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DePuy Synthes Receives 510(k) FDA Clearance for VELYS™ Robotic-Assisted Solution Designed for Use with the ATTUNE Total Knee System

The Johnson & Johnson Medical Devices Companies announced that DePuy Synthes has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VELYS Robotic-Assisted Solution designed for use with the ATTUNE® Total Knee System and its cleared indications for use.

Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

Sterilization Leaders Pool Knowledge in Unprecedented Collaboration

Industrial Sterilization: Process Optimization and Modality Changes AAMI has published a free collection of articles showcasing best practices and alternative strategies for medical device and packaging sterilization. The 11 peer-reviewed articles in Industrial Sterilization: Process Optimization and Modality Changes are from experts representing a range of influential organizations within the medical industry.

The goal of this special supplement to AAMI’s journal, BI&T, is to share practices for optimization and encourage innovation. It was sponsored by Johnson & Johnson, Boston Scientific, STERIS, BD, Nordion, Medtronic and WuXi AppTec.

“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.”

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.

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. “You can’t optimize 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.”

Download the free Industrial Sterilization: Process Optimization and Modality Changes at www.aami.org/sterilization-supplement-2020.

Call for Papers!
Share your knowledge and make a difference in your field by submitting a paper to AAMI’s peer-reviewed journal, BI&T. Please submit a brief description of your article idea by contacting Editor-in-Chief Gavin Stern at gstern@aami.org.

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