The global COVID-19 outbreak has exposed the best and worst in our society.
On one hand, it is incredibly encouraging to see the efforts and sacrifices that are being made. Communities have come together to combat the spread of the disease, ironically, by staying apart. Governments continue to work night and day to protect the interest of the people and our nations.
However, these efforts pale in comparison to the sacrifices health care workers are making daily. While most of the country has shut down, our doctors and nurses remain on the front line, putting their own health and safety at risk to save others.
We Are Not Prepared
This outbreak has also shown how ill-prepared we have been for a pandemic of this magnitude.
Due to a massive shortage of Personal Protective Equipment (PPE), our doctors and nurses are facing increased risks of contracting the virus themselves.
As the virus transmits through the air as tiny droplets, facial medical protections are the most effective method to protect health care workers. However, due to depleting supplies, doctors and nurses have been, or will soon be, working without masks, or reusing old, potentially contaminated, masks.
This realization has prompted governments and private healthcare providers all over the world to scramble to find mask supply. As demand for masks has skyrocketed, factories from all over the world are attempting to ramp-up production to deliver supply. Even with these efforts, we know that we will still be behind.
Unfortunately, all masks are not created equal. There is a large variety of masks with different protection levels and a variety of certifications. In the age of “fake news” and widespread misinformation, Healthcare organizations are struggling to find credible supply sources with legitimate products that have been approved for medical use.
This post intends to dispel misconceptions regarding medical masks and provide more information to help Healthcare and organizations make the best decisions to protect our doctors, nurses, and administrative staff. We have a responsibility to protect those that put their own lives on the line to protect us.
Masks: What We Need to Know
If you have been watching the news, the term “mask” has been mentioned countless times by government officials. But what do they mean when they say “mask”?
Colloquially, the term “mask” has been used liberally to include all forms of protective facial protections. However, from a technical standpoint, there are countless types of protective facial protections, including surgical masks, respirators, gas masks, full-face respirators, etc.
With regard to the fight against COVID-19, only the surgical mask and respirator are relevant to the majority of the population.
| The Surgical Mask
Common surgical masks generally can help to prevent the wearer from getting others sick through their spit. It does not do a great job protecting healthy people from acquiring an illness as the loose fit leaves lots of room for bacteria to still get on the face. With respect to the transmission of COVID-19, people showing any symptoms should be wearing these. However, they generally are not sufficient for use for doctors and nurses.
| The Respirator
Respirators, on the other hand, are designed to have a very close facial fit and protect the wearer from a majority of micro bacteria.
There are a variety of designs for the respirator and not all of them are designed specifically for medical use. The U.S. recently made an emergency change to allow for non-medical N95 masks to still be sold to Healthcare organizations by waiving legal liabilities for mask manufacturers.
Although respirators do not completely eliminate the transmission risk of illness, they are by far the most critical mask required to combat the spread of COVID-19.
What does N95 mean?
The term “N95 mask” has been used extensively both in the news and on social media and has generally been understood to simply refer to the respirator design described above. However, N95 is not a design but is, in fact, a specification.
The N simply means “Not resistant to oil”, and the 95 means that when subjected to careful testing, the item blocks at least 95 percent of very small (0.3 microns) test particles.
To clarify, not all respirators are N95. Surgical masks can technically be designated N95 as long as they are not resistant to oil and block at least 95 percent of small test particles.
In essence, whenever a government official gives a briefing on TV to address the shortage of “masks”, they are usually referring specifically to respirators with N95 specifications, or N95 Respirators in short.
Since the shortage has garnered tremendous international attention, many factories have popped up and claim to be producing masks. How can we be sure that these products are exactly what these factories claim them to be?
In North America, N95 Respirators fall under the jurisdiction of the Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH). Subject to Memorandum of Understanding 225-18-006, these 2 governing entities have a framework in place to coordinate and collaborate with regards to regulating the production of these items.
However, as these are still 2 separate governing entities, factories producing N95 Respirators would need to pass 2 separate audits to receive each designation.
Another form of certification is CE which refers to products that have been manufactured to the European Economic Area (EEA) standards.
The key difference between an FDA approval and a CE approval is that the FDA approval requires full clinical trial or trials, whereas CE approval can be obtained through a clinical evaluation – a review of published data for existing equivalent devices.
In essence, a factory producing N95 Respirators could be NIOSH-approved or FDA-approved or CE-approved, or a combination of the above. If the factory cannot produce any certification documentation, or the documentation seems to be forged, there is no guarantee that the N95 Respirators will function properly and can put health care workers at risk.
N95 and International equivalents:
The following items meet the standards above and can be expected to function similarly to the N95 Respirator (United States NIOSH-42CFR84) standard:
• FFP2 (Europe EN 149-2001)
• KN95 (China GB2626-2006)
• P2 (Australia/New Zealand AS/NZA 1716:2012)
• Korea 1st class (Korea KMOEL – 2017-64)
• DS (Japan JMHLW-Notification 214, 2018)
We will never be able to repay our health care workers for their service and the risks they are taking by being on the frontline. We send them our unending gratitude. We owe it to them and their families to ensure that the most-effective masks and other PPE are there to protect them now.