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

Yongtian He, David Eguren, Trieu Phat Luu, Jose L Contreras-Vidal, Yongtian He, David Eguren, Trieu Phat Luu, Jose L Contreras-Vidal

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: Ekso; FDA; HAL; Indego; ReWalk; Rex.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Entities involved in the risk management of exoskeleton.
Figure 2
Figure 2
Procedures for obtaining medical device approval in the USA, EU, and Japan. The USA requires applications to be approved by a federal agency, namely the FDA, whereas the EU distributes the responsibility to many independent notified bodies. Japan’s government reviews reliability of the manufacturers both on site and via documents, while the USA and the EU leave that responsibility to manufacturers themselves. The bottom panel about Japan was adapted from the diagram on Page 11 in the materials of the 2011 AHC Workshop on Medical Devices. Tamura A. Understanding Japanese medical device requirements. 2011. Available from: https://www.pmda.go.jp/files/000164006.pdf. Abbreviations: CE, European Conformity; EU, European Union; FDA, US Food and Drug Administration; MHLW, Ministry of Health, Labour, and Welfare; PMDA, Pharmaceuticals and Medical Device Agency; QMS, quality management system.

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