This is an unprecedented time and the infection control measures that we
learned back when we went to school: one gown, one mask for one patient a
day or per time.
This is a different time.
How did you find that? You find a good supply?
We have had to change the way we did.
This controversial moment that took place in the Oval Office on National
Nurses Day highlights just how challenging it's been for our nation's
health care providers.
The nurses were explaining that they've instituted new policies that
allows them to sanitize and reuse their gear.
If I can sanitize it and it's still fits and perform the same form, fit and
function. Why not reuse?
The Centers for Disease Control and Prevention, or CDC, released
recommendations for extended use and limited reuse of the N-95 respirator.
Plus the Food and Drug Administration, or FDA, is issuing new approvals
for companies developing innovative ways to sanitize PPE.
PPE, or Personal Protective Equipment, worn by health care providers
protects them from exposure while treating patients or while working in a
laboratory environment.
PPE is everything from the gloves that you put on to the gown that goes
over your scrubs.
It's all the materials that you need to protect yourself and also protect
others. One specific type of PPE that has been in high demand is the N-95
respirator. N-95 filtering face piece respirators block out at least 95% of
very small test particles.
The CDC does not recommend the general public use the N-95 respirator.
Instead, it recommends the general public use a cloth face covering to
help slow the spread of the virus.
The difference between a mask and a respirator is how it seals around you
and how it protects the flow of particles from your respiration.
So a mask is in a general sense, going to protect particles from going out
rather than coming in.
But a regular mask isn't going to have the seal around the face or the
positive pressure airflow to protect individuals who are wearing them from
being exposed to droplets.
The respirators, when you put them on, are designed to seal to your face.
So now it is touching my face all the way around.
And when I put it on these headbands help keep it tight to my face.
Now, it doesn't need to be digging way into my face, but it needs to touch
the edge of my face.
And that's the really important thing for any respirator, whether it's
brand new or whether it's been decontaminated five times, is to make sure
you still have that seal.
In the US, PPE is regulated by a complex network of federal agencies.
The National Institute for Occupational Safety and Health, which is NIOSH,
sets the requirements for how N-95s have to perform.
The Occupational Safety and Health Administration, OSHA, tells us how to
select and use the respirators.
So they say where they can be used and how much training people have to
have for certain types of respirators like you would use in surgery.
The Food and Drug Administration has some requirements if you're going to
use the respirators as a medical device and then the Centers for Disease
Control and Prevention offers guidelines for use during outbreaks and
other emergencies.
Different hospitals also have different approaches and requirements for
PPE, which during the pandemic has unfortunately been somewhat dictated by
the availability of the gear.
At Johns Hopkins, our PPE plan is either a papper or an N-95 with a vizor
face shield. So you're protecting the entire respiratory system and you're
protecting the eyes and then in addition, when you go into the patient
room, you're going to have a gown on, a fluid impermeable gown on and two
pairs of gloves. But if hospitals are really in a very sort of crisis
situation, then one of the things that they can consider is
decontamination of these disposable devices.
PPE is traditionally designed for single use.
A lot of our PPE is not simply a flat surface like those vizors are.
You know, masks have contours, they have seams, they have ridges and all
of those things make them a little harder to decontaminate.
In a very clean environment like the hospital, the respirator filter
material is going to continue to be very good.
It will last for a very long time in a clean environment.
But the concern is that these are designed so that the straps maybe won't,
they'll stretch out after a while or perhaps the nose clip that you have
to bend this metal piece.
Maybe that won't bend as well.
In response to the Covid-19 pandemic, the regulatory agencies have been
exploring ways to sanitize and reuse PPE.
So the first strategy is, if you have enough respirators to give every
health care worker five, then you should put it in a bag like a paper
lunch bag and wait five days.
And after five days, the virus will be deactivated and it can't infect
anyone anymore. And the reason they recommend that first is because that's
not doing any damage to the head straps or the nose clip.
However, if people don't even have enough respirators to give everyone
five and to be waiting, then the CDC has recommended several methods of
commercial decontamination and the FDA has approved the certain companies
that make these machines to be able to put respirators in them.
The FDA has issued emergency use authorizations or EUAs for organizations
to be able to sterilize and reuse PPE.
The types of decontamination that have been authorized by the FDA, the
companies include vaporized hydrogen peroxide and moist heat right now.
