Just 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.
“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,” said Joyce Hansen, vice president of microbiological quality and sterility assurance at Johnson & Johnson and Chair of the 2019 Kilmer Conference.
“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,” she said.
That knowledge not only consists of best practices within companies, but also an understanding of why previous methods for sterilization were adapted or changed to match the scientific data available.
“You can’t optimize or innovate a process if you don’t understand why requirements were developed in the first place,” said Hansen. “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.”
The future also has more resources from AAMI and the Kilmer Conference collaboration team in store, especially if the number of companies willing to share their knowledge continues to grow.
“Sharing this type of knowledge and best practices doesn’t take away from the development of company-specific products or threaten intellectual property,” Hansen added, “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.”
About AAMI
AAMI is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 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.
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