抗菌矫形器械的发展和美国食品及药物管理局的监管挑战

Mehdi Kazemzadeh-Narbat, Asija Memic, Kevin B McGowan, Adnan Memic and Ali Tamayol
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引用次数: 0

摘要

由生物膜(尤其是抗生素耐药菌)形成引起的植入物相关感染是骨科植入物失效的主要原因之一。目前抗感染和生物膜的策略主要是抑制细菌生长或防止细菌附着导致生物膜的形成。尽管研究人员开发了许多抗菌骨科设备,但迄今为止,还没有一种可靠的解决方案被应用于临床。其中一个关键瓶颈是研究人员与监管机构之间的脱节。在这篇综述中,我们概述了尽量减少骨科植入物相关感染的最新策略。此外,我们还讨论了食品药品管理局的相关监管观点和挑战。我们还强调了新兴技术以及该领域有望扩展的方向。我们深入探讨了面临的挑战,其中包括确定可使植入物永久抗菌或长期抗菌的策略,而无需使用可能使病原体产生抗药性并对骨结合产生负面影响的抗菌化合物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Advances in antimicrobial orthopaedic devices and FDA regulatory challenges
Implant-associated infections, caused by the formation of biofilms especially antibiotic resistant organisms, are among the leading causes of orthopaedic implant failure. Current strategies to combat infection and biofilm focus on either inhibiting bacterial growth or preventing bacterial adherence that could lead to biofilm creation. Despite research on developing numerous antimicrobial orthopaedic devices, to date, no robust solution has been translated to the clinic. One of the key bottlenecks is the disconnect between researchers and regulatory agencies. In this review, we outline recent strategies for minimizing orthopaedic implant-associated infections. In addition, we discuss the relevant Food and Drug Administration regulatory perspectives, challenges. We also highlight emerging technologies and the directions the field that is expected to expand. We discuss in depth challenges that include identifying strategies that render implants antibacterial permanently or for a long period of time without the use of antimicrobial compounds that could generate resistance in pathogens and negatively impact osseointegration.
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