use and evaluations in healthcare or reuse. Today's webinar will provide a brief overview on elastomeric half mask respirators, which will be referred to as EHMR's during this webinar. And then we will be sharing the re-use study findings. First I'll be providing very brief introduction for NIOSH NPPTL and for EHMR's. And then I will go over the methods and background for this study. Finally, you will hear from the three universities that we contracted to perform this study. Emory University, University of Texas-Houstin, and Wayne State University as they present their individual site findings from this study. NPPTL or the National Personal Protective Technology Laboratory is a division of NIOSH that focuses on personal protective technology. The vision of NPPTL is to be the leading provider of quality, relevant and timely personal protective technology research, training and evaluation. The mission of the Personal Protective Technology Program and the National Personal Protective Technology Laboratory is to prevent work related injury, illness and death by advancing the state of knowledge and the application of personal protective technologies. As a disclaimer, the findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. The mention of any company or product does not constitute endorsement by the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. N95 and NIOSH approve are certification marks of the US Department of Health and Human Services, registered with the United States and several international jurisdictions. The elastomeric half mask respirators or EHMR's are a tight-fitting respirators made of synthetic or rubber material. The exact elastic material differs from brand to brand, but this type of material permits them to be repeatedly disinfected, cleaned and redonned, which is a desirable trait in the healthcare setting. EHMR's can be equipped with replaceable filters or cartridges depending on the use environment. And may have disposable components. At NIOSH we have been exploring the use of EHMR's in healthcare since at least 2014. All respirators used during the course of this study were NIOSH approved and have an OSHA assigned protection factor or APF of 10, which his the same APF as an N95 filtering face piece respirator or FFR. EHMR's are designed for long term use, which means they will be reused time and again, and can be cleaned without damaging the respirator. For this study, the Honeywell RU85004 with P100 filter cartridges was used. It was chosen due to having desirable traits for the healthcare setting. Including a speech diaphragm to facilitate clear communication, filter covers to protect the cartridges from potential splashes and sprays and an exhalation diverter cover to prevent the users exhale breath from being directed at a patient. P100 filter cartridges were used as they come in hard plastic cartridge instead of an open pancake type filter, allowing them to be easily disinfected and more protected from splashes and sprays. The largest hurdle to switching to or use of the EHMR's may be the fit test requirement. As these are tight fitting respirators, all workers who use them must be fit tested for that specific make, model and size as per 29CFR1910-134 the respiratory protection standard. This ensures the respirator fits the user properly, thus providing the anticipated respiratory protection. As a note, this study was originally designed in 2017 and the first portion began implementation in 2018. So while respirator models have since come onto the market that are aimed at healthcare, the RU85004 model was kept for consistency throughout the projects lifespan. Also due to hospital policy, for source control in 2022, when the final part of the study was implemented, all sites used Halyard pediatric size procedure masks over the respirators exhalation port for source control. Now that you have a little background on NIOSH NPPTL and EHMR's, I'll be going over the background and methods for the reuse study. This was a large project done in three parts over the course of five years. Initially designed to explore what alternative respirators might be viable in a hospital setting, should there be a shortage of FFR's. Part I was JET FIT, or just in time, elastomeric fit test and training. This looked at rapidly transitioning hospital staff to the EHMR, which mean training and fit testing done over a week period. Webinar presentations for JET FIT were held in March of 2020 and February of 2021. Part II was response or randomized controlled elastomeric studies with PCR technology, disinfection safety and effectiveness. This looked at lab based efficacy of different disinfectant wipes at removing bacteria and viruses that are common to a hospital setting from the Honeywell IU85004. It also looked at the efficacy in both time and load removal of different wiping methods when performed by healthcare personnel. The results of this study determined which wipe would be used in part III. The presentation for response was held in July of 2023. Part III reuse or routine elastomeric use and evaluations in healthcare is what we are presenting on today. The goal of REUsE was to evaluate EHMR's in a hospital setting over a set time period. Three sites, Emory, Wayne State and University of Texas each recruited at least 100 healthcare personnel to use an EHMR for three months during patient care or whenever respiratory protection would normally be required over the course of their jobs. At a final count, 279 completed the study across all three sites. Some participants did previously participate in part I JET FIT as well. All participants were qualitatively fit tested, trained to use the EHMR, trained to care for the EHMR including inspection, end of shift cleaning and storage. And then were trained to disinfect the EHMR using disinfectant wipes, either between patient encounters or when the healthcare personnel doff the respirator if it was worn consecutively between patients. So over the course of the study participants were given three types of surveys. Pre-survey study given after completing their training and fit testing. A bi-weekly survey, which was given every two weeks during the three month study period. A post study survey, given when the participant completed the three month study period. Surveys were distributed via red cap and were the same across all three sites. Participants were given the pre-study survey before they began a three month period to establish a baseline of how they perceived EHMR's. The survey established the amount of respirator use they had prior to the study. What types of respirators they might have used, and question of how the pandemic may have affected any prior use patterns. Also established was prior use of any other personal protective equipment types. Comfort level and knowledge base of the steps in using a respirator and the participants initial opinion on comfort, use and reliability of EHMR's. Participants were given by the bi-weekly survey every two weeks after beginning the three month study period. These surveys recorded data such as the amount of respirator use per shift. If the healthcare personnel used a respirator other than the EHMR, such as FFR and why that might have been. How often they disinfected the EHMR after doffing and if any problems were found with the disinfection wipes such as access to the wipes, skin and/or eye irritation and time required to complete the disinfection process. Also noted were comforts and discomforts while wearing EHMR, such as heat build up, skin irritation, strap discomfort, discomfort breathing and etc. And if the EHMR interfered with performing their normal patient care tasks, we wanted to know what tasks those might have been, such as starting an IV or an A-line, taking vitals, intubation, physical exams, communication and anything else. Once the three month study was complete, participants were given the post-study survey. This survey included many of the same questions from the pre-study survey, so any changes in the pending and knowledge could be seen. Questions were also added to gage how the healthcare personnel felt about EHMR's versus FFR's. Now the likelihood experience with both types of respirators. These questions addressed topics such as use preference, comfort and general usage. Also included were open answer questions where participants could write any other feedback from their time using EHMR's. Now that you have a general understanding of the background and methods for the study, I'm going to turn it over to the three presenters who will detail some of their sites results from the studies. First you'll hear from Dr. Colleen Kraft of Emory University. Then Dr. Lisa Pompeii who is representing the University of Texas-Houston and to close it out we'll hear from Dr. Youcheng Liu from Wayne State University. After all presenters have finished we will have a question and answer session. Beginning with the questions that were submitted on the registration page. If you do have a question during any of the presentations, please put it into chat and we will address them at the end.

