Clinical Application Evaluation of Color Ultrasound Diagnostic Instrument
Based on Real World Data
ZHU Mingyue, HE Wei, CUI Zhigang, YANG Chunhua, QIAN Ying, LI Xin
Department of Clinical Medical Engineering, The First Affiliated Hospital with Nanjing Medical University/
Jiangsu Province Hospital, Nanjing Jiangsu 210029, China
Abstract:Objective To establish a feasible and reliable evaluation index system for color ultrasound diagnostic instrument, and
to provide references for its procurement and application. Methods By collecting data from the hospital’s medical equipment
information system and asset management system, and retrieving quality control reports of color ultrasound diagnostic instruments
from the past three years, an analysis was conducted from three aspects: clinical application, health economics, and reliability. This
analysis aimed to generate real-world evidence, summarize the strengths and weaknesses among different brands of color ultrasound
diagnostic instruments, and establish an evaluation system for this type of instrument; statistical analysis was performed on the
output sound intensity, detection depth, axial (longitudinal) geometric position indication error, lateral (transverse) geometric position
indication error, and Doppler blood flow velocity measurement error of convex array and linear array probes in different brands of
color ultrasound diagnostic instruments. Results Brand C was used more frequently in routine clinical ultrasonography examinations,
while Brands A and D were more preferred for vascular examinations. Brand B was predominantly chosen for angiographic
examinations, and routine superficial examinations were mainly performed by Brand E. The net profit ratio of Brand B was 31.32%,
the highest among the five brands, but the number of probe replacements was significantly higher than other brands. In terms of
reliability analysis, Brand E had a relatively high number of probe replacements with the least number of uses, indicating a shorter
lifespan for its probes; the number of probe replacements for Brands A and D was significantly lower than other brands. The H test
results of parameter data for convex array and linear array probes indicated that there was no significant difference in performance
among different brands (P>0.05). Conclusion This paper analyzes the real-world data of color ultrasound diagnostic instruments and
establishes a scientific and sound evaluation system for this type of instrument. This system can guide the procurement of this type of
instrument, improve their utilization rate, and enhance the efficient allocation of hospital resources.
竺明月,何伟,崔志刚,杨春花,钱英,李鑫. 基于真实世界数据的彩色超声
诊断仪临床应用评价[J]. 中国医疗设备, 2024, 39(2): 130-135.
ZHU Mingyue, HE Wei, CUI Zhigang, YANG Chunhua, QIAN Ying, LI Xin. Clinical Application Evaluation of Color Ultrasound Diagnostic Instrument
Based on Real World Data. China Medical Devices, 2024, 39(2): 130-135.