COVID-19: Collection, Disinfection and Storage Processes for Single-Use N95 Filtering Facepiece Respirators

Foreword

This publication uses the term "disinfection" of N95 filtering facepiece respirators (FFRs) (also referred to as N95 masks) to refer to the chemical or physical process that inactivates infectious agents. It should be noted that the various reference publications and documents on the subject consulted by the Centre d’expertise en retraitement des dispositifs médicaux (CERDM) use the terms "decontamination," "disinfection," or both. The CERDM has chosen the term "disinfection" to conform to the reprocessing nomenclature that is generally accepted in Canada (CSA Z314.18).

Context

The CERDM evaluated the available options for disinfecting used N95 FFRs in the context of a possible shortage of respiratory protection devices in health care facilities due to the COVID-19 pandemic (INSPQ, 2020a). This constitutes a solution of last resort to be applied in the case of an anticipated shortage1 of N95 FFRs so as to be able to distribute them to workers during a real shortage2 of N95 FFRs when all other strategies for addressing the shortage fail to suffice. This process falls within the context of efforts to identify alternative strategies that would provide the best possible protection for workers in the event of a shortage. Alternative control measures that differ from the usually accepted measures may be implemented alone or in combination (CDC, 2020).

Currently, Health Canada has authorized the following manufacturers' technologies for the disinfection of N95 FFRs under the Interim Order regarding the use of medical devices in relation to COVID-19 (Health Canada, 2020) (INSPQ, 2020b):

  • Low-temperature sterilizers: Sterrad from the company ASP (2020), Sterizone/VP4 from the company Stryker (2020) and V-Pro from the company Steris (2020a).
  • High-temperature sterilizers (steam sterilizers): Amsco 400 and Century Medium from the company Steris (2020b).
  • Hydrogen peroxide vaporizer (room disinfection device): Bioquell (2020).
  • Disinfection device combining several technologies (UVC, vaporized hydrogen peroxide and ozone): Clean Flow Health Care Mini from the company Clean Works Medical (Clean Works, 2020).

Objectives

This document is intended for managers and clinical personnel involved in medical device reprocessing (MDR).

Its purpose is to describe the guidelines to be followed for the overall process of collecting, disinfecting and storing N95 filtering facepiece respirators (FFRs) (also known as N95 masks) in order to :

  • Ensure the safety of personnel.
  • Ensure compliance with and implementation of infection prevention and control (IPC) measures associated with disinfection activities.
  • Ensure compliance with the disinfection procedures for used N95 FFRs as per the manufacturer's instructions for the technologies chosen to perform the disinfection.
  • Standardize the process for disinfecting used N95 FFRs.

1 Strategies to be applied in the event of an anticipated shortage, but while supplies are available (after verification with the procurement department and the Ministère de la Santé et des Services sociaux (MSSS)).
2 Strategies to be applied in the event of a known shortage (after verification with the procurement department and the MSSS).