
APIC and FDA Webinar: Regulatory Science Tools for Reprocessing of Medical Devices
Recorded On: 02/09/2023
- Registration Closed
APIC and FDA Webinar: Regulatory Science Tools for Reprocessing of Medical Devices
Originally presented on Thursday, February 9, 2023 @ 1 pm ET
Speakers: Dr. Katharine Segars and Dr. Jon Weeks
The current antimicrobial technologies available may be less effective due to multi-drug resistant bacteria and the propensity of biofilm formation on medical devices, making infections more difficult to prevent, detect, and treat. To assist stakeholders in evaluating safety and effectiveness of technologies to reduce health care related infections, our focus will be on standardizing methodologies to evaluate reprocessing instructions for medical devices including cleaning, drying, and reduction of biofilms.

Katharine Segars, PhD.
Assistant Director-Sterility and Infection Control Program
Food and Drug Administration/CDRH/OSEL/DBCMS
Katharine Segars is currently serving as the Assistant Director of the Sterility and Infection Control Program in the Office of Science and Engineering Laboratories. After earning her Ph.D. in Applied and Environmental Microbiology from Georgia State University, Dr. Segars completed the FDA Commissioner’s Fellowship Program by performing research related to microbial contamination of powered infant formula. She subsequently joined the Center for Devices and Radiological Health (CDRH) as a Lead Reviewer with a concentration in infection control topics, including microbiological safety of medical devices, reprocessing of reusable devices, and terminal sterilization. Dr. Segars later went to work for the US Military Academy overseeing the Life Science laboratories.

Jon W. Weeks, PhD.
Microbiologist
Food and Drug Administration/CDRH/OSEL/DBCMS
Jon Weeks is a Microbiologist with the Food and Drug Administration in the Center for Devices and Radiological Health (CDRH), and the Office of Science and Engineering Laboratories. Dr. Weeks completed his PhD. and postdoctoral research in the area of multidrug resistance in gram-negative bacteria before joining CDRH. Dr. Weeks has been with the Agency for over 6 years acting as both a regulatory reviewer and research scientist. His research has focused on varied issues related to terminal sterilization of medical devices as well as cleaning and disinfection of reusable medical devices.
Key:




