As we try to follow official recommendations, guidelines, and mandates to protect ourselves against the COVID-19 coronavirus, we often find ourselves spending more time than seems reasonable to ensure that we have access to masks. We need to wear masks both to protect ourselves but also to protect others.

However, there is a great deal of contradictory information regarding where we are supposed to actually get these devices. In the earliest days of the pandemic, we were warned by those in the CDC to avoid using masks, not because they would not protect us, but because there was an immediate shortage of the highest tiers of masks, namely the N95 respirator. These devices were meant to be reserved for those who were (and still are) on the front lines of this crisis. Those who need the N95 respirator include medical professionals, but also anyone else who comes in regular contact with those who have been infected with the virus.

Soon after this, we were then given instructions to always wear a mask within a public space. This is, of course, a solid recommendation since the use of a mask has been proven to be the single most effective way of preventing the spread of the disease. However, finding high quality masks is not always easy.

In this article we will attempt to explain the reasons why access to these devices has been difficult, what the different types of masks there are, and what to do about these shortages. This is particularly the case for those who work in high-risk environments, who must supply their staff with adequate Personal Protective Equipment (PPE). However, before we start, first let us address the reasons why medical masks and respirators (particularly the N95 respirator) are in short supply. 

Complexity of Design and Manufacturing

While simple cloth masks are relatively easy to construct (it can be done with any spare piece of fabric and a sewing machine), these are not considered to be effective PPE. For the more effective respirators and surgical masks, there are many complex materials that are required for their manufacture. In order to create these, it is necessary to obtain the correct materials to create non-woven materials, which include various metals (for the strips which affix the mask to the face, and nose) and oils which go into the polyethylene plastics from which the masks themselves are created. Other materials, such as cotton, may be used for the ear loops or straps for affixing the masks to the face and head of the wearer. The polyethylene must be woven into small fragments to be able to create a maze-like pattern of fibers by which these masks trap small particulates. 

Because of this, the manufacture of these devices requires some fairly specialized equipment. Many factories in the U.S. were not already equipped to be able to produce these materials. Most factories who can produce these masks are overseas in countries such as China.

Supply Chains

To be able to gather together all of these materials, one needs to ensure that there is proper shipping and distribution of key ingredients. The materials include the aforementioned metals, plastics, and cloth. 

Unfortunately, there exist bottlenecks within the supply chains, making it difficult to bring all of these materials into the same place for construction. There are few manufacturers within the U.S. who produce these ingredients.  In many cases this means getting other countries to be able to provide these materials.

Also unfortunately, the COVID-19 pandemic is global in nature. It is affecting pretty much every country on the planet. Many of the countries, such as China, who manufacture these materials are requiring them to be used for domestic purposes. As a result, access to these devices in countries such as the United States has proven to be limited.

Distribution and Trade Restrictions

The ability to distribute these materials between countries has caused some serious shortages within the U.S.  Some bottlenecks related to logistics and transportation have appeared. Because of the aforementioned needs in other countries, some nations have imposed restrictions on the export of these key materials; many manufacturers within these countries have been prevented from distributing these products internationally. Often the existing stocks of these materials have been purchased entirely by the governments who want to ensure that there are enough supplies for their own populations 

This has caused problems, not only for the United States, which does not manufacture these materials in great amounts, but also in other countries. Some countries have imposed regulations prohibiting these exports, which unfortunately in turn have made it difficult to obtain other materials which may be required in turn. This has further exacerbated the scarcity of materials required for creating PPE. 

The large number of people falling ill has itself disrupted the ability of companies within this field to be able to change their manufacturing or be able to produce these PPE devices. This too has impacted the distribution of materials within the U.S. As the health infrastructure was ill-prepared for the impact of this virus, distribution channels have been impacted by employees becoming ill.

Demand is higher than Supply

Due to the limited amount of time that surgical masks and respirators should be used (typically 4 hours for a surgical mask and 8 hours for an N95 respirator), and the fact that they are recommended to be disposed of after this use, this results in a high demand, particularly in high-risk situations, such as in medical environments.

The general public may not need to wear masks constantly for the entire duration of the effectiveness of the device, as they may not necessarily always be in an environment where they interact with others. A mask can be reused as long as the amount of time wearing it does not exceed the above guidelines. However, for many in public-facing positions, they may need to wear these devices consistently, resulting in a much higher necessity to replace them regularly. This may also impact people other than those who work within healthcare or patient facing environments. The need for constant mask wearing can apply to anyone who works in a customer-service role where they interact with the public regularly, including supermarkets, restaurants, or other such establishments. At least two masks per day should be required in these circumstances.

