Antimicrobial and Anti-Biofilm Medical Devices: Public Health and Regulatory Science Challenges

Abstract

This chapter introduces the public health challenge of medical device healthcare associated infections (MD-HAIs) and the regulatory science challenges involved with antimicrobial and anti-biofilm medical device technologies, including coatings and other modifications. In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. Good regulatory science can facilitate consumer access to innovative medical products that are safe and effective. Section I looks at our increasing understanding of how colonization and biofilm may play a role in the pathogenesis of medical device associated infections as well as in the emergence of drug resistant microbes. Device colonization and biofilm have unique clinical features such as persistence that make them challenging to address. This challenge requires a coordinated response from medical device manufacturers, clinicians and public health/regulatory authorities. In Section II, we take a broad view beyond antimicrobial coatings to consider the range of possible medical therapies (e.g., device coatings, antimicrobials, vaccines) to prevent MD-HAIs, their use, limitations and safety. In Section III, we discuss regulatory definitions of the different types of technology and discuss mechanisms of action and the importance of understanding combination products. Then in Section IV, we focus specifically on the regulatory science of antimicrobial technologies for medical devices. We show how the paradigm shift from a planktonic model of microbial life to a biofilm model introduces significant challenges to the scientific assessment process.