The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Biofilms, Medical Devices and Anti-Biofilm Technology – Challenges and Opportunitiesâ€. FDA is co-sponsoring this workshop with the Center for Biofilm Engineering (CBE) of Montana State University.
The biochemical and physiochemical characteristics of biofilms have been studied in-vitro, but the role that biofilms play in the development of device-related and other Healthcare Associated Infections, and their connection with development of resistant infections has been less widely studied until recent years, where research is increasingly making great strides.
With the increasing use of implanted and indwelling devices, understanding biofilm development on these devices and factors that impact biofilm formation is critical for protecting/promoting public health. Research on the basic science of biofilms may provide insight on device-associated biofilms, ultimately advancing research on technologies that are intended to prevent biofilm formation.
This State of the Art public workshop seeks to share scientific information between the academic and healthcare communities, industry interested in developing products to address biofilm contamination, and US Government scientists.
Major topics to be covered at this workshop are:
1. Research on biofilms and their public health impact
2. Challenges faced by the scientific community, clinical community, government, and industry on addressing biofilm contamination of medical devices
3. Critical areas of research that will address the scientific and clinical challenges faced by the stakeholders when developing technologies that are intended to prevent biofilm formation.
This public workshop may also form the basis for future discussions related to novel biofilm prevention technologies that could benefit US public health.
- Date, Time and Location
- Federal Register Notice
- Agenda
- Registration
- Contact Us
FDA Campus Information
The workshop will also be available via webcast.
AGENDA (DRAFT)
Time
Subject
Name of Speaker
7:45 – 8:25 am
Registration and networking
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8:25 – 8:35 am
Welcome and opening remarks – FDA
Dr. Steve Pollack, Director, Office of Science Engineering Laboratories, CDRH-FDA
8:35 – 8:45 am
Welcome and opening remarks – CBE
Dr. Phil Stewart, Director, CBE, Montana State University
8:45 – 9:15 am
Keynote address
Dr. Javad Parvizi, Director, Clinical Research, Rothman Institute, Professor, Department of Orthopedic Surgery, Jefferson Medical College
9:15 – 9:45 am
Introduction to Biofilms and Medical Device Infections – HAIs and Public Health Impact
Dr. Rod Donlan, Director, CDC Biofilms Laboratory
9:45 – 10:15 am
Medical Device Biofilms from a Clinician’s Perspective
Dr. Todd Heniford, Chief, Division of Gastrointestinal and Minimally Invasive Surgery Carolina Med Center, University
10:15 – 10:30 am
BREAK
BREAK
10:30 – 11:00 am
Bacterial Interactions with Medical Device Materials
Dr. Matthew Libera, Director, Stevens Laboratory of Multiscale Imaging, Professor, Stevens Institute of Technology
11:00 – 11:30 pm
Biofilm Explant Analysis
Dr. Chuanwu Xi, Professor, University of Michigan, School of Public Health
11:30 – 12:00 am
In-vitro Biofilm Reactors and Device Test Models
Dr. Garth James, CBE Medical Projects Manager
12:00 – 12:20 pm
CDRH/ODE perspectives on adding antibiofilm technology/agents to devices
Ms. Angela Krueger, Policy Advisor, ODE-CDRH
12:20 – 12:30 pm
Wrap-up
LCDR Dr. K. Scott Phillips, Regulatory Research Scientist, FDA
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Morning presentations moderator
Dr. Geetha Jayan, CDRH/FDA
12:30 – 1:15 pm
NETWORKING LUNCH – ON SITE
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1:15 – 1:35 pm
Regulatory Challenges of Biofilm Models
Dr. Steve Tomasino, EPA, Office of Pesticide Programs
1:35 – 1:55 pm
Biofilm Preventing Medical Device Technologies
Dr. Dustin Williams, Curza
1:55 – 2:15 pm
Antimicrobial Industrial Compounds
Dr. John Chapman, Ashland Chemical
2:15 – 2:35 pm
Industrial biofilms and testing
Dr. Paul Sturman, CBE
2:35 – 2:45 pm
Wrap up of afternoon session
Dr. Mike Waters, CDRH/FDA
2:45 – 3:05 pm
BREAK
BREAK
3:05 – 4:45 pm
PANEL DISCUSSION – Anti-biofilm technology and medical devices
Panel discussion moderator – LCDR Dr. K. Scott Phillips, Regulatory Research Scientist, FDA
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Afternoon presentations moderator
Dr. Thelma Valdes, CDRH/FDA
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Registration to Attend the Workshop:
If you wish to attend this Workshop, you must register by close of business on February 14, 2014. There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
CBE Website: For lodging information please visit CBE’s website at: https://mtds.emeetingsonline.com/emeetings/websitev2.asp?mmnno=305pagename=SITE30335
If you require special accommodations due to a disability, or need additional information regarding registration, please contact: Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, [email protected].
[email protected] OR
Kenneth Scott Phillips, Division of Chemistry and Material Science – Office of Science and Engineering Laboratories, 10903 New Hampshire Avenue, Bldg. 66, 301-796-0238, [email protected]
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