医疗器械临床前研究中的人因可靠性分析

Analysis of human reliability during preclinical studies of medical devices

医疗器械的临床前研究是医疗器械风险控制的重要环节。在进行医疗器械的临床前研究过程中,人因可靠性是影响临床前研究结果有效性的重要因素。作者论述了人因可靠性研究的发展历程和人因可靠性分析方法,并结合医疗器械临床前研究特点,分析在医疗器械临床前研究中影响人因可靠性的相关因素,就如何提高医疗器械临床前研究中的人因可靠性提出建议和措施。

Preclinical studies of medical devices are the important parts of risk management of medical devices.During the course of preclinical study of the medical devices,human factors are vital affecting reliability and the effectiveness of preclinical studies.This article discussed the development and analysis methods of human reliability.The related factors of human reliability were analyzed combined with the characteristics of preclinical studies of the medical devices.Measures regarding how to improve the human reliability in preclinical studies in the medical devices have been proposed.