Mac McKeen (Fellow, Regulatory Science, Boston Scientific)
Date: Wednesday, December 2
Time: 9:00am - 9:30am
Track:
MedTech Mornings: Medical Packaging
Vault Recording: TBD
Due to the EPA shut down of a number of contract sterilizer facilities, 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 issue 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.
Topics covered include:
- An analysis of the FDA efforts to reduce EtO emissions
- How companies can develop methodologies to validate lower EtO gas concentrations
- Ways to engage regulators without disrupting the sterilization supply chain and network
