Category: Education

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TERUMO BCT SENIOR DESIGN PROJECT - CENTRIFUGE LOADING HUMAN FACTORS COLORADO STATE UNIVERSITY SCHOOL OF BIOMEDICAL ENGINEERING Team Members: Brett Baeverstad 1 , Emma Lichtenfels 1 , Minh Anh Nguyen 1 , Megan Rives 1 , Evan Siebenmorgen 1 , Briden Stanton 2 1 Colorado State University, 2 Terumo BCT Abstract Centrifuge leaks in the Spectra Optia machine due to the misloading of the disposable kit is identified as a human factor error. These errors can either be designed out, or signal a notification to the operator before blood enters the system. A machine vision and audio system have been selected as final concepts and are in development as the methods for detecting misloads in the Spectra Optia . Goals Objectives Design out Human Error in Loading the Disposable OR Notify operator prior to leak in the Machine Develop non-leak related modification of machine Detect Misload prior to end of disposables check Detect Misload Channel Height Detect Camera Image Differences Detect Audio Signal Differences Prevention of tubing behind cassette Acknowledgments We would like to thank Terumo BCT, Jeff Carroll, Dr. Ellen Brennan-Pierce, Nicole Ramo , Cognex , Colorado Water Jet and the School of Biomedical Engineering for their help and contributions to the project. Channel Loading A LED casts a beam of light parallel to the centrifuge filler top surface . Using the AIM camera, light gradient can be determined and processed using external control systems If there is light detected on top surface, the test is considered a FAIL If no light is detected on top surface, the test is considered a PASS Control Systems The MATLAB program is used to analyze and compare both image and audio files . If one image or audio file is not correctly set, then an error message will display . Human Factors As devices become more prevalent, there is a need to mitigate human-based errors . Mistakes made during operation can obstruct effective patient treatment, and monitoring . Knowledge -based errors occur when the user is unfamiliar with the device . Slip errors occur due to forgetfulness. Detection Systems For the detection of the misloaded upper and/or lower bearing component(s) inside the centrifuge basin A microphone detection and machine vision system ( Cognex In-Sight Explorer ) Both systems will verify correct loading prior to patient connection Valve Block Modification The valve block modification acts to block tube access to the loading area of the cassette Designed for reliability, manufacturability, and user-friendliness Potential for human factor errors have been eliminated through the design Initial Project Goals Background Terumo BCT is a Global Leader in blood component technologies The Spectra Optia is a therapeutic apheresis device used for blood component separation, collection, and exchange Misloaded kits by the operator in the Spectra Optia may cause Centrifuge leaks Human Error is common among Medical Device usage In a continual effort to pursue new ways to ensure customer safety, Terumo BCT is constantly developing improvements for this device Spectra Optia Machine Valve Block Modification Audio File Error Image File Error Correctly Loaded Incorrectly Loaded Loading Process Lower Bearing Misload Upper Bearing Misload Mounted Cameras and Microphone

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