Preclinical performance testing of medical devices with antimicrobial effects

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.