CLEVAIR AND THE MEDICAL COMMUNITY

The COVID pandemic has required a switch from typical 3-ply surgical masks used pre-covid, to KN95 masks, which have more constricted airflow, fogging issues, and cannot be used repeatedly. This results in a forced compromise, where masks are reused longer than recommended, as they’re no longer abundantly available for sale.

Wearing a KN95 mask longer than recommended results in facial irritations, perspiration, discomfort, and chafing from ear straps. The masks break down over time, and decomposed fibers circulate inside the mask along with moisture from sweat, because the KN95 mask is not manufactured to remain intact for extended use.

Among the medical community, the common theme is a variety of burdensome “work-arounds” and extra effort added to the lives of medical personnel wearing KN95 masks. For example, putting a KN95 mask on without using the ear straps, and then placing a regular 3-ply mask on top of it for the straps, so that the KN95 mask does not create chafing on the ears. 

Surgeons and medical staff on the front lines have to “break-scrub” in order to remove or re-position masks that have become unbearably irritating. This process is not only time-consuming, but requires entirely new sets of gloves and gowns, depleting hospital resources at least twice the normal rate and adding unnecessary waste and pollution. 

CLEVAIR eliminates these issues through a patent pending combination of variable speed internal fan mechanism and personal UV sterilization technology. Hospitals have only recently begun using ultraviolet light to sterilize operating rooms before surgery. With CLEVAIR, the UV light is incorporated into each personal mask, along with a fan to prevent moisture from sweat, and irritation from the exposed fibers characteristic of an overused mask. 

A leading differentiator is the simple fact that CLEVAIR is comfortable all day long, an added benefit to the surgeon, anesthesiologist, tech, and nurse who use CLEVAIR for protection against exposure to viruses and particulates in the hospital setting. CLEVAIR's extreme comfort and protection make it easy to wear in daily life, the O.R., and everywhere in-between. It's a seamless compliment to everyday lifestyle without being constantly front of mind.

    

 

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“If everyone had one of these masks, we'd see the infection rates drop in the hospital setting. It's so important to provide these to people on the front lines who are seeing patients. This is the mask that's going to keep a lot of people safe moving forward.”

 

   

  

Dr. Pazmiño uses CLEVAIR in his surgical and office practices, and he demands that everyone working with him in his clinical practice use it daily. Dr Pazmiño and his staff, including anesthesiologist, nurses, techs, and others, have been using the CLEVAIR mask in multiple procedures. When asked about the mask for medical application and everyday life, Dr Pazmiño shared the following. 

        

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INTERVIEW WITH DR PABLO PAZMIÑO, MD

Please introduce yourself and tell us about your experience with standard surgical and KN95 masks used in hospitals today.

My name is Dr. Pablo Pazmiño. I'm an orthopedic spine surgeon, board certified with the American Board of Orthopedic Surgery. My practice is in Santa Monica, California.

The standard mask that we use in surgery is a typical 3-ply surgical mask. The typical mask that's provided has a little bit of an adhesive for the nose so that it eliminates any fogging. With the coronavirus, we felt safer using a KN95 mask, which is a standard white mask, which does some filtration.

The problem with the KN95 mask is it allows for less air circulation and more fogging. We have to do a lot in terms of taping the mask to our face to eliminate that. That has been the standard. The other problem with the mask is it's something we can't use over and over again. But they were hard to come by, and it's costly, and therefore we held onto them a little bit too long before disposing of them.

  

 

With the coronavirus now, we've been using a KN95 mask in the operating room. And in that setting, it's been an issue because the KN95 mask doesn't allow the same amount of air filtration as our old mask, that we used to use and are accustomed with. And so we would get a lot of fogging. To eliminate that, we'd use a lot of tape, which would then become burdensome and uncomfortable.

The other issue with the KN95 mask was that we were reluctant to throw it away, because they were rare and hard to come by. As a result, the more you wore them and talked into them, it would start to delaminate the inner surface of the mask. You would get a lot of fibers that would come off the mask, and they would start to become irritating. The fibers would tickle your face the more you talked to the point where inside the mask, you were dealing with a hot sweaty, wet mask that at the end of the case, you really wanted to throw away. But you couldn't, because we had to recycle these masks and use them again.

