Both of you served as trainers for a recent AAMI (Assn. for the Advancement of Medical Instrumentation) University webinar entitled, “Packaging for Terminally Sterilized Medical Devices: How to Find Your Way in this Globally Regulated Industry.” What is going on in the medical device community, and how do standards and regulations play a role in this industry?
John Spitzley: Curt and I find that standards on terminally sterilized medical devices haven’t changed as much as have the people entering the medical device business who need training and awareness on the ISO 11607 standards (see sidebar below). There's been considerable turnover among packaging engineers and people who are assigned to packaging within medical device companies. Even in just the last couple of years, we find more people really don't understand that key standard and what it's all about.
