FDA Grand Rounds: Anti-biofilm Technologies for Medical Device Safety Webinar
Summary
The FDA Grand Rounds webinar, presented on May 29, 2025, by Dr. Jayaleka J. Amarasinghe of the Winchester Engineering and Analytical Center, explores two innovative anti-biofilm technologies for medical device surfaces: photothermal ablation using gold nanorod coatings and electrical stimulation to disrupt biofilm formation. The presentation addresses the challenge of biofilm resistance to conventional antimicrobials and highlights novel approaches being evaluated at WEAC/FDA to enhance medical device safety. This is an informational scientific presentation covering regulated product areas including biologics, drugs, and medical devices.
“Biofilms are communities of microorganisms encased in extracellular polymeric substances that adhere to surfaces, such as medical devices, contributing to chronic infections.”
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What changed
The FDA Grand Rounds webinar presents research on two emerging anti-biofilm technologies being evaluated at the Winchester Engineering and Analytical Center: photothermal ablation using gold nanorod coatings and electrical stimulation for disrupting biofilm formation. Biofilms are described as communities of microorganisms encased in extracellular polymeric substances that adhere to medical device surfaces, contributing to chronic infections due to their resistance to conventional antimicrobials.
Manufacturers of medical devices, particularly those with surfaces prone to microbial colonization, should monitor FDA research in this area as these technologies may inform future regulatory expectations for device surface safety. The presentation represents FDA's ongoing scientific evaluation efforts rather than formal guidance or new regulatory requirements.
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Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Date: May 29, 2025 Time: 12:00 p.m.
- 1:00 p.m.
ET
Webcast Recording
Speaker
Jayaleka J. Amarasinghe, Ph.D.
Microbiologist
Winchester Engineering and Analytical Center (WEAC)
Office of Specialty Laboratories & Enforcement Support (OSLES)
Office of Chief Scientist (OCS)
Office of the Commissioner (OC)
About the Speaker
Dr. Jayaleka Amarasinghe is a microbiologist at the Winchester Engineering and Analytical Center (WEAC), within Office of Specialty Laboratories & Enforcement Support (OSLES), the Office of the Chief Scientist (OCS), in Winchester, Massachusetts. Since joining the FDA in 2014, she has led pioneering research on characterization of biofilms associated with medical device surfaces, driving efforts to develop innovative, antimicrobial-free strategies aimed at enhancing medical device safety. Dr. Amarasinghe earned her undergraduate degree in Biology from Bay Path University in Longmeadow, Massachusetts, and her Ph.D. in Oral Biology from the University at Buffalo, State University of New York. She also completed a postdoctoral fellowship in Infectious Diseases at the New York State Department of Health. Her work has been crucial in advancing novel approaches to anti-biofilm technologies for medical devices.
About the Presentation
Biofilms are communities of microorganisms encased in extracellular polymeric substances that adhere to surfaces, such as medical devices, contributing to chronic infections. Their resistance to conventional antimicrobials makes biofilms particularly difficult to eradicate, highlighting the urgent need for novel approaches. This presentation explores two innovative technologies evaluated at WEAC/FDA to address biofilms on medical device surfaces: photothermal ablation using gold nanorod coatings and electrical stimulation aimed at disrupting biofilm formation.
- ## Content current as of:
04/27/2026
Regulated Product(s)
- Biologics
- Drugs
- Medical Devices
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