Important Regulatory Considerations for the Reprocessing of Single Use N95 Respirators during the COVID-19 Response: Notice

Published: April 8, 2020

Updated: May 10, 2020

On this page

• Context
• Regulatory requirements
• Health Canada reprocessor application requirements
• Decontamination in hospitals and healthcare settings

Context

Single Use N95 respirators are disposable filtering face pieces covering the mouth, nose and chin that capture airborne particles from the air on the filter. While it is preferable to use a new N95 respirator each time it is required in accordance with the manufacturer's directions for use, due to critical shortages, Health Canada is currently monitoring and assessing the acceptability of various decontamination methods for the reprocessing of single-use N95 respirators in the context of the COVID-19 outbreak. The intention is to extend the usability of compatible N95 or N95-equivalent respirators through reprocessing and reuse to ensure the continued availability of these devices.

Reprocessing single use devices is not a new concept as it has been successfully applied to other licensed devices that are used in Canada. Existing technology may be applied to N95 respirators. As SARS-CoV-2 (the virus causing COVID-19) is a novel virus, there is:

• limited data to support the effectiveness of decontamination methods specifically against the virus itself
• evidence from studies with similar viruses that can be used to assess the safety and effectiveness of reprocessing strategies

To meet current needs, Health Canada is looking for safe and effective innovative solutions from re-processors of normally disposable N95 respirators and from manufacturers of reprocessing equipment. In its publication Decontamination and Reuse of Filtering Facepiece Respirators, the United States Center for Disease Control (CDC) is encouraging efforts to be focused on ultraviolet germicidal irradiation (UVGI), vaporous hydrogen peroxide (VHP), and moist heat, since these technologies have shown the most promise as potential methods to decontaminate face filtering respirators (FFRs). Further, the CDC is not recommending the use of ethylene oxide as a decontamination method since there are potential risks associated with it that may have negative effects on the wearer. As with all COVID-19 related products, these technologies and accompanying submissions are given priority and expedited review by Health Canada.

With regard to reprocessing and decontamination on-site by hospitals, Health Canada will continue to respect the current oversight provided at the provincial and territorial level and guidance provided by the Public Health Agency of Canada.

Regulatory requirements

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

1. Authorize reprocessing devices that are manufactured and sold to decontaminate N95 respirators
2. Authorize companies to reprocess and distribute decontaminated N95 respirators to healthcare facilities

   1. Reprocessing devices that are manufactured and sold to decontaminate N95 respirators

   Devices that decontaminate N95 respirators are classified as Class II medical devices. Device manufacturers are required to comply with either the licensing requirements of the Medical Device Regulations, or through the Interim Order pathway.

   2. Companies who reprocess and distribute reprocessed N95 respirators to healthcare facilities

   Under the federal regulatory framework, companies that reprocess and distribute medical devices to Canadian healthcare facilities originally authorized and labelled for single use, will be held to the same requirements as manufacturers of new devices.

   In accordance with Health Canada's Notice to Stakeholders - Health Canada's Regulatory Approach to Commercial Reprocessing of Medical Devices Originally Labelled for Single Use, a company that reprocesses N95 respirators becomes the legal manufacturer of the reprocessed N95 respirators. As the manufacturer of these devices, the reprocessor is required to continue to meet appropriate standards for safety, effectiveness and labelling. It must also demonstrate a certain level of assurance that the respirators can be effectively disinfected.

   N95 respirators are Class I medical devices. However, given the requirement for a scientific review in advance of authorization for reprocessed devices, manufacturers should submit applications for reprocessed N95 respirators through the Interim Order pathway as opposed to the Medical Device Establishment Licence (MDEL) regulatory pathway.

   Health Canada is also evaluating the guidance of the U.S. Food and Drug Administration (FDA) with respect to FDA's Intended Approach for Emergency Use Authorizations (EUAs) for Masks and Respirators and the strategies of the US Centers for Disease Control and Prevention (CDC) for optimizing the reuse of respirators.

Health Canada reprocessor application requirements

During the COVID-19 response, Health Canada will align with the FDA's Intended Approach for EUAs for Masks and Respirators (Section VI, Part A) which is part of FDA's Enforcement Policy for Face Masks and Respirators During the COVID-10 Public Health Emergency - Guidance for Industry and FDA Staff (March 2020). This includes proposed evidence requirements for reprocessed N95 respirators (as much as is available) in order to facilitate the application and evaluation process.

