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轮椅安全——向美国食品药品监督管理局提交的不良报告。

Wheelchair safety--adverse reports to the United States Food and Drug Administration.

作者信息

Kirby R L, Ackroyd-Stolarz S A

机构信息

Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

出版信息

Am J Phys Med Rehabil. 1995 Jul-Aug;74(4):308-12. doi: 10.1097/00002060-199507000-00009.

DOI:10.1097/00002060-199507000-00009
PMID:7632389
Abstract

Evidence has been accumulating that injuries related to wheelchair use are common and sometimes serious. The object of this study was to evaluate the databases of the Food and Drug Administration (FDA) for insights to the nature and causes of such problems. We analyzed 651 records that were received by the FDA between 1975 and 1993. There were 368 injuries, 21 of which were fatal, affecting 334 wheelchair users. Fractures were the most common (45.5%), with lacerations (22.3%) and contusions/abrasions (20.1%) accounting for most of the remainder. The proportion of incidents related to the use of scooters, powered wheelchairs, and manual wheelchairs were 52.8%, 24.6%, and 22.6%, respectively. Four broad classes of contributing factors, often acting in combination, were implicated: engineering (60.5%), environmental (25.4%), occupant (9.6%), and system (4.6%). Of the tips and falls, those in the forward direction were most common in incidents affecting manual or powered wheelchairs, but the sideways direction was most common in scooters. The FDA database provides a unique perspective on wheelchair safety, with implications for clinicians, users, manufacturers, and regulatory bodies.

摘要

越来越多的证据表明,与轮椅使用相关的损伤很常见,有时还很严重。本研究的目的是评估美国食品药品监督管理局(FDA)的数据库,以深入了解此类问题的性质和原因。我们分析了FDA在1975年至1993年间收到的651份记录。共有368起损伤事件,其中21起是致命的,涉及334名轮椅使用者。骨折最为常见(45.5%),其余大部分为撕裂伤(22.3%)和挫伤/擦伤(20.1%)。与踏板车、电动轮椅和手动轮椅使用相关的事件比例分别为52.8%、24.6%和22.6%。有四类主要的促成因素,通常相互作用:工程因素(60.5%)、环境因素(25.4%)、使用者因素(9.6%)和系统因素(4.6%)。在倾倒和跌倒事件中,向前倾倒在影响手动或电动轮椅的事件中最为常见,但向侧面倾倒在踏板车事件中最为常见。FDA数据库为轮椅安全提供了独特的视角,对临床医生、使用者、制造商和监管机构都有启示。

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