外来医疗器械是指医疗器械生产厂家、公司租借或免费向医院提供的可重复使用的医疗器械,如各类骨科植入物、内固定手术的操作器械等。它是市场经济的产物,主要用于骨科手术。这些器械不属于医院所有,在各个医院间流动使用,在处理、使用与管理中,都存在交叉感染的潜在危险,造成极大的安全隐患。现将外来医疗器械监管存在问题及管理对策 External medical devices refer to reusable medical devices such as various types of orthopedic implants and internal fixation instruments operated by medical device manufacturers, companies leased or provided to hospitals free of charge. It is the product of a market economy and is mainly used for orthopedic surgery. These devices, which are not owned by the hospital and flow in various hospitals, present a potential risk of cross-infection in handling, use and management, posing a great security risk. Now the foreign medical equipment regulatory problems and management strategies