Pallotta Arnaud, Clarot Igor, Sobocinski Jonathan, Fattal Elias, Boudier Ariane
CITHEFOR, Université de Lorraine, F-54000 Nancy, France.
CHU Lille, INSERM U1008, Université de Lille, 59006 Lille, France.
ACS Appl Bio Mater. 2019 Jan 22;2(1):1-13. doi: 10.1021/acsabm.8b00612. Epub 2019 Jan 7.
Many novel medical devices (implantable or not) include nanomaterials through either surface-coating by nanoparticles or by direct nanostructuration of the surface. In this review, we have identified several medical devices currently on the market in various health domains (wound healing, prevention or treatment of infectious diseases, cardio-vascular diseases, organ or joint replacement, and finally medical devices associated with nanomedicines). The very peculiar physicochemical characterization of the nanostructured medical devices is described. Keys to understand their possible interaction with the organism (positive or negative via toxicity) are given. Finally, as a conclusion, we discuss the specific quality control as well as the regulatory issues arising from the lack of regulation for approving nanomaterial combining medical devices.
许多新型医疗设备（无论是否可植入）都通过纳米颗粒表面涂层或表面直接纳米结构化的方式包含了纳米材料。在本综述中，我们确定了目前在各个健康领域市场上的几种医疗设备（伤口愈合、传染病的预防或治疗、心血管疾病、器官或关节置换，以及最后与纳米药物相关的医疗设备）。描述了纳米结构医疗设备非常特殊的物理化学特性。给出了理解它们与生物体可能相互作用（通过毒性产生正面或负面作用）的关键。最后，作为结论，我们讨论了由于缺乏批准纳米材料与医疗设备结合的监管而产生的特定质量控制以及监管问题。
