The Association for the Advancement of Medical Instrumentation (AAMI) has published a new, free resource showcasing the best practices and strategies for the sterilisation of medical devices and packaging.
The intent of Industrial Sterilisation: Process Optimisation and Modality Changes, a peer-reviewed supplement to AAMI’s journal, BI&T, is to share practices for optimisation and encourage innovation.
Optimal sterilisation helps ensure that healthcare products meet a defined microbiological quality and/or a sterile label claim. Every aspect of a mechanical ventilator, for example, must be as clean as medical professionals anticipate. Likewise, the packaging that holds biological samples cannot compromise the promised quality of that sample, lest test results become skewed.
Rob Jensen, president and CEO of AAMI, said: “Helping to facilitate a sharing of sterilisation knowledge between industry leaders is right in line with AAMI’s mission to ensure the effective development and use of medical devices. Using the best practices possible is everyone’s desire. That’s why we’re proud to publish this essential sterilisation resource.”
The publication offers 11 articles from experts hailing from laboratories, consulting firms, and industry leaders. It was sponsored by Johnson & Johnson, Boston Scientific, STERIS, BD, Nordion, Medtronic, and WuXi AppTec.
Many of these articles address the need to provide awareness of alternative sterilisation methods and recent advancements. Others explore challenges impacting patient safety, business continuity planning, and ways to improve current methodology.
Emily Craven, director of sterility assurance at Boston Scientific, said: “It’s not a question of whether or not products are sterile, but there is always room for improvement for how we get there. It's really about challenging ourselves to make sterilisation more efficient. What we want people to think about is whether what is familiar is actually optimal.”
Back in 2016, worldwide industry sterility assurance leaders met during the Kilmer Conference. There, they discussed new approaches for the sterility assurance community in areas of industrial sterilisation, aseptic processing, microbiology, as well as the challenges their field currently faces. The challenges discussed during the conference identified the continuing need to collaborate.
Last year, the Kilmer sterility assurance community met again with the intent to address industry collaboration to support innovation. Prior to the conference, the leaders were polled to identify areas of concern for the industry and collaboration teams were formed to address these topics.
Joyce Hansen, vice president of microbiological quality and sterility assurance at Johnson & Johnson, said: “The collaboration teams identified that the lack of innovation or change was often because individuals felt that there was a hurdle or roadblock that prevented action. They were not aware of the alternatives available.
“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.”
That knowledge consists of best practices within companies, and an understanding of why previous methods for sterilisation were adapted or changed to match the scientific data available.
Hansen added: “You can’t optimise or innovate a process if you don’t understand why requirements were developed in the first place. I hope these articles will start really piquing people's interest about the science of what we do today while challenging them to think differently for the future.
“Sharing this type of knowledge and best practices doesn’t take away from the development of company-specific products or threaten intellectual property. So, I'd like to encourage others in my position and similar positions to think about contributing to a frequent cross-pollination of information, which allows us all to learn and grow as a community.”
