Technical and Regulatory Aspects of the Extended Use, Reuse, and Reprocessing of Respirators during Shortages, 10 June 2020

ABSTRACT

Summary: • N95 or equivalent respirators are single-use personal protective equipment (PPE) designed for use by health workers that provide direct care to patients with diseases transmitted by aerosols or during aerosol generating procedures (AGP) for patients with acute respiratory disease, as is the case of COVID-19. • Given the current shortage of N95 and equivalent respirators, the World Health Organization (WHO) has suggested the possibility of their extended use by the same individual for up to 6 hours or the reprocessing of respirators when necessary. • During shortages of N95 and equivalent respirators, stopgap measures for optimizing their use may be considered, among them extended use and reuse. Since risks are associated with these measures, special criteria and precautions should be used when adopting them, confining their use to situations where they are indispensable. • Extended use is recommended over reuse, because the latter requires a controlled procedure in the health services and implies that the staff performing it will come into contact with contaminated respirators, increasing the risk of occupational exposure. • During critical respirator shortages, reprocessing can be considered. Although saturated steam, UVC radiation, and gas plasma or vaporized hydrogen peroxide sterilization are the respirator reprocessing methods with the most evidence of efficacy to date, no method can be adopted without prior local validation testing in the health facility. A written protocol for the procedure should be also prepared and health workers trained in the proper use of the reprocessed respirators. Respirator reprocessing should be regulated by the regulatory authority with jurisdiction over these medical devices. • The method selected by a health facility will depend on its infrastructure and ability to prepare and implement operating protocols that guarantee the efficacy and safety of the respirators after reprocessing...