>> Dr. Colleen Kraft: Thank you so much Caitlin. And I wanted to start with the Emory Reuse Results. And you have the context of what this was designed to achieve. And so I'm not going to restate a lot of the methods, but I will give you our results. As you know, this is - this is a very interesting and now historical slide to me. So in our hospital, at least unless we're doing patient care, we're no longer wearing masks. But this was during the time when we were getting masks ready early in the Covid 19 pandemic in 2020. And trying to figure out how to disinfect them, which we already talked about at a previous webinar. But this was a way we were trying some UV light. So if - I think most of us are trying to not go back to this time in - in healthcare, healthcare care. But this was a time when we were trying out a bunch of different respirators. And one of the things I was very excited about as an infectious disease physician and as a hospital leader was that we actually were already involved in this study using EHMR's and that that was a very viable option for our staff. And I hope to convince you by the end that it's going to continue to be a viable option for our staff going forward. There's a lot of issues with the reuse of respirators. I took a lot of pictures during this time, but I liked this one. UV will disinfect respirators. I just showed you a picture of how we were trying to do that. Which by the way, we didn't do that for very long because it wasn't that effective. We - it will not remove stains like make up. If make up causes heavy soiling, then replace your mask. But this is a sort of way we are communicating this and we are also making small marks on our N95's and different masks to show how many times they had been cleaned or reused. We also were trying to employ various different methods. But as you know none of these things could really scale. So we tried peppers. We actually also had cappers on site. I'm not going to really talk about those today. But again, the availability of these and then the instructions on use, made these sort of a limited option really for our healthcare center in the care of patients with Covid. So we really again, we're grateful to be in this study, having already done sort of JET FIT where we practice even before there was a pandemic in a pandemic situation. On how quickly we could train people on EHMR's. So now we got to in the middle of a pandemic, actually see how this worked for our healthcare workers. So again, really grateful to be part of this study and this work. So we wanted to assess our healthcare experience with the implementation and use of EHMR's directly in their patient care. We wanted to of course see our feasibility in - some ways our acceptability. We wanted to figure out the opinions of healthcare leadership on the feasibility at a larger scale. And then our hospital management experience with implementation. So we were able at Emory healthcare specifically Emory University Hospital to recruit 73 healthcare personnel. As Caitlin has already mentioned we wore them with this pediatric mask. As source control, covering the exhalation valve whenever it was used, and then also the use of these occurred whenever you would have used an N95 FFR instead. So you were basically substituting your N95 for this EHMR covered by the pediatric mask. We provided disinfection stations with Oxivir wipes and replacement parts on the units that worked under this intervention. And we restocked them as needed. And here's sort of a somewhat blurry picture, but of what it looked like in our hands. So we recruited from two hospital units within our hospital. The neurosurgery and neurology ICU. And we had an entire floor that was considered the care initiation unit, caring for Covid 19 patients. We chose these because these staff groups tended to be very flexible. And were very interested in trying new ways of being comfortable while carrying for patients with Covid. Our unit leadership then on those two units were enrolled as super users. And the nurses, nurse's aids and patient care assistants were recruited as participants. We think that's really important. Because not everybody spends the same amount of time in the room, and not everybody does the same tasks. So we wanted to have as many individuals as possible with their tasks. You've already learned from Caitlin too that we had a pre-survey on comfort, which I'm going to show you our pre and post survey data. We did five bi-weekly surveys and then we did some open ended feedback questions. So we have pretty good retention. We ended up having 101 enrolled participants. 73 of who finished. Our post survey made it to about 72% of our enrollment and so we were very grateful for the interest and enthusiasm of our participants. We, because they were all co-located on the unit, it was easier for us to remind them to be taking these surveys. Although they all worked at different times obviously. This - this demographic table and this has been also submitted to ICHEJ, the Infection Control Hospital Epidemiology Journal. You could see that we had the most percentage of age nurses and techs and patient care assistants were in the 18 to 25 age. That's fairly - something that we see a lot when we're doing research type studies is that age range tends to have a lot of interest in participating. We had - the majority were female, which matches sort of our - our work force. We had a fairly diverse, could have always been more diverse group in terms of race and individuals could select more than one option. So we had about - our biggest two groups were Black or African American at 32% and White at 53%. And the use of respirators prior - prior to the pandemic 75% had obviously worn an N95. There were actually 18% that had not worn a respirator. And then we had a few that worn EHMR's before, PAPR's, I should remind you that we have a bio-containment unit on our campus. And so we train a lot in PAPR's. And then you can see here the diversity of the job title are most nurses, but we did have some patient care assistants and again most worked in the ICU. So I really liked this pre-study survey slide because you can see here that it's pretty comfortable to begin with. And so I think that's one of the reasons why we were excited to do this work is because we already felt that this was something that could be achievable and from our previous studies we learned that this was something that people would accept. And so some people thought it was extremely comfortable. And I will tell you that a lot of those individuals probably to this day are still wearing EHMR's in our healthcare system. So through all the tasks that we asked them about, they considered this to be quite comfortable. If you look at the post-study survey, so after you've worn it for a number of weeks, you could see that it actually becomes something that they get more used to, and they find it extremely comfortable. So that was exciting to us to see that that change and that sort of increased acceptance, based on such a positive response on the pre-survey comfort. Individuals spent a lot of different hours. So some of them that were enrolled did not wear it. Some in - that were involved wore it most of the time was about one to three hours. And that tapered off. We did have some individuals that wore it for greater than 11 hours, which would have been a lot of - a lot of time wearing that mask. We surveyed the healthcare leadership focus groups. My role at Emory is as an associate Chief Medical Officer and this was very important to me to understand sort of all the perspectives of how we would want to do this. So we had asked in our focus groups given the resources required for the deployment of EHMR's as part of the feasibility study, do you believe it would be feasible to deploy EHMR's throughout the healthcare system? And obviously it - you know it all centered really around availability. I think the other thing we're working on now with so much turnover in our staff is try to figure out who can train individuals any longer. So we've lost a lot of our trainers and a lot of our methods and staff to be able to train people and fit test. And so it's something that we're actually actively working on as a healthcare system. We also have a robust relationship with our health and safety office. An d so we though a lot about how EHMR's would fit in with the respiratory protection program. And so our responses included plans for roll out given the limited amounts. We would essentially have them be you know, sort of the third choice. So if they couldn't get fit tested on the three M or the Halyard that were - that we're currently using, they would then go to the EHMR. And we think that you know this additional respirator to offer to our staff, really helps our sustainability as everyone sort of struggled with, especially early in the pandemic. And you know, especially in situations and some of the examples that Caitlin showed were in individuals in non-healthcare roles. Thinking about other situations where you may have to wear PPE all day, not just intermittently as you go into a patient room. Some feedback. We took all this very seriously. A participant felt like they had to shout. And so we would recommend sort of improving that speech diaphragm. This is something we worried about from the very beginning since even with a regular mask you can't really see, or lip read if you need to lip read. We added a notch in the nose piece if individuals felt that there was more fogging up. And then many times it wasn't that it was fogging up, it was just that your glasses were sort of displaced. So thinking about how we might fix that. Obviously a recommendation of a less bulky design, since it looks at times sort of imposing. And I think there's probably no better time to try this study than during a pandemic when everybody was wearing a lot of personal protective equipment. Some of it was very, very bulky. But again, in terms of trying to like get it seamlessly into clinical care, that was something that there was a concern. And then the cleaning process, for some individuals was too long, especially if you cleaned between the patient. We had a very specific way that we validated to clean. And so I think it was one of those things we were trying to figure out how to be prepared as you clean in your workflow processes, so you don't have to do it quickly, or you don't have to rely on doing it quickly. So we had fairly large number of healthcare providers, EHMR was one for patient care during a public health emergency. We deployed them, again for the overall studies, you're about to see the other two facilities. And we only use one model of EHMR which some - it could be a strength of a limitation. I think at least trying to figure out if that type of EHMR for our location would actually be able to help individuals be comfortable and be sustainable. And something that is similar to all the other ones around it was actually there's some benefits to having one model. The limitations would be that it'd be nice to test other models. But this is the one we had chosen far before the pandemic. So we had actual - actual inventory of that. And so in many of our surveys we felt that nurses - nurses and unit leadership really did prefer the EHMR for themselves over an N95 because of its perceived higher protection, improved comfort and because of the support of the healthcare system. Deployment was really considered to be successful. Nurses responded that they would like to continue and there are still some that continue to wear this during - when airborne precautions are warranted. And for our participants they were allowed to keep the EHMR. But they felt that it was difficult to get back to sort of that little - we used to have that station that they could disinfect them. So trying to figure out how to make that a more universal practice in our hospital, if we continue to support the use of these. And we've been thinking about masks for a long time. So I just thought I'd stick in this old time mask look. And we really appreciate the opportunity to participate and share our information with you. Thank you.

