Following a unique collaboration between medical industry leaders, the Association for the Advancement of Medical Instrumentation (AAMI) has published a new, free resource showcasing the best practices and strategies for the sterilization of medical devices and packaging. The intent of Industrial Sterilization: Process Optimization and Modality Changes, a peer-reviewed supplement to AAMI’s journal, BI&T, is to share practices for optimization and encourage innovation.
In any end-to-end sterility assurance program, sterilization is a critical step. Optimal sterilization 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.
“Helping to facilitate a sharing of sterilization knowledge between industry leaders is right in line with AAMI’s mission to ensure the effective development and use of medical devices,” said Rob Jensen, president and CEO of AAMI. “Using the best practices possible is everyone’s desire. That’s why we’re proud to publish this essential sterilization resource.”
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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 sterilization methods and recent advancements. Others explore challenges impacting patient safety, business continuity planning, and ways to improve current methodology.
“It’s not a question of whether or not products are sterile, but there is always room for improvement for how we get there,” explained Emily Craven, director of sterility assurance at Boston Scientific. “It's really about challenging ourselves to make sterilization 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 newly revived Kilmer Conference. There, they discussed new approaches for the sterility assurance community in areas of industrial sterilization, aseptic processing, microbiology, as well as the challenges their field currently faces. The challenges discussed during the conference identified the continuing need to collaborate.