COVID

On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. They also make it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. Health Canada will be updating the content of this page soon. For more information, please refer to the notice on Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices and guidance on Medical devices for use in relation to COVID-19.

Particulate filtering facepiece respirators (FFRs) for medical use:

FFRs:

Certification organizations like the Canadian Standards Association (CSA) Group and the U.S. National Institute for Occupational Safety and Health (NIOSH) evaluate, test and certify FFRs. Certified respirators must:

FFRs with certification will have a symbol of the certification body. 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. These standards include the:

Commercial-grade (non-medical) and surgical/medical CA-N95, 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 FFRs 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 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:

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

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.

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.

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.

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

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.

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:

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.

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:

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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