浅谈医疗器械不良事件报告的组织实施

李潇1 ，罗静2 ，胡志纲3

（1. 宝鸡市中心医院医学装备科，陕西 宝鸡，721008；2. 宝鸡市中医医院骨伤科，陕西 宝鸡，721001； 3.宝鸡市中心医院放疗科，陕西 宝鸡，721008）

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摘要：

医疗器械行业的迅速发展，在为医疗救治提供良好条件的同时，也存在医疗器械不良事件的频发。医疗器械不良事件 报告的组织实施，旨在规范医疗器械不良事件报告的组织实施办法，以期提升不良事件报告质量，完善医院不良事件监测体系，更好地促进医院医疗事业的发展。因此本文对医疗器械不良事件报告实施的前提、保障、实施途径、实施重点等进行了分 析总结，站在更好的服务社会、服务患者、减少医疗器械不良事件的角度，查找医疗器械不良事件报告组织实施中存在的问题。

关键词：医疗器械；不良事件报告；不良事件监测体系

中图分类号：R052文献标志码：A文章编号：2096-1413(2018)01-0176-02

Organization and implementation of medical devices adverse event reporting

LI Xiao 1, LUO Jing2, HU Zhi-gang3
(1. Medical Equipment Department, Baoji Central Hospital, Baoji 721008; 2. Orthopedic Surgery Department, Traditional Chinese Medicine Hospitals of Baoji, Baoji 721001; 3. Radiotherapy Department, Baoji Central Hospital, Baoji 721008, China)

ABSTRACT: Medical equipment industry is developing rapidly, which provides good conditions for medical treatment and there are also frequent medical device adverse event. The organization and implementation of medical device adverse event reporting aims at standardizing the organization and implementation of medical device adverse event reports, improving the quality of adverse event reports, optimizing the hospital adverse event monitoring system, and promoting the development of hospital medical care. Therefore, this article analyzed and summarized the implementation of the premise, security, implementation, and implementation focus on the medical device adverse events to better serve the community and patients, reduce the medical device adverse events, and find the remaining problems of medical device adverse events reports.

KEYWORDS: medical equipment; adverse event reporting; adverse event monitoring system

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