Abstract: OBJECTIVE To evaluate the current management status of external medical devices and implants in medical institutions in Tianjin, identify weak links, and provide a basis for optimizing regional management strategies. METHODS To evaluate the current management status of external medical devices and implants in medical institutions in Tianjin, identify weak links, and provide a basis for optimizing regional management strategies.RESULTS Management responsibilities were concentrated in tertiary hospitals, which handled 62.50% of the total volume across the city. The survey revealed multiple weak management links. Only 29.17% of institutions used temperature-pressure instruments to detect physical parameters during initial validation, and 39.58% of institutions did not seek opinions from the central sterile supply department before admitting external medical devices. In terms of supplier data provision, the provision rate of critical device diagrams was only 62.50%. Although 83.33% of used devices underwent cleaning, gaps were found in closed-loop management, with 14.58% returned by the operating room and 4.17% returned directly without cleaning. Only 58.33% of medical institutions achieved full information-based traceability. CONCLUSIONS A preliminary institutional framework for the management of external medical devices has been established in Tianjin. However, deficiencies remain, particularly in the implementation of technical specifications, supplier coordination, closed-loop post-use processing and informatics support. Therefore, efforts should be made to strengthen standard implementation, improve the supplier management system, rigorously enforce centralized processing procedures, accelerate information system development, and establish a whole-lifecycle traceability management system.