Research on the Domestication and Standardization of Respiratory Medical Devices for Primary Healthcare Institutions

Abstract

This study addresses the core challenges of high import dependency, poor scene adaptation, and high maintenance costs of respiratory medical devices in primary healthcare institutions in China. Through multidimensional surveys, technological development, and clinical verification, a comprehensive domestication and standardization system was established. A stratified sampling method was employed to survey 200 primary healthcare institutions across 10 provinces in eastern, central, and western China, with 1,200 valid questionnaires and 80 in-depth interviews. The study identified three-dimensional requirements in terms of environment (high-altitude pressure compensation and cold fog prevention), operation (simplified interface and voice guidance), and cost (procurement ≤ $3,000 per unit, maintenance ≤ $200 per year). Core components such as low-noise permanent magnet synchronous motors (noise 36 dB, cost reduced by 40%) and aging-resistant silicone (leakage rate 4.8%, lifespan over 6 months) were developed, along with environment-adaptive algorithms (92.1% effective in high-altitude treatment, 100% success rate in low-temperature fog prevention). A multicenter controlled trial involving 50 institutions and 400 COPD patients verified that the domestic devices had a failure rate of 5.0% (compared to 12.0% for imported devices) and reduced maintenance costs by 62.1% (p<0.05). Ultimately, a three-tier standard system of “foundation — technology — evaluation” was constructed, proposing a weighted evaluation model with 40% for technical adaptability, 30% for cost adaptability, and 30% for maintenance adaptability. The research provides technical support and standard basis for the domestication of respiratory devices in primary healthcare institutions, contributing to the upgrade of grassroots medical equipment in “Healthy China 2030”.