Part 1 | Join the Mask Force: Get Masks to Front-of-the-Line Healthcare Workers

Pictures of nurses wearing diapers, bandanas, and hand-sewn masks are going viral on social media. Our healthcare heroes are in dire need of masks and other personal protective equipment. However, it’s bigger than a mask shortage, and it’s time we step to the plate. We’ve outlined a few ways you can get masks to front-of-the-line healthcare workers (the right way). 

“I don’t have any confidence [my hospital will be able to] protect me. This is not necessarily their fault; they can’t get the gear,” said Megan Sims, a critical care nurse who works in the emergency room of a Minnesota hospital.

The first question we beg to ask is: Is the United States healthcare system failing us, or is it the hospitals themselves? How can this issue be solved other than citizens having to step in to help? The answer to that question isn’t as straight forward as we hoped. 

After doing some research, making calls, and speaking to countless hospitals, consultants, and manufacturers, the cause of the delay isn’t just a limited supply. It’s also a supply chain issue. 

Hospitals and health systems also call on what’s known as the Strategic National Stockpile, a federal store of masks, medicine, and medical equipment. But the outbreak (in addition to the fires a few months back) has already strained stockpiles. 

In addition to the Strategic National Stockpile that hospitals rely on, there’s also HPP (Hospital Preparedness Program). HPP, in addition to being a great resource, also provides hospitals with funding grant opportunities.

So why can’t they just find a new supplier? Why can’t they order directly from China like all these other businesses? There’s a handful of reasons, let’s dive in, so you understand and hopefully help solve this growing issue. 

The teams that come together to solve all these puzzles will help healthcare workers in a much bigger way than donating small orders of masks, and worse, masks they might not even be able to use. 

International Manufacturers

Since hospitals are used to working with US-based manufacturers, they are used to a standard ordering process. They reach out to their pre-vetted roster, request certain model types their staff is fit-tested for annually (click here to learn more about fit-testing), and they set up a PO (Purchase Order) with net terms of 30, 60, or 90 days. 

The above standards don’t pose to be a problem for the US-based manufacturers. However, this has been a roadblock with international suppliers. Since US suppliers are out of stock, we need to find individuals to help solve the gap between hospitals and these international suppliers. Let’s dive into how. 

Mask Types 

The mask type is where things start to get tricky. Countless mask types are used for all kinds of purposes in different settings across many industries. Although some may look the same and sound the same, they are very different in their own ways. Medical professionals most commonly use two types of masks, surgical masks and N95 respirators (also referred to as a mask). Each mask type is highly regulated by NOISH, the CDC, and the FDA when used in a healthcare setting; for a good reason. The last thing we need in healthcare is exposure to pathogens because a manufacturer decided to cut corners. If you can find the blow types, these are the ones preferred.

N95 Respirators 

Healthcare workers are fit-tested annually to ensure that the style/model and size N95 mask they are using has a tight seal. This seal is what protects the worker from the virus or other pathogens. If alternative mask sizes are secured from donations (such as a KN95), the fit isn’t ensured, and the healthcare worker could be putting themself at risk. Is it better than nothing? Absolutely. However, finding the real thing should be the focus of as many people as possible. 

Unlike surgical masks, respirators are specifically designed to provide respiratory protection by forming a tight seal against the wearer’s skin and efficiently filtering out airborne particles, including pathogens. The N95 designation indicates that the respirator filters at least 95% of airborne particles.

Safety and health standards have been established by the Occupational Safety and Health Administration (OSHA), the Joint Commission, the Food and Drug Administration (FDA).

You need to be aware of the following considerations with respiratory protection products:

• Follow the guidance of your organization’s respiratory protection program, including medical clearance
• Be sure you are using a NIOSH-approved respirator
• Get fit-tested on an annual basis
• Know how to don and doff the specific brand and model of respirator you are using
• Know how to use the respirator safely and effectively

N: This is a Respirator Rating Letter Class. It stands for “Non-Oil,” meaning that if no oil-based particulates are present, then you can use the mask in the work environment. Other masks ratings are R (resistant to oil for 8 hours) and P (oil proof).

95: Masks ending in a 95, have a 95 percent efficiency. Masks ending in a 99 have a 99 percent efficiency. Masks ending in 100 are 99.97 percent efficient, and that is the same as a HEPA quality filter.

.3 microns: The masks filter out contaminants like dust, mists, and fumes. The minimum size of .3 microns of particulates and large droplets won’t pass through the barrier, according to the Centers for Disease Control and Prevention (CDC).

Exhalation Valves

An N95 respirator with an exhalation valve does provide the same level of protection to the wearer as one that does not have a valve. The presence of an exhalation valve reduces exhalation resistance, which makes it easier to breathe (exhale). Some users feel that a respirator with an exhalation valve keeps the face cooler and reduces moisture build-up inside the facepiece. However, respirators with exhalation valves should not be used in situations where a sterile field must be maintained (e.g., during an invasive procedure in an operating or procedure room) because the exhalation valve allows unfiltered exhaled air to escape into the sterile field.

KN95 Respirators 

If you’ve been on social media or are working in the healthcare field, chances are you’ve heard of a KN95 mask. That’s because the CDC recently came forward with a document outlining alternatives to N95 respirators, and the KN95 is/was listed as an alternative. However, the KN95, although listed as an alternative to optimizing the supply of N95 respirators, is not a mask that healthcare workers are annually fit-tested for. They are not meant to be used as an equivelant to an N95 respirator. 

Surgical Masks 

FDA Compliance 

510(k) Number 

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. 

NIOSH 

NIOSH Approval: Approval means a certificate or formal document issued by NIOSH stating that an individual respirator or combination of respirators has met the minimum requirements of 42 CFR Part 84 and that the applicant is authorized to use and attach an approval label to any respirator, respirator container, or instruction card for any respirator manufactured or assembled in conformance with the plans and specifications upon which the approval was based, as evidence of such approval.  

The masks that are NIOSH approved are mostly manufactured in Taiwan. To make matters worse, the Taiwan government has banned exporting N95 respirators and 3ply level 1 maks. However, they are now prioritizing applications for manufacturers that wish to be NIOSH approved. 

The CDC, Department of Health and Human Services as well as NIOSH came together to make this document to help educate healthcare workers on how to check NIOSH. 

FDA & NOISH 

FDA and NIOSH are sister Agencies within the Department of Health and Human Services (HHS). Both Agencies’ missions include protecting public health. Both Agencies are authorized to regulate certain RPDs but have different statutory authorities and responsibilities.

The collaboration is intended to streamline regulatory oversight of N95s used in healthcare settings, is expected to help ensure the availability of safe and effective products, particularly during times of increased demand.

Alternatives 

At this point, you’re probably feeling pretty lost and discouraged. We are here to help. If you can’t get your hands on real N95 masks that are NIOSH approved (as the example above), the following chart shows what types of masks are IDEAL for healthcare workers in the meantime. 

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“In settings where N95 respirators are so limited that routinely practiced standards of care for wearing N95 respirators and equivalent or higher level of protection respirators are no longer possible, and surgical masks are not available, as a last resort, it may be necessary for HCP to use masks that have never been evaluated or approved by NIOSH or homemade masks. It may be considered to use these masks for the care of patients with COVID-19, tuberculosis, measles, and varicella. However, caution should be exercised when considering this option.1,2” – CDC 

Continue with the second part here.

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