>> Lisa Pompeii: My name is Lisa Pompeii. And I have co-lead this study at the University of Texas with my colleague Janelle Rios. I've also listed the other members of our research team here. We conducted this study at a tertiary care medical center in Houston Texas. The healthcare workers for our part of the study were eligible to be included had to be at least 18 years of age. Provide direct patient care, in-person counseling or case management with patients. They had to be previously fit tested to wear a respirator in the prior two years. And have no facial hair, no facial injuries or adornments. They had to be medically cleared per OSHA, per the OSHA medical evaluation questionnaire. So appendix C. And they did not have a decrease or absence of smell or taste. And so we targeted our recruitment to healthcare providers that provided care and was more likely to care for patients with known or suspected aerosol transmissible diseases. So we targeted the emergency department, a range of critical care units and then some designated acute Covid 19 units. Because of Covid we were not allowed to enter the hospital to recruit participants. And so all of our recruitment efforts occurred online. Workers were sent an email invitation from their managers that included a red cap link to our online recruitment web page. This included informational video about the study. They were informed that they would be asked to wear their elastomeric respirator at times when they used their already fit tested N95 filtering face piece respirator would be warranted. They were going to be followed for three months, asked to complete seven online surveys. They would be incentivized up to $450 depending on the number of surveys they completed. And then on the recruitment page they completed an inclusion questionnaire. They completed the OSHA medical evaluation form, a study consent form and then they signed up for fit testing and a training session. The training session occurred at the study hospital. Workers received a drawstring bag. I have that illustrated here. It included their EHMR and written instructions. They then watched a training video on how to use the EHMR. They were fit tested and then trained in person on how to disinfect the respirator. And we used Oxivir wipes for that. I believe that was what was used across all study sites, that was recommended. They then completed a baseline survey right there at the fit testing site. And then they received an initial incentive for that participation. So as we indicated before, participants were followed for three months and asked to complete a survey every two weeks, which included the R-COMFI questionnaire, which is a validated questionnaire pertaining to the aspects of respirator comfort, or really they ask about the discomfort. Workers were also asked about the hours of their use, the ease of disinfecting the respirator, how they carried and stored their respirators and what they liked and disliked about the respirators. Over the three months, we had 110 workers that stayed in the study, out of 112 that were recruited. They were employed in various occupations and across numerous work units. So we had a very nice range of nurses, PT/OT, respiratory therapists, etc. across four or five different areas. And then we also had a large cadre of workers that floated from area to area or unit to unit, which was great to have them in there. Because they had different challenges with respect to storing the respirator, carrying it and disinfecting it. So at study week 10 and I chose to look at differences between weeks two and 10. Just because that was kind of the book ends of these bi-weekly surveys. So at study week 10 more than half of the participants indicated they wore their respirators one to three hours in the prior two weeks. With the second longest time period being one to two continuous hours of use. When asked about performing specific tasks while wearing the respirator, more than half indicated they had difficulty communicating with patients and so that was really kind of the significant issues that workers complained about with the use of the EHMR. However less than one-fourth indicated having problems with other types of tasks, such as walking and repositioning the patient, as well as administering oxygen. Few indicated problems with other tasks listed here such as bathing and feeding the patient. Taking vital signs or dressing the patient. In addition, only a small percentage indicated having difficulty performing tasks listed here such as performing tracheostomy care, oral suctioning and blood draws. We examined changes in respirator comfort level among participants that indicated that they wore the respirator at week two and week 10. And so we had 83 participants that were wearing at both those time periods. And we observed that some comfort measures improved between the two time periods such as facial heat, facial irritation and tightness of straps. Those - that improved slightly while nose pinching continued to be a problem actually more reported it as a discomfort in week 10. Similarly, workers reported less discomfort with the lack of fresh air, interference with glasses, experience headache and frustration, overall frustration with wearing at week 10 compared to week two. Discomfort measures were similar across time periods for week two and week 10. But overall we're low at both time periods including interference with patient duties, obstructed vision and affected concentration. Again the one issue and we asked it in two different ways. That was consistently stood out was verbally communicating while wearing the elastomeric respirator. When asked about patients and workers perception of the elastomeric respirator, a small proportion, less then 10% indicated that co-workers reacted negatively to the respirator. While approximately 20% at week two and 13% at week 10 indicated that patients reacted negatively. With regard to disinfecting the elastomeric respirator, 85% indicated that they typically disinfect their respirator after use. Reported problems with EHMR disinfection included not having access to the wipes. The disinfection took too long and the wipes irritated their face, their hands or their lungs. We asked workers where they stored their respirator between use with more than half indicating that they stored it in their office or their locker. One-third indicated that they carried the bag with them, or they carried the respirator with them in the bag that we provided. And so we gave them these bags with for the purpose of having them carry them. And so some people used it, but then again some people didn't. And so storing their respirator away from them while they're providing patient care is certainly a barrier to having it easily accessible and using it. When asked about future elastomeric respirator use, a large proportion indicated that they felt comfortable doing so during the remainder of the pandemic. And also in non-pandemic conditions. As well as feeling comfortable recommending the EHMR to their colleagues. So overall the elastomeric respirator we felt was really positively received. When asked what they liked best about the respirator, some indicated that it was more comfortable than the filtering face piece respirator the N95. They felt it was less wasteful and more sustainable. And they felt that it provided greater protection. Even though it's the same API, they just felt that they were more protected. When asked what they didn't like, some indicated that the cleaning process was tedious including the drying time and finding a space to actually clean. Some indicated that it was difficult to communicate with others as I previous indicated it was too bulky or heavy. It was hot and they had trouble wearing it with their glasses. We asked workers why they chose to participate. And some were interested in finding respirator that works best for healthcare workers. They were hoping that the elastomeric would provide more protection and comfort than the N95. They wanted to help with the shortage of the N95's or they were hoping that it would help with that. and that they would have more respirator options to choose from. Some limitations of our research. We did not have access to the study hospital. Our research team isn't employed by that hospital so we weren't physically inside there to be able to get in and talk to workers, which was really different than our initial first step of the JET FIT where we rapidly fit tested and trained workers. We were able to go to team meetings and talk to workers and recruit them. And we weren't able to do that during the pandemic. So our recruitment options were a bit limited. We were unable to directly assess their actual use of the elastomeric respirator, when were they using it, actually talk to them about their use on a day to day basis. We weren't able to set up elastomeric disinfectant stations on each of the units. And that actually I think would have fostered the process of disinfection to some degree. And we weren't able to insure their access to the Oxivir wipes. And we found at times like that was a problem. And we had to do a lot of work around to make sure that they had those. So in conclusion, we found that the EHMR was a suitable alternative to the N95 filtering face piece respirator. Workers were able to conduct most of the basic care and procedural tasks wearing elastomeric. Workers were comfortable wearing it in the pandemic and indicated they would also wear it in non-pandemic conditions. And again, communication was a significant barrier warranting the need for an improve EHMR decision. So I'll go ahead and end there and turn this over to Emory.

