He Yongtian, Eguren David, Luu Trieu Phat, Contreras-Vidal Jose L
Laboratory for Noninvasive, Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA.
Med Devices (Auckl). 2017 May 9;10:89-107. doi: 10.2147/MDER.S107134. eCollection 2017.
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.
步态障碍是全球范围内的一个重大医疗保健问题。动力外骨骼最近已成为一种设备，可使步态障碍患者以直立姿势行走，并可能带来其他临床益处。2014年，美国食品药品监督管理局批准将ReWalk™个人外骨骼作为具有特殊控制功能的II类医疗器械进行销售。从那时起，Indego™和Ekso™也获得了监管批准。随着全球范围内的类似趋势，这个行业可能会迅速发展。另一方面，动力外骨骼的监管科学仍在发展中。这些设备可能存在的风险类型和程度尚待了解，行业标准也尚未制定。为了填补这一空白，我们在制造商和用户设施设备经验、Clinicaltrials.gov以及PubMed数据库中搜索了有关使用下肢动力外骨骼的不良事件报告以及纳入和排除标准。发现目前可确定潜在风险的纳入和排除标准各不相同。报告的不良事件和当前设备已识别的风险也多种多样。鉴于这些发现，我们还比较了美国、欧洲和日本目前医疗器械应用的法规、标准和监管程序。有必要提高人们对使用动力外骨骼可能存在的风险的认识，并为这些人机系统制定适当的应对措施、标准和法规。通过适当的风险缓解策略、充分的标准、不良事件的全面报告以及监管监督，动力外骨骼也许有一天能让步态障碍患者安全、独立地行走。
