G-12.02-陈敏的-光纤和医用激光设备整体质控的研究.pdf

光纤和医用激光设备整体质控的研究 陈敏1 叶中琛2 金若男1 1 国家食品药品监督管理局医疗器械技术审评中心 北京 100044 2 中怡医疗科技（上海）有限公司 上海 201318 基金项目：国家科技支撑计划课题（2012BAI22B04） 摘要：医用光纤是以光导纤维为激光传播介质, 通过对光信息的处理和光能的 利用而进行诊断和治疗的医疗器械。光纤对于光信息的准确处理和光能的安全使 用均会产生重要的影响，是医用激光设备的关键部件，其可靠性对激光设备整体 的临床安全有效性有直接的影响。本文介绍了光纤以及医用激光设备在医学上的 应用，并根据 YY/T 0316-2008《医疗器械 风险管理对医疗器械的应用》以及美 国 FDA MAUDE数据库的有关报告记录，总结了常见的风险，并提出了相应的风险 控制措施。希望能促进各???合理控制风险，使其发挥更大的作用。 关键词：风险管理；激光；光纤；医疗器械； Quality Control Research on Medical Laser Equipment with Fiber Chen Min1 Ye Zhongchen2 Jin Ruonan1 1 Center For Medical Device Evaluation, SFDA，Beijing 100044 2 Johnyee Medical Tech.(Shanghai), Inc.,Shanghai 201318 Abstract：Medical fiber is an application of optical fibers, used as laser guides to perform optical information processing and laser energy utilizing, for the purpose of diagnostics and therapeutics. It is also one of critical components of medical laser equipment, and has significant impact on proper and safe use of laser. Its reliability directly contributes to the entire safety and effectiveness of equipment-fiber system. We studied quantities of relevant medical device reports (MDRs) from FDA MAUDE(Manufacturer and User Facility Device Experience) database. Based on the study, we concluded common risks and suggested their control measures according to YY/T 0316-2008 Medical devices-Application of risk management to medical devices. This research can be used as recommendations of proper risk control of medical laser equipment with fiber for the stakeholders, thus promotes its application in medical field. Key Words: Risk Mangement；Laser；Fiber；Medical Device 0 引言 1960 年，世界上第一台红宝石激光器诞生，宣告了激光技术的诞生，之后 各类激光器随之竞相发展。1965 年，激光技术首先进入我国眼科领域，半个世 纪以来，人们不断探索各种激光器的医学应用[1]。从体表到腔内，从诊断到治疗， 从屈光手术到整形手术，从理疗到光动力治疗，激光在眼科、皮肤科，耳鼻喉科、 外科、妇科、口腔科、耳鼻喉科、泌尿、理疗科等各医疗领域发挥着日益重要的 作用。 激光是受激发射放