With the KN95, an issue was it had these ear loops, and so you'd have to place each of the loops behind your ear. After about doing a three hour surgery, that became very uncomfortable. Your ears started to hurt. They started to chafe. What myself and a lot of surgeons did is we would start modifying the masks, cutting those loops, and forming them into regular surgical ties just to make it so the mask was bearable to wear. What a lot of surgeons were doing is they put the KN95 mask without any loops on, and then on top of that put a regular mask to just help hold it to their face. People were looking for ways around these uncomfortable ear loops, which were not only a burden, but a pain and a distraction during surgery itself.

   

How long are your surgeries? Do you need to wear a mask all day long?

Generally, our surgeries span anywhere from one hour or hour and a half, to sometimes as long as six, eight, 12 hours. Wearing a mask during that time can become uncomfortable. It can become something where you sometimes take a break just to reposition the mask and then scrub back into surgery. It's something we didn't have to deal with before the coronavirus or any issues with our prior surgical masks. 

One issue that comes up during surgery is once you're scrubbed in, your hands are sterile, and you're in a completely sterile gown. You're no longer able to use your sterile hands to touch, let's say, your mask, your face, your hat, your glasses, anything. And so if you have something that's a burden, or something that's itching you, or something that's uncomfortable, you literally have to break scrub, leave the operating room, reposition it, and then scrub back in to the operating room. Every time you're doing that, you're putting on new gloves and a new gown, and these are all incurred charges to the hospital and therefore to the patient.

   

   

Do you see the SafeMed CLEVAIR Mask as a solution to these challenges?

The CLEVAIR Mask has come up with a lot of ways around some of those issues that many people hadn't thought of before. One thing is there's an internal fan mechanism that during surgery makes breathing through these masks very comfortable. The KN95 mask filters a certain percentage of air. This filters even more, up to 99%, is my understanding.

On top of it, there's a UV light in the CLEVAIR Mask. We were just starting to use UV lights in the operating room to sanitize the room between surgeries, and now the fact that it is incorporated directly into the mask. 

It was a great idea from the standpoint of comfort during surgery, that with CLEVAIR we have a fan constantly blowing fresh air in and around our face. So that stops a lot of the issues we were having with the KN95 mask, because it was becoming hot and sweaty the more we talked. It would accumulate water and moisture inside the mask, and as a result, we would start getting irritation. We noticed that the mask started to break down, and the fibers would become exposed. With CLEVAIR we have a mask with an internal fan, that’s constantly cooling the inner aspect of the mask. This is something we don't even have to worry about anymore.

 

   

How often are you using your CLEVAIR Mask? 

Since getting my hands on the CLEVAIR Mask, I've been using it nonstop. I'm using it in the office setting. I've been using it in the operating room. I use it even between cases when I'm just hanging out in the surgeon's lounge, because you never know who's around you and what their exposure has been. As a result of the comfort level provided with this mask, it's not something that as soon as I'm out of the operating room, I just want to rip it off. It's something that I can leave on, and I can wear comfortably throughout the day both in the office setting and in the operating room.

   

What are the positive effects that you feel from the CLEVAIR Mask during a normal day in the office?

There are a lot of positive effects from the standpoint of the mask itself. We live in California. My practice is in California. This past week, we've gone through a heat wave to a certain extent. It's been very hot, very uncomfortable. One day in the office, the air conditioning wasn't working so well. This mask actually has an internal fan mechanism that makes it a unique, comfortable environment under the mask, which is something that, before coronavirus, we didn't even have to think about or worry about. Now, I can wear the CLEVAIR Mask comfortably throughout the day.

Before California, I lived in Texas where we're used to a hundred degree weather. I have family in Texas, who are physicians going into the hospitals and would really benefit from this mask too, because it’s a hot humid environment. But on top of that, we have to wear a mask and are not allowed to take it off, because we're walking into a hospital, an operating room, or into a dental theater.

