“How do we simplify sterilization modality changes and process optimization?” This question was the catalyst for a year-long collaboration that started with a small team of sterility assurance professionals and eventually grew to include the entire Kilmer Sterility Assurance Community.
As coleaders in answering this question, our first job was to bring together a team of individuals with the diversity of technical backgrounds necessary to seed our collaboration with great ideas and information. We recruited experts in established and novel sterilization modalities, reusable device processing, regulatory affairs, and microbiology. These individuals represent medical device manufacturers, contract sterilization service providers, contract labs, and regulators. The team goal was not only to find answers to the questions we were asked, but also to find a way to make this information more widely available to the entire industry.
Our official “Collaboration Event” was hosted at the AAMI headquarters in Arlington, VA in May 2019. During this two-day meeting, we worked together to define the scope of what we wanted to accomplish through friendly debate and structured information gathering. The group came out with four distinct challenge questions:
What is the source or reason for resistance to changing modalities and/or optimizing sterilization processes? What tools, resources, etc. are needed to assist in overcoming the resistance to change?
What is the barrier to accept or adopt novel sterilization methods? What tools or information might we gather to assist in a transition to a novel sterilization method?
How do we efficiently use the capacity that is available for gamma and ethylene oxide (EO) sterilization processing?
What tools or resources are needed to assist with a transition from gamma or EO to other modalities?
During the Kilmer Conference in June 2019, we presented the same four questions to the conference participants. Once we gathered responses from the larger group, the team worked to consolidate and analyze the input from the original team meeting in Arlington and the input from the conference participants. The team identified several items that would support changes needed in the industry; these items include targeted publications, training/education opportunities, tools for information sharing, and better guidance on existing standards and regulations.
We are therefore very pleased to have worked with AAMI to present this publication of invited articles on topics that can provide guidance and insight into process optimization and modality changes. This is the first step in many to help answer these important questions.
Special thanks to the collaboration team:
Arlington event: Phil Cogdill (Medtronic), Bart Croonenborghs (Sterigenics), Melissa Escobedo (Johnson & Johnson), Tony Faucette (BD), Nupur Jain (Intuitive Surgical), Vu Le (Abbott), Brian McEvoy (STERIS), George Ngatha (Food and Drug Administration), Neville Niessen (Baxter), Patrick Weixel (Food and Drug Administration). Thanks also to Martell Winters (Nelson Labs), for his role as team scribe.
Expanded team participants: Alpa Patel (Nelson Labs), John Williams (Medtronic)