>> Okay let me get it started. This is over a study - over a study [inaudible] of elastomeric respirators. The healthcare delivery setting somehow [inaudible] by Caitlin earlier. So I would [inaudible] service side and located in the School of Medicine here and Wayne State University, Dr. Marc Rosenthal and Dr. Robert Sherwin both MD [inaudible] emergency medicine here in School of Medicine. And so at Sinai Grace Hospital, the study hospital. And Jazmine is my researcher coordinator. And Dr. Jinping Xu here, our [inaudible] also my assistant [inaudible]. I serve as PI and project manager. Okay so you have heard about the baseline data from Dr. Kraft and also bi-weekly data [inaudible] and others during the study. [inaudible] So our focus here is the predictors. What the [inaudible] comfort barriers they use frequency. But in general there's the research here in terms of comfort, discomfort, symptoms or use barriers. Because elastomeric half mask respirators widely used in general industry. And in healthcare organizations they're not very familiar with this kind. Especially healthcare workers. So research is limited in terms of in healthcare setting. So [inaudible] borders in time and right before the pandemic when we conducted first part of the study which was JET FIT and training, and fit testing before the pandemic. And actually the pandemic came to Seattle. So we used that as the simulation originally when you think about how to simulate it. But the pandemic just [inaudible] so it was real. Everybody in the study hospital was kind of afraid, you know what are we going to do about it? So here we talk about the second project, which was actually used [inaudible]. But in terms of objectives here we focused on the feasibility dating can we ask them to use it in patient care, [inaudible]. And originally it was six months used. But it might have been total. So it change in total three months. So feasibility [inaudible] you know, they experience how they like it. And any discomfort, use barrier. So symptoms during the use and frequency of course in how many hours on basis they can use it is also the key because if they [inaudible] others cannot have much you know, especially during the pandemic. Have to use the respirator. The more you use it, the better. We don't know how often they use it. So in terms of recruitment on our site we approached the different units, mostly focused on the ED, emergency medicine or department. But ICU, SICU, NICU. In the NICU, SICU, no NICU. So they are a part of it. Besides we have other units involved such as Psychiatry. And in terms of recruitment methods. So we conducted at the later than the other two sides, so pandemic was almost over last year. So me and my research assistants we went to different departments, especially ED and SICU/NICU. And NICU, I tend to like NICU somehow because I did study earlier in NICU. In any case, so we used the various approaches. We talked to the nurses station, nurses - we went to the [inaudible] put the flyers everywhere in the hospital. Especially the laundry room. And we also asked them to tell their colleagues about our study, anybody interested please call us. So here my research assistant [inaudible] and research assistant here [inaudible] and this is me. And this is the laundry room. Everybody was inside it [inaudible]. We told them that we have a second project going to come up - come up. But because of the pandemic, three years we were not able to go. And the hospital didn't allow us to go. So we waited and waited and eventually the pandemic was almost over. [inaudible] so here are some of the where pictures [inaudible] this is conference room. And this is laundry room. So in the conference room we train them and we tested. And bi-weekly survey of the discomfort in years time symptoms and use barriers interfere with the patient care work, is our focus you know. So discomforts, we had same questionnaire across the three sides, similar as Dr. Pompeii talked about. That include trial for discomfort. And symptoms altogether is nineteen so this is to - this is kind of to ask them questions in negative way. For example how often did the wearing the mask and respirator in the past two weeks cause - cause the discomfort, affect the comfort? So this is negative. So the answer is you know, true, is no good. All the time is discomfortable. If it's an [inaudible] it's good. So remember the system here and the higher the bad, the worst. The barrier is the interference with patient care, some items. So this is not zero to two. But one to four. Agree or disagree or strongly agree. Again this is negative statement. So strongly agree is worse. Okay. So we also surveyed the use frequency or daily hours of use. So this classification of four categories is the same as the other two sides. So in terms of statistical analysis we consider this as you know, different categories. So we use the times squared to examine the differences of all the data across the six bi-weekly surveys. And the analysis of the discomfort symptoms and barrier scores. So here as I explained in the previous slides, it's score. So we calculate the first means score and the extent of the variation across the six weekly surveys. To see if they are different. Because we were assuming that in the beginning maybe it was not comfortable. And after a while they adapted, you know? So that's not the case when we talk about the data. So no difference across the six bi-weekly surveys. But we also calculate the total score, you know adding everything together. You know 12 plus seven, 19 items. So you have the graded score on each one. And add it together, how much is the total? So that total can be used as separating the data. But in terms of the predictors and analysis across the six bi-weekly surveys, all categorized by the demographic characteristics we used [inaudible]. But we also used the multiple regression to try to identify the significant predictors. So what we found in terms of results. First discomfort. That included also the symptoms. So age is a predictor you know? Younger age, but more discomforts. [inaudible] index some on the lower end and higher discomforts. And education obviously is as you can see here on the second chart, the highest bar is high school. Less education, more education, more comfort. Less education, less comfort. And on the left is occupation. So - and the patient [inaudible] and higher discomfort and others. Okay. so continue the discomfort score and respirator use is - is very important. So it's the - you can have less use [inaudible] like zero to two years of experience, which means less use barriers and have a higher discomfort. There is also high part