Microbiological Testing for Contact Lens Care Products

1
Microbiological Testingfor Contact Lens Care
Products

• Malvina B. Eydelman, M.D.
• Director
• DOED/ODE/CDRH/FDA

2
LOGISTICS

• Floor Map
• Escorts
• Liquids
• Refreshments / Lunch

3
Contact Lens Safety

• 34 million contact lens wearers in U.S.
  significant public health impact
• FDA Guidance for CLs and CL Care Products
• FDA Website
• Standards
• Recent Outbreaks
• 2006 Fusarium keratitis
• 2007 Acanthamoeba keratitis

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FDAs Response

• 6/10/08 Ophthalmic Devices Panel Meeting
• CL Website Update http//www.fda.gov/cdrh/contactl
  enses/index.html
• Developing standardized method for Acanthamoeba
  with standards organizations
• Recommending only rub directions for use in
  labeling
• Revising Guidance Documents

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Workshop on Microbiological Testing for Contact
Lens Care Products

• Need for an expeditious discussion on
  Acanthamoeba and other microbiological test
  methods that will emulate the real world of CLs
• All inclusive Government (FDA, CDC), Ophthalmic
  and Optometric Professional Organizations,
  Industry, Academia
• Our co-sponsors
• American Academy of Ophthalmology
• American Academy of Optometry
• American Optometric Association
• Contact Lens Association of Ophthalmologists
• Desired Outcomes
• Brings us closer to standardized methodology
• Enhances further collaborations within the
  eye-care community