In healthcare fields, while not all staff will come into contact with those who may have the coronavirus, many will. As a result, a much larger number of masks will be required to be worn during any given day. This puts an increased level of demand on the availability of these masks and respirators than there exist supplies. 

Problems with Profitability

Within the PPE industry, there are problems with the initial amount of investment required to ramp up to make N95 respirators and masks.  

While polypropylene, the plastic which is used in the construction of N95 respirators and surgical masks is widely produced, the type that Is needed for masks requires a finer level of refinement. Very few companies in the U.S. are involved in the creation of these materials. Access to these materials creates a roadblock in the creation of PPE.

Many companies are unwilling to make this sort of investment without a guarantee of continuing need and demand. Because of this many companies that could begin making masks and respirators choose not to do so. In the United States, due to the cost of materials and the pricing that one can affix to these devices, it is not profitable to spend the months required in order to create a single manufacturing line.

China is well suited for creating these materials, however due to restrictions and demands in their own countries, this can cause problems for the U.S. markets. While they have increased manufacturing, it has not been enough to close the gap required. 

Lack of Coordinated Efforts

This problem could have been solved if, under the Defense Production Act, the federal government had stepped in and mandated the creation of these materials, unfortunately, for whatever reasons, this did not occur. 

While there were efforts that were made to put pressure on private business in the US to create ventilators, which were necessary to enable patients in critical care facilities to be able to breathe, there has been no such coordinated effort for the creation of PPE, such as surgical masks or respirators. While the U.S. federal government may have had the ability to pressure companies to create these types of materials under its powers of the Defense Production Act, no such proclamation has been made by the executive branch of the United States government.   

As a result, availability of masks and other PPE has been restricted by existing market forces. 

Types of Masks

One of the things that may make it difficult to purchase the correct mask may be a lack of understanding of the different types of masks that exist. Some are easier to obtain than others.

Cloth Masks

Cloth masks are easy to manufacture and are widely available. This type of mask can easily be manufactured at home with some cloth and a sewing machine (or can be made with thread and needle if one is so inclined) or may be purchased in a wide variety of different locations. If one is to make these oneself, it is recommended that they have at least two layers of fabric, and should be attachable either behind the head with two straps, or at least affixed to the ears, using elastic, cotton, or other flexible material.

However, while they are effective at reducing the spread of the virus in the general population, cloth masks are not considered to be the Personal Protective Equipment (PPE) recommended by the CDC. They are better than wearing no protection at all but are not ideal for medical environments.

Surgical Masks

Surgical masks are medical equipment that are approved by the Food and Drug Administration (FDA), or by the American Society for Testing and Materials (ASTM). These are designed specifically to protect patients from external infections. They may be useful for the general public at preventing the spread of the disease, as they are somewhat effective at catching exhaled materials. They are not closely fit around the face of the user, and are therefore not designed to protect the wearer against inhaled particles (though they may provide some basic protection here).

Within the ASTM guidelines, there is some variability in the quality of the masks that are produced. These are divided into three categories. These are measured according to the categories of filtration, fluid resistance, features, and fit. The primary difference between levels 1, 2, and 3, is surrounding the fluid resistance.

Level 1 masks protect against 80 mmHg of liquid pressure, level 2 against 120 mmHg, and level 3 against 160 mmHg. For most medical situations, only the ASTM level 3 is recommended. 

N95 Respirators

These are shell-shaped and designed to fit closely against an individual's face. They are considered to be the most effective type of PPE for protecting the wearer from inhaling foreign substances, such as the virus.

These are the masks we refer to the most when we speak of the shortages. They require a wide range of materials and specialized equipment for their manufacture.  Restrictions have been put into place in many places due to the need to ensure that front-line medical staff are given first access.

Where to obtain medical masks online?

Despite the difficulties in obtaining access to materials and problems within the supply chain, there are still some resources available which can provide access to these devices. While it may be tempted to try and find materials online in places such as Amazon, the quality of PPE to be found can vary; there is no overriding requirement in these reseller markets to authenticate that their products have been approved by legitimate authorities.

It makes more sense to purchase your masks and respirators directly from a site which specializes in these materials, and follows all official FDA, ASTM, and NIOSH guidelines for providing quality PPE. For this reason it makes sense to purchase products directly from Clinical Supplies USA.