Reprocessing of N95 Respirators for Healthcare Professionals - Notice

April 17, 2020

Healthcare professionals providing direct care to patients across the country above all need to be able to count on having access to the personal protective equipment (PPE) they need for each and every shift, which includes N95 respirators. As we know, the COVID-19 pandemic has created unprecedented demand for certain supplies, including PPE. Healthcare professionals can be assured that the Government of Canada is using a range of strategies to respond to this increased demand by purchasing as many additional supplies as possible, increasing domestic production, and looking to extend the use of N95 respirators through reprocessing, as required.

Reprocessing of devices intended for single use only is not a new concept. It has been done successfully with other devices used in Canada and similar technology can be applied to N95 respirators. To do this, Health Canada has invited applications from medical device companies with extensive experience manufacturing the equipment used in reprocessing in order to authorize these technologies to safely and effectively reprocess N95 respirators. As with all COVID-19 related products, Health Canada is expediting applications for these products and making them our top priority.

Health Canada’s regulatory requirements for manufacturers will continue to apply to ensure that products and manufacturing processes meet the standards required for safety, quality and effectiveness to protect the health and safety of Canadians. In response to the COVID-19 crisis, Health Canada introduced new interim regulatory measures to expedite the review of medical devices, such as sterilizers that can be used to decontaminate single-use respirators. Our rigorous review standards will ensure that the requirements for the integrity of N95 respirators and their continued intended functions are maintained following reprocessing so that the reprocessed N95 respirators will be as safe and effective as the new ones.

A list of all authorized N95 respirators and all authorized equipment used in the reprocessing of N95 respirators is available on Health Canada’s website. You can also find information about guidance we have provided to industry on the minimum requirements that must be met to receive an authorization for equipment used in the reprocessing of N95 respirators originally intended for single use only.

To enable the safe and effective use of all authorized equipment used in the reprocessing of N95 respirators, as a component of authorization, we are requiring supporting materials from companies including specification sheets, updated operating manuals, and fact sheets for healthcare workers. This information should be consulted for specific instructions on the uses and limitations of each authorized decontamination method.

Although COVID-19 is a novel virus, there is evidence from studies with similar viruses that can be used to assess the safety and effectiveness of reprocessing strategies.

At a minimum, Health Canada’s evidence requirements will include:

• demonstration that the number of pathogens have been reduced;
• demonstration that respirator filter and fit performance are maintained;
• evidence that there is no residual chemical hazard related to reprocessing;
• and ensuring adequate labelling that describes the validated methods and reprocessing conditions applied to the respirator.

During the COVID-19 response, Health Canada’s approach has been informed by the U.S. Food and Drug Administrations (FDA’s) Intended Approach for Emergency Use Authorizations (EUAs) for Masks and Respirators and will align with the FDA’s Intended Approach for EUAs for Masks and Respirators Enforcement Policy for Face Masks and Respirators During the COVID-10 Public Health Emergency – Guidance for Industry and FDA Staff (March 2020).

Reprocessing and decontamination on-site by hospitals or other healthcare settings will continue to be overseen at the provincial and territorial level including the collection and storage of used masks. Health Canada and the Public Health Agency of Canada are building on the collaborative work with the provinces and territories on procurement and allocation of personal protective equipment (PPEs) to further address health system needs and will continue to ensure that information on equipment used in the reprocessing of N95 respirators is made available via the health professional link as soon as authorized in a timely manner.