Abstract:Medical device safety (adverse) event management plays an important role in security management of clinical use of
medical devices, and medical device adverse event report is the precondition of finding latent danger and making risk management
practices. For a preferable and effective management of medical device adverse event, we searched for the root of management
default, established countermeasures, and made monitoring management system via PDCA tool aiming at current situations. In
three consecutive years’ execution and tracking, the reports increased greatly in quantity and quality, meanwhile the probability of
adverse consequences and harm decreased a lot, and therefore the management of medical device adverse event was obvious to all,
which contributed to security management system of clinical use of medical devices promotion and perfection and enhanced our risk
management ability.
蔡银. PDCA在我院医疗器械安全(不良)事件管理中的应用[J]. 中国医疗设备, 2018, 33(5): 161-164.
CAI Yin. Application of PDCA in the Management of Safety (Adverse) Events of Medical Devices in Hospital. China Medical Devices, 2018, 33(5): 161-164.