A discussion about how to prevent and control adverse event of medical device based on metal materials science
10.3969/J.ISSN.1672-8270.2017.04.013
- VernacularTitle:基于金属材料科学的医疗设备不良事件防控探讨
- Author:
Chao QIN
;
Dan LI
- Keywords:
Medical equipment;
Metal material;
Adverse event;
Adverse event monitorin
- From:
China Medical Equipment
2017;14(4):51-54
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To discuss the effect of metal materials science for how to prevent and control adverse events of medical devices, and provide forewarning measures for preventing this kind of events. Methods: To analyze the adverse events report of medical devices, and summarize 10 kinds of fault phenomenon and clinical manifestation of adverse events came from metal materials, such as respiration device and its accessories, color ultrasonic imaging device and ultrasound intervention, intracavity diagnosis and implants, and so on. To analyze the reason of the medical equipment accidents;and provide countermeasures for monitoring and management of adverse events of medical devices. Results: The advantages of preventing and controlling adverse events of medical equipment based on metal material science were:①monitor the metal material performance changes occur in force or strain and early alarming, ②identify implanted medical consumables degradation. Conclusion: The fatigue damages and defects of metal materials were the main reason of medical device adverse events. The hospital needs to establish the medical device adverse event reporting, evaluation model, evaluation and classification of time report supervision mechanism; establish and improve the monitoring and management mechanism, technical personnel and regulations; perfect the corresponding technical support system, and achieve monitoring and risk management for adverse events of clinical medical devices.
