The need for personal protective equipment has increased, causing firms to supply such items as N95 masks from outside Canada in the face of the COVID-19 pandemic.
Importers need to know that face masks of all kinds for use in medical environments are class I medical devices and that Health Canada is required to import and distribute class I medical devices with a Medical Device Establishment license.
If you do not have a license to establish a medical device, the process for you to obtain a license during the COVID-19 pandemic is expedited for Santé Canada.
Health Canada does not regulate facial masks that are not presented or sold for medical purposes, like those which are bought in a hardware store.
The Contribution of Surrey Company
A Surrey-based company has been formally licensed by Santé Canada and CSA for the local breathing masks. Eternity Medical Equipment was the first to manufacture N95 similar masks known as ECAN95 in British Columbia.
In October, South Surrey opened a 13,000-square-foot facility.
CEO Jeffrey Wang of Infinity said the $500,000 cleanroom creates 30,000 masks a day with two assembly lines.
In August, as explained by Wang, they submitted to Health Canada. The company requested CSA certification while waiting for approval.
On the same day, Dec. 18, they received CSA and temporary order from Health Canada. Health
Eternity is one of 25 Surrey companies taking part in the urban initiative 'Surrey Makes PPE' launched at the end of April.
The City Councilor Allison Patton told us of Surrey that we had the major production center in Surrey. Since April 23, they have seen $12 million of sales from PPE... and more than one thousand full-time employers, as Patton said.
Wang said his business has 17 employees and expects to hire more when production rises. We already have a million breathing machines on the market.
Manufacturing Process of the Company
South Surrey was formally licensed and accredited by Santé Canada and started producing surgical masks by the end of last year.
Eternity Medical Equipment started to manufacture ECAN95 particulate respirator masks in Campbell Heights in November and December, equivalent to N95 masks in the USA.
The masks were tested at a CSA Group in Toronto, where experiments, such as the quantitative fit, airflow resistance, and filtration performance, were carried out.
They have been very welcome and have tested our ECAN95 so far. Since the beginning, they have been actively working on certification.
They are grateful that our ECAN95 is the first Canadian mask to be legally accredited CSA. We began this voyage in April, and discovering that our masks are now being used in British Columbia is very humiliating to us.
Wang was inspired to start the company in a news release announcing the launch of the company last November, after seeing how difficult it was for our frontier staff to procure N95 and surgical masks from abroad.
According to the Monday release, up to 2.5 million masks are available every month for Infinity Medical Equipment, which runs in state-of-the-art space for 13,000 square feet.
Use of N95 Respirators Beyond Their Life
Many respirators have a short shelf life, usually to be recycled. A respirator's length of time after its lifetime may influence its efficiency or prescribed storage conditions. This includes the filter media, headbands, and components of nose foam that can impact the seal made.
N95 and similar breathers that have passed their designated shelves are no longer NIOSH-certified since all requirements of use designated by the producer must be met in order to retain the NIOSH approval. However, healthcare providers may consider using obsolete respirators in periods of higher demand and lower availability. An outdated respirator will still protect health care providers successfully if:
- It could be checked
- Straps remain unchanged
- No visible injury signs occur
The respirator should be tested and the seal checked by health professionals.
How long the respirator will be found appropriate for use after the expiration date is not clear.
In addition to their lifespan, surgical masks may be used to secure providers of healthcare. Health care professionals should make sure the belts remain intact, and no noticeable signs of injury are present.
How long the mask is deemed appropriate for use after the expiration date is not clear.
Use of non-medical N95 respirators
- Where the N95 medical level or corresponding breathable agents are not available during the COVID-19 epidemic, healthcare institutions can purchase and use, at their discretion:
- Breathable advertising N95 (or P95 and the like)
- Industrial equivalents, like KN95 (or KP95) inhalation aircraft
- Such substitute commercial-grade fake filtering respirator counterparts, such as the N99, N100, P95, R 95, P100, R99, P99, and R100 breathers, are as protective as those of commercial-grade N95 breather filters.
- P100 breathers are filtering, industrial breathers immune to gasoline. Their airborne particles’ filter output is comparable to the N95 respirators but is over 95% (99.97 percent ).
- N100 breathers are the same as P100, but they are not oil-tolerant (similar to the N95).
- R respirators guard against oils but have a roughly 8-hour short lifetime.
Respirators with Exhalation Valves
Some commercially produced respirators have exhaust valves that keep the breather secure for the person using them but still allow for the release of contagious respiratory droplets.
Others would not be shielded from COVID-19 by the use of exhaust valves. To avoid COVID-19 dissemination, do not use respirators containing exhalation valves.
Approved Respirators’ Use
Equivalent alternative masks are also appropriate for the maximum supply of N95 medical and other non-medical respirators. This involves respirators that are accredited in compliance with the requirements used in other countries similar to the N95 breathing devices authorized by NIOSH. The medical and commercial respirator regulations can vary from those in North America in various countries.
For example, this includes KN95 or FFP2 respirator for medical as well as commercial breathing devices that follow standards:
- EN 149-2001
- GB 2626-2006
- GB 19083-2010