Risk management and regulations for lower limb medical exoskeletons: a review

Yongtian He, David Eguren, Trieu Phat Luu, Jose L Contreras-Vidal Laboratory for Noninvasive Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA Abstract: Gait disability is a major health care problem worldwide. Powere...

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Autores principales:	He Y, Eguren D, Luu TP, Contreras-Vidal JL
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	FDA ReWalk Indego Ekso HAL REX Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/52cc68f23a804869adf711e8d1011629
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spelling	oai:doaj.org-article:52cc68f23a804869adf711e8d10116292021-12-02T01:02:27ZRisk management and regulations for lower limb medical exoskeletons: a review1179-1470https://doaj.org/article/52cc68f23a804869adf711e8d10116292017-05-01T00:00:00Zhttps://www.dovepress.com/risk-management-and-regulations-for-lower-limb-medical-exoskeletons-a--peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Yongtian He, David Eguren, Trieu Phat Luu, Jose L Contreras-Vidal Laboratory for Noninvasive Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA Abstract: Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly. On the other hand, the regulatory science of powered exoskeletons is still developing. The type and extent of probable risks of these devices are yet to be understood, and industry standards are yet to be developed. To address this gap, Manufacturer and User Facility Device Experience, Clinicaltrials.gov, and PubMed databases were searched for reports of adverse events and inclusion and exclusion criteria involving the use of lower limb powered exoskeletons. Current inclusion and exclusion criteria, which can determine probable risks, were found to be diverse. Reported adverse events and identified risks of current devices are also wide-ranging. In light of these findings, current regulations, standards, and regulatory procedures for medical device applications in the USA, Europe, and Japan were also compared. There is a need to raise awareness of probable risks associated with the use of powered exoskeletons and to develop adequate countermeasures, standards, and regulations for these human–machine systems. With appropriate risk mitigation strategies, adequate standards, comprehensive reporting of adverse events, and regulatory oversight, powered exoskeletons may one day allow individuals with gait disabilities to safely and independently ambulate. Keywords: FDA, ReWalk, Indego, Ekso, HAL, RexHe YEguren DLuu TPContreras-Vidal JLDove Medical PressarticleFDAReWalkIndegoEksoHALREXMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 10, Pp 89-107 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	FDA ReWalk Indego Ekso HAL REX Medical technology R855-855.5
spellingShingle	FDA ReWalk Indego Ekso HAL REX Medical technology R855-855.5 He Y Eguren D Luu TP Contreras-Vidal JL Risk management and regulations for lower limb medical exoskeletons: a review
description	Yongtian He, David Eguren, Trieu Phat Luu, Jose L Contreras-Vidal Laboratory for Noninvasive Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA Abstract: Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly. On the other hand, the regulatory science of powered exoskeletons is still developing. The type and extent of probable risks of these devices are yet to be understood, and industry standards are yet to be developed. To address this gap, Manufacturer and User Facility Device Experience, Clinicaltrials.gov, and PubMed databases were searched for reports of adverse events and inclusion and exclusion criteria involving the use of lower limb powered exoskeletons. Current inclusion and exclusion criteria, which can determine probable risks, were found to be diverse. Reported adverse events and identified risks of current devices are also wide-ranging. In light of these findings, current regulations, standards, and regulatory procedures for medical device applications in the USA, Europe, and Japan were also compared. There is a need to raise awareness of probable risks associated with the use of powered exoskeletons and to develop adequate countermeasures, standards, and regulations for these human–machine systems. With appropriate risk mitigation strategies, adequate standards, comprehensive reporting of adverse events, and regulatory oversight, powered exoskeletons may one day allow individuals with gait disabilities to safely and independently ambulate. Keywords: FDA, ReWalk, Indego, Ekso, HAL, Rex
format	article
author	He Y Eguren D Luu TP Contreras-Vidal JL
author_facet	He Y Eguren D Luu TP Contreras-Vidal JL
author_sort	He Y
title	Risk management and regulations for lower limb medical exoskeletons: a review
title_short	Risk management and regulations for lower limb medical exoskeletons: a review
title_full	Risk management and regulations for lower limb medical exoskeletons: a review
title_fullStr	Risk management and regulations for lower limb medical exoskeletons: a review
title_full_unstemmed	Risk management and regulations for lower limb medical exoskeletons: a review
title_sort	risk management and regulations for lower limb medical exoskeletons: a review
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/52cc68f23a804869adf711e8d1011629
work_keys_str_mv	AT hey riskmanagementandregulationsforlowerlimbmedicalexoskeletonsareview AT egurend riskmanagementandregulationsforlowerlimbmedicalexoskeletonsareview AT luutp riskmanagementandregulationsforlowerlimbmedicalexoskeletonsareview AT contrerasvidaljl riskmanagementandregulationsforlowerlimbmedicalexoskeletonsareview
_version_	1718403315511853056

Risk management and regulations for lower limb medical exoskeletons: a review

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