Abstract

Indwelling and implanted medical devices are subject to contamination by microbial pathogens during surgery, insertion or injection, and ongoing use, often resulting in severe nosocomial infections. Antimicrobial peptides (AMPs) offer a promising alternative to conventional antibiotics to reduce the incidence of such infections, as they exhibit broad-spectrum antimicrobial activity against Gram-negative and Gram-positive bacteria, microbial biofilms, fungi, and viruses. In this review-perspective, we first provide an overview of the progress made in this field over the past decade with an emphasis on the local release of AMPs from implant surfaces and immobilization strategies for incorporating these agents into a wide range of medical device materials. We then provide a regulatory science perspective addressing the characterization and testing of AMP coatings based on the type of immobilization strategy used with a focus on the US market regulatory niche. Our goal is to help narrow the gulf between academic studies and preclinical testing, as well as to support a future literature base in order to develop the regulatory science of antimicrobial coatings.

摘要

留置和植入的医疗器械在手术、插入或注射以及持续使用过程中会受到微生物病原体的污染，通常会导致严重的医院感染。抗菌肽 (AMP) 是传统抗生素的一种有前景的替代品，可降低此类感染的发生率，因为它们对革兰氏阴性和革兰氏阳性细菌、微生物生物膜、真菌和病毒具有广谱抗菌活性。在这篇综述中，我们首先概述了过去十年在该领域取得的进展，重点是从植入物表面局部释放 AMP，以及将这些药剂纳入各种医疗器械材料的固定策略。然后，我们提供了一个监管科学观点，根据所使用的固定策略类型来解决 AMP 涂层的表征和测试，重点是美国市场监管利基。我们的目标是帮助缩小学术研究和临床前测试之间的鸿沟，并支持未来的文献库，以发展抗菌涂料的监管科学。