医院卫生技术评估在创新医疗设备准入管理中的应用——以支气管镜热蒸汽消融术为例OACSTPCD

Objective To conduct a hospital-based health technology assessment(HB-HTA)based on the effectiveness,safety,adaptability,and cost-effectiveness of introducing bronchoscopic thermal vapor ablation supporting medical equipment in a tertiary hospital in Shanghai,and to evaluate the application of HB-HTA on the innovation of the innovative medical equipment field.Methods An evaluation template of the introduction of new technologies for medical devices in the EU HB-HTA guidance manual was used as the framework for the study.Results The literature research results showed that FEV1%,SGRQ and 6MWD of patients had been significantly relieved after the treatment of bronchoscopic thermal vapor ablation and adverse events also could be resolved by standard care.The results of expert consultation,group discussion,and real-world data analysis showed that the equipment had personnel and venue conditions,met the hospital's disciplinary development plan,and was technically suitable for the population.It was optimistic that the equipment was expected to recover costs in about 6 years,and the disease burden of a single person was reduced.Conclusion The introduction of bronchoscopic thermal vapor ablation technology can effectively improve patient lung function,improve patient quality of life,have good safety,and have configuration value;This research model can drive the development of respiratory intervention treatment centers and help improve the diagnosis and treatment level of severe emphysema.It can provide decision-making evidence for the introduction of new technologies in hospitals and improve the management level of medical equipment in hospitals.