Medical Devices
FDA/AAO/AAO/AOA/CLAO Workshop: Microbiological Testing for Contact Lens Care Products, January 22-23, 2009
Meeting Materials
- Meeting Summary
- Attendee Roster
- Breakout Group Participants
- Breakout Discussion Notes
- Discussion Questions
- Overall Review From Breakout Discussion
- Workshop Evaluation Summary
- Closing Comments
- Co-Sponsors
- FDA (PowerPoint)
- Presentations
Date, Time and Location
The meeting was held on January 22 - 23, 2009 from 8:00 a.m. to 5:00 p.m. at the following location:
Food and Drug Administration
Building 2
10903 New Hampshire Ave.
Silver Spring , MD 20993
Agenda & Presentations
All presentations are in PowerPoint format unless otherwise noted. For FDA and CDC materials, captions and alternative text are available in the speaker notes.
| Date/Time | Agenda |
|---|---|
| January 22, 2009 8:00 – 8:15 |
Welcome Malvina Eydelman, MD, FDA Jonathan Sackner-Bernstein, MD, FDA |
| 8:15 – 8:30 |
DISINFECTION EFFICACY TESTING - Acanthamoeba Disinfection efficacy testing and Acanthamoeba-FDA perspective |
| 8:30 – 9:10 | Acanthamoeba keratitis update Jonathan Yoder, MD, CDC Charlotte Joslin, OD |
| 9:10 – 9:30 | Biology and Immunology of Acanthamoeba keratitis Jerry Y. Niederkorn, PhD, University of Texas Southwestern Medical Center |
| 9:30 – 10:10 | Test Methods to Evaluate Efficacy against Acanthamoeba (10 min presentation + 10 min Q&A) Simon Kilvington, PhD, Advanced Medical Optics Megan Shoff, MS, Ohio State University |
| 10:10 – 10:20 | BREAK |
| 10:20 – 11:40 | Test Methods cont'd Claude Anger, MS Govinda Visvesvara, PhD, CDC Hassan Alizadeh, PhD, University of Texas Southwestern Medical Center Masaki Imayasu, PhD, Menicon |
| 11:40 – 12:00 | Instructions for Breakout Groups James Saviola, OD; Capt USPHS; FDA; Facilitator |
| 12:00 – 1:00 | LUNCH |
| 1:00 – 2:30 | Breakout Groups Discuss Questions |
| 2:30– 3:00 | BREAK |
| 3:00 – 4:30 | Breakout Group Discussion Continues |
| 4:30 | Breakout Group Discussion Ends - ADJOURNMENT |
| January 23, 2009 8:00 – 10:00 |
Facilitated Discussion of Breakout Groups’ Recommendations James Saviola, OD; Capt USPHS; FDA; Facilitator |
| 10:00 – 10:15 | BREAK |
| 10:15 – 10:30 |
“REAL WORLD” DISINFECTION EFFICACY TESTING FDA guidance on disinfection efficacy testing – history and background |
| 10:30 – 12:00 | Disinfection Efficacy Methodology Presentations (20 min presentation + 10 min Q&A) Mary Mowrey McKee, PhD, CIBA Vision Mahmoud Ghannoum, PhD, Case Western Reserve University Mark Willcox, PhD, Vision Cooperative Research Centre |
| 12:00 – 1:00 | LUNCH |
| 1:00 – 3:00 | Disinfection Efficacy Methodology Presentations, cont’d Roya Borazjani, PhD, Alcon Simon Kilvington, PhD, AMO Donald Ahearn, PhD, Georgia State University (PDF) Sue Norton, MS, Bausch & Lomb |
| 3:00 – 3:15 | BREAK |
| 3:15 – 4:15 | Disinfection Efficacy Methodology Presentations, cont’d Ralph Stone, Ph.D Charles Clavet, MS, FDA |
| 4:15 – 5:00 |
Closing Remarks FDA American Academy of Ophthalmology American Academy of Optometry Contact Lens Association of Ophthalmologists |
| 5:00 | ADJOURNMENT |
Contacts
The workshop organizers may be contacted at:
Daryl L. Kaufman, M.A.
Center for Devices and Radiological Health
U.S. Food and Drug Administration
9200 Corporate Blvd (HFZ-460)
Rockville, Maryland 20850
240-276-4200
FAX: 240-276-4234,
e-mail: Daryl.Kaufman@fda.hhs.gov
Marc W. Robboy, OD
Center for Devices and Radiological Health
U.S. Food and Drug Administration
9200 Corporate Blvd (HFZ-460)
Rockville, Maryland 20850
240-276-4232
FAX: 240-276-4111,
e-mail: Marc.Robboy@fda.hhs.gov