消毒药械及一次性使用器械、器具证件审核创新实践

Innovative practice of auditing qualification documents of disinfectant,disinfection devices and disposable medical devices

消毒药械及一次性使用器械、器具的质量关乎患者安全,医院感染管理部门应切实履行证件审核职责,从医院层面保证使用产品合法、安全、有效。该文从制度建设、流程改造、证件审核范围和要点以及证件管理等方面介绍了四川大学华西医院医院感染管理部门在消毒药械及一次性使用器械、器具证件审核工作的实施情况。

The quality of disinfectant, disinfection devices and disposable medical devices is closely related to the patients＇ safety. Hospital infection management department must carry out the audit responsibilities for qualification documents of disinfectant, disinfection devices and disposable medical devices, to guarantee legality, safety and effectiveness of products used in hospital. This paper mainly introduces the implementation of qualification documents audit in West China Hospital, Sichuan University, including system construction, process reengineering, documents audit scope and key points, and document management.