TITLE:
Clinical Translation Challenges and Future Paradigms of Advanced ECMO Coatings: Scalability, Hemocompatibility, and Regulatory Barriers
AUTHORS:
Yun Chang, Bingbo Wang, Yitong Guo, Xiaoyu Liang, Chunyue Guo, Wenqing Gao, Xiaomin Hu
KEYWORDS:
Extracorporeal Membrane Oxygenation, Surface Modification, Polyvinyl Chloride Tubing, Hollow Fiber Membrane, Thromboinflammation, Immune Modulation
JOURNAL NAME:
Journal of Biosciences and Medicines,
Vol.14 No.5,
May
29,
2026
ABSTRACT: Extracorporeal membrane oxygenation (ECMO) triggers severe thromboinflammatory responses upon prolonged blood contact with synthetic interfaces. While advanced surface modifications aim to actively remodel the local immune microenvironment to surpass the limitations of conventional heparin coatings, their clinical translation remains constrained. This narrative review systematically evaluates the technical and regulatory barriers impeding the commercialization of next-generation ECMO coatings. It analyzes the distinct engineering requirements for primary blood-contacting components: achieving long-term mechanical stability against extreme hemodynamic shear stress in polyvinyl chloride tubing, and resolving the mass transfer paradox to maintain high gas permeability in hollow fiber membrane oxygenators. Furthermore, the review examines critical industrial hurdles, including the degradation of bioactive molecules during mandatory sterilization, complex regulatory pathways for drug-device combination products, and the lack of standardized multi-scale dynamic preclinical evaluation models. Overcoming these multi-dimensional challenges necessitates rigorous interdisciplinary collaboration among materials engineering, clinical medicine, and regulatory science.