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IMPORTANCE OF MASKS AND RESPIRATORS
Masks and respirators (personal respiratory protective devices) are essential during the COVID-19 outbreak. They help slow the spread of the disease in Canada and protect health care providers. Both masks and respirators need to be used in combination with appropriate eye protection (e.g., face shield, goggles) to achieve full protection of the eyes, nose and mouth.
There are a number of different types of masks and respirators. They each have a particular use in a particular setting. A definition for respirators and masks is provided on the Public Health Agency of Canada' s (PHAC) website.
N95 RESPIRATORS FOR MEDICAL APPLICATIONS
N95 respirators (or particulate filtering face-piece respirators) are Class I medical devices. They are manufactured and/or imported by companies that hold a Medical Device Establishment Licence (MDEL) and include those that are authorized by Health Canada under the Interim Order for COVID-19 medical devices. See below for more information on expedited review and approval pathways for masks and respirators in relation to COVID-19.
N95 respirators achieve a minimum filtration efficiency of 95% when worn properly. The edges of the mask form a seal around the nose and mouth. N95 respirators (not medical masks) are designed to reduce the risk of inhaling hazardous airborne particles and aerosols.
N95 respirators are produced in many different styles, such as cup-style (see image), flatfold or duckbill. They may or may not have an exhalation valve.
In a healthcare setting, N95 respirators protect against exposure to respiratory viruses and bacteria.
The U.S. National Institute for Occupational Safety and Health (NIOSH) evaluates, tests and certifies N95 respirators. The masks must pass minimum performance requirements, such as filter efficiency and breathing resistance. All N95 respirators certified by NIOSH must have an approval number stamped on the mask, represented as TC-84A-####n.
Health Canada, the regulator for medical devices in Canada, accepts the NIOSH certification as an appropriate quality standard for N95 respirators used by healthcare providers. Equivalent alternate standards are also acceptable (see below for information on respirators approved in other countries).
The N95 respirator is the U.S./NIOSH standard for respirators and KN95 is the Chinese standard. Commercial-grade (non-medical) and medical-grade N95 and KN95 respirators are similar with respect to design, filtration, performance and material standards. In Canada, it is the labelling, indications for use and claims that contribute to the classification of a product as a medical device.
Use of N95 and equivalent respirators beyond their shelf life
Most respirators have a limited shelf life; after which they should be discarded. The length of time a respirator is stored beyond its shelf life or recommended conditions of storage may affect its performance. This includes not only the filter media but also headbands and nose foam components, which may affect the seal that is created.
N95 and equivalent respirators that are past their designated shelf life are no longer NIOSH-certified, as all manufacturer-designated conditions of use must be met to maintain the NIOSH approval. However, in times of increased demand and decreased supply, consideration can be made to use these expired N95 respirators. An expired respirator can still be effective at protecting health care provider if:
Health care providers should inspect the respirator and perform a seal check.
There is no specific timeframe beyond the expiry dates for N95 and equivalent respirators at which they would no longer be considered suitable for use.
Masks (surgical, procedure or medical masks)
Masks, for example surgical masks, are worn by operating room personnel during surgical procedures (see image). They protect both the patient and operating room staff from the transfer of micro-organisms, body fluids and particulate material.
There are 3 classifications under the American Society for Testing and Materials (ASTM):
Unlike N95 respirators, masks are looser in fit. As a result, they do not provide the same level of filtration.
Use of surgical masks beyond their shelf life
Masks can still be used beyond their shelf life to protect health care providers. Health care providers should check that the straps are intact and there are no visible signs of damage.
There is no specific timeframe beyond the expiry dates for masks at which they would no longer be considered suitable for use.
Non-medical N95 respirators
Commercial-grade (non-medical) and medical-grade N95 respirators are similar with respect to design, filtration, fit, performance, and material standards. In Canada, it is the labelling, indications for use and claims that make a product a medical device.
There is a subset of medical N95 respirators labelled as surgical respirators. These devices are sold sterile and are tested for fluid resistance (penetration by synthetic blood) under ASTM F1862. Because COVID-19 is transmitted by respiratory droplets, the use of surgical N95 respirators in most instances is not considered essential.
Use of commercial-grade N95 respirators
Health care institutions may, at their discretion, purchase and use commercial-grade N95 (or P95 etc.) respirators (or equivalents such as commercial-grade KN95 (or KP95) respirators) in a health care setting during the COVID-19 outbreak when medical N95 (or equivalent) respirators are not available.
Commercial-grade (non-medical) respirators do not qualify as a medical device and therefore, an authorization under the Interim Order (IO) or a Medical Device Establishment Licence (MDEL) is not necessary. It is important that the label be limited to a filtration indication, and that no medical claim can be made.
Respirators Approved Under Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Respirators
To expand the availability of medical and non-medical N95 respirators during the pandemic, equivalent alternate standards may also be acceptable. This includes respirators that are approved or certified under standards used in other countries that are similar to NIOSH-approved N95 respirators.
For example, this includes both medical and commercial (non-medical) KN95 or medical FFP2 respirators (including those with head band or ear loops) that meet standards:
The United States Food and Drug Administration (FDA) also issued a revised guidance on May 7, 2020, indicating that certain filtering face-piece respirators from China may not provide adequate respiratory protection. The FDA will still consider KN95 respirators medical devices equivalent to N95s (as the FDA and U.S. Centers for Disease Control and Prevention (CDC) consider GB2626-2006 to be equivalent to NIOSH N95) but authorization for KN95 respirators will require additional validation and review by the FDA.
Recent testing performed by the CDC resulted in concerns with some KN95 respirators (specifically those with ear loop design) that pose a difficulty in achieving a proper fit, which is essential for use. This is in contrast to N95s that use a head band design (not ear loops), which appears easier to achieve a proper fit and seal. In addition, several models of respirators, including some KN95 respirators, failed to meet the filtration criteria of 95%.
In response to these findings, Health Canada has asked manufacturers and importers to stop the sale of any products that did not meet the filtration criteria of 95% and re-label them as face masks, as they could be used in settings where 95% filtration is not needed. KN95s that meet the filtration criteria may continue to be sold and used as respirators.
This action does not implicate KN95 respirators purchased by the Government of Canada and tested by the Public Health Agency of Canada (PHAC). Before allocating any personal protective equipment to the provinces or territories for frontline healthcare workers, PHAC conducts a quality verification. For KN95 respirators, this includes a visual inspection to check for defects in design and construction, and testing to confirm that they meet filtering specifications. KN95 respirators distributed to provinces and territories by PHAC meet the Government of Canada's technical specifications for healthcare settings for COVID-19 response.
Manufacturers wishing to sell KN95s as respirators in Canada are invited to submit an application for authorization under Health Canada’s Interim Order for the Importation and Sale of Medical Devices.
Health Canada will continue to authorize KN95 medical respirators in Canada through the Interim Order pathway. As of May 7, 2020, Health Canada will request test results from independent testing facilities to validate the effectiveness of these respirators.
The Government of Canada has developed detailed specifications for personal protective equipment such as disposable N95 respirators.
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