As of May 20th, only twelve entries of EUAs have been documented on the
FDA's website.
We've tested some of our most popular respirators in the systems and we are
able to say using that system for five cycles, for example, does not
damage the filter media or the headbands or the nose belt.
We are learning that we can safely decon N-95 multiple times and still know
that it fits and that the filter is working.
I'd be much more comfortable going into that patient room with that PPE
rather than a mask that is not meant for someone who is on droplet
precautions. Companies are trying to develop other ways to sanitize PPE,
although on Feb. 27, the FDA issued a reminder that machines using ozone
gas or UV light have not yet been approved for decontamination.
We're a company that sanitizes specifically mattresses, soft surfaces and
textiles. We had to pivot and we had to pivot fast.
When I said, let's grab a few masks and see if we can run through a
machine and test them and see what they look like afterwards.
And so work through the weekend, built a rack on Monday.
We were sanitizing some masks and doing some tests.
We realized that we could sanitize masks.
Clean Sleep uses UVB light to sanitize mattresses and is trying to provide
the same service for PPE.
While they may not be up to the FDA standards for medical devices, Clean
Sleep said they're servicing the masks of people who work in senior living
facilities, student housing and other nonmedical uses of masks.
We had a third party company do the testing on the efficacy of our machine.
They've been able to prove that we can eradicate C.
Diff, Staph, MRSA, VRE, all the critical pathogens and viruses found in
the healthcare sector today.
So the CDC is allowing for us to make that claim based on eradicating all
these other viruses and bacterias because no one wants to get their hands
on this stuff, right? And even begin to start culturing it and trying to
test it like that's not happening.
So, if we can disrupt the RNA and the DNA of the virus, then that's enough
proof to say that we can eradicate it.
We have also filed for the emergency use application through the FDA.
We were able to keep operations going, keep our employees.
And, you know, expand the opportunity.
Plus, we're also serving a good cause, right?
This is something that, you know, is making an impact to our frontline
workers. Clean Sleep is charging about 50 cents per sanitized mask.
They're also able to provide the same mask in a sanitized container back
to the person who gave them the mask for decontamination.
I would imagine that it's easier and better to have the same mask back to
you purely for that fit purpose.
I think that UV light doesn't damage the filter media for most of the
systems we've looked at or the head bands.
So we're waiting to see the FDA authorize that use, because when the FDA
authorizes the use of a system, then they also make available the specific
instructions.
The coronavirus pandemic will have a lasting impact on all aspects of
life, but experts say it could lead to some positive changes in the
medical supply chain.
Finding new ways to sanitize and reuse PPE may cut down on the amount of
medical waste produced per hospital.
PPE is definitely a contributing factor to waste in the medical field.
We use it because it keeps us safe and it keeps our patients safe and it
creates a sterile environment, but it does create a lot of waste.
A mask doesn't need to be thrown away because it's been utilized for six
hours, eight hours, 12 hours, right?
There's nothing wrong with this.
Coronavirus is changing the way we think about disease and hospitals may
decide that they need more respirators in their stockpiles.
They may also decide to order more reusable respirators and PPE.
One of the options that we make available now to health care and and
discuss with them are the reusable respirators.
One thing with both the Ebola outbreaks recently and this Covid-19 pandemic
have shown us is that we have to look at new strategies for both reuseable
PPE and alternatives to our standard PPE.
I think we're a long way from having broad scale up of those approaches,
but there are definitely companies working on this right now.
Some local governments have requested that the general public wear a
homemade face coverings when social distancing is not an option.
Those masks could be sanitized by companies like Clean Sleep or a wash at
home by the wearer.
Gowns and other types of PPE used in nonmedical settings can be cleaned at
home as they are not strictly regulated.
With more people using PPE, the increased demand may also lead to design
changes. PPE is cumbersome.
It's hard to work in.
It creates an impersonality when you're interacting with a patient and it
fatigues people. It's hard to breathe in a papper.
It's hard to breathe in a respirator, like an N-95.
It makes you more tired.
It can overheat your or overexert you depending on the environment.
So we have to be innovators in the way that we think about creating PPE,
how we evaluate its efficacy, how quickly we can change.
PPE is not a place where we innovate in a meaningful way.
If you're in this space and you recognize and capture the opportunities to
help, right?
Create a sanitized environment, I think that we stand to to continue to
grow and to continue to serve.