Turnbull Lynne, Leigh Roger, Cavaliere Rosalia, Osvath Sarah R, Nolan Laura M, Smyth Daniel, Verhoeven Kristien, Chole Richard A, Whitchurch Cynthia B
The iThree Institute, University of Technology Sydney, Ultimo, NSW 2007, Australia.
Cochlear Limited, 1 University Avenue, Macquarie University, Sydney, NSW 2109, Australia.
Microorganisms. 2021 Aug 25;9(9):1809. doi: 10.3390/microorganisms9091809.
Recalcitrant chronic infections of implanted medical devices are often linked to the presence of biofilms. The prevention and treatment of medical device-associated infections is a major source of antibiotic use and driver of antimicrobial resistance globally. Lowering the incidence of infection in patients that receive implanted medical devices could therefore significantly improve antibiotic stewardship and reduce patient morbidity. Here we determined if modifying the design of an implantable medical device to reduce bacterial attachment, impacted the incidence of device-associated infections in clinical practice. Since the 1980s cochlear implants have provided long-term treatment of sensorineural hearing deficiency in hundreds of thousands of patients world-wide. Nonetheless, a relatively small number of devices are surgically explanted each year due to unresolvable infections. Features associated with the accumulation of bacteria on the Cochlear™ Nucleus CI24RE™ model of cochlear implant devices were identified using both in vitro bacterial attachment assays and examination of explanted devices. Macro-scale design modifications that reduced bacterial attachment in vitro were incorporated into the design of the CI500™ and Profile™ series of Nucleus implant. Analyses of mandatory post-market vigilance data of 198,757 CI24RE and 123,084 CI500/Profile series implantation surgeries revealed that these design modifications correlated with significantly reduced infection rates. This study demonstrates that a design-centric approach aimed at mitigating bacterial attachment was a simple, and effective means of reducing infections associated with Cochlear Nucleus devices. This approach is likely to be applicable to improving the designs of other implantable medical devices to reduce device-associated infections.
植入式医疗设备的顽固性慢性感染通常与生物膜的存在有关。医疗设备相关感染的预防和治疗是全球抗生素使用的主要来源和抗菌药物耐药性的驱动因素。因此，降低接受植入式医疗设备患者的感染发生率可显著改善抗生素管理并降低患者发病率。在此，我们确定了修改植入式医疗设备的设计以减少细菌附着，是否会影响临床实践中与设备相关的感染发生率。自20世纪80年代以来，人工耳蜗已为全球数十万感音神经性听力缺陷患者提供了长期治疗。尽管如此，由于无法解决的感染问题，每年仍有相对少量的设备需要通过手术取出。使用体外细菌附着试验和对取出设备的检查，确定了与人工耳蜗设备的Cochlear™ Nucleus CI24RE™模型上细菌积累相关的特征。将在体外减少细菌附着的宏观设计修改纳入Nucleus CI500™和Profile™系列植入物的设计中。对198,757例CI24RE和123,084例CI500/Profile系列植入手术的强制性上市后监测数据进行分析后发现，这些设计修改与感染率显著降低相关。这项研究表明，以设计为中心的旨在减轻细菌附着的方法是一种简单有效的减少与Cochlear Nucleus设备相关感染的手段。这种方法可能适用于改进其他植入式医疗设备的设计，以减少与设备相关的感染。
