中国と米国における神経刺激デバイスの感染制御：MCSフレームワークを用いた比較分析

Neurostimulation devices, including deep brain stimulation (DBS) and spinal cord stimulation (SCS) systems, have transformed treatment for neurological disorders and chronic pain. However, device-related infections remain a critical challenge with global incidence rates of 3-7%. This narrative review introduces the Mechanism-Clinical-System (MCS) framework to comprehensively evaluate infection control practices in China and the United States, integrating evidence from 2020 to 2025. At the mechanism level, fundamental differences in sterilization technologies-ethylene oxide dominance in the US versus hydrogen peroxide plasma preference in China-create distinct operational profiles, though clinical outcomes appear equivalent. China's 10-fold higher antibiotic consumption drives elevated antimicrobial resistance (MRSA: 60-75% vs. 40-55%). Clinically, DBS infection rates remain comparable between countries (US: 3.5-6.5%; China: 5.7%), while prolonged antibiotic prophylaxis (5-14 days) persists in China despite evidence supporting 24-h protocols. At the system level, divergent regulatory frameworks-FDA mandatory compliance versus NMPA's tiered implementation-create fundamental practice variability. Neither healthcare system demonstrates uniform superiority. The US achieves greater standardization through regulatory stringency, while China demonstrates remarkable adaptability and innovation velocity. Evidence-based harmonization strategies-including international registries, standardized surveillance, and antimicrobial stewardship-offer substantial potential to optimize patient safety globally.