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REVAMPING MICROBIOLOGICAL TEST METHODS FOR CONTACT LENSES, PRODUCTS, AND ACCESSORIES TO PROTECT HEALTH AND ENSURE SAFETY

The Food and Drug Administration (FDA) Center for Devices and Radiological Health, the American Academy of Optometry (AAO), the American Academy of Ophthalmology (AAOph), the American Optometric Association (AOA), and the Contact Lens Association of Ophthalmologists (CLAO) are co-sponsoring this one-day workshop on Friday, September 12, 2014 at the FDA White Oak Campus in Silver Spring, MD. 

Loretta Szczotka-Flynn, OD, PhD, FAAO will represent AAO.  Joseph P. Shovlin, OD, FAAO, Michael R. DueƱas, O.D. and Jeffrey J. Walline, OD, PhD, FAAO will represent AOA. Deborah S. Jacobs, MD, and Deepinder K. Dhaliwal, MD, L. AC., will represent CLAO.  Bennie H. Jeng, MD, and Thomas (Tim) L. Steinemann, MD, will represent AAOph.

FDA Notice

FDA Notice


This workshop will not only cover the continuing rise in keratitis associated with Acanthamoeba but will also present information on other emerging pathogens in infectious keratitis.  We will also discuss the progress made in the development of Acanthamoeba test methodology.  The goal of the workshop is to establish uniform testing methods for Acanthamoeba disinfection efficacy, to consider emerging pathogens in the premarket testing of lens care products, and to discuss methods for conducting real-world simulated testing of contact lens care products.  The meeting will bring together scientists, clinicians, and industry experts to discuss critical aspects of disinfection efficacy testing.

Some of the topics planned for discussion are:

  • Regulation of Contact Lenses and associated Care Products;
  • Preclinical Test Methods for Contact Lenses and Care Products; 
  • History & Rationale for the Panel of Test Organisms for Contact Lens Care Products;
  • Causes of  Contact Lens-Related Infectious Keratitis in the US:
  • Historical Trends and Emerging Pathogens;
  • International Patterns of Contact Lens-Related Infectious Keratitis;
  • The Potential Impact of Environmental Changes on Clinical Acanthamoeba Keratitis;
  • Definition of Organic Soil and the Relevant Components of an Artificial Tear Model;
  • Measuring the Efficacy of Organic Soil Removal;
  • Incorporating Organic Soil in the Preclinical Testing of Contact Lenses and their Products: 
  • Historical Perspective and Current Methods;
  • Acanthamoeba Keratitis: Biology of the Organism and Host Factors; and
  • Disinfection Efficacy: Test Methods for Acanthamoeba.

Share your thoughts with our workshop panelists and other attendees in advance of the meeting on our workshop blog page where you can review the panel questions and provide comments.

FDA Research Lab

FDA Research Lab