Improving contact lens product testing and advocating universal lens-care guidelines will improve contact lens safety, according to key recommendations at last week's US Food and Drug Administration meeting in Washington.
A coalition of US ophthalmic organisations recommended the FDA work closely with industry to expand and strengthen contact lens solution and product testing to protect consumers.
In a statement from The American Academy of Ophthalmology, spokesman Elmer Tu, director of the cornea and external disease service at the University of Illinois, said: 'Now is the time to tighten the safety net around contact lens products. While improved testing and consumer awareness of lens-care guidelines may not prevent future outbreaks of eye infections, they will provide an important additional layer of safety for contact lens wearers.'
Contact lens solution testing should be updated to ensure products are effective against a more diverse and representative set of infectious organisms, including Acanthamoeba.
A standardised and validated testing protocol should be adopted to ensure all contact lens products are meeting the same demands.
CL solution testing should be more rigorous to include standardised real-world scenarios, such as effectiveness while in a CL case and when solution evaporates.
The FDA should re-examine equivalency testing to determine if new products are substantially similar to existing approved products, when a revised formula is submitted. Each product should be evaluated on its own.
With infections like Acanthamoeba keratitis and Fusarium keratitis not typically tracked by federal health authorities, the organisations recommended the FDA consider the feasibility of developing a mechanism to monitor contact lens infections and the frequency and distribution of the organisms causing the infections.
The associations outlined important steps consumers should take to safeguard against eye infections. Dr William Ehlers, a corneal specialist, added that CL wearers should be examined by an eye care provider annually and more often as needed. The statement added that ophthalmologists remain concerned about the practice of 'passive verification' of CL prescriptions.
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