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Article

Device Design Modifications Informed by In Vitro Testing of Bacterial Attachment Reduce Infection Rates of Cochlear Implants in Clinical Practice

1
The iThree Institute, University of Technology Sydney, Ultimo, NSW 2007, Australia
2
Cochlear Limited, 1 University Avenue, Macquarie University, Sydney, NSW 2109, Australia
3
National Heart and Lung Institute, Imperial College London, London SW3 6LR, UK
4
Washington School of Medicine in St Louis, Washington University in St. Louis, St. Louis, MO 63110, USA
5
Quadram Institute Bioscience, Norwich Research Park, Norwich NR4 7UQ, UK
6
School of Biological Sciences, University of East Anglia, Norwich NR4 7TK, UK
*
Author to whom correspondence should be addressed.
Academic Editor: Ute Römling
Microorganisms 2021, 9(9), 1809; https://doi.org/10.3390/microorganisms9091809
Received: 15 April 2021 / Revised: 28 July 2021 / Accepted: 20 August 2021 / Published: 25 August 2021
(This article belongs to the Special Issue Clinical Implications of Microbial Biofilm)
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. View Full-Text
Keywords: biofilm; medical device; infection; antibiotic resistance; AMR biofilm; medical device; infection; antibiotic resistance; AMR
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MDPI and ACS Style

Turnbull, L.; Leigh, R.; Cavaliere, R.; Osvath, S.R.; Nolan, L.M.; Smyth, D.; Verhoeven, K.; Chole, R.A.; Whitchurch, C.B. Device Design Modifications Informed by In Vitro Testing of Bacterial Attachment Reduce Infection Rates of Cochlear Implants in Clinical Practice. Microorganisms 2021, 9, 1809. https://doi.org/10.3390/microorganisms9091809

AMA Style

Turnbull L, Leigh R, Cavaliere R, Osvath SR, Nolan LM, Smyth D, Verhoeven K, Chole RA, Whitchurch CB. Device Design Modifications Informed by In Vitro Testing of Bacterial Attachment Reduce Infection Rates of Cochlear Implants in Clinical Practice. Microorganisms. 2021; 9(9):1809. https://doi.org/10.3390/microorganisms9091809

Chicago/Turabian Style

Turnbull, Lynne, Roger Leigh, Rosalia Cavaliere, Sarah R. Osvath, Laura M. Nolan, Daniel Smyth, Kristien Verhoeven, Richard A. Chole, and Cynthia B. Whitchurch 2021. "Device Design Modifications Informed by In Vitro Testing of Bacterial Attachment Reduce Infection Rates of Cochlear Implants in Clinical Practice" Microorganisms 9, no. 9: 1809. https://doi.org/10.3390/microorganisms9091809

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