The Food and Drug Administration (FDA) announced a public Workshop entitled: “Biofilms, Medical Devices and Anti-Biofilm Technology – Challenges and Opportunities”. FDA co-sponsored 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 sought 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 covered at this workshop were:
- Research on biofilms and their public health impact
- Challenges faced by the scientific community, clinical community, government, and industry on addressing biofilm contamination of medical devices
- 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.
This meeting was held February 20, 2014, beginning at 8:00 a.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
The workshop is also available via webcast.
|Time||Subject||Name of Speaker|
|7:45–8:25 am||Registration and networking|
|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. Rodney 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 University Med Center|
|10:30–11:00 am||Biofilm Explant Analysis||Dr. Chuanwu Xi, Professor, University of Michigan, School of Public Health|
|11:00–11:30 pm||Bacterial Interactions with Medical Device Materials||Dr. Matthew Libera, Director, Stevens Laboratory of Multiscale Imaging, Professor, Stevens Institute of Technology|
|11:30–12:00 am||In-vitro Biofilm Reactors: Relation to In-vivo and Clinical Outcomes||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–Product Jurisdiction Officer, CDRH/ODE|
|12:20–12:30 pm||Wrap-up||Dr. K. Scott Phillips, LCDR, USPHS, Regulatory Research Scientist, CDRH/OSEL|
|Morning presentations moderator||Dr. Geetha Jayan, Senior Science Health Advisor - CDRH/OCD|
|12:30 –1:15 pm||NETWORKING LUNCH–ON SITE|
|1:15–1:45 pm||EPA Development of a Biofilm Modelfor Pesticides||Dr. Stephen Tomasino, Senior Scientist, EPA Environmental Center, Microbiology Laboratory|
|1:45–2:05 pm||Anti-biofilm Technologies||Dr. Dustin Williams, Chief Scientific Officer, Curza|
|2:05–2:25 pm||Antimicrobial – Resistance||Dr. John Chapman, Scientist, Ashland Chemical|
|2:25–2:45 pm||Standard Methods for Testing Anti-Biofilm Technology: Progress and Future Directions||Dr. Paul Sturman, Industrial Coordinator & Research Professor, CBE|
|2:45–2:55 pm||Wrap up of afternoon session||Dr. Michael Waters, Reviewer, CDRH/OIR|
|Afternoon presentations moderator||Dr. Thelma Valdes, Biomedical Engineer, CDRH/ODE|
|3:15–4:45 pm||PANEL DISCUSSION–Anti-biofilm technology and medical devices||Panel discussion moderator: Dr. K. Scott Phillips (LCDR, USPHS); Dr. Dinesh Patwardhan: CDRH/OSEL|
For questions regarding workshop content please contact: Geetha Jayan, Center Science Council – Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-6300, Geetha.email@example.com 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, Kenneth.firstname.lastname@example.org