What You Need to Know About Medical-Grade Masks and COVID Prevention Right Now
With the discovery of the new B.1.1.7 variant of the COVID-19 virus, medical experts are beginning to point to the need for greater protections to slow down the spread of a strain that is proving to be at least 50% more easily transmissible. Recently new legislation has begun sweeping across Europe, mandating medical-grade face masks, rather than cloth face coverings, be required in the workplace, on public transportation, and in stores. Over the last few days, major news outlets in Canada and the U.S. have been talking about the importance N95 Respirator masks can play in doubling-down on efforts to slow the pandemic’s momentum.
Transmission, as we know, largely stems from aerosolized droplets of the virus that are expelled through the mouth and nose of an infected person. There are a number of possibilities why the new variant is more easily communicable, from a greater viral load within a person’s exhalation to more efficient aerosolization with this strain.
The positive news is that we still know the best way to prevent this virus from spreading is through blocking that transmission point from happening. While any type of mask provides a level of protection, the N95 style respirator is, by far, the most comprehensive protection.
Joseph Allen, a professor and director at Harvard University’s T.H. Chan School of Public Health writes in an article for The Washington Post: “To see the true power of masks as a public health tool, we have to examine them in the context of everyone wearing them, where the power of each mask doubles. That’s because the particles have to pass through the material twice — once after being emitted and again before someone breathes them in. Take the example of two 70 percent efficient masks, which combine to reduce 91 percent of particles. Not bad. But two N95s result in greater than a 99 percent reduction in exposure.”
Common sense would say that 99 percent protection against airborne transmission would be a game-changer. As with every other facet of this pandemic, there’s no such thing as a simple fix. N95 respirators were not a household item before 2020. The supply chain for respirators and other PPE was right-sized for the needs of a niche market – it was not prepared for a global surge in popularity. The supply chain of N95 manufacturers in North America in the spring of 2020 was woefully inadequate to cover the growing need for respirators, even for healthcare workers, let alone the general public.
So what exactly is an N95 and why is it so special? An N95 is not a brand name, it refers to the fact that this respirator will block at least 95 percent of very small (0.3 micron) test particles, which is the size range of most viruses. Prior to the pandemic all N95 respirators had been certified by one governing body in North America, The National Institute for Occupational Safety and Health (NIOSH), a U.S. Centers for Disease Control and Prevention unit that was tasked with approving respirator design and manufacturing. The NIOSH system worked perfectly when the need for respirators was a steady stream. However, as it became clear that the current supply chain was not able to cope with the tsunami of urgent need for billions of respirators per year, NIOSH was overloaded with manufacturers requesting certification – a normally lengthy and tightly controlled process.
Urgent need in the face of increasing deaths and economic challenges produced creative solutions as the pandemic took hold. In April of 2020, Steve Mai, the CEO of Eclipse Automation decided to take matters into his own hands regarding the supply chain issues for PPE in North America. He knew that his team could design and build anything, and in record time, so he set about creating a local supply chain of reliable, quality N95 style respirators and procedure masks at his head office in Cambridge, Ontario.
Although the Eclipse team were used to building custom systems for other manufacturers, this time they set out to source the most efficient equipment and best quality materials to manufacture respirators and masks in-house. The team went through numerous equipment modifications and materials testing to make the end product outstanding. The respirators were testing at an exceptional 99 percent particulate filtration efficiency. In less than six months from the initial idea, Eclipse Innovations was born, and began producing two types of surgical-grade respirators and a level 3 procedure mask for the North American market.
It is one thing to make great PPE, it is another to be granted the ability to get it to market. With NIOSH in a backlog, a new Health Canada interim order certification was developed to acknowledge the same stringent safety requirements that NIOSH would demand of any product. In the fall, Eclipse Innovations was granted Health Canada’s interim order certification for both their ARC and HORIZON respirators. This certification allowed the product to finally be sold in Canada at the N95 equivalency for a specific period of time, reflecting the nature of this interim solution being a stop-gap to a more permanent certification. Health Canada has done great work setting up the interim order system and in preparing a road map for a permanent domestic equivalent to NIOSH certification by 2022.
Of course we have a lot of pandemic to get through before 2022, which means that government intervention is desperately needed to enable changes to legacy regulations that are bogging down the ability to get safe domestic PPE into the hands of Canadians today.
At full capability, Eclipse Innovations could produce 40M respirators and 44M procedure masks in 2021. This should be tremendous news for Canadians looking for a reliable, quality source of local PPE. However, the short-term nature of an interim order makes it difficult for healthcare networks to commit to large purchases, with no guarantee of the interim order covering the full time they would be using this stock. This interim solution, which Health Canada has moved mountains to provide, needs the government to intervene and support an expedited, stable pathway. Only the government can legitimize updated protocols which would remove risk during this gap in the certification system; allowing the healthcare sector to procure this product with full assurances.
The federal and provincial governments have talked initiatives, spread out funding here and there, and said that they were committed to fighting the pandemic. The part they have missed is that the entire supply chain process has to be supported, not just pieces of it. It isn’t enough to pat manufacturers on the back for pivoting to develop and build homegrown PPE, the government needs to see it through, clearing bottlenecks caused by the application of an old system for new challenges. They need to get behind regulations for a sustainable way to ensure high-quality PPE can enter the market with long-term viability and they need to educate buyers on the credibility of the new system so that they can feel confident in their purchase. This is how you support the progressive companies who have come to the table to provide urgent help in a crisis, and this is how you keep a domestic supply chain alive for the future.
Currently, without a long-term solution for domestic PPE certifications and without any commitments from the government, Eclipse Innovations has applied for U.S. based NIOSH certification and hopes to gain this within the next 90 days. Once the ARC and HORIZON respirators have NIOSH certification they will have permanent validation within a long-recognized system and can be sold across North America.
Eclipse CEO, Steve Mai, says: “I know what I wanted for the country when I set out on this journey; to get safe, affordable PPE into the hands of healthcare workers and provide a domestic supply so that Canada would never be caught short like this again. I’ve done everything I could to make it happen but the provincial and federal governments have not stepped up to purchase locally or make it possible to sell our PPE to healthcare institutions in the long-term. At the end of the day, I’m a business man and responsible for the 750+ employees at Eclipse, so we will definitely secure buyers for this PPE but it may not be domestic customers and that is a shame.”
It is widely thought that the current global supply of respirators and procedure masks will be decimated when this growing wave of legislation that everyone, not just healthcare professionals, wear medical-grade masks to safeguard themselves from the new COVID variant. All available stock will be reserved and materials to make more will be scarce, and prohibitively expensive if available at all. “We won’t be able to fix this for Canada, if it isn’t done right now. The window is closing fast.” Mai warns.
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