In either instance presented above, the manufacturer/reprocessor is required to provide the following information to Health Canada to support its application for authorization:

• a description of the reprocessing process including a scientific rationale and description of applicable controls
• disinfection validation including sporicidal and viral inactivation studies
• a description of chain of custody and safeguards to prevent inadvertent re-use of a contaminated mask
• material compatibility
• testing for performance characteristics including:
  • filtration performance
  • fit test data (airflow resistance, exhalation valve leakage)
• a copy of the reprocessed device product labelling including the:
  • maximum number of times that the device can be reprocessed
  • method for tracking the number of times the device has been reprocessed
• supporting materials including:
  • specification sheets
  • updated operating manuals
  • fact sheets for healthcare providers and facilities

Pre-market technical reviews will help ensure:

• reprocessed N95 respirators will be effectively disinfected
• the integrity of N95 respirators and their intended functions are maintained

Health Canada has identified the following minimum requirements within the current context and key data/test requirements for decontamination processes:

1. Reduce pathogen burden:
   • worst-case bacterial sporicidal testing evidencing a sterility assurance level (SAL) of 10-6 for the chosen reprocessing method, such as:
     • Bacillus atrophaeus for dry heat and ethylene oxide
     • Geobacillus stearothermophilus spores for hydrogen peroxide and steam
   • viral inactivation testing (4 log reduction) including:
     • H1N1
     • MERS-CoV
     • SARS-CoV
     • SAR-CoV-2
     • Influenza A/PR/8/34
     • surrogates
   • Risk Group 2 (RG2) bacteria or viruses as surrogates, or other microorganisms, not required to handle in Containment Level 3 (CL3) laboratories can be considered.
2. Maintain performance:
   • for N95 respirators: testing requirements are outlined by NIOSH/FDA MOU 225-18-006 including particle filtration efficiency such as breathability and valve leak (where applicable) as per Original Equipment Market (OEM) product label claim, bacterial filtration and fit.
     • For particle filtration efficiency, bacterial filtration and fit testing, maximum suggested reprocessing cycles must be tested and an acceptable performance needs to be demonstrated at the maximum number of cycles
     • Available scientific literature stating that certain respirators can be reprocessed without significant change to their effectiveness can be considered
   • for surgical masks: performance testing (including breathability, bacterial filtration and fluid resistance) in accordance with applicable standards such as ASTM F2100 or EN 14683
   • validation reports must specify the makes and models of respirators/masks tested
   • alternative proposals may be considered if appropriate justification is provided
3. Demonstrate acceptable residual limits:
   • measurement and risk assessment of chemical residuals pertinent for the proposed reprocessing method, including:
   1.  
      • residual chemicals or gases on the respirators at the end of the decontamination cycle
      • security of the chamber with regards to acceptable environmental exposure limits
4. Provide adequate labelling to users/reprocessors including:
   • validated methods and reprocessing conditions such as:
     • RH
     • density
     • temperature
     • contact time
     • disinfectant concentration
   • instructions on how facilities/users are to operate the reprocessor
   • instructions for facilities/users on how to conduct ongoing monitoring and validation of the reprocessing cycles to ensure decontamination
   • warnings to users and healthcare professionals, including any original performance or safety testing that has not been validated
   • directions to facilities/users/ healthcare professionals on how to identify incompatible materials/respirator types with the reprocessing method
   • directions to users regarding acceptability of fit
   • a method to facilities/users/healthcare professionals indicating the number of cycles a specific respirator has undergone reprocessing (traceability)
   • information on how to report incidents

Health Canada will continue to update this notice as more information becomes available.

To submit an application for authorization under the Interim Order for COVID-19 medical devices, please first consult the guidance document on how to apply for medical devices for use in relation to COVID-19. To obtain further information regarding medical device licensing, please contact the Medical Devices Directorate at devicelicensing-homologationinstruments@hc-sc.gc.ca.

Decontamination in hospitals and healthcare settings

Health Canada authorization is not required if:

• hospitals are decontaminating N95 respirators within their institutions for their own re-use
• hospitals are decontaminating N95 respirators from an external institution and sending the respirators back to the same institution

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 pathway 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 reprocessor application requirements.

Health Canada will continue to:

• respect the current oversight provided at the provincial and territorial level and guidance provided by the Public Health Agency of Canada.
• build on the collaborative work with the provinces and territories on procurement and allocation of personal protective equipment (PPEs)
• make information on authorizations available in a timely manner

Related links

• Technical requirements for UV decontamination devices: Notice to manufacturers
• About medical devices
• Optimizing the use of masks and respirators during the COVID-19 outbreak
• Decontamination and Reuse of Filtering Facepiece Respirators
• Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary