During the COVID-19 pandemic, the demand for personal protective equipment (PPE), especially medical face masks and respirators, surged dramatically, leading to widespread shortages. In response, many new suppliers entered the market, often unaware of the stringent testing requirements necessary for FDA-issued emergency use authorizations (EUAs) for face mask approval. This webinar will explore the critical developments and adaptations that occurred during this period, providing a comprehensive overview of the challenges and solutions implemented to ensure the safety and efficacy of PPE.
Viewers will gain historical insights into how laboratories, hospitals, and regulatory bodies worldwide collaborated to address the PPE shortage. This included the development of novel decontamination techniques for N95 respirators, which were in particularly short supply. These decontamination methods allowed for the safe re-use of respirators initially intended for single use, helping to mitigate supply constraints. The session will cover the evaluation of these techniques and the emergency approvals granted for their use, illustrating the rapid innovation and regulatory flexibility demonstrated during the crisis.
By the end of this webinar, participants will have a thorough understanding of the regulatory landscape for PPE during the pandemic, the testing requirements for masks and respirators, and the innovative solutions developed to enhance the safety and availability of these critical protective devices. This knowledge is invaluable for suppliers, manufacturers, healthcare professionals, and regulatory personnel involved in the production, approval, and management of PPE, equipping them to navigate future challenges with greater preparedness and insight.