Outside the O.R., CLEVAIR has made it more comfortable for us in a world where we didn't use to wear masks all the time. Now we're in that world where we have to wear masks, and it's nice to have something that not only keeps us safe, because it has more filtration available than any other commercially available mask that I'm aware of, but also is comfortable to wear. 

One comfort is the internal fan mechanism that constantly keeps the inner aspect of the mask dry and not collecting moisture. 

 

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“CLEVAIR Mask has actually made me comfortable, and I go back to where I was before the coronavirus pandemic where I don't have to think about the mask. I just turn it on and I'm comfortable for the whole procedure. It’s a considerable addition to our armory.”

   

Another aspect is that the mask is well-designed. Even though I've been wearing it constantly both in the office setting in an operating room, the CLEVAIR Mask doesn't break down like the KN95 mask. I think the KN95 mask is a more disposable mask, but I've noticed in the operating room people are using the KN95 masks, and then they're sterilizing them and repurposing them. You're supposed to grab one and use some mask that someone else has previously worn.

The CLEVAIR Mask, even through constant wear, is not breaking down like the other masks. Inside I'm not noticing little fibers that would break down in other masks and irritate my face from constant talking. 

Also, we don't have to worry about ear loops. I know most people just walking around have masks that have ear loops. Maybe I have sensitive ears, but they really start irritating me after I'm doing a long surgery, or even just wearing them throughout the day in the clinic. 

The CLEVAIR Masks have a standard surgical apparatus with a two strap method, one that goes higher up on the skull, and one that goes lower. That’s more comfortable, and it’s how we've been using masks forever in surgery. Now we're seeing masks as a result of coronavirus that have these ear loops, which are never the type of masks that surgeons wore previously. If you gave surgeons a lineup of masks ... This one has ear loops. These three don't. No one's ever going to pick the one with the ear loops, because we've always disliked those. The fact that CLEVAIR eliminates one of the more uncomfortable features of the KN95 mask is huge.

   

How have you and your hospital and office staff felt since you started using the CLEVAIR Mask?

As soon as I got my hands on the CLEVAIR Mask, I said, "We have to get this for everyone in my office." 

Since then, everyone in my office, all my staff has been using the CLEVAIR Mask. I often ask them how they like it, and they tell me they wear it throughout the weekend, too. I know it's the best quality mask, and I insisted everyone in my office use it for patient interaction, so that I know they're safe here in the office setting. It's something that I think would benefit people outside of my office in the general setting.

  

 

Could the CLEVAIR Mask help people, from the general public to medical providers on the front lines, during the pandemic?

I think if everyone had one of these CLEVAIR Masks, we’d see an increase in the general population wearing masks, because this mask is actually more comfortable than any other mask. And as a result, I think we'd see infection rates drop in the hospital setting. It's so important to provide these masks to people on the front lines who are seeing patients. Because from the standpoint of this virus, we don't know who has it. It could be a patient that just walks in. And if you put this mask in the hand of every medical provider, especially those on the front line, then I think not only would they run to their locker to grab it, they would never have to run anywhere to grab it because they'd be wearing it already.

This is the mask that's going to keep a lot of people safe moving forward.

 

Describe your first experience with the CLEVAIR Mask.

I think my first experience with the CLEVAIR Air Mask is going to be similar to what you're going to hear other users describe. As soon as you put it on, everyone in the room is going to look at you and say, "What are you wearing, and how can I get one of those?" That's what happened to me. The first time I wore it in the operating room, It was instantly comfortable.

At first glance, people think, ‘Oh, that's a KN95 mask.’ But as they look closer, they see there's are lights. They see that there's little mechanism on the outside, and they start wondering. “I've never seen something like that before. Where can I get that?” 

Well, within 15 minutes, our anesthesiologist requested one and was given one. People in the operating room around me all of a sudden were wearing the CLEVAIR mask. It made them more comfortable, but it also made me more comfortable, knowing that they were actually wearing something better than a two or three ply mask.

