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Medical device manufacturer responds to recent FDA guidance update to ensure hospital compliance.
October 22, 2020
By: Michael Barbella
Managing Editor
InstruSafe by Summit Medical, an Innovia Medical Company, announced the U.S. availability of its new CycleTrak Robotic Module, which is the first and only system on the market that allows users to track individual reprocessing cycles for all robotic instruments and accessories. Developed in partnership with Practico Solutions, CycleTrak is a compliance solution that tracks and records individual reprocessing cycles for da Vinci Xi, Si, SP instruments and accessories. CycleTrak was created as a direct response to the U.S. Food and Drug Administration’s recent guidance that states “devices with a specific maximum number of reprocessing cycles not be exceeded.” CycleTrak differs from traditional instrument management solutions through its affordable one-year subscription, simplistic design that uses existing hardware and quick implementation time of days versus weeks or months. “The objective of the Summit/Practico partnership was to develop a tracking solution that was affordable and that could be implemented very quickly. We believe that CycleTrak offers the shortest possible path to tracking and compliance on the market today,” said Jeff Swanson, principal at Practico Solutions. “Practico Solutions helped create a simple, yet focused solution. We enjoyed collaborating on the development of this new robotic module for tracking individual reprocessing cycles,” said Marcus Super, director of Sales and Marketing at Summit Medical. “As the exclusive worldwide distributor, we look forward to solving the unique compliance issues our customers face.”
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