Medical Device Sterilization with FDA
Complimentary
Learning Level: Intermediate/Advanced
Time: 1100 - 1200 EDT
Session Length: 1 hour
The most commonly used method in the U.S. to sterilize medical devices is ethylene oxide (EtO), and it is widely used by medical device manufacturers and contract sterilizers worldwide. There are more than 20 billion devices sold in the US every year that are sterilized with EtO, accounting for approximately 50% of the devices that require sterilization. Another 40-45% of medical devices are sterilized by gamma radiation and the remaining 5-10% are sterilized by a variety of alternative modalities. While some alternative modalities appear promising, no single modality can currently replace the use of EtO for many devices. Maintaining the integrity of the supply chain so that patients and providers have continued access to the sterile devices they need is part of FDA’s mission to protect and promote the public health. To meet this goal, FDA continues to take a multipronged approach via regulatory flexibilities, collaboration, innovation, and communication. Today, our team will be focusing on the events related to EtO use concerns, the mobilization of a Tiger Team as part of FDA’s response, and the forward leaning approaches the Office of Supply Chain Resilience are/have been taking to ensure patients have access to the safe and sterile medical devices they need.
Learning Objectives
- Describe recent events relating to ethylene oxide (EtO) use for the sterilization of medical devices.
- Describe the establishment and role of FDA’s EtO Tiger Team in seeking to reduce reliance on EtO
- Describe the role of the Office of Supply Chain Resilience (OSCR) and how to report potential or actual supply chain challenges
