Methodological Study of Reliability Test of Percutaneous Ventricular Assist Device
10.3969/j.issn.1671-7104.230439
- VernacularTitle:介入式心室辅助装置可靠性试验方法学研究
- Author:
Xun LIU
1
;
Da ZHU
;
Yujing ZHANG
;
Xiangbin PAN
Author Information
1. 上海市医疗器械检验研究院,上海市,201318;国家药品监督管理局医用电气设备重点实验室,上海市,201318
- Keywords:
percutaneous ventricular assist device;
ventricular assist device;
reliability
- From:
Chinese Journal of Medical Instrumentation
2024;48(1):70-74,93
- CountryChina
- Language:Chinese
-
Abstract:
Prior to clinical application,reliability of percutaneous ventricular assist devices(pVAD)requires to be tested systematically.Currently,there's a lack of dedicated reliability testing equipment and methodologies for pVAD.Considering the structural and functional aspects of percutaneous ventricular assist devices,this study conducts research on pVAD reliability test engineering.Test setups,clinical conditions,failure modes,effects analysis,and evaluation models have been investigated.A highly feasible methodological approach for percutaneous ventricular assist device reliability assessment has been formed.This study offers valuable insights into standardizing their reliability evaluation in clinical settings.
