关键词: 消毒供应中心；医疗器械；使用说明书

Abstract: Objective: To understand the application status of medical device instructions in Central Sterile Supply Departments (CSSDs), and put forward specific solutions standardizing the application of medical device instructions. Methods: Stratified sampling method was used to investigate the use of medical devices in sterilized supply centers (rooms) of 340 hospitals in China. Results: 84.12% of the implants and external medical devices were provided without instructions offered by manufacturers, 33.53% of the users did not understand the contents contained in the instructions. 41.18% of CSSD staff had not fully referred to the instructions of implants and external medical devices in usage and 87.65% of them had not regularly participated in relevant training. 62.35% of the departments had not formulate rules on the instructions and management system for medical devices, and 59.41% of the CSSDs investigated had not assigned staff to manage the instructions of medical devices. The status of instructions for medical devices in CSSD of hospitals on different levels were compared, such as the application of the instructions in verifying a newly purchased medical device for the first time as well as in long-term maintenance, and statistically significant differences were observed (P<0.05). Conclusion: Medical device manufacturers are unfamiliar with and have paid little attention to the state management requirements for medical device instructions. The medical device users in CSSD have also failed to understand the importance of the instructions of medical devices resulting from lack of professional training and standard management of instructions CSSD, which could cause a high risk for the management of surgical instruments.

Key words: Central Sterile Supply Department; medical device; instruction