COVID-19 medical masks and respirators: Reprocessing N95 respirators

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Using reprocessed N95 respirators

N95 respirators are a type of disposal filtering facepiece respirator (FFR), designed and labelled for single use by the original manufacturer.

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

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.

While it is preferable to use a new N95 respirator each time it is required, due to critical shortages, Health Canada has approved various decontamination methods for the reprocessing of single use N95 respirators. The intention is to extend the usability of compatible N95 respirators through reprocessing and reuse to provide the option of continued availability of these devices as a contingency measure during the COVID-19 pandemic.

Testing of reprocessed N95 respirators

Reprocessed N95 respirators:

However, reprocessed N95 respirators:

The regulatory review of decontamination medical devices (Class II) considers the:

The maximum number of cycles recommended is based on the performance of the N95 respirator, including filtration efficiency and the ability to achieve an adequate fit or seal.

Reprocessed N95 respirators are not retested for fluid resistance.

Some manufacturers are conducting their own testing to evaluate the effect of decontamination methods. Health Canada encourages contacting OEMs directly for reprocessing advice or testing conducted specific to their devices. For example, 3M recently published the 3M Decontamination Methods for 3M Filtering Facepiece Respirators (FFRs). This bulletin presents NIOSH-based testing on their FFRs following reprocessing with several reprocessing devices currently approved for use.

Health Canada advises that reprocessed N95 respirators meeting safety and effectiveness requirements can be used for aerosol generating medical procedures (AGMP) when:

However, this should only be considered as a contingency measure, based on a point-of-care risk assessment (PCRA).

Limitations on the reprocessing of N95 respirators

Both new and reprocessed N95 and N95 equivalent respirators have not been approved for use after an AGMP.

N95 respirators that have been used for AGMP or that are soiled should never be reprocessed.

The manufacturer's labelling of reprocessed respirators directs users to check for soiling following use. The risk of soiling is higher in AGMPs.

Also, as SARS-CoV-2 (the virus causing COVID-19) is a novel virus, validation evidence for each decontamination processes includes:

You can find a list of N95 respirators and equipment used in the decontamination of N95 respirators authorized under the Interim Order on Health Canada's website.

Reprocessing of N95 respirators

Currently, respirators containing cellulose or latex are not recommended for decontamination. Additionally, there is no evidence to support the decontamination of:

There are currently no Interim Orders issued for the reprocessing of N95 respirator equivalents. This guidance applies exclusively to reprocessed N95 respirators.

For information on Health Canada's requirements for reprocessed respirators, please see the notice on Reprocessing of Single Use N95 Respirators during the COVID-19 Response.

All reprocessed N95 respirators must be labelled and clearly marked as being reprocessed with the name and address of the reprocessor. This clear identification is also recommended for health care facilities conducting decontamination processes on-site. This labeling should also indicate how many times the N95 respirator has been reprocessed and come with an instruction sheet for the end user.

This document is not meant to replace processes, procedures or guidelines established by provinces and territories and their health care facilities with regard to reprocessing and decontamination on-site by hospitals.

It is the individual end user's decision to use a reprocessed N95 respirator in accordance with their point-of-care risk assessment (PCRA).

The Public Health Agency of Canada continues to recommend the use of certified N95 respirators in accordance with the manufacturer's directions. However, in response to critical shortages, there are important considerations for use of reprocessed N95 respirators.

Key considerations for use of reprocessed N95 respirators

To reduce the risk of infection, health care facilities using reprocessed N95 respirators should, in addition to following the instructions provided by the manufacturer:

Health care facilities should also:

When using a reprocessed N95 respirator, it is recommended that the end user undertake the following measures:

The respirator should be discarded if the integrity of any of its parts are compromised or it becomes hard to breathe through.

It is recommended that the end user conduct a seal check (in accordance with CAN/CSA Z94.4) immediately after donning. For reprocessed N95 respirators that no longer pass a leakage test, the labelling recommends discarding them.

Regulatory requirements for reprocessing N95 respirators

In response to the COVID-19 crisis, Health Canada introduced new interim regulatory measures to expedite the review of medical devices. These measures include regulatory requirements for 2 separate authorization strategies for reprocessing single use N95 respirators:

Please refer to the Reprocessing of Single Use N95 Respirators Notice for an outline of the regulatory and application requirements. As with all COVID-19 related products, Health Canada is expediting applications for these products and making them our top priority.

To obtain further information regarding medical device licensing, please contact the Medical Devices Directorate at

Decontamination in hospitals and health care settings

The considerations for use of reprocessed respirators apply to all circumstances where health care facilities are reusing such devices through:

Health Canada authorization is not required if:

However, if a hospital is decontaminating N95 respirators obtained from an external institution and sending the respirators to a different institution, then this becomes a regulated activity. In such cases, the institution can apply under the Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19 to become a reprocessor.

A device manufacturer could apply for an Interim Order authorization for their decontamination device and sell it to a hospital to use as outlined in the Reprocessing of Single Use N95 Respirators Notice.

Health Canada will continue to:

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