Event
MSE Seminar: Dr. Kim Chaffin, Medtronic, Inc.
Wednesday, September 24, 2025
3:30 p.m.
Room 2108 Chemical and Nuclear Engineering Building
Sherri Tatum
301-405-5240
statum12@umd.edu
Ethylene Oxide Sterilization: What alternatives are available for Medical Devices?
Abstract: More than half of all medical devices in the United States are sterilized with ethylene oxide (EO). This amounts to more than 20 billion devices each year. New emission requirements on commercial EO sterilizers combined with increased medical device volumes have stressed the infrastructure. As a result, the search for suitable alternatives to EO are being pursued by medical device manufacturers and the regulatory bodies (FDA and TÜV SÜD) to prevent medical device shortages. In this seminar, I will review commercially available alternatives to EO, discuss the challenges of transitioning legacy devices to new sterilization modalities, and present material stability data for common medical device materials of construction after exposure to various alternative chemistries. Finally, I will discuss the recent re-categorization of one alternate method by the FDA, moving vaporized hydrogen peroxide from Category B (novel method) to Category A (established method), simplifying the regulatory pathway for this alternate modality.
Bio: Dr. Kim Chaffin is a Vice President, Bakken Fellow and Technical Fellow in the Global Technology and Innovation group at Medtronic, Inc. Kim is a recognized expert in material thermodynamics and characterization, especially as it relates to structure-property relationships that govern long-term stability and performance. Kim holds a Ph.D. in chemical engineering from the University of Minnesota (advisor: Frank Bates) and master’s and bachelor’s degrees in chemical engineering from the University of Michigan. She is a licensed Professional Engineer in the state of Minnesota.
