Description: Due to the EPA shut down of a number of contract sterilizer facilities in the US, the FDA has established a major initiative and focus on reducing the amount of EtO used to sterilize medical devices and address the issue of Fugitive Emissions as the EPA is imposing a proposed rule to strictly limit the EtO emissions from sterilization facilities. With the sterilization network operating at near capacity in the US this has impacted and continues to threaten the availability of medical products to the US healthcare system and patients that presents new and unprecedented regulatory challenges. In a very unique and remarkably proactive manner, the FDA is enacting streamlined regulatory processes to reduce the risk of shortages and encourage companies to reduce the amount of EtO used in their sterilization cycles. As a result of this high profile in the US, the EU MDR also introduces challenges for the company to manage the timing of changes to the cycle within the strict deadlines and transition timelines that have an impact on a Global scale. This session will delve into and analyze the FDA efforts to reduce EtO emissions using a variety of regulatory process application and least burdensome approaches including expedited PMA supplements and the Master File Pilot program for both PMA and 510k products. This will cover real world examples of how companies can develop methodologies to validate lower EtO gas concentrations used in sterilization cycles as well has facing the challenges of engaging regulators around the world to find the most efficient and effective pathways to reducing the EtO usage in your cycles without disrupting the sterilization supply chain and sale of the companies products.
Learning Objectives:
Session will present regulatory strategies to engage FDA and EU MDR regulators on the most efficient pathways to obtain approvals
of reduced EtO sterilization cycles across the global sterilization network.
The session will provide a high level technical methodology for updating current EtO cycles to reduce EtO levels to an optimized level while
continuing to meet sterility requirements and standards.
Strategies on how to manage and address supply chain challenges to minimize disruption to sterilization Operations and potential impact on product availability and sales.