COVID-19 medical masks and respirators: Information for health professionals

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FFRs for medical use

Particulate filtering facepiece respirators (FFRs) for medical use:

N95 respirators:

image of cup-style N95 respirator

The U.S. National Institute for Occupational Safety and Health (NIOSH) evaluates, tests and certifies N95 respirators. Certified respirators must:

Health Canada, the regulator for medical devices in Canada, accepts the NIOSH certification as an appropriate quality standard for N95 respirators. The Canadian Standards Association (CSA) Group launched a certification program in October 2020, which provides an alternative to NIOSH for Canadian manufacturers of FFRs. Respirators certified through this program will be designated 95PFE.

CSA Group certifies FFRs in Canada in accordance with Health Canada's respirator guidance document (until a national respirator standard is developed). Currently, the Canadian respirator guidance is based on NIOSH requirements and promotes a similar level of quality standards in its certification program.

For a depiction of the NIOSH symbol, refer to the NIOSH website. The CSA Group website also lists CSA-certified respirators.

Equivalent respirators approved under standards used in other countries are also acceptable such as medical KN95 respirators and FFP2 respirators, if the manufacturer can provide evidence demonstrating testing to the appropriate standards.

Respirators can be tested to different international standards, including the U.S. NIOSH standard for N95s, European EN 149 standard (FFP2 or FFP3),GB 19083 for Chinese medical respirators and GB2626 for Chinese KN95s. However, only NIOSH, CSA, CNAS-registered Chinese respirators and CE-marked respirators are certified by a conformity assessment body, which requires that product quality is maintained over time.

Commercial-grade (non-medical) and surgical/medical N95, 95PFE, FFP2 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.

There is also a subset of FFRss labelled as surgical respirators. These devices may or may not be sold sterile and, along with filtration efficiency, may be tested for additional requirements such as fluid resistance. Because respiratory droplets may transmit COVID-19, the use of surgical respirators in most instances is not considered essential.

Medical masks (surgical and procedural masks)

Medical masks are worn by operating room personnel during surgical procedures (see image) to prevent the spread of pathogens to the external environment. They also protect wearers from the transfer of:

For example, according to ASTM International standards, there are 3 classifications :

image of medical mask

Unlike FFRs, medical masks are looser in fit. As a result, they do not provide the same level of particulate filtration.

Strategies to address shortages

Due to critical shortages during the COVID-19 response, we are implementing and/or proposing a range of strategies to respond to the increased demand for medical masks and respirators.

Use of FFRs beyond their shelf life

Most respirators have a limited shelf life, after which they should normally be thrown out. The length of time a respirator is stored beyond its shelf life or recommended conditions of storage may affect its performance. This includes the filter media, the headbands and the nose foam components, which may affect the seal that is created.

FFRs that are past their designated shelf life may not meet the performance claimed in the standards against which they are tested. However, in times of increased demand and decreased supply, health care providers may consider using expired respirators. An expired respirator can still be effective at protecting health care providers if:

Health care providers should inspect the respirator and perform a seal check.

It is unknown how long after the expiry date the respirator would be considered suitable for use.

Use of medical masks beyond their shelf life

Medical masks can be used beyond their shelf life provided they have been kept in accordance with their labelled storage conditions and have not been used. Users should check that the straps are intact and there are no visible signs of damage.

It is unknown how long after the expiry date the mask would be considered suitable for use.

Use of non-medical (commercial-grade) FFRs

During the COVID-19 outbreak when surgical FFRs aren't available, health care institutions may, at their discretion, purchase and use:

Respirators with exhaust valves

Some commercially available respirators have exhaust valves, which are intended to make the respirator more comfortable for the person wearing it. However, the valves also allow infectious respiratory droplets to be released outside the respirator.
Use of respirators with exhaust valves will not protect others from COVID-19. Please do not use respirators with exhalation valves to prevent the spread COVID-19.

Use of respirators approved under standards used in other countries

To expand the availability of 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. Note that different countries may regulate surgical and commercial respirators differently than in North America.

For example, this includes both medical and commercial (non-medical) KN95 or medical FFP2 respirators (including those with head straps or ear loops) that meet standards:

Important information about KN95 respirators

In relation to respirators, the United States Food and Drug Administration (FDA) issued a revised guidance on October 15, 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 GB2626-2019 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/NIOSH 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 the findings from May 2020, Health Canada has asked manufacturers and importers to stop the sale of any products that do not meet the filtration criteria of 95% and re-label them as non-medical use face masks, as they could be used in settings where 95% filtration is not needed. Authorized KN95s that meet the filtration criteria may continue to be sold and used as respirators.

Manufacturers wishing to sell KN95s as medical respirators in Canada are encouraged 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 accredited testing facilities to validate the effectiveness of these respirators.

Use of reprocessed FFRs

FFRs are considered single-use medical devices. However, given the current crisis, extending the usability of these respirators through reprocessing and reuse can be considered to enable the continued availability of these devices. Health Canada is assessing the acceptability of various decontamination methods for the reprocessing of single-use FFRs. Visit Health Canada's reprocessing of single-use respirators page for information on:

What you should do before wearing your respirator

In addition to the application of routine practices and additional precautions (RPAP) based on a point-of-care risk assessment (PCRA), you can protect your own health by checking your respirator prior to use. This includes checking:

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