The Microbiology and Infection Control Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to ensure patients have access to safe and effective medical devices that are free of microbial and biochemical contamination. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Microbiology, Infection Control, and Medical Devices

Infections can be caused by pathogens, such as bacteria, fungi, and viruses, which can be introduced to the human body through almost every class of medical devices. With the increasing use of medical devices and their promise to improve quality of life, preventing device-associated infection, contamination and failure is a public health priority.

A large subset of medical devices is reused more frequently and new types of materials, processes, devices, and biothreats are introduced. Accordingly, regulatory concerns need to be addressed to prevent contamination, elucidate mechanisms of immune responses to microbial contamination, and develop test methods and endpoint measurements for device safety as new infection and contamination issues emerge.

Regulatory Science Gaps and Challenges

Major regulatory science gaps and challenges that drive the Microbiology and Infection Control Program are:

• Lack of reliable and reproducible methods for evaluating effectiveness of cleaning, disinfection, and reprocessing of devices.
• Lack of focused studies to meet antimicrobial claims in devices and challenges to testing antimicrobial efficacy.
• Lack of understanding of mechanisms of bacterial adhesion on an indwelling device and routes of bacterial infection and spread through device use.
• Lack of rapid identification and characterization of bacterial and biochemical contaminants on devices as well as testing strategies of emerging microorganisms.

The Microbiology and Infection Control Program is intended to fill these knowledge gaps by fostering the establishment of a regulatory science knowledge base to reduce device-associated infections and evaluate rapid detection and mitigation strategies to respond to bio-threats.

Microbiology and Infection Control Program Activities

The Microbiology and Infection Control Program focuses on regulatory science research in these areas:

• Methods for quality control for incorporation into premarket guidances and for investigations into postmarket signals
• Simulated wound fluids (SWFs) to evaluate antibacterial wound dressing claims, using microbiology and flow cytometry
• Mechanisms of bacterial adhesion on an indwelling device and routes of bacterial infection and spread through device use
• Rapid identification methods for microbial contamination.
• Studies on immune and cell regulation in host and microbe interactions resulting from devices and their materials.
• Device and assay evaluation for pathogenic microorganisms (fungal, bacterial, and viral agents)

For more information, email [email protected]