here, which is [inaudible] six to 10 years. It's also high. In fact, it's the highest and we don't know why. Respirator wear time, four to six hours a day showed the most discomfort. And in terms of barrier, barrier scores this is multiple regression. So from less than one hour to six hours, [inaudible] or less than [inaudible]. That is the regression coefficient significant and is the [inaudible]. The higher hours are not significant. But that is the respirator wear time. The race and education is also - also predictors for barriers. We talked about them in the discomfort scores. But here barrier scores had fewer variables than the discomfort score. Discomfort scores had more variables that affected. Okay so this is a summary, basically it's the same statement as explained earlier. So earlier presented statistical results. But in fact we also have some notes here you know, statistically summarize. Just based on notes. So let me try to read it. [inaudible] was hospital policy during the study. [inaudible] show significant change over time. Basically during the three months, six bi-weekly they are pretty much a staple. And in fact, they are pretty similar to what Dr. Kraft and Dr. Pompeii presented. And in terms of the whole work shift, it's higher in our side. I think it's 20%, you know [inaudible] like one-third use on shift. Three out of 20 they decided you know, not to use for whole shift. Especially not the same patients you know, working on the computers they don't like to wear this kind of respirator. So in terms of reasons now when the [inaudible] sometimes they left and home and forgot - and forgot to bring it. The cleaning, disinfectant will use the same wipe. The two sides identified [inaudible] and they like [inaudible] in fact, [inaudible] to use we gave them a container. We brought everybody one container. So that was in - for them to use. But in fact, the hospital was also - and in it probably was different type. But that was used to [inaudible] not [inaudible]. So if we're running out of our container wipes, we ask them to use the hospitals. But that was variations in terms of the - so the next several slides was focused on the management of the respirator. I mean the respiratory protection program in general. And EHMR in particular [inaudible] you know, manage our respirator. But this is from one focus group meeting. The attendance was asking workers no, administrators. We were supposed to sample administrators. For most administrators, over 20 of them were assembled for the same meeting. The DMC, the Detroit Medical Center was - the hospitals overhead, you know. In the same center, so somehow although we got the [inaudible]. That the compliance office somehow tried to block the meeting because they didn't want any administrators involved in research. They said it's okay you know, for healthcare workers to participate in the study. We needed to ask our legal team. So eventually they contact us. So here most of the summaries are from again five healthcare workers. In terms of management, they didn't have [inaudible] occupational [inaudible]. So each respirator program was managed [inaudible] individually. So this managers [inaudible] so sometimes [inaudible]. Therefore purchase and the distribution was [inaudible] so you don't have large copies to distribute and centrally purchased. So in terms of storage, I mean mostly probably N95, so they have - they are limit [inaudible] N95. They can ask the unit and manager to purchase it for them. And then the nurse manager can report of 10 and higher level [inaudible] so that's the - so the next one is continued on the storage. So the storage basically had some suggestions. They don't like really N95 and centrally managed or stored. So they like to manage and take care of it themselves. And they suggested you know, [inaudible] you know, access close to their work place or be beneficial, you know for storage cabinet or something like that. So in terms of training is also [inaudible] based cleaning, I think mostly they provided some suggestions for our respirator. So they said that you know the NIOSH tested Oxivir wipe as disinfection. [inaudible] that one cost - probably cost one healthcare worker to have [inaudible] spot on the facial skin. So somehow that was the case. So we start from continuation and later our spot on the facial skin fade, you know, a couple weeks. It was our wipe. [inaudible] But in terms of cleaning they had a good suggestion, like tissue wash [inaudible] cleaning first before [inaudible] infection. Okay we also ask filter change, nobody told them based on our [inaudible] property that have filters on the elastomeric respirator can be good for one year because in hospital in the air, it don't have lot of dust [inaudible] and particles fungi [inaudible] in the air. But how exactly they can get a filter change so they have their good suggestions. They said you know, if you provide them [inaudible] can use a lot, so basically it would be good for air testing, to change it. So there are other suggestions you know, and not going to go over all of them. But in terms of conclusions, I think we reached the pretty similar conclusions as Dr. Kraft and Dr. Pompeii. Mostly [inaudible] pretty comfortable. And that can be kind of told from the statistical results. All the negatives you know, on the [inaudible] side, less barrier, less discomfort side and use the [inaudible] occasionally you will have computation problem, have other issues. It's all close to zero in any case. We concluded that the conversion to the use of EHMR is to consider, some risk factors or predictors were identified, such as demographics you know, education and training of course is before you try to convert the use of this respirator. [inaudible] I think it's - it's most of this includes support to current NIOSH and probably change the [inaudible] during the pandemic it was one of the [inaudible] of [inaudible] respirators along with [inaudible] N95. You can use this one, you know they're probably available from Home Depot, but normally the hospital knows so they don't buy them. Okay so we very much thank the NIOSH for the support. And we really appreciate the you know, NIOSH including our side of the - our side was always falling behind kind of late. But eventually we get very good and we recorded similar number of participants for this study. We consented [inaudible] and we had 70 participating. We finished with 68. Whether or not everybody had every, you know survey filled out. [inaudible] Okay. So this is my contact information, email it's Youchangliu@wayne.edu I'm in Family Medicine and Public Health Science. My training is [inaudible]. Thank you everybody.

