国产超声诊断设备的示范应用评价研究

An Application Evaluation Research of Domestic Ultrasonic Diagnostic Equipment

目的通过对国产超声诊断设备的示范应用评价,进一步完善国产超声诊断设备的临床评价并提升技术,促进我国医疗器械的优化改进与技术创新,推动国产医疗器械在医疗机构的推广应用。方法 2012年1月至2014年6月对重庆博恩富克医疗设备有限公司全数字便携式超声诊断系统BNBC/B3600型进行临床应用,并与进口同档次设备GE LOGIQ A1进行对比临床观察,检验其图像质量、主要技术参数及设备的稳定性、可靠性、安全性等。结果国产超声诊断设备在设备稳定性、安全性、可靠性等方面与进口同档次设备相当(P>0.05);图像质量略逊于进口同档次设备,但差异无统计学意义(P>0.05);部分技术参数逊于进口同档次设备,差异有统计学意义(P<0.05)。结论国产超声诊断设备具有较好的设备稳定性、安全性、可靠性及经济性,且临床应用功能齐全,能满足临床常见病及多发病的超声诊断需要,特别适用于基层医疗机构使用;在改进提升国产超声设备(BNBC/B3600型)的图像质量、部分技术参数及应用软件的同时,应大力促进国产彩色超声诊断设备的研发应用推广,以促进国产医疗器械的发展应用,提高国产医疗器械的核心竞争力和社会认同度。

Objective Through demonstrating、applying and evaluating domestic ultrasonic diagnostic equipment,to further improve the clinical evaluation of domestic ultrasonic diagnostic equipment and promote technology development,facilitate optimal improvement and technology innovation of the domestic medical equipment,promote popularization and application of domestic medical device in medical institutions. Methods Applied type BNBC /B3600 digital portable ultrasonic diagnostic system of Chongqing BORN- FUKE Medical Equipment Limited Company between January 2012 and June 2014 and compared with the same grade import equipment（ GE LOGIQ A1）,testing the image quality、main technical parameters and the stability、security、reliability of equipment. Results The stability,security,reliability of domestic ultrasonic diagnostic equipment and import were relatively the same（ P〉0. 05）; the image quality of domestic ultrasonic diagnostic equipment was inferior to the import,but the difference had no statistical significance（ P〉0. 05）; some technical parameters was inferior to the import and the differences were statistically significant（ P〈0. 05）. Conclusion Domestic ultrasonic diagnostic equipment has good stability,safety,reliability and economy,and the clinical application of the function is complete; it can satisfy the needs of the ultrasound diagnosis of clinical common disease and frequently- occurring disease,especial y suitable for the grass- roots medical institutions; In the process of improving the image quality、 partial technical parameters and application software, we should also vigorously promote domestic color ultrasonic diagnostic equipment research、application and extension to expedite the development of domestic medical device applications,enhance the core competition of the domestic medical equipment and social perception.