医疗器械的合理应用与全球应对

Rational Use and Global Response of Medical Devices

医疗器械是用于医疗诊断和治疗的一类设备、仪器、用品以及辅助设备,已经成为医务人员进行预防、诊断、治疗、康复的必需工具。然而,医疗器械的不正确选择、应用,使医疗费用大幅提高,影响了卫生资源的合理配置和利用,限制了国家社会经济的发展。世界卫生大会第WHA 60.29(2007)和WHA 67.20(2014)号决议对改善医疗器械合理应用提出应对措施,WHO举行了4次全球医疗器械论坛,目的是应对全球医疗器械面临的挑战。本文介绍当前医疗器械卫生技术评估、创新、优先选择、安全、5A、监管和BME人力资源等热点问题,以及WHO面对可持续发展目标要求提出的相关指南、清单。

Medical devices may be broadly as diagnosis and therapeutic equipment,instruments,supplies and ancillary equipment.They have become a necessary tool for health care participants for prevention,diagnosis,treatment and rehabilitation.However,the improper selection and use of medical devices have greatly increased health-care expenses,affected the rational allocation and utilization of health resources,and restricted the development of social economy of the country.World Health Assembly resolutions WHA 60.29(2007)and WHA 67.20(2014)put forward countermeasures to improve the rational use of medical devices.World Health Organization(WHO)has held four the Global Forums Medical Devices from 2010 to 2018.The purpose is to address the challenges on global medical devices.This paper introduces the current hot issues of medical device,as health technology assessment,innovation,priority selection,safety,5A(Available,Accessible,Appropriate,Affordable,Acceptable),regulation and BME human resources.WHO presents relevant guidelines and lists in response to the requirements of sustainable development goals.