>> Thank you very much all, to our presenters for all of the information they have shared today. Now we're going to move on to the question and answer session. We have about 15-20 minutes for that. So I'm going to start with the questions that were initially submitted during registration. So first question that I'll address from the registration questions was, was the use of elastomeric respirators in the peri-operative setting evaluated in this study? So not specifically.

>> I can answer that. We actually didn't go into the peri-operative setting and we didn't do it because there was a risk of exposure to the sterile field. So we did have pediatric masks that went over the exhalation valves. But at least in our study, hospital the infection control leaders just didn't feel comfortable with us using them in the OR, so we didn't.

>> We explored using it with endoscopy because it would be a little bit easier about sort of - without having to be concerned about the patients you know, sort of feedback. That's some of the questions I've been answering in the chat. So - but again we had sort of Covid areas of care, we sort of kind of pivoted towards that. But we did think about endoscopy because it would have the sterile issues that Dr. Pompeii's talking about and it wouldn't have the patient perception. So we could talk about - we could study in a different way how - how the communication between healthcare providers could be impaired or not impaired by the use of those.

>> Dr. Liu do you have anything to add?

>> Yeah, I didn't hear the question. I didn't pay attention. Could you repeat the question?

>> Was the use of the EHMR's in the peri-operative setting actually evaluated in the study? So what different departments were you recruiting from?

>> Oh, yeah that was in my slide. We recruit quite a few. So mostly the emergency department because they are you know, [inaudible] is in charge of their - of the healthcare disaster response team. So as emergency department they often need to respond quickly to public health disasters like the pandemic. But ICU was also our favorite. You know they were active in both [inaudible] and the studies the active participated. And quite a few were from the first study.

>> Thank you.

>> You're welcome.

>> Next question was can a [inaudible] be used to complete the annual fit testing for these respirators? And the answer to that is yes. Both the qualitative and quantitative fit test work for the elastomeric respirators. Next question was who does the sanitizing? The individual wearer or dedicated facility station? And this actually falls down to hospital policy. So for this study all three sites had the individual be responsible for storing and cleaning and inspecting their respirators. There are other hospitals however, who have a central disinfection station where hospital workers actually drop off their respirators at the end of a shift and pick it up at the start of their shift. So at this point it's all hospital based decisions. Would anyone like to chime in? Dr. Kraft? Dr. Pompeii? Dr. Liu?