During the case, I noticed I wasn't having the discomfort of fibers against my face, which on a typical KN95 mask would break down and become uncomfortable, as they gathered moisture and started to irritate my face. Another thing, since medical school on a regular surgical mask, I've had to put a piece of tape to seal the mask against the remainder of my face to prevent it from fogging my glasses. During surgery, we wear glasses that are lead-lined to prevent us from getting cataracts or blood splatter. I've always had to wear a piece of surgical tape between the mask and my skin to prevent that fog from making the glasses unusable.

The CLEVAIR Mask has a silicone seal inside it, so I really don't have to use a lot of tape. The mask just naturally allows this kind of comfort, but also prevents the fog from going into my glasses. When I first started using it in the OR, a lot of people around me looked at it and asked, "How can I get one?" 

And during the case itself, it was more comfortable than I'd been before, because you have this internal fan which is constantly refreshing the air under the mask... And we've never had any mask that does that, quite frankly.

  

  

I do spine surgery for a living. When I'm doing the surgeries, there's an intense focus that actually exhausts you. One thing we never had to worry about was our masks. Then coronavirus changed things, because then we started wearing these KN95 masks that didn't let us breathe comfortably throughout the day. We were dealing with moisture, and wearing masks that we couldn't dispose of after each case.

We found that the longer we were wearing and recycling these KN95 masks, they would start to break down and become uncomfortable. They would start to gather moisture, and it became hard for me to give instructions during surgery. People who watch TV think we're listening to music and doing whatever, but we're actually giving specific instructions to control our environment, so that the team is doing exactly what we need in order to make everything flow smoothly.

What we were finding during the procedure itself, as we were wearing these KN95 masks where we couldn't breathe, that it would limit what I could do efficiently. I noticed it became an economy of thought, because I would debate with myself, ‘Is it worth getting into this? The more I'm talking about this, the more it's just going to create moisture, and I'm going to become more uncomfortable. I'm just going to deal with it.’ I was becoming uncomfortable as a result. 

I started using the CLEVAIR Mask. It let me breathe more comfortably, and give instructions or have normal discussions as I used to. It's really nice to have an apparatus that not only gives me UV, but also has a built in fan air conditioner, so that now during surgery as I'm operating, I'm more comfortable. It's actually nice. 

And, fingers crossed, we all get through the coronavirus and it passes, and I think you're going to find surgeons are still using the CLEVAIR Mask in the O.R. It's really nice to have.

 

What effect does the CLEVAIR Mask have on your microscopic procedures?

I think one thing people don't realize is when we're using the microscope during surgery, we focus our attention so much on what we're doing that we're not noticing elements in the environment around us, and we're especially not taking into account our comfort. Then when we finally get to a break, we realize, "Oh my God. I just realized inside my mask is completely filled with moisture. My ears are killing me from these little ear straps," or, "I just need to take a break and reposition this mask."

Now when I get to that break, I realize I can keep going, because I'm actually comfortable wearing the CLEVAIR Mask. 

I don't have to break scrub, rip off my gown, change gloves, just to reposition the mask, or ask someone to come and run their finger around my ear strap just to give some circulation to this part of the ear, which the KN95 mask used to strangle. 

With CLEVAIR I don't have to worry about that and I can just keep operating. I can actually be comfortable to proceed with the next more crucial stage of surgery.

And so when we're working under the microscope, we control the lighting in the O.R. If there's a lamp that's just angled 25 degrees, that annoys me. I'm like, "Get that out of my way." We need to take control of every little thing and interact with our environment in a specific way. These procedures can be anywhere from 45 minutes long, to an hour and a half, to sometimes eight or 12 hour long procedures. 

CLEVAIR Mask has actually made me comfortable, and I go back to where I was before the coronavirus pandemic where I don't have to think about the mask. I just turn it on and I'm comfortable for the whole procedure. It is a considerable addition to our armory.

 

For more information on Dr Pazmiño and his practice at SpineCal in Santa Monica, California, go to SpineCal.com.