TY - GEN
T1 - Risk and adverse events related to lower-limb exoskeletons
AU - He, Yongtian
AU - Eguren, David
AU - Luu, Trieu Phat
AU - Contreras-Vidal, Jose L.
N1 - Funding Information:
This work has been funded in part by Mission Connect - A TIRR Foundation.
Publisher Copyright:
© 2017 IEEE.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2018/6/12
Y1 - 2018/6/12
N2 - Since the marketing clearance from the U.S. Food and Drug Administration (FDA), powered lower-limb exoskeletons have been proposed as a promising tool in gait assistance and rehabilitation. However, previous studies often overlooked the potential risk and adverse events related to the device. Without a clear understanding and comprehensive knowledge of adverse events and the risks users face, it is difficult to evaluate the risk-to-benefit ratio of powered exoskeletons. We reviewed all publically available exoskeleton-related adverse events, and compared the result to the risks that were identified by the FDA. Results showed that bone fracture is a serious risk that was not considered in previous literatures. Additionally, skin and soft tissue damage is common across subjects, studies, and devices. It was often treated as an incidental minor event and overlooked. We encourage more effort at keeping the safety of exoskeleton users in future studies.
AB - Since the marketing clearance from the U.S. Food and Drug Administration (FDA), powered lower-limb exoskeletons have been proposed as a promising tool in gait assistance and rehabilitation. However, previous studies often overlooked the potential risk and adverse events related to the device. Without a clear understanding and comprehensive knowledge of adverse events and the risks users face, it is difficult to evaluate the risk-to-benefit ratio of powered exoskeletons. We reviewed all publically available exoskeleton-related adverse events, and compared the result to the risks that were identified by the FDA. Results showed that bone fracture is a serious risk that was not considered in previous literatures. Additionally, skin and soft tissue damage is common across subjects, studies, and devices. It was often treated as an incidental minor event and overlooked. We encourage more effort at keeping the safety of exoskeleton users in future studies.
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U2 - 10.1109/WEROB.2017.8383850
DO - 10.1109/WEROB.2017.8383850
M3 - Conference contribution
AN - SCOPUS:85049927428
T3 - 2017 International Symposium on Wearable Robotics and Rehabilitation, WeRob 2017
SP - 1
EP - 2
BT - 2017 International Symposium on Wearable Robotics and Rehabilitation, WeRob 2017
PB - Institute of Electrical and Electronics Engineers Inc.
T2 - 2017 International Symposium on Wearable Robotics and Rehabilitation, WeRob 2017
Y2 - 5 November 2017 through 8 November 2017
ER -