>> The only thing I want to add to that is that Anne Marie was in a unique situation and that they the study population was on like two or three very designated areas, it was a little bit more confined and controlled. And they were able to set up disinfection stations. Where we weren't able to do that and we had a lot of workers that floated from place to place, so they carried their disinfection supplies with them or we kept them on designated units. And I do think that was a bit of a barrier. Some of them complained that they just didn't have the space to do it. So I do think when we followed up later with some of the managers, and we asked them like do you have space? Some units said that they would have had space to disinfect and others didn't. And so I do think that's something that organizations need to think about when they move forward on if they are going to have the worker do that themselves that they got it - they've got a method to set that up. And a place for them to do that. And Colleen do you have something to add to that?

>> No I just would say that if we had done ours in the emergency department we wouldn't have had space to disinfect. So yeah, I think everything you said makes a lot of sense. I think in general we're trying to figure out if there's a better way to interact with PPE from a supply chain aspect, like Jill Morgan on our team is really interested in a vending machine type thing. Where there can be some accountability about who is taking it out. But also there can be an aspect of it has to be cleaned before it gets put into that machine. And so this would not work well with this study. But I think in general trying to figure out like how - how you set that up and supply your staff with disinfection is much harder than - than you think it is. So I think - I'm glad that you brought that up Dr. Pompeii in your - in your narrative.

>> I was like to focus on the disinfection with the elastomeric respirator during the study. So basically we had the container that had Oxivir wipes and they could use it [inaudible] in focus group meeting we did ask them about the N95 disinfection you know. Centralized or [inaudible] we didn't focus on that. So I think the questionnaire probably [inaudible] component. Basically we're not sure about the N95. For this respirator during our study everybody was using the CDC tested Oxivir. But as I said earlier they have their own surface cleaning wipes, which they should be pretty similar container. I'm not sure what they used was tested, you know, what was the logic behind for the selection.

>> I do want to chime in with what you said. These were not necessarily CDC tested wipes that we used. These were wipes that we tested in a prior portion of this study. And decided to use the Oxivir one or the Oxivir TB wipes, which had a .5% H2O2 as a disinfectant. Next registration question or his resistance to fit testing healthcare workers with facial hair and the requirement to be clean shaven. Were there any issues with that? There was a requirement at recruiting that no participants could actually participate in the study if they were - would not stay appropriately clean shaven as that does go against respirator use guidance. So that is just something that everyone who is implementing respirator use, respirator program needs to be aware of, that you cannot use a respirator and not be clean shaven or have appropriate small - appropriate facial hair styles as shown by NIOSH infographics.

>> I think the intent are participating in our studies, the true project, both studies had experience in quite a few talking to the interested. They are not eligible, but they told us when you have this [inaudible] study in coming, please let me know I would be interested in participating.

>> So we're down into the questions from chat. One of the first questions was what model pediatric face mask was used for source control? That was the Halyard procedure mask. For pediatrics, I think it was aged 4-12 and we ended up using that after some just minor testing to make sure what types of procedure masks may or may not impair breathing resistance. So that was the one we ended up using for ease - ease of use and comfort of users. Next question, do the EHMR have an accessory option for built in exhalation valve filter? And if so, did it meet the hospital requirement for source control? So this exact model does not. This model is chosen at the beginning of the study back in 2017, 2018 and we kept it for consistency throughout the lifespan of the study. However over the last two to three years, may different designs have come onto the market to address source control. And those will be addressed in future studies. But at the time of this study design, the source control was addressed by using the exhalation diverter valve, which just directed the exhale breath at the wearers chest and away from the patient's breathing zone. There was a question directed at UT, Lisa I saw that you had answered at least part of it. But what was the drawstring bag made of and were workers given any instructions on maintaining the bag?

>> Yeah I can answer that. so the bag was cottony. It was almost like a linen. They were instructed to wash it, to keep it clean. If they put a dirty respirator in there then they needed to wash it. What we did find though, and we should have tested this beforehand, that some workers complained later that it left like cotton fibers on the outside of the mask. So if they threw the mask in there when it was wet and it wasn't totally dry when they brought it out, it was wet. So then in a follow up study that wasn't a CDC study we ended up - and I've got it here, I'll just show you. So if you're interested we use this type of bag. That is washable, it's breathable. It also has an inside pocket, an outside pocket. And what we learned talking to some of the workers was we wanted to be able to walk out of the room if the respirator was dirty, that they could put it in the front pocket where it was dirty. And then later clean it and stick it on the inside pocket. But then they were also instructed to regularly wash their bag in the washing machine. But for that initial study they were instructed - they got written instructions on what to do with that bag and how to manage it. So I just would suggest if you're going to do this, stay away from a cotton bag. We had no idea that that would be an issue. So -

>> Lisa if you were trying to show the bag, your camera is off.

>> Well I'm showing that I can see me. Can you not see me?

>> No.

>> I can see you. It's just that she has a blurred background, so it was hard to see -

>> Oh here. So here's the bag. It's just you know it's a plasticky like athletic bag. It's still drawstring. And then it's got a front pocket too. It's got an outside pocket. So the workers - this was a different study. When they walked out of the room they put their dirty respirator in the front. So if they were quickly going off to the next thing, they didn't have to stop and clean the respirator then. And then once it was cleaned it went into the inside of the big bag, the big pocket of the bag. So anyway - that was it. It wasn't super fancy. It's simple. But we just changed it up.

>> Thank you. Dr. Kraft or Dr. Liu did you have similar findings? Or do you have -

>> No we didn't do the same. So they ended up just putting it in their locker, in the breakroom.

