Contact lens care guides scrutinized by FDA panel
Plans to revisit aging federal guidance documents regarding proper contact lens use are underway with the AOA poised to provide expert insight into current care practices.
Members of the U.S. Food and Drug Administration's (FDA's) Ophthalmic Devices Panel of the Medical Devices Advisory Committee convened May 13 to discuss revising two FDA premarket guides—a 1994 guidance document on daily wear contact lenses, and a 1997 guidance document for contact lens care products—to reflect new evidence and knowledge collected in the decade because that will ensure safe, effective consumer products.
As we improve products for our patients, we need to continually assess the guidelines to make sure that our patients are safe.
The deliberations on guideline alterations stem from two nationwide keratitis outbreaks in 2006 and 2007 that led to numerous infections and the voluntary recall of separate multipurpose contact lens solutions. That, in part, initiated a joint FDA/Centers for Disease Control and Prevention (CDC) investigation into certain silicone hydrogel lens-solution incompatibilities.
Presentations from both the CDC and FDA to the device panel acknowledged their work with the AOA, and recommended updates to the existing guidance documents. Both agencies also referenced AOA efforts to halt illegal sales of decorative contact lenses to which panel members encouraged more work.
Although no immediate action was taken, the FDA did request comment from the panel regarding lens care and premarket considerations. Optometry is represented in a non-voting role on the panel alongside other medical specialists and scholars.
Among areas of discussion, the panel deliberated on patient non-compliance with regard to the extended use of care solutions, and whether tap water could be used to wash lenses before reinserting them into the eyes, especially in the case of rigid gas-permeable (RGP) lenses.
As the FDA continues its work to revise these guidelines, the AOA is present and working with the Contact Lens and Cornea Section (CLCS), the AOA's experts on contact lens care and usage, to develop recommendations.
"The Contact Lens and Cornea Section of the AOA continues to make sure that these guidelines are practical and effective in order to maintain the high standards necessary for healthy contact lens wear," says Jeffrey Walline, O.D., Ph.D., CLCS vice chair.
Meeting of the minds
AOA members have been actively involved in this ongoing federal review of contact lenses and care products from the beginning, and will continue to lend their proficiency in the field as part of the next iteration of an AOA co-sponsored ophthalmic workshop later this fall.
In January 2009, the AOA partnered with the FDA and other ophthalmic leaders for the "Microbiological Testing for Contact Lens Care Products" workshop at the FDA headquarters, where members deliberated on improved test methods for stemming Acanthamoeba infections.
That legacy will carry over with the next workshop, titled: "Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety." The workshop will address public health questions regarding lens safety with an aim of moving toward a resolution and new lens regulations.
"The field of contact lenses continually advances," Dr. Walline says. "As we improve products for our patients, we need to continually assess the guidelines to make sure that our patients are safe and the products are effective."
The meeting is co-sponsored by the AOA, together with the American Academy of Optometry, American Academy of Ophthalmology and Contact Lens Association of Ophthalmologists, and will take place Sept. 12 at the FDA headquarters. The workshop will become available via a webinar.
For a behind-the-scenes look at AOA members' work with federal entities, read the June issue of AOA Focus.