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  • Review Article
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Preclinical performance testing of medical devices with antimicrobial effects

Nature Reviews Bioengineering volume 1, pages 589–605 (2023)Cite this article

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Abstract

Infections associated with medical device use can have serious consequences for patients. Such healthcare-associated infections are often challenging to treat because of the persistence of microbial biofilms and the presence of antimicrobial-resistant microorganisms. The risks of device-associated infections can be reduced by using medical devices with antimicrobial effects. In this Review, we discuss preclinical performance testing of medical devices with antimicrobial effects, including in vitro strategies, animal models and computational modelling. We examine the clinical performance of antimicrobial bone cements, urinary catheters, venous catheters and wound dressings. Rational preclinical test strategies are needed to obtain information to estimate how well a device will benefit the patient in clinical use. We outline the potential of ex vivo models, microphysiological systems, organoids and medical devices-on-chips as complementary testing strategies. To move preclinical tests from the bench to the bedside, we propose a systems approach to address the many interrelated aspects of medical device interactions using a question-based rubric.

Key points

  • Infections associated with medical devices are a major public health challenge that could be mitigated in part by devices with antimicrobial effects.

  • Microbial biofilm plays an important part in the pathogenesis of device-associated infections and is a key target of devices with antimicrobial effects.

  • Preclinical performance testing is essential for the understanding of antimicrobial performance and safety of medical devices.

  • In vitro antimicrobial performance testing of medical devices can be improved through a systems approach to develop a testing strategy, and the development of improved formats, such as ex vivo tissue models, microphysiological systems, organoids and medical devices-on-chips.

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Fig. 1: Biological reactions to a medical device implant.
Fig. 2: In vitro technologies to test antimicrobial medical devices.

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Acknowledgements

The authors thank reviewers from the Center for Devices and Radiological Health — CDRH/OSEL/DBCMS, CDRH/OPEQ/OHT6 and CDRH/OPEQ/OHT4 — for critical feedback on the manuscript.

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Authors and Affiliations

  1. United States Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry and Materials Science, Silver Spring, MD, USA

    Hao Wang, J. Alex Chediak & David M. Saylor

  2. California Baptist University, Department of Mathematical Sciences, Riverside, CA, USA

    J. Alex Chediak

  3. United States Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of Health Technology 6, Office of Orthopedic Devices, Division of Joint Arthroplasty Devices, Silver Spring, MD, USA

    Philip J. Belmont Jr

  4. United States Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of Health Technology 6, Office of Orthopedic Devices, Division of Restorative, Repair and Trauma Devices, Silver Spring, MD, USA

    K. Scott Phillips

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K.S.P., H.W. and J.A.C. developed the overall manuscript content. All authors researched and wrote at least one section in the manuscript. All authors reviewed and edited the manuscript.

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The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. The findings and conclusions in this paper have not been formally disseminated by the US Food and Drug Administration and should not be construed to represent any agency determination or policy. The authors have no other competing interests to disclose.

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Wang, H., Chediak, J.A., Belmont, P.J. et al. Preclinical performance testing of medical devices with antimicrobial effects. Nat Rev Bioeng 1, 589–605 (2023). https://doi.org/10.1038/s44222-023-00060-6

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