"To error is human." When it comes to delivery of healthcare error can ruin lives, or worse yet, end a life. So, eliminating errors is the ongoing effort of our industry. Many times the bottom-line reason for human error is the weaknesses and foibles inherent in each and every one of us. Sometimes, however, the source of error is actually designed into the system itself. By that, I mean that no matter how vigilant the human, the system will produce mistakes. As part of its review and update of device review process, the FDA has authored a draft guidance for device design with focus on the "human factors" engineering and the role this plays in limiting (or promoting) human error. Concurrently, AAMI has launched a work group to author guidance for device manufacturers to improve the design from a cleaning perspective. Whether a user or a device manufacturer, this should be of interest to all of us. The time to comment on the draft FDA Guidance is now. The time to participate in the AAMI work group is this Fall during the Sterilization Standards Committee meeting in late October.


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