Analysis and evaluation of quality concerns of fluid infusion and blood transfusion warmer
10.19745/j.1003-8868.2023211
- VernacularTitle:输液输血加温设备质量关注要点分析与评价
- Author:
Peng-Tao MOU
1
;
Ke ZHANG
;
Hui-Fang NIU
;
Li FU
;
Jian LU
;
Zai-Ai ZHANG
;
Jian-Zhong HUANG
Author Information
1. 山东省医疗器械和药品包装检验研究院医用电器质量评价中心,济南 250101
- Keywords:
fluid infusion and blood transfusion warmer;
adverse events;
quality evaluation;
utilization risk
- From:
Chinese Medical Equipment Journal
2023;44(10):76-80
- CountryChina
- Language:Chinese
-
Abstract:
The main components and working principle of the fluid infusion and blood transfusion warmer were introduced,and the causes for the adverse events of the warmer were summarized based on National Medical Device Adverse Event Monitoring Information System and related literature in the world.The potential risks of the warmer were analyzed during operation,and the quality concerns and corresponding evaluation methods were proposed for the warmer from the aspects of device marking and documentation,structure,and temperature.References were provided for standard preparation,pre-market technical review and system verification of the fluid infusion and blood transfusion warmer.[Chinese Medical Equipment Journal,2023,44(10):76-80]
