Abstract：Objective To discuss the application effect of risk management in medical device classification. Methods A total of 650
pieces of medical devices from various departments from February 2020 to February 2021 were selected as the experimental group
to implement risk management and a total of 650 pieces of medical devices from various departments before the implementation
of risk management from January 2019 to January 2020 were selected as control group to implement routine management. And
the quality of medical device management and the incidence of management defects before and after the implementation of risk
management were compared. Results After the implementation of risk management, the placement and arrangement, quantity and
specification of medical devices, the integrity of small parts of the device and the placement qualification rate of additional items
were significantly higher than those before the implementation (P<0.05). The total incidence of medical device management defects
after the implementation was 0.61%, significantly lower than 6.31% before the implementation (P<0.05). After the implementation,
the supply and recovery timeliness, safety performance, cleanliness and packaging quality scores were significantly higher than before
the implementation (P<0.05). Conclusion The implementation of risk management for medical devices can effectively improve the
management quality and level, and it is worth popularizing.
盖玉斋. 风险管理在医疗器械管理中的应用[J]. 中国医疗设备, 2022, 37(4): 129-131.
GE Yuzhai. Application of Risk Management in Medical Device Classification. China Medical Devices, 2022, 37(4): 129-131.