>> Yeah sometimes they took it, took the respirator to their car. Because probably they didn't want to contaminate their locker or their home, you know? They - I think there was the case for the participant [inaudible] spot [inaudible] because she probably didn't wait until the wet evaporated before using it. So I think somehow the [inaudible] was not.

>> Lisa it does look like there's a follow up question. Did they bring the bag into the - I guess the patient rooms with them at all?

>> Yeah they did. So they carried that with them just like they would carry a stethoscope or any of their other equipment. They weren't instructed to keep the bag outside.

>> All right, next question. As communication continues to be a major factor during use of the EHMR, did any sites continue - or consider or trial use of some form of throat microphone or other communication enhancement? So no extra accessories like microphones were used. However I believe it was noted that some workers used pen and paper or white board if communication was seriously impacted.

>> Yeah so at Emory we have tried to use these types of microphones in our biocontainment unit with our PAPR's. That's where we've had the most concern. And so we've not found a solution that's scalable. It would be especially for the biocontainment unit because you can't take that thing in and out. Like it has to be in there. So we - we did not think about doing that because we haven't sort of solved our original problem. But I do think it's important. But in terms of like blue tooth and we've messed around with all sorts of things in our bio containment unit. Blue tooth stethoscopes, the feedback, the issue with the other devices in the hospital room. I'm waiting for somebody to come up with a really cool device for this.

>> I think [inaudible] was rated very high on our study scale as a barrier. But when I was trying to attend the meetings in the morning or in the evening and you know try to tell people our study, ask them to participate and they couldn't hear me. So later I didn't use this respirator. I just used the N95 probably is more communicable. But I think it's not a big problem. People just needed to talk louder. And for me I think it's the language barrier issue rather than sound volume.

>> Dr. Pompeii did you have anything to add?

>> I don't have anything to add. We didn't do any augmentation of the voice piece. Because if I recall correctly that pretty well had some type of voice box in it. But I didn't really find that that helped at all. It - no we didn't, we never tried anything else.

>> Thank you. The next question. Did anyone consider comparing the incidents of respiratory illness and the population of workers who wore the FFR's, versus those who wore EHMR's versus no respiratory protection? So this was strictly a study to look at comfort and feasibility of using an elastomeric in the healthcare setting. So we didn't have a population of no protection versus FFR's, versus EHMR's. That would be a completely different study and require completely different IRB approval levels.

>> I also answer that question a little bit lower because we did not have - we did not have the ability to - you know during a pandemic setting to ever have anybody in our hospital setting be without respiratory protection in these settings.

>> We don't want to put the workers at a risk like that. Was there any thought about asking patients their perceptions of workers who wore FFR's versus EHMR's. Did they have any trouble communicating with the workers or anxiety when a worker actually wore an EHMR versus an FFR? So that was not addressed in this particular study because as we were looking at just comfort and feasibility of elastomeric; however that is being addressed in upcoming studies that are still getting off the ground. So hopefully in the next couple years we will have a proper answer to that question. Next question, did any of the studies evaluate or compare the experience of healthcare workers using FFR's for the same factors or is there any kind of evaluation plan for the study in the future? As far as I know we do not have any - as far as I know personally there is nothing in the works for FFR's versus EHMR's specifically. We were looking in this study to an extent of current EHMR use versus prior FFR use and opinions.

>> I mean we could elaborate on that a little bit. I mean we didn't really show the study findings for that. But it is in the manuscript that probably will be submitted soon. But we did look at - we asked workers. You know because they were all experienced, most of them wearing the N95's, the disposable N95's and we asked them to compare the comfort between the EHMR and the N95. And for a lot of the metrics the measurements that they felt the EHMR was more comfortable. Now the EHMR isn't super comfortable. We're not like saying this is the slam dunk, but they did find it more comfortable I would say overall than they found the N95. So there's some promising findings there. I think for some workers who are really struggling with the N95, that perhaps the EHMR would be a better alternative. But that's just you know, that's their recalling these discomfort metrics for the N95. You know they hadn't worn it for like three months. So I'll just end there. But more work needs to be done with that.

>> Okay. So we did have a question. Did the hospitals that had a central disinfection station use the same wipes? Yes, so all three sites used about the same wipes. The Oxivir one versus Oxivir TB there's very little difference. Both types of wipes have the .5% H2O2 as a disinfectant. So that was one thing we made sure was the same across all sites. There was also a comment on full face piece respirators being used with an APF of 10. I will say full face piece respirators actually have an APF of 50. Not 10, so it is a higher protection factor. As for the rest of your comments, most would allow this recording to a footnote. That I cannot speak on, but I will just note that it is an APF of 50, not 10 if that impacts your decision at all. Are there any questions that were missed in chat? Or that people have for this time period? Okay, did any site go beyond the disinfecting wipe approach and the full disassembly cleaning as most EHMR IFU's contain? So the disinfection wipe was to be like between patient or after doffing disinfection, so that you can continue about your work day without a wet elastomeric respirator. At the end of every shift the worker was supposed to disassemble and do a full clean with respect to the manufacturers instructions. Are there any other questions? Soiling with artificial soils, mucus, blood, etc. been considered. Are you - had disinfection in a lab setting. Is that what you mean?

>> I think that's what's meant. I think about - we've done this in many other scenarios, but we haven't done it with the respirator. And I think it would have to be in a laboratory situation because I think the inhalation, yeah for surgical - we have not done that. We've done many of fake blood and mucus and stool on other research projects, but not in this one.

>> And we did do across our site at Emory. We did do a lab based study looking at inactive pathogens that were placed on the respirator and examined the effectiveness of disinfection using various wipes. And I think we actually presented that. That's probably sitting out there on YouTube. We presented that three or four weeks ago. And was in process -

>> That presentation is not yet uploaded, we're finished process for it. But it should be uploaded soon. Any other questions? If not, I will wrap that up for the - for the morning. Thank you all for joining us. And have a good rest of your morning.