Following a unique collaboration between medical industry leaders, the Association for the Advancement of Medical Instrumentation (AAMI) has published the latest installment in a growing collection of best practices and strategies for the sterilization of medical devices and tools. The new document, titled “Industrial Sterilization: Challenging the Status Quo, Driving for Continuous Improvement,” is a freely available and peer reviewed supplement to AAMI’s journal, BI&T.
“This is the second in what is hoped to be an ongoing series of publications based on industry-led collaborations inspired by the 2019 Kilmer Conference,” authors Emily Craven and Joyce Hansen explain.
The Kilmer Conference, revived by Johnson & Johnson with AAMI’s support in 2016 and chaired by Hansen, vice president of microbiological quality and sterility assurance at Johnson & Johnson, is a premier global forum focused on sterility assurance and sterilization. The conference welcomes professionals from industry, academia, government agencies, and healthcare delivery organizations. During the 2019 conference, polling and subsequent meetings of the Kilmer Conference Collaboration Modalities Team, co-led by Craven, director of global sterility assurance at Boston Scientific Corporation, revealed a strong need for a freely accessible collection of sterilization information and best practices.
“The collaboration teams identified that the lack of innovation or change [in our industry] was often because individuals felt that there was a hurdle or roadblock that prevented action. They were not aware of the alternatives available,” said Hansen. “Until now, we as an industry haven’t done our best to preserve and publish the historical knowledge or rationales for why we have specific requirements.”
The first resulting BI&T supplement, Industrial Sterilization: Process Optimization and Modality Changes, was their answer. Following its success, a call for abstracts was made to help this budding collection of knowledge grow.
“For this second publication, the call for submissions focused on the need for case examples of successes and challenges and discussions surrounding collaboration and innovation to support product transfers between sterilization modalities, ensuring ethylene oxide (EO) process optimization, and overcoming challenges with reusable medical devices,” the authors explained.
Examples of content featured in the new publication include an exploration of the potential for inducing radioactivity in tools or devices processed with X-ray energy, safe methods for transitioning from gamma radiation to X-ray processing, best practices for making the use of EO sustainable, and other recommendations for helping professionals choose the right sterilization modality to fit their specific needs.
“By publishing new research and methods, we lay the groundwork for supporting new standards and guidance to meet the needs of an ever-changing industry, whether it’s novel sterilization methods to deal with sensitive materials, transfers between sterilization modalities, process optimization to meet capacity demands or sustainability initiatives, or the complexity of procedures associated with the safe reuse of medical devices,” the authors added. “Peer-reviewed publications help to improve the standards over time, thereby allowing ‘lessons learned’ to be adopted into the standards for clarification and/or expansion.”
Hansen and Craven continue to call for submissions, already planning for a third document later this year. The response for this second installment was so robust that the authors admit they were unable to include every suitable submission. Instead, they have prepared an eight-part series of informative webinars to release before the next supplemental publication.
AAMI (www.aami.org) is a nonprofit organization founded in 1967. It is a diverse community of more than 10,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.