ABSTRACT

The use of medical masks and respirators as personal protective equipment is critical in decreasing the amount of biological hazard to healthcare personnel which are exposed during outbreaks of highly spreadable diseases such as recently discovered SARS-CoV-2 coronavirus. The COVID-19 pandemic, which began in 2020, has significantly increased the demand for personal protective equipment (PPE) because it acts as one of the methods of reducing coronavirus transmission. Despite of coronavirus vaccines availability, the Center for Disease Control and Prevention (CDC) and European centre for disease prevention and control (ECDC) and the World Health Organization (WHO) still recommends PPE, as well as the production has also increased in order to satisfy demand and as a result, some inferior products also entered the market. Many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs), have been seriously damaged by the COVID 19 pandemic. As a result, the food and drug administration (FDA) and European medicines agency (EMA) has granted an Emergency Use Authorization (EUA) allowing the use of industrial N95 respirators as well as the importation of N95-masks which meets the international requirements such as KN95 masks from China and FFP2 masks from the European Union. The main aim is to provide comparative regulatory changes implemented in respirators because of COVID 19 scenario. Keywords: Respirators, COVID 19, USA, EUROPE, Regulatory changes
Publication date: 01/06/2024

https://ijbpas.com/pdf/2024/June/MS_IJBPAS_2024_8025.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.6.8025