Medical Devices

Public Workshop – Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety, September 12, 2014.

The Food and Drug Administration (FDA), American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Optometric Association (AOA), and Contact Lens Association of Ophthalmologists, Inc. (CLAO) are co-sponsoring the following workshop entitled “Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety.” The purpose of this workshop is to discuss adequate testing of contact lens care products for disinfection efficacy against emerging pathogens as well as common infectious etiologies.


Date, Time and Location:

This meeting will be held September 12, 2014, beginning at 8:00 am – 5:00 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

FDA Campus Information


Webcast

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Agenda

8:00am-8:05am Welcome & Goals – Food and Drug Administration (FDA) Malvina Eydelman, MD
8:05am-8:10am Welcome – American Academy of Ophthalmology (AAO) Thomas Steinemann, MD
8:10am-8:15am Welcome – American Academy of Optometry (AAOpt) Loretta Szczotka-Flynn, OD
8:15am-8:20am Welcome – American Optometric Association (AOA) Joseph Shovlin, OD
8:20am-8:25am Welcome – Contact Lens Association of Ophthalmologists (CLAO) Deborah Jacobs, MD
8:25am-8:35am Regulation of Contact Lenses and Associated Care Products Denise Hampton, PhD (FDA)
8:35am-8:45am Preclinical Test Methods for Contact Lenses and their Care Products Jeffrey Brocious, MS (FDA)
8:45am-8:55am History & Rationale for the Panel of Test Organisms for Contact Lens Care Products Ralph Stone, PhD

Panel 1: Emerging Pathogens in Contact Lens-Related Keratitis

Moderator Loretta Szczotka-Flynn, OD (AAO)
PANELISTS Suzi Fleiszig, OD, PhD, Michelle Callegan, PhD, Michael Gilmore, PhD, Mark Willcox, PhD, Eduardo Alfonso, MD, Jennifer Cope, MD, MPH (CDC), Jonathan Yoder, PhD (CDC), Elmer Tu, MD, John Dart, MD
8:55am-9:10am Causes of Contact Lens-Related Infectious Keratitis in the U.S.: Historical Trends and Emerging Pathogens Jonathan Yoder, PhD (CDC)
9:10am-9:25am International Patterns of Contact Lens- Related Infectious Keratitis John Dart, MD
9:25am-9:40am Impact of Changing Water Restrictions on Contact Lens-Related Infectious Keratitis Elmer Tu, MD
9:40am-10:40am Panel Discussion Question #1
10:40am-10:55am Break

Panel 2: Role of Soil in Disinfection Efficacy Testing

Moderator Michael Duenas, OD (AOA)
PANELISTS Carol Lakkis, PhD, Suzi Fleiszig, OD, PhD, Michelle Callegan, PhD, Michael Gilmore, PhD, Mark Willcox, PhD, Ralph Stone, PhD
10:55am-11:10am 
  
Definition of Organic Soil and the Relevant Components of an Artificial Tear Model  Mark Willcox, PhD
11:10am-11:25am Incorporating Soil in the Preclinical Testing of Contact Lenses and their Products: Historical Perspective & Current Methods Scott Steffen, PhD (FDA)
11:25am-11:40am Measuring the Efficacy of Organic Soil Removal Joseph Hutter, PhD (FDA)
11:40am-12:40pm Panel Discussion Question #2
12:40pm-1:40pm LUNCH

Panel 3: Acanthamoeba:  The Organism and Test Methods

Moderator Deepinder Dhaliwal, MD (CLAO)
PANELISTS Donald Ahearn, PhD, Simon Kilvington, PhD, Elmer Tu, MD, Ralph Stone, PhD, Mary Mowrey-McKee, PhD
1:40pm-1:55pm Acanthamoeba Keratitis: Biology of the Organism and Host Factors Donald Ahearn, PhD
1:55pm-2:10pm Disinfection Efficacy Test Methods for Acanthamoeba Daniel Fedorko, PhD (FDA)
2:10pm-2:25pm Disinfection Efficacy Test Methods for Acanthamoeba Simon Kilvington, PhD
2:25pm-4:25pm Panel Discussion Questions #3-5
4:25pm-5:00pm Closing Remarks
CLAO Deepinder Dhaliwal, MD
AOA Joseph Shovlin, OD
AAOp Loretta Szczotka-Flynn, OD
AAO Thomas Steinemann, MD
FDA Malvina Eydelman, MD
5:00pm ADJOURN

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Registration to Attend the Workshop:

To register for the public workshop, please visit http://www.clwkshop.org. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. If there are any questions with registration, please contact Ms. Cindy Groff at cgroff@convergence-us.com. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.

Registration is $250 for members of the American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Optometric Association(AOA), or Contact Lens Association of Ophthalmologists, Inc. (CLAO); or $400 for non-members and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online. The deadline for online registration is September 5, 2014 at 4:00 PM EDT. There will be no onsite registration on the day of the public workshop.

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, susan.monahan@fda.hhs.gov.

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Contact Us

For questions regarding workshop content please contact:

Jeffrey Brocious, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Phone: 240-402-3797, email: Jeffrey.Brocious@fda.hhs.gov.

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Page Last Updated: 10/02/2014
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