Advances in antimicrobial orthopaedic devices and FDA regulatory challenges.

Implant-associated infections, caused by the formation of biofilms especially antibiotic resistant organisms, are among the leading causes of orthopaedic implant failure. Current strategies to combat infection and biofilm focus on either inhibiting bacterial growth or preventing bacterial adherence that could lead to biofilm creation. Despite research on developing numerous antimicrobial orthopaedic devices, to date, no robust solution has been translated to the clinic. One of the key bottlenecks is the disconnect between researchers and regulatory agencies. In this review, we outline recent strategies for minimizing orthopaedic implant-associated infections. In addition, we discuss the relevant Food and Drug Administration regulatory perspectives, challenges. We also highlight emerging technologies and the directions the field that is expected to expand. We discuss in depth challenges that include identifying strategies that render implants antibacterial permanently or for a long period of time without the use of antimicrobial compounds that could generate resistance in pathogens and